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Merck & Co.(2)
USINFO | 2013-08-02 10:08
Products under development
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.[22]
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 aclinical 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.[23] 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
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..."[24] 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.[25] 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.[25] In November 2007, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits.[26][27] 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.[25]
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.[28] All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.[29]
Mectizan
In 1987, Merck & Co. began a program with UNICEF to donate its new drugMectizan to "all that need it for as long as needed"[30] in an effort to combat Onchocerciasis, also known as river blindness, primarily in Africa. Up to that point, the World Health Organization had fought the disease through the use of insecticides to lower the population of its primary vector, theBlack Fly.[31] However, when studies in the 1980s showed how effective the drug was at treating and preventing the disease, the WHO agreed to use it instead of its previous strategies. Merck's involvement is considered a key factor in the success against the disease all over the world,[32] and the decision to donate the entirety of the drug to all those in need of it is used as part of the Mectizan Donation Program that covers countries such as Yemen and in African countries.[33] This donation program can be touted as the longest ongoing drug donation program of its kind and is used as a case study in corporate ethics today.
Currently, more than 700 million people have been treated since the inception of the program with a staggering 80 million people still undergoing treatment in Africa, Latin America, and Yemen. Blindness caused by onchocerciasis is decreasing and there are regions of Latin America and Africa that have been shown to have completely eliminated the disease altogether.[33]
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.[34]
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.[35]
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.[36][37]
The drug was later approved by the EMA on July 3, 2008.[38][39]
Phony medical journal
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.[40] In 2009, the CEO of Elsevier's Health Sciences Division, Michael Hansen, admitted that the practice was "unacceptable".[41]
Medicaid overbilling
A US Justice Department fraud investigation began in 2000 when allegations were brought in two separate lawsuits filed by whistleblowers under the False Claims Act.[42] They alleged that Merck failed to pay proper rebates toMedicaid and other health care programs and paid illegal remuneration to health care providers.[43] 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 settlement was one of the largest pharmaceutical settlements in history. The federal government received more than $360 million, and 49 states and Washington, DC, over $290 million. One whistleblower received a $68 million reward.[42][44] Merck made the settlement without an admission of liability or wrongdoing.[45]
Environmental record
Merck & Co. once used methylene chloride, an animal carcinogen on the United States Environmental Protection Agency's list of pollutants, as an ingredient in some of its pharmaceuticals. Merck chemists and engineers subsequently replaced the compound with others having fewer negative environmental effects. Merck has also modified its equipment to protect the environment, installing a distributed control system that coordinates chemical reactions more efficiently and expedites manufacturing by 50 percent, eliminating the need for the disposal and storage of harmful waste. Biological oxygen demand has also been reduced.[46]
In 1991, Merck's Kelco subsidiary was responsible for 1/3 of the volatile organic compound (VOC) emission pollution in the San Diego area. Ground level ozone was causing lung tissue damage by exposure to harmful bacteria.[47]
In 1996 Merck paid $1.8 million for polluting the air. New machines were installed to reduce smog emissions by 680,000 lb (310,000 kg) a year.[48]
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.[49] Isentress was approved by the FDA on October 12, 2007.[50]
Singulair
The FDA is looking into a link between Merck's Singulair and suicide and is considering further studies of the drug. Singulair blocks the leukotriene pathway in asthma and allergic rhinitis.[51]
Propecia
Merck is currently being sued over failing to warn patients of persistentsexual dysfunction, loss of libido, severe depression, cognitive impairment,Peyronie’s disease, penile shrinkage and gynecomastia from Propecia. In July 2012, the Post Finasteride Syndrome Foundation was formed to help victims of Propecia.[52]
Fosamax [edit]
In December 2012, internal Merck emails were released to the public which demonstrated evidence that the company knew Fosamax was causing osteonecrosis of the jaw in patients that took the drug as far back as 2004. In the same email, Merck bone scientist, Don Kimmel, mocked patients who were suffering from osteonecrosis when he wrote "Ma toot hurts so bad". According to court documents, Merck withheld crucial safety data from the American Society for Bone and Mineral Research (ASBMR) when the group sought to develop a position paper on bisphosphonate-related ONJ. Of 428 suspected ONJ cases related to Fosamax, 378 of which were highly likely to be ONJ, only 50 cases were shared with ASBMR, according to court documents.[53][54]
- Anacetrapib
- Deforolimus
- Odanacatib
- Rolofylline
- Telcagepant
- An antidote for statin toxicity involving CoQ10[18] (which has been held for over 20 years without producing it)
Patient assistance programs
Merck & Co. was one of the first American pharmaceutical companies to offer assistance to those unable to afford its medications, beginning a program in the 1950s.[19] Currently, Merck & Co. offers 7 patient assistance programs, each with specific eligibility requirements.[20][21]Available programs
-
Act Program For Emend
- Emend (aprepitant)
-
ACT Program For Zolinza
- Zolinza (vorinostat)
-
Merck Anti-Infective Hotline
- Cancidas (caspofungin)
- Invanz (ertapenem)
- Primaxin (imipenem with cilastatin)
-
Merck Patient Assistance Program
- Cosopt (dorzolamide and timolol)
