Right To Try and Saving Lives

 by James Veltmeyer, MD | Mar 05, 2019

 Although it has drawn far less public attention than the battle over illegal immigration, trade wars, North Korea or Supreme Court appointments, the Trump Administration is quietly initiating a revolution in health care. This Administration’s more decentralized approach to this issue will result in better care at lower costs and many more lives saved.

The reforms at the Veterans’ Administration are one example. Our great veterans are now being given a choice in doctors, allowing them to escape the maddening and inefficient bureaucracy of the VA to receive care from private physicians on a timely basis.

Likewise, the Department of Health and Human Services under President Trump is granting waiver after waiver to the states to give Medicaid patients more choices in health care. Association health insurance is being encouraged by executive order and the direct primary care model is looked on more favorably.

Perhaps one of the most exciting developments is the President’s signature on the Right to Try Act of 2018.

Formally known as the “Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2018,” this legislation amended existing federal law to permit certain unapproved, experimental drugs to be administered to terminally ill patients who have exhausted all other approved treatment options and are unable to participate in clinical drug trials. These drugs are not snake oil cures; they all must have completed an FDA-approved Phase I clinical trial and be in an active clinical trial as well as being in ongoing active development or production.

For years prior to the passage of the “Right to Try” Act, thousands of Americans have been forced to go abroad in search of possible life-saving treatments for terminal illnesses. The Food and Drug Administration – which was created for the purpose of ensuring that only safe drugs and medications enter the U.S. market –has too often been a burdensome obstacle in the way of fast-tracking life-saving medications. Like most government bureaucracies, the FDA has constructed a byzantine complex of regulations and compliance costs that result in long delays in drug approval and massively increased research costs in health care.

The foot-dragging on the part of the FDA became even more serious after 1962, as a result of the Kefauver-Harris legislation which dramatically increased the agency’s power. Enacted as a result of some unfortunate tragedies associated mainly with two drugs — including Thalidomide — these amendments led to a steep drop in the number of new drugs entering the market each year. The reason for the decline was due to the hugely expensive and restrictive regulations imposed on the pharmaceutical companies, causing research and development costs to soar. Thanks to FDA regulations over the last half-century, the United States fell behind the rest of the world in gaining access to important medications. It is estimated that if we were to calculate the number of premature deaths caused by drug delays, deaths due to loss of innovation, and deaths due to the FDA’s suppression of life-saving information, nearly half of the people who have died since 1962 had their lives shortened by eleven years.

Just the application process alone can take up to 100 hours, according to the FDA’s own estimates. If you are dying, 100 hours is a lifetime and you can’t wait!

As a physician who faces life and death decisions every day and whose wife is battling Stage IV Breast Cancer, I am angered by the FDA’s policies. It is one thing to prevent dangerous, adulterated drugs from flooding the American market, it is something else to prolong the approval process to the point that terminally ill patients actually die or are forced to go overseas where these drugs have existed safely for years. And, no one can say that the FDA has had a perfect record in protecting American consumers. In 1999, the agency approved a drug called Vioxx which wound up killing 60,000 people and triggered 140,000 heart attacks. The agency has also looked the other way as cheap generics manufactured in highly-questionable drug factories in China and India are permitted to enter the U.S. market.

With the “Right to Try” legislation, however, Congress and the Trump Administration are making an end-run around the red-tape bureaucrats at the FDA. We know of some of our fellow citizens who have already benefited.

Bloomberg News reported in January that a California man diagnosed with glioblastoma, a type of brain cancer that is usually fatal within two years, had been granted access to a therapy called Gliovac, produced by a Belgian pharmaceutical. This individual is one of approximately two dozen or so people currently taking Gliovac. He is paying nothing for the drug and there have been no side effects in the trial so far.

In another case, Matt Bellina – a former Navy pilot who suffers from ALS ( also known as “Lou Gehrig’s Disease” ) and one of the individuals the law was named for – has been receiving the experimental therapy NurOwn which is in phase III clinical trials.

Prior to “Right to Try,” the process for obtaining experimental drugs was so challenging that fewer than 1,000 people sought and received federal approval to take such drugs in 2013. That’s what led to similar legislation being enacted in forty states over the last several years, with bipartisan support. President Trump’s signature to the federal law is a crowning achievement in what has been a long overdue gift to the terminally ill.

Today, we stand at the leading edge of the most dramatic and exciting technological and research breakthroughs in the history of science and medicine.

Immunotherapies and other promising treatments are offering a realistic vision –in the near future —  of a world without cancer, Alzheimer’s, Parkinson’s and other dreaded diseases. It’s time for Big Government to get out of the way and let the scientists, researchers, and innovators do what they do best – find ways to make us live longer, healthier, and happier lives.

Dr. James Veltmeyer is a prominent La Jolla physician voted “Top Doctor” in San Diego County in 2012, 2014, 2016 and 2017.  Dr. Veltmeyer can be reached at dr.jamesveltmeyer@yahoo.com

 

Dr. James Veltmeyer is Chief of the Department of Family Medicine at Sharp Grossmont Hospital in La Mesa, California. His views are his own and do not necessarily reflect the views of Sharp Grossmont Hospital or its staff. Dr. Veltmeyer can be reached at cadoc06@yahoo.com