Merck Baby Vaccines Not Pure – LAT/ FDA Advisory-Crestor / Zyprexa Lawsuit charges Lilly concealed Diabetes risk

Merck Baby Vaccines Not Pure – LAT/ FDA Advisory-Crestor / Zyprexa Lawsuit charges Lilly concealed Diabetes risk

Fri, 11 Mar 2005

The FDA’s failure to carry out its watchdog responsibility to protect the public from unsafe drugs, has encouraged the pharmaceutical industry to conceal the risks and deceive the public. Like the tobacco industry, and gun manufacturers, drug manufacturers have been cashing in by marketing products they know pose serious, life-threatening health hazards. Since 1990 fourteen drugs have been withdrawn from the US market because they were unsafe-but not before they killed. See: http://www.economist.com/agenda/displayStory.cfm?story_id=3688601

Neurological harm from mercury-laced vaccines:

On February 8, The Los Angeles Times disclosed the content of a leaked memo from 1991, written by a former Merck scientist who calculated that 6-month-old children who received their shots on schedule could receive a mercury dose up to 87 times higher than the guideline for the maximum daily consumption of mercury from fish. See: http://www.ahrp.org/infomail/05/02/08.php

In a follow up report, the LAT reports that contrary to a 1999 public announcement by Merck, “Now, Merck’s infant vaccine line is free of all preservatives,” the company continued to distribute mercury laced vaccines as late as 2002.

Merck’s reputation suffered irreparable damage when it was revealed that Merck failed to dislcose the risk of heart attacks and strokes linked to the painkiller, Vioxx. The revelations about the baby vaccines show another instance of deceptive marketing: Congressman Dave Weldon, a Florida Republican and a physician, said what Merck did was “misleading.” “You had people literally into 2002 getting shots with mercury, having been told it was all taken out in 1999.”

Since immunizations are mandatory, the Center for Disease Control and the FDA bear even greater responsibility for ensuring that babies are protected from defective vaccines or vaccines containing hazardous substances.

More than 4,200 claims have been filed in the federal Vaccine Injury Compensation Program by parents alleging that their children suffered autism or other neurological disorders from mercury in their shots. To shield Eli Lilly from liability in lawsuits for damage from its vaccines containing mercury, the White House had slipped into the Homeland Security Law a clause giving Lilly immunity. That clause, however, was repealed by Congress. See: http://www.ahrp.org/infomail/1102/15.php

The cholesterol reducing statin, Crestor, is linked to severe, life-threatening muscle damage: The Washington Post reports that after much criticism, the FDA has issued an advisory warning about the risks posed by the statin, Crestor. But Sidney Wolfe of Public Citizen’s Health Research Group, petitioned the FDA in October to ban Crestor-because, he said, since the drug came on the market (September 2003) it has been linked to 117 cases of rhabdomyolysis and 41 cases of kidney failure — which he said are higher totals than for other statins on the market.

Wolfe called FDA action “yet another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs.” Germany, Norway and Spain, have not approved Crestor because of these safety concerns.

Zyprexa (olanzapine) is linked to Hyperglycemia and diabetes mellitus: Eli Lilly faces numerous lawsuits involving its best selling drug, Zyprexa (olanzapine), which was approved by the FDA in 1996 for the treatment of schizophrenia, and in 2000 for short term treatment of bi-polar (manic-depressive) disorder. Zyprexa is the focus of several class action lawsuits in the US and Canada, by plaintiffs who allege they have contracted diabetes as a result of taking the drug. See: Legal News Watch http://www.legalnewswatch.com/news_347.html

Olanzapine produced serious adverse side effects in 22% of adult patients with schizophrenia in whom it was tested in clinical trials. Among the reported severe adverse effects of the drug were cardiovascular complications (10% to 15%); acute weight gain (50%); Parkinson-like motor impairment (11.7%); and unbearable restlessness (akathisia) (7.3%). Whitaker & Kong (1998) prize winning series, Doing Harm, Boston Globe, Nov 15-18.

By 2001, FDA’s MedWatch has received at least 384 reports of diabetes in patients prescribed Zyprexa. Those reports represent 3% to 10% of actual adverse drug events. A review of those MedWatch reports by medical officers from FDA’s Center for Drug Evaluation and Review and Duke University found a causal association between Zyprexa and diabetes, including in adolescents–a condition that is rare in adolescents. See: Koller, E., Malozowski S, Doraiswamy PM. 2001. Letter. Atypical Antipsychotic Drugs and Hyperglycemia in Adolescents. Journal of the American Medical Association Vol. 286 No. 20, November 28, 2001. http://jama.ama-assn.org/issues/current/ffull/jlt1128-4.html .

