Showing posts with label APA. Show all posts
Showing posts with label APA. Show all posts

Sunday, July 20, 2008

SCHATZBERG DISCLOSURE

SCHATZBERG DISCLOSURES

Questions continue to buzz about Dr. Alan Schatzberg’s and Stanford’s claims that he complied with the university’s disclosure requirements. Dr. Schatzberg is chair of Stanford’s department of psychiatry and the founder of a company called Corcept Therapeutics. I have commented previously on the University’s (mis)management of Dr. Schatzberg’s conflict of interest vis a vis Corcept and his NIH funding.

The two most informative documents released by Stanford University are dated 23 May 2008 and 25 June 2008. The first is an amended response to Senator Charles Grassley. The second is a public statement concerning Sen. Grassley’s investigation of Dr. Schatzberg through the Senate Finance Committee.. The complete texts are available on-line here: http://ucomm.stanford.edu/news/052308conflict_of_interest.pdf (1)

and here http://ucomm.stanford.edu/news/062508conflict_of_interest.pdf (2)

Additional perspective is to be found in an article in the Stanford Daily here:
http://www.stanforddaily.com/article/2008/7/10/senatorTargetsSchatzbergForConflictOfInterest (3)

Stanford’s policy requires that
“Disclosure of potential conflicts of interest at the time of any transaction,
such as when the faculty member receives a research grant or gift or has
intellectual property licensed, is a critical component of our conflict of
interest policy. Transactional disclosures of conflicts of interest are required
when submitting a grant, negotiating a contract, during licensing activities,
submitting protocols for human subjects research or animal research, entering
into material transfer agreements or collaboration agreements, receiving gifts
or entering into procurement activities. … Our standard for a significant
financial interest is whether the faculty member has received $10,000 or more in
income, holds $10,000 or more in equity in equity for publicly traded companies
or has any equity if the company is privately held. This ad hoc disclosure is
used to mitigate, manage or remove such specific conflicts, and, for all
research funded by NIH, as a basis for reporting to NIH. All such conflicts are
also reported in the annual disclosure, and thus are also part of the University
information on conflict of interest (emphases added) (1).
Likewise, the Stanford Daily reported that
“the University said in its letter to Grassley that it holds a “zero-dollar
threshold for disclosure.” This requires that faculty members divulge any and
all financial gains made through outside interactions that could have bearing on
what they are doing on campus.” (3)
The sale of Corcept Therapeutics stock by Dr. Schatzberg in 2005 was not reported to the University. (1) Dr. Schatzberg’s attempted sales of stock in 2002 and 2004 in connection with Corcept’s planned stock IPOs also were not reported to the University. (1) Proceeds of the 2005 sale to Dr. Schatzberg were over $109,000. Projected proceeds of the failed attempts to sell stock during the IPOs were $7-11 million. In terms of the policy described above, these must be considered “transactions” and “income” and “financial gains.” Stanford did not document compliance by Dr. Schatzberg with University policy. The stock sale is not mentioned in Dr. Schatzberg’s 2005 disclosure to the University. (1) Indeed, Stanford prevaricated on this issue by stating “…information about his stock ownership and stock sales was publicly disclosed through SEC filings and is available online through financial reporting services.” (2)

This explanation is laughable. Since when does a University rely on SEC filings and online financial reporting services to learn about the transactions and financial conflicts of its faculty members in order to discharge its fiduciary duty to disclose these transactions to NIH?

Even worse, the American Psychiatric Association has parroted Stanford’s assertion that Dr. Schatzberg made the required disclosures. In an interview with the New York Times, Dr. Nada L. Stotland, president of the psychiatric association, said the group had studied Mr. Grassley’s letter and Stanford’s response and agreed with Stanford. Dr. Schatzberg will take over as president of the association as planned, she said. The association and the University here are being disingenuous – treating an ethical issue as a technical legalism. But even on legally technical grounds their case fails. Is that the standard that Stanford and the APA wish to state for the record?

Once again, it is time for Stanford to get real about the boundary between commerce and academia. And, in view of the unjustified promotion of their commercial interest by Dr. Schatzberg and his corporate associates through academic outlets, it is time for the American Psychiatric Association to grasp the nettle and to reconsider Dr. Schatzberg’s fitness to serve as president in 2009.

