INFORMED CHOICE
Conflicts of interest —
trail
Conflicts of interest —
trailIn a compulsory inoculation program, it is the responsibility of the developers, promoters and enforcers to prove safety and efficacy
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INFORMED CHOICE
Conflicts of interest — trailIn a compulsory inoculation program, it is the responsibility of the developers, promoters and enforcers to prove safety and efficacy
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| © 2004 Pittsburgh Post Gazette |
excerpt— Add up the published claims about disease prevalence and the average American has at least two ailments at a time. Who's pushing the high numbers? Skeptical bio-statisticians blame drug companies and reporters for much of the hype. They also blame research institutes and disease foundations seeking more public spending on particular diseases.
"They always take the high-end numbers," said Mary Grace Kovar, a senior health statistician at the University of Chicago's National Opinion Research Center in Washington. "They want the money, power and prestige" that flow when a disease looks like a major problem.
Former National Institutes of Health director Dr. Harold Varmus, who's now the president of Memorial Sloan-Kettering Cancer Center in New York, fought hard against using such estimates to justify research spending. He called it "body-based budgeting" and argued that NIH's billions should be targeted instead to areas that promise the greatest scientific and therapeutic advances.
… According to the Atlanta Journal-Constitution, 17 million Americans are compulsive shoppers. A doctor on the British Broadcasting Corp.'s popular health Web site (www.bbc.co.uk/health) says it's 15 million. Ronald Faber, a University of Minnesota Twin Cities professor whose 1992 study provided the high-end figures for both articles, begs to differ. Faber said reporters almost always ignore his report's conclusion that the low-end estimate of 2 million to 4 million was the better one. " Everybody wants the topic they're talking about to sound important," Faber said in an interview. "To get the story read, you need to grab people's attention, and big numbers grab attention."
Daniel Zelterman, a biostatistics professor at Yale University Medical School in New Haven, Conn., said all the ominous health numbers obscured the real bottom line: "People are living longer. We're living better. Things are looking up, looking good, as far as health is concerned." Zelterman's theory is that prevalence statistics routinely are skewed by the researcher's motive: "Do you want to say we're winning the war on cancer or that we need more research?" There's plenty of room for subjectivity, given the way most of these numbers are generated: A researcher selects a random population of several thousand or less and asks a series of carefully worded questions. To the answers, the researcher applies one of several official definitions of a disease and determines approximately how many people in the test group have it. This estimate is expressed as a range and projected onto a much larger population.
Reporters and patients' lobbies often seize the range's high end, drop the low end and hype the disease's prevalence with statements such as "Researchers estimate that as many as 30 million …" Even from authoritative, disease-specialist institutes such as NIH, "you're much more likely to get an overestimate than an underestimate" of a disease's prevalence, said Susan Ellenberg, a professor of biostatistics at the University of Pennsylvania School of Medicine in Philadelphia. The reason: "The more people who have something, the more likely they'll get funding for it," Ellenberg said.
"Most people at NIH institutes have more of a sense of moral responsibility than to do that," said Ronald Manderscheid, a top health-data expert at the federal Substance Abuse and Mental Health Services Administration. While some disease foundations use high-end estimates, not all of them do. The American Cancer Society, for example, omits from its figures on cancer's prevalence the minor skin cancers and slow-growing tumors that pose no health threats. Were it raising alarms, it would count them. According to bio-statistician John Bailar, an adviser to the National Academy of Sciences, prevalence numbers are so untrustworthy that he and his colleagues usually ignore them. Estimates based on doctors' reports or mortality statistics derived from death certificates are more reliable, he said.
Deceptions involving prevalence, Bailar said, generally entail "accurate but misleading" numbers that are "presented to the public with the understanding that a lot of people won't understand what they're being told." Drug makers, research institutes and reporters sometimes end up working together in these efforts.
In the height of the 2004 flu vaccine shortage crisis public health officials and the media grossly inflated (i.e. > ten-fold exaggeration) mortality figures for influenza, even for a bad year such as 1981! See the actual statistics provided by the American Lung Association:
'91 Memo Warned of Mercury in Shots
A memo from Merck & Co. shows that, nearly a decade before the first public disclosure, senior executives were concerned that infants were getting an elevated dose of mercury in vaccinations containing a widely used sterilizing agent.The March 1991 memo, obtained by the Times, said that 6-month-old children who received their shots on schedule would get a mercury dose up to 87 times higher than guidelines for the maximum daily consumption of mercury from fish.
"When viewed in this way, the mercury load appears rather large," said the memo from Dr. Maurice R. Hilleman, an internationally renowned vaccinologist. It was written to the president of Merck's vaccine division. The memo was prepared at a time when U.S. health authorities were aggressively expanding their immunization schedule by adding five new shots for children in their first six months. Many of these shots, as well as some previously included on the vaccine schedule, contained thimerosal, an antibacterial compound that is nearly 50% ethyl mercury, a neurotoxin.
