STUDY: AT LEAST 30% OF FDA--APPROVED DRUGS HAVE DANGEROUS OR DEADLY SIDE EFFECTS

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• You must have watched those TV commercials with happy, smiling people telling how their symptoms of some relatively minor, non-life-threatening ailment have subsided thanks to a particular medication, while a voice in the background rushes the obligatory reading of side effects. 
• Those side effects are invariably many times worse than the illness they claim to alleviate, and as that voice tells you, they may even be fatal.  
• There is both a comical and a tragic aspect to those commercials, because although they are hilariously funny, you know these commercials influence desperate, trusting, vulnerable patients, and so the pharmaceutical industry continues to rake in billions in profits.   
• Some doctors are complicit in the prescription of suspect pharmaceuticals because they have been influenced by benefits from the pharmaceutical industry.  
• The current opioid crisis that is killing thousands of addicted people has its origin in the medical office, when doctors prescribe these extremely addictive medications for sometimes minor and temporary cases of pain. 
• A landmark review (July 26, 2000) in the Journal of American Medical Association, by Dr. Barbara Starfield, found that, every year in the US, FDA approved drugs kill 106,000 people. Extrapolating to a decade, that would be a million deaths.
• Under Trump, the FDA is urged to speed up the drug-approval process. It’s good for business. For patients, it’s a disaster on top of the already existing disaster.

Recently it has been revealed that up to 30% of FDA-approved drugs have serious side effects.   The new study is what intelligence agencies would call a limited hangout, which is a public admission of part of a problem or scandal that is, in fact, much bigger. The huge scandal, in this case, is the routine death-by-medicine numbers every year—which is ignored by the press and the government.

 

A new study, published in the Journal of American Medical Association, examined all 222 drugs approved by the FDA between 2001 and 2010.

 

The finding? Years after approval, roughly a third of the medicines were then labeled with warnings about serious adverse effects; and some of those warnings indicated life-threatening complications, such as cancer, liver damage.  Consumption of many of them can result in death.

 

The Washington Post reports: “Among the drugs with added warnings [years after the drugs were approved, as safe, for public use]: Humira, used for arthritis and some other illnesses; Abilify, used for depression and other mental illness; and Pradaxa, a blood thinner. The withdrawn drugs [taken off the market] and the reason: Bextra, an anti-inflammatory medicine, heart problems; Raptiva, a psoriasis drug, rare nervous system illness; and Zelnorm, a bowel illness drug, heart problems.”

 

A pharma trade-group spokeswoman told the Post: “Even with rigorous clinical studies and regulatory review it may be impossible to detect certain safety signals until several years after approval, once the medicine is in broader use.”

 

In particular, drugs used to treat mental health issues such as depression, and those that had been rushed through the approval process, were more likely to have safety issues down the line.

 
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The study is particularly timely, with the government currently calling on the FDA to speed up the drug approval process. 

"It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up," said lead researcher Joseph Ross from Yale University. 

 

The research looked into 222 therapeutic drugs approved by the FDA between 2001 and 2010, and found that 32 percent of them - almost one third - were affected by a postmarket safety event.

 

The majority of pivotal trials used to make approval decisions lasted six months or less, which makes it difficult to identify long-term safety issues.

 

There's also the fact that drugs are sometimes rushed through the process if they're deemed urgent enough - and the latest study found that these drugs in particular are more likely to have higher rates of safety interventions.

 

One of the reasons for this, Ross told Sydney Lupkin from Kaiser Health News, is that drugs being rushed through often rely on something called 'surrogate endpoints' - which means researchers measure outcomes that are related to therapeutic benefit, such as changes in tumour size, instead of patient survival directly.

 

"This [finding on surrogate endpoints] has the greatest relationship to policy today," Ross told Lupkin. "In the 21st Century Cures Act, there's a push to have the FDA move to further support the use of surrogate markers … [but] they're more likely to have concerns in the post-market setting."

 

The FDA has said that they're reviewing the latest study, and the researchers hope it will be used to influence drug approval policy in future.

 

"This analysis highlights that there is residual uncertainty about the risks and benefits of new drugs at the time of approval, thereby demonstrating the need for all stakeholders engaged in the drug development process to commit to the generation of clinically useful information both before and after regulatory approval," said Downing.

Source

The research has been published in the Journal of the American Medical Association.     http://jamanetwork.com/journals/jama/article-abstract/2625319
Other sources

http://www.sciencealert.com/nearly-1-in-3-drugs-have-safety-issues-even-after-fda-approval

https://www.infowars.com/new-study-fda-approved-drugs-are-dangerous/

 

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