Friday, June 27, 2008

Florida Seroquel Case - AstraZeneca CEO Deposed

The News Journal
Astra CEO in London trial will take stand
AstraZeneca faces 8,440 cases over Seroquel risks

By Andrew Eder
June 20, 2008

The chief executive of AstraZeneca is set to be deposed today regarding allegations the company hid the risk that its anti-psychotic drug Seroquel could cause diabetes in users.

David Brennan, who led AstraZeneca's U.S. unit in Fairfax before being appointed CEO of the London-based drug maker in 2006, will answer questions in London from attorneys representing thousands of plaintiffs across the Unites States.

"A lot of very good people have been severely injured for the rest of their life because of the conduct of this company and the effect of this drug," said attorney Paul Pennock of the New York firm Weitz & Luxenberg, which is handling about 2,500 Seroquel cases in federal and state courts.

In all, AstraZeneca said it faces 8,440 personal injury lawsuits from more than 12,000 plaintiffs over Seroquel, a drug developed in Delaware by AstraZeneca's corporate predecessor Zeneca Group.


Florida Reporters Win Award for Antipsychotic Stories

Florida Reporters Win Award for Antipsychotic Stories

Florida Society of Newspaper Editors
First Place
Robert Farley & Kris Hundley
St. Petersburg Times
“Drugs to Market”
Tackling a subject of national importance, the Times raised questions about the way the Food and Drug Administration licenses drugs. The pieces chronicled financial conflicts involving doctors and firms that cast doubt on the impartiality of the clinical trials that are the key feature of drug licensing.

Thursday, June 26, 2008

Florida may Limit Paying for Some Kids Drugs! - Pass the word!

(The application of Florida Medicaid rules to antipsychotic drugs for children mentioned in the below article can be found here:
Miami Herald
State may limit paying for some kids drugs
The state's healthcare agency is considering limiting payments for strong drugs prescribed to young children for illnesses such as autism and bipolar disorder.
Thu, Jun. 26, 2008

TALLAHASSEE -- Florida's massive healthcare agency may cut back on paying for powerful drugs now prescribed for young children, although a final decision could be weeks or months away. 
Since late April, the Agency for Health Care Administration has required doctors to obtain permission before the state's Medicaid program will pay for drugs prescribed to children under the age of six for autism, bipolar disorder or attention deficit hyperactivity disorder. Any new prescriptions must be evaluated by psychiatrists at the University of South Florida in Tampa.

The reason for the change: the increase in the number of children prescribed the drugs in the past several years, especially since the U.S. Food and Drug Administration does not recommend anymore the use of what are known as ''atypical antipsychotic'' drugs in young children. Previous published reports have said that the number of children in Medicaid getting such drugs has grown from more than 9,000 kids in 2000 to more than 18,000 in 2006.

A state panel met Wednesday to consider whether Florida should craft a more detailed policy to decide when it should pay for such drugs. The meeting drew a smattering of attendance, in person and on the phone, including a representative of the Citizens Commission on Human Rights, an offshoot of the Church of Scientology, who said the state was violating its own rules by paying for drugs not recommended by the FDA.   [audio testimony here: ]

Dr. Jerome Isaac, a Bradenton pediatrician on the panel, questioned whether the state was pushing the issue to save money, saying that Medicaid should pay for a medication if it is recommended by a doctor.

''I see this as a cost-containment measure by putting obstacles in the way of physicians,'' Isaac said.

Others on the panel disagreed, saying that at a minimum the state should consider refusing to pay for any new prescriptions unless the child has previously been evaluated by a psychiatrist.

Anne Wells, the Medicaid Pharmacy Services bureau chief, said state officials were ''parents'' and ''pharmacists'' and that the right policy for children is a ``bigger issue than cost containment.'' 


Wednesday, June 25, 2008

Audio - Florida - Antipsychotics Under Attack!

(Image from the St. Pete Times)
Florida's Agency for Health Care Administration has announced that antipsychotic prescriptions for children 5 and under must now have prior authorization from the State!
In addition, today a workshop was held at Florida's Agency for Health Care Administration regarding antipsychotics and children.
Audio:  You can hear  4 minutes of testimony right now:

Tuesday, June 24, 2008

NY Times: "I told him (the psychiatrist) to stop the medications and stay away from Mom."

New York Times
June 24, 2008

Ramona Lamascola thought she was losing her 88-year-old mother to dementia. Instead, she was losing her to overmedication.

Last fall her mother, Theresa Lamascola, of the Bronx, suffering from anxiety and confusion, was put on the antipsychotic drug Risperdal. When she had trouble walking, her daughter took her to another doctor — the younger Ms. Lamascola’s own physician — who found that she had unrecognized hypothyroidism, a disorder that can contribute to dementia.

