With all that as background - I present...
An Op-Ed from the smartest man I know.... THE TRIAL OF TRIALS!
The right-to-try law, enacted in 31 of our states, asserts that any individual diagnosed with an "incurable disease" or "terminal illness" has the "right to try" any treatment "that has been deemed safe in Phase 1 testing, even though the agency [FDA] hasn't determined their effectiveness." However, the right-to-try does not mean that you really have ACCESS to these treatments. Rather, it is just that someone recognized your right to try them. It's as if you have been given a driver’s license and a car, but no keys. Despite this law, barriers to access continue. Patients remain burdened with the need to find a physician who agrees to prescribe the medicine/treatment, as well as a facility that will accept the risk of treating a patient in this manner. A drug company must provide these outrageously priced medicines, otherwise the patient must find a way to pay for them and all the additional components. Any person dealing with a significant disease process is well aware of and familiar with insurance denial of services!! All this combines to make "the-right-to-try" a necessary, but far from sufficient condition, to insure access to treatment when it is most needed.
What we really need, I think, is a duty-to-provide law - an idea that is very straightforward, but exceedingly difficult to implement in our current medical structure. The dysfunction of our current drug development and delivery system revolves around three issues: Money. Science. Death. Making money is the primary goal and money, i.e. the financing of the pharmaceutical industry and interrelationship between Big Pharma, the NIH, and the government agencies that are supposed to regulate them, is entirely tilted in the direction of making sure Pharma makes its money. Sadly, science is merely a tool Pharma uses in order to make its products. There is no commitment to science per se. There is no expectation or facility to move forward in a thorough, scientific manner in which data is collected, utilized and compared by ALL participants. Pharma, the NIH and the FDA do not really care about the individuals they abuse in order to make the science work for them. The people in clinical trials are mere statistical fodder. Death is the ultimate threat that Pharma, health insurance companies, etc. use to compel hapless patients to "volunteer" for their trials and enforce their regulations and rules in what is often an arcane process of their own design. Ironically, death is also often noted to be the end point of their studies.
The clinical trial system needs to be revamped so that patients are matched to treatment options that give them the best chance to survive their disease. Currently, when seeking initial care, though the system is not particularly user friendly and many needed options remain unavailable, like adjuvant care in early stage melanoma, patients do have better access to treatment. Treatment options change dramatically for patients who have been in the system for some time, having tried many prior therapies, yet are now STILL in desperate need of treatment. These souls ironically find doors to additional options firmly closed through bureaucratically created trial exclusions. Bottom line - terminal patients, no matter how they arrive at that point - should have access to the complete range of drugs - every drug in every phase - that may help them.
I call this "The Trial of Trials”! The mother of all trials, because it would allow a group of physicians, or a board of physicians, to provide access to any trial with the most potential to help the individual patient. The right to try means that, patients who are: Stage IV, have a terminal illness, have no other options, have arbitrary exclusions preventing their participation in existing trials, have tried other things, for whom nothing is working, and they are themselves willing to take the risk - should have any treatment made available to them. The duty-to-provide comes in through making sure that the financial access is provided by big Pharma and the insurance companies. Utilizing this idea, I think we could do a lot better in terms of providing patients for clinical trials and achieving valuable information about what works and what doesn’t more quickly by using supercomputers and other advanced techniques to ferret out the data. The data itself must be completely transparent, so that all of the people who are participating in the process, patients and the entire scientific community included, know exactly what has happened. This is something that’s been specifically avoided in the current system in order to maintain the proprietary nature of the data to protect the drugs and their financial reward for the pharmaceutical companies. The secretive nature of the current system impedes science and enhances human suffering. We can do better.
Although these are new approaches, they are not impossible, rather, they are imminently feasible benefiting patients, pharmaceutical companies, insurance payers, and ultimately science. Real. Live. Science.
~Brent Morris, MD
Science with a heart. Who knew? Thanks, B. - c