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Merck - Vioxx Controversy

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Merck - Vioxx Controversy

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Withdrawn April 7, 2005 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

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