Australian face exposure to toxic drugs under law changes: experts

A view of a laboratory of the pharmaceutical company Chemie Gruenenthal, manufacturer of the drug Thalidomide. File: April 21, 1969 Source: AP

An Australian professor is warning the deregulation of the US Food and Drug Administration's drug approval process could expose patients to toxic drugs.

An Australian expert is warning that deregulation of America's drug approval process, a move flagged by US President Donald Trump, would see a flood of unproven and even harmful new drugs enter the market.

In a speech to Congress last week Mr Trump said the US Food and Drug Administration's drug approval process was "too slow and burdensome" and he promised to "slash the restraints".

His comments reinforced earlier remarks he made to pharmaceutical industry executives in January.

Professor John Rasko from the University of Sydney and Royal Prince Alfred Hospital says Mr Trump's "extreme" view on the issue could potentially expose patients to toxic drugs.

"They argue that potentially harmful drugs can be identified quickly after they go on sale," says Professor Rasko.

But this approach has been proven to be harmful, he says.

In an editorial published in medical journal Nature, Prof Rasko, US policy researcher Douglas Sipp and health economist Christopher McCabe point to the iconic example of thalidomide - a 1950s drug prescribed for nausea during pregnancy - that caused more than 10,000 birth defects worldwide.

"Even in the past dozen years, initially promising drugs, such as torcetrapib (for reducing cholesterol and heart-disease risk) and semagacestat (for improving cognition in people with Alzheimer's disease), were found to cause harm only after they had been tested in large, mandatory trials -- effects that were not seen in the smaller trials," they wrote.

Another problem, they argue, is the sale of safe but 'useless' drugs.

"Untested drugs can be reasonably safe but provide no benefit," said Prof Rasko.

"These ineffective pills and potions are a massive waste of money and provide false hope to millions of people worldwide. What's more, for progressive diseases such as cancer or multiple sclerosis, if a doctor were to prescribe a drug that didn't work, she'd be giving a disease a free pass," Prof Rasko said.

The three experts say patients and doctors must have access to reliable information to make educated and ethical choices.

"Rigorous clinical studies are still the best way to learn whether a drug works, and regulation is essential to ensure that these studies are conducted," they wrote.

The Australian Therapeutic Goods Administration was contacted by AAP and a spokesperson said they would not he commenting on "conjecture" and "speculation".

Source AAP

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