Archives for March 2015

Open Letter to Texas Legislature on “Right to Try” Bill SB 694

SB 694 is a potentially life-saving bill. It recognizes the right to life of our terminally ill citizens by allowing them the Right to Try drugs, devices and biological products that have not yet completed the FDA’s regulatory process. Patients who take advantage of this opportunity might not only benefit personally, but would provide valuable insight that could accelerate the development process by optimizing clinical trial design at an early stage. Thus, Right to Try patients might actually help bring life-saving drugs to others more quickly in the future. In the unfortunate case where the drug would cause harm, Right to Try patients will be forewarning developers about potential problems, thereby saving future patients from unanticipated side effects.

Opponents of Right to Try generally believe that allowing early access will discourage patients from entering clinical trials, thereby making it difficult to determine if the drugs, devices, or biological products are effective. First of all, only a small number of patients are needed for such trials. Secondly, only a small percentage of patients with a particular disease will qualify for these trials, which have many restrictions and require a uniform population. As Chair of an Institutional Review Board in Austin, Texas, which oversees the ethical conduct of such studies, and a former writer of such protocols, I review such items regularly.

The vast majority of terminally ill individuals will be denied investigational treatment via clinical trial; these are the most likely patients to exercise their Right to Try. Can we ethically keep them from receiving a treatment that could save their lives because their only hope is tied up in regulatory red tape?

Tufts University has found that the average drug, device, or biological product takes about 14 years to go from the lab bench to the market (1). Dying people can’t wait this long. During the AIDS epidemic, desperate activists hired black market chemists to manufacture the patented drugs under development by the pharmaceutical firms and distributed them throughout the AIDS community (2). I was an Upjohn scientist working on a treatment for AIDS; we had to wait for new patients to be diagnosed in order to test our products, which slowed the regulatory process further.

Had drug distribution occurred legally instead of underground, the pharmaceutical firms would have gained insight into how to design their clinical trials so that they could get to market faster. Instead, all of this treasure-trove of valuable information was lost. Without the Right to Try, other terminally ill patients may be forced to turn to the black market, possibly exposing themselves to sub-standard products and compromising future drug development efforts.

Our nation was founded on the concept of individual freedom and the right to life, liberty, and the pursuit of happiness. Right to Try legislation honors the choice of terminally ill individuals to fight for their lives. Many of us might not choose to take an investigational medication, but it certainly is our right, as Americans, to make that choice.

1. J.A. DiMasi, “New Drug Development in the United States from 1963 to 1999,” Clinical Pharmacology & Therapeutics 69: 286-296, 2001.

2. J. Kwitny, Acceptable Risks (New York, NY: Simon & Schuster, 1992).

Is Big Brother Shackling Our Free Press?

The Internet is the free press of the 21st century, giving us news from around the world at the speed of light. Knowledge is freely available on virtually any subject. Those of us who grew up without it can especially appreciate the quantum leap that the Internet provides.

However, there are still a few things that you can’t find on the Internet—like the Federal Communications Commission’s 332 page regulatory plan for it. The FCC claims its “net neutrality” plan will “protect the open Internet,” but when the plan is kept secret, one is naturally suspicious.

If these new regulations are so great, why not shout them from the rooftops? It’s human nature to boast about our proudest moments, while carefully hiding what won’t be well-received. If these regulations are so beneficial to us, why aren’t we, the people, allowed to see them? Knowledge is power, and the FCC clearly wants to keep power over us by hiding what it’s actually doing. Why would it do that unless it fears our reaction?

Maybe the FCC knows it’s interfering where it has no business doing so. Last year, the U.S. Court of Appeals for the D.C. Circuit told the FCC that it didn’t have authority over broadband—and why should it? The Internet isn’t a utility, it’s a network of hundreds of thousands of individuals. It’s the “people’s press” and regulators should leave well enough alone.