The Vioxx

Motel Hell psp trial that is ongoing in Australia and which has shed new light on the questionable tactics Merck & Co. used to market the dangerous painkiller has, said the Australian, involved a leading American cardiologist who testified that Vioxx played a “substantial contributing role” to the heart attack suffered by a 58-year-old Australian.

Vioxx was approved for use in the U.S. in 1999 and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Vioxx was also recalled in more than 80 countries that year. The Vioxx recall spawned thousands of product liability lawsuits and in 2007, Merck agreed to settle most U.S. Vioxx claims for $4.85 billion. But, Merck continues to defend lawsuits in other countries, including Australia.

According to Douglas Zipes’— a cardiologist from Indiana University—testimony, he “strongly believed” Vioxx was a significant contributing factor in Graeme Peterson’s –a 58-year-old former Australian Navy Officer—2003 heart attack. The class action is against U.S. Vioxx manufacturer Merck & Co as well as its Australian subsidiary Merck, Sharp and Dohme, said The Australian. Richard Harper, from Melbourne’s Monash University told the court that Vioxx “exacerbated” Peterson’s risk factors saying, “I believed Vioxx doubled his risk of heart attack. It increased the risk of someone who was already at a high risk,” quoted The Australian. The Australian reported that other experts found no so-call physical “footprint” to prove Vioxx caused the heart attack, citing other risk factors. One of the claims being made in the large class action is that Merck was aware of Vioxx’s cardiovascular risks long before the drug’s withdrawal from the market.

Meanwhile, recently the Australian Vioxx trial also revealed that Merck paid so-called nurses to look through medical records in search of potential Vioxx patients, said BNET in a prior report. According to the Australian court, the nurses accessed patient records without obtaining physician permission in the hopes of garnering 100 patients per doctor, explained BNET. Patients were sought who were not taking, but were seen as potential candidates to take, Vioxx, said BNET, citing a prior The Australian report.

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It seems, said The Australian, that the drug giant urged pharmacists to recommend Vioxx to those patients who were prescribed paracetemol by providing them with free copies of the Merck manual, according to BNET. Merck also apparently put on a year-end “skit” in which Merck sales reps mocked the Journal of the American Medical Association. The Journal published an article discussing Vioxx and issues with its cardiovascular side effects, said BNET.

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News of the skit is somewhat ironic, especially given recent reports on one of the most shocking tactics used by Merck to push Vioxx in Australia: The use of a fake medical journal. The journal, published by Elsevier, was offering it like other peer-reviewed medical journals, but contained only reprinted or summarized articles, all of which presented Merck products, including Vioxx, in a favorable light. According to an earlier New York Times piece, Merck published several issues of the “journal,” entitled Australasian Journal of Bone and Joint Medicine, between 2002 and 2005, presenting the journal to doctors as a real medical journal.

The ongoing Vioxx trial in Australia has just revealed that Merck, the maker of the controversial drug, paid so-called nurses to look through medical records in search of potential Vioxx patients, BNET reports. According to the Australian court, the nurses accessed patient records without obtaining physician permission in the hopes of garnering 100 patients per doctor, explained BNET. Patients were sought who were not taking, but were seen as potential candidates to take Vioxx, said BNET, citing The Australian.

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Vioxx was approved for use in the U.S. in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Vioxx was also recalled in more than 80 countries that year.

It seems, said The Australian, that the drug giant urged pharmacists to recommend Vioxx to those patients who were prescribed paracetemol by providing them with free copies of the Merck manual, according to BNET. Merck also apparently put on a year-end “skit” in which Merck sales reps mocked the Journal of the American Medical Association. The Journal published an article discussing Vioxx and issues with its cardiovascular side effects, said BNET.

News of the skit is somewhat ironic, especially given recent reports on one of the most shocking tactics used by Merck to push Vioxx in Australia: The use of a fake medical journal. The journal, published by Elsevier, was offering it like other peer-reviewed medical journals, but contained only reprinted or summarized articles, all of which presented Merck products, including Vioxx, in a favorable light. According to an earlier New York Times piece, Merck published several issues of the “journal,” entitled Australasian Journal of Bone and Joint Medicine, between 2002 and 2005, presenting it to doctors as a real medical journal.

Hondo video The New York Time also reported that the Australian trial revealed that Vioxx sales reps in that country were given a training manual called the “Vioxx Objection Handling Module.” This manual schooled reps in methods of deflecting doctors’ questions about the drug’s side effects, and easing their concerns. According to The New York Times, Merck began distributing the manual in 2001 as studies began to emerge that pointed to the drug’s heart and stroke risks.