Federal health officials disclosed for the first time in 1999 that many infants were being exposed to mercury above health guidelines through routine vaccinations. The announcement followed a review by the U.S. Food and Drug Administration that was described at the time as a first effort to assess the cumulative mercury dose. But the Merck memo shows that at least one major manufacturer was aware of the concern much earlier.
"The key issue is whether thimerosal, in the amount given with the vaccine, does or does not constitute a safety hazard," the memo said. "However, perception of hazard may be equally important." Merck officials would not discuss the contents of the memo, citing pending litigation. Separately, the drug giant is trying to fend off a legal onslaught over Vioxx, the popular painkiller it introduced in 1999. The company, based in Whitehouse Station, N.J., faces hundreds of lawsuits claiming that the drug caused heart problems and that Merck concealed the risks. Merck, which in September pulled Vioxx off the market, has denied the allegations.
The legacy of thimerosal, meanwhile, also is causing problems for Merck and other drug companies. More than 4,200 claims have been filed in a special federal tribunal, the Vaccine Injury Compensation Program, by parents asserting that their children suffered autism or other neurodevelopmental disorders from mercury in vaccines. A handful of similar claims are awaiting trial in civil courts. The plaintiffs cite various scientific studies that they say prove the dangers of thimerosal, including at the levels found in vaccines.
Thimerosal has been largely removed from pediatric vaccines in recent years in what health officials have described as a precautionary measure. (This has been accomplished as drug makers have voluntarily switched from multi-dose vials of vaccine, which require a chemical preservative like thimerosal, to single-dose containers.) In September, Gov. Arnold Schwarzenegger signed legislation prohibiting vaccines with more than trace amounts of thimerosal from being given to babies and pregnant women. Iowa has a similar ban.
For their part, Merck and other vaccine makers, along with many government health officials and scientists, say there is no credible evidence of harm from the amounts of mercury once widely present in kids' shots. They cite a report in May by a committee of the national Institute of Medicine concluding that the evidence "favors rejection of a causal relationship" between vaccines and autism. The seven-page Merck memo was provided to the Times by James A. Moody, a Washington lawyer who works with parent groups on vaccine safety issues. He said he obtained it from a whistle-blower whom he would not name.
The memo provides the "first hard evidence that the companies knew - or at least Merck knew - that the children were getting significantly more mercury" than the generally accepted dose, the lawyer said. He also provided a copy to attorneys for Vera Easter, a Texas woman who blames thimerosal for the condition of her 7-year-old son, Jordan, who is autistic and mentally retarded. The Easter lawsuit is pending in U.S. District Court for the Eastern District of Texas. The defendants include Merck; rival vaccine makers GlaxoSmithKline, Aventis Pasteur Inc. and Wyeth; and thimerosal developer Eli Lilly & Co.
Easter's lawyer, Andy Waters, described the memo as "incredibly damning and incredibly significant." After receiving it in the fall, he confronted Merck lawyers about why he hadn't seen it earlier. In a letter to Waters in October, Merck attorneys said they had in fact made available 32 boxes of records, but that the copying service hired by the plaintiffs for some reason had failed to copy several of the boxes - including the one with the Hilleman memo. "The memo," said company spokeswoman Mary Elizabeth Blake, "was produced voluntarily by Merck in the ordinary course of discovery proceedings."
Hilleman is a former senior vice president of Merck who developed numerous vaccines for the company. A 1999 profile in the Philadelphia Inquirer said that "it is no exaggeration to assert, as many scientists do, that Maurice Hilleman has saved more lives than any other living scientist." Hilleman, 85, currently director of the Merck Institute for Vaccinology, had officially retired and was a consultant to Merck when he wrote the '91 memo. He declined to be interviewed.
The memo was sent to Dr. Gordon Douglas, then head of Merck's vaccine division and now a consultant for the Vaccine Research Center at the National Institutes of Health. Douglas also declined to comment. The memo stated that regulators in several countries had raised concerns about thimerosal, including in Sweden, where the chemical was being removed from vaccines.
"The public awareness has been raised by the sequential wave of experiences in Sweden including mercury exposure from additives, fish, contaminated air, bird deaths from eating mercury-treated seed grains, dental amalgam leakage, mercury allergy, etc.," the memo said. It noted that Sweden had set a daily maximum allowance of mercury from fish of 30 micrograms for a 160-pound adult, roughly the same guideline used by the FDA. Adjusting for the body weight of infants, Hilleman calculated that babies who received their shots on schedule could get 87 times the mercury allowance.
The Swedish and FDA guidelines work out to about four-tenths of a microgram of mercury per kilogram of body weight. A stricter standard of one-tenth of a microgram per kilogram has been adopted by the Environmental Protection Agency and endorsed by the National Research Council. These standards are based on methyl mercury, the type found in fish and airborne emissions from power plants. Though toxic, the ethyl mercury in thimerosal may be less hazardous than methyl mercury, some scientists say, because it is more quickly purged from the body.
