Dr. Jay L. Wile*

Those who consider vaccines to be unsafe or ineffective have a serious problem when faced with the medical literature, because study after clearly shows that vaccines are both safe and effective. Of course, this is not a problem for many in the anti-vaccination movement, as they are unfamiliar with the scientific literature. However, those who are familiar with the scientific literature are forced to find some way to discount this overwhelming evidence. Thus, they often posit that the medical literature is controlled by the "evil" pharmaceutical companies. According to the theory, these pharmaceutical companies are so heavily invested in the production of medicines that they keep the bad news about vaccines from getting out, and they "rig" the studies that are published in order to make sure that vaccines come out looking good.

There are, of course, several things wrong with such an outlandish conspiracy theory. First and foremost, the vast majority of those who perform and publish the studies which appear in the medical literature are not associated in any way with any pharmaceutical company. Thus, they would have no reason to do the pharmaceutical companies' bidding.

Second, if the pharmaceutical companies really were able to manipulate the research, they would be just as likely to "rig" the data of a study on a competitor's product to make it look bad as they would be to "rig" a study on their product to make it look good! For example, GLAXO Smithkline makes a Hepatits A vaccine. However, it does not make an MMR vaccine. Merck and company makes both. Clearly, GLAXO Smithkline would benefit greatly if it were determined that the MMR vaccine is fatally flawed. This would cause Merck and company to lose profits, possibly putting it out of business. If that were to happen, GLAXO Smithkline would suddenly get all of the Hepatitis A vaccine business. Thus, from a business point of view, GLAXO Smithkline should "rig" the studies on the MMR vaccine. Nevertheless, we do not see these things happening.

Thirdly, you might not be familiar enough with the medical literature to know this, but studies come out regularly which are really bad for the pharmaceutical companies. Let's start with vaccines themselves. Respiratory Syncytial Virus (RSV) is one of the biggest killers of infants and young children in the U.S. For years, pharmaceutical companies have tried to make a vaccine. If a pharmaceutical company could get an RSV vaccine licensed, it would make millions! However, one has never been approved. Why? Because the studies done on the vaccines that have been made demonstrate that they are not safe enough or effective enough to be considered a reliable medicine1,2.

Now if the pharmaceutical companies were able to "rig" things to make their products look good so as to cash in on the misery of the American people, why didn't they "rig" these studies to show that the RSV vaccines were safe and effective? After all, since RSV is still a big childhood killer, they would stand to make a lot of money if they could get their vaccine licensed. Nevertheless, they are missing out on this cash cow just because of a couple of annoying studies. Why haven't they buried those studies or "rigged" them to come out in favor of the vaccine?

Another example of how the medical literature is clearly not slanted in the pharmaceutical companies' favor comes from studying the history of the rotavirus vaccine. In 1998, the rotavirus vaccine was licensed because it passed all levels of controlled studies required for licensure. However, in the final level of clinical study, five children of the 10,054 who received the vaccine came down with a serious bowel obstruction. Only one child of the 4,633 who did not receive the vaccine (the control group) came down with the same malady. However, the difference between five out of 10,054 and one out of 4,633 was not statistically significant, so the vaccine was licensed3. Even though it was licensed, this serious bowel obstruction was listed as a possible side effect and was specifically flagged for surveillance once the vaccine was given to the general public.

In 1999 (just ONE YEAR later), the Vaccine Adverse Effects Reporting System (VAERS) logged 15 reported cases of the serious bowel obstruction amongst those who received the rotavirus vaccine. Even though the frequency of this side effect was low (15 out of 1.5 million doses), it generated enough concern that studies were quickly done to see if these cases were related to the vaccine.

Several studies were done4-5. The most thorough one demonstrated that there was a slightly elevated risk of serious bowel obstructions (one case in every 11,073 children vaccinated) for those who received the vaccine. Even though the risk is rare, the severity of the bowel obstruction combined with the low mortality of rotavirus in the United States led to the decision to pull the rotavirus vaccine from the standard vaccination schedule.

This story is illustrative in three ways. First, it shows the efficacy of the surveillance that is constantly done on vaccines. In just over one year after the licensure of the vaccine, an extremely rare side effect was reported, analyzed, and was serious enough to outweigh the benefits of the vaccine. As a result, the vaccine was pulled from the vaccination schedule. Second, it shows the risk/benefit analysis that is important for any medicine. The rotavirus vaccine was effective. It prevented the disease in many children who would have otherwise gotten it. However, the risk of death or long-term side effect from the disease is relatively low. Thus, even though this vaccine produced a benefit, that benefit was small. In addition, the medical studies clearly showed a risk that, although small, was not insignificant. Thus, the data indicated that on balance, children were probably more at risk getting the vaccine than not getting the vaccine, so the vaccine was pulled from the standard vaccination schedule. This is the kind of solid, medical reasoning that must be used when evaluating any medicine, including a vaccine.

Finally, this story clearly shows that the pharmaceutical companies do not manipulate the scientific studies. Even the studies done for licensure noted the problem. Those studies suggested surveillance after the vaccine was given to the general public. Thus, the pharmaceutical company did not "hide" the problem. In fact, they made sure that the problem was well understood so that surveillance could be done. Then, when the problem began to appear on VAERS, studies were quickly done, and the studies implicated the vaccine, causing it to be pulled from the vaccination schedule.

