Grassley Seeks More Info on Conflict of Interest Policies at Medical Schools
Written by Administrator   
Thursday, 25 June 2009

June 25, 2009
by Evelyn Pringle

 

In a June 24, 2009 letter, Senator Chuck Grassley asked 23 medical schools for information about their policies for conflicts of interest and requirements for disclosure of financial relationships between faculty members and the pharmaceutical industry.

 

“I recently learned from an American Medical Student Association report, AMSA PharmFree Scorecard 2009, that your institution either had “no response” or “declined to submit policies” when asked to supply conflicts of interest policies,” he said in the letter.

 

Grassley asked the Universities to respond by no later than July 15, 2009.

 

Of the 149 schools asked, 126 provided information to the AMSA. The Scorecard 2009 was released on June 16, 2009. Thirty-five schools, or 23%, received an F. Seventeen got a D, 18 received a C, 36 were graded B, and only 9 schools received an A.

 

“There’s a lot of skepticism about financial relationships between doctors and drug companies,” Grassley said in a press release. “Disclosure of those ties would help to build confidence that there’s nothing to hide.”

 

“Requiring disclosure is a common sense reform based on the public dollars and public trust at stake in medical training, medical research and the practice of medicine,” he added.

 

Grassley has been working to achieve uniform and universal disclosure of the money that pharmaceutical, medical device and biologic companies give to physicians. He has conducted extensive oversight of financial relationships, especially among doctors who conduct research with the $24 billion awarded annually in federal grants by the National Institutes of Health, the press release explains.

 

Institutions receiving federal money dollars are required to track financial relationships, “but Grassley has found enforcement of those requirements often to be either lax or in violation,” it said.

 

“Beginning last summer,” Grassley wrote in the letter, “I began releasing information that made the point that universities are not managing their professors’ financial conflicts of interest and that change is needed at the NIH.” He listed a few examples as:

 

  • Chairman of psychiatry at Emory 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 Inspector General (HHS OIG) is now investigating. [That would be Charles Nemeroff].
  •  
  • Chairman of psychiatry at Stanford received an NIH grant to study a drug, while partially owning a company that was seeking Food and Drug Administration (FDA) approval of that drug. He was later removed from the grant. [The name here is Alan Schatzberg].
  •  
  • Three professors at Harvard failed to report almost a million dollars each in outside income while heading up several NIH grants. Harvard plans to release a report and is working to update their conflict of interest policies. [These professors are Joseph Biederman, Timothy Wilens, and Thomas Spencer].
  •  
  • Host of a show that ran on the National Public Radio (NPR) satellite station received over a million dollars from pharmaceutical companies to give promotional talks. The show had received funding from the NIH and has been cancelled. [That would be Fredrick Goodwin]
  •  
  • Chair of orthopedic surgery at the University of Wisconsin reported taking more than $20,000 from a company every year, for five years. The actual amount was around $19 million. The University of Wisconsin is revising its rules. [The name here is Thomas Zdeblick].
  •  
  • Professor at the University of Texas received an NIH grant to study Paxil in kids, while also giving dozens of promotional talks on Paxil. This matter has been referred to Health and Human Services, Office of the Inspector General. [This professor is Karen Wagner]
  •  
  • Professor at the University of Washington in St. Louis who was formerly at Walter Reed Army Hospital failed to report hundreds of thousands of dollars he had received from a device company to develop their products. [That would be Timothy Kuklo].

 

“To bring some greater transparency to this issue, Senator Kohl and I introduced the Physician Payments Sunshine Act (Act),” Grassley said in the letter the Universities. “This Act will require drug, medical device, and biologics companies to report publicly any payments that they make to doctors, within certain parameters.”

 

The latest addition to the Grassley list is Emory University’s Zachary Stowe, for not disclosing money he received from drug makers at the same time that he was conducting federally funded research on the use of antidepressants, such as Paxil, by pregnant and nursing mothers.