"It appears essentially impossible, based on current information, to ascertain whether thimerosal in vaccines constitutes or does not constitute a significant addition to the normal daily input of mercury from diverse sources," the memo said. "It is reasonable to conclude" that it should be eliminated where possible, he said, "especially where use in infants and young children is anticipated."
In the U.S., however, thimerosal continued to be added throughout the '90s to a number of widely used pediatric vaccines for hepatitis B, bacterial meningitis, diphtheria, whooping cough and tetanus. It was added to multi-dose vials of vaccine to prevent contamination from repeated insertion of needles to extract the medicine. It was not needed in single-dose vials, but most doctors and clinics preferred to order vaccine in multi-dose containers because of the lower cost and easier storage. The Hilleman memo said that unlike regulators in Sweden and some other countries, "the U.S. Food and Drug Administration ... does not have this concern for thimerosal."
A turning point came in 1997 when Congress passed a bill ordering an FDA review of mercury ingredients in food and drugs. Completed in 1999, the review revealed the high level of mercury exposure from pediatric vaccines and raised a furor. In e-mails later released at a congressional hearing, an FDA official said health authorities could be criticized for "being 'asleep at the switch' for decades by allowing a potentially hazardous compound to remain in many childhood vaccines, and not forcing manufacturers to exclude it from new products."
It would not have taken "rocket science" to add up the amount of exposure as the prescribed number of shots was increasing, one of the e-mails said. While asserting that there was no proof of harm, the U.S. Public Health Service in July 1999 called on manufacturers to go mercury-free by switching to single-dose vials. Soon after, Merck introduced a mercury-free version of its hepatitis B vaccine, replacing the only thimerosal-containing vaccine it was still marketing at the time, a company spokesman said.
By 2002, thimerosal had been eliminated or reduced to trace levels in nearly all childhood vaccines. One exception is the pediatric flu vaccine made by Aventis and still sold mainly in multi-dose vials.
I ran an interesting article about a 1991 Merck memo uncovered by the Los Angeles Times that expressed concerns babies were receiving elevated amounts of mercury —as much as 87 times higher than the maximum daily "consumption" of mercury from fish. Now, we find out Merck lied about this potent neurotoxin being present in vaccines and allowed it to be injected in millions of unsuspecting newborns. There are only two words I can think of for this— reprehensible evil.
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| by Dana Summers |
I am highly challenged to understand how Merck can get away with this. How can any company say that a potent neurotoxin is not present in something that is mandated by law to be injected into helpless infants and then not be penalized for the crime it committed. Folks something isn't right here.
Before you decide to vaccinate your children, I strongly recommend you do them a favor and closely examine the serious risks and side effects associated with vaccines. Doing so could very well mean the difference between life and death for your child. If aid in your research you might want to consider:
If, after researching and reviewing the sources listed above, you are not convinced of the value and safety in avoiding vaccines, you should, at the very least, avoid exposing your child to vaccines from multi-dose vials. Inform the physician or nurse that you want the single-dose vaccine container and request that you want to actually witness them removing it from the vial and would like the empty vial to take home with you as proof that your child did not receive the mercury-contaminated vaccine. This way, you will at least avoid one of the problems associated with vaccines.
Parents balk at idea of STD drug for kids
Sunday, April 03, 2005
by ED SILVERMAN
At first blush, a vaccine that prevents a deadly form of cancer would seem like a no-brainer for parents. But as two major drug makers prepare to introduce such a product, sides are already being drawn in what promises to be an all-out culture clash. Within two years, Merck and GlaxoSmithKline hope to market a pair of groundbreaking vaccines to prevent a sexually transmitted disease. Known as the human papillomavirus, or HPV, the disease is a leading cause of cervical cancer.
About 5,000 women in the United States die each year from cervical cancer, and the drug makers expect to use this as a rallying cry to make their vaccines widely available and generate billions of dollars in sales. One drug maker, Merck, says it will try to convince states to require vaccination before children as young as 12 can enter school.
"The best way to prevent infection is to vaccinate the population just before they become sexually active, which is when they're young," Eliav Barr, Merck's senior director of biologics clinical research, said. "This way, it can be folded into routine medical care."
But the rollout of the vaccines promises be anything but routine. Vaccinating children for a disease caused by sexual activity will be a tough sell, especially for parents who fear children will take it as a green light to have sex. The HPV vaccine is likely to become a flashpoint for the pharmaceutical industry, public health officials and parents, who are gearing up for a heated debate about the finer points of cancer prevention, health-care costs and teenage sex. The vaccines are still in the final stages of testing, but some groups are already concerned.
"The best way to prevent HPV is through abstinence," said Bridget Maher, an analyst at the Family Research Council, a conservative group that expects to campaign against making the vaccines mandatory for entering school. "I see potential harm in giving this vaccine to young women."
She isn't alone. A Merck study of 2,053 parents released last year found 11 percent of parents with 13-year-old girls probably or definitely wouldn't want them vaccinated before their 18th birthday. Another 27 percent were undecided. A separate study last year in the Journal of Lower Genital Tract Disease found 24 percent of 575 parents opposed a vaccine and believed it would lead children to engage in sexual activity sooner than they would otherwise.
