Informed Dissent

H1N1 Vaccine is Here With Too Few Takers

Parents want the best for their children – happiness, success and good health. But nearly two-thirds plan on delaying or denying vaccinations against the H1N1 flu to their kids. It’s more than ironic to me, especially when so many complain about the lack of access to preventative care in this country.

Two similar polls just came out – one from the Associated Press-GfK and the other from Consumer Reports – that demonstrate that only about half of the U.S. population will be vaccinated. It’s not big news, though. This sort of result has been the unfortunate norm.

Why haven’t the numbers improved? Why are people so wary? Why are there so many who actively oppose vaccination? Is this just a case of people not being adequately informed? And, is this the government’s fault? The report published by the AP said that “The survey raises questions about government efforts to stem illnesses already spreading widely across the country.” I’m not quite sure what this statement is based on but my view is that the public-private partnership that has made millions of doses available is an impressive achievement.

So, allow me to briefly address some of the suspicions and concerns:

Flu isn’t all that serious. Influenza and pneumonia are the eighth leading cause of death in the U.S. (over 56 thousand annually).

It may be safe but I worry about side effects. Everything we do carries a risk. One must weigh the risk of injection site swelling and pain against contracting the flu with its potentially serious sequelae.

The vaccine hasn’t been adequately tested. Again, nothing is fool-proof, nothing is risk-free. FDA’s requirements for safety and effectiveness, however, are demanding. Moreover, the methodology for manufacturing the H1N1 vaccine is no different from other flu vaccines – vaccines that have an excellent safety record.

Vaccines can cause autism and other diseases. We may never know with 100 percent certainty but every credible study and review thus far (the most recent having been conducted by the Institute of Medicine) has concluded that there is no causative link.

I don’t think I/my children will get the flu. Sure, you might get lucky but why count on this wishful thinking? It has already been reported in 37 states – a much more rapid spread than in previous years.

I don’t trust it if the government is behind it. Fine, have a healthy skepticism but please don’t take it too far. Don’t undermine your health or the health of your family by listening to the fringe opinions of people like Rush Limbaugh who recently said that “All of this is designed to get people to respond to government orders, not to do things or to do things. It is designed to expand the role and power of governments and schools, and the media, of course, just falls right in line here with amplifying the nature of the crisis.” It's too bad there's no vaccine for paranoia.

If there are such good responses to these concerns, why aren’t people listening? Why aren’t people better informed?

My sense is that people are listening. They listen to and are informed by people that make sense to them. The CDC and NIAID have been all over the news with compelling information. About half of the country will act on what they heard. The other half will not be convinced. The message from anyone employed by or connected to these sources will not be trusted.

This is a barrier that will probably take a long time to breach. The ongoing outreach and education must continue while new efforts must be established to address the reasons why health messages bounce off of so many. Politics and conspiracy theories aside, elevating the public’s health and science literacy may give everyone a common ground from which to make their healthcare choices.

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Swine Flu's Teachable Moment

An Opportunity for Public Health and Vaccine Manufacturers

It was disturbing to read about a growing public health threat in "Vaccine Refusal, Mandatory Immunization, and the Risks of Vaccine-Preventable Diseases" in this week's New England Journal of Medicine (Omer et al.). The bottom line is that there is a critical need for new education and policy efforts to protect children (sometimes from their own parents) and the general public.

Here's an example of some of the bad news: In the case of measles, it's been estimated that more than two million cases occurred each year in the U.S. before a vaccine was available. In a triumph of science and medicine, the number of cases dropped to a mean of 62 per year between 2000 and 2007. In the first four months of 2008, however, 64 cases were reported with 63 of those occurring in children who were not vaccinated. Why?

• Past success. With a number of diseases nearly wiped out by vaccines, it seems as though our memories have been wiped out as well. As time marches on, many have forgotten the potential severity of vaccine-preventable diseases. Using the measles example, some cases can cause pneumonia, seizures, meningitis or even death.


• Alternative medicine and junk science. Of course, "western medicine" does not have all the answers. But it's been reported that parents of unvaccinated children "were more likely than parents of vaccinated children both to have providers who offered complementary or alternative health care and to obtain information from the Internet and groups opposed to aspects of immunization."


• Ease of opting out. Although the constitutionality of mandatory immunizations has been upheld, individual states have the ability to set the bar and allow exemptions based on personal or religious beliefs. In another unfortunate example, "the mean annual incidence of pertussis was almost twice as high in states with administrative procedures that made it easy to obtain exemptions as in states that made it more difficult." It was reported also that children with exemptions were 35 times more likely to contract measles.


• Denial. Compared to parents of vaccinated children, significantly more parents of unvaccinated children believed their kids had a low susceptibility to diseases (58% vs. 15%) and that the severity of disease was low (51% vs. 18%).


• Lack of trust. Again, compared to parents of vaccinated children, significantly more parents of unvaccinated children believed that vaccine efficacy and safety were low (58% vs. 17%, 60% vs. 15%).

Although the hearts of parents who withhold vaccinations from their children for non-medical reasons might be in the right place, their brains are not. In the "rugged individualism" that many Americans use to define themselves, there is a consequence of putting others in harm's way. Those who are unvaccinated put their communities at a higher risk of disease outbreak.

Now, there's a race to develop another vaccine -- this one against the swine (H1N1) flu. Although no one wants a new disease to contend with, there may be a silver lining -- a chance to reengage the public on the importance of immunizations. No doubt there will be an educational push when the vaccine is available. But at the same time, a campaign should be tied-in to reverse the dangerous growth of vaccination exemptions.

No vaccine is risk-free and not every mind can be changed. Still, the CDC (with their reach and clout), vaccine manufacturers (who can gain sales and reputation) and health care providers (who are a trusted source and carry influence on family health care decisions) should join forces to develop a new dialogue with the public. And let's sustain the discussion, let's put the science and evidence in perspective, and let's build some trust.

Let’s Not Get Burned and Drowned (By Information)

Right, Wrong; Too Much, Too Little; Too Early, Too Late
If Martha Stewart was in public relations she might say, “Information – it’s a good thing.” Information can educate. It can inspire. But, it can confuse. It can even harm.

We’re exposed – sometimes bombarded – by health information everyday. It comes from our healthcare providers, from the media, from consumer groups, from government institutions and advertisements. Shirley Wang wrote in The Wall Street Journal last week, “Too much information about drug safety – disseminated through media, online alerts from consumer watchdog groups and even by the Food and Drug Administration itself – might overwhelm patients and raise undue alarm, some medical professionals caution." Indeed, also reported in this story was a survey of 300 medical professionals released last March by Pfizer that found nearly all (89 percent) were at least “somewhat concerned that patients might stop their medications if potentially negative safety information was released to the public too early."

The clutter and confusion is an issue not only for patients and caregivers but for physicians, too. The database of clinical guidelines (those standards of care developed by a wide array of medical societies) maintained by the American Medical Association contains over 2,200 entries. Some were not subjected to peer review and some contradict others outright. Dr. Darshak Sanghavi, a pediatric cardiologist at the University of Massachusetts Medical School, wrote in The New York Times recently that in the past year “the American Academy of Pediatrics abruptly reversed its recommendation that healthy infants avoid peanuts and other potential food allergens, without citing any new data. Weeks after the American Heart Association widely publicized the need to perform cardiac testing in children treated with drugs for attention problems, the academy issued a contradictory guideline discouraging such testing.”

