THE LETHAL DANGERS OF THE BILLION-DOLLAR VACCINE BUSINESS WITH GOVERNMENT APPROVAL, DRUG COMPANIES SELL VACCINES THAT CAN LEAVE YOUR CHILD BRAIN

This article is from 1996 but is very relevant today & for decades down the road.

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(MONEY Magazine) – When Miriam Silvermintz of Fair Lawn, N.J. took her seven-month-old son Nathan to the pediatrician for his third series of vaccinations on Feb. 18, 1991, she was thrilled to hear the doctor say her baby was growing beautifully. Just five hours later, as Nathan lay in his crib, he shrieked in pain. Terrified, Miriam ran in and cradled her baby in her arms. Nathan collapsed, his eyes rolling back in his head, as he suffered a severe seizure. "We called 911, and they worked on him for 45 minutes," says Miriam, "but I knew when I held him in my arms that he was dying."

What killed Nathan? "When I first called the pediatrician after the ambulance arrived, he said Nathan probably was just having a reaction to his DPT shot," Miriam recalls. "But when Nathan died, the doctor did an about-face and said it had nothing to do with the vaccine." Nathan's death was officially attributed to a congenital heart defect. But Miriam, now 36, and her husband Steven, 37 (pictured on page 151), couldn't shake the feeling that Nathan's death was somehow linked to the shot.

They began to search for details on DPT, which prevents diphtheria, pertussis (familiarly known as whooping cough) and tetanus. The search led them to the National Vaccine Information Center of Vienna, Va., a 14-year-old nonprofit educational and support group for parents whose children have been harmed by vaccines. There, the Silvermintzes learned that a DPT shot can indeed cause death--as well as adverse reactions ranging from fever and irritability to the permanent brain damage suffered by Joshua Reed, now 13 (pictured opposite), of Great Bend, Pa. They also discovered that some batches of the vaccine cause more problems than others. In fact, because of lax federal recall regulations, Nathan appears to be the first of nine children who died shortly after getting a shot from the same DPT lot.

Finally, the Silvermintzes were confronted by the most painful discovery of all. "We learned," says Miriam, "that there were safer ways to manufacture DPT that weren't being used in this country."

In 1994, the U.S. Court of Federal Claims awarded damages to the Silvermintzes under the National Childhood Vaccine Injury Act of 1986. "It was bad enough suspecting that Nathan's death was caused by a vaccine," says Miriam, "but still I had believed it was one of those one-in-a-million things. When I learned that his death was followed within three weeks by another in New Jersey and then another in Illinois and another in Pennsylvania and five more after that while this batch of vaccine stayed on the market for an entire year, it broke my heart. I feel betrayed by the drug companies who make vaccines and by the doctors and government agencies I'd always trusted to protect us."

Vaccines are indispensable. They save lives, cutting the number of U.S. pertussis deaths to about five last year, for example, from 1,118 in 1950 before state governments made the vaccination mandatory for school admission. No one is suggesting that your kids skip their shots. However, shouldn't your children receive the safest vaccines that can be made? And shouldn't your doctors always alert you to the danger signs--before and after immunization--that you should watch for to prevent tragedy? Neither is the case now. A MONEY investigation of the booming vaccine industry (estimated revenues of more than $1 billion a year in the U.S. alone, up from $500 million in 1990) and of its federal regulatory agencies reveals severe violations of public trust. In probing the politics and economics of the two vaccines that have been used longer than any others in this country, DPT and polio, MONEY found that health officials publicly downplay the lethal risks. In addition, medical experts with financial ties to vaccine manufacturers heavily influence government decisions that have endangered the health of immunized kids while enhancing the bottom line of drug companies.

Among MONEY's disturbing findings, we learned that DPT shots cause brain damage at the rate of one case for every 62,000 fully immunized kids. The shots also kill at least two to four people a year, according to a federally funded Institute of Medicine study, and perhaps as many as 900 a year--including a great number misclassified as victims of sudden infant death syndrome--according to the independent National Vaccine Information Center. What's worse, these tragedies can be virtually eliminated by a vaccine that would cost $19.43 a dose, just $9 more than the current product. Who wouldn't pay $9 to protect their child even from a one-in-62,000 risk of severe illness, let alone death?