Theresa Lamascola was moved to a nursing home to get these problems under control. But things only got worse. “My mother was screaming and out of it, drooling on herself and twitching,” said Ms. Lamascola, a pediatric nurse. The psychiatrist in the nursing home stopped the Risperdal, which can cause twitching and vocal tics, and prescribed a sedative and two other antipsychotics.

“I knew the drugs were doing this to her,” her daughter said. “I told him to stop the medications and stay away from Mom.”

Not until yet another doctor took Mrs. Lamascola off the drugs did she begin to improve.

The use of antipsychotic drugs to tamp down the agitation, combative behavior and outbursts of dementia patients has soared, especially in the elderly. Sales of newer antipsychotics like Risperdal, Seroquel and Zyprexa totaled $13.1 billion in 2007, up from $4 billion in 2000, according to IMS Health, a health care information company.

Part of this increase can be traced to prescriptions in nursing homes. Researchers estimate that about a third of all nursing home patients have been given antipsychotic drugs.

The increases continue despite a drumbeat of bad publicity. A 2006 study of Alzheimer’s patients found that for most patients, antipsychotics provided no significant improvement over placebos in treating aggression and delusions.

In 2005, the Food and Drug Administration ordered that the newer drugs carry a “black box” label warning of an increased risk of death. Last week, the F.D.A. required a similar warning on the labels of older antipsychotics.

The agency has not approved marketing of these drugs for older people with dementia, but they are commonly prescribed to these patients “off label.” Several states are suing the top sellers of antipsychotics on charges of false and misleading marketing.

Ambre Morley, a spokeswoman for Janssen, the division of Johnson & Johnson that manufactures Risperdal, would not comment on the suits, but said: “As with any medication, the prescribing of a medication is up to a physician. We only promote our products for F.D.A.-approved indications.”

Nevertheless, many doctors say misuse of the drugs is widespread. “These antipsychotics can be overused and abused,” said Dr. Johnny Matson, a professor of psychology at Louisiana State University. “And there’s a lot of abuse going on in a lot of these places.”

Wednesday, June 18, 2008

Doctors' prescriptions need dose of disclosure

Chicago Sun Times
Doctors' prescriptions need dose of disclosure
June 18, 2008

When your doctor gives you a prescription, you expect full disclosure and a little straight talk.

Full disclosure on the research behind the drug.

Straight talk from your doctor on why he is recommending this drug over another.

But far too often, that full disclosure and straight talk are deeply compromised by money and perks from your friendly global drug company, though you may never know. Recent reports reveal that drug companies quietly pay billions of dollars to the medical researchers who study new drugs and the doctors who prescribe them.

Three prominent psychiatrists at Harvard Medical School and an affiliated hospital recently were caught greatly underreporting the amount of money that drug companies have put in their pockets over the years. Two of the researchers were paid $1.6 million each in consulting fees from drug companies between 2000 to 2007, while the third was paid more than $1 million -- much of it never reported, as required, and revealed only after a congressional inquiry.

What's particularly unsettling is that the researchers specialize in children with psychiatric problems, and they have been effective boosters of using strong antipsychotic drugs for treatment.

As for the doctors who do the prescribing, a survey published last year in the New England Journal of Medicine revealed that more than a third of the doctors had been reimbursed by drug and medical device companies for professional meetings or continuing education, and more than 25 percent got money for consulting, giving speeches or enrolling patients in medical trials.

A Senate bill, sponsored by Republican Sen. Charles Grassley and Democratic Sen. Herb Kohl, offers a reasonable antidote. It would require big drug and medical device companies to report payments to doctors that exceed $500 a year, information that would be posted online.

What a fine idea.

Given how much money drug companies throw around, a second opinion can't hurt.



Tuesday, June 17, 2008

Black Box Warning Ordered on Older Antipsychotic Drugs

Washington Post
FDA Issues Warning on Some Antipsychotic Drugs
By Shankar Vedantam
Tuesday, June 17, 2008

The Food and Drug Administration yesterday warned doctors that elderly patients with dementia who are being treated with an older class of antipsychotic drugs appear to be at increased risk of dying.

The agency ordered a "black box" warning placed on the labels of drugs such as haldol and thorazine, which are sometimes used to pacify demented patients who become aggressive or disturbed. A similar warning was placed on the newer class of "atypical" antipsychotic drugs three years ago.

Although information on the use of the older drugs in nursing homes and elsewhere is spotty, the regulatory agency said it thinks the older drugs were not as widely used as the newer ones, which include Risperdal, Zyprexa and Seroquel.

Thomas Laughren, director of the FDA's Division of Psychiatry Products in the Center for Drug Evaluation and Research, said none of the drugs is currently approved for use among elderly patients with dementia, meaning that doctors are using the drugs "off-label" -- which they can legally do, based on their judgment. Laughren said it is important for doctors to know that the drugs carry an elevated risk.

He said the agency is not saying the drugs should never be used with elderly demented patients.

