In my post Patents Kill: Compulsory Licenses and Genzyme’s Life Saving Drug, I noted that, due to the monopoly granted by patent (yes, it is a monopoly), people are literally dying because the drug Fabrazyme is in short supply and the sole, monopolistic manufacturer, Genzyme, can’t make enough quickly enough–and no one else is permitted to make it due to the patent.
In response to my blogging about this, I received an email today from (ironically) a patent attorney (appended below), C. Allen Black, Jr. Yes, I know he’s a patent attorney–but nonetheless, he is heroically representing pro bono two victims of the murderous FDA-patent regulatory system caused drug shortage. As noted in the press release issued by Black on behalf of his clients:
Mr. Joseph M. Carik was diagnosed with Fabry disease in 2005, before the shortage so he receives only a 30% dose. Ms. Britton was diagnosed in 2010 after the shortage so she is not allowed access to the drug. As a result of rationing, all petitioners have had their symptoms return, including pain and burning in their extremities (neuropathy); decreased kidney function (proteinuria), severe gastrointestinal symptoms, and cardiac problems.
This is an outrage–a clear example of the destruction to human life caused by the state–in particular, its patent and FDA systems. As noted above, there is a shortage because of the patent, but combined with the FDA. I frankly do not understand why Genzyme itself has not licensed its patent to others, at least for the time being, if only for humanitarian reasons. But even if they don’t the FDA/fedgov ought to impose a compulsory license, which it has the statutory power to do; and/or the FDA ought to approve the “alternative drug, Replagal® manufactured by Shire Pharmaceuticals.” This mess is the result of the intersection of state regulatory systems. I’ve noted this before in my posts State Antitrust (anti-monopoly) law versus state IP (pro-monopoly) law; When Antitrust and Patents Collide (Rambus v. FTC); The Schizo Feds: Patent Monopolies and the FTC; The Schizophrenic State; Intel v. AMD: More patent and antitrust waste; Are Patents “Monopolies”?; Patents, Prescription Drugs, and Price Controls. The FDA imposes costs and delays, and then the state and IP proponents use this as an excuse to argue for a patent system: the patent monopoly price is needed to “make up” to the pharmaceutical companies the damage they suffer from the FDA system (which is not really always a damage, since it works in some ways like a patent since the FDA might approve your drug and not those of competitors, giving you a patent-like monopoly; and also because the relatively high cost FDA compliance imposes on smaller companies–for examples of how large corporations often lobby for and benefit from (relatively speaking) antitrust and other regulations, see State Antitrust (anti-monopoly) law versus state IP (pro-monopoly) law).
In this case, as explained by Black’s email, there is a shortage because
62% of Fabrazyme (Genzyme Corp) is sent overseas even though overseas patients have access to the alternative treatment, Replagal by Shire Pharmaceuticals. Replagal is not approved for use in the US and Shire has withdrawn its FDA application for approval, so no alternative treatment exists for Americans …. The result is the tragically ironic situation that there is no drug shortage overseas, but, here in the US, no new patients receive treatment and pre-existing patients are still rationed to less than half the recommended dose. There have already been three deaths reported in the US under the rationing, but none reported overseas. Even more bizarre, is that the FDA is importing Replagal to replace the Fabrazyme that was shipped overseas in the first place. However to receive treatment the patients must show “critical medical need” on an individual basis.
The FDA-patent victims here tried to get another manufacturer into the market but the NIH said “no.” As Black told me, “The FDA is our last resort because they are the only administrative body that can allocate drug during a crisis.” So now, these poor, sick people, who are denied access to a necessary drug because of the state’s murderous regulations, have to petition and beg the FDA to use its emergency decree powers to help ameliorate a crisis that it (and the fedgov) caused in the first place. Their plight reminds of those poor, sick people who need medical marijuana but have to skulk in the shadows, live in fear, or beg their master-the-state for permission to ease their own misery.
Here are Black’s email to me and press release. Please consider signing the Citizen Petition to help these people out: it’s available at http://www.patentlawyersite.com/files/Download/Web%20CITIZEN%20PETITION%20TO%20ALLOCATE%20AGALSIDASE%20BETA.doc.
Black has more information on his clients and this situation at his page Fabrazyme and March-In Rights. [continue reading…]
Mr. Koepsell,
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