Gardasil receives ACIP recommendation for girls 11-26

We're in Atlanta for the summer ACIP meeting, where the biggest news coming out of the CDC is the (not unexpected) action on Gardasil. In short, the ACIP unanimously recommended that all 11-12 year old girls receive the 3-dose series, although vaccination can begin as young as 9, at the physician's discretion. Additionally, a 'catch-up' immunization program was recommended for girls and women through age 26.

Here's the coverage from the New York Times, Associated Press, Los Angeles Times, and Reuters, as well as the press releases from Merck and the CDC. Also of interest is this transcript of a CDC media briefing held this afternoon shortly after the recommendation.

In many respects, today's proceedings were rather anti-climactic, despite a standing-room-only crowd in the meeting auditorium. Coming after four hours of presentations and discussion on HPV vaccines at the February ACIP meeting, there was very little new information presented this morning. The pre-vote discussion was equally subdued, as Gardasil's trial data and FDA indications provided few alternatives beyond the recommendation as approved. That's probably a good thing, as decisions made amid uncertainty or a significant division in opinion would likely mean that things hadn't been thoroughly explored prior to the meeting. Clearly, the committee was well prepared and ready to act.

Personally, we were curious to see whether any of the groups opposing state mandates for HPV vaccination would use the "public comment" time to continue making themselves heard (as the Family Research Council did at the February meeting). Once again, however, no fireworks to report, as all nine public commenters strongly supported the vaccine. Commenters included representatives from the National Coalition for Cancer Survivorship, the Planned Parenthood Federation of America, AmeriChoice, The Balm in Gilead, the American Social Health Association, the Celebrate Life Foundation, Women in Government, and the International RRP ISA Center. Also commenting was Dr. Otis Brawley, a professor at Emory University. While unanimously praising the ACIP's recommendation, several commenters advocated broadening the vaccine's target groups in the future to include boys as well, an action that will surely occur in the not-too-distant future.

It should be noted that several opponents of state mandates, while not vocal at today's meeting, are quoted in some of the news stories linked above.

With licensure and a recommendation secured this month, the fate of Gardasil now depends on a variety of financing programs to make the vaccine available and affordable to all who should receive it, a comprehensive education program for parents and physicians alike, and the actions of all 50 state departments of health, whose decisions regarding school-entry mandates will impact greatly the degree of vaccine uptake and, thus, the overall benefit of the vaccine for society. Stay tuned.

Should Gardasil be called a 'cancer vaccine'?

A few weeks back, we were asked by a reporter whether it was misleading to refer to Gardasil as a 'cancer vaccine'. The phrase has been widely used of late -- and not only by the media. Both the FDA and Merck refer to Gardasil as a 'cervical cancer vaccine' in their press releases this month announcing the product's licensure.

We hadn't thought much about the issue at the time, but it didn't (and still doesn't) strike us as dishonest. There's no dispute regarding the link between HPV and cervical cancer, and the data show that Gardasil prevents infection from HPV strains responsible for 70% of such cancers. The fact that the vaccine is less than 100% protective against cervical cancer has no impact on whether it can rightly be called a 'cervical cancer vaccine,' since no vaccine available provides complete protection.

Gardasil is beneficial for multiple reasons, but cervical cancer is clearly the most prominent of the group. From a medical perspective, referring to it as a cervical cancer vaccine is prudent, as public awareness of HPV (and, in particular, its close link to cancer) is lacking. A vaccine against cervical cancer is much more likely to attract patient interest than one against 'human papillomavirus,' meaning that more people who should receive the vaccine actually will. Meanwhile, there's no denying that the branding of Gardasil as a cervical cancer vaccine is a shrewd (but appropriate) marketing decision by Merck.

A story in today's Charleston (W.V.) Gazette is the first we've seen that discusses this topic. Most of those interviewed in the story appear to share our view, with the chief reservation being that the branding ignores the other benefits of vaccination. True, but the additional attention Gardasil receives as a 'cervical cancer vaccine' will likely put it in a better position to accomplish its full range of benefits for a greater number of people.

