Valueless Vaccines?

Under Food and Drug Administration rules, drugs sold in the U.S. must be both safe and effective. But vaccines, which are active biological materials and come under the jurisdiction of another Department of Health, Education and Welfare agency, the Division of Biologies Standards, appear to have eluded the effectiveness requirement. According to a report by the General Accounting Office, DBS, over many years, has allowed 32 substances including some flu vaccines to be marketed though they were virtually useless. Some may also be dangerous.

Undertaken at the request of Senator Abraham Ribicoff of Connecticut, the Accounting Office's report is a damning document. Its conclusions are based entirely on the DBS's own records and show that the agency consistently released vaccines that it knew were of dubious quality. Some of them even failed to match the strength claimed by their manufacturers. DBS did not reject a single lot of flu vaccine, although some tested out at less than 1 % of purported potency. Nor did it stop the sale of weak vaccines that were known to produce annoying side effects. One drug, licensed in 1956 for the treatment of upper respiratory infections, carried a warning that it could result in fever and abdominal cramps.

Neither the report nor experts in the field accuse DBS--or the substances in question--of damaging public health. Many of the 32 items have never been in wide use because they are designed to control rare diseases. Most doctors have realized all along that flu and cold vaccines, which have been given to tens of millions of people, are of uncertain value. There is no challenge to vaccines used for combatting serious public health problems like polio, German measles (rubella) and measles.

But the indictment is important nonetheless. As the report makes clear, DBS inaction resulted at least in part from uncertainty over its legal authority to regulate vaccine potency and how much power HEW could delegate to DBS. A HEW directive seems to have resolved these doubts. A more formal cure is proposed in legislation now before Congress. The bill would combine DBS and FDA into an independent and expanded drug regulatory agency. Meanwhile, health officials would not discuss the charges.

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