ACNP Summary Report Criticized as "Junk Science"

ACNP Summary Report Criticized as “Junk Science”

Sun, 25 Jan 2004

related links:
Reply to ACNP Report – Jonathan Leo, Ph.D.
FDA Sham Conflicts of Interest Policy

Most of the National press coverage of the controversy swirling around the claims and counter claims about drug suicidal obsessive thinking and behavior in some children prescribed SSRI antidepressants has been deplorable.

An example was how the press reported the announcement by the American College of Neuropsychopharmacologists (ACNP) that its SSRI Task Force, headed by Dr. John Mann and Dr. Graham Emslie. Both have longstanding financial ties to the pharmaceutical industry. Dr. Mann has also served as expert witness for both Pfizer and GlaxoSmithKline Beecham on the safety issues of antidepressants, and was a member of ACNP’s 1993 SSRI task force.

Just like its 1993 predecessor, the current ACNP task force claims to have found no evidence of an increased suicidal link in children prescribed SSRIs compared to placebo. This bald pronouncement was made even as the authors admitted they didn’t have the full data to substantiate their conclusion.

Yet, few in the national press reported the obvious conflict of interest of the ACNP Task Force. Few questioned the validity or scientific merit of claims which were made without accompanying data so that they could be examined and either validated or refuted. Few in the national press expressed skepticism about the timing of an optimistic report released just 2 weeks before an FDA advisory committee meeting dealing with an SSRI increased suicidal risk for children. Few noted ACNP’s substantial financial support from the pharmaceutical industry–which sponsors ACNP’s annual convention in such getaways as the Caribe Hilton in San Juan, Puerto Rico.

The Herald (South Carolina) did report, “Of the 10 doctors on the ACNP task force, six have direct affiliations with drug manufacturers. Two task force members were added last week to the FDA’s psychopharmacologic drugs advisory committee.” But most national science reporters focused on the academic credentials of the task force, as if their credentials could somehow substitute for verifiable scientific evidence.

The Herald provides readers with greater understanding of the controversy which pits independent doctors and scientists who have analyzed the raw clinical trial data, against the industry-influenced psychiatric establishment. ACNP members are psychiatrists who promote the unfettered use of psychotropic drugs. In the US, but not in Europe, SSRIs are prescribed even for personality enhancement and pre-menstrual cramps (PMDD). Eli Lilly withdrew PMDD from the European Prozac label.

Andy Vickery, an attorney who battles drug companies in court, has just written an illuminating article in which he demonstrates (with specific examples) why “Executive Summaries” are problematic and misleading. He describes the shoddy methodology used by ACNP scientists who issued a consensus statement in 1993 exonerating SSRIs as safe and effective, and finding no suicidal link. ACNP claimed the task force had reached their conclusion after examining company data on 2,963 patients. But in a court deposition, when confronted with the actual patient chart data, Dr. John Mann, co-author of the new ACNP report and a member of the ACNP 1993 task force, acknowledged under oath that the task force may not have actually examined the data itself–only “summary tables.” See: www.justiceseekers.com

How can we believe ACNP’s new SSRI task force findings? Where is a careful analysis of the actual data?

See also coverage by WebMD at:
http://my.webmd.com/content/Article/79/96376.htm?printing=true

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http://www.heraldonline.com/local/story/3264586p-2918424c.html

Report casts doubt on drug, suicide link
Published: Friday, January, 23rd, 2004

By Jason Cato, The Herald

A national medical group has taken a shot at what likely will be the defense of a Chester County boy charged with double murder by claiming antidepressants do not increase suicide risk in children. The statement comes from the American College of Neuropsychopharmacology. After reviewing clinical trials of more than 2,000 youth, an ACNP task force said it found no statistically significant increases in suicide attempts, suicidal thoughts or self-harm caused by antidepressants classified as selective serotonin reuptake inhibitors, or SSRIs.

The task force cautioned its findings are preliminary. A full report will not be released until spring or summer. Other researchers are adamant that a link exists between SSRIs and suicide. Some have said the trigger causing suicide attempts can lead to violent behavior. They say these side effects are not experienced by all SSRI patients, just a small number believed to be less than 5 percent. Family and supporters of Christopher Pittman claim adverse effects of Paxil and Zoloft led him to kill his grandparents and burn their house down when he was 12. The bodies of Joe Frank Pittman and Joy Roberts Pittman were found in the rubble of the rural Chester County home on Nov. 29, 2001. Christopher, now 14, faces charges as an adult and could spend life in prison if convicted.

