“Right to Try” is a relatively new way to express our fundamental human “right to life” and the “right to health.” There has been universal recognition of these rights for many decades but rather than advancing the access to new safe, innovative options for chronic diseases consistent with those rights, a bill is stalled in the House which could set us back if passed in its current form.
The purpose of Right to Try laws are to expand access to potentially lifesaving treatments years before patients would normally be able to access them. Last fall, an enlightened and extraordinary humanitarian bill, the Right to Try Act of 2017 was passed 94-1 by the Senate. But, simply put, now there is a problem: A version of the act, with continued bipartisan support, was expected to similarly be passed by the House but it has run into resistance from FDA. FDA is ok with it for terminal illnesses but wants to take access to not-yet-approved options for life-threatening diseases out of the final bill.
We get it. A key element of FDA’s mission is to ensure we aren’t harmed by unproven drugs and devices — but the process of approvals for new drugs and devices that address terminal and life-threatening diseases is far longer than the prognosis that these patients will typically face. FDA Commissioner Scott Gottlieb is understandably concerned about putting patients in harm’s way. Gottlieb told lawmakers at an Oct. 3, 2017, hearing that the Senate's right-to-try bill contained flawed criteria, which he said could expose more people unnecessarily to potentially dangerous side effects. He called for changes to the bill.
He points to the FDA’s expanded access program for terminally ill patients, also referred to as “compassionate use” as a solution that is working. The trouble is that since 2010, the FDA has approved an average of about 1,200 applications per year for compassionate use. That is a rounding error of the 1 million patients per year that die of terminal illnesses — not to mention the tens of millions who suffer from life-threatening diseases like congestive heart failure (6 million) Alzheimer’s Disease (4 million), and certain autoimmune diseases like diabetes, lupus, and scleroderma. Add in cancer and opioid addiction, the need for expanded access at scale becomes paramount.
And while we have many approved drugs and devices that do extend life they don’t necessarily improve the quality of life for the severely ill nor reverse the course of those with terminal diseases. In point of fact, it is often said the side effects of many drugs make the cure worse than the disease. More on that in a moment; first, here is a snapshot of the history that supports Right to Try Laws.
Our rights to health and life are universally agreed upon: Internationally, this was first articulated in the 1946 Constitution of the World Health Organization (WHO). In the preamble it states that “the enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being without distinction of race, religion, political belief, economic or social condition.” The right to life and health was covered from more than one angle in the United Nations’ 1948 Universal Declaration of Human Rights: “Everyone has the right to life (emphasis added), liberty and security of person.” (article 3) and "Everyone has the right to a standard of living adequate for the health and well-being of himself and of his family including food, clothing, housing and medical care…." (article 25). The right to health was again recognized as a human right in the 1966 International Covenant on Economic, Social and Cultural Rights. There are even more declarations and treaties to cite but you get the point.
The DOJ and FDA have not interfered with Right to Try laws as they are protected by the 10th Amendment of the U.S. Constitution, which states, “The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” Because the Constitution does not grant the federal government any authority with regards to regulation of food and drugs, the Tenth Amendment explicitly leaves that power with the individual states.
This is important not just to the patients who have these well-established, deep-rooted rights to their health and life itself. There are approximately 75 million patients in our country that suffer from two or more chronic diseases, many of which are terminal or life-threatening illnesses. This segment of our population is estimated to cost the U.S. healthcare system $2 trillion of our $3.2 trillion annual healthcare spend. Adult stem cell therapy and other novel but similarly safe options are the most likely solution to the vexing problem of people living longer but not better — but costing taxpayers ever increasing sums.
Providing some hope, Gottlieb said the FDA in recent weeks has "made an effort to make ourselves available to Congress in trying to work for a solution that can work on behalf of patients." He went on to say, "There's a lot of people interested in this, both in the patient community, and obviously, in the administration and also on Capitol Hill… I think we'll get there," he said.
Rather than the FDA stand down or stand up to the Senate version, we advocate for Commissioner Gottlieb to recognize our internationally accepted human rights to life and health by partnering with the bipartisan supporters of the Senate’s version of the Right to Try bill.
Richard S. Bernstein, CEO of Richard S. Bernstein & Associates, Inc., West Palm Beach, is an insurance advisor for high net worth business leaders, families, businesses, municipalities, and charitable organizations. An insurance advisor to many of America’s wealthiest families, he is a writer, trusted local and national media resource and expert speaker on estate planning and health insurance. Visit his website at www.rbernstein.com. To read more of his reports — Click Here Now.
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