16 December 2015

Can Someone Please Hang Him from the Empire State Building by His Underwear?

Martin Shkreli is at it again:
After dropping $2 million on a Wu-Tang Clan album, the pharmaceutical executive Martin Shkreli has found a new project: making an essential treatment unaffordable for poor immigrants from Latin America.

Shkreli, otherwise known as “pharma bro,” gained notoriety earlier this year when his company, Turing Pharmaceuticals, increased the price of a drug used to treat AIDS patients from around $13.50 to $750. He’s now the CEO of KaloBios Pharmaceuticals, which recently announced its plans to submit benznidazole, a treatment for Chagas disease purchased earlier this month, for Food and Drug Administration approval next year. The Centers for Disease Control and Prevention estimates that about 300,000 people in the United States have the deadly disease. Most of them are immigrants from Latin America, where as many as 8 million people are infected.


Right now, doctors in the U.S. obtain benznidazole free of charge through the CDC. According to Rachel Cohen, the regional executive director of the Drugs for Neglected Disease Initiative in North America, the drug sells in Latin America for somewhere between $60 and $100 for each course of treatment. Both of these would change the moment the FDA approved benznidazole from any company—and Shkreli, in particular, seems determined to price this drug out of reach of the people who need it. In filings with the Securities and Exchange Commission, KaloBios wrote that it expects to price the Chagas drug similarly to antivirals for Hepatitis C, which can cost almost $100,000 for a single course of treatment in the United States.


The CDC currently purchases benznidazole from a Brazilian company. They used to send less than a dozen treatments a year to physicians across the country, according to Susan Montgomery, who leads the epidemiology team at the CDC’s Parasitic Diseases Branch. But after blood banks started testing people for Chagas in 2007, that number spiked.

In theory, FDA approval for benznidazole would make it more accessible to patients: Right now, because benznidazole isn’t approved, a patient who needs the drug has to be enrolled in a clinical trial in order to receive it from the CDC. In practice, though, the current plans for pricing will negate any good that could come from removing the drug’s “experimental” label.


Recently, the FDA added Chagas to a special program for neglected diseases. If a pharmaceutical company submits a drug for a disease on the program’s list, the FDA gives the company a “priority review voucher.” That voucher lets companies bring another drug to the FDA for expedited review, usually around six months between submitting the application and receiving a decision (a process that usually takes years. The hope is that the program will incentivize companies to invest in new treatments for neglected diseases that afflict the poorest regions of the world. But companies aren’t required to come up with new drugs to get those fast-track vouchers. The drugs only have to be new to the FDA. (Companies can also sell those vouchers for big money—last August, for example, United Therapeutics sold its voucher for $350 million.)

Last month, Doctors Without Borders, joined by a number of other public-health organizations, asked the Senate Committee on Health, Education, Labor, and Pensions to amend this voucher program. The groups argued that companies should be eligible only if they actually invest in researching and developing new treatments for neglected diseases, and that they should be required to submit a strategy for how they would keep the drugs accessible for patients.

“If this price hike were to happen, it would be a complete disaster for Chagas patients in the United States,” Cohen said. “People affected by this disease in the United States are poor, are marginalized, have very limited access to health care to begin with. It would be catastrophic.”
2 years ago, on the occasion of actor Jack Klugman's death, I noted that one of the things that he was lauded for was lobbying for the Orphan Drug Act of 1983.

I took issue, and said that the effect of the act was to manufacture non-patent monopolies that primarily served to raise the cost of drugs through rent-seeking behavior.

The IP restrictions and incentives that are a part of the US medication development regime are killing and impoverishing us.

How about price controls and compulsory licensing?  That sounds good.


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