At the same time, though, these studies suggest most parents do support vaccinating their children. The results also indicate some parents become supportive after learning about the health benefits or hearing doctors recommend vaccination. Some doctors believe parents may become more supportive when they learn HPV can be transmitted through sexual contact, and not necessarily intercourse, according to a study in the American Journal of Epidemiology.
"This will be an arduous educational mission," said Daron Ferris, a professor of family medicine and obstetrics/gynecology at the Medical College of Georgia, who also ran trials for the Merck vaccine. "But once they realize we have a vaccine to prevent cancer, I'd expect parents will want to protect their loved ones."
Convincing parents may be harder for Merck than Glaxo, a British drug maker. Unlike Glaxo, Merck will also target genital warts with its vaccine.Doctors caution this may fuel more controversy if teenagers see a vaccine as an easy way to combat yet another increasingly common sexually transmitted disease.
This is why some experts see trouble ahead. They point to the heated battle concerning an over-the-counter, morning-after pill a federal panel in 2003 recommended for girls as young as 16. Anti-abortion groups opposed the contraceptive pill, and the Food and Drug Administration has still not approved it. "Sex is a scary thing in this culture, and the age of the girls to be vaccinated will really be an issue," said Janice Irvine, a University of Massachusetts sociology professor and author of "Talk About Sex," a book on sex education. "You can expect opposition to this vaccine."
These predictions worry the drug makers. As some best-selling drugs face competition from cheap generic rivals, vaccines will become a source of much-needed revenue. This is especially true for Merck. The Whitehouse Station-based drug maker next year loses patent protection on its cash cow, the Zocor cholesterol pill.
As Wall Street sees it, an HPV vaccine holds tremendous promise. The global market could hit $4.3 billion in revenue by 2010, according to a recent report by Richard Evans, an analyst at Sanford C. Bernstein. His projection anticipates adolescent girls and boys, as well as women in their 20s and 30s, will be vaccinated.
The heady forecasts stem from data showing cervical cancer is widespread: About 500,000 women worldwide are diagnosed each year, leading to 230,000 deaths, according to the World Health Organization. In the United States, about 15,000 women are diagnosed annually. For the companies to realize the billions of dollars in annual revenue, they are expected to advertise widely and charge a lot. Merck will likely charge $100 for each of three needed doses, Evans said, while Glaxo may place an $80 price tag on each dose.
At those prices, an HPV vaccine would cost more than other childhood vaccines, according to an article in Clinical Infectious Diseases, which was written by officials at the Centers for Disease Control and Prevention. An average dose of vaccine for measles, mumps and rubella cost $34.73 in 2003, while a dose of chickenpox vaccine was $58.11.
The HPV vaccines would be "fairly expensive for this country," said Lauri Markowitz, chief of epidemiology research in prevention of sexually transmitted diseases at the CDC, which believes a vaccine would help prevent cervical cancer. An official CDC endorsement would not only influence doctors to recommend vaccination, but health plans would also be spurred to cover the cost.
The drug makers are unwilling to discuss prices, but note diagnosing and treating HPV is expensive. Related health costs were estimated to be at least $1.6 billion annually, according to a 1999 CDC study. The costs include doctor visits, Pap tests to detect cervical cancer and follow-up procedures.
"A vaccine would be a more efficient use of health-care dollars," said Evan Myers, an associate professor of obstetrics and gynecology at Duke University and a consultant to Merck, who has studied the economic impact of an HPV vaccine. The best way to maximize savings, the companies maintained, is to vaccinate children as young as possible. Glaxo plans to push for vaccinating girls as young as 10, according to David Pernock, senior vice president for pharmaceuticals and vaccines.
"Anyone who thinks a lot of teenagers aren't sexually active has their head in the sand," said Cody Meissner, a pediatrics professor at Tufts New England Medical Center and vice chair of the American Academy of Pediatrics' infectious disease committee. "No one's pleased about that, but it's a fact of life. And if the results of the final-stage clinical trials for these vaccines are consistent with what's known so far, they will be a wonderful contribution to public health."
But convincing doctors may prove much easier than swaying state officials to require vaccination before youngsters can attend school, as Merck intends to do. The potential for controversy is so great that one New Jersey health official said he does not want to get involved. "I don't think we'd require the schools to mandate something like this," said Eddy Bresnitz, deputy commissioner of the state Department of Health and Senior Services. "I'm sure the battle will be huge, and I'm not sure it's a battle we should be fighting."
Victims increasingly view U.S. compensation program as adversarial and tightfisted.
excerpt— … the Vaccine Injury Compensation Program, informally known as the vaccine court. Created by Congress and jointly run by the Department of Health and Human Services, the Justice Department and the U.S. Court of Federal Claims, it was designed to shield vaccine makers from damage awards that were threatening to drive them from the business.
