Memo From The Front: Pity The Poor Drug Makers

- Jim Edwards

One of the weird complications of health marketing is that it is possible for the government to put you in prison simply for describing truthfully what your drugs or medical devices can do. That, in fact, is happening right now in Chicago where the president and vice president of Abtox have been convicted of promoting the Plazlyte surgical sterilizing system in a way that the Food and Drug Administration had not approved.

The pair apparently described accurately how the device worked, and offered hospitals reimbursement if Plazlyte damaged any instruments—even if those instruments were damaged when Plazlyte was used for non-FDA- approved purposes.

A federal investigation found that Abtox's reimbursements and its executives' truthful descriptions of what the device could do amounted to a criminal conspiracy to market the Plazlyte in an "off-label," or unapproved, manner. The two executives began their five- and 10-year sentences last year. They have appealed.

In light of the Abtox case and others like it, some in the drug industry are questioning whether the off-label law makes any sense. They'd like to see it loosened or ended completely. The Washington Legal Foundation, a right-leaning legal think tank, has filed a friend-of-the-court brief in the Abtox appeal, arguing that the conviction infringes the executives' First Amendment right to speak the truth. If the court agrees, the off-label marketing law could be abandoned in whole or in part.

The off-label law seems doubly puzzling when you consider that drug and device companies are even banned from talking about scientific studies published in medical journals that describe off-label uses of products.

Why shouldn't companies be able to talk truthfully about scientific studies that have used their products in ways not specifically approved by the FDA? The studies are out there. Doctors are already reading them. And, unlike marketers, the FDA gives doctors wide latitude in exploring off-label treatments. It's silly that the law forces drug companies to pretend the studies don't exist when everyone else knows that they do.

Some influential people in the drug business support the WLF's position on scientific studies. Pfizer senior counsel Arnold Friede said as much at the Association of National Advertisers' Advertising Law conference (Brandweek, Jan. 22), though his position isn't officially supported by his company.

Friede and executives like him want to be allowed to distribute copies of medical studies in which their drugs are used for off-label purposes. They believe their companies have a simple right to tell the truth under the First Amendment.

But before we march on Washington in support of oppressed drug companies yearning to breathe free, let's look more closely at history.

It turns out that medical journals are not the bastion of scientific accuracy and honesty that we sometimes think they are. Take, for instance, Merck's study of the now-withdrawn Vioxx as published in the New England Journal of Medicine. The piece neglected to mention that three patients died after the study's official cutoff date. Even respected medical journals cannot be completely trusted because drug companies tend to only publish positive research results (Brandweek, June 5).

The WLF's brief makes a compelling case that telling the truth should not be criminalized. But it doesn't describe what actually happened at the hospitals that used Abtox's device: Eighteen patients were blinded in cataract operations when Plazlyte sterilizing fluid reacted with brass instruments to form poisonous copper acetate, according to the FDA.

So this is not simply a matter of whether drug companies should enjoy the freedom to tell the truth about what their products can do. It's about whether off-label uses have been adequately investigated for safety. Which, of course, is what the FDA approval process is supposed to do.

That is why, on behalf of those who would not like to be blinded by companies that want to promote off-label information about their drugs and devices, I'd like to urge the judges in Chicago to leave the law the way it is.



E-mail: jedwards@Brandweek.com.