Explanation of; Merck Misled Patients
Two of the most common questions people ask me are : "How do I find a lawyer to sue for Vioxx?" and "How do I find a Vioxx Lawyer?" That's why I wrote this page; hopefully it will help people find lawyers who specialize in Vioxx lawsuits:
About the authors of this article: Jerrold S. Parker Esq limits his practice to
cases regarding drug and medical device liability. Mr. Parker frequently
appears on Court TV and Good Day America.
By repeatedly vouching for the safety of its highly profitable NSAID painkiller, Vioxx (despite credible medical and scientific evidence it had in is possession to the contrary) the pharmaceutical giant, Merck & Co. ("Merck"), appears to have been disrespectful of the truth.
Merck's lack of candor, throughout this latest episode of a "miracle" drug gone bad, is an example of the process by which pharmaceutical manufacturers manipulated and exploit scientific data in order to market a prescription drug.
In our action against Merck, we shall endeavor to prove that the pharmaceutical industry in general and Merck in particular:
- Withhold or otherwise concealing critical research or clinical data from the public prior to securing FDA approval.
- Rush drugs to market before any long-term side effects can be identified or studied under controlled conditions.
- Spend enormous sums of money ($3.8 billion annually) on Direct to Consumer Advertising (DTC) that utilize everything from celebrity spokespersons to famous rock and roll songs from the 1960s and 1970s to encourage patients to demand specific drugs from their doctors without regard to the serious risks associated with those drugs.
- Engaging in damage control designed to minimize liability while maximizing profit retention.
Much has been written about the rush to market new drugs before they are adequately tested and well before their long-term effects are known.
We endeavor to prove that Vioxx, represents one of the most extreme cases of a drug which never should have been marketed.
The evidence to support this conclusion is extensive and compelling. Most experts familiar with the history of Vioxx from either a medical or business perspective were not surprised by Merck's sudden withdrawal of the drug from the market.
Merck marketing campaign goes full force despite data indicating COX-2's posed a cardiovascular risk:
Between January 2003 and June 2004, Merck & Co. spent almost $123.9 million dollars in DTC advertising to persuade the public that Vioxx offered safe and effective treatment for acute and chronic pain associated with osteoarthritis, primary dysmenorrhea (moderate to severe menstrual pain), and other problems.
Celebrities, like Olympic figure skating champion Dorothy Hammil, pitched the drug in carefully orchestrated commercials set to The Rascals' 1968 hit "Beautiful Morning."
This aggressive advertising campaign continued although Merck, the FDA, and many highly respected medical experts were aware that the drug was considerably more dangerous than the public knew or even suspected.
Merck refused to acknowledge the significant (heart-related) danger Vioxx posed. To the contrary, Merck was always committed to obtaining approval for wider applications for the drug.
On September 8, 2004, only three weeks before Vioxx was pulled from the market, the FDA approved the use of Vioxx in the treatment of rheumatoid arthritis in children as young as two.
Chronology of events shows the troubling sequence of events that was occurring while Vioxx generated sales in the billions of dollars for Merck:
November 23, 1998:
Merck submitted its New Drug Application (NDA) to the FDA.
April 20, 1999:
The Advisory Committee on Arthritis Drugs (FDA) met to review Vioxx.
May 20, 1999:
The FDA approved Vioxx for the management of acute pain in adults and for relief of the signs and symptoms of osteoarthritis. (The original safety database included approximately 5,000 patients on Vioxx and did not, according to Merck, show an increased risk of heart attack or stroke).
October 8, 1999:
Merck updated the Vioxx package insert.
November 18, 1999:
A meeting of the Data and Safety Monitoring Board (DSMB) concerning the Vioxx/VIGOR study (in which all voting members of the committee were to be independent from Merck) took place at which the Board discussed its concerns over the "excess deaths and cardiovascular adverse experiences" that was observed in the group using Vioxx as compared to the patients who were taking Naproxen.
The FDA required Merck to add labeling information about a possible link to possible increased heart attack and stroke risk.
Information was presented at the European United League against Rheumatism, of which Merck is a member and corporate sponsor, which demonstrated a statistically significant increase in hypertension and myocardial infarction.
The VIGOR study (sponsored by Merck) was submitted to the FDA (VIGOR - Vioxx® Gastrointestinal Outcomes Research which is the same study that gave rise to the lengthy memorandum by Dr. Targum, referred to below). The study was primarily designed to look at side-effects such as stomach ulcers and bleeding. It showed that patients taking Vioxx had fewer stomach ulcers and bleeding than patients taking Naproxen.
February 8, 2001:
The VIGOR study was discussed at an FDA Arthritis Advisory Committee meeting. The Committee was specifically concerned with the unexpected findings of potential cardiovascular risks and myocardial infarctions associated with the use of Vioxx as opposed to the side effects (stomach ulcers and bleeding) that the VIGOR study was aimed at.