"What we want to do is make them aware of this risk," the official said. "We would hope they would discuss -- in this case not with the patient, because the patients have dementia -- but with caregivers and families. These are very difficult patients to manage. They can become very aggressive and violent and injure other patients and staff."

Link to story:

Sample black box warning
In the United States, a black box warning (also sometimes called a black label warning or boxed warning) is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It is so named for the black border that usually surrounds the text of the warning. A black box warning means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.

Monday, June 16, 2008

British Expose Antipsychotics on Children

Luckily the psychiatric antipsychotic plague is now being exposed by major media in Britain as well as the U.S.
The Independent
Britain's child victims of the chemical cosh      [chemical cosh - n. a drug or mix of drugs used to subdue a patient, prisoner, or other person.]
Powerful anti-psychotic drugs designed for adults are being used to treat children
By Brian Brady and Nina Lakhani
Sunday, 15 June 2008
The number of powerful psychiatric drugs prescribed to England's children has risen by more than half in four years, government figures have revealed.
GPs in England are handing out prescriptions for anti-psychotic drugs for children as young as seven at the rate of 250 a day, according to figures obtained by The Independent on Sunday.

Latest data compiled for the NHS show that tranquillisers designed to treat serious conditions including schizophrenia in adults were prescribed to young people 57,000 times in 2003. But the total had risen to more than 90,000 by 2006 – a 59 per cent rise in three years. The figures do not include drugs dispensed in hospitals. Experts believe the increase is partly down to early detection and treatment of serious mental health problems in children, but there is also concern they are being used inappropriately to treat psychological and learning difficulties. Shortage of staff and resources are further factors.

The drugs, which are designed to treat symptoms such as visual hallucinations, hearing voices and delusional thoughts, have serious side effects including weight gain, tiredness, sexual dysfunction and lactation. The safety and effectiveness of these drugs, which were designed for adults, have not been fully tested on children.

Official guidelines say they should be used only as part of a wider treatment package, but there are concerns GPs are relying on them too heavily because other treatments are unavailable. Some GPs, however, stand accused of ignoring or being ignorant of the guidelines.

England's mental health chief, Louis Appleby, said, "We are aware that anti-psychotic drugs are sometimes used as a last resort by clinicians dealing with highly disturbed behaviours in young people, and we are now considering how to prepare clinical guidance on this area of practice."

Psychiatrists and mental health charities have warned against using anti-psychotic drugs on developing minds. Paul Corry, director of public affairs for the mental health charity Rethink, said: "It is worrying that these very powerful drugs designed for adults are being given in such high numbers to children before their brains are fully developed.


Saturday, June 14, 2008

Florida Says Legal Drugs Kill Far More Than Illegal

Remarkably, the New York Times failed to reveal that William H. Janes, the Florida director of Drug Control, mentioned in the below article is on TeenScreen's national advisory council whose members have major documented ties to psychiatric drug manufacturers. 
You want evidence, eh?
TeenScreen's Advisory Board documented ties to drug companies:
New York Times
Legal Drugs Kill Far More Than Illegal, Florida Says
June 14, 2008

MIAMI — From “Scarface” to “Miami Vice,” Florida’s drug problem has been portrayed as the story of a single narcotic: cocaine. But for Floridians, prescription drugs are increasingly a far more lethal habit.

An analysis of autopsies in 2007 released this week by the Florida Medical Examiners Commission found that the rate of deaths caused by prescription drugs was three times the rate of deaths caused by all illicit drugs combined.

Law enforcement officials said that the shift toward prescription-drug abuse, which began here about eight years ago, showed no sign of letting up and that the state must do more to control it.

“You have health care providers involved, you have doctor shoppers, and then there are crimes like robbing drug shipments,” said Jeff Beasley, a drug intelligence inspector for the Florida Department of Law Enforcement, which co-sponsored the study. “There is a multitude of ways to get these drugs, and that’s what makes things complicated.”

The report’s findings track with similar studies by the federal Drug Enforcement Administration, which has found that roughly seven million Americans are abusing prescription drugs. If accurate, that would be an increase of 80 percent in six years and more than the total abusing cocaine, heroin, hallucinogens, Ecstasy and inhalants.

The Florida report analyzed 168,900 deaths statewide. Cocaine, heroin and all methamphetamines caused 989 deaths, it found, while legal opioids — strong painkillers in brand-name drugs like Vicodin and OxyContin — caused 2,328.

Drugs with benzodiazepine, mainly depressants like Valium and Xanax, led to 743 deaths. Alcohol was the most commonly occurring drug, appearing in the bodies of 4,179 of the dead and judged the cause of death of 466 — fewer than cocaine (843) but more than methamphetamine (25) and marijuana (0).

The study also found that while the number of people who died with heroin in their bodies increased 14 percent in 2007, to 110, deaths related to the opioid oxycodone increased 36 percent, to 1,253.

Florida scrutinizes drug-related deaths more closely than do other states, and so there is little basis for comparison with them.

It has also witnessed several highly publicized cases in recent years that have highlighted the problem. Only last year, an accidental prescription drug overdose killed Anna Nicole Smith in Broward County.

Still, the state has lagged in enforcement. Thirty-eight other states have approved prescription drug monitoring programs that track sales. Florida lawmakers have repeatedly considered similar legislation, but privacy concerns have kept it from passing.

As a result, federal, state and local law enforcement officials say, Florida has become a source of prescription drugs that are illegally sold across the country.

“The monitoring plan is our priority effort, but that is not enough,” William H. Janes, the Florida director of drug control, said in a statement accompanying the study. He said Florida was also looking at ways to curb illegal Internet sales and to encourage doctors and pharmacists to identify potential abusers.

Some local police departments have taken a more novel approach.

In Broward County on May 31, deputies completed a “drug takeback” in which $5 Wal-Mart, CVS or Walgreens gift cards were distributed to 150 people who cleaned out their medicine cabinets and turned in unused drugs in an effort to keep them out of young people’s hands.

“The abuse has reached epidemic proportions,” said Lisa McElhaney, a sergeant in the pharmaceutical drug diversion unit of the Broward County Sheriff’s Office. “It’s just explosive.”

Link to story: 


Friday, June 13, 2008

TeenScreen Lawsuit and No Child Left Undrugged

All of the documents filed in the TeenScreen lawsuit can be found here:
The last entry is from Teresa Rhoades' attorney (plaintiff) asking for a trial by jury "to be held as soon as is expeditiously available on the Court’s calendar"
The Rutherford Institute filed the lawsuit in federal court in Indiana on behalf of the Rhoades' family whose 15-year-old daughter, Chelsea Rhoades, was subjected to a mental health screening examination at her school without her parents’ knowledge or consent and then was diagnosed with two mental "disorders".  Institute attorneys charge that school officials  violated Michael and Teresa Rhoades’ constitutional right, as parents, to control the care, custody and upbringing of their daughter when Chelsea was subjected to TeenScreen withouth their knowledge or consent.
Rutherford Institute
No Child Left Undrugged
By John W. Whitehead
According to autopsy reports, 4-year-old Rebecca Riley died from an overdose of psychiatric drugs. At age 2, Rebecca was diagnosed with attention deficit hyperactivity disorder (ADHD). At 3, she was diagnosed with bipolar disorder, also known as manic depression. By the time she died on Dec. 13, 2006, little Rebecca was taking Clonidine, as well as the anti-convulsant Depakote and the anti-psychotic Seroquel.

John Whitehead

What were some of the symptoms that prompted such treatment plans? As her mother described it, Rebecca was “constantly getting into things, running around, not being able to settle down.”

Rebecca’s diagnosis was not a medical aberration. Her 10-year-old brother and 4-year-old sister were already being treated for manic depression. Indeed, nearly one million children are reportedly diagnosed as bipolar, making it more common than autism and diabetes combined. From 1994 to 2003, the number of children treated for bipolar disorder increased 40 percent, a jump that many experts attribute to more doctors aggressively applying the diagnosis.

An increasing number of medical officials are voicing the concern that children are being misdiagnosed. Dr. John McClellan, who runs a children’s psychiatric hospital in the state of Washington, suggested that the bipolar diagnosis has become a catch-all for aggressive and troubled children.

Likewise, child psychiatrist John Holttum believes that the definition of bipolar disorder is expanding. Whereas children who were seen as troubled or irritable 10 or 15 years ago might have been treated with counseling, parental training for their caregivers or other social interventions, children with similar symptoms today are being diagnosed as bipolar and treated with medication. Unfortunately, for many families, therapy is not even an option. According to Dr. Michael Brody, a child psychiatrist at the University of Maryland, since insurance companies often do not support therapy, most parents opt for medication.

Not surprisingly, the pharmaceutical companies are reaping the rewards, aided by the medical community and the media. Bipolar disorder medication is typically three to five times more expensive than medications prescribed for other disorders, such as depression or anxiety. As the News Tribune of Tacoma, Wash., points out, “Furthering the trend is extensive marketing of atypical anti-psychotics by the companies that make them, and media coverage of bipolar disorder as a childhood disease.”

Yet many of the anti-psychotic drugs being prescribed for children have not been approved by the Food and Drug Administration for use on them. Of the two that have been approved for children, Risperdahl and Abilify, they’ve only been approved for short-term use. Nevertheless, as the News Tribune points out, because these drugs have been approved for adults, “doctors are free to prescribe drugs to anyone and in any way they see fit once they have been approved for some purpose.”

What this means is that in addition to being misdiagnosed, there is an increased likelihood that children are also being overdrugged. Concern about this scenario has prompted Dr. Jeffrey Thompson, chief medical officer for the Washington state Medicaid program, to provide more stringent guidelines to ensure that anti-psychotic drugs are prescribed to Medicaid children only when truly needed and at proper dosages.

While Thompson’s actions signal a move in the right direction, at least for minor-aged Medicaid recipients in his state, it will do little to help children in private care and in other states.

When confronted with the numbers of children being diagnosed with bipolar disorder—about 800,000 in 2003, and likely much higher now—it is hard to know how to respond. Could that many young people truly be suffering from this disorder? It is tempting to lay the blame on an over-zealous medical community or a greedy pharmaceutical industry. There is no doubt that they have benefited financially from the sharp rise in bipolar cases among young people.

Is it more a case of kids just being kids—noisy, rambunctious, hyperactive, disorderly? Or is there something else going on here? Curiously, one study released in 2007 indicated that among children diagnosed with bipolar disorder, two-thirds of them were boys.

While there are undeniably cases where children are actually suffering and are helped by diagnosis and medication, I have to wonder about the majority. Little is said in the studies I have read about the impact that family life and the environment may have on the behavior of children diagnosed as bipolar, or even ADHD, yet they can’t be ruled out.

Society as a whole has become irresponsible in its duty to young people. Obsessed with materialism, we have handed over our young people to marketing mavens and corporations eager to make a quick buck. Distracted by entertainment, we have relinquished our children to television babysitters, allowing them to become turned on by and tuned into mindless television programs, video games and advertising that promote violence and premarital sex, among other unhealthy behaviors. Children need human touch and love. All too often, parents give them over to others for care. They also leave them floating in the non-real world of virtual reality.

Thus, it is little wonder that so many children are out of control, disorderly and unable to settle down. But they shouldn’t be victimized and punished for our neglect. Nor should they be drugged into compliance. Our children are screaming for help, but we’re not listening to what they’re saying. Instead, many parents are just hoping to shut them up—whether with drugs or entertainment—and get a little peace and quiet. But that’s not the answer.

A solution will not be found by passing another law. Rather, it must start at home and in the community. When the family breaks down, everything breaks down. We need to start by re-building families. Parents need to be parents and stop over-scheduling their children. They need to start spending time with them.

Finally, parents need to say no to drugs for their children. They need to control what their children watch and listen to. And they need to take off the headphones, turn off the cell phones and try communicating with their children.

Constitutional attorney and author John W. Whitehead is founder and president of The Rutherford Institute. His new book The Change Manifesto (Sourcebooks) will be out in August 2008.



Tuesday, June 10, 2008

Florida Newspaper Spanks Harvard Antipsychotic Shrinks

St. Petersburg Times
A Times Editorial
Medicine research corrupted
In print: Tuesday, June 10, 2008
The pharmaceutical industry's corrupting influence on medical research has reached a new low with a case that has stained the reputations of Harvard University and three of its top researchers in child psychiatry. It took a congressional investigation to uncover a conflict of interest that could violate federal and university rules. As a result, the credibility of a supposed breakthrough in treating childhood bipolar disease is now in doubt.

Dr. Joseph Biederman and two colleagues — who have promoted the use of antipsychotic drugs to treat bipolar children — withheld information about payments they were getting from drugmakers. While the Harvard faculty members were doing their research, some of it paid for by taxpayers, they were quietly taking millions of dollars from drug companies such as Johnson & Johnson, Eli Lilly and others that profited from the findings, the New York Times reported.

The researchers were supposed to report earnings in excess of $10,000 as consultants for drug companies, but they failed to do so. Even after Senate investigators forced Biederman to disclose his income, he reported receiving less than the drug companies say they gave him. In all, the three researchers accepted drug company payments of at least $2.6-million over the past seven years.

Did such hefty inducements affect the outcome of their research? It's a question that so far is unanswered. The doctors' findings have been influential but controversial, with 500,000 bipolar children being prescribed antipsychotic drugs. Some doctors say the medication saves young lives, though the side effects can be serious. Others say it is an experimental treatment that hasn't been proved effective over time.

There is no doubt what effect the scandal has had on the medical research field, which relies on a voluntary honor system. "The price we pay for these kinds of revelations is credibility, and we just can't afford to lose any more of that in this field," said Dr. E. Fuller Torrey of the Stanley Medical Research Institute.

Neither the pharmaceutical industry nor the medical researchers they try to influence can be trusted under the current system. Sen. Charles Grassley, R-Iowa, wants to create a national registry of drug research to keep track of such payments. Maybe a new bureaucracy isn't the answer, but something has to be done before people are injured and the public loses all trust in medical research.

Link to editorial:


Sunday, June 08, 2008

Antipsychotic Shrinks Fail to Reveal Pay from Drug Companies - New York Times

New York Times
Child Experts Fail to Reveal Full Drug Pay
By Gardiner Harris and Benedict Carey 
June 8, 2008

A world-renowned Harvard child psychiatrist whose work has helped fuel an explosion in the use of powerful antipsychotic medicines in children earned at least $1.6 million in consulting fees from drug makers from 2000 to 2007 but for years did not report much of this income to university officials, according to information given Congressional investigators.

Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from consulting fees.
Dr. Joseph Biederman belatedly reported at least $1.6 million in consulting fees.

By failing to report income, the psychiatrist, Dr. Joseph Biederman, and a colleague in the psychiatry department at Harvard Medical School, Dr. Timothy E. Wilens, may have violated federal and university research rules designed to police potential conflicts of interest, according to Senator Charles E. Grassley, Republican of Iowa. Some of their research is financed by government grants.

Like Dr. Biederman, Dr. Wilens belatedly reported earning at least $1.6 million from 2000 to 2007, and another Harvard colleague, Dr. Thomas Spencer, reported earning at least $1 million after being pressed by Mr. Grassley’s investigators. But even these amended disclosures may understate the researchers’ outside income because some entries contradict payment information from drug makers, Mr. Grassley found.

In one example, Dr. Biederman reported no income from Johnson & Johnson for 2001 in a disclosure report filed with the university. When asked recently to check again, he reported receiving $3,500. But Johnson & Johnson told Mr. Grassley that it paid him $58,169 in 2001, Mr. Grassley found.

The Harvard group’s consulting arrangements with drug makers were already controversial because of the researchers’ advocacy of unapproved uses of psychiatric medicines in children.

In an e-mailed statement, Dr. Biederman said, “My interests are solely in the advancement of medical treatment through rigorous and objective study,” and he said he took conflict-of-interest policies “very seriously.” Drs. Wilens and Spencer said in e-mailed statements that they thought they had complied with conflict-of-interest rules.

John Burklow, a spokesman for the National Institutes of Health, said: “If there have been violations of N.I.H. policy — and if research integrity has been compromised — we will take all the appropriate action within our power to hold those responsible accountable. This would be completely unacceptable behavior, and N.I.H. will not tolerate it.”

The federal grants received by Drs. Biederman and Wilens were administered by Massachusetts General Hospital, which in 2005 won $287 million in such grants. The health institutes could place restrictions on the hospital’s grants or even suspend them altogether.

Alyssa Kneller, a Harvard spokeswoman, said in an e-mailed statement: “The information released by Senator Grassley suggests that, in certain instances, each doctor may have failed to disclose outside income from pharmaceutical companies and other entities that should have been disclosed.”

Ms. Kneller said the doctors had been referred to a university conflict committee for review.

Mr. Grassley sent letters on Wednesday to Harvard and the health institutes outlining his investigators’ findings, and he placed the letters along with his comments in The Congressional Record.

Dr. Biederman is one of the most influential researchers in child psychiatry and is widely admired for focusing the field’s attention on its most troubled young patients. Although many of his studies are small and often financed by drug makers, his work helped to fuel a controversial 40-fold increase from 1994 to 2003 in the diagnosis of pediatric bipolar disorder, which is characterized by severe mood swings, and a rapid rise in the use of antipsychotic medicines in children. The Grassley investigation did not address research quality.

Doctors have known for years that antipsychotic drugs, sometimes called major tranquilizers, can quickly subdue children. But youngsters appear to be especially susceptible to the weight gain and metabolic problems caused by the drugs, and it is far from clear that the medications improve children’s lives over time, experts say.

In the last 25 years, drug and device makers have displaced the federal government as the primary source of research financing, and industry support is vital to many university research programs. But as corporate research executives recruit the brightest scientists, their brethren in marketing departments have discovered that some of these same scientists can be terrific pitchmen.

To protect research integrity, the National Institutes of Health require researchers to report to universities earnings of $10,000 or more per year, for instance, in consulting money from makers of drugs also studied by the researchers in federally financed trials. Universities manage financial conflicts by requiring that the money be disclosed to research subjects, among other measures.

The health institutes last year awarded more than $23 billion in grants to more than 325,000 researchers at over 3,000 universities, and auditing the potential conflicts of each grantee would be impossible, health institutes officials have long insisted. So the government relies on universities.

Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures.

“It’s really been an honor system thing,” said Dr. Robert Alpern, dean of Yale School of Medicine. “If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don’t even know how to check on that.”

Some states have laws requiring drug makers to disclose payments made to doctors, and Mr. Grassley and others have sponsored legislation to create a national registry.

Lawmakers have been concerned in recent years about the use of unapproved medications in children and the influence of industry money.

Mr. Grassley asked Harvard for the three researchers’ financial disclosure reports from 2000 through 2007 and asked some drug makers to list payments made to them.

“Basically, these forms were a mess,” Mr. Grassley said in comments he entered into The Congressional Record on Wednesday. “Over the last seven years, it looked like they had taken a couple hundred thousand dollars.”

Prompted by Mr. Grassley’s interest, Harvard asked the researchers to re-examine their disclosure reports.

In the new disclosures, the trio’s outside consulting income jumped but was still contradicted by reports sent to Mr. Grassley from some of the companies. In some cases, the income seems to have put the researchers in violation of university and federal rules.

In 2000, for instance, Dr. Biederman received a grant from the National Institutes of Health to study in children Strattera, an Eli Lilly drug for attention deficit disorder. Dr. Biederman reported to Harvard that he received less than $10,000 from Lilly that year, but the company told Mr. Grassley that it paid Dr. Biederman more than $14,000 in 2000, Mr. Grassley’s letter stated.

At the time, Harvard forbade professors from conducting clinical trials if they received payments over $10,000 from the company whose product was being studied, and federal rules required such conflicts to be managed.

Mr. Grassley said these discrepancies demonstrated profound flaws in the oversight of researchers’ financial conflicts and the need for a national registry. But the disclosures may also cloud the work of one of the most prominent group of child psychiatrists in the world.

In the past decade, Dr. Biederman and his colleagues have promoted the aggressive diagnosis and drug treatment of childhood bipolar disorder, a mood problem once thought confined to adults. They have maintained that the disorder was underdiagnosed in children and could be treated with antipsychotic drugs, medications invented to treat schizophrenia. 

Other researchers have made similar assertions. As a result, pediatric bipolar diagnoses and antipsychotic drug use in children have soared. Some 500,000 children and teenagers were given at least one prescription for an antipsychotic in 2007, including 20,500 under 6 years of age, according to Medco Health Solutions, a pharmacy benefit manager.

Few psychiatrists today doubt that bipolar disorder can strike in the early teenage years, or that many of the children being given the diagnosis are deeply distressed.

“I consider Dr. Biederman a true visionary in recognizing this illness in children,” said Susan Resko, director of the Child and Adolescent Bipolar Foundation, “and he’s not only saved many lives but restored hope to thousands of families across the country.”

Longtime critics of the group see its influence differently. “They have given the Harvard imprimatur to this commercial experimentation on children,” said Vera Sharav, president and founder of the Alliance for Human Research Protection, a patient advocacy group.

Many researchers strongly disagree over what bipolar looks like in youngsters, and some now fear the definition has been expanded unnecessarily, due in part to the Harvard group.

The group published the results of a string of drug trials from 2001 to 2006, but the studies were so small and loosely designed that they were largely inconclusive, experts say. In some studies testing antipsychotic drugs, the group defined improvement as a decline of 30 percent or more on a scale called the Young Mania Rating Scale — well below the 50 percent change that most researchers now use as the standard.

Controlling for bias is especially important in such work, given that the scale is subjective, and raters often depend on reports from parents and children, several top psychiatrists said.

More broadly, they said, revelations of undisclosed payments from drug makers to leading researchers are especially damaging for psychiatry.

“The price we pay for these kinds of revelations is credibility, and we just can’t afford to lose any more of that in this field,” said Dr. E. Fuller Torrey, executive director of the Stanley Medical Research Institute, which finances psychiatric studies. “In the area of child psychiatry in particular, we know much less than we should, and we desperately need research that is not influenced by industry money.”    

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psychs busted!

June 8 (Bloomberg) -- Harvard Medical School doctors who helped pioneer use of psychiatric drugs by children violated U.S. government and school rules by failing to properly disclose at least $3.2 million from drugmakers including Johnson & Johnson and Eli Lilly & Co., a U.S. senator said.

Joseph Biederman, Timothy Wilens and Thomas Spencer all conducted studies on how kids are affected by drugs including Lilly's attention deficit treatment Strattera. They filed yearly disclosure forms with the Boston school showing they got a total of $120,000 from drugmakers, Senator Charles Grassley said in the Congressional Record. When Grassley sought added documentation in March, they admitted getting more, he said.

Grassley, an Iowa Republican, said the ethics violations put the medical school and the affiliated Massachusetts General Hospital, where the three work, in jeopardy of losing federal funds. The hospital and school said they will investigate the researchers and review current ethics policies.

``Obviously, if a researcher is taking money from a drug company while also receiving federal dollars to research that company's product, then there is a conflict of interest,'' Grassley said in a statement he entered into the Congressional Record. He sent letters to the medical school and the U.S. National Institutes of Health last week.

Biederman directs, and Wilens and Spencer are affiliated with, a research center at Mass General that studies psychiatric medications in children. Biederman is the leading proponent of the idea that bipolar disorder, once viewed as an adult disease, can begin early in childhood and be treated with drugs.

Bipolar Disorder

Biederman's research helped convince many psychiatrists and pediatricians to look for and diagnose bipolar disorder in children, said Larry Diller, a behavioral pediatrician in Walnut Creek, California who has written two books on the overuse of psychiatric drugs by children.

