TCS Daily


Political Expediency vs. Science

By John Ford - June 13, 2005 12:00 AM

A bill introduced by Congressman Maurice Hinchey (D, NY) that attempts to end financial conflicts of interest among FDA advisory committee members passed by a vote of 218 to 210. The bill prevents the FDA from empaneling scientists with financial ties to companies whose products they are evaluating by eliminating FDA fees to such scientists.

This step by Congress appears to make sense. But as often happens, there can be unfortunate unintended consequences.

The FDA uses experts to staff advisory committees that analyze the risks and benefits of new medications and medical devices. The agency typically calls upon the most knowledgeable "opinion leaders". For example, a committee charged with the task of evaluating a new heart medication would likely be composed of eminent cardiologists as well as expert pharmacologists.

Such a committee reviews all possible data on the product and will compose a recommendation to the FDA. The FDA will then evaluate the recommendation and either approve or disapprove the product for marketing. Advisory committee recommendations are not binding. It is rare however for the FDA to overrule their own committees.

The alleged problem has been that occasionally committee members have financial ties with companies producing the drugs or devices being examined. Such ties may be in the form of consulting fees, research grants or the holy grail of remuneration, equity. There have been some instances where at the very least the appearance of a financial quid pro quo has occurred.

 

This bill represents a solution that is every politician's dream. It requires the expenditure of very little political capital and will make everyone look good in the eyes of their constituents. On the surface, it seems to make sense.

The problem is that things aren't quite as simple as they appear. Such a bill would be perfectly acceptable if there were a very large pool of experts in a particular field to choose from. Unfortunately, this is rarely the case. The most knowledgeable experts usually represent a very select group. Unfortunately, these people are those most sought after by the drug and medical device industry.

In other words, those most qualified to serve on FDA advisory committees are those most likely to have the above-mentioned conflicts of interest. To statutorily eliminate all such individuals from serving guarantees that these committees will be filled with second-tier members. Do we really want to hobble the FDA in its effort to get the best, most well thought out, most current thinking on these very complex medical products?

I believe financial ties to industry are more than a theoretical problem. And yes, I believe there have been situations where the public trust has been violated. But at the same time, we have to be realistic. The best scientists will be accepting fees, grants and equity from business. If we indiscriminately require them to not do so as a condition of serving on these important committees, the result is predictable.

They will simply opt out.

Their collective brain trust will be denied to the FDA who will then have to rely on the next lower level of expertise for guidance. It is doubtful that the agency and hence the public will be served by such second-tier recommendations. This is a classic case of balancing competing needs.

The New England Journal of Medicine was concerned that their editorials on medical products might be tainted by financial conflicts of interest. In 1992, they therefore published the following guidelines:

 

"Because the essence of reviews and editorials is selection and interpretation of the literature, the Journal expects that authors of such articles will not have any (my emphasis) financial interest in a company (or its competitor) that makes a product discussed in the article."

 

Ten years later, the Journal's editors felt compelled to revise this policy and replaced "any" with "any significant". Significant was defined as equity, stock options, patent interest or fees in excess of $10,000. The reason for the shift was that they couldn't find top experts to write editorials and reviews free of financial relationships to meet their older policy. In effect, the New England Journal of Medicine had to grapple with the current economic realities of big science.

Likewise, the FDA should be permitted to grapple with such realities in their own way as well. While the FDA may very well be overly lax in monitoring potential conflicts of interests, they should be given the opportunity for doing so themselves. Otherwise, they won't be able to balance their need for clinical objectivity (which the House bill seeks) with their need for the best and most authoritative opinions. Maybe provisions need to be made for the secret balloting of committee member votes (at least giving members a modicum of protection from the scrutiny of their sponsors). Certainly other creative options can be considered.

This important problem will ultimately require a light touch, not the heavy-handed approach of new federal law. I would hope that more thoughtful minds will prevail and that the many problems of the FDA will not be exacerbated by this example of political expediency.

John S. Ford, MD, MPH is Assistant Professor of Medicine, David Geffen School of Medicine at UCLA. You can find more of his writing here.

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