Real science is never settled, and anyone who has certainty on such things is not qualified to discuss it.
Safe and effective?
Everything that can be corrupt always is. Except of course, elections.
2023-08-10. Emphasis added.
The 21st Century Cures Act (Cures Act), signed into law in December 2016, was created to help accelerate medical product development and “bring new innovations and advances” to patients quicker and more efficiently. Yet some researchers suggest the law is being used to bypass the once rigorous and evidenced-based standards for new drug approvals, allowing novel drugs to flood the market without adequate data and public transparency.
According to a research letter published on August 8 in the Journal of the American Medical Association Network Open (JAMA), 24 of the 37 drugs approved in 2022 by the U.S. Food and Drug Administration (FDA) were based on a single study, with only four drugs having more than three studies to support their approval.
“I’m not surprised,” David Gortler, a pharmacologist, pharmacist, and FDA reform advocate at the Ethics and Public Policy Center, told The Epoch Times in an email. As a former senior advisor to the FDA commissioner, Mr. Gortler said he saw the agency grant expedited approval to a medication called aducanumab—used to treat Alzheimer’s disease “based on zero positive studies.”
“They did the same with other monoclonal antibodies for Alzheimer’s disease,” Mr. Gortler said.
According to the research letter, most of the 413 studies evaluating the 37 drugs approved in 2022 were sponsored by the industry—meaning they were manufactured, funded, and analyzed by the company producing the product, seeking FDA approval, and standing to benefit financially from the drug.
FDA Is Not Enforcing Reporting Requirements for Clinical Trials
...Perhaps even more concerning is that these organizations consisting of pharmaceutical companies, universities, and medical centers failed to meet a single deadline. Those considered “habitual violators” didn’t report results in 67 percent of their trials and were an average of 268 days late disclosing data past their original deadlines....
The FDA and NIH did not respond to requests for comment at the time of press.
WIND: a single study funded by Big Pharma with massive financial incentive for approval. What could go wrong? The financial conflict of interest is groteseque.
Aas in politics, the gears of the machine are plain to see here: the FDA is a wholly captive agency of Big Pharma, with revolving doors to/fro.
It should be illegal for Big Pharma to have any role in studying their own drugs—require funding but total hands-off and total blinding until study carried out to conclusion. Testing should forbid any financial relationship between researchers and pharma. But it’s the opposite: juicy incentives to find benefits, huge incentive to design studies in a biased way. And if it does not work out, the study is halted and results never published; try again, designing the study to avoid the issues of failure.
The public (you and me) are guinea pigs that will suffer harm and die to winnow out the drugs that shouild never have been approved. We will pay for that privilege, all so billions in profits can be made for Big Pharma.
Harming people for profit
The drug industry is shameless and vicious. They have and will kill people for profit.
The article I was alerted to in JAMA Network Open is a letter from Stanford professor Robert Kaplan about how the FDA drug-approval process has been streamlined to the point of almost non-existence. Which, of course, is exactly what the pharmaceutical industry that has captured the various regulatory bodies (mainly the FDA) in Washington wants.
According to my source
Stanford researcher Robert Kaplan finds that 65% of the drugs approved by the FDA in 2022 were done so based on a single study. Kaplan also found that the majority of the 413 total studies related to the 37 new drugs were sponsored by the pharmaceutical industry, with only 55% of the studies evaluating the drugs in a randomized controlled trial. Much of the decline of regulatory thoroughness can be traced to the 2016 passes of the 21st Century Cures Act, say researchers at the National Center for Health Research. The act, they write, “allows anecdotal/unreliable and easily manipulated sources of health data to be used to approve new drugs.”
When you consider this new laxity in the approval process in light of a study from six years ago showing a third of approved drugs end up with safety issues, it becomes extremely worrisome.
Nearly one out of every three drugs approved by the Food and Drug Administration (FDA) have a new safety issue detected in the years after approval, says a Yale-led study.
Other than in my earliest days of practice (before I was scarred by bad patient outcomes), I have never been one to jump on and start prescribing (or taking) the new drugs. Now I’ll be even less eager to use them. You should be, too.