PMLive
August 30, 2011

A report by the Financial Times has claimed a group of pharmaceutical companies has paid doctors in the US almost $150m so far during 2011.

Prepared in conjunction with the data provider, PharmaShine, the figures show the money was paid by pharmaceutical firms, including Eli Lilly, AstraZeneca (AZ) and Pfizer, for doctors’ travel and entertainment expenses as well as education and consultancy fees.

Of those companies who have released data, Lilly is reported to have paid $48m and Pfizer to have paid $42m.

AZ, who recently launched a database containing payments made to doctors and institutions, said $24.7m was paid out in associated compensation for the second quarter of 2011, with $8.1m going to individual physicians and $16.6m going to institutions.

In a post on the company’s AZ Health Connections blog, US compliance officer, Marie Martino, gave reason as to why the company was releasing its data.

She said: “AstraZeneca believes it is important to be open about how we conduct our business, and this new reporting expands on a major initiative announced three years ago to provide greater public visibility into how we do business.”

Around 165,000 doctors have received related payments in 2011 so far, compared to 262,000 doctors who received payment in 2010.

The report comes at a time when US government agencies are preparing guidelines to make the publication of industry support for medical professionals compulsory by 2013.

This is part of ongoing US healthcare reforms as an attempt to allow better, more consistent understanding of the pharmaceutical industry’s relationship with healthcare professionals in the US.

In the UK, the Association of the British Pharmaceutical Industry (ABPI) changed its code of practice at the beginning of 2011 to help increase transparency of working practices between the pharmaceutical industry and healthcare professionals to help increase trust.

Companies will have to declare payments to healthcare professionals for services including speaker fees, advisory boards and consultancy, and sponsorship for attendance at meetings on an annual basis. The first declaration will be made in 2013 for payments made in 2012.

http://www.pmlive.com/find_an_article/allarticles/categories/General/2011/august_2011/news/big_pharma_pays_us_doctors_$150m_in_2011

« Return to news items

News Feed

Related Posts

• Cause for alarm: Antipsychotic drugs for nursing home patients (0)
• Seven Ways Medical Conflicts of Interest are Disguised (0)
• Antipschotic Drugs—Side Effects May Include Lawsuits (0)
• Professor of Bioethics—Co-opted by market forces, clinical drug trials are now just covert instruments for promoting drugs (0)
• 4 Creepy Ways Big Pharma Peddles its Drugs (0)

 In a letter to OMB [ Office of Management and Budget]  Sen. Chuck Grassley warned the administration not to back off from a proposed rule that would create a website to disclose medical researchers’ conflicts of interest. “I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers.” Grassley said he’s worked tirelessly “to shine light on these relationships, including with the help of Sen. Kohl in securing the passage of the Physician Payment Sunshine Act of 2009.” Read the letter here: http://1.usa.gov/r0OLYG

The Honorable Jacob J. Lew
Director
Office of Management and Budget
Eisenhower Executive Office Building
1650 Pennsylvania Avenue, NW
Washington, DC 20503

Dear Director Lew:
I write to you today regarding public disclosure of financial relationships between physicians and the drug, device and biologic industries. For the past three years I have worked to shine light on these relationships, including with the help of Senator Kohl in securing the passage of the Physician Payment Sunshine Act of 2009 (PPSA).

Before the passage of PPSA, in summer of 2008, I began releasing the results of my oversight work that demonstrated that universities are not and have not managed their professors’ financial conflicts of interest and that change is needed at the National Institutes of Health (NIH). Specifically, I found:

The Chair of the Psychiatry Department at Emory University failed to report hundreds of thousands of dollars in payments from a pharmaceutical company while researching that same company’s drugs with an NIH grant. The Health and Human Services Office of the Inspector General (HHS OIG) is now investigating the matter.

The Chair of the Psychiatry Department at Stanford University received an NIH grant to study a drug while partially owning a company that was seeking FDA approval of said drug. He was later removed from the grant.