 

Stowe has been the primary investigator of an NIH grant since 2004 to study children delivered by women who may also be taking antidepressants. From 2003 to July of 2008, he was the primary investigator of another grant that looked at fetal exposure to medications consumed by pregnant mothers. In 2008, Stowe was the primary investigator of another NIH grant where the stated purpose was “to stimulate vigorous debate with the emphasis on the reproductive safety of antidepressant medications,” according to a June 2, 2009, letter from Grassley to Emory University.

 

In 2007 and 2008 alone, Stowe received about a quarter of a million dollars from Paxil-maker, GlaxoSmithKline, mostly for giving promotional talks, the letter shows.

 

Grassley was especially disturbed by an email between Glaxo employees and a public relations firm Glaxo hired, titled “For your review/Paxil Breast Milk Press Release” which states:

 

“[P]lease review the attached press release and forward me any comments/edits. As you may know, Dr. Stowe is on board for publicity efforts and NAME REDACTED and I are coordinating time to meet with him next week to arm him with the key messages for this announcement, which is slated for early February. We are sending the release for your review at the same time in efforts to secure distribution on Emory letterhead (as you know, would provide further credibility to data for the media).”

 

During a 2008 deposition in a birth defects lawsuit against Glaxo, Stowe confirmed that the press release was written by the PR firm and concerned his research on Paxil, and explained that placing the press release on Emory letterhead would make the data more credible to the public, as opposed to Glaxo letter head, Grassley said.

 

Stories on the internet show the Emory name was apparently used to add credibility to Paxil studies. For instance, citing a February 2, 2000, press release by Emory University School of Medicine, titled “New Study Shows Paxil Not Found in Breast-Fed Infants of Depressed Mothers,” on March 13, 2000, the StorkNet website featured an article with the headline: “Study Results Show Paxil Safe for Use by Breastfeeding Mothers With Depression.”

 

The story included the following paragraph with Emory specifically mentioned and Stowe’s comments:

 

“Due to the increased occurrence of mood and anxiety disorders during child-bearing years, it is imperative that we continue to research and make treatment options such as Paxil available for mothers who want the opportunity and benefit of breastfeeding their children,” said study leader Dr. Zachary N. Stowe, director of Emory University School of Medicine’s Pregnancy and Postpartum Mood Disorders Program.

 

“This study provides compelling data that Paxil is a viable treatment option for mothers who would like to continue breastfeeding.”

 

In the deposition, Stowe said he had been on Glaxo’s speaker’s bureau since 1999 and claimed that on top of his $232,000 Emory salary, he earned an additional 20 – 30% more doing work for drug companies.

 

On June 10, 2009, on the “Carlat Psychiatry Blog,” Dr Daniel Carlat noted that, “Stowe appears to have been deceptive during a recent deposition, when he claimed that on top of his $232,000 Emory salary, he earned an additional 20 – 30% more doing work for pharmaceutical companies.”

 

If he made $154,400 from GSK alone in 2007, “by my calculation this is already 66% more salary than he got from Emory,” Carlat said. “And Stowe did work for lots of other companies as well.”

 

Here is his disclosure from a Medscape CME gig he did in March 2007: “he has received grants for clinical research, grants for educational activities, and has served as an advisor or consultant to GlaxoSmithKline, Wyeth, and Pfizer. … he has served as an advisor or consultant for Bristol-Myers Squibb. … he has served on the speaker’s bureau for GlaxoSmithKline, Wyeth, Pfizer, and Eli Lilly.”

 

“Who knows how much money he was also getting from Wyeth, Pfizer, Bristol-Myers Squibb and Eli Lilly?” Carlat wrote. “He may very well have doubled his Emory salary, or more.”

 

“Furthermore,” he explained, “the $154,400 disclosed by GSK does not include all the cash they paid Stowe through laundered CME money.”

 

“For example, here is a CME program Stowe did for Medscape that was funded by GSK,” Carlat said, and wrote:

 

“The program is entitled “Long-term health risks of antiepileptic drugs in women” and is essentially a commercial for using Lamictal in pregnant women with bipolar disorder.”

