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A Timeline on the Poison that is Vioxx and or Merck

Just before Vioxx was approved in the States and Canada in 1999, drug maker Merck launched a study it hoped would prove that Vioxx was superior to older painkillers, because it caused fewer gastrointestinal problems. Instead of proving what it wanted to prove..  the study ended up showing that Vioxx could be deadly. It caused heart attacks and strokes, among other maladies.  Worldwide, over 80 million were prescribed this drug. This does not include those given the drug by their doctors to try before being given the prescription.

November 1998: Merck asks the U.S. (F.D.A.) as well as Canada for approval of Vioxx, having tested the drug on 5,400 subjects in eight studies.

January 1999: Merck launches the Vioxx Gastrointestinal Outcomes Research study (VIGOR). They used more than 8,000 people in the study, and it was the largest study ever done on this drug. Half of the participants would take Vioxx and the other half would take naproxen. The clinical trial was designed to see if Vioxx was going to be safer for the digestive system than naproxen, an older painkiller was.

May 1999: The FDA approved Vioxx, making the drug available by prescription in the United States, and shortly after, in Canada.

October 1999: They held the first meeting of the VIGOR study's data and safety monitoring board (DSMB). As of Oct. 1, 1999, the study would show that Vioxx patients did have fewer ulcers and less gastrointestinal bleeding than patients taking naproxen. It appeared at that time, as if the study would end up being a complete success for Merck.

November 1999: They held the second meeting of the VIGOR safety panel. At this discussion they dwelt on heart problems. Since Nov. 1, 1999, 79 patients out of the 4,000 participants that were taking Vioxx ended up having serious heart problems or died. That was compared to the 41 patients taking naproxen. The minutes of the panel's November meeting state that "while the trends are disconcerting, the numbers of events are small." The panel responds by voting to continue the study and to meet again in a month.

December 1999: The safety panel meets again, as stated, and ends up holding its last meeting. It's told that as of Dec. 1, 1999, the risk of serious heart problems and death among Vioxx patients has ended up being twice as high as in the naproxen group.

The DSMB votes to continue the study, but decides Merck needs to develop a plan to analyze the study's cardiovascular results before the study ends. DSMB Chairman Michael Weinblatt and Merck statistician Deborah Shapiro draft a letter and send it to Merck's Alise Reicin (now vice president of Merck's clinical research).

Later on, they defended their decision to continue the study. The safety panel said they couldn't tell if Vioxx was causing the heart problems or if naproxen, acting like low-dose aspirin, protected people from them, making Vioxx just look risky by comparison.

January 2000: Merck balks and resists at developing the analysis plan. They want to wait and combine the cardiovascular results of VIGOR with results from other Vioxx studies. Weinblatt, the safety panel chair and a rheumatologist with Brigham & Women's Hospital in Boston, pushes for an immediate analysis.

February 2000: After further discussions, Merck and Weinblatt agree to analyze heart problems reported by Feb. 10, 2000 — at least a month before the last patient leaves the study. Events reported later won't be included in the initial analysis.

Feb. 7, 2000: Weinblatt fills out a financial disclosure form that says he and his wife own $72,975 of Merck stock.

Feb. 15, 2000: Weinblatt agrees to a new consulting contract with Merck. "We are delighted that you have agreed to serve as a member of the VIOXX Multidisciplinary Advisory Board," Merck writes in an invitation to Weinblatt to attend his first advisory board meeting.

Weinblatt signs the new contract on March 6. It involves 12 days of work over two years, at the rate of $5,000 per day.

March 2000: Merck gets all of the results of the VIGOR trial.

May 2000: Merck submits the VIGOR paper to the New England Journal of Medicine (NEJM) for publication. The data did not include everything. They would include only 17 of the 20 heart attacks Vioxx patients have.

July 5, 2000: A memo from the Merck statistician Deborah Shapiro to Merck scientist Alise Reicin (both are listed as authors of the NEJM paper) refers to heart attacks 18, 19 and 20 suffered by patients taking Vioxx during the study.

July 2000/November 2000: VIGOR authors submit two sets of corrections to their NEJMmanuscript. However, there is no mention of the three additional heart attacks.

Oct. 13, 2000: Merck tells the FDA about heart attacks 18, 19 and 20.

Nov. 23, 2000: The VIGOR results are published in NEJM. There is still no mention of the three additional heart attacks in the Vioxx group. The published results also leave out data on many other kinds of cardiovascular and other adverse events.

February 2001: The FDA holds an advisory meeting on the VIGOR trials. It publishes complete VIGOR data on its Web site, including the additional heart attacks and data on other cardiovascular events.

May 2001: Merck issued a press release stating that Vioxx had a "favourable cardiovascular safety profile."

Aug. 22, 2001: Cardiologists Debabrata Mukherjee, Steven Nissen and Eric Topol go on to publish their own analysis in the Journal of the American Medical Association, based on complete VIGOR data that the FDA has made available. They say that the heart attack rate for patients taking Vioxx were significantly higher than for patients taking a sugar pill (placebo).

Their analysis is extremely significant because they take all the VIGOR data from the FDA Web site, recrunch them, and cast serious doubt on the hypothesis that naproxen protects the heart.

