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Vaccine Controversies Continue

Vaccine controversies continue to make news, with several stories making headlines within the past week. Several news outlets recently reported (e.g., here and here) on a study published in The Lancet that challenged conventional wisdom about the effectiveness of flu vaccines. According to one report, until recently the CDC vastly overstated the effectiveness of flu vaccines, then sharply (and quietly) downgraded its assessment (from 70-90% to 50-70%) only after it learned about the impending publication of The Lancet study.

Last week The Washington Post reported that a working group of the National Biodefense Science Board has advocated “inject[ing] healthy children with the anthrax vaccine to see whether the shots would safely protect them against a bioterrorism attack.” The recommendation is controversial because the risk of children being exposed to anthrax in a terrorist attack is speculative, and there is a dispute among researchers about the safety of the vaccine. In light of that dispute, it is doubtful researchers could demonstrate that children participating in this research would not be subjected to more than minimal risk, or that the risk is justified by the potential benefits to these children, as is generally required by the regulations governing federally-funded research on human subjects. (At a more practical level, the proposed research also raises the question of what parents would volunteer their children to participate in this study. As a father of two, I’m not exactly jumping at this opportunity.)

Perhaps most controversially, last Tuesday The New York Times ran a front-page story on a recommendation by the CDC’s Advisory Committee on Immunization Practices that boys and young men should be vaccinated against human papillomavirus (HPV), a sexually-transmitted disease. If some people recoiled at the idea of giving the HPV vaccine to pre-teen girls (perhaps on the assumption that their own daughters would be chaste), it’s reasonable to expect an even more visceral response to the idea that young boys should receive the vaccine – particularly because HPV-related complications in men are most common among those who engage in homosexual conduct.

I’m not in a position to second-guess the Advisory Committee’s HPV recommendation, but I suspect the argument against it would run something like this: According to The Kinsey Institute, roughly 4-6% of American males have ever had same-sex contact. Among those who do, most never develop HPV-related health problems. Each year the total number of American men who develop HPV-related cancer is about 1,900, or approximately .0006% of the population. While studies performed to date have not identified any serious health risks from the HPV vaccine, there are no published studies of its long-term side effects. In sum, would you vaccinate your young son, without knowing the long-term risks of the vaccine, to guard against the possibility that he will later have sex with other men, and contract HPV, and develop an HPV-related cancer? Some parents might vaccinate their boys for the additional reason that it would prevent them from transmitting the virus to women, who face greater risks from HPV, but I suspect that number would be low.

The prevailing conventional wisdom in the U.S. seems to strongly favor the rapid adoption of new vaccines. No doubt much of this enthusiasm stems from the history of successful vaccination campaigns and reasonable assessments of the relative risks and benefits offered by new vaccines. However, some of it may also be fueled by backlash against anti-vaccine advocates who make alarming claims that appear to lack any scientific basis. Some of the enthusiasm may also be driven by Americans’ unbounded faith in science, which can often lead (particularly within the scientific community) to a bias in favor of technology’s anticipated benefits and a downplaying of potential risks.

This bias can be reinforced by public health officials, whose primary interest is promoting the health of populations rather than individuals. Vaccinating an entire population can have a positive impact on public health, even when many individual members of that population are unlikely to benefit from the vaccine – as, for example, in the case of giving the HPV vaccine to boys to prevent them from transmitting the virus to women. If the CDC exaggerated the effectiveness of the flu vaccine, the agency may have been motivated by a compelling interest in maximizing the number of people who choose to be vaccinated – 50-70% protection against the flu is still much better than none, assuming the vaccines’ risks are minimal. But misrepresenting the benefits of vaccines is both unethical and shortsighted. It undermines trust in public health agencies and provides fodder for anti-vaccine advocates.

This problem is compounded when commercial interests are allowed to drive vaccine policy. In 2006-2007, dozens of state legislatures considered bills that would have made the HPV vaccine mandatory for many school-aged girls. Texas Governor Rick Perry went furthest, signing an executive order requiring young girls to receive the vaccine. The tide turned against mandatory HPV vaccination laws when it was discovered that the vaccine’s maker, pharmaceutical giant Merck, had been a driving force behind much of the proposed legislation. While Merck responded to the public backlash by putting its lobbying efforts on hold, the company was back in action last year, donating thousands of dollars to California legislators who supported a bill that allowed children 12 and order to be vaccinated against sexually transmitted diseases without their parents’ consent. Gov. Jerry Brown signed the bill into law last month.

The enormous power of state and federal governments to sacrifice individual liberties in the interest of protecting public health creates a corresponding responsibility to wield that power cautiously and honestly. Fulfilling that obligation requires making sober assessments of vaccines’ risks and benefits — assessments that are free from influence by commercial interests and mindful of the fact that many medical interventions once considered “safe” have later been found to carry unacceptable risks.

Matt Lamkin
Twitter: @lawbioethics

5 Responses to “Vaccine Controversies Continue”

  1. hgreely says:

    On the HPV vaccine, Matt, you say

    “Some parents might vaccinate their boys for the additional reason that it would prevent them from transmitting the virus to women, who face greater risks from HPV, but I suspect that number would be low.”

    I suspect you would be right if the issue were phrased exactly that way, but women who acquire genetic HPV infections will almost always have acquired them from me. Building up herd immunity will not only protect other people’s daughters from HPV acquired from your (hypothetical) son, but it would also help protect your (non hypothetical) daughters, certainly if they had not been vaccinated and, given that vaccination is not perfect, even to some extent if they had been vaccinated for HPV.

