Posts Tagged ‘Alan Schatzberg’

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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American Psychiatric Association Stunned Again with Ghostwriting Controversy

Wednesday, April 13th, 2011
Project Government Oversight- April 12, 2011
By Paul Thacker

Like an aging, punch drunk fighter struggling through the twelfth round, the American Psychiatric Association (APA) can’t seem to slip the punches coming its direction. Last week, a host of blogs went after them for refusing to print a letter written by three academics that was critical of a medical textbook the APA published with help from the ghostwriting company Scientific Therapeutics Information (STI).

The letter criticized the APA for failing to publish records that explain the provenance of the textbook, including drafts, contracts with STI and/or GlaxoSmithKline, and any communications regarding editing. The text’s purported authors are Dr. Charles Nemeroff of the University of Miami and Dr. Alan Schatzberg of Stanford University.

As The New York Times reported, the textbook was funded by GlaxoSmithKline. Author and blogger Dr. Danny Carlat reviewed the book and wrote that it read like “an advertisement for Paxil.”

Yesterday, a writer over at MIWatch landed a blistering combination on the APA. When she poked them for a response, the APA covered up and peeked back through their gloves. “The APA’s official response has been unconvincing,” she jabbed.

She then landed a solid uppercut.

Before the controversial textbook ended up in the story in The New York Times, she wrote, STI displayed a picture of the book’s cover in their results portfolio. They’ve now yanked the page from their website, but the MIWatch writer found an older version of the page on the Wayback Machine. When you click on the “publications” button and scroll down, you can see a picture of the textbook’s cover.

Wayback shot
The APA caught a few more whallops this morning from HealthCare Renewal and The Carlat Psychiatry Blog. Over at Pharmalot, Ed Silverman scored a brief interview with STI’s CEO John Romankiewicz.  When asked why the book had disappeared from STI’s website, Romankiewicz said,  “Thanks for the inquiry, but we don’t display that kind of stuff on our web site.”

He then hung up the phone.

The APA’s reluctance to engage with critics may be due to the association’s cozy ties to STI. In 2007, STI “medical writer” Sally Laden was deposed during litigation regarding Paxil. POGO has acquired a copy of the deposition. There are quite a few editing errors, so bear with us. Some interesting tidbits from pages 237-238:

Question: Okay So we talked about the workbooks And now I think we are down to the next topic

Sally Laden: Which is an APA symposia

Question: Okay Did STI help well you tell me What go ahead Keep taking me through this

Sally Laden: We worked on a number of APA the American Psychiatric Association has an annual meeting some time in the spring every year And for many years we helped them with programs symposia at the APA

Question: Okay And so what is the next topic here?

Sally Laden: It says who chose topics and speakers

Question: Okay And what was the answer to that?

Sally Laden: The general topics say depression  in the elderly would be chosen by GSK  Saying can you help us with the symposium  on that And we have already spoken to a  Chairperson Now will you work with the Chairperson to come up with the agenda and the speakers for this program

Question: Okay Do you recall setting up speakers to talk on the topic of adolescent depression?

Sally Laden: Sometimes we did I don t remember if we did one at APA or not

Question: I m sorry?

Sally Laden: I don t remember if there was an APA symposia on adolescent depression

Seems like the American Psychiatric Association and Scientific Therapeutics Information have been friendly for some time, no?

Paul Thacker is a POGO Investigator.

http://pogoblog.typepad.com/pogo/2011/04/american-psychiatric-association-stunned-again-with-ghostwriting-controversy.html

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American Psychiatric Association’s Ghost Written (Allegedly Pharma Funded) Book Magically ‘Disappears’

Tuesday, April 12th, 2011

Pharmalot

by Ed Silverman – April 12, 2011

File this under The Case of The Missing Book. When last seen, Scientific Therapeutics Information was at the center of an ongoing controversy over an allegedly ghostwritten book – yes, an entire book – that was published in 1999 by the American Psychiatric Association. Funding came from a grant provided by SmithKline Beecham, which is now part of GlaxoSmithKline (back story).

The listed co-authors were Charles Nemeroff, who chairs the psychiatry department at the University of Miami medical school, and Alan Schatzberg, who until recently chaired the psychiatry department at the Stanford University School of Medicine. Both men were at the center of a long-running probe by the US Senate Finance Committee into undisclosed conflicts of interest among academic researchers. They were also regular speakers for Glaxo, which makes the Paxil antidepressant (see here and here).

