Mass Torts - Written by Beasley Allen on Monday, July 10, 2006 8:17 - 1 Comment

Merck’s 18-Month Myth Is Now Totally Deflated

Merck & Co. has been playing fast and loose with the truth for years relating to its testing and marketing of Vioxx. Finally, in an admission that undermines its core defense in -related lawsuits, Merck has finally decided to tell the truth. Merck now says it erred when it reported in early 2005 that a crucial statistical test showed that caused heart problems only after 18 months of continuous use. Merck admits now – after lying for months to the media and even in courts – that a statistical analysis test does not support Merck’s 18-month theory about . Merck’s admission, when considered along with the results of other clinical trials of the drug and studies tracking real-world use, supports critics’ longstanding contentions that causes heart problems quickly. Dr. Alastair J. J. Wood, a drug safety expert at Vanderbilt University, correctly observed, “There never was any evidence for the 18-month story.”

Merck’s cadre of witnesses has been telling courts and juries for months that there was an 18-month use requirement. Clearly, the 18-month issue is crucial for the 20 million Americans who took . Taking has caused thousands of folks to have heart attacks and strokes. An official with the FDA puts the number at about 40,000. Merck has used the 18-month theory as a defense since was withdrawn from the market in September 2004. In defending the lawsuits, Merck, which knew it was scientifically wrong, has consistently taken the position that can cause heart problems only if it is used continuously for more than 18 months. Merck has based the 18-month theory largely on data from the APPROVe study, in which the company tracked 2,600 patients in a test to see whether could prevent colon polyps. The media was hoodwinked into buying the myth, and I am told that even they now realize it was all a big lie!

In the study, twice as many patients taking suffered heart attacks or strokes as those taking a placebo. When it reported the APPROVe results in The early last year, Merck said that it had performed a statistical test to examine whether ’s risk changed over time. According to Merck, that test found with almost total certainty that the drug had significantly higher risk than placebo only after the 18-month benchmark — but no extra risk before that time. Now Merck said it had made a mistake in reporting that result last year. In reality, the test that the company said it had used to check the results is proof that causes heart attacks both before and after the 18-month benchmark is reached.

Dr. Steven E. Nissen, the interim chairman of cardiovascular medicine at the Cleveland Clinic, says the mistake Merck now admits is just another example of Merck’s mishandling data to make seem safer. In this regard, Dr. Nissen says:

They’re acknowledging that they misrepresented the APPROVe data, when they reported that there was a statistically significant difference between the first and the second 18 months. There is no biologically plausible reason to expect an 18-month delay. I never thought it made any sense.

Families who have been hurt by Merck’s lying about have a right to be outraged. The federal government should now do a thorough investigation of Merck’s conduct and take appropriate action. Because I have little confidence that the FDA will take any real action because of Merck’s power and influence, it will be up to judges and juries to get to the bottom of all of this.




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Margaret Williams
Sep 13, 2009 6:02

