Wednesday, September 29, 2010

A 21st Century FDA

We have been learning a lot about the new generation of cancer drugs, some of which have the potential to bring us tantalizingly close to the holy grail of "cure". Many are in the controlled trial stages of FDA approval, where the treatments are scrutinized for their long term effects before hitting the open market. I ran across this NYT article last week, which weighs the pros and cons of the  approval process against the very real need for dying patients to receive proven treatments.

The story goes that two cousins happened to be diagnosed with invasive melanoma around the same time that a novel therapy was entering its final Phase III trial. Both cousins qualified for the trial, but only one was given the new treatment (the other was placed in the 'control' group with a less effective treatment). The first cousin's condition improved; the second succumbed to the disease.

It is complicated scenarios like this one that exposes the limitations of our outdated FDA approval process. The cumbersome path puts doctors in the awkward position of telling a patient "Sorry, you can't have this life-saving treatment" and more importantly puts patients lives in jeopardy. Worse, the current 'fast-track' process would limit approval to only the sickest patients, which gives drug companies an incentive to wait for long-term results in order to gain approval for a wider market.

The debate is full of complexity, including factors like cost effectiveness, quality vs. length of life, and insurance coverage. Obviously, we want a rigorous safety/efficacy test for emerging treatments so we don't poison our patients (Vioxx, Avandia, etc), but 21st century research deserves an equally responsive FDA. The "priority review voucher" law passed in 2007 has the potential to speed up the process, which helped accelerate approval of Coartem, an anti-malaria drug. The idea may soon expand to some cancer research as well, where a bill was recently introduced to include rare pediatric cancers in a very capacity. The expansion of Health Information Technology (HIT) and health reform's Patient Centered Outcome Research Institute must play crucial roles in the evolution of obtaining such research data, as well, though I'll leave these concepts for a future post.

Friday, September 24, 2010

Health Reform: Six-Month Anniversary

Yesterday marked the 6 month anniversary of the President signing health reform into law. How time flies...what did you do with your copy of the 2,700 page law to celebrate your anniversary? I took mine to a nice steak dinner...

Aside from the nostalgia, the 180-day mark is an critical juncture for the new law. Numerous provisions went into effect yesterday, and some of the worst abuses in the health insurance market are now a thing of the past. Here are some of the major ones:

-Young adults up to age 26 will be guaranteed to be able to stay on their parents insurance, helping over 2 million Americans gain coverage
-Children can no longer be denied insurance coverage because they have a pre-existing condition
-Ends the practice of rescissions, making it illegal for insurers to drop an individual who gets sick and 'unprofitable'
-Ends lifetime caps on insurance claims for all individuals, assuring individuals with a chronic disease or medical emergency the security to access vital services
-Requires new plans to offer proven preventive care (mammograms, vaccinations, blood pressure/cholesterol screenings, etc.) with NO cost sharing or co-pays, assuring access to these vital services even in economic hardship
-Allows women to directly access OBGYN services, without the need of a referral

Thursday, September 23, 2010



I would like to officially welcome you to my new blog, where I hope to explore a diverse range of topics in health, medicine, and policy. As a two-month old medical student, I couldn't think of a more important and exciting time to be entering the field. Health reform implementation, emerging medical discoveries, and the advancement of health care into the 21st century will fundamentally change how the American health care system operates. Whether you are a fellow medical student, policy wonk, or someone with any interest in health care topics, I hope that this blog can be a source of useful, thought-provoking material and commentary.