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WASHINGTON – Sen. Chuck Grassley is asking the drug maker, Eli Lilly and Company, for information related to the risks and marketing of the anti-psychotic drug Zyprexa.

Grassley made this request in response to allegations that the company downplayed safety risks and engaged in other improper marketing practices that may be jeopardizing patients’ health. The text of Grassley’s letter follows here.

April 4, 2007
Via Electronic Transmission
Sidney Taurel
Chairman and Chief Executive Officer
Eli Lilly and Company
Lilly Corporate Center
Indianapolis , IN 46285

Dear Mr. Taurel:

As a senior member of the United States Senate and as Ranking Member of
the Committee on Finance (Committee), I have an obligation to ensure that the public’s money is properly spent to provide safe and effective treatments to the vulnerable populations that are beneficiaries of the Medicare and Medicaid programs.

I am aware of several pending products liability actions regarding Zyprexa, an anti-psychotic drug manufactured by Eli Lilly and Company (Eli Lilly). Specifically, questions have been raised regarding safety information and marketing practices relating to that drug. Furthermore, I understand that Eli Lilly produced certain documents in the course of these litigations that shed light on issues of interest to the Committee.

On December 20, 2006, I wrote to Dr. David Egilman, a plaintiffs’ expert, to request information and documents related to Zyprexa. Dr. Egilman did not provide any confidential Eli Lilly documents regarding Zyprexa. Instead, Dr. Egilman responded to my request by providing the Committee with a copy of a discovery order, dated December 15, 2006, instructing him to return Eli Lilly documents in his possession to Richard D. Meadow of the Lanier Law Firm. Eli Lilly had alleged that some of its confidential documents had been disseminated without the company’s authorization. Although no one affiliated with the Committee was a party to that dispute, I decided to suspend efforts to obtain the relevant documents until that dispute was resolved.

On February 14, 2007, Judge Jack Weinstein of the U.S. District Court for the Eastern District of New York issued a decision regarding the confidential Eli Lilly documents. The court enjoined several individuals from further disseminating the protected documents and ordered them to return any such documents and copies still in their possession or control. Contrary to what was reported in Judge Weinstein’s decision, the Committee’s Chief Investigative Counsel, Emilia DiSanto, did not receive any protected documents related to Zyprexa from Mr. James Gottstein or Dr. Egilman. Nor did Mr. Gottstein or Dr. Egilman provide any protected documents related to Zyprexa to other Committee staff.

As the dispute regarding the dissemination of the documents is now resolved, I believe the time is now right for the Committee to pursue its request for the documents. I am writing to request your cooperation with the Committee’s inquiry. In that regard please provide to the Committee all documents and materials, including, but not limited to, emails, letters, reports, and memoranda, that were made available to the court-appointed Plaintiffs’ Steering Committee I and II pursuant to pretrial discovery in In re Zyprexa Prods. Liab. Litig.

Thank you in advance for assisting the Committee. I would appreciate receiving the requested documents in an electronic and searchable format by no later than April 25, 2007.


Charles E. Grassley
United States Senator
Ranking Member, Committee on Finance

Connecticut Aims to Pass Second Landmark Law

Regarding Parent Protections & Psychiatric Products and Services

Proposed Bill 6202, LCO No 919

ep_07_03_00_connecticut, Cofounder Sheila Matthews with Bill Sponsor Representative Hetherington at New Canaan Chamber of Commerce Luncheon displays New Parent Protection Bill regarding Informed Consent and the Right to Refuse Psychiatric Testing in Public Schools. To learn more about Proposed Bill 6202, parent rights relating to psychiatric testing and drug use visit


In 2001 the State of Connecticut passed the first law in the Country that prohibited school personnel from recommending psychiatric drugs to parents for their children, Public Act 01-124. Connecticut legislation stood as a model where other States quickly followed with similar legislation. This law fueled a national movement that resulted in the Federal law “The Child Medication Safety Act”, which received overwhelming support from both political parties.
Contact: Sheila Matthews (203) 966-8419

Showdown Looms in Congress Over Drug Advertising on TV

New York Times
Published: January 22, 2007

Drug advertising aimed at consumers, a fast-growing category that reached $4.5 billion last year, will face hard scrutiny in the new Congress, according to industry critics in both the House and Senate.

