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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: http://www.tampabay.com/opinion/editorials/article614734.ece ALLIANCE FOR HUMAN RESEARCH PROTECTION Promoting Openness, Full Disclosure, and Accountability http://www.ahrp.org and http://ahrp.blogspot.com
FYI
A front page article in the New York Times by Gardiner Harris and Ben Carey undercuts the professional credibility of the most influential child psychiatrists in the world-- Harvard affiliated Dr. Joseph Biederman and Dr. Timothy Wilens.
Senator Chuck Grassley has uncovered evidence showing that these renowned Harvard child psychiatrists, recipients of substantial federal grants from the National Institute of Mental Health, failed to disclose at least $3.2 million dollars they had received from drug companies between 2000 and 2007.
Such failure to disclose is a violation of federal law. The evidence uncovered by Senator Grassley is now in the Congressional Record.
Universities ask professors to report their conflicts but do almost nothing to verify the accuracy of these voluntary disclosures. But, as Dr. Robert Alpern, dean of Yale School of Medicine, acknowledges, "It's really been an honor system thing. If somebody tells us that a pharmaceutical company pays them $80,000 a year, I don't even know how to check on that."
Universities are dependent on taxpayer largesse, they should not be absolved from being held accountable. The health institutes could place restrictions on Mass General hospital's grants or even suspend them altogether. But will the NIMH take action or pretend the problem is isolated?
Harvard- Mass-General's consulting arrangements with drug makers, the Times notes, "were already controversial because of the researchers' advocacy of unapproved uses of psychiatric medicines in children....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."
Indeed, the Pediatric Bipolar Program at Mass General has been in the forefront of aggressive recruitment campaigns for manic-depression studies. A television ad (November, 2001), MGH sought 4 to 18 year old child subjects making false claims suggesting: "Your child may be facing a chemical problem that you can't manage without help." "We're Mass General, and we can help." This is an example of disease mongering. See: YouTube link at: http://ahrp.blogspot.com/2008/04/psychiatrist-sued-in-death-of-4-year.html
The enormous influence wielded by Dr. Biederman and his Harvard colleagues who have been conducting dubious industry-sponsored drug experiments on young children demonstrates that the Harvard mantle bestows a veneer of credibility even for medically unsupportable, radical use of toxic drugs in young children.
The Times notes that although many of Dr. Biederman's 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 and a rapid rise in the use of antipsychotic medicines in children.
AHRP urges Sen. Grassley to obtain informed consent documents and adverse event reports from ALL pediatric psychotropic drug trials conducted by Harvard-Mass-General psychiatrists--whether published or not.
Of note: Dr. Kayoko Kifuji, the Tuft's trained child psychiatrist who "diagnosed" Rebecca Riley as bipolar when she was 28 months old, and prescribed a lethal drug cocktail that killed the child at age 4, insists that she followed Harvard-recommended psychopharmacological prescribing practices.
Contact: Vera Hassner Sharav veracare@ahrp.org 212-595-8974
http://www.nytimes.com/2008/06/08/us/08conflict.html THE NEW YORK TIMES June 8, 2008, Front Page Researchers Fail to Reveal Full Drug Pay By GARDINER HARRIS and BENEDICT CAREY
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.
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 to check again, he said he received $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."
Copyright 2008 The New York Times Company
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