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Start Preamble Centers for Medicare & order cialis. Medicaid Services (CMS), HHS. Extension of timeline for publication of final rule. This notice announces an extension of the timeline for publication of a Medicare final rule order cialis in accordance with the Social Security Act, which allows us to extend the timeline for publication of the final rule.

As of August 26, 2020, the timeline for publication of the final rule to finalize the provisions of the October 17, 2019 proposed rule (84 FR 55766) is extended until August 31, 2021. Start Further Info Lisa O. Wilson, (410) order cialis 786-8852. End Further Info End Preamble Start Supplemental Information In the October 17, 2019 Federal Register (84 FR 55766), we published a proposed rule that addressed undue regulatory impact and burden of the physician self-referral law.

The proposed rule was issued in conjunction with the Centers for Medicare &. Medicaid Services' (CMS) Patients over Paperwork initiative and the Department of Health and Human Services' (the Department or HHS) Regulatory Sprint order cialis to Coordinated Care. In the proposed rule, we proposed exceptions to the physician self-referral law for certain value-based compensation arrangements between or among physicians, providers, and suppliers. A new exception for certain arrangements under which a physician receives limited remuneration for items or services actually provided by the physician.

A new order cialis exception for donations of cybersecurity technology and related services. And amendments to the existing exception for electronic health records (EHR) items and services. The proposed rule also provides critically necessary guidance for physicians and health care providers and suppliers whose financial relationships are governed by the physician self-referral statute and regulations. This notice announces an extension of the order cialis timeline for publication of the final rule and the continuation of effectiveness of the proposed rule.

Section 1871(a)(3)(A) of the Social Security Act (the Act) requires us to establish and publish a regular timeline for the publication of final regulations based on the previous publication of a proposed regulation. In accordance with section 1871(a)(3)(B) of the Act, the timeline may vary among different regulations based on differences in the complexity of the regulation, the number and scope of comments received, and other relevant factors, but may not be longer than 3 years except under exceptional circumstances. In addition, in accordance with section 1871(a)(3)(B) of the Act, the Secretary may extend the initial targeted publication date of the final regulation if the Secretary, no later than the regulation's previously established proposed publication date, publishes a notice with the new target date, and such notice includes a brief explanation of the justification order cialis for the variation. We announced in the Spring 2020 Unified Agenda (June 30, 2020, www.reginfo.gov) that we would issue the final rule in August 2020.

However, we are still working through the Start Printed Page 52941complexity of the issues raised by comments received on the proposed rule and therefore we are not able to meet the announced publication target date. This notice extends the timeline for publication of the final rule until August 31, order cialis 2021. Start Signature Dated. August 24, 2020.

Wilma M. Robinson, Deputy Executive Secretary to the Department, Department of Health and Human order cialis Services. End Signature End Supplemental Information [FR Doc. 2020-18867 Filed 8-26-20.

8:45 am]BILLING order cialis CODE 4120-01-PToday, the U.S. Department of Health and Human Services (HHS), through the Health Resources and Services Administration (HRSA), announced over $117 million in quality improvement awards to 1,318 health centers across all U.S. States, territories and the District of Columbia. HRSA-funded health centers will use these funds to further strengthen quality improvement activities and expand quality primary health care service delivery.“These quality improvement awards support health centers across the country in delivering care to nearly 30 million people, providing a convenient source of quality care that has grown even more important during order cialis the erectile dysfunction treatment cialis,” said HHS Secretary Alex Azar.

€œThese awards help ensure that all patients who visit a HRSA-funded health center continue to receive the highest quality of care, including access to erectile dysfunction treatment testing and treatment.”Health centers deliver comprehensive care to people who are low-income, uninsured or face other obstacles to getting health care. On top of the safety-net that they provide, health centers have been on the front lines preventing and responding to the erectile dysfunction treatment public health emergency, including providing over 3 million erectile dysfunction treatment tests. Health centers continue to provide essential services for our nation’s most vulnerable and medically underserved populations, including those who often do not have access to care, before, during and after the order cialis erectile dysfunction treatment cialis.HRSA’s quality improvement awards recognize the highest performing health centers nationwide as well as those health centers that have made significant quality improvements from the previous year.Health centers are recognized for achievements in various areas. Improving cost-efficient care delivery.

Increasing quality of care. Reducing health order cialis disparities. Increasing both the number of patients served. Increasing patients’ ability to access comprehensive services.

Advancing the use of health information order cialis technology. And Achieving patient-centered medical home recognition.“Nearly all HRSA-funded health centers have demonstrated improvement in their clinical quality measures reflecting HRSA’s strong commitment to providing high value health care,” said HRSA Administrator Tom Engels. €œHealth centers serve approximately 1 in 11 people nationally. These awards will support health centers as they continue to be a primary medical order cialis home for communities around the country.

Today, nearly 1,400 health centers operate nearly 13,000 service delivery sites nationwide.”For a list of today’s award recipients, visit. Https://bphc.hrsa.gov/programopportunities/fundingopportunities/qualityimprovement/index.html To locate a HRSA-funded health center, visit. Https://findahealthcenter.hrsa.gov/..

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WASHINGTON, DC – Today, U.S generic cialis prices http://www.securityresources.com/lasix-uk-buy/. Secretary of Labor Eugene Scalia traveled to Johnstown, Pennsylvania, where he joined Congressman John Joyce, M.D. (PA-13) and generic cialis prices Congressman Glenn “G.T.” Thompson (PA-15) to highlight workforce development through apprenticeships.

Secretary Scalia and the congressmen toured JWF Industries and met with company leadership and apprentices.“I am always encouraged to see businesses using apprenticeships to equip workers with skills that lead to good paying jobs,” said U.S. Secretary of Labor Eugene Scalia. €œApprenticeships play a key role generic cialis prices in getting Americans back to work.

The President’s actions to expand these programs, along with pro-business policies such as tax cuts, deregulation, and fair and reciprocal trade agreements will bolster our economic recovery. I would like to thank Congressmen Joyce and Thompson for joining me today and being valuable partners in rebuilding Pennsylvania’s economy.” “It was a pleasure to welcome Secretary Scalia to JWF Industries today to showcase a true manufacturing powerhouse right here in Johnstown," said Congressman Glenn “G.T.” Thompson. "Workforce development is critically important to the resiliency of our community, our economy, and our national supply chain, and I'm grateful for the role that JWF Industries plays in creating job opportunities in our region.” “It was an honor to welcome Secretary Scalia to Johnstown to witness firsthand the incredible drive and commitment generic cialis prices of our workforce.

JWF Industries is a shining example of America’s manufacturing excellence,” said Congressman John Joyce, M.D. €œThe JWF team is part of the long tradition of dedicated Pennsylvanians who have built our nation and forged our defenses. By investing in workers and creating generic cialis prices defense jobs in Johnstown, JWF is producing benefits for our community, our economy, and for our nation.

As he visits Pennsylvania, I thank Secretary Scalia for his partnership and commitment to create American jobs for American workers.” The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States. Improve working conditions. Advance opportunities for profitable employment generic cialis prices.

And assure work-related benefits and rights.Heads Up - Changes Coming April 2021 Once again, NYS is changing the way people without Medicare access prescription drugs. Since October 2011, most people who do not have Medicare obtained their drugs throug their Medicaid managed care plan. At that time, this drug benefit generic cialis prices was "carved into" the Medicaid managed care benefit package.

Before that date, people enrolled in a Medicaid managed care plan obtained all of their health care through the plan, but used their regular Medicaid card to access any drug available on the state formulary on a "fee for service" basis without needing to utilize a restricted pharmacy network or comply with managed care plan rules. COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans. That means that members of managed care plans will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers generic cialis prices.

How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under Medicaid managed generic cialis prices care.

Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have drug generic cialis prices formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs.

The Pharmacy Benefit will vary by plan. Each plan will have its own formulary and drug coverage policies like generic cialis prices prior authorization and step therapy. Pharmacy networks can also differ from plan to plan.

Prescriber Prevails applies in certain drug classes. Prescriber prevails applys to medically necessary precription drugs generic cialis prices in the following classes. atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics.

Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- This website provides very helpful information on a plan by plan basis generic cialis prices regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future.

Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care. The form will be posted on the Pharmacy Information Website generic cialis prices in July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price.

CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?. Changing plans is often an effective strategy for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part generic cialis prices D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care.

Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan generic cialis prices for the rest of the year. Consumers can switch plans during the “lock in” period only for good cause.

The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, Medicaid managed care enrollees can switch plans at any time generic cialis prices. STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements.

If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal generic cialis prices and external review process for complaints and appeals of service denials. Some plans may develop special procedures for drug denials.

Information on these procedures generic cialis prices should be provided in member handbooks. Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD.

See model Denial FAD Notice and FAD Notice to Reduce, Suspend or generic cialis prices Stop Services. The enroll has the right to request a fair hearing to appeal an FAD. The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals.

The plan may extend the time to decide both standard and expedited appeals by generic cialis prices up to 14 days if more information is needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing. The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time.

See more about the changes in Managed generic cialis prices Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care. Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications.

Consumers who experience problems with access to prescription drugs should always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below generic cialis prices. ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization.

These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's generic cialis prices preferred drug list. The full Medicaid formulary can be searched on the eMedNY website. Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated.

Prior authorization is required for original generic cialis prices prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months. Click here for more information on NY's prior authorization process.

The New York State Board of Pharmacy publishes an annual list of the 150 most frequently generic cialis prices prescribed drugs, in the most common quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs.

Click here to view New York State Medicaid’s generic cialis prices Pharmacy Provider Manual. WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline. 1-888-614-5400 NY State Department of Health's Managed Care generic cialis prices Hotline.

1-800-206-8125 (Mon. - Fri. 8:30 am - generic cialis prices 4:30 pm) NY State Department of Insurance.

1-800-400-8882 NY State Attorney General's Health Care Bureau. 1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump administration has taken steps to end TPS generic cialis prices status.

Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links to status in generic cialis prices all countries, including HAITI.

See also Pew Research March 2019 article. Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public generic cialis prices charge rules here.

What is Temporary Protected Status?. TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely. On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake that occurred there on January generic cialis prices 12.

TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation and allows them to work legally. It is generic cialis prices important to note that the U.S.

Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs. In New York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program generic cialis prices.

Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status. For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public health generic cialis prices insurance.

Individuals will need to bring. 1) Proof generic cialis prices of identity. 2) Proof of residence in New York.

3) Proof of income. 4) generic cialis prices Proof of application for TPS. 5) Proof that U.S.

Citizenship and Immigration Services (USCIS) has received the application for TPS. Free Communication Assistance All applicants for public health insurance, generic cialis prices including Haitian Creole speakers, have a right to get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English.

A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office. Important documents, such as Medicaid applications, should be translated either orally or in writing generic cialis prices. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants.

An applicant must never be asked to bring their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti generic cialis prices and the designation of Haiti for Temporary Protected Status. A copy of the list is posted at the NYIC’s website at http://www.thenyic.org.

o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP.

CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m. To 8:00 p.m.Saturday-Sunday, from 9:00 a.m.

To 5:00 p.m. Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society.

1/29/10, updated 3/1/10, updated 8/15/19 by NY Legal Assistance Group.

WASHINGTON, DC order cialis – Today, U.S. Secretary of Labor Eugene Scalia traveled to Johnstown, Pennsylvania, where he joined Congressman John Joyce, M.D. (PA-13) and order cialis Congressman Glenn “G.T.” Thompson (PA-15) to highlight workforce development through apprenticeships. Secretary Scalia and the congressmen toured JWF Industries and met with company leadership and apprentices.“I am always encouraged to see businesses using apprenticeships to equip workers with skills that lead to good paying jobs,” said U.S.

Secretary of Labor Eugene Scalia. €œApprenticeships play a key role in getting Americans order cialis back to work. The President’s actions to expand these programs, along with pro-business policies such as tax cuts, deregulation, and fair and reciprocal trade agreements will bolster our economic recovery. I would like to thank Congressmen Joyce and Thompson for joining me today and being valuable partners in rebuilding Pennsylvania’s economy.” “It was a pleasure to welcome Secretary Scalia to JWF Industries today to showcase a true manufacturing powerhouse right here in Johnstown," said Congressman Glenn “G.T.” Thompson.

"Workforce development is critically important to the resiliency of our community, our economy, and our national supply chain, and I'm grateful for the role that order cialis JWF Industries plays in creating job opportunities in our region.” “It was an honor to welcome Secretary Scalia to Johnstown to witness firsthand the incredible drive and commitment of our workforce. JWF Industries is a shining example of America’s manufacturing excellence,” said Congressman John Joyce, M.D. €œThe JWF team is part of the long tradition of dedicated Pennsylvanians who have built our nation and forged our defenses. By investing in workers and creating defense jobs in Johnstown, order cialis JWF is producing benefits for our community, our economy, and for our nation.

As he visits Pennsylvania, I thank Secretary Scalia for his partnership and commitment to create American jobs for American workers.” The mission of the Department of Labor is to foster, promote, and develop the welfare of the wage earners, job seekers, and retirees of the United States. Improve working conditions. Advance opportunities order cialis for profitable employment. And assure work-related benefits and rights.Heads Up - Changes Coming April 2021 Once again, NYS is changing the way people without Medicare access prescription drugs.

Since October 2011, most people who do not have Medicare obtained their drugs throug their Medicaid managed care plan. At that order cialis time, this drug benefit was "carved into" the Medicaid managed care benefit package. Before that date, people enrolled in a Medicaid managed care plan obtained all of their health care through the plan, but used their regular Medicaid card to access any drug available on the state formulary on a "fee for service" basis without needing to utilize a restricted pharmacy network or comply with managed care plan rules. COMING IN April 2021 - In the NYS Budget enacted in April 2020, the pharmacy benefit was "carved out" of "mainstream" Medicaid managed care plans.

That means that members of managed care plans will access their drugs outside their plan, unlike the rest of their medical care, which is accessed from in-network providers order cialis. How Prescription Drugs are Obtained through Managed Care plans No - Until April 2020 HOW DO MANAGED CARE PLANS DEFINE THE PHARMACY BENEFIT FOR CONSUMERS?. The Medicaid pharmacy benefit includes all FDA approved prescription drugs, as well as some over-the-counter drugs and medical supplies. Under order cialis Medicaid managed care.

Plan formularies will be comparable to but not the same as the Medicaid formulary. Managed care plans are required to have order cialis drug formularies that are “comparable” to the Medicaid fee for service formulary. Plan formularies do not have to include all drugs covered listed on the fee for service formulary, but they must include generic or therapeutic equivalents of all Medicaid covered drugs. The Pharmacy Benefit will vary by plan.

Each plan will have its own formulary and drug coverage policies like prior authorization and step therapy order cialis. Pharmacy networks can also differ from plan to plan. Prescriber Prevails applies in certain drug classes. Prescriber prevails order cialis applys to medically necessary precription drugs in the following classes.

atypical antipsychotics, anti-depressants, anti-retrovirals, anti-rejection, seizure, epilepsy, endocrine, hemotologic and immunologic therapeutics. Prescribers will need to demonstrate reasonable profession judgment and supply plans witht requested information and/or clinical documentation. Pharmacy Benefit Information Website -- http://mmcdruginformation.nysdoh.suny.edu/-- order cialis This website provides very helpful information on a plan by plan basis regarding pharmacy networks and drug formularies. The Department of Health plans to build capacity for interactive searches allowing for comparison of coverage across plans in the near future.

Standardized Prior Autorization (PA) Form -- The Department of Health worked with managed care plans, provider organizations and other state agencies to develop a standard prior authorization form for the pharmacy benefit in Medicaid managed care. The form will be posted on the Pharmacy Information Website in order cialis July of 2013. Mail Order Drugs -- Medicaid managed care members can obtain mail order/specialty drugs at any retail network pharmacy, as long as that retail network pharmacy agrees to a price that is comparable to the mail order/specialty pharmacy price. CAN CONSUMERS SWITCH PLANS IN ORDER TO GAIN ACCESS TO DRUGS?.

Changing plans is often an effective strategy order cialis for consumers eligible for both Medicaid and Medicare (dual eligibles) who receive their pharmacy service through Medicare Part D, because dual eligibles are allowed to switch plans at any time. Medicaid consumers will have this option only in the limited circumstances during the first year of enrollment in managed care. Medicaid managed care enrollees can only leave and join another plan within the first 90 days of joining a health plan. After the 90 days has expired, enrollees are “locked in” to the plan for the rest of the order cialis year.