If the pharmaceutical companies were able and willing to manipulate the studies, they certainly did not do it here, and the result was a huge loss of money! Clearly, at a rate of 1 case every 11,073 children, this problem could have been easily "swept under the rug." However, it was not. Why? Because the scientific literature is not easily manipulated.

I want to pause here a moment and point out that this whole rotavirus vaccine issue once again shows how ignorant anti-vaccine advocates are when it comes to the medical literature. If anti-vaccine advocates were even passingly familiar with the medical research on vaccination, they would not only know about the rotavirus vaccine issue, but they would also notice that many of the same authors on the study showing a definite problem with the rotavirus vaccine are also authors of studies that show other vaccines do not have problems. For example, these authors: Destefano F, Lieu T, Black SB, Shinefield H, and Chen RT are all a part of the study that caused the rotavirus vaccine to be pulled from the market. However, they are all also on a major study that showed no connection between thimerosal-containing vaccines and autism or ADD.6 So could some anti-vaccination advocate please explain to me how these same authors can be "in league" with the big, bad pharmaceutical companies when it comes to thimerosal-containing vaccines, but not when it comes to the rotavirus vaccine?

Vaccine studies are not the only ones that end up being bad for the pharmaceutical companies. Studies are constantly being performed on medicines that have been licensed by the FDA. Although most of these studies end up demonstrating the safety and efficacy of the medicine studied, this is not always the case. For example, a recent study shows that Lipitor and other cholesterol-lowering drugs can cause nerve damage7. Drug companies raked in more than 9 billion dollars on such drugs in the year 2000. Nevertheless, this study will reduce sales considerably, as it identifies an entire class of people who should not be taking such drugs.

Another example of a medical study that is bad for the pharmaceutical companies comes from the area of estrogen therapy. A major study was recently published which shows that estrogen therapy can have significant side effects8-9. This has already radically changed how doctors are prescribing the third most prescribed drug in the United States. Wyeth, a leading maker of estrogen therapy drugs, made more than 2 BILLION dollars from them in 2001. The company's stock plunged 24% when the study's results were announced. Wyeth itself actually informed all of the doctors in its database about the study, even though they knew it would dramatically decrease sales.10

So you see that the medical literature is decidedly not "pro-pharmaceutical company." It is simply a forum for the publication of data. These data many times support the medicines made by the pharmaceutical companies, but sometimes they do not. It is the data, not the finances of the pharmaceutical companies, that drives the medical literature. Anyone who has dealt with the rigorous peer-review process necessary to publish in the standard medical journals knows that. However, the public does not, and anti-vaccination advocates prey on the public's ignorance so as to cast doubt on the reliability of medical science.



REFERENCES

1. Fulginiti VA, et al. "Respiratory virus immunization. A field trial of two inactivated respiratory virus vaccines: An aqueous trivalent parainfluenza virus vaccine and an alum-precipitated respiratory syncytial virus vaccine." Am J Epidemiol 1969; 89: 435-448. Return to Text

2. Chin J., Magoffin R.L., Shearer L.A., Schieble J.H., Lennette, E.H. "Field evaluation of a respiratory syncytial virus vaccine and a trivalent parainfluenza virus vaccine in a pediatric population." Am J Epidemiol 89, 449-63 (1969) Return to Text

3. Rennels M.B., Parashar U.D., Holman R.C., Le C.T., Chang H.C., Glass R.I. "Lack of an apparent association between intussusception and wild or vaccine rotavirus infection." Pediatr Infect Dis J 1998;17:924-5 Return to Text

4. Kramarz P., et al., "Population-based study of rotavirus vaccination and intussusception." Pediatr Infect Dis J. 2001 Apr;20(4):410-416 Return to Text

5. A good review of many of the studies: Morbidity and Mortality Weekly Report, 48: 577; 1999. Return to Text

6. Verstraeten T., et. al., "Safety of thimerosal-containing vaccines: a two-phased study of computerized health maintenance organization databases." Pediatrics 112:1039-48, 2003 Return to Text

7. Gaist D, Jeppesen U., Andersen M., Garcia Rodriguez L.A., Hallas J., Sindrup S.H. "Statins and risk of polyneuropathy: a case-control study." Neurology 2002 May 14;58(9):1333-7. Return to Text

8. Writing Group for the Women's Health Initiative Investigators, "Risks and Benefits of Estrogen Plus Progestin in Healthy Postmenopausal Women: Principal Results From the Women's Health Initiative Randomized Controlled Trial" JAMA 2002; 288:321, Return to Text

9. Lacey, James V. Jr, et al. "Menopausal Hormone Replacement Therapy and Risk of Ovarian Cancer" JAMA 2002; 288:334 Return to Text

10. Thayer, Ann "Halted Estrogen Study Hits Wyeth" Chemical and Engineering News, July 15, 2002; 8 Return to Text





*Dr. Wile is not a medical doctor. He is a nuclear chemist. As a result, he does not dispense medical advice. He simply educates the public about scientific issues. Please consult a board-certified medical doctor before making any medical decisions for yourself or your family. Return to Text
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