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informed consent?…

Posted on Thursday 30 December 2010

So we had a New York Times front page ad for $eroquel XR that says " Adding

SEROQUEL XR for depression may help. " Down at the bottom it says " Roll-over for

MORE Important Safety Information " in small print. As mentioned before in this

blog, $eroquel is an Atypical Antipsychotic originally approved by the FDA for

the treatment of Schizophrenia [1997]. Since then, it has been approved for

other things but it has been at the center of innumerable suits for false

advertising, and harming patients. For example, the manufacturer settled a suit

for $520 M, but since they make $4-5 B from the drug yearly, what’s half a

billion in the scope of things? Truth be told, $eroquel is a paradigmatic

example of the excesses of PHARMA. Every piece of this ad is carefully and

deceptively phrased:

" ADDING " : One way to increase sales of a drug is to get FDA approval for new

uses. In this case, Astrazeneca got this drug approved for use in patients with

Major Depressive Disorder [severe Depression] who are treatment resistant to

monotherapy [meaning they haven't responded to SSRIs such as Prozac or Paxil].

" SEROQUEL " : $eroquel is an Atypical Antipsychotic approved for the treatment of

Schizophrenia because these drugs may have less propensity to have neurological

consequences [Tardive Dyskinesia]. It is less effective as an antipsychotic than

the older drugs.

" XR " : Adding a time release pill is a way of having something new to sell. It

adds little, if anything to the therapeutic effectiveness of the drug.



And $eroquel is anything but a benign medication. It regularly causes weight

gain sometimes leading to Type 2 Diabetes. It can cause irreversable Tardive

Dyskinesia, etc etc. Note the following:

AstraZeneca Pays Millions to Settle Seroquel Cases

New York Times

By DUFF WILSON

October 29, 2009

The pharmaceutical company AstraZeneca said Thursday that it had reached a $520

million agreement to settle two federal investigations and two whistle-blower

lawsuits over the sale and marketing of its blockbuster psychiatric drug

Seroquel. One of the investigations related to “selected physicians who

participated in clinical trials involving Seroquel,†AstraZeneca disclosed in

a government filing. The other case related to off-label promotion of the drug.

nited States since 2004, according to IMS Health, a research firm…

Mr. Blizzard said he did not know what clinical trials were part of the inquiry.

But in one trial, known as Study 15, he noted, an e-mail message showed a

company official saying “a great ‘smoke and mirrors’ job’ †had been

done on a “buried†study in 1997, the year the F.D.A. approved Seroquel…

While I would personally see this ad as false advertising, they’ve stayed

inside the letter of the law [barely]. This ad is driven by this fact -

" Seroquel was the top-selling antipsychotic drug in America. It had $17 billion

in sales in the United States since 2004. " Since it is potentially toxic and

probably only really useful in cases where the person taking it is psychotically

depressed, it’s the kind of thing you might try if you’re treating someone

like Virginia Woolf or Styron [Darkness Visible] - people with

life-threatening Depressive Illness.

But this ad is aimed at a different group - the people who might read ads in the

New York Times. And the point is to get someone who is depressed who hasn’t

responded to an SSRI to mention it to their Primary Care Physician - neither

doctor nor patient having read Questions loom over drug given to sleepless vets,

AstraZeneca gives investors a boost, AstraZeneca Said to Pay $55 Million Over

Seroquel, AstraZeneca Pays Millions to Settle Seroquel Cases, or the countless

other reports about Seroquel.

In medicine, we have a concept - informed consent. It means if something is

risky, the patient is entitled to know those risks up front. That ad up there

flies in the face of informed consent. And it sure flies in the face of rational

science…

UPDATE: Commenter Ivan adds a few more $eroquel references for your holiday

reading:

Nemeroff, Seroquel, and ACCME

" Buried Data, " a " Smoke-and-Mirrors Job " and a " Positive Spin " on a " Cursed

Study "

More Documents About the Selling of Seroquel Show How Research Was " Subordinated

to Commercial Goals "

More on the Misleading Promotion of Seroquel

Geodon Ineffective for Bipolar Depression; or, Watch ClinicalTrials.gov in

Action!

Editorial Support, CME, and the Primary Care Companion

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