Post on 05-Dec-2014
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Vioxx Controversy
Romain Floyd, Suki Fuller, Andrea Villanera, Michele Barone, Steven Smith
Merck
• Merck & Co., Inc. (NYSE: MRK)
• Hdqtr: Whitehouse Station, NJ
• Founded:1891 George Merck
• Chairman, President & CEO: Richard T. Clark
• Sales: $24.2 billion in 2007
• Employees: ~ 59,800
• “Merck Puts Patients First”
Major Players
• Raymond Gilmartin: Former CEO
• Edward Scolnick: Former President Merck Research Laboratories
• Cardiologist: Dr. Eric Topol
• Victim: Newton Acker (no picture)
Reputation
• Stellar – High powered
• Blockbuster drugs– Fosamax®, Zetia®, Zocor®, Cozaar®
• Quick approval by FDA– Meticulous – Between1995 – 2000– 13 major new drugs reviewed and approved
in less than eleven months
Pipeline
Competition to Vioxx®
Pfizer (PFE) – only major competition– Bextra® (valdecoxib)
• Withdrawn April 7, 2005 • Increase risk of heart attack, stroke, and
some fatal skin reaction• Recent lawsuits settled October 2008
– $894 million
– Celebrex® (celecoxib) • Still marketed claims safe and effective
– Sales $589 million 3Q08
What is Vioxx®?
• Brand name for Merck’s anti-inflammatory drug and pain medication
• A prescription medicine used to relieve signs and symptoms of arthritis, acute pain in adults, and painful menstrual cycles
• It is also related to the nonselective NSAIDs, such as ibuprofen, Naproxen®, Celebrex® and Bextra®
Description
• White to off white to light yellow powder tablet
• Oral administration contains either 12.5 mg, 25 mg or 50 mg
• Once a popular class of painkillers that generated billions of dollars in annual sales
• The drugs work by blocking COX-2, an enzyme that inflames the joints
Clinical Studies of Vioxx®
• Significant reduction in joint pain and joint swelling
• Treatment of the signs and symptoms of Osteoarthritis of the knee and hip
Vioxx® Indications and Usage
• For relief of the signs and symptoms of osteoarthritis
• For relief of the signs and symptoms of rheumatoid arthritis in adults
• For relief of the signs and symptoms of pauciarticular or polyarticular course Juvenile Rheumatoid Arthritis in patients 2 years and older and who weighs 10 kg (22 lbs) or more
• For the management of acute pain in adults
• For the treatment of primary dysmenorrhea
• For the acute treatment of migraine attacks with or without aura in adults
Vioxx® advantage
• Provides Once Daily Power in chronic OA• The only COX-2 targeted agent that
reduced the need for rescue narcotic analgesia
• Not contraindicated in patients with sulfonamide allergies
• Demonstrated safety profile in patients 80 years or older
• Least expensive and branded NSAID
Contraindications
• In patients with known hypersensitivity to component of rofecoxib
• Should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after aspirin or other NSAIDS
• Caution should be exercise when Vioxx® is given to patient
Warnings
• Gastrointestinal (GI) Effects– Risk of GI Ulceration, bleeding, and
perforation. Patients should be informed about the signs and symptoms
• Anaphylactic Reactions– Should not be given to patients with the
aspirin triad• Advanced Renal Disease
– Not recommended in patients with advanced renal disease
• Pregnancy– In late pregnancy, Vioxx® should be avoided
because it may cause premature closure of the ductus arteriosus
• Not a substitute for aspirin
Sales Incentives
• Sales reps received $2,000 bonus for attaining 55% and 61% monthly new Rx share of Vioxx®
• Business managers also earned a bonus for each region that achieved the 55% and/or 61% goals
• Hospital sales reps also received of $2,000 for attaining 55% and 61% monthly
• Hospital business managers earned a bonus for each of their territories that achieved the 55% and or 61% goals
• Creating cardiovascular card
Marketing Vioxx®
• Unusually aggressive• Share of Vioxx® in the A & A market is up
to 17% and 51.2% in the Coxib® market before the problems erupted.
