October 26

Antidepressant Controversy: Media Conflicts of Interest – New York Times

Antidepressant Controversy: Media Conflicts of Interest – New York Times

Thu, 25 Mar 2004

FDA’s advisory warning about antidepressant drugs received wide press coverage nationally. But few in the national media mentioned conflicts of interest as the obstacle to disclosure of evidence showing these drugs’ adverse effects. Among the few exceptions: The Washington Post (below) and The Herald (So. Carolina) http://www.heraldonline.com/local/story/3443345p-3060286c.html The New York Times front page article provided an overview of the controversy and noted the economic stakes-namely, that antidepressants generate $12 billion in sales. See: Gardiner Harris, Regulators Want Antidepressants to List Warning, NYT, March 23, 2004, A-1 http://www.nytimes.com/2004/03/23/health/23DEPR.html?hp

Contrary to FDA’s continued efforts to protect drug manufacturers by reassurances that no evidence has demonstrated a link between suicide and antidepressants, children and adolescents did commit suicide after being prescribed one of these drugs. In controlled clinical trials, children taking an antidepressant were at two-to-three-fold risk of suicidal acts. An analysis of that evidence led British drug regulators to ban the drugs for children under 18. The FDA has yet to issue clear and unambiguous warnings indicating that evidence shows a connection between the effects of antidepressant drugs and hazardous behavioral changes, including sudden violent uncontrolled outbursts that psychiatrists call “toxic behavior.”

The evidence comes from both clinical trials–mostly concealed until uncovered during court procedures–and the evidence comes from the real world of clinical care. The concealed trial evidence corroborates the testimonies of families who testified before FDA’s advisory committee on February 2. FDA’s ambiguous warning suggests the possibility of suicidal thinking at start of treatment, but is couched with disclaimers indicating lack of evidence. This equivocation raises doubts about the validity of the warning.

In fact, FDA officials have known for over a decade that antidepressants were linked to mania, agitation, extreme physical and psychological restlessness (called akathisia), and violent and suicidal behavior (euphemistically called “emotional lability”) in children and adults who tested the drugs, compared to those given a placebo. In truth, the public was deliberately misled to believe the drugs were “safe and effective.”

Indeed, expert psychiatrists from prestigious academic institutions–including the National Institute of Mental Health–consistently assured the public through media infomercials and uncritical news reports, that antidepressants were “safe and effective,” encouraging screening for undiagnosed depression so that treatment could begin early in children and adults.

A clear eyed column by Gene Metrick, senior writer and copy desk chief for the Rocky Mount Telegram (below) is an indication that Americans in the hinterland are watching the spectacle and see through the smokescreens.

By contrast, a follow-up article in the New York Times appears to be doing damage control. This article transmits false assertions of stakeholders in the drug industry. Those who have for years deluded the public, with unsubstantiated claims that antidepressant drugs were “safe and effective.” The Times follow-up states:

“Studies in children taking the antidepressants have not found an increase in suicide. But studies of some drugs have suggested that they might increase the risk of suicidal thought and behaviors…There is no solid data linking use of the drugs to suicide in adults.” Readers are led to think that “some drugs” but not antidepressants increase the risk of suicide. See: Overprescribing Prompted Warning on Antidepressants By Denise Grady and Gardiner Harris, NYT, March 24, 2004 P. A-13 http://www.nytimes.com/2004/03/24/health/24DEPR.html?pagewanted=print&position=

Such misleading statements bring into focus a major issue that compromises most medical news reports in the major American press/media. An issue that is never discussed or acknowledged is the media’s own conflict of interests.

The pharmaceutical industry spent $3.2 billion in direct consumer advertising in 2003–an increase of 22.5% since 2002. Industry’s lavish purchase of advertising space bought influence and good will. That influence has penetrated the editorial boards and science news departments of prestigious newspapers, including the New York Times, the major TV networks, as well as local news outlets, and supermarket pulp publications.

Industry’s overpowering influence is reflected in what, and how, medical drug related issues are reported and distorted. The American media has become the purveyor of (mostly) upbeat reports about medical breakthroughs–that almost never actually materialize. The media also engages in promotions of screening for “disease of the month” campaigns that are in fact, marketing campaigns.

News reports, such as the follow-up report about the FDA advisory is an accommodation to its advertisers and to the stakeholders in the psychotropic drug industry. Not only does the Times reveal advertising bias, but it fails to vet their sources of information for conflicts of interest.

The Times quotes Dr. Harold Koplewicz, indicating only that he is the director of the NYU Child Study Center: “The fear I have about this warning is that many teenagers will not get the medicine because it will build resistance among their parents, and that is really a tragic outcome.”