Consumers can switch plans during the “lock in” period only for good cause. The pharmacy benefit changes are not considered good cause. After the first 12 months of enrollment, order cialis Medicaid managed care enrollees can switch plans at any time. STEPS CONSUMERS CAN TAKE WHEN A MANAGED CARE PLAM DENIES ACCESS TO A NECESSARY DRUG As a first step, consumers should try to work with their providers to satisfy plan requirements for prior authorization or step therapy or any other utilization control requirements.

If the plan still denies access, consumers can pursue review processes specific to managed care while at the same time pursuing a fair hearing. All plans are required to maintain an internal and external review process order cialis for complaints and appeals of service denials. Some plans may develop special procedures for drug denials. Information on these procedures should be provided in order cialis member handbooks.

Beginning April 1, 2018, Medicaid managed care enrollees whose plan denies prior approval of a prescription drug, or discontinues a drug that had been approved, will receive an Initial Adverse Determination notice from the plan - See Model Denial IAD Notice and IAD Notice to Reduce, Suspend or Stop Services The enrollee must first request an internal Plan Appeal and wait for the Plan's decision. An adverse decision is called a 'FInal Adverse Determination" or FAD. See model Denial FAD Notice and FAD Notice to Reduce, order cialis Suspend or Stop Services. The enroll has the right to request a fair hearing to appeal an FAD.

The enrollee may only request a fair hearing BEFORE receiving the FAD if the plan fails to send the FAD in the required time limit, which is 30 calendar days in standard appeals, and 72 hours in expedited appeals. The plan may extend the time to decide both standard and expedited appeals by up to 14 days if more information is order cialis needed and it is in the enrollee's interest. AID CONTINUING -- If an enrollee requests a Plan Appeal and then a fair hearing because access to a drug has been reduced or terminated, the enrollee has the right to aid continuing (continued access to the drug in question) while waiting for the Plan Appeal and then the fair hearing. The enrollee must request the Plan Appeal and then the Fair Hearing before the effective date of the IAD and FAD notices, which is a very short time - only 10 days including mailing time.

See more about order cialis the changes in Managed Care appeals here. Even though that article is focused on Managed Long Term Care, the new appeals requirements also apply to Mainstream Medicaid managed care. Enrollees who are in the first 90 days of enrollment, or past the first 12 months of enrollment also have the option of switching plans to improve access to their medications. Consumers who experience problems with access to prescription drugs should order cialis always file a complaint with the State Department of Health’s Managed Care Hotline, number listed below.

ACCESSING MEDICAID'S PHARMACY BENEFIT IN FEE FOR SERVICE MEDICAID For those Medicaid recipients who are not yet in a Medicaid Managed Care program, and who do not have Medicare Part D, the Medicaid Pharmacy program covers most of their prescription drugs and select non-prescription drugs and medical supplies for Family Health Plus enrollees. Certain drugs/drug categories require the prescribers to obtain prior authorization. These include brand name drugs that have a generic alternative under New York's mandatory generic drug program or prescribed drugs that are not on New York's order cialis preferred drug list. The full Medicaid formulary can be searched on the eMedNY website.

Even in fee for service Medicaid, prescribers must obtain prior authorization before prescribing non-preferred drugs unless otherwise indicated. Prior authorization order cialis is required for original prescriptions, not refills. A prior authorization is effective for the original dispensing and up to five refills of that prescription within the next six months. Click here for more information on NY's prior authorization process.

The New York State Board of Pharmacy publishes an annual list of the 150 most frequently prescribed drugs, in the most common order cialis quantities. The State Department of Health collects retail price information on these drugs from pharmacies that participate in the Medicaid program. Click here to search for a specific drug from the most frequently prescribed drug list and this site can also provide you with the locations of pharmacies that provide this drug as well as their costs. Click here to view New York State Medicaid’s Pharmacy Provider order cialis Manual.

WHO YOU CAN CALL FOR HELP Community Health Advocates Hotline. 1-888-614-5400 NY order cialis State Department of Health's Managed Care Hotline. 1-800-206-8125 (Mon. - Fri.

8:30 am order cialis - 4:30 pm) NY State Department of Insurance. 1-800-400-8882 NY State Attorney General's Health Care Bureau. 1-800-771-7755Haitian individuals and immigrants from some other countries who have applied for Temporary Protected Status (TPS) may be eligible for public health insurance in New York State. 2019 updates - The Trump administration has taken steps order cialis to end TPS status.

Two courts have temporarily enjoined the termination of TPS, one in New York State in April 2019 and one in California in October 2018. The California case was argued in an appeals court on August 14, 2019, which the LA Times reported looked likely to uphold the federal action ending TPS. See US Immigration Website on TPS - General TPS website with links to status in all order cialis countries, including HAITI. See also Pew Research March 2019 article.

Courts Block Changes in Public charge rule- See updates on the Public Charge rule here, blocked by federal court injunctions in October 2019. Read more about this change in public charge rules here order cialis. What is Temporary Protected Status?. TPS is a temporary immigration status granted to eligible individuals of a certain country designated by the Department of Homeland Security because serious temporary conditions in that country, such as armed conflict or environmental disaster, prevents people from that country to return safely.

On January 21, 2010 the United States determined that individuals from Haiti warranted TPS because of the devastating earthquake order cialis that occurred there on January 12. TPS gives undocumented Haitian residents, who were living in the U.S. On January 12, 2010, protection from forcible deportation and allows them to work legally. It is important to order cialis note that the U.S.

Grants TPS to individuals from other countries, as well, including individuals from El Salvador, Honduras, Nicaragua, Somalia and Sudan. TPS and Public Health Insurance TPS applicants residing in New York are eligible for Medicaid and Family Health Plus as long as they also meet the income requirements for these programs. In New order cialis York, applicants for TPS are considered PRUCOL immigrants (Permanently Residing Under Color of Law) for purposes of medical assistance eligibility and thus meet the immigration status requirements for Medicaid, Family Health Plus, and the Family Planning Benefit Program. Nearly all children in New York remain eligible for Child Health Plus including TPS applicants and children who lack immigration status.

For more information on immigrant eligibility for public health insurance in New York see 08 GIS MA/009 and the attached chart. Where to Apply What to BringIndividuals who have applied for TPS will need to bring several documents to prove their eligibility for public health insurance order cialis. Individuals will need to bring. 1) Proof of identity.

2) Proof of residence in New York. 3) Proof of income. 4) Proof of application for TPS. 5) Proof that U.S.

Citizenship and Immigration Services (USCIS) has received the application for TPS. Free Communication Assistance All applicants for public health insurance, including Haitian Creole speakers, have a right to get help in a language they can understand. All Medicaid offices and enrollers are required to offer free translation and interpretation services to anyone who cannot communicate effectively in English. A bilingual worker or an interpreter, whether in-person or over the telephone, must be provided in all interactions with the office.

Important documents, such as Medicaid applications, should be translated either orally or in writing. Interpreter services must be offered free of charge, and applicants requiring interpreter services must not be made to wait unreasonably longer than English speaking applicants. An applicant must never be asked to bring their own interpreter. Related Resources on TPS and Public Health Insurance o The New York Immigration Coalition (NYIC) has compiled a list of agencies, law firms, and law schools responding to the tragedy in Haiti and the designation of Haiti for Temporary Protected Status.

A copy of the list is posted at the NYIC’s website at http://www.thenyic.org. o USCIS TPS website with links to status in all countries, including HAITI. O For information on eligibility for public health insurance programs call The Legal Aid Society’s Benefits Hotline 1-888-663-6880 Tuesdays, Wednesdays and Thursdays. 9:30 am - 12:30 pm FOR IMMIGRATION HELP.

CONTACT THE New York State New Americans Hotline for a referral to an organization to advise you. 212-419-3737 Monday-Friday, from 9:00 a.m. To 8:00 p.m.Saturday-Sunday, from 9:00 a.m. To 5:00 p.m.

Or call toll-free in New York State at 1-800-566-7636 Please see these fact sheets and web sites of national organizations for more information about the new PUBLIC CHARGE rules. Printable Fact Sheets for Distribution This article was co-authored by the New York Immigration Coalition, Empire Justice Center and the Health Law Unit of the Legal Aid Society. 1/29/10, updated 3/1/10, updated 8/15/19 by NY Legal Assistance Group.

What side effects may I notice from Cialis?

Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • changes in hearing
  • chest pain
  • fast, irregular heartbeat

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • back pain
  • dizziness
  • flushing
  • headache
  • indigestion
  • muscle aches
  • stuffy or runny nose

This list may not describe all possible side effects.

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Nine new cases of erectile dysfunction treatment were diagnosed in the 24 hours to 8pm last night, bringing the total number of cases in NSW to 3,977.Confirmed cases (including interstate residents in NSW health care facilities)3,977Deaths (in NSW from confirmed cases)54Total tests carried out​​2,480,838There were 14,426 canada cialis over the counter tests reported https://www.kuecheaktiv.de/filialen/ in the 24-hour reporting period, compared with 20,211 in the previous 24 hours.Of the nine new cases to 8pm last night. Four are returned overseas travellers in hotel quarantineOne is locally acquired and under investigationFour are locally acquired and linked to a known case or cluster Two new cases are household contacts of a previously reported case linked to the Eastern Suburbs Legion Club canada cialis over the counter cluster. Both had been in self-isolation while infectious. Two new cases are household contacts of a previously reported case canada cialis over the counter linked to the St Paul’s Catholic College Greystanes cluster.

Both had been in self-isolation while infectious. A known case visited KFC Concord, 307 Concord Rd, Concord, on canada cialis over the counter 6 September between 1pm and 1:20pm. Anyone who attended this venue at this time is considered a casual contact and must monitor for symptoms and get tested immediately if they develop canada cialis over the counter. After testing, they must remain in isolation until a negative test result is received.

Locations linked to known cases, advice on testing and isolation, and areas identified for increased testing canada cialis over the counter can be found at NSW Government - Latest new and updates. NSW Health is treating 83 erectile dysfunction treatment cases, including six in intensive care, three of who are being ventilated. Eighty-six per cent of cases canada cialis over the counter being treated by NSW Health are in non-acute, out-of-hospital care. erectile dysfunction treatment continues to canada cialis over the counter circulate in the community and we must all be vigilant.

To help stop the spread of erectile dysfunction treatment. If you are unwell, get tested canada cialis over the counter and isolate right away – don’t delay.Wash your hands regularly. Take hand sanitiser with you canada cialis over the counter when you go out.Keep your distance. Leave 1.5 metres between yourself and others.Wear a mask on public transport, ride share, taxis, shopping, places of worship and other places where you can’t physically distance.A full list of erectile dysfunction treatment testing clinics is available or people can visit their GP.

Confirmed cases to dateOverseas2,104Interstate acquired89Locally acquired – contact of a confirmed case and/or in a known cluster1,389Locally acquired – contact not identified395Under investigation0Counts reported for a particular day may vary over time with ongoing enhanced surveillance activities.Returned travellers in hotel quarantine to date canada cialis over the counter Symptomatic travell​ers tested​5,065Found positive123 Asymptomatic travellers screened at day 223,215Fo​und positive115 Asymptomatic travellers screened at day 1035,737Found positive120​Video update​​Six new cases of erectile dysfunction treatment were diagnosed in the 24 hours to 8pm last night, bringing the total number of cases in NSW to 3,968.Confirmed cases (including interstate residents in NSW health care facilities)3,968Deaths (in NSW from confirmed cases)54Total tests carried out​​2,466,412There were 20,211 tests reported in the 24-hour reporting period, compared with 22,805 in the previous 24 hours.Of the six new cases to 8pm last night. €‹One is a returned overseas traveller in hotel quarantineFive are locally acquired and linked to a known case or cluster Four of the new cases are close contacts of previous cases associated with Concord Hospital.Another of the new cases is a household contact of a previously reported case linked to the St Paul’s Catholic College Greystanes cluster.One of the new cases is a student of Blue Mountains Grammar School. Anyone already canada cialis over the counter identified as a close contact is being informed they must immediately get tested and isolate for 14 days. The school is being cleaned.A previously reported case attended Katoomba Aquatic Centre on Friday 4 September from 11.30am-1.30pm.

Anyone who was at the venue at this time is advised to monitor canada cialis over the counter for symptoms and immediately self-isolate and get tested if symptoms develop, however mild, and remain isolated until a negative result is received. NSW Health is alerting anyone who attended KFC at 2A Bunting St Emerton on Monday 7 September between 12.00pm to 9:30pm to be alert for symptoms and immediately get tested if any develop, and stay isolated until canada cialis over the counter a negative test result is received. Anyone already identified as a close contact is being informed they must isolate for 14 days, get tested and stay isolated even if a negative test result is received within this period.Anyone who travelled on the following bus routes must be alert for symptoms and immediately get tested if any develop, and stay isolated until a negative test result is received. €‹379 Bronte Beach – Bondi Junction station, 7 September 2020, 11.08am-11.24am316 Avoca St Randwick – Bondi Junction station, 8 September 2020*, 10.44am-11.05am * not 7 September as previously reported​.Locations linked to known cases, advice on testing and isolation, and canada cialis over the counter areas identified for increased testing can be found at NSW Government - Latest new and updates.​ As announced yesterday, one previously reported case - a staff member of Concord Hospital – has been excluded after further testing and this is reflected in today’s case total.NSW Health is treating 84 erectile dysfunction treatment cases, including six in intensive care, four of whom are being ventilated.

Eighty-six per cent of cases being treated by NSW Health are in non-acute, out-of-hospital care.erectile dysfunction treatment continues to circulate in the community and we must all be vigilant. To help canada cialis over the counter stop the spread of erectile dysfunction treatment. €‹If you are unwell, get tested and isolate right canada cialis over the counter away – don’t delay.Wash your hands regularly. Take hand sanitiser with you when you go out.Keep your distance.

Leave 1.5 metres between yourself and others.Wear a mask on public transport, ride share, taxis, shopping, places of worship and canada cialis over the counter other places where you can’t physically distance. A full list of erectile dysfunction treatment testing clinics is available or people can visit their GP.​ Confirmed cases to dateOverseas2,100Interstate acquired89Locally acquired – contact of a confirmed case and/or in a known cluster1,385Locally acquired – contact not identified394Under investigation0 Counts reported for a particular day may vary over time with ongoing enhanced surveillance activities.Returned travellers in hotel quarantine to dateSymptomatic travell​ers tested​5,037Found positive123Asymptomatic travellers screened at day 222,796Fo​und positive112Asymptomatic travellers screened at day 1035,322Found positive120​​​​​.

Nine new cases of erectile dysfunction treatment were diagnosed in the 24 hours to 8pm last night, bringing the total number of cases in NSW to 3,977.Confirmed cases (including interstate residents in NSW health care facilities)3,977Deaths (in NSW from confirmed cases)54Total tests carried best place to purchase cialis online out​​2,480,838There were 14,426 tests reported in the 24-hour reporting period, compared with 20,211 in the order cialis previous 24 hours.Of the nine new cases to 8pm last night. Four are returned overseas travellers in hotel quarantineOne is locally acquired and under investigationFour are locally acquired and linked to order cialis a known case or cluster Two new cases are household contacts of a previously reported case linked to the Eastern Suburbs Legion Club cluster. Both had been in self-isolation while infectious.

Two new cases are household contacts of a order cialis previously reported case linked to the St Paul’s Catholic College Greystanes cluster. Both had been in self-isolation while infectious. A known case visited KFC Concord, 307 Concord Rd, Concord, on 6 September between 1pm and order cialis 1:20pm.

Anyone who attended this venue at this time is considered a casual contact and must monitor for symptoms and get tested immediately if order cialis they develop. After testing, they must remain in isolation until a negative test result is received. Locations linked to known cases, advice on testing and isolation, and areas identified for increased testing can be found at NSW order cialis Government - Latest new and updates.

NSW Health is treating 83 erectile dysfunction treatment cases, including six in intensive care, three of who are being ventilated. Eighty-six per cent of order cialis cases being treated by NSW Health are in non-acute, out-of-hospital care. erectile dysfunction treatment continues to circulate in the order cialis community and we must all be vigilant.

