By Bryan A. Liang
Dear Mr. President:
Thanks for your focus on health care reform in the recently released budget. We, the patients and providers of America, appreciate the details on what you are proposing. But please be careful: We need to give the right medicine for lasting health care reform. Otherwise, we risk making the problem worse.
First, we note you haven't provided details on how and who will have health insurance. But beware: Access to health care in this country means access to health insurance. If you are not considering a universal mandate, we strongly encourage you to do three things to maximize insurance access to maximize our citizens' health.
One: Underwrite aggressive outreach for those eligible for public insurance. Twelve million uninsured Americans, including three-quarters of all uninsured children, are already eligible for public insurance. Get them enrolled, including use of "express lane" eligibility as we have done in California, where those registered for other public assistance programs are rapidly enrolled in public health insurance.
Two: Sign up the more than 5 million uninsured Americans who already qualify for health insurance coverage through their employers. Over twenty-five percent of eligible workers are not signed up, according to the Urban Institute, and using an "opt out" system that has been successful in getting low-income workers into 401(k) plans can be used to increase the number of insured.
Third: Extend tax credits to small businesses that need help particularly during these troubled economic times to help them offer their employees health insurance. This approach has been found by the California Healthcare Foundation to be an effective means of expanding insurance access, particularly for low-wage workers.
We note you are pinning some of your hopes on follow-on biologics - copies of large, complex protein injectible drugs - including a savings of more than $9 billion. But beware: Your own scientists at the FDA (Food and Drug Administration) indicate the current state of science makes prediction of adverse events of any copy virtually impossible to do.
This isn't trivial: Biologic copies made by cooperating companies resulted in an allergic immune reaction in patients that not only made them allergic to the drug, but also to their own body's form of the drug.
Clinical trials for any follow on forms, such as those mandated in Europe, should be performed, particularly because follow-on products cannot rely on safety data of the originally approved product.
Finally, we note that you are considering allowing drug importation into this country. But beware: Drugs from "safe" countries such as Canada are imported from suspect countries such as China and India. As you know, from toys to toothpaste, and from pet food to pharmaceuticals, the quality of drugs and other products imported from the Far East has killed and harmed those in this country, including the recent Heparin debacle.
Instead, focus on ensuring that vulnerable patients in this country get access to safe drugs regulated here. Expand no-cost/low-cost drug access programs for low-income individuals by building on private industry efforts such as the Partnership for Prescription Assistance, possibly including a corporate participation mandate in exchange for FDA new or abbreviated drug application review.