FDA Drug Advertising Policy: Don't Ask, Don't Tell

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SSRI-Research@

Wed, 9 Nov 2005 19:29:55 -0500

[sSRI-Research] FDA Drug Advertising Policy: " Don't Ask,

Don't Tell "

 

 

 

 

FDA Drug Advertising Policy: " Don't Ask, Don't Tell "

 

ALLIANCE FOR HUMAN RESEARCH PROTECTION (AHRP)

Promoting Openness, Full Disclosure, and Accountability

www.ahrp.org

 

FYI

The FDA's dereliction of public responsibility--that of ensuring that

only scientifically valid claims are disseminated to physicians and

the public about the safety and effectiveness of marketed drugs. FDA's

failure to carry out its mandate has resulted in deadly drugs being

widely marketed to an ever wider unsuspecting public.

 

On October 29, NewsInferno.com reported that some 200 prominent

scholars from top medical schools in the U.S., including Harvard,

Johns Hopkins, University of Pennsylvania, Columbia, Stanford, Yale,

Duke, University of California-San Francisco, and two former

editors-in-chief of the New England Journal of Medicine, have all

signed a statement calling for a ban on direct-to-consumer

prescription drug advertisements.

 

Organized by the nonprofit advocacy group Commercial Alert, the

statement was presented to the Food and Drug Administration (FDA)

hearing November 1-2.

 

" In 2004, pharmaceutical companies spent more than $4 billion in an

onslaught of advertising to promote prescription drugs. This

advertising does not promote public health. It increases the cost of

drugs and the number of unnecessary prescriptions, which is expensive

to taxpayers, and can be harmful or deadly to patients, " the

professors said.

 

These and many other prominent medical experts believe that the drug

advertising campaigns make patients desire specific drugs and

therefore request them drugs from their doctors. This puts pressure on

doctors to prescribe the requested drugs which may be less effective

or more expensive than other available medications.

 

The statement called the advertisements " inherently misleading, " and

said that they do not promote or contribute to public health. Instead,

the ads, whose cost is reflected in soaring drug prices, serve one

purpose only--they increase the number of prescriptions and,

therefore, they increase profits. See petition at:

http://www.newsinferno.com/storypages/10-29-2005%7E001.html

 

The lead article in the December issue of PLoS Medicine, Serotonin

and Depression: A Disconnect between the Advertisements and the

Scientific Literature,

 

by Jeffrey R. Lacasse, Jonathan Leo, provides documented evidence

that can be used by State Attorneys General to indict the purveyors of

SSRI antidepression drugs who used decepton to market these drugs.

http://www.plos.org/press/plme-02-12-leo.pdf

 

Drug manufacturers in partnership with the academic psychiatric

establishment have knowingly deceived physicians, the media, and the

public by disseminating false and unsubstantiated claims about

depression, and other psychological " conditions " for which they

promoted SSRIs. Their claims are contradicted by the scientific

evidence--evidence they controlled.

 

Key opinion leaders in academic psychiatry have continued to make the

unsubstantiated, largely discredited claim that depression and other

mental disorders are caused by a " chemical imbalance " in the

brain--the chemical they have " selected " is serotonin. Table 1

provides a selection of quotations by leading neuroscience

experts--including authors of psychopharmacology textbooks--all of who

dismiss the serotonin theory for lack of evidence and implausibility.

 

For example, Stanford psychiatrist David Burns, winner of the A.E.

Bennett Award given by the Society for Biological Psychiatry for his

research on serotonin metabolism,

 

" I spent the first several years of my career doing full-time research

on brain serotonin metabolism, but I never saw any convincing evidence

that any psychiatric disorder, including depression, results from a

deficiency of brain serotonin. In fact, we cannot measure brain

serotonin levels in living human beings so there is no way to test

this theory. Some neuroscientists would question whether the theory is

even viable, since the brain does not function in this way, as a

hydraulic system "

 

Psychiatrist Kenneth Kendler the coeditor-in-chief of Psychological

Medicine, " We have hunted for big simple neurochemical explanations for

psychiatric disorders and have not found them " [56].

 

In the PLoS press release about the Lacasse / Leo article, professor

David Healy, author of the seminal book, Antidepression Era, said:

 

" The serotonin theory of depression is comparable to the masturbatory

theory of insanity. Both have been depletion theories, both have

survived in spite of the evidence, both contain an implicit message as

to what people ought to do. In the case of these myths, the key

question is whose interests are being served by a widespread

promulgation of such views rather than how do we test this theory. "

See: http://www.eurekalert.org/pub_releases/2005-11/plos-afs103105.php

 

Table 2 cites selected statements from specific direct to consumer

advertisements for Celexa (citalopram), Lexapro (escitalopram), Prozac

(fluoxetine), Paxil (paroxetine), and Zoloft (sertraline).

 

Lacasse and Leo demonstrate how the the public has been methodically

deceived by the purveyors of deceptive, widely disseminated

advertisements. The ads make false claims about the drugs' action, the

nature of the condition, and the about these drugs' benefits that are

unsupportable by the evidence.

 

Federal regulations proscribing advertisements whose content

" contains favorable information or opinions about a drug previously

regarded as valid but which have been rendered invalid by contrary and

more credible recent information " Despite the debunking of the

" chemical imbalance " " serotonin theory " antidepressant drug

advertisements continue to promote this invalid theory in order to

persuade uninformed consumers to buy their drugs. All the while, the

FDA has turned a blind eye to the blatant deception of the public.

 

Lacasse and Leo end their article with the following conclusion: " The

incongruence between the scientific literature and the claims made in

FDA-regulated SSRI advertisements is remarkable, and possibly

unparalleled. "

 

PLoS (Public Library of Science) is a peer reveiewed open access, free

online library. It serves a much much needed public service--that of

providing otherwise difficult to access information about

controversial issues in medicine.

 

 

 

Jeffrey Lacasse jeffreylacasse

+1-850-294-0875

Jonathan Leo jleo1

+1-941-321-9034 or +1-941-723-8710

 

 

 

 

Contact: Vera Hassner Sharav

212-595-8974

veracare