Merck & Co: Wikis


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Merck & Co., Inc.
(Merck Sharp & Dohme (MSD) outside the United States and Canada)
Type Public (NYSE: MRK)
Founded 1891 as a subsidiary of Merck KGaA
1917 as an independent company
Headquarters Whitehouse Station, New Jersey, United States
Key people Richard T. Clark,
Chairman, President & CEO

Stanley F. Barshay, EVP and president, Consumer Health Care
Richard S. Bowles, Ph.D., chief compliance officer
Willie A. Deese, EVP and president, Merck Manufacturing
Kenneth C. Frazier, EVP and president, Global Human Health
Mirian Graddick-Weir, Ph.D., EVP, Human Resources
Peter N. Kellogg, chief financial officer
Peter S. Kim, Ph.D., EVP and president, Merck Research Laboratories
Raul E. Kohan, president, Animal Health
Bruce N. Kuhlik, general counsel
J. Chris Scalet, chief information officer, Global Services

Mervyn Turner, Ph.D, chief strategy officer
Industry Pharmaceuticals
Products Gardasil
Singulair
Propecia/Proscar
Zocor Vioxx Fosamax
See more complete products listing.
Employees 61,500 (2005)
Website www.merck.com

Merck & Co., Inc. (NYSEMRK), also known as Merck Sharp & Dohme or MSD outside the United States and Canada, is one of the largest pharmaceutical companies in the world. The headquarters of the company is located in Whitehouse Station, New Jersey, an unincorporated area in Readington Township. It was established in 1891 as the United States subsidiary of the German company now known as Merck KGaA. In common with many other German assets in the United States, Merck & Co. was confiscated in 1917 during World War I and set up as an independent company. It is currently one of the seven largest pharmaceutical companies in the world both by market capitalization and revenue.

Merck & Co. or MSD describes itself as a "a global research-driven pharmaceutical company. Merck discovers, develops, manufactures and markets a broad range of innovative products to improve human and animal health, directly and through its joint ventures." The Merck Company Foundation has distributed over $480 million to educational and non-profit organizations since it was founded in 1957.[1]

Merck publishes the The Merck Manuals, a series of medical reference books that includes the Merck Manual of Diagnosis and Therapy, the world's best-selling medical textbook, and the Merck Index, a collection of information about chemical compounds.

Contents

History

Merck & Co. traces its origins to Friedrich Jacob Merck who purchased a drug store in Darmstadt, Germany in 1668; and Emanuel Merck who took over the store several generations later, in 1816. Emanuel and his successors gradually built up a chemical-pharmaceutical factory that produced — in addition to raw materials for pharmaceutical preparations — a multitude of other chemicals.

In 1891, George Merck established his roots in the United States and set up Merck & Co. in NY as the US arm of the family partnership, E. Merck (named for Emanuel Merck), which is now Merck KGaA. Merck & Co. was confiscated in 1917 during World War I and set up as an independent company in the United States. Between the wars and during World War II, the company was led by George W. Merck, who oversaw America's germ-warfare research at Fort Detrick. Today, the US company has about 51,000(S&P NetAdvantage) employees in 120 countries and 31 factories worldwide. It is one of the top 7 pharmaceutical companies worldwide, much larger than its German ancestor, which currently employs around 32,800 people in 62 countries.

In 2005, CEO Raymond Gilmartin retired at the age of 64 following Merck's voluntary worldwide withdrawal of Vioxx. Former president of manufacturing Richard Clark was named CEO and President of the company.

In November 2009, Merck merged with Schering-Plough in a US$41 billion deal.[2][3][4][5] As a result of the merger, the company will use the trade name Merck in the United States and Canada and elsewhere use the trade name MSD.

Corporate governance

As of November 3, 2009 (2009 -11-03) the members of the board of directors of Merck & Co. are: Richard T. Clark, Leslie A. Brun, Thomas R. Cech, Ph.D., Thomas H. Glocer, Steven F. Goldstone, William B. Harrison, Jr., Harry R. Jacobson, M.D., William N. Kelley, M.D., C. Robert Kidder, Rochelle B. Lazarus, Carlos E. Represas, Patricia F. Russo, Thomas E. Shenk, Ph.D., Anne M. Tatlock, Samuel O. Thier, M.D., Craig B. Thompson, M.D., Wendell P. Weeks, and Peter C. Wendell.[6]

Products

Products on the market

Products from Schering-Plough

Products under development

Patient assistance programs

In the early 1950s, Merck & Co. was one of the first pharmaceutical companies to provide patient assistance programs in the U.S. to those unable to afford their medications.[7] Currently, Merck & Co. offers 7 patient assistance programs, each with specific eligibility requirements.[8][9]

