They have a tough job, those government doctors, scientists, and bureaucrats who are charged with assessing the safety and effectiveness of proposed new medical products. As you know, they rely largely on studies presented by the applicants.
The Food and Drug Administration (FDA) has the power to not approve a new drug or product or even pull it off the market. Right now it is considering limiting or pulling GlaxoSmithKline’s (GSK) diabetes drug, Avandia, because of newly discovered data that it may have caused heart attack in some patients –- data mysteriously not shown in GSK’s own studies. If the drug is pulled it will cost GSK billions of dollars in lost revenue but, from the FDA’s point-of-view, it will be protecting the public. And, after all, there are safer diabetes drugs on the market as alternatives. Read more »
*This blog post was originally published at Andrew's Blog*
Today I participated in a conference call with Billy Tauzin, CEO of PhRMA (the Pharmaceutical Research and Manufacturers of America). The goal of the call was to let bloggers know about PhRMA’s position on healthcare reform. I counted at least 12 bloggers on the call, and I was the only physician. It pains me to see how few physicians participate in reform discussions and I’d like to get more of us involved.
The salient points, as I understood them, were:
1. PhRMA would like all Americans to have health insurance. They believe that Medicare Part D is a model health insurance program. They do not support a single payer system because it would likely attempt to cut costs by rationing care and denying options to patients. They don’t believe that insurance coverage mandates are a good idea unless the insurance is subsidized to the point of being affordable for all. They favor the current public (Medicare and Medicaid for the elderly, poor, or disabled) private blend of insurance, with roughly 50% of the population in each category.
2. PhRMA would like to support “precision medicine” where treatments are tailored more effectively to the individual. Mr. Tauzin suggested that some FDA-approved drugs are only effective for 30% of the patients in a given disease class. He’d like to see more research devoted to figuring out why that is, and supports comparative clinical effectiveness research insofar as it furthers this agenda.
3. PhRMA wants to preserve the unique features of the American healthcare system – to maintain our leadership in biomedical research and new drug development, and to protect the sacred shared decision-making between physicians and patients (to shield it from government intervention).
4. PhRMA wants to support IT infrastructure that would track patient medication compliance and let physicians know when/if they fill their prescriptions.
Now, the business case for all four of these positions is clear – the pharmaceutical industry benefits from having everyone able to afford medications (i.e. universal coverage), personalized medicine would reward the development of new and innovative drugs and establish a consumer base for many different treatments, protecting the doctor-patient relationship allows for off-label use of medications and a broader array of similar drugs, and IT infrastructure would help to increase drug purchase and compliance with treatment regimens, thus increasing overall sales.
However, the truth is that PhRMA’s positions on healthcare reform – beneficial as they are to themselves – also happen to be beneficial to patients. Increasing the number of insured improves access to medical care, personalized medicine could create more effective treatments with fewer failure rates and side effects, shared-decision making empowers patients to make the right decisions for their circumstances (with their physician’s guidance), and IT solutions that facilitate medication adherence, tracking, and reminder systems could improve patient health outcomes and keep them out of the hospital.
So, in a way pharmaceutical companies, advocacy groups, and physicians are fairly well aligned on many aspects of healthcare reform. Now if certain members of Big Pharma would please give up on those “me-too” drugs, stop creating more expensive medicines by simply combining two perfectly good ones into a new pill, stop hiding negative research studies, and refrain from aggressive direct-to-consumer marketing tactics, we might all really be on the same page.
Interesting factoids from call:
- Medicines only account for 10% of total healthcare costs (unchanged from the 1960s), but they “feel” like a larger cost driver because health insurance doesn’t cover their cost as completely as they do hospital fees.
- There are about 750 new cancer drugs in the research pipeline.
- Half of all prescriptions remain unfilled.
- Physicians provide 30 billion dollars a year in free care.
- The United States conducts 70% of the world’s research in biomedicines.
Please check out Billy Tauzin’s amazing story of triumph over cancer.