I have read so much about the Vioxx settlements. Congrats to all those who won. I was hoping to find an avenue for my husband to get his share of the ‘funds’ set aside as a Vioxx user and victim. This has taken its toll on me as well as my husband. We filed all the necessary papers and waited. Was turned down on Proximity. Appealed and once again lost the appeal. The doctors knew he was taking Vioxx, but we had no ‘up to date script’ to prove it. No heads-up about the danger involved either. We saved his Vioxx samples and put them in an old Vioxx prescription bottle for convenience sake. He used them as needed when his knees would be unbearable with pain and fluid build up. Vioxx helped the pain, but he would ultimately end up having the fluid drawn. The samples were saved because Vioxx was an expensive medication. We are our only proof that he ingested those pills several weeks prior to his massive heart attack. On October 28, 2004 I drove him to his doctor. The doctor drew fluid, ordered him to have an Ultrasound on the same knee at our local hospital. We left his office had the Ultrasound done and came home. All day my husband’s breath was terrible. I could detect it from several feet away. He was not aware of this, but I was. Never before have I smelled such a foul odor from a live human being’s mouth. I am sure the medical personnel at the hospital noticed it, as did his doctor. No one said anything about it. Maybe they were being polite not to call attention to such an embarrassing moment. Everything was being rushed as the doctor was flying to New York that Friday evening and had a 5:00PM flight to catch. We left the hospital and on the way home my husband said, “Do you have to go get your paycheck today, or can it wait until Monday”? This was around 4:40PM. Little did I know. He was not only feeling bad and in pain from his knee problem, but he was on his way to having a massive heart attack. We never heard from the Ultrasound results that evening. The doctor was gone and it would be Monday before we could expect to hear back from him. At 7:20PM I was rushing my husband back to the hospital. I gave him an aspirin and told him to start coughing and keep coughing. He ask no questions, he just trusted me. We made it to the ER in one minute and forty five seconds. After his admission to the hospital, when ask, I told them the medications he had been taking. The Vioxx was omitted from the list of medications in his records. There is a blank hand-drawn line below the list of medications in his records. ALL the meds were written on hand-drawn lines. The last line was blank. After being admitted to the Cardiac Intensive Care Unit, I ask them not to administer anything that would cause him more grief. Then I told them he had taken Vioxx for his knee, and had just come from the doctor from having fluid drawn. I wanted them to know his knee was very painful and sore from the swelling. I was with him when his meds were about to be given. I ask what the meds were and one was Celebrex. I ask them not to give this as I had heard that it could cause a stroke or a heart attack. The nurse noted the chart and spoke with the doctor. I don’t know what was substituted, but the nurse told me it was not Celebrex. We were never told that Vioxx could cause heart attacks. He did not take Vioxx that day. He had not had dinner and always took his meds with food. He is the first to have a heart attack in his family. He did not have high B/P. His two brothers, nor his sister have any B/P or heart conditions. Several weeks after his release from the hospital, he had orders to return so they could fix his rapid heart beat. I decided to obtain a copy of his hospital records to learn more about what was going on. I did not understand some of the language used, but I read every word of his records and never found the word Vioxx once. What stands out in my mind is that his enzyme level was elevated along with other elevated levels of ’something’. There was mention in the records that a medication could have cause these elevations, but they (doctors) never said anything to me or my husband about this. When I went to pick up a complete copy of his hospital medical records, I was told by the Medical Records Supervisor that all of his records prior to October 28, 2004 had been destroyed. I ask why and she told me she did not know. No one could tell me the whereabouts of his heart surgeon so I could get a copy of his office records. NO ONE. Nor could I find out where his records were. Later I was told he had retired and left the area. To this day I have yet to locate the heart surgeon or his records. Since all this, I have lost my mother after caring for her for over nine months, have severe health problems of my own (a blood clot blew and a small piece went to the end of my left index finger, turning it black after several weeks, and I thought I was going to lose it). I have two stints because of that incident. I also suffer from Polymyalgia Rheumatica, and GCA. Yes, we both have severe medical problems. I feel for my husband and share the misery of this heavy burden he has to bare. This Vioxx thing has taken a toll on both of us. We went through Katrina and lost a lot, to say the least. Most of all my husband has lost hope of recovering from taking Vioxx. As his wife and best friend I want to back him and help him to the very end of this mess…but I failed somewhere in finding the answer that would have proven he was a victim and his heart a by-product of the drug Vioxx. WE know he should receive compensation and we KNOW that Vioxx caused our lives to be changed forever. A small sum would have made him feel that he DOES matter to those who helped make him very ill. Are those same people sorry at all for their disaster? Really deep-down soul-searching sorry? Who ever they were their names will be known, even to their young. That is what happens when you make history. Thank you for listening. I know it was lengthy, and I apologise. I had to tell our side to someone, whoever you are. Prayers for all who suffer and for the loved ones who have endured.

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