Different River

”You can never step in the same river twice.” –Heraclitus

June 15, 2005

Drug Companies, Drug Safety, and Profits

Filed under: — Different River @ 2:47 pm

Those who think that pharmaceutical companies blindly pursue profits without regard to drug safety are goign to have a bit of trouble explaining this story:

A panel of experts headed by one of the world’s most respected cardiologists has prescribed some tough medicine for Johnson & Johnson.

The drug giant convened the ten-member panel, headed by Eugene Braunwald of Harvard Medical School in Boston, to examine the safety of heart-failure treatment Natrecor. The drug … has been under intense scrutiny since concerns were raised that it might harm the kidneys and increase the risk of death.

Braunwald’s panel recommended that use of Natrecor be limited to a more restricted population than that for which the drug is approved. It advised that Johnson & Johnson institute a plan to educate doctors about when to use the drug. The panel also approved J&J’s existing plans to test Natrecor–which include a large-scale trial that appears to have previously gone unannounced.

The experts described a very specific clinical trial that would put Natrecor through the ringer, comparing it to the standard of care in heart failure. It would include several thousand patients, and would be designed to show whether the drug causes a 15% or greater increase in kidney problems or death after three months. Moreover, it would look for a difference in the mortality rate of patients on the drug and those on the standard of care after six months.

Darlene Horton, a senior vice president at the company’s Scios division, said, “We accept the panel’s recommendations and are pleased the panel endorsed our current and planned development programs.”

So, the drug company discovered some problems, convened a panel of experts, and decided to limit the potential market for their drug, in the interest of safety. And they did it all in the public eye, even though doing so may leave them more vulnerable to lawsuits later (claiming “they knew their drug wasn’t totally perfect! See, they convened a panel to study the dnagers.”)

Normally, companies try to expand, rather than restrict, the market for their products — and to hide, rather than publicize, their products’ imperfections. Johnson & Johnson is putting patient safety ahead of profits, and that’s a good thing. It may even lead to greater profits in the long term, if Johnson & Johnson has more credibility as a result. Unless the class-action tort lawyers skewer them for admitting there was a problem in the first place.

2 Responses to “Drug Companies, Drug Safety, and Profits”

  1. anon Says:

    I like how J&J is being put thru the “ringer”. In the old days we put companies thru wringers.

  2. Different River Says:

    Interesting point. I did two Google searches, one on put through ringer and another on put through wringer. “Ringer” has 269,000 hits and “wringer” has 67,400 hits. So even if Forbes is spelling it wrong, at least they are in the (vast) majority. (Of course, a linguist will tell you the majority is right — wright? — by definition.

    And anyway, it was Natrecor, not J&J, which is being put through the (w)ringer.

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