Sunday, June 15, 2008

MEDSCAPE'S CME ETHICS

17 June 2008

MEDSCAPE’S CME ETHICS

Like global warming, the erosion of professional values and medical education by commerce shows no sign of slowing. The latest scandals involve Medscape. Medscape is a medical communications company that produces and distributes CME programs and other quasi-educational offerings, such as “Expert Interviews” and News items. A subsidiary of WebMD, Medscape is accredited by ACCME, and it relies on drug company money for its production costs. Medscape also displays multiple advertisements on every web page. Medscape uses salaried and contract medical writers to produce the “educational material.” The content is pedestrian, mainly because it makes no pretense of really educating – it is primarily a vehicle for promoting the sponsors’ products with varying degrees of slyness and subtlety, as Daniel Carlat has documented here http://carlatpsychiatry.blogspot.com/2008/06/medscapes-cme-corruption.html#links Some items are academic wallpaper, non-promotional pieces designed to create an appearance of commitment to education. For most featured items, Key Opinion Leaders (KOLs) are hired to push the material. These KOLs are paid for their roles, although Medscape never says so, much less discloses how much it pays. If they wish to be engaged regularly, the KOLs know they need to stay “on message.” These are standard arrangements in today’s amoral world of CME. Daniel Carlat recently published a fine exposé of Medscape’s corruption of CME standards (link above).

An especially distasteful practice is Medscape’s use of the names, reputations, and credibility of major professional societies to give its indifferent CME offerings and infomercials more pizzaz. Just to give two examples, Medscape web pages are currently hijacking the public images of both the American Psychiatric Association (APA) and the American College of Neuropsychopharmacology (ACNP), featuring highlights of these organizations’ annual meetings as CME and other items. These “highlights” from the APA and ACNP meetings are offered by Medscape FOR CME CREDIT!!! For us to call this presumptuous would be an understatement. For Medscape to dress it up with sanctimonious statements about avoiding conflict of interest is insufferable.

Both APA and ACNP annual meetings are closed events, so how does a commercial CME outfit like Medscape get its hands on these restricted materials? The most likely explanation is that venal KOLs accept Medscape payments for producing puff pieces with the organizational tagline (highlights of the APA/ACNP meeting!). In effect, these KOLs trade on their membership in professional organizations for personal gain in return for “authoring” Medscape-produced CME items, “Expert Interviews” and News pieces. How tacky is that? The KOLs who “authored” mini-manuscripts or provided “Expert Interviews” for Medscape’s “highlights” of the 2007 ACNP annual meeting, whether as infomercials or wallpaper, should know better. You can find them here and in the associated links: http://www.medscape.com/viewprogram/8683

Medscape is paid by Pharma to produce these items. The APA 2008 annual meeting highlights on Medscape’s website were supported by an “independent educational grant” from Shire and by an “unrestricted educational grant” from Bristol-Myers Squibb Company/Otsuka America Pharmaceuticals, Inc. It is a good bet that Medscape shares none of that revenue with the APA. Likewise, the ACNP 2007 annual meeting “highlights” were supported by an “independent educational grant” from Vanda Pharmaceuticals. We can be sure ACNP saw none of that revenue.

So what we have is Medscape profiting from Pharma sponsors while juicing up their mediocre CME offerings with tag lines to “highlights” of the APA and ACNP annual meetings. How tacky can you get? How tacky? This tacky: Here is the disclaimer published by Medscape’s lawyers regarding the ACNP meeting.

Legal Disclaimer
The materials presented here do not reflect the views of Medscape or the companies providing unrestricted educational grants. These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. A qualified healthcare professional should be consulted before using any therapeutic product discussed. All readers or continuing education participants should verify all information and data before treating patients or employing any therapies described in this educational activity.
The materials presented here were prepared by independent authors under the editorial supervision of Medscape and do not represent a publication of the American College of Neuropsychopharmacology. These materials and the related activity are not sanctioned by the American College of Neuropsychopharmacology or the commercial supporter of the conference and do not constitute an official part of that conference.
Copyright © 2008 Medscape.


An additional disclaimer states, “This activity is not sanctioned by, nor a part of, the American College of Neuropsychopharmacology.” Well, fine. If it wasn’t sanctioned, why is Medscape splashing it over its web pages? I am confident ACNP gave Medscape no such authorization.

One hopes that APA and ACNP will publicly disown this corrupt use of their names and reputations for commerce by Medscape. The situation with APA is problematic because the incoming APA president, Alan Schatzberg, has been a frequent “Expert Interviewee” on Medscape. It remains to be seen whether his compromise and conflict will affect the organization’s response.

So, nobody at Medscape is accountable for the bias and bs in these items, even though they were written by Medscape staff and contractors. Medscape’s disclaimer tells us to go after the “independent authors.” That’s exactly what I intend to do in my next posting. Meanwhile, if Medscape wants credibility it will need to clean up its act. A good place to start would be to stop using these compromised KOLs who push infomercials and who provide soothing wallpaper. The real solution would be for Medscape to stop its skimming and money laundering activities altogether. Perhaps that is hoping for too much. Or they could just run naked advertising and they won’t need to bother with ACCME requirements. On the other hand, self-respecting health care professionals can just say no to Medscape’s kind of crap.

And what exactly does an “independent educational grant” mean, anyway? We will examine that trope in my next posting, which features the poster boy for compromised KOLs in psychiatry, Charles Nemeroff, MD from Emory University’s department of psychiatry. In that example, Medscape joins forces with Nemeroff to promote an entirely new level of sleaze. Stay tuned.