STI, which was also targeted by the same committee over alleged ghostwriting activities surrounding Merck’s Vioxx painkiller (see here), provided drafts directly to Glaxo for comments and sign-off, as well as this 1997 status report and page proofs to the credited authors. Nemeroff and Schatzberg, however, have insisted they did all the work on the book. For its part, the APA has denied any ghostwriting, although the organization has stonewalled requests to disclose paperwork that might support its position (see this).

However, MI Watch, a non-profit devoted to tracking mental illness issues, discovered STI listed the book, entitled “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” in the portfolio section on its web site (see this). At least, until recently. A visit to the site now yields a message saying the page cannot be found. None of its published work, in fact, is currently visible. This is an odd turn of events for a firm that boasts “STI’s dedicated and experienced editorial staff can create a strategic publication plan to meet your goals and messaging.”

So we called John Romankiewicz, a PharmD who started the firm 26 years ago, to ask about the missing info. His explanation? “Thanks for the inquiry,” he responded abruptly, “but we don’t display that kind of stuff on our web site.” We replied by noting that the info had been there previously, but then we heard a loud…click. Perhaps, he realized that listing the book as a portfolio product does not easily square with the APA position that ghostwriting did not take place. And taking down the product portfolio might also make it more difficult to scrutinize other STI work. Given how fast he hung up, though, one might have thought we uttered the magic word: “Boo!”

http://www.pharmalot.com/2011/04/a-ghostwritten-book-mysteriously-disappears/

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American Psychiatric Association’s Interests in Conflict

Friday, December 31st, 2010

CounterPunch New Year’s Edition
December 31, 2010 – January 2, 2011

by Martha Rosenberg

At the annual American Psychiatric Association meeting in New Orleans this summer, 200 protestors chanted “no conflicts of interest” and held up photos of individual doctors outside the convention center. Inside the hall, their charges were verified.

The meeting’s Daily Bulletin disclosed that the APA president himself, Alan Schatzberg, has 15 links to drug companies including stock ownership and serving on a speakers bureau.

Doctors on other speaker bureaus like Shire’s Ann Childress and Wyeth’s Claudio Soares gave presentations and workshops that — surprise! — extolled company drugs.

And signing books, side by side, was the duo now accused of penning an entire book for the drug industry: Alan Schatzberg and Charles Nemeroff.

This month ProPublica and the New York Times report that Schatzberg and Nemeroff’s book, Recognition and Treatment of Psychiatric Disorders: A Pharmacology Handbook for Primary Care, may be the first entirely drug industry-approved textbook ever. Published in 1999, the book’s preface says it was funded by an unrestricted education grant to Scientific Therapeutics Information through London-based GlaxoSmithKline (GSK). Scientific Therapeutics Information of Springfield, NJ is the same medical publishing company that spun Vioxx.

Schatzberg was investigated by the Senate in 2008 which found “a lack of consistency” between what he earned from drug companies and what he reported to Stanford where he continues to head the psychiatry department. He owns $6 million of stock in a company he co-founded, Corcept Therapeutics, which sought FDA approval for a psychiatric drug despite Schatzberg’s APA position.

Nemeroff, for his part, left Emory University in disgrace after a 2008 Congressional investigation unearthed $1.2 million in drug industry income, his $9 million NIH grant was terminated (a rare occurrence) and he was banned from further NIH grants for two years. But he resurfaced as head of the psychiatry department at the University of Miami in 2009 after the medical school dean, Pascal Goldschmidt, was assured by crony Thomas Insel, director of the National Institute of Mental Health (NIMH), that Nemeroff could still draw NIH money, according to the Chronicle of Higher Education. It was payback for when Nemeroff got Insel a job, say observers. Nemeroff still sits on NIH scientific panels reviewing others’ grant applications, ensuring further cronyism.

Ghostwriting, of course, solves the “Company-Says-Company’s-Product-Is-Great” problem and increases the chance of a paper’s publication in a journal. It helps “authors”‘ careers and may even spur their individual prescribing habits since studies show doctors prescribe more of a drug they are paid to promote.

