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Editorial: Scapegoating

Understanding Religious Wars

Vaccines: For Your Health or Their Profit?

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Black Myths

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For Your Health or

The Shadow Relationship Between Government and Global Vaccine Manufacturers

by Edward R. Rosick, DO, MPH
art/Eachean Edmundson

PRIMUM NON NOCERE. An ancient Latin saying, generally attributed to Hippocrates, the acknowledged founder of Western medicine. Translated, it reads First, Do No Harm. This simple but powerful statement was to be the guiding principle of medicine throughout the ages, from the time Greek gods ruled over the earth to when humankind was unraveling the genetic code of life. Yet as we all know, especially those of us trained as physicians, it is an admonition that time and time again has been thrown aside. Examples of physicians' indifference abound, from the treatment of people with poisonous compounds of mercury and arsenic during the middle ages, to the Tuskegee study, lasting from 1932 to 1972, where three hundred and ninety-nine black sharecroppers were studied like lab rats as syphilis racked their bodies and brains, even when safe antibiotic treatments were available.

Many people would say that the above examples are relics of a myopic past. They would point out that today we live on the cusp of a new era, a time when the promise of future cures for everything from cancer to AIDS seems real. They would point with pride at the use of vaccines to eradicate smallpox and make the fear of polio and measles all but footnotes in the medical history books.

It has been over 200 years since a British physician, Edward Jenner, used an eight-year old boy to test his theory of whether or not infecting someone with a relatively benign disease, cowpox, could protect one against a potentially lethal disease, smallpox. Ever since Jenner's risky experiment (at least for the boy), his proponents have touted vaccinations as a way to rid the world of the diseases that have plagued humans since the dawn of time. Still, there are those who are skeptical of the near miracles that vaccine proponents tout. Skeptics counter that the decreases seen in communicable diseases such as smallpox and measles are as much, if not more, as a result of such mundane advances as public sanitation, purified drinking water, and better nutrition.

There are also those who have resented and resisted government attempts to inoculate themselves or their children with vaccines they believed to be harmful. But their voices were silenced in a 1905 landmark case (Jacobson v. Commonwealth of Massachusetts) when the U.S. Supreme Court ruled that for the greater good, an individual's right to refuse vaccinations could be swept away. Because of this ruling, it is now standard medical protocol mandated by state law for children to have received up to thirty-two vaccinations before they can attend public school. If the current research in new vaccines continues, it is predicted that soon, children will be subjected to up to fifty shots before they begin kindergarten.

On the surface, the vaccine skeptics and dissenters appear to be nothing more than another lunatic fringe, composed of right-wing extremists and left-wing anarchists spouting vitriolic nonsense. However, a closer look reveals many of them to be sincere, well-trained professionals, including nurses and physicians. Through careful thought and research, they have come to question the claims of almost perfect safety for vaccines and the industry that produces them. Vaccine skeptics also view with trepidation the vaguely incestuous relationship between the U.S. government and the multinational pharmaceutical corporations that control the multibillion-dollar vaccine market.

Through takeovers and mergers, three global corporations--Merck, Aventis, and American Health Products--have emerged, for all practical purposes, to control the manufacture and marketing of vaccines around the world. The vaccine market is one of the most lucrative endeavors of the pharmaceutical industry, estimated to reap profits of at least seven billion dollars this year, and up to twelve billion or more annually by the year 2005. This growth shows no signs of slowing down, and in fact, since 1986, profits from vaccines have increased at least ten to fifteen percent every year. Much of this has been paid for by patients: from 1986 to 1997, the average cost to immunize a child with all vaccines mandated by law has increased 243 percent.

The year 1986 proved to be a pivotal year in the life of the vaccine industry. At the time, profits were stagnant, and many companies were seriously considering getting out of the business altogether. Claiming that their profits were being squeezed out of them by frivolous lawsuits, vaccine manufacturers were given a great gift by the U.S. Congress -- damn near full protection from any legal action arising from harm or death caused by their vaccines. At the companies behest, a system known as the Federal Vaccine Injury Compensation Program was set up at the taxpayers' expense to compensate anyone harmed or killed by vaccines, the very same vaccines which the taxpayers and their children are required by law to receive. It is a lawsuit-safe, profit ensuring system that other manufacturers only dream of.

This 1986 ruling was a shot in the arm, so to speak, for the pharmaceutical companies, and has fueled a meteoric rise in their profits from vaccine sales ever since. It has also fueled a slew of new vaccines reaching the market, with 200 more in the pipeline for release in the coming years. Vaccine proponents see this as wonderful news; vaccine skeptics tend to be much more cautious, if not outright alarmed. To them, this is just another example of drugs, in this case, vaccines, being pushed on an uninformed public by multinational corporations out to maximize their coffers.

To gain access to the lucrative U.S. market, vaccines and all other drugs must be approved by the Food and Drug Administration (FDA). The Centers for Disease Control (CDC) also play in a role in the approval of vaccines through the Advisory Committee on Immunization Practices (ACIP). This committee examines data submitted by vaccine manufacturers, holds discussions, and then votes whether or not to recommend that the FDA approve the vaccine for public use.

To quote directly from a report on the FDA web page entitled How FDA Works to Ensure Vaccine Safety: "FDA advisory committees [the ACIP] are groups of experts outside government that review data and issues associated with products and recommend what action the agency should take. . . Committee recommendations are not binding on the FDA, but the agency considers them carefully when deciding whether to license a vaccine for marketing."

What this FDA report fails to mention is that members of the ACIP are often nominated by pharmaceutical companies whose products are being looked at by the ACIP. While members of the ACIP are no longer permitted to directly vote on issues regarding a company they have financial ties to, they can actively participate in discussions and talks, thus allowing them to influence the recommendations ultimately made to the FDA.

