The Food and Drug Administration needs to come with a warning label: “Do Not Heed If Seriously Ill.” At least, that was the recommendation of sixty-one percent of American oncologists (cancer specialists) in a poll published in April by the Competitive Enterprise Institute, a Washington-based free market think tank. The majority of cancer specialists agreed that the FDA takes too much time to approve new medical drugs and devices, while sixty percent also agreed that the FDA’s approval process “costs lives by forcing people to go without potentially beneficial therapies.” Advocates for the FDA’s abolition have been claiming for years that the agency is hardly abiding by the charge to “do no harm” (required by all doctors in the Hippocratic Oath). This damning testimony from the men and women whose livelihoods are most directly impacted by the FDA ought to be reason enough to reconsider the merits of the agency.
Unfortunately, the public has little idea of what it’s doing by keeping this regulatory abomination alive. When asked if the general public understood the “human cost” of the FDA approval process—that is, that some people may suffer or die while waiting for the FDA to act, 41 percent of oncologists said that the public understands “only a little of the human cost,” while 29 percent believed that the public doesn’t “understand the human cost at all.”
In general, the public perceives the Food and Drug Administration as a benevolent watchdog that keeps dangerous European drugs off the market. While not all of the drugs and devices rejected by the FDA are European, freedom of medicine (at least when it comes to drug approval) is one of those few political areas where Europe actually has a leg up on the United States. The reality of public perception of drug regulation in this country is that the public fears of a free drug market far outweigh the (undervalued, as this poll shows) costs of the FDA’s work. Unfettered freedom of prescription comes across to the man on the street as far more frightening than the potential for thousands of terminally ill patients dying every year because they and their doctors weren’t permitted to take a chance on new drugs.
The misperception of the FDA by the public is understandable. After all, the spin-machine at the FDA during the 90’s, led by then-director and current Yale School of Medicine Dean David Kessler, included gross public exaggerations and misleading statements. In December 1995, the FDA claimed, “[its] tough standards do not delay consumer access to important new drugs, compared to other countries.” However, the study the FDA used considered drugs put on the world market from January 1990 to December 1994, the dates when things looked best for the agency, ignoring many of the drugs first introduced in Europe in the 80’s and then submitted for approval in the US in the 90’s.
The trouble with the public’s view of the FDA is that for most doctors, the agency is not the relevant arbiter of what is and what is not good medicine; their peers are. The CEI poll reiterated a fact already known to advocates of free prescription: the most important factor the surveyed oncologists considered when deciding whether or not to use a new drug was its analysis by “persuasive published research.” An overwhelming 78 percent of oncologists put research as the most decisive factor, while a mere 13 percent cited regulatory approval in other medically advanced countries as their weightiest factor.
Essentially, a supermajority of doctors stated that the FDA’s approval process can do nothing but prevent them from using all of the drugs their expert opinions say are good to use. Naturally, this means some drugs are outlawed which are desired for use both by the man who’s risking his life and by the one who knows what he’s talking about when it comes to medicine. The Food and Drug Administration represents a needless intrusion into personal (and informed) decisions, with fatal consequences for those terminally ill patients denied access to the medicines with the potential to cure them.
A study was done in 1999 by CEI of emergency room physicians that showed very similar results. 64 percent of emergency room physicians believed that the FDA was too slow in approving new drugs and medical devices. An astounding 51 percent believed that the long time it takes for the FDA to approve drugs and devices cost lives since it left patients without access to the latest in life-saving medical technology.
While the Food and Drug Modernization Act of 1997 helped things, it was still not strong enough in getting the regulatory burden off Americans’ backs. The act gave the FDA greater discretion in expediting the review process for drugs for certain severe illnesses. However, the FDA does not have to use that discretion. Although it is true that the average time span for drug approvals has fallen since 1990 from 30 months, to less than 17 months now, this is still three times higher than is required by law. Remember that this 17 months is on top of an average of six years of clinical trials. The 17 months is only for approval and committee hearings, not for actual research.
Many have suggested that the FDA allow a “third-party” approval system, whereby independent private agencies licensed by the FDA could recommend to the FDA what to approve so that the regulatory time span is shorter. This is already done in Europe and the FDA tried this out about seven years ago and actually concluded that this program worked. However, Kessler stifled the program’s further enactment, since it would have probably meant cuts in the agency’s budget and a decrease in the amount of money the FDA could extort from drug companies as part of the fees it charges for approval filings.
Of course, the FDA is but one arm of the many-tentacled Lovecraftian cephalopod that is the nanny state. Forbidding drugs desired by both doctor and patient is just the tip of the iceberg. Speed limits that encourage aggressive driving, recreational drug laws that foster violence and drug abuse, gun control laws that murder inno- Continued from page 4 cents, foreign interventions that get Americans killed and foster murderous hatred of this country, and mandatory social security “investments” that return less than sticking one’s money in a mattress are only the nanny state’s most visibly egregious offenses. Any real-life nanny that took care of its charges this poorly would be fired, at the very least. Americans must take it upon themselves to rid themselves of this aspect of the government which coddles about as carefully as Frankenstein. Speak out, and don’t let any more people get hugged to death.
Jonathan Berry is a freshman in Exra Stiles College.