Rofecoxib /ˌrɒfᵻˈkɒksɪb/ is a nonsteroidal anti-inflammatory drug (NSAID) that has now been withdrawn over safety concerns. It was marketed by Merck & Co. to treat osteoarthritis, acute pain conditions, and dysmenorrhea. Rofecoxib was approved by the U.S. Food and Drug Administration (FDA) on May 20, 1999, and was marketed under the brand names Vioxx, Ceoxx, and Ceeoxx.
Rofecoxib gained widespread acceptance among physicians treating patients with arthritis and other conditions causing chronic or acute pain. Worldwide, over 80 million people were prescribed rofecoxib at some time.[1]
On September 30, 2004, Merck withdrew rofecoxib from the market because of concerns about increased risk of heart attack and stroke associated with long-term, high-dosage use. Merck withdrew the drug after disclosures that it withheld information about rofecoxib’s risks from doctors and patients for over five years, resulting in between 88,000 and 140,000 cases of serious heart disease.[2] Rofecoxib was one of the most widely used drugs ever to be withdrawn from the market. In the year before withdrawal, Merck had sales revenue of US$2.5 billion from Vioxx.[3] Merck reserved $970 million to pay for its Vioxx-related legal expenses through 2007, and has set aside $4.85bn for legal claims from US citizens.
Rofecoxib was available on prescription in both tablet-form and as an oral suspension. It was available by injection for hospital use.
Vioxx Recall Information
Just a few years after the U.S. Food and Drug Administration (FDA) approved Vioxx, the drug was recalled because of the risk of deadly heart attacks and strokes.
Vioxx (rofecoxib), a non-steroidal anti-inflammatory drug (NSAID) and a prescription painkiller, was approved for use by the FDA in 1999. In the years that followed, it was mired in scandal. Merck was accused of misleading doctors and patients about the drug’s safety, fabricating study results to suit the company’s needs, continually thwarting an FDA scientist from revealing the drug’s problems and skirting federal drug regulations.
In 2004, Merck withdrew the drug from the market after a study revealed the drug more than doubled the risk of heart attacks and death. By that point, more than 38,000 deaths were related to Vioxx use, and up to 25 million Americans had taken the drug.
The Vioxx Recall and FDA Scandal
Vioxx caused so much damage and destruction that some have called it the worst drug disaster in history. The Vioxx scandal wasn’t just devastating to the injured patients and their families; it also underscored problems within the FDA. Many suspect that the New Jersey-based Merck and the FDA worked together to keep the drug on the market and quiet the health concerns.
The suspicions about the Merck-FDA tie ran deep. They started early on when Merck tried to convince the FDA that Vioxx was better than other NSAIDs because it caused few digestive tract problems. Even before the drug was FDA approved, the company launched its Vioxx Gastrointestinal Outcomes Research study (VIGOR) to determine the digestive risks. While the study did show that Vioxx was easier on the digestive system than other NSAIDs, it also revealed that it increased the risk of heart problems.
After that, Merck continually hounded the FDA to allow the drug to drop the digestive warnings on the label. In February 2001, the FDA approved Merck’s request to change the drug’s label to reflect that it’s safer on the stomach than other NSAIDs. Although that label change would later be overturned, it was a feather in the Merck cap. About the same time, the FDA ordered the company to send doctors a letter explaining the drug’s heart risks. And it wouldn’t be the first time that Merck’s huge marketing monster was reprimanded.
The whole time that Merck was promoting Vioxx as a superior alternative for those with gastrointestinal problems, the company was also brushing aside the drug’s cardiovascular risks. It wasn’t until April 2002, years after the VIGOR trial results showed the risks, that the FDA and Merck decided to include the heart and stroke information on the drug label. Critics would later point to this as evidence of the cozy relationship between Merck and the FDA and the company’s blasé attitude toward the risks.
