Transcript Slides - American Heart Association

Industry Influence Profoundly
Affects Professional Medical Societies
and Must be Strictly Controlled
Steven E. Nissen MD
Disclosure
Consulting: AstraZeneca, Abbott, Atherogenics, Bayer, Lipid Sciences, Wyeth,
Novartis, Pfizer, Sankyo, Haptogard, Hoffman-LaRoche, Kemia, Takeda, Kowa,
Sanofi-Aventis, Protevia, Novo-Nordisk, Eli Lilly, Kos, GlaxoSmithKline, Forbes Meditech, Vasogenix,Vascular Biogenics, Isis Pharma, Viron Therapeutics, Roche, and
Merck–Schering Plough
Clinical Trials: AstraZeneca, Eli Lilly, Takeda, Novartis, Sankyo, Sanofi-Aventis,
Roche, and Pfizer.
Companies are directed to pay any honoraria directly to charity. No personal
reimbursement is accepted for directing or participating in clinical trials.
A Perspective
• Industry is vital to the development of new therapies
for cardiovascular disease and pharmaceutical
research efforts should be encouraged.
• However, professional societies and physician
leaders must independently assess both the
effectiveness and safety of these therapies without
undue industry influence.
• This is particularly true in educating colleagues where
excessive industry influence may distort the benefits
and risks of treatments, raising healthcare costs and
compromising quality of care.
Annual Spending on CME by Industry (US)
Now exceeds 50%
of all CME spending
ACCME Annual Report
Why Does Industry Spend So Much on CME?
A. Pharmaceutical and device companies are
really just large philanthropic organizations.
B. Companies really care about physicians and
don’t want them to have to pay for their CME.
C. Pharma and device companies have so much
money, they just don’t know how to spend it.
D. CME helps companies to sell their products
and provides a good return on investment.
Why Is Industry Willing to Spend So Much?
What is the annualized return on CME spending?
– A. 10%
– B. 20%
– C. 50%
– D. 100%
– E. 350%
Source: Scott Neslin ROI Analysis of Pharmaceutical Promotion
Per Capita Spending (Drugs/Nondurables)
United States
2006 data
R2 = 0.22
$90 billion
spending gap
France
Czech Republic
Spain
Canada
Germany
Iceland
Portugal
South
Korea
Poland
Source: Organization for Economic Cooperation and Development
Switzerland
The Problem with Industry-Sponsored CME
A. The topics are chosen by the sponsor and
always designed to support their product(s).
B. The recipients of industry money know that
they will receive future funding only if the CME
program supports the company’s goals.
B. So, consciously or unconsciously, CME
providers choose speakers and topics they
know will please the sponsor.
C. Speakers know that if they do not promote the
sponsor’s products, they will not be invited back.
Industry-Sponsored CME Topics You’ll Never See
A. How to choose generic drugs to save your
patient and the health care system from undue
expense.
B. Common serious adverse reactions to widely
used pharmaceutical agents.
C. How to avoid using CRT in patients who will not
benefit.
D. Which commonly used therapies are not cost
effective.
Anatomy of an Industry
Sponsored CME Program
Med IQ: A Medical Education and
Communications Company (MECC)
For educational activities during the period of 2008-2009, Med-IQ
acknowledges commercial support from the following companies:
Abbott Laboratories
The Alliance for Better Bone Health
Boehringer Ingelheim Corporation
Bristol-Myers Squibb
Cordis Corporation
CV Therapeutics
Daiichi Sankyo-Lilly
Eisai Inc.
Eli Lilly and Company
GlaxoSmithKline
Merck & Co., Inc.
Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Procter & Gamble
Pfizer Inc.
Roche Pharmaceuticals
sanofi-aventis
Sepracor Inc.
Schering-Plough Corporation
Shire Pharmaceuticals
St. Jude Medical
Takeda Pharmaceuticals
TAP Pharmaceuticals
Teva Pharmaceuticals US
The Medicines Company
UCB
Vertex Pharmaceuticals
Watson Pharmaceuticals, Inc.
Optimizing Patient Outcomes in Acute Heart Failure
Syndromes: Strategies to Preserve Cardiorenal Function
• If you watch this CME Program on Cardiosource,
you can learn about the wonders of a drug known as
rolofylline, a selective adenosine A1 antagonist that:
– Functions as a vasodilator, improving heart
failure symptoms
– Preserves renal blood flow
– Promising agent for treatment of acute
congestive heart failure
Merck & Co., Inc. to Acquire NovaCardia, Inc., to Boost
Clinical Pipeline of Cardiovascular Drug Candidates
Acquisition Gives Merck Access to KW-3902, an Investigational
Phase 3 Compound for Acute Congestive Heart Failure
WHITEHOUSE STATION, N.J. and SAN DIEGO, July 25, 2007 - Merck & Co.,
Inc., one of the world's leading research-based pharmaceutical companies, and
NovaCardia, Inc., a privately held clinical-stage pharmaceutical company focused
on cardiovascular diseases, today announced that they have entered into a
definitive agreement under which Merck will acquire NovaCardia.
