Posts Tagged ‘Harvard University’

US health agency revises conflict of interest rules

Tuesday, August 23rd, 2011

From Project on Government Oversight:

In recent years, Senator Grassley exposed several academic physicians for taking large amounts of money from companies with a direct financial interest in their research, some of it funded by the NIH. The list reads like a who’s who in academic research:

    • Dr. Charlie Nemeroff, former Chair of the Psychiatry Department at Emory University, who failed to report hundreds of thousands of dollars in payments from GlaxoSmithKline while researching that same company’s drugs with an NIH grant.  Dr. Nemeroff was bounced from Emory and has now taken over the Chair of Psychiatry at the University of Miami.
    • Dr. Alan Schatzberg, former 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. An NIH oversight group recommended that Stanford’s clinical trial on mifepristone be “terminated immediately and permanently.”  The recommendation was made because of concerns over conflicts of interest, patient safety and other issues.
    • Dr. Joseph Biederman and two other researchers at Harvard University failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard later disciplined the three physicians.

US health agency revises conflict of interest rules

From Reuters – August 23 – 2011

by  Alina Selyukh

WASHINGTON,  – The U.S. National Institutes of Health revised on Tuesday its 16-year-old conflict of interest rules for medical researchers, lowering the amount of money that constitutes a financial conflict and expanding the required disclosures.

The 1995 regulations effectively put responsibility for tracking scientists’ financial conflicts of interest on their universities. The rule required researchers to disclose conflicts to their institutions, which then had to assure the NIH the conflict had been managed, reduced or eliminated.

The new rule extends that requirement so researchers report not only the fact of a conflict of interest, but also its details such as value, specific nature, why it is a conflict and the impact it might have on research.

It lowers the amount a researcher must disclose if received from an industry or held in company stock to $5,000 from about $10,000.

Research institutions, in turn, are now required to report that information to the federal grant-awarding agency alongside details of how the conflicts are managed. Also, before spending any grant money, the institution has to post information about the financial conflicts on a public website.

The new rules will affect about 2,000 organizations that are awarded public health science funding every year and some 38,000 scientists who participate in research funded by these grants and have a “significant financial interest,” NIH said.

Concern about the integrity of research in the United States has grown since 2008, when Iowa Republican Sen. Charles Grassley criticized prominent Harvard University psychiatrist Dr. Joseph Biederman and others for failing to fully disclose payments from drug companies.

In a more recent example, medical device maker Medtronic Inc (MDT.N) came under fire over accusations that doctors paid by the company had failed to disclose major side effects from a bone growth drug in clinical trials.

A 2009 report by the Institute of Medicine, one of the National Academies of Sciences that advises U.S. policymakers, called on doctors to strictly disclose research funding to strengthen protection against conflicts of interest. The report called for virtually anyone involved in medicine — academic medical centers, journals, professional societies, researchers and doctors — to set up or strengthen conflict of interest guidelines.

From 1996 to 2007, relationships between individual academic researchers and industry nearly doubled, according to a study cited by NIH in its final rule. From 1994 to 2003, the amount of financial support for biomedical research almost tripled to $94.3 billion, with 57 percent of that funding coming from industry sources, according to analysis cited by NIH. (Additional reporting by Anna Yukhananov; editing by Andre Grenon)

http://www.reuters.com/article/2011/08/23/health-science-conflicts-idUSN1E77M1PB20110823

 

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Seven Ways Medical Conflicts of Interest are Disguised

Friday, November 12th, 2010

FoodConsumer, November 12, 2010
by Martha Rosenberg

“Trust me” used to be the punch line about how a certain obscenity is uttered by Hollywood agents.

It also used to govern the conflicts of interest policies at hospitals, universities, medical schools and scientific journals about doctors’ and researchers’ financial links.

But conflicts of interest (COI) at Harvard and other universities, medical journals, professional groups and at the FDA itself have ushered in a kind of disclosure fever. In addition to the Physician Payment Sunshine Act which requires drug and device makers to report physician payments yearly, medical schools are starting to reject industry money that traditionally funded Continuing Medical Education (CMEs).

Individual doctors’ COIs have also been a problem for medical groups and journals.

The American Psychiatric Association,  in its 240 page guide to its May annual meeting, “forgot” to mention the conflicts of interest of its own president Alan Schatzberg, MD. It had to print them on the newsletter circulated the third day of the meeting. Nor were names even alphabetized for easy information retrieval. (Schatzberg is financially linked to Eli Lilly, GSK, Merck, Pfizer, Forest, Takeda, Sanofi-Aventis and eight other companies.)

Joan Luby, MD, a pediatric depression expert says in the Archives of General Psychiatry in March she didn’t disclosure lectures she gave for AstraZeneca and other pharma ties “because they were not relevant to the subject of the article.” Maybe that’s why the New York Times magazine didn’t disclose Luby’s links in the August “Can Preschoolders be Depressed?” and five Wyeth links in April’s “The Estrogen Dilemma.”