Vioxx Controversies
When the VIGOR trial results were finally published in the prestigious New England Journal of Medicine, no one knew that it was missing some key information. Later, the public would learn that Merck scientists left out key data on heart patients to make the drug seem safer. The editor of the journal later demanded a correction, but the scientists who conducted the study refused.
While the drug was removed from the market on Sept. 30, 2004, it was just the beginning of the controversies surrounding it. The U.S. Department of Justice and the U.S. Securities and Exchange Commission investigated the company for its deceptive and strong-arm marketing practices. An FDA scientist who discovered the Vioxx heart connection early on said his FDA bosses forced him to quash information that was potentially damaging to Merck. Government officials continually question the relationship between Merck and the FDA.
And perhaps in the most shocking turn of events, and perhaps underscoring Merck’s close relationship with the FDA and other drug-regulatory agencies, advisory panels in both the United States and Canada in 2005 voted that Vioxx could return to the market under certain circumstances and restrictions. So far, Vioxx remains recalled.
Unintended Consequences of Vioxx Recall
The Vioxx Disaster: A Pain Worse than Arthritis
Merck & Co. will pay $4.85 billion to end thousands of lawsuits over its painkiller Vioxx in what is
MERCK AND VIOXX – THE RELATIONSHIP BETWEEN BIG PHARMA AND DOCTORS.
Barbara Seaman, a writer and patients’ rights advocate who was one of the first people to bring the issue of women’s reproductive health to wide public attention, died on Wednesday at her home in Manhattan. She was 72.
The cause was lung cancer, her family said.
Ms. Seaman’s first book, “The Doctors’ Case Against the Pill” (P. H. Wyden), was considered groundbreaking when it was published in 1969. It argued that oral contraceptives, which then contained high doses of estrogen, posed serious, possibly fatal, health risks, and that doctors routinely failed to inform women of those risks. Among the risks Ms. Seaman listed were heart attacks, strokes, blood clots, cancer and suicidal depression.
“The Doctors’ Case Against the Pill” was credited with inspiring a generation of women, who had long been discouraged by male doctors from asking too many questions, to take control of their health care. It was also credited with helping bring about Senate hearings in 1970, led by Gaylord Nelson, Democrat of Wisconsin, on the safety of oral contraceptives.
As a result of the hearings, birth control pills were required to carry a printed warning that discussed risks in general and clotting disorders in particular. These days, the pill contains far less estrogen than in the past.
For her work, Ms. Seaman was often described in the popular press as “the Ralph Nader of the pill.” Her other books include “Free and Female: The Sex Life of the Contemporary Woman” (Coward, McCann & Geoghegan, 1972); “The Greatest Experiment Ever Performed on Women: Exploding the Estrogen Myth” (Hyperion, 2003); and “Lovely Me: The Life of Jacqueline Susann” (Morrow, 1987).
With four other women, Ms. Seaman founded the National Women’s Health Network, an advocacy group based in Washington, in 1975.
Barbara Ann Rosner was born in Brooklyn on Sept. 11, 1935. She earned a bachelor’s degree in history from Oberlin College in 1956 and a certificate in science writing from the Columbia University Graduate School of Journalism in 1968.
In the early 1960s, Ms. Seaman, with her husband, Dr. Gideon Seaman, wrote a column on marriage for Brides magazine; Ms. Seaman was later a columnist for Ladies’ Home Journal and an editor at Family Circle. With Dr. Seaman, a psychiatrist, she wrote “Women and the Crisis in Sex Hormones” (Rawson Associates), published in 1977.
Ms. Seaman’s first marriage, to Peter Marks, was annulled. Her second, to Dr. Seaman, ended in divorce, as did her third, to Milton Forman. She is survived by three children from her marriage to Dr. Seaman, Noah, Elana and Shira Seaman, all of Manhattan; two sisters, Jeri Drucker and Elaine Rosner-Jeria; her stepmother, the journalist Ruth Gruber; and four grandchildren.
