Merck - Vioxx Controversy
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Merck - Vioxx Controversy Presentation Transcript

  • 1. Vioxx Controversy Romain Floyd, Suki Fuller, Andrea Villanera, Michele Barone, Steven Smith
  • 2. 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”
  • 3. Major Players
    • Raymond Gilmartin: Former CEO
    • Edward Scolnick: Former President Merck Research Laboratories
    • Cardiologist: Dr. Eric Topol
    • Victim: Newton Acker (no picture)
  • 4. 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
  • 5. Pipeline
  • 6. 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        • Withdrawn April 7, 2005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
  • 7. 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®
  • 8. 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
  • 9. 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
  • 10. 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
  • 11. 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
  • 12. 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
  • 13. 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
  • 14. 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
  • 15. 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
  • 16. 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
  • 17. Vioxx® and Merck
    • Merck’s Reputation
      • Talented scientists
      • Renown research facilities
      • Arrogance
      • Self-righteous
    • FDA
      • Speedy approvals
      • Organizational favoritism
      • Lackluster policy
  • 18. Vioxx and Industry
    • Vioxx® Recall
    • Industry Competition
      • Pfizer
    • Industry Reaction and Effects
  • 19. 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
  • 20. 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”
  • 21. 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
  • 22. 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
  • 23. 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
  • 24. 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 ”
  • 25. 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)
  • 26. 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
  • 27. Closing Statement / Questions Questions?
  • 28. 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
  • 29. 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.
  • 30. 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