MMWR: Flu recommendations and polio eradication update

Several interesting items related to vaccination appear in today's issue of MMWR. Among them:

-- A revision to the ACIP document "Prevention and Control of Influenza," an expansive review of all aspects of seasonal flu vaccination guidance and related data. Notable in this updated version is additional encouragement aimed at promoting influenza vaccination of health care workers as well as information on the composition of the 2007-08 vaccine.

-- A report on worldwide progress toward polio eradication, as of May 2007. The number of polio-endemic countries remains at four (Pakistan, Afghanistan, Nigeria, and India) with the vast majority of the 1,997 cases reported in 2006 occurring in Nigeria (1,123) and India (676). Global vaccination coverage stands at 78%, a number that is well over 90% in the Americas but far lower in Nigeria (39%) and India (58%). Those interested in polio eradication should visit our previous posts about polio, which include several items discussing the merits and challenges associated with pursuing eradication.

February ACIP Minutes Available

The minutes of the February meeting of the CDC's Advisory Committee on Immunization Practices are now available here. The 96-page report includes discussions of the report this spring of a possible link between RotaTeq and intussusception, an overview of the thimerosal/safety debate, an update on pandemic flu vaccine development, and presentations from Merck and GSK on their HPV vaccines.

As always, very interesting reading for those seeking unfiltered coverage (comparatively speaking) of the latest in federal vaccine policy.

Gardasil: Recommendations published, views on industry role, male vaccination, N.M. mandate, and more

Some updates from the past 10 days or so on recent news about Gardasil and the ongoing discussions about mandates...

• Last Monday, the official ACIP recommendations on Gardasil were published online in MMWR. These are essentially the same recommendations that were announced in June 2006 (which we first wrote about here) -- there is an increasingly longer lag between such announcements and publication in MMWR. One important consequence of publication is that it typically pressures insurance companies who have not yet agreed to cover the cost of the vaccine to do so.

• A story in today's Detroit Free Press asks, "Why aren't more girls getting HPV vaccine?" The story relies more on anecdotal reports than any real data, however. The two million doses of Gardasil shipped in the 9 months since licensure is a not-insignificant number, particularly considering the delays in insurance coverage in many cases. Nevertheless, it may be a question worth asking. This AP story may be relevant to the discussion, examining continued public ignorance about HPV, despite the attention it's received in the past year.
  

• An interesting (and provocative) opinion from Adrian Fugh-Berman on "Bioethics Forum" (the blog of the Hastings Center, the bioethics think-tank) -- "Cervical Cancer Vaccines and Industry Influence". Fugh-Berman's conclusion: "Cervical cancer is uncommon in the United States. This is not an emergency; this is not SARS. Listen only to public health people without conflicts of interest. There’s time for a discussion – but ban industry from the room in which any decisions on public health are made." Worth reading, regardless of one's own opinion on the topic.
  

• Following up on our colleague James Colgrove's perspective on HPV mandates in NEJM last fall (which we noted then), several letters to the editor were published earlier this month in response. One letter highlights the potential value of vaccinating males, and another takes issue with the use of the word "compulsory" to describe vaccination requirements that allow for informed refusal. This point goes to the increasing use of the term "opt-out requirement" when discussing what have traditional been known as state mandates.

• Speaking of vaccinating males, yesterday's Los Angeles Times took a closer look at some of the unique issues regarding HPV infection in men and the potential value of vaccination.
  

• New Mexico appears to be the next state on the verge of an HPV school-entry requirement. Here's a story from last week about the passage of a bill in its state legislature. As best as we can tell, the bill is still awaiting Gov. Bill Richardson's signature, which could happen at any time. Many other states -- too many to count -- have bills at some stage of the legislative process.

• The Powerpoint slides from last month's ACIP meeting were recently posted here. Updated Gardasil efficacy data from Merck's Eliav Barr are available there, as is a general overview of the American HPV vaccine landscape by CDC's Lauri Markowitz. It's very interesting for those looking for somewhat less-filtered information than what appears in the popular media.

