Ethical Concerns Over Whooping Cough Vaccine
An investigation by the Watchdog Institute and KPBS has found that the two leading global makers of whooping cough vaccines, Sanofi Pasteur and GlaxoSmith Kline, have funded expert groups that recommend vaccine policy on the disease to government agencies.
Last April, vaccine manufacturer Sanofi Pasteur launched a Facebook campaign to get 50,000 fans for a page it called “Sounds of Pertussis.” The company promised to donate $5,000 to the March of Dimes once the goal was met.
Little more than six months later, the results were in: “We did it!” the company announced in a status update. By Dec. 1, 12,000 more people “liked” the page.
With that Facebook page, Sanofi Pasteur attained several goals at once. It raised awareness about pertussis, the disease characterized by an uncontrollable whoop-like cough, it taught people how to protect themselves and their families through immunization, and it got the attention of more than 62,000 potential customers for its vaccines.
This campaign may have been smart public relations, but ethicists say when vaccine manufacturers reach beyond their research labs and sales operations and step into educational and public health policy, they enter a prickly territory. This has been particularly evident during the pertussis epidemic, where the universal recommendation for avoiding the disease is vaccination – even though some scientists have raised questions about the efficacy of these vaccines.
An investigation by the Watchdog Institute, an investigative reporting center at San Diego State University, and KPBS, San Diego’s public broadcast affiliate, has found that the two leading global makers of pertussis vaccines, Sanofi Pasteur and GlaxoSmith Kline, have funded expert groups that recommend vaccine policy on the disease to government agencies.
Sanofi Pasteur funds the most influential group, the Global Pertussis Initiative, which is 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 GlaxoSmithKline (GSK).
GSK funded a second, smaller group, the International Consensus Group on Pertussis Immunisation, which one former member says is no longer operational. But for several years, at least 8 of its members were receiving consultation, research or speaking funds from GSK while publishing recommendations about pertussis vaccine policy. Several members have also received funding from Sanofi Pasteur, the Watchdog Institute found.
Globally, vaccines were a $22 billion industry last year and according to one forecast, sales are expected to top $34 billion by 2012.
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.”
Rather than answer questions, GSK directed a Watchdog Institute reporter to its website helppreventwhoopingcough.com.
The recommendations and research by the distinguished members of these two groups is 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.
The Centers for Disease Control and Prevention (CDC) has cited the Global Pertussis Initiative in its publications. Internal documents of the World Health Organization (WHO) 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.
Michael Kalichman, professor of pathology and director of the UC San Diego Research Ethics Program, understands both sides of 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 non-experts to be the ones who make decisions.”
On the other hand, 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 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.
In the worst outbreak of this disease in 60 years, California has had more than 7,000 reported cases of pertussis this year, including 10 infant fatalities. The Watchdog Institute-KPBS investigation found that many people contracting whooping cough were immunized.
Mooi says 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.” Much money has been invested in the current vaccine, Mooi said, and if he is right about a new strain, a different vaccine would need to be developed.
Mooi said it was a “positive step,” when told recently that the CDC has announced it is studying pertussis bacterial strains.
What all these scientists do agree on is that current vaccine and its boosters may not be perfect, but they’re far better than having no protection at all.
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 making a comeback after decades of retreat.
It was the first time international researchers with diverse medical specialties – pediatrics, health economics, epidemiology and others – systematically tackled pertussis on a regular basis, said Stanley Plotkin, an emeritus professor of pediatrics and microbiology with the University of Pennsylvania who chairs the group and was one of its founding members.
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 advocates for expansion of immunization and booster shots, rather than the development of new pertussis vaccines.
Plotkin was upfront about the group’s connections to the vaccine maker. Without being asked, he offered this disclosure: “It should be stated that the initiative is funded by Sanofi Pasteur under an educational grant. So that the money for travel, etcetera, comes ultimately from a vaccine manufacturer.”
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.
