Thursday, January 10, 2013

Yet Another Ruse by Pharma to Muddle Conflict-of-Interest Rules

On January 7, Medscape  reported, "The American Psychiatric Association (APA) has fired back a strong response to a recent article in theWashington Post questioning the possibility of pharmaceutical industry influence on decisions regarding the upcoming fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)." 

David Kupfer, MD, chair of the DSM-5 Task Force, said in a news release, "While speculation is bound to occur, we think it is important to stay focused on the fact that APA has gone to great lengths to ensure that DSM-5 and APA's clinical practice guidelines are free from bias."

In his news release, in which he defended the policies regarding conflict of interest in the members of the different groups that were working on the DSM -5, published in the Psychiatric Times, he stated“… all individuals agreed that, starting in 2007 and continuing for the duration of each individual member’s work on DSM-5, that individual’s total annual income derived from industry sources (excluding unrestricted research grants) [italics mine] would not exceed $10,000 in any calendar year, and he or she would not hold stock or shares of a pharmaceutical or device company valued at more than $50,000."

So nothing to worry about?  No conflict of interest here?

Unfortunately, that part I highlighted in the above quote is big enough to drive the proverbial truck through. As the article in the Washington Post of 12/26/12, pointed out, “Members [of the various task forces creating the new DSM] could also receive unlimited amounts of money from pharmaceutical companies to conduct research.”

If the drug companies are supporting the research of an "expert," how is that not financial influence?  Most of these experts are academics; if they do not get funding, they often cannot keep their jobs! Depending on Pharma for your income is hazardous to your objectivity.

This very sly loophole in disclosure and conflict-of-interest rules has also been exploited by some Pharma-funded researchers who label themselves as “unpaid consultants” in the “disclosures” attached to journal articles.

As was pointed out by Alan Blum, a fellow member of Healthy Skepticism:

“I wanted to share my view that the term seems disingenuous and may not even make any sense. Is the reader supposed to believe that the author has served a multi-billion dollar company out of the goodness of his or her heart? Indeed, such a term seems even more offensive than "paid consultant" by possibly trying to take the reader for a fool.”

For example, “…the author of the Grand Rounds in JAMA [Journal of the American Medical Association] discloses that she receives funding "through research grants to her university" from Pfizer, for which, she also discloses, she "has served as an unpaid consultant."

In other words, what the “unpaid” part merely means is that she wasn’t paid directly for work done for the company. The money was funneled to her indirectly through research grants and other monies given to her employer, the university.

But back to the DSM workgroups. New definitions of psychiatric disorders can provide a financial windfall for a drug company, which suddenly has a whole new group of customers defined as having the disorders for which their drugs are indicated. So of course they do anything they can to influence these definitions in ways that feed their bottom line.

This strategy is part of a two-pronged attack that influences clinicians without the drug companies appearing to have had any involvement at all.  Covertly, they are pulling strings behind the scenes. 

The second part of the attack comes through the production of treatment guidelines, which are published by various professional organizations. (I touched on this in my post about PTSD treatment guidelines about guidelines that prohibit a class of drugs effective in panic disorder with no mention being made of the widespread co-occurrence of panic disorder in PTSD sufferers).

The involvement of big Pharma companies in the production of treatment guidelines, and the biases this produces, is well known.  The Washington Post article lists some of the problems this has created:

“But the associations and medical societies that develop these guidelines ... quite often  receive money from pharmaceutical companies, often through advertising at conferences and sometimes through outright grants for developing the guidelines. In recent years, those relationships have come under sharp criticism:

■ Guidelines written by the National Kidney Foundation and sponsored by the drugmaker Amgen effectively raised the recommended doses of the company’s drug. Those higher dosing targets are now considered unsafe. Eleven of the 16 members of the panel that approved the guidelines were found to have financial connections from the affected drug makers — they reported receiving consultant pay, speaker fees or research funds, according to a published paper by Daniel Coyne, a professor of medicine at Washington University.

■ An analysis last year of 17 guidelines used in cardiology indicated that 56 percent of members of work groups reported a conflict of interest, according to an investigation published in the Archives of Internal Medicine. A related study showed that about half of the treatment guidelines in cardiology were based on doctors’ opinions rather than more substantial evidence.

■ An international conference on early breast cancer that was issuing guidelines expressed a preference for a group of expensive proprietary drugs that appear to be no better than others in terms of patient survival. Twenty-four of 43 members on the panel, including both chairs, had financial ties to the makers of the proprietary drugs, according to a published account by Päivi Hietanen, the medical editor of the Finnish Medical Journal."

In the Washington Post article, APA chief executive James H. Scully Jr. was quoted as defending the APA’s conflict of interest policy for the DSM task forces.  He said that  said that if no financial ties were permitted, many knowledgeable psychiatrists would be excluded because so many university studies are funded by pharmaceutical companies.  He said The APA sought to have a balance:

“Our dilemma is: Do we not have the world’s experts, or do we have limits and disclosures [of their financial ties]... You could say absolutism should prevail, but then where are you going to get your experts?”

The Post article counters: It’s hardly impossible to find medical experts without financial ties to industry, however, according to research. A survey of academic researchers, for example, showed that 36 percent of full professors at medical schools report no financial connections to the industry in the previous year. The idea ‘that every expert in the field has industry relationships is not supported by the data,’ said Eric Campbell, a medical professor at Harvard University, who conducted the surveys. Instead, he said, such claims are rather ‘propagandist in nature.’”

No kidding.

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