Breaking News 

Stimulants for ADHD Shown to Cause Sudden Death in Children

By Dr. Peter Breggin
June 17, 2009

A new study, published Monday in the American Journal of Psychiatry, confirms what I've been warning about for years in my scientific books and articles. The stimulants used to treat children for so-called ADHD can cause sudden cardiac arrest and death in kids. The study was published by the journal online in advance of regular publication in the near future. On Monday, I had the opportunity to comment on the study on Good Morning America. Here is more detail.

The stimulant group of drugs includes amphetamines like Adderall and Dexedrine and methylphenidate products such as Ritalin, Concerta, and Focalin. The study focused on Ritalin because at the time it was more commonly used than the amphetamines, although amphetamines are probably even more toxic to the heart.

The results of the study were as dramatic as they are tragic. Children and youth age 7 to 19 taking prescribed Ritalin for ADHD were four to five times more likely to die of sudden unexplained cardiac arrest than other children who were not taking Ritalin.

Despite these ominous results, the study was skewed to hide just how many children die of sudden death when taking Ritalin. The study relied heavily on identifying cases through toxicology reports at autopsy. But autopsy studies for the detection of these controlled substances are geared to detect more massive doses from addiction and overdose. They are not sensitive enough to detect many cases of routine prescription use. As a result, many stimulant-caused deaths were probably missed.

Also, the study excluded a large number of sudden deaths if the children had even the slightest evidence of pre-existing heart disease. They excluded these children even when the coroner thought that heart disease played no role in the death. For example, if a child was taking stimulants and had minimal heart disease, such as a slightly enlarged heart, the researchers didn't include the case as a possible death due to the stimulant. They also did not count children who were severely obese, anorexic, or asthmatic. But all of these children, especially ones with undetected heart disease, are much more highly at risk for of stimulant-induced sudden death. They even excluded children whose parents had some forms of heart disease.

It's as if they did not want to confirm the obvious--that an examination of children with heart disease and related disorders would swell the numbers of those killed by Ritalin. In fact, the current FDA approved label specifically mentions the risk of cardiac sudden death when Ritalin is given to children with heart conditions.

Unconscionable, the study researchers were trying not to prove that stimulants cause sudden death in children. They made the findings despite their own attempts to avoid it. I was not surprised to find that some of the researchers for this study are among the biggest advocates of psychiatric medications for children.

Sudden cardiac death in children is rare, probably occurring--as the study notes--in a slightly little less than 1 in 100,000 children. But we need to take a few other facts into account. First, the rate is going to be much higher in children taking stimulant drugs. Not just the four or five times higher found in this study, but many more times higher when vulnerable children are included such as those with undetected heart disease, severe obesity, asthma, or anorexia. Second, stimulant drugs are one of the few causes of cardiac death in otherwise normal children, making it impossible to detect the risk before it happens.

There is also evidence from studies of stimulant addicts and case reports that stimulant drugs can cause heart disease, including inflammation and scarring. When drugs like Ritalin and Adderall are prescribed in routine pediatric doses, they commonly cause hypertension, which can lead to an enlarged heart. Yet children with even slightly enlarged hearts were excluded from the study. So the researchers ended up excluding any children with enlarged hearts caused by the stimulant treatment itself.

The same is true in regard to anorexia. Stimulants commonly cause anorexia. The researchers therefore excluded cases of stimulant-induced death in anorexic patients when the anorexia itself could have been caused by the stimulant.

Meanwhile the psychiatric establishment--represented by American Psychiatric Association, NIMH and drug companies--has been quick to dismiss the importance of the study. Instead, they should be emphasizing that the study detected the risk even though the highest risk patients were excluded, including some who were displaying toxic stimulant effects such as heart disease and anorexia.

Meanwhile, it's hard to imagine a greater tragedy for the surviving family than the unexpected death of a child from taking a medication prescribed by a doctor. I've been involved as a medical expert or consultant for families in several tragic cases of stimulant-induced cardiac death. I've also been an expert in cases of suicide in children caused by stimulants. These tragic deaths are always heartbreaking. Years afterward, the emotional wounds remain as raw as ever for their parents and brothers and sisters. The family's trust for doctors and the healthcare system can be forever shattered.

Yet the answer to this problem is simple. Don't give stimulants to children. There are far better non-drug ways to deal with so-called ADHD. ADHD is defined as involving hyperactivity, inattention, and impulsivity. These are not diseases--they are disciplinary and educational problems. Very often these children improve dramatically when parents develop a more consistent, rational and loving plan for discipline. Sometimes the problem completely disappears when the child is assigned a better teacher.

