Merck Lied on Vaccines, Some Say

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Los Angeles Times
March 7, 2005
By Myron Levin, Times Staff Writer

Drug maker Merck & Co. continued to supply infant vaccine containing a mercury-based preservative for two years after declaring that it had eliminated the chemical.

In September 1999, amid rising concern about the risks of mercury in childhood vaccines, Merck announced that the Food and Drug Administration had approved a preservative-free version of its hepatitis B vaccine.

“Now, Merck’s infant vaccine line,” the company’s press release said, “is free of all preservatives.”

But Merck continued to distribute vaccine containing the chemical known as thimerosal, along with the new product, until October 2001, according to an FDA letter sent in response to a congressional inquiry.

The thimerosal-containing supplies had expiration dates in 2002.

Merck executives confirmed the details in the FDA letter but defended the accuracy of Merck’s announcement in 1999, saying the company had indeed begun to produce preservative-free vaccine.

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Google News
Published originally at EtherZone.com
By: Alan Stang

http://www.etherzone.com/2005/stang030405.shtml

Recently we wrote about the 72-year-old Florida grandmother whom the Food and Drug Administration Nazis are charging with a couple of felonies and some misdemeanors for helping cancer victims get the laetrile (Vitamin B-17) they need. There is still time for you to help her. Please let me know.

Now here come these same offspring of unmarried female canines, with a scheme that may outlaw dietary supplements as soon as June of this year. Yes, we are talking about vitamins, minerals and herbs.

Starting in June, dietary supplements in this country will be defined and controlled by the World Trade Organization (WTO) and the World Health Organization (WHO). The scheme is called the Codex Alimentarius (food code) and it mandates supplement standards for all member countries.

Codex nailed down “Step 8 (the final stage),” in a secret meeting in November, 2004, and if you are hearing about it for the first time, you are no doubt wondering how such an outrage could happen.

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Theglobeandmail.com
By CAROLYN ABRAHAM MEDICAL REPORTER
Friday, February 25, 2005 Updated at 2:57 PM EST

Dosanjh says Merck withheld safety data

Canada’s Health Minister has accused the makers of Vioxx of holding back safety data from drug regulators in the months after the company yanked its blockbuster painkiller off the market.

“I can tell you that I am extremely concerned and disappointed with Merck [Frosst Canada] withholding data from Health Canada, even after it pulled the drug. I think they have an obligation and they have some explaining to do,” Ujjal Dosanjh said yesterday in an interview with The Globe and Mail.

The minister said that as a result he is contemplating new legislation to give Health Canada the power to force companies to hand over information as the drug regulator requests it.

“I am not satisfied with the responses that Merck has given,” he said. “I want to make sure that they understand that I take it very seriously, and I will, in fact, regardless of whether or not they provide us with information, I would try and have legislation developed . . . to deal with that vacuum of authority.”

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Terminator Trees

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ISIS Press Release 02/03/05
By Prof. Joe Cummins and Dr. Mae-Wan Ho

Sterile GM trees cannot contain transgenes, instead, they raise special safety concerns for health and biodiversity

Transgenic or genetically modified (GM) trees have been tested extensively in large open plots with little concern over the spread of transgenes. Studies on the dispersal of pollen and seeds from forest trees have shown that gene-flow can be measured in kilometres. It is clear that the transgenes from GM trees cannot be contained once released into the environment. For that reason, a great deal of effort has been devoted to developing genetic modifications – commonly referred to as terminator techniques - that prevent flowering or pollen production.

In view of the serious threats posed by GM forest trees to the forest ecosystems of the world (see “GM forest trees – the ultimate threat”, this series http://www.i-sis.org.uk/GMFTTUT.php), commercial release of transgenic trees is widely rejected unless strict containment of transgenes can be assured, it is hoped, through engineering such `terminator trees’.

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Los Angeles Times
THE NATION
March 2, 2005
By Marla Cone, Times Staff Writer

Study finds more sex organ abnormalities in 1950s, when chemicals were more widespread.

Scientists who compared frogs collected over the last 150 years have discovered a dramatic increase in hermaphrodites during the times when contamination from the pesticide DDT and other chlorinated compounds was widespread.

Frogs with both male and female reproductive organs were rare in the 19th and early 20th centuries but more common during the 1950s, when the largest volumes of the chemicals were used.

The findings, reported Tuesday in the journal Environmental Health Perspectives, add to the growing evidence that an array of pesticides and industrial chemicals can alter the sex hormones of animals.

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Warning Didn't Slow Approval of MS Drug

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March 2, 2005
Los Angeles Times
By Ricardo Alonso-Zaldivar and Denise Gellene, Times Staff Writers

A specialist in the disease repeatedly questioned Tysabri's safety before a patient's death.

