The FDA permits data scams

Yoho MD, Robert. Butchered by “Healthcare”: What to Do About Doctors, Big Pharma, and Corrupt Government Ruining Your Health and Medical Care (pp. 55-57). Inverness Press. Kindle Edition. The FDA permits data scams. Researchers from the Yale University School of Medicine looked at trials between 2005 and 2012. They found that the FDA based many drug approvals on studies that used various forms of data cheating. Donald Light and Ben Goldacre separately confirmed this story. They wrote: ✪ Thirty-seven percent of the drugs had only a single study. ✪ Forty-five percent of the trials for drug approval used study endpoints such as blood sugar or cholesterol (surrogate markers) rather than hard endpoints such as death or another clinical finding. ✪ Nearly a third 0f all the studies made a comparison with an older drug. When two drugs are found to be about the same, the companies usually claim some obscure advantage for the recent one. This games the approval process and allows the industry to market expensive “me-too” medications that offer no benefit over the older ones. ✪ To make a drug look good, the companies often exclude people who are more likely to have adverse outcomes. Other times, they use people who are more likely to have problems, which can make an older drug look bad. ✪ When companies do nonrandomized trials on unrepresentative populations, they can create almost any result. ✪ Experiments are sometimes run that lack a comparator or control arm. This is called a single-arm trial and has little validity. ✪ Some experimenters do approval studies that are not randomized, controlled, and double blinded, which is the current standard of proof. Some allow studies that are easily unblinded. ✪ To show benefit, sometimes doses of a test drug are used that are too high for routine clinical use. These studies last long enough to show benefits but are kept short enough to conceal adverse reactions. ✪ The other way this is played is to use high doses of the comparison drug. This creates side effects that make the new drug look great by comparison. ✪ Another often-used ploy is inaccurate measurement and improper reporting of the number needed to treat and number needed to harm. ✪ Huge trials are sometimes stopped early because results appear beneficial or harmful at that point. This prevents full evaluation and complete reporting. Physicians should be trained to detect these commonplace forms of deceit when reading medical journals. I spotted them as I learned more. In a 2012 BMJ editorial analysis, Donald Light and Joel Lexchin wrote that, of all the new products developed in the past 50 years, 85-90 percent produced many harms but few benefits. Most of them are me-too drugs used for established markets. They are not improvements. These medications are 80 percent of the US increase in drug spending.

Yoho MD, Robert. Butchered by “Healthcare”: What to Do About Doctors, Big Pharma, and Corrupt Government Ruining Your Health and Medical Care (pp. 55-57). Inverness Press. Kindle Edition.

 

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