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Changing the way drugs are approved in the UK should not jeopardize safety


Michelle Durbano

Last month, plans were announced to change the way new drugs are evaluated. National Institute for Health and Care Excellence (NICE).. The agency determines the drugs available for national health services in England and Wales. Some suggestions are clearly welcome, such as having companies submit to NICE in plain English, but others need attention, such as accepting less rigorous exams as supporting evidence.

According to NICE, this change aims to accelerate the introduction of new drugs and support innovation by pharmaceutical companies. We also want to encourage pharmaceutical companies to launch their products in the UK first. Britain is currently leaving the European Union. Faster access to medicines sounds like a good thing that isn’t alloyed, but the US Food and Drug Administration’s (FDA) experience when trying to achieve the same is a cautionary story.

The FDA does a different job than the NICE. It’s about assessing whether a new drug is safe, effective, and manufactured properly. There are equivalent agencies in the UK that do that. It is the Medicines and Healthcare Products Regulatory Agency. NICE evaluates medicines on the fourth criterion. It is whether the benefits of treatment are worth the price. Nonetheless, both the FDA and NICE act as a brake that keeps pharmaceutical companies from selling their favorite drugs.

The FDA has been criticized for allowing more and more products to be reviewed under fast-track schemes that require less stringent evidence. Companies with expedited approval should conduct randomized controlled trials after the product launch to show that it is really effective and stop selling the drug if the trials show that it does not work. It has become.

However, the system is not always working as intended.Often in the enterprise Post-approval exams will be postponed for years.. The drug may not be withdrawn, even if the trial is negative. In a study of anticancer drugs being followed in the United States, One-third was still in use years after it turned out to be non-functional..

The FDA’s recent controversy was in June over the approval of aducanumab to treat Alzheimer’s disease. Scientific Advisory Board advised against movement, Trigger resignation and inquiry.

The fact that the FDA has these problems does not mean that NICE will proceed in the same way.But of NICE Consultation documentsCalling the public for feedback on a proposal gives the impression that there is little need for attention. The website says the move is to enable “faster patient access to valuable and innovative treatments.” Few would say that they want to slow down access to the drug. This suggests that consultation is like a PR practice.

Another proposed change is to accept less rigorous forms of supporting evidence: non-randomized controlled trials and “real-world evidence.” In fact, the latter means listening to reports from people with relevant medical conditions about the experience of using the drug or how much you want to receive it.

Such testimony can be prejudiced, as it is often organized by manufacturer-funded patient advocacy charities. Seven of the ten such charities that have contributed to NICE’s reputation have recently received money from the drug manufacturers under review. 2019 study..

NICE is already doing a difficult job, balancing patient needs with the budget for the National Health Service without much upset for the big pharmaceutical companies. Now there are politicians who want to play another role in showing that Brexit is successful. We hope that this important medical institution will be able to walk the tightrope successfully.

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Changing the way drugs are approved in the UK should not jeopardize safety

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