Fwd: AstraZeneca Smoke-And-Mirrors Job

[Guest guest]

ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com FYIThe lid of yet another pharmaceutical company's Pandora Box has been lifted:Lawyers agreed to unseal most AstraZeneca documents that had been collectedduring  Seroquel litigation in Florida. The unsealed documents reveal thatthe company "buried" unfavorable studies that showed the drug posed aserious risk for diabetes.The Wall Street Journal reports (below) that these court documents "suggest"that AstraZeneca told U.S. sales reps to say their antipsychotic drug didn'tcause diabetes, even though a 2000 position paper about the safety ofSeroquel sent to Dutch regulatory authorities, an AstraZeneca doctor, WayneGeller MD, wrote that there was a relationship between the drug anddiabetes: "There is reasonable evidence to suggest that Seroquel therapy cancause impaired glucose regulation including diabetes melliutus in certainindividuals." WSJ cites a 1997 document that describes internal company deliberations overhow to report "Study 15," a study comparing Seroquel to Haldol, anolder-generation psychiatric drug. "In the document, an AstraZeneca employeenamed Richard Lawrence writes to his team that one of his colleagues haddone a great "smoke and mirrors job," and another had suggested an approachthat "should minimise (and dare I venture to suggest) could put a positivespin (in terms of safety) on this cursed study."Bloomberg News cites a 1999 email by John Tumas, an AstraZeneca publicationsmanager company: "The larger issue is how we face the outside world whenthey begin to criticize us for suppressing data."In a 1997 e-mail Richard Lawrence, an AstraZeneca official boasted that thecompany had engaged in a "great smoke-and-mirrors job" in dealing with U.S.and Canadian investigators on the trial's results.  "Adopting the approachDon has outlined should minimize (and dare I venture to suggest) could put apositive spin (in terms of safety) on this cursed study."Lawyers for AstraZeneca urged the judge not to lift the seal on nine otherfiles, including some that reveal what AstraZeneca told foreign regulatorsabout Seroquel.Judge David Baker's response: "The court has a duty to make sure things arenot inappropriately kept secret."  Indeed, American consumers should not be exposed to drugs whose hazards andlack of efficacy are concealed from physicians, public health agencies thatapprove payment for drugs, and consumers who bear the adverse healthconsequences of  such drugs.  More than 15,000 patients have sued AstraZeneca, claiming the companywithheld information of a connection between diabetes and Seroquel use fromdoctors and patients.  Yet, the FDA is considering EXPANDING the use ofSeroquelContact: Vera Hassner Sharavveracare212-595-8974~~~~~~~~~~~~~The Wall Street JournalFEBRUARY 27, 2009, page B3AstraZeneca Papers Raise Seroquel Issues By SHIRLEY S. WANG and AVERY JOHNSONORLANDO, Fla. -- AstraZeneca PLC instructed its U.S. sales representativesto tell doctors that its powerful psychiatric drug, Seroquel, didn't causediabetes even though a company physician had at one point stated yearsearlier that such a link was probable in some individuals, documentsunsealed in a federal court case here show.The documents -- ranging from unpublished study results to previouslyundisclosed depositions -- are among more than 100 the U.K. drug makeragreed to unseal Thursday in lawsuits brought by plaintiffs who allege theywere harmed by the multibillion-dollar antipsychotic drug. Many of the caseshave been consolidated in the U.S. District Court for the Middle District ofFlorida.In an Aug. 15, 2005, voicemail message addressed to company salespeople, anAstraZeneca employee named Christine Ney followed up on a "weight anddiabetes sell sheet" they had recently been sent. The sales representativesshould assuage doctors' fears about their patients' weight gains, she saidin the voicemail, by telling them that data showed no causal link betweendiabetes and the drug."Our objective is to neutralize customer objections to Seroquel's weight anddiabetes profile," Ms. Ney said, according to a transcript of the voicemailmessage. She then instructed representatives to "refocus the call" away fromdiabetes to the drug's tolerability, the transcript shows.The voicemail to the sales representatives raises questions about whetherthere was a contradiction between Ms. Ney's instructions and an AstraZenecadrug-safety expert's own assessment of Seroquel's link to diabetes yearsearlier. In a 2000 position paper about the safety of Seroquel sent to Dutchregulatory authorities, an AstraZeneca doctor named Wayne Geller wrote thatthere was a relationship between the drug and diabetes."There is reasonable evidence to suggest that Seroquel therapy can causeimpaired glucose regulation including diabetes melliutus in certainindividuals," Dr. Geller wrote.AstraZeneca acted "responsibly and appropriately as it developed andmarketed Seroquel," company spokesman Tony Jewell says. "From the time itwas first approved, the Seroquel labeling alerted physicians that diabetesmellitus, hyperglycemia and weight gain had been observed in clinicaltrials. We've continued to update the label as the findings have developed."Mr. Jewell says the document written by Dr. Geller doesn't accuratelyreflect the company's position in 2000. "In fact, it was not Dr. Geller'sultimate view either. It was an initial draft for discussion purposes. Afterrigorous discussion of the scientific evidence, Dr. Geller and hiscolleagues concluded the evidence did not establish that Seroquel causesdiabetes."Dr. Geller retracted his statement in a May 2008 deposition with plaintiffs'attorneys. In response to a plaintiffs' attorney's question, Dr. Gellerresponded that the statement was "an artifact of an earlier discussiondocument." AstraZeneca declined to make Dr. Geller and Ms. Ney, who are bothstill employed by the company, available for comment. Neither could bereached for comment late Thursday night.AstraZeneca had argued that the documents should remain under seal becausethey contained proprietary information that could hurt the company if it wasrevealed to competitors and could harm the public if interpreted out ofcontext. But the company agreed to make public most of the documentsfollowing negotiations with plaintiffs' attorneys that concluded in theearly hours of Thursday morning."AstraZeneca believes communications from the FDA [Food and DrugAdministration] to doctors is the appropriate way to notify patients and thepublic about a medicine's benefits and risks, not a court proceeding," Mr.Jewell says.Makers of antipsychotic drugs have come under intense scrutiny over whetherthey knew early on