Available programs

Vioxx

In 1999, the U.S. Food and Drug Administration (FDA) approved Vioxx (known generically as rofecoxib), a Merck product for treating arthritis. Vioxx was stronger than existing medications, while easier on the stomach than established anti-inflammatory drugs such as naproxen. Vioxx became one of the most prescribed drugs in history. According to internal e-mail traffic released at a later lawsuit, Merck had a list of doctors critical of Vioxx to be "neutralised" or "discredited." "We may need to seek them out and destroy them where they live," wrote an employee. Also alleged were intimidation of researchers and impingement upon academic freedom.[10]

Thereafter, studies by Merck and by others found an increased risk of heart attack associated with Vioxx use when compared with naproxen. There was no indication of this risk in the original placebo-controlled safety trials, and it was possible that the effect was more related to naproxen decreasing the risk of heart attacks than one of Vioxx increasing the risk. Merck adjusted the labeling of Vioxx to reflect possible cardiovascular risks in 2002.

On September 23, 2004, Merck received information about results from a clinical trial it was conducting that included findings of increased risk of heart attacks among Vioxx users who had been using the medication for over eighteen months.[11] On September 28, 2004, Merck notified the FDA that it was voluntarily withdrawing Vioxx from the market, and it publicly announced the withdrawal on September 30. The FDA has since recommended that Vioxx be put back on the market, but with a more prominent warning regarding cardiovascular risks on its label.[citation needed]

On November 5, 2004 the medical journal The Lancet published the results of its analysis of the available studies. It concluded that "the unacceptable cardiovascular risks of Vioxx (rofecoxib) were evident as early as 2000..." [12] The journal's editors criticized Merck for having kept the drug on the market as long as it did before withdrawing it, and also criticized the FDA for its failure of regulatory oversight.

About 50,000 people have sued Merck claiming that they or their family members have suffered medical problems such as heart attacks or strokes after taking Vioxx.[13] In 2005, Merck was found liable in the first case that went to trial and the plaintiff was awarded $253.4 million in damages; however, the judgement was subsequently reduced to $20 million and then, upon appeal, the verdict was reversed in 2008.[13] In November 2007, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits.[14][15] The settlement will require that claimants provide medical proof of having suffered a heart attack or a stroke and show they received at least 30 Vioxx pills. This proposed settlement is generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck's liability reached as high as $50 billion. As of mid-2008, plaintiffs have prevailed in only three of the twenty cases that have reached juries, all with relatively small awards.[13]

On May 20, 2008, Merck was found liable for using deceptive marketing tactics to promote Vioxx and 30 states will split the $58 million settlement. The amount is the largest multi-state settlement against a pharmaceutical company.[16] All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.[17]

From 2002 through 2005 the Australian affiliate of Merck sponsored the eight issues of a medical journal, the Australasian Journal of Bone and Joint Medicine, published by Elsevier. Although it gave the appearance of being an independent peer-reviewed journal, without any indication that Merck had paid for it, the journal actually reprinted articles that originally appeared in other publications and that were favorable to Merck. The misleading publication came to light in 2009 during a personal injury lawsuit filed over Vioxx; 9 of 29 articles in the journal's second issue referred positively to Vioxx.[18]

Cordaptive

On September 4, 2007, Merck & Co. introduced the experimental drug Cordaptive, which can both raise HDL and lower LDL (combining an extended-release form of the B vitamin niacin with laropiprant, a novel compound intended to inhibit flushing or redness of the face). Cordaptive caused 18% drop in levels of LDL-C00, a 26% drop in triglycerides, and a 20% increase in HDL-C. Merck's cholesterol statin drug Zocor has seen sales plunge since its patent expired in 2006. In addition, Merck and partner Schering-Plough Corp. jointly market two other cholesterol drugs, Zetia and Vytorin.[19]

On April 24, 2008, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of the combination, to be marketed in Europe as Tredaptive.[20]

On April 28, 2008, the FDA issued a "not approvable" letter for Cordaptive. In the FDA's letter, the agency rejected the proposed trade name CORDAPTIVE for MK-0524A.[21][22]

The drug was later approved by the EMA on July 3, 2008.[23][24]

Medicaid overbilling

An US Justice Department fraud investigation began in 2000 when allegations were brought in two separate lawsuits filed by whistleblowers under the False Claims Act.[25] They alleged that Merck failed to pay proper rebates to Medicaid and other health care programs and paid illegal remuneration to health care providers.[26] On February 7, 2008 Merck agreed to pay more than $650 million to settle charges that it routinely overbilled Medicaid for its most popular medicines. The federal government received more than $360 million, and 49 states and Washington, DC, over $290 million. One whistleblower received a $68 million reward.[25][27] Merck made the settlement without an admission of liability or wrongdoing.[28]

