Though I agree with President Reagan's determination to "get the government off our backs," there is a danger that the deregulation effort may go too far. There are federal regulatory agencies that serve a vital purpose.
One such agency is -- or should be -- the Food and Drug Administration. It is supposed to make absolutely certain that products offered for sale are safe to consume, with no unknown harmful side effects. In the case of drugs, the FDA is also supposed to determine whether a new product will actually do what its manufacturer claims it will.
The trouble with the FDA is that, like all too many other federal watchdogs, it often acts more like the pet poodle of the industry it is supposed to be protecting the public from. A disturbing example of this relationship involves the controversial drug Bendectin, an anti-nausea medication prescribed for millions of pregnant women each year.
In past columns, I exposed the faulty process that led to Bendectin's approval in 1956. Internal documents revealed that the drug's manufacturer, Merrell Laboratories (now Merrell Dow Pharmaceuticals), barely tested the drug for safety and withheld damaging information about the drug's effects from the FDA and the public.
Merrell is being sued by several women who took Bendectin during pregnancy and subsequently gave birth to severly deformed babies. Even the drug's creator, Merrell's research director, Dr. Raymond Pogge, testified at one point that he will not prescribe it for his own patients.
Now my reporters Indy Badhwar and Judy Grande have obtained additional Merrell documents. These show that when word got around FDA that the formidable Mike Wallace was preparing to ask agency officials some tough questions about the drug, Marion Finkel, associate director for new drug evaluation, asked Merrell for a briefing on Bendectin's safety. I have obtained copies of handwritten notes of the meeting made by a company official.
The notes show that Findel and her assistant, Jack Purvis, met with Merrell's vice president and general counsel, Fred Lamb, and the company's medical research director, Dorsey Holtkamp. They discussed ways to give Bendectin a defense in the face of Wallace's expected assault.
According to the notes, the government and company officials rambled at length through the history of the drug, the studies that had been done, the number of reported birth defects in Merrell and FDA files and the lawsuits filed against the company. The handwritten notes are larded with references to the dreaded "60 Minutes" investigation.
Soon after the meeting, FDA issued a four-page public statement on Bendectin in response to inquiries. A comparison of the FDA statement with the notes of the secret Merrell-FDA meeting shows that the statement reflects the discussion that took place that day in April 1977.
The FDA statement, for example, supports Merrell's position -- based on studies mentioned in the meeting -- that birth defects occur less frequently among Bendectin users than among the general population.
This claim, which is vehemently disputed by many experts, is based primarily on a study of 2,000 infants whose mothers had taken Bendectin during their pregnancies. What is shocking is that the FDA cited this study as an accurate safety evaluator even though it was aware -- and in fact admitted in its statement -- that the study was riddled with "methodological defects."
In addition, a few years after the drug was approved, it was listed in the Federal Register as "possibly effective." This designation cost Merrell substantial sales to government agencies, which are forbidden by law to buy drugs that are only "possible effective." This meant a big loss for Merrell.
The company complained to the same Marion Finkel at FDA, and Bendectin's designation was changed to "probably effective" a label that allowed government agencies to buy it.
Footnote: Finkel refused to accept calls from my office even when informed that she was directly involved. Both FDA and Merrell officials denied any collusion, and the company insisted that Bendectin is safe. It is still on the market. Incidentally, the "60 Minutes" segment on Bendectin never aired.