Another member, James Cherry, a professor of pediatric infectious diseases at UCLA’s medical school, said the funds only cover 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.
Plotkin said he recognizes the pitfalls of taking money from vaccine makers for meetings, but sees medical research as in an increasingly difficult position: if they take money from industry, they are seen as ethically compromised, and if they do not, then they lack the funds to make progress.
“… All I can say about it is that if this kind of educational group is not organized by industry, who is going to do it?” he asked.
The group’s recommendations are guided by the same financial pragmatism. Cherry said a new, better vaccine is a long way off because it would be too expensive.
“I think the likelihood of the logistics of getting a new vaccine right now in this country is almost impossible, because of the FDA rules and requirements,” he said. “There’s a lot of things you could do (to improve current vaccines), but to get it approved would cost billions of dollars. So the incentive is not there yet.”
Instead, the initiative’s recommendations focus on three readily attainable 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 people who come into contact with them.
Plotkin said the group doesn’t keep track of how much impact it is making or who is following its recommendations.
“The people on the GPI obviously attempt to influence what goes on in their countries,” he said. The target is “mainly individual doctors, although I would hope other organizations would take some note of them.”
Cherry is one of the most respected and influential vaccine experts in the U.S. and a vocal member of the initiative. He has served as a peer reviewer for the highly respected Journal of the American Medical Association, and is often quoted in media reports endorsing vaccination and boosters.
Another initiative 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.
Five other doctors recently participated in influential WHO committees. Claire-Anne Siegrist is part of the SAGE group, which sets vaccine and immunization policy, and the rest were members of WHO’s pertussis immunization working group, which just concluded its research and reporting, Nicole Guiso, an infectious disease expert in France, Carl-Heinz Wirsing von König, a professor in Germany, a Canadian professor named Scott Halperin, and Kathryn Edwards, with Vanderbilt University.
Plotkin asserts the initiative’s recommendations are not influenced by the vaccine maker. However, Plotkin has worked for Sanofi Pasteur since 1991 (which operated under a different name then) and has been listed as a shareholder in disclosure documents. Two members have looser ties with Sanofi Pasteur: Annelies Van Rie, a professor of epidemiology at the University of North Carolina, Chapel Hill, was employed by Aventis Pasteur, Sanofi Pasteur’s parent company, for a year, and a former member of the initiative. David Greenberg, has worked for Sanofi Pasteur since 2004 and donated $500 to a Sanofi Pasteur PAC in 2005, according to campaign finance records.
In addition, records obtained through a database from ProPublica, a nonprofit news organization, show that five of the group’s U.S. doctors accepted a total of $58,300 in 2009 and 2010 from GlaxoSmithKline for speaking and consulting services. They are Plotkin, Cherry, Tina Tan, a professor of pediatrics with Northwestern University, Stanley Gall, a professor of obstetrics, gynecology and women's health at the University of Louisville, and Edward Rothstein, a pediatrician in Pennsylvania. Sanofi Pasteur does not publicly disclose payments to doctors.
Several members from the Global Pertussis Initiative participated in the second, smaller expert group. That group was financed by GSK and many of its members received individual funds from vaccine makers. Both groups made similar recommendations – increase immunization and booster shots – and they occasionally cited one another. Cherry said the GSK group was not well organized and eventually fizzled.
Art Caplan, director of the University of Pennsylvania’s Center for Bioethics, said vaccine researchers often feel like they have no option but to collaborate with pharmaceutical companies.
“There are a lot of ties between vaccine makers and vaccine researchers, but they're not out there (published),” he said. “It’s tough to find money from any other source to do meetings because foundations and the government agencies are not set up to fund that. It’s a huge problem, because often times the researchers in the vaccine area are kind of stuck with pharma money because there’s not many other places to go.”
Plotkin says the conference money from Sanofi Pasteur has allowed experts to address an escalating health crisis and create solutions that have dramatically impacted 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.”