On May 30, 2018, Donald Trump signed the Right to Try Act, which created a uniform, federal system for terminally ill patients to access experimental treatments not yet approved by the Food & Drugs Administration (FDA).
This Right to Try Act has enabled many terminally ill patients to find alternative, experimental treatments to try to prolong their lives. Before this law, the FDA only offered the possibility of accessing them in clinical trials, without the patient knowing if he or she would really receive the treatment, or if he or she would belong to the control group to which a simple placebo would be administered.
For decades, the FDA has been the target of criticism from many affected people, who saw how health and pharmaceutical regulation deprived them of their freedom when it came to seeking their own healthcare.
Two films have been key in exposing the drama that patients and their families had to go through when confronting the FDA before the Right to Try Act went into effect. Lorenzo’s Oil (1992), starring Nick Nolte and Susan Sarandon, and more recently, Dallas Buyers Club (2010), for which Matthew McConaughey and Jared Leto each won an Oscar for their performances.
Both based on real events, Lorenzo’s Oil tells the story of the struggle against the health and political establishment of the parents of Lorenzo Odone, a boy affected by a rare disease called adrenoleukodystrophy (ALD). Meanwhile, Dallas Buyers Club focuses on the story of Ron Woodroof, a Dallas cowboy who was diagnosed with HIV during the early 1980s.
Augusto and Michaela Odone, an American family of Italian descent, saw their lives turned upside down when their five-year-old son Lorenzo was diagnosed with ALD. This is a disease that causes the body to produce an excessive amount of fat, damaging the brain and generating sensory and motor problems and affecting speech. With no known cure, it leads to a quick and painful death.
These parents saw that no doctor or hospital was able to offer a solution for their child, since researching such a rare disease did not compensate for the high costs that had to be faced. Furthermore, they realized that the associations of those affected by this strange disease were only concerned with accessing government subsidies for palliative care, not with finding a cure.
Rebelling against this injustice, their parents dedicated themselves to research on their own, quitting their jobs and spending long hours in the library, becoming true specialists on this disease. Thanks to their personal effort and the help of other individuals and private companies, they discovered that by synthesizing drop by drop a simple olive oil, a radical improvement of the patient is achieved.
Sadly in real life, Lorenzo, who had been given a life expectancy of just eight more years, died the day after his 30th birthday in 2013, surviving his own mother, who died in 2000.
The oil treatment invented by his father is only effective in the early stages of the disease and is still not approved by the FDA. Augusto Odone received an honorary doctorate from the University of Stirling, and made these moving remarks.
“I am a father. And my involvement in the disease called ‘Adrenoleukodystrophy’ does not come, therefore, from love for science but from love for my son Lorenzo and my desire to help him. He should have died when he was 13… and today he is 24. Of course, he has good days and bad days, he is bedridden and can only eat through a tube… but his mind is still there. He likes to have music played for him, to be read to… and he always knows who is around him.”
Dallas Buyers Club
In 1985 Ron Woodroof is diagnosed with HIV and told that he only has one month to live. Despised by his family and friends, he begins treatment with AZT, which is the only antiretroviral approved by the FDA for use with humans.
Because Woodroof suspects that he is part of a control group that is only being given a placebo, he decides to act on his own. First, by bribing a hospital cleaner to smuggle him the AZT, and then, in view of the worsening he perceives, he travels to Mexico where an American doctor with a revoked license explains to him that the AZT is poisonous and prescribes him vitamin supplements, Zalcitabine and T-peptide, which are not approved by the FDA.
When he sees that his quality of life has improved enormously, he decides to set up a buyers’ club in Dallas, where all HIV patients will be able to purchase these medications, thus creating a business that will allow him to finance his own treatment. Despite the fact that the official AZT treatment is giving more problems than solutions, and that Woodroof’s alternative treatment is proving to be very effective and beneficial for all its users, the FDA embarks on a crusade against Woodroof, subjecting him to raids and fines.
In 1987, the FDA changes its regulations, and all drugs that are not approved become illegal. Woodroof then files a lawsuit against the FDA, trying to get the judge to allow him to continue taking the treatments that were having such a good effect on him. We must remember that his initial life expectancy was one month and he had already been living two years with a substantial improvement in his quality of life.
Although the judge understands that the drugs he is taking are not toxic, he can only admonish the FDA for bullying against Woodroof and his clients, but he does not have the legal capacity to allow him to continue his treatment since the legislation prevents him from doing so.
In 1992, the year Lorenzo’s Oil was released, Ron Woodroof died, seven years after his one-month diagnosis. Two decades later, the Dallas Buyers Club was created and in 2018 the Right to Try Act was passed, which would have allowed the judge to guarantee his right to health, which had previously been undermined by the FDA.
Right to Try Act and the cultural impact of films
Only a strong and informed civil society can assert its rights in the face of government abuses. Watching these films has certainly helped the public understand the importance of measures such as the Right to Try Act passed by Donald Trump, especially now that, at the time of COVID-19 and the race against time for the development of his vaccine, the debate on government regulations on drug development is back on the table.
Operation Warp Speed, also sponsored by Donald Trump, has gone in this same vein as the Right to Try Act to lighten the bureaucracy and hyper-regulation of the pharmaceutical sector, in order to substantially cut the time needed for the development and approval of new medicines and treatments in extreme or emergency cases.
Although the debate on the safety of drugs and vaccines is not without controversy, the truth is that these new measures have brought great hope to many sick people whose conditions mean they cannot afford to wait for the FDA’s approval.