Terminally Ill Mainers Should Have Right-to-Try


There is a humanitarian movement growing momentum right now at the state level referred to as Right-to-Try.  This movement transcends partisan lines and is about recognizing the right of terminally ill patients and their physicians to choose the best course of action regarding the quality of their lives the direction of treatment.

While the need for drug safety is essential, the process for FDA approval in this country is wrought with bureaucracy, road blocks and red tape that erect insurmountable barriers and prohibit potentially life-saving drugs from ever making it to consumers.  The process to approve a new drug in this country can cost upwards of $1 billion before a single dose has even been delivered to a patient and is so lengthy that some patients are dying needlessly during the approval process.

Back in the 1980’s, an AIDS advocacy group by the name of ACT Up marched on FDA headquarters in Maryland to fight for the right of AIDS patients to gain access to experimental medication.  The FDA responded by instituting a so-called “compassionate-use” program to allow patients to gain access to unapproved drugs by filling out a form that takes upwards of 100 hours to complete and requires seven attachments once the drug has passed Phase I of the safety trial process.

To give you a picture of how difficult this process is, think about this: The American Cancer Society reports that in 2012, 1,638,910 patients were diagnosed with cancer and that about 577,190 died from cancer.  This does not account for the millions of patients diagnosed with other forms of terminal illnesses.  That same year, the FDA approved only 940 requests for experimental drug treatment under their “compassionate use” program.

While the FDA has stated that they are “committed to streamlining the process” and have made a plan to reduce the 100-hour form to a 45-minute form in response to the growing tide of Right-to-Try laws passing around the country, the American people have had enough.  At least fourteen states have enacted Right-to-Try legislation with wide bi-partisan margins so far and many other states are currently considering  legislation (including Maine).

Last year Legislative Document 180, sponsored by Representative Thomas Longstaff (D-Waterville), Senator Eric Brakey (R-Androscoggin) and nine other co-sponsors, was introduced and carried over to this year.  Although Maine Medical Association is neutral on the bill, Executive Vice President Gordon Smith stated “If you’ve been told that you have a terminal illness and that nothing more can be done, but a clinical trial is going on somewhere in the country with promising results, who amongst us would want to deny you a chance to try that?”

Senator Brakey pointed out that even if this bill is approved, the patient, doctor and pharmaceutical company would all have to agree to the course of treatment, which in no way guarantees an outcome.  The point of this legislation, and other bills like it around the country, is to give the patient a choice in their own destiny.

State Right-to-Try laws do not circumvent the FDA.  They establish that patients and physicians may seek to use drugs still in the experimental phase once they have passed the FDA’s first round of safety tests, and that they may negotiate with drug companies for access to potentially life-saving drugs.  If this movement gains enough traction at the state level, it is highly likely that the issue will make it all the way to Congress.

The President can stand behind his podium and deliver as many inspirational speeches on curing cancer and AIDs and other life-threatening illnesses as his heart desires, but the fact is this: until the entire FDA drug approval process has been put under the microscope and the bureaucracy is seriously addressed, terminally ill Americans will continue to die every day from illnesses that patients in other countries around the world are spared from by drugs that are held up for years by an insurmountable level of red tape and unnecessary protocols in America.

Terminally ill Americans should have the right to make their own decisions when it comes to their quality of life and treatment.  Being stripped of the ability to make your own decisions and steer your own destiny is an egregious affront to basic human rights.