Illegal Promotion of a Drug That Causes Birth Defects

My June 2010 column discussed the criminal and civil penalties of $81 million paid by Johnson & Johnson for illegally promoting its anti-epilepsy drug topiramate (TOPAMAX) for nonapproved uses.

TOPAMAX was illegally promoted for a variety of psychiatric problems, including drug and alcohol dependency.

A psychiatrist whistleblower who initiated the case involving TOPAMAX stated that: "I found it outrageous that Ortho-McNeil [a Johnson & Johnson subsidiary] would try to pay doctors to influence them to prescribe a drug for uses that clearly endangered patients’ health."

In last month's issue of Worst Pills, Best Pills News, we summarized the results of our study of 20 years of illegal civil and criminal activities by the pharmaceutical industry, pointing out that one of the most rapidly growing categories was illegal off-label promotion. The reason that criminal penalties are associated with this type of illegal activity is that if the company is promoting the drug for unapproved (off-label) uses, there is clearly a lack of evidence that the benefits outweigh the risks, and patients could well be harmed by this dangerous promotional activity.

The most recent Food and Drug Administration (FDA) action concerning TOPAMAX in March of this year emphasizes the dangers of such promotional activity. The FDA found that women who used the drug during the first trimester of pregnancy were much more likely to have a baby with cleft lip and cleft palate. In these birth defects, parts of the lip or palate do not completely fuse together early in the first trimester of pregnancy, a time when many women do not know they are pregnant. The defects range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating and talking, and to ear infections.

Although the studies were based on results in women taking the drug for treatment of epilepsy, there is every reason to think that the same increased risk of birth defects occurs in women taking the drug for any of the illegally promoted, off-label psychiatric uses. This is not the first time Johnson & Johnson has been caught illegally marketing drugs.

Unfortunately, this lawlessness will not stop until the government forces companies to pay amounts of money at least equal to the gains derived from the illegal activity, not just small fractions thereof. It also must be stated that in none of the cases involving large pharmaceutical companies have any corporate officials been jailed.

To this end, the chief of litigation at the FDA, Eric Blumberg, has stated that:

"...unless the government shows more resolve to criminally charge individuals—at all levels in the corporate hierarchy—...we can not expect to make progress in deterring...off-label promotion."