Industry Influence ProfoundlyIndustry Influence ProfoundlyAffects Professional Medical SocietiesAffects Professional Medical Societies

and Must be Strictly Controlledand Must be Strictly Controlled

Industry Influence ProfoundlyIndustry Influence ProfoundlyAffects Professional Medical SocietiesAffects Professional Medical Societies

and Must be Strictly Controlledand Must be Strictly Controlled

Steven E. Nissen MDSteven 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 Medi-tech, 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.

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 Medi-tech, 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 PerspectiveA PerspectiveA PerspectiveA 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.

• 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)Annual Spending on CME by Industry (US)Annual Spending on CME by Industry (US)Annual Spending on CME by Industry (US)

ACCME Annual Report

Now exceeds 50%of all CME spending

Why Does Industry Spend So Much on CME?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.

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?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%

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 PromotionSource: Scott Neslin ROI Analysis of Pharmaceutical Promotion

Spain

Poland

Portugal

SouthKorea

Czech Republic Germany

France Canada

IcelandSwitzerland

United States

Per Capita Spending (Drugs/Nondurables)Per Capita Spending (Drugs/Nondurables)Per Capita Spending (Drugs/Nondurables)Per Capita Spending (Drugs/Nondurables)

Source: Organization for Economic Cooperation and Development

$90 billionspending gap

2006 dataR2 = 0.22

The Problem with Industry-Sponsored CMEThe 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 thatthey 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 theyknow will please the sponsor.

C. Speakers know that if they do not promote the sponsor’s products, they will not be invited back.

A. The topics are chosen by the sponsor and always designed to support their product(s).

B. The recipients of industry money know thatthey 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 theyknow 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

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.

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 ProgramAnatomy of an Industry

Sponsored CME Program

Abbott LaboratoriesThe Alliance for Better Bone HealthBoehringer Ingelheim CorporationBristol-Myers SquibbCordis CorporationCV TherapeuticsDaiichi Sankyo-LillyEisai Inc.Eli Lilly and CompanyGlaxoSmithKlineMerck & Co., Inc.Ortho-McNeil-Janssen Pharmaceuticals, Inc.Procter & Gamble

Abbott LaboratoriesThe Alliance for Better Bone HealthBoehringer Ingelheim CorporationBristol-Myers SquibbCordis CorporationCV TherapeuticsDaiichi Sankyo-LillyEisai Inc.Eli Lilly and CompanyGlaxoSmithKlineMerck & Co., Inc.Ortho-McNeil-Janssen Pharmaceuticals, Inc.Procter & Gamble

Med IQ: A Medical Education and Communications Company (MECC)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:For educational activities during the period of 2008-2009, Med-IQ acknowledges commercial support from the following companies:

Pfizer Inc.Roche Pharmaceuticalssanofi-aventisSepracor Inc.Schering-Plough CorporationShire PharmaceuticalsSt. Jude MedicalTakeda PharmaceuticalsTAP PharmaceuticalsTeva Pharmaceuticals USThe Medicines CompanyUCBVertex PharmaceuticalsWatson Pharmaceuticals, Inc.

Pfizer Inc.Roche Pharmaceuticalssanofi-aventisSepracor Inc.Schering-Plough CorporationShire PharmaceuticalsSt. Jude MedicalTakeda PharmaceuticalsTAP PharmaceuticalsTeva Pharmaceuticals USThe Medicines CompanyUCBVertex PharmaceuticalsWatson Pharmaceuticals, Inc.

Optimizing Patient Outcomes in Acute Heart Failure Syndromes: Strategies to Preserve Cardiorenal Function

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

• 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 adenosine-mediated 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 function.

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 adenosine-mediated 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 function.

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

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.

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 Cardiologyand Heart Rhythm Society

Get Caught in an Industry Scam

The American College of Cardiologyand Heart Rhythm Society

Get Caught in an Industry Scam

Afibprofessional.org

Facts about ‘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.

• 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?

Does the AHA any better at seeking independence from industry?

What is the price tag for inclusion in the AHA Pharmaceutical Roundtable?

What is the price tag for inclusion in the AHA Pharmaceutical Roundtable?

$1 million per year$1 million per year

What do pharmaceutical companiesreceive in exchange for this “philanthropy”?

What do pharmaceutical companiesreceive in exchange for this “philanthropy”?

The price for accepting industry fundingThe price for accepting industry funding

Heart Group Backs Drug Made by AllyBy 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.

Heart Group Backs Drug Made by AllyBy 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.

• 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.

• 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.

CMSS: Bold New Guidelines?CMSS: Bold New Guidelines?

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.”

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.”

SummarySummary• 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.

• 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.