Whooping cough shot didn't protect two-thirds of local cases
Vaccine makers fund whooping cough advisory panels
If scientists don't take money from drug companies, how will important medical research be funded?
But if they do take the money, will they be biased in favor of the company that funds them?
These questions, common in the medical field, are pertinent during the pertussis epidemic, when the universal recommendation for avoiding the disease is vaccination and when some scientists are debating the efficacy of the vaccine.
The Watchdog Institute, an investigative reporting center at San Diego State University, and KPBS have found that the two leading global makers of pertussis vaccines, Sanofi Pasteur and GlaxoSmithKline, have funded expert groups that recommend vaccine policy on the disease to government agencies.
GSK and Sanofi Pasteur make all pertussis vaccines sold on the U.S. market.
Sanofi Pasteur funds the most influential group, the Global Pertussis Initiative, made up of 35 medical experts from 16 countries.
The Watchdog Institute and KPBS found that 24 of the group's members have received funding from Sanofi Pasteur, its parent company Sanofi-Aventis, and/or GSK.
GSK funded a second, smaller group, the International Consensus Group on Pertussis Immunisation, which one former member said is no longer operational.
But for several years, at least eight of its members were receiving consultation, research or speaking funds from GSK while the group published recommendations about pertussis vaccine policy.
Pertussis, also known as whooping cough, is a highly contagious respiratory illness that may mimic a cold for the first 10 days.
It then can produce a violent and persistent cough with a unique "whooping" sound.
For adults, pertussis may only be a nuisance, like a bad cold.
But to infants, it can be deadly, because they can't cough up what collects in their lungs and infections can spread.
Vaccinations nearly wiped out whooping cough more than 30 years ago.
But it has made a vengeful comeback in highly vaccinated communities around the U.S., with more than 7,000 cases reported in California this year ---- including 10 infant fatalities ---- and more than 1,000 cases reported in San Diego County.
The Watchdog Institute-KPBS investigation found that many people contracting whooping cough were immunized, including more than two-thirds of local cases.
Globally, vaccines were a $22 billion industry last year, and according to one forecast, sales are expected to top $34 billion by 2012.
The state of California has spent more than $206 million on pertussis vaccines from Sanofi and GSK since 2007, including $56.9 million this year.
Sanofi Pasteur declined to answer questions, but prepared a statement:
"Sanofi Pasteur is committed to public health and we routinely review epidemiological data, as well as the safety and effectiveness of all our vaccines, to ensure that we are offering high quality vaccines to patients. At the present time, there is no evidence to suggest current pertussis vaccines lack effectiveness."
GSK directed a Watchdog Institute reporter to its website, helppreventwhoopingcough.com.
The Global Pertussis Initiative was founded in 2001 by a group of scholars from around the world who decided to get together periodically and discuss the ways to control whooping cough, which was once nearly wiped out in many countries.
It has three goals: to increase infant vaccination rates, to increase booster shots among adolescents and adults, and to "cocoon" infants who are too young to get the vaccine by vaccinating those who come into contact with them.
Over the past decade, its members have published in respected scientific journals, including Vaccine, Clinical Infectious Disease and the Pediatric Infectious Disease Journal.
Their research urges expansion of immunization and booster shots, rather than the development of new pertussis vaccines.
The recommendations and research by the distinguished members of these two groups are widely cited.
For example, when setting vaccination schedules or publicizing health guidelines, medical associations and health agencies from New Zealand to India to Alaska cite the Global Pertussis Initiative.
Experts widely influential
The Centers for Disease Control and Prevention has cited the Global Pertussis Initiative in its publications.
Internal documents of the World Health Organization show that members of the initiative have made recommendations to that body as well, and four sat on the pertussis vaccine advisory committee for WHO.
One member, Janet Englund, a pediatric infectious disease expert with the University of Washington, is on the CDC's Advisory Committee on Immunization Practices, which sets immunization schedules and other key health guidelines.
Stanley Plotkin, an emeritus professor of pediatrics and microbiology with the University of Pennsylvania and one of the initiative's founding members, was candid about the group's connections to the vaccine maker.
"It should be stated," he said, "that the initiative is funded by Sanofi Pasteur under an educational grant. So that the money for travel, etc., comes ultimately from a vaccine manufacturer."
Plotkin also has worked for Sanofi Pasteur since 1991 (which operated under a different name then) and has been listed as a shareholder in disclosure documents.
He said he doesn't know how much the initiative receives from Sanofi Pasteur, but assured that the vaccine maker does not participate in making recommendations or steering discussions.
Michael Kalichman, professor of pathology and director of the UC San Diego Research Ethics Program, understands both sides of the industry's financial contributions and notes that corporations fund all kinds of research at universities and other places.
"There's a very good reason for people who are authoritative and perhaps paid by companies to be some of the people who are asked for advice about what to do," he said. "We don't want people who are nonexperts to be the ones who make decisions."
Ethics require disclosure
However, receiving any contribution from industry introduces "some level of conflict," he said, adding that "people might, because they're being paid, overlook risks, overlook a lack of efficacy, in ways that people who weren't paid would not."
In addition, whether or not the contributions foster biases, what is unethical is not disclosing them to the public, he said.
One pertussis expert who believes that the conflicts of interest on the Global Pertussis Initiative are clear is Frits Mooi, a vaccine and infectious disease researcher with the National Institute of Public Health and the Environment in The Netherlands, the equivalent of the CDC.
Mooi has been advocating for the development of better vaccines against whooping cough.
Mooi said the Global Pertussis Initiative has ignored his theories about a new, more toxic strain of the disease.
"They just don't want to listen," he said.
"They kept it out of their articles, and it's a kind of censorship."
Mooi said it was a "positive step," when told recently that the CDC announced it is studying pertussis bacterial strains.
What all these scientists do agree on is that the current vaccine and its boosters may not be perfect, but they're far better than having no protection at all.
Frugal travel funding
James Cherry, a professor of pediatric infectious diseases at UCLA's medical school, is one of the most respected and influential vaccine experts in the U.S. and a vocal member of the initiative.
He said the funds cover only necessary travel expenses.
"They didn't throw money around. It was very Spartan in some ways. Like, if you wanted to have your wife go, you paid everything," he said.
He also said researchers and policymakers are in a difficult position, because making new vaccines is an expensive and lengthy process ---- and consequently unlikely to happen any time soon.
Plotkin said the conference money from Sanofi Pasteur has allowed experts to address an escalating health crisis and create solutions that have dramatically affected public health.
"I do think there has been considerable movement towards pertussis immunizations," he said. "I don't think you can say this is definitely the result of the GPI, but I do think that it's helping."
Plus, he noted, no one else is able or willing to foot the bill.
"If this kind of educational group is not organized by industry, who is going to do it?" he asked.
Roxana Popescu is a San Diego-based freelance reporter and contributing writer at the Watchdog Institute.
KPBS is the Public Broadcasting affiliate in San Diego. The Watchdog Institute is an independent nonprofit investigative journalism center. Both are based at San Diego State University.
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