President Donald Trump signed the Right to Try Act of 2017 in May this year. Under the Act, patients can directly approach a drug manufacturing company for access to investigational medicines bypassing the authorization of the FDA.
We already have a similar program called the Expanded Access by the FDA, which grants terminally and seriously ill patients access to investigational devices and drugs since 1987. But the Right to Try Act has specific differences with the Expanded Access program. Under Right to Try, drug manufacturers won’t need the authorization of access from FDA and IRB, neither will they require specified content of informed consent.
The companies also don’t need to get the risks and benefits of treatment determined by the institutional review boards or FDA. But they do have to provide for investigational labeling and cannot promote or charge the patient for the drugs.
The Implications of the Right to Try Act
The Right to Try Act seems to be a benevolent policy aimed at helping seriously and terminally ill Americans. But if we evaluate it under the current socio-political environment, we can see the matter is not that simple!
For starters, the Right to Try Act can be used as a political technique to win votes. Time and again, we have seen the influence of politics on healthcare, which only makes the water murky. Surely we don’t want a tool that can save the lives of Americans to turn into a piece of political machinery.
Critics have also pointed out that the Act can influence drug companies to reduce their research and investments in patient safety and undermine the authority of the FDA. Scott Gottlieb, Commissioner of FDA, had expressed last year that the Act can devastate the drug approval process put in place by FDA. It can also lead to situations when the FDA cannot protect the interests and health of the public.
We could also develop a pure market approach to the distribution of drugs that sacrifices public safety and an evidence-based approach to treatment.
Do we need to open another Can of Worms?
Our healthcare system is already chaotic, and indeed we don’t want any more complications. Right to Try can be categorized with fundamental rights such as free speech and the right to choose, and it should remain that way. A person should have all the freedom to choose the way they want to live. But the problem is the authorities have not defined the Act in good words, which leads up to all sorts of confusion.
Does the Act mean that anyone could get their hands on anything? I don’t see a problem with that as long as it doesn’t cause any jeopardy to the patient, physician, or the care provider- it should not cause harm to any other person.
We are also not sure who is going to provide the care and in which way. For all we know, it can turn into a monopolized healthcare system where some chosen doctors or networks only provide the Right to Try; that would fail the mission of the Act!
The government is said to be taking some steps so that the Act doesn’t transform patients into guinea pigs of the lab and so that they can prevent the explosion of unjust treatment. We have the necessity of investigational labeling, which needs testing and evaluation of the drug for specifics like side effects and dosage.
Like every other policy, it can also get plagued with endless mandates giving rise to gaping loopholes in the system exploited by corporate entities. Is it really what we want?
The Genuine Right to Try
Every patient has the Right to Try, but it has to be individualized based on the patient and the physician's skills. The Act leaves room for patients to work with their physicians to get in touch with drug manufacturers dealing with investigational medicines. Right to Try should be based on patient needs and clinical judgments like every other medical procedure.
On its extreme, the Act can be compared to active euthanasia or the right to die on the patient's decision. Everybody has the right to live a life of dignity free from pain, and we must respect that. Everyone should have the right to live a painless life and be free to decide whether to undertake treatment or not as long as it doesn’t end up harming the patient. Sometimes we also have to accept that the treatment only provides short-term psychological or physical benefits to the patient without long-term benefits. We also have to take it if the patient wants to go through short-term pain and discomfort to get a positive outcome in the end.
We cannot have this right taken over by corporate and monopolistic interests. We always respect a patient’s rights, especially if they are terminally ill or dying from a disease. We need to empower the patients and the physicians because they are the only ones who can deliver a safe passage to Right to Try. Governments should facilitate the process with compliance, benchmarking, quality control feedback, and peer reviews so that public safety is not compromised. Also, pharmaceutical companies and insurance companies shouldn’t be allowed to reap profit out of the process.
Physicians should help out their patients with the Right to Try without feeling threatened by the mandates or the process, but under current circumstances, we have to wait for a little longer to play it out accordingly.
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