GAITHERSBURG, MD — Some outside advisers on Friday criticized a major part of the government's efforts to improve drug safety, saying a new oversight board needs independent voices and should consider meeting in public.
The Drug Safety Oversight Board was announced a year ago as a step to help regulators quickly respond to signs of unexpected side effects after a drug reaches the market.
Board members are senior U.S. Food and Drug Administration officials, plus experts from other government agencies. They meet periodically in private to discuss how to address emerging issues. Brief summaries are released to the public.
The board is separate from other FDA drug safety activities and an external advisory panel that provides input on drug risks when the agency requests it.
Dr. Peter Gross, the advisory panel chairman, praised the FDA as "incredibly competent" but said the board would benefit from outside views.
"You are setting yourself up for failure with this oversight board," Gross told FDA officials at a meeting of the advisory panel. "In this age of transparency, you decide to have a committee that's responsible, according to its name, for overall safety, and yet it meets in private. You don't have public representatives."
The board was established in the wake of Merck & Co. Inc.'s <MRK.N> recall of arthritis drug Vioxx and other safety controversies that sparked criticism of the FDA's oversight.
The board is a good step that "addresses some of the perceived weaknesses," said Dr. Curt Furberg, an adviser from Wake Forest University School of Medicine in North Carolina.
Arthur Levin, director of the Center for Medical Consumers, said the board's name was misleading. "I don't think it's a drug safety board. ... The model is bad, the name is bad. Why can't there be an audience?"
FDA officials said the board was designed to be an internal management group, in part because officials must discuss confidential company information.
Adding nongovernment members would require a lengthy screening process for conflicts of interest that could delay action on important issues, they added.
source: http://today.reuters.com/investing/financeArticle.aspx?type=governmentFilingsNews&storyID=URI:urn:newsml:reuters.com:20060210:MTFH94586_2006-02-10_22-03-13_N10218606:1 11feb2006
WASHINGTON -- Ritalin and other stimulant drugs for attention deficit hyperactivity disorder should carry the strongest warning that they may be linked to an increased risk of death and injury, federal health advisers said Thursday.
The Food and Drug Administration advisory panel voted for the warning on cardiovascular risks after hearing about the deaths of 25 people, including 19 children, who had taken the drugs. The vote was 8-7, with one abstention. The FDA isn't required to follow panel recommendations but usually does.
Doctors prescribe the drugs to about 2 million children and 1 million adults a month.
source: http://www.suntimes.com/cgi-bin/print.cgi?getReferrer=http://www.suntimes.com/output/health/cst-nws-rit10.html# 11feb2006
BEIJING — A Food and Drug Administration (FDA) advisory panel voted Thursday to put the most severe possible on drugs used to treat attention deficit hyperactivity disorder (ADHD).
Such druggs include adderall, Ritalin, Concerta, Methylin and Metadate.
While not binding, the advisory panels' recommendations usually are followed.
The action was prompted by an FDA review prepared for the advisory panel, which indicated the medications might have played a role in 25 deaths and 54 cases of serious medical problems between 1999 and 2003.
The problems included heart attacks, strokes, hypertension, palpitations and the overly rapid heartbeats known as arrhythmia.
Nineteen of the deaths involved children, and an accompanying FDA analysis suggested the risk of sudden cardiac death in children taking ADHD drugs was 1.5 to 2.5 times greater than in the general population.
Although the cases of such adverse events account for fewer than one in 1 million, the panel voted 8-7 to recommend a warning because millions of people could be affected. One member of the panel abstained.
Health practitioners, however, expressed reservations over the FDA panel's decision.
"In my opinion, this panel's reaction was too strong," said Dr. Louis Kraus, chief of child psychiatry at Rush University Medical Center.
Dr. Sharon Hirsch, a child psychiatrist at the University of Chicago Hospitals, advised patients and parents to remain calm and said "there's no reason to stop your medication."
Dr. Joyce Kocher, a child psychiatrist in the northern suburbs, thinks the benefits of these medications far outweigh the risks. "If your kid can't color, can't read, can't sit still, is in timeout all day, is failing and getting held back—what's the benefit in that?" she said.
People with ADHD are impulsive and have problems concentrating. By some estimates, 6 percent of children and 2 percent of adults have the condition, though debate has raged for more than a decade over whether ADHD is overdiagnosed and drugs for it overprescribed. More than 2.5 million children and 1 million adults take ADHD medications.
source: http://news.xinhuanet.com/english/2006-02/10/content_4161434.htm 11feb2006
GAITHERSBURG, Md., Feb. 9 — Stimulants like Ritalin could have dangerous effects on the heart, and federal regulators should require manufacturers to provide written guides to patients and place prominent warnings on drug labels describing these risks, a federal advisory panel voted on Thursday.
The panel's recommendation promises to intensify a long-running debate about whether the medicines are overused. Nearly four million patients take the drugs to treat attention deficit disorder and hyperactivity, and committee members said they wanted to slow explosive growth in the drugs' use.
The committee's action was unexpected. The Food and Drug Administration had convened the panel to help it determine how to research possible heart risks of the drugs. The agency had not asked the committee to address the drugs' labels, and agency officials seemed taken aback by the votes, saying they would not act on the committee's recommendations anytime soon.
"We don't think anything different needs to be done right now," Dr. Thomas Laughren, director of the Division of Psychiatry Products at the agency, said at a hastily arranged news conference after the meeting. "We think the labeling right now is adequate."