September 2001: The FDA issued a severe warning letter to Merck finding that Merck's representations in the May, 2001 press release concerning Vioxx's safety, were "simply incomprehensible, in light of the known data that cardiovascular events (such as heart attacks) were twice as likely in Vioxx patients.

January 2002 to August 2004: There are numerous epidemiological studies throughout this time , which pointed to Vioxx's increased risk of cardiovascular problems.

April 2002: The FDA tells Merck to change its Vioxx label to include information about the cardiovascular risks from the VIGOR study.

October 2003: Merck study finds 39% increased risk within first 909 days when compared to Celebrex.

September 2004: Merck withdraws Vioxx after a colon-polyp prevention study, called APPROVe, shows that the drug raises the risk of heart attacks after 18 months. By the time that they remove Vioxx from the market, an estimated 20 million Americans and untold (anyone have this number?) Canadians have taken the drug.

Research later published in the medical journal Lancet estimates that 88,000 Americans had heart attacks from taking Vioxx, and 38,000 of them died.

July 14, 2005: NEJM editor-in-chief, Dr. Jeffrey Drazen, told the NPR that the journal had been "hoodwinked" by Merck, and that the authors of the VIGOR paper should have told the journal about the additional data.

August 2005: A Texas state jury returned with a verdict against Merck in the first Vioxx liability case to go to trial. Some 13,000 lawsuits have been filed against the company on behalf of 23,000 plaintiffs who allege the drug caused heart attacks and strokes.

November 2005: NEJM executive editor Dr. Gregory Curfman is deposed in connection with the Vioxx product-liability cases. At that time, he learned about the July 5, 2000, memo, which showed that the Merck VIGOR authors knew about heart attacks 18, 19 and 20 well before the paper was published in NEJM.

December 2005: NEJM issues an *Expression of Concern*, and wrote that "inaccuracies and deletions" in the VIGOR manuscript Merck submitted to the journal "call into question the integrity of the data." The journal asked the study authors to submit a correction to the journal.

March 2006: The VIGOR study authors responded to NEJM's Expression of Concern with the following: "Our evaluation leads us to conclude that our original article followed appropriate clinical trial principles and does not require a correction." The three heart attacks in question, the authors went on to say... occurred after the study's "prespecified cutoff date" for reporting cardiovascular problems.

Journal editors stand by their call for a correction, replying that the cut-off date appeared to be selected shortly before the trial ended, and was a month earlier than VIGOR's cutoff date for gastrointestinal problems. Such a trial design, according to NEJM, "skewed" results.

May 2006: Outside analysis of data sent to the FDA from the Vioxx APPROVe study show that the cardiovascular risks from Vioxx began soon after the patients started taking the drug. The data also indicate that the risks from Vioxx remained long after the patients stop taking the drug.

Merck disagrees with the analysis and maintains that patients aren't at risk unless they had taken the drug for more than 18 months.

This point is worth billions for Merck. Many of those suing the company say they took Vioxx for less than 18 months.

June 2006: The seventh trial against Merck begins, with plaintiff Elaine Doherty, 68, alleging the painkiller caused her heart attack and subsequent double heart bypass surgery. The trial, before the New Jersey superior court, is the first since the release of the new Vioxx research results. The data raises questions about how quickly the drug could cause harm and could undermine Merck's credibility.

Out of the six cases that have already gone to trial to this point, Merck has won three and lost three.

Research published in the medical journal Lancet estimates that 88,000 Americans had heart attacks
from taking Vioxx, and 38,000 of them died.  Still looking for more data on Canadians. It seems harder to come by.

January 19, 2012: The proposed settlement of the Canadian Vioxx suit.

November 2007: Merck announces it will pay $4.85 billion to end thousands of lawsuits over its painkiller Vioxx. The amount, to be paid into a so-called settlement fund, is believed to be the largest drug settlement ever.

The Whitehouse Station, N.J.-based drug maker emphasized that it is not admitting fault.

The settlement lets Merck avoid the personal-injury lawsuits of some 47,000 plaintiffs, and about 265 potential class-action cases filed by people or family members who claimed the drug proved fatal or injured its users.

March 11, 2009: Scott S. Reuben, former chief of acute pain at Baystate Medical Center in Springfield, Mass, revealed that data for 21 studies he had authored for the efficacy of the drug (along with others such as celecoxib) had been fabricated in order to augment the analgesic effects of the drugs. There is no evidence however, that Dr. Reuben colluded with Merck in falsifying his data. Dr. Reuben was also a former paid spokesperson for the Drug company Pfizer (which owns the intellectual property rights for marketing celecoxib in the U.S.). The retracted studies were not submitted to either the FDA or the European Union's regulatory agencies prior to the drugs approval. Drug manufacturer Merck had no comment on the disclosure.


January 19, 2012: There was a tentative settlement with the Vioxx Class Action suit in Canada.

Here is a copy of the settlement.  Have a look at them, and then speak out, if you disagree with the conclusion. Don't let the courts approve this. Don't let Merck walk away admitting nothing, and doing nothing for most of the victims of their greed and avarice.

January 19, 2012, it was posted that a tentative settlement was made with the Canadian Class Action suit against Merck. The settlement was pretty horrific. Many of us will receive nothing, in spite of our lives being demolished in many different levels. Stroke patients will receive a cap of $5,000. That is the MOST that they can receive. How sad is that?  This blog is for information and sharing, and for gathering our voices together in opposition.