- Cozaar/Hyzaar (losartan)
- Fosamax (alendronate)
- Fosamax Plus D (alendronate/vitamin D)
- Janumet (sitagliptin/metformin)
- Januvia (sitagliptin)
- Maxalt (rizatriptan)
- Singulair (montelukast)
- Timoptic (timolol)
- Trusopt (dorzolamide)
-
Merck Prescription Discount Program
- Cosopt (dorzolamide and timolol)
- Cozaar/Hyzaar (losartan)
- Emend (aprepitant)
- Fosamax (alendronate
- Fosamax Plus D (alendronate/vitamin D)
- Indocin (Indometacin)
- Janumet (sitagliptin and metformin)
- Januvia (sitagliptin)
- Maxalt (rizatriptan)
- Singulair (montelukast)
- Timoptic (timolol)
- Trusopt (dorzolamide)
-
Merck Vaccine Patient Assistance Program
- Gardasil (HPV vaccine)
- MMR Vaccine
- Pneumovax 23 (Pneumococcal polysaccharide vaccine)
- Recombivax HB (hepatitis B vaccine)
- Vaqta (Hepatitis A vaccine)
- Varivax (Varicella vaccine)
- Zostavax
-
SUPPORT Program For Crixivan
- Crixivan (indinavir)
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.[22]
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 aclinical 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.[23] 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
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..."[24] 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.[25] 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.[25] In November 2007, Merck proposed to pay $4.85 billion to settle most of the pending Vioxx lawsuits.[26][27] 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.[25]
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.[28] All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.[29]
Mectizan
In 1987, Merck & Co. began a program with UNICEF to donate its new drugMectizan to "all that need it for as long as needed"[30] in an effort to combat Onchocerciasis, also known as river blindness, primarily in Africa. Up to that point, the World Health Organization had fought the disease through the use of insecticides to lower the population of its primary vector, theBlack Fly.[31] However, when studies in the 1980s showed how effective the drug was at treating and preventing the disease, the WHO agreed to use it instead of its previous strategies. Merck's involvement is considered a key factor in the success against the disease all over the world,[32] and the decision to donate the entirety of the drug to all those in need of it is used as part of the Mectizan Donation Program that covers countries such as Yemen and in African countries.[33] This donation program can be touted as the longest ongoing drug donation program of its kind and is used as a case study in corporate ethics today.
Currently, more than 700 million people have been treated since the inception of the program with a staggering 80 million people still undergoing treatment in Africa, Latin America, and Yemen. Blindness caused by onchocerciasis is decreasing and there are regions of Latin America and Africa that have been shown to have completely eliminated the disease altogether.[33]
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.[34]
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.[35]
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.[36][37]
The drug was later approved by the EMA on July 3, 2008.[38][39]
Phony medical journal
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.[40] In 2009, the CEO of Elsevier's Health Sciences Division, Michael Hansen, admitted that the practice was "unacceptable".[41]
Medicaid overbilling
A US Justice Department fraud investigation began in 2000 when allegations were brought in two separate lawsuits filed by whistleblowers under the False Claims Act.[42] They alleged that Merck failed to pay proper rebates toMedicaid and other health care programs and paid illegal remuneration to health care providers.[43] 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 settlement was one of the largest pharmaceutical settlements in history. The federal government received more than $360 million, and 49 states and Washington, DC, over $290 million. One whistleblower received a $68 million reward.[42][44] Merck made the settlement without an admission of liability or wrongdoing.[45]
Environmental record
Merck & Co. once used methylene chloride, an animal carcinogen on the United States Environmental Protection Agency's list of pollutants, as an ingredient in some of its pharmaceuticals. Merck chemists and engineers subsequently replaced the compound with others having fewer negative environmental effects. Merck has also modified its equipment to protect the environment, installing a distributed control system that coordinates chemical reactions more efficiently and expedites manufacturing by 50 percent, eliminating the need for the disposal and storage of harmful waste. Biological oxygen demand has also been reduced.[46]
In 1991, Merck's Kelco subsidiary was responsible for 1/3 of the volatile organic compound (VOC) emission pollution in the San Diego area. Ground level ozone was causing lung tissue damage by exposure to harmful bacteria.[47]
In 1996 Merck paid $1.8 million for polluting the air. New machines were installed to reduce smog emissions by 680,000 lb (310,000 kg) a year.[48]
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.[49] Isentress was approved by the FDA on October 12, 2007.[50]
Singulair
The FDA is looking into a link between Merck's Singulair and suicide and is considering further studies of the drug. Singulair blocks the leukotriene pathway in asthma and allergic rhinitis.[51]
Propecia
Merck is currently being sued over failing to warn patients of persistentsexual dysfunction, loss of libido, severe depression, cognitive impairment,Peyronie’s disease, penile shrinkage and gynecomastia from Propecia. In July 2012, the Post Finasteride Syndrome Foundation was formed to help victims of Propecia.[52]
Fosamax [edit]
In December 2012, internal Merck emails were released to the public which demonstrated evidence that the company knew Fosamax was causing osteonecrosis of the jaw in patients that took the drug as far back as 2004. In the same email, Merck bone scientist, Don Kimmel, mocked patients who were suffering from osteonecrosis when he wrote "Ma toot hurts so bad". According to court documents, Merck withheld crucial safety data from the American Society for Bone and Mineral Research (ASBMR) when the group sought to develop a position paper on bisphosphonate-related ONJ. Of 428 suspected ONJ cases related to Fosamax, 378 of which were highly likely to be ONJ, only 50 cases were shared with ASBMR, according to court documents.[53][54]