February 1, 2001:
Dr. Shari L. Targum, submitted a memorandum with respect to her review of the available data concerning Vioxx. Dr. Targum was a Medical Officer in the FDA's Division of Cardio-Renal Drug Products. The 37-page memorandum documented the serious cardiac events, myocardial infarctions, and related deaths for participants in the VIGOR study who had used Vioxx. She indicated that as early as November 18, 1999, the VIGOR Data and Safety Monitoring Board had discussed the "excess deaths and cardiovascular adverse experiences" in the group using Vioxx.
April 2001 Public Citizen advised the public not to use Vioxx because of potential heart-related risks. Merck continued to minimize this risk in its advertisements.
May 22, 2001:
Despite the mounting evidence of the association of Vioxx to strokes and heart attacks, Merck issued a press release entitled "Merck Confirms Favorable Cardiovascular Safety Profile of Vioxx", also claiming Vioxx has a "favorable cardiovascular safety profile"
June 16, 2001:
Merck issued another press release (released in Europe), entitled "Vioxx Similar to Placebo and Three (3) Widely Prescribed NSAIDs Regarding Cardiovascular Events".
July 11, 2001:
Merck again modified the package insert for Vioxx.
August 22, 2001:
A study published in the Journal of the American Medical Association (JAMA) by Drs. Mukherjee, Nissen, and Topol, researchers from the Cleveland Clinic, indicated that Vioxx was linked to a 200% increase in blood clots, heart attacks and strokes based on their review of previous clinical trials.
The American Heart Association, the National Stroke Association and the Arthritis Foundation asked Merck to test whether Vioxx increased the risk of heart attack and stroke.
September 17, 2001:
The FDA issued an 8-page warning letter to Merck concerning its false and misleading promotional campaign. The FDA found:
"You have engaged in a promotional campaign for Vioxx that minimizes the potentially serious cardiovascular findings that were observed in the VIOXX Gastrointestinal Outcomes Research (VIGOR) study, and thus, misrepresents the safety profile for VIOXX. Specifically, your promotional campaign discounts the fact that in the VIGOR study, patients on VIOXX were observed to have a four to five fold increase in myocardial infarctions (MIs) compared to patients on the comparator non-steroidal anti-inflammatory drug (NSAID), Naprosyn (naproxen)."
The FDA demanded that Merck discontinue promoting Vioxx to doctors for unofficial uses and found after a review of several of Merck's promotional conference calls and sales pitches, that the promotions by Merck "are false, lacking in fair balance, or otherwise in misleading in violation of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations," It also required Merck to send letters about the deception to the medical community.
Public Citizen publishes information concerning the FDA warning letter. At this time, Merck was also aware of increased risks of thrombotic (blood clotting) adverse effects such as strokes and blood clots in the legs, hypertension, and altered kidney function.
April 11, 2002:
The FDA instructed Merck to include in the package insert certain precautions based on results of the VIGOR studies. The possible link to high blood pressure and an increase in the risk of heart attacks were to be added.
April 11, 2002:
Merck announced that it had added rheumatoid arthritis to the list of approved uses for Vioxx.
Drs. Topol and Falk published an editorial in The Lancet encouraging further warnings and labeling regarding the cardiovascular effects of COX-2 inhibitors. Kaiser Permanente, the largest HMO in the United States, found the incidence of sudden cardiac death to be three times greater for Vioxx than Celebrex among its patients. Cigna Health Care regarded Vioxx as a "non-preferred medication" for its policy holders.
Aetna, Inc., the third largest health insurer in the United States, announced that Vioxx was the subject of an ongoing study and recommended "alternative drugs" be prescribed in its place.
October 5, 2002:
A study done at Vanderbilt University, and published in The Lancet, noted that patients taking 50mg. of VIOXX for more than 5 days demonstrated a 70% greater likelihood of developing coronary heart disease (CHD).
Despite requests from the American Heart Association, the National Stroke Association, and the Arthritis Foundation that Merck conduct additional safety studies, Merck claimed that Vioxx was safe and that it did not plan to conduct any such study.
A study, which was funded by Merck, disclosed that Vioxx posed a risk of heart attack and stroke which was three times greater than that of other COX-2 pain relievers. Shockingly, when this finding was made, Merck had the name of its scientist removed from the list of authors on the study.
April 2004: A study published in the journal, Circulation, observed an elevated risk of hospitalization for acute myocardial infarction (AMI) among elderly Medicare enrollees treated with rofecoxib. This risk was higher in persons taking >25 mg of rofecoxib than in patients taking the most common dosages used of 25 mg. The risk was elevated during the first 90 days of exposure but not thereafter.
At the annual meeting of The International Society for Pharmacoepidemiology, in Bordeaux, France, new data from a trial sponsored by the FDA indicated that patients taking 25 mg or more of Vioxx per day had a risk of experiencing AMI or sudden cardiac death more than three times greater than patients taking non-selective NSAIDs.
About the author: Jerrold S. Parker Esq. limits his practice to cases regarding drug and medical device liability. He has most recently appointed to the Plaintiff's Steering Committee in the Zyprexa Products Liability Litigation (MDL # 1596). He makes frequent appearances on television shows such as Court TV and Good Day New York.
See Also: YourLawyer.com; extensive database of data and case-law regarding drug liability actions .
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