The Japanese Ministry of Health issued a safety alert about the drug’s links to diabetes in 2002: in Japan the drug is contraindicated in patients with diabetes or a history of diabetes. But the FDA allowed the drug to be marketed without an explicit warning about the nature of the diabetes-Zyprexa risk until 2004:

” Hyperglycemia and Diabetes Mellitus– Hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine.”

In pre-marketing clinical trials, the death rate in Zyprexa was higher than in any other neuroleptic drug trial in history. See: Healy, (2002) Randomized controlled trials: Evidence biased psychiatry, online at: http://www.ahrp.org/COI/healy0802.php ;

Contact: Vera Hassner Sharav
212-595-8974

http://www.latimes.com/business/la-fi-merck7mar07,1,738151.story
THE LOS ANGELES TIMES
Merck Misled on Vaccines, Some Say The firm supplied shots containing a mercury compound after saying it had halted its use.
By Myron Levin
March 7, 2005

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. Merck continued to supply the preservative-containing version “during the transition period to ensure an adequate supply of vaccine to help protect the nation’s children,” said spokeswoman Mary Elizabeth Blake. She said package labels disclosed which lots of vaccine were preservative-free.

Parent groups and a congressional critic of U.S. vaccine policy are crying foul. “As far as the world knew, the product coming out of Merck had no thimerosal in it,” said Sallie Bernard, executive director of Safe Minds, a group concerned about childhood exposure to mercury, a neurotoxin. Parents and doctors who wanted a thimerosal-free product “would be totally confused,” she said.

Rep. Dave Weldon, a Florida Republican and a physician, said what Merck did was “misleading.” “You had people literally into 2002 getting shots with mercury, having been told it was all taken out in 1999,” he said. “There should have been a much more cautious announcement that we’re going to eliminate the mercury over time.” The FDA letter was sent to Weldon in June 2003 in response to his questions about progress in removing mercury from vaccines.

Thimerosal, which is nearly 50% ethyl mercury, has largely been eliminated from most routine childhood vaccines, though it still is present in most flu shots. It had been widely used as a sterilizing agent to prevent bacterial contamination from repeated insertion of needles into multi-dose vials of vaccine.

More than 4,200 claims have been filed in the federal Vaccine Injury Compensation Program by parents alleging that their children suffered autism or other neurological disorders from mercury in their shots.

Last year California banned thimerosal in childhood vaccines as of 2006. Vaccine makers and many health officials say there is no credible evidence of harm from the small doses of mercury once widely present in kids’ shots. They cite a report last May by the prestigious Institute of Medicine of the National Academy of Sciences, which concluded that available evidence “favors rejection of a causal relationship” between vaccines and autism.

Parents have cited contrary findings and say the studies cited by the institute’s panel were flawed. Though they said there was no proof of harm, the U.S. Public Health Service and the American Academy of Pediatrics in July 1999 acknowledged that mercury exposures from a multitude of shots exceeded federal health guidelines, and they called on manufacturers to voluntarily eliminate thimerosal from kids’ vaccines.

Last month The Times disclosed a leaked Merck memo from 1991 showing that the company was aware at that time of concerns about thimerosal. In the memo, a former Merck scientist calculated that 6-month-old children who received their shots on schedule could receive a mercury dose up to 87 times higher than the guideline for the maximum daily consumption of mercury from fish.

“When viewed in this way, the mercury load appears rather large,” said the memo by Dr. Maurice R. Hilleman, an internationally renowned vaccinologist and a former senior vice president of Merck. “The key issue is whether thimerosal, in the amount given with the vaccine, does or does not constitute a safety hazard.” Hilleman and Merck executives have declined to discuss the memo.

Merck’s announcement of the new thimerosal-free vaccine figured strongly in a shift in federal immunization policy. In issuing their 1999 appeal, federal authorities also recommended that the first hepatitis B shot, typically given to newborns in their first 12 hours of life, be postponed except for at-risk infants – those whose mothers had tested positive or whose hepatitis B status was unknown.

But that caveat was lost in confusion over the new policy, and some hospitals delayed the birth dose even for at-risk children. Fearing that these babies could contract the serious disease, the Centers for Disease Control and Prevention reinstated the birth dose for all newborn babies, citing the availability of the new Merck vaccine. The Merck release was issued Sept. 9, 1999, and the CDC announced the revised policy the next day.

The CDC notice cited the introduction of the Merck vaccine and the expectation that a preservative-free version from a second manufacturer would be available soon. It called on hospitals and doctors to assure that they had enough of the new product for newborns before giving it to older babies.

“There was a belief there was enough thimerosal-free hepatitis vaccine, so they went back to the birth dose,” said Glen Nowak, a spokesman for the CDC.

Dr. Eric Mast, chief of the prevention branch in the CDC’s division of viral hepatitis, said the agency had not conducted surveys to determine the percentage of newborns who got mercury-free shots. But he said the CDC had not received reports “from state health departments or providers that there was a problem with access” to preservative-free vaccine.