Smallpox vaccine 'possible' cause of soldier's death; vaccinations to continue

This Department of Defense press release and AP story report that the death of a 26-year old soldier from myocarditis may be linked to smallpox and flu vaccines administered 16 days before his sudden death. The press release explains:

"Following evaluation of multiple specialized test results, the panel considered a cause-and-effect relationship to be 'possible.' The smallpox vaccine received by [Pfc. Christopher] Abston is known to cause an inflammation of the heart muscle or myocarditis, a condition found at his autopsy.

Evidence of the vaccinia virus, the main ingredient of smallpox vaccine, was not found in his heart muscle, but evidence of a different virus, parvovirus B19, was found.Natural infection with parvovirus B19 is another known cause of heart inflammation and death. The expert panel cautioned that the findings pointing to vaccinations were neither probable nor unlikely, but they do suggest the possibility that the vaccines may have caused Abston’s death."

Today, the lead story of the Defense Department's website is an item titled "DoD to continue smallpox vaccinations despite soldier's death." The story notes that over 1 million service members have been vaccinated since DoD's smallpox vaccination program began in December 2002. Cardiac side effects have occurred in 120 people, but none died prior to Pfc. Abston.

This is the latest development in what has been a controversial program since its inception 3.5 years ago. To address worries and criticisms, the government has an impressive website at www.smallpox.mil that explains their rationale for the program and offers extensive resources regarding safety concerns, among other topics.

"Merck's vaccine victory not yet complete"

So notes a story on TheStreet.com, the financial news and opinion site, that looks ahead to this week's ACIP actions on Gardasil and subsequent decisions that will be made at the state level. We agree wholeheartedly with the gist of the story, particularly because it quotes at length an earlier post from this very site.

Waive parental consent for HPV vaccination?

That's the position of physicians from Brown Medical School, The Miriam Hospital, and elsewhere in a letter published in the July issue of The Lancet Infectious Diseases. The letter, "Where to begin human papillomavirus vaccination?" (subscription required), emphasizes the need to direct HPV vaccination efforts at African-American women, a group disproportionately affected by cervical cancer in the U.S. For those without subscription access, here's a press release from the lead author's institution.

The authors cite data showing that African-American women have a lifetime risk of cervical cancer 0.25% higher than in white women (0.94% compared to 0.69%) and are twice as likely to die from it. The reasons underlying these disparities aside, the authors propose a multi-dimensional, targeted HPV vaccination campaign for African-American women, including school-based vaccination clinics in schools with high percentages of African-American students as well as vaccine distribution in juvenile detention centers. Finally, the authors write,

"Parental consent ought to be waived for HPV vaccination as it is for other sexually transmitted infection-related health care."

It's a provocative claim for which no further explanation is offered. While the authors' interest in maximizing the availability of HPV vaccines is clear, it's possible that attempting to circumvent parental authority in this case would actually have the reverse effect. Such a move would greatly increase the level of criticism the vaccine receives, particularly from groups already arguing strongly that the decision to vaccinate should be left to parents in all cases.

Trying to define "acceptable risk"

Last month, we wrote about a paper in the Journal of General Internal Medicine that examined how individuals' opinions regarding vaccination vary based on the role the person is asked to assume (i.e., as a patient, a parent, a physician, or a public health director). See our full post: "Study asks, 'Would you take a risky flu vaccine?'" here.

A piece in today's New York Times discusses the study as part of a broader look at the definition of 'acceptable risk' and the challenges physicians face in attempting to discuss accurately the risks and benefits of treatment options. It's an incredibly complex topic to tackle in a 750-word story, but the Times provides a useful introduction to an important issue.

Jail for man trying to sell unapproved flu vaccine

News from our backyard that should be noted by anyone seeing flu vaccine on the shelves of their local convenience store. Mahmoud Abuarqoub, the former owner of a 7-11 in Atlantic City, was convicted of attempting to sell 5,000 doses of unapproved flu vaccine to N.J.-area hospitals during the 2004 vaccine shortage. The vaccine had been manufactured in France and distributed via a Saudi Arabian company, but it was not licensed for use in the U.S. The Cherry Hill (N.J.) Courier-Post has the story, as does the Associated Press.