The consumer ads will be on the griddle early in this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it.

The pharmaceutical industry, which often gets what it asks for from Congress and the executive branch, seeks to renew the law and add a new set of user fees that would be pay salaries for additional F.D.A. employees to evaluate all consumer drug ads, before they are shown on television. Both the industry and its critics agree that there should be a pause before the advertising starts — to allow time for doctors to learn about a new drug.

The companies want the delay to be left up to them, but critics say the F.D.A. should require a wait of up to two years. Criticism of direct-to-consumer advertising has intensified since 2004, after Merck withdrew Vioxx, a heavily advertised painkiller, after a clinical trial showed that it sharply increased the risk of heart attacks and strokes.

“From the beginning , everyone, including the company, agreed that not everybody ought to be getting Vioxx,” said Helen Darling, president of the National Business Group on Health, an organization of large employers. “But the ads implied there was a widespread need for it.”

Spending on consumer drug advertising, meanwhile, has been growing robustly, from $1.1 billion in 1997 to $4.2 billion in 2005, according to a recent report to Congress by the Government Accountability Office . In the first nine months of 2006, spending rose 8.4 percent to $3.29 billion, on track toward $4.5 billion for the year, according to TNS Media Intelligence, an advertising research firm.

Spending on the ads faltered in 2005 after soaring 27 percent in 2004, before Vioxx was withdrawn, said David Kweskin, a senior executive at the firm. “Now they are in a catch-up phase.”

Two independent government watchdog groups sharply criticized consumer drug advertising recently, and a separate survey Jan. 9 commissioned by the PricewaterhouseCoopers accounting and consulting firm indicated that skepticism is widespread among the public, too. Only 1 in 10 consumers said the direct-to-consumer, or D.T.C., ads could provide useful information to a large audience, the survey said. (Consumer drug advertising is not permitted in most of the world, except New Zealand and the United States.)

The pharmaceutical industry itself acknowledges having an image problem.

“It would be naïve to not acknowledge the fact that D.T.C. advertising is also a lightening-rod in the health care debate in this country,” said Billy Tauzin, the former congressman who is now president and chief executive of the Pharmaceutical Research and Manufacturers of America, in a speech to venture capitalists last spring. There is “one great problem” that the manufacturers face, he said: “in a word, it is trust.”

“While individual patients find the information useful in discussions with their physicians,” he added in his speech, “patients, physicians and consumers generally express unhappiness with D.T.C. advertising.”

Mr. Tauzin’s organization issued voluntary guidelines for consumer ads, which took effect last year. Under the guidelines, the companies have promised to hold off on consumer advertising of a new medicine for an unspecified “appropriate” period. That would allow time to tell doctors about risks and benefits, before television and Web site viewers see an ad and demand a prescription.

Twenty-seven members of the pharmaceutical manufacturers organization have endorsed the guidelines, but it is hard to figure exactly how long the delays in advertising will run. Bristol-Myers Squibb has said that it would delay for 12 months. Johnson & Johnson and Pfizer said they would wait six months. The manufacturers group cannot say how other companies have interpreted the guidelines, a spokesman said.

But according to TNS Media Intelligence, the companies have actually been waiting 15 months, on average, since the Vioxx debacle. Critics say that even after F.D.A. approval, the full safety profile of a new drug cannot be known until it has been widely used for a number of years.

But the manufacturers’ guidelines have to be voluntary, said Daniel E. Troy, a former chief counsel of the F.D.A., because the Supreme Court has “struck down restrictions on advertising of tobacco, alcohol, gambling and unapproved compounded drugs.”

The agency sent 15 warning letters to drug companies regarding ads in 2005 and a total of 22 complaints last year.

The F.D.A. told AstraZeneca, for example, to “immediately cease” a “misleading superiority claim” in a 2005 TV commercial. The ad said AstraZeneca’s Crestor was “clearly the best” in a “head to head” test with the three largest-selling cholesterol drugs.

Emily Y. Denney, an AstraZeneca spokeswoman, said that by the time the letter was received, in March 2005, the ads were no longer running. The company defended its message in the advertising as “appropriate.”

Another F.D.A. letter told Amgen, a biotechnology company, to stop running commercials for Enbrel, a treatment for the skin disease psoriasis, that the F.D.A. said minimized “serious risks” associated with the drug. Amgen immediately withdrew the commercial.

