When Marketing Trumps Science

A Review by Jule Klotter

The HPV Vaccine on Trial by Mary Holland, JD, Kim Mack Rosenberg, JD, and Eileen Iorio.  Foreword by Dr. Luc Montagnier.

Skyhorse Publishing, New York, New York; www.skyhorsepublishing.com

Softbound; 461 pp; 2018; $19.99 (US)

In September 2005, seven months before FDA approval of its Gardasil vaccine, Merck commenced a direct-to-consumer marketing campaign that connected the human papilloma virus (HPV) to cervical cancer. Once that connection was widely accepted and their HPV vaccine had been approved, the company played on cancer fear and parental guilt, advocating that young women “Be One Less.” Merck gained endorsements from multiple medical associations, women’s health groups, and government agencies for its campaign and even lobbied state legislators to make the vaccine mandatory for all sixth-grade girls. As a result, Gardasil has become a huge money maker for the company: global sales were $2.3 billion for the first nine months of 2018.¹

Of course, marketing in itself is not evil. But in the arena of public health, one hopes that products offered for sale provide more benefit than risks. In reading The HPV Vaccine on Trial, it is difficult to believe that general welfare and reducing cancer is Merck’s primary goal—especially when it is clear that Merck continually asserts safety without ever using a saline placebo in its original clinical trials, as the book’s authors explain at length and members of the Cochrane Collaboration described in the British Medical Journal last year.²

The HPV Vaccine on Trial is a thorough, well-documented examination of the conflicts of interest, compromised research, and marketing strategies that have allowed HPV vaccination to be widely promoted. The case presented by Mary Holland, JD, research scholar and director of the Graduate Legal Skills Program at New York University School of Law; Kim Mack Rosenberg, JD, a private practice attorney; and writer Eileen Iorio raises compelling questions about the safety and effectiveness of this type of vaccine, in particular Merck’s Gardasil.

As the authors point out, many factors contribute to the development of cervical cancer—as is true of other cancers. Certain strains of HPV have been associated with cervical cancer, but several other factors also increase cancer risk, including immunosuppression, early sexual activity, tobacco smoking, nutrient-poor diet, and being a DES daughter. A healthy immune system successfully combats HPV infections in most people; and Pap screening (in countries where it is available) has been very effective in greatly reducing the incidence of cervical cancer. Only 0.6 percent of US women will receive a cervical cancer diagnosis in their lifetimes, and survival rate is over 90 percent when caught early. Even before a vaccine came on the market, low-resource countries like Colombia have seen a decline in cervical cancer as socioeconomic conditions improve and new methods for screening become available.

Despite widespread belief that HPV vaccines prevent cervical cancer, that has yet to be proven. It takes years for cervical cancer to develop. Historically, it has affected older women (median age 50 years, according to the National Cancer Institute). The clinical trials used cervical lesions, abnormal tissue called CIN2 and CIN3, as a surrogate for actual cervical cancer. As the authors point out, these lesions do not necessarily lead to cancer—in fact, most do not lead to cancer: “The NCI reports that 50 percent or less, and perhaps as low as 30 percent, of CIN3 lesions progress to cervical cancer. Cochrane Collaboration recently assessed the probability of CIN3 progression to cervical cancer to be as low as 12 percent (may depend on location and other risk factors).” So, the vaccine’s actual effectiveness in reducing cervical cancer is still unknown; it hasn’t been on the market long enough to see if the cancer rate among older women will decline.

While the vaccine benefit is unknown at this point, reports of adverse effects associated with these vaccines are very troubling. Using data from the Gardasil package insert, the authors say the rate of serious adverse reactions during clinical trials was 81.49/10,000 (128/15,706 participants), and the death rate was 13.3/10,000 (21/15706). In contrast, the cervical cancer rate in East Africa, which has the highest incidence in the world, is 4.27/10,000 (2012 IARC figures) and the death rate is 2.76/10,000. The death rate among those receiving the vaccine was nearly five times higher than the death rate from cervical cancer in East Africa.

Now granted, not all of the adverse reactions may have been due to the vaccine, but the lack of an inert placebo clouds the issue. All but one Gardasil trials used AAHS, Merck’s aluminum-containing adjuvant, as the control, making it impossible to compare the incidence of adverse events in treated to untreated girls. Tables in a 2006 FDA review document, obtained by the authors, showed that about 50 percent of the trial participants reported having “new medical conditions” arise after receiving the vaccine: “Gardasil: 5842 out of 11778 (49.6%) ‘Placebo’ 4750 out of 9686 (49%), Day 1 through Month 7.” These medical conditions include thyroiditis, arthritis, multiple sclerosis, other diagnosed autoimmune disorders, neurological disorders, immune, reproductive, cardiac disorders, and psychological problems. What would the numbers look like if a saline placebo had been used? Unfortunately, FDA did not ask the manufacturer to conduct such studies.

