ness of its thyroid drug, Synthroid, with its only rival, Levoxyl, and two cheaper generic versions. The study was a valid one conducted on patients dependent upon a daily dose of the hormone they lacked. The outcome was significant for 8 million hypothyroid patients in the United States alone..

Sales of this product were worth $600,000 a year to Boots. (Just the sort of steady, captive drug market drug companies thrive on.)

Part way through the study, Boots kept asking for information that would have invalidated it by destroying the secrecy of the double blind procedure. Dr. Dong refused. When the study had been completed, more or less in spite of the sponsor's objections, it turned out that the four drugs were bioequivalent, meaning that they were processed by the human body in exactly the same way.

Boots was not pleased and "came out swinging" finding all sorts of objections, 136 of them just on the patient forms (which were of its own design).

Begun in 1989 and lasting into 1990, the study passed peer review by UCSF and the
Journal of the American Medical Association (JAMA) and was finally due to be printed in the issue of January 15, 1995. It would mean that doctors could confidently prescribe one of the less expensive versions of the drug thereby saving Americans alone as much as $365 million a year.

But Boots had one last trick up its sleeve. Its 21-page contract with Dr. Dong contained a provision that the results of the study could not be published without its approval. The company rallied its lawyers to put pressure on both
JAMA and UCSF.  UCSF, which had stood firmly behind Dr. Dong's study, hired a new lawyer who threatened that Dr. Dong and her six associates might wind up defending themselves in court with no help from UCSF. Lacking resources to fight such a suit, they withdrew.

Why did Boots act in this manner? In addition to losing part of its thyroid-pill business, the truth might have adversely affected the deal that was underway to sell the pharmaceutical manufacturing part of its business to BASF AG, a German firm that was offering to pay $1.4 billion for it. (Ralph T. Kind, Jr.
The Wall Street Journal April 25, 1996)

Thanks to reporter King and the
WSJ, this information has been made available to the public, but this is not the sort of "journal" that gives Dr. Dong and colleagues the professional recognition their findings warrant.

DRUG DISASTER AVERTED
October 9, 1996: A subscriber phoned from Arizona to explain how the chance remark of a pharmacist may have solved the problem of her ailing husband's nausea and lack of appetite. The pharmacist was partially refilling a prescription for digoxin, a form of digitalis marketed by Burroughs Wellcome as Lanoxin and Lanoxicaps, because the doctor was unavailable to approve a prescription renewal.

"We need to check because this drug is very hard on the eyes," he said. BINGO! My friend remembered that her husband had complained of inability to see and strange, flashing lights when getting into the car. Then she remembered that while he was in the hospital having a defibrillator implanted in his chest, his dosage of the drug had been quadrupled to 0.25 milligrams, a normal dose, but not the one he was accustomed to.

Dr. Sidney Wolfe's
Worst Pills Best Pills recommends that people over 60, like this man, should be taking less than the standard 0.25 milligram dose, "especially if you have impaired kidney function." This patient lost a kidney in childhood and has had a great deal of trouble with the remaining one over the years.

His wife arranged for blood tests including one for digoxin which revealed a level of 4.5 ppm instead of a desirable 0.2ppm. Even a level of 2.5 ppm is considered dangerous and an indication that medical assistance should be sought promptly. No wonder this man was suffering severe side effects including nausea and dizziness as well as vision problems.

This experience shows how individuals have to be alert to the dangers of prescription drugs, even one like digitalis with a long history of benefit to humans. Incidentally, the LD50 (lethal dose needed to kill 50% of a group of test animals) for this drug is 670 times higher for rats than cats. Digitalis raises blood pressure in dogs but has proved helpful in alleviating this condition in humans, a prime example of the folly of relying on animal experiments to predict effects for humans.


PMU HURTS ENVIRONMENT
The production of Premarin, an estrogen replacement for older women, from pregnant mare urine has resulted in a sewage lagoon reeking with 19,000 litres of decomposing urine,expected to reach 40,000 litres in 1997. The lagoon covers 300,000 square meters (c. 60 acres) and threatens Manitoba's already polluted Assiniboine River because it exceeds the capacity of the local sewage plant. Discharges contain algal blooms that deprive fish and other animals of oxygen. Winter temperatures prevent decomposition. Manitoba environmental groups seek a ban on sewage lagoons as in Ontario and Quebec. (
Legislative Newsletter Summer 1996 Animal Alliance of Canada, 221 Broadview Avenue, Toronto, Ont. M4M 2G3 Canada)

This is anoher example of the effect of factory farming practices on the environment and another reason for those who accept estrogen replacement therapy to reject Premarin. Many doctors prefer to prescribe synthetic estrogen because they have found it delivers more satisfactory results. Also, it does not involve confining pregnant mares in contraptions to collect their urine and sending their foals to slaughter as the production of Premarin does.


LIMIT ANTIBIOTICS
Dr. Jack Dillenberg, new president of the Association of State & Territorial Health Officials, urges reduced use of antibiotics in order to prevent disease organisms from developing resistance to them.

"People should only be using antibiotics for strep, middle ear infections, and infections where the bacterium is confirmed by a culture," he told a reporter. (
Mesa Tribune October 24, 1996)

Nothing was said about the antibiotics present in some meat, eggs, and dairy products.


PROZAC SURVIVORS GROUP                                home

Adverse reactions to the anti-depressant drug Prozac, over 35,000 of them on file with the FDA, have spawned the Prozac Survivors Support Group, Inc. (POB 1727, Pacific Palisades CA 90272 1-800-392-0640) which serves as an information source without either condemning or approving this controversial drug.

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RESEARCH WITHOUT ANIMALS
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VEGETARIAN IMMUNE SYSTEMS
Researchers at the German Cancer Research Centre at Heidelberg com

(Continued on page 12)

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