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Top News arrow Conflict of Interest arrow A Matter of Disclosure: Shame on JAMA editor / Shame on Harvard Scientists / FDA Adds SSRIWarnings
A Matter of Disclosure: Shame on JAMA editor / Shame on Harvard Scientists / FDA Adds SSRIWarnings Print E-mail
Thursday, 20 July 2006
The Associated Press reports (1, 2 below) that the FDA has just issued new warnings about two additional life-threatening risks induced by SSRI antidepressants: Serotonin Syndrome and Persistent Pulmonary Hypertension in newborn babies.

Serotonin Syndrome is another term for drug toxicity (poisoning):
FDA described the life-threatening effects of Serotonin Syndrome: “restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea.”

Doctors who have been prescribing a combination of SSRIs (or the newer SNRIs, such as Effexor and Cymbalta) and medications for migraine headache have put patients at significant increased risk of drug toxicity (Serotonin Syndrome).

Persistent Pulmonary Hypertension in newborns has been documented for years but the FDA did nothing to warn doctors or the public. See: discussion about the finding of a six-fold increased risk for infants, in the Feb. 2006 report in the New England J of Medicine: http://www.ahrp.org/cms/content/view/75/28/  

Patients’ lives—including developing babies in the womb—have been put at increased risk of health hazards and death because FDA dragged its feet for years as drug manufacturers falsely advertised these drugs as “wonder drugs” inventing an imaginary “chemical imbalance” in the brain of depressed patients. The FDA permitted false and unscientific information to be disseminated about the drugs’ action when there is no scientific evidence that antidepressants “balance” or normalize a fictional “chemical imbalance.”

FDA’s failure to warn about hazardous drug effects—while at the same time intervening on behalf of drug manufacturers in legal actions claiming that FDA’s preemptive authority over what is disclosed in drug labels—is difficult to sustain once the public has learned about undisclosed lethal drug effects.  There are far too many drug casualties to sustain FDA denials.

A review by an expert panel of the National Toxicology Program (NTP)-Center for the Evaluation of Risks to Human Reproduction (CERHR) issued its final report in April, 2004, concluding:  "The Expert Panel concluded that there is sufficient evidence in humans to determine that prenatal exposure to fluoxetine [Sarafem, Prozac] results in poor neonatal adaptation . . . at typical therapeutic exposures (20-80mg/day orally) during the third trimester of pregnancy." [1]

By now, these drugs have clearly lost their allure: antidepressant sales are flat as more people learn about the hazards.  Unscrupulous psychiatrists at premier academic institutions have embarked on a disinformation campaign urging pregnant women to continue using antidepressants despite knowledge about the multiple risks of harm that these drugs pose.
If these “experts” did not know about the drugs’ lethal risks, what then, is the basis for their expertise and “authority?”

Last week, following an investigative report by David Armstrong, in The Wall Street Journal, which revealed that psychiatrists from Harvard, UCLA and Emory, whose report published in the American Medial Association (JAMA) urged pregnant women to continue taking antidepressants, had financial interests in making those recommendations.  Dr. Catherine DeAngelis admitted that JAMA published the report without disclosing authors' ties to the manufacturers of the drugs they recommended for pregnant women.. See:   http://www.ahrp.org/cms/content/view/286/55/

When questioned further by the Chicago Tribune, Dr. DeAngelis snapped: [2]

 "I don't give people lie detector tests," the editor said. "I am not the FBI."
 

Then, “just days after announcing a crackdown on researchers who fail to disclose drug company ties,” the Associated Press reports (below 3) the editor of JAMA was again confronted with evidence that the authors of a report in the current issue, failed to disclose their financial ties. [3] http://jama.ama-assn.org/cgi/content/full/296/3/283#AUTHINFO

The authors claim a link exists between migraine headaches and heart attacks. Since migraines are treated with drugs, the finding provides a rationale for aggressive treatment of migraines. [4]  JAMA editor claims she was snookered again.

AP reports that all six authors—five from Harvard, one from Germany [see affiliations below] “have done consulting work or received research funding from makers of treatments for migraines or heart-related problems….The authors said they did not report their financial ties because they did not believe they were relevant to the study.”

AP reports that the lead investigator, Dr. Tobias Kurth, a scientist at Harvard School of Public Health and Brigham and Women's Hospital, acknowledged having “received research funding from the makers of Bayer aspirin, Tylenol and Advil, pain relievers sometimes used to treat migraines.”

