Jesus was fond of parables: punchy short stories with a moral message. One of his more memorable tales was one about a helpful Samaritan who gave comfort to a mugging victim. The story of the Good Samaritan was meant to encourage empathy for people in need of assistance.
Now imagine another parable, one in which a perfectly healthy passerby is tackled to the ground by The Relentless and Overbearing Samaritan who demands that the healthy stranger go with him to a hospital three times to swallow some new medicine, month after month, because the Samaritan is convinced the medicine might benefit the healthy passerby, some day. What would be the moral of this parable? That bullies know what’s best? If you believe that this weird parable sends a creepy moral message that no sane person would embrace, then you haven’t met Rick Perry, the governor of Texas.
On Ground Hog Day of 2007, the governor of Texas, who fancies himself to be a Christian and a conservative, snubbed the state legislature altogether and declared, by executive decree, that beginning in September of 2008 every girl in Texas who is about to enter the sixth grade must submit to three injections of Gardasil, a vaccine marketed by Merck & Company. The Texas Samaritan-in-Chief proclaimed that “The HPV vaccine provides us with an incredible opportunity to effectively target and prevent cervical cancer.” He offered the opinion that this vaccine is no different from those vaccines that protected children from polio. Even if this were true it would be frightening.
1954
On Wednesday, June 9th, 1954, I and some of my eight-year-old classmates were led to the gymnasium of Ridgeway Elementary School in White Plains, New York. We were marshaled into single file and one by one we were injected with a new vaccine. After my injection, I was given a card that declared me to be a Polio Pioneer for having participated in the first national trial of a vaccine against infantile paralysis.
A few months later, on April 12, 1955, a soft-spoken Dr. Jonas Salk approached a podium at the University of Michigan and announced that he had created a polio vaccine. It was the same vaccine that had been injected into me ten months earlier. That very afternoon the government of the United States licensed the Salk vaccine for mass inoculation.
Dr. Salk had concocted his novel vaccine by growing live polio virus on the kidney tissue of Asian rhesus monkeys. The harvested virus was then killed with formaldehyde. When the dead virus was injected into human beings, the immune systems of the host humans produced antibodies against the dead virus. Henceforth, the host human would be immunized against any future exposure to any live polio virus. It was a work of genius. Within weeks, vaccine was injected into the bodies of millions of Americans.
1959
Injections of the Salk vaccine had continued unabated for four years before an alert researcher at the National Institutes of Health noticed that monkey kidney cells of the sort that were used in the production of the Salk vaccine were withering away for no apparent reason. It was then that Bernice Eddy prepared kidney extracts from rhesus monkeys and injected tiny amounts of the extracts under the skins of 23 newborn hamsters. Within a mere nine months 20 of the 23 hamsters had developed “large, malignant, subcutaneous tumors.” Eighty-seven percent of the host hamsters had developed cancer.
On July 6th, 1960, Bernice Eddy disclosed her concern that some unknown monkey virus might be contaminating the Salk vaccine. Later that year, doctors at a Merck laboratory in Pennsylvania isolated Bernice Eddy’s phantom virus. They labeled it SV-40 – simian virus 40 – because it was the fortieth virus found in rhesus monkey tissue.
1961
By 1961 nearly 98 million Americans had been injected with the Salk dead-virus vaccine. By then a new oral polio vaccine developed by virologist Albert Sabin was about to be licensed for public consumption in the United States. The Sabin vaccine employed a weakened live polio virus to excite an immune reaction in its human hosts. Both the Salk and Sabin vaccines were contaminated with SV-40, the Asian-rhesus-monkey virus. By then public health officials knew that a third of the Salk vaccine was tainted with SV-40. They also knew that SV-40 was generating cancer in laboratory animals. In March of 1961 the U.S. Public Health Service ordered vaccine producers to rid polio vaccines of SV-40 contamination. By that time well-intentioned adults had already demanded that I swallow the contaminated Sabin polio vaccine.
From then on, vaccine was produced using uncontaminated African green monkeys. Even so, a full year’s supply of tainted vaccine was held and dispensed by America’s doctors. The fact that SV-40 caused cancer in animals was concealed from the American public. The government do-gooders were fearful that telling the truth about vaccine contamination would jeopardize their vaccination campaigns. On July 26th, 1961, the New York Times disclosed that Merck and other vaccine producers had ceased vaccine production until they could rid their products of “a monkey virus.” All these decades later, the effect of SV-40 on humans is largely unexplored. We know for certain that it generates brain and lung cancers in research animals.