that the powerful psychiatric medicines -- which are usedto treat schizophrenia and bipolar disorder -- caused serious side effectssuch as diabetes. Most of the drugs were approved for sale in the 1990s, buttheir side effects didn't become widely known until earlier this decade. Thedrug makers have also been accused of marketing the drugs outside of theirapproved indications, which is against U.S. law.Internal company documents proved damaging to Eli Lilly & Co., which agreedto pay $1.4 billion to settle off-label promotion claims last month with theU.S. attorney for the Eastern District of Pennsylvania. Company e-mails andmemos leaked in 2006 showed that Lilly played down the health risks of itsantipsychotic drug, Zyprexa.In 2007, Bristol-Myers Squibb Co. agreed to pay $515 million to settleanother federal investigation over its marketing practices for itsantipsychotic drug, Abilify.AstraZeneca faces more than 9,000 lawsuits from patients who allege theyhave been harmed by Seroquel. Most of the cases have been consolidated intoone group being heard in the Florida federal court. The first two of thesecases, considered bellwethers that would have helped predict the outcomes ofthe remaining lawsuits, were supposed to have been tried earlier this month,but the judge dismissed them on the grounds that the evidence failed toprove that Seroquel had caused their diabetes. More than 2,300 other caseshave also been dismissed. A separate tranche of state cases is also workingits way through the courts, with the first set to go to trial in Delaware,where AstraZeneca has its U.S. headquarters. The company says it will defenditself vigorously against the suits.Pennsylvania, Montana, Arkansas and South Carolina have all suedAstraZeneca, alleging that they were bilked into paying for the medicine foroff-label usage and seeking reimbursement for alleged injuries sustained byindividuals as a result of the drug. AstraZeneca acknowledges that the U.S.attorney for the Eastern District of Pennsylvania, Laurie Magid, isinvestigating Seroquel but wouldn't say when the investigation started orwhat it involves. A spokeswoman for Ms. Magid declined to comment.When Seroquel was approved in 1997, it contained information in the "adversereactions" section of the product label concerning diabetes, hyperglycemiaand weight gain that had been observed in clinical trials, says Mr. Jewell.In 2003, the FDA mandated a stricter precaution, upgrading the diabetes riskto the label's "warnings" section -- even though the agency said at the timethat it wasn't certain that a causal relationship existed.Last month Seroquel's label was updated to include data on children andadolescents, including blood-glucose levels, cholesterol, weight gain andincreased appetite. It also voluntarily agreed to move information aboutincreased blood sugar to the "warnings" section of the label, according to acompany lawyer's testimony in court Thursday.Among the unsealed documents, another set goes back to the late 1990s andraises further questions about whether AstraZeneca kept a lid onunflattering Seroquel studies.A document dated Feb. 12, 1997, describes internal company deliberationsover how to report "Study 15," a study comparing Seroquel to Haldol, anolder-generation psychiatric drug. In the document, an AstraZeneca employeenamed Richard Lawrence writes to his team that one of his colleagues haddone a great "smoke and mirrors job," and another had suggested an approachthat "should minimise (and dare I venture to suggest) could put a positivespin (in terms of safety) on this cursed study."It isn't clear what Mr. Lawrence's comments were referring to. He couldn'tbe reached late Thursday, and AstraZeneca declined to discuss the emails. EdBlizzard, an attorney with the Houston law firm Blizzard, McCarthy & Nabers,who is one of the lawyers for the plaintiffs, says the document refers tothe fact that "the weight gain data was bad, and that's why we believe thestudy was buried."In a series of emails in 1999, AstraZeneca executives discuss withholdingthe results of another Seroquel study, known as COSTAR. That study comparedSeroquel to Risperdal, another antipsychotic drug made by Johnson & Johnson.On Dec. 6, 1999, an AstraZeneca employee named John Tumas, the publicationsmanager for Seroquel, wrote to his colleagues, "There is growing pressurefrom outside the industry to provide access to all data resulting fromclinical trials conducted by industry. Thus far, we have buried" certainstudies. Referring to COSTAR, he added: "We must find a way to diminish thenegative findings. But in my opinion we cannot hide them."Mr. Tumas couldn't be reached late Thursday. AstraZeneca's Mr. Jewelldeclined to comment about the 1990s e-mails and documents other than to notethat the FDA "vetted and substantiated the safety data for Seroquel,"including the data from both Study 15 and COSTAR. "The FDA has approved themedicine as a safe and effective treatment for schizophrenia and bipolardisorder," he says.-Jeanne Whalen contributed to this article.Write to Shirley S. Wang at shirley.wang and Avery Johnson atavery.johnson Copyright 2008 Dow Jones & Company, Inc. ~~~~~~~~~~~~ http://www.bloomberg.com/apps/news?pid=20670001 & refer=home & sid=aS_.NqzMArG8BLOOMBERG NEWSAstraZeneca Seroquel Studies 'Buried,' Papers Show By Jef Feeley and Margaret Cronin FiskFeb. 27 (Bloomberg) -- Unfavorable studies about the antipsychotic drugSeroquel were "buried" by AstraZeneca Plc, according to an internal e-mailunsealed as part of litigation over the medicine. The drugmaker failed to publicize results of at least three clinical trialsof Seroquel and engaged in "cherry picking" of data from one of thosestudies for use in a presentation, an AstraZeneca official said in aDecember 1999 e-mail unsealed yesterday under an agreement between thecompany and lawyers for patients. The company faces about 9,000 lawsuitsclaiming it failed to properly warn users that Seroquel can cause diabetesand other health problems. "The larger issue is how we face the outside world when they begin tocriticize us for suppressing data," John Tumas, an AstraZeneca publicationsmanager, told colleagues in the e-mail. More than 15,000 patients have sued AstraZeneca, claiming the companywithheld information of a connection between diabetes and Seroquel use fromdoctors and patients. Many of the lawsuits also claim AstraZeneca promotedSeroquel, approved by the U.S. Food and Drug Administration forschizophrenia and bipolar disorder, for unapproved uses. "AstraZeneca has studied Seroquel extensively and shared all relevant andrequired data with the FDA -- both before and after the agency approved itas safe and effective," Tony Jewell, AstraZeneca's spokesman, said in ane-mailed statement. 