Keeping big pharma in check?

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A review of the book:

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA
A book by Daniel Carpenter Princeton  

http://www.bmj.com/content/342/bmj.d1103.full

"This comprehensive, authoritative, and insightful history of the US Food and Drug Administration enables a reader to understand how the FDA garnered power over one of the most powerful industries in the world; the myriad forces that have influenced FDA decisions; and the social and political factors that shaped the FDA and those that continually buffet it. The story of the FDA is a tale of gradual accretion of authority, influenced from time to time by legislation, and punctuated not only by occasional national drug disasters but also by some almost calamitous near misses."

 

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA
A book by Daniel Carpenter Princeton    

BMJ 2011; 342:d1103 doi: 10.1136/bmj.d1103
(Published 10 March 2011)
Cite this as: BMJ 2011; 342:d1103
Views & Reviews Review of the Week
http://www.bmj.com/content/342/bmj.d1103.full

Keeping big pharma in check?

Reviewed by:

Jerome P Kassirer, distinguished professor, Tufts University School of Medicine; visiting professor, Stanford University; and editor in chief emeritus, New England Journal of Medicine JPKassirer{at}aol.com   

This comprehensive, authoritative, and insightful history of the US Food and Drug Administration enables a reader to understand how the FDA garnered power over one of the most powerful industries in the world; the myriad forces that have influenced FDA decisions; and the social and political factors that shaped the FDA and those that continually buffet it. The story of the FDA is a tale of gradual accretion of authority, influenced from time to time by legislation, and punctuated not only by occasional national drug disasters but also by some almost calamitous near misses. 

The book is a lesson on the numerous constituencies upon which a government agency relies to preserve and maintain its reputation. It is an impressive and moving story about government employees who have served the public well by approving drugs with proved efficacy and safety, basing decisions on solid science, often under criticism from industry, legislators, academics, professional societies, disease based organisations, and patients. 

But it is also a story of how science and a reputation based on rigorous scientific conduct is not necessarily sufficient to sustain an optimal choice of prescription drugs. Despite its reputation as an inflexible bureaucratic organisation, the FDA does change its drug approval practices from time to time in response to public outcries, as it did when drugs for HIV infection first emerged or when promising treatments for a previously untreatable disease were introduced. But these public influences pale in comparison with those that waft in with changes in the direction of political winds. 

In the tug of war over the approval and labelling of prescription drugs, industry would prefer to offer fewer clinical trial data and fewer warning labels on existing products. The companies would like fewer advertising restrictions and fewer requirements for postmarketing surveillance. They desire less scrutiny of their submitted data, more rapid approvals, and more sway over all FDA decisions. For decades, by virtue of its accrual of power and its stellar reputation, the FDA has been able to staunch these industry cravings. Although some drugs that the FDA approved in the recent past have been removed from the market, or are now subject to stringent prescribing restrictions (for example, valdecoxib, rofecoxib, and rosiglitazone), it is too easy to be critical of risky drugs with hindsight bias: approval decisions should not be judged solely by their outcomes. It is fair to conclude that prescription drugs on the market are generally safe and effective. If we accept this premise, then any erosion of the power of the FDA could easily lead to approval of drugs that are less effective and more risky. 

How could this change happen? In fact, this has happened already. A pro-industry Congress, bolstered by huge financial contributions from the drug industry, has gradually had its way. The Prescription Drug User Fee Act of 1992 brought more money and personnel to the FDA from industry, but at the cost of adding industry seats at the table. In 1997, a restriction on direct to consumer advertising was lifted. And in

2007 amendments to the Food and Drug Administration Modernization Act required the FDA to approve drugs within a set period rather than take the time perceived necessary to do a proper review. Appointments to top positions in the FDA by a pro-business executive have led to some inexplicable approval decisions and rotating door appointments of strident FDA critics with ready access to national op-ed pages. 

Until recently, when new FDA leaders were appointed, loosened conflict of interest requirements allowed many consultants paid by industry to sit and vote on major FDA committees. Pending court decisions threaten to further weaken the FDA’s sway. These decisions are based on industry’s assertion of a right to so called free commercial speech, the concept that companies should have the right to promote claims about their products without FDA approval. Such an action would put the onus on the FDA to later prove companies’ claims wrong. The basis of such a scheme is the proposition that a company would only disseminate such claims if they were true. Given recent experiences in which companies have hidden adverse data and marketed products in defiance of the law (for examples, see www.citizen.org/documents/rapidlyincreasingcriminalandcivilpenalties.pdf),

trusting companies to inhibit their marketing departments from doing more of the same would be at least irresponsible. 

It all seems so simple: decisions on drug approval, labelling, and postmarketing assessments should be based strictly on science. How reliable are the clinical data? Are there other agents available? How great is the benefit of a new drug? How serious is the risk? What is the relationship between the benefits and risks? Yet science itself has suffered in recent years. Though the practice of science is unchanged, its reputation has faltered. 

And here may be the most serious problem of all—namely, the failure of many to appreciate and understand the rigours of science. Too few people trained in science are serving in state and national legislatures. Too few judges are adequately versed in science. Too many people believe that science is just another belief system. Too many regard evolution as a theory, believe in creationism, and reject the evidence that global warming may be of human origin. 

The assault on FDA practices is falling on the susceptible ears of those who believe that economics should rule major decisions; that what is good for the prescription drugs business is good for patients; and that public perceptions and company marketing decisions yield self correcting errors and so serve to eliminate faulty products. Such notions are a callous deception. 

In fact, business is amoral, and when it dominates, people can get hurt. 

Notes

Cite this as: BMJ 2011;342:d1103 

Footnotes

Reputation and Power: Organizational Image and Pharmaceutical Regulation at the FDA A book by Daniel Carpenter Princeton University Press, $29.95, 856 pp ISBN 978-0691141800

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