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Kids and FDA drug trials? Not a good idea


STANFORD, Calif. -- If you've filled a prescription recently, you may have had a nasty surprise. Antibiotics or a tube of steroid cream used to cost a few bucks, but now the prices are soaring.

A few examples of the cost of a week's supply of drugs: The antibiotic clarithromycin is $75; Rocalcitrol, a vitamin D derivative, is $55 to $385, depending on the dosage; and erythropoietin, for anemia, is $324 to $486.

Why? In large part, it's your tax dollars at work. Government regulation imposes enormous "taxes" on drug development, decreasing the number of drugs developed. Ultimately, these "taxes" are passed along to consumers.

The feds were at it again recently when the Food and Drug Administration announced that drug companies will be required to test in children the medicines they sell for adults, and to put the pediatric dosages on the label.

That might sound benign, or even desirable, but these new requirements ignore the realities of drug testing.

They may actually be detrimental to kids and could actually delay the availability of new drugs, if the FDA withholds approval for adult uses while data from pediatric studies are being collected.

Moreover, according to many pediatricians, the regulation is a rigid, centralized governmental solution to a nonproblem.

Even the FDA concedes that physicians commonly and safely prescribe pain relievers, asthma drugs, antihistamines, antibiotics and other therapeutics millions of times annually for children, despite the clinical trials of those products having been performed only with adults.

"Pediatricians routinely tailor dosages for children by adjusting the dosage according to the patient's weight," confirms Michael H. Mellon, a pediatric allergist for Kaiser Permanente, a health maintenance organization.

Other possible steps

Even if additional testing of drugs in children were needed, there are more imaginative and effective ways to accomplish it.

For example, the FDA could simply require a prominent label or logo on drug preparations whose safety and efficacy have not yet been determined in children.

Or the agency could publish a list of such drugs annually. This would make parents and physicians aware that such information is not available, and they, in turn, could exert moral and economic pressure on drug companies to obtain it.

(It is in the drug companies' own interest to expand the population that will purchase and benefit from their products, and to avoid harming patients.)

Challenging assignment

The FDA seems unaware of the nuances of drug development. For a number of reasons, creating a dosage appropriate for children is often especially challenging

Can the active ingredient be incorporated in a chewable or syrup form? Will it have special storage requirements and adequate shelf life? Does it taste good enough so that kids will actually take it?

A pediatric form of Glaxo Wellcome's antibiotic Ceftin required more than double the cost and man hours to develop than did its adult formulation.

The same company also experienced serious problems in finding effective preservatives for its pediatric syrup form of Epivir, an AIDS drug, even after the adult formulation had been fully developed.

What's more, clinical trials are difficult to perform with children. For ethical reasons, testing is done in patients, not in healthy volunteers.

Study participants may be scarce because a disease is rare in children or because parents are reluctant to enroll their sick children in an "experiment."

Finally, for the purposes of drug testing, "children" is by no means a homogenous category. The term implies several groups that are physiologically and metabolically distinct: newborns, infants, preschoolers, children in primary school and teen-agers.

Moreover, children may pass through two or more age groups during the course of a multi-year clinical study, confounding statistical analysis.

As regulatory requirements are ratcheted ever upward, drugs are moving more sluggishly through the clinical-testing pipeline.

The total time required for drug development, from synthesis of the molecule to the patient's bedside, has almost doubled during the past three decades, from 8.1 years to 15.2 years.

And the United States' $500 million tab for each drug approved is by far the most expensive in the world.

Why does the FDA impose unnecessary regulations, which are expensive, rigid and inimical to free-market forces, at a time of supposed "reinventing government" and regulatory reform?

When regulation is excessive, everyone is a loser -- except government regulators themselves.

Money spent by the government, industry and consumers on FDA regulation is money not spent on something else, including the ability to protect public health in other ways -- for example, by increasing the rate of vaccination or performing diagnostic testing.

Consider, for example, the potential benefits of spending the estimated $21 million annual cost of the FDA's new regulation on, instead, screening for cervical cancer. According to public health statistics, the money would save 14,700 to 31,500 years of life.

The FDA's new regulation is the latest example of Big Brother deciding where the private sector's scarce resources for research and development are best spent.

In the process, the FDA is increasing costs to consumers, putting them at risk as the introduction of new drugs is delayed.

This regulation, the first to appear under new FDA Commissioner Jane Henney, suggests that she will show a greater commitment to rhetoric than to the reality of protecting the public health.

Henry I. Miller, a physician, is a fellow at Stanford University's Hoover Institution and was an FDA official from 1979 to 1994. He wrote this for Bridge News.

Pub Date: 12/21/98

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