    In light of the broad public health benefits to half the species, shouldn’t the government advocate subjecting the other half to a safe and effective vaccine (assuming, of course, that it really is safe and effective)? Whether coercion is an appropriate governmental action seems to me a close call, but a governmental thumb on the scales – a “nudge” as Cass Sunstein would call it – seems right to me.

    Our son is 23 and beyond our coercive power. If he were 10, I would have him vaccinated against HPV in light of this CDC report. If you had a 10 year old son, would you?

  2. Matt Lamkin says:

    I’m not anti-vaccine – I’ve received many and so have my daughters. Nor am I opposed in principle to vaccinating one group of people primarily for the benefit of another group (although this has the potential to raise some interesting issues), assuming the vaccine is safe.

    If I had a 10 year-old son, would I have him vaccinated against HPV? I don’t know. Since I’m not a doctor, I have no choice but to rely on experts’ assessments of interventions’ risks and benefits – which is why it’s so critical to be able to trust those experts. Like the overwhelming majority of Americans, I don’t trust the companies that stand to profit from widespread adoption of these interventions. I would like to be able to trust public health officials, but that trust is undermined when these agencies exaggerate the benefits of an intervention, or allow corporate interests to drive policy.

    More fundamentally, I worry that public health officials may make different assessments of acceptable risk/benefit profiles than I would make for my own children. Part of that difference (if there is one) may be attributable to the difference between creating policies to protect public health and making decisions about risks and benefits for particular individuals. But another part could simply be a matter of psychological orientation. Many people seem to have a generally pro-intervention outlook – one that emphasizes the potential benefits of new technologies. Presumably this is the orientation shared by advocates of testing the Anthrax vaccine on healthy children to help protect future children against the speculative danger of a bioterrorism attack. Others are more wary of the risks of intervening in an extremely complex system (the human body) that we know relatively little about. This view is informed by a spectacularly long list of interventions that the medical community enthusiastically embraced, only to discover that the interventions carried unacceptable risks (thalidomide, hormone replacement therapy, Vioxx…). If you have this orientation, you’re more likely to take a wait-and-see approach to new interventions – especially if the benefits appear less than overwhelming or not particularly urgent in terms of timing.

    Of course, even if policymakers have a pro-intervention orientation, there is nothing improper about giving a “nudge” that they believe will protect public health. But today’s recommendations often become tomorrow’s mandates. The FDA approved Gardasil on June 8, 2006. By February of 2007 – prior to any meaningful post-marketing surveillance – the New York Times had run an
    editorial
    calling on legislatures in all 50 states to “require that all young girls be given this vaccine.” Dozens of legislatures took up that call (only to drop those efforts when Merck’s lobbying efforts were exposed). It’s one thing to make a recommendation on the basis of pro-intervention enthusiasm, and quite another to override parental choices on that basis.

    How would I decide whether to vaccinate my hypothetical 10 year-old son against HPV today? I’d ask my dad, who practiced medicine for 35 years. He always urged against medical interventions unless they were absolutely necessary. Accordingly, if he gave the HPV vaccine the thumbs-up, I would give his recommendation much more credence than those of the CDC (or the New York Times). The credibility of our public health guardians might benefit from more of this kind of skepticism.

  3. Gabriel Sulem says:

    The vaccine event of Bio-Law group 2 months ago was dressing exactly this problem.
    The speaker was mentioning that there was a statistical correlation between the number of vaccine given to children, and the general health state, with increased obesity or autism for example.
    It is true that we miss data, but to my understanding of how vaccine work (injecting a small dose of virus or bacteria for correct anti-corpse to be selected so that body will later be able to react quickly to an attack) I do not see how long term effects could occur. If someone has a cue, please reply.
    But it seems obvious that we are maybe more sensitive to see our child ill because of our decision (give a vaccine) rather than because of bad luck (infection), a fortiori if it is other’s children.
    Since theoretically a vaccine campaign is still efficient if we vaccinate all but one, I would not like to discuss that for public safety some decisions have to be imposed by the government and cannot rely on everyone’s choice, but it seems also reasonable (although I would love to hear pharmaceutical point of view about that) that evaluation of any vaccine risk (at least short term risks) has to be guaranteed independent and neutral.

  4. Birgit Calhoun says:

    I have looked into controversies revolving around vaccination. The most disturbing item I have come across is described in a book called “The River: A Journey to the Source of HIV and AIDS.”

    I am tempted to lose my trust in some of the practices that the pharmaceutical companies are thought to have engaged in. Amazon says about this book:

    While science has devoted much of its efforts to finding a cure for AIDS, the sources of this deadly epidemic remain largely unexamined. Distinguished science journalist Edward Hooper presents the meticulously researched — and highly readable — history of HIV and its possible origins. Pursuing leads across the U.S., the Caribbean, Europe, and Africa, Hooper pieces together the tantalizing clues offered by long-archived blood samples, early AIDS-like cases (such as the “Manchester sailor” case of 1959), immunodeficiency viruses (SIVs), and the medical interventions in Africa and elsewhere that may have played a role in SIVs’ crossover into humans.

    These medical interventions were polio vaccine trials in Africa.

    Some of these activities are depicted in the fictional John LeCarre novel “The Constant Gardener.” I have no personal experience regarding these types of events. Does anyone care to comment?

  5. Matt Lamkin says:

    An article in New Scientist about the HPV vaccine raises some of the same questions discussed in the post above: “Whenever a new medical intervention comes onto the scene, doctors have hard choices to make. Do we really know enough about its potential benefits and risks to recommend using it? If in doubt, should we err on the side of caution or on the side of hope?” You can find the article here: http://goo.gl/3Jft5.

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