It also was supposed to compensate victims in rare cases of injury under a flexible, no-fault system that would avoid the rancor and delay of traditional litigation. Claims were to be handled "quickly, easily and with certainty and generosity," said a House report accompanying the legislation in 1986. Instead, say advocates for families with injury claims, federal officials often fight them with such zeal that many who deserve help are denied it, and even successful cases get bogged down for years.
The program "was supposed to be non-adversarial and it's become very adversarial," said Rep. Dan Burton (R-Ind.), whose House Subcommittee on Human Rights and Wellness has held hearings on the matter. Many have "had legitimate claims and they went on for eight, nine, 10 years." Vaccine compensation officials refused to be interviewed, but in written statements they said the program had "an excellent record of promptly and appropriately compensating" valid claims.
Over the years, about $1.5 billion has been paid out in compensation and legal fees for more than 1,800 families, most of which would have had little chance of winning a civil trial, the officials said. They insisted that the vaccine court was less adversarial than civil courts, but said they were obliged to fight claims that weren't based on good science.
This was "never intended to serve as compensation source for conditions that are not vaccine-related," said Joyce Somsak, the program's acting director. But in trying to weed out undeserving claims, critics say, the government has insisted on a level of proof of injury that is almost impossible to meet.
And a Times analysis of claims data shows that the court has become more unyielding over time: Officials are much less likely than in earlier years to concede that a vaccine was responsible for an injury or death. The percentage of people getting awards also has declined. Even when families do win compensation, officials have some times battled them over just a few dollars.
In one case, government representatives argued that $150 a year was too much to spend on wheelchair maintenance. They have haggled over how much to allow for replacement shoes and braces for people with polio. Another time, they recommended rubber sheets for the bed of an incontinent person because they were cheaper, although less comfortable, than disposables costing $135 a year.
"We never anticipated the extent [they] would go to deny these kids compensation," said Barbara Loe Fisher of the National Vaccine Information Center, who lobbied for the bill that created the program.
Viewed another way, by being tightfisted, officials have been good stewards of the vaccine injury trust fund, the self-insurance pool that pays awards to the injured. In fact, the fund — fed by a surcharge of 75 cents per vaccine dose — has ballooned to more than $2 billion, while earning about as much in annual interest as it pays in awards. But the fund was not meant to be a moneymaker. The idea was that it was better to "err on the side of compensating the victim," said Rep. Henry Waxman (D-Los Angeles), sponsor of the legislation.
… In 1995, the government changed the rules of the vaccine court in a way that made cases more contentious, protracted and harder for petitioners to win. Officials amended the vaccine injury table, a set of guidelines that had tilted many cases in petitioners' favor. According to the table, if certain symptoms appeared within a specified time after a shot, the vaccine was deemed the culprit unless the government could prove another cause. Many "table injuries" were simply conceded by the government, leaving only the amount of compensation to be determined.
A few amendments changed all that. In one major shift, "seizure disorder" was scratched from the table as a telltale sign of injury from a DPT shot. And a new, more restrictive definition of encephalopathy — or brain dysfunction — meant that many conditions that had been table injuries suddenly were not. Somsak said the table was changed for one reason only: to better "conform with the scientific evidence."
But the upshot was that in many cases the burden shifted from the government to prove the shot didn't cause injury to the petitioner to show that it did. Because it's usually hard to prove with certainty that a vaccine caused harm, the effect of the change was profound.
The Times analyzed a vaccine court database of 10,741 claims filed over 16 years. The analysis showed that in the three years before the changes, the government conceded one-third of all claims. Of cases filed in that period, compensation was awarded in just over half. But since the changes took effect March 10, 1995, the government has conceded just one claim in seven. About 35% of petitioners have received compensation.
And cases dragging beyond five years have become increasingly common. Even the court's top judicial officer, Chief Special Master Gary J. Golkiewicz, has lamented the drift toward "full-blown litigation." "Clearly," he said in one of his rulings, "that is not what Congress intended when it designed the program as an alternative to tort litigation."
Clifford J. Shoemaker, a lawyer for petitioners, said if the government softened its stance, the worst that would happen is that a "family that needs some money to deal with their profoundly injured child is going to get it. Is that such a terrible thing?" he asked.
Some observers have warned that the government's uncompromising attitude could backfire. Although the law directs all claims to vaccine court, it allows those who disagree with a ruling — or have waited more than 240 days — to sue vaccine makers in civil court. So far, few have. But by their tough stance, officials may be inviting more civil suits, Rep. Waxman said. "The whole idea of the compensation system is to be generous so they [petitioners] won't want to go to court."
… Although the vaccine compensation program was billed as more flexible, its three-year statute of limitations is draconian compared with rules of civil courts in all 50 states, which place no deadlines on the filing of injury claims for minors. In the Spohn case, the doctor's records were a mess, alternately giving July 17 and July 19, 1992, as the date of the fateful shot. The family's lawyer filed the petition July 18, 1995, thinking he had made the deadline with a day to spare. In fact, he was a day late. Seizing on the error, the Justice Department moved for dismissal. Special Master Elizabeth Wright concurred, citing the Spohns' "failure to use due diligence in pursuing the claim."
