Voices raise against the proposed deregulation of medicines approval process


The last position against the proposal to deregulate the approval of new medicines by the Food and Drug Administration, made by the US President Donald J. Trump during the recent speach at the Congress, has been published by the medical journal Nature.

According to the report, such a deregulation of the drug testing and approval processes will harm health everywhere, not just in the US. A move, argue the authors, that will also stifle innovation and waste patients’ and taxpayers’ money. The paperi s signed by Douglas Sipp, researcher at the RIKEN Center for Developmental Biology in Kobe, Japan, and visiting professor at Keio University School of Medicine and Global Research Institute, Tokyo, Christopher McCabe, an health economist at the University of Alberta, Edmonton, Canada, and John E. J. Rasko, head of the Department of Cell and Molecular Therapies at Royal Prince Alfred Hospital in Sydney, Australia.

Trump’s claims reinforce comments he made in January during a meeting with the pharmaceutical industry executives, where Mr. President said: “We’re going to be cutting regulations at a level that nobody’s ever seen before,” and added that up to 80 per cent of regulations could be slashed. But, according to the three authors of the report, relaxing the FDA’s regulatory system will subject patients to drugs that may be toxic.

For professor John Rasko, Trump’s argument is consistent with a history of neoliberal economic thinking that claims regulatory agencies are systematically biased towards excessive caution, and that the burden of testing a drug’s efficacy before it comes to market outweighs the benefits. “They argue that potentially harmful drugs can be identified quickly after they go on sale,” says professor Rasko, “and that the FDA runs an overly stringent system that withholds or delays safe and effective drugs from patients”.

The authors of the report also put into evidence the possible risks if reliable information on safety and efficacy would be be collected just after a drug is on sale, through observational studies or using biomarkers. Risk that can be resumed with the iconic example of thalidomide, that in the 1950s 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,” say the authors. The current regulatory system is working well, say Rasko and his colleagues.

Another potential pitfall is recognised by the authors in the fact that untested drugs might result of no benefit: ‘futile drugs’, according to profossor Rasko, who adds: “We only have to consider the multibillion-dollar industries in homeopathy and other pseudo-medicines to see this”. In January 2017, the FDA released a report identifying 22 products that were initially promising but disappointed in later-stage clinical trials: 14 for lack of efficacy, one for lack of safety, and seven for both reasons.

As per the new legislation introduced in 1962, marketed drugs have to also pass through well-controlled studies to test for therapeutic benefit, and not only to the demostration of safety required by the 1938 US Food, Drug, and Cosmetic Act. The more stringent requirements resulted in the withdrawal of more than 1,000 medical products with little or no evidence of efficacy. “The free market that existed before 1962 revealed no connection between a drug’s ability to turn a profit and its clinical usefulness”, says Rasko. The same is likely to be true of any future deregulated market, the experts warn in Nature, also adding that reliable information costs money and no one will invest in producing good quality evidence if they can make the same profit on a drug or technology without it. “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.”
Source: ScienceDirect
Journal Reference: Douglas Sipp, Christopher McCabe, John E. J. Rasko. Show drugs work before selling them. Nature, 2017; 543 (7644): 174 DOI: 10.1038/543174a



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