History of American Home Products/Wyeth-Ayerst/Lederle

Any information obtained here is not to be construed as medical or legal advice. The decision to vaccinate and how you implement that decision is yours and yours alone.

A little summary of American Home Products & Wyeth-Ayerst history and practices so you get the greater picture of the MESS!

History & practices of Wyeth-Ayerst/Amer Home Products!

. Track record of American Home Products

American Home Product’s recent track record in the consumer drug area. Here is a list of some of the company’s recent problems:

1998- American Home recalled their drug “Duract”, a painkiller that caused fatal liver problems in some long-term users.

July 99- the company halted shipments of its rotavirus vaccine, used to prevent diarrhea in young children after it was linked to bowel obstructions in infants.

August 99- AHP recalled 600,000 defective allergy kits used by people at risk for severe reactions from bee stings, certain foods or asthma.

August 99- AHP agreed to pay $50 million to settle a class action law suite brought by women who used its contraceptive Norplant. The drug was reported to cause headaches, irregular menstrual bleeding and nausea.

September 99- AHP is involved in an investigation being conducted by the FBI for allegedly withholding information indicating that their diet drug “Redux” can result in heart valve problems.

June, 2000

http://web.philly.com/content/inquirer/2000/06/16/business/WYETH16.htm Feb 1, 2000
American Home Targeted in Wrongful Death Suit Over Vaccine Use

Los Angeles, Feb. 1 American Home Products Corp., the No. 5 U.S. drugmaker, is accused in a lawsuit of making and marketing an oral polio vaccine that caused the death of a 2 1/2-year-old Los Angeles boy.

Friday, June 16, 2000
FDA seizes Wyeth drugs, citing quality standards

Rotavirus Vaccine - Here was the first report of problems, with 15 cases reported to VAERS in the first 10 months of vaccine use:

MMWR Morb Mortal Wkly Rep 1999 Jul 16;48(27):577-81

Intussusception among recipients of rotavirus vaccine--United States, 1998-1999.

On August 31, 1998, a tetravalent rhesus-based rotavirus vaccine (RotaShield, Wyeth Laboratories, Inc., Marietta, Pennsylvania) (RRV-TV) was licensed in the United States for vaccination of infants. The Advisory Committee on Immunization Practices (ACIP), the American Academy of Pediatrics, and the American Academy of Family Physicians have recommended routine use of RRV-TV for vaccination of healthy infants

During September 1, 1998-July 7, 1999, 15 cases of intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment) among infants who had received RRV-TV were reported to the Vaccine Adverse Event Reporting System (VAERS). This report summarizes the clinical and epidemiologic features of these cases and preliminary data from ongoing studies of intussusception and rotavirus vaccine.

PMID: 10428095, UI: 99355049

And here's the 1998 analysis by the academic vaccine yes-men which supported licensing the vaccine initially:

Pediatr Infect Dis J 1998 Oct;17(10):924-5

Lack of an apparent association between intussusception and wild or vaccine rotavirus infection.

Rennels MB, Parashar UD, Holman RC, Le CT, Chang HG, Glass RI

Department of Pediatrics and Center for Vaccine Development, University of Maryland School of Medicine, Baltimore, USA. mrennels@umaryland.edu

PMID: 9802640, UI: 99017640

It seems too many uninformed "experts" agree with Dr. Blanck's comment that vaccines cannot cause long-term health effects.

How did FDA approve this one? Did they test the vaccine themselves? Did they inspect the plant? Did they look at clinical trial data? (And assuming they performed these required oversight activities, they still made a serious mistake in licensing this vaccine. Are their procedures adequate to the task of keeping unsafe products off the market?)

Intussusception does NOT naturally occur in 5 out of 10,000 babies. Did FDA check? Drs. Macdonald IA, and Beattie TF, from the Accident and Emergency Department, Royal Hospital for Sick Children, Edinburgh, UK, reported on only 100 patients over ten years who presented to their pediatric emergency room with intussusception. (PMID: 8581242)

Let's run the numbers: I believe at least a million babies got this 3 dose vaccine. If more than 5/10,000 developed intussusception, then more than 500 "expected" cases would have occurred. But the media report that only 100 cases occurred. The AP article below suggests that many more than 5/10,000 cases occurred.

Dr. Ellenberg is head of biostats at FDA. She provided testimony to Shays' Subcommittee designed to obscure the issue of anthrax vaccine-related illness. Is this her work again?

Rotavirus is a very common cause of diarrhea, and normally causes a mild illness. It leads to an expected 30-60 infant deaths per year in the US due to the secondary effect of diarrhea: dehydration. Perhaps the money spent on the vaccine would have been better spent informing new mothers how to deal with dehydration, for if they sought medical attention early enough, there should be almost no deaths.

What I want to emphasize is that you can't miss intussusception (if you miss it the baby dies). Furthermore, the package insert listed intussusception as a potential side effect.

Yet only 15 cases (the tip of the iceberg) were reported to VAERS in the first 10 months the vaccine was used, although it appears that well over 500 cases have occurred. And there are no negative repercussions to doctors or parents for reporting.

If less than 3% of cases were reported to VAERS for this condition, and over 300 VAERS have been filed for anthrax vaccine, what will be the size of the anthrax iceberg?

Meryl Nass, MD

Source: AP Fri 15 Oct 1999

Diarrhea Vaccine Pulled From Market

American Home Products pulled its vaccine against the leading cause of childhood diarrhea off the market today, because of concerns that it may increase infants' risk of bowel obstruction.

The government in July [1999] advised doctors to temporarily stop giving children the vaccine against rotavirus after counting at least 20 infants who developed a bowel obstruction. But the vaccine's manufacturer took the bigger step today of withdrawing the vaccine from the market because reports of bowel obstruction possibly linked to the product have reached about 100, said spokesman Doug Petkus.