At times the child diagnosed with ADHD is simply a little delayed in learning self-discipline or finding the motivation to study. Often something is distressing the youngster, such as peer ridicule and abuse. Or the child may be especially full of life and need more opportunity to run, to play, and to be creative.

Whatever these children need, they don't need toxic drugs that can lead to drug addiction, cause psychosis and depression, stunt growth, impair brain function, and even cause sudden cardiac arrest. I describe and document all of these adverse stimulant effects, and many more, in my medical book, Brain-Disabling Treatments in Psychiatry: Drugs, Electroshock, and the Psychopharmaceutical Complex, Second Edition (2008).

Our children don't need drugs--they need us to protect them from misguided health professionals while we make every effort to meet their real needs in our families and schools. It's time for all of us to retake responsibility for our children.

Dr. Breggin's latest book is Medication Madness: The Role of Psychiatric Drugs in Cases of Violence, Suicide and Crime (St. Martin's, 2008). It is now in paperback.

Dr. Breggin's website is www.breggin.com
Email: psychiatricdrugfacts@hotmail.com

Bloomberg News
Grassley Probes Financing of Advocacy Group for Mental Health

By Nicole Gaouette
April 6

U.S. Senator Charles Grassley expanded his investigation into drug company influence on the practice of medicine by asking a nonprofit mental-health- advocacy group about its funding.

In a letter sent today to the National Alliance for Mental Illness, based in Arlington, Virginia, Grassley asked the nonprofit group to disclose any financial backing from drug companies or from foundations created by the industry.
The Iowa Republican, in a series of hearings and investigations, has focused on financial ties between the drug industry, doctors and academic institutions. His efforts have led New York-based Pfizer Inc. to begin disclosing consulting payments to U.S. doctors, and Harvard Medical School in Boston to reexamine its conflict-of-interest policies. Now Grassley is expanding his inquiries to nonprofit groups.

"I have come to understand that money from the pharmaceutical industry shapes the practices of nonprofit organizations which purport to be independent in their viewpoints and actions," Grassley wrote in his letter.
Officials at the National Alliance for Mental Illness didn't return calls for comment.
The group identifies itself as the largest grassroots organization in the U.S. for people with mental illness and their families. The group came under scrutiny in 1999, when the magazine Mother Jones reported that 18 drug companies gave the group $11.7 million from 1996 to mid-1999. The article reported that at one point an executive of Indianapolis-based Eli Lilly & Co. worked out of the nonprofit group's headquarters.

A 2007 annual report showed that the group's corporate partners at that time included Madison, New Jersey-based Wyeth; London-based GlaxoSmithKline Plc; Eli Lilly, which makes Prozac; and the Washington-based trade group Pharmaceutical Research and Manufacturers of America.

Financial Report

A separate financial report shows the National Alliance for Mental Illness brought in $10.5 million in contributions in the year that ended June 30, 2007. The donors aren't broken out.

Vera Sharav, president of the Alliance for Human Research Protection, a New York-based nonprofit that promotes ethical research, said the National Alliance for Mental Illness may have drawn Grassley's attention because it lobbies Congress for mental-health funding.

"Academics and physicians give an appearance of authority," Sharav said by telephone. "Industry gives them the money. Grassley has been going after each group systematically, and the dots are being connected."

In January, Grassley and Senator Herb Kohl, a Wisconsin Democrat, reintroduced the Physician Payment Sunshine Act, which would require manufacturers to report on payments to doctors and any physician-owned facility.

Pfizer Announcement

Grassley's investigations have led to changes in industry and academia. Pfizer made its announcement about disclosing physician payments in February. In March, the American Psychiatric Association said it would no longer accept industry support for symposiums and meals at its annual meetings.

On April 1, Stanford University School of Medicine, near Palo Alto, California, said it would post on a Web site all income faculty earned from royalty payments and outside consulting.

In the March 31 issue of the Journal of the American Medical Association, a group of researchers and physicians called for professional medical associations to transform their operations to avoid conflicts of interest posed by "extensive funding from pharmaceutical and device companies." The group included Steven Nissen, a Cleveland Clinic cardiologist.

Exhibit Educates Public on Psychotropic Drugs

Sunday, January 18, 2009 9:09 PM EST
By SLOAN BREWSTER, Press staff
MIDDLETOWN

Ritalin, Adderall, Thorazine, Zoloft, Prozac... The list of psychotropic drugs goes on and on, along with a host of disorders for which the medications are prescribed, but few people are aware of the process that brings a disorder into existence.