The Courier-Post headline calling the vaccine 'fake' is misleading, as the doses in question were actual flu vaccines approved for use internationally. (The vaccine was Vaxigrip, manufactured by Sanofi-Pasteur.) As the story notes, it's unlikely there would have been any public health risk had the vaccines been purchased by hospitals and administered. (Neither happened.) Nevertheless, this type of conduct by individuals is strongly discouraged, to say the least. Mr. Abuarqoub's conduct netted him 3 years in federal prison for mail fraud, introducing an unapproved new drug into interstate commerce, introducing a misbranded drug into interstate commerce, wholesale distribution of drugs without a license and smuggling.

Editorial pages on the future of HPV vaccines

A number of newspapers, both large and small, published editorials on Gardasil over the past few days. The pieces look at what lies ahead regarding the vaccine's availability, recommended use, and possible requirements. It's a good time to do so, as we're just about halfway between FDA licensure (which came June 8) and ACIP recommendations (June 30). Here's a sampling of editorial views from around the nation:

• "A major advance in women's health" (Philadelphia Inquirer): "As states address this issue in the coming months, they should remember they have a wide range of policy choices between mandatory vaccination and silence. Although abstinence is the safest choice before marriage, public health policy should not ignore the fact that nearly every person engages in sexual activity at some point in life."

• "Preventing a cancer" (Boston Globe): "But the greatest potential benefit of Merck's Gardasil vaccine will come only if parents, doctors, policymakers, public health professionals, and school officials work together to ensure that all pre-teen girls get the full vaccine regimen of three shots."

• "Vaccine will save lives" (Fort Wayne Journal Gazette): "Protecting women from cervical cancer should trump patriarchal concerns about women becoming promiscuous. Any negative reaction to a vaccine that will protect millions of women’s lives is nothing less than misogyny."

• "A vaccine that fights cancer" (Clarksville, TN Leaf Chronicle): "By all means, those families with a strong belief in sexual abstinence until marriage should share that with their children — especially with all the mass media messages that young people are constantly exposed to concerning sex. Unfortunately, though, the parents' best hopes don't always work out. It's estimated that by high school, half of all teens are sexually active. Even for a girl who is committed to abstinence before marriage, there's always the possibility that a sexual assault could leave her exposed. One also must take into account that just because a young woman waited until marriage, her groom may not have."

• "Cancer breakthrough" (Providence Journal): "Further, some conservative organizations oppose requiring the vaccine. They argue that it will promote promiscuity, and that sexual abstinence before marriage is the better route to preventing illness. That seems farfetched. Few adolescents struggling over a decision to have sex will be deterred by fears that they could contract cancer in adulthood. Moreover, depriving anyone of this life-saving vaccine for "moral" purposes is a reckless roll of the dice."

CDC: 2005-06 flu season mild; vaccine an ideal match

Last week's MMWR included a report on the flu season that concluded last month. It noted that this year was milder than the past several flu seasons and that the three flu strains selected for the '05-'06 vaccine matched the predominant strains isolated throughout the season. As the selection of viral strains to be included in the next year's vaccine is by no means an error-proof process, WHO should be lauded for their work.

The University of Minnesota's CIDRAP has a story of its own on the CDC report.

Caplan MSNBC column on Gardasil

Our own Art Caplan has written a column about Gardasil and related issues for his twice-monthly MSNBC.com column, Breaking Bioethics. An excerpt...

"Medicine is poised to take a giant leap forward in the war on cervical cancer. But every American needs to think hard about the challenge this medical opportunity creates. The issue of cervical cancer vaccine will soon come to your school, church, synagogue, mosque and doctor's office. The right thing to do is to ensure as best we can that all young women are vaccinated. Now is the time to push politicians to make sure that the money will be there to make this happen. If insurance companies don't have to pay and public health departments cannot afford to then all the other moral issues surrounding this new vaccine become moot. It's time to prevent that from happening."

Gardasil approved -- $360 for 3-dose series

By no means surprising news, but Merck's HPV vaccine, Gardasil, was approved by the FDA earlier today. Here's the initial AP story, courtesy of the Washington Post, followed by the lengthy Merck press release which carries the triumphant headline, "FDA Approves Merck's GARDASIL, the World's First and Only Cervical Cancer Vaccine," a not-so-subtle jab at GSK in winning the race to be first with a licensed HPV vaccine. More importantly, the press release includes the first mention of Gardasil's 'catalog price': $120/dose, with 3 doses required for protection. The press release also announces the launch of www.gardasil.com, which (at least for now) only carries a "Coming Soon" banner.

We'll be watching for the arrival of the next phase of Merck's "Tell Someone" campaign (which we've previously discussed here and here) that will surely promote Gardasil, both in TV ads and on the websites that (so far) have made no mention of HPV vaccines.

Plenty of media coverage tomorrow, no doubt. We'll post some of the best here.

Gates gives $27.8 million to study rollout of HPV vaccines in developing world

As Reuters and the Seattle Post-Intelligencer are reporting today, the Gates Foundation has awarded $27.8 million for HPV implementation research to PATH, a Seattle-based non-profit and frequent recipient of Gates funding. (In April, PATH received $75 million from Gates for research on next-generation pneumonia vaccines, as we discussed here.)

This project is intended to determine the best approach for introducing HPV vaccines to developing countries. Initially, PATH will conduct pilot studies in India, Peru, Uganda, and Vietnam. As the PATH press release describes, both Merck and GSK are onboard with this program, pledging to provide their vaccines (once licensed) to the research initiatives. Dr. Regina Rabinovich, director of infectious diseases at the Gates Foundation, describes PATH's objective this way:

"PATH will help determine how to deliver these vaccines in developing countries, where systems to reach young women with health services are fragile, and cervical cancer may not be seen as a problem because so few women are screened."

There's no doubt that HPV vaccines would prevent far more cervical cancer deaths in developing countries than in the developed world, yet its projected cost and a host of implementation challenges mean that those populations needing the vaccine most will likely be among the last to receive it. Ultimately, finding a way to reduce dramatically (or underwrite) the vaccine's cost will be the greatest obstacle to HPV vaccines' global availability, but today's news is, by any estimation, a positive step toward that goal.

More on HPV vaccine criticisms, collaboration, and competition

As predicted, a slew of stories are appearing about HPV vaccines, with Gardasil's expected licensure later this week. A sampling of the best:

• Merck's $4 billion PR problem (Fortune) -- A look ahead at the (possible) battles that await Gardasil, particularly regarding opposition to state mandates. Includes quotes from Barbara Loe Fisher, perhaps the most prominent critic of vaccines, vaccine safety, and U.S. vaccination regulation and policy.

• Vaccine helps show value of partnerships (Boston Globe) -- Examines the collaboration between researchers at the National Cancer Institute, particularly Dr. Douglas Lowy, and subsequent commercial partners Merck and GSK in bringing HPV vaccines from the earliest stages of research through licensure. A great example of a successful public-private partnership, but one all but certain to add to the uneasiness of those who think the relationship between government and the pharmaceutical industry are too cozy.

• Cancer vaccine shows promise for older women (Reuters) -- Realizing the massive attention Merck's Gardasil will receive this month while its vaccine is months behind, GSK chose a conference this weekend to release new trial data on Cervarix. A 666-subject study of women age 15-55 showed that the vaccine generated antibody levels equal to those seen in younger women in earlier trials. What isn't answered in this or other stories is how beneficial it would be to launch HPV vaccination campaigns for older women, as many will have already been infected with the HPV types included in the vaccine.
  

Ethics of HPV vaccine policy options in Vaccine

The May 29 issue of Vaccine includes a paper that we have been expecting since first seeing a draft online back in March: "Ethical analysis of HPV vaccine policy options" written by Richard K. Zimmerman (Vol. 24, p.4812-4820 -- free abstract, subscription required for full text). Zimmerman is an Associate Professor at the University of Pittsburgh School of Medicine and a former ACIP member. (The bio on his website is out-of-date.)

Kudos to the editors at Vaccine for recognizing the importance of discussions at the intersection of ethics and policy, specifically regarding HPV vaccines. As a glance at any of its table of contents will attest, a paper on ethics is a rarity in the science-focused publication. Unfortunately, the paper doesn't quite live up to our hopes or even its own title. It reads more as a (simplified) primer to the major ethical theories than a useful discussion of the ethics of HPV vaccine policy. (See the two full paragraphs on the criticisms of utilitarianism with nary a mention of HPV therein.)

After brief examinations of HPV vaccination through the lenses of utilitarianism, the doctrine of double effect, and principlism (oddly, Kantian deontology is excluded), the paper concludes in this way:

"Given concerns for autonomy, justice, as not all persons are at risk, and non-maleficence, HPV vaccine should not be mandated for school or college entry."

Accepting the paper's ethical arguments would make it difficult to support mandating any vaccine, particularly new products with unclear risk profiles. (To be fair, Zimmerman doesn't take his argument that far, though there have been papers that do.) The most noteworthy omission from the paper is a discussion of the risks of vaccination compared to the risks of doing nothing (both the risk of infection and the consequences thereof, to individuals as well as populations). Criticisms aside, Zimmerman's offering is a laudable contribution to what should be a robust dialogue of the ethics of vaccination policy.

"Get wild at a measles party"

Der Spiegel is rarely on the list of news sources we scan for developments in the world of vaccines, but we admit being intrigued upon seeing the headline above. Ironically, the story appears in a section of the site dubbed the "Germany Survival Bible," a traveler's guide to the upcoming World Cup. The story's subhead only adds to the fascination:

"Imagine being invited to a party where the sole purpose is to infect your child with measles. It's actually not all that uncommon in Germany. But then, many in the country are afraid of vaccines."

The premise is that the country's lack of vaccination requirements, national skepticism over ingesting chemicals, and what the story describes as the "widespread German feeling that whatever doesn't kill you makes you stronger" combine to explain the motivation behind the practice. We're by no means experts on German culture or its public health attitudes, but the story sounds eerily similar to the all-anecdote, no-data 'hot new trend' stories that surface from time to time in U.S. publications.

Catholic medical group speaks against vaccines originally derived from fetal tissue

A few weeks ago, we saw this press release from the Catholic Medical Association titled "Vaccines derived from aborted human fetuses: A statement." To the best of our knowledge, the statement generated zero media interest until this Catholic News Service piece published today.

The background: Several vaccines, particularly those for rubella and hepatitis A, were initially developed by research that involved tissue from fetuses that had been voluntarily aborted. In some cases, the research in question occurred as long as 40 years ago. (It should go without saying that there is no fetal material in the vaccines actually administered, nor has there ever been.)

Catholic groups have been among the most vocal critics of these vaccines' origins, raising questions about the morality of receiving them in light of the teachings of their religion. The question becomes particularly difficult for them when there is no alternative vaccine available in the U.S. not derived from fetal tissue. (This is the case with rubella and Hep A, although alternative vaccines are available internationally).

Last summer, the Pontifical Academy for Life issued a document titled "Moral reflections on vaccines prepared from cells derived from aborted human fetuses." The points made in it are largely echoed by the Catholic Medical Association's statement, namely:

1) When alternative vaccines are available, they should be used.
2) If no alternative is available, it is permissible to forego vaccination only if doing so does not place others at significant health risks.
3) If no alternative is available, it is permissible to receive the vaccines in question in order to avoid a significant health risk.
4) There is a duty to lobby for the development or importation of morally acceptable vaccines.

Ultimately, this question is more about morality than ethics, but it's an interesting and little-known bit of history about the origins of very common vaccines still in use today. As a Google search will reveal, there are strong feelings on the topic, just as with many aspects of the U.S. vaccination landscape.