• Spent $160 million in advertising Vioxx® alone
Vioxx® Dangers
• Cox-2 Inhibitor Research
• Merck “Mishandling” -Pre-existing research
-Merck funded research
-Research findings
• Vioxx® and the cardio-vascular system – Heart attack– Stroke – Merck’s reaction
Vioxx® and Merck
• Merck’s Reputation– Talented scientists– Renown research facilities – Arrogance– Self-righteous
• FDA – Speedy approvals– Organizational favoritism– Lackluster policy
Vioxx and Industry
• Vioxx® Recall
• Industry Competition– Pfizer
• Industry Reaction and Effects
Industry Analysis
Good
• Life saving therapy• Improve quality of life• Innovative research and
development
Bad
• Perception of greedy multinationals– Capitalizing on ills of mankind
for a profit– Opportune timing in
developing and marketing drugs
– Potential danger to patients
• Lack of potential ‘blockbusters’
• Declining research and development budgets
Industry Analysis (continued)
• “Promotions targeting physicians account for the majority of drug industry spending on marketing and promotion. In 2003, pharmaceutical companies spent $9 billion on marketing and promotion. Of this amount, $5.7 billion (over 60%) was aimed at physicians. As many as ninety thousand sales representatives meet with physicians about their companies’ products every day”
Vioxx® Evaluation
• Among the first of COX-2 inhibitors• Considered one of Merck’s largest products in 2001
– Sales of $2.5 billion
• Dr. Deepak L. Bhatt (cardiologist at the Cleveland Clinic) recommended Merck conduct a study of Vioxx® in patients with severe chest pain. – Merck declined
• March 2000 study indicates “5xs as many patients taking Vioxx® had heart attacks as those taking naproxen”
• 2002 study examined Vioxx® and other anti-inflammatory drugs interaction with lipids– Vioxx® damaged lipids in a way that made them more susceptible to
clotting
Pulling Vioxx From the Market
• Four years after May 2000 meeting Merck pulled drug off market in the justification that:– Long term clinical trial showed some patients
developed serious cardiovascular problems after 18 months
– 15 cases of heart attack, stroke, or blood clot per 1,000 people
Merck Analysis
• Patents on several popular drugs expired in 2000 and 2001– Increased exposure to generic competition
• Vioxx® was considered ‘safe until proven otherwise’• Executives rejected cardiovascular study on Vioxx® in
2000– Would have required as many as 50,000 patients– Marketers feared this would portray lack a lack of confidence in
product– Competition from Celebrex®
• Accused of withholding information on Vioxx® side effects• Rushed to be first to market with product and slow to react• Aggressive marketing of new drugs
Merck Analysis (continued)
• 3,000 highly trained representatives marketed to doctor’s offices and hospitals with misleading information about Vioxx® risks– Marketed Vioxx® 8 to 11 times safer than other anti-inflammatory drugs
• Omitted VIGOR study
• Based on data FDA considered to be inappropriate for safety analysis
– Prohibited representatives from discussing contrary studies
– Instructed “NOT to initiate discussion on FDA Arthritis Committee”
– Sales force awarded with thousands of dollars in cash bonuses for meeting sales goals
“A heart attack in exchange for an ulcer is poor treatment”
Future Outlook
• Vioxx® Lawsuit Damages– 50,000 state and federal suits– $4.85 billion settlement– Damage to reputation
• Patent Expiration– Zocor® – Cholesterol cutting drug (2005)– Propecia® – Hair loss drug (2006)– Fosamax® – Bone disease drug (2007)– Cozaar® – Hyper tension drug (2010)
Recent Headlines
• Merck Cuts 7,200 Jobs (fiercepharma.com)• Merck Wrote Drug Studies For Doctors (nytimes)• Gardasil® Released – Cervical Cancer Drug
– FDA Expands Gardasil® Warnings• Link to fatalities and Paralysis
(washingtontimes)–17 deaths so far
• Merck Ghost Writes Own Articles
Closing Statement / Questions
Questions?
Sources
• Smith, Aaron. Zocor and Zoloft face patent expiration. CNNMoney.com 15 June 2006 http://money.cnn.com/2006/06/15/news/companies/zoloft_zocor/index.htm
• Smith, Aaron. Merck’s Fosamax Get The Ax. CNNMoney.com. 6 Feb 2006 http://money.cnn.com/2008/02/05/news/companies/fosamax/
• Fagan, Amy. Merck, FDA expands Gardasil Warning. The Washington Times. 10 July 2008. http://www.washingtontimes.com/news/2008/jul/10/merck-fda-expand-gardasil-warnings/
• Death toll linked to Gardasil vaccine rises. WorldNetDaily.com 30 June 2008. http://www.worldnetdaily.com/index.php?fa=PAGE.view&pageId=68454
• Bruderlin-Nelson, Christe. Merck To Cut 7,200 Jobs. 22 FiercePharma.com Oct 2008. http://www.fiercepharma.com/story/merck-cut-7-200-jobs/2008-10-22
Sources
• Merck & Co., Inc. http://www.merck.com/product/usa/pi_circulars/v/vioxx/vioxx_pi.pdf.
• http://www.ssem.com/investigations/vioxx/merck-vioxx-sales.html
• http://www.fda.gov/CDER/DRUG/infopage/vioxx/vioxx.html.
• http://oversight .house.gov/features/vioxx/Tab.14.pdf, retrieved 11/07/08.
Sources
• Medical News Today http://www.medicalnewstoday.com/articles/104365.php
• The New England Journal of Medicine http://content.nejm.org/cgi/content/full/351/17/1707
• Merck pipeline http://www.merck.com/finance/pipeline.swf• Merck http://www.merck.com/• “Pfizer Settles Claims Over Celebrex, Bextra”
http://online.wsj.com/article/SB122424333713244271.html?mod=googlenews_wsj
• Phone call: Dr. Steve Chen 11/06/08• Email: Dr. Robert Bresalier 11/6/08