The Australian trial has also demonstrated how disillusioned doctors felt when they learned Merck had tried to obscure Vioxx’s safety issues. For example, in an e-mail message dated October 2, 2004, Dr. James V. Bertouch, an Australian physician who had been a member of Merck’s arthritis advisory board, told fellow board member that he felt “like the proverbial mushroom” and asked colleagues how they felt being kept in the dark about Vioxx.

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The Vioxx recall spawned thousands of product liability lawsuits. In 2007, Merck agreed to settle most U.S. Vioxx claims for $4.85 billion; however, Merck continues to defend lawsuits in other countries, including Australia.The Kovak Box rip

A Vioxx trial in Australia has shed new light on the questionable tactics Merck & Co. used to market the dangerous painkiller. The strategies, detailed in an article published by The New York Times, will not surprise anyone who has followed this blog’s Vioxx coverage.

Vioxx was approved for use in the U.S. in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The painkiller was pulled off the market in 2004 after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. Vioxx was also recalled in more than 80 countries that year.

The Vioxx recall spawned thousands of product liability lawsuits. In 2007, Merck agreed to settle most U.S. Vioxx claims for $4.85 billion. But the company is still defending lawsuits in other countries, including Australia.

We’ve already reported on one of the most shocking tactics used by Merck to push Vioxx in Australia – the use of a fake medical journal. The journal, published by Elsevier, looked like other peer-reviewed medical journals, but contained only reprinted or summarized articles – all of which presented Merck products, including Vioxx, in a favorable light.

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According to the New York Times, Merck published several issues of the “journal”, entitled Australasian Journal of Bone and Joint Medicine, between 2002 and 2005. It was presented to doctors as a real medical journal.

The New York Time is also reporting that the Australian trial has revealed that Vioxx sales reps in that country were given a training manual called the “Vioxx Objection Handling Module.” This manual schooled reps in methods of deflecting doctors’ questions about the drug’s side effects, and easing their concerns. According to The New York Times, Merck began distributing the manual in 2001 as studies began to emerge that pointed to the drug’s heart and stroke risks.

The Australian trial has also demonstrated how disillusioned doctors felt when they learned Merck had tried to obscure Vioxx’s safety issues. For example, in an e-mail message dated Oct. 2, 2004, Dr. James V. Bertouch, an Australian physician who had been a member of Merck’s arthritis advisory board, told fellow board member that he felt “like the proverbial mushroom” and asked colleagues how they felt being kept in the dark about Vioxx.

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In the most recent debacle over Merck’s Vioxx

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, Merck is accused of hiring a ghostwriter for a Circulation paper likely written to minimize issues linked to Vioxx’s safety. The Heart.org said well-known cardiologist Dr. Marvin Konstam of Tufts University Medical Center agreed to act as lead author in 2001. Claims just made in an Australian court allege the paper was written by Merck’s in-house scientists, a conflict of interest.

It is believed the Merck paper was developed in defense of an article published in the Journal of the American Medical Association (JAMA) that broke with news that Vioxx increased cardiovascular side effects, said The Heart.org. It took until 2004 for Vioxx to be globally withdrawn. “During the three years after publication of the Konstam manuscript, millions of patients around the world were prescribed rofecoxib by physicians who believed that the drug was safe. In this case, a ghostwritten article caused great harm to the public health,” said Dr. Steve Nissen of the Cleveland Clinic and author of the JAMA paper, quoted The Heart.org.

News of the scandal is surfacing in Australia amid a class-action lawsuit against Merck and its subsidiary, Merck, Sharp and Dohme, and following the Pharmaceutical Research and Manufacturers of America’s (PhRMA) issuance of “revised principles” on communicating clinical trial results, said The Heart.org, such as limiting author credits to those who actually made so-called “substantial” research contributions. Nissen told heartwire, “We must not view this situation as ‘old news.’ We had long suspected that this [Circulation] manuscript was ghostwritten, but definitive proof was lacking. These court documents finally confirm our suspicions,” quoted The Heart.org.

Of note, said The Heart.org, Konstam does not have specific expertise in meta-analyses or COX-2 inhibitors and was also apparently not first choice as lead author. The paper was originally rejected by JAMA for “fast-track publication” before being accepted by Circulation for publication, said TheHeart and, it seems that there was a connection between Konstam and the American Heart Journal—another publication possibility—which increased Konstam’s attractiveness in speeding up review processes.

The Australian reported that an email sent to the Federal Court as part of the class-action against Merck, by senior scientist Briggs Morrison mentioned concerns about the article’s peer review process, “I guess what I am saying is that the data appears to have been interpreted to support a preconceived hypothesis rather than critically reviewing the data to generate hypotheses.” According to Professor Jelinek, a witness involved in the case “… it is inappropriate for a pharmaceutical company to seek to release its own scientific content effectively disguised as independent research or commentary. In my opinion, the ghost-written material from Merck and MSDA … does not disclose that the content was written or directed by Merck or MSDA, and is, therefore, likely to mislead readers about the true nature or purpose of its contents.”