Sound like a simple solution? Don't count on it. Although they are now making some small moves, the government and the drug industry have an appalling record of facing up to vaccine problems. For example, MONEY has learned that:

--For decades, American pharmaceutical companies have known how to produce the safer DPT vaccine but decided not to bring it to market because it would increase production costs and lower the drug's 50% or higher profit margins.

--The only cause of polio in the U.S. for the past 17 years has been the oral version of the vaccine itself, and though the Food and Drug Administration has finally recommended a reduction of the oral product's use, there are no plans to take it off the market. The twice-as-costly vaccine administered by injection does not cause polio.

--The oral polio vaccine and the injected variety are commonly made using monkey tissues, which contain viruses that can be harmful to humans. A safer injected vaccine, using human tissue, is available in Canada but not in the U.S., even though it is made by the same company that produces all U.S. injected polio vaccine.

--Federal regulators have stymied many efforts to investigate the impact of those monkey viruses but are now paying attention to particularly disturbing research by a Chicago molecular pathologist linking one to human cancer. This is the same monkey virus that a new Italian study suggests is being passed on sexually by people throughout the world, and from mothers to babies in the womb.

HOW A SAFER DPT SHOT HAS BEEN DELAYED

Manufacturers put profits ahead of vaccine safety--with impunity. A 1986 law promoted by the drug industry dramatically limits vaccine manufacturers' legal liability in cases where their products cause injury or death. The law was enacted to help prevent vaccine manufacturers from being driven out of business by rising liability costs. That was a worthy goal. But in practice the reform effectively removed one of the drug industry's most compelling incentives to ensure that its products are as safe as possible. Rather than filing lawsuits against drug companies or against physicians, victims or their families now must first file claims under a federal vaccine injury compensation program. Also, the damages awarded are not paid by drug companies; they are paid by you--in the form of a user tax tacked onto the price of each vaccination. The tax totals $33 for a child fully immunized--five vaccinations for DPT, four for polio and two for measles, mumps and rubella--in accordance with federal requirements.

To date, the users taxes have been spent to compensate more than 1,000 people, including the Silvermintzes, at a cost to taxpayers of half a billion dollars. Meanwhile, manufacturers' profits have risen as the average cost to fully immunize a child at a private physician's office has climbed 243% since 1986, from $107 to $367. The most prominent beneficiaries have been the two producers who dominate the U.S. market for DPT and polio vaccines, Connaught Laboratories ($300 million in U.S. sales last year) and Wyeth-Lederle Vaccines & Pediatrics ($350 million). U.S. revenues for both companies have increased 300% since 1986, estimates David Molowa, international pharmaceutical analyst at the Wall Street investment firm Bear Stearns.

While the drug companies' revenues have soared, people have needlessly suffered. For example, though most kids develop only minor reactions such as fever and irritability following a DPT vaccination, about one in 310,000 injections results in permanent brain damage, according to a 1993 British study that followed children over a 10-year period. Since damage can occur with any one of the full series of five DPT shots, the odds of suffering brain damage for a child receiving all five doses of vaccine works out to one in 62,000. Additionally, based on a 1979 study conducted jointly by the FDA and UCLA researchers, the National Vaccine Information Center calculates that DPT deaths could exceed 900 per year. And while a 1979 study may seem outdated, consider that in the U.S. the pertussis portion of the vaccine, the component that causes the damage, is little changed from the original crude formula introduced in the 1920s.

At the same time, the safer vaccine costing $9 more a dose has been used in Japan since 1981. Patented there by scientist Yuji Sato, it has wiped out 83% of minor reactions such as fever and swelling and virtually eliminated seizures, brain damage and death. The reason: The Japanese use an acellular vaccine, extracting only the portion of the pertussis bug that will trigger the body's immune response to protect against the disease. They remove or neutralize poisons that are byproducts of the bacteria, including endotoxin, a substance scientists say can cause serious afflictions, such as Joshua Reed's brain damage. By contrast, until recently, the two licensed U.S. DPT manufacturers, Wyeth-Lederle and Connaught Laboratories, used only the whole bacteria, toxins and all, yielding a whole-cell vaccine that former FDA researcher Charles Manclark has described as being "crude and impure." What's more, tests completed in Italy and Sweden in 1995 indicated that the purified acellular vaccine was not only safer than the whole-cell vaccine but was up to twice as effective in preventing pertussis.