Dr. Koplewicz, not only is one of the staunchest promoters of psychotropic drugs for children, he was a co-investigator and co-author of a major Paxil study (329) in which he and the pillars of American child psychiatry claimed to have found that Paxil was “well tolerated and effective” for adolescents. The article has now been discredited by the FDA. Furthermore, an internal 1998 memo by the manufacturer of Paxil indicates that only the positive data from study 329 would be published, but the negative findings would not.

Readers trust the New York Times, believing that the experts selected by the Times for their views, are objective unless identified as having a financial interest in the product/ company or have taken a position. The Times failed to disclose any of the relevant background information that demonstrates a decidedly biased point of view. The Times article also failed to disclose the very substantial financial ties to the drug industry of either Dr. Koplewicz or the NYU Child Study Center.

If the NY Times with its vast resources and expertise is so easily misled by industry-sponsored market expansion campaigns which are led by doctors who serve the industry as paid consultants, whose claimed scientific findings have been shaped by industry’s directives, what can we expect from family advocacy groups who also receive substantial financial support from the same industry?

Failure to disclose financial and professional conflicts of interest undermines the integrity of Times science / medicine news reports. One wonders whether the NY Times should revise its motto, from “All the News that’s Fit to Print” to All the News that Increases Pharmaceutical Advertising?

See: Keller MB, Ryan ND, Strober M, Klein RG, Kutcher SP, Birmaher B, Hagino OR, Koplewicz H, Carlson GA, Clarke GN, Emslie GJ, Feinberg D, Geller B, Kusumakar V, Papatheodorou G, Sack WH, Sweeney M, Wagner KD, Weller EB, Winters NC, Oakes R, McCafferty JP. Efficacy of paroxetine in the treatment of adolescent major depression: A randomized, controlled trial. Journal of the American Academy of Child & Adolescent Psychiatry, 2001, 40:762-772.

See: U.S. Food and Drug Administration (FDA) CDER. Memorandum from Thomas P. Laughren, MD, to Members of PDAC and Peds AC January 5, 2004. Online at: http://www.fda.gov/ohrms/dockets/ac/04/briefing/4006b1.htm

See: GSK 1998 memo online at: https://ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

Contact: Vera Hassner Sharav
Tel: 212-595-8974


New Warning Urged On Antidepressants
Alert Would Address Suicidal Tendencies

By Shankar Vedantam
Washington Post Staff Writer
Tuesday, March 23, 2004; Page A03

The Food and Drug Administration urged drugmakers yesterday to put new warning labels on popular antidepressant medications, including Paxil, Zoloft and Luvox, alerting doctors and consumers to watch for suicidal tendencies, hostility and agitation in patients taking the drugs.

The agency’s action focuses on 10 antidepressant drugs in all and follows a warning by the British government last year advising physicians not to prescribe most widely used antidepressants to children. Last month, families of American adolescents who killed themselves while taking the medications implored the FDA to take comparable steps, and an expert advisory committee urged greater vigilance in the use of the medications in children with depression.

The agency said it does not know whether the medications — which include several drugs known as selective serotonin reuptake inhibitors, or SSRIs — are responsible for reported side effects such as inner restlessness, agitation and suicidal thoughts in some people. Officials said they are drawing greater attention to known cautionary information while a team of outside researchers completes a comprehensive analysis of the possible risks.

Patients taking the drugs who experience behavioral side effects should contact their physicians, said Russell Katz, director of neuropharmacological drug products at the FDA. If the symptoms are new or severe, he added, doctors should consider lowering the dose or stopping the drug.

Yesterday’s move by the agency calls for warning-label changes for adults as well as children, and for patients who are depressed as well as those who use the drugs for unrelated problems.

“The advice applies across the board whether the drugs are used for any indication — psychiatric or not,” Katz said.

Critics of the medications called yesterday’s move a victory and demanded that the FDA go further. Although Prozac is the only one of this class of drugs that has been specifically approved to treat depression in children, doctors are writing tens of thousands of prescriptions for many of the others, based on their clinical judgment that the drugs are safe and effective.

“Doctors are going to be on the line not to prescribe them as if they were pacifiers,” said Vera Hassner Sharav, president of the Alliance for Human Research Protection, a patient advocacy group based in New York.

Many critics complain that a majority of studies of the drugs in children found that the medications did no better than dummy pills in treating depression, but that these studies have been hidden from doctors and the public. The companies say the studies are proprietary.