Three psychiatrists at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard released a report on the matter, and a briefing has been scheduled with my office.
I am concerned about recent reports that the Office of Management and Budget (OMB) may be attempting to weaken conflicts of interest rules proposed in May 2010 by the Department of Health and Human Services (HHS).

According to an article in Nature, OMB has removed the requirement for a publicly available website that would publish the conflicts of interests of researchers funded by taxpayers.1 I am troubled that taxpayers cannot learn about the outside income of the researchers whom the taxpayers are funding, and this flies in the face of President Obama’s call for more transparency in the government. The public’s business should be public. The consequences of a lack of transparency include doctors’ possibly using taxpayer-funded grants to leverage their own financial interests, to the detriment of consumers. Transparency is a backstop against such practices. I urge OMB to follow through and approve a rule that includes a publicly available website. OMB is the final arbiter of this decision. Any weakening of publicly available information requires careful scrutiny.

In order to understand why OMB appears to have concluded that weakening the HHS proposed conflict of interest rule is appropriate, I would appreciate your response to the following requests for documents:

1) Please provide all records relating to communications, including emails, with OMB staff regarding the Department of Health and Human Services’ proposed conflicts of interest rule from May 1, 2010, to the present.

2) Please provide all records, including calendar entries, relating to meetings with Administrator Cass Sunstein, OMB Office of Information and Regulatory Affairs, from May 1, 2010, to the present.

I request that OMB respond to my request by no later than August 25, 2011. Thank you for your attention to this important matter.

Sincerely,
Charles E. Grassley
Ranking Member
See the letter here: http://1.usa.gov/r0OLYG

« Return to news items

News Feed

Related Posts

• DSM Panel Members Still Getting Pharma Funds (4)
• U.S. to Force Drug Firms to Report Money Paid to Doctors (0)
• NY Times—Payments to Doctors by Pharma Raise Issues of Conflicts, CCHR warns of tainted mental health policies (0)
• Big pharma pays US doctors $150m in 2011 (0)
• US health agency revises conflict of interest rules (0)

Pharmalot
By Ed Silverman
May 24th, 2011

Image thanks to tyger lyllie on flickr

In another effort to shed light on untoward relationships, the FDA has just issued a draft guidance on financial conflicts of interest for clinical investigators and the drugmakers that enlist their assistance. The document is designed to revise a 10-year set of rules and address an issue that has grown increasingly contentious in recent years.

“During the intervening years, interest has grown in the public disclosure of industry financial arrangements with physicians,” the agency writes. The “FDA is striving to achieve a proper balance between transparency and the right to privacy of clinical investigators with respect to their financial arrangements as expressed in the agency’s protection of privacy regulation.”

The guidance would require any drugmaker to submit financial disclosures for all investigators who work on studies that would be used by the FDA to assess effectivenesss or any study in which a single investigator makes a significant contribution to demonstrate safety. However, this would not include Phase 1 tolerance studies or pharmacokinetic studies, most clinical pharmacology studies, large open safety studies conducted at multiple sites, treatment protocols and expanded access protocols.

What has to be disclosed? Compensation given an investigator by any sponsor of a covered clinical study in which the value could be affected by the outcome. A proprietary interest in the tested product including, but not limited to, a patent, trademark, copyright or licensing deal. Any equity interest in any sponsor of the study, such as ownership interest, options or other financial interest whose value cannot be readily determined through reference to public prices. This requirement applies to interests held during the time the investigator is working on the study and for one year afterwards.

What else? Any equity interest in any sponsor of the study if the sponsor is a publicly held company and the interest exceeds $50,000 in value. This requirement also applies to financial interests held during the time of the study and for one year after completion. And yes, this includes financial info for a spouse and any dependent children. And yes, the same financial disclosure obligations are required whether studies are conducted at foreign or domestic sites.