Weldon, however, said that with the old product continuing to flow into the market, he was “fairly confident that newborns continued to get mercury-containing vaccines.” “It would have to be a very well-informed and diligent pediatrician to make sure all of the stock he supplied contained no mercury,” he said.

http://www.washingtonpost.com/ac2/wp-dyn/A2787-2005Mar2?language=printer
Crestor May Pose Risk of Muscle Damage
FDA Issues Warning on Use of Cholesterol Drug, Especially by Asians
By Marc Kaufman
Washington Post Staff Writer
Thursday, March 3, 2005; Page A14

The popular new cholesterol-lowering drug Crestor may cause an increased risk of potentially life-threatening muscle damage, especially in people of Asian ancestry, the Food and Drug Administration said yesterday.

In a formal advisory, the agency said the risk is small and was largely identified and understood when the drug was approved in 2003. But because of new post-market studies that underscored the concerns, the agency concluded that the public should be informed and that warnings on the product label should be strengthened.

The advisory, and accompanying new instructions to physicians, reflect a recent policy shift in how and when the FDA releases potentially troublesome information about a product. In the wake of criticism that the agency did not move fast enough in communicating potential problems with COX-2 painkillers, including Merck’s Vioxx, FDA officials said they plan to give out more preliminary information than in the past. “Today’s FDA advisory on Crestor is part of an ongoing effort to notify the public of potentially significant emerging safety data so that they can make more informed choices about their medical care,” said Steven Galson, acting director of the FDA’s Center for Drug Evaluation and Research.

The manufacturers of Crestor, AstraZeneca, said the label revisions proposed by the company, and approved by the FDA, “provide physicians with further clarification on how best to use Crestor with their patients.” The company added: “We continue to believe Crestor is safe and effective when used according to the prescribing information.”

Crestor, an especially powerful statin that can lower high cholesterol levels faster than many others, has been linked to some fatal cases of muscle damage known as rhabdomyolysis, which can lead to kidney failure. In its advisory, the FDA said clinical trials of Crestor and post-market studies had found that in rare cases it, like other statins, caused muscle damage.

The advisory was sharply criticized by Sidney Wolfe of Public Citizen’s Health Research Group, a consumer advocacy organization. Wolfe’s group petitioned the FDA in October to ban Crestor, and he called yesterday’s FDA action “yet another example of the agency’s dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs.”

Wolfe said that since the drug came on the market in September 2003, it has been linked to 117 cases of rhabdomyolysis and 41 cases of kidney failure — which he said are higher totals than for other statins on the market. He also said that because of the safety concerns, several countries, including Germany, Norway and Spain, have not approved Crestor.

In their statements, the FDA and AstraZeneca said patients should no longer be started at what had been the highest approved dose of 40 milligrams, but at 20 milligrams. The FDA said that at higher doses, Crestor appeared to cause more bits of protein and blood in urine, a precursor to possible kidney trouble. In his statement, Wolfe said Crestor is the only statin for which higher doses are linked to a higher rate of these side effects.

The FDA also said that in a study of a broad range of Asians, Crestor levels in the blood were found to be twice as high as with white people given the same dosage.

C 2005 The Washington Post Company

http://www.canoe.ca/NewsStand/EdmontonSun/News/2005/03/08/953731-sun.html
MedResource
Tue, March 8, 2005
Lawsuit launched over antipsychotic drug
By KATE DUBINSKI, EDMONTON SUN

Two Albertans who took the antipsychotic drug Zyprexa and then developed diabetes have launched a lawsuit against drug giant Eli Lilly & Co. A third person – the spouse of a man who claims he developed diabetes after taking the drug – is also named as a plaintiff in the lawsuit.

The suit alleges the company, which makes and distributes Zyprexa, knew about complications with the drugs and failed to warn patients and physicians.

Zyprexa is used to treat schizophrenia, bipolar disorder, depression, anorexia and Alzheimer’s. The suit is seeking $900 million in damages.

“This is a serious problem, because Zyprexa is still on the market,” said the plaintiffs’ lawyer, Colin Stevenson. “The British and Japanese had serious problems with it, and it’s quite (strange) as to why it hasn’t been taken seriously here.”

According to the suit, the Japanese Ministry of Health issued a safety alert about the drug’s links to diabetes in 2002, and contraindicated the drug for use in patients with diabetes or a history of diabetes.

The suit also claims that Britain ordered Eli Lilly to revise its Zyprexa package to include information about 40 cases of hyperglycemic abnormalities associated with the drug. “There is no what I would call ‘black box’ warning given to doctors about this drug,” Stevenson said. “The maker still hasn’t seen enough.”

The suit also lists several studies which have linked Zyprexa to diabetes and diabetes-related diseases. The action has yet to be certified as a class action suit. Similar actions have been launched in Ontario, B.C. and Quebec.

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