To help stop the spread of erectile dysfunction treatment. If you are unwell, get tested and isolate right away – don’t delay.Wash your order cialis hands regularly. Take hand order cialis sanitiser with you when you go out.Keep your distance.

Leave 1.5 metres between yourself and others.Wear a mask on public transport, ride share, taxis, shopping, places of worship and other places where you can’t physically distance.A full list of erectile dysfunction treatment testing clinics is available or people can visit their GP. Confirmed cases to dateOverseas2,104Interstate acquired89Locally acquired – contact of a confirmed case and/or in a known cluster1,389Locally acquired – contact not identified395Under investigation0Counts reported for a particular day may vary over time with ongoing enhanced surveillance activities.Returned travellers in hotel quarantine to date Symptomatic travell​ers tested​5,065Found positive123 Asymptomatic travellers screened at day 223,215Fo​und positive115 Asymptomatic travellers screened at day 1035,737Found positive120​Video update​​Six new cases of erectile dysfunction treatment were order cialis diagnosed in the 24 hours to 8pm last night, bringing the total number of cases in NSW to 3,968.Confirmed cases (including interstate residents in NSW health care facilities)3,968Deaths (in NSW from confirmed cases)54Total tests carried out​​2,466,412There were 20,211 tests reported in the 24-hour reporting period, compared with 22,805 in the previous 24 hours.Of the six new cases to 8pm last night. €‹One is a returned overseas traveller in hotel quarantineFive are locally acquired and linked to a known case or cluster Four of the new cases are close contacts of previous cases associated with Concord Hospital.Another of the new cases is a household contact of a previously reported case linked to the St Paul’s Catholic College Greystanes cluster.One of the new cases is a student of Blue Mountains Grammar School.

Anyone already identified as a close order cialis contact is being informed they must immediately get tested and isolate for 14 days. The school is being cleaned.A previously reported case attended Katoomba Aquatic Centre on Friday 4 September from 11.30am-1.30pm. Anyone who was at the venue at this time is advised to monitor for symptoms and order cialis immediately self-isolate and get tested if symptoms develop, however mild, and remain isolated until a negative result is received.

NSW Health is alerting anyone who attended KFC at 2A Bunting St Emerton on Monday 7 September between 12.00pm to 9:30pm to order cialis be alert for symptoms and immediately get tested if any develop, and stay isolated until a negative test result is received. Anyone already identified as a close contact is being informed they must isolate for 14 days, get tested and stay isolated even if a negative test result is received within this period.Anyone who travelled on the following bus routes must be alert for symptoms and immediately get tested if any develop, and stay isolated until a negative test result is received. €‹379 Bronte Beach – Bondi Junction station, 7 September 2020, 11.08am-11.24am316 Avoca St Randwick – Bondi order cialis Junction station, 8 September 2020*, 10.44am-11.05am * not 7 September as previously reported​.Locations linked to known cases, advice on testing and isolation, and areas identified for increased testing can be found at NSW Government - Latest new and updates.​ As announced yesterday, one previously reported case - a staff member of Concord Hospital – has been excluded after further testing and this is reflected in today’s case total.NSW Health is treating 84 erectile dysfunction treatment cases, including six in intensive care, four of whom are being ventilated.

Eighty-six per cent of cases being treated by NSW Health are in non-acute, out-of-hospital care.erectile dysfunction treatment continues to circulate in the community and we must all be vigilant. To help stop the spread of order cialis erectile dysfunction treatment. €‹If you are unwell, get tested and isolate right away – don’t order cialis delay.Wash your hands regularly.

Take hand sanitiser with you when you go out.Keep your distance. Leave 1.5 metres between yourself and others.Wear a mask on public transport, ride share, taxis, order cialis shopping, places of worship and other places where you can’t physically distance. A full list of erectile dysfunction treatment testing clinics is available or people can visit their GP.​ Confirmed cases to dateOverseas2,100Interstate acquired89Locally acquired – contact of a confirmed case and/or in a known cluster1,385Locally acquired – contact not identified394Under investigation0 Counts reported for a particular day may vary over time with ongoing enhanced surveillance activities.Returned travellers in hotel quarantine to dateSymptomatic travell​ers tested​5,037Found positive123Asymptomatic travellers screened at day 222,796Fo​und positive112Asymptomatic travellers screened at day 1035,322Found positive120​​​​​.

Cialis for women reviews

Elon Musk on Friday unveiled a coin-sized prototype of a cialis for women reviews brain implant developed by his startup Neuralink to enable people who are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last summer.In an event live-streamed on YouTube to more than 150,000 viewers at one point, the company staged a demonstration in which it trotted out a pig named Gertrude that was said to have had the company’s device implanted in its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence cialis for women reviews that the signals — rendered in beeps and bright blue wave patterns on screen — were, in fact, emanating from the pig’s brain.A pig presented at a Neuralink demonstration was said to have one of the company’s brain implants in its head.

YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories. €œThe future’s going to be weird.”advertisement Musk said that in cialis for women reviews July Neuralink received a breakthrough device designation from the Food and Drug Administration — a regulatory pathway that could allow the company to soon start a clinical trial in people with paraplegia and tetraplegia. The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development.

Advertisement Friday’s event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot cialis for women reviews that could easily have been mistaken for a giant Apple device. Musk described the event as a “product demo” and said its primary purpose was to recruit potential new employees. It was unclear whether cialis for women reviews the demonstration was taking place at the company’s Fremont, Calif., headquarters or elsewhere.

Musk proceeded to reveal the new version of Neuralink’s brain implant, which he said was designed to fit snugly into the top of the skull. Neuralink’s technological design has changed significantly since its last big cialis for women reviews update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to be positioned behind the back of a person’s ear, with several wires stretching to the top of the skull.

After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone using cialis for women reviews the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation from the FDA — designed to speed up the lengthy regulatory process — is a step forward, cialis for women reviews but it by no means guarantees that a device will receive a green light, either in a short or longer-term time frame.

After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roadster into space, Musk didn’t hesitate to use the event to cross-promote his electric car company. Asked whether the Neuralink cialis for women reviews chip would allow people to summon their Tesla telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future.

Still, Musk said cialis for women reviews. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017. At last July’s event, Musk said — without providing evidence — that a monkey had controlled a computer with its brain.At that same cialis for women reviews July 2019 event, Neuralink released a preprint paper — published a few months later — that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals.

Critically, the work did not show where in the brain the implanted electrodes were recording from, for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress the company reported on Friday fell far short of that cialis for women reviews. Neuralink’s prototype is ambitious, but it has yet to show evidence that it can match up to the brain-machine interfaces developed by academic labs and other companies.

Other groups have shown that they can listen in on neural activity and allow primates and people to control a computer cursor with their brain — so-called “read-out” technology — cialis for women reviews and have also shown that they can use electrical stimulation to input information, such as a command or the heat of a hot cup of coffee, using “write-in” technology. Neuralink said on Friday that its technology would have both read-out and write-in capabilities.Musk acknowledged that Neuralink still has a long way to go. In closing the event after more than cialis for women reviews 70 minutes, Musk said.

€œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”Following the news this week of what appears to have been the first confirmed case of a erectile dysfunction treatment re, other researchers have been coming forward with their own reports. One in Belgium, another in the cialis for women reviews Netherlands. And now, one in Nevada.What caught experts’ attention about the case of the 25-year-old Reno man was not that he appears to have contracted erectile dysfunction (the name of the cialis that causes erectile dysfunction treatment) a second time.

Rather, it’s that his second bout was more serious than his first.Immunologists had expected that if the immune response generated after an initial could not prevent a second case, then it should at least stave cialis for women reviews off more severe illness. That’s what occurred with the first known re case, in a 33-year-old Hong Kong man.advertisement Still, despite what happened to the man in Nevada, researchers are stressing this is not a sky-is-falling situation or one that should result in firm conclusions. They always presumed people would become vulnerable to erectile dysfunction treatment again some time after recovering from an cialis for women reviews initial case, based on how our immune systems respond to other respiratory cialises, including other erectile dysfunctiones.

It’s possible that these early cases of re are outliers and have features that won’t apply to the tens of millions of other people who have already shaken off erectile dysfunction treatment.“There are millions and millions of cases,” said Michael Mina, an epidemiologist at Harvard’s T.H. Chan School of Public Health cialis for women reviews. The real question that should get the most focus, Mina said, is, “What happens to most people?.

€advertisement But with more re cialis for women reviews reports likely to make it into the scientific literature soon, and from there into the mainstream press, here are some things to look for in assessing them.What’s the deal with the Nevada case?. The Reno resident in question first tested positive for erectile dysfunction in April after coming down with a sore throat, cough, and headache, as well as nausea and diarrhea. He got better over cialis for women reviews time and later tested negative twice.

But then, some 48 days later, the man started experiencing headaches, cough, and other symptoms again. Eventually, he became so sick that he had to be hospitalized and was found to have pneumonia.Researchers sequenced cialis samples from both of his s and found they were different, providing evidence that this was a new distinct from the first. What happens when we get erectile dysfunction treatment in the cialis for women reviews first case?.

Researchers are finding that, generally, people who get erectile dysfunction treatment develop a healthy immune response replete with both antibodies (molecules that can block pathogens from infecting cells) and T cells (which help wipe out the cialis). This is what happens after other viral s.In addition to fending off cialis for women reviews the cialis the first time, that immune response also creates memories of the cialis, should it try to invade a second time. It’s thought, then, that people who recover from erectile dysfunction treatment will typically be protected from another case for some amount of time.

With other erectile dysfunctiones, protection is thought to last for perhaps a little less than a year to about three years.But researchers cialis for women reviews can’t tell how long immunity will last with a new pathogen (like erectile dysfunction) until people start getting reinfected. They also don’t know exactly what mechanisms provide protection against erectile dysfunction treatment, nor do they know what levels of antibodies or T cells are required to signal that someone is protected through a blood test. (These are called the “correlates of cialis for women reviews protection.”) Why do experts expect second cases to be milder?.

With other cialises, protective immunity doesn’t just vanish one day. Instead, it cialis for women reviews wanes over time. Researchers have then hypothesized that with erectile dysfunction, perhaps our immune systems might not always be able to prevent it from getting a toehold in our cells — to halt entirely — but that it could still put up enough of a fight to guard us from getting really sick.

Again, this is what cialis for women reviews happens with other respiratory pathogens.And it’s why some researchers actually looked at the Hong Kong case with relief. The man had mild to moderate erectile dysfunction treatment symptoms during the first case, but was asymptomatic the second time. It was a demonstration, experts said, of what you would want your cialis for women reviews immune system to do.

(The case was only detected because the man’s sample was taken at the airport when he arrived back in Hong Kong after traveling in Europe.)“The fact that somebody may get reinfected is not surprising,” Malik Peiris, a virologist at the University of Hong Kong, told STAT earlier this week about the first re. €œBut the re didn’t cause disease, so that’s the first cialis for women reviews point.”The Nevada case, then, provides a counterexample to that. What kind of immune response did the person who was reinfected generate initially?.

Earlier, we described the robust immune response that most people who cialis for women reviews have erectile dysfunction treatment seem to mount. But that was a generalization. s and the immune responses they induce in different people are “heterogeneous,” said Sarah Cobey, an epidemiologist and evolutionary biologist at the University of Chicago.Older people often generate weaker immune responses than younger cialis for women reviews people.

Some studies have also indicated that milder cases of erectile dysfunction treatment induce tamer immune responses that might not provide as lasting or as thorough of a defense as stronger immune responses. The man in Hong Kong, for example, did not generate antibodies to the cialis after his first cialis for women reviews , at least to the level that could be detected by blood tests. Perhaps that explains why he contracted the cialis again just about 4 1/2 months after recovering from his initial .In the Nevada case, researchers did not test what kind of immune response the man generated after the first case.“ is not some binary event,” Cobey said.

And with re, “there’s going to be some viral replication, but the question is how cialis for women reviews much is the immune system getting engaged?. €What might be broadly meaningful is when people who mounted robust immune responses start getting reinfected, and how severe their second cases are. Are people who have erectile dysfunction treatment a second cialis for women reviews time infectious?.

As discussed, immune memory can prevent re. If it can’t, it might stave off serious illness cialis for women reviews. But there’s a third aspect of this, too.“The most important question for re, with the most serious implications for controlling the cialis, is whether reinfected people can transmit the cialis to others,” Columbia University virologist Angela Rasmussen wrote in Slate this week.Unfortunately, neither the Hong Kong nor the Reno studies looked at this question.

But if most people who get reinfected don’t cialis for women reviews spread the cialis, that’s obviously good news. What happens when people broadly become susceptible again?. Whether it’s six months after the first or nine months or a year or longer, at some point, protection for most cialis for women reviews people who recover from erectile dysfunction treatment is expected to wane.

And without the arrival of a treatment and broad uptake of it, that could change the dynamics of local outbreaks.In some communities, it’s thought that more than 20% of residents have experienced an initial erectile dysfunction treatment case, and are thus theoretically protected from another case for some time. That is still below the point of herd immunity — when enough people are immune that transmission doesn’t occur — but still, the fewer vulnerable people there are, the less likely spread is to occur.On the flip side though, if more people become susceptible to the cialis again, that could increase cialis for women reviews the risk of transmission. Modelers are starting to factor that possibility into their forecasts.A crucial question for which there is not an answer yet is whether what happened to the man in Reno, where the second case was more severe than the first, remains a rare occurrence, as researchers expect and hope.

As the Nevada researchers wrote, “the generalizability of this finding is unknown.”An advocacy group has asked the Department of Defense to investigate what it called “an apparent failure” by Moderna (MRNA) to disclose millions of dollars in awards received from the Defense Advanced Research Projects Agency in patent cialis for women reviews applications the company filed for treatments.In a letter to the agency, Knowledge Ecology International explained that a review of dozens of patent applications found the company received approximately $20 million from the federal government in grants several years ago and the funds “likely” led to the creation of its treatment technology. This was used to develop treatments to combat different cialises, such as Zika and, later, the cialis that causes erectile dysfunction treatment.In arguing for an investigation, the advocacy group maintained Moderna is obligated under federal law to disclose the grants that led to nearly a dozen specific patent applications and explained the financial support means the U.S. Government would cialis for women reviews have certain rights over the patents.

In other words, U.S. Taxpayers would have an ownership stake in treatments developed by the company.advertisement “This clarifies the public’s cialis for women reviews right in the inventions,” said Jamie Love, who heads Knowledge Ecology International, a nonprofit that tracks patents and access to medicines issues. €œThe disclosure (also) changes the narrative about who has financed the inventive activity, often the most risky part of development.” advertisement One particular patent assigned to Moderna concerns methods and compositions that can be used specifically against erectile dysfunctiones, including erectile dysfunction treatment.

The patent names a Moderna scientist and a former Moderna scientist as inventors, both of which acknowledged performing work under the DARPA awards in two academic papers, according to the report by the advocacy group.The group examined the 126 patents assigned to Moderna or ModernaTx as well as 154 patent applications. €œDespite the evidence that multiple inventions were conceived in the course of research supported by cialis for women reviews the DARPA awards, not a single one of the patents or applications assigned to Moderna disclose U.S. Federal government funding,” the report stated.We asked Moderna and the Department of Defense for comment and will update you accordingly.The missive to the Department of Defense follows a recent analysis by Public Citizen, another advocacy group, indicating the National Institutes of Health may own mRNA-1273, the Moderna treatment candidate for erectile dysfunction treatment.

The advocacy group noted the federal government filed multiple patents covering the treatment and two patent applications, in particular, list federal scientists as co-inventors.The analyses are part of a larger campaign cialis for women reviews among advocacy groups and others in the U.S. And elsewhere to ensure that erectile dysfunction treatment medical products are available to poor populations around the world. The concern cialis for women reviews reflects the unprecedented global demand for therapies and treatments, and a race among wealthy nations to snap up supplies from treatment makers.

In the U.S., the effort has focused on the extent to which the federal government has provided taxpayer dollars to different companies to help fund their discoveries. In some cases, advocates argue that federal cialis for women reviews funding matters because it clarifies the rights that the U.S. Government has to ensure a therapy or treatment is available to Americans on reasonable terms.One example has been remdesivir, the Gilead Sciences (GILD) treatment being given to hospitalized erectile dysfunction treatment patients.