'Acted Responsibly'  "None of the documents can obscure the fact that AstraZeneca actedresponsibly and appropriately as it developed and marketed Seroquel," Jewellsaid. Seroquel, which generated sales of $4.45 billion in 2008, is company'ssecond-biggest seller after the ulcer treatment Nexium. The company hasdenied wrongdoing in its handling of the drug and is vowing to fight thelawsuits in court. The company said today that the FDA asked for more information on itsapplication to expand the use of Seroquel XR to include adults withgeneralized anxiety disorder, following a similar request in Decemberseeking additional data on the drug for major depression in adults. Theagency has scheduled an advisory panel meeting on April 8 to review thedrug's safety and effectiveness, AstraZeneca said on Feb. 25. AstraZeneca fell 153 pence, or 6.5 percent, to 2,204 pence at 11:11 a.m. inLondon trading. The U.K. drugmaker agreed to release more than 100 files with informationabout the drug after Bloomberg News filed a motion this month to unsealrecords in the case. Unsealed Documents The company and lawyers for former Seroquel users agreed to unseal thousandsof documents just before appearing yesterday before U.S. Magistrate JudgeDavid A. Baker in Orlando, Florida, for a hearing on that motion. The London-based drugmaker is urging the judge to continue the confidentialdesignation on nine other files, including some that involve whatAstraZeneca told foreign regulators about Seroquel and salesrepresentatives' notes on doctors' meetings. The company's U.S. headquartersis in Wilmington, Delaware. "The court has a duty to make sure things are not inappropriately keptsecret," Baker said at yesterday's hearing. One unsealed document showed AstraZeneca officials considered Trial 15, oneof the studies Tumas described as 'buried," to be a problem because itdidn't produce favorable results on the issue of weight gain for patientstaking the drug. Gaining weight can be a factor in the development ofdiabetes. 'Smoke-And-Mirrors Job' Richard Lawrence, an Astra Zeneca official, said in a February 1997 e-mailthat the company had engaged in a "great smoke-and-mirrors job" in dealingwith U.S. and Canadian investigators on the trial's results.  "Adopting theapproach Don has outlined should minimize (and dare I venture to suggest)could put a positive spin (in terms of safety) on this cursed study,"Lawrence said in the e- mail. It isn't clear from the e-mail which personLawrence is referring to. In his December 1999 e-mail, Tumas pointed out that AstraZeneca had "buriedtrials 15, 31, 56," and was considering a study listed as COSTAR. Thefocuses of the trials weren't specified in the e-mail. He also noted "thereis growing pressure from outside the industry to provide access to all datafrom clinical trials conducted by industry." Tumas chastised colleagues for using favorable data produced by Trial 15without disclosing the full study results, according to his unsealed e-mail."There has been a precedent set regarding 'cherry picking of data," he said.The data was used in "the recent Velligan presentations," he noted. "Thusfar, I am not aware of any repercussions regarding interest in theunreported data." 'Ethical Behavior' The publications manager indicated that AstraZeneca had a favorablereputation for engaging in "ethical behavior" when it came to disclosingstudy results on its drugs. "We must decide if we wish to continue to enjoythis distinction," he wrote. "The reporting of the COSTAR results will notbe easy," he added. "We must find a way to diminish the negative findings.But, in my opinion, we cannot hide them." Among the unsealed documents was a March 2000 e-mail from Tumas in which henoted a study comparing Seroquel to Risperdal, Johnson & Johnson's rivalantipsychotic drug, produced data "that don't look good." The results showed that Seroquel failed to best Risperdal in at least fivedifferent categories and only out-performed the placebo used in the study,according to study data made public yesterday. Those categories includedmood, anxiety and hostility, the documents showed. Zyprexa Settlements Seroquel is part of class of newer antipsychotic drugs, including Risperdaland Eli Lilly & Co.'s Zyprexa, which studies have linked to an increasedrisk of diabetes. That research prompted the FDA in September 2003 torequire AstraZeneca and other drugmakers to warn doctors of the risks. Lilly has agreed to pay at least $1.2 billion to settle lawsuits filed byabout 31,000 patients who used Zyprexa. The Indianapolis-based drugmakersaid last month it would pay an additional $1.42 billion to resolve claimsby state and federal officials that it marketed the drug for unapproveduses. Lilly also agreed to plead guilty to a criminal charge. AstraZeneca officials have vowed to defend the Seroquel cases "on theirindividual merits" and have refused to settle any claims. Lawyers for formerSeroquel users contend that AstraZeneca knew of Seroquel's risks yearsbefore the FDA required a stronger warning. The first two lawsuits set for trial in federal court in Orlando weredismissed last month when U.S. District Judge Anne Conway determined theplaintiffs couldn't prove Seroquel contributed to their development ofdiabetes. First Trial The first Seroquel trial is set for April in state court in Delaware.AstraZeneca officials have criticized lawyers for former Seroquel users forpushing to have documents in the case unsealed. "It is not surprising thatplaintiffs' lawyers have resorted to these tactics to distract attentionfrom their lack of success on the merits of the claims," Jewell said in his statement. The case is In Re Seroquel Products Litigation, 06-MD-01769, U.S. DistrictCourt, Middle District of Florida (Orlando). To contact the reporters on this story: Margaret Cronin Fisk in Southfield,Michigan, at mcfisk; Jef Feeley in Wilmington, Delaware, atjfeeley. FAIR USE NOTICE: This may contain copyrighted (C ) material the use of whichhas not always been specifically authorized by the copyright owner. Suchmaterial is made available for educational purposes, to advanceunderstanding of human rights, democracy, scientific, moral, ethical, andsocial justice issues, etc. It is believed that this constitutes a 'fairuse' of any such copyrighted material as provided for in Title 17 U.S.C.section 107 of the US Copyright Law. This material is distributed withoutprofit. _____________Infomail1 mailing listto send a message to Infomail1-leave =====In accordance with Title 17 U.S.C. Section 107, this material is distributed without profit to those who have expressed a prior interest in receiving the included information for research and educational purposes.

