How the Drug Industry's Power Goes Unchecked and Why the Problem Is Likely to Get Worse
THE U.S. FOOD AND DRUG ADMINISTRATION HAS long been the target of both industry and ideological forces seeking to scale back regulation. With a Republican now in the White House, conservatives are once again sounding the call. On February 2, The Wall Street Journal published an editorial railing against the FDA's "costly and archaic system of drug regulation." Enabling consumers to access the "wonder drugs" of the twenty-first century, the Journal argued, requires eliminating "the last century's regulations."
President Bush, who received contributions of $456,000 from the pharmaceutical industry during his 2000 election campaign, will likely prove receptive to such pleas. Conservatives have been pushing Bush to appoint a new, more industry-friendly FDA commissioner. And next year, when key FDA legislation comes up for reauthorization, it is widely expected that pharmaceutical and biotech firms will mobilize their supporters to ease agency regulations.
But this is the wrong remedy for what ails the FDA. In the late 1980s, the FDA embarked on a series of reforms intended to bring new drugs for AIDS and other life-threatening diseases to market more quickly. While many of these early changes were necessary, subsequent laws, passed in 1992 and again in 1997, have taken deregulation too far and left the FDA beholden to the very industry it is supposed to regulate and the public vulnerable to unsafe drugs. Indeed, a large number of medications approved since these reforms went into effect have been withdrawn or severely restricted following reports of severe side effects and deaths. In nearly all these cases, the FDA had clear evidence of the impending health risks at the time of review but nonetheless went ahead with drug approval.
The drive to expedite drug approvals has undermined a review system that was once the world's gold standard. Today "the pressure to meet deadlines is enormous," Dr. Solomon Sobel, director of the FDA's metabolic-and-endocrine-drug division throughout the 1990s, told the Los Angeles Times. "The basic message is to approve." Dr. Rudolph M. Widmark, who served as a medical officer at the agency for 11 years until 1997, declared: "The people in charge don't say, `Should we approve this drug?' They say, `Hey, how can we get this drug approved?'" Whereas in the early 1990s the FDA approved 60 percent of the industry's applications for new products, by the end of the decade 80 percent were getting approved.
The federal government normally prohibits the FDA from relying on experts who have financial conflicts, but the agency has waived this restriction more than 800 times since 1998. According to an investigation conducted last year by USA Today, more than half the outside experts hired by the FDA to advise it on the safety and effectiveness of new medical products have financial relationships with pharmaceutical companies that will be affected by their decisions.
THE FOOD AND DRUG ADMINISTRATION PERFORMS NO independent drug testing of its own. It relies on the research of the pharmaceutical industry for virtually all of its clinical data on the safety and efficacy of the drugs it regulates. Until recently, the potential for conflicts of interest was moderated by the role of relatively disinterested academic researchers. Over the last decade, however, sweeping changes have enabled the pharmaceutical industry to gain far greater influence over the process of drug testing, development, and FDA approval, thereby threatening the integrity of clinical research itself. As recently as 1991, nearly 80 percent of industry-sponsored clinical trials were performed by experienced investigators in nonprofit academic medical centers. Today, according to CenterWatch, a Boston-based group that tracks the situation, the portion of this research performed in the academic sector has been cut to 40 percent, while the remaining 60 percent has shifted to for-profit firms paid by the drug industry, which increasingly contracts out clinical-trial work to physicians in private practice who have little or no training in the specialty field of clinical research. …