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WASHINGTON, Aug. 3 — An influential Republican senator says he will propose legislation requiring drug makers to disclose the payments they make to doctors for services like consulting, lectures and attendance at seminars.

The lawmaker, Charles E. Grassley of Iowa, the senior Republican on the Senate Finance Committee, cited as an example the case of a prominent child psychiatrist, who he said made $180,000 over just two years from the maker of an antipsychotic drug now widely prescribed for children.

Mr. Grassley is one of several lawmakers to propose a federal registry of such payments. Minnesota, Vermont and Maine already have similar registries, and other states are considering them.

The proposals are a response to growing concerns that payments from drug makers can affect doctors’ prescribing habits, increase the cost of health care and, in some cases, endanger patients’ health.

The drug industry opposes such registries, saying they would discourage doctors from receiving needed education. John Bentivoglio, a lawyer in Washington who represents drug makers, said the registries would be a burden for the companies and might be misinterpreted.

“One of the concerns is that these payments are seen as bribes,” Mr. Bentivoglio said. “That’s not the case. The vast majority are lawful payments for services.”

In a speech on the Senate floor on Thursday, Mr. Grassley said he had started an investigation into these practices. Noting that most universities require academic researchers to disclose such payments, he said, “I have sent letters to a handful of universities to understand how well such a reporting system actually works.”

These letters have uncovered several problems, Mr. Grassley said. First, universities do not verify the information filed by their professors, so “the only person who knows if the reported income is accurate and complete is the doctor who is receiving the money.”

Also, the universities generally keep this information secret from patients, who have no way of knowing whether their doctor is on a drug maker’s payroll, he said.“So if there is a doctor getting thousands of dollars from a drug company — payments that might be affecting his or her objectivity — the only people outside the pharmaceutical industry who will probably ever know about this are the people at that very university,” he said.

Mr. Grassley said that he had asked how much the child psychiatrist, Dr. Melissa DelBello at the University of Cincinnati, made from AstraZeneca, the London-based drug giant that manufactures the antipsychotic Seroquel.

Dr. DelBello’s studies of Seroquel in children have helped to fuel the widespread pediatric use of antipsychotic medicines. Those studies were inconclusive, but she has described them as demonstrating that Seroquel is effective in some children.

Asked in a past newspaper interview how much she was paid by AstraZeneca to help market Seroquel, she had said, “Trust me, I don’t make very much.” Mr. Grassley said this week that her disclosure forms at the University of Cincinnati show she received $100,000 from AstraZeneca in 2003 and $80,000 in 2004. Dr. DelBello consults for seven other drug makers as well. She did not respond to requests for comment this week.

Richard Puff, a university spokesman, said he did not know how much Dr. DelBello made in combined payments from all eight drug makers. Asked if the institution did anything to verify its professors’ financial disclosures, he replied, “We do trust our faculty when they’re making these disclosures.”

Mr. Grassley said he would propose that drug makers make public any payments made to doctors who bill the federal Medicare and Medicaid programs, which would include nearly all doctors.

Noting that voters can easily look up the contributions made to elected officials, he asked, “Shouldn’t we hold doctors to similar standards?”

GRASSLEY SEEKS MARKETING AND SAFETY DOCUMENTS FROM MAJOR DRUG MAKER

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.

Sincerely,

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

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.)

“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.

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FDA Talk Paper

FDA Updates Its Review of Antidepressant Drugs in Children
Agency Details Plans to Present Data to Advisory Committees in September and Seek Advice on Appropriate Regulatory Actions

As part of its commitment to keep the American public fully informed about the status of its review of data concerning the use of antidepressants in pediatric patients, the Food and Drug Administration (FDA) is issuing this update to provide health care providers and patients with the most current information on this topic.

FDA has completed a new analysis of pediatric suicidality (suicidal thoughts and actions) data submitted to the agency and will be posting its analysis on its web site. FDA will also be posting on its web site additional summaries of pediatric efficacy studies from drugs that have been studied in depression in pediatric patients. Although specific new labeling language has yet to be developed, FDA will assure that the labels of the antidepressants used in pediatric patients reflect the most recent information obtained from these studies and analyses.

Next month, on September 13 and 14, 2004, FDA officials will be discussing this issue at a public meeting of its Psychopharmacologic Drugs and Pediatric Advisory Committees, at which time the agency will hear from the public and solicit the advice of the committees on these labeling changes and other possible regulatory actions.

Background

FDA has been closely reviewing the results of antidepressant studies in children since June 2003, after an initial report on studies with paroxetine (Paxil) appeared to suggest an increased risk of suicidal thoughts and actions in the children given Paxil, compared to those given placebo. Later reports on studies of other drugs supported the possibility of an increased risk of suicidal thoughts and actions in children taking these drugs. There were no suicides in any of the trials.

FDA has closely examined the studies of the antidepressants because of the potential public health impact of a link between the drugs and suicidality and the importance of these drugs in treating depression and other serious mental health conditions. On close examination of the initial reports of suicidality, it was unclear whether some of the identified suicidal behaviors reported in these studies represented actual suicide attempts or self-injurious behavior that was not suicide-related. FDA therefore arranged with Columbia University suicidality experts to review these reports.

Meanwhile, FDA brought the available information to its Psychopharmacologic Drugs Advisory Committee (PDAC) and Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committees on February 2, 2004. The advisory committee members advised FDA that even before the Columbia analysis was complete, the labeling should draw more attention to the need to monitor patients closely when antidepressant therapy is initiated. Based on this recommendation, FDA asked manufacturers to change the labels of ten drugs to include stronger cautions and warnings about the need to monitor patients for worsening of depression and the emergence of suicidality, whether such worsening represents an adverse effect of the drug or failure of the drug to prevent such worsening. The new warning language has now been added to the labels for seven of these products. Sponsors for the other three drugs have agreed to adopt the language.

The "Columbia" Study

Because of concerns about whether the varied events identified by sponsors under the broad category of "possibly suicide-related" could all reasonably be considered to represent suicidality, FDA asked Columbia University to assemble an international panel of pediatric suicidality experts to undertake a blinded review of the reported behaviors using a rigorous classification system. The Columbia group submitted its completed review to FDA last month.

FDA has developed its analysis of the pediatric suicidality data, based on case classifications provided by Columbia University, and will be posting the analysis on its web site. While there are findings among these data suggestive of an increased risk of suicidality for some of these drugs, there remain inconsistencies in the results, both across trials for individual drugs and across drugs. Thus, an overall interpretation of these findings represents a substantial challenge.

The September FDA Advisory Committee Meeting

FDA's next step, planned for some time, will be to update the Psychopharmacologic Drugs and the Pediatric Advisory Committees about the results of these reviews and to seek assistance from the committees in interpreting the data and in considering what additional regulatory actions may be needed to promote the safe use of these drugs.

As a public health agency, FDA must weigh the possibility of an increased risk of suicidality in young patients taking these drugs against the known risk of suicide in patients whose depression goes untreated.

FDA will be bringing the following issues and draft questions to the committees for their input:

Lawmaker Calls for Registry of Drug Firms Paying Doctors

FDA Talk Paper

FDA Updates Its Review of Antidepressant Drugs in Children Agency Details Plans to Present Data to Advisory Committees in September and Seek Advice on Appropriate Regulatory Actions

Background

The "Columbia" Study

The September FDA Advisory Committee Meeting

FDA Updates Its Review of Antidepressant Drugs in Children
Agency Details Plans to Present Data to Advisory Committees in September and Seek Advice on Appropriate Regulatory Actions