[Guest guest]

AstraZeneca has quite a history. You should have

seen the coverup in the Tamoxifen case. In fact,

here a copy of one of my articles I wrote on the issue. Regards, Betty

 

Mon, 06 Apr 1998 17:00:59 -0400

constitution

Betty Martini <bettym19

Tamoxifen, Tears and Terror

 

 

Dear Editor: I read the article DRUG NEARLY HALVES BREAST CANCER.

Actually, it was the Atlanta Constitution that has done such an excellent

expose on Tamoxifen. Some of the titles by Jeff Nesmith of your

Washington Bureau says it all:

 

News of cancer death-tamoxifen link delayed

Uproar over faked data slows breast cancer study (3/30/94)

Tamoxifen deaths kept in dark (4/23/94)

Breast cancer study warnings were rejected (3/19/94)

 

Tamoxifen, is a controversial synthetic hormone also sold in England as

Nolvadex. A world best seller to the tone of $500 million a year, it's

sold to women after breast surgery to prevent cancer from spreading to the

other breast. Science News of March 4, l989 reported slight benefits: 9%

in one study, 6% in another, but the negative effects increased by hundreds

of percent!

 

A Swedish trial indicated a 400% increased risk of endometrial cancer for

those 5 years on tamoxifen. With longer use the risk might be higher as

" duration (of use) is more important than dosage " said Flora van Leeuwen of

the Netherlands Cancer Institute. What she said is easy to understand:

few smokers get cancer from tobacco in five years; it takes time. A five

year study would probably pronounce nicotine as safe as nectarines. they

want to dose us with Tamoxifen for life but only count the corpses for five

years. The bottom line is that the longer you take this " " preventative "

the more likely you are to die of cancer!

 

A March 1994 Journal of Clinical Oncology report showed that 67% of the

tumors in tamoxifen users were " high-grade " compared to only 24% of

endometrial cancers in other women, which works out to an 180% increase in

bad tumors. For women with breast tumors who were later diagnosed with

endometrial cancer the interval averaged 12 years for those who did not use

Tamoxifen. This shortened to 5 years for users of the drug. Perhaps they

should rename it TUMOR OFTEN!

 

 

R. J. Kedar of King's College School of Medicine and Dentistry in London

studies 61 women in a tamoxifen trial and said: " Our study detected

endometrial abnormalities at various times from THE FIRST TABLET OF

TAMOXIFEN. " The endometrium appeared abnormally thick in 24 of these women

(39%) and 10 of these underwent potentially pre-cancerous changes. Science

News reported that in this test only 5 of the 50 women given a placebo had

an abnormal endometrium, and none showed the cell changes. The score was

10 to Zero against Tamoxifen. (Science News, June 4, 1994 - Study

Reaffirms Tamoxifen's Dark Side).

 

Imperial Chemical Industries, with its affiliate Zeneca Group PLC got the

National Cancer Institute to spring for a $68,000,000 " study " on 11,000

victims to procure a blessing on TAMOXIFEN as a " breast cancer

preventative. " Then Imperial cut a deal with the University of Pittsburgh

to have Dr. Bernard Fisher lead the tests on healthy female volunteers.

Imperial also cut a $600,000 check to the University of Pittsburgh in honor

of Doc Fisher. No sense taking a chance the test results won't be good

with billions$ at stake!

 

The tests began in 1992 without telling the women that Tamoxifen caused

fatal endometrial cancer , serious eye damage and blood clots which can

lead to strokes. The UP and Imperial knew this from an earlier 5 year test

in which the Tamoxifen group developed 23 womb cancers while the untreated

control group had only 2 such malignancies. SCORE: Tamoxifen cancer

increase, 1,050%!

 

Imperial/Zeneca and U of P concealed these hazards from the volunteers in

the 1993 test, fearing " potential negative publicity " (Let the women die!)

/ This is the same Zeneca that was being sued by the United States and the

State of California for allegedly dumping DDT and PCBS into Los Angeles and

Long Beach harbors. In June of 1993 they demerged from Imperial Chemical

Industries. Zeneca also makes $300 million worth of carcinogenic herbicide

called acetochlor every year. First they give us cancer with a poison,

then they concoct another to treat us!

 

 

Under the headline " Uproar Over Faked Data " the Atlanta Constitution on

March 30, 1994 revealed that for two years the organizers of the Tamoxifen

study knew a Canadian researcher submitted fake data on more than 100

women. Included in his phony research was follow-up data on a woman who

was already dead for two years. Dr. Fisher was removed from the program.

 

Two epidemiologists, Dr. Trudy Bush and Dr. Kathy Halzosouer, predict

endometrial cancers plus other side effects; eye damage and strokes which

have been ignored in the damage estimates for the test. On Dec 14, l994

Dr. Bush (University of Maryland School of Medicine), told me when I

mentioned Tamoxifen has to target other organs - " I tried to tell them,

they wouldn't listen " . She gave me the new predictions for the study:

 

122 breast cancers will be avoided (hopeful guess)

84 endometrial cancers will be caused (could be more)

??? Side effects, eye damage, strokes, etc. (not considered)

 

If Tamoxifen creates 84 endometrial cancers in 5 years, how many more will

it cause in 6 or 10 years, or a lifetime? Suppose there was a great new

experimental drug for testicular cancer and the NCI funded $70 million for

a test on 16,000 young men in good health. Further suppose the designers

of the test predicted it would prevent 122 cases of cancer of the

testicles, but would require 84 penildectomies. Additionally, an unknown

number of the guys would go blind, and others would have a stroke and lose

the ability to speak; but these injuries were not to be considered. How

many would sign up for the test? Just imagine that by some crazy crooked

contrivances this stuff got approved by the FDA as a cancer preventative;

how would it sell to American males for just $1200/year.