Ironically, Sato was merely applying technology developed--but then abandoned--by American manufacturers. By 1972, six U.S. pharmaceutical companies had worked up some purified form of the pertussis vaccine that was safer than whole cell. One of the companies, Eli Lilly, marketed its vaccine, Trisolgen, for 15 years before getting out of the vaccine business in 1976 and selling the rights to Wyeth. Internal Lilly documents reveal that reported adverse reactions to Trisolgen were only a fifth of those to their whole-cell product and that "severe reactions virtually do not occur." Nevertheless, Wyeth and other manufacturers initially rejected this process. According to a 1977 Wyeth document, its scientists analyzed the Lilly formula and found that the purification process would yield 80% less of the component that fights pertussis than the whole-cell formula, which would result in "a very large increase in the cost of manufacture."

Wyeth-Lederle told MONEY that clinical studies did not show that Wyeth's version of Trisolgen was safer than the whole-cell vaccine. Accordingly, Wyeth-Lederle says, Wyeth began looking into developing an acellular vaccine.

THEY STILL DON'T GET IT

"Sure, you can produce a much less toxic product in very low yields, and anyone who has worked on pertussis knows this," Dennis Stainer, an assistant director of production and development at Connaught Medical Research Laboratories in Canada, told a 1982 symposium sponsored by U.S. Government health officials. "What we are really faced with, I think now, is going from a vaccine that costs literally cents to produce to one that I believe is going to cost dollars to produce."

Connaught began research into an acellular vaccine in 1979 and in 1996 obtained an FDA license to sell it. "To criticize as slow, scientists who achieved the first U.S. license for infant use of Tripedia, an acellular pertussis vaccine, is like criticizing a gold-medal hurdler for not having started the race or cleared the hurdles as early as you think she should have," Christine Grant, Connaught's vice president for public policy, told MONEY.

Since July, Connaught's infant DPT vaccine with a Japanese acellular pertussis component has been on the market. Nevertheless, whole cell continues to be used in about 90% of all U.S. vaccinations. "The FDA needs to pull the license on whole-cell vaccine, as Japan did, and get it off the market," says Mark Geier, a physician and geneticist who worked for nine years at the National Institutes of Health researching toxins and other vaccine contaminants. But the medical community continues to defend the old vaccine. For example, Neal Halsey, chairman of the committee that makes vaccine recommendations at the American Academy of Pediatrics, says, "While acellular does cause lower rates of minor [problems], it doesn't mean whole cell is all bad or shouldn't be used."

Halsey's view is shared by many doctors. Says Geier: "The fact that a lot of pediatricians think whole-cell pertussis vaccine doesn't cause brain damage shows what a lot of money can do. Drug companies have paid a lot of money to people like James Cherry to put forth that image."

Cherry, a physician and professor of pediatrics at the University of California at Los Angeles, is a widely recognized pertussis expert who has been a leader on advisory committees that help frame immunization policy for the American Academy of Pediatrics and the Centers for Disease Control. Back in 1979, at a symposium, he said, "All physicians are aware that pertussis vaccine occasionally produces severe reactions and that these may be associated with permanent sequellae [complications caused by the vaccine] or even death." But by 1990, Cherry had changed his mind, proclaiming in the Journal of the American Medical Association that severe brain damage caused by pertussis vaccine was nothing but "a myth." From 1980 through 1988, Cherry got about $400,000 in unrestricted grants that he termed "gifts" from Lederle. From 1988 through 1993, he was given $146,000 by Lederle for pertussis research, and from 1986 through 1992, UCLA received $654,418 from Lederle for pertussis research. Additionally, drug manufacturers paid Cherry and UCLA $34,058 for his testimony as an expert witness in 15 DPT lawsuits brought against the companies.

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