Under the agreement, Merck will acquire all of the outstanding equity of
NovaCardia for $350 million…
NovaCardia's lead product candidate KW-3902, an adenosine A1 receptor
antagonist, is being studied in Phase 3 clinical trials in patients with acute
congestive heart failure (CHF). KW-3902 is believed to block adenosinemediated constriction of blood flow to the kidneys and inhibit reabsorption of salt
and water by the kidney, thereby increasing urine volume and maintaining renal
function in patients with CHF. To date, no other vasodilator has demonstrated the
selective renal vasodilation attribute of KW-3902 that helps preserve renal
This CME program is known a “market
preparation” business activity
designed to hype a yet unapproved
product in anticipation of successful
near-term launch of a new drug
Rolofylline fails to PROTECT in acute heart failure
SEPTEMBER 1, 2009
Sue Hughes
Barcelona, Spain - The selective A1 adenosine receptor
antagonist rolofylline (Merck), showed no difference from
placebo in the main efficacy end points in the PROTECT trial in
acute heart-failure patients. The drug was also associated with
an increased rate of seizures and strokes compared with
placebo.
These results are particularly disappointing given that an
earlier pilot trial with rolofylline in this indication showed much
promise. The drug, previously known as KW-3902, has now
been dropped from development.
The American College of Cardiology
and Heart Rhythm Society
Get Caught in an Industry Scam
Afibprofessional.org
Facts about ‘afibprofessional.org’
• A joint project of the ACC and HRS, sponsored by a
single company, Sanofi-Aventis.
• Both organizations receive presumably huge, but
completely undisclosed financial compensation.
• The site is purely promotional without even the guise
of CME!
• The Editor of the site and major new lecturer are both
Sanofi-Aventis paid consultants and advisors.
• Neither physician discloses their conflicts on the
website until the media expose this outrage.
The goal of the site is the shameless
promotion of dronedarone
Complete with a new “guideline” algorithm
that prominently features dronedarone
The ACC and HRS sold their
imprimatur for hard cold cash
Does the AHA any better at seeking
independence from industry?
What is the price tag for inclusion in the
AHA Pharmaceutical Roundtable?
$1 million per year
What do pharmaceutical companies
receive in exchange for this “philanthropy”?
The price for accepting industry funding
Heart Group Backs Drug Made by Ally
By STEPHANIE SAUL
Published: January 24, 2008
After a study last week showed Vytorin, an expensive combination
of two drugs for cholesterol, worked no better than cheap Zocor
alone in reducing artery plaque that can lead to heart attacks, the
American Heart Association came to the drug’s defense.
In a statement issued on Jan. 15, the day after the report’s
release, the heart association said the study was too limited to
draw conclusions about Vytorin’s ability to reduce heart attacks or
deaths compared to Zocor alone. The group advised patients not
to abruptly stop taking it without consulting their doctors.
What the association did not note in its statement, however, was
that the group receives nearly $2 million a year from
Merck/Schering-Plough Pharmaceuticals, the joint venture that
markets Vytorin.
CMSS: Bold New Guidelines?
• Societies will only accept Corporate Sponsorship of
an item or program if the item or program is aligned
with the Society’s strategic plan and mission.
• Societies will require Satellite CME Symposia to
undergo an application and selection process.
• Societies will adopt written policies that govern the
nature of exhibits and the conduct of exhibitors,
including by requiring exhibitors to comply with
applicable laws, regulations, and guidance.
• Societies will base Clinical Practice Guidelines on
scientific evidence.
Cleaning Up Medical Advice
Editorial in the New York Times, April 30th, 2010
“The code’s main weakness is the lack of any effort to
wean the societies from their dependence on money
from the makers of drugs, biological medicines and
medical devices. There have been complaints in
recent years that some societies conduct educational
programs that feel more like marketing sessions for
products or issue practice guidelines that push their
members to use treatments favored by their industrial
benefactors.”
Summary
• We need industry to develop vital new therapies.
• However, physician education (CME) must be
objective and independent of industry influence.
• If industry is paying the bills, they expect a substantial
return on their investment.
• Professional societies must avoid accepting industry
funding to maintain the necessary independence:
– To write objective guidelines.
– Speak out on public health issues.
– Encourage cost-effective medical practice.