Last year, the company obtained F.D.A. approval of the contents of a new Enbrel television ad before showing it, David Polk, an Amgen spokesman said. Corporate lawyers say such advertising is protected by the First Amendment under a doctrine of commercial free speech. But some experts say the limits of the protection are murky.

The closest approach to clarity was in 2002 when the Supreme Court rejected, by a 5-to-4 vote, a federal restriction on advertising by pharmacists who make their own compounds.

“It is a giant game of chicken between the government and the industry,” said R. Alta Charo, a law professor and bioethics specialist at the University of Wisconsin in Madison. “I don’t believe either side really wants to see a definitive case go to the Supreme Court because neither side is willing to take the risk that they will lose.”

Professor Charo was a member of a committee of experts of the Institute of Medicine, which examined drug safety issues at the request of the F.D.A. Last fall, the committee called on Congress to give the F.D.A. new authority over advertising, including the power to require a two-year moratorium on advertising before approving a new drug.

“I think the Congress has clearly indicated its strong interest and concerns about the F.D.A. and drug safety for consumers,” said Sheila P. Burke, a longtime Republican health policy expert who headed the Institute of Medicine committee. “Broad-scale advertising can sometimes lead to a rapid increase in the use of a drug” that raises the risk of harm for patients, she said.

F.D.A. regulators would be granted the power to require moratoriums under a bill sponsored by Senators Edward M. Kennedy and Michael B. Enzi, the chairman and ranking Republican member of the Senate Health, Labor, Education and Pensions Committee.

“Patients deserve the best and most accurate information about the medicines they take,” Senator Kennedy said in a statement. “An essential part of any drug safety proposal must be to give the F.D.A. the authority and resources it needs to oversee direct-to-consumer advertising, and to allow the F.D.A. to impose conditions or limits on that advertising, where needed to protect the public health.”

Testifying for the pharmaceutical industry last year, Dr. Adrian Thomas, a vice president of Johnson & Johnson, insisted that “the important First Amendment issues that arise from banning truthful speech, even for a period of time, must be carefully considered before legislating in this area.”

The Government Accountability Office said last November that the F.D.A. should be doing a better job of overseeing consumer drug ads. Now, the F.D.A. reviews only a small fraction of the advertising, picking and choosing without proper priorities, the G.A.O. said.

The G.A.O. report had been requested by three influential senators: Bill Frist, a doctor, before he stepped down as Republican leader of the Senate; Charles E. Grassley , now the ranking Republican on the finance committee, and Herb Kohl, a Democrat who heads an appropriations subcommittee that oversees the F.D.A.

Representative Henry A. Waxman, a California Democrat who is chairman of the House Oversight and Reform Committee, added a further criticism: that the F.D.A. had been slow to crack down on drug ads that included “false and misleading” claims, he said in a telephone interview.

F.D.A. officials said they had to deal with 54,000 drug promotions each year, aimed at both doctors and consumers.

* “We are seriously considering all of the recommendations” of the Institute of Medicine report, said Thomas Abrams, director of the F.D.A.’s division of drug marketing, advertising and communications.
Copyright 2007 The New York Times Company
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Showdown Looms in Congress Over Drug Advertising on TV

By Milt Freudenheim, The New York Times.

Drug advertising aimed at consumers, a fast-growing category that reached $4.5 billion last year, will face hard scrutiny in the new Congress, according to industry critics in both the House and Senate.

The consumer ads will be on the griddle early in this session at hearings on the user fees that manufacturers pay to speed the reviewing of new drugs by the Food and Drug Administration. The user fee law will die in the fall unless Congress acts to renew it.

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Parents Join State Legislators in Calling for Investigation into School Shootings and Psychiatric Drug Use

Patricia Weathers
(845) 677-8115

Sheila Matthews
National Vice President
(203) 966-8419

Three school shootings in the past week have left 11 dead and 29 wounded, prompting the Bush administration to call for a school violence summit with education and law enforcement officials to help communities prevent violence and deal with its aftermath. Yet parents and legislators say that the government has consistently ignored the correlation between school shooters and psychiatric drug use and are likely to do so again at the upcoming summit.

