A $2.3 billion settlement by pharmaceutical giant Pfizer for illegal promotion of unapproved use of a drug highlights a significant problem in American health care.
Pfizer developed Bextra, a pain-killing drug that the Food and Drug Administration approved for use in treating arthritis and menstrual cramps. The company then launched an aggressive ad campaign urging patients to ask for -- and doctors to prescribe -- Bextra for other complaints, for which the FDA had not judged the drug suitable. The agency was concerned that Bextra posed risks of damage to the heart, kidneys and skin. The drug has since been pulled from the market.
Perhaps even worse, Pfizer paid doctors, as consultants, to promote Bextra for its unauthorized, "off-label" uses. Pfizer has been involved in other cases and has reached settlements with respect to four drugs. Another drug giant, Eli Lilly, paid $1.4 billion earlier this year in a comparable case, so this practice is not unique.
Where does that leave patients? They can't trust pharmaceutical manufacturers not to promote medications for unauthorized uses. They may not be able to trust their doctors, who may be receiving checks from the pharmaceutical company.
The good guy in the affair is the federal government, which brought the case through the departments of Justice and Health and Human Services. The $2.3 billion settlement with Pfizer is more than a rap on the knuckles, even though the amount represents a small fraction of the company's annual sales. The money will be divided among whistle-blowers in the company who revealed what Pfizer was doing, Medicaid, Medicare and the U.S. Treasury.
The lesson for Americans is that they should study any medication suggested to them, by advertising or by a doctor, and pose hard questions before taking it.