How weak regulation and strong special interests weaken our health
Doctors at Memorial Sloan-Kettering Cancer Center recently took a stand. The hospital will no longer purchase Zaltrap, a superfluous drug that, they contend, is harder to administer and delivers no better treatment than the existing alternative—despite being twice as expensive.
But Sloan-Kettering is just a single hospital making a principled stand. Medicare is still obligated by law to cover every drug that the Federal Drug Administration approves at the exorbitant prices dictated by manufacturers. Contrary to common sense, Medicare is prohibited from negotiating with pharmaceutical companies over the drugs it purchases under Part D of the Medicare Modernization Act, signed by President Bush in 2003.
There ought to be bipartisan outcry at the perverse practice of putting profits before patients. Republicans especially ought to decry provisions like Part D and excessive patent protections that distort the cherished free market. Unfortunately, our current government acts as a wholly owned subsidiary of corporations more often than a ruling body concerned for its constituents.
Neither the Republicans nor Democrats would dare to push back against a health services industry that will spend $187 million in campaign contributions in 2012 alone. Instead, health legislation is often crafted with extensive interference from insurance and pharmaceutical special interest groups. Congress slashes funding and weakens the mandate of the agencies charged with securing Americans from the possible excesses of corporations.
The FDA is underfunded, understaffed, and starved of power and only nominally regulates the lucrative drug market as a result. Drugs can be rubber-stamped by the FDA even if test results are faked, advances are minimal, or costs are excessive. Antithetical to the spirit of medical progress, the strict patent protections for prescription drugs enforced by the FDA encourage drug inventors to stall innovation in hope of prolonged, hefty profits.
Current patents protect drugs for 20 years after they are invented. Once patent protections expire, generic manufacturers can produce the drugs. That is, unless name-brand pharmaceutical companies pay generic manufacturers not to produce any drugs in order to continue to pass off ridiculously high prices to consumers. These companies shamelessly exploit a legal loophole mandating the FDA to freeze approval for 30 months when a generic drug is challenged in court in order to delay much cheaper generics. A provision intentioned to protect the health of patients is perverted simply to increase revenues, patients’ welfare be damned.
Companies also skirt patent expirations by producing drugs with very slight chemical modifications that add very little to actual patient health in order to preserve the enormous profits associated with patent protection. The FDA does little to stop this dubious practice.
In fact, the FDA is one of the worst examples of a “revolving door” in which personnel freely move between regulatory and industry positions. Executives who move through the revolving door promote poor regulation in the hope of capturing a high-salaried industry job. As a result of such a flimsy separation, the FDA has been captured by the very industry it was designed to regulate.
Such a revolving door leads to examples like Michael R. Taylor, current Deputy Commissioner for Foods at the FDA and former vice president for public policy at Monsanto, a multinational biotechnology corporation known for its promotion of genetically modified foods. Under food safety czar Taylor, the FDA has maintained its policy of exempting GMOs, as foods “generally recognized as safe,” from premarket approval. This comes despite growing scientific evidence linking GMO consumption with cancer and other illnesses.
But now Taylor is trusted to ensure the safety of the nation’s food.
FDA inefficacy is but a particular instance of an endemic culture of corruption that has infected nearly every governmental agency inside the Beltway. The only way to protect American citizens from unreliable and unsafe foods and drugs is to legislate sweeping reforms of the system that reclaim the FDA for the people from industry.
But the money that promotes terrible regulation at the FDA is the very same money that is funneled torrentially into the coffers of congressional candidates on both sides of the aisle. Real reform can’t happen until the system making our representatives beholden to drug companies for reelection campaigns is drastically changed. Otherwise, the industries expected to deliver health and sustenance might be doing just the opposite.
Idrees Kahloon ’16 lives in Weld Hall. His column appears on alternate Tuesdays.