It was "very much an injustice," said Veronica's mother, Karen Spohn, a nurse in Butler, Pa. "I had a normal child, and all of a sudden in one day, within hours of the vaccine — she became a child with a disability" who is "going to need assistance for the rest of her life."
"They didn't rule that she didn't have damage. All they did was say, you filed 12 hours too late — too bad on you." Spohn said she was too heartsick at that point to look into filing a civil lawsuit. "Emotionally I couldn't deal with" continuing the fight, said Spohn, who preferred to "accept what you're dealt with and go through life."
Lengthy Legal Battle
In the case of Dustin Barton, the government fought so long that the Albuquerque boy did not live to see the resolution of his claim. As an infant, he had suffered seizures and brain damage after a DPT shot. But Dustin had a congenital neurological condition, known as periventricular leukomalacia, that the government blamed for his injuries. His mother, Lori Barton, filed the claim in November 1991. The case dragged on for years. Barton told friends and family that she suspected the government was waiting for Dustin to die — noting that it would be cheaper for the program to pay the death benefit of $250,000 than to buy an annuity to cover lifetime care.
Dustin eventually did die of a seizure, nearly six years into the case, but the government continued to fight. Finally in May 2000, 8 1/2 years after the petition was filed, the family won a ruling that Dustin's injuries were vaccine-related. Not ready to give up, Justice Department lawyers considered an appeal. Then they offered a deal: They would drop the challenge if the Bartons agreed the decision would remain unpublished. This meant it would not be sent to legal databases, such as Westlaw, where attorneys for other petitioners could see it.
Lori Barton, who has since died, described her reaction at a congressional hearing in December 2001: "To me, it was extortion." But Barton, who then was seriously ill and had borrowed thousands of dollars to pay expert witnesses, took the deal. In a statement to the Times, the Justice Department said it had made similar deals "on very rare occasions." It happens when the government "disagrees with a decision but believes that settlement is fair and in both parties' interests."
Family Finances Ruined
Rachel Zuhlke's claim was filed in September 1992. The government blamed her brain injuries on complications from a strep infection she had about the same time she got her DPT shot. Janet Zuhlke said Rachel's illness contributed to the breakup of her marriage. She also lost her job as a dental assistant because of frequent absences to deal with Rachel's medical emergencies. Even with health insurance, the family's finances were wrecked.
"We had a lot of hot dogs," Zuhlke said. "We had two other children that went without many, many, many things — because I couldn't afford them." Her case moved at a crawl, getting repeatedly reassigned to different special masters, and from one Justice Department lawyer to another, who repeatedly got extensions to complete filings in the case.
Nearly eight years into the case, Golkiewicz, the chief special master, brought in a mediator for settlement talks. Zuhlke recalled her despair — and the special master's shock — when the Justice Department refused to make a settlement offer. "You should have seen Golkiewicz's face fall on the table," she said.
Golkiewicz said recently that he was disappointed that the case didn't settle, but that didn't mean "that one side or the other was at fault." Still, he said, the case took far too long, and the Zuhlkes "had every reason to feel frustrated."
As it turned out, the government lost its all-or-nothing gamble. In July 2001, Special Master George Hastings ruled that Rachel was entitled to compensation. Fifteen months later, he granted a multimillion-dollar award, including $925,000 for her pain and suffering, future lost earnings and past medical bills, and at least $90,000 a year for living and healthcare costs.
Although relieved that the case is finally over, Zuhlke still struggles with grief over what happened to her child, now a young woman. Rachel's life, she said, "is so different from what it should be at 20." And she still finds it "unfathomable" that the government fought her claim for so long, Zuhlke said. "My little girl hadn't done anything wrong."
Four leading Midland doctors who deemed the controversial MMR vaccine safe have links to the drug giants who make or supply the jab. Campaigners have called for the General Medical Council to investigate the senior Government advisors, who all hold scientific posts in the Midlands and sat on key committees which declared the vaccine safe.
Now Jonathan Harris, West Midlands campaigner for vaccination awareness group JABS (Justice Awareness and Basic Support) is calling for the GMC to investigate the work of the medics.
Autistic
Only two of Mr Harris's six children had the MMR vaccine and both of them are autistic. "A total of 19 Government experts are connected to the drugs industries that deal with the MMR vaccines," he said. "Shouldn't this be considered a conflict of interests?
"These experts are advising the Government about the safety of the MMR vaccine at the same time as receiving payments or holding shares in the companies selling the jab. "The Government requested that the GMC investigate the work of Dr Andrew Wakefield, who first proposed the link between MMR and autism.
"They declared it was 'a matter of urgency' when it emerged that he had received funding from lawyers representing parents of children who felt they had been damaged by the vaccine. So why shouldn't they investigate these doctors who have links to the drugs industry while they are at it?"
