Phenylephrine and other related medications, like Sudafed PE, don’t work. A small example of the larger problem. This is nothing new in our privatized, deregulated US medical system. Most drugs don’t work, and most treatments by physicians don’t work.
Whether it’s stenting of those with stable heart disease, where 75% of stents are unneeded, or C-sections, a national tragedy, physicians are doing procedures for profit regardless of whether the procedure works or harms the patient. Like medical treatments, most drugs don’t work either. The FDA continues to review drugs that came on the market before its current safety and efficacy standards went into effect. That means a variety of older drugs can be sold without proof that they work, and without proof that they are safe. This is similar to what is happening at the FDA today, where drugs are approved without data about efficacy. As an example, half of cancer drugs don’t work or have not been tested to see if they work. Other drugs, for example from a company in Texas and led by a physician who attained his medical degree from the China Medical College, may be approved after the physicians commit fraud in attaining their pre-clinical and clinical data. The US now has a treatment for profit system that is euphemistically called healthcare.
The FDA has been reviewing the efficacy of older drugs for years and they’re really far behind, largely because of the agency’s other priorities – namely bringing new drugs to market. Aa a privatized institution that suffers from extreme regulatory capture, bringing drugs to market in support of the medical industry, physicians and drug companies, is their current priority. Before the 1930s, the FDA didn’t require safety studies of any drugs, simply requiring that the label accurately describe what’s on the bottle. In theory, things have changed – but read on, and you’ll see things haven’t changed that much.
Not until the sulfanilamide tragedy where more than 100 deaths occurred due to a drug formulation that included diethylene glycol, a toxic compound, that eventually led to the passage of the Food and Drug Act in 1938. This was an updated version of the original 1906 law. That was the first time drugs were required to be safe. Efficacy of drugs wasn’t required until the Kefauver-Harris Amendments in the 1962.
In the arcane world of medicine and drugs, the first mandatory general classification of drugs into prescription or nonprescription categories resulted from FDA regulations issued in 1944. Under the 1938 regulations, the only means for determining whether a drug was prescription-only was whether the manufacturer chose to label it accordingly. Contrary to what the naive might expect, manufacturers labeled many drugs that were safe for self-medication as prescription-only because they were able to make higher profits with this limitation. Only the technical sales reps for the drug companies, physicians, could sell the drug, and so higher prices could be demanded.
So up until the 1960s, drugs could be on the market, and they had to have some evidence that they’re safe, but they didn’t have to have any evidence that they work. Physicians could give damn near anything to their patients as long as the drug had evidence that it didn’t immediately kill or maim the person. As an example, thalidomide was a widely used drug in the late 1950s and early 1960s for the treatment of nausea in pregnant women. It became apparent in the 1960s that thalidomide treatment resulted in severe birth defects in thousands of children. At this point, FDA thought there needed to be some cleanup of drugs that had already been on the market and were thought to be safe but hadn’t didn’t have any evidence to be effective. That started in the 1970s.
But then the 1980s brought us Ronald Reagan, a shill for the wealthy and corporations. Privatization and deregulation were his mantra. His was ideology without evidence. Let business do business. Physicians and drug companies prospered by conducting their unfettered businesses. The FDA would be largely privatized with drug companies running their own clinical trials instead of third parties, and 75% of the FDA’s budget for drug approvals would come from the very companies they are supposed to regulate. Physicians at the FDA were paid-off by the drug companies to approve their drugs. Instead of calling this scam, “bribery,” the industry and it’s physicians would call it a “conflict of interest.” A very nice euphemism for bribery. Payoffs would continue until this day. Whether it’s dermatologists, ophthalmologists, family practice, or psychiatrists (who have a relatively high level of psychopathy), bribes to physicians are a huge problem. For many physicians, the practice of medicine means they are highly paid technical sales reps working for the drug companies who pay them. John Kapoor, an Indian who moved to the US to start an opioid company and became a billionaire, addicted and slaughtered thousands of Americans with the help of physicians he was paying-off. The narrative about these drug scams is frequently about how bad are pharma companies, but none of this happens without the corrupt technical salespeople for the drug companies – physicians.
Scientists have known for a long time that phenylephrine doesn’t work, but physicians at the FDA allowed it on the market for decades. They’ve had more important things to do. Making money by approving new drugs was the physician’s lead role. This is a big money maker for physicians, directly and indirectly. If the physicians don’t accept bribes from the drug companies, then physicians in practice won’t have drugs to sell to their patients. Remember, only physicians can sell prescription drugs. It’s their business model. That physician business model doesn’t include prevention and natural remedies, like diet and exercise – no money to be made there.
The Consumer Healthcare Products Association is furious about the physician’s decision to pull phenylephrine from the market. “Simply put, the burdens created from decreased choice and availability of these products would be placed directly onto consumers and an already-strained U.S. health care system,” according to the statement from Marcia D. Howard, the group’s vice president of regulatory and scientific affairs. Because it’s a consumer product, and not a prescription, there was no incentive for physicians to keep it on the market- this product, as a consumer product and not a prescription, is something physicians don’t sell. There are many other drugs on the market that don’t work, and only cause harm. Part of the Medicalization of America. But physicians and drug companies, not to mention insurance companies and hospitals, make billions selling these drugs that don’t work.
When the physician Scott Gottlieb, M.D. headed the FDA between 2017 and 2019, he said that he was in favor of using the Reagan playbook and having free market forces influence the prescription of drugs. He wanted to bring more drugs to the market and let the physicians and patients decide which ones were going to be used. If the drug made physicians much money, then the drug was a success. And if the drug didn’t immediately kill or maim patients, the drug was doubly successful. One drug that we know of was approved in 2016 by Janet Woodcock, M.D. at the FDA because Woodcock didn’t want the drug company going out of business if the drug wasn’t approved. Scientists had told her that the drug didn’t work, but she as a physician had the authority to approve the drug, and did so even though the drug didn’t work.
What started with Reagan, and accelerated under Trump, was a tsunami of drug approvals under Scott Gotleib, M.D. And many of the drugs were approved under the accelerated approval mechanism, where you needn’t show that the drug works. As long as the drug doesn’t kill or maim people immediately, it’s approved. Forget that most clinical trials are plagued by fraud and/or poor experimental design, many approved drugs have never had a clinical trial! The drug companies didn’t even have to bother to commit fraud for an approval. Many people, including physicians and those at drug companies are making much money selling drugs that don’t work and that are actually harmful. They know the drugs don’t work. But don’t worry, it’s good for the GDP and that’s what counts in the USA – just ask Ron DeSantis and Greg Abbott.
Stem Cells, Health, Technology 