Sunday, February 1, 2015

Precision medicine, trade policy and the cost of drugs: benefiting people or profit for business?

In a recent (January 29, 2015) New York Times Op-Ed, Mayo Clinic anesthesiologist Michael Joyner writes that “’Moonshot’ medicine will let us down”. What Dr. Joyner is referring to is what is now most commonly called, particularly in the large academic medical centers that have bought into it in a big way, “precision medicine” or occasionally “personalized medicine”. This is the concept that, by knowing your individual genetics, medicine can devise targeted treatments for diseases (most of the emphasis is on cancer) that will work for you, but maybe not for other people. Maybe the treatment most commonly used for the disease isn’t right for you; this would find it out.

It is a very attractive concept, and one that has clearly gained traction since the first complete sequencing of the human genome in 2003, moving from a science fiction idea to a mainstream investment by many institutions. As Dr. Joyner notes, “President Obama’s new budget is expected to include hundreds of millions of dollars for so-called precision medicine. The initiative, which he introduced last week in his State of the Union address, has bipartisan support and is a bright spot in the otherwise tight funding environment for medical research.” That is the “moonshot” part – hundreds of millions of dollars. When other funding for research is stagnant or being cut. Because it sounds cool, exciting, really like something cutting edge, a step toward the day when disease will no longer bedevil the human race. However, Dr. Joyner adds: “Unfortunately, precision medicine is unlikely to make most of us healthier.” Bummer.

Maybe he is wrong. Maybe the medical centers investing heavily in precision medicine, and the federal government which will fund it (of course, the “investing heavily” is not unrelated to the “hundreds of millions in federal funding) are right. “Star Trek” here we come! But let us look at the evidence that Dr. Joyner presents. He notes that most common diseases that affect people, even those with clear association with families and thus likely genetics, such as Type II diabetes, are not the result of a single or even a few genes that could be targeted if they could be fixed. There are multiple genetic characteristics that impact whether someone has a tendency to get DM2. Moreover, whether it actually occurs is a result of a complex interplay between those genetic risks and actual behaviors such as diet and exercise. He argues that it is obesity, caused by behaviors but certainly abetted by social changes in our lives, jobs, and easily availability of cheap high-calorie food leading to obesity, that has been the major culprit, given that DM2 (and obesity) is an epidemic of the last half-century, therefore not a result of any genetic change. In addition, even when there are genetic factors for differences between people in their response to treatment, it turns out that these do not explain most of the difference (“missing heritability”), such as in response to the anticoagulant warfarin (a so-far failed effort to use precision medicine to choose treatment). Treatment of chronic diseases like cystic fibrosis by genetic intervention has been unsuccessful, and cancer (like microbes) mutates a lot faster than genetically normal cells.

Joyner also raises the very real concern that people’s behaviors will change in ways that work against their health when they learn their genetic risk. Some people will use the information that they are at lower genetic risk to adopt risky behaviors. This has been described in many areas, everything from people with negative cardiac tests continuing to smoke and overeat to men who have had negative HIV tests and circumcision to decrease their risk of spreading HIV increasing their unsafe sex practices. He also notes that the opposite test result, finding yourself to be at greater genetic risk, can also lead to unsafe practices because you figure you’re doomed anyway. In addition, he notes that there are some people (“worriers”), “…who might embark on a course of excessive tests and biopsies ‘just in case.’ In a medical system already marked by the overuse of diagnostic tests and procedures, this could lead to even more wasteful spending.”

The main message here is only in part that “precision medicine” is something whose time has not yet come and may or may not ever come. More important thing is that, despite this, the government is planning to invest hundreds of millions of dollars in it. Most important is that money is not being spent on implementing treatments for conditions that we do know how to treat. People who are poor or uninsured cannot access many already available – and often incredibly expensive – treatments for diseases like cancer (see my piece “Squeezing the needy: a truly flawed financing system for healthcare”, March 2, 2013) or hepatitis C or many neurologic diseases. “Precision medicine” treatments are certainly going to be even more costly. In addition, we do not spend the necessary money to address the social determinants of health--housing and food and warmth and education--that make more of a difference in health than all of health care.

Indeed, we invest large amounts of money, public as well as private, in programs that effectively make our health worse. Sometimes this is in subsidies to major environmental polluters (BP, anyone? How about fracking and the Keystone XL pipeline?), and sometimes it is more direct, when we actually invest government funds in making treatments more expensive and less accessible to people, albeit to the benefit of the drug companies? Noted economist Joseph Stiglitz takes this on in another recent Times Op-Ed, “Don’t trade away our health” (January 30, 2015). He describes how the US Trade Representative, who negotiates trade agreements “supposedly on behalf of the American people”, is in fact consistently working on behalf of big corporations. In the case of the Trans-Pacific Partnership, this will mean increased obstacles to lower-cost generic drugs by making competition more difficult.Just the availability of generics drives prices down: In generics-friendly India, for example, Gilead Sciences, which makes an effective hepatitis-C drug, recently announced that it would sell the drug for a little more than 1 percent of the $84,000 it charges here.”  This competition should be encouraged; it is the essence of capitalism. But our trade representative is representing big business, not people.

Of course, high drug costs are already a reality. On January 28, 2015, the Times’ Business Section previewed a study coming out in the New England Journal of Medicine from Harvard. “Study finds HIV drugs priced out of reach”. Much of the great advance made against HIV in the last few decades come from effective and more tolerable drug regimens. Atripla, for example, is a once-daily combination of 3 drugs (2 made by Gilead, one by Merck), that is extremely effective. But this study shows that the “flexibility” available to insurers under ACA will mean that folks with worse insurance (usually poorer people) will have to pay $3,000 a year more for Atripla than those with better policies. Again, the poor pay more.

Precision medicine may sound good, and certainly cool, and sexy. It may even benefit some people, if at very high cost, in the future. But right now, today, there are lots of conditions we know how to treat and lots of people who are not getting that treatment because they don’t have the money, are not desirable, have diseases not in the most preferred “product lines”. And we are spending federal money on making some of the drugs that we have that we know are effective less available.

Despite publicity about or funding for precision medicine or any other “new idea”, the fatal flaw is that our health system is not about improving our health, it is about profit. This is intolerable.

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