Vioxx is the target of a federal probe and numerous lawsuits following an analysis that linked it to over 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. After Vioxx was pulled, it was revealed that the U.S. Food and Drug Administration (FDA) tried to silence the drug expert heading that study via veiled threats and intimidation. In 2007, Merck agreed to settle most of its Vioxx claims for $4.85 billion. Last April, an analysis of court documents uncovered in the course of Vioxx injury lawsuits, found Merck employees worked alone or with publishing companies to write Vioxx study manuscripts and later recruited academic medical experts to put their names as first authors on the studies.

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Vioxx is the target of a federal probe, Merck & Co. announced yesterday. According to Reuters, the grand jury investigation involves Merck’s research, marketing and selling activities regarding Vioxx, which was pulled from the market in 2004.

Vioxx was approved for use in 1999, and quickly became a blockbuster for Merck, with annual sales of $2.5 billion. The Food & Drug Administration (FDA) ordered the painkiller off the market after an analysis of patients using Vioxx linked the defective drug to more than 27,000 heart attacks or sudden cardiac deaths in the U.S. from 1999 through 2003. More Merck Faces Vioxx Grand Jury Probe

Medical journals have been asked to retract 21 studies that touted the benefits of Vioxx, Celebrex and other drugs. According to The Wall Street Journal, Baystate Medical Center, Springfield, Mass. is asking the journals to make the retractions because its former chief of acute pain, Dr. Scott S. Reuben, had faked data used in the studies.

In addition to Vioxx and Celebrex, some of the 21 studies involved the fibromyalgia drug Lyrica and the antidepressant Effexor XR. Reuben’s study claimed to show that these drug worked well as painkillers, the Journal said. All of the studies were published between 1996 and 2008. More Researcher Faked Data for 21 Studies Involving Vioxx, Celebrex and Other Drugs

Vioxx, Celebrex, ibuprofen and other NSAID painkillers increase the chances that heart attack and heart failure patients will experience a second heart attack or death, a new study says.  According to Danish researchers, the risk of a second heart attack or death actually doubled within the first 90 days of starting Vioxx or Celebrex.  Other painkillers, like ibuprofen, increased the risk between 2.1 and 1.3 times.

The study was presented this week at the American Heart Association meeting in New Orleans.  At least one of the researchers recommended that physicians now avoid these types of painkillers, or use low doses, in patients with a history of heart attack or heart failure. More Vioxx, Celebrex, Other Painkillers Up Risks for Heart Failure, Heart Attack Patients

A new study that confirms the heart risks associated with a class of drugs called NSAIDs has found that the increased risk correlates to the specific pain-causing molecule they act against.   According to the study, NSAIDS that are cox-2 inhibitors are more likely to increase the risks of heart attacks and strokes.

NSAIDs  are the most prescribed medications for treating conditions such as arthritis. Most people are familiar with over-the-counter, nonprescription NSAIDs, such as aspirin and ibuprofen. NSAIDs also include prescription drugs like Celebrex, as well as the now-banned Vioxx. More COX-2 Inhibitors More Likely to Raise Heart Risks Than Other NSAIDs

Pfizer has reached a tentative agreement to settle lawsuits involving its Bextra and Celebrex painkillers for  $894 million.  If it goes forward, the Pfizer Bextra and Celebrex settlement will resolve roughly 90 percent of the personal injury lawsuits the company faces because of the drugs.

Celebrex and Bextra are COX-2 inhibitors, a class of drugs that also includes Merck’s recalled Vioxx.  Such medications are linked to an increased risk of blood clots, heart attacks and strokes. Pfizer withdrew Bextra from the market in 2005, and  Celebrex is the only COX-2 inhibitor still on the market in the United States. More Pfizer Announces Bextra, Celebrex Settlement

Heart risks from Vioxx, the defective painkiller pulled from the market in 2004, lingered long after many patients stopped taking the drug.  According to a report in The Washington Post, a study conducted by researchers at the M.D. Anderson Cancer Center in Houston, TX found that Vioxx increased the risk of heart attack and stroke by “close to twofold, and the risk persisted for approximately a year”.

The authors of the study, which was published online by the journal Lancet, also believe that long-term use of other NSAIDs, including now-banned Bextra, as well as Celebrex, and over-the-counter versions of ibuprofen and naproxen,  increase stroke and heart attack risks to some extent. More Vioxx Heart Risks Long-Lasting