Sunday, April 11, 2004

Fear of the Free Market -- Part II

In Part I of this series (second post under April 8, 2004), I pointed out that
[i]t is easier to list those markets in which the government doesn't intervene (namely, "black markets") than it is to list those markets in which the government does intervene. There simply isn't a lawful business activity that isn't affected by government regulation….[G]overnment intervention in the market for any product or service tends to reduce the supply of that product or service.

Health care, being something almost everyone needs (like electricity and phone service), has been regulated to the point of being nationalized (see Part I). Yet it is unclear that the regulation of health care does anything but restrict our access to doctors and drugs. Licensing exams have no meaningful effect on our ability to choose competent doctors (see Part I).

What about FDA approval of drugs? The FDA doesn't test drugs, it prescribes testing procedures for drugs. The responsibility for testing falls to the maker of the drug. According to a statistics published on the FDA web site, The FDA ultimately approves about 20% of applications for new drugs. The three phases of the FDA's prescribed testing process last at least one year and sometimes six years and longer. What does the FDA hope to accomplish through its approval process? Here's some of what the FDA's Ken Flieger has to say:
Most of us understand that drugs intended to treat people have to be tested in people. These tests, called clinical trials, determine if a drug is safe and effective, at what doses it works best, and what side effects it causes--information that guides health professionals and, for nonprescription drugs, consumers in the proper use of medicines.
Clinical testing isn't the only way to discover what effects drugs have on people. Unplanned but alert observation and careful scrutiny of experience can often suggest drug effects and lead to more formal study. But such observations are usually not reliable enough to serve as the basis for important, scientifically valid conclusions. Controlled clinical trials, in which results observed in patients getting the drug are compared to the results in similar patients receiving a different treatment, are the best way science has come up with to determine what a new drug really does. That's why controlled clinical trials are the only legal basis for FDA to conclude that a new drug has shown "substantial evidence of effectiveness."

It boils down to safety and effectiveness. But safety and effectiveness are also your doctor's concern. Do you suppose that your doctor would prescribe a drug that its manufacturer hadn't thoroughly tested for safety and effectiveness? Of course, your doctor might well flub his diagnosis (something that happens a lot, despite the medical licensing exam) and prescribe the wrong medication. Or your doctor might diagnose you correctly but prescribe a medication that produces an unpleasant side effect. In summary, the safety and effectiveness of the drugs your doctor prescribes depends mainly on your doctor's competence.

Misadventure is more likely with non-prescription (over-the-counter) drugs. As the FDA acknowledges, "Most OTC drug products have been marketed for many years, prior to the laws that require proof of safety and effectiveness before marketing." Very interesting. As with prescription drugs, OTC drugs, used to be available without the FDA's imprimatur. That is, individuals used to be trusted to buy and use OTC drugs wisely, but then the FDA got into the act. Why? According to the FDA:
Languishing in Congress for five years, the bill that would replace the 1906 [Food and Drugs Act] was ultimately enhanced and passed in the wake of a therapeutic disaster in 1937. A Tennessee drug company marketed a form of the new sulfa wonder drug that would appeal to pediatric patients, Elixir Sulfanilamide. However, the solvent in this untested product was a highly toxic chemical analogue of antifreeze; over 100 people died, many of whom were children. The public outcry not only reshaped the drug provisions of the new law to prevent such an event from happening again, it propelled the bill itself through Congress. This was neither the first nor the last time Congress presented a public health bill to a president only after a therapeutic disaster. FDR (pictured at left) signed the Food, Drug, and Cosmetic Act on 25 June 1938.

The new law brought cosmetics and medical devices under control, and it required that drugs be labeled with adequate directions for safe use. Moreover, it mandated pre-market approval of all new drugs, such that a manufacturer would have to prove to FDA that a drug were safe before it could be sold. It irrefutably prohibited false therapeutic claims for drugs, although a separate law granted the Federal Trade Commission jurisdiction over drug advertising. The act also corrected abuses in food packaging and quality, and it mandated legally enforceable food standards. Tolerances for certain poisonous substances were addressed. The law formally authorized factory inspections, and it added injunctions to the enforcement tools at the agency's disposal.
And on it went:
Enforcement of the new law came swiftly. Within two months of the passage of the act, the FDA began to identify drugs such as the sulfas that simply could not be labeled for safe use directly by the patient--they would require a prescription from a physician. The ensuing debate by the FDA, industry, and health practitioners over what constituted a prescription and an over-the-counter drug was resolved in the Durham-Humphrey Amendment of 1951. From the 1940s to the 1960s, the abuse of amphetamines and barbiturates required more regulatory effort by FDA than all other drug problems combined.
Notice that the focus is always on abuses and never on successes. Here's what The Cato Institute's Handbook for Congress has to say about the FDA::
As an agency, the FDA has a strong incentive to delay allowing products to reach the market. After all, if a product that helps millions of individuals causes adverse reactions or even death for a few, the FDA will be subject to adverse publicity with critics asking why more tests were not conducted. Certainly, it is desirable to make all pharmaceutical products as safe as possible. But every day that the FDA delays approving a product for market, many patients who might be helped suffer or die needlessly.

For example, Dr. Louis Lasagna, director of Tufts University’s Center for the Study of Drug Development, estimates that the seven-year delay in the approval of beta-blockers as heart medication cost the lives of as many as 119,000 Americans. During the three and half years it took the FDA to approve the drug Interleukin-2, 25,000 Americans died of kidney cancer even though the drug had already been approved for use in nine other countries. Eugene Schoenfeld, a cancer survivor and president of the National Kidney Cancer Association, maintains that ‘‘IL-2 is one of the worst examples of FDA regulation known to man.’’

In the past two decades patients’ groups have become more vocal in demanding timely access to new medication. AIDS sufferers led the way. After all, if an individual is expected to live for only two more years, three more years spent testing the efficacy of a prospective treatment does that person no good. The advent of the Internet has allowed individuals suffering from specific ailments and patient groups to use websites and chat rooms to exchange information and to give them an opportunity to take more control of their own treatment. They now can track the progress of possible treatments as they are tested for safety and efficacy and are quite conscious of how FDA-imposed delays can stand in the way of their good health and even their lives….

[I]n a free society individuals should be free to take care of their physical well-being as they see fit. The advent of the Internet gives individuals even more access to information about medical products and treatments. Individuals should be allowed to choose the treatments they think best. Such liberty does not open the door for fraud or abuse any more than does a free market in other products. In fact, informed consent by patients probably will become more sophisticated as the market for information about medical treatments becomes more free and open.
Government regulation of health-care products and services makes them harder to get and more expensive than the products and services that would be delivered in the absence of regulation. Would quality suffer in a free-market health-care system? It might in some cases, but competition among producers and providers would lead to an overall increase in quality, in response to consumers' demands for competent medical practitioners and effective drugs.

If it's unnecessary to regulate health care, can we take the next step and de-nationalize it? What about other industries and types of economic activity? Stay tuned for Part III of this series.