And statin investigator, Harvard’s Paul Ridker, MD, apologized to JAMA readers in 2006 for an incomplete financial disclosure for an article about cardiovascular clinical trials. He thought he only had to report funding for the “study at hand” and had omitted mentioning funding from AstraZeneca, Bayer, Novartis, Roche, Sanofi-Aventis and five other pharmaceutical companies.

Disclosure is especially tricky for medical journals whose lifeblood is often drug ads and reprints of article for drug companies to pass out to physicians.

Here are some of the ways conflicts of interest are finessed.

1) Omnibus disclosure. All of a study’s authors are listed with all the pharma links in one block of solid type. Who goes with whom? You’ll never know — but the author with no links sure isn’t happy about shared guilt.

2) Initials. “R.L.T. has consulted for Merck” is set in 8 point type at the end of the article. Will readers return to the study’s start, five pages ago where there are eight authors, four with first names that begin with R?

3) Disclosures You Have To Work For. COIs of CME faculty are often given online but the information is tucked away in a pull-down, scroll menu. It is user-unfriendly like the drug side-effects found on the scrolling ads on the same site.

4) One Disclosure is Enough. When a previous article is cited in journal letters sections, the author disclosures are said to “be found with the original article.” Surely you have that issue, published four months ago, on your desk.

5) Protective Coloring. Disclosures of drug company links are embedded between government grants and charitable foundations. Government grants and charitable foundations are not conflicts of interest — though some say taking government money along with industry should be.

6) Paying Customers Only. 20 million citations of medical literature appear on the US National Library of Medicine web site. Many have author’s institutions and email. But do the abstracts show COIs? Not unless you’re a paid subscriber. Password please.

7) Paying Customers Only…Even When You Are Reading A Hard Copy. In hard copies of the August 5 New England Journal of Medicine, the disclosures of authors of “Suicide-Related Events in Patients Treated with Antiepileptic Drugs” are absent and said to be found with the “full text” of the article at NEJM.org.

When we asked Karen Pedersen Buckley, NEJM manager of media relations, why  disclosure information about doctors who challenge an 2008 FDA warning* were not available in the journal’s hard copy, she said the web site was being redesigned. “We hope that many of our readers will have access to the full text and disclosure forms through an institutional subscription at their hospital, university or library,” she added.

And for those who don’t? Trust us.

*FDA warned about seizure drugs’ suicide side effects. The authors largely find the drugs safe.

http://www.foodconsumer.org/newsite/Non-food/Healthcare/seven_ways_medical_conflicts_of_interest_are_disguised_111110061.html

See also CCHR’s expose, Shrinks For Sale: The Corrupt Alliance of the Psychiatric Pharmaceutical Industry

Joseph Biederman

Pharma Poster Boy, Psychiatrist Joseph Biederman http://www.cchrint.org/cchr-issues/the-corrupt-alliance-of-the-psychiatric-pharmaceutical-industry/

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DSM Panel Members Still Getting Pharma Funds

Friday, May 21st, 2010

Despite promises to cut back on Pharma funds, 56% of DSM V panel members have reported industry ties— Zero improvement over the percent of DSM-IV members.


By CCHR International
May 21, 2010

Due to Senate investigations into the American Psychiatric Association, psychiatrists have promised to cut back on their conflicts of interest (pharma funds), but of the current DSM task force members, those who will be deciding on the holy grail of psychiatric disorders (DSM) and what constitutes a “mental illness” are still heavily funded by Pharma. In fact, there is no improvement over cutting down the number of panel members who are getting paid by industry over the last DSM revision in 1994. It was 56% then and its 56% now. So much for psychiatry’s promises…

Former APA president Nada Stotland stated: “We are in the midst of a revolution caused by public and legislative concern about the influence of the for-profit sector….” [Emphasis added] Part of that public pressure for the APA to disclose its conflicts of interest with pharmaceutical companies was driven by Lisa Cosgrove Ph.D. et al’s study of DSM-IV and DSM-IV-TR committee members, which found that of the 170 members, 56% had one or more financial associations with companies in the pharmaceutical industry.  Pharma’s psychotropic drug profits have soared commensurately with the increased numbers of disorders voted into the DSM.

  • Of the 137 DSM-V panel members who have posted disclosure statements, 56% have reported industry ties—no improvement over the percent of DSM-IV members.
  • Writing in Psychiatric Times (March 6, 2010), Cosgrove and Harold J. Bursztajn, MD, stated: “Although the APA recently announced that it would phase out the visibly industry-supported educational programs, the organization has remained curiously silent about acknowledging and monitoring industry funding of the 2 philanthropic arms of the APA—the American Psychiatric Foundation (APF) and the American Psychiatric Institute for Research and Education (APIRE).”
  • APF’s 15-member board of directors includes 4 high-level executives from pharmaceutical companies that either manufacture drugs recommended by APA (i.e.; in APA’s Clinical Practice Guidelines [CPG]) or have products in development targeted for mental disorders.
  • Other board members include 2 more with industry ties and a senior vice president at one of the largest public relations agencies in the world, whose clients include 6 drug companies.
  • APF’s corporate advisory council comprises pharmaceutical companies that contribute significant funding to APF and manufacture drugs recommended in the APA’s CPG; 6 of the companies give $40,000 “and above” per year.
  • APIRE, like APF, does not require disclosure of financial conflicts of interests, yet 9 of 16 of its board members have industry ties.
  • At least a quarter of the presenters at this year’s APA congress have significant pharmaceutical company ties.

