The following open letter to FDA Commissioner, Dr. Scott Gottlieb, calling for immediate investigations into many facets of the clinical trials for Gardasil sponsored by Merck was emailed today. Dear Dr. Gottlieb: This open letter, written on behalf of medical consumers around the world, is an urgent request for you to investigate potential malfeasance perpetrated by Merck during their clinical trials of Gardasil, the human papillomavirus vaccine that the FDA approved in June 2006. A new book, The HPV Vaccine on Trial: Seeking Justice for a Generation Betrayed, by Holland, Rosenberg, and Iorio, outlines at least four areas requiring the FDA’s urgent attention.
The largest, most expensive antidepressant efficacy study involving over 4,000 initial participants ended in 2006. The purported intention of the study was to provide real-life results instead of the shorter clinical trial results that are done to get antidepressant drugs approved. But the results were not clear regarding antidepressants' true efficacy compared to clinical trials. Safety was not a consideration, just efficacy at reducing depression. A new study has recently re-analyzed this massive STAR*D (Sequenced Treatment Alternatives to Relieve Depression) study funded by the National Institute of Mental Health (NIMH) and found evidence that there was obfuscation, intended or unintended, that made antidepressant efficacy look better than it actually is. Earlier this year, 2018, a published paper, Do outcomes of clinical trials resemble those “real world” patients? A reanalysis of the STAR*D antidepressant data, demystified this study and provided a clearer picture of real-world antidepressant efficacy. As one psychiatrist skeptical of antidepressants, Dr. Joanna Moncrieff, reported after reviewing the 2018 reanalysis of the STAR*D paper: "[The 2018 reanalysis was done] 14 years after the [STAR*D] study was finished. What in the world were the main findings of the world's largest ever antidepressant trial doing being presented now in a little-known journal? The answer may lie in the fact that they show how miserably poor the results of standard medical treatment for depression really are! … people taking antidepressants do not do very well. In fact, given that for the vast majority of people depression is a naturally remitting condition, it is difficult to believe that people treated with antidepressants do any better than people who are offered no treatment at all."
The HPV vaccine was just approved for adults, despite Merck’s concerning research data. The FDA made its determination in the face of substantial evidence of the dangers of the HPV vaccine and the existence of safer alternatives. For women who have already been exposed to certain strains of the HPV virus, vaccination can actually increase the risk of precancerous lesions by 44.6%. That’s right: if you are already infected with HPV, getting vaccinated could increase your risk of getting cancer. To put this in perspective, 79 million Americans are thought to be infected with HPV, and about 14 million are newly infected each year, making HPV the most common sexually transmitted infection. Often there are no symptoms. The CDC says that “HPV is so common that almost every person who is sexually active will get HPV at some time in their life.” A large, government-backed push to get more people vaccinated for HPV could actually increase many people’s risk of getting cancer.
The high cost of prescription drugs has recently made headlines, evidenced by price-gouging schemes that cause drug prices to skyrocket 5,000% (as in the case with the infamous Martin Shkreli and the drug Daraprim) or Mylan’s more recent price hike on EpiPen’s to over $600 for a two-pack. What’s often left out of these stories, however, is how the federal government helped the pharmaceutical industry have this kind of power over drug pricing by allowing the industry to take advantage of publicly-funded research. Universities get government money to do research, patent any novel inventions that arise from that research, and sell the patents to the pharmaceutical industry. Consumers are forced to pay monopoly prices for drugs that their tax money helped develop. We see pharmaceutical companies turning supplements into drugs, selling them at exorbitant prices, and removing the supplement versions. Our tax dollars fund their blockbuster drugs, and with those profits they are taking our supplements away. This cannot be allowed to stand.
Last year, the FDA announced the approval of Endari, a drug for sickle cell disease. Endari is an oral powder comprised of L-glutamine, an important amino acid currently available as a supplement. The drug company, Emmaus Medical, Inc., filed an investigational new drug (IND) application—demonstrating their investigation of L-glutamine as a drug. If a drug company begins investigating a nutrient for use in a drug before a supplement company files an NDI notification on that nutrient, the company can ask the FDA to have supplement version removed from the market, leaving consumers with no other option than the drug. Currently, a 120-pill bottle of L-glutamine can be purchased for less than $10; a year’s worth of Endari will reportedly cost consumers more than $40,000. CBD oil faces a similar threat.
The first U.S. study of the effect on people of exposure to a hormone-disrupting chemical widely used in food packaging showed that levels the Food and Drug Administration deems “safe” can alter insulin response, a key marker for diabetes. The groundbreaking study, published in the Journal of the Endocrine Society, administered low doses of bisphenol A, or BPA, to 16 people, then tested their insulin production in response to glucose, commonly called blood sugar. When insulin and blood glucose levels were compared to the same measurements taken without exposure to BPA, researchers found that BPA significantly changed how glucose affected insulin levels. Similar insulin and glucose tests are used by doctors for diagnosing diabetes.