The committee voted unanimously to recommend patient guides, and it voted 8 to 7 to suggest that stimulant labels carry the most serious of the agency's drug-risk warnings — a "black box."
"I must say that I have grave concerns about the use of these drugs and grave concerns about the harm they may cause," said Dr. Steven Nissen, a cardiologist at the Cleveland Clinic and a panel member.
The votes came after F.D.A. medical officers described reports of 25 sudden deaths among people taking stimulants — the deaths were mostly children — and a preliminary analysis of millions of health records that suggested stimulants might increase the risks of strokes and serious arrhythmias in children and adults. The reports of sudden deaths never exceeded one in a million for any stimulant drug, although the F.D.A. usually receives reports of only a fraction of drug problems.
The preliminary analysis suggested that the stimulants might increase heart risks more than twofold. Such an increase may not be significant in children, whose heart risks are low, but could cause concern in adults, panel members said.
One of the drugs, Ritalin, has been marketed since 1955, and dozens of studies have shown it to be safe and effective. But no studies have been of sufficient duration or included enough participants to evaluate stimulants' long-term effects on the heart.
But the drugs' soaring popularity and increasing use in adults, panel members said, mean that the F.D.A. should study them more closely and warn patients and doctors about the potential risks to the heart.
Arthur A. Levin, director of the Center for Medical Consumers in New York City and a member of the panel, said that patients assumed that stimulants were safe, but that that confidence was misplaced.
"For us to sit around and talk about it, and for us to not make a very strong warning about the uncertainty of these drugs and their possible risks, would be unethical," Mr. Levin said.
Dr. Thomas R. Fleming, a professor of biostatistics at the University of Washington and a panel member, said stimulants might be far more dangerous to the heart than Vioxx or Bextra, drugs that were withdrawn over the past two years because of their ill effects on the heart.
The committee was composed largely of drug-safety specialists. Next month, the F.D.A. will ask another committee, mostly pediatricians and psychiatrists, to weigh the same issues. Such clinicians tend to focus on drug benefits and oppose warnings that might scare patients.
The vote by the drug-safety panel reflects changing notions about what the drug agency should do in the face of uncertainty. For decades, it generally refused to warn doctors about theoretical medical risks, even when there were strong hints of danger. But the committee said such silence was a mistake, particularly when millions took the drugs.
"Put yourself in our shoes," said Dr. Peter A. Gross of Hackensack University Medical Center in New Jersey and the panel's chairman. "Most of us see our role as protecting the public health. As often happens, the data we would like to see is not clear. In that setting, what we would like to see is a clearer warning."
But top F.D.A. officials said warning patients about theoretical risks might scare many away from needed treatment. "I think it's important not to minimize the benefits of these drugs," Dr. Laughren said.
Representatives of Johnson & Johnson, the maker of Concerta, and Shire, the maker of Adderall, two stimulants, said they would work with the drug agency on any label changes.
Dr. Todd Gruber, an executive of Novartis, which makes Ritalin, has said that Novartis has found no evidence that the drug raises the risks of heart problems.
Stimulants are the most widely prescribed medicine for childhood behavioral problems. Data presented at the meeting suggest that about 2.5 million children and 1.5 million adults are taking them. More than 30 million prescriptions for the drugs are written annually.
Several F.D.A. medical officers addressed the committee, and each suggested that the risks could be significant. Dr. Kate Gelperin, a medical officer in the Office of Drug Safety at the agency, began her presentation by telling the committee, "This morning I'm going to tell you a little bit about why the F.D.A. is so worried about these issues."
Dr. Gelperin noted that stimulants had long been known to increase blood pressure and heart rates. Other studies have shown conclusively that increased blood pressure leads directly to increased deaths from heart problems, she said.
Dr. Andrew Mosholder, also a medical officer in the Office of Drug Safety, said he reviewed the chemical structures of stimulants, and he noted that these structures were similar to drugs like ephedrine that had proven heart risks.
Dr. David Graham, another medical officer in the drug safety office, described the agency's preliminary analysis of millions of medical records that suggested an increased risk of strokes and arrhythmias.
"The number of arrhythmia hospitalizations really struck us as surprising," Dr. Graham said. "Arrhythmia is believed to be the pathway for sudden unexplained death."
In an interview after his presentation, Dr. Graham said, "There's smoke. Does that represent a fire? We want to answer that question."
After hearing the presentations, most committee members decided they should do more than simply make suggestions for further research.
"I want to cause people's hands to tremble a little bit before they write that prescription," Dr. Nissen said.
Psychiatrists and psychologists who treat and study attention deficit disorder and hyperactivity were deeply divided over the decision.
"I'm not saying a warning would be baseless, but if we're not careful we're going to engage in a Chicken Little scenario in which we sensationalize what is a very, very low-probability event," said Dr. Russell Barkley, a research professor of psychiatry at the State University of New York Upstate Medical University in Syracuse.
Others said that a black-box warning could prompt families to explore behavioral treatments as an alternative to drugs, which "would be a very good outcome for kids with A.D.H.D. and their families," said William Pelham, director of the Center for Children and Families at the State University of New York at Buffalo.
All agreed that parents of children on stimulants who have pre-existing heart conditions should consult their doctors.
Benedict Carey contributed reporting from New York for this article.
source: http://www.nytimes.com/2006/02/10/health/policy/10drug.html?_r=1&hp&ex=1139547600&en=a9e539d075ea6760&ei=5094&partner=homepage&oref=slogin 11feb2006
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