Wednesday, January 9, 2013

Why We Need Independent Drug Research

History quiz--in what year was this statement made in Congress as a reason to propose new legislation on standards for drug approval?

As the law reads at present, the FDA determines the safety and efficacy of a drug solely on the basis of information supplied by the drug company making the application. The dangers involved in the dependence on drug firms to perform, direct, or arrange for the testing of drugs in which they have a financial interest is obvious..... [T]here is an inevitable tendency--no matter how conscientious the firm--to emphasize the positive features and deemphasize the negative. Many of the people they engage to do their testing are equally anxious to secure additional contracts for drug testing... A physician who turns in unfavorable reports on the drug he is testing may not have his contract renewed... [S]ome firms have been guilty of misrepresenting, distorting, and even withholding information developed in their testing of drugs which might in any way retard or prevent an approval to market. Injury and death have resulted from such actions.

Testing of drugs should be done by specialists who have no direct relationship with the manufacturer, who cannot benefit financially from the results, who are not motivated even subconsciously by the desire to get anything but the truth. We must remove the responsibility for testing drugs from the applicant who has a financial interest in the drug.

Answer: 1971 (Sen. Gaylord Nelson)

I blogged previously about Marc Rodwin's important book on conflicts of interest and drug development:
Professor Rodwin (of Suffolk U. Law School in Boston) has now written a law review paper--
--recommending that we reinvigorate this longstanding quest for a financially independent way to do clinical research on drugs, and to eliminate the corrupt influence of industry money on the present pharmaceutical research enterprise.

As the introductory quotation indicates, Prof. Rodwin is big on history and carefully reviews both the story of the FDA and its enabling legislation, and four different Senate hearing cycles (by Senators Kefauver, Humphrey, Nelson, and Kennedy) between 1960 and 1980, before which evidence was repeatedly presented to show the failure of current efforts to regulate drug research successfully so long as the financial incentives continued as they were. He concludes with an argument to move toward some form of government-overseen, independent method for conducting the research needed for new drug approvals, and a reply to criticisms of such proposals.

Prof. Rodwin frames his argument by noting the possible spectrum ranging from total manufacturer control to total government control over clinical trials of drugs:
  1. Drug firms conduct their own trials; minimal regulation
  2. FDA oversees drug-firm-sponsored trials
  3. Only government-certified researchers allowed to do trials
  4. Government promotes transparency by requiring registration of trials, disclosure of data, etc.
  5. Government selects independent researchers to conduct trials
  6. Government agency conducts all trials
To date we have relied mostly on #2 with some elements of #4. Rodwin argues that this has been shown extensively to have failed and we should be moving toward #5 or #6.

Rodwin cites extensive past work arguing for this same conclusion (as I reviewed in HOOKED where I made basically the same recommendation). Now all we need is the political will to actually do something. Rodwin is largely silent on where that is going to come from-- he assumes that further scandals will eventually turn the tide. One can read HOOKED and this blog and wonder if past scandals have not moved the needle any farther than they have, what exactly it would take to light a fire under us.

No comments: