Senator Charles E. Grassley pushed three experts in child psychiatry at Harvard to expose their income from 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.”

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.

Vermont is one of only several states which require pharmaceutical companies to disclose money paid to influence doctor's prescribing practices. The New York Times reported on June 27, 2007 Psychiatrists Top List in Drug Maker Gifts: "drug company payments to psychiatrists in the state (Vermont) more than doubled last year (2006), to an average of $45,692 each from $20,835 in 2005. Antipsychotic medicines are among the largest expenses for the state’s Medicaid program."

The below article shows that one year later Vermont psychiatrists are raking in even more from pharma: "Eleven psychiatrists received a total of almost $630,000, or about 20 percent of combined marketing expenditures in the state, the study found. That amounts to about $57,000 per psychiatrist, on average."

Jul 9, 2008

MONTPELIER - Pharmaceutical manufacturers are using their vast marketing budgets to influence the types of medications prescribed by Vermont doctors, Attorney General Bill Sorrell said Tuesday.

The pharmaceutical industry spent $3 million last year to promote its products in Vermont, according to a report from the Office of the Attorney General. The marketing expenditures, up by 33 percent over Fiscal Year 2006, represent the highest single-year spending since the state began tracking data in 2003.

"This report shows, once again, that the pharmaceutical industry has too much influence over the practice of medicine in Vermont," Sorrell said in a statement. "It is particularly troubling that the industry is paying large sums of money to influence prescribing practices involving psychiatric drugs."

Drug makers paid out more money to psychiatrists last year than any other type of doctor in Vermont. And four of the five most heavily marketed drugs are used to treat either attention deficit hyperactivity disorder or depression, the report found.

"When you start looking at the particular types of payments being made, the heavy weight toward psychiatrists as well as psychiatric drugs, it does become particularly troubling," said Assistant Attorney General Julie Brill.

England town that just happens to be the state capital.

Ken Johnson, senior vice president for the Pharmaceutical Research and Manufacturers of America, called Vermont's report "misleading" and said the data "serve only to misconstrue the value of interactions between pharmaceutical research companies and health care professionals."

In 2003, Vermont became the first state in the country to require drug manufacturers to disclose the gifts, payments, travel reimbursements and other financial donations to doctors and others in the field.

Johnson said in an e-mail Tuesday that such expenditures are used to inform and educate physicians on new medications entering the marketplace. Any legislation that might discourage those interactions, Johnson said, does a disservice to patients.

"The current statute in Vermont does not acknowledge that meetings with technically trained pharmaceutical research company representatives - many of whom are health care professionals themselves - are one of several important ways for physicians to receive the information they need to make sure medicines are used properly and patients are safely and effectively treated," Johnson said.

According to Brill, drug companies have concentrated the bulk of their marketing budgets on only a small group of physicians.

"We have seen more money being spent and we have seen that money concentrated in fewer people and concentrated in fewer practice areas," Brill said. "Part of that is manufacturers are focused on thought leaders - people influential in the prescribing community either because they're conducting studies or they're people who are well-respected in their fields."

Eleven psychiatrists received a total of almost $630,000, or about 20 percent of combined marketing expenditures in the state, the study found. That amounts to about $57,000 per psychiatrist, on average.

Physicians specializing in cardiovascular disease received the second largest aggregate amount, with two doctors splitting a total of more than $300,000. Laws protecting trade secrets prevent the Office of the Attorney General from disclosing the names of specific physicians receiving payments.

Brill said the data offers no insight on whether marketing budgets directly influence prescribing behavior.

"We don't have any definitive information on it yet, but some people certainly believe that to be the case," Brill said.

This report marked the first year that Vermont required manufacturers to disclose which drugs were being marketed. She said the state will use that information in a future study to determine whether prescription rates rise alongside marketing budgets.

Ken Libertoff, executive director of the Vermont Association for Mental Health, said he worries that financial incentives are playing a role in doctors' prescribing behaviors.

"This report confirms that there's been an enormous intrusion of pharmaceutical marketing and pharmaceutical gifts to physicians throughout the state," Libertoff said. "… The mixture of marketing and money and medicine is a formula for disaster, and we think that this report confirms concerns about whether consumers and patients are receiving the best care and the best practice."

While recognizing the potential benefits of psychotropic medications for certain mental health patients, Libertoff said drug makers may use financial incentives to conceal or downplay adverse side effects.

"What we would consider huge financial payments have basically polluted health care," Libertoff said.

Libertoff said that in order for Vermont physicians to "reclaim their high status as patient-centered health care providers," they must refuse to take any gifts or payments from the pharmaceutical industry.

He called on industry leaders, including the Vermont Medical Society and Vermont Psychiatric Association, to fashion an official policy calling on doctors to decline any future payments.

The National Association of Medicaid Fraud Control Units reported in July that 43 states, the District of Columbia and the federal government settled with New York-based Bristol-Myers for $389 million plus interest. The settlement resolved allegations of illegal drug marketing and pricing of prescription medications paid by the states’ Medicaid programs.

“This is a significant case, and we hope this will lead to better practices and greater accountability in this segment of the heatlhcare industry,” Tennessee Attorney General Bob Cooper said in a statement.

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13 states to go - if dollar amounts are not listed for your state below, contact your own State Attorney General here. Ask for the Media Relations person and then ask for the press release (or the settlement dollar amount) on the Bristol-Myers Squibb settlement for illegally promoting their antipsychotic drug Abilify for use in kids and the elderly.

Then flip the press release to your local newspaper.

Articles from each state here

Despite voluminous warnings on the health dangers of antipsychotic drugs, the use is increasing. Who prescribes antipsychotic drugs? Mainly - psychiatrists:

"The study, which looked at visits to pediatricians and other doctors, found that psychiatrists were the most likely to prescribe antipsychotic drugs." New York Times, June 6, 2006

By Jim Warren

Kentucky's Medicaid program has spent more than $40 million since 2001 filling prescriptions for certain powerful drugs that help youngsters with emotional problems, but also could pose risks for their physical health.

Now, the program's medical director, Dr. Thomas Badgett, wants to rein in prescriptions for so-called "atypical anti-psychotic" drugs in children. Badgett plans to launch an effort early next year alerting Kentucky Medicaid providers to prescribe the drugs for youngsters only when their use is appropriate and to carefully monitor patients for problems.

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Antipsychotic drugs also known as "psychiatric chemical lobotomies"

They are not FDA approved for "dementia" in the elderly.

Concern has been expressed in the United States and Britain that high usage of antipsychotics in the elderly carries potential health risks including possible increased risk of stroke and higher death rates.

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He is the Chief of Psychiatry over Florida's Department of Children and Families.

This 2-1/2 minute video shows Tandon joking about his own profession - Psychiatry:

Tandon's activities as a Florida government official include the promotion of antipsychotic drugs which is costing Florida millions upon millions of Medicaid dollars.

According to the below documentation Tandon has been working as a Florida government official while concurrently working for drug companies.

Top Florida Psychiatrist, Rajiv Tandon:  financial connections to antipsychotic drug makers:

May 1, 2004 - Starting working at Florida's Department of Children and Families while "on loan" from Florida State University

June 1, 2004 - Link - Dr. Tandon is on the Speakers Bureau for Astra Zeneca, Bristol-Myers Squibb, Eli Lilly, Janssen, and Pfizer.

December 2004 - Source - Rajiv Tandon, MD, Chief of Psychiatry, Florida Department of Children and Families, Tallahassee, Florida - Dr Tandon reports serving as a consultant to AstraZeneca LP, Bristol-Myers Squibb Company, Eli Lilly and Company, Janssen Pharmaceutica, and Pfizer Inc.

November 22, 2006 - Source

Rajiv Tandon, M.D., of the University of Florida in Tallahassee gave a presentation. The symposium was sponsored by Janssen pharmaceuticals. Both Dr Tandon and Dr. Feldman are members of the speakers bureau for Janssen, the sponsor of the symposium, and have financial relationships with Pfizer, AstraZeneca, and Bristol-Meyers Squibb as well.

(1 = consultant or advisory board; 4 = speakers’ bureau)

By GARDINER HARRIS

November 18, 2008

WASHINGTON - Powerful antipsychotic medicines are being used far too cavalierly in children, and federal drug regulators must do more to warn doctors of their substantial risks, a panel of federal drug experts said Tuesday.

More than 389,000 children and teenagers were treated last year with Risperdal, one of five popular medicines known as atypical antipsychotics. Of those patients, 240,000 were 12 or younger, according to data presented to the committee. In many cases, the drug was prescribed to treat attention deficit disorders.

But committee members unanimously rejected the agency’s proposals, saying that far more needed to be done to discourage the medicines’ growing use in children, particularly to treat conditions for which the medicines have not been approved.

Drug agency officials responded that they had already placed strongly worded warnings on the drugs’ labels.

Kara Russell, a spokeswoman for Johnson & Johnson, said, “Adverse drug reactions associated with Risperdal use in approved indications are accurately reflected in the label.”

But panelists said the current warnings were not enough.

While panel members spoke at length about Risperdal, they said their concerns applied to the other medicines in its class, including Zyprexa, Seroquel, Abilify and Geodon.

The committee’s concerns are part of a growing chorus of complaints about the increasing use of antipsychotic medicines in children and teenagers. Prescription rates for the drugs have increased more than fivefold for children in the past decade and a half, and doctors now use the drugs to settle outbursts and aggression in children with a wide variety of diagnoses, even though children are especially susceptible to their side effects.

From 1993 through the first three months of 2008, 1,207 children given Risperdal suffered serious problems, including 31 who died. Among the deaths was a 9-year-old with attention deficit problems who suffered a fatal stroke 12 days after starting therapy with Risperdal.

At least 11 of the deaths were children whose treatment with Risperdal was unapproved by the F.D.A. Once the agency approves a medicine for a particular condition, doctors are free to prescribe it for other problems.

Panel members said they had for years been concerned about the effects of Risperdal and similar medicines, but F.D.A. officials said no studies had been done to test the drugs’ long-term safety.

“I have a bias that extra-pyramidal side effects are being under-recognized with these agents,” Dr. Dure said.

Dr. Laughren of the F.D.A. said the agency could do little to fix the problem. Instead, he said, medical specialty societies must do a better job educating doctors about the drugs’ side effects.

Several states are have filed lawsuits against drugmakers - Lilly, AstraZeneca and Johnson & Johnson - for alleged improper marketing and failing to disclose serious side effects, all of which prompted state Medicaid programs to overpay for the meds, which include Zyprexa, Seroquel and Risperdal. A few hours ago, Lilly agreed to pay $15 million to settle a lawsuit filed by Alaska, which claimed the drugmaker hid side effects caused by Zyprexa.

Whether such a small settlement will motivate other states to pursue investigations remains unclear. Alaska spent $40 million over five years on Zyprexa and so the recovery is modest, to say the least. We have placed a call to a spokesman for NJ Attorney General Anne Milgram, who last year formed a task force to explore the relationship between drugmakers and docs. We will update you when we receive a reply.

Contact the Anchorage Daily News Senior Vice President, Pat Dougherty, and ask him to place a video camera in the courtroom and broadcast the trial on the net so the public can watch - for free! After all - his paper today announced that this is "one of the biggest civil trials ever in Alaska.".

A national business hired a local photographer to set up cameras and technical equipment in the courtroom for a daily live feed to interested paying clients, once the trial begins. "Our market is attorneys, trial consultants, legal educators and the financial community," said John Shin of CourtroomLive, reached on his Baltimore-area cell phone Tuesday Clients can either watch streaming live video, or get video on demand of trial events after the fact for $300 a day, or both for $400, Shin said.

Comment on Alaska story here. s can be made here.

Millions of dollars at stake in Zyprexa trial CIVIL SUIT.

State is suing Eli Lilly for not publicizing risks of mental health drug.

State AG sues two drug companies

February 22, 2008

By CHARLES S. JOHNSON, Helena IR.

Attorney General Mike McGrath has sued two national pharmaceutical companies and accused them of manufacturing certain prescription drugs that were “in defective condition and unreasonably dangerous.”

McGrath filed the complaint in state district court in Helena Wednesday against Janssen Pharmaceutica Inc. and AstraZeneca Pharmaceuticals LP over their prescription drugs Risperdal and Seroquel, respectively. These medicines were intended to treat adult schizophrenia and short-term treatment of acute mania associated with bipolar disorder.

He charged that the two companies “have engaged in false and misleading marketing, advertising and sales campaigns to promote these drugs for non-medically indicated uses.” McGrath said the companies “successfully deceived physicians, citizen-users and others in the medical community” about the safety of these drugs compared to other antipsychotic drugs in order to carve out a greater market share.

This false promotion of these two atypical antipsychotic drugs have led to some Montanans who faced “serious injuries, illnesses, diseases or death,” McGrath said. He said the two companies illegally marketed and promoted Risperdal and Seroquel for uses not approved by the U.S. Food and Drug Administration, including treatment of dementia, sleep disorders, depression, attention deficit disorder, autism, depression, mood disorders and others.

That unlawful marketing and promotion turned Risperdal inState AG sues two drug companiesto one of the best-selling prescription drugs last year, with $4.2 billion in sales, McGrath said. Likewise, Seroquel captured 24 percent of the market in 2006, with $3.4 billion in sales to make it AstraZeneca’s top-selling prescription drug, he said.