WASHINGTON — A multiple sclerosis drug pulled off the market after a patient died was approved by the Food and Drug Administration even though a prominent neurobiologist and a top medical journal had questioned the drug's safety.

When the FDA gave the drug, Tysabri, so-called fast-track approval in November, "there was already somebody out there saying 'Whoops,' " Arthur Levin, director of the New York-based Center for Medical Consumers, said Tuesday.

"It's a legitimate question to ask if the FDA paid any attention to those concerns, and if not, why not?"

Dr. Lawrence Steinman, a Stanford University professor and an MS specialist, said he repeatedly wrote and spoke about the potential for serious immune-system side effects with this type of drug. The MS patient who died while taking Tysabri suffered from progressive multifocal leukoencephalopathy, or PML, a rare central nervous system disease usually seen in AIDS patients.

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Side Effects Of The Drug Scares

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BusinessWeek online
News: Analysis & Commentary
March 7, 2005
By John Carey with Kerry Capell in London

New fears give rise to a more honest look at the risks for a pill-popping nation


It's enough to make your head spin. In September, Merck & Co. (MRK ) pulled its blockbuster painkiller Vioxx from the market because a study linked it to heart attacks and strokes. Another study fingered Celebrex, a similar drug made by rival Pfizer Inc. (PFE ). The Food & Drug Administration quickly came under attack for failing to protect the public from these dangerous drugs. At a three-day FDA advisory committee hearing in late February, 32 outside experts agreed that these relatively new nonsteroidal anti-inflammatory drugs (NSAIDs) do pose serious risks.

But wait. Despite the hazards, the panel also concluded that some older NSAIDs could be just as dangerous as Celebrex -- and that all should stay on the market. The committee even decided that Vioxx, which may have caused thousands of deaths, is useful enough that it shouldn't be banned.

Is this Solomonic wisdom or simply more confusion? Both. The saga starkly illuminates larger underlying problems in drug regulation and use -- and the implications go far beyond painkillers. Here are some of the key insights and issues:

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By ASHA KRISHNAKUMAR
Frontline (India's national magazine)

http://www.frontlineonnet.com/fl2205/stories/20050311003312500.htm

Agribusiness giant Monsanto faces criminal and civil charges in the United States for bribery and other offences committed in Indonesia.

In a setback to the cheerleaders of the multinationals-driven genetically modified (GM) crops, agribusiness giant Monsanto, which controls most of the global GM seed market, was recently caught bribing Indonesian officials to scrap the requirement that GM crops be subject to an environmental assessment, so that it could freely develop GM crops in that country. This has vindicated the stand that some 650 civil society organisations from over 80 countries took last year against the United Nations' Food and Agricultural Organisation (FAO) report "Agricultural biotechnology: Meeting the needs of the poor", which sees GM crops as the answer to the plight of poor farmers.

Monsanto faced both criminal and civil charges from the Department of Justice and the Securities and Exchange Commission (SEC) in the United States. The MNC agreed to pay $1 million to the Department of Justice, adopt internal compliance measures, and cooperate with continuing civil and criminal investigations. It will also pay $500,000 to the SEC to settle the bribe charge and other related violations.

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The New York Times
February 25, 2005
By GARDINER HARRIS and ALEX BERENSON


Ten of the 32 government drug advisers who last week endorsed continued marketing of the huge-selling pain pills Celebrex, Bextra and Vioxx have consulted in recent years for the drugs' makers, according to disclosures in medical journals and other public records.

If the 10 advisers had not cast their votes, the committee would have voted 12 to 8 that Bextra should be withdrawn and 14 to 8 that Vioxx should not return to the market. The 10 advisers with company ties voted 9 to 1 to keep Bextra on the market and 9 to 1 for Vioxx's return.

The votes of the 10 did not substantially influence the committee's decision on Celebrex because only one committee member voted that Celebrex should be withdrawn.

Eight of the 10 members said in interviews that their past relationships with the drug companies had not influenced their votes. The two others did not respond to phone or e-mail messages.

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Town Gives Radio Frequency IDs an F

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Los Angeles Times
By Eric Bailey, Times Staff Writer

When an elementary school required students to wear radio frequency IDs, some parents saw the specter of Big Brother.

SUTTER, Calif. — This little Northern California farm town is blissfully unaccustomed to turmoil. But recent weeks dished up a hopper of dissent.

It started with a girl who went home from junior high saying she felt like an orange.

Lauren Tatro, 13, told her parents the plain facts. Every student at Brittan Elementary School had to wear a badge the size of an index card with their name, grade, photo — and a tiny radio identification tag. The purpose was to test a new high-tech attendance system. To the eighth-grader, it seemed students had been turned into grocery items on the shelf, slabs of sirloin at the meat counter, fruit in the produce section.

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