But the consumer version, unbranded advertising, is also effective: radio and TV commercials posing as public service announcements that push “awareness” of diseases like ADHD, Irritable Bowel Syndrome (IBS), Restless Legs Syndrome (RLS) or Excessive Sleepiness (ES) and drive worriers to sites where they can self-diagnose with simple quizzes.

Meanwhile, the consumer version of bought doctors is “Astroturf” or patient front groups like the “grassroots” National Alliance on Mental Illness (NAMI), investigated by Congress for drug industry links. These bought patients flash mob the FDA with sob stories when an expensive drug is up for approval and lobby Medicaid to not substitute less expensive drugs, inflating entitlement program and insurance premium costs for industry’s benefit.

In the war against drug industry duplicity, company employees are increasingly reporting misdeeds thanks to provisions that entitle whistleblowers to 15 and even 30 percent of fraud settlement sums, in some cases. And last month the Justice Department filed the first criminal, not civil, charges against a the drug industry operative, Lauren Stevens, a former VP and assistant general counsel at GlaxoSmithKline. But as long as politicians like former Louisiana Rep. Billy Tauzin, who headed the industry trade group PhRMA, and former CDC director Julie Gerberding, now head of Merck vaccines, are willing to parlay a career’s worth of knowledge and relationships to sell product, the government is essentially fighting itself.

Read the article here: http://www.counterpunch.org/rosenberg12312010.html

For more information on the APA/Conflicts of Interest see:

CCHR: American Psychiatric Association Called Upon to Cut Drug Company Ties and Put Lives of Children Before Profits http://www.cchrint.org/2010/05/21/apa-leaders-called-upon-to-cut-drug-company-ties-and-put-the-lives-of-children-ahead-of-personal-profits/

CCHR: DSM Panel Members Still Getting Pharma Funds http://www.cchrint.org/2010/05/21/dsm-panel-members-still-getting-pharma-funds/

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Drug Maker Wrote Book Under 2 Doctors’ Names, Documents Say

Tuesday, November 30th, 2010

Alan F. Schatzberg

Note from CCHR: The two “prominent authors” of this Pharma-funded handbook for diagnosing and drugging patients, are psychiatrists Alan F. Schatzberg and Charles Nemeroff.   Schatzberg is the former President of the American Psychiatric Association and owned $6 million equity in drug developer Corcept Therapeutics at the same time that he was principle investigator in an NIH-funded, Stanford-based study of Corcept’s drug mifepristone.

Charles Nemeroff

Charles  Nemeroff was Professor and Chairman of Psychiatry and Behavioral Sciences, Emory University School of Medicine in Atlanta. Senate investigations revealed Nemeroff failed to disclose at least $1.2 million in Pharma funding including GlaxoSmithKline.



The New York Times
November 29, 2010
by Duff Williams

Two prominent authors of a 1999 book teaching family doctors how to treat psychiatric disorders provided acknowledgment in the preface for an “unrestricted educational grant” from a major pharmaceutical company.

From the book “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care.”

But the drug maker, then known as SmithKline Beecham, actually had much more involvement than the book described, newly disclosed documents show. The grant paid for a writing company to develop the outline and text for the two named authors, the documents show, and then the writing company said it planned to show three drafts directly to the pharmaceutical company for comments and “sign-off” and page proofs for “final approval.”

“That doesn’t sound unrestricted to me,” Dr. Bernard Lo, a medical ethicist and chairman of an Institute of Medicine group that wrote a 2009 report on conflicts of interest, said after reviewing the documents. “That sounds like they have ultimate control.”

The 269-page book, “Recognition and Treatment of Psychiatric Disorders: A Psychopharmacology Handbook for Primary Care,” is so far the first book among publications, namely medical journal articles, that have been criticized in recent years for hidden drug industry influence, colloquially known as ghostwriting.

“To ghostwrite an entire textbook is a new level of chutzpah,” said Dr. David A. Kessler, former commissioner of the Food and Drug Administration, after reviewing the documents. “I’ve never heard of that before. It takes your breath away.”

The book has never been in wide circulation and has not been sold for a few years. Guidelines restricting the use of industry money to support medical journal articles or doctors’ research have come into wide acceptance within the last several years, to try to minimize the influence of companies’ marketing on medical practices.

The book’s listed co-authors were Dr. Charles B. Nemeroff, chairman of psychiatry at the University of Miami medical school since 2009 and Emory University before that, and Dr. Alan F. Schatzberg, who was chairman of psychiatry at the Stanford University School of Medicine from 1991 until last year.

