In light of the death of a teenage girl in the UK following HPV vaccination* and the outrageously rapid PR campaign to take blame away from the vaccine [“The postmortem examination was carried out with unprecedented speed. That and the unusual step taken by Grainger in making a public announcement of the early results, not much more than a day after Natalie’s death, are a clear indication of the anxiety among public health officials over the potential threat to the national teenage vaccination programme.“], and the ongoing push towards H1N1 mass vaccinations, the following article is now essential reading. Before posting selected excerpts, please note that with regard to HPV vaccines –

1. There is no evidence that HPV vaccination protects against cervical cancer.
2. There is no evidence that the protection against HPV infection from vaccination lasts more than 6 years
3. There is concern that mass vaccination costing billions per annum will have no effect on cervical cancer rates or mortality
4. There is concern that women will reduce their Papanicolaou (smear) testing frequency once vaccinated, possibly increasing cancer rates
5. Vaccinating against HPV16 and HPV18 may leave a pathological niche which will be rapidly filled by other HPV strains to unknown effect.

These are not my opinions, they are those of the highest qualified physicians writing in the editorials of the best jourmals about HPV vaccine.

In this context, read the full article “Marketing HPV Vaccine: Implications for adolescent health and Medical Professionalism” at JAMA, one of the very highest rated medical journals in the world.  Here are some highlights:

This HPV vaccine was approved by the US Food and Drug Administration in 2006,² and worldwide sales in 2008 were $1.4 billion.³ In the United States, 25% of girls aged 13 to17 years have received at least 1 of 3 recommended doses.⁴ […] This HPV vaccine […] was identified by a trade name, Gardasil, and promoted primarily to “guard” not against HPV viruses or sexually transmitted diseases but against cervical cancer.⁵ The marketing campaign that followed, according to Merck’s chief executive officer, proceeded “flawlessly.”⁶ In 2006, Gardasil was named the pharmaceutical “brand of the year” for building “a market out of thin air.”⁶

Merck developed and tested an HPV-16 vaccine […]. Because of “ethical and scientific” concerns,⁵ investigators did not make cervical cancer their end point, substituting, as a “reasonable surrogate,”⁵ persistent HPV infection. Still, they concluded that “[i]mmunizing HPV-16-negative women may reduce their risk of cervical cancer.”⁵

Accompanying editorials were more circumspect. The vaccine appeared most effective against the least dangerous cellular changes and not protective or therapeutic for women with prior infections. Although HPV-16 and HPV-18 were most frequently associated with cellular changes, “the contribution of non-vaccine HPV types . . . was sizeable.”¹⁶ Another editorial suggested that “[t]he new treatment raises many scientific, medical, economic, and sociological questions.”¹⁷

“We still lack sufficient evidence of an effective vaccine against cervical cancer.”²¹ No data were available to establish the duration of efficacy, possible adverse effects on natural immunity, whether vaccinated women will forgo Papanicolaou tests, and whether after suppressing HPV-16 and HPV-18, “other strains may emerge as significant oncogenic serotypes.”²¹ Accordingly, the editorial concluded, “With so many essential questions still unanswered, there is good reason to be cautious about introducing large-scale vaccination programs.”²¹

The manufacturer’s marketing strategy […]: avoid limiting the vaccine to high-risk populations, promote it for all women, and secure government reimbursement and mandates. To these ends, Merck funded established PMAs including the American College of Obstetricians and Gynecologists and smaller groups, including the American Society for Colposcopy and Cervical Pathology (ASCCP), the Society of Gynecologic Oncologists (SGO), and the American College Health Association (ACHA).

The [Merck-provided] Speaker Lecture Kit encourages speakers and their audiences to help in “convincing states and federal agencies to pay for the vaccine, convincing insurance to pay for it [and] encouraging state mandates for use” (slide 131).¹⁰ “All of us who are involved with cervical disease are going to need [to] work at the state and local levels to assure that the HPV vaccines are funded” (notes, slide 128).¹⁰

Society of Gynecologic Oncologists. […] Determined to increase industry funding, the SGO in 2006 established what was in effect an HPV vaccine speakers’ bureau.³⁹ Funded by Merck, along with GlaxoSmithKline, Cytyc, and Myriad, […]. Panel members, some with financial ties to Merck, composed the curriculum and, initially, delivered the talks (34 speakers in 16 states).^41–42

The SGO teaching materials omitted cautionary qualifications. The frequently asked questions section, for example, opened with “Why is this vaccine important?” The answer repeated the manufacturer’s explanation: “This is the first vaccine directed against a cancer.”⁴³ […] It did not include data on disparities in cervical cancer incidence and outcomes. This section also failed to include questions such as “Do I still need Papanicolaou tests?” “How long will efficacy last?” “How long has the vaccine been used?” and “Might risks outweigh benefits?”

American College Health Association. […] With funding from this vaccine manufacturer, the ACHA created an HPV Vaccine Toolkit for clinicians, including talking points, sample e-mail messages to students and parents, sample press releases, and public service announcements.⁴⁶ If a female student responded “no” when asked if she was sexually active, clinicians were supposed to explain that the HPV vaccine is most effective for her.⁴⁶ If she was sexually active, clinicians were instructed to say that she probably had not been infected with all 4 viruses.⁴⁶

A sample letter/e-mail to students announced a new vaccine “that protects against HPV—and it could help save your life.”⁴⁶ It listed college students’ everyday worries—dates, examinations, roommates—and declared, “Well now there’s something you don’t have to worry about anymore. And this worry is a big one. Why worry about cervical cancer?”⁴⁶ Sample public service announcements reiterated the message: “Hey ladies. You worry about tests. . . . You worry about your next date. Well now there’s something you don’t have to worry about any more—and it could help save your life.”⁴⁶ Sample letters to parents included the following: “Will she get good grades? Will she call home often? The last thing you want her to worry about is cervical cancer. . . . Encourage your daughter to ‘Be Smarter and Get Vaccinated’ at the Student Health Service—it could help save her life.”⁴⁶ In none of these cases was Merck funding mentioned.

As marketing of this HPV vaccine demonstrates, pharmaceutical company campaigns can undercut the most cost-effective and appropriate use of new agents to the detriment of adolescent health. By making this vaccine’s target disease cervical cancer, the sexual transmission of HPV was minimized, the threat of cervical cancer to all adolescents maximized, and the subpopulations most at risk practically ignored.

My emphasis at end. This is a beautiful piece of well-considered, fully-referenced writing that has undergone the peer-review process and whose authors fully declare their competing interests (none) and funding sources (charity). Next time you read about HPV, chickenpox, MMR, HBV, swine flu or any other new and ‘essential’ vaccine, this article provides the context in which it should be evaluated.

*Addendum: It is worth noting that dying from a ‘serious underlying medical condition’ post-vaccination is now considered an excuse for having no concern about HPV vaccine. In the case of swine flu, the vast majority of the (relatively few) deaths were in indiviuals with ‘serious underlying medical conditions’, yet each death was treated as yet another warning as to how deadly and vicious this virus was/is to the general population. Horses for vaccination courses, n’est pas?

This entry was posted on Wednesday, September 30th, 2009 at 10:23 am and is filed under Beautiful, Fear-mongering, Medicine, Money, Someone Clever Said.