Pamela A. Popper, Ph.D., N.D.

Wellness Forum Health

The Nordic Cochrane Center has filed a complaint against the European Medicines Agency over the way the EMA has handled safety issues concerning human papillomavirus (HPV) vaccines. Cochrane is an independent, non-profit and non-governmental organization that consists of researchers in over 130 countries. The group was formed to analyze medical information in order to assist health professionals, patients, and others in making medical decisions according to the rules of evidence. It is one of the most independent medical research organizations in the world.

Several months ago, a physician in Denmark asked the EMA to look at safety issues concerning the HPV vaccine after analyzing several case reports in which girls experienced symptoms, some quite serious, after getting the vaccine. The EMA conducted a review and reported that “evidence does not support that vaccines caused” the chronic symptoms.

However, several researchers questioned both the review process and the conclusions, which led Cochrane, headed by Peter Gøtzsche, to file the complaint. Gøtzsche has been outspoken regarding other issues about which he thinks the public is being misled and has written two books, Mammography: Truth, Lies and Consequences and Deadly Medicines and Organised Crime. Gøtzsche says it is becoming increasingly difficult to get truthful information published in medical journals, which prompted him to write the books. His insistence on informing the public with truthful information is most likely the impetus for this complaint.

The complaint states that there were several flaws in the review, including the fact that much of the information came from manufacturers of the vaccines; and that in clinical trials an aluminum adjuvant was given to the control group instead of a saline placebo. Cochrane also took issue with the secrecy surrounding the review. The experts who were involved were not named and signed an agreement not to disclose what was discussed. This is highly unusual. As flawed as the U.S. FDA is, at least advisory committee members are disclosed, documents are posted online, and meetings are open to the public and streamed online. Cochrane argues that there is no reason not to make information about the investigation into HPV safety issues public.

Another issue is how the EMA has handled the Danish whistleblower. Louise Brinth, Ph.D., M.D. is the Danish doctor who analyzed the case reports of harm. Her conclusion was that medical authorities should look into the safety of the HPV vaccine. She is not the first person who has been dismissed and/or punished for suggesting simply that the medical community should conduct more research on such an important issue. This is what happened to Andrew Wakefield, the gastroenterologist who lost his medical license in England because he was outspoken about vaccine safety issues. Dr. Brinth joined the complaint with Cochrane and has published her own lengthy response to the EMA report.

The EMA findings should not surprise anyone. It is considered medical heresy to question vaccine dogma. In the U.S., both the FDA and CDC aggressively push the HPV vaccines, along with all other vaccines, and continue to insist that there is no link between the symptoms which are consistently reported and the HPV vaccine or any other vaccine. Both of these agencies are funded heavily by the vaccine makers (see previous articles in the Health Briefs Online Library), which should disqualify them from reviewing vaccines for efficacy and safety, and commenting on these issues. Both agencies say the HPV vaccine has an “excellent safety record.”

U.S. medical associations are equally aggressive in promoting vaccines, including HPV. The American Society of Clinical Oncology (ASCO) published a statement in April 2016 urging aggressive efforts to increase the HPV vaccination rate in order to “protect young people from life-threatening cancers.” But the lead author of this statement, Howard Bailey, says that safety concerns outlined in the Cochrane complaint should not be dismissed and should be taken seriously.

In the Cochrane complaint, the group acknowledges that it is difficult to show a causal relationship for many of the symptoms reported after the HPV vaccine. These include chronic fatigue syndrome, postural orthostatic tachycardia syndrome (POTS), and chronic regional pain syndrome (CRPS), which are difficult to diagnose, typically underreported, and poorly understood. But the bigger issue, according to Cochrane, is the discrepancy between the EMA’s official public report and the EMA’s internal and very lengthy (256 pages) report. The official report outright dismisses the claims. The internal report, while it was supposed to be confidential, has been leaked and shows that several of the experts thought the vaccine might not be safe and that further research was needed. There was nothing about this in the official public version.

Additionally, the EMA review was based on data collected by the makers of the vaccines, which include GlaxoSmithKline, Merck, Sharp and Dohme, and Sanofi Pasteur MSD. Essentially the EMA asked the drug companies to look for side effects of the vaccine in their own databases and did not independently verify the information it was given. Since worldwide sales of the HPV vaccine are over $27 billion (U.S.) per year, it is hard to imagine that the drug companies were diligently looking for side effects in their data bases. Cochrane says the companies have a huge vested interest in not finding side effects resulting from the vaccines.

In fact in the internal report, one of the experts noted that the manufacturers changed the criteria of the reported conditions in order to disqualify many of the cases, resulting in a lower number of adverse events.

This is typical of how vaccine safety issues are handled. In 2014, the Danish Health and Medicines Authority asked Sanofi Pasteur MSD to review its own data base for adverse effects to the HPV vaccine. The criteria were set so that only 3 of 26 known and reported cases of POTS showed up in the review. The big question is that since everyone knows this, why do government agencies continue to let this misbehavior go on? And why does this not bother medical doctors and their professional associations?

The placebo issue in the clinical trials is an egregious violation of the rules concerning study design that should have disqualified the trials from consideration. The control group was given a placebo containing aluminum, a suspected neurotoxin. The EMA internal report notes that initially the vaccine was compared with a real placebo and the adverse reactions in the vaccine group were considerably higher and more serious than in the control group. After these results, study design was changed and aluminum was added to the placebo. Cochrane says that the EMA internal report states clearly that the results from a genuine placebo trial were lumped together with trials in which aluminum was used as placebo, which skewed the outcomes data.

Cochrane also alleges scientific misconduct in other data delivered to the EMA by the drug makers, which included safety data from trials in which an active comparator, such as an older vaccine, was used.

Adverse events resulting from the HPV vaccine have reported in every country in which the vaccine is used. Japan has removed the HPV vaccine from the schedule and has set up a national program to deal with injured women. When will the rest of the world catch up?

Dr. Brinth says one of the problems is that physicians are afraid to speak up. She says other doctors have contacted her and said that they have the same concerns and have seen the same side effects. She says, “I find that we have established a culture where it is not acceptable to have a critical approach towards vaccines.”

I found Dr. Bailey’s response to this issue almost unbelievable. He says, “I would be very reluctant right now to shut down the goals of vaccination over what has been reported, because the bottom line is that we have a tremendous problem with the rising incidence of HPV-related cancers, including in men as well as women when it comes to oropharyngeal cancers here in the States.” But, he added, “Maybe if it was my daughter, I would feel differently.”

Zosia Chustecka “Complaint Filed Over EMA’s Handling of HPV Vaccine Safety Issues.” Medscape July 5 2016