The letter documenting the relationship between Dr. Nemeroff, a writing company and SmithKline was dated Feb. 4, 1997. It and a “preliminary draft” of the book, dated Feb. 21, 1997, and adding Dr. Schatzberg’s name were released Monday by the Project on Government Oversight, a Washington advocacy group. They were attached to a letter of complaint to Dr. Francis S. Collins, director of the National Institutes of Health. In the letter, Danielle Brian, executive director of the project, and Paul Thacker, an investigator, formerly with the staff of Senator Charles Grassley of Iowa, also cited other examples of what they termed ghostwriting and asked the N.I.H. for better policing of such practices.

The documents were separately obtained by The New York Times from the Los Angeles law firm of Baum Hedlund, which received them as part of discovery in lawsuits against the drug company, now known as GlaxoSmithKline, involving Paxil. Leemon B. McHenry, a bioethicist with California State University, Northridge, who consults for the law firm, said many similar documents remain sealed. “This is only the tip of the iceberg,” he said.

Responding to questions by e-mail last week, Dr. Nemeroff and Dr. Schatzberg emphasized the “unrestricted” nature of the grant from the drug maker to develop the book and said they did most of the work. SmithKline “had no involvement in content,” Dr. Schatzberg said, adding, “An unrestricted grant does not give the company any right of sign-off on content and in fact they had no sign-off in content.”

Dr. Nemeroff said he and Dr. Schatzberg “conceptualized this book, wrote the original outline and worked on all of the content.”

But the writing company, Scientific Therapeutics Information of Springfield, N.J., had developed “a complete content outline” for Dr. Nemeroff’s comment, according to the 1997 letter from one of the company’s officials. The company also said it had “begun development of the text.” The writing company did not respond to requests for comment.

Kevin G. Colgan, a spokesman for GlaxoSmithKline, said the company’s role in the book was described in its preface. In recent years, he added, the company has tightened its internal guidelines for medical writers.

Ron McMillen, chief executive of American Psychiatric Publishing, which published the book, said he reviewed files on it Monday and found no evidence of influence by the writing company or GlaxoSmithKline. But Mr. McMillen also said he had been unaware of the plan outlined in the two-page letter to Dr. Nemeroff.

“This would show more involvement than we would accept,” he said after reviewing it.

The book sold about 26,000 copies, including 10,000 bought by SmithKline Beecham for American family doctors and 10,000 purchased by the Dutch pharmaceutical company Organon, Mr. McMillen said. The authors together received a 15 percent royalty of the $120,000 sales, or about $18,000, he said.

Since there are about 100,000 family physicians in the United States, the book reached only a small percentage of them and has probably declined in usage since 1999. Dr. Howard A. Brody, an author, blogger and professor of family medicine at the University of Texas Medical Branch at Galveston, speculated that family doctors may have had some resistance to a book from a psychiatric press.

Mr. McMillen said the book was co-published with the American Medical Association. He said it was distributed until a few years ago.

Dr. Nemeroff said the book was written to fill an unmet need in educating family doctors and primary care physicians on how to provide adequate treatment for people with mental illness. “Remarkably, the book remains quite accurate and relevant to clinical practice today,” he said.

Dr. Nemeroff said he and Dr. Schatzberg “scrutinized every page and rewrote and edited as we deemed necessary,” keeping control of the final draft.

Dr. Schatzberg said he had not seen the 1997 letter to Dr. Nemeroff. He termed it “a theoretical proposal that bears little, if any relationship to what actually happened.”

Dr. Lo, who is a professor of medicine and director of the medical ethics program at the University of California, San Francisco, said that medical textbooks and handbooks should make it clear — as peer-reviewed journals now do — whose idea it was, who wrote the first draft, and who edited. Dr. Lo and other experts said ghostwriting has receded in recent years with tougher journal standards.

Dr. Nemeroff and Dr. Schatzberg have been listed on other titles, including co-editors of the Textbook of Psychopharmacology, a book for psychiatrists and medical students, whose third edition appeared in 2003. In 2008, Emory University imposed a two-year ban on Dr. Nemeroff receiving N.I.H. grants after a Senate inquiry found that he had failed to disclose at least $1.2 million in industry financing over seven years from pharmaceutical companies, including GlaxoSmithKline.