 

 

Ever since God created Eve men have admired our breasts as enchanting

symbols of feminity, beauty, motherhood, nurture and grace. Vulgar Zeneca

sees them only as a crass business opportunity!

 

In his book INDICTED: CANCER RESEARCH, Tibor J. Hegedus PhD says:

" Tamoxifen is given to women with breast cancer to block the entrance of

estradiol into the tumor cells dependant upon this hormone to stimulate

growth. When the hormones are blocked from reaching their primary targets,

they are forced to travel to other organs. " This stimulates proliferation

of cells in the lining of the womb, and in certain cases Bingo:

Endometrial Cancer! Dr. Hegedus says other side effects are nausea,

vomiting, menstrual irregularities, vaginal bleeding, pulmonary embolism.

 

" Tamoxifen stimulates cell proliferation by sensitizing cells to

proliferative effects of IGF-I " wrote L R Wiseman, Pathologist at the Royal

Victoria Infirmary, in a paper on breast cancer. IGF, is a hormone

designed to make things grow up, calves and babies, it also stimulates and

accelerates cancer in sensitized women, those taking Tamoxifen.

 

One of the reasons for the uproar in Monsanto marketing the bovine growth

hormone which is injected into cows is the outrageous increase in IGF

(insulin growth factor) which will yield a firestorm of cancer from the

milk. A chemical company is selling us a gasoline named Tamoxifen to

put out the fire.

 

>From the book MILK: THE DEADLY POISON by Robert Cohen it says: " The

single most disturbing aspect of rBGH from a human safety standpoint,

concerns Insulin-like Growth Factor-I (IGF-1), which is linked to breast

cancer. IGF-I occurs naturally in human beings as well as cows, but rBGH

injections cause substantial and sustained increases of IGF-I levels in

milk says Samuels S Epstein, M.D., professor of occupational and

environmental medicine at the Illinois School of Public Health. Worse yet,

'IGF-I is not destroyed by pasteurization, survives the digestive process,

is absorbed into the blood and produces potent growth promoting effects, "

according to Epstein. He says it is highly likely that IGF-I helps

transform normal breast tissue to cancerous cells, and enables malignant

human breast cancer cells to invade and spread to distant organs. "

 

 

Get the picture? Can you imagine anyone using both the milk and

Tamoxifen!!? In l994 I wrote in an article: " Tamoxifen has been tested and

retested for more than 15 years. The testers admitted fraud, many

contraindications were just ignored, test results were limited in duration

and after-effects not tallied, though women sickened and died from them.

The tests didn't prove the stuff works, so they're doing them over again,

with your money. They'll keep testing until they can figure a way to rig

the results in favor of healthy women buying the poison for a disease we

don't have, but the drug will give it to us! " Is that day here?

 

In April, l996 the World Health Organization of the United Nations formerly

declared Tamoxifen a carcinogen, but Zeneca wants to market it anyway. To

take a carcinogen to stop the spread the cancer is simply Russian Roulette

using an automatic!

 

As founder of Mission Possible International, warning the world off the

deadly neurotoxin aspartame (marketed as NutraSweet, Equal, Spoonful, etc.)

I am familiar with industry research. Two U.S. Prosecutors were told to

indict Searle, the original manufacturer of aspartame, for fraud.

(Monsanto bought Searle in l985). Both prosecutors went to work for the

law firm defending the case and let the statute of limitations expire. When

the District Attorney goes to work for the godfather accept acquittal.

These same studies ended up approving aspartame when Dr. Arthur Hull Hayes,

FDA Commissioner, over-ruled his own Board of Inquiry. Then he went to

work for the PR firm of the manufacturer and has refused to speak to the

press ever since. The FDA report last 92 documented symptoms from four

types of seizures to coma and death. No doubt more people have died from

aspartame than victims in many wars.

 

I hope that more will be written about Tamoxifen bringing out its past

coverups, the subjects in the studies who lost their lives to endometrial

cancer, and other information that will prevent women from consuming a

carcinogen to stop the spread of cancer.

 

Notwithstanding triumphs of science that benefit humanity, we must bear in

mind that scientists are only human. They are not beyond temptation and

corruption. Their motives are not always noble. Truly, science has its

proper place in society, but it is not an infallible guiding light in an

ever darkening world. Today we see so much fraud in science that consumers

must now take responsibility for their own health.

 

Betty Martini, Founder

Mission Possible International

770 242-2599

www.mpwhi.com, www.dorway.com and www.wnho.net

Aspartame Toxicity Center, www.holisticmed.com/aspartame

 

At 09:05 PM 2/27/2009, Viviane Lerner wrote:

 

 

 

>

>

>ALLIANCE FOR HUMAN RESEARCH PROTECTION

>Promoting Openness, Full Disclosure, and Accountability

><http://www.ahrp.org>http://www.ahrp.org and

><http://ahrp.blogspot.com>http://ahrp.blogspot.com

>

>FYI

>

>The lid of yet another pharmaceutical company's Pandora Box has been lifted:

>

>Lawyers agreed to unseal most AstraZeneca documents that had been collected

>during Seroquel litigation in Florida. The unsealed documents reveal that

>the company " buried " unfavorable studies that showed the drug posed a

>serious risk for diabetes.

>

>The Wall Street Journal reports (below) that these court documents " suggest "

>that AstraZeneca told U.S. sales reps to say their antipsychotic drug didn't

>cause diabetes, even though a 2000 position paper about the safety of

>Seroquel sent to Dutch regulatory authorities, an AstraZeneca doctor, Wayne

>Geller MD, wrote that there was a relationship between the drug and

>diabetes: " There is reasonable evidence to suggest that Seroquel therapy can

>cause impaired glucose regulation including diabetes melliutus in certain

>individuals. "

>

>WSJ cites a 1997 document that describes internal company deliberations over

>how to report " Study 15, " a study comparing Seroquel to Haldol, an

>older-generation psychiatric drug. " In the document, an AstraZeneca employee

>named Richard Lawrence writes to his team that one of his colleagues had

>done a great " smoke and mirrors job, " and another had suggested an approach

>that " should minimise (and dare I venture to suggest) could put a positive

>spin (in terms of safety) on this cursed study. "

>

>Bloomberg News cites a 1999 email by John Tumas, an AstraZeneca publications

>manager company: " The larger issue is how we face the outside world when

>they begin to criticize us for suppressing data. "

>

>In a 1997 e-mail Richard Lawrence, an AstraZeneca official boasted that the

>company had engaged in a " great smoke-and-mirrors job " in dealing with U.S.

