Other Topics: With regard to criminal (racial) profiling, 67.3 percent stated they had a written and enforced policy prohibiting such profiling. Only 23 percent of the respondents felt that civilian-review boards are effective in handling citizen complaints against police officers, while 58.7 said their subordinates attended sensitivity training classes.

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Vermont Writers Cite Health Flaw in Polio Vaccine
By Mark Pendergrast

The Virus and the Vaccine: The True Story of a Cancer-Causing Monkey Virus, Contaminated Polio Vaccine, and the Millions of Americans Exposed, by Debbie Bookchin and Jim Schumacher

The seed for "The Virus and the Vaccine" was planted almost by accident. In 1995, Jim Schumacher was working for a Burlington law firm, doing research in an unusual custody dispute. The ex-husband in the case was suing to force his former wife to vaccinate their child. She refused. Among other material Schumacher read to support her case, he ran across an article by molecular biologist Michele Carbone in a medical journal, linking contaminated polio vaccine with a rare form of lung cancer. Schumacher came home and showed the report to his wife, writer Debbie Bookchin.

"We were both fascinated that this simian virus had contaminated a polio vaccine given to millions of children," Bookchin recalls. "I was interested in health and science topics, and Jim has a strong science background, so we pursued it together." In 1997, they published a full-page article in The Boston Globe, then a long investigative piece in The Atlantic Monthly in 2000, and finally they received a book contract with St. Martin's Press.

With their commitment to the book, they really got busy, criss-crossing the country to conduct interviews, visit laboratories and delve into medical archives. After three years of intensive research, writing and polishing one another's prose, they finished their work in 2004, and "The Virus and the Vaccine" was published.

Every married couple knows writing a book together could be a recipe for disaster, but Schumacher and Bookchin not only survived the experience, but they look forward to working on another yet-to-be-decided subject. The two courted when they worked for Rep. Bernard Sanders. Schumacher, whose father was a doctor, took pre-med courses before becoming a lawyer. Bookchin, whose parents are left-leaning political activists and writers, worked for many years as a Burlington-based reporter for the Rutland Herald.

What lessons did the Burlington couple learn from their research? "There is no doubt that vaccination against preventable diseases is critical," Bookchin says. "But not all vaccines are adequately tested. They are the only government-mandated medical procedure in which children are forcibly injected with foreign material."

Before they wrote their book, she and Schumacher had their daughter, Katya, vaccinated without thinking much about it. Today, they would look at their decision a lot harder, knowing what they know. "Our book raises poignant questions that remain relevant today, as the recent news of the contaminated flu vaccine indicates. When you leave health matters up to private industry without adequate supervision, too often profit considerations outweigh safety concerns."

Bookchin and Schumacher hope the book will lead to changes in the way vaccines are regulated and to more funding for research on vaccine contaminants and the role of viruses in causing cancer. They also hope to shine a spotlight on some of the courageous scientists profiled in the book, such as Bernice Eddy, a brilliant, dogged biologist who first blew the whistle on the harmful effects of the contaminated vaccine and whose career suffered as a consequence. Indeed, she would make a fine heroine in a movie based on the book.

I confess that when I initially picked up the book my thought was that "The Virus and the Vaccine" might be one of those over-the-top government conspiracy books, something from the kind of anti-vaccinators who rely primarily on anecdote, hyperbole and paranoia. A sensationalistic subtitle made me even warier.

But the subtitle is accurate. This is a well-researched, well-documented book that unfurls a compelling scientific saga and leaves readers - at least this baby-boom reader - wondering exactly what was in the polio vaccine they got as children. Not only that, it's written with the zing of a medical thriller, featuring fully realized characters, dramatic conflicts, high-level politics and scientific egos big enough to levitate Stone Mountain.

The first 10 chapters cover the early years of polio, including material on Franklin Roosevelt, the March of Dimes and the miraculous Salk vaccine, which promised to end the paralytic scourge that terrified mothers every summer. On April 12, 1955, the 10th anniversary of Roosevelt's death, the Salk field trials were pronounced a success, and the vaccine was rushed into the waiting arms and rear ends of the nation's children.

