Patent Dispute Prevents Patients From Getting Promising Drug for Lou Gehrig’s Disease

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May 17, 2009

Patent Dispute Prevents Patients From Getting Promising Drug for Lou Gehrig’s Disease

Speaking of the debate over patents interfering with medical care, there’s a story in today’s New York Times that mentions the drug Iplex, which has shown promise for treating Lou Gehrig’s disease — a deadly and thus far untreatable degenerative disease (also known as amyotrophic lateral sclerosis).

From the article:

Iplex … is believed to protect the motor neurons whose
death leads to paralysis in A.L.S. Some patients had persuaded their
doctors to prescribe the drug when the F.D.A. approved it in late 2006
for children with growth deficiencies. “I started on Tuesday,” Debbie Gattoni, an A.L.S. patient in New Jersey, had written on a Web discussion forum, “and on Sunday, I noticed that my right index finger, which was bent, was straightening and moving on its own.”

But
almost immediately, the drug’s maker, Insmed, lost a patent
infringement lawsuit to a biotechnology firm that was already selling a
drug for short stature that had similar properties. Iplex , however, was thought to be more potent for treating A.L.S. Insmed agreed to pull its drug off the market. Only the Italian Health Ministry, which had begun to distribute the drug to A.L.S. patients under a compassionate use program, could continue to buy it … [but] only Italian citizens could receive Iplex through the program.

This situation is quite different from the breast cancer gene patent situation I wrote about in my recent Slate Double X column — the Iplex dispute is over drugs, which are clearly inventions, and no one is questioning the legality of drug patents. But it does raises some relevant questions about the intersection of patents and medical care.

9 Responses to “Patent Dispute Prevents Patients From Getting Promising Drug for Lou Gehrig’s Disease”

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Mike Olson says:

August 1, 2009 at 12:50 pm

I can only agree with what has already been said. But, I figure by posting, I’m rewarding the author with greater response numbers, which in turn will lead to more posts of a similar nature. Thanks for posting this.
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MMORPG says:

July 29, 2009 at 5:20 am

That’s lame, those patients need those durgs, I find it absurd that patents are preventing it.
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Kevin says:

July 11, 2009 at 11:58 am

Thanks for this post. My friend living near the Eiffel Tower may need to look into this. However, I am skeptical at drug companies and their promises. I wonder if this will be another one of those “lifetime treatments” or cures.
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Julie Simon Lakehomer says:

July 7, 2009 at 12:02 pm

Hi, again, Rebecca, I’m so glad to read not only this blog entry, but the article in Slate. I was appalled when this gene patenting began with the Human Genome Project. But your Slate article give great reasons why it’s an inhuman practice, and great examples of other such inhuman practices. Problem is the “Bush” Court. Gotta up my ACLU donation.
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Comrade PhysioProf says:

June 6, 2009 at 11:06 am

Sklooty! Come back!
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Nils Ross says:

May 19, 2009 at 5:08 am

I’m not sure I understand. Why isn’t the patent holder simply demanding a cut of the profits, or else manufacturing the drug themselves?
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Graham Steel says:

May 17, 2009 at 2:22 pm

Thanks for blogging about this, Rebecca.
As you say, “it does raise some relevant questions about the intersection of patents and medical care”.
—
An informative link supplied already c/o David which I’ve added to this thread of the ALSTDI Forum:-

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Rebecca Skloot says:

May 17, 2009 at 12:52 pm

Huh, that’s interesting. Thanks for posting. Will take a look.
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David says:

May 17, 2009 at 12:43 pm

The FDA posting is a pretty good summary of the evidence (http://www.fda.gov/cder/drug/infopage/mecasermin_rinfabate/default.htm). This page also links to the Italian summary and a statement from the sponsor company. In the FDA’s review of available evidence, Iplex was not significantly better than placebo in any of 5 controlled trials, and in 2 of these it was associated with a numerically higher death rate than placebo (though not statistically significant). Take a close look at the survival curve for the japanese study. The current round of enthusiasm is set of by the sponsor company presenting new uncontrolled data on a small cohort that looks promising.