Another example of Big Pharma suppressing (or ignoring) the truth


Category : General, Medical Rants, Pharma

Lucrative Drug, Danger Signals and the F.D.A.

Dozens had died and more than 100 patients had suffered serious heart problems by March 1998 after taking Propulsid, a popular medicine for heartburn. Infants, given the drug to treat acid reflux, seemed particularly at risk. Federal officials told Propulsid’s manufacturer, Johnson & Johnson, that the drug might have to be banned for children, or even withdrawn altogether. Instead, the government and the company negotiated new warnings for the drug’s label – though not nearly as tough as regulators had wanted.

Propulsid had a good year anyway. Sales continued to surpass $1 billion. Johnson & Johnson continued to underwrite efforts that promoted Propulsid’s use in children. A survey that year found that about 20 percent of babies in neonatal intensive care units were being given the drug.

Two years later, as reports of heart injuries and deaths mounted, Johnson & Johnson continued defending the safety of Propulsid, but then pulled it from the market before a government hearing threatened to draw attention to the drug’s long, largely hidden, record of trouble.

That record, pieced together from newly obtained corporate and government documents, provides an in-depth view of a pharmaceutical company trying to save a lucrative drug in the face of growing evidence of harmful side effects. It is a story that has particular resonance now, as troubled arthritis painkillers – Vioxx, Celebrex and Bextra – have again focused attention on what critics say is the federal Food and Drug Administration’s inability to monitor and regulate pharmaceuticals effectively once they are on the market.

Documents from lawsuits against Johnson & Johnson show that the company did not conduct safety studies urged by federal regulators and their own consultants that could have revealed Propulsid’s danger early on. The F.D.A., moreover, did not disclose company research that cast doubt on Propulsid’s effectiveness against digestive disorders it was being used to treat, since the studies are considered trade secrets.

The familiarity of this story disheartens this writer. Our pharmaceutical system does not work as well as we deserve.

I support free market economics. However, as I understand free market economics, the costs and benefits should be discoverable. Certainly, we see cheating in all businesses. As Benny Binion (famous casino owner) allegedly said, “Everyone’s honest, when they can afford to be.” (Quote found James Swain’s new novel “Mr. Lucky”).

As a physician or patient, we cannot rely on Big Pharma to tell us the truth about efficacy or side-effects. Yet we need the truth. Our current system, which relies on Big Pharma to fund studies and selectively release results, is broken. We must fix it. And once again it will require Congress to act decisively. I am not holding my breath.

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Comments (1)

You correctly point out that we doctors need the truth. What you didn’t point out in the case of propulsid is that we had the truth right there in front of us. Although J&J apparently negotiated with the FDA to soften the language the warnings were there, and clear enough for any doctor who bothered to pay attention. The study by Smalley showed that doctors ignored FDA letters and a strong boxed warning for at least a year after publication. (See JAMA. 2000;284:3036-3039 and its accompanying editorial)!

We have no room to complain that we weren’t given the truth. Had it not been for rampant contraindicated prescribing this wouldn’t have happened. Propulsid was an unforgiving drug, although not an inherently bad drug.

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