The doctors' watchdog GMC agreed to consider a full investigation into the work of Dr Wakefield last week at the request of the Health Minister John Reid. The medical researcher provoked a furore when he first proposed a link between MMR and autism in a paper published in The Lancet magazine in 1998. In a press conference later he also recommended parents opt for single jabs.
The editor of The Lancet has since said that he would not have printed the study if he had known Dr Wakefield had received funding for it from the Legal Aid Board. It emerged that Dr Wakefield received pounds 55,000 from the Board to investigate claims by parents that their children had been damaged by the measles, mumps and rubella jab.
And the GMC has agreed to consider a full inquiry into the study following a request from the Secretary of Health John Reid stating that it 'was a matter of urgency'.
A spokesman for the GMC confirmed that the four Midland medics were registered with them but declined to say whether it would consider opening an investigation into their work and links with the drugs firms. None of the doctors were available for comment last night. Their personal and non-personal interests have all been openly declared to the independent advisory committees on which they sit.
excerpt— "Could you design a system more irrational, wasteful, corrupt, unfair, and inefficient than capitalism in this late, degenerate stage?"
Pediatricians praise pentavalent vaccine, question cost
Kids can expect fewer vaccine shots in the future. With the promised, year-end introduction of a vaccine to include antigens for diphtheria, tetanus, pertussis, polio and hepatitis B, doctors will be able to reduce the number of injections their youngest patients must endure in a single visit.
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| Photo from 'USA Today' August 3, 1999 |
The pentavalent vaccine, which insiders expect to be approved by the Food and Drug Administration this month, will be manufactured by GlaxoSmithKline and is expected to be the first of an increasing number of vaccines that protect against five and even six diseases. "It's less painful for the child. It is less stressful for the medical staff that is administering the vaccine, and it's less stressful for the parent who's watching it," said Edgar Marcuse, MD, MPH, professor of pediatrics at the University of Washington, Seattle.
Experts say multivalent vaccines may increase vaccination rates and make parents more willing to let children get all the shots they need in one visit, rather than scheduling multiple appointments, which can lead to late vaccinations. "I'm excited about it," said Robert Yetman, MD, professor of pediatrics at the University of Texas Medical School at Houston. "If the number of vaccines we are currently giving patients is a reason for some parents to avoid getting their children immunized, then this will help eliminate this roadblock to improving our immunization rates."
Reimbursement barrier
Vaccines with antigens for five or six diseases are already in widespread use around the world. But in the United States no currently available vaccine includes more than three. Still, as much as physicians say multivalent vaccines are a significant step in the right direction, there are many concerns that reimbursement issues may impact the number of doctors who administer the new vaccine.
The cost of the vaccine may not be adequately covered by insurance. In addition, physicians may receive less reimbursement for administering fewer injections in one visit despite the fact that the same number of antigens are being delivered to the patient. With the number of combination vaccines expected to increase significantly over the next few years, the issue is one of great concern and is expected to come up at this month's American Medical Association Interim Meeting in New Orleans.
"Without reimbursement, this will not be adopted," said Gary L. Freed, MD, MPH, director of general pediatrics at the University of Michigan School of Public Health in Ann Arbor.
There are also concerns that problems with record keeping combined with a mobile population may lead to overimmunization. Children may shift from one doctor to another, both of whom may stock different combinations. Records may be incomplete or get lost. "As we get additional combinations licensed, and the combinations share common components but also have different components, it's going to increase the chance of confusion and miscommunication and make far more important the maintenance of very accurate records," Dr. Marcuse said.
Children also may shift back and forth between public-sector vaccine sources and private physicians. Most believe that the public sector may be the slowest in adopting the multivalent vaccines, primarily because of cost issues. "The public sector may choose not to buy this vaccine if it costs a lot more than the individual vaccines themselves," Dr. Freed said.
Also, not all vaccines included in the pentavalent vaccine are always delivered at the same time. Currently, hepatitis B is also frequently administered at birth, by itself, as well as additional doses during the visits at two and six months when it is given along with IPV, DTaP and several other vaccines not planned to be included in the five-valent mix.
"If a physician or hospital gives a child the newborn dose of hepatitis B yet wants to use this vaccine for at least a portion of the primary immunization series, they will have to be careful they don't give a child too many vaccines," Dr. Freed said. "There's no known harm to giving an extra vaccine, but we need to realize that that is a possibility."
And despite recent anxieties expressed by certain vaccine awareness and parent advocacy groups over the combined measles, mumps and rubella vaccine, physicians say that most of their patients would prefer the reduction in needlesticks. "More than likely, parents will welcome the chance for the child to get fewer injections," Dr. Freed said.
The initial hope is that the multivalent vaccines will reduce the number of needlesticks kids must endure. In addition, though, many suspect it will simply make room in the schedule for new vaccines that are just around the corner.
