Riaz K Tayob
riaz.tayob at gmail.com
Wed Jun 20 02:42:54 PDT 2012
[Will someone please turn on the lights on evidence-based health at WHO?]
June 19, 2012
A Conversation with David Healy, MD
Has the Drug Industry's Grip On Health Care Become a Pharmageddon?
by MARTHA ROSENBERG
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.
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
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.
Martha Rosenberg's is an investigative health reporter. Her first book,
Born With A Junk Food Deficiency: How Flaks, Quacks and Hacks Pimp The
Public Health, has just been released by Prometheus books.
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