Showing posts with label Vioxx. Show all posts
Showing posts with label Vioxx. Show all posts
Saturday, November 14, 2009
Monday, March 09, 2009
Merck buy Schering Plough - megamergers a la mode
Bye bye.Merck & Co Inc said on Monday that it would acquire Schering-Plough Corp for $41.1 billion, uniting the makers of cholesterol drugs Zetia and Vytorin, in the second megadeal for Big Pharma in weeks.
Source
Wednesday, November 19, 2008
Guess what's on the FDA's mind in this post-Vioxx world?
The rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration's top worries and is changing how the agency weighs new medicines, a top FDA official said on Tuesday.
The agency is thinking about how to weigh such possible side effects as more drugs that treat diabetes, pain and other conditions also appear linked to heart attacks and other complications, Dr. John Jenkins, director of the FDA's Office of New Drugs, told the Reuters Health Summit in New York.
"That has been the biggest safety shift in the last few years, and it's also, I think, a driver for a lot of the public concern about drug safety," he said.
"We are thinking about what the implications of these new data and these new findings are for all chronically-used drugs," he said.
The agency has already said that it plans to give specific advice to drug makers about what kinds of data they will need to sell diabetes drugs in the United States.
The FDA's recommendation, or guidelines, will be released "very soon," Jenkins said.
In July, an FDA panel of outside advisers said companies should have to conduct long-term studies of cardiovascular effects or provide equivalent evidence to rule out an "unacceptable" risk of heart problems.
Source
The agency is thinking about how to weigh such possible side effects as more drugs that treat diabetes, pain and other conditions also appear linked to heart attacks and other complications, Dr. John Jenkins, director of the FDA's Office of New Drugs, told the Reuters Health Summit in New York.
"That has been the biggest safety shift in the last few years, and it's also, I think, a driver for a lot of the public concern about drug safety," he said.
"We are thinking about what the implications of these new data and these new findings are for all chronically-used drugs," he said.
The agency has already said that it plans to give specific advice to drug makers about what kinds of data they will need to sell diabetes drugs in the United States.
The FDA's recommendation, or guidelines, will be released "very soon," Jenkins said.
In July, an FDA panel of outside advisers said companies should have to conduct long-term studies of cardiovascular effects or provide equivalent evidence to rule out an "unacceptable" risk of heart problems.
Source
Thursday, October 02, 2008
Merck - Vioxx: just when they thought it was all behind them
Florida has joined eight other states in suing drug manufacturer Merck over what the state alleges was deceptive marketing of its former prescription painkiller Vioxx.
In a lawsuit brought by Florida Attorney General Bill McCollum, the state is seeking restitution for all money spent by state health programs on Vioxx, plus interest.
Florida's Medicaid program alone spent more than $80 million on Vioxx, once a blockbuster arthritis treatment, between 1999 and 2004. Merck pulled Vioxx from the market four years ago after its own research showed the pill doubled risk of heart attack and stroke.
The lawsuit alleges that "Merck's costly promotional campaign was intended to convince purchasers that the drug was not only safe, but that they should demand it from their healthcare professionals for pain treatment," according to a statement from the attorney general.
The suit also seeks civil penalties of up to $10,000 for each time that Merck's advertising caused a Vioxx purchase to be made, an amount that a court would have to determine, according to a spokeswoman for McCollum.
"The company also allegedly tried to intimidate physicians and researchers who questioned the safety of Vioxx," the statement adds.
Monday, September 01, 2008
Wednesday, August 27, 2008
Tuesday, August 19, 2008
Merck - Vioxx: a spoonful of sugar
Background: Seeding trials, clinical studies conducted by pharmaceutical companies that are designed to seem as if they answer a scientific question but primarily fulfill marketing objectives, have not been described in detail.
Purpose: To describe a known seeding trial, ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness), through documents of the trial sponsor, Merck & Co. (Whitehouse Station, New Jersey).
Data Sources: Merck internal and external correspondence, reports, and presentations elicited to inform legal proceedings of Cona v Merck and Co., Inc., and McDarby v Merck and Co., Inc. The documents were created between 1998 and 2006.
Data Extraction: An iterative case-study process of review, discussion, and re-review of documents to identify themes relevant to the design and conduct of ADVANTAGE. To supplement the case-study review, the authors did a systematic review of the literature to identify published manuscripts focused on seeding trials and their conduct.
Data Synthesis: Review of the documents revealed 3 key themes: The trial was designed by Merck's marketing division to fulfill a marketing objective; Merck's marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination; and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members. Although the systematic review of the literature identified 6 articles that focused on the practice of seeding trials, none provided documentary evidence of their existence or conduct.
Limitations: The legal documents in these cases provide useful, but limited, information about the practices of the pharmaceutical industry. This description of 1 company's actions is incomplete and may have limited generalizability.
Conclusion: Documentary evidence shows that ADVANTAGE is an example of marketing framed as science. The documents indicate that ADVANTAGE was a seeding trial developed by Merck's marketing division to promote prescription of Vioxx (rofecoxib) when it became available on the market in 1999.
Source
Purpose: To describe a known seeding trial, ADVANTAGE (Assessment of Differences between Vioxx and Naproxen To Ascertain Gastrointestinal Tolerability and Effectiveness), through documents of the trial sponsor, Merck & Co. (Whitehouse Station, New Jersey).
Data Sources: Merck internal and external correspondence, reports, and presentations elicited to inform legal proceedings of Cona v Merck and Co., Inc., and McDarby v Merck and Co., Inc. The documents were created between 1998 and 2006.