The APA should sever all ties to pharmaceutical company interests. The US Senate Finance Committee has investigated at least a dozen APA psychiatrists over their undisclosed financial ties to drug companies, including:

Investigated - Alan Schatzberg, APA President: Owned $6 million equity in and as co-founder of drug developer Corcept Therapeutics while principle investigator in an NIH-funded, Stanford-based study of Corcept’s drug mifepristone. Schatzberg initiated the patent application on mifepristone to “treat psychotic depression” in 1997. In 2008, after months of Congressional scrutiny, Schatzberg stepped down from his position as principal investigator in the study.


Investigated – Joseph Biederman: Chief of the Program in Pediatric Psychopharmacology, Massachusetts General Hospital, he earned $1.6 million in consulting fees from drug makers between 2000 and 2007, most of which was not disclosed to Harvard University officials. In March 2009, court documents showed Biederman promised Johnson & Johnson in advance that his studies of their antipsychotic Risperidone would prove effective when used on preschool age children.


Investigated - Melissa DelBello: Research psychiatrist, University of Cincinnati failed to disclose all her Pharma earnings. In 2002, she was the lead author of a study that reported patients benefited from Seroquel by AstraZeneca, which paid her $180,000. She disclosed receiving $100,000 from the company between 2005 and 2007, but federal investigators discovered it was more than double that—$238,000.


Investigated - Frederick Goodwin: Former NIMH director, Goodwin earned at least $1.3 million between 2000 and 2007 for marketing lectures to physicians on behalf of drug makers, which he did not reveal to the producers of “The Infinite Mind” that he hosted on the National Public Radio during its 10-year run. NPR removed the program.


Investigated - Charles Nemeroff: Perhaps the most egregious case exposed was that of Dr. Nemeroff, chair of Emory University’s department of psychiatry and, along with Schatzberg, coeditor of the influential Textbook of Psychopharmacology. He received more than $960,000 from GSK, but reported to Emory $35,000.  He earned a further $2.8 million from various drug makers but failed to report at least $1.2 million. Nemeroff resigned his position at Emory in 2008.


Investigated - Martin Keller: Professor of Psychiatry at Brown University. His (and others’) Study 329 (ghostwritten by a GSK rep.) on Paxil use in children allegedly misrepresented data and suppressed information linking Paxil to suicidal tendencies. Keller didn’t disclose the full extent of his financial ties with companies to medical journals that published his research. In another matter, following a criminal investigation, Brown University returned $300,170 to the state of Massachusetts for research Keller’s department never performed. Keller stepped down as chair of psychiatry at Brown.


Investigated - Augustus John Rush: Former Vice-Chairman of the Dept. of Clinical Sciences at the University of Texas Southwestern Medical Center. He reported only $3,000 of the nearly $18,000 that Eli Lilly paid him in 2001.  Between 2000 and 2007, he failed to report another $12,000 from various drug companies.


Investigated - Karen Wagner: Professor, University of Texas Medical Branch failed to disclose more than $160,000 in payments from GSK, reporting only $18,000. Wagner worked on NIH-funded studies on the use of Paxil to treat teen depression and was a co-researcher on Study 329 (see Keller), for which she was paid more than $18,000. In 2002, Eli Lily paid her over $11,000, which was not disclosed.


Investigated – Thomas Spencer: Assistant Director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Associate Professor of Psychiatry, Harvard Medical School, reportedly failed to disclose at least $1 million in earnings from drug companies between 2000 and 2007.


Investigated - Timothy Wilens: Associate Professor of Psychiatry at Harvard Medical School allegedly failed to report he had earned at least $1.6 million from drug makers.


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Kids diagnosed ADHD prescribed ‘medical’ marijuana. Harvard Psych agrees – Says he has no hesitation doping kids

Wednesday, December 2nd, 2009

David Knowles
SPHERE
November 24, 2009

In California, the state with the nation’s most permissive medical marijuana law, several doctors say that some children with attention deficit hyperacitivty disorder, or ADHD, are being treated with marijuana — a fact that has sparked a heated debate.

Reliable figures on the use of marijuana to treat ADHD are hard to come by, as reported by The New York Times . Though California says it has issued more than 36,000 medical marijuana cards since 2004, the state does not compile statistics on prescriptions for specific conditions, such as ADHD. And many doctors and patients are reluctant to talk about it. Still, experts say such prescriptions are becoming more common as the number of pot dispensaries and doctors prescribing marijuana continues to grow.

And not everyone is happy about it.

“Let me count the ways in which prescribing marijuana for teens with ADHD is a bad idea,” said Stephen Hinshaw, professor of psychology at the University of California at Berkeley. Marijuana, Hinshaw said, is a “cognitive disorganizer” that produces roughly the same effect in users as those associated with ADHD.

Read entire article: http://www.sphere.com/2009/11/24/marijuana-prescribed-to-kids-with-adhd/

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