Editor's note: This is the first of two articles.
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For the second part in this series, please click here.
The old saying in Washington that 'when something has been repeated three times it becomes a fact' has been applied lately to supposed shortcomings in the safety of prescription drugs. The reality is that although all drugs have side effects – which can be serious and/or frequent – modern pharmaceuticals have wrought miracles in the control of pain; the treatment and prevention of infections; and the amelioration of the diseases of aging, such as arthritis and cancer.Regulators need to balance patients' access to therapies with ensuring the safety of drugs. The consequences of poor decisions can be dire: Promote access at the expense of safety, and a dangerous product can cause incalculable harm; over-emphasize safety at the expense of access, and patients suffer from the absence of life-saving and life-enhancing medications.Recently, beleaguered by congressional and other critics, the FDA has been pedaling as fast as it can to demonstrate its commitment to drug safety — but without at all addressing a far more pervasive, more intransigent problem: unwise, unproductive, risk-averse regulation that itself has severe side effects.
In spite of increasingly more powerful and precise technologies for drug discovery, purification and production, during the past twenty years development costs have skyrocketed. The trends are ominous: The length of clinical testing for the average drug is increasing, fewer drugs are being approved, and the number of applications to FDA by industry for marketing approval has been decreasing for more than a decade. In January, the FDA announced new initiatives directed at the safety of new drugs, including a plan to perform a comprehensive assessment of the safety of some new drugs within 18 months after their introduction, and to issue a “report card” on their performance. Although this may sound plausible, it appears to be inconsistent with data which show that in fact newer drugs confer an advantage over older ones in reducing mortality. In a study of patients who took drugs during January to June 2000, those who took newer medications were less likely to die by the end of 2002. The estimated mortality rates were directly related to time that had elapsed since approval of the drugs: For pre-1970 drugs, the estimated mortality rate was 4.4 percent, while the mortality rates for drugs approved during the 1970s, 1980s, and 1990s were 3.6 percent, 3.0 percent, and 2.5 percent, respectively. Not surprisingly, drugs are getting better all the time.A related point is the myth, often cited as fact by regulators and members of Congress, that rapid advances in science are outstripping regulation. Although some fields, such as human gene therapy, offer significant challenges, innovations such as improved gene-splicing and separation and analytical technologies have led to the manufacture of more highly purified drugs – especially vaccines, hormones and antibody preparations – which are less problematic for regulators. The FDA's “cover” for these ill-advised innovations is that they are a response to a report on “drug safety” published last Fall by the quasi-governmental Institute of Medicine. However, the IOM's deeply flawed, one-sided analysis will remedy few, if any, of the FDA's shortcomings. In fact, many of their recommendations would make the agency even more risk-averse, reduce the number of drugs emerging from the R&D pipeline, and compromise public health. Neither the Congress nor FDA (nor the IOM) is willing to admit that the agency's most significant problems are mismanagement and excessive risk-aversion. It's much easier to conclude that there is insufficient regulation and to throw more resources at the problem. (And recall economist Milton's Friedman's wry observation that only government responds to a failed program or project by expanding it.) Meanwhile, regulators keep raising the bar for approval, especially for innovative, high-tech products. The FDA is requiring ever larger numbers of patients in clinical trials, its demands for post-marketing clinical trials have proliferated wildly, and “risk management” plans for newly approved drugs have been inconsistently applied, punitive and often more appropriate for weapons-grade plutonium than prescription drugs.Historically, the pendulum has swung back and forth about what kinds of problems predominate in the regulation of drug development. Thirty years ago, the concerns were primarily about “drug lag” – indolent reviews and approvals by the FDA that put Americans at disadvantage to consumers in other countries; but in recent years there have been repeated accusations about what might be called “drug leap” – a supposedly “too cozy” relationship between regulators and industry, and too little attention paid to drug safety, possibly as the result of regulators' struggling to meet arbitrary deadlines. No longer are federal regulators called to account for the unnecessary deaths of patients who don't get the new drugs they need in a timely way. Unfortunately, these contemporary views are shared by many influential leaders of Congress. Given the long-standing, more-regulation-is-always-better prejudices of many of the new committee chairmen, including Senator Ted Kennedy (D-Mass.) and Reps. John Dingell (D-Mich.) and Henry Waxman (D-Calif.), hearings and new lawmaking will focus on alleged under-regulation and the need for additional power and resources for the FDA . User-fees on drug companies – another name for a discriminatory tax on a single industrial sector – will likely be increased. Part 2 of this article will discuss two recent, wrong-headed legislative proposals introduced in the Senate. But even in the absence of new legislation (which could be vetoed by the president), oversight hearings will push the FDA to regulate more aggressively and punitively, and regulators will be only too happy to comply.It is both unseemly and dangerous to public health for FDA officials to cavort like an organ-grinder's monkey trying to distract attention from the 800-pound gorilla. What the FDA needs is competent management, acknowledgement of its weaknesses, discipline in the ranks, more effective risk-benefit balancing, and a commitment to permitting patients and physicians to assume more responsibility for the risk of medical interventions..