The role played by cialis for women reviews the U.S. Government in developing remdesivir to combat erectile dysfunctiones involved contributions from government personnel at such agencies as the U.S. Army Medical Research Institute of Infectious Diseases.As for the Moderna treatment, earlier this month, the company was awarded a $1.525 billion contract by the Department of Defense and the Department of Health and Human Services to manufacture cialis for women reviews and deliver 100 million doses of its erectile dysfunction treatment.

The agreement also includes an option to purchase another 400 million doses, although the terms were not disclosed. In announcing the agreement, the government said it would ensure Americans receive cialis for women reviews the erectile dysfunction treatment at no cost, although they may be charged by health care providers for administering a shot.In this instance, however, Love said the “letter is not about price or profits. It’s about (Moderna) not owning up to DARPA funding inventions.

If the cialis for women reviews U.S. Wants to pay for all of the development of Moderna’s treatment, as Moderna now acknowledges, and throw in a few more billion now, and an option to spend billions more, it’s not unreasonable to have some transparency over who paid for their inventions.”This is not the first time Moderna has been accused of insufficient disclosure. Earlier this month, Knowledge Ecology International and Public Citizen maintained the company failed to disclose development costs in a $955 million contract awarded cialis for women reviews by BARDA for its erectile dysfunction treatment.

In all, the federal government has awarded the company approximately $2.5 billion to develop the treatment.The coming few weeks represent a crucial moment for an ambitious plan to try to secure erectile dysfunction treatments for roughly 170 countries around the world without the deep pockets to compete for what will be scarce initial supplies.Under the plan, countries that want to pool resources to buy treatments must notify the World Health Organization and other organizers — Gavi, the treatment Alliance, as well as the Coalition for Epidemic Preparedness Innovations — of their intentions by Monday. That means it’s fish-or-cut-bait time for the so-called COVAX facility.Already, wealthy countries — the United States, the United Kingdom, Japan, Canada, and cialis for women reviews Australia, among others, as well as the European Union — have opted to buy their own treatment, signing bilateral contracts with manufacturers that have secured billions of doses of treatment already. That raises the possibility that less wealthy countries will be boxed out of supplies.advertisement And yet Richard Hatchett, the CEO of CEPI, insists there is a path to billions of doses of treatment for the rest of the world in 2021.

STAT spoke with cialis for women reviews Hatchett this week. A transcript of the conversation, lightly edited for clarity and length, follows. You said this is a cialis for women reviews critical time for CEPI.

Can you explain what needs to happen between now and mid-September for this joint purchasing approach to be a success?. Advertisement The critical moment is now for countries to commit to the COVAX facility, because that will enable us to secure ample quantities of treatment and then to be able to convey when that treatment is likely to become available based on current information.What we’re cialis for women reviews now here asking countries to do is to indicate their intent to participate by Aug. 31, and to make a binding commitment by Sept.

18. And to provide funds in support of that binding commitment by early October. Our negotiations with companies are already taking place and it will be important for us from a planning purpose that countries indicate their intent to participate.Those binding commitments we think will be sufficient to allow us to then secure the advance purchase agreements, particularly with those companies that don’t have a prior contractual obligation to COVAX.

And then obviously, we need the funds to live up to those advance purchase agreements.Is it possible this thing could still fall apart?. There appears to be some concern COVAX has been boxed out by rich countries. There was always a possibility that there wouldn’t be sufficient uptake.

But I think we’re very encouraged at this point by the level of commitment, both from countries that would be beneficiaries of the advance market commitment — that’s the lower-income, lower-middle-income countries — as well as the self-financing countries. To have over 170 countries expressing interest in participating — they see the value.We’re much more encouraged now that it’s not going to fall apart. We still need to bring it off to maximize its value.

And we’re right at the crunch moment where countries are going to have to make these commitments. So, the next month is really absolutely critical to the facility. I am confident at this point that the world recognizes the value and wants it to work.I’ve been keeping tabs on advance purchase agreements that have been announced.

And at this point, a small number of rich countries have nailed down a lot of treatment — more than 3 billion doses. How hard does that make your job?. The fact that they’re doing it creates anxiety among other countries.

And that in itself can accelerate the pace. So, I’m not going to say that we’re not watching that with concern.I will say that for COVAX and the facility, this is absolutely critical moment. I think we still have a window of opportunity between now and mid-September — when we’re asking that the self-financing countries to make their commitments — to make the facility real and to make it work.

Between doses that are committed to COVAX through the access agreements and other agreements — these are discussions with partners that CEPI has funded as well as partners that CEPI has not funded — we still see a pathway for COVAX to well over 3 billion doses in 2021.I think it’s really important to bear in mind is that there are at least a few countries — and I think the U.S. And the U.K. Most publicly — that may be in a situation of significant oversupply.

I believe the U.S. And U.K. Numbers, if you add them together, would result in enough treatment for 600 million people to receive two doses of treatment each.

And, you know, there is no possible way that the U.S. Or the U.K. Can use that much treatment.So, there may be a lot of extra supply that looks like it’s been tied up sloshing around later.

I don’t think that the bilateral deals that have been struck are going to prevent COVAX from achieving its goals.But if so much treatment has been pre-ordered by rich countries, can countries in the COVAX pool get enough for their needs?. One of the things that we’ve argued through COVAX is that to control the cialis or to end the acute phase of the cialis to allow normalcy to start to reassert itself, you don’t have to vaccinate 100% of your population.You need to vaccinate those at greatest risk for bad outcomes and you need to vaccinate certain critical workers, particularly your health care workforce. And if you can achieve that goal, which for most countries means vaccinating between 20% and maybe 30% of the population, then you can transform the cialis into something that is much more manageable.

Then you can buy yourself time to vaccinate everybody who wants to be vaccinated.We’ve argued the COVAX facility really offers the world the best shot at doing that globally in the fastest possible way, as well as providing for equitable access. This is a case where doing the equitable thing is also doing the efficient thing.CEPI has provided funding to nine treatments. Is it true that all those manufacturers aren’t required to provide the COVAX facility with treatment?.

That is correct. One of the things that we did, and I think it was an important role that CEPI played early on, was that we moved money very, very quickly, in small increments. You know, some of the early contracts were only $5 million or $10 million, to get programs up and running while we potentially put in place much larger-scale, longer-term contracts.If you were doing it over again, would you have given money without strings attached?.

Yes, I think I would have. I think that was critically important to initiating programs.Our contract with Moderna was established in about 48 hours. And that provided critical funding to them to manufacture doses that got them into clinical trials within nine weeks of the genetic sequences [of the erectile dysfunction cialis] being released.And if you look at the nine programs that we’ve invested in, seven are in clinical trials.

Two — the AstraZeneca program now and the Moderna program — are among the handful in Phase 3 clinical trials. And, I think the number of projects that that we funded initially, which started in kind of a biotech or academic phase that have now been picked up by large multinational corporations, there’s at least four. The Themis program being picked up by Merck, Oxford University by AstraZeneca, the University of Queensland by CSL, and Clover being in partnership with GSK, I think that speaks to the quality of the programs that we selected.So, I think that combination of rapid review, speed of funding, getting those programs started, getting them oriented in the right direction, I think all of that is critical to where we are now.Companies that got money from CEPI to build out production capacity — that money came with strings attached, right?.

Yes, exactly. So, where CEPI has made investments that create manufacturing, or secure manufacturing capacity, the commitment has been that the capacity that is attributable to the CEPI investment is committed — at least right of first refusal — to the global procurement facility.WASHINGTON — The Trump administration removed a top Food and Drug Administration communications official from her post on Friday in the wake of several controversial agency misstatements, a senior administration official confirmed to STAT.The spokeswoman, Emily Miller, had played a lead role in defending the FDA commissioner, Stephen Hahn, after he misrepresented data regarding the use of blood plasma from recovered erectile dysfunction treatment patients. The New York Times first reported Miller’s ouster.

Miller’s tenure at as the top FDA spokeswoman lasted only 11 days. Her appointment was viewed with alarm by agency officials who felt her presence at the agency was emblematic of broader political pressure from the Trump administration, STAT first reported earlier this week.advertisement Before joining the FDA, Miller had no experience in health or medicine. Her former role as assistant commissioner for media affairs is typically not an appointment filled by political appointees.

The FDA’s communications arm typically maintains a neutral, nonpolitical tone.Miller’s appointment particularly alarmed FDA staff and outside scientists given her history in right-wing political advocacy and conservatism journalism. Her résumé included a stint as a Washington Times columnist, where she penned columns with titles that include “New Obamacare ads make young women look like sluts,” and a 2013 book on gun rights titled “Emily Gets Her Gun. But Obama Wants to Take Yours.”advertisement She also worked as a reporter for One America News Network, a right-wing cable channel that frequently espouses conspiracy theories and has declared an open alliance with President Trump.Miller quickly made her presence known at the FDA.

In the wake of Hahn’s misstatements on blood plasma, she aggressively defended the commissioner, falsely claiming in a tweet that the therapy “has shown to be beneficial for 35% of patients.” An FDA press release on blood plasma, issued less than a week after her appointment, similarly alarmed agency insiders by trumpeting the emergency authorization as “Another Achievement in Administration’s Fight Against [the] cialis.”.

Elon Musk on Friday unveiled a order cialis coin-sized prototype of a brain implant developed by his startup Neuralink to enable people who are paralyzed to operate smartphones and robotic limbs with their thoughts — and said the company had worked to “dramatically simplify” the device since presenting an earlier version last summer.In an event live-streamed on YouTube to more than 150,000 viewers at one point, the company staged a demonstration in which it trotted out a pig named Gertrude that was said to have had the company’s device implanted http://www.businessmattersnj.com/peerless-media-group/ in its head two months ago. The live stream showed what Musk claimed to be Gertrude’s real-time brain activity as it sniffed around a pen. At no point, though, did he provide evidence that the order cialis signals — rendered in beeps and bright blue wave patterns on screen — were, in fact, emanating from the pig’s brain.A pig presented at a Neuralink demonstration was said to have one of the company’s brain implants in its head. YouTube screenshot“This is obviously sounding increasingly like a Black Mirror episode,” Musk said at one point during the event as he responded affirmatively to a question about whether the company’s implant could eventually be used to save and replay memories. €œThe future’s going to be weird.”advertisement Musk said that in July Neuralink received a breakthrough device designation from the Food and Drug Administration — a regulatory pathway that could allow the company to soon order cialis start a clinical trial in people with paraplegia and tetraplegia.

The big reveal came after four former Neuralink employees told STAT that the company’s leaders have long fostered an internal culture characterized by rushed timelines and the “move fast and break things” ethos of a tech company — a pace sometimes at odds with the slow and incremental pace that’s typical of medical device development. Advertisement Friday’s event began, 40 minutes late, with a glossy video about the company’s work — and then panned to Musk, standing in front of order cialis a blue curtain beside a gleaming new version of the company’s surgical “sewing machine” robot that could easily have been mistaken for a giant Apple device. Musk described the event as a “product demo” and said its primary purpose was to recruit potential new employees. It was unclear whether order cialis the demonstration was taking place at the company’s Fremont, Calif., headquarters or elsewhere. Musk proceeded to reveal the new version of Neuralink’s brain implant, which he said was designed to fit snugly into the top of the skull.

Neuralink’s technological design order cialis has changed significantly since its last big update in July 2019. At that time, the company’s brain implant system involved a credit-card sized device designed to be positioned behind the back of a person’s ear, with several wires stretching to the top of the skull. After demonstrating the pig’s brain activity at Friday’s event, Musk showed video footage of a pig walking on a treadmill and said Neuralink’s device could be used to “predict the position of limbs with high accuracy.” That capability would be critical to allowing someone using the device to do something like controlling a prosthetic limb, for example.Neuralink for months has signaled that it initially plans to develop order cialis its device for people who are paralyzed. It said at its July 2019 event that it wanted to start human testing by the end of 2020. Receiving the breakthrough device designation from the FDA — designed to speed up the lengthy regulatory process — is a order cialis step forward, but it by no means guarantees that a device will receive a green light, either in a short or longer-term time frame.

After Musk’s presentation, a handful of the company’s employees — all wearing masks, but seated only inches apart — joined him to take questions submitted on Twitter or from the small audience in the room.In typical fashion for a man who in 2018 sent a Tesla Roadster into space, Musk didn’t hesitate to use the event to cross-promote his electric car company. Asked whether the Neuralink chip would allow people to summon order cialis their Tesla telepathically, Musk responded. €œDefinitely — of course.”Matthew MacDougall, the company’s head neurosurgeon, appearing in scrubs, said the company had so far only implanted its technology into the brain’s cortical surface, the coaster-width layer enveloping the brain, but added that it hoped to go deeper in the future. Still, Musk said order cialis. €œYou could solve blindness, you could solve paralysis, you could solve hearing — you can solve a lot just by interfacing with the cortex.”Musk and MacDougall said they hoped to eventually implant Neuralink’s devices — which they referred to on stage simply as “links” — in the deeper structures of the brain, such as in the hypothalamus, which is believed to play a critical role in mental illnesses including depression, anxiety, and PTSD.There were no updates at the event of Neuralink’s research in monkeys, which the company has been conducting in partnership with the University of California, Davis since 2017.

At last July’s event, Musk said — without providing evidence — that a monkey had controlled order cialis a computer with its brain.At that same July 2019 event, Neuralink released a preprint paper — published a few months later — that claimed to show that a series of Neuralink electrodes implanted in the brains of rats could record neural signals. Critically, the work did not show where in the brain the implanted electrodes were recording from, for how long they were recording, or whether the recordings could be linked to any of the rats’ bodily movements.In touting Friday’s event — and Neuralink’s technological capabilities — on Twitter in recent weeks, Musk spoke of “AI symbiosis while u wait” and referenced the “matrix in the matrix” — a science-fiction reference about revealing the true nature of reality. The progress order cialis the company reported on Friday fell far short of that. Neuralink’s prototype is ambitious, but it has yet to show evidence that it can match up to the brain-machine interfaces developed by academic labs and other companies. Other groups have shown that they can listen in on neural activity and allow order cialis primates and people to control a computer cursor with their brain — so-called “read-out” technology — and have also shown that they can use electrical stimulation to input information, such as a command or the heat of a hot cup of coffee, using “write-in” technology.

Neuralink said on Friday that its technology would have both read-out and write-in capabilities.Musk acknowledged that Neuralink still has a long way to go. In closing the event after more than 70 minutes, Musk said order cialis. €œThere’s a tremendous amount of work to be done to go from here to a device that is widely available and affordable and reliable.”Following the news this week of what appears to have been the first confirmed case of a erectile dysfunction treatment re, other researchers have been coming forward with their own reports. One in Belgium, another in the Netherlands order cialis. And now, one in Nevada.What caught experts’ attention about the case of the 25-year-old Reno man was not that he appears to have contracted erectile dysfunction (the name of the cialis that causes erectile dysfunction treatment) a second time.

Rather, it’s that his second bout was more serious than his first.Immunologists had expected that if the immune response generated after an initial could not prevent a second case, order cialis then it should at least stave off more severe illness. That’s what occurred with the first known re case, in a 33-year-old Hong Kong man.advertisement Still, despite what happened to the man in Nevada, researchers are stressing this is not a sky-is-falling situation or one that should result in firm conclusions. They always presumed people would become vulnerable to erectile dysfunction treatment again some time after recovering from an initial case, based on how our immune systems respond to order cialis other respiratory cialises, including other erectile dysfunctiones. It’s possible that these early cases of re are outliers and have features that won’t apply to the tens of millions of other people who have already shaken off erectile dysfunction treatment.“There are millions and millions of cases,” said Michael Mina, an epidemiologist at Harvard’s T.H. Chan School order cialis of Public Health.

The real question that should get the most focus, Mina said, is, “What happens to most people?. €advertisement But with more re reports likely to make it into the scientific literature soon, and from there into the mainstream press, here are some things to look for in assessing them.What’s the deal order cialis with the Nevada case?. The Reno resident in question first tested positive for erectile dysfunction in April after coming down with a sore throat, cough, and headache, as well as nausea and diarrhea. He got order cialis better over time and later tested negative twice. But then, some 48 days later, the man started experiencing headaches, cough, and other symptoms again.