Within three weeks, however, it became clear that some shots contained live, not killed, virus and that they were causing, not preventing, polio. A nationwide panic ensued, but fortunately it was laid to rest by the Epidemic Intelligence Service of the Centers for Disease Control, which determined that only two contaminated lots made by Cutter Laboratories were at fault. The "Cutter incident" traumatized the U.S. health establishment and made it particularly defensive about the polio vaccine.

Enter Bernice Eddy, a virologist from rural West Virginia who, beginning in 1959, injected rhesus monkey kidney cell cultures into hamsters, 70 percent of which developed cancerous tumors. Joe Smadel, her boss at the Division of Biologic Standards within the National Institutes of Health, was infuriated, because the polio vaccine was grown in a culture of rhesus kidney cells, and Eddy's experiment might once again raise flags about the vaccine's safety.

Monkey kidneys are, as Bookchin and Schumacher write, full of "parasites, bacteria, unknown viruses." Scientists knew this and, in fact, were finding dozens of new viruses in the rhesus kidneys. The first, discovered in 1954, was named Simian Virus 1, or SV1. The 40th in the series, SV40, was the nasty little virus that probably caused the hamster tumors.

Most health officials were not initially concerned, since they presumed that the formaldehyde that killed the polio virus in the "cooking" process for the vaccine also killed SV40. But it turns out that some SV40 survived the process. Vaccines injected into millions of children may have contained the monkey virus until 1963, when it was finally produced on an SV40-free substrate, albeit still on monkey kidneys. By that time, nearly half of the American population may have been exposed to virus-contaminated Salk vaccine.

With Chapter 11, the book jumps to 1986, when Italian biologist Carbone arrived at the NIH in Bethesda, Md. Carbone, a black belt in karate who cooks gourmet dinners in his spare time, replicated and refined Eddy's SV40 experiments, discovering that the monkey virus, when injected into hamsters, appeared to cause malignant mesothelioma, a fatal cancer of the lungs previously associated only with asbestos inhalation in humans.

No room here for the details, but suffice it to say that Carbone - no longer at NIH - and other scientists such as Janet Butel have since compiled disturbing evidence that SV40 is probably a human carcinogen. In 2003, Butel and other colleagues performed a meta-analysis of studies that, they asserted, demonstrate a significant statistical association between SV40 and many tumor types, including a higher association with mesothelioma than that linking smoking to cancer. "As of 2003," write Bookchin and Schumacher, "researchers have found SV40 in human tumors in China, Japan, New Zealand, Australia, Spain. ." And it is found in 14 other countries, including, of course, the United States.

Alarming? Yes. And the authors present evidence that SV40 may have contaminated some polio virus vaccines even in the years after 1963. Only in 2000 did American vaccines stop using monkey kidneys as vaccine substrates. Could SV40 explain some increased cancer prevalence in the last few decades? That is hard to say, as a 2002 review by the Institute of Medicine concluded. Epidemiological studies - examining exposed populations vs. non-exposed - are almost meaningless for SV40, since the virus appears to have spread widely among the population, perhaps from mother to child, regardless of vaccination dates.

Here is one crucial place where Bookchin and Schumacher have left an unsatisfactory hole in their narrative: The book does not fully explore the issue of how SV40 spreads among humans, but it does offer a few brief hints. Part of the problem, of course, is that there just has not been much research on that issue.

"The Virus and the Vaccine" raises important issues, not only about SV40, but about how science can be affected by politics and ego. The authors take care to emphasize that "it would be a disastrous turn of events if vaccine-preventable epidemics returned," but their book is a cautionary tale that should find a wide readership.

Drug Maker Eli Lilly Knew Prozac
Increased Suicide Risks 15 Years Ago

(CNN) -- Internal documents from Eli Lilly and Co. appear to indicate that the drug maker had data more than 15 years ago showing that adverse-effect reports for Prozac were far more likely to list suicide attempts and violence than reports for other antidepressants.