Gardasil round-up: Merck lobbying, ACIP chair comments, Virginia mandate, and more

There continues to be a steady trickle of news about Gardasil, largely centered on the ongoing debate regarding possible state mandates. Rather than attempt to keep up with each day's new op-eds, news stories, and the rest, we've decided to combine several of the most interesting items from the past 10-14 days into a single post. With that, here are some recent items making headlines:

• Perhaps the biggest news from the past few weeks was Merck's decision to stop participating in lobbying efforts for state mandates. Here's one account of the story from late February, courtesy of Reuters. It quotes Merck's Richard Haupt calling the company's activities a "potential distraction." Few would disagree with this assessment, and it is surprising, given the company's extensive and seemingly well orchestrated marketing and education efforts, that it would commit so significant a public relations blunder.

• Since that announcement, there has been no shortage of stories and op-eds more or less making the same point, namely, that the Texas political controversy and Merck's lobbying efforts have obscured the scientific and medical aspects of the vaccine and its potential benefits. That's the thesis of this New York Times editorial, "A Necessary Vaccine," (subscription required) which generated a number of letters in response. Also: a story in today's Times titled "A Vital Discussion, Clouded."

• Sunday's Washington Post also looked at these issues ("Parents Question HPV Vaccine: Push to Mandate Shots Rapidly Creates Backlash") Quoted in this story is ACIP chair Dr. Jon Abramson, who makes clear here and elsewhere that he is no supporter of current attempts to mandate vaccination. Abramson is also featured in this essay by Arthur Allen, "Why It's Too Soon for a Mandatory HPV Vaccine," published in the New Republic Online.

• Also mentioned in the Washington Post story above is the imminent action by Virginia Gov. Tim Kaine to sign legislation making his state the second to mandate HPV vaccination. The requirement would not take effect until 2008 or 2009 and would include the traditional types of exemptions (increasingly referred to in the media, accurately, as an 'opt-out provision'.) More information can be found in this story.
  

ABC "20/20" segment on risks of vaccination

On February 23, ABC News' 20/20 featured a series of reports by John Stossel under the heading "Scared Stiff: Worried in America." Among the topics he explored was the general question "are vaccines safe?" His conclusion: Yes, they are. An article closely based on the piece is available here.

Supporting Stossel's conclusion was Dr. Paul Offit; taking the other side, as usual, was Barbara Loe Fisher. She was hardly portrayed in a positive light by Stossel. Most damning was Fisher's unwillingness to acknowledge that, on balance, vaccines have done more good than harm for society throughout history, a position that all but the most fervent opponents of vaccination readily accept.

Needless to say, Fisher was less than pleased with the program's discussion, Stossel's assessment, and the way in which she and her organization were perceived. Her response can be viewed here.

Texas HPV vaccine mandate in the news

There has been a great deal in the news this week about Gardasil (and a corresponding spike in our traffic), much of which has been triggered by Texas Gov. Rick Perry's executive order on Friday requiring sixth-grade girls to be vaccinated against HPV. Here's the text of the executive order and an accompanying press release from the governor's office. Quoting Perry, "Requiring young girls to get vaccinated before they come into contact with HPV is responsible health and fiscal policy that has the potential to significantly reduce cases of cervical cancer and mitigate future medical costs."

Perry, a Republican, has received criticism for this decision from members of his own political party and conservative organizations, as this AP story and this Houston Chronicle story explain. Perry released a second statement over the weekend, saying, in part,

"Providing the HPV vaccine doesn’t promote sexual promiscuity anymore than providing the Hepatitis B vaccine promotes drug use. If the medical community developed a vaccine for lung cancer, would the same critics oppose it claiming it would encourage smoking?

"Finally, parents need to know that they have the final decision about whether or not their daughter is vaccinated. I am a strong believer in protecting parental rights, which is why this executive order allows them to opt out."

