Wyeth-Ayerst Laboratories has developed an injectable antibiotic called Tigecycline. It can be used to treat resistant pathogens -- bacteria that are immune to standard antibiotics.
However, the Food and Drug Administration (FDA) has changed the rules for measuring drug efficiency in trials of antibiotics. It has ordered Wyeth-Ayerst Laboratories to double the number of patients in trials from 4,000 to 8,000.
Wyeth-Ayerst has already conducted two human studies, and was planning a third and final one. Because of the massive increase in cost, in order to comply with the FDA mandate, the company has put further development of Tigecycline on hold.
Another example of keeping drugs off the market is FDA's denial of approval of a vaccine to prevent meningitis C. This is a bacteria that infects thousands of Americans and kills hundreds each year. No conjugated vaccine (one comprised of linked components) is approved for use in the United States. Three such products are available in Canada and Europe, where 20 million doses of the vaccine have already been administered. As a turf-protecting measure, our FDA refuses to recognize foreign drug approvals.
So what's the story? Is the FDA out to deliberately kill Americans? No, but the end result is the same. Dr. Henry Miller, a physician, a Hoover Institution fellow and former FDA official, explains in the June 15 Washington Time. FDA officials can make two kinds of errors. They can approve a drug that has unanticipated, dangerous side effects that might cause illness and death. Or, they can err by either not approving or causing huge delays in the use of a safe and effective drug. Statistically, these are known as Type I and Type II errors. What are the FDA incentives?
If FDA officials err on the side of under-caution in approving an unsafe drug, they are attacked by the media and patient groups, and investigated by Congress. Their victims, sick and dead people, are highly visible. If FDA officials err on the side of over-caution, keeping a safe and effective drug off the market, who's to know? The victims are invisible.
For example, neither the Americans who get sick or die from meningitis C this year, nor their loved ones, will know that their illness or death could have been prevented had it not been for errors by FDA officials.
It's a no-brainer to figure out which error FDA officials prefer to make. If you conclude they have a bias toward errors that create invisible victims, who don't know whom to blame for their illness or death, step to the head of the class. By the way, FDA conduct demonstrates that the admonition, "One can never be too safe," is something we should take with a grain of salt.
Sometimes, drug companies produce a drug that's safe and effective, but the disease it treats is rare. There aren't enough patients available to go through the FDA's costly approval procedure to make the drug economically worthwhile. Those drugs are designated "orphan drugs."
Prior to the Reagan administration's steps to correct this situation, thousands of people suffered or died needlessly. It's estimated that the 216 orphan drugs approved since 1983 are estimated to have prevented 108,000 deaths from rare diseases. Right now, there are scores of "orphan drugs" unavailable to physicians for treatment options.
In addition to FDA policy that leads to the illness and deaths of untold numbers of Americans is the issue of drug costs. I'm disgusted whenever I hear politicians pontificating about high drug costs and the need for prescription-drug handouts. Congress, the FDA and the courts are largely responsible for the escalating costs of drugs.