Sharav and other critics charge that the FDA and the American psychiatric establishment, which has broadly supported the efficacy of the drugs, have been unduly influenced by the pharmaceutical industry. Dozens of lawsuits against the medications have been filed around the country.

Many psychiatrists say the medications save lives and warn that discouraging patients from taking them could lead to greater numbers of suicides. They insist that suicidal tendencies or attempts among patients taking the drugs are the result of underlying disorders, not the medications.

Rates of suicide among adolescents have generally declined as antidepressant use has surged in recent years, said Thomas P. Laughren, FDA team leader for psychiatric drug products. While no one knows whether the two trends are linked, he said at a news conference yesterday, such data framed the context in which the FDA acted.

The drugs affected by yesterday’s announcement are Prozac, Zoloft, Paxil, Luvox, Celexa, Lexapro, Wellbutrin, Effexor, Serzone and Remeron.

C 2004 The Washington Post Company


Metrick: Is treatment worse than depression?
By Gene Metrick, Rocky Mount Telegram

It seems the pharmaceutical industry may have to add another side effect to the long list of warnings that accompanies the stable of antidepressant drugs it has been hawking for the past dozen years or so. The ads touting these drugs as the latest wonder cures for depression or anxiety appear repeatedly each day on television. The commercials always end with a standard disclaimer advising of the possible side effects of their use: nausea, dry mouth, sleeplessness, decreased libido, constipation, diarrhea, loss of appetite, etc.

Now the companies might just be warning that the use of an antidepressant may also increase the risk of suicide.

The U.S. Food and Drug Administration on Monday asked drug makers to include detailed warnings alerting doctors and consumers to watch for suicidal tendencies, agitation and hostility in patients using the drugs. The new warnings cover Prozac, Paxil, Zoloft, Effexor, Celexa, Lexapro and Luvox – known as seratonin reuptake inhibitors (SSRIs) – as well as Wellbutrin, Serzone and Remeron, which are a different class of drugs.

The FDA’s move comes on the heels of an emotionally charged public hearing in February in which dozens of distraught family members testified that they blamed the drugs for the suicides or suicide attempts of their loved ones.

Unfortunately, it’s uncertain what effect the FDA ruling will have on drug makers, who have not said whether they will comply with the agency’s request. Vera Hassner Sharav, president of the New York-based patient advocacy group, the Alliance for Human Research, told me that she sees the ruling as “equivocating and ambiguous.”

“It gives a warning but says, ‘We don’t have the evidence.’ Now, if you don’t have the evidence that the drugs are to blame, what’s the point of putting the warnings on them?” she said. “The FDA has had this data in their files for years – either they didn’t warn the public in order to shield the industry, or they’re incompetent.”

Dozens of lawsuits have been filed against drug makers by families of patients who committed or attempted suicide while taking antidepressants. For its part, the FDA says it is reviewing 25 clinical trials of the drugs on children and will release its findings this summer.

The British government last year banned the use of all such drugs except Prozac for the treatment of depression in children. But the problem is not confined to adolescent patients.

Independent studies have suggested a link between antidepressants and suicide since 1990, when Harvard researcher Dr. Martin Teicher reported that an internal Eli Lily study of adults showed “a greater incidence of suicide attempts in people in the study receiving Prozac than in people receiving placebo …”

The big drug companies have labeled those kinds of studies as “proprietary” and have refused to release the findings of such reports. But they’ve been very forthcoming in releasing research results that show no links between antidepressants and an increased risk of suicide.

Remember, these antidepressant medications have become a giant cash cow for the pharmaceutical industry, with as many as 30 million Americans estimated to be taking one or another of them. Heck, you can even visit any number of online pharmacies for a free medical consultation with a doctor and have your prescription shipped to you right away.

Of course, as one of the service representatives for prescriptiondrugs.com told me Wednesday over the telephone, you do have to answer the doctor’s questions “truthfully.”

Depression is a very serious and debilitating disease. And antidepressants can play a vital role in helping people overcome it. But the rush to overprescribe these drugs for a vast array of ailments is quite disturbing, especially when the full range of risks that accompany them seem to still remain pretty much uncertain.

It’s part of a syndrome that can be thought of as the “Drugging of America,” a growing trend reminiscent of the “Brave New World” described by Aldous Huxley in his novel of the same name. The residents of Huxley’s future world were freed from the anxieties, cares and conscience of their present-day counterparts through the use of the drug “Soma,” which brought the phrase, “Don’t worry, be happy” to a whole new level. Better living through chemistry, indeed.

Gene Metrick is a senior writer and copy desk chief for the Rocky Mount Telegram.

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