The culture of corruption in academia has evidently lowered the intelligence quotient of highly trained and credentialed academics at the nation’s premier academic medical institution. Harvard scientists seem not to comprehend that the explanations they offer for their failure to disclose conflicts of interest are patently absurd.

Indeed, unlike scientists employed by industry—whose bias is transparent—prominent experts in academia’s most prestigious institutions who neglect to disclose their financial ties to the companies, may be accused of conspiring with industry. These academics lend a false veneer of objectivity to studies that are, in reality, driven by corporate market expansion goals. Invariably, physicians with financial ties to drug companies recommended treatment regimens that help increase profit-margins for their corporate benefactors.

Academics who are “on the take,” have grown accustomed to readily available supplemental incomes from industry. They apparently think nothing about violating the physician’s oath—“First, do no harm.” Nor are they above manipulating data to provide a rationale in support for the use of drugs—even when harm is likely to occur.
 
How serious is JAMA about its failure to ensure that financial conflicts of interest are disclosed by authors of reports it approves for publication?
Dr. DeAngeles has not even taken the basic step of disclosure: she has not alerted JAMA readers (online) that the authors of the report, Migraine and Risk of Cardiovascular Disease in Women, have undisclosed financial ties to drug manufacturers.

Does the editor of the official journal of the American Medical Association bear no responsibility to post a prominent editorial note at the top of a report whose authors violated the journal’s disclosure policy?


Reference:

1. NTP-CERHR Final Report. The Reproductive and Developmental Toxicity of Fluoxetine. April, 2004: http://cerhr.niehs.nih.gov/chemicals/fluoxetine/fluoxetine_final.pdf
See also, AHRP Infomail: http://www.ahrp.org/infomail/04/06/29.php

2. Japsen, B. and Dow Jones News Wires, Journal tightens rules for authors: Doctors must disclose conflicts of interest, Chicago Tribune, July 12, 2006, http://www.chicagotribune.com/business/chi-0607120198jul12,1,1635801.story?coll=chi-business-hed 

3. Migraine and Risk of Cardiovascular Disease in Women  Tobias Kurth, MD, ScD; J. Michael Gaziano, MD, MPH; Nancy R. Cook, ScD; Giancarlo Logroscino, MD, PhD; Hans-Christoph Diener, MD, PhD; Julie E. Buring, ScD  <http://jama.ama-assn.org/cgi/content/full/296/3/283 > JAMA. 2006;296:283-291.

Author Affiliations:
Divisions of Preventive Medicine (Drs Kurth, Gaziano, Cook, and Buring) and Aging (Drs Kurth, Gaziano, Logroscino, and Buring), Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Department of Epidemiology, Harvard School of Public Health (Drs Kurth, Cook, Logroscino, and Buring), Massachusetts Veterans Epidemiology Research and Information Center, Boston VA Healthcare System (Dr Gaziano), and Department of Ambulatory Care and Prevention, Harvard Medical School (Dr Buring), Boston, Mass; and Department of Neurology, University of Duisburg-Essen, Essen, Germany (Dr Diener).

4.BBC reported : "The doctors said further research would be needed to determine if migraine with aura was itself a modifiable risk factor for CVD [cardiovascular disease], and if medicines to prevent migraine might cut CVD risk."   See: http://news.bbc.co.uk/1/hi/health/5190480.stm

Contact: Vera Hassner Sharav
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1. http://www.cnn.com/2006/HEALTH/07/19/pg.antidepressants.ap/
F.D.A. Takes Action on Antidepressants and Migraine Drugs
By THE ASSOCIATED PRESS
July 20, 2006

WASHINGTON, July 19 (AP) — The Food and Drug Administration asked Wednesday that manufacturers of Prozac and similar antidepressants change their labels to include information about an uncommon but life-threatening lung problem that can affect babies born to mothers who take the drugs during pregnancy

The agency also issued an alert about the possible risk of combining antidepressant medications with common migraine  drugs called triptans, saying a life-threatening condition called serotonin syndrome might occur when the drugs are combined.

The agency said it was seeking more information on both risks.

Babies with the lung disorder, called persistent pulmonary hypertension, have high pressure in the blood vessels of their lungs and are not able to get enough oxygen into their bloodstreams. One or two babies per 1,000 develop the disorder shortly after birth. But a study published Feb. 9 in The New England Journal of Medicine found that infants whose mothers took antidepressants in the second half of pregnancy had six times the expected risk of it.