Environmental record

Merck & Co. used methylene chloride which is an animal carcinogen and is on the Federal Environmental Protection Agency's list of pollutants. To get rid of this problem Merck chemists and engineers discovered a new way to manufacture products without using methylene chloride. The new way of creating chemicals seemed to have fewer negative environmental effects. Merck has also changed its equipment to protect the environment. Merck installed a computerized distributed control system that runs chemical reaction steps more effectively and has increased the process of operations by 50 percent. With the new machines, they have eliminated the need for the disposal and storage of harmful waste. The biological oxygen demand was reduced by 75% with a new process to help with water waste and other polluting waste.[29] In 1991, Kelco, owned by Merck, was responsible for 1/3 of the VOC emission pollution in the San Diego area. The ground level ozone was causing health problems such as lung tissue damage and making the lungs easily vulnerable to harmful bacteria.[30] In 1996 Merck paid 1.8 million dollars in a settlement that accused them of polluting the air. In addition, new machines were installed to cut the air pollution that the company's facilities were giving off. The new machines reduce the smog level emissions by 680,000 lb (310,000 kg) a year.[31]

Isentress

Raltegravir (Isentress), Merck's HIV integrase inhibitor was unanimously recommended for accelerated approval by the FDA's Advisory Committee on September 5, 2007. Isentress works by acting on a specific enzyme in HIV, integrase, that allows the RNA from HIV to become part of human DNA in the replication process.[32] Isentress was approved by the FDA on October 12, 2007.[33]

Singulair

The FDA is beginning to look into a link between the Merck drug Singulair, suicide and other psychological side effects, and is conducting research to see if Singulair should be reviewed further. Singulair works on blocking the Leukotriene pathway in both Asthma and Allergic Rhinitis.[34]

Awards

Merck & Co. has been consistently named one of the 100 Best Companies for Working Mothers by Working Mothers magazine.

One of the Most Admired Companies for Minority Engineers by Black Engineer

Top 50 Companies for African-American MBAs by Black MBA

Ranked #18 by Business Week as The Best Places to Launch a Career; the top 50 employers for new college grads

Top 10 Most Generous Corporate Givers by Business Week

Ranked Second in Ethical Companies by Covalence Ethical Ranking

Top 50 Companies for Diversity, Top 10 Companies for People with Disabilities and Top 10 Companies for Asian Americans by DiversityInc

Great Place for Black Women to Work by Essence

Fortune 500, Global 500 and Top Employers for Women by Fortune magazine

Top 50 Most Military-Friendly Employers 2006 (MMFE) by G.I. Jobs

Top 100 Companies for Latinos by Hispanic Magazine

National Associate of Female Executives (NAFE) – Top 50 Companies for Executive Women

Top 10 Funders for Giving Back Awards by Newsweek

MSN Money named Merck the best performing large drugmaker stock in 2006, with shares rising 37 percent on the year, compared with an 8.2 percent increase in the American Stock Exchange's Pharmaceutical Index, which follows 15 major drugmakers.

Named as a top 20 company as a 2006 Top Biotech and Pharma Employers by Science

Top 10 winner of the 4th” Annual Best Companies for Blacks in Technology Award by the National BDPA, Black Data Processing Associates and WorkplaceDiversity.com

Top 10 Best Places for Life Scientists to Work by The Scientist

100% score on the Human Rights Campaign's 2009 Corporate Equality Index, dealing with gay rights.

