Healthy Skepticism Library item: 17634

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

The next Vioxx: Off-label drug marketing puts consumers at risk. Soon, it could be legal
Merced Sun-Star 2010 Apr 15
http://www.theoneclickgroup.co.uk/news.php?id=4639#newspost

Full text:

The following editorial appeared in the St. Louis Post-Dispatch on Thursday, April 15:

A new class of pain relievers called Cox II inhibitors burst onto the U.S. market in the 1990s and quickly became blockbuster best sellers.

One reason was the marketing. The drugs arrived as federal officials were relaxing traditional standards that blocked most advertising aimed at consumers.

But it wasn’t only patients who were getting the hard sell. Recently released documents show that drug companies also were bombarding doctors with information about potential uses for the drugs, including some uses for which the medications had not been approved.

That’s illegal. Since 1962, pharmaceutical companies have been required to prove that their drugs are safe and effective for specific uses. Marketing drugs for unapproved, or “off-label” uses, is a criminal offense.

That may be about to change. Allergan, Inc., the company that makes Botox, has sued the U.S. Food and Drug Administration, claiming that the ban violates its free speech rights. The case is scheduled for a hearing later this month.

Off-label marketing may be against the law, but off-label prescribing is perfectly legal, even common. About one in five prescriptions written in the United States each year is for an off-label use.

The contradiction between how drugs are marketed and how they are prescribed creates a gray area that opened the door for the Allergan case.

The company is best known for Botox Cosmetic, widely used by plastic surgeons to treat wrinkles. In higher concentrations, Botox is approved to treat crossed eyes, eyelid spasms and some forms of dystonia, a neurological disorder.

Some doctors also use the drug off-label to treat muscle spasticity in adults who have had strokes and in children with cerebral palsy.

In 2007, 7-year-old Kristen Spears died in California after receiving a Botox injection to treat muscle spasticity in her legs.

Last year, the FDA required Allergan to provide doctors with new information on the risks of Botox for off-label uses such as muscle spasticity.

The company said it also wanted to give them truthful information about the benefits of those uses. But the scientific evidence supporting those uses is, at best, incomplete or inadequate. Otherwise, the company would have sought FDA approval for those uses.

Allergan says it can’t provide information about the benefits of off-label use without violating FDA regulations, so it filed suit to have those rules thrown out.

This is a very strange argument: We can talk only about risks, not about untested benefits, so it’s a violation of our free speech rights.

That’s no way to protect consumers.

Rightly or wrongly, doctors rely on pharmaceutical company marketing as an important source of information about drugs.

Letting drug companies stack the deck by providing truthful but incomplete information about off-label uses increases the odds that doctors will write prescriptions for those uses. The case in point: Cox II inhibitors.

The drugs were approved to treat arthritis pain without causing stomach or intestinal problems. Studies conducted a decade ago found that most users of those medicines weren’t at risk for those problems.

You might think it wouldn’t matter. The evidence shows otherwise. Two of the most popular Cox II inhibitors, Vioxx and Bextra, later were taken off the market after testing showed that they increased the risk of fatal heart problems and strokes.

If Allergan wins its suit, the door will be wide open for similar drug marketing based on unproven claims and inadequate scientific information. This case isn’t about free speech, it’s about the right of patients to be adequately protected by federal regulators.