In 2014, Harvard University stated that prescription drugs are the 4th leading cause of death, yet pharmaceutical companies continue to hide behind their profits and promote their products as safe. Doctors and even their patients are willing to turn a blind eye to many of the adverse side effects of drugs, opting for the “bandaid” effect they provide instead of seeking alternative treatments and preventative methods.
A recent study published in the Journal of the American Medical Association and conducted by a team of researchers from Yale University studied the effectiveness of the FDA’s drug approval process. The team discovered that nearly one in three drugs that the FDA tests and approves ends up having safety issues.
Research Finds Serious Issues With FDA Drug Approval Process
In order to establish whether or not pharmaceutical drugs are safe for consumers, the FDA implements drug testing and clinical trials. These trials typically test fewer than 1,000 patients over a short timeframe, usually around six months or less. The Yale researchers suggested that safety issues could only truly be detected if more patients were studied over a longer period of time, speaking to the ineffectiveness of the FDA’s testing.
To identify how to effectively determine any safety issues with pharmaceutical drugs, the Yale researchers studied data on new drugs approved between 2001 and 2010, with follow up through 2017. Their findings proved that approximately 32% of new drugs approved by the FDA had notable safety issues.
A shocking 71 of the 222 drugs approved within this timeframe were withdrawn, had a “black box” warning regarding the side effects, or required a safety announcement to the public about newfound risks. This begs the question: Why are these drugs being approved in the first place if they warrant so many safety concerns?
“That is very rarely a drug withdrawal, but more commonly a black box warning, or drug safety communication issued by the FDA to let physicians and patients know that new safety information has been determined,” explained Associate Professor of Medicine and Public Health Dr. Joseph Ross, who led the research team.
The researchers also specified characteristics of pharmaceuticals that were more likely to pose a higher risk of safety issues to patients, including biologic therapies and drugs that were approved through the FDA’s accelerated approval pathway. The accelerated approval process often uses surrogate endpoints, which means that the researchers measured a factor other than survival, such as tumour size, to figure out whether the drugs should be approved.
“This [finding on surrogate endpoints] has the greatest relationship to policy today,” Ross further elaborated. “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.”
“While the administration pushes for less regulation and faster approvals, those decisions have consequences,” Ross stated. The Yale team’s previous studies exposed that the FDA approval process for drugs is much faster than that of other government organizations in Europe, which is interesting given the nature of the business in both countries. Prices of drugs are far higher in America than they are abroad, and Americans take a lot more drugs, meaning U.S. pharmaceutical companies make a lot more money.
The timing of this study is interesting too, as the FDA has been facing increased pressure lately to quicken the drug approval process. “It shows that there is the potential for compromising patient safety when drug evaluation is persistently sped up,” said Ross. “At the very least, the study should inform ongoing debate about premarket drug evaluation,” the researchers concluded.
Dr. Caleb Alexander, co-director of the Johns Hopkins Center for Drug Safety and Effectiveness, weighed in on the study, commending the researchers for their work. “It’s important to keep in mind that the post-approval safety issues cover the spectrum from relatively minor to serious,” Alexander said.
“A good next step would be to dig into the extremely serious safety problems, determine whether the FDA could have flagged them sooner and how they might have been missed,” he continued.
“All too often, patients and clinicians mistakenly view FDA approval as [an] indication that a product is fully safe and effective,” Alexander explained. “Nothing could be further from the truth. We learn tremendous amounts about a product only once it’s on the market and only after use among a broad population.”
Dr. Alexander makes a great point: Just because a drug is approved by the FDA, doesn’t mean it’s safe. In an ideal world, FDA approval would mean that the drug is entirely safe to use, but the reality is that the testing is not extensive enough to even determine the safety of the drug, let alone guarantee it.
Far too often, people place their doctors and health care practitioners on pedestals and fail to conduct their own research. Though I am not qualified to professionally advise anyone on their health, I certainly do not trust everything that my doctor recommends, which is largely because no doctor knows everything there is to know about health. It’s up to you to figure out your own health, not your doctor.
Though doctors can provide wonderful advice and can help immensely when diagnosing and treating illnesses, they can also drastically hinder your health. However, that’s not necessarily their fault, it’s often yours. The onus is on you to conduct your own research, get multiple professional opinions if need be, and ensure you are making informed decisions.
Further Proof of Misconduct at the FDA
In journalism, embargo refers to a “back-room deal” in which journalists and their sources agree not to publish an article prior to a specific date or time. The FDA goes one step further by implementing a “closely held embargo,” which gifts the organization complete control over all new FDA information privy to exposure for the American public.
The FDA’s use of the “close embargo” reveals that the institution likely wants to prevent reporters from leaking information. The biggest concern seems to be that, when officials begin giving the go-ahead for this special access, it makes it much easier for the agency to prevent stories they don’t like from being exposed.
For more than a decade, the FDA has shown a pattern of burying the details of misconduct. As a result, nobody ever finds out which data is bogus, which experiments are tainted, and which drugs might be on the market under false pretenses. The FDA has repeatedly hidden evidence of scientific fraud not just from the public, but also from its most trusted scientific advisers, even as they were deciding whether or not a new drug should be allowed on the market. Even a congressional panel investigating a case of fraud regarding a dangerous drug couldn’t get forthright answers. For an agency devoted to protecting the public from bogus medical science, the FDA seems to be spending an awful lot of effort protecting the perpetrators of bogus science from the public.
You can read more about that in the following CE article:
The FDA also works hand-in-hand with pharmaceutical companies, which you can read about in the following CE article:
To make matters worse, pharmaceutical companies also hold close ties to doctors, which you can learn about here:
To be clear, 128,000 people die every year in the U.S. from drugs prescribed to them, which is being done under the approval of the FDA and doctors. The reality is, drug companies make a lot of money from selling prescriptions, and so do those involved with them, including doctors.
At the end of the day, the medical industry is a booming business, one that thrives off sick people. These companies actually benefit when their drugs cause adverse effects, because they then have additional reasons to sell you even more drugs. The system is designed to help you in one way, and then disadvantage you in another. In essence, they want you healthy, but not too healthy, and until we educate ourselves and take control of our health, we will continue to perpetuate this cycle.