With so much attention on Ebola and the need for more treatments and cures, we are getting into aspects of health care policy that are rarely in the public sphere.
Most political debates center on health care payment and delivery issues: How can we make sure that people have access to the care they need at an affordable price? Those are the discussions that interest me most, mostly because I know the direction that I think is best: A market-based system that encourages providers to compete for customers will deliver the best value, and government aid should focus on helping people access that system by providing financial support for those who need it due to poverty or circumstances that make them expensive to insure or treat.
But there are a lot of other policy issues involved in the health care arena, many of which are far less black-and-white.
Patent policy, for example, can be tricky: Those who develop treatments and cures need to have patent protection so that they can recoup the tremendous investments that must be made in order to develop and test such innovations. More than that, we want there to be a big financial incentive for companies and entrepreneurs to dedicate the resources needed for medical advancement. I’m sure that those working on an Ebola cure and vaccine now are very motivated by the desire to end the humanitarian crisis in Africa and the pandemic threat – but I also want them to be financially rewarded if they succeed. Some people are uncomfortable with the profit motive, but it is surely the best way to encourage advancement and innovation across the board.
Yet patent protections also ought not last forever – at some point, companies should be able to build on others’ research and produce similar drugs and treatments, which is critical to bringing down prices and making new medical advancements widely available to the public. How long, exactly, then should those patents last? That’s a matter of legitimate debate: It’s a balancing act of competing interests, and not entirely a matter of principle.
That’s why it’s strange to see groups that jump in with such force and attempt to demonize those who disagree with them on these grey issues.
Take this bizarre press release from the Society for Women's Health Research.
The issue at stake is the use of “biosimilars” – which is the name for the generic versions of a certain kind of drugs which are made from living cells taken from patients and transformed to fight some of our worst and most stubborn diseases, such as cancer and Alzheimer’s. The Affordable Care Act was supposed to facilitate the entrance of these new drugs into the US market. This is a version of the patent question discussed above: The drug makers who developed these elaborate new drugs understandably don’t want generics to enter the market and bring down their price, but without that competition, these drugs will remain staggeringly expensive, and therefore not reach all the people who need them.
Again, there are legitimate arguments on both sides, including the need to ensure the safety of biosimilars, as well as to make sure that patent protections remain adequate so that companies will continue to invest in new research.
But the Society for Women’s Health Research wants to turn this into a gender thing as they weigh in on trying to slow down the FDA’s approval of a pathway for the use of biosimilars. The press release laments how women are under-represented in clinical trials even though women often have different manifestations of illnesses and react differently to treatments.
I’m not sure of the data on women’s representation in clinical trials, but that’s certainly a fine point to make and to encourage the FDA to make sure that women are properly represented and studied when approving new drugs and treatments.
Yet it seems to have essentially nothing to do with the issue at hand, and whether or not the FDA ought to make it more difficult for biosimilars to be put into use by creating a complex new, separate naming system for those products. I live in Germany, and biosimilars have been on the market here in Europe since 2006 using the same scientific names as the biologic components they mimic. At this point, 8 years of data on the naming issue exists, and the EU has had no safety or efficacy problems.
It’s strange that these women’s groups would adopt such a stance, especially since it seems to be counter to the interest of the people they say they represent. In delaying a path forward on bringing biosimilars to market, they’re preventing women from having access to more affordable drugs, which are currently extremely expensive and highly specialized.
The Society for Women’s Health Research seems to think that throwing up a charge of sexism will help tilt the debate, even if there is nothing substantive, sexist, or even really pertinent in the charge. Let’s hope the FDA ignores the interference of charges like this, and instead focuses on making the important, difficult determinations of how to make new treatments and cures more accessible, without discouraging the creation of the next round of much needed innovation.