The Indelible Bonobo Experience

Lord save us from lawyers, especially the big shots who graduate from élite law schools and advise administrations. (Brenner is a Harvard man; Bobbitt and Mukasey are Yalies.) With some honorable exceptions, their primary function is protecting the interests of the political and corporate establishments, often by finding some novel and tendentious way to legitimate their self-interested actions. When lesser mortals object, they turn around and accuse them of being ignorant of the law. The evolution of the legal framework surrounding electronic spying provides a textbook example of this process at work. In the past decade or so, some of the best legal minds in the country, working for the Bush and Obama Administrations, have reshaped a shadow system of court hearings and court orders that was originally created to serve as a check on the executive branch, but which, in practice, serves to justify its ever-expanding reach. Built upon repeated amendments to the Foreign Intelligence Surveillance Act of 1978, the system is so secretive it is virtually impossible for the American public, journalists included, to know how it operates. About all we can say is that it rubber-stamps a large number of requests from the intelligence agencies, including one, revealed to us by Snowden, that enables them to sweep up the telephone records of anybody who has service provided by a Verizon subsidiary. (via N.S.A. Scandal: God Save Us From the Lawyers : The New Yorker)

“Jamie got that it had to be a dollar a day, that it wasn’t $400 a year, that the price of a dollar a day would move the whole debate,” Weissman said. Hamied’s offer made headlines around the world. It set a floor in the market and lead the prices for name brand drugs to fall precipitously. “Before all this, we had a meeting with the U.S. Trade Representative and we were talking about how keeping these prices and patents in place was costing millions and millions of lives in Africa,” Weissman recalled, referring to Love and himself. “And the Trade Rep. said to us — I’ll never forget this — ‘I don’t work for millions of people in Africa.’” The $10,000 that pharmaceutical companies were willing to charge for ARVs — and that their US government was willing to defend as reasonable at the WTO — was egregious in part because the drugs can be produced so cheaply, as Cipla proved. But the prices were also impossible to justify because the development cost for the first generation of ARVs was close to nothing for private industry. The drugs, known as dideoxynucleotides, were almost all developed in the 1960s at Wayne State University under National Institutes for Health (NIH) grants to research cancer therapies. And, in the 1980s, it was again NIH researchers who thought to test the compounds against the AIDS virus. Love traces the genesis of the idea to a similar situation, this one involving cancer drugs. In the early 1990’s, Love began investigating Taxol for Senator Ron Wyden of Oregon. The drug is used to treat breast and ovarian cancer, and was developed by the NIH and produced for less than a dollar per milligram for clinical trials. Bristol-Meyers Squibb, once effectively given the patent, sold the drug for $4.87 per milligram, roughly moving the price from $100 per dose to $850 per dose. “I do a lot of historical research on the things I do. I like to go back and look at earlier disputes and case studies on particular drugs or legislation or just try to figure out how we got where we are,” Love said. One of the cases Love climbed into involved Cisplatin, the drug that saved Lance Armstrong’s life. The drug was also developed within NIH and effectively handed to Bristol-Meyers. (via How Drug Companies Keep Medicine Out of Reach - Brian Till - The Atlantic)

• Love’s idea suggests the use of cash prizes — rather than patents — to incentivize research; say, $2 billion for an effective therapeutic drug for Chagas disease. A cure, once developed, proven, and awarded a prize, would then exist as open-access intellectual property, with manufacturers around the world competing to produce the drug in the most cost effective manner. Implementing the idea, Love said, “is effectively leveraging the power of the free market twice, once to produce the thing you want and then again to manufacture it as economically as possible.” The concept is known as delinking.
• The prospect also has interesting second-order effects. “The numbers have to be big enough,” Love said. “You can’t replace monopolies that involve billions of dollars with prizes that involve thousands of dollars, but it’s financially easy to do that because the savings from delinking are so big.” Because drug makers are no longer dependent on sales, delinking would relieve huge strains on budgets beyond research and development; the industry only spends about 16 cents on the dollar for R&D. Massive ad campaigns, for instance, would become obsolete in such a system, because the innovator’s profits are no longer tethered to sales, the same for gifts and meals to woo physicians.
• Last November, the Obama administration made its most strident effort to date to stall the idea. Because successive U.S, administrations have stonewalled the process so effectively, negotiations on actual language for an R&D treaty have never begun. That hasn’t prevented the intellectual scaffolding beneath the idea from developing, though.
• The battle for the idea has peaked at a time when the pharmaceutical industry finds itself under extraordinary duress. Despite significant advances in drug development technology, the number of new drugs per billion dollars spent on R&D has halved every decade since 1950. And the industry, over the course of the current decade, is watching many of its most profitable drugs come off of patent. In November 2011, Pfizer lost exclusivity on the most lucrative drug ever made, Lipitor. The statin grossed more than $130 billion for the company. The patent on GlaxSmithKline’s Advair also went dry in 2011. The drug made $7.8 billion in 2009 alone. Eli Lilly, which has been hit hardest by the patent cliff, lost its patent on Zyprexa in 2011. The antipsychotic made them close to $5 billion per year. The firm is projected to lose half of its total sales across the decade.
• Jack Scannell is one of the people trying to usher in a new era of drug discovery. “In very broad terms, I’m pretty pessimistic about the industry,” Scannell said. “I don’t think at a sort of aggregate, macro level classical R&D as it’s been done for the last forty or fifty years has a particularly bright future.” Scannell is British, and dropped out of medical school in favor of a PhD in computational neuroscience from Newcastle University. He met Malcolm Young there, and the pair worked a together on systems for analyzing networks, specifically for mapping neuronal activity.
• “Historically, you can make a very strong case that the way drugs were discovered when it was cheap and easy — you can’t do all this now because of the regulators, but some of this you might be able to do — was essentially through broad phenotypic screening, very often in man,” Scannell said. “Drugs were regarded as potential tools that might do something useful, and then people essentially searched for uses for the tool. And today we do the exact opposite. Which is we say, we want something that cures Alzheimer’s disease, let’s design something that cures Alzheimer’s disease, and frankly that just doesn’t work.”
• I asked Derek Lowe, the chemist and blogger, for his thoughts on the principle of delinking R&D from the actual manufacture of drugs, and why he thought the industry, facing such a daunting outlook, would reject an idea that could turn fallow fields of research on neglected diseases into profitable ones. “I really think it could be viable,” he said. “I would like to see it given a real trial, and neglected diseases might be the place to do it. As it is, we really already kind of have a prize model in the developed countries, market exclusivity. But, at the same time, you could look at it and it will say, ‘You will only make this amount of money and not one penny more by curing this tropical disease.’ Their fear probably is that if that model works great, then we’ll move on to all the other diseases.”
• This R&D void was also acknowledged by John-Arne Røttingen, the Norwegian doctor who led the second expert working group for the WHO, known as the Consultative Expert Working Group (CEWG). The report of a first expert group was thrown out for issues of political malfeasance — it became clear that proposals from developing countries were excluded from consideration, and that experts met with pharmaceutical industry representatives but not civil society members.
• Love and others point to Gates’s complicated history with Microsoft and his departure from Harvard as an undergraduate as coloring his view on the need for strong intellectual property law.

• In the current debate, documents submitted to WHO working groups attacking the idea were largely authored by individuals and groups that receive support from Gates. The Gates Foundation was also the largest funder of Nils Dualaire’s Global Health Council. They donated more than $30 million.