Are alternative drugs being ignored because of the substantial economic opportunities that come from vaccine manufacturers?

BY AMANDA WILLIAMS

One of The Food and Drug Administration’s responsibilities is to ensure the safety, efficacy, and security of drugs to protect public health. Still, over time, approved drugs have caused an epidemic of harmful side effects even when properly prescribed. An article from Harvard University shows 53,000 excess hospitalizations and about 2,400 excess deaths occur in the United States every week.

Is the FDA somehow dropping the ball? Research indicates that the FDA has a history of misconduct, fraud, and conflicts of interest and is dismissed as the revolving door of money, perks, and opportunities.

In 1984, Monsanto employee Margaret Miller was asked to submit a report on recombinant bovine growth hormone (rBGH) to the FDA to determine its safety. Miller later left Monsanto to work at the FDA, where she was responsible for deciding whether or not to approve the same report she worked on while at Monsanto. Five years later, MD Samuel Epstein warned the FDA commissioner about health dangers, including cancers caused by drinking milk from hormone-treated cows but was ignored. Since 1993 the FDA has received criticism for using rGBH despite being banned in both EU and Canada.

Former FDA employees have made efforts to shed light on FDA practices and shady behaviour. In an interview with PBS, MD Raymond Wesley, who was once considered for the FDA commissioner position, reflected on the process and stated, “It was clear that people like myself who care about drug safety had become too controversial. They didn’t want someone who was going to focus on toxicity and effects.”

User fees paid by the industry through the Prescription Drug User Fee Act (PDUFA) are used to speed up the review and approval process to meet target dates for drug manufacturers. They have been the primary source of the FDA since 1992 and have climbed from 35% to 71%, while sections that monitor safety, ensure manufacturing standards, and check for accuracy have shrunk, according to the Boston Globe.

Ron Kavanagh, a former drug reviewer from 1998-2008, says that target dates for PDUFA do not leave enough time to review submissions. Kavanagh told Project on Government Oversight (POGO), “Reviewers were told not to worry about studying all the material.”

In 2009, nine members from the FDA wrote an anonymous letter to Barack Obama to shed light and clean up the corrupt FDA. The letter revealed that medical devices get approved against unanimous opinions of scientific staff. Former Chief Scientist Frank Torti Sr. of the FDA responded by sending out an email to employees to silence any other potential whistle-blowers.

More than half of the experts hired to advise the government on the safety and effectiveness of medicine have financial ties to pharmaceutical industries. The Center for Responsible Politics shows that between 2009-2011 prescription drugs, biotechnology, and medical device companies spent more than $700 million lobbying Congress and the Obama administration.

In an analysis taken from the Open Payments website, findings indicate that between 2013 to 2016, 93% of funds for personal payments to the 16 top-earning advisers came from the same drug makers they previously reviewed. Many retired FDA officials later found lucrative jobs at the same companies they were regulating. While federal law prohibits the FDA from using experts with a financial conflict of interest, FDA had waived these restrictions over 800 times in only two years.

In 2015, Professor Charles Seife and his students found evidence of fraud in medical trials, including fake x-ray reports, forged retinal scans, phony lab tests, and secretly amputated limbs. Out of 600 clinical trials investigated, 100 cases clearly stated which study, drug, and pharmaceutical companies were involved. The FDA covered up details in the other 500 cases.

The FDA knows about dozens of scientific papers floating around whose data is questionable. One of them is the RECORD-4 Study that was declared “unreliable” but is still available on the Lancet without mentioning any objectionable practices. Even as wrongful death lawsuits multiplied, the FDA failed to notify the public.

The FDA hides drug-related misconduct by using the “Orange Box,” a clinical listing of drugs in the United States. Once fraud was announced, the FDA did not change their drug ratings, claiming that they do not want to confuse the public by telling us about problems that do not pose immediate risks.

Today, government health officials and their experts ignore the widespread advocacy for Ivermectin as a cure for COVID-19. While the government is aware of trials that clearly show its effectiveness, health officials believe they are insufficient. Are alternative drugs being ignored because of the substantial economic opportunities that come from vaccine manufacturers?

MD Marcia Angell, former editor-in-chief of the New England Journal of Medicine, says, “It’s time to take the Food and Drug Administration back from the drug companies.”

What do you think?