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Back The new compensation program was to establish a non-adversarial ``no fault'' system -- one giving aggrieved parents a medical benefit of the doubt in claims that their infants and toddlers were injured or killed by reactions to childhood shots against several diseases. It would provide, promised Martin Smith, an official of the American Academy of Pediatrics, ``simple justice to children.'' Instead, a four-month, computer-assisted investigation by Gannett News Service, supplemented by government responses to six separate Freedom of Information Act requests, shows:
One family's wait Larry Gray, a home repair salesman from Harrah, Okla., falls into the category of those long awaiting payment. He first filed a claim for his blind, non-speaking, wheelchair-confined son Christopher, now 9, in 1989. In August 1993, he won a ruling that the DPT vaccine was to blame and that his son was entitled to compensation. So far, Gray has seen zero. The Justice Department kept questioning the life-care plan. Finally, on Friday (Aug. 7), Gray and his Idaho attorney Curtis Webb stipulated to compensation of what will amount to about $2 million if the boy lives to be 20. His doctors have told him he won't. Gray should have funds for long-term care by November. In serious-injury cases like Christopher's, life-care plans must be worked out even after compensation is awarded. And Justice lawyers sometimes spend months squabbling over expenses like the projected cost of diapers in a certain state in the next century. Since such children have a shortened life expectancy and since unused compensation dollars go back to the government if an injured child dies, parents of such children are understandably suspicious of delays. John Euler, the Justice Department attorney who supervises defending against vaccine claims, said the Gray case took so long because the father and son moved from California to Oklahoma. Euler denies undue delays: ``I don't think we are undermining the congressional scheme. ... For the most part, the pace of the settlement is in the hands of the petitioners.'' `We're going back to war' Some lawyers experienced at bringing claims are so frustrated with the federal program they are threatening to abandon it and return to the practice of suing doctors and the big drug companies that make the vaccines. ``We're going back to war,'' said Boston attorney Michael Hugo, who has handled more than 300 vaccine injury cases. ``I think the vaccine program is an abysmal failure. It is an uncertain, slow, horrible system that is broken.'' But Balbier insisted the program does not unnecessarily delay claims. ``We have every interest in trying to have these cases adjudicated as quickly as possible,'' he said. ``The program has been extraordinarily successful on that level. It takes an average one to two years to get through the system from the time a claim is filed.'' If families go through the courts, he said, it could take seven to eight years. Lawyers for petitioning parents also complain that the government seeks to reduce claims by trying to push them into quitting the vaccine-injury practice. They say the government slows payment of fee awards, disputes expenses as small as taxi fares to court and, most importantly, is making it ever harder to win compensation by constantly redefining the rules. The program's Vaccine Injury Table, designed by pediatricians, neurologists and immunologists as a definitive guide to speed cases by lessening the scientific burden of proof in areas of cause and effect, has been narrowed consistently by federal administrators. Harder to prove claims To win compensation, it used to be enough to demonstrate certain timely symptoms. But three years ago, Health and Human Services Secretary Donna Shalala, according to critics, gutted the injury table associated with the most reactive of childhood vaccines: the DTP shot. DTP stands for diphtheria, tetanus and pertussis (or whooping cough). And of $916 million awarded in compensation since the start of the program, $739 million, or 81 percent, has been for DTP cases. Scientists say the culprit in DTP reactions is the pertussis portion of the inoculation, mainly because it is made from the killed whole cells of pertussis bacteria. Shalala raised the bar on standards of DTP vaccine injury by deleting seizure and shock collapse disorders, making anaphylactic reactions occur within four hours of the shot, and drastically redefining evidence of acquired brain damage or brain inflammation to a stupor that persists for at least 24 hours and requires hospitalization. Shalala's little-publicized revisions have touched off a drumfire of protest from family advocates and those who represent vaccine-damaged kids. ``The DTP kids are going to start losing by the trainload,'' predicted California lawyer Andrew Dodd, one of the more active lawyers for parents and children making vaccine-related claims in the program. ``The new standards are very difficult to meet. You have to have, basically, a child in a coma within 72 hours.'' Clifford Shoemaker, a Virginia attorney who has represented close to 100 petitioning parents and children, said, ``The changes in the compensation program have made it extremely difficult for these people to prevail. Changing all those definitions after the law was written is just ridiculous.'' Vaccine injury lawyers appealed Shalala's changes immediately to the U.S. Court of Appeals, claiming she did not have authority to change the injury table. The court ruled in Shalala's favor, giving the HHS secretary broad power to make medical decisions in the future. Science or politics? Barbara Fisher, founder of the Virginia-based National Vaccine Information Center, a group of parents and health advocates concerned about vaccine safety, thinks Shalala changed the rules because the huge agency felt too many awards were being made for DTP injuries and deaths, and ``each award is an acknowledgment the vaccine can kill and injure.'' Shalala refused repeated GNS requests to answer specific questions about the program and vaccines, instead issuing a boilerplate endorsement of childhood vaccinations. ``Like other medications, vaccines will never be 100 percent safe -- but they save thousands of our children's lives every year,'' she said in her statement. ``For those very few cases where a vaccine may cause