See also

References

  1. ^ Princeton University and The Merck Company Foundation Announce Creation Of New Global Health Scholars Program and Lecture Series
  2. ^ Singer, Natasha (March 10, 2009). [www.nytimes.com/2009/03/10/business/10drug.html "Merck to Buy Schering-Plough for $41.1 Billion"]. The New York Times. www.nytimes.com/2009/03/10/business/10drug.html. Retrieved 2009-11-14. 
  3. ^ Merck & Co. (November 3, 2009). [www.merck.com/newsroom/news-release-archive/corporate/2009_1103.html "Merck and Schering-Plough to Complete Merger Today"]. Press release. www.merck.com/newsroom/news-release-archive/corporate/2009_1103.html. Retrieved 2009-11-13. 
  4. ^ Merck & Co. (November 4, 2009). [www.merck.com/newsroom/news-release-archive/corporate/2009_1104.html "New Merck Begins Operations"]. Press release. www.merck.com/newsroom/news-release-archive/corporate/2009_1104.html. Retrieved 2009-11-13. 
  5. ^ [phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MjA0NDh8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1 "Notice of Reorganization Event"]. November 12, 2009. phx.corporate-ir.net/External.File?item=UGFyZW50SUQ9MjA0NDh8Q2hpbGRJRD0tMXxUeXBlPTM=&t=1. Retrieved 2009-11-13. 
  6. ^ [www.merck.com/about/leadership/board-of-directors/home.html "Merck Board of Directors"]. www.merck.com/about/leadership/board-of-directors/home.html. Retrieved 2009-11-13. 
  7. ^ "Merck to Create New Patient Assistance Program for Vaccines" Retrieved on May 20, 2008.
  8. ^ "Patient Assistance - Available Prescription Assistance Programs From Merck & Co." Retrieved on May 20, 2008.
  9. ^ [www.merck.com/responsibility/pap-information.html Merck Patient Assistance Programs]
  10. ^ Rout, Milanda (2009-04-01). "Vioxx maker Merck and Co drew up doctor hit list". The Australian. http://www.theaustralian.news.com.au/story/0,25197,25272600-2702,00.html. Retrieved 2009-04-26]. 
  11. ^ http://finance.senate.gov/press/Gpress/2004/prg101504.pdf
  12. ^ Elsevier
  13. ^ a b c Courts Reject Two Major Vioxx Verdicts, The New York Times, May 30, 2008
  14. ^ Merck proposes $4.85B Vioxx settlement, USA Today, November 12, 2007
  15. ^ "Merck's outlook revised to developing from negative on Vioxx agreement - Moody's". forbes.com. Thomson Financial. 2007-11-12. http://www.forbes.com/feeds/afx/2007/11/12/afx4326773.html. Retrieved 2009-05-04. 
  16. ^ Arizona gets $2.3 Million from Vioxx Settlement 92.3 KTAR Retrieved on May 19, 2008
  17. ^ Merck Agrees to Settlement Over Vioxx Ads, The New York Times, May 20, 2008]
  18. ^ Singer N (2009-05-13). "Merck paid for medical 'journal' without disclosure". The New York Times. http://www.nytimes.com/2009/05/14/business/14vioxxside.html. Retrieved 2009-06-17. 
  19. ^ Yahoo.com, Merck niacin drug controls cholesterol
  20. ^ Merck & Co., Inc. press release - Two Merck Medicines Recommended for Approval in the European Union Retrieved on April 30, 2008.
  21. ^ Merck & Co., Inc. press release - Merck Receives Not Approvable Letter from FDA for MK-0524A (ER niacin/laropiprant) Retrieved on April 30, 2008.
  22. ^ Carey, John (April 29, 2008). [www.businessweek.com/bwdaily/dnflash/content/apr2008/db20080429_182260.htm "FDA Rejects Merck's Cordaptive"]. BusinessWeek. www.businessweek.com/bwdaily/dnflash/content/apr2008/db20080429_182260.htm. Retrieved 2009-11-13. 
  23. ^ Merck & Co., Inc. press release - TREDAPTIVE (nicotinic acid /laropiprant) Approved in the European Union: New Lipid-Modifying Therapy to Treat LDL-C, HDL-C and Triglycerides Retrieved on July 26, 2008.
  24. ^ [www.emea.europa.eu/humandocs/Humans/EPAR/tredaptive/tredaptive.htm "Tredaptive European Public Assessment Report"]. European Medicines Agency. www.emea.europa.eu/humandocs/Humans/EPAR/tredaptive/tredaptive.htm. Retrieved November 13, 2009. 
  25. ^ a b Johnson, Carrie (February 8, 2008). "Merck to Pay $650 Million In Medicaid Settlement". The Washington Post. http://www.washingtonpost.com/wp-dyn/content/article/2008/02/07/AR2008020701336.html. Retrieved 8 February 2010. 
  26. ^ USDOJ.GOV, Merck to Pay More than $650 Million to Resolve Claims of Fraudulent Price Reporting and Kickbacks. February 7, 2008
  27. ^ Pharmalot.com: Ed Silverman, Merck To Pay $670 Million Over Medicaid Fraud.
  28. ^ "Merck Resolves Federal and State Investigations Related to Certain Past Pricing And Certain Past Sales and Marketing Activities". Merck. Feb. 7, 2008. http://www.merck.com/newsroom/news-release-archive/corporate/2008_0207.html. Retrieved 8 February 2010. 
  29. ^ http://www.p2pays.org/ref%5C01/00155.pdf
  30. ^ ET 10/96: Repairing a legacy of pollution by Kelco
  31. ^ U.S. SETTLES $1.8 MILLION POLLUTION CASE WITH MERCK AND MONSANTO | Newsroom | US EPA
  32. ^ Merck.com FDA Advisory Committee Unanimously Recommends Accelerated Approval of ISENTRESS (raltegravir), Merck's Investigational Oral Integrase Inhibitor, for Treatment of HIV
  33. ^ [www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124040.htm "FDA approval of Isentress (raltegravir)"]. U.S. Food and Drug Administration (FDA). June 25, 2009. www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm124040.htm. Retrieved 2009-11-15. 
  34. ^ "FDA looks into Singulair, risks of suicidal thoughts", USA Today

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