>and Canadian investigators on the trial's results. " Adopting the approach

>Don has outlined should minimize (and dare I venture to suggest) could put a

>positive spin (in terms of safety) on this cursed study. "

>

>Lawyers for AstraZeneca urged the judge not to lift the seal on nine other

>files, including some that reveal what AstraZeneca told foreign regulators

>about Seroquel.

>Judge David Baker's response: " The court has a duty to make sure things are

>not inappropriately kept secret. "

>Indeed, American consumers should not be exposed to drugs whose hazards and

>lack of efficacy are concealed from physicians, public health agencies that

>approve payment for drugs, and consumers who bear the adverse health

>consequences of such drugs.

>

>More than 15,000 patients have sued AstraZeneca, claiming the company

>withheld information of a connection between diabetes and Seroquel use from

>doctors and patients. Yet, the FDA is considering EXPANDING the use of

>Seroquel

>

>Contact: Vera Hassner Sharav

><veracareveracare

>212-595-8974

>~~~~~~~~~~~~~

>The Wall Street Journal

>FEBRUARY 27, 2009, page B3

>AstraZeneca Papers Raise Seroquel Issues

>By SHIRLEY S. WANG and AVERY JOHNSON

>

>ORLANDO, Fla. -- AstraZeneca PLC instructed its U.S. sales representatives

>to tell doctors that its powerful psychiatric drug, Seroquel, didn't cause

>diabetes even though a company physician had at one point stated years

>earlier that such a link was probable in some individuals, documents

>unsealed in a federal court case here show.

>The documents -- ranging from unpublished study results to previously

>undisclosed depositions -- are among more than 100 the U.K. drug maker

>agreed to unseal Thursday in lawsuits brought by plaintiffs who allege they

>were harmed by the multibillion-dollar antipsychotic drug. Many of the cases

>have been consolidated in the U.S. District Court for the Middle District of

>Florida.

>

>In an Aug. 15, 2005, voicemail message addressed to company salespeople, an

>AstraZeneca employee named Christine Ney followed up on a " weight and

>diabetes sell sheet " they had recently been sent. The sales representatives

>should assuage doctors' fears about their patients' weight gains, she said

>in the voicemail, by telling them that data showed no causal link between

>diabetes and the drug.

>

> " Our objective is to neutralize customer objections to Seroquel's weight and

>diabetes profile, " Ms. Ney said, according to a transcript of the voicemail

>message. She then instructed representatives to " refocus the call " away from

>diabetes to the drug's tolerability, the transcript shows.

>

>The voicemail to the sales representatives raises questions about whether

>there was a contradiction between Ms. Ney's instructions and an AstraZeneca

>drug-safety expert's own assessment of Seroquel's link to diabetes years

>earlier. In a 2000 position paper about the safety of Seroquel sent to Dutch

>regulatory authorities, an AstraZeneca doctor named Wayne Geller wrote that

>there was a relationship between the drug and diabetes.

> " There is reasonable evidence to suggest that Seroquel therapy can cause

>impaired glucose regulation including diabetes melliutus in certain

>individuals, " Dr. Geller wrote.

>AstraZeneca acted " responsibly and appropriately as it developed and

>marketed Seroquel, " company spokesman Tony Jewell says. " From the time it

>was first approved, the Seroquel labeling alerted physicians that diabetes

>mellitus, hyperglycemia and weight gain had been observed in clinical

>trials. We've continued to update the label as the findings have developed. "

>

>Mr. Jewell says the document written by Dr. Geller doesn't accurately

>reflect the company's position in 2000. " In fact, it was not Dr. Geller's

>ultimate view either. It was an initial draft for discussion purposes. After

>rigorous discussion of the scientific evidence, Dr. Geller and his

>colleagues concluded the evidence did not establish that Seroquel causes

>diabetes. "

>

>Dr. Geller retracted his statement in a May 2008 deposition with plaintiffs'

>attorneys. In response to a plaintiffs' attorney's question, Dr. Geller

>responded that the statement was " an artifact of an earlier discussion

>document. " AstraZeneca declined to make Dr. Geller and Ms. Ney, who are both

>still employed by the company, available for comment. Neither could be

>reached for comment late Thursday night.

>

>AstraZeneca had argued that the documents should remain under seal because

>they contained proprietary information that could hurt the company if it was

>revealed to competitors and could harm the public if interpreted out of

>context. But the company agreed to make public most of the documents

>following negotiations with plaintiffs' attorneys that concluded in the

>early hours of Thursday morning.

>

> " AstraZeneca believes communications from the FDA [Food and Drug

>Administration] to doctors is the appropriate way to notify patients and the

>public about a medicine's benefits and risks, not a court proceeding, " Mr.

>Jewell says.

>

>Makers of antipsychotic drugs have come under intense scrutiny over whether

>they knew early on that the powerful psychiatric medicines -- which are used

>to treat schizophrenia and bipolar disorder -- caused serious side effects

>such as diabetes. Most of the drugs were approved for sale in the 1990s, but

>their side effects didn't become widely known until earlier this decade. The

>drug makers have also been accused of marketing the drugs outside of their

>approved indications, which is against U.S. law.

>

>Internal company documents proved damaging to Eli Lilly & Co., which agreed

>to pay $1.4 billion to settle off-label promotion claims last month with the

>U.S. attorney for the Eastern District of Pennsylvania. Company e-mails and

>memos leaked in 2006 showed that Lilly played down the health risks of its

>antipsychotic drug, Zyprexa.