For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year. Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company which holds drug market exclusivity requests FDA do so. Unless we change the rules, we may see a government-sponsored monopoly on CBD oil, and in the near future, additional monopolies on other cheap, safe, and effective supplements. This threat to affordable CBD oil shows how broken this system is. An opioid epidemic is ravaging our country, with drug overdose deaths surpassing car accident fatalities. People are addicted to and dying from FDA-approved drugs, yet the agency is poised to eliminate consumer access to a non-addictive, cheap, safe, and effective alternative in CBD oil—all so one drug company can charge tens of thousands of dollars for what currently costs a few dollars. The FDA will not protect us—they’re in on it! More drugs mean more user fees—more money—for the agency, so don’t expect the FDA to defend your access to supplements.
On September 12, the FDA’s advisory committee on compounded medicine—medicine made for individual patients at specialized pharmacies—will meet to discuss five ingredients: alpha lipoic acid, CoQ10, creatine monohydrate, pyridoxal 5 phosphate (P5P), and quercetin dihydrate. If the agency doesn’t hear from patients and concerned citizens, we may lose access to individualized preparations of these important dietary ingredients. The Pharmacy Compounding Advisory Committee (PCAC) advises the FDA in writing new rules regarding what supplements and drugs can be made individually for patients with specific needs by compounding pharmacies. The main motivation behind the FDA’s attacks on compounded medicine is to protect the pharmaceutical industry from competition. With no other choice, patients who rely on compounded medicine would have to buy Big Pharma’s drugs. We can’t let them whittle away the ingredients allowed to be compounded. This “death by a thousand cuts” could end access for us to compounding pharmacies altogether.
In February 2018, the FDA and CDC approved the recommendation for a new hepatitis B vaccine, Heplisav-B for adults over the age of 18. The U.S. Food and Drug Administration (FDA) had twice rejected the application for licensure for Heplisav-B in the past four years because of safety signals. Heplisav-B differs from other licensed hepatitis B vaccines in that it contains a new synthetic adjuvant known as cytosine phosphoguanine 1018 (CpG 1018) composed of short synthetic DNA molecules. In 2016, the FDA rejected an application for licensure for the Heplisav-B vaccine, because the agency was concerned about an increased rate of heart attacks and deaths in people who had been given the vaccine. During the trial, approximately 14 subjects had heart attacks. In July 2017, the FDA committee convened to re-evaluate the scientific evidence and make a decision on whether Heplisav B should or should not be approved for use in the U.S. This committee had only one cardiologist on the team, Milton Packer, MD, who is a distinguished scholar in cardiovascular science at the Baylor University Medical Center in Dallas, Texas. According to Dr. Packer, it was possible that the Heplisav B vaccine’s novel adjuvant was related to the higher number of heart attacks in study participants who received the experimental vaccine. He stated: "To know if the 7 -1 heart attack imbalance represented a real risk, we’d need comparative data in 50,000 people." However, the only way to conduct such a large trial would be to approve the vaccine and see what happens in the public. With Dr. Packer abstaining in his vote to recommend the vaccine, the FDA committee approved it anyway. Dr. Packer stated: "Why did I abstain? Based on the available data, it was impossible for anyone to know if the increase in heart attack risk was real. There is a simple rule in life: if you don’t know, you should say you don’t know." The vaccine is now available to the public, and all those who receive it are basically guinea pigs to find out if heart attacks will result from the experimental vaccine, and if it will continue to have FDA approval.
As pharma companies underwrite three-fourths of the FDA’s budget for scientific reviews, the agency is increasingly fast-tracking expensive drugs with significant side effects and unproven health benefits. Nuplazid, a drug for hallucinations and delusions associated with Parkinson’s disease, failed two clinical trials. In a third trial, under a revised standard for measuring its effect, it showed minimal benefit. Overall, more patients died or had serious side effects on Nuplazid than after receiving no treatment. Patients on Uloric, a gout drug, suffered more heart attacks, strokes and heart failure in two out of three trials than did their counterparts on standard or no medication. Nevertheless, the U.S. Food and Drug Administration approved both of these drugs — with a deadly aftermath. Uloric’s manufacturer reported last November that patients on the drug were 34 percent more likely to die from heart disease than people taking an alternative gout medication. And since the FDA fast-tracked approval of Nuplazid and it went on the market in 2016 at a price of $24,000 a year, there have been 6,800 reports of adverse events for patients on the drug, including 887 deaths as of this past March 31. The FDA is increasingly green-lighting expensive drugs despite dangerous or little-known side effects and inconclusive evidence that they curb or cure disease. Once widely assailed for moving slowly, today the FDA reviews and approves drugs faster than any other regulatory agency in the world.