The Citizens Commission on Human Rights, which was founded by the Church of Scientology, wants people to hear their take on the matter - a take they couple not with conjecture, but with countless indications of proof, including statistics, documentation, videotaped conferences on mental health, interviews with psychologists and psychiatrists and decades of historical data.

The commission's touring exhibit, "Psychiatry: An Industry of Death," opened last Tuesday and will run through Jan. 30 in the first floor of Main Street Market, in the space formerly occupied by It's Only Natural. Hours are Monday through Saturday from 10 a.m. to 8 p.m. and Sunday from 11 a.m. to 4 p.m.
The exhibit includes screenings of interviews with patients and conversations with mental health professionals, who admit brain scans do not offer evidence to prove the existence of mental health disorders and say drugs are often prescribed without any verification they will solve the problems.

"There are no tests to confirm," said one psychologist during one such taped conversation. "I just speak with people and I make a decision as to the diagnosis."

In one short film, a patient with a hidden camera visited several different mental health clinics. In each visit, the patient complained of the same symptoms. Each psychiatrist, psychologist or therapist offered a different diagnosis and some prescribed a number of drugs. Then there are the interviews with parents or family members of many patients who have taken their own lives while on psychotropic drugs or in the care of mental health professionals.

Visitors of the exhibit are led on a tour of the room and given the opportunity to read statistics, historical data and to see sometimes graphic depictions of restrained patients and other disturbing imagery.

"It was wrong what we were doing," one psychologist said during an interview shown in the exhibit. "We were looking at five minutes of their life and diagnosing."

"More than 100,000 patients die each year in psychiatric institutions around the world," reads one statistic the commission lists. "An estimated 15,000 American children have died as a consequence of taking psychiatric drugs." Visitors sit at stations set up throughout the exhibit and watch short films that offer evidence to prove the claims the commission makes. "It is an educational exhibit; CCHR is the premiere psychiatric watchdog in the world," said Noelle Talevi, executive director of the commission's Connecticut chapter. "We're the only ones telling this side of the story - Their side of the story is that there is mental illness. Every behavior from the cradle to the grave is labeled as mental illness - the only answer is drugs."

At the end of the exhibit, visitors return to a table near the entrance to the room, where they can get reading material to bring home, a DVD compilation of screenings shown in the exhibit or a documentary film called "Making a Killing: The Untold Story of Psychotropic Drugging." Some people who have been to the exhibit said they feel vindicated by what they have seen as they already suspected a lot of what the exhibit portrays, Talevi said. Some have indicated they were "blown away," she said. "They now know they weren't crazy."

Others are surprised when they see things such as films of psychiatrists voting on disorders. "They are shocked to learn that ADHD was literally voted into existence," Talevi said.

Samantha Kovath and Melissa Grover went on the tour last Wednesday. "It seems like the government is using medication as a way to brainwash people," Grover said. "They want money. What better way to get money than to brainwash the people that work?" One of the last stations, "Masterminds of Destruction," shows a disturbing quote suggesting the purpose of decades of prescribing adults and children with psychotropic drugs has been done with the intent of social control: "To achieve world government it is necessary to remove from the minds of men their individualism, loyalty to family traditions, national patriotism and religious dogmas." The quote was made by psychiatrist G. Brock Chisholm, co-founder of the World Federation for Mental Health.

"[Chisholm] was saying it as part of a plan," Talevi explained. "It was part of a speech to the World Federation for Mental Health."

Mayor Sebastian N. Giuliano also took the tour Wednesday. "Some of the stuff I knew, especially the stuff about kids," the mayor said. "Where was all this when I was growing up?"

PHARMACEUTICAL COMPANY ELI LILLY TO PAY RECORD $1.415 BILLION

Criminal Penalty is Largest Individual Corporate Criminal Fine Ever

See National - Fox News VIDEO by clicking here: http://tmap.wordpress.com/videos/

Zyprexa is one of the newer, more expensive "atypical antipsychotics". Others include Abilify, Geodon, Risperdal and Seroquel. These powerful drugs with horrific side effects are costing State Medicaid programs millions yet they have been found to be no more effective than the "older" much less expensive antipsychotics.

Heart risk cited in newer antipsychotic drugs

Zyprexa, Risperdal and Seroquel, among the 10 most commonly prescribed medications, are just as likely as older antipsychotic drugs to cause a fatal heart attack, a study finds.