Then there’s something called SPOOS, or significant payments of other sorts, which the FDA defines as payments with a cumulative value of $25,000 or more made by any sponsor of a covered study to the investigator or the investigator’s institution, during the time the clinical investigator is carrying out the study and for one year afterwards. This payment would be made beyond the costs of conducting the study (such as a grant to the investigator or to the institution to fund the investigator’s ongoing research or compensation in the form of equipment), or to provide other reimbursements, such as retainers for ongoing consulting work or honoraria.

You can read the entire guidance here.

Read article here:  http://www.pharmalot.com/2011/05/fda-issues-draft-guidance-for-investigator-conflicts/

« Return to news items

News Feed

Related Posts

• U.S. to Force Drug Firms to Report Money Paid to Doctors (0)
• Big pharma pays US doctors $150m in 2011 (0)
• Why Drug Companies Are Shy About Sharing On Facebook (0)
• Twisted web of lies in Maryanne Godboldo Case: Big Pharma, multiple agencies, judge, DHS all profit from child abduction (2)
• Grassley Wants Website Disclosing Conflicts of Interest—Letter Cites Harvard Psychiatrists Failure To Report Nearly $1 Million (0)

« Return to news items

News Feed

Related Posts

• Antipschotic Drugs—Side Effects May Include Lawsuits (0)
• ONE DRUG TO MAKE YOU HAPPY (1)
• Are Psychiatric Medications Making Us Sicker? (0)
• Big Pharma’s Slimy Crusade to Push Anti-Psychotics on Kids (0)
• Mass psychosis in the US—How Big Pharma got Americans hooked on anti-psychotic drugs (1)

PsychCentral -

By John M Grohol PsyD

Who were the top 50 psychiatrists in the U.S. paid by the top seven pharmaceutical companies? This past week, ProPublica, an independent, non-profit newsroom that produces investigative journalism in the public interest, recently decided to answer that question by compiling a list of 384 physicians and health care providers who earned more than $100,000 total from one or more of the seven companies that have disclosed payments in 2009 and early 2010. Click here for the full list of 384 physicians.

We combed that list and found the top 50 psychiatry earners for the past two years (2009-2010). You can click on any name below to learn more about the physician.

According to an accompanying article to this data, ProPublic notes that “[p]ayments to doctors for promotional work are not illegal and can be beneficial. Strong relationships between pharmaceutical companies and physicians are critical to developing new and better treatments.” Perhaps, but for far too long, companies have used physicians as empty-headed mouthpieces for their marketing propaganda.

Transparency helps ensure these relationships are now out in the open, so that other docs and health care professionals know exactly what they’re getting when a doctor speaks to them about a particular drug’s benefits.

ProPublic also found some concerns in their overall analysis of this data, namely that some doctors on the list faced disciplinary action, and others had resumes that wouldn’t support their use as an “expert” in the field, discussing a company’s research in context of the entire research base.

Read the rest of the article here: http://psychcentral.com/blog/archives/2010/10/23/top-50-psychiatrists-paid-by-pharmaceutical-companies/

Read ProPublica’s article: Docs on Pharma Payroll Have Blemished Records, Limited Credentials

« Return to news items

News Feed

Related Posts

• Big pharma pays US doctors $150m in 2011 (0)
• Grassley Wants Website Disclosing Conflicts of Interest—Letter Cites Harvard Psychiatrists Failure To Report Nearly $1 Million (0)
• FDA Issues Draft Guidance For Investigator Conflicts (0)
• “Sunshine: Best Rx for good medicine” by U.S. Senator Chuck Grassley (0)
• The Troubling Link Between Big Pharma and the American Psychiatric Association (0)

The Faster Times
By Alison Bass
March 30, 2010

First the good news: The Physician Payment Sunshine Act is now law, signed by President Obama as part of the health care bill overhaul. Starting in 2012, drug and medical device companies must report all consulting, speaking and other payments to doctors and teaching hospitals in excess of $100 annually to the federal Department of Health and Human Services, which will post the payments on a public website. This is an important first step toward making transparent the pervasive financial ties between doctors who are studying or promoting specific drugs and medical devices and the companies that manufacture these products.