``He single-handedly put pediatric bipolar disorder on the map,'' Diller said in a telephone interview yesterday.

The number of kids diagnosed as bipolar increased 40-fold between 1994 and 2003, according to a recent study. Sales of drugs used to treat the condition doubled from 2003 to 2006.

Grassley, a member of the Senate Finance Committee, has proposed legislation that would require disclosure of the fees physicians receive for speaking, consulting and research.

Repeated attempts yesterday to reach the three doctors by telephone and e-mail were unsuccessful. Grassley also wasn't immediately available for comment.

`Examining Policies'

Arch MacInnes, a spokesman from Mass General, said in an e- mail that the hospital is investigating the doctors' disclosure and conflict of interest forms in coordination with Harvard Medical School. The hospital and its corporate parent, Partners HealthCare, have also convened a commission to ``re-examine its policies to ensure that they appropriately address all issues in the relationships between Partners institutions and its physicians and industry,'' MacInnes said.

Harvard Medical School's office of the dean has referred the case to the Standing Committee on Conflicts of Interest and Commitments, Robert Neal, a spokesman for the school, said yesterday in an e-mailed statement.

The university and hospital ban researchers from working on a company's product if they receive more than $20,000 a year from the company, Neal said. The limit was $10,000 before 2004.

Tara Ryker, a spokeswoman for Indianapolis-based Lilly, said in a phone interview yesterday that she had no information about payments to the doctors, and that the company supports Grassley's legislation.

``The bill is a really important step in trying to build public trust and confidence in the relationship between the pharmaceutical industry and physicians,'' she said.

A telephone message for Srikant Ramaswami, a Johnson & Johnson spokesman, was not immediately returned.

$10,000 Limit

The National Institutes of Health, which oversees $24 billion in federal health funding, requires researchers to disclose to their institutions relationships of least $10,000 with companies whose products are involved in studies.

Biederman is currently recruiting 4- to 6-year-olds with bipolar disorder to test London-based AstraZeneca Plc's Seroquel, and 6- to 12-year-olds with the condition to test Equetro, developed by U.K.-based Shire Ltd, according to a U.S.- run registry of clinical trials.

According to Grassley, the three researchers initially disclosed receiving less than $80,000 from Lilly, the maker of Zyprexa, an antipsychotic, and Strattera, a drug used to treat attention deficit disorder. On further review, in March, they said they had received $172,198 while the company told Grassley it had paid the three a total of $259,756.

Biederman initially said he had gotten less than $10,000 from Johnson & Johnson, the maker of the antipsychotic Risperdal. In March, he said the amount was $5,500. The company told Grassley it paid Biederman $64,378.

John Burklow, a spokesman for the NIH, said in an e-mail that if the agency finds its policies were violated ``we will take the appropriate action and consider the full range of options'' including terminating grants or withholding the award of money committed for future projects.


Tuesday, June 03, 2008

12% of ER Visits - Adverse Effects from Drugs

"Central nervous system medications such as opioid painkillers, antipsychotics for those with mental health issues, sleeping pills, and antidepressants were the types of drugs most likely to cause problems."

Letters to the Editor:

Vancouver Sun
Side effects lead to ER visits

Twelve per cent of patients rushed to VGH have adverse reaction to medications, study finds
Pamela Fayerman
June 03, 2008

VANCOUVER - Twelve per cent of patients who rush to the emergency room at Vancouver General Hospital are there because of adverse effects from medications, according to study findings being published Tuesday in the Canadian Medical Association Journal.

The 11 international authors of the study said patients with medication-related complaints are more likely to be admitted to hospital beds after they've been seen in the ER and occupy those beds far longer than others, a result the authors described as "striking."

..."We've proven in this study that we've got a problem in the health care system with patients who experience bad effects from medications and we have to figure out how to reduce those problems," said lead investigator Dr. Peter Zed, who was working at VGH during the study but is now at the Queen Elizabeth Health Sciences Centre in Halifax.

"The solutions will involve better communication among doctors, pharmacists and patients," Zed said in an interview. "Simply handing out a pamphlet at the pharmacy that lists all the potential side-effects doesn't work. Patients don't read them or they don't understand the information."

Problems stemmed from a variety of issues including patients being prescribed the wrong drugs, given wrong dosages, allergic reactions, interactions between drugs and patients not following instructions for how or when to take their medications.

...Health Minister George Abbott said in an interview the study points to the need for "continuous improvement when it comes to misuse, overuse and abuse of drugs."

The province plans to establish a patient safety and quality council to reduce adverse events, promote transparency and identify best practices to improve patient care, Abbott said.

Central nervous system medications such as opioid painkillers, antipsychotics for those with mental health issues, sleeping pills, and antidepressants were the types of drugs most likely to cause problems.

Entire story can be found here: