Congressman Henry Waxman “is a hero on this debate.”That sentiment has frequently been expressed by liberal-leaning organizations on a wide range of issues during Waxman’s long 34-year career in Congress.
The current praise comes, however, from a more unlikely source: the top pharmaceutical policy expert at the American Enterprise Institute. The issue: upholding the public’s confidence in childhood vaccinations in light of a purported (and still unproven) link to autism.
The California Democrat got that ringing endorsement on Oct. 10 from Jack Calfee, who typically addresses health care issues from a position almost diametrically opposed to Waxman. From the AEI perspective, Waxman is often the epitome of too much government regulation and too much the friend of liability lawyers.
But on vaccine safety, the representatives of two ideologies find themselves aligned. The confluence of views on vaccine safety between AEI and Waxman should bode well for a continued climate of support for vaccines from the federal government, but challenges still persist.
The chief challenge is the continuing political appeal of the groups seeking to link autism to vaccinations.
Calfee’s praise for Waxman came during a question and answer session at an October 10 AEI session on a new book on the science and politics of autism by Paul Offit, the chief of the vaccine education division at Children’s Hospital of Philadelphia.
Offit’s book, “Autism’s False Prophets,” recounts how the proponents of a link between childhood vaccines and autism have pressed the issue into common parlance. The book traces the origins and issues raised from the decade-old effort to describe a link.
Offit, who bravely accepts the challenge to counter the attempt to tie autism to vaccines, notes that there has been a long history stretching back over 200 years of people looking at vaccines as the source of diseases arising from unknown causes. “Vaccines have been blamed for many diseases for which there are no clear causes,” he told AEI, citing multiple sclerosis, epilepsy, diabetes and mental retardation.
“Autism, like those disorders, has no clear cause or cure.” In that context, Offit observes, “it was just a matter of time” until a link to autism was suggested.
During the AEI event, Stephen Cha, an aide to Waxman, noted that the congressman has also taken a public stand to keep attention focused on the weight of scientific studies refuting the link between autism and vaccines.
Waxman recently sent a summary of the major studies to other members of Congress recently to counter arguments at a briefing on autism sponsored by Rep. Carolyn Maloney (D-NY).
Maloney, a liberal Democrat from Manhattan, is the sponsor of a bill (HR 2832) to require the National Institutes of Health to conduct a comparative study of vaccinated and non-vaccinated populations as a way to examine the allegations of a link between thimerosol and autism.
According to blog reports, the Maloney hearing drew representatives from 59 House offices and 30 Senate offices, including Barack Obama’s office.
The high attendance at the Maloney event demonstrates the persistent political attention to the issue. It even raised its head during the presidential campaign earlier in the spring, pushing Obama, John McCain, and even traditional supporters of vaccines like Hillary Clinton to speak out for caution.
Offit suggests that some of the skepticism about vaccine safety arises ironically from well-intentioned but maladroit efforts to reassure the public.
Offit’s account of the problems generated for vaccines by responding to safety questions too rapidly holds a lesson and warning for other segments of the drug industry and for drug regulators as they head further into the age of post-marketing surveillance reports from a wide variety of sources.
“The precipitous and frightening removal” of thimerosol from vaccines for young children rapidly within three years of the first charges of danger from the preservative actually fed concerns about vaccine safety, Offit told AEI. The effort to get the ingredient out rapidly was led by the American Academy of Pediatrics and “to a lesser extent” by the Centers for Disease Control & Prevention.
By handling the removal “in the manner that it was done,” it scared parents, Offit maintains. Because of the rush parents reasonably “would ask why would one take this ethyl-mercury containing preservative out of vaccines in such a precipitous manner if it wasn’t harmful.”
Offit notes that the “American Academy of Pediatrics put themselves in a position to try to communicate something that was virtually impossible to communicate: ‘yes we are taking it out, but there is not a problem.’”
The academy was put in the awkward position of trying to explain why it had urged action if it felt that vaccines were safe. “If you look at the way that they describe” the push to get thimerosol removed, Offit said, “they say that there is no evidence that thimerosol-containing vaccines are harmful, but to make safe vaccines even safer we’re going to take it out.”
“If it had not been shown to be harmful, how does taking it out make it any safer?,” Offit asks. “It doesn’t; it only makes it perceived to be safer.”
If there is a lesson from the autism debate, the right responses to safety concerns for vaccines (and drugs) in the future are going to take fortitude, careful judgment—and more heroes.
If the report can break through and dominate local news in those reasons, expect Waxman to move forward with an effort to bring the drug pricing and Part D programs back into the political spotlight, with a hearing or further request for information from Part D plans. Waxman’s oversight committee staff extracted the pricing information for the October 15 study from private plans by threatening to subpoena the information last spring. A hearing on the report was scheduled for Thursday, October 11 but was postponed.
Using private data and bidding information provided by 12 large Part D companies (representing 318 drug and Medicare Advantage plans), Waxman calculated that each Medicare beneficiary pays $180 a year to cover overhead and profits to administer the program: $107 for administration; $30 for sales and marketing; $43 for profits. Spread over the entire Part D beneficiary population of 24.1 million, that creates an administrative cost estimate of $4.3 billion.