an injury, we need to provide fair compensation. We also need to work vigorously to provide the safest possible vaccines. But most of all, we must not forget the great benefit we are gaining from widespread vaccination.'' In publishing the changes in the Federal Register, Shalala indicated she made them ``to reflect the latest scientific knowledge'' because the original injury table ``was out of step with the state of medical knowledge.'' The National Vaccine Information Center, vaccine injury lawyers and some doctors say Shalala is the one scientifically out of step. ``They made the table more restrictive when the data was becoming less restrictive,'' Dr. Mark Geier, a Maryland geneticist frequently called as a medical expert for petitioners, told GNS. Dr. J. Anthony Morris, the former Food and Drug Administration research virologist who first labeled the notorious swine flu vaccine dangerous in 1976 and was fired by the FDA for his trouble, said HHS changed the DTP injury table because ``there were so many cases of pertussis-induced encephalitis being won.'' The changes, he told GNS, ``were all political -- not scientific, but political.'' How safe is DTP? Geier and other HHS critics refer to two analyses -- in 1991 and 1994 -- done by the prestigious Institute of Medicine here as follow-ups to an extensive British investigation called the National Childhood Encephalopathy Study. The British review suggested DTP shots might cause long-term brain dysfunction. In the 1991 report, the Institute of Medicine found a link between DTP and acute encephalopathy based on the British studies. In 1994, the Institute reported ``the evidence suggests -- but does not prove -- a possible link between DTP and chronic brain dysfunction, or death, in some of the children who experience a serious, acute neurologic illness within seven days of vaccination.'' Compensation program director Balbier discounts the studies as ``mixed conclusion.'' He stressed that they also state ``overall'' there is ``no proven link between DTP whole-cell vaccine and chronic neurologic illness.'' And Balbier noted that health policy groups in Canada, the United States and Great Britain maintain ``proven evidence is lacking, thus rejecting the purported `new science.' '' Despite continued safety assurances by immunization officials at HHS and other federal agencies, the Institute also complained that no scientific studies have been conducted on about two-thirds of some 60 health problems suspected of connection to various vaccinations. The Physicians' Desk Reference, the most commonly used prescription guide for doctors, lists under ``significant reactions'' to whole-cell pertussis shots ``encephalopathy resulting in death or permanent damage to the central nervous system'' (estimated to occur in 1 per 330,000 doses) and ``convulsion or transient shock-like episode occurring within 48 hours of vaccination'' (1 per 1,750 doses). The people who run the National Vaccine Injury Compensation Program say the mounting criticism is hogwash. Balbier, the program's director, said the compensation system has several distinct advantages over the old tort system, including privacy. And, he said, ``You don't have to prove the vaccine caused the injury and attorney fees are paid whether you win or lose.'' The program, he said, ``works exceedingly well for families that have somehow incurred a vaccine-related injury.'' Congress may step in Criticism of the 10-year-old compensation program may evolve into a lively public policy debate. A concerned Rep. Henry Waxman, D-Calif., who as chairman of the House Health Subcommittee helped mold the compensation system, told GNS that if he still chaired that panel, he would have oversight hearings quickly. ``The whole idea of the system was to show through a no-fault process that an injured child would be compensated generously and easily,'' he said. ``We wanted to err on the side of compensating kids.'' Waxman said he will recommend to the subcommittee's current chairman, Rep. Michael Bilirakis, R-Fla., that he have hearings on the program and the vaccine injury table. ``I had hoped this program would be successful, and if there are problems, I want to find out about them,'' he said. Bilirakis said he would consider hearings after reviewing more detailed information on the situation. Although the subject draws relatively little attention in the mainstream media, past and present public health officials -- constantly noting that vaccines have a long history of global success in suppressing disease -- tend to blame the press for any bad publicity about reactions. The ``growing misconception that vaccines do more harm than good,'' former HHS Secretary Louis W. Sullivan said in July at a national immunization conference in Atlanta, ``is not only preposterous, it is dangerous.'' Sullivan said vaccination programs have ``become fodder for misguided critics and the story-hungry media.'' Parents, he said, ``are constantly reading and hearing about the very rare adverse reactions linked to the vaccines that have nearly vanquished these (disease) threats. This creates a climate for the erosion of public trust.'' Americans have no choice Vaccines are the only substance Americans are forced to put in their bodies. State and federal governments, to control disease, demand it of citizens or they will be shunned from normal society: denied admission to daycare centers, schools, colleges, the military, health insurance coverage, some jobs. Victor Fadayel, a Daly City, Calif., grocery store proprietor and father of a quadriplegic daughter injured by oral polio vaccine, settled with the compensation program for more than $5 million. Fadayel noted that with the per-dosage excise tax, ``These kids buy their own insurance when they are vaccinated. Why is it they have to wait years afterward to collect?'' Others take a different view of the compensation fund. ``It is not an insurance fund,'' said Catholic University
ethics and politics professor David Walsh, ``but one for victims of the
government's own mistreatment. The effort to redress the injury after the fact
is hardly a good defense to the conditions that actually caused them. The only
legitimate instrument remaining to public health policy is that of persuasion
and moral pressure. The health of the majority will not be bought at the expense
of the injury of a statistically small minority.'' |
