Life Science Compliance Update

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23 posts from November 2008

November 26, 2008

Letters from Grassley: UnPublic Radio

Senator Grassley has taken on yet another psychiatrist on the issue of conflict of interest in what could be considered an “unfairness” doctrine.  This time he is not a researcher but a talk show host. 

Senator Grassley has forced National Public Radio to pull the long running Infinite Mind radio program hosted by Fredrick Goodwin, MD, former director of the National Institute of Mental Health, a leading expert on bipolar disorder and adjunct professor at George Washington University Medical Center.

According to Senator Grassley, Dr. Goodwin has taken millions of dollars in speaking and consulting fees from industry including $1.2 million in speaking fees from GlaxoSmithKline.

What started this investigation and subsequent dismissal of Fred Goodwin, MD was a May 9th article in Slate online titled:  Stealth Marketers: Are doctors shilling for drug companies on public radio?  In the article they describe an episode of Infinite Mind titled: Prozac Nation Revisited in which the speakers all had at one time done research or received speaking fees from Eli Lilly, the original manufacture of Prozac (Prozac has been a generic since 2002).  Actually, one speaker, Peter Pitts from Center for Medicine in the Public Interest (CMPI) - his crime is that in addition to his organization Peter works for the PR firm of Manning Selvage and Lee, and they have pharmaceutical companies as some of their clients.  This is the equivalent of attacking an attorney of a 4,000 person firm simply because they have clients in the area you are discussing.  The real purpose of the Slate piece was to attack Peter Pitts for standing up for industry, an unforgivable crime in today’s world.

From his speech on the floor of the Senate, Senator Grassley states:

Last May, a couple of reporters for a news site called ``Slate'' wrote about an episode of ``The Infinite Mind'' called Prozac Nation: Revisited. During this episode, three guests on the show discussed problems with antidepressants. After listening to a recording of the show, it appeared to me that the real effect of this particular episode was to undercut any criticism that antidepressants might be linked to an increased risk of suicide. This is an issue I tackled a few years back.

Maybe these three guests felt that there really is no problem with antidepressants. But a large number of experts believe that antidepressants may be associated with an increased risk of suicide, particularly in kids. In fact, last March, two months before this show aired, Britain's Medicines and Healthcare Regulatory Authority MHRA, concluded a 4 year investigation of the antidepressant, Paxil. That report found that GSK had been aware since 1998 that Paxil was associated with a higher risk of suicidal behavior in adolescents.

Now don't get me wrong, experts on public radio have a right to express their own opinions. However, I am concerned that the host of ``The Infinite Mind'' never pointed out that all three of the show's guests had strong financial ties to the pharmaceutical industry.

That is right. Every one of them. And this was never mentioned during the program or by the guests who appeared.

What listeners also never learned is that the host of ``The Infinite Mind'' has his own ties to drugmakers. When a show runs on National Public Radio, NPR, doesn't the public have a right to know where the show's host gets his money?

    

I agree, the listeners do have a right to know where the host gets his money, and also the right to know where members of congress get their money.  Has a member of congress ever disclosed on the radio to their audiences that since 2000 I have received $150,000 from any industry?  I don’t ever remember that happening.

It is sad the NPR has adopted a cut and run mentality at the first sign of a problem.  NPR bears responsibility in not informing their syndicated programs about their conflict of interest policies and not providing clear guidance on how to comply (which is the problem with Conflict of Interest in general, everyone has a conflict of one type or another otherwise they would not be an expert). 

The experts involved on the program quoted Prozac Nation Revisited including the current President of the American Psychiatric Association, are all reputable physicians and would have gladly shared any conflict of interest if they were asked. After listening to thousands of hours of talk radio I never remember ever hearing any “expert” sharing their conflict of interest statements with the audience.  If this was a requirement, it seems to me that everyone involved would have happily participated.

Dr. Goodwin is a classic case of someone starting something ten years ago (this is when the Infinite Mind Program was started) when the environment was different, and being punished for not keeping up with the new policies. 

It is not clear that Dr. Goodwin actually violated any rules or regulations.  This is because Dr. Goodwin does not work for NPR, but has his own business and collects a paycheck from a production company not NPR.

It does state on the NPR website that employees and hosts have the responsibility to disclose potential conflicts of interest

NPR issued a statement on this issue that they are not responsible for the content of Infinite Mind:

“The Infinite Mind” is not an NPR program. NPR does not produce “The Infinite Mind,” nor does NPR distribute the program or market it to our member stations. No one associated with “The Infinite Mind” team is an NPR employee.

“The Infinite Mind” has aired on one of two channels that NPR programs on Sirius Satellite Radio. All programs on NPR’s Sirius channels are expected to adhere to the same code of ethics and practices that apply to programs produced and distributed by NPR. It appears that “The Infinite Mind” was in direct violation of that code, and is being removed from the channel."

This statement does not hold water as their most popular show Car Talk is shamelessly commercial and offered every weekend on NPR.

In addition to his floor testimony Senator Grassley sent letters to the Interim Director of the National Institute of Health and the Director of the National Science Foundation asking for all information they had on relationships supporting the infinite mind program and any other consulting, or research projects they had going on with Dr. Goodwin, and of course they have until December 3rd to get everything back to the Senators office. 

Senator Grassley also sent a letter to Best Practices LLC CEO, Roger Meyer asking if explanation of the information found on your company’s website (older version) and whether off label promotion was offered by your company and if such services are currently offered.

Senator Grassley is using this as one more example of why Congress should adopt his Physician Payment Sunshine Act (you need a problem to propose a solution). 

If politicians are successful with these types of intimidation tactics, it will only be a matter of time when other good physicians are expelled from public life, called out on their views, exposed as conflict of interest violators.   

I have had discussions with several psychiatrists and they are convinced that this focus on psychiatry is not coincidental, that these are part of a larger scheme to discredit modern psychiatry, which uses both counseling and treatments to treat very complex problems.

All these investigations from the surface are very similar to all thought investigations. They depend on fear, fear that perhaps people are incapable of sorting out when something is a conflict and when something is not. 

It is predicated on the assumption that expert physicians are evil because they somehow have become corrupted working with industry to develop and promote new therapies.

The real victims will be patients who would otherwise be helped by these medications.

The Car Guys who also have a popular NPR program and recommend car parts, to people on welfare, and they conduct shameless commerce better look out over their shoulder, as Senator Grassley will be sending them the next letter.

Key Documents:

Grassley: Congressional Record Testimony 11-19-08

Grassley: Letter to NIH 11-19-08

Grassley: Letter to NSF 11-19-08

Grassley: Payments to Dr. Goodwin from GSK

Grassley:  Letter to Best Practices LLC

NPR Statement: Infinite Mind

New York Times: Popular Radio Host Has Drug Company Ties

Wall Street Journal Blog: Grassley Knocks Radio Host Goodwin for Drug-Industry Conflicts

Pharmalot: Talk is Cheap: NPR Host Has Ties to Pharma

Slate Online: Stealth Marketers: Are doctors shilling for drug companies on public radio? 

Infinite Mind Radio: Prozac Nation Revisited

November 24, 2008

AMA CEJA: Taking a New Road on Commercial Support

According to Medical Meetings the AMA CEJA committee looks like they have taken the proposed ban on commercial support off the table for the upcoming CEJA report.  CEJA reported this in a progress update to the AMA at the AMA fall meeting recently held in Orlando, Florida.

CEJA’s report, “Industry Support for Professional Education in Medicine,” is a work in progress and is scheduled for release at the 2009 annual meeting next June. However, CEJA council member John McMahon, MD, corporate medical director, Mountain Pacific Quality Health Foundation, Helena, Mont., said that the council made clear in its progress update at the Interim Meeting that it does not support eliminating commercial support.

As  previously reported CEJA is revising the report and will be working with the AMA Council on Medical Education which will provide for a much more balanced report.

This past summer AMA CEJA’s report Industry Support for Professional Education in Medicine, was soundly rejected by their constituencies including, medical schools, associations, hospitals, and state medical societies.  Even the Medical Student Section came out against the report.  The reference committee had sent it back for more work.

The AMA CEJA and CME committees will be soliciting commentary from stakeholders on the issue of commercial support in CME, according to the staff the comment period is now open, so this is an opportunity to participate in the process.

Medical Meetings: CEJA Takes New Stance on Commercial Support

Policy and Medicine:  AMA CEJA: Round 2

                                     AMA CEJA:  Back to the Drawing Board

November 20, 2008

Healthcare Reform: Waxman Emerges as the New Chairman

Rep. Henry Waxman (D-Calif.) has emerged as the champion, in the fight for the Chairmanship of the US House Energy and Commerce Committee defeating current  chairman John Dingell (D-Mich.), as Democratic lawmakers voted 137-122 in their caucus meeting this morning.

The vote may mark the beginning to the end of the seniority system Democrats have honored for decades.  

Speaker Nancy Pelosi (D-Calif.) emerged a winner on this one,  as Waxman is who is ideologically aligned with her and she has clashed repeatedly with Dingell.

Rep. George Miller (D-Calif.), one of her top lieutenants, helped lead the charge for Waxman.

What's next for Dingell — who, with 27 terms under his belt, is the dean of the House —One option for him would be to take the gavel of the Energy and Commerce Subcommittee on Health, a reduced though still significant portfolio as lawmakers gear up for an expected health care overhaul

Waxman at the leadership helm of the Energy and Commerce Committee will mean that Healthcare will emerge as the top priority in the House.  It will be interesting to see, this is a seismic shift change for the powerful committee and Congressman Waxman is completely focused on reforming Healthcare.   This adds to the almost perfect circumstances, with Senator Kennedy passing the healthcare reform baton over to Senator Baucus yesterday and the appointment of Tom Daschle as HHS Secretary, we are now assured a healthcare reform package will be passed early in the Obama administration.


 

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