 

“In it, Stowe begins by saying nasty things about Lamictal’s competitors, Depakote and Tegretol, and then minimizes a large study showing that Lamictal causes cleft palate.”

 

“I’m sure he got paid a lot for this, and that he did plenty of other similar CME programs that are scattered somewhere throughout the internet.”

 

“The bottom line is that Stowe has run into the same ethical problem as his boss Dr. Nemeroff-he was taking public NIH money to conduct research, while at the same time giving dozens of promotional talks for a company that stood to benefit from the results of that research,” Carlat pointed out.

 

On June 10, 2009, the Wall Street Journal health blog reported that, “Emory University has disciplined a prominent psychiatrist who was being paid by an antidepressant maker at the same time he was conducting federal research about the use of such drugs in pregnant women.”

 

The university said its medical school dean issued a letter of reprimand on April 30 to psychiatrist Zachary Stowe related to his “external relationships,” the WSJ wrote.

 

Emory has reprimanded Stowe, “who was instructed to immediately eliminate conflicts related to current federal grants,” the health blog noted.

 

Also, “the National Institute of Mental Health said it is reviewing Stowe’s activities, prompted by a letter from a U.S. Senate committee that said Stowe received $253,700 in 2007 and 2008 for “essentially promotional talks” for the drug maker GlaxoSmithKline,” the Atlanta Journal-Constitution reported on June 11, 2009.

 

http://www.lawyersandsettlements.com/blog/grassley-seeks-more-info-on-conflict-of-interest-policies-at-medical-schools.html

Last Updated ( Thursday, 25 June 2009 )
 
New Fax Campaign
Written by Administrator   
Saturday, 16 May 2009

Why The MOTHERS Act Should Not Be Passed

 

Please go to  http://www.box.net/shared/810kj0b8g7 and  print a PDF that you can fax to the Senate: http://www.box.net/shared/4qx33jhgen

 

Here is the text of the fax if you want to format your own letter:

 

WHY THE MOTHERS ACT SHOULD NOT BE PASSED

 

On the surface, The MOTHERS Act (S. 324) reflects its sponsors’ compassion for mothers suffering from postpartum depression and psychosis. But when one looks closely at the important sections of the legislation, it is clear that this costly and sweeping mental health legislation not only fails the mothers of America, it’s intended to inflate the balance sheets of Big Pharma.

 

  • The bill omits language clearly stating there will be an evaluation of the large amount of data available on the known risks of antidepressant and antipsychotic medications currently being prescribed to pregnant women and nursing mothers (including birth defects, heart defects, spontaneous abortions, and infant deaths). See May 9, 2009 Vogue article, “Pregnant Pause: With a flurry of recent reports challenging the safety of antidepressant drugs for unborn babies, doctors and concerned mothers-to-be are rethinking the guidelines” by Alexis Jetter at http://www.box.net/shared/deulxo16fp

    The bill defines ‘postpartum condition’ as only ‘postpartum depression (PPD) or postpartum psychosis.’ The danger is that per these DSM-extracted terms to label women with mental disorders, this is only psychological, not physiological conditions which will be checked for, ruling out discovery of any real physical causes, such as hormonal imbalances or vitamin and mineral deficiencies, and neglecting the treatments thereof. This relates to the issue of “screening tools” in development cited in the bill. Are these merely psychological questionnaires, and who is developing them? Are they pharmaceutically funded? 

    The bill cites various “entities” that will be eligible for grants and for participating in research and/or development of screening methods and/or treatments and delivery. Who or what are these “entities?” Are they pharmaceutically funded? Do they have conflicts of interest? There are ongoing investigations of various “non-profit” organizations who heavily promote or conduct screening. For example, Screening for Mental Health, Inc., and its sub-organization Signs of Suicide, who heavily promote and conduct mental health screening, received $4,985,925 from pharmaceutical companies prior to 2008. The National Alliance for the Mentally Ill (NAMI) receives 56% of its funding from pharmaceutical companies. Ten leading psychiatric researchers (many from prominent universities) have been exposed in the last year for failing to disclose millions of dollars in pharmaceutical payments – yet this bill contains no provisions for full disclosure of conflicts of interest for any “entity” receiving federal taxpayer funded grants.