The secret dimension of the government’s mandatory live-virus vaccination campaign was the fact that vaccine recipients would shed the live polio virus by bodily contact to unvaccinated friends and family members. There was a secret plan to immunize every person in America. Several people contracted polio from live virus particles shed by vaccine recipients. No one was told that the polio vaccine recipients were also shedding SV-40 all over America. By 1960, when the SV-40 contamination was first detected, it was too late to prevent its dissemination to the entire population. By 1963 there had already been 98 million tainted vaccinations. The National Institutes of Health identified high levels of SV-40 contamination in vaccines dispensed in Oregon, Wyoming, Washington, Iowa, Minnesota, Utah, Michigan, Illinois, Wisconsin, Washington, DC, Delaware, Pennsylvania, Maryland, Connecticut, Rhode Island, New Hampshire, Massachusetts and New York. SV-40 at lesser levels was found in vaccines dispensed in Arizona, New Mexico, Colorado, California, Nebraska, Kansas, North Dakota, Missouri, Kentucky, Ohio, Georgia, Louisiana, Tennessee, West Virginia and Texas, where the governor now wants to launch yet another mandatory vaccination campaign with a very new vaccine.
Researchers offer us the cold comfort that vaccine recipients stop shedding virus particles by age fifteen. This leaves me to wonder if the SV-40 I shed from age eight to age fifteen caused my non-smoking mother’s fatal lung cancer or my father’s rare and fatal bone marrow cancer. Grant requests to study the effects of simian virus on humans are routinely denied. Noting that nearly one hundred million Americans had been contaminated with SV-40 by the government, microbiologist Howard Urnovitz told the Boston Globe that, “The government will not fund science that makes it look culpable.” Dr. Urnovitz believes that human immunodeficiency virus, type one, (HIV-1) is a hybrid monkey virus that infected 320,000 Africans when they were injected with a polio vaccine contaminated with live simian immunodeficiency virus (SIV) in the late 1950s. A hybrid virus (chimera) is the consequence of a virus uniting with viral fragments of another sort. Official assertions that Americans vaccinated in the 1950s do not have higher cancer rates than the rest of the population mean nothing in a nation that was saturated with monkey virus as an unintended consequence of a secret government program to inoculate everyone by the method of virus shedding.
The Lone Star Stalin
Governor Rick Perry advertised himself as a Christian and a conservative and then demonstrated that he has no understanding of either philosophy. Using his executive powers to force repeated vaccine injections on young girls is neither Christian nor consonant with conservatism. Texas legislators saw Mr. Perry’s public-health commandment as an abuse of executive authority – all the more abusive because that state’s founders had intended the executive branch of the Texas government to be comparatively weak.
On March 14, 2007, the Texas House voted 118 to 23 to stop the health commission from issuing any mandates. A Senate version of the bill allowed the ban to expire in four years; this version was passed by a veto-proof House vote of 135 to 2 on April 25th, 2007. The lawmakers may revisit the issue when they meet again in 2009.
“We did not want to be the first in offering young girls for the experiment to see if this vaccine is effective or not,” remarked Rep. Dennis H. Bonnen, who sponsored the ban in the House. Senator Glenn Hegar, Jr., who sponsored the Senate bill, observed that “There was no public testimony – why we were jumping so fast into a vaccine that was not for a true communicable disease.” He meant communicable by casual social interaction. The governor’s attempts to liken his compulsory Gardasil campaign to the compulsory polio vaccination campaigns of the 50s and 60s were political hokum. In the end, the incendiary blend of sex education, cancer and under-age girls proved to be too much for a Texas politician. The ban had cleared the Senate by a vote of 30 to 1.
The single nay vote was cast by Senator Leticia van de Putte, a Democrat and also a pharmacist. Said Ms. Van de Putte: “I’m thinking of the women that will die because we didn’t act.” It doesn’t seem to have occurred to her that women might seek vaccination voluntarily. In fact, voluntary vaccination has been brisk and enthusiastic.
Texas state Senator Jane Nelson, chairman of the health and human services committee, understood that her constituents had elected her to represent them, not to dictate to them. Nelson observed that “Lawmakers should have been allowed to hear from doctors, scientists and patients before the state implemented such a sweeping mandate. This is not an emergency.” Good point. So why the big rush?
The Big Rush
It costs an enormous amount of money to develop, test and bring any new medicine to market. Not every medicine is a money maker. Every year the rights to exclusively market patented medicines expire, allowing the makers of generic medicines to erode the profits of the medicine inventors with cheaper generic drugs. The inventor of a profitable medicine has only a limited period in which to reap the rewards of his considerable investment of sweat, money and genius.