During HPV vaccine trials in India, the high numbers of adverse events, including deaths, loss of menstrual cycles, depression, and anxiety led to a Parliamentary investigation into clinical trial laws and rebukes against the country’s medical agencies. The high number of adverse reactions in Japan led that country’s Ministry of Health, Labor, and Welfare to withdraw its recommendation to add the HPV vaccine to its vaccine schedule, “due to ‘an undeniable causal relationship between persistent pain and the vaccination.'” In Columbia hundreds of girls reacted to a second dose given in 2014, some severely; they experienced severe headaches, convulsions, fainting, and paralysis. Government officials ascribed the reports to mass hysteria without ever having examined the girls. In the US, 57,620 reports of injury, including 420 deaths from HPV vaccine, were recorded by the voluntary US Vaccine Adverse Event Reporting System (VAERS) as of May 2018.

Merck asserts that the adverse events are not related to the vaccine. Yet, information about the known effects of the vaccine ingredients suggest the potential for its causing diverse symptoms, including postural orthostatic tachycardia syndrome, small fiber neuropathy, complex regional pain syndrome, and chronic fatigue syndrome. Holland et al point out that AAHS is a nanoscale adjuvant that has ‘enhanced binding capacity’ to antigens. Its small size allows macrophages to carry the AAHS nanoparticles across the blood-brain barrier and, possibly, cause inflammation and neurological effects. In addition to AAHS, the vaccine contains polysorbate 80, which is known to aid delivery of active ingredients to the brain. A study back in 1984 showed that polysorbate 80 caused steep blood pressure drops and decreased heart rate in dogs. Also, injecting polysorbate 80 in mammals has produced ovary damage. Since none of these ingredients have been tested in humans against a saline control (FDA does not require such testing), it is impossible to say if they are safe or are causing harm.

Despite the numerous reports of adverse effects and the lack of saline placebo safety studies, the CDC’s Advisory Committee on Immunization Practice (ACIP), the expert committee that makes federal vaccine recommendations, added Gardasil and, later Gardasil 9 (which has more HPV strains) to the vaccine schedule. Many ACIP members have financial ties to industry. ACIP approval means vaccine manufacturers have tort liability protection, provided by the 1986 National Childhood Vaccine Injury Act. People injured by a vaccine cannot sue the manufacturer. Instead, they must sue the US Department of Health and Human Services for compensation. In 2011, the Supreme Court case Bruesewitz v. Wyeth determined that only the FDA has the authority to decide if a vaccine design is defective. Jennifer Robi v. Merck and Kaiser Permanente, now being heard in Los Angeles Superior Court, will consider whether Merck committed fraud during its clinical trials, bypassing the issue of safety.³

FDA recently approved Gardasil’s use in adults (male and female), age 27-45,⁴ even though Merck’s own data found that women who had evidence of current or past HPV 16 or 18 infection before getting the vaccine were 44.6 percent more likely to develop CIN2, CIN3 lesions, or worse compared to the control group. In addition, clinical studies have shown that pregnant women receiving the new Gardasil 9 within 30 days of conception had over twice the miscarriage rate of those who received Gardasil: 28.4 percent in Gardasil 9 vs 12.7 percent in Gardasil control. Again, no saline placebo or untreated group was used as a control. Apparently, the agency does not ascribe to the precautionary principle.

The HPV Vaccine on Trial provides documentation that regulators and manufacturers are downplaying safety issues. Vaccines, by definition, are given to healthy people in order to prevent illness. As Nobel Prize winner Dr. Luc Montagnier states in his Preface to the book: “Historically, vaccines have protected many people. Presently, over these last many years, too many vaccines, HPV and others, have harmed and killed so many people. Let us mandate that ALL vaccines be safe for everyone.” But this is only possible when government agencies and manufacturers have higher standards for clinical trials; and that requires educated medical professionals and consumers who demand a change.

References

1. Collins D. Merck’s Gardasil Had Solid Growth in the Third Quarter. October 31. 2018. Marketrealist.com

2. Jørgensen L, Gøtzsche PC, Jefferson T. The Cochrane HPV vaccine review was incomplete and ignored important evidence of bias. BMJ Evidence-Based Medicine. October 2018;23(5):165-168.

3. Redwood L. Court Hears Gardasil Science and Moves Forward. January 29, 2019.

4. Associated Press. FDA expands use of an HPV vaccine up to age 45. October 6, 2018.

Blurb

“Because vaccines are administered to healthy individuals, ‘the highest standards of safety are [rightly] expected of them.’” (p. 98)