Eventually, he became so sick that he had to be hospitalized and was found to have pneumonia.Researchers sequenced cialis samples from both of his s and found they were different, providing evidence that this was a new distinct from the first. What happens when we get erectile dysfunction treatment in the order cialis first case?. Researchers are finding that, generally, people who get erectile dysfunction treatment develop a healthy immune response replete with both antibodies (molecules that can block pathogens from infecting cells) and T cells (which help wipe out the cialis). This is what happens after other viral s.In addition to fending off the cialis the first time, that immune response also creates memories of the cialis, order cialis should it try to invade a second time. It’s thought, then, that people who recover from erectile dysfunction treatment will typically be protected from another case for some amount of time.

With other erectile dysfunctiones, protection is thought to last for perhaps a little less than a year to about three order cialis years.But researchers can’t tell how long immunity will last with a new pathogen (like erectile dysfunction) until people start getting reinfected. They also don’t know exactly what mechanisms provide protection against erectile dysfunction treatment, nor do they know what levels of antibodies or T cells are required to signal that someone is protected through a blood test. (These are order cialis called the “correlates of protection.”) Why do experts expect second cases to be milder?. With other cialises, protective immunity doesn’t just vanish one day. Instead, it wanes order cialis over time.

Researchers have then hypothesized that with erectile dysfunction, perhaps our immune systems might not always be able to prevent it from getting a toehold in our cells — to halt entirely — but that it could still put up enough of a fight to guard us from getting really sick. Again, this is what happens with other respiratory pathogens.And it’s why some researchers actually looked at the Hong Kong case order cialis with relief. The man had mild to moderate erectile dysfunction treatment symptoms during the first case, but was asymptomatic the second time. It was a demonstration, experts said, of what order cialis you would want your immune system to do. (The case was only detected because the man’s sample was taken at the airport when he arrived back in Hong Kong after traveling in Europe.)“The fact that somebody may get reinfected is not surprising,” Malik Peiris, a virologist at the University of Hong Kong, told STAT earlier this week about the first re.

€œBut the re didn’t cause order cialis disease, so that’s the first point.”The Nevada case, then, provides a counterexample to that. What kind of immune response did the person who was reinfected generate initially?. Earlier, we described the robust immune response that most order cialis people who have erectile dysfunction treatment seem to mount. But that was a generalization. s and the immune responses they induce in order cialis different people are “heterogeneous,” said Sarah Cobey, an epidemiologist and evolutionary biologist at the University of Chicago.Older people often generate weaker immune responses than younger people.

Some studies have also indicated that milder cases of erectile dysfunction treatment induce tamer immune responses that might not provide as lasting or as thorough of a defense as stronger immune responses. The man in Hong Kong, for example, did not generate antibodies to the cialis after his order cialis first , at least to the level that could be detected by blood tests. Perhaps that explains why he contracted the cialis again just about 4 1/2 months after recovering from his initial .In the Nevada case, researchers did not test what kind of immune response the man generated after the first case.“ is not some binary event,” Cobey said. And with re, “there’s going to be some viral replication, but order cialis the question is how much is the immune system getting engaged?. €What might be broadly meaningful is when people who mounted robust immune responses start getting reinfected, and how severe their second cases are.

Are people who have erectile dysfunction treatment order cialis a second time infectious?. As discussed, immune memory can prevent re. If it can’t, it might stave off serious illness order cialis. But there’s a third aspect of this, too.“The most important question for re, with the most serious implications for controlling the cialis, is whether reinfected people can transmit the cialis to others,” Columbia University virologist Angela Rasmussen wrote in Slate this week.Unfortunately, neither the Hong Kong nor the Reno studies looked at this question. But if most people order cialis who get reinfected don’t spread the cialis, that’s obviously good news.

What happens when people broadly become susceptible again?. Whether it’s six months after the first or nine months order cialis or a year or longer, at some point, protection for most people who recover from erectile dysfunction treatment is expected to wane. And without the arrival of a treatment and broad uptake of it, that could change the dynamics of local outbreaks.In some communities, it’s thought that more than 20% of residents have experienced an initial erectile dysfunction treatment case, and are thus theoretically protected from another case for some time. That is still below the point of herd immunity — when enough people are immune that transmission doesn’t occur order cialis — but still, the fewer vulnerable people there are, the less likely spread is to occur.On the flip side though, if more people become susceptible to the cialis again, that could increase the risk of transmission. Modelers are starting to factor that possibility into their forecasts.A crucial question for which there is not an answer yet is whether what happened to the man in Reno, where the second case was more severe than the first, remains a rare occurrence, as researchers expect and hope.

As the Nevada researchers wrote, “the generalizability of this finding is unknown.”An advocacy group has asked the Department of Defense to investigate what it called “an apparent failure” by Moderna (MRNA) to disclose millions of dollars in awards received from the Defense Advanced Research order cialis Projects Agency in patent applications the company filed for treatments.In a letter to the agency, Knowledge Ecology International explained that a review of dozens of patent applications found the company received approximately $20 million from the federal government in grants several years ago and the funds “likely” led to the creation of its treatment technology. This was used to develop treatments to combat different cialises, such as Zika and, later, the cialis that causes erectile dysfunction treatment.In arguing for an investigation, the advocacy group maintained Moderna is obligated under federal law to disclose the grants that led to nearly a dozen specific patent applications and explained the financial support means the U.S. Government would have order cialis certain rights over the patents. In other words, U.S. Taxpayers would have an ownership stake in treatments order cialis developed by the company.advertisement “This clarifies the public’s right in the inventions,” said Jamie Love, who heads Knowledge Ecology International, a nonprofit that tracks patents and access to medicines issues.

€œThe disclosure (also) changes the cialis costo 5mg narrative about who has financed the inventive activity, often the most risky part of development.” advertisement One particular patent assigned to Moderna concerns methods and compositions that can be used specifically against erectile dysfunctiones, including erectile dysfunction treatment. The patent names a Moderna scientist and a former Moderna scientist as inventors, both of which acknowledged performing work under the DARPA awards in two academic papers, according to the report by the advocacy group.The group examined the 126 patents assigned to Moderna or ModernaTx as well as 154 patent applications. €œDespite the evidence that multiple inventions were conceived in the course of research supported by the DARPA awards, not a single one of the patents or applications assigned order cialis to Moderna disclose U.S. Federal government funding,” the report stated.We asked Moderna and the Department of Defense for comment and will update you accordingly.The missive to the Department of Defense follows a recent analysis by Public Citizen, another advocacy group, indicating the National Institutes of Health may own mRNA-1273, the Moderna treatment candidate for erectile dysfunction treatment. The advocacy group noted the federal government filed multiple patents covering the treatment and two patent applications, in particular, list federal scientists order cialis as co-inventors.The analyses are part of a larger campaign among advocacy groups and others in the U.S.

And elsewhere to ensure that erectile dysfunction treatment medical products are available to poor populations around the world. The concern reflects the unprecedented global demand for order cialis therapies and treatments, and a race among wealthy nations to snap up supplies from treatment makers. In the U.S., the effort has focused on the extent to which the federal government has provided taxpayer dollars to different companies to help fund their discoveries. In some cases, advocates argue that federal funding matters because it order cialis clarifies the rights that the U.S. Government has to ensure a therapy or treatment is available to Americans on reasonable terms.One example has been remdesivir, the Gilead Sciences (GILD) treatment being given to hospitalized erectile dysfunction treatment patients.

The role played by order cialis the U.S. Government in developing remdesivir to combat erectile dysfunctiones involved contributions from government personnel at such agencies as the U.S. Army Medical Research Institute of Infectious Diseases.As for the Moderna treatment, earlier this month, the company was awarded a $1.525 billion contract by the Department of Defense and the Department of Health and Human Services to manufacture and deliver 100 million order cialis doses of its erectile dysfunction treatment. The agreement also includes an option to purchase another 400 million doses, although the terms were not disclosed. In announcing the agreement, the government said it would ensure Americans receive the erectile dysfunction treatment at order cialis no cost, although they may be charged by health care providers for administering a shot.In this instance, however, Love said the “letter is not about price or profits.

It’s about (Moderna) not owning up to DARPA funding inventions. If the order cialis U.S. Wants to pay for all of the development of Moderna’s treatment, as Moderna now acknowledges, and throw in a few more billion now, and an option to spend billions more, it’s not unreasonable to have some transparency over who paid for their inventions.”This is not the first time Moderna has been accused of insufficient disclosure. Earlier this month, order cialis Knowledge Ecology International and Public Citizen maintained the company failed to disclose development costs in a $955 million contract awarded by BARDA for its erectile dysfunction treatment. In all, the federal government has awarded the company approximately $2.5 billion to develop the treatment.The coming few weeks represent a crucial moment for an ambitious plan to try to secure erectile dysfunction treatments for roughly 170 countries around the world without the deep pockets to compete for what will be scarce initial supplies.Under the plan, countries that want to pool resources to buy treatments must notify the World Health Organization and other organizers — Gavi, the treatment Alliance, as well as the Coalition for Epidemic Preparedness Innovations — of their intentions by Monday.

That means it’s order cialis fish-or-cut-bait time for the so-called COVAX facility.Already, wealthy countries — the United States, the United Kingdom, Japan, Canada, and Australia, among others, as well as the European Union — have opted to buy their own treatment, signing bilateral contracts with manufacturers that have secured billions of doses of treatment already. That raises the possibility that less wealthy countries will be boxed out of supplies.advertisement And yet Richard Hatchett, the CEO of CEPI, insists there is a path to billions of doses of treatment for the rest of the world in 2021. STAT spoke order cialis with Hatchett this week. A transcript of the conversation, lightly edited for clarity and length, follows. You said this is a order cialis critical time for CEPI.

Can you explain what needs to happen between now and mid-September for this joint purchasing approach to be a success?. Advertisement The order cialis critical moment is now for countries to commit to the COVAX facility, because that will enable us to secure ample quantities of treatment and then to be able to convey when that treatment is likely to become available based on current information.What we’re now here asking countries to do is to indicate their intent to participate by Aug. 31, and to make a binding commitment by Sept. 18. And to provide funds in support of that binding commitment by early October.

Our negotiations with companies are already taking place and it will be important for us from a planning purpose that countries indicate their intent to participate.Those binding commitments we think will be sufficient to allow us to then secure the advance purchase agreements, particularly with those companies that don’t have a prior contractual obligation to COVAX. And then obviously, we need the funds to live up to those advance purchase agreements.Is it possible this thing could still fall apart?. There appears to be some concern COVAX has been boxed out by rich countries. There was always a possibility that there wouldn’t be sufficient uptake. But I think we’re very encouraged at this point by the level of commitment, both from countries that would be beneficiaries of the advance market commitment — that’s the lower-income, lower-middle-income countries — as well as the self-financing countries.

To have over 170 countries expressing interest in participating — they see the value.We’re much more encouraged now that it’s not going to fall apart. We still need to bring it off to maximize its value. And we’re right at the crunch moment where countries are going to have to make these commitments. So, the next month is really absolutely critical to the facility. I am confident at this point that the world recognizes the value and wants it to work.I’ve been keeping tabs on advance purchase agreements that have been announced.

And at this point, a small number of rich countries have nailed down a lot of treatment — more than 3 billion doses. How hard does that make your job?. The fact that they’re doing it creates anxiety among other countries. And that in itself can accelerate the pace. So, I’m not going to say that we’re not watching that with concern.I will say that for COVAX and the facility, this is absolutely critical moment.

I think we still have a window of opportunity between now and mid-September — when we’re asking that the self-financing countries to make their commitments — to make the facility real and to make it work. Between doses that are committed to COVAX through the access agreements and other agreements — these are discussions with partners that CEPI has funded as well as partners that CEPI has not funded — we still see a pathway for COVAX to well over 3 billion doses in 2021.I think it’s really important to bear in mind is that there are at least a few countries — and I think the U.S. And the U.K. Most publicly — that may be in a situation of significant oversupply. I believe the U.S.

And U.K. Numbers, if you add them together, would result in enough treatment for 600 million people to receive two doses of treatment each. And, you know, there is no possible way that the U.S. Or the U.K. Can use that much treatment.So, there may be a lot of extra supply that looks like it’s been tied up sloshing around later.

I don’t think that the bilateral deals that have been struck are going to prevent COVAX from achieving its goals.But if so much treatment has been pre-ordered by rich countries, can countries in the COVAX pool get enough for their needs?. One of the things that we’ve argued through COVAX is that to control the cialis or to end the acute phase of the cialis to allow normalcy to start to reassert itself, you don’t have to vaccinate 100% of your population.You need to vaccinate those at greatest risk for bad outcomes and you need to vaccinate certain critical workers, particularly your health care workforce. And if you can achieve that goal, which for most countries means vaccinating between 20% and maybe 30% of the population, then you can transform the cialis into something that is much more manageable. Then you can buy yourself time to vaccinate everybody who wants to be vaccinated.We’ve argued the COVAX facility really offers the world the best shot at doing that globally in the fastest possible way, as well as providing for equitable access. This is a case where doing the equitable thing is also doing the efficient thing.CEPI has provided funding to nine treatments.

Is it true that all those manufacturers aren’t required to provide the COVAX facility with treatment?. That is correct. One of the things that we did, and I think it was an important role that CEPI played early on, was that we moved money very, very quickly, in small increments. You know, some of the early contracts were only $5 million or $10 million, to get programs up and running while we potentially put in place much larger-scale, longer-term contracts.If you were doing it over again, would you have given money without strings attached?. Yes, I think I would have.

I think that was critically important to initiating programs.Our contract with Moderna was established in about 48 hours. And that provided critical funding to them to manufacture doses that got them into clinical trials within nine weeks of the genetic sequences [of the erectile dysfunction cialis] being released.And if you look at the nine programs that we’ve invested in, seven are in clinical trials. Two — the AstraZeneca program now and the Moderna program — are among the handful in Phase 3 clinical trials. And, I think the number of projects that that we funded initially, which started in kind of a biotech or academic phase that have now been picked up by large multinational corporations, there’s at least four. The Themis program being picked up by Merck, Oxford University by AstraZeneca, the University of Queensland by CSL, and Clover being in partnership with GSK, I think that speaks to the quality of the programs that we selected.So, I think that combination of rapid review, speed of funding, getting those programs started, getting them oriented in the right direction, I think all of that is critical to where we are now.Companies that got money from CEPI to build out production capacity — that money came with strings attached, right?.

Yes, exactly. So, where CEPI has made investments that create manufacturing, or secure manufacturing capacity, the commitment has been that the capacity that is attributable to the CEPI investment is committed — at least right of first refusal — to the global procurement facility.WASHINGTON — The Trump administration removed a top Food and Drug Administration communications official from her post on Friday in the wake of several controversial agency misstatements, a senior administration official confirmed to STAT.The spokeswoman, Emily Miller, had played a lead role in defending the FDA commissioner, Stephen Hahn, after he misrepresented data regarding the use of blood plasma from recovered erectile dysfunction treatment patients. The New York Times first reported Miller’s ouster. Miller’s tenure at as the top FDA spokeswoman lasted only 11 days. Her appointment was viewed with alarm by agency officials who felt her presence at the agency was emblematic of broader political pressure from the Trump administration, STAT first reported earlier this week.advertisement Before joining the FDA, Miller had no experience in health or medicine.

Her former role as assistant commissioner for media affairs is typically not an appointment filled by political appointees. The FDA’s communications arm typically maintains a neutral, nonpolitical tone.Miller’s appointment particularly alarmed FDA staff and outside scientists given her history in right-wing political advocacy and conservatism journalism. Her résumé included a stint as a Washington Times columnist, where she penned columns with titles that include “New Obamacare ads make young women look like sluts,” and a 2013 book on gun rights titled “Emily Gets Her Gun. But Obama Wants to Take Yours.”advertisement She also worked as a reporter for One America News Network, a right-wing cable channel that frequently espouses conspiracy theories and has declared an open alliance with President Trump.Miller quickly made her presence known at the FDA. In the wake of Hahn’s misstatements on blood plasma, she aggressively defended the commissioner, falsely claiming in a tweet that the therapy “has shown to be beneficial for 35% of patients.” An FDA press release on blood plasma, issued less than a week after her appointment, similarly alarmed agency insiders by trumpeting the emergency authorization as “Another Achievement in Administration’s Fight Against [the] cialis.”.

Cialis bathtub logo

We live cost of cialis 20mg in canada in unprecedented times cialis bathtub logo. But what makes them without parallel is not the current cialis crisis nor the continued problems facing minorities in our institutions. Rather, it’s that for the first time, the problems of cialis bathtub logo accessibility, rights and freedoms are now invading privileged spaces. There can be no ‘getting back to normal’, because ‘normal’ only ever benefited the white, Western, patriarchal, abled and cis ideals. For many, the world is not suddenly on fire.

