June 17, 2012 at 20:48:37
A Conversation
with David Healy, MD, author of the new book Pharmageddon
David Healy, MD by Healy
Rosenberg: Your new book, Pharmageddon, gives a
bleak picture of the doctored data, skewed drug trials and rigged treatment
guidelines that characterize today's pharmaceutical industry. Many people will
be shocked to learn the abuses are not limited to the US, where
direct-to-consumer advertising is legal, but found in Europe.
Healy: The situation is identical. Pharma
actually finds socialized health care systems easier to exploit. And despite
direct-to-consumer advertising, more money is spent on marketing to doctors who
are the real consumers. They are also pressured by the treatment guidelines
process which is based on "evidence" that Pharma makes sure to keep
secret so they are really in the dark, though they may not realize it.
Rosenberg: One example you give of Pharma's reach and
power is the eerie symmetry between the Texas Medication Algorithm Project
(TMAP), conceptualized and funded by US Pharma, and Britain's National
Institute for Health and Clinical Excellence (NICE).
Healy: Despite their public/private differences,
both organizations recommend the use of branded antipsychotics like Risperdal,
Zyprexa and Seroquel before the use of older, affordable antipsychotics which
of course enriches Pharma. One of the other issues is this--there is a new bill
aimed at speeding up the FDA approval process yet again--and also getting
regulators to take into account the jobs that come with a strong pharmaceutical
sector. Both America and Europe
have been keen to keep their companies happy and have turned a blind eye to the
outsourcing of clinical trials to Asia and Eastern Europe.
Rosenberg: In Pharmageddon, you chronicle how
clinical trial oversight has gone from a hospital and university-based system
to a for-profit system run by clinical research organizations or CROs.
Healy: The drug companies have outsourced all
their operations from drug development and testing to clinical trials to
scientific and academic writing so that they have become nothing but marketing
organizations at their core. At each juncture where they have spun off a
traditional responsibility, no one has objected and so it continues.
Rosenberg: There have been reports of risks to human
subjects in overseas trials as well as bribes and protocol irregularities. Who
oversees the ethics of outsourced trials and the quality of their data?
Healy: Clinical trials are overseen by private
Institutional Review Boards, which are funded by the organizations they
regulate--
Rosenberg: Like Moody's and Standard & Poor's are
funded by their clients?
Healy: Yes. A recent large trial for the
antipsychotic Abilify demonstrates the danger with outsourced clinical trials.
On the basis of about 28 trials in the US, Abilify did not prophylactically stabilize
mood as the manufacturer wants to claim. But when data from just two trials
from Mexico were mixed in, it did.
Rosenberg: Most of Pharma's power to mislead and harm
comes from such opaque and distorted data, you charge in Pharmageddon.
Healy: Without access to the raw drug data,
medical professionals cannot practice responsible medicine and guidelines
cannot be written. Yet Pharma, with very few exceptions, refuses to publish the
data and share them with practitioners. This result is guidelines that are
fictions and doctors who lack critical information they need to prescribe and
treat.
Rosenberg: Pharma's stonewalling of data and use of
ghostwriters has resulted in articles in major medical journals that made
Vioxx, hormone therapy and
Neurontin look safe when they weren't. Another example you give is a paper in
the
Journal of the American Association of Child and Adolescent Psychiatry in which GlaxoSmithKline (GSK) has made
the antidepressant Paxil look safe by hiding raw data. Then editor, Mina
Dulcan, says about the missing data, which hid Paxil's suicidal side effect in
children, "I can't control the authors. No, I don't have regrets."
Healy: If we were getting our drug information
from the
New York Times
instead of medical journals, we would all be a lot safer. When the
Times reporter Jayson Blair was found to have
fabricated stories, he was history. But the editors and writers involved with
journal fraud still have their jobs and the articles are not even retracted. In
fact, Liz Wager, the chair of the Committee on Publication Ethics (COPE) is
herself Pharma linked.
[ Ed note. The COPE site says, "Liz
provides writing, editing, training and consultancy services for various
pharmaceutical companies (most recently Astra Zeneca, Cephalon, Cordis,
GlaxoSmithKline, Eli Lilly, Janssen-Cilag, Merck Serono, Mundipharma, Norgine,
Novo Nordisk, Sanofi Pasteur and Vifor). ]
Rosenberg: Many conflicts of interest in your book,
including COPE's leadership, are structural and create a closed loop of
misinformation, especially because of the money that Pharma wields. How can
sunlight and transparency ever break through?
Healy : Some colleagues and I are in the process
of fine-tuning a free web site that offers FDA MedWatch data with other crucial
dug information but gets people affected by treatment to report in detail for
perhaps the first time. The site, called RxISK.org, also helps patients file an
adverse event report to US and Canadian authorities, with other countries to
follow. For too long, patients, doctors and pharmacists have been isolated from each other when they encounter
adverse drug events and only Pharma's messages get out. This will help them
communicate directly. END
Pharmageddon
David Healy
University of California Press; 1 edition
Hardcover: 320 pages
David Healy is
a Professor of Psychiatry at Bangor University. He is a former Secretary of the
British Association for Psychopharmacology, and author of over 175 peer
reviewed articles, 200 other pieces and 20 books, including The Antidepressant
Era, and The Creation of Psychopharmacology from Harvard University Press, The Psychopharmacologists Volumes 1-3, Let
Them Eat Prozac, Mania, & Pharmageddon. He has been involved as an expert witness in homicide,
suicide and birth defect legal actions involving psychotropic drugs, and in
bringing problems with these drugs to the attention of American and British
regulators, as well raising awareness of how pharmaceutical companies sell
drugs by marketing diseases and co-opting academic opinion-leaders, ghostwriting
their articles .
Martha Rosenberg is a health reporter and commentator whose work has
appeared in Consumers Digest, the Boston Globe, San Francisco
Chronicle, Chicago Tribune, New Orleans Times-Picayune, Los Angeles
Times, Providence Journal and Newsday. She serves (
more...)
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