Well into the 1990's, the use of the oral poliovirus vaccine (OPV), a vaccine made from live polio virus, was recommended by the ACIP. OPV (manufactured by Wyeth Lederle, which is a subsidiary of American Health Products) was endorsed and pushed by the FDA because of its ability to produce what is known as herd immunity. Herd immunity comes about through the shedding of the still partially living poliovirus in feces. Because of this, it is possible that people other than those directly receiving the vaccine could also ingest the poliovirus, albeit without their knowledge (the virus can sometimes survive through the sewage treatment process), and become immune to polio.

Unfortunately, OPV, besides producing herd immunity, can also cause polio itself. OPV was the known cause of 119 cases of polio in the U.S. between 1980 and 1994. There were no cases of naturally-occuring or "wild-type" polio during that time, since polio was eradicated in the U.S. in 1979. A furor arose in the vaccine skeptic's camp because during that time period there was in fact an alternative vaccine: Inactivated poliovirus vaccine (IPV), which is made from inactivated, or dead, poliovirus, cannot cause polio in those who receive it, or anyone else. Throughout the 1980s and 1990s, there was clamor to switch from OPV to IPV. In 1995, 16 years after polio had been vanquished from the Western Hemisphere, a CDC advisory committee met to discuss whether or not to continue to recommend the use of OPV over IPV. After deliberation, the committee voted to recommend continuing the use of OPV, knowing full well that their recommendation meant that they were subjecting unsuspecting citizens to a deadly disease.

It was revealed later that five out of the nine members of that CDC committee had financial ties to the polio vaccine manufacturers.

In 1998, a new vaccine called RotaShield was introduced to the U.S. market. Rotashield, also produced by Wyeth Lederle, was said to protect infants against rotavirus, a disease which can cause diarrhea, sometimes severe, in young infants and children. Rotashield had sailed through the FDA approval process, getting a full recommendation from the ACIP. It was also heartily recommended for routine use in all infants by the American Academy of Pediatrics.

A year after its introduction, Rotashield was voluntarily withdrawn from the market, following numerous reports of a condition called intussusception in infants that were given the vaccine. Intussusception is an extremely painful, sometimes fatal process whereby the infant's intestines become twisted and obstructed. By September of 1999, there had been 99 reported cases of intussesception in infants given RotaShield. Two of those infants died. Later investigation of the vaccine revealed that there had been an increased risk of intussusception seen in pre-market trials, yet this information was not required to be given to parents whose infants were given the vaccine. It was also discovered that three out of the five members of an FDA advisory committee voting to approve the vaccine in December of 1997 had ties to pharmaceutical companies developing rotavirus vaccines. Six out of the ten members on a 1998 committee that developed guidelines for giving the vaccine also had ties to pharmaceutical companies engaged in rotavirus vaccine development.

Vaccine skeptics claimed that the rotavirus debacle shed a revealing light on the suspicious relationship between the multinational pharmaceutical industry and the government. However, vaccine proponents actually tried to spin the rotavirus vaccine failure into a success story. They claimed that the withdrawal of the vaccine from the market showed that the surveillance system of the FDA, known as the Vaccine Adverse Event Reporting System (VAERS), alerted public health authorities in a timely manner about problems with RotaShield, although not so timely as to prevent the deaths of two innocent infants.

For other vaccines, the VAERS seems strangely to have little relevance in discontinuing, or even investigating, the vaccine. From July 1, 1990, to October 21, 1998, the VAERS received 17,497 reports of adverse reactions to the hepatitis B vaccine. The hepatitis B vaccine was introduced with much fanfare in 1986 as the first recombinant vaccine on the US market. The hepatitis B vaccine was developed by Chiron, which subsequently licensed it to Merck. Even with the huge number of adverse reactions reported, the vaccine continues to be pushed on the public by government edicts. In 42 states, it is now law that children entering grade school be vaccinated against hepatitis B, with State health boards recommending that infants be given the three dose schedule at 2, 4, and 6 months of age. Vaccine skeptics point out that in 1996, only 54 cases of Hepatitis B were reported in babies less than one year old. During that same time, there were 1,080 reports of adverse reactions in infants less than a year old, with 47 deaths. In spite of these grisly and frightening facts, the FDA continues to extol the virtues of the hepatitis B vaccine, and has no plans for any major studies on the possible myriad of side effects of the vaccine. It also has failed to answer questions concerning the rationale of using a vaccine for a disease that is primarily transmitted by sharing needles or unsafe sex to two month-old infants, most of which do not engage in such risky activities.

Since 1986, the development, production, and sale of vaccines has changed from a minor part of pharmaceutical sales to one of a hugely profitable multibillion dollar industry and has become a guaranteed money maker for global pharmaceutical companies.

These companies are protected by government laws against lawsuits and the vaccines are mandated by government law for every child in this country. The companies' studies of the safety profile of vaccines rests in the hands of men and women who are often part of the very industry they are appointed to investigate. Even if there is no definite proof of harm from vaccines, the government is obligated to put significantly more money into studies of the safety profile of vaccines, and thoroughly investigate the claims made by thousands of ordinary citizens of harm done to themselves and their children by vaccines. It would also be comforting to see such national medical organizations like the American Medical Association (AMA) and the American Osteopathic Association (AOA) show some intestinal fortitude by demanding that the CDC and ACIP advisory members have no financial ties to vaccine manufacturers; that parents are given all warnings and possible side effects of vaccines that are required for their children; and that full and definitive scientific analysis of the risks and benefits of vaccines are made top priority by the FDA. Only by taking these very needed steps can the AMA, the AOA, and the tens of thousands of physicians they represent heed the still relevant words spoken by Hippocrates many years ago.

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