Flawed drug approval process puts patients’ safety at risk

I’m sick of hearing about Big Pharma putting profits before safety when it comes to prescription drugs. Nowhere is this more apparent than our drug approval processes… something that a recent study, reported in the Journal of the American Medical Association, highlights only too well.

Researchers at Brigham and Women’s Hospital in Boston uncovered shocking failures in safety testing when they examined data about 222 new drugs that had been passed as safe by America’s drug regulator, the Food and Drug Administration (FDA), between 2001 and 2010. The researchers found that nearly a third of the drugs were affected by a post-market ‘safety event’. This included three drugs being withdrawn because they were so dangerous, 61 given ‘boxed warnings’ – the FDA’s most serious alert before a drug is taken off the market, and means the drug may cause dangerous or even potentially fatal side effects – and 59 of the drugs having their safety questioned.

The drugs with potentially fatal side effects included SSRI (selective serotonin reuptake inhibitor) antidepressants, antipsychotics and a new class of drugs that treat auto-immune problems. Because trials conducted to evaluate a drug for approval typically enrol less than 1,000 patients, who are followed for six months or less, long-term safety risks may not be evident until the drugs are approved and used by a greater number of individuals for a longer period of time. In the current study, the average time from approval to an initial safety event was found to be 4.2 years.

What makes these results particularly shocking is that in each of these cases, doctors and patients would have assumed these drugs were safe because they had passed all the usual tests and checks for safety and effectiveness before being given the all-clear and a licence. The researchers involved in the study, concluded by saying: “The high frequency of post-market safety events highlights the need for continuous monitoring of the safety of novel therapeutics throughout their life cycle.”

Dr. Cassie Frank, a physician at Cambridge Health Alliance and an instructor in medicine at Harvard Medical School, spoke out about the safety issues of drugs fast-tracked through the FDA approval process following a study aptly titled: ‘Era Of Faster FDA Drug Approval Has Also Seen Increased Black-Box Warnings And Market Withdrawals’.

Dr Frank said: “The FDA is under constant pressure to rush new drugs through the pipeline to approval. In its hurry, the FDA is apparently failing to distinguish useful drugs from toxic ones, and more dangerous drugs are slipping through. By the time many drugs receive serious safety warnings, millions of Americans have already been exposed to their side effects, which can sometimes be fatal. As a doctor, I try to keep my patients safe by avoiding new drugs, when there are similar, older ones available”.

The bottom line is that safety needs to be put before profits, which means drugs should not be fast-tracked through the approval process. Rigorous testing needs to be undertaken, there needs to be full disclosure of the results including any safety concerns… and patients should stop being used as guinea pigs.

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References

JAMA, 2017; doi: 10.1001/jama.2017.5150

Health Affairs, 2014; 33 (8): 1453 DOI: 10.1377/hlthaff.2014.0122