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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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Psychiatric Times – Let’s Call the Whole Thing Off

Thursday, May 27th, 2010

“The proposed DSM5 would be a giant step backwards for psychiatry. American psychiatrists should petition the APA to drop this ill-conceived and badly executed project.”

Psychiatric Times
By Irwin Feinberg, MD
May 27, 2010

A vital consideration we learn in medicine is that continuing life support for a moribund patient past a certain point is harmful to the lives of all concerned. We have reached that point with DSM5. Dr Allen Frances has outlined compelling clinical arguments against many of the new disorders DSM5 proposes and he has shown how their adoption could have far-reaching, unintended, and damaging consequences for the patients we have pledged not to harm, and for society generally.

I write from the vantage point of 50 years of psychobiological research. Most of it is in the field of sleep neuroscience. However, as often happens in science, one thing leads to another and my observations enabled me to propose that the human brain undergoes a profound reorganization during adolescence driven by synaptic pruning and that some cases of schizophrenia might be caused by errors in this process. My association at NIMH with Edward V. Evarts, one of the great neurophysiologists of the last half century, stimulated me to propose that the hallucinations of schizophrenia result from a failure of feed-forward mechanisms that distinguish self-initiated neural activity from that produced by external stimulation, resulting in auditory hallucinations and other first-rank symptoms.

It is difficult and time-consuming to produce reliable new knowledge; it cannot be accomplished by committee fiat, as Drs Kupfer, Schatzberg and Regier seem to be believe. Dr Frances has mentioned the damage to psychiatric research that several new, ill-conceived categories in DSM5 could inflict. He also pointed out that changing nomenclature and diagnostic standards in the absence of compelling scientific justification will severely damage psychiatric research as well as clinical practice. Many of these changes would make it impossible to compare decades of epidemiological results with new findings. Moreover, the sloppy thinking and language in the proposed revision will be apparent to any educated layman. The “field trials” and timetables proposed for new categories are laughable to any statistically trained psychologist. The inevitable public exposure of the gross defects in DSM5 will bring our entire field into disrepute and diminish public support for the research we need.

There have been no research advances that demand new diagnoses and syndromes. Despite many intriguing findings, no psychiatric disease can be diagnosed by a biological or psychological test.

Read entire article:  http://www.psychiatrictimes.com/display/article/10168/1576554?CID=rs

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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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American Psychiatric Association Called Upon to Cut Drug Company Ties and Put Lives of Children Before Profits

Friday, May 21st, 2010

Also see: DSM Panel Members Still Getting Pharma Funds

By CCHR International
May 21, 2010

NEW ORLEANS – As psychiatrists from around the world flood the area this weekend to take part in the Annual Meeting of the American Psychiatric Association (APA), psychiatric watchdog Citizens Commission on Human Rights (CCHR) is demanding that the APA sever all ties to pharmaceutical company interests and that psychiatrists stop killing children with harmful drugs.

The APA is expected to release its guidelines to reduce pharmaceutical industry ties at its convention, but it is likely to be self-serving and occurred only after public and legislative pressure forced the issue.

The US Senate Finance Committee has investigated at least 16 APA psychiatrists over their undisclosed financial ties to drug companies, including the APA’s own President, Alan Schatzberg who has stepped down as principal investigator of a National Institute of Health (NIH) funded study after months of Congressional scrutiny into his ties to the drug he was studying.  He was found to have actually initiated the patent application of the drug he was studying to “treat psychotic depression.”

Other notable APA members under scrutiny by the Senate Finance Committee and scheduled to present in New Orleans are Thomas Spencer, Assistant Director of the Pediatric Psychopharmacology Unit at Massachusetts General Hospital and Dr. Joseph Biederman, Chief of the Program in Pediatric Psychopharmacology, Massachusetts General Hospital.

Dr. Spencer reportedly failed to disclose at least $1 million in earnings from drug companies between 2000 and 2007. Dr. Biederman earned $1.6 million in consulting fees from drug makers during the same period, 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 (Risperdal) would prove effective when used on preschool age children. Risperdal has been linked to potentially life-threatening diabetes and Neuroleptic Malignant Syndrome.  The FDA database from 2000 to 2004 found at least 45 deaths in children under 18 with newer antipsychotics and 1,328 reports of other serious side effects, some life-threatening.