€¦IntroductionMinecraft is a computer cialis bathtub logo game with no specific goals to accomplish. The gameworld consists of three-dimensional (3D) cubes and objects which the player (Steve) can mine and build into infinitely complex (and logically impossible) structures. Steve sometimes cialis bathtub logo encounters other characters (‘mobs’), such as animals and hostile creatures. He can ‘spawn’ and destroy them. While it looks like a harmless game of logical construction, it conveys some worryingly delusive ideas about the real world.

The difference between real and imagined structures cialis bathtub logo is at the heart of the age-old debate around categorising mental disorders.Classification in mental health has had various forms throughout history. Mack and colleagues set out a history of psychiatric classification beginning in 2600 BC with Egyptian references to melancholia and hysteria. Through the Ancient Greeks with Hippocrates’ phrenitis, mania, cialis bathtub logo melancholia, epilepsy, hysteria and Scythian disease. Through the Renaissance period. Through to 19th-century psychiatry featuring Pinel (known as the first psychiatrist), Kraepelin (known for observational classification) and Freud (known for classifying neurosis and psychosis).1Although the history of psychiatric classification identifies some common trends such as the labels ‘melancholia’ and ‘hysteria’ which have survived millennia, the label ‘depression’ is relatively new.

The earliest usage noted by Snaith cialis bathtub logo is from 1899. €˜in simple pathological depression…the patient exhibits a growing indifference to his former pursuits…’.2 Snaith noted that early 20th-century psychiatrists like Adolf Meyer hoped that ‘depression’ would come to encompass a broad category under which descriptions of subtypes would emerge. This did not happen cialis bathtub logo until the middle of the 20th century. With the publication of the sixth International Classification of Diseases (ICD) in 1948 and the Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1952 and their subsequent revisions, the latter half of the 20th century has seen depression subtype labels proliferate. In their study of the social determinants of diagnostic labels in depression, McPherson and Armstrong illustrate how the codification of depression subtypes in the latter half of the 20th century has been shaped by the evolving context of psychiatry, including power struggles within the profession, a move to community care and the development of psychopharmacology.3During this period, McPherson and Armstrong describe how subsequent versions of the DSM served as battlegrounds for professional disputes and philosophical quarrels around categorisation of mental disorders.

DSM I cialis bathtub logo and DSM II have been described as products of an American Psychiatric Association dominated by psychoanalytic psychiatrists.4 DSM III and DSM III-R have been described as a radical rejection of psychoanalytic thinking, a ‘neo-Kraepelinian revolution’, a reference to the observational descriptive techniques of 19th-century psychiatrist Emil Kraepelin who classified mental disorders into two broad categories. €˜dementia praecox’ and ‘manic-depression’.5 DSM III was seen by some as a turning point in the use of the medical model of mental illness, through provision of specific inclusion and exclusion criteria, and use of field trials and a multiaxial system.6 These latter technocratic additions to psychiatric labelling served to engender a much closer alignment between psychiatry, science and medicine.The codification of mental disorders in manuals has been described by Thomas Schacht as intrinsic to the relationship between science and politics and the way in which psychiatrists gain significant social power by aligning themselves to science.7 His argument drew on Szasz, who saw the mental health establishment as a therapeutic state. Zimbardo, who cialis bathtub logo described psychiatric care as a controlling force. And Foucault, who described the categorisation of the mentally ill as a force for isolating ‘the other’. Diagnostic critique has been further developed through a cultural relativist lens in that what Western psychiatrists classify as a depression is constructed differently in other cultures.8 Considering these limitations, some critics have gone so far as to argue that psychiatric diagnostic systems should be abolished.9Yet architects of DSM manuals have worked hard to ensure the technology of classification is regarded as genuine scientific activity with sound roots in philosophy of science.

In their philosophical defence of DSM IV, Allen Frances and colleagues address their critics under the headings ‘nominalism vs realism’, ‘empiricism vs rationalism’ and ‘categorical vs dimensional’.10 The implication is that cialis bathtub logo there are opposing stances in which a choice must be made or a middle ground forged by those reasonable enough to recognise the need for pragmatism in the service of clinical utility. The nominalism–realism debate is illustrated using as metaphor three different stances a cricket umpire might take on calling strikes and balls. The discussion cialis bathtub logo sets out two of these as extreme views. €˜at one extreme…those who take a reductionistically realistic view of the world’ versus ‘the solipsistic nominalists…might content that nothing exists’. Szasz, who is characterised as holding particularly extreme views, is named as an archetypal solipsist.

There is implied to be a degree of arrogance associated with this view in the illustrative cialis bathtub logo example in which the umpire states ‘there are no balls and there are no strikes until I call them’. Frances therefore sets up a means of grouping two kinds of people as philosophical extremists who can be dismissed, while avoiding addressing the philosophical problems they pose.Frances provides little if any justification for the middle ground stance, ‘There are balls and there are strikes and I call them as I see them’, other than to focus on its clinical utility and the lack of clinical utility in the alternatives ‘naïve realism’ and ‘heuristically barren solipsism’. The natural conclusion the reader is invited to reach is that a middle ground of a heuristic concept is naturally right because it is cialis bathtub logo not extreme and is naturally useful clinically, without specifying in what way this stance is coherent, resolves the two alternatives, and in what way a heuristic construct that is not ‘real’ can be subject to scientific testing.Similarly, in discussing the ‘categorical vs dimensional’, Frances promotes the ‘prototype approach’. Those holding opposing views are labelled as ‘dualists’ or ‘dichotomisers’. The prototypical approach is again put forward as a clinically useful middle ground.

Illustrations are drawn from natural cialis bathtub logo science. €˜a triangle and a square are never the same’, inciting the reader to consider science as value-free. The prototypical cialis bathtub logo approach emerges as a natural solution, yet the authors do not address how a diagnostic prototype resolves the issues posed by the two alternatives, nor how a prototype can be subjected to natural science methods.The argument presented here is not a defence of solipsism or dualism. Rather it aims to illustrate that if for pragmatic purposes clinicians and policymakers choose to gloss over the philosophical flaws in classification practices, it is then risky to move beyond the heuristic and apply natural science methods to these constructs adding multiple layers of technocratic subclassification. Doing so is more like playing Minecraft than cricket.

The National Institute for Health cialis bathtub logo and Care Excellence (NICE) guideline for depression is taken as an example of the philosophical errors that can follow from playing Minecraft with unsound heuristic devices, specifically subcategories of persistent forms of depression. As well as serving a clinical purpose, diagnosis in medicine is a way of allocating resources for insurance companies and constructing clinical guidelines, which in turn determine rationing within the National Health Service. The consequences for recipients of healthcare are cialis bathtub logo therefore significant. Clinical utility is arguably not being served at all and patients are left at risk of poor-quality care.Heterogeneity of persistent depressionAndrea Jobst and colleagues note that ‘because of their chronic clinical course, approximately 40% of CD [chronic depression] patients also fulfil criteria for TRD [treatment resistant depression]…usually defined by the number of non-successful biological treatments’.11 This position is reflected in the DSM VAmerican Psychiatric Association (2013), the European Psychiatric Association (EPA) guidance and the ICD-11(World Health Organisation, 2018), which all use a ‘persistent’ depression category, acknowledging a loosely defined mixed group of long-term, difficult-to-treat depressive conditions, often associated with dysthymia and comorbid common mental disorders, various personality traits and psychosocial disability.In contrast, the NICE 2018 draft guideline separates treatments into those for ‘new episodes’ of depression. €˜further-line’ treatment of depression (equivalent to TRD), CD and ‘depression with co-morbidities’.

The latter is subdivided into cialis bathtub logo treatments for ‘complex depression’ and ‘psychotic depression’. These categories and subcategories introduce an unfortunate sense of certainty as though these labels represent real things. An analysis follows of how these definitions play out cialis bathtub logo in terms of grouping of randomised controlled trials in the NICE evidence review. Specifically, the analysis reveals the overlap between populations in trials which have been separated into discrete categories, revealing significant limitations to the utility of the category labels.The NICE definition of CD requires trial samples to meet the criteria for major depressive disorder (MDD) for 2 years. Dysthymia and double depression (MDD superimposed on dysthymia) were included.

If 75% of the trial population met these criteria, the trial cialis bathtub logo was reviewed in the CD category.12 The definition of TRD (or ‘further-line treatments’) required that the trial sample had demonstrated a ‘limited response to previous treatment’ and randomised to the further-line treatment at this point. If 80% of the trial participants met these criteria, it was reviewed in the TRD category.13 Complex depression was defined as ‘depression co-existing with personality disorder’. To be classed as complex, 51% of trial cialis bathtub logo participants had to have personality disorder (PD).14It is immediately clear from these definitions that there is a potential problem with attempting to categorise trial populations into just one of these categories. These populations are likely to overlap, whether or not a trial protocol sets out to explicitly record all of this information. The analysis below will illustrate this using examples from within the NICE review.Cataloguing complexity in trial populationsWithin the category of further-line treatments (TRD), 64 trials were reviewed.

Comparisons within these trials were further subcategorised into ‘dose escalation strategies’, ‘augmentation cialis bathtub logo strategies’ and ‘switching strategies’. In drilling down by way of illustration, this analysis considers the 51 trials in the augmentation strategy evidence review. Of these, two were classified by the reviewers as also fulfilling the criteria for CD but were not analysed in the CD category (Study IDs. Fonagy 2015 and Kocsis 200915) cialis bathtub logo. About half of the trials (23/51) did not report the mean duration of episode, meaning that it is not possible to know what percentage of participants also met the criteria for CD.

Of trials that did report episode duration, 17 reported a mean duration cialis bathtub logo longer than 24 months. While the standard deviations varied in size or were unreported, the mean indicates a good likelihood that a significant proportion of the participants across these 51 trials met the criteria for CD.Details of baseline employment, trauma history, suicidality, physical comorbidity, axis I comorbidity and PD (all clinical indicators of complexity, severity and chronicity) were not collated by NICE. For the present analysis, all 51 publications were examined and data compiled concerning clinical complexity in the trial populations. Only 14 of 51 cialis bathtub logo trials report employment data. Of those that do, unemployment ranges from 12% to 56% across trial samples.

None of cialis bathtub logo the trials report trauma history. About half of the trials (26/51) excluded people who were considered a suicide risk. The others did not.A large proportion of trials (30/51) did not provide any data on axis 1 comorbidity. Of these, 18 did not exclude cialis bathtub logo any diagnoses, while 12 excluded some (but not all) disorders. The most common diagnoses excluded were psychotic disorders, substance or alcohol abuse, and bipolar disorder (excluded in 26, 25 and 23 trials, respectively).

Only 7 of cialis bathtub logo 51 trials clearly stated that all axis 1 diagnoses were excluded. This leaves only 13 studies providing any data about comorbidity. Of these, 9 gave partial data on one or two conditions, while 4 reported either the mean number of disorders (range 1.96–2.9) or the percentage of participants (range 68.1–96.7) with any comorbid diagnosis (Nierenberg 2003a, Nierenberg 2006, Watkins 2011a, Town 201715).The majority of trials (46/51) did not report the prevalence of PD. Many stated PD cialis bathtub logo as an exclusion criterion but without defining a threshold for exclusion. For example, PD could be excluded if it ‘impacted’ the depression, if it was ‘significant’, ‘severe’ or ‘persistent’.

Some excluded certain PDs (such as antisocial or borderline) and not others cialis bathtub logo but without reporting the prevalence of those not excluded. In the five trials where prevalence was clear, prevalence ranged from 0% (Ravindran 2008a15), where all PDs were excluded, to 87.5% of the sample (Town 201715). Two studies reported the mean number of PDs. 2.0 (Nierenberg cialis bathtub logo 2003a) and 0.85 (Watkins 2011a15).The majority of trials (43/51) did not report the prevalence of physical illness. Many stated illness as an exclusion criterion, but the definitions and thresholds were vague and could be interpreted in different ways.

For example, illness could be cialis bathtub logo excluded if it was ‘unstable’, ‘serious’, ‘significant’, ‘relevant’, or would ‘contraindicate’ or ‘impact’ the medication. Of the eight trials reporting information about physical health, there was a wide variation. Four reported prevalence varying from 7.6% having a disability (Eisendrath 201615) to 90.9% having an illness or disability (Town 201715). Four used cialis bathtub logo scales of physical health. Two indicating mild problems (Nierenberg 2006, Lavretsky 201115) and two indicating moderately high levels of illness (Thase 2007, Fang 201015).The NICE review also divided trial populations into a dichotomy of ‘more severe’ and ‘less severe’ on the grounds that this would be a clinically useful classification for general practitioners.

NICE applied a bespoke methodology for creating this dichotomy, abandoning validated measure cialis bathtub logo thresholds in order first to generate two ‘homogeneous’ groups to ‘facilitate analysis’, and second to create an algorithm to ‘read across’ different measures (such as the Beck Depression Inventory, the Hamilton Rating Scale for Depression (HRSD) and the Montgomery-Asberg Depression Rating Scale).16 Examining trials which use more than one of these measures reveals problems in the algorithm. Of the 51 trials, there are 6 instances in which the study population falls into NICE’s more severe category according to one measure and into the less severe category according to another. In four of these trials, NICE chose the less severe category (Souza 2016, Watkins 2011a, Fonagy 2015, Town 201715). The other two trials were designated more cialis bathtub logo severe (Barbee 2011, Dunner 200715). Only 17 of 51 trials reported two or more depression scale measures, leaving much unknown about whether other study populations could count as both more severe and less severe.Absence of knowledge or knowledge of absence?.

A key philosophical error cialis bathtub logo in science is to confuse an absence of knowledge with knowledge of absence. It is likely that some of the study populations deemed lacking in complexity or severity could actually have high degrees of complexity and/or severity. Data to demonstrate this may either fall foul of a guideline committee decision to prioritise certain information over other conflicting information (as in the severity algorithm). The information may be non-existent as cialis bathtub logo it was not collected. It may be somewhere in the publication pipeline.

Or it may be sitting in a database with a research team that has run out of cialis bathtub logo funds for supplementary analyses. Wherever those data are or are not, their absence from published articles does not define the phenomenology of depression for the patients who took part. As a case in point, data from the Fonagy 2015 trial presented at conferences but not published reveal that PD prevalence data would place the trial well within the NICE complex depression category, and that the sample had high levels of past trauma and physical condition comorbidity. The trial also meets the guideline criteria for CD according to the guideline’s own appendices.17 Reported axis 1 comorbidity was high (75.2% had anxiety cialis bathtub logo disorder, 18.6% had substance abuse disorder, 13.2% had eating disorder).18 The mean depression scores at baseline were 36.5 on the Beck Depression Inventory and 20.1 on the HRSD (severe and very severe, respectively, according to published cut-off scores). NICE categorised this population as less severe TRD, not CD and not complex.Notes1.

Avram H cialis bathtub logo. Mack et al. (1994), “A Brief History of Psychiatric Classification. From the Ancients to DSM-IV,” cialis bathtub logo Psychiatric Clinics 17, no. 3.

515–9.2. R. P. Snaith (1987), “The Concepts of Mild Depression,” British Journal of Psychiatry 150, no. 3.

387.3. Susan McPherson and David Armstrong (2006), “Social Determinants of Diagnostic Labels in Depression,” Social Science &. Medicine 62, no. 1. 52–7.4.

Gerald N. Grob (1991), “Origins of DSM-I. A Study in Appearance and Reality,” The American Journal of Psychiatry. 421–31.5. Wilson M.

Compton and Samuel B. Guze (1995), “The Neo-Kraepelinian Revolution in Psychiatric Diagnosis,” European Archives of Psychiatry and Clinical Neuroscience 245, no. 4. 198–9.6. Gerald L.

Klerman (1984), “A Debate on DSM-III. The Advantages of DSM-III,” The American Journal of Psychiatry. 539–42.7. Thomas E. Schacht (1985), “DSM-III and the Politics of Truth,” American Psychologist.

513–5.8. Daniel F. Hartner and Kari L. Theurer (2018), “Psychiatry Should Not Seek Mechanisms of Disorder,” Journal of Theoretical and Philosophical Psychology 38, no. 4.

