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.

More like this

Last week we spent some time discussing the shortcomings of the generic vs. brand name drug debate, focusing on an example of non-bioequivalence between the antidepressant Wellbutrin XL and its generic competitors. Three days later, I then received an e-mail from one John Procter about a movement…
...my attention was raised to another mitochondrial glycolysis inhibitor being touted for anticancer utility. From a 1 April New York Times Op-Ed by Ralph W. Moss entitled, "Patents Over Patients": In 2004, Johns Hopkins researchers discovered that an off-the-shelf compound called 3-bromopyruvate…
As Dave Barry would say, I am not making this up. In yesterday's Wall Street Journal (sub req'd, but I'll quote extensively), Stacy Meichtry wrote on an Italian Roman Catholic religious order whose cancer research laboratory, owned formerly by Pfizer, has recently entered partnerships with this and…
Students and laypeople alike often view biotech patents with baffled disbelief. How is it possible to patent bacteria? Mice? Cell types and DNA sequences? How can someone else "own" gene sequences that all of us have carried inside our bodies since birth? Honestly, as a biologist, the concept of…

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.

Huh, that's interesting. Thanks for posting. Will take a look.

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?

By Nils Ross (not verified) on 18 May 2009 #permalink

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.

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.

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.

By Mike Olson (not verified) on 01 Aug 2009 #permalink