>In 2007, Bristol-Myers Squibb Co. agreed to pay $515 million to settle

>another federal investigation over its marketing practices for its

>antipsychotic drug, Abilify.

>AstraZeneca faces more than 9,000 lawsuits from patients who allege they

>have been harmed by Seroquel. Most of the cases have been consolidated into

>one group being heard in the Florida federal court. The first two of these

>cases, considered bellwethers that would have helped predict the outcomes of

>the remaining lawsuits, were supposed to have been tried earlier this month,

>but the judge dismissed them on the grounds that the evidence failed to

>prove that Seroquel had caused their diabetes. More than 2,300 other cases

>have also been dismissed. A separate tranche of state cases is also working

>its way through the courts, with the first set to go to trial in Delaware,

>where AstraZeneca has its U.S. headquarters. The company says it will defend

>itself vigorously against the suits.

>

>Pennsylvania, Montana, Arkansas and South Carolina have all sued

>AstraZeneca, alleging that they were bilked into paying for the medicine for

>off-label usage and seeking reimbursement for alleged injuries sustained by

>individuals as a result of the drug. AstraZeneca acknowledges that the U.S.

>attorney for the Eastern District of Pennsylvania, Laurie Magid, is

>investigating Seroquel but wouldn't say when the investigation started or

>what it involves. A spokeswoman for Ms. Magid declined to comment.

>

>When Seroquel was approved in 1997, it contained information in the " adverse

>reactions " section of the product label concerning diabetes, hyperglycemia

>and weight gain that had been observed in clinical trials, says Mr. Jewell.

>In 2003, the FDA mandated a stricter precaution, upgrading the diabetes risk

>to the label's " warnings " section -- even though the agency said at the time

>that it wasn't certain that a causal relationship existed.

>

>Last month Seroquel's label was updated to include data on children and

>adolescents, including blood-glucose levels, cholesterol, weight gain and

>increased appetite. It also voluntarily agreed to move information about

>increased blood sugar to the " warnings " section of the label, according to a

>company lawyer's testimony in court Thursday.

>

>Among the unsealed documents, another set goes back to the late 1990s and

>raises further questions about whether AstraZeneca kept a lid on

>unflattering Seroquel studies.

>

>A document dated Feb. 12, 1997, describes internal company deliberations

>over how to report " Study 15, " a study comparing Seroquel to Haldol, an

>older-generation psychiatric drug. In the document, an AstraZeneca employee

>named Richard Lawrence writes to his team that one of his colleagues had

>done a great " smoke and mirrors job, " and another had suggested an approach

>that " should minimise (and dare I venture to suggest) could put a positive

>spin (in terms of safety) on this cursed study. "

>It isn't clear what Mr. Lawrence's comments were referring to. He couldn't

>be reached late Thursday, and AstraZeneca declined to discuss the emails. Ed

>Blizzard, an attorney with the Houston law firm Blizzard, McCarthy & Nabers,

>who is one of the lawyers for the plaintiffs, says the document refers to

>the fact that " the weight gain data was bad, and that's why we believe the

>study was buried. "

>

>In a series of emails in 1999, AstraZeneca executives discuss withholding

>the results of another Seroquel study, known as COSTAR. That study compared

>Seroquel to Risperdal, another antipsychotic drug made by Johnson & Johnson.

>

>On Dec. 6, 1999, an AstraZeneca employee named John Tumas, the publications

>manager for Seroquel, wrote to his colleagues, " There is growing pressure

>from outside the industry to provide access to all data resulting from

>clinical trials conducted by industry. Thus far, we have buried " certain

>studies. Referring to COSTAR, he added: " We must find a way to diminish the

>negative findings. But in my opinion we cannot hide them. "

>

>Mr. Tumas couldn't be reached late Thursday. AstraZeneca's Mr. Jewell

>declined to comment about the 1990s e-mails and documents other than to note

>that the FDA " vetted and substantiated the safety data for Seroquel, "

>including the data from both Study 15 and COSTAR. " The FDA has approved the

>medicine as a safe and effective treatment for schizophrenia and bipolar

>disorder, " he says.

>

>-Jeanne Whalen contributed to this article.

>Write to Shirley S. Wang at

><shirley.wangshirley.wang and Avery Johnson at

><avery.johnsonavery.johnson

>Copyright 2008 Dow Jones & Company, Inc.

>~~~~~~~~~~~~

><http://www.bloomberg.com/apps/news?pid=20670001 & refer=home & sid=aS_.NqzMArG8>ht\

tp://www.bloomberg.com/apps/news?pid=20670001 & refer=home & sid=aS_.NqzMArG8

>

>BLOOMBERG NEWS

>AstraZeneca Seroquel Studies 'Buried,' Papers Show

>By Jef Feeley and Margaret Cronin Fisk

>

>Feb. 27 (Bloomberg) -- Unfavorable studies about the antipsychotic drug

>Seroquel were " buried " by AstraZeneca Plc, according to an internal e-mail

>unsealed as part of litigation over the medicine.

>

>The drugmaker failed to publicize results of at least three clinical trials

>of Seroquel and engaged in " cherry picking " of data from one of those

>studies for use in a presentation, an AstraZeneca official said in a

>December 1999 e-mail unsealed yesterday under an agreement between the

>company and lawyers for patients. The company faces about 9,000 lawsuits

>claiming it failed to properly warn users that Seroquel can cause diabetes

>and other health problems.

> " The larger issue is how we face the outside world when they begin to

>criticize us for suppressing data, " John Tumas, an AstraZeneca publications

>manager, told colleagues in the e-mail.

>

>More than 15,000 patients have sued AstraZeneca, claiming the company

>withheld information of a connection between diabetes and Seroquel use from

>doctors and patients. Many of the lawsuits also claim AstraZeneca promoted

>Seroquel, approved by the U.S. Food and Drug Administration for

>schizophrenia and bipolar disorder, for unapproved uses.