Merck’s HPV vaccine Gardasil, which promised to defend women from the four strains of virus that play a role in the genesis of seventy percent of cervical cancers, was immediately desirable to young women and their nail-biting moms. Merck had a big-bucks winner; they were elated. There was, however, this one dark cloud on Merck’s bright horizon: the pharmaceutical giant GlaxoSmithKline was brewing another HPV vaccine called Cervarix. When Cervarix was market-ready Merck’s profits would fall. Merck’s marketing division saw Cervarix for the menace that it was and felt an urgency to push Gardasil sales fast and hard.
Merck salesmen understood that if American girls could be compelled to endure Gardasil injections, then Gardasil would be an instant economic blockbuster. The salesmen also understood that in American society only one party is legally empowered to compel citizens to do anything. That party is the government. With this understanding, the Merck salesmen began lavishing cash on lawmakers, including a group of female legislators called Women in Government. The Merck money was well spent. An executive from Merck’s vaccine division, Deborah Alfano, sat on the business council of Women in Government. Many of the state bills promoting Gardasil vaccination campaigns have been spearheaded by members of this group. Women in Government has refused to disclose how much of Merck’s money it pocketed.
Having convinced the FDA that Gardasil should be fast tracked to early licensure in the summer of 2006 and with the blessing of the CDC’s Advisory Committee on Immunization Practices, Merck was on a roll. Twenty-four states were considering compulsory Gardasil vaccination programs. Governor Rick Perry’s signature made Texas the first state to require that 11- and 12-year-old girls submit to three injections of Gardasil before they would be allowed school admittance. Merck’s lobbying campaign was complemented by assertive Merck salesmen who implored doctors to endorse Gardasil. Televised sales pitches urged young women to get vaccinated so that there would be “one less” cancer patient.
Governor Perry’s heavy-handed dictate took on a nasty stink when it was revealed that Merck’s paid lobbyist in Austin was Mike Toomey, who had previously been Governor Perry’s chief of staff from 2003 to 2004. The mother-in-law of Perry’s present chief of staff was state Rep. Dianne White Pelisi, who was also a state director of Women in Government. Perry had also accepted six thousand dollars from Merck’s political action committee. According to the New York Times (4/26/07), “A Merck spokesman declined to comment on the company’s lobbying.” Gardasil injections cost between $120 and $150 each, so Merck was poised to rake in a fortune. That’s when Merck’s big plan began to fall apart.
Revolt of the Guinea Pigs
The stink from Austin began to waft across Texas. A revolt by Texas lawmakers overwhelmingly overturned Governor Perry’s executive order. In the more than twenty states that were considering mandatory vaccination for girls, a resistance has developed. The New York Times reported that “Virginia recently became the sole state with a law requiring the vaccination for girls entering the sixth grade but allowing parents to refuse shots for their children.” (5/12/07)
The brass-knuckle tactics were not necessary. Some clinics had four-month waiting lists for Gardasil inoculation. Some clinics ran out and awaited resupply. In the first five months of 2007, New Hampshire “distributed more than 14,000 doses and is trying to obtain more doses for physicians with waiting lists.” (NY Times, 5/12/07) South Dakota and Washington poured millions of the taxpayer’s dollars into voluntary dosing programs for young girls.
Is It Safe?
Are vaccines safe? The answer depends on what is meant by the word “safe.” When pharmaceutical companies declare their products to be safe for human consumption they are using a definition of that word that might make an anxious parent cringe. If tests on humans suggest that nasty consequences are rare, then a drug may be approved for sale. In the realm of commerce a fit-for-sale drug has met the definition of “safe” if it doesn’t damage the health of more than some “acceptable” number of people. Drugs are commonly sold with printed disclaimers and cautions about possible side effects.
The printed disclaimer for Gardasil calls the product a quadrivalent Human Papillomavirus Recombinant vaccine. It says that “the main ingredients are purified inactive proteins that come from HPV Types 6, 11, 16 and 18.” It says that the most commonly reported side effects are swelling, pain and itching at the injection site, and fevers. Some patients have reported “difficulty breathing.” It helpfully adds that, “If you or your child has any unusual or severe symptoms after receiving Gardasil, contact your health care professional right away.” It offers no hint as to what these “severe symptoms” might be. Anyone who is allergic to any of the vaccine’s ingredients is cautioned to forego vaccination.
Though Gardasil has been hailed as “one of the major health advances of the 21st Century,” it only immunizes females against two of more than 20 strains of virus that can cause uterine cancer. It can provide protection from only two of the many strains that generate genital warts. It’s a start, but it’s no panacea. Gardasil is altogether useless against any virus to which a human has already been exposed.