Many in the legal and medical fields fired back at the task force. They claim the findings come from scientists closely tied to a drug industry bent on warping public perception before a Food and Drug Admin-istration hearing on the effects of antidepressants in children. A FDA advisory panel will meet Feb. 2 in Bethesda, Md.

Last year, U.S. and United Kingdom drug regulatory agencies began looking into a possible link between children on SSRIs and suicide when British drug giant GlaxoSmithKline, maker of Paxil, published summaries of nine clinical trials. The studies showed children given Paxil were about three times more likely to consider or attempt suicide than those given a placebo.

ACNP task force co-chair Dr. J. John Mann called evidence linking SSRIs to suicide ‘weak.’ In addition to Paxil and Zoloft, SSRIs include Celexa, Effexor, Lexapro, Luvox and Prozac. They work by blocking cells from reabsorbing serotonin, a mood-altering chemical, once released in the brain. In Decem-ber, the British government all but banned doctors from prescribing SSRIs to depressed children because of concerns about the possible SSRI/suicide link. The lone exception was Prozac, the only FDA-approved SSRI for treating depression in patients younger than 18. All SSRIs, however, are widely prescribed to children.

Dr. Graham Emslie, task force co-chair and a psychiatry professor at the University of Texas Southwestern Medical Center, claimed the potential benefits of SSRIs outweigh their risk. ‘The most likely explanation for the episodes of attempted suicide while taking SSRIs is the underlying depression, not the SSRIs,’ he stated in the release.

In a New York Times article published in August, however, he said he knew of negative SSRI studies involving children that have been withheld by drug companies. Emslie himself was a researcher in four Paxil studies. Mann, a psychiatry professor at New York’s Columbia University medical school, served as a medical expert for Glaxo in a Wyoming wrongful death suit. Glaxo settled an appeal in 2001 after a jury blamed Paxil for 80 percent of a murder/suicide and awarded the family $6.4 million. Neither Emslie nor Mann could be reached for comment.

Of the 10 doctors on the ACNP task force, six have direct affiliations with drug manufacturers. Two task force members were added last week to the FDA’s psychopharmacologic drugs advisory committee.

Last year, task force member Dr. Karen Wagner published the findings of a Zoloft study funded by drug maker Pfizer. Wagner has been criticized for failing to include data on patients who dropped out of the study. Even with that, the results showed Zoloft to be only 10 percent more effective than a sugar pill.

Dr. David Healy, director of the U.K.’s North Wales department of psychological medicine, criticized the task force for including scientists who’ve conducted favorable SSRI studies paid for by drug companies. ‘This is likely to be one of the most infamous articles of all time,’ Healy said of the report. ‘I’d say many of this panel have quite a bit to feel awkward about.’

Attorneys with Baum Hedlund, a Los Angeles law firm that specializes in cases against drug companies, referred to the task force — which admitted that it has not gained access to a ‘substantial amount of data’ from the FDA and drug companies — as ‘drug company hacks.’ ‘They admit they don’t have access to all the data, but they’re making these broad statements,’ said attorney Karen Barth Menzies. ‘It’s like a measure of damage control in advance. Their timing is obviously intentional.’

Ann Tracy, head of the International Coalition for Drug Awareness, said the timing was an attempt to make the FDA hearing ‘seem like a waste of time.’ ‘This is just business as usual, even while people are dying. What happened to Christopher Pittman is happening all over the nation,’ Tracy said.

Dr. Joseph Glenmullen, a psychiatry professor at Harvard Medical School, said there’s no question that SSRIs can drive some patients to attempt or think about suicide. He said the ACNP is ‘trotting out junk science.’

‘I don’t think it makes much sense for the ACNP to make these statements,’ Glenmullen said. ‘I find them useless and unproductive.’

The nonprofit ACNP gets some revenue from unrestricted educational grants from the drug industry, though it stated that no financial support from that industry went to the task force.

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