New Study Shows That The FDA Drug Testing Process Fails Miserably

United States consumers have always been told that their outrageously high cost of prescription drugs is due to the lengthy, expensive and vital regiment of testing that the Food and Drug Administration requires to insure the safety of new drugs before their release in the US market. Drug manufacturers have always used these rigid, and in their propaganda, burdensomely expensive, regulations as their rationale for prices that are unaffordable to most people, and to keep foreign-made drugs they allege as unsafe due to lessor regulations in other countries from becoming available for purchase in the US.

Is all this just a big pile of lies and deceit, used merely as a pretext to justify such outrageous prices? Well, a new study released this week from researchers at the Department of Medicine at Brigham and Women's Hospital has found that, in effect, such FDA testing requirements may be practically worthless, as they determined that 31% of 222 drugs approved between 2001 and 2010, have had significant post-release safety concerns, including 61 that received what are called “boxed warnings” which are issued when new, life-threatening risks are identified, 59 that had elicited safety communications, which are issued when new, serious risks are identified, and three that were found to have safety concerns serious enough to have been totally withdrawn from the market. There was overlap among drugs receiving these concerns, as the total number of drugs receiving them was 71 of the 222.

The study, “Postmarket Safety Events Among Novel Therapeutics Approved by the US Food and Drug Administration Between 2001 and 2010”, published on May 9, 2017 in the Journal of the American Medical Association should give pause to everyone who takes prescription drugs relying on what for generations has been described as a stringent and successful process for the assurance of drug safety. In addition, as to those people who face food or rent versus medication decisions and who have been through or are approaching bankruptcy due to the outlandish cost of health care and medication in the United States, especially as compared to other countries around the world, the question has to be asked “WHY”, when the justification for a significant portion of those costs, attributed to the necessities of achieving drug safety, now appears to be little more than myth.

Lead research Nicholas Downing, MD, was quoted as stating that their findings mean that “patients are exposed to these medications before the risks become clear”.

The study also revealed that postmarked safety events were significantly more frequent among drugs receiving accelerated approval and those with near-deadline approval, meaning that a frequent “rush to market” for many drugs produced less than adequate testing and approvals that perhaps were unwarranted.

The 71 flagged drugs included top-selling drugs used to treat depression, arthritis, infections and blood clots. Reported safety issues included risks for serious skin reactions, liver damage, cancer and even death.

According to Dr. Joseph Ross, the study's lead author and Associate Professor of Medicine and Public Health at Yale University, the study revealed that once put into distribution to the public, many drugs produced side effects that were not seen during the FDA review process.

This raises significant issues for consumers across the country, and raises concerns not just for their health and well-being, but begs the question What in the Hell are we paying for when after years and years of expensive testing new drugs that are released in the marketplace are NOT SAFE?

The Wright Stuff