189–204.9. Sami Timimi (2014), “No More Psychiatric Labels. Why Formal Psychiatric Diagnostic Systems Should Be Abolished,” Journal of Clinical and Health Psychology 14, no. 3. 208–15.10.

Allen Frances et al. (1994), “DSM-IV Meets Philosophy,” The Journal of Medicine and Philosophy. A Forum for Bioethics and Philosophy of Medicine 19, no. 3. 207–18.11.

Andrea Jobst et al. (2016), “European Psychiatric Association Guidance on Psychotherapy in Chronic Depression Across Europe,” European Psychiatry 33. 20.12. National Institute for Health and Care Excellence (2018), Depression in Adults. Treatment and Management.

Draft for Consultation, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/full-guideline-updated, 507.13. Ibid., 351–62.14. Ibid., 597.15. Note that in order to refer to specific trials reviewed in the guideline, rather than the full citation, the Study IDs from column A in appendix J5 have been used. See www.nice.org.uk/guidance/gid-cgwave0725/documents/addendum-appendix-9 for details and full references.16.

National Institute for Health and Care Excellence (2018), Depression in Adults. Treatment and Management. Second Consultation on Draft Guideline – Stakeholder Comments Table, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/consultation-comments-and-responses-2, 420–1.17. National Institute for Health and Care Excellence (2018), Depression in Adults, appendix J5.18. Peter Fonagy et al.

(2015), “Pragmatic Randomized Controlled Trial of Long-Term Psychoanalytic Psychotherapy for Treatment-Resistant Depression. The Tavistock Adult Depression Study (TADS),” World Psychiatry 14, no. 3. 312–21.19. American Psychological Association (2018), Clinical Practice Guideline for the Treatment of Depression in Children, Adolescents, and Young, Middle-aged, and Older Adults.

Draft.20. Jacqui Thornton (2018), “Depression in Adults. Campaigners and Doctors Demand Full Revision of NICE Guidance,” BMJ 361. K2681..

We live in unprecedented order cialis times. But what makes them without parallel is not the current cialis crisis nor the continued problems facing minorities in our institutions. Rather, it’s that for the first time, the problems of accessibility, rights and freedoms are order cialis now invading privileged spaces.

There can be no ‘getting back to normal’, because ‘normal’ only ever benefited the white, Western, patriarchal, abled and cis ideals. For many, the world is not suddenly on fire. €¦IntroductionMinecraft is a order cialis computer game with no specific goals to accomplish.

The gameworld consists of three-dimensional (3D) cubes and objects which the player (Steve) can mine and build into infinitely complex (and logically impossible) structures. Steve sometimes encounters other characters (‘mobs’), such as order cialis animals and hostile creatures. He can ‘spawn’ and destroy them.

While it looks like a harmless game of logical construction, it conveys some worryingly delusive ideas about the real world. The difference between real and imagined structures is at the heart of the age-old debate around categorising mental disorders.Classification in mental order cialis health has had various forms throughout history. Mack and colleagues set out a history of psychiatric classification beginning in 2600 BC with Egyptian references to melancholia and hysteria.

Through the order cialis Ancient Greeks with Hippocrates’ phrenitis, mania, melancholia, epilepsy, hysteria and Scythian disease. Through the Renaissance period. Through to 19th-century psychiatry featuring Pinel (known as the first psychiatrist), Kraepelin (known for observational classification) and Freud (known for classifying neurosis and psychosis).1Although the history of psychiatric classification identifies some common trends such as the labels ‘melancholia’ and ‘hysteria’ which have survived millennia, the label ‘depression’ is relatively new.

The earliest order cialis usage noted by Snaith is from 1899. €˜in simple pathological depression…the patient exhibits a growing indifference to his former pursuits…’.2 Snaith noted that early 20th-century psychiatrists like Adolf Meyer hoped that ‘depression’ would come to encompass a broad category under which descriptions of subtypes would emerge. This did not happen until the middle order cialis of the 20th century.

With the publication of the sixth International Classification of Diseases (ICD) in 1948 and the Diagnostic and Statistical Manual of Mental Disorders (DSM) in 1952 and their subsequent revisions, the latter half of the 20th century has seen depression subtype labels proliferate. In their study of the social determinants of diagnostic labels in depression, McPherson and Armstrong illustrate how the codification of depression subtypes in the latter half of the 20th century has been shaped by the evolving context of psychiatry, including power struggles within the profession, a move to community care and the development of psychopharmacology.3During this period, McPherson and Armstrong describe how subsequent versions of the DSM served as battlegrounds for professional disputes and philosophical quarrels around categorisation of mental disorders. DSM I and DSM II have been described as products of an American Psychiatric Association dominated by psychoanalytic psychiatrists.4 DSM III and DSM III-R have been described as a radical rejection of psychoanalytic thinking, a ‘neo-Kraepelinian revolution’, a reference to the observational descriptive techniques of 19th-century psychiatrist Emil order cialis Kraepelin who classified mental disorders into two broad categories.

€˜dementia praecox’ and ‘manic-depression’.5 DSM III was seen by some as a turning point in the use of the medical model of mental illness, through provision of specific inclusion and exclusion criteria, and use of field trials and a multiaxial system.6 These latter technocratic additions to psychiatric labelling served to engender a much closer alignment between psychiatry, science and medicine.The codification of mental disorders in manuals has been described by Thomas Schacht as intrinsic to the relationship between science and politics and the way in which psychiatrists gain significant social power by aligning themselves to science.7 His argument drew on Szasz, who saw the mental health establishment as a therapeutic state. Zimbardo, who order cialis described psychiatric care as a controlling force. And Foucault, who described the categorisation of the mentally ill as a force for isolating ‘the other’.

Diagnostic critique has been further developed through a cultural relativist lens in that what Western psychiatrists classify as a depression is constructed differently in other cultures.8 Considering these limitations, some critics have gone so far as to argue that psychiatric diagnostic systems should be abolished.9Yet architects of DSM manuals have worked hard to ensure the technology of classification is regarded as genuine scientific activity with sound roots in philosophy of science. In their philosophical defence of DSM IV, Allen Frances and colleagues address their critics order cialis under the headings ‘nominalism vs realism’, ‘empiricism vs rationalism’ and ‘categorical vs dimensional’.10 The implication is that there are opposing stances in which a choice must be made or a middle ground forged by those reasonable enough to recognise the need for pragmatism in the service of clinical utility. The nominalism–realism debate is illustrated using as metaphor three different stances a cricket umpire might take on calling strikes and balls.

The discussion order cialis sets out two of these as extreme views. €˜at one extreme…those who take a reductionistically realistic view of the world’ versus ‘the solipsistic nominalists…might content that nothing exists’. Szasz, who is characterised as holding particularly extreme views, is named as an archetypal solipsist.

There is implied to be a degree of arrogance order cialis associated with this view in the illustrative example in which the umpire states ‘there are no balls and there are no strikes until I call them’. Frances therefore sets up a means of grouping two kinds of people as philosophical extremists who can be dismissed, while avoiding addressing the philosophical problems they pose.Frances provides little if any justification for the middle ground stance, ‘There are balls and there are strikes and I call them as I see them’, other than to focus on its clinical utility and the lack of clinical utility in the alternatives ‘naïve realism’ and ‘heuristically barren solipsism’. The natural conclusion the order cialis reader is invited to reach is that a middle ground of a heuristic concept is naturally right because it is not extreme and is naturally useful clinically, without specifying in what way this stance is coherent, resolves the two alternatives, and in what way a heuristic construct that is not ‘real’ can be subject to scientific testing.Similarly, in discussing the ‘categorical vs dimensional’, Frances promotes the ‘prototype approach’.

Those holding opposing views are labelled as ‘dualists’ or ‘dichotomisers’. The prototypical approach is again put forward as a clinically useful middle ground. Illustrations are order cialis drawn from natural science.

€˜a triangle and a square are never the same’, inciting the reader to consider science as value-free. The prototypical approach emerges as a natural solution, yet the authors do not address how a diagnostic prototype resolves the issues posed order cialis by the two alternatives, nor how a prototype can be subjected to natural science methods.The argument presented here is not a defence of solipsism or dualism. Rather it aims to illustrate that if for pragmatic purposes clinicians and policymakers choose to gloss over the philosophical flaws in classification practices, it is then risky to move beyond the heuristic and apply natural science methods to these constructs adding multiple layers of technocratic subclassification.

Doing so is more like playing Minecraft than cricket. The National Institute for Health and Care Excellence (NICE) guideline order cialis for depression is taken as an example of the philosophical errors that can follow from playing Minecraft with unsound heuristic devices, specifically subcategories of persistent forms of depression. As well as serving a clinical purpose, diagnosis in medicine is a way of allocating resources for insurance companies and constructing clinical guidelines, which in turn determine rationing within the National Health Service.

The consequences for recipients of healthcare are therefore significant order cialis. Clinical utility is arguably not being served at all and patients are left at risk of poor-quality care.Heterogeneity of persistent depressionAndrea Jobst and colleagues note that ‘because of their chronic clinical course, approximately 40% of CD [chronic depression] patients also fulfil criteria for TRD [treatment resistant depression]…usually defined by the number of non-successful biological treatments’.11 This position is reflected in the DSM VAmerican Psychiatric Association (2013), the European Psychiatric Association (EPA) guidance and the ICD-11(World Health Organisation, 2018), which all use a ‘persistent’ depression category, acknowledging a loosely defined mixed group of long-term, difficult-to-treat depressive conditions, often associated with dysthymia and comorbid common mental disorders, various personality traits and psychosocial disability.In contrast, the NICE 2018 draft guideline separates treatments into those for ‘new episodes’ of depression. €˜further-line’ treatment of depression (equivalent to TRD), CD and ‘depression with co-morbidities’.

The latter is subdivided order cialis into treatments for ‘complex depression’ and ‘psychotic depression’. These categories and subcategories introduce an unfortunate sense of certainty as though these labels represent real things. An analysis follows of how these definitions play out in terms of grouping of randomised controlled trials in the order cialis NICE evidence review.

Specifically, the analysis reveals the overlap between populations in trials which have been separated into discrete categories, revealing significant limitations to the utility of the category labels.The NICE definition of CD requires trial samples to meet the criteria for major depressive disorder (MDD) for 2 years. Dysthymia and double depression (MDD superimposed on dysthymia) were included. If 75% of the trial population met these criteria, the trial was reviewed in the CD category.12 The definition of TRD (or ‘further-line treatments’) required that the trial sample had demonstrated a order cialis ‘limited response to previous treatment’ and randomised to the further-line treatment at this point.

If 80% of the trial participants met these criteria, it was reviewed in the TRD category.13 Complex depression was defined as ‘depression co-existing with personality disorder’. To be classed as complex, 51% of trial participants had to have personality disorder (PD).14It is immediately clear from these definitions that there is a potential problem with attempting to categorise trial populations into order cialis just one of these categories. These populations are likely to overlap, whether or not a trial protocol sets out to explicitly record all of this information.

The analysis below will illustrate this using examples from within the NICE review.Cataloguing complexity in trial populationsWithin the category of further-line treatments (TRD), 64 trials were reviewed. Comparisons within these trials were further subcategorised into ‘dose escalation strategies’, ‘augmentation strategies’ and ‘switching strategies’ order cialis. In drilling down by way of illustration, this analysis considers the 51 trials in the augmentation strategy evidence review.

Of these, two were classified by the reviewers as also fulfilling the criteria for CD but were not analysed in the CD category (Study IDs. Fonagy 2015 and Kocsis 200915) order cialis. About half of the trials (23/51) did not report the mean duration of episode, meaning that it is not possible to know what percentage of participants also met the criteria for CD.

Of trials that did report order cialis episode duration, 17 reported a mean duration longer than 24 months. While the standard deviations varied in size or were unreported, the mean indicates a good likelihood that a significant proportion of the participants across these 51 trials met the criteria for CD.Details of baseline employment, trauma history, suicidality, physical comorbidity, axis I comorbidity and PD (all clinical indicators of complexity, severity and chronicity) were not collated by NICE. For the present analysis, all 51 publications were examined and data compiled concerning clinical complexity in the trial populations.

Only 14 of order cialis 51 trials report employment data. Of those that do, unemployment ranges from 12% to 56% across trial samples. None of the trials order cialis report trauma history.

About half of the trials (26/51) excluded people who were considered a suicide risk. The others did not.A large proportion of trials (30/51) did not provide any data on axis 1 comorbidity. Of these, order cialis 18 did not exclude any diagnoses, while 12 excluded some (but not all) disorders.

The most common diagnoses excluded were psychotic disorders, substance or alcohol abuse, and bipolar disorder (excluded in 26, 25 and 23 trials, respectively). Only 7 of 51 trials clearly stated that all order cialis axis 1 diagnoses were excluded. This leaves only 13 studies providing any data about comorbidity.

Of these, 9 gave partial data on one or two conditions, while 4 reported either the mean number of disorders (range 1.96–2.9) or the percentage of participants (range 68.1–96.7) with any comorbid diagnosis (Nierenberg 2003a, Nierenberg 2006, Watkins 2011a, Town 201715).The majority of trials (46/51) did not report the prevalence of PD. Many stated PD as an exclusion criterion but without defining a threshold for order cialis exclusion. For example, PD could be excluded if it ‘impacted’ the depression, if it was ‘significant’, ‘severe’ or ‘persistent’.

Some excluded certain order cialis PDs (such as antisocial or borderline) and not others but without reporting the prevalence of those not excluded. In the five trials where prevalence was clear, prevalence ranged from 0% (Ravindran 2008a15), where all PDs were excluded, to 87.5% of the sample (Town 201715). Two studies reported the mean number of PDs.

2.0 (Nierenberg 2003a) and 0.85 (Watkins 2011a15).The majority of trials (43/51) did not report the prevalence order cialis of physical illness. Many stated illness as an exclusion criterion, but the definitions and thresholds were vague and could be interpreted in different ways. For example, illness could be excluded if it was ‘unstable’, ‘serious’, ‘significant’, ‘relevant’, order cialis or would ‘contraindicate’ or ‘impact’ the medication.

Of the eight trials reporting information about physical health, there was a wide variation. Four reported prevalence varying from 7.6% having a disability (Eisendrath 201615) to 90.9% having an illness or disability (Town 201715). Four used order cialis scales of physical health.

Two indicating mild problems (Nierenberg 2006, Lavretsky 201115) and two indicating moderately high levels of illness (Thase 2007, Fang 201015).The NICE review also divided trial populations into a dichotomy of ‘more severe’ and ‘less severe’ on the grounds that this would be a clinically useful classification for general practitioners. NICE applied a bespoke methodology for creating this dichotomy, abandoning validated measure thresholds in order first to generate two ‘homogeneous’ groups to ‘facilitate analysis’, and second to create an algorithm order cialis to ‘read across’ different measures (such as the Beck Depression Inventory, the Hamilton Rating Scale for Depression (HRSD) and the Montgomery-Asberg Depression Rating Scale).16 Examining trials which use more than one of these measures reveals problems in the algorithm. Of the 51 trials, there are 6 instances in which the study population falls into NICE’s more severe category according to one measure and into the less severe category according to another.

In four of these trials, NICE chose the less severe category (Souza 2016, Watkins 2011a, Fonagy 2015, Town 201715). The other two order cialis trials were designated more severe (Barbee 2011, Dunner 200715). Only 17 of 51 trials reported two or more depression scale measures, leaving much unknown about whether other study populations could count as both more severe and less severe.Absence of knowledge or knowledge of absence?.

A key philosophical error in science is to confuse an absence of knowledge order cialis with knowledge of absence. It is likely that some of the study populations deemed lacking in complexity or severity could actually have high degrees of complexity and/or severity. Data to demonstrate this may either fall foul of a guideline committee decision to prioritise certain information over other conflicting information (as in the severity algorithm).

The information may order cialis be non-existent as it was not collected. It may be somewhere in the publication pipeline. Or it may be sitting in a database with a research team that has run out of order cialis funds for supplementary analyses.

Wherever those data are or are not, their absence from published articles does not define the phenomenology of depression for the patients who took part. As a case in point, data from the Fonagy 2015 trial presented at conferences but not published reveal that PD prevalence data would place the trial well within the NICE complex depression category, and that the sample had high levels of past trauma and physical condition comorbidity. The trial also meets the guideline criteria for CD according to the guideline’s own appendices.17 Reported axis 1 comorbidity was high (75.2% order cialis had anxiety disorder, 18.6% had substance abuse disorder, 13.2% had eating disorder).18 The mean depression scores at baseline were 36.5 on the Beck Depression Inventory and 20.1 on the HRSD (severe and very severe, respectively, according to published cut-off scores).

