US state passes law allowing experimental drugs to be prescribed

The US state of Montana has become the first in the country to let patients try experimental drugs – even if they are not terminally ill.

The new law allows doctors to refer patients to licensed “experimental treatment centres”, where they can access drugs that have only passed phase 1 clinical trials – the earliest stage of testing in humans.

This goes far beyond existing federal law, which only allows terminally ill patients to access such drugs under the Right to Try Act, passed in 2017.

Montana already had a fairly permissive right to try law, which was originally designed to let terminally ill patients access treatments that hadn’t yet received full approval by the drug regulator.

In 2023, that law was expanded to include patients with any medical condition. The latest law goes even further, creating a formal system for clinics to offer these experimental treatments.

According to an article in MIT Technology Review, the new law was shaped and promoted by a group of longevity advocates – a mix of scientists and influencers who are focused on extending human life.

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Before new medicines reach the market, they usually go through several stages of testing. A phase 1 trial is the first step in human studies and is designed to find a safe dose and spot early side-effects. It typically involves a small group – between 20 and 100 people – and does not prove the drug works.

Only around 12% of drugs that enter phase 1 trials go on to gain full approval. Many fail due to safety issues or lack of effectiveness.

Montana’s new law allows access to these early-stage treatments with a doctor’s recommendation – even for patients who are not terminally ill. Clinics must be licensed as experimental treatment centres, and 2% of their profits must be used to help low-income patients access these therapies.

Supporters say it gives people more control over their own health and could help boost innovation in areas like cancer, neurodegenerative disease and age-related decline. There is also hope it could turn Montana into a destination for medical tourism, attracting biotech investment.

But critics warn that the move could put vulnerable patients at risk.

Drugs in phase 1 trials may be safe enough to test – but their long-term effects are still unknown, and they may not work. There are also concerns over whether insurers will cover complications, since the drugs are not approved. Legal protections for both patients and doctors remain unclear.

The situation in other countries

Elsewhere in the world, access to experimental drugs is more tightly controlled.

In the UK, experimental drugs are usually only available through formal clinical trials or special “compassionate use” requests – all subject to strict oversight by regulators like the Medicines and Healthcare products Regulatory Agency and the Health Research Authority.

The same applies across the EU, where compassionate use is typically limited to drugs in later stages of testing.

Japan has a similar system, called “expanded access clinical trials”, which also limits use to drugs already in phase 2 or beyond.

And in South America, some countries allow patients to keep receiving experimental drugs after trials end – but not to start them outside of a trial.

Montana’s decision marks a bold new approach in the continuing debate over patient rights. It raises big questions about safety, ethics, regulation and the role of government in balancing innovation with public health. It could end up being a model for other states – or a cautionary tale.

This article is republished from The Conversation, a nonprofit, independent news organization bringing you facts and trustworthy analysis to help you make sense of our complex world. It was written by: Dipa Kamdar, Kingston University

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Dipa Kamdar does not work for, consult, own shares in or receive funding from any company or organisation that would benefit from this article, and has disclosed no relevant affiliations beyond their academic appointment.