>

> " AstraZeneca has studied Seroquel extensively and shared all relevant and

>required data with the FDA -- both before and after the agency approved it

>as safe and effective, " Tony Jewell, AstraZeneca's spokesman, said in an

>e-mailed statement.

>

>'Acted Responsibly'

> " None of the documents can obscure the fact that AstraZeneca acted

>responsibly and appropriately as it developed and marketed Seroquel, " Jewell

>said.

>Seroquel, which generated sales of $4.45 billion in 2008, is company's

>second-biggest seller after the ulcer treatment Nexium. The company has

>denied wrongdoing in its handling of the drug and is vowing to fight the

>lawsuits in court.

>

>The company said today that the FDA asked for more information on its

>application to expand the use of Seroquel XR to include adults with

>generalized anxiety disorder, following a similar request in December

>seeking additional data on the drug for major depression in adults. The

>agency has scheduled an advisory panel meeting on April 8 to review the

>drug's safety and effectiveness, AstraZeneca said on Feb. 25.

>

>AstraZeneca fell 153 pence, or 6.5 percent, to 2,204 pence at 11:11 a.m. in

>London trading.

>The U.K. drugmaker agreed to release more than 100 files with information

>about the drug after Bloomberg News filed a motion this month to unseal

>records in the case.

>

>Unsealed Documents

>The company and lawyers for former Seroquel users agreed to unseal thousands

>of documents just before appearing yesterday before U.S. Magistrate Judge

>David A. Baker in Orlando, Florida, for a hearing on that motion.

>

>The London-based drugmaker is urging the judge to continue the confidential

>designation on nine other files, including some that involve what

>AstraZeneca told foreign regulators about Seroquel and sales

>representatives' notes on doctors' meetings. The company's U.S. headquarters

>is in Wilmington, Delaware.

> " The court has a duty to make sure things are not inappropriately kept

>secret, " Baker said at yesterday's hearing.

>

>One unsealed document showed AstraZeneca officials considered Trial 15, one

>of the studies Tumas described as 'buried, " to be a problem because it

>didn't produce favorable results on the issue of weight gain for patients

>taking the drug. Gaining weight can be a factor in the development of

>diabetes.

>

>'Smoke-And-Mirrors Job'

>Richard Lawrence, an Astra Zeneca official, said in a February 1997 e-mail

>that the company had engaged in a " great smoke-and-mirrors job " in dealing

>with U.S. and Canadian investigators on the trial's results. " Adopting the

>approach Don has outlined should minimize (and dare I venture to suggest)

>could put a positive spin (in terms of safety) on this cursed study, "

>Lawrence said in the e- mail. It isn't clear from the e-mail which person

>Lawrence is referring to.

>

>In his December 1999 e-mail, Tumas pointed out that AstraZeneca had " buried

>trials 15, 31, 56, " and was considering a study listed as COSTAR. The

>focuses of the trials weren't specified in the e-mail. He also noted " there

>is growing pressure from outside the industry to provide access to all data

>from clinical trials conducted by industry. "

>Tumas chastised colleagues for using favorable data produced by Trial 15

>without disclosing the full study results, according to his unsealed e-mail.

> " There has been a precedent set regarding 'cherry picking of data, " he said.

>The data was used in " the recent Velligan presentations, " he noted. " Thus

>far, I am not aware of any repercussions regarding interest in the

>unreported data. "

>

>'Ethical Behavior'

>The publications manager indicated that AstraZeneca had a favorable

>reputation for engaging in " ethical behavior " when it came to disclosing

>study results on its drugs. " We must decide if we wish to continue to enjoy

>this distinction, " he wrote. " The reporting of the COSTAR results will not

>be easy, " he added. " We must find a way to diminish the negative findings.

>But, in my opinion, we cannot hide them. "

>Among the unsealed documents was a March 2000 e-mail from Tumas in which he

>noted a study comparing Seroquel to Risperdal, Johnson & Johnson's rival

>antipsychotic drug, produced data " that don't look good. "

>

>The results showed that Seroquel failed to best Risperdal in at least five

>different categories and only out-performed the placebo used in the study,

>according to study data made public yesterday. Those categories included

>mood, anxiety and hostility, the documents showed.

>

>Zyprexa Settlements

>Seroquel is part of class of newer antipsychotic drugs, including Risperdal

>and Eli Lilly & Co.'s Zyprexa, which studies have linked to an increased

>risk of diabetes. That research prompted the FDA in September 2003 to

>require AstraZeneca and other drugmakers to warn doctors of the risks.

>

>Lilly has agreed to pay at least $1.2 billion to settle lawsuits filed by

>about 31,000 patients who used Zyprexa. The Indianapolis-based drugmaker

>said last month it would pay an additional $1.42 billion to resolve claims

>by state and federal officials that it marketed the drug for unapproved

>uses. Lilly also agreed to plead guilty to a criminal charge.

>

>AstraZeneca officials have vowed to defend the Seroquel cases " on their

>individual merits " and have refused to settle any claims. Lawyers for former

>Seroquel users contend that AstraZeneca knew of Seroquel's risks years

>before the FDA required a stronger warning.

>

>The first two lawsuits set for trial in federal court in Orlando were

>dismissed last month when U.S. District Judge Anne Conway determined the

>plaintiffs couldn't prove Seroquel contributed to their development of

>diabetes.

>

>First Trial

>The first Seroquel trial is set for April in state court in Delaware.

>AstraZeneca officials have criticized lawyers for former Seroquel users for

>pushing to have documents in the case unsealed. " It is not surprising that

>plaintiffs' lawyers have resorted to these tactics to distract attention

>from their lack of success on the merits of the claims, "

>

>Jewell said in his statement.

>

>The case is In Re Seroquel Products Litigation, 06-MD-01769, U.S. District

>Court, Middle District of Florida (Orlando).

>

>To contact the reporters on this story: Margaret Cronin Fisk in Southfield,

>Michigan, at

><mcfiskmcfisk;

>Jef Feeley in Wilmington, Delaware, at

><jfeeleyjfeeley.

>

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