There is one significant loophole in the law: according to thefinal provisions, payments related to clinical trials or product development agreements for new products are allowed a publication delay of four years or until product approval, whichever comes first. So if a particular doctor is researching a drug that has not yet been approved for a specific condition, we will have to wait four years to find out whether he or she is on the drug company’s payroll. But at least the disclosure will eventually see the light of day, and patients who are prescribed the drug in question can seek a second opinion from a doctor who is not on the drug firm’s payroll and whose medical judgment can be trusted.

The Physician Payment Sunshine Act, however, only goes so far. While it covers doctors and teaching hospitals, it does not extend to all the advocacy groups and professional organizations that have substantial influence on over how particular illnesses are treated. For example, as I reported, the National Alliance for the Mentally Ill (NAMI), the most powerful advocacy group for people with mental illness, received millions of dollars in funding from drug companies for years — a payola that no doubt spurred this group’s embrace of potent psychoactive drugs over alternative methods of treating mental illness.

And now, in the current Psychiatric Times, two Massachusetts researchers tear the veil off efforts by the American Psychiatric Association (APA) to hide industry funding of its two philanthropic arms — the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE). As Lisa Cosgrove and Harold Burszstajn report: “While the APA recently announced it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding” of APF and APIRE.

Read entire article:  http://thefastertimes.com/healthinvestigations/2010/03/30/the-troubling-link-between-big-pharma-and-the-american-psychiatric-association/

« Return to news items

News Feed

Related Posts

• Psychiatrists And Pharma: Undue Influence? Concern about corruption increasing… (1)
• DSM Panel Members Still Getting Pharma Funds (4)
• Citing public’s growing distrust of psychiatry, NIMH Chief says psychiatry must “Clean up our act” (3)
• Sen Grassley’s bill now requires public disclosure of ALL Pharma $$ to doctors— Top Psychiatrist calls for “Ethics Cleanup” (1)
• Harvard Expert Ties Mental Illness “Epidemic” to Big Pharma’s Agenda (0)

IowaPolitics.com
November 19, 2009

WASHINGTON — Senator Chuck Grassley has asked leading medical schools to describe their policies on ghostwriting as part of his continuing effort to shed light on financial ties between the pharmaceutical industry and medical professionals.

“I’m interested in transparency, and academic institutions play an important role in establishing adequate and meaningful disclosure. Letting the sun shine in and making information public is basic to building people’s confidence in medical research and the practice of medicine,” Grassley said.

Last July, Grassley wrote to eight leading medical journals to ask the same kinds of questions he’s presented to the medical schools. Prior to that, he asked two major drug companies about allegations that they hired ghostwriters to draft articles promoting company products and seek academics to sign on as primary authors.

Grassley also has conducted oversight and sought disclosure with physicians, continuing medical education and the patient advocacy community. He has worked to expose cases where there was vast disparity between drug-company payments received and reported by leading medical researchers. The National Institutes of Health is working on new disclosure guidelines for federal grant recipients in response to Grassley’s work.

In January, Grassley and Senator Herb Kohl introduced, for the second time, the Physician Payments Sunshine Act. The legislation would require annual public reporting by drug, device and biologic manufacturers of payments made to physicians nationwide. It was included in the health care reform bill passed in October by the Senate Committee on Finance.

Read entire article: http://www.iowapolitics.com/index.iml?Article=177376

« Return to news items

News Feed

Related Posts

• Big pharma pays US doctors $150m in 2011 (0)
• Grassley Wants Website Disclosing Conflicts of Interest—Letter Cites Harvard Psychiatrists Failure To Report Nearly $1 Million (0)
• Beware the ghost(writer)s of medical research (0)
• FDA Issues Draft Guidance For Investigator Conflicts (0)
• Profiting from mental ill-health (1)