Merck & Co.: Difference between revisions

In 1987, Merck began a program with [[UNICEF]] to donate its new drug [[Mectizan]] to "all that need it for as long as needed" 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, the [[Black Fly]]. 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, 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 African countries. More than 700 million people have been treated since the inception of the program with 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 eliminated the disease altogether.

In 1999, the [[Food and Drug Administration (United States)|U.S. Food and Drug Administration]] (FDA) approved Vioxx (known generically as [[rofecoxib]]), a Merck product for treating [[arthritis]]. Vioxx was designed as a selective inhibitor of the enzyme [[cyclooxygenase-2]]. Such compounds were expected to cause less gastrointestinal bleeding than older [[anti-inflammatory]] drugs such as [[naproxen]], which were associated with 20,000 hospitalizations and 2000 deaths each year. Vioxx became one of the most prescribed drugs in history.

Thereafter, studies by Merck and by others found an increased risk of heart attack associated with [[Vioxx]] use when compared with naproxen. 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. 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. An analysis for the period 1999–2004, based on U.S. Medical Expenditure Survey data, reported that Vioxx was associated with 46,783 heart attacks, and along with the other popular [[COX-2 inhibitor]] [[Celebrex]], an estimated 26,603 deaths from both.

About 50,000 people sued Merck, claiming they or their family members had suffered medical problems such as heart attacks or strokes after taking Vioxx. In November 2007, Merck agreed to pay $4.85 billion to settle most of the pending Vioxx lawsuits. The settlement required that claimants provide medical and pharmacy records confirming the occurrence of a heart attack, ischemic stroke, or sudden cardiac death; the receipt of at least 30 Vioxx pills within 60 days prior to the injury or death; and confirmation of Vioxx being used within 14 days of the Vioxx-related event. The settlement was generally viewed by industry analysts and investors as a victory for Merck, considering that original estimates of Merck's liability reached between $10 billion and $25 billion. As of mid-2008, when the plaintiff class had reached the threshold percentage required by Merck to go through with the settlement, plaintiffs had prevailed in only three of the twenty cases that had reached juries, all with relatively small awards.

According to internal e-mail traffic released at a later lawsuit, Merck had a list of doctors critical of Vioxx to be "neutralized" or "discredited". "We may need to seek them out and destroy them where they live," wrote an employee. A Stanford Medical School professor said that Merck was engaged in intimidation of researchers and infringement upon [[academic freedom]].

On May 20, 2008, Merck settled for $58 million with 30 states alleging that Merck engaged in deceptive marketing tactics to promote [[Vioxx]]. All its new television pain-advertisements must be vetted by the Food and Drug Administration and changed or delayed upon request until 2018.

Fosamax ([[alendronate]]) is a [[bisphosphonate]] used for the treatment of post-menopausal osteoporosis and for the prevention of skeletal problems in certain cancers. The American College of Clinical Endocrinology, the [[American College of Obstetricians and Gynecologists]], the [[North American Menopause Society]] and the UK National Osteoporosis Guideline Group recommend alendronate and certain other bisphosphonates as first line treatments for post-menopausal osteopotosis. Long-term treatment with bisphosponates produces anti-fracture and bone mineral density effects that persist for 3–5 years after an initial 3–5 years of treatment. Alendronate reduces the risk of hip, vertebral, and wrist fractures by 35-39%.

In December 2013, Merck agreed to pay a total of $27.7 million to 1,200 plaintiffs in a class action lawsuit alleging that the company's osteoporosis drug had caused them to develop osteonecrosis of the jaw. Prior to the settlement, Merck had prevailed in 3 of 5 so-called bellwether trials. Approximately 4000 cases still await adjudication or settlement as of August 2014.

A fraud investigation by the [[United States Department of Justice]] began in 2000 when allegations were brought in two separate lawsuits filed by whistleblowers under the [[False Claims Act]]. They alleged that Merck failed to pay proper rebates to [[Medicaid]] and other health care programs and paid illegal remuneration to health care providers. 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 [[List of Largest Pharmaceutical Settlements|largest pharmaceutical settlements]] in history. The federal government received more than $360 million, plus 49 states and Washington, DC, received over $290 million. One whistleblower received a $68 million reward. Merck made the settlement without an admission of liability or wrongdoing.

In 191 of 193 countries, the original Merck company, the [[Merck Group]] of Darmstadt, owns the rights to the "Merck" name. In the United States and Canada, the company trades under the name EMD (an abbreviation of Emanuel Merck, Darmstadt), its legal name here says ''Merck KGaA, Darmstadt, Germany'', and instead of "Merck Group", the "EMD Group" name is used. In the United States and Canada, Merck & Co. holds the rights to the trademark "Merck", while in the rest of the world the company trades under the name MSD (an abbreviation of Merck, Sharp & Dohme) and its legal name says here ''Merck Sharp & Dohme LLC., a subsidiary of Merck & Co., Inc. Kenilworth, NJ, USA''.

In 2015 the [[Merck Group]] adopted a new logo and said it will be "much more aggressive" about protecting the brand of "the real Merck". Merck of Darmstadt has initiated litigation against its former subsidiary, Merck & Co. (MSD) of Kenilworth, in several countries over infringing use of the Merck name. In 2016, the [[High Court of Justice]] in the [[United Kingdom]] ruled that MSD had breached an agreement with its former parent company and that only Merck of Darmstadt is entitled to use the Merck name in the United Kingdom. The judge also held that MSD's use of "Merck" as part of branding on its global websites were directed to the UK and infringed Merck's trade mark rights in the UK.

In response to the ruling, MSD initiated counter-litigation in the United States in January 2016 by filing a federal lawsuit which accused its former parent company of "infringing on its trademark" through actions that included the increased usage of "Merck KGaA" and "MERCK" in branding in the US as well as on its social media presence. Further Merck & Co. has also accused the Merck Group of federal trademark dilution, unfair competition, false advertising, deceptive trade practices, breach of contract, and [[cybersquatting]]. The case came to a head when a research scientist believed he was communicating with Merck & Co regarding a research grant in oncology, when in fact he was talking with the Merck Group. As a result, Merck & Co. asked the federal court to stop the Merck Group from using "Merck" on any products or marketing materials in the United States. As a direct result, Merck & Co is seeking "''all monetary gains, profits, and advantages''" made by the Merck Group and three-times the damage, plus additional punitive damages.

In April 2020, in the course of litigation of Merck against MSD in Switzerland, the [[Federal Supreme Court of Switzerland]] ruled that MSD's use of the "Merck" brand in its global websites could, absent [[geotargeting]] mechanisms, have "commercial effect" in Switzerland and could therefore violate Merck's rights (if any) to the "Merck" brand in Switzerland.

In 2021, an investigation by [[Reuters]] revealed that Merck's baldness drug [[Finasteride|Propecia]] caused persistent sexual dysfunction in men. The drug has been linked to over 700 incidences of suicidal thoughts and 110 deaths. Merck has been receiving reports since 1998, but never included the risks on the label. In 2015, Merck was sued by consumer-rights law firm Hagens Berman over a wrongful death linked to Propecia.