Doctors who still have doses of the vaccine in their offices should immediately return them to the manufacturer.

The obstruction occurs when one part of the bowel becomes enfolded within another. Symptoms include vomiting, bloody stools and abdominal pain. Surgery is often needed to clear the blockage if it isn't caught early.

An estimated 1 million infants were vaccinated with RotaShield since it received government approval to sell a year ago. The three-dose series is given at ages 2 months, 4 months and 6 months.

Before its approval by the Food and Drug Administration, 5 cases of the bowel obstruction were reported for every 10 000 vaccine recipients. As a result, the bowel obstruction was listed as a potential adverse reaction on the package insert. But concern arose when doctors discovered that the rate of the problem appeared much higher.

[By Lauran Neergaard, AP Medical Writer]

articles that have implied that the manufacturer of the vaccine and members of the FDA and CDC knew of the vaccine's dangers before the vaccine was ever approved. Congressional Hearing was being held to discuss Conflicts of Interest and Vaccine Development.

from Michael Belkin...

As someone trained in economics, finance and statistics, I find the models the medical profession uses for vaccines to be seriously flawed. Bean counters are using economic justifications (parental hours of work saved, cost per life-year saved, etc.) to ramrod unsafe products into the population. This is total Orwellian doublespeak and no one should trust any epidemiologist who utters such nonsense.

"Drug maker American Home Products Corp. has priced its new vaccine against pneumococcus bacteria so high it will be the first vaccine in U.S. history that fails to produce a cost savings to society, Harvard researchers found ... Researchers determine whether a vaccine offers a cost savings to society by calculating the cost of vaccinating the concerned population and then subtracting out how much would be saved in prevented illnesses and lost economic output. In the case of Prevnar, the cost per life-year saved would come to $80,000, well over the informal benchmark of $50,000 per year at which drugs are deemed cost effective."


Fen Phen

CBS News report on another FDA expose playing out at the same time as Henry Waxman, the drug companies and the FDA are trying to defend the FDA/Drug company relationship. Go to cbsnews.cbs.com/now/story/0,1597,181616-412,00.shtml FDA doctor, Dr. Leo Lutwak, who accuses the drug companies of covering up information. He says "I felt from the very beginning the drug companies were covering up. I felt from the very beginning that these drugs were dangerous." Dr. Leo Lutwak FDA scientist - this is about fen-phen but why should the vaccines situation be any different. He claims American Home Products twisted the meaning of his research to make it seem as if there was no way to predict fen-phen's hazards. "What I had actually written was, that in view of the covering up of information by the drug company, the FDA had no way of predicting some of these side effects," he said.

Dr. Lutwak's testimony is crucial to fen-phen cases like Buol's (A lady suing the maker of fen-phen. But the FDA won't let him testify. Now Lutwak says he's planning to retire, making him free to testify at will. "I followed the rules and regulations, I didn't go public. I tried to work within the system, it didn't work. People died as a result of a dangerous deadly drug being released," he said. Defendant American Home Products would not be interviewed, but has said in the past it "acted responsibly and lawfully."

FDA Commissioner Jane Henney refused a CBS News request to answer the allegations.

I also quote what they reported from the past commissioner: "The agency's last commissioner, Dr. David Kessler, criticized the agency's current approach to drug regulation. "I have some concerns that we may be losing sight of what the FDA is all about," said Kessler. "The question is, who's the agency's customers? Who's the agency partner?"

Consumer advocates say the FDA is constantly keeping damaging information from the public. "They view the drug industry in many ways as their customers, at least the bosses do, as opposed to viewing the public as the customers they need to protect from some of the excesses of the drug industry," said Sidney Wolfe of Public Citizen. Concerns about the FDA also emerged during the controversy over the diabetes drug Rezulin. Kessler said the agency needs to realize the American consumer is its customer.

American Home Products also makes such drugs as Caordarone, Sectral, Protonix, Synvisc and Pnu-Imune. It goes on and on, not a conspiracy, but simple greed, laziness and incompetence by government bureaucrats. I experienced it personally back in the mid-70's when I was a very close friend of one of the doctor/scientists involved with the approval process for G.D. Searle's sugar substitute "aspartame". He regularly stated something like "It's unbelievable how much money we are spending on this approval process and not one penny is being spent to test or improve the product, it's all being used to entertain or meet and negotiate with the FDA people and to change and manipulate the data and results of experiments to get the stuff approved"


Wyeth-Ayerst Pays $30 Million for FDA Violations
By Lauran Neergaard
The Associated Press

WASHINGTON (AP) - A major vaccine manufacturer agreed Tuesday to pay a $30 million fine for repeatedly violating federal drug-quality rules at two of its manufacturing plants, including a flu-shot factory whose temporary closure contributed to this year's delay in flu vaccine.

Maker of Premarin

Premarin is also brought to you by that wonderful company that brings you Prevnar and brought you Rotavirus and Norplant!

Wyeth-Ayerst (division of American Home products)

The Truth About Premarin




Instead of Premarin
(also list of other American Home Products to Boycott - besides vaccines!)

Premarin, Politics & the Public Health

http://google.yahoo.com/bin/query?p=premarin&hc=1&hs=3 and many more links

AHP also makes (which you may to boycott!):

Anbesol (oral analgesic)
Caltrate Plus (calcium supp)
Centrum (vitamins)
Chap Stick (lip balm)
Clearblue Easy (preg test)
Denorex (shampoo)
Dimetap (cold med)
Fibercon (laxative)
Preparation H
Primatene (asthma relief)
Robitussin (cough medicine)
Chef Boyardee
Goulden's mustart
Jiffy Pop Popcorn
PAM cooking spray
Polaner fruit spread

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