"We need to make room because there are more vaccines that will be coming, and you just can't keep giving more shots to children," said Mark Blatter, MD, medical director of Primary Physicians Research in Pittsburgh, the company that ran many of the trials on the new vaccine. "After years of increasing the number of shots, for the first time, we will be able to decrease the number of shots by as many as six."
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LONDON — Scientists said on Thursday that vaccinating children against chickenpox (varicella) could increase the risk that adults would develop shingles, a painful blistering rash that is potentially dangerous in the elderly. The team, at Britain's Public Health Laboratory Service (PHLS), said that although vaccination would save thousands of lives over time, thousands of elderly people could also die from the complications of shingles, known as herpes zoster.
Writing in the journal Vaccine, they called for a re-evaluation of the policy of mass chickenpox vaccination that has been introduced already in the United States and is imminent in many other countries. In 1995, the chickenpox vaccine was approved for use in children over 1 year of age in the US and is now required for school entry.
After a bout of naturally-occuring chickenpox, the varicella zoster virus remains dormant in the body and may reactivate decades later to cause shingles, a painful rash that typically strikes chickenpox veterans after the age of 60. Marc Brisson and his team say their research shows that adults living with children have more exposure to the virus that causes chickenpox and enjoy high levels of protection against shingles. Being close to children means that adults are exposed to the virus, which acts like a booster vaccine against shingles, they believe. But if all children were vaccinated, adults who have had chickenpox would no longer be protected against developing shingles.
The researchers worked out a mathematical model that predicts that eliminating chickenpox in a country the size of the United States would prevent 186 million cases of the disease and 5,000 deaths over 50 years. However, they said it could also result in 21 million more cases of shingles and 5,000 deaths. The PHLS said in a statement it was working out what the impact might be of introducing a chickenpox vaccine in Britain.
"As more evidence becomes available, it will be shared with the Joint Committee on Vaccination and Immunisation, which advises the Department of Health on the immunisation schedule.
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| Above: Parade Magazine, January 9, 2000. Pediatrician advises, "Rotovirus infection causes 'winter diarrhea' and can be fatal. A vaccine is available.. ask your doctor if your child needs to have it." In October 1999, after receiving 15 reports of intestinal blockage (intussusception, which can also be fatal) among children who had recently received the Rotashield vaccine, the CDC recommended that the vaccine be withdrawn from the market pending an investigation. This reference is provided to illustrate the point that commercial magazines may not be the best source of medical advice. |
This senator handles his family company's legislative prescriptions.
excerpt— Some companies hire lobbyists to work Congress. Some have their executives lobby directly. But Tennessee's Frist family, the founders of Columbia/HCA Healthcare Corp., the nation's largest hospital conglomerate, has taken it a step further: They sent an heir to the Senate. And there, with disturbingly little controversy, Republican Sen. Bill Frist has co-sponsored bills that may allow his family's company to profit from the ongoing privatization of Medicare.
The senator's father, Dr. Thomas Frist Sr., was a founder of Columbia/HCA, the country's biggest chain of for-profit hospitals, a $20 billion health care empire that includes 340 hospitals, 135 outpatient surgery centers, and 200 home health care agencies in 38 states. The family has spent lavishly on political campaigns for years. Patricia C. Frist -- wife of Bill's brother, Columbia/HCA vice chairman Tommy Frist Jr. -- won herself a place on this year's Mother Jones 400 list (see #326) by giving $100,000 in soft money to the Republican National Committee. Add in PAC and coordinated executive donations, and the company's largesse comes to more than $360,000 just for 1995-96 -- not including campaign contributions from other family members.
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| THE TRUTH BEHIND THE VACCINE COVER-UP by Russell Blaylock, MD |
| AUTISM RESEARCH TAKES WRONG TURN Government is throwing money away by Howard Urnovitz, PhD |
| glaringly inequitable National Vaccine Injury Compensation Program CONGRESSIONAL TESTIMONY by Clifford J. Shoemaker, Esq. |
| custody battle To vaccinate, or not to vaccinate? West Chester Daily Local by Michael P. Rellahan |
 | Disclaimer / Investigate: The intent of this website is to raise awareness about the controversial aspects of vaccination. Many vaccines still contain thimerosal (49.6% ethylmercury by weight.) While mercury is a highly toxic element second only to radioactive plutonium, when combined with other ingredients, specifically aluminum and formaldehyde, the synergistic effects increase 10,000-fold. Individuals who suffer from chronic mercury exposure will have a unique expression of symptoms. This presentation is not to be construed as medical or legal advice: locate and confer with a trusted physician and lawyer.
Competing interests: In March 1991 I developed undifferentiated connective tissue disease and peripheral sensory neuronopathy within days of receiving my third hepatitis B vaccine. In 1994 my adverse event report was filed with the Vaccine Adverse Event Reporting System (VAERS). Prior to August 1997 the vaccine wasn't covered by the 1986 Childhood Injury Act. In 1999 I became a complainant to the National Vaccine Injury Compensation Program (NVICP). A court date is still pending. —Susan Kreider, RN, MS |