The parts of the Gardasil mixture that provoke the human immune system to generate antibodies are the isolated husks of no-longer-living viruses. These protein structures prompt the immune system to create antibodies that will bond to any virus with a similar protein structure. Vaccination is the creation of protective antibodies against disease causing viruses.
So . . . is it safe? Of the more than 25,000 people who participated in the clinical trials for Gardasil, only 1,184 were preteen girls (4.7%). That’s a rather thin base on which to erect state-sponsored programs of compulsory Gardasil injections. Merck & Company has admitted that it has no clue whether Gardasil will provide lifetime protection against any virus that provokes uterine cancer. The benefit may wear off; more injections may be needed to sustain protection. The trials suggest that Gardasil will be effective for at least five years.
After the imperious Governor Perry demanded that the female flower of Texas must be injected with Gardasil, parents began to scrutinize the safety, efficacy and cost of Gardasil. Was it worth all the fuss and bother? Cervical cancer is rare in America and can be stopped cold by routine examinations and early treatment of pre-cancerous growths. It’s a condition of much older females. Routine examinations would still be a part of any wise woman’s health program because Gardasil protects against so few cancer-causing papilloma viruses.
Parents and social conservatives were the first folks to recoil from Rick Perry’s brass-knuckled I-know-what’s-good-for-you stance. They were soon joined by another circumspect group of concerned citizens: doctors.
Members of the American Academy of Pediatrics and the Texas Medical Association (TMA), which represents 41,000 Texas physicians, cautioned against a rush to mandatory inoculation. Dr. Bill Hinchey, president-elect of the TMA, declared, “We support physicians being able to provide the vaccine, but we don’t support a state mandate at this time.” It was a wise position: women were eager to accept inoculation; doctors had waiting lists to receive Gardasil; there was a long tradition of vaccines winning public acceptance through voluntary inoculation and becoming mandatory only after a pressing public-health menace had been demonstrated. There is no epidemic of cervical cancer in America where it accounts for only a little over six-tenths of one percent of American cancer deaths. Parents and doctors were wary of exposing young girls to the unforeseen side effects of a new vaccine because it might protect them from a disease that was no longer common in their homeland and is typically a problem for much older women. Parents and doctors were advising caution. Governor Perry brushed caution aside; he knew better than everyone. He was, after all, “a Christian.” Please don’t mention the six-grand contribution from Merck & Co.
The 60,000-member American Academy of Pediatrics expressed concern about the Texas governor’s mandate, which was a sharp departure from past practice. School immunizations, the AAP reminded us, were begun to protect schoolchildren from outbreaks of highly contagious diseases which might spread like wildfire in a school setting. Vaccination against hard-to-catch diseases was left to personal choice. The least amount of time in which any previous vaccine had gone from approval to mandatory in Texas was for the chicken pox vaccine, and that took five and a half years.
The AAP statement also expressed concern that this unnecessary Gardasil campaign would deplete funds for vaccination programs that were already pinched for money. At $360 for the three required Gardasil shots, Gardasil costs over eight times as much as a measles-mumps-rubella shot at $42.85 per dose. Was it worth the expense to protect an 11-year-old girl from a virus she could only contract from a steamy sex romp with a contaminated classmate?
What About the Boys?
Why not force schoolboys to submit to Gardasil injections? After all, boys get genital warts. Why not pump them full of Gardasil? The truth is that warts just aren’t that scary. Cancer is scary. A politician who accepts cash from a pharmaceutical company can pass himself off as a Good Samaritan if he seems to be protecting schoolgirls from something scary.
Just when this potentially lucrative boy market seemed unobtainable to the merchants at Merck, along came a research study from the Johns Hopkins Kimmel Cancer Center in Baltimore. It was all funded by the National Institutes of Health and reported on the pages of the New England Journal of Medicine. It was a potential goldmine for Merck.
In a nutshell, the report confirmed that kissing, sucking and licking the sex organs of other people can increase the likelihood that a person will develop oropharyngeal cancer. Yup, the human papillomavirus has been linked to a rise in cancer and its all because of a widespread habituation to oral sex among adolescents. Didn’t President Clinton assure us that oral sex wasn’t really sex? And what adolescent boy doesn’t want to get “presidential” with his girlfriend. It all seemed so harmless.
One of the study’s authors, oncologist Maura L. Gillison, tells us that, “It’s hard to question whether HPV causes oropharyngeal cancer. I think this study turns the final question mark into an exclamation point.” About 12,000 new cases of tongue and throat cancer occur each year in the United States. It kills about 2,000 men and women annually.