One memo suggests a strategy for talking to doctors about unfavorable clinical trial data showing an increased risk of nervousness, anxiety, agitation, insomnia and sedation among patients.

Lilly officials said Tuesday numbers in the documents made public Monday represented not clinical trials but "adverse effects" reported to the U.S. Food and Drug Administration. The company acknowledged the documents belong to Lilly.

The data were reviewed extensively at the time, said Dr. Charles Beasley of Lilly, but "we did not believe this data, for a number of reasons, were terribly useful or informative in terms of suggesting anything about a causal link between the drug and the adverse effects being reported."

The documents were provided to CNN by the office of Rep. Maurice Hinchey, D-New York, who has called for tightening FDA regulations on drug safety. "The case demonstrates the need for Congress to mandate the complete disclosure of all clinical studies for FDA-approved drugs so that patients and their doctors, not the drug companies, decide whether the benefits of taking a certain medicine outweigh the risks," he said.

One of the documents cites what a Lilly official told CNN were 14,198 adverse-effect reports in which 3.7 percent were suicide attempts by people on fluoxetine -- the generic name for Prozac. That rate was far higher than those cited for any of four other commonly used antidepressants.

The document also states that 2.3 percent of those adverse-effect reports concerned psychotic depression while on the drug, more than double the next-highest rate of patients using any of the other antidepressants. In addition, the document said that 1.6 percent were reported incidents of hostility -- more than double the rate reported on any of the other commonly used antidepressants.

And, the document says, 0.8 percent of adverse-effect reports concerned patients causing an intentional injury -- eight times the rate associated with any of the other antidepressants.

Lilly officials said Prozac had only recently been approved in the United States at the time those data were compiled and as a result the drug was under close scrutiny by physicians, receiving more adverse effect reports than the older antidepressants. Such reports would be expected to decrease the longer any drug remains on the market, Beasley said.

Among the documents is a memo in which the author says the drug may produce nervousness, anxiety, agitation or insomnia in 19 percent of patients, and sedation in 13 percent of patients. Beasley did not dispute the contents and said he likely authored the memo, titled "Activation and sedation in fluoxetine clinical trials."

The memo said, "Several suggestions may be helpful in presenting this information to physicians," including emphasizing that more patients on another class of antidepressants stopped taking their drugs than did those on Prozac.

The existence of the documents obtained by CNN and other documents was reported last week by the British Medical Journal. Its editors said the documents had been reported missing from a 10-year-old murder case, and that they had sent them to the FDA for review.

The journal said the documents disappeared in 1994, during the case of Joseph Wesbecker, a printing press operator who had killed eight people at his Louisville, Kentucky, workplace five years before, while taking fluoxetine. He then shot and killed himself.

Each of the four pages of the documents obtained by CNN is stamped "Confidential" and "Fentress," the name of one of Wesbecker's victims.

That stamp, said Lilly spokesman Morry Smulevitz, likely was used because the documents were provided to plaintiffs' attorneys in the trial. He said the documents did not disappear, but have always been available.

In a civil suit against Eli Lilly, victims' relatives contended the company had long known about the side effects of fluoxetine, including its alleged role in increasing a user's propensity to violence.

Lilly initially won the case, but it was later forced to admit that it had made a secret settlement with the plaintiffs during the trial, which meant that the verdict was invalid, the journal said.

The FDA has recently warned that antidepressants can cause side effects such as agitation, panic attacks, insomnia, and aggressiveness.

In a statement posted on Lilly's Web site, the company said, "To our knowledge, there has never been any allegation of missing documents from the Wesbecker trial or any other trial involving Lilly. Further, it has always been Lilly's objective to publicly disclose data about both the safety and efficacy of fluoxetine.

"Lilly has made several requests to the BMJ to obtain copies of the supposed 'missing' documents; we still await these documents. We are surprised and concerned that a leading medical journal would not find it important to share these documents with us so that we could respond to the public in a meaningful way."

Based on its history of having provided regulatory authorities with study results, the statement said, "Lilly believes that there is no new scientific information to review on this topic."

About 54 million people worldwide have taken Prozac, Smulevitz said.

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