The FDA Is Working to Prevent . . .
Drugless Children

With great fanfare, the Clinton Administration has paid lip service to the cause of drug-abused children; that is, there should be less use of social management drugs such as Ritalin® and Prozac®. Then, out of the other side of their mouths, they have also recently "discovered" that few drugs have been approved for use in children, especially for really serious diseases such as cancer. Joining the march into the future of managed care from cradle to grave, in lock step, has been the Food and Drug Administration . . . balancing benefits and risks, while keeping a firm eye on safety and efficacy, as befits the "venerable" institution that said very little back in 1991 when a pediatrician (Dr. David Kessler) took the helm of the agency. However, nothing was done until 1997, when President Clinton announced that the FDA would require drug companies to test drugs for safety in treating children. But that hasn't even begun to solve the problem.

Requiring drug testing for safety in children hasn't worked because of the issue of informed consent. Not surprisingly, parents will not let their children participate in drug trials that entail potentially dangerous side effects, and no one (yet) has attempted to force anyone to participate. In Britain recently, the Public Health Laboratory Service announced that trials of a new children's meningitis vaccine had been delayed for up to a year because only half the 2000 volunteers needed had been recruited. In particular, they lacked recruits aged three to four.

Testing on children also hasn't worked because, from the perspective of the pharmaceutical companies, there is not much money to be made in children's drugs, especially given the downside: the potential legal liability is huge (enough to have the tort lawyers already licking their chops and gathering at the gates). Children consume small quantities of drugs and are a small proportion of the market.

So the Administration is trying another strategy. It might be called bribery if it weren't done at the lofty heights of politics. In the USA, drug companies will soon have an incentive to overcome the obstacles mentioned above. As part of the new fast-track enactment, for 493 drugs that the FDA considers a priority, the manufacturers will be granted a six-month extension of their patent rights in exchange for comprehensive pediatric data provided to the government. This could be lucrative: a 1993 report estimated that for an average drug company, each year of exclusivity in selling a product is worth $100 million. But there is still no reason to believe that parents will give consent if they judge the drugs to be dangerous. And class-action lawsuits can wipe out a company, perhaps even an entire industry. Drug companies have been offered the additional bait that they will be given patent extensions and possible tax abatement.

The Administration likes to say that "We did it for the children." Ruby Ridge, Waco, and Miami come to mind as prominent examples of what that can mean. Fortunately, the world of nutrients is, for the most part, not a pawn to government edicts, and more studies that recruit children are coming down the pike. One such study is the focus of an article in this issue of Life Enhancement on 5-HTP and the pain of migraine and hyperalgesia. A bonus from this study is that it underscores how innocuous most nutrients can be and thus illustrates that they are in a special class. They are not drugs, as the FDA would like us to believe.

All of this has not fulfilled the need to develop drugs for use in emergencies, so into the foreseeable future we will have to rely on good judgment. Physicians, lacking the hard scientific evidence that drugs of a critical nature are appropriate for children, have put humanitarian interests ahead of the needs of the drug bureaucracy - fortunately!

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