    Given that the Senate Finance Committee recently exposed the financial conflicts of interest of the top ten psychiatric researchers in the U.S., it is no small issue that The MOTHERS Act provides no research guidelines for public disclosure.

    Under The MOTHERS Act’s current language, research will be conducted without peer review – no checks and balances, no one to validate the integrity of the research which then will be used to determine a woman’s mental health status.  
  •  
  • Simultaneously, without allowing any checks and balances whatsoever on the research, it promotes a national “public education” campaign to include Public Service Announcements and television and radio advertisements, essentially giving Pharma an opportunity for free, federally-funded advertising.

 

SUMMARY: Without a fully completed, published, and publicly disclosed investigation of the dangers of current methods of treatment (drugs), efficacy of non-drug treatments, and discovery and disclosure of the causes for these conditions, clearly defined and available for review by the medical/scientific community and consumers, there should be no endorsement of a national educational or advertising campaign. There must be no new or massive utilization or promotion of any “screening tools” without first disclosing the researchers, entities, and methods used to develop these “screening tools.” 

 

Therefore, as a concerned citizen and voter, I urge you to vote “NO” on The MOTHERS Act (S. 324). 

 

Sincerely,                                                                                  Address:

 

 

 

Stress Testing The MOTHERS Act

by Kelly Patricia O’Meara

May 7, 2009

 

It seems these days that everything is a test. Yes, the powers that be have decided that taxpayer benevolence now is contingent upon passing a stress test. But much to the dismay of those being tested, the results may reveal, for example, that the nation’s financial wizards and auto giants are actually bankrupt midgets and unworthy of America’s support.

 

Given that officialdom has embraced the stress test as a barometer of future viability and success and a determinant for public financing, it seems reasonable to request that other important issues that very personally impact the health and welfare of the American people be subjected to similar stress tests. There is none more deserving of stress testing than the proposed MOTHERS Act.

 

On the surface, the MOTHERS Act reflects its sponsors overwhelming compassion and empathy for women suffering from alleged mental health disorders resulting from childbirth – often referred to as Postpartum Depression. But when one conducts a brief stress test on important sections of the legislation, taxpayers may find that this costly and sweeping mental health legislation actually fails women of America, but goes a long way in inflating the balance sheets of one of the most lucrative industries in the nation – big Pharma.

 

For instance, the MOTHERS Act legislation that currently is pending in the U.S. Senate states that the Secretary of Health and Human Services may “make grants to eligible entities…” to deliver essential services to individuals with a postpartum condition. What the legislation doesn’t delineate is who and what entities may receive these grants. Are these “entities” funded by pharmaceutical companies? Lawmakers have not specified what constitutes an “entity” so it will be impossible to know if there are conflicts of interest between those who develop the screening tools and conduct research and the pharmaceutical companies who most certainly will benefit financially from the increased diagnosing.

 

Furthermore, no research guidelines have been provided for public disclosure. This is no small issue, given that the Senate Finance Committee recently exposed the conflicts of interest of the top ten psychiatric researchers in the U.S. who had received millions of dollars in pharmaceutical funding. Where is the guarantee that the “entities” are not pharmaceutical front-men?

 

The legislation also allows for the “expansion and intensification of activities” into the research of Postpartum conditions and “evaluation of new treatments.” This is a humdinger. Despite ever-increasing published data and clinical studies challenging the safety of antidepressants and other antipsychotic drugs, there is no guidance provided by lawmakers to mandate that the public be made aware of the avalanche of scientific data that not only questions the efficacy of the drugs available to mothers suffering from these conditions, but also warning of the dangers associated with currently available “treatments.”

