Fwd: [SSRI-Research] Antidepressant Controversy: Media Conflicts of Interest - New York Times

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[sSRI-Research] Antidepressant Controversy: Media Conflicts of Interest

- New York Times

 

Antidepressant Controversy: Media Conflicts of Interest - New York

Times

 

www.ahrp.com

 

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:

http://www.ahrp.org/risks/SSRI0204/GSKpaxil/pg1.html

 

Contact: Vera Hassner Sharav

Tel: 212-595-8974

 

 

~~~~~~~~~~~~

http://www.washingtonpost.com/ac2/wp-dyn/A16214-2004Mar22?

language=printer

THE WASHINGTON POST

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

 

http://www.rockymounttelegram.com/news/newsfd/auto/feed/news/

2004/03/24/1080176226.26609.0348.7142.html

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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