These guidelines carry weight in determining if a drug, device or procedure will be reimbursed by insurance, and are supposed to be developed using hard clinical data – so called evidence-based medicine. But here, too, lie a bevy of contradictions. For example, Stephanie Saul wrote in The New York Times last week about the CyberKnife, an FDA approved treatment for the treatment of a variety of tumors made by Accuray. In prostate cancer, the key advantage is that treatments take five days instead of eight weeks for conventional cancer radiation. “As it turns out, Medicare pays for the treatments in 33 states — but not in 17 others. “You can live on one side of the street and get a procedure, but on the other side of the street you can’t,” said Dr. Steven D. Pearson, president of the Institute for Clinical and Economic Review.”

Where does this leave us? Here are a few thoughts:

For consumers: Trust, but verify. We’re told to rely on sources of information that we trust. But be careful. Trust is easily misplaced – just ask those who invested with Bernard Madoff. Look for information that lists its authors. Look for references. Additional comfort can be gained if the information is attached to a major medical institution, or a government agency like the NIH or CDC.

For health information providers: Release information when it’s ready, not when it’s half-baked. Many studies and interim results are made public too early. Clearly, if there’s a serious potential adverse event or public health issue, it’s important to err on the side of safety. But, in other cases, try less for a change. Not everything is news, not everything needs an announcement.

For healthcare decision-makers: Set expectations in advance for what information is needed to render judgment, while leaving room for some flexibility in a dynamic field. We need a clearer understanding of the thresholds of acceptability, when enough information is enough and transparency in the review process.

Positive steps have been taken, to be sure, but we still need to work to ensure that information is of higher quality, delivered at the right time and conveyed in language appropriate to the audience.

Personalized Promise

Preparing For the Era of DNA-Guided Medicine

I have been involved with the field of personalized healthcare since helping to lobby for the Human Genome Project bill in the late 1980s. In 2000, it was great to see the first “working draft” of the genome get published ahead of schedule.

Like any new technology, however, there has been a lag in translating discovery into practical application. Although DNA-guided medicine – getting the right drug to the right patient in the right amount at the right time – is not moving into mainstream medicine as quickly as we would like, we can be optimistic that it will displace traditional trial-and-error approaches with increasing speed. In addition to the ongoing efforts in the diagnostic and biopharmaceutical industries, academia and government, a new piece of legislation should spur the development and adoption of personalized medicine.

The boost may come from The Genomics and Personalized Medicine Act, first introduced in 2006 as S. 3822 by then Senator Obama and now being expanded by Representative Patrick Kennedy in H.R. 6498. The bill acknowledges that promoting the shift toward personalized medicine “will require continued Federal leadership and agency collaboration, expansion and acceleration of genomics research, a capable genomics workforce, incentives to encourage development and collection of data on the analytic and clinical validity and clinical utility of genomic tests and therapies, and improved regulation over the quality of genetic tests, direct-to-consumer advertising of genetic tests, and use of personal genomic information.”

In addition, the bill directs the Director of the Centers for Disease Control and Prevention (CDC) to “expand efforts to educate and increase awareness of the general public about genomics and its applications to improve health, prevent disease and eliminate health disparities.” Yet, it seems that these efforts might be limited to the “ongoing collection of data on the awareness, knowledge and use of genetic tests through public health surveillance systems, and analysis of the impact of such tests on population health.”

I’m afraid that what might be collected is more about what we already know – public understanding of health and science, much less genomics, is low. (Really low. Of those surveyed by the National Science Foundation, about 10 percent knew what a molecule was, about 30 percent could define DNA and about half knew that it takes the earth one year to orbit the sun!) I’d like to see the legislation strengthened by including an initiative to identify gaps in public understanding which would then lead to new efforts in public education.

Why? It’s the only way to develop and sustain trust in the new technology. Despite assurances in the Genetic Information Nondiscrimination Act of 2008, people are wary about sharing their DNA. People need know what personalized medicine can and can’t deliver. Without some greater understanding and trust in the science – and the system of collecting and processing samples – we won’t see appropriate demand, we won’t see appropriate utilization and we won’t see enough people benefiting from the information that resides in their own bodies.