That report was issued just days after The Journal of the American Medical Association published a study illustrating the potential risk of depression relapse in women who stopped taking prescribed antidepressants during pregnancy. Taken together, the two studies worried many women because they implied that there were risks during pregnancy in both continuing on the medications and not.

The drugs, also called selective serotonin reuptake inhibitors, or S.S.R.I.’s, include Prozac, Zoloft, Paxil and Lexapro. The F.D.A. said Wednesday that it would issue further updates on the drugs’ labels as more information became available.

“It is important to emphasize that the F.D.A. recommends that women who are expecting and currently taking antidepressants should not discontinue use without first talking with a doctor,” said Susan Bro, a spokeswoman for the agency.
~~~~~~~~

2. http://www.fda.gov/cder/drug/advisory/SSRI_SS200607.htm
Associated Press
FDA: Mixing migraine, depression meds risky
Wed Jul 19, 8:33 PM ET

People taking migraine drugs together with some antidepressants are at risk of a life-threatening condition, health officials warned Wednesday.

Serotonin syndrome can occur when migraine headache drugs called triptans are taken with antidepressants known as selective serotonin/norepinephrine reuptake inhibitors, or SSRIs and SNRIs. The syndrome occurs when the body has too much of the nervous system chemical serotonin.

Patients taking the drug combination can experience restlessness, hallucinations, loss of coordination, fast heart beat, rapid changes in blood pressure, increased body temperature, overactive reflexes, nausea, vomiting and diarrhea, the FDA said.

Commonly prescribed SSRIs include Prozac, Zoloft, Paxil and Lexapro. SNRIs include Cymbalta and Effexor. Triptans include Amerge, Axert, Imitrex and Zomig.

The FDA asked the manufacturers of all three types of drugs to update their prescribing information to warn of the potential risk of serotonin syndrome.

Patients taking a triptan with either an SSRI or SNRI should talk to a doctor before stopping their medications, the FDA said.

~~~~~~~~~~~
3. http://hosted.ap.org/dynamic/stories/J/JOURNALS_CONFLICTS?
 The Associated Press
JAMA Misled Again Over Industry Ties
By Lindsey Tanner
July 19, 2006,

 
CHICAGO - Just days after announcing a crackdown on researchers who do not disclose drug company ties, the editor of a prestigious medical journal says she was misled again - this time by the authors of a study linking severe migraines to heart attacks in women.
 
All six study authors have done consulting work or received research funding from makers of treatments for migraines or heart-related problems. Their research appears in today's Journal of the American Medical Association, a week after the crackdown was announced.
 
The authors said they did not report their financial ties because they did not believe they were relevant to the study.
 
Dr. Catherine DeAngelis, JAMA's editor in chief, said journal editors did not know about the ties until The Associated Press brought them to her attention late last week. "We'll get killed," she said, referring to the potential damage to the journal's reputation.
 
She said she would have published the authors' associations with drug makers had she known about them. "Let me decide what's pertinent or not," DeAngelis said. "The issue is not what can those companies possibly gain; it is the issue of perception."
 
Last week, JAMA disclosed that the authors of a depression study failed to report ties to makers of antidepressants. And two months ago, the journal reported similar omissions from authors of a study linking certain arthritis drugs to cancer.
 
JAMA has long required researchers whose articles it will publish to sign statements disclosing all potential financial conflicts. An editorial last week said JAMA was getting tougher as a result of the recent breaches. JAMA's new policy, effective in January, requires disclosures even before articles are accepted for publication. Other leading medical journals, including the New England Journal of Medicine, JAMA's main competitor, have disclosure requirements, but DeAngelis said hers are the toughest. Editors say disclosures are necessary to help readers judge the reliability of research.
 
DeAngelis said a letter from the authors explaining the omissions would be published online and in an upcoming issue of the journal, along with her response. "Authors should always err on the side of full disclosure," she wrote in her response.
 
Dr. Tobias Kurth, the study's lead author, said the researchers were not trying to mislead the journal. He said they believed their financial ties were irrelevant because the study does not promote drug treatment, but rather reports a potential link between women with severe migraines and an increased risk of heart attacks. "They do not represent a conflict of interest," Kurth, a scientist at Harvard's Brigham and Women's Hospital, said. Kurth said he has received research funding from the makers of Bayer aspirin, Tylenol and Advil.
 
Co-author Nancy Cook said in an e-mail that she received "minor compensation" for a one-time consulting stint for Bayer, but that she did not think it was relevant to her work on the migraine study. "I do believe that conflicts sometimes exist and should be disclosed, but I hope this issue does not get overblown by the media," Cook said.
 
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