The aptly named Right to Try bill gives those with terminal illnesses the opportunity to use experimental treatments (potentially including medical cannabis) not previously approved by the government.
The bill was passed unanimously by the Senate last summer and was rubber-stamped by the House of Representatives in May 2018 in a vote of 250 to 169. Prior to the passing of the bill, patients were only able to apply to the US Food and Drug Administration for access to non-approved drugs, however, 99% of applicants were actually granted permission for these types of treatments.
It would certainly appear that there are a whole range of potential pro’s and con’s with the new law, while reaction has been mixed with advocacy groups including the American Cancer Society opposing the new piece of legislation.
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Medical Cannabis In line for Approval
While the bill focused on a wide variety of different treatments and medicines, it would appear that they may also include medical cannabis.
Indeed, one such trial that could potentially meet the new criteria is currently being conducted by the Multidisciplinary Association of Psychedelic Sciences (MAPS). In this trial, currently, in the second phase of the FDA approval process, MAPS are testing the effectiveness of medical cannabis in veterans with PTSD.
Existing Process for the Approval of New Treatments
For a new drug to be given FDA approval, it must go through many phases of clinical trials. This process will often result in years of testing and analysis.
In the first stage of analysis, the drug manufacturer must prove that the drug is safe for human consumption. These trials may involve as few as just 30 patients. At this stage, around 70% of drugs will move to the next phase of analysis. At this point, the manufacturer must ensure that the drug is an effective treatment for the specific condition it is being marketed for. Crucially, the drug must not have any severe or dangerous side effects.
Following this stage of the trials, only 33% of drugs will actually progress to the final phase of testing. During this final phase, the company must further test the drug on a considerably larger sample group of up to 3000 patients.
The bottom line is that if you are suffering from a potentially fatal illness, you really don’t have the time to wait for the FDA to give their approval to a new drug.
What has Changed with the Right to Try Act?
The new bill will give patients with life-threatening diseases the opportunity to bypass the FDA’s existing application process which has already allow for the “compassionate use” of experimental treatments not yet approved. Under the new proposals, patients who want access to so-called “investigational drugs” will now only require the permission of their physician as well as the drug manufacturer.
At present, there are currently 38 states that already have existing right-to-try laws, but by passing this bill at a federal level, patients from all across the country will now have access to these types of treatments. A recently passed law in Utah specifically addressed the right of terminally ill patients to try cannabis. However, because cannabis remains illegal at a federal level, a patient who had been granted the “right to try” was still in violation of federal law. The mind truly boggles at such injustices.
In passing this bill, patients who already had access to these treatments will no longer have any reason to fear a prosecution at Federal level. Also, other states that have not previously passed any right to try laws, will now provide patients with the access to these types of treatments. Moreover, the new bill protects physicians and pharmaceutical companies from the potential legal risks of allowing unapproved treatments.
With any new piece of legislation, there are plenty of issues and potential grey areas that still need to be addressed. Indeed, the new bill would seem to have left a lot of room for interpretation. Under the rather generalized wording of the federal bill, it is not clear what is considered to be a “life-threatening” condition while no specific illnesses are actually mentioned.
Instead, a patient deemed to be eligible is defined as having “Diseases or conditions where the likelihood of death is high unless the course of the disease is interrupted; and Diseases or conditions with potentially fatal outcomes, where the endpoint of clinical trial analysis is survival.”
While a stage 5 cancer sufferer would surely fall under that banner, PTSD, for example, may not, even if those suffering from it have some of the highest rates of suicide in the country.
Advocacy groups who were opposed to the bill also spoke out against the new law, suggesting that it would give terminally ill patients false hope since pharmaceutical companies are not even necessarily required to give terminally ill patients the treatments they might request. 38 of these groups addressed a letter to outgoing Speaker Paul Ryan and Democratic leader Nancy Pelosi, detailing their fears that removing the FDA from the current process would "likely do more harm than good".
Significantly, and disappointingly, the new bill does not dictate that pharma companies give access to unapproved drugs when patients request them. For most patients, the central issue has rarely been about getting FDA approval (with 99% of all requests granted) but rather the approval of the drug manufacturers themselves, who often deny the requests of those with terminal illnesses.
Unfortunately, the bill does not make any allowances for this issue and as is currently the case, drug manufacturers themselves will have the final say on any future requests.
Lengthy Application Process
The criteria of the new bill, though, is certainly lengthy. It states that the patient be in “a stage of a disease or condition, in which there is reasonable likelihood that death will occur within a matter of months,” and/or “a disease or condition that would result in significant irreversible morbidity that is likely to lead to severely premature death.”
It is also a prerequisite that patients must have exhausted all existing treatment options and must be unable to take part in the ongoing trials investigating the drug they are seeking access to.
Furthermore, consent from a qualified physician who does not stand to profit from the trial must be submitted.
The passing of the bill is, however, not without its critics. FDA commissioner Scott Gottlieb, a physician and a cancer survivor, had previously expressed his own concerns to Congress last year despite the agency accepting the proposed bill.
Gottlieb, when speaking in front of Congress, said: "The clinical trial process is crucial to the development of innovative new medical products that can improve or save patients' lives," Dr Gottlieb stated that it was vital that a balance remained in place which ensured giving patients the access to investigational treatments, while also ensuring new products are both safe and effective.
A similar program, “Expanded Access (Compassionate Use)” has been in effect since the 1970s. The FDA states on its website that it authorizes “over 99% of expanded access requests it receives.” Treatment, according to the site, may begin 30 days after it receives an investigational new drug application.
Most requests were actually approved within a few days and even in emergency situations, often immediately via telephone. That being the case, cynics might suggest that this piece of legislation is little more than an opportunistic attempt to garner some positive media coverage or, rather simply, Trump signing a new bill because, well, he just loves signing new pieces of legislation.
With so many grey areas and such a lengthy qualification process, one has to wonder at the actual legitimacy of the bill and whether it will actually serve to make the process easier for terminally ill patients. This remains to be seen.
A Positive Change?
During Trump’s typically grandiose signing ceremony, he stated that the new bill will save thousands of lives despite an apparent lack of evidence to quantify that statement.
Trump declared: “We will be saving — I don’t even want to say thousands, because I think it’s going to be much more - thousands and thousands, hundreds of thousands. We’re going to be saving tremendous numbers of lives”. While this kind of bluster hardly comes as a surprise, is it really a good thing to give such raised expectations to people who are suffering from terminal illnesses?
One can only hope that the law has been written for the benefit of the people and not the benefit of the current administration. Still, if medical cannabis is given more exposure and more opportunity to help those who need it most, the bill will at least provide one significant benefit to our society.