NICE categorised this population as less severe TRD, not CD and not complex.Notes1. Avram H order cialis. Mack et al.

(1994), “A Brief History of Psychiatric Classification. From the Ancients to DSM-IV,” Psychiatric Clinics 17, no order cialis. 3.

Snaith (1987), “The Concepts of Mild Depression,” British Journal of Psychiatry 150, no. 3. 387.3.

Susan McPherson and David Armstrong (2006), “Social Determinants of Diagnostic Labels in Depression,” Social Science &. Medicine 62, no. 1.

52–7.4. Gerald N. Grob (1991), “Origins of DSM-I.

A Study in Appearance and Reality,” The American Journal of Psychiatry. 421–31.5. Wilson M.

Compton and Samuel B. Guze (1995), “The Neo-Kraepelinian Revolution in Psychiatric Diagnosis,” European Archives of Psychiatry and Clinical Neuroscience 245, no. 4.

198–9.6. Gerald L. Klerman (1984), “A Debate on DSM-III.

The Advantages of DSM-III,” The American Journal of Psychiatry. 539–42.7. Thomas E.

Schacht (1985), “DSM-III and the Politics of Truth,” American Psychologist. 513–5.8. Daniel F.

Hartner and Kari L. Theurer (2018), “Psychiatry Should Not Seek Mechanisms of Disorder,” Journal of Theoretical and Philosophical Psychology 38, no. 4.

189–204.9. Sami Timimi (2014), “No More Psychiatric Labels. Why Formal Psychiatric Diagnostic Systems Should Be Abolished,” Journal of Clinical and Health Psychology 14, no.

(1994), “DSM-IV Meets Philosophy,” The Journal of Medicine and Philosophy. A Forum for Bioethics and Philosophy of Medicine 19, no. 3.

207–18.11. Andrea Jobst et al. (2016), “European Psychiatric Association Guidance on Psychotherapy in Chronic Depression Across Europe,” European Psychiatry 33.

20.12. National Institute for Health and Care Excellence (2018), Depression in Adults. Treatment and Management.

Draft for Consultation, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/full-guideline-updated, 507.13. Ibid., 351–62.14. Ibid., 597.15.

Note that in order to refer to specific trials reviewed in the guideline, rather than the full citation, the Study IDs from column A in appendix J5 have been used. See www.nice.org.uk/guidance/gid-cgwave0725/documents/addendum-appendix-9 for details and full references.16. National Institute for Health and Care Excellence (2018), Depression in Adults.

Treatment and Management. Second Consultation on Draft Guideline – Stakeholder Comments Table, https://www.nice.org.uk/guidance/gid-cgwave0725/documents/consultation-comments-and-responses-2, 420–1.17. National Institute for Health and Care Excellence (2018), Depression in Adults, appendix J5.18.

Peter Fonagy et al. (2015), “Pragmatic Randomized Controlled Trial of Long-Term Psychoanalytic Psychotherapy for Treatment-Resistant Depression. The Tavistock Adult Depression Study (TADS),” World Psychiatry 14, no.

3. 312–21.19. American Psychological Association (2018), Clinical Practice Guideline for the Treatment of Depression in Children, Adolescents, and Young, Middle-aged, and Older Adults.

Draft.20. Jacqui Thornton (2018), “Depression in Adults. Campaigners and Doctors Demand Full Revision of NICE Guidance,” BMJ 361.

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RESEARCH

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My research is interdisciplinary and multi-level, and it coalesces around the broad areas of strategy, technology and innovation. Strategic innovation is the process by which an organization reinvents or redesigns its strategy to drive change, enhance value creation across stakeholders, and, ultimately, to sustain itself. Thus, it focuses on the art, science, and process of building, implementing, and constantly evaluating strategy in organizational settings. It integrates traditional approaches to strategic management, with the tools, frameworks, and values related to design thinking and innovation. As my record indicates, most of my research focuses specifically on the way information technology is used in organizational settings to help organizations achieve competitive advantage. I look toward the future, it is at this intersection and integration of disciplines and “schools of thought” that great opportunity for impact and contribution exists.

My passion is to understand how organizations can improve their capacity to innovate, change, and reinvent themselves through a more effective strategic innovation process, and re-conceptualizing the role of information technology. By developing and cultivating their strategic innovation capability, organizations will sustain themselves and create greater value for a broader range of stakeholders. While using theories and frameworks from diverse disciplines (strategy, social and cognitive psychology, innovation management, information systems), I examine how strategy and innovation occur within individuals, teams, organizations, inter-firm relationships, and even value chains and how it ultimately impacts value creation for diverse stakeholders. In doing so, I explore strategic innovation in both established and entrepreneurial firms and at multiple levels of analysis (network, inter-firm, organizational, and individual).

I resist reductionism when studying strategic innovation, and have a strong bias toward holistic and systems orientations to understand organizational systems and the inherently complex process of strategic innovation. In most cases, I explore these issues through in-depth, longitudinal qualitative case studies and have a strong action research orientation, though I believe strongly in the power of both qualitative and quantitative techniques if adequately applied. My current and future research streams are mentioned below.

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  1. Strategy Making Processes – In this stream I investigate the process of strategy making. and utilize an action research approach to examine it in its real world context and contribute to our collective understanding of how we can do it better.
  2. Innovation Management Processes – I focus specifically on design thinking and also utilize an action research methodology to contribute to our collective understanding of its efficacy and explore methods for making it even more useful in organizational settings.
  3. Strategic Innovation – This stream focuses on the linkages between strategy making and innovation management in organizational settings.


PUBLICATIONS

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Lewis, M., Hayward, S., Baxter, R., & Coffey, B.  “Stakeholder Enrolment and Business Network Formation: A Process Perspective on Technology Innovation.” International Journal of Technoentrepeneurship. Forthcoming.

Hornyay, R., Lewis, M., & Sankaranarayanan, B. “Radio Frequency Identification–Enabled Capabilities in a Healthcare Context: An Exploratory Study.” Health Informatics Journal, vol. 22, no. 3, 562–578.

Lewis, M., Hayward, S., & Kasi, V. 2015. “The Peril of One: Architecting a Sourcing Strategy at Edwards Paper Co.” Business Case Journal, vol. 22, no. 1.

Lewis, M., & Elevar, R. 2014. “Managing and Fostering Creativity: An Integrated Approach.” International Journal of Management Education, vol. 12, no. 3, 235–247.

Lewis, M., Hayward, S., & Kasi, V. 2013. “The Hazards of Sole Sourcing Relationships: Challenges, Practices, and Insights.” Advanced Management Journal, vol. 78, no. 3, 28–37.

Lewis, M., Baxter, R., & Pouder, R. 2013. “The Development and Deployment of Electronic Personal Health Records: A Strategic Positioning Perspective.” Journal of Health Organization and Management, vol. 27, no. 5, 577–600.

Lewis, M., Sankaranarayanan, B., & Rai, A. 2012. “Technology and Context: A Sociomaterial Perspective on Technology Enabled Change.” Academy of Management Annual Meeting Proceedings. 

Lewis, M. 2011. “An Integrated Approach to Teaching the Capstone Strategic Management Course: A Left- and Right-Brained Approach.” Business Education Innovation Journal, vol. 3, no. 2, 66–72.

Lewis, M., Mathiassen, L., & Rai, A. 2011. “Scalable Growth in IT-enabled Service Provisioning: A Sensemaking Perspective.” European Journal of Information Systems, vol. 20, no. 3, 285–302.

Gogan, J., & Lewis, M. 2011. “Peak Experiences and Strategic IT alignment at Vermont Teddy Bear.” Journal of Information Technology Teaching Cases.  No. JIT031-PDF-ENG

Rai, A., Venkatesh, V., Bala, H., & Lewis, M. 2010. “Transitioning to a Modular Enterprise Architecture: Drivers, Constraints, and Actions.” Management Information Systems Quarterly Executive, vol. 9, no. 2.

Lewis, M., Hornyak, R., Patnayakuni, R., & Rai, A. 2008. “Business Network Agility for Global Demand–Supply Synchronization: A Comparative Case Study in the Apparel Industry.” Journal of Global Information Technology Management, vol. 11, no. 2, 5–29.

Lewis, M., Young, B., Mathiassen, L., Rai, A., & Welke, R. 2007. “Business Process Innovation Based on Stakeholder Perceptions.” Information, Knowledge, and Systems Management, vol. 6, nos. 1-2, 7–27.

Lewis, M., Rai, A., Forquer, D., & Quinter, D. 2007. UPS and HP: Value Creation Through Supply Chain Partnerships. London, ON: Ivey Publishing. No. 907D02-PDF-ENG (Over 8,000 copies sold to date.)

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Lewis, M., Rai, A., & Mathiassen, L. 2016. The Enactment of Interorganizational Relational Strategy and the Dynamics of Governance. Academy of Management National Meeting, Anaheim, CA.

Lewis, M., & Pouder, R. 2015. Highland Brewing Company: Nipping at our Heels and Sitting on our Heads. North American Case Research Association Annual Conference, Orlando, FL.

Lewis, M., Hayward, S., & Baxter. R. 2013. Architecting a Sourcing Strategy: The Peril of One and the Downside of Many at Atlantico. North American Case Research Association Annual Conference, Victoria, BC.

Lewis, M., Sankaranarayanan, B., & Rai, A. 2012. Technology and Context: A Sociomaterial Perspective on Technology Enabled Change. Academy of Management National Meeting, Boston, MA.

Lewis, M., Sankaranarayanan, B., & Rai, A. 2011. RFID-Enabled Innovation and Its Impact on Healthcare Process Performance: A Multilevel Analysis. International Conference on Information Systems, St. Louis, MO.

Lewis, M., & Baxter, R. 2010. Negotiating the Pack: The Development and Deployment of Electronic Personal Health Records. TIM Track, Academy of Management National Meeting, Montréal, QC.

Gogan, J., Lewis, M., Sankaranaryanan, B., & Johnson, E. 2010. Aiming at a Moving Target: IT Alignment in Toy Companies. European Conference on Information Systems, Perto, South Africa.

Lewis, M., Sankaranarayanan, B., & Rai, A. 2009. Exploring Transition in Healthcare Information Systems: A Process Perspective on RFID Enabled Change. 29th Annual International Conference on Information Systems, Phoenix, AZ.

Baxter, R., & Lewis, M. 2009. The Influence of Industry Structure on the Development and Deployment of a Personal Health Record System. Organizations and Society in Information Systems (OASIS) Conference, Phoenix, AZ.

Lewis, M., Sankaranarayanan, B., & Rai, A. 2009. RFID-Enabled Process Capabilities and Their Impacts on Healthcare Process Performance: A Multilevel Analysis. European Conference on Information Systems, Verona, Italy.

Lewis, M., Mathiassen, L., & Rai, A. 2009. Developing IS-Enabled Capabilities for a Vendor: A Case Study. Americas Conference on Information Systems, San Francisco, CA.

Lewis, M., & Rai, A. 2007. Building Sustainable Partnerships. MISQ-Executive Workshop.

Lewis, M. 2005. Sensemaking in Strategic Outsourcing Partnerships: A Multilevel Investigation of IT enabled Dynamic Capabilities. Research Poster in the IFIP TC 8 WG 8.6 International Working Conference Notebook, Atlanta, GA.

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Lewis, M., & Rai, A. 2006. Building Sustainable Partnerships: Ensuring Your Supply Chain Partnerships are Built to Last. Supply Chain Strategy, MIT.

Rai, A., Sambamurthy, V., & Lewis, M. 2002. Adaptive Logistics and Transportation. SAP Sponsored Thought Leadership Forum on Adaptive Supply Chain Networks.

Rai, A., Ruppel, C., & Lewis, M. 2002. Sense and Respond. SAP Sponsored Thought Leadership Forum on Adaptive Supply Chain Networks.

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Lewis, M., Hornyak, R., & Pouder, R. 2016. Highland Brewing Company: A Case of Product and Experience Design. Craft Beverages and Tourism, Volume 1: The Rise of Breweries and Distilleries in the United States. Forthcoming.

 



COURSES

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AppLab is multidisciplinary course that uses design thinking to solve real world problems. It is team taught with a diverse group of faculty across the university and draws students from an equally diverse set of disciplinary backgrounds. It his highly experiential, problem based, and adopts a action learning pedagogy. Click here for course brochure and click here for press related to AppLab.

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I teach Strategic Management by integrating traditional strategic management frameworks and design thinking. The traditional strategic management frameworks are useful for helping students understand what strategy is and for assessing “as-is” states of organizations, but in my mind it falls short when helping to guide the creation of strategic priorities, initiatives, and measures (that move beyond incremental adjustments) as part of a strategic planning process. Therefore, to fill this gap, I utilize design thinking in the formulation stages to support ideation and support implementation efforts. Within strategic management I teach the following courses:

  • MBA 5750 – At the graduate level I push much of the content online and focus class time on the class project. Students are divided into teams and have an external client for which they are responsible for developing a strategic plan.
  • MGT 4750 – At the Undergraduate level I divide the course in two halves. The first focuses on learning the traditional strategic management frameworks. The second half focuses on applying the frameworks to a real life strategic planning project.

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This course explores individual level factors that can impede and enhance creativity, and then does a deep dive on the design thinking process. We conclude with a short module on the impact of the organizational environment for supporting design oriented work. Like most of my classes, this is also centered on a real world project with external clients.

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  • Managerial Decision Making
  • Introduction to Information Systems


CONSULTING

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My consulting is delivered through Trailhead Design Co. Trailhead’s purpose is to help organizations achieve Peak Performance by integrating innovation and strategy. We do this by helping you drive innovation throughout your organization and carve out a unique position in your industry to create competitive advantage. This integration of innovation and strategy leads to a powerful engine that drives sustainable growth. To achieve this, we focus on two key practice areas:

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Innovation Workshops: Our innovation workshops focus on helping you build the internal capabilities to continuously innovate. We offer them at three levels:

  • Design Thinking- At the process level we focus on design thinking, a problem framing and solving process that drives innovation. If we can help everyone in your organization learn design process and share a common vocabulary for innovation, great things can happen. Click here for our current design thinking workshop.
  • Innovative Environment – Great processes need to be embedded in organizational environment that support them. So we work with organizations to evaluate and then enhance their culture, organizational design, and leadership practices through our Innovative Environment offering.
  • Personal Mastery – Innovation is hard work, organizations need individuals that understand their unique role in enabling innovation to occur. So our third area of focus relates to personal mastery, or helping individuals develop the capacities to become positive change makers in their organizations.

Innovation Consulting:

  • Design Studio – Our design studio offering takes the hard work of design and innovation off of your shoulders. Come to us with a design challenge that you simply don’t have bandwidth to tackle internally, and we will assemble a diverse team of experts to deliver solutions at a fraction of the cost of larger design firms.

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Strategy Workshop: Our strategy workshop focuses on helping you build internal strategic planning capabilities so you can drive the process yourself, continuously.

  • Strategic Planning – This workshop teaches a novel approach to strategic planning that integrates traditional strategic planning frameworks with design thinking. Doing so helps clients challenge the status quo and discover novel ways to position themselves in their competitive industries, respond to environment changes, and create value for all stakeholders. The process culminates with clearly defined strategic priorities, initiatives, and measures to help your organization achieve Peak Performance.

Strategy Consulting: Let’s face it. You are busy. In this offering we do the heavy lifting. Where the most renowned strategic consultancies have MBAs, our team generally has PhDs. Yet, given lower overhead, we work for a fraction of the cost.

  • Strategy Consulting – We collect the data, we analyze and interpret it, and we formulate into a set of actionable priorities, initiates, and measures that help your company move forward. Of course, we do this while working side-by-side with you. We are experts in the process, in collecting and analyzing data to generate important insights, and framing it in actionable ways so you can move forward. You are experts in your business. Let’s work together.

Trailhead’s website is currently underdevelopment and will go live in Summer, 2017. Until then, contact me at markolewis@gmail.com for more information. We would love to help your organization become alive again, by enhancing its capacity to innovate and positioning it for continued success!

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