Last year, following the Red Lake Minnesota school shootings and the revelation that the shooter Jeff Weise was under the influence of the antidepressant Prozac, a coalition of Tribal leaders and National Foundation of Women Legislators (NFWL) issued a joint resolution calling on Congress to fully investigate the correlation between psychiatric drug use and school shooters that had left 29 dead and 62 wounded. Ablechild also requested an investigation at that time.

The joint resolution called for such an investigation “to include all autopsies, toxicology reports, dosages of drugs that school shooters were either taking or withdrawing from, and testimony from medical experts who have exposed the dangers of these events”.

To date Congress has not acted upon this request. Nearly a year later, the Rocky Mountain News reported that Colorado school shooter Duane Morrison had an antidepressant in his car. Morrison took several girls hostage, killing one of them before committing suicide.

The evidence tying psychiatric drugs to acts of violence continues to mount; the FDA has warned that antidepressants can cause suicidal ideation, mania, and psychosis. The manufacturers of one antidepressant, Effexor, warn the drug can cause homicidal ideation. And earlier this month a study published in the Public Library of Science-Medicine journal found that the antidepressant Paxil raises the risk of violence. Though the study focuses specifically on Paxil, the researchers concluded that antidepressant drugs such as Prozac, Celexa, and Zoloft most likely pose the same risk. Lead researcher of the study, Dr. David Healy, director of Cardiff’s University’s North Wales Department of Psychological Medicine stated, “We’ve got good evidence that the drugs can make people violent and you’d have to reason from that that there may be more episodes of violence.”, a national grassroots parent’s organization, calls on all concerned citizens to contact their federal representatives, urging them to conduct a full investigation into the link between the spate of school shootings and possible psychiatric drug use of the shooters. Furthermore, state officials must demand full toxicology reports on all three recent school shooters to determine psychiatric drug usage or withdrawal. The victim’s families and the public at large deserve no less.

Study: ADHD Drugs Send Thousands to ERs

By LINDA A. JOHNSON, Associated Press Writer

Accidental overdoses and side effects from attention deficit drugs likely send thousands of children and adults to emergency rooms, according to the first national estimates of the problem.

Scientists at the U.S. Centers for Disease Control and Prevention estimated problems with the stimulant drugs drive nearly 3,100 people to ERs each year. Nearly two-thirds — overdoses and accidental use — could be prevented by parents locking the pills away, the researchers say.

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Tots Used as Human Guinea Pigs?

Joseph Rhee Reports:

ABC News has learned that a Massachusetts hospital is currently recruiting pre-schoolers to test the safety and effectiveness of a powerful antipsychotic drug called Quetiapine. (SEROQUEL AstraZeneca – Vince)

The study, conducted by the Department of Pediatric Psychopharmacology at Massachusetts General Hospital, is testing subjects from four to six years of age with Bipolar Disorder. An earlier Massachusetts General study of the antipsychotic drugs Risperidone and Olanzapine recruited children as young as three years old.

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ADHD Children ‘Suffer Strokes’

CHILDREN as young as five have suffered strokes, heart attacks and hallucinations after taking drugs to treat attention deficit hyperactivity disorder (ADHD).

Almost 400 serious adverse reactions to the two most used ADHD drugs, Ritalin and Dexamphetamine, had been reported to the Therapeutic Goods Administration (TGA), The Australian reported today.

Almost 60 of the adverse reaction reports dating back to 1980, obtained under freedom of information laws, involved children under the age of 10, the newspaper said.

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Warning Urged on Stimulants Like Ritalin

By Gardiner Harris

GAITHERSBURG, Md., Feb. 9 — Stimulants like Ritalin could have dangerous effects on the heart, and federal regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal advisory panel voted on Thursday.

The panel’s recommendation promises to intensify a long-running debate about whether the medicines are overused. Nearly four million patients take the drugs to treat attention deficit disorder and hyperactivity, and committee members said they wanted to slow explosive growth in the drugs’ use.

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FDA Reports 51 Deaths of Attention Drug Patients

(Reuters) WASHINGTON – Deaths of 51 U.S. patients who took widely prescribed drugs to treat attention deficit disorder prompted regulators to start watching for heart attacks, high blood pressure and other problems in 2004, a report released on Wednesday said.

The U.S. Food and Drug Administration staff did not say the drugs were responsible for the fatalities, but they urged close monitoring for “the rare occurrence of pediatric sudden death during stimulant therapy.”

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