 

The section of the legislation dealing with expanding the research into the causes of Postpartum conditions is wholly void of any guidelines that insure the validity of the research conducted, and provides nothing in the way of public disclosure or peer-review of research before it is launched in education campaigns. In the real world, research is conducted and submitted for peer review. In this instance, it appears that Congress has learned nothing from the ongoing banking debacle and naively believes that the researchers will be on their best behavior – self-policing themselves. This is a dangerous omission in the legislation, especially since the Senate Finance Committee has exposed the serious conflicts of interest that exist between researchers and pharmaceutical companies.

 

Making matters worse, much of the legislation revolves around funding national education campaigns about Postpartum Depression, including Public Service Announcements and television and radio advertisements. Based on the current language of the legislation, research will be conducted without peer review – no checks and balances; no one to validate the integrity of the research which then will be used to determine a woman’s mental health status. Given that this research will be used to develop questions or tests for screening new mothers for possible mental disorders, one might find it important to know that the research has integrity and has been validated by the scientific community, free of pharmaceutical largesse. Congress apparently didn’t think integrity of the research is important and there are no provisions to protect women from pharmaceutical driven research.

 

Taxpayers may also expect that such important legislation would make provisions for some kind of oversight; some government entity that could provide feedback on the success or failure of this mental health campaign. One avenue that may help lawmakers’ determine if these new programs are working is the Food and Drug Administration’s MedWatch Adverse Event Reports. MedWatch collects information about people who have experienced adverse reactions to drugs overseen by the FDA. With the increased drugging that most certainly will occur with the increase in diagnosing, it seems logical that lawmakers would insert provisions in the legislation to annually review Adverse Event Reports collected by MedWatch, especially those relating to drugs prescribed in the treatment of Postpartum Depression. Unfortunately, because the nation’s lawmakers have provided no provisions for oversight, countless numbers of women may be harmed by the “treatments” but will be none the wiser because no protections were provided in the legislation.

 

There also is the very basic question of why the government is endorsing this sweeping mental health legislation and sanctioning a national advertising campaign about Postpartum Depression when there is no definitive data about the cause of the condition or that it is an objective confirmable abnormality – the scientific standard for disease. Given that there are so many unknowns in this legislation, it seems irresponsible to go forward without reasonable protections in place.

 

Congress must insure that all research and screening tests proposed and endorsed by this legislation be disclosed for peer-review and consumer input before implementing any screening tests and approving any research to be used in the national education campaign, including Public Service Announcements and radio and television advertising.

 

Given the documented risks related to the current modes of treatments, including antidepressant and antipsychotics, which are commonly prescribed for Postpartum Depression and documented to cause birth defects and host of other issues in pregnant and nursing mothers, Congress must include mandatory reviews of published research and clinical data on the drugs prescribed for the treatment of Postpartum Depression.

 

Finally, Congress must protect the integrity of the research by providing strict guidelines to insure that there are no conflicts of interest between the researcher and the pharmaceutical industry.

 

Without these safeguards, the MOTHERS Act cannot today, or ever, pass a stress test of viability and mothers and their children certainly will be on the losing end of this mental health campaign. Sometimes it’s in the best interest of the people for Congress NOT to act, and until our lawmakers are confident that all legislative precautions have been taken to insure optimum results, this is one of those times.

 

About the author:

 

Kelly Patricia O’Meara is an award-winning investigative journalist who authored more than two dozen articles examining the psychiatric pharmaceutical industry during her tenure at the Washington Times’ Insight Magazine. Her articles resulted in record sales of the issues in which they appeared and among the national and international press that have featured her articles are Fox News, the O’Reilly Factor, CBS News, BBC, ABC’s 20/20 and Hannity and Colmes. She is also the author of Psyched Out: How Psychiatry Sells Sickness and Pushes Pills that Kill. Prior to working as an investigative journalist, O’Meara spent sixteen years on Capitol Hill and was the lead investigator in several Congressional investigations. She holds a B.S. in Political Science from the University of Maryland.

Last Updated ( Wednesday, 03 June 2009 )
 

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