Los Angeles Times
By Thomas H. Maugh II
January 15, 2009

A widely used class of antipsychotic drugs that includes bestsellers Zyprexa, Risperdal and Seroquel is just as likely -- perhaps even more likely -- to cause a fatal heart attack as older antipsychotic drugs like haloperidol, researchers reported today.

The findings, which run contrary to a long-standing belief, add to a growing drumbeat of criticism about this class of drugs, known as atypical antipsychotics. Zyprexa, Risperdal and Seroquel are among the 10 most commonly prescribed medications in the world, with annual sales estimated at $14.5 billion.

Researchers are especially concerned about the rising use of atypical antipsychotics in the elderly and the young -- both groups that are fragile and more susceptible to adverse effects of powerful medications.

Last week British researchers reported in the journal Lancet Neurology that Alzheimer's patients given the drugs to control aggression were nearly twice as likely to die from any cause as patients who did not receive them.

Some studies have shown that as many as 40% of Alzheimer's patients in nursing homes receive the drugs for unapproved use.

The number of prescriptions for the drugs written for children and adolescents doubled to 4.4 million from 2003 to 2006, in part because of increases in diagnoses of bipolar disorder. Their efficacy in children and Alzheimer's patients has never been demonstrated, experts said.

More here: http://www.latimes.com/news/nationworld/nation/la-sci-schizodrugs15-2009jan15,0,3295418.story

AstraZeneca Drug Raises Diabetes Risk, Doctor Says

Bloomberg News
By Sophia Pearson and Doris Bloodsworth
Jan. 16, 2008

AstraZeneca Plc’s antipsychotic drug Seroquel raised by almost 400 percent the risk of developing diabetes when compared with first-generation medications in its class, a doctor testified in a court case against the drugmaker.

A 2004 article published in Psychiatric Services, a journal of the American Psychiatric Association, reported the increased risk in males who were exposed to Seroquel for at least 60 days. The study, which involved 1,629 patients, compared the exposure of a newer class of antipsychotics including clozapine and Seroquel with an older class of drugs, Jennifer Marks, a Miami- based endocrinologist, said during a pre-trial hearing yesterday in federal court in Orlando, Florida.

“Seroquel is a substantial factor in diabetes and weight gain,” Marks said, noting the 389 percent rise.

AstraZeneca, the U.K.’s second-largest drugmaker, faces about 9,000 lawsuits in the U.S. over claims Seroquel causes diabetes and other health problems. Seroquel, which generated sales of $4.03 billion in 2007, is the London-based company’s second-biggest seller after the ulcer treatment Nexium. Marks testified on behalf of former Seroquel user Linda Guinn, the first case to come to trial over the drug.

More here: http://www.bloomberg.com/apps/news?pid=20601202&sid=av_Gg66oOeWA&refer=healthcare

28,093 Signatures Against TeenScreen. Petition: http://www.petitiononline.com/TScreen/petition.html
Video: http://www.youtube.com/watch?v=RfU9puZQKBY

Lawmaker Calls for Registry of Drug Firms Paying Doctors

New York Times

By GARDINER HARRIS

Published: August 4, 2007

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

http://grassley. senate.gov/ index.cfm? FuseAction= PressReleases. Detail&PressRele ase_id=5343& Month=4&Year= 2007

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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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:

• Please comment on our approach to classification of the possible cases of suicidality (suicidal thinking and/or behaviors) and our analyses of the resulting data from the 23 pediatric trials involving 9 antidepressant drugs.

• Do the suicidality data from these trials support the conclusion that any or all of these drugs increase the risk of suicidality in pediatric patients?

• If the answer to the previous question is yes, to which of these 9 drugs does this increased risk of suicidality apply? Please discuss, for example, whether the increased risk applies to all antidepressants, only certain classes of antidepressants, or only certain antidepressants.

• If there is a class suicidality risk, or a suicidality risk that is limited to certain drugs in this class, how should this information be reflected in the labeling of each of the products? What, if any, additional regulatory actions should the Agency take?

• Please discuss what additional research is needed to further delineate the risks and benefits of these drugs in pediatric patients with psychiatric illness.

The meeting will be held in Bethesda, Maryland on September 13 and 14, 2004. So that all interested parties will have ample opportunity to review the information to be discussed next month, FDA will be posting information on its website at: http://www.fda.gov/cder/pediatric/Summaryreview.htm and http://www.fda.gov/ohrms/dockets/ac/04/briefing/2004-4065b1.htm.