"Pneumococcal Vaccine and Otitis Media" by Dr. Erdem Cantekin

Erdem Cantekin, Ph.D., is Professor of Otolaryngology, University of Pittsburgh. An internationally recognized authority on otitis media and has studied causes and treatments for ear infection and sinusitis in his 25 year career. An early, outspoken critic of the overuse of antibiotics to treat ear infections, Dr. Cantekin has published more than 150 articles and abstracts in the medical literature on eustachian tube function, ear tube surgery, antibiotic resistance and conflicts of interest in biomedical research and manufacturer sponsored medicine.

Cantekin discussed the new Prevnar vaccine for pneumococcal, as endorsed by the American Academy of Pediatrics. "The alleged benefits for this new vaccine are greatly exaggerated and the risks are significant," said Cantekin. "The bacteria pneumococcus, with more than 90 serotypes, is a common pathogen. Though pneumococcus causes various diseases the carriage rate and serotype distribution rates in different groups are not know. Also, it is not known how pneumococcus transmutes itself into a pathogen. The role of pneumococcus in the microbiological balance is not known. It does contribute to 3,000 cases a year of meningitis, 50,000 a year of bacteremia, 500,000 cases of pneumonia, and seven million cases of otitis media or ear infections.

"With all of these unknowns, the vaccination of newborns with seven pneumococcal serotypes and possible eradication of those serotypes, is an uninformed experiment at best," said Cantekin.

"Unfortunately, our public health officials have no good estimates of these carriage rates in common populations. The rates of healthy newborns contracting these diseases are not well documented and yet to be determined. Yet in February 2000 Prevnar, a seven-valent, conjugate vaccine was approved for infants and toddlers. The FDA did not approve pneumococcal for pneumonia or otitis media. This approval was limited and paradoxical because three years earlier the New England Journal of Medicine the scientists had concluded that 'bacterial meningitis in the US is now a disease predominately of adults rather than infants and young children."

Cantekin pointed out that the study on Prevnar violated rules of internationally accepted methods of reporting clinical trials by publishing the results when they were incomplete. For example, regarding pneumonia there was no information at all. All the results were presented in a "confusing nonstandard format." Also, the control group for the study did not receive a placebo, but another meningitis vaccine.

Other questions remained unanswered: "If this HMO trial was going to be the only foundation to vaccinate every newborn in the United States, why were those findings, involving 38,000 captive HMO children, not published in a leading medical journal? The results were instead published in a journal well known to be the mouthpiece of drug manufacturers. It is also troubling that, prior to the publication of primary results, the medical economic analysis was rushed to publication in the Journal of the American Medical Association. Then a string of publications appeared in print - this was a well-organized effort to capture the newborn population as quickly as possible. ¦Prevnar is not effective for otitis media or pneumonia and the prevention of meningitis data are inconclusive. Why does the American Academy of Pediatrics want our children to be immunized using Prevnar? Why are all those experts excited about this new vaccine? I'm afraid the answer does not lie in the scientific realm. Endorsements by experts become more puzzling if we examine the adverse or peculiar effects of the vaccine in the HMO trial. As shown here, Prevnar had four times more seizures, four times more gastritis than the control group, significantly more developed asthma, one death in the Prevnar group. Strangely, there were twice as many SIDS in the control group, but remember the control group was receiving another experimental vaccine.

"The big push for Prevnar came from its supposed prevention of otitis media, even though it had not been approved for this use. The promise of saving children from this common, self-limiting disease now turned into persistent childhood pest, is an excellent strategy, for marketing. Every parent knows and abhors otitis media.

"Simple facts about otitis media is that 60 percent of the cases are viral, less than 40 percent are bacterial, and perhaps 25 percent of all otitis media is due to pneumococcus. In two days, 90 percent of the otitis cases resolve by itself without treatment. Regardless of these facts our experts for two decades have been recommending aggressive interventions, such as long duration antibiotic therapy and designer drugs, antibiotic prophylaxis and then followed by aggressive surgery. This clinical practice, not supported by existing scientific based evidence, fuels our $5 billion a year otitis media medical economics. So if Prevnar could stop the cycle of drug and slash, it would have been a great public benefit. But that is not the case. The FDA data both from Finland and the HMO trial show that the prevention benefit is less than four percent. Despite this, the economic spin goes on."

When the JAMA rushed to publish the economic analysis deployment of Prevnar in the US prior to the publication of the HMO trial results, Cantekin wrote a letter to the editor. In this letter he pointed out that all of the money the vaccine was supposed to save health care consumers would be saved without the vaccine if health care providers would stick to the clinical guidelines for the treatment of otitis media. His letter to the editor was rejected. "Prevnar will have the same effect that antibiotic abuse currently has because, by changing serotype, it will exert selective pressure on the microbial ecology. This vaccine is the perfect example of a profit driven health care with no checks and balances. In our $1 trillion health care system the public health for people's interest are supposedly in the hands of three government agencies: the FDA, the CDC, and the NIH. These three pillars of our public health system are more and more in the hand of expert panels and advisory committees with ad hoc appointed outsiders. Such experts dictate policies, control the complex biomedical information system, and directly influence the taxpayers' health and wealth. Those experts are frequently in the state of conflict of interest because they also serve those special interest groups who profit from their expert decisions. Most experts are in financial relationships with these special interest groups and are usually registered with the speaker offices of various manufacturers. In other words, they are paid lobbyist. The perils of such interlocking conflicts are dangerous to public health. With increasing frequency we witness the media exposures of these white coat crimes. I think it is time that a reform act was in order and the people demand better controls from the government to protect their health and their pocket books."

(To see some of the 150 papers Dr. Cantekin has written, go to the National Library of Medicine, PubMed, at http://www.ncbi.nlm.nih.gov/entrez/query.fcgi)