Indeed, likely lost in the headlines pointing to a "mandate" is the important point that the exemption policies already in place in Texas will apply to HPV vaccination in the same way, including parents having the ability to decline vaccination for 'philosophical reasons'. In fact, proponents of vaccine mandates will likely be disappointed to learn that the executive order also instructs state officials to make the exemption process easier by creating a system in which parents can decline vaccination online.

Today's New York Times includes an editorial praising Perry for the decision. In fairness, it argues far more convincingly for HPV vaccination generally than it does for a state mandate (though strong arguments can certainly be made for it.)

Independent of discussions about the appropriateness of philosophical exemptions from vaccination (such as Paul Offit's op-ed we noted here), the current state mandate system means that no parents will be forced to vaccinate their children against their will. However, years of experience have shown that state mandates provide the structures and encouragement necessary to maximize a vaccine's benefit across communities, particularly reaching those without regular access to medical care whom cervical cancer targets disproportionately.

When considering vaccine mandates, we should not focus our attention on those with strong beliefs opposing vaccination, as the exemption procedures provide, for better or worse, a relatively simple remedy. Instead, we must consider those silent in these debates, those not receiving even basic medical care, much less tracking the minute-by-minute developments regarding Gardasil. For them, state mandates have been shown repeatedly to provide the awareness and stimulus needed for the vaccine to reach all who could benefit from it.

Offit on vaccine exemptions

Our colleague Paul Offit published an op-ed in the Wall Street Journal last week titled "Fatal Exemption" (Unfortunately, subscription is required for full access). In it, Offit notes the findings published in JAMA last month showing a significant increase in the number of vaccine exemptions and the corresponding increase in vaccine-preventable illnesses. The chief culprit, says Offit: the growing use of 'philosophical exemptions'. He writes, in part:

"When it comes to issues of public health and safety, we invariably have laws. Many of these laws are strictly enforced and immutable. We don't allow philosophical exemptions to restraining young children in car seats, to smoking in restaurants or to stopping at stop signs. And the notion of requiring vaccines for school entry, while it seems to tear at the very heart of a country founded on the basis of individual rights and freedoms, saves lives. Given the increasing number of states allowing philosophical exemptions to vaccines, at some point we will be forced to decide whether it is our inalienable right to catch and transmit potentially fatal infections."

For the bookshelf: Vaccine by Arthur Allen

A new book released this month is sure to be of interest to readers of this site: Vaccine: The Controversial Story of Medicine's Greatest Lifesaver by Arthur Allen. Allen is a journalist who has written frequently in the popular press on vaccine-related issues. We haven't yet read the book, so we can't vouch for its merits, but all accounts point to it being a comprehensive work (as any 500+ page book is likely to be) tracing the history of vaccination from Jenner to today.

Allen has published vaccine-related essays in several publications this month, providing well-timed promotion for his book. On January 15, Allen wrote a piece for Slate titled "The Autism Numbers: Why There's No Epidemic" that looks broadly at the rise in autism rates in recent years, including the alleged link to vaccines.

Last Thursday, Allen had an op-ed published in the New York Times titled "For the Good of the Herd," a strong defense of the merits of vaccination framed by some of the major events (both good and bad) of U.S. vaccination programs in the 20th century. By the end of the op-ed, there's little doubt that Allen is a strong proponent of vaccination. He writes:

"But the experts are certain that it is only a matter of time before a flu pandemic strikes. Keeping the vaccine pipeline running and building immunity against all types of flu will help us prepare. Even in apparently humdrum flu years like this one, it behooves us to join the herd and be vaccinated."

Finally, the book's website, www.vaccinecontroversy.com, includes an extended essay by the author with his take on "how to think about vaccination."

Update, 2/6/06: In this weekend's New York Times, David Oshinsky gave the book a quite favorable review.

From NEJM: Ethics and Politics of HPV Mandates

This week's New England Journal of Medicine includes a commentary titled "The Ethics and Politics of Compulsory HPV Vaccination" by James Colgrove, an Associate Research Scientist at Columbia's Center for the History and Ethics of Public Health.