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.

While APA leaders and members profit from their industry connections to the drugs they are promoting; children are being killed by these same drugs.

Also see:  Meet the Psychiatrist Pushing For A Brave New World of Pre-Drugging Kids—Patrick McGorry

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How Vested Interests Created the Perfect Marketing/Lobbying Machine: Mental Health “Advocacy” Groups—Funded by Pharma

Thursday, December 10th, 2009

by CCHR International

An ongoing U.S. Senate investigation headed by Senator Charles Grassley has  sought disclosure of pharmaceutical funding paid to researchers, physicians,  medical schools and medical journals.  Some of the nation’s most prominent psychiatrists have now been exposed for extensive conflicts of interest amounting to millions in undisclosed pharmaceutical funding, including Dr. Charles Nemeroff, Dr. Joseph Biederman, Dr. Melissa DelBello, Dr. Timothy Wilens, Dr. Thomas Spencer, Dr. Alan Schatzberg, Dr. Martin Keller, Dr. A. John Rush, Dr. Karen Wagner, Dr. Jeffrey Bostic and Dr. Frederick Goodwin — many of which serve as advisory board members to mental illness “advocacy groups” which are now also the subject of the Senate investigation for their undisclosed pharmaceutical funding.

The majority of the public may or may not be familiar with these so-called mental health advocacy organizations, such as the National Alliance on Mental Illness (NAMI), Children and Adults with Attention Deficit Hyperactivity Disorder (CHADD) or the myriad of bipolar, depression or ADHD “support groups” that are inundating the internet.

But they need to be.

These are groups operating under the guise of advocates for the “mentally ill,” which in reality are heavily funded pharmaceutical front groups – lobbying and working on state and federal laws which effect the entire nation — from our elderly in nursing homes to our military, pregnant women, nursing mothers and school children. Presenting themselves as patient advocacy groups is highly disingenuous not only to their membership, many of which may have a sincere desire to help a loved one or a family member with mental problems, but to legislators, the press and the American public — for they have consistently lobbied for legislation that benefits the mental health and pharmaceutical industries which fund them, and not patients they claim to represent.

Certainly any organization claiming to be for the rights of patients diagnosed mentally ill would have as their primary goal, full informed consent in the field of mental health – including full and complete disclosure of all drug risks, the right to refuse treatment, the right to know that psychiatric diagnoses are not medical conditions (evident by the fact there is not one confirmatory medical/scientific test). Above all such groups would provide patients with an abundance of information on non-harmful, non- drug, medical solutions and options considering the dangerous and well documented risks of psychiatric drugs by international drug regulatory agencies.

These groups do not.

A patients rights group for the mentally ill would never endorse something as absurd and obviously dangerous as giving electroshock to pregnant women, nor condone schools being able to require children to take a psychiatric drug as a condition of attending school. Furthermore, they would never be opposed to the FDA actually doing its job and finally issuing long overdue warnings that antidepressants can cause children to commit suicide, or issue warnings that ADHD drugs have serious and even deadly side effects. Yet these are just some of the actions condoned and promoted by these so-called patients rights groups.

As another example take the federally proposed bill, The Mothers Act; a previous version of this bill called on using a method of “screening” pregnant women and new mothers called EPDS, a screening method documented to triple the number of women diagnosed with Postpartum depression, according to a study published in Obstetrics & Gynecology. The Scandinavian Journal of Public Health stated that EPDS screening was unethical and should not be used. None of the so called advocacy groups for the mentally ill had any objections to this bill whatsoever, or endorsing such an unethical screening tool. They supported it. The bill would have passed with no objections from them whatsoever, if not for the dedication of real advocacy groups with no vested interests (ties to Pharma) opposing language in this bill that would have led to women being falsely diagnosed and put on dangerous psychiatric drugs to “treat” them, unnecessarily placing new mothers and their infants at great risk.

To put it simply, these groups are not what they appear to be. Yet their influence over legislation, lobbying, drug regulation (or lack thereof), and public relations campaigns is substantial and effects the entire nation. For they claim to be the voice of the “mentally ill.” But are they? Or are they the result of a brilliant marketing/lobbying campaign designed to benefit the industry that funds them—the Psycho/Pharmaceutical industry.

To find out how it all started click here: http://www.cchrint.org/psycho-pharmaceutical-front-groups/

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