Article I, Section 8, Clause 8 of the U.S. Constitution (1787) "[T]he Congress shall have power . . . to promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries."
If you're going to break the law, you might as well do it in style. Why bother speeding, shoplifting, or stealing cable service, when the sky's the limit? Aim high.
Senator Bernie Sanders (I-VT) aimed high, and did so with style. He wants to violate the Constitution by ignoring the concept of intellectual property rights, which has been in effect for 228 years. Somehow, he thinks it's a good idea to do so at the expense of two drug companies, Gilead and AbbVie, which made the grievous error of inventing groundbreaking drugs that are capable of wiping out hepatitis C— a serious viral infection of the liver with a prevalence of 3.2 million people in the U.S. and 170 million worldwide—roughly four-times that of HIV.
Left untreated, the virus slowly but relentlessly destroys the liver, causing cirrhosis, hepatocarcinoma (liver cancer), and end-stage liver disease. It is the leading cause of liver transplants in the U.S.
The hepatitis C virus (HCV), which is transmitted almost exclusively by blood, was unknown until 1989. By 1992 a blood test for the virus was accurate enough to completely eliminate the transmission of the virus from transfusions. But it was way too late. Millions of people were already infected, primarily from the use blood or blood products, and from contaminated needles. Symptoms of liver damage from the infection typically don't even become apparent for 2-3 decades (this is why it is sometimes called "The Silent Killer"), so very few people who were infected had any idea of their status until signs of liver deterioration became manifest.
By the mid-1990s, an enormous campaign had been launched by virtually every major pharmaceutical company, as well as a number of startups, to look for a replacement for the only therapeutic option available, interferon (IFN) plus ribavirin (RBV)—a poor option because it was far from effective (depending on the strain of the virus, the cure rate was as low as 20 percent), but also very difficult to tolerate. The severity of side effects from the IFN/RBV is qualitatively comparable to that of many chemotherapy regimens for cancer.
During this time, many hundreds of scientists (myself included) were working feverishly to discover an effective and tolerable drug to stop the virus from replicating. Given such a massive effort, we could have never possibly envisioned how difficult this was going to be. But it was. The time interval between the discovery of the virus and the approval of Gilead's game changing antiviral drug Sovaldi was 25 years. During that time hundreds of clinical and preclinical candidates went down in flames.
Sovaldi is arguably one of the greatest successes in drug discovery history. It was the first drug to eliminate the need for IFN, and resulted in cure rates in the 90-95 percent range. Harvoni, a combination of Sovaldi with another Gilead drug ledispavir, raises the cure rate to nearly 100 percent.
Sovaldi and Harvoni are two of the drugs that Sanders wants to steal. The other is AbbVie's Viekera Pak, another two-drug combination with similar efficacy. Why? Because they are both very effective and quite expensive. Expense and drug company profits are the reasons that Sanders gives for violating the constitution by breaking the patents of these drugs, and if I'm Gilead or AbbVie, I'm not going to be especially delighted by this. If Sanders gets his way (I wouldn't worry too much about this, since it will be a hot day in Yakutsk when this actually happens) he will effectively be punishing two companies because they were successful—as good an example of a violation of the carrot/stick axiom, as well as an innovation killer if ever there was one.
Sanders wrote in a letter to Robert McDonald, the U.S. Department of Veterans Affairs Secretary, “I cannot think of another situation where the government-use provision [of the law that allows the VA to break the patents] should be applied. Our nation’s veterans cannot, and should not, be denied treatment while drug companies rake in billions of dollars in profits.”
Well Bernie, please explain why you cannot think of another situation where patents should be invalidated in the name of public health. because I think you are lying. There are plenty of even more expensive drugs out there for leukemia, breast cancer, and MS that are just as vital to patients suffering from these diseases as veterans suffering from HCV infection. And I'm willing to bet that you would be only too happy to get rid of those nasty capitalist profits as well given half a chance.
You are also lying, albeit by omission, about the cost of Sovaldi, etc., since the VA already gets a 25-50 percent discount on these drugs. The Federal Bureau of Prisons gets a 44 percent discount.
If there is a single group of people that deserves all the benefits that the U.S. has to offer more than our veterans, I cannot think of it. Should they get these miracle hepatitis C drugs? You bet. But you don't have to violate the Constitution to do it. Fund the program properly, and negotiate with the drug companies.
What you don't do is invalidate patents, because as surely as the sun rises in the east, there will be other cases where this happens. Should this "one time" ever become common, you can forget about ever seeing a new drug again. There will be no more Sovaldis to steal.
But, at least the pharmaceutical industry won't make billions of dollars in profits. I think this might make Bernie quite happy.
Bernie Sanders Vs. Gilead And The Constitution
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