What happens when a pharmaceutical company discovers that a drug that brings in hundreds of millions of dollars per year causes deadly side effects more often than a similar generic drugs?

I should have asked a question like that of West Virginia U. alumnus and Bayer Corporation CEO Gregory Babe when he was on campus last Friday.

Trasylol: Bayer’s blunder

I should have asked Babe about Trasylol, a Bayer drug used to control blood loss during surgery that has been implicated in thousands of deaths – even after Bayer had the results of a study that demonstrated the drug’s dangers.

In 2005, Trasylol sales topped $300 million, and they were expected to reach $750 million in 2006, until studies surfaced showing increased rates of kidney failure and death among patients who received the drug.

Those studies suggested two generic medicines offered the same benefits as Bayer’s drug without the side effects – and at one-twentieth of the price.

When the FDA convened a hearing on Trasylol’s safety, Bayer had the results of a new study it had commissioned that further demonstrated Trasylol’s dangers.

But the two Bayer representatives who were at the hearing didn’t mention the study, and, as a result, Trasylol wasn’t then banned.

The chair of the FDA committee, Dr. William Hiatt, later said had he known about Bayer’s study, he would have voted to take Trasylol off of the market.

In other words, had Bayer disclosed their findings, thousands of lives could have been saved.

Babe’s lecture at WVU

I didn’t ask Mr. Babe about Trasylol because that makes a nasty question, and the guy was at his alma mater to be honored.

He was given a Mountaineer made of coal!

His talk was titled, “Sound Science: Creating an Informed Citizenry.”

There are few topics more important, and, in retrospect, I think the subject’s importance trumps decorum. The tough question ought to have been asked.

His speech was eloquent, and I agree with most of what he said – especially of the importance of training American scientists, using science to inform policy and promoting scientific literacy among the public.

Where he went off the rails, though, was suggesting the public has been spooked by environmental and human health phantoms, and industries such as chemical manufacturing deserve more of our trust.

BPA: health danger or phantom risk?

Babe’s phantom of choice was bisphenol A (BPA), a component of plastics that has garnered a great deal of attention in recent years for its health risks. Several billion pounds of BPA are manufactured annually in the U.S., much by Bayer, and it is found in the urine of 95 percent of Americans.

Babe cited two studies that didn’t find dangers associated with BPA and concluded the compound is safe. In fact, of 13 industry-funded studies on BPA, none have found health risks.

In contrast, of the 167 publicly funded studies on BPA, 153, 92 percent, have found adverse health effects, from cancer to neurological to abnormal weight gain.

If Babe really thinks looking at two of 13 industry studies and ignoring 167 public studies is sound science, he should choose other topics on which to lecture.

Bayer’s integrity

I learned about Trasylol because I was looking for an example of Bayer impeding sound science, so Bayer could argue I sought out a worst-case example not representative of standard practices. Indeed, Bayer’s PR defense has been to acknowledge that withholding the study was a mistake, but it represented an anomaly, a glitch in their standards.

I would respond that just as a person’s integrity is tested when no one is watching, corporate integrity should be judged by what happens when profit motives conflict with public interest, and no one outside the company knows of the threat to the public.

That’s just what happened with Trasylol, and Bayer failed that test.

In contrast to Trasylol, BPA is Babe’s chosen example. He wanted an example of a phantom the public has been scared of in spite of “sound science” to show how lack of scientific understanding needlessly hampers business.

Is a compound that 153 of 180 studies (of any funding source) have demonstrated carries serious health risks really the best he could come up with?

Science, innovation and regulation

In this great experiment that is capitalism, profit motive is the engine and regulations are the tracks.

Companies like Bayer drive forward innovation, and they should be commended for that. But they cannot be expected to police themselves.

Science leads to innovation, and it also alerts us to risks. Regulations informed by comprehensive, quality science are the only way the public can be protected and regulatory burdens minimized.

To promote such a system, we should increase funding for the National Science Foundation, the National Institutes of Health and the Environmental Protection Agency.

For their part, corporations should disclose their studies before they begin and make all their data public.

If they think they deserve our trust, sharing what they know about the safety of their products and processes would go a long way toward earning it.