In recent years oncologists have seen an increase in this type of cancer which was previously confined to older heavy drinkers and smokers. Now the doctors were receiving patients in their 30s and 40s who were never puffers or boozers. The Johns Hopkins researchers found HPV-16 in 72 percent of the tumors they examined. It’s one of the viruses that cause cervical cancer. People who admitted to having oral contact with the genitals of more than six people were 8.6 times more likely to develop an HPV-related cancer. Dr. Gillison speculated that HPV-generated throat cancers may one day be more common than those caused by tobacco and alcohol consumption.
Robert Haddad, clinical director of the head and neck oncology program at the Dana-Farber Cancer Institute in Boston remarked: “I’m seeing patients in their late 20s and early 30s with oropharyngeal cancer. This is because of HPV. It’s very alarming.” He added. “The next logical step is to think about the vaccine for both men and women.”
Reporters were quick to catch the import of that remark. According to a staff reporter at the Newark Star Ledger (5/10/07, pg3), “HPV 16 is one of the strains covered by Gardasil, the recently approved vaccine by Merck, based in Whitehouse Station. Richard Haupt, executive director of medical affairs in the Merck vaccine division, said the company has spoken to Gillison and others at the Johns Hopkins School of Public Health about studies of Gardasil and oropharyngeal cancers.
“ ‘This affects men and women, and is a potential area of research that we are interested in,’ Haupt said.”
So now the well-intentioned totalitarians have a medical pretext for dictating universal inoculation of schoolchildren against a self-contracted social disease. Only our steadfast attachment to the principles of individual liberty and the dignity of each person will save us from the Overbearing Samaritans of the looming nanny state.
Tina Walker, the mother of an 11-year-old schoolgirl in Flower Mound, Texas, told the Wall Street Journal that she would prefer to wait several years before exposing her daughter to any novel vaccine. She captured the essence of Rick Perry’s social engineering perfectly: “We are all guinea pigs here.”
Where We Are Now
Virginia has become the first state to order schoolgirls to accept Gardasil injections. Twenty-two other states continue to entertain compulsory Gardasil vaccination programs. The Texas legislature gave the girls of Texas a temporary respite from compulsory vaccination, but held fast to the possibility of repealing their ban in 2009. Why didn’t they just crush the governor’s obnoxious dictate like a bug and be done with it forever? Would they lift their ban if Merck & Co. made contributions to their re-election campaigns or am I just being cynical?
Meanwhile, in New Jersey, the legislature has passed a bill called The Access to Medical Research Act. A more fitting title would be The Access to Helpless Patients Act, because it allows curious researchers to experiment on humans without their consent.
According to Glenn E. McGee, the director of the Alden March Bioethics Institute at Albany Medical College in New York, “If signed into law, this bill will allow court-appointed guardians to ‘volunteer’ patients for these kinds of clinical trials – patients they probably have never met.”
Back in 1996, the Food and Drug Administration had allowed researchers to give untested experimental drugs to patients with life-threatening conditions, despite the serious ethical concerns that such dosing created. Because of mounting complaints, the FDA recently ordered a review of all clinical trials conducted without patient consent. The New Jersey Access to Medical Research Act flies in the face of these ethical concerns.
Under the provisions of the proposed legislation, any critically injured or diseased person in New Jersey might receive the best state-of-the-art medical care, or some untested experimental drug, or a placebo, which is to say no beneficial drug at all, depending on which course of treatment best served the needs of some researcher. The people who should have been setting off alarm bells at the legislative hearings for this bill, such as the state health department which regulates the hospitals where the proposed research will be conducted, had nothing to say. There was no discussion of ethical concerns.
For the purposes of the New Jersey bill, a new or novel procedure is defined as a diagnostic or therapeutic modality that:
“1. Is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its intended use and poses a potential risk of physical or emotional harm to a patient; or
“2. Is a new application of a procedure which has been generally recognized as safe and effective for its traditional use but is not yet generally recognized as safe and effective by experts in the field who are qualified by scientific training and experience to evaluate the safety and effectiveness of the procedure for its new application and the new application poses a potential risk of physical or emotional harm to a patient.”
In other words, if this bill becomes law it will be a big green light for human experimentation without the patient’s consent. The ugly truth is that our elected representatives are too easily swayed by commercial interests – by the wealthy companies that profit from pharmaceuticals, diagnostic machines and therapeutic modalities. All of them, acting in concert, will always cloak their true intentions in the rhetoric of humanitarianism: “We are doing this for the greater good of humanity.”
Don’t fall for it. Legislation that robs us, as individuals, of our sovereign control of our own bodies is the most profound deprivation of our liberty. Medical knowledge acquired by such devious means can only be called the fruit of a poisonous tree.
Thomas Clough
Copyright 2007
July 4, 2007