Colgrove -- a contributor to our Ethics of Vaccines Project -- does an excellent job outlining the many competing considerations that will influence states' decisions regarding possible mandates of HPV vaccination as a condition of school or day-care attendance. While there is not much new in the essay (particularly for regular visitors to this site), Colgrove's essay is, by far, the best available synopsis of the topic in print to date. Thanks to the folks at NEJM, its full text is available for free.

One problem (perhaps the only one) with the essay is Colgrove's simplistic characterization of the perspectives of bioethicists on the topic, a description that comes perilously close to caricature. He writes:

"Bioethicists, who generally hold the values of patient autonomy and informed consent to be preeminent, tend to be skeptical about compulsory vaccination laws. Not surprisingly, some have expressed wariness about or opposition to mandating HPV vaccination."

Colgrove surely must be aware that any attempt to describe how "bioethicists tend" to think about a specific policy issue is about as useful as trying to capture in one sentence what "politicians tend to think" about Iraq or what "judges tend to believe" about civil liberties, as though a single, dominant position exists on these topics. In fact, many bioethicists, particularly those coming from a public health background, are quite comfortable with state vaccine mandates, including those for HPV vaccination.

As for the "some" bioethicists expressing wariness, Colgrove cites only two papers on ethical aspects of HPV vaccination, one of which is written by Pitt's Richard Zimmerman (a paper we previously discussed here). While Zimmerman has written frequently on ethical topics in journals of the vaccinology community, it is a stretch to identify him as a bioethicist, let alone as one of two who represent how the discipline as a whole tends to think about vaccine mandates.

These criticisms aside, Colgrove's essay is well worth reading for anyone thinking seriously about the appropriateness of HPV mandates.

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.

Seattle Children's Hospital to host conference on pediatric vaccine ethics

The Treuman Katz Center for Pediatrics Bioethics at Children's Hospital & Regional Medical Center in Seattle is hosting a conference July 14-15 titled "Current Controversies: Ethical Issues Related to Vaccination of Children".

The conference aims to address the following, among other topics:

• Do "wealthy" nations have an ethical obligation to develop vaccines for diseases that occur primarily in developing nations and to fund vaccination programs for children of impoverished nations?
• Is it appropriate to do human vaccine testing in developing nations and, if so, under what conditions?
• How should priorities be set regarding the development of new vaccines?
• How should vaccines be distributed in a shortage situation?
• Should vaccination programs be government funded or market based?
• Should parents be able to refuse vaccinations for their children?
• How should health care providers respond to parents who are reluctant to vaccinate their children?
• When does the community interest in public health justify restricting the freedom to choose regarding vaccination?
• Are school mandates too restrictive, too weak or appropriately written?

Quite a broad spectrum of questions to tackle in two days, but it looks to be an excellent program.

Parents challenging school exclusion policies for unvaccinated

While vaccinations are required in every state in the U.S. as a condition of public school or day-care attendance, all allow for exemptions in certain circumstances, namely medical, religious, or philosophical reasons (or a combination thereof, depending on the state). However, most states warn that those exempted from vaccinations may be prohibited from attending school in the event of an outbreak. With the current mumps epidemic in the Midwest, this policy is being tested, with mixed results...

• In Kansas, 15-year old David Brockway was not permitted to attend school for 12 days after another student contracted mumps. Brockway's father, who had acquired a religious exemption for his son and signed a form acknowledging suspensions such as this were possible, protested the action to the school board and won, according to the Wichita Eagle. The compromise: Brockway's father had to sign a 'waiver' specific to mumps, calling into question whether the motivation for the school board's actions is a concern over public health and limiting the transmission of the virus or merely insulating itself against potential liability. Since it's acknowledged that those vaccinated are not 100% protected against mumps, the school board may have actually put themselves at greater legal risk, if other students get mumps as a result of Brockway being an ideal vector for transmission.

• In Edwardsville, MO, two students were escorted from school by police when they attempted to attend classes despite being prohibited from school because of not being vaccinated for mumps, the St. Louis Post-Dispatch reports. One parent is reportedly meeting with a lawyer over the matter.