Monday, December 10, 2007

Why It Takes a Village (To Afford a Prescription)

I once heard columnist George Will refer to a general election as a futile narcissistic exercise. I thought that proposition ridiculous at the time, but now I find it harder to argue against. The Bush administration has embroiled us in a costly, unpopular and seemingly endless war, and the Democratic congress repeatedly sacrifices the public interest to public relations, the promises of comity and bipartisanship long forgotten. Both parties have been irresponsibly spendthrift. Never before have I heard so many veteran policy wonks wish a plague on both their houses.However, when it comes to the intrusiveness of the regulatory agencies that affect our lives repeatedly and profoundly every day - dictating which detergents, medicines, foods, bug-repellents, herbicides, appliances and automobiles we can buy, and at what price - there is a palpable difference between the parties. I was reminded of that by a recent report, "Prescriptions for Drug Safety: Reforming U.S. Prescription Drug Regulations to Protect Consumers," by the Center for American Progress (CAP), a liberal organization that serves as a home for many old Clinton administration officials. The organization is headed by John Podesta, Bill Clinton's former White House chief of staff, and its fellows include Tom Daschle, the former senate Democratic leader; Gene Sperling, former economic adviser to President Clinton; and Bill Schulz, a senior FDA official during the Clinton administration. This group believes that big government "can improve the lives of everyday Americans by playing an active role in solving social and economic problems," and its roster reads like a self-styled, ready-to-go list of senior political appointees in a Hillary Clinton administration. That's what worries me.In spite of increasingly more powerful and precise technologies for drug discovery, purification and production during the past twenty years, development costs have skyrocketed. On average it takes 12-15 years and costs over a billion dollars to bring a drug to market. Of that amount, capitalized out-of-pocket preclinical costs and clinical testing each account for about half. Chasing these skyrocketing costs, between 1995 and 2006 U.S. research-based drug companies' expenditures on clinical trials almost tripled, to $43 billion, while the number of drugs approved decreased by about two-thirds. The number of marketing approval applications to the FDA and the number of approvals are now at a ten-year low. So what do the CAP folks propose for FDA "reform?" (In other words, what could we expect President Hillary's regulatory agenda to be?) Changes that will push drug development costs further into the stratosphere and ensure that even fewer innovative new medicines become available. The CAP proposals include:O Elimination of much of the patent exclusivity allowed under current law to compensate drug innovators for regulatory delays, which would favor generic drug companies' ability to compete with the research-intensive, innovator companies. That would lower drug prices in the short term, to be sure, but it's tantamount to eating your seed corn: A 1994 study - at a time when drug development was much cheaper - showed that only 3 in 10 approved drugs ever recoup their development costs, and the change proposed by CAP would make it even harder for innovator drugmakers.O An end of direct-to-consumer advertising - in spite of the fact that studies have shown that it spurs patients to visit their physicians at an earlier time, to discuss their symptoms. O "Discourage the proliferation of 'me too' drugs by requiring that new drugs go through extensive comparative clinical trials and are tested for safety and efficacy." This meddling in the drug development process demonstrates a lack of understanding of clinical medicine.
First of all, new drugs are already extensively tested for safety and efficacy. (That's where most of the billion dollars in development costs goes.) Second, comparative studies in which a new drug is tested against another approved medicine (as opposed to testing against a placebo) can be hugely expensive because vast numbers of patients may be required to show statistically significant superiority. The folks at CAP seem not to understand that "me, too" drugs - which are not very different from already-approved medicines - are an important element in individualizing therapy for each patient. Because patients' responses to medicines are widely variable, physicians need to be able to choose among various drugs for the same disease or symptom. This is especially true, for example, for patients who are suffering from infections, pain from any cause, psychiatric disease, or cancer. It is the reason that the medical literature and FDA-approved drug labeling use terms like "first-line" and "second-line" therapy. Often, the first choice, or guess, about which medicine to use on an individual patient fails, and we try a second one. A requirement for comparative clinical trials versus existing approved therapies is an inappropriate and dangerous standard. O "Create an independent Center for Post-Market Drug Evaluation and Research outside of the FDA to establish an effective system for post-marketing surveillance of drugs." The problem with this is that the new organization would have as its single raison d' tre the removal of drugs from the marketplace. We have already seen the confusion and damage wrought by antipathy to safe, effective and important drugs by zealots within the FDA who are focused on drug safety but who fail to give due consideration to drug benefits or to the need for a choice of drugs for a given purpose. Recent allegations from the media and others that insufficient attention is paid to drug safety, and new legislation have caused an already risk-averse agency to become even more conservative and defensive in its decision-making. In recent years, the FDA has steadily made it more difficult to initiate and perform the clinical testing of new drugs, and regulators have seldom been called to account for the unnecessary suffering and deaths of patients who don't get the new drugs they need in a timely way. The FDA has required 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. According to a 2006 survey of biopharmaceutical companies' views of FDA oversight, more than a third of companies complained that the FDA had changed its position in the middle of the testing of a product, while more than half said that the FDA "needs the most improvement" in "risk-based decision-making," which is supposed to be its essential stock in trade.Times are tough for drug development, they are deteriorating, and the return to government of the old Clinton crowd will make things far worse. Their approach to governance exemplifies Milton Friedman's observation that only in government do we observe the failure of a program and conclude that we need to expand it. What is especially ominous is that the liberal Democrats' plan for the FDA offers only a microcosm of the likely impacts on our lives that would be wrought by the big-government, nanny-state crowd.Henry I. Miller, a physician and fellow at Stanford University's Hoover Institution, was at the NIH and FDA from 1977 to 1994. He is the author, most recently, of "The Frankenfood

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