Joe Biden wants to be president, the champion of working families. But there is another side to the former vice president: protector of big pharmaceutical companies, indifferent to the harsh consequences of high drug prices. If Biden wants to pursue a future in politics, he ought to consider a reboot on drug pricing issues.
First, a bit of history.
In 2012, the controller of the Indian Patents Office granted a compulsory license to patents for the cancer drug sorafenib, marketed as Nexavar by Bayer, a German pharmaceutical company. A compulsory license allows a company to produce a patented drug without the consent of the patent owner. (Compulsory licenses on patents are allowed in international trade agreements but are controversial, especially when cancer drugs are involved.) This license gave Natco Pharma, an Indian drug manufacturer, the right to make and sell generic versions of sorafenib in the Indian market at a deep discount over the Bayer price.
That decision was quickly challenged by Bayer. As the dispute dragged through the courts, the CEO of Bayer told investors that the compulsory license would not affect its profits because “we developed this product for Western patients who can afford this product, quite honestly.”
The Nexavar decision was just the tip of the iceberg. The government of India was considering granting licenses on a dozen expensive cancer drugs, none of which were remotely affordable to most of the 1.3 billion people living in India or to the 6 billion living in countries where access to patented cancer drugs is severely restricted because of high prices. For them, an affordable generic from India was a plausible option.
Drug companies around the world were alarmed by the Nexavar compulsory license. They enlisted the Obama administration to seek a reversal and, even more important, to block similar actions on other drugs.
Biden personally pressured the Indian government on the compulsory licensing issue, in India and in the United States. His efforts were a factor in the decision by Prime Minister Narendra Modi to block further compulsory licenses from being issued. What was a win for the Obama/Biden team was a catastrophic loss for cancer patients living in developing countries.
In 2014, Colombia was struggling to find ways to obtain more affordable cancer drugs. Biden wrote President Juan Manuel Santos Calderón to complain about Colombia’s efforts to create an abbreviated path of approval for biosimilar drugs.
In 2016, when drug pricing became a hot topic in the United States, my organization, Knowledge Ecology International, and the Union for Affordable Cancer Treatment filed a petition with the U.S. National Institutes of Health and the U.S. Army, asking the Obama administration to grant a compulsory license or use its royalty-free right from the Bayh-Dole Act for the patents on enzalutamide, a prostate cancer drug marketed as Xtandi by the Japanese drug company Astellas. At the time, the annual price for Xtandi in the U.S. was $129,000 per year. Today it is more than $137,000, a cost 2.5 to 4 times higher than in any other high-income country.
While the Xtandi case was under review, Biden held court in Davos, Switzerland, on the cancer moonshot with NIH Director Francis Collins and Dr. Charles L. Sawyers, a Memorial Sloan Kettering Cancer Center researcher who also sits on the board of directors of Novartis. Sawyers is the principal inventor of Xtandi, which he developed while at the University of California, Los Angeles, working on grants from the U.S. Army and the National Institutes of Health. On June 20, Collins formally rejected our march-in request (which would have allowed the NIH to “march in” to the commercialization process and require licenses for this federally funded invention) without even granting a hearing or sharing any of the correspondence from Astellas on the case.
During 2016, Knowledge Ecology International filed objections to 16 proposed exclusive licenses to patents owned by the NIH; most of these were for cancer drugs. Each objection asked the NIH to at least require the companies getting the licenses to charge U.S. residents no more than the median price for the drugs in seven other high-income countries. The NIH rejected conditions on affordability in every case.
Biden’s high-profile work on cancer, motivated by the death of his son, Beau, from brain cancer in 2015, helped him create the Biden Cancer Initiative with his wife, Jill. To lead the organization, he picked Greg Simon, a former senior vice president at Pfizer who had served as the executive director of the White House Cancer Moonshot Task Force. Simon, who has previously been treated for chronic lymphocytic leukemia, has a long history of working in government, investments, and the drug industry, and was a founding president of FasterCures, a charity that included several drug companies as partners.
This is the Biden’s second cancer charity. The first was the Biden Breast Health Initiative, which was supported by AstraZeneca, a giant Swedish-owned company that sold drugs for breast cancer. One of his sons, Hunter, once worked as a drug company lobbyist.
As vice president, Biden had endless opportunities to propose measures to deal with high drug prices. But when pressed about the issue, he framed it in terms of the amount of insurance coverage people would have rather than the excessive nature of drug prices. The report of the Cancer Moonshot Task Force offered suggestions to lower the cost of pharmaceutical research and development but not the price patients would have to pay for treatments, even though the report was issued in the middle of a huge public debate on drug prices.
After leaving office, Biden claimed that he would seek a “more rational way of paying” for expensive treatments, whatever that means. By hiring a former Pfizer executive to run his charity, count me as skeptical that Biden is about to do anything that really challenges the pharmaceutical industry. That’s not only a shame, it’s illustrative of the gap between Biden’s man-of-the-people rhetoric and his pandering to corporate interests.
Both Biden and Simon frequently remind people of their own personal connections with cancer, in part as motivation to promote innovation. But it’s also true that after personally experiencing the impact of a cancer diagnosis, and knowing how important it can be to have access to treatment, Biden’s attacks on access to treatment in developing countries and his indifference to the impact of high prices at home should be seen in a more critical light, rather than a more lenient one.
At age 75, Biden can still change — and he should if he wants to be taken seriously as a leader. Many people expect politicians to actually walk the talk these days, and take sides on issues like drug pricing. Biden could start by reaching out to people who are actually working on drug pricing issues, especially those who aren’t funded by companies that sell high-priced drugs.
James Love is director of Knowledge Ecology International, a not-for-profit organization that advocates for access to medicines at affordable prices. He was a pro-bono expert in the Nexavar compulsory licensing case, and is currently a member of the board of directors of the Union for Affordable Cancer Treatment, a group he cofounded with his wife, Manon Ress, who has stage 4 breast cancer. She benefits from an effective treatment that is priced out of reach for most of the women in the world who need it.
Good piece. We need policy to be as nimble as enterprise, which turns on a dime, seeks new opportunities, innovates and competes so better products, better services, and lower costs wins. Instead, US policy is bought by well endowed enterprises that love the old ways and status quo.
Health policy, drug policy, device policy, the medical/dental divide, the insurance and payment system in the U.S. are episodic, lumpy, outdated, and highly infected with conflict viruses, and clunky operating systems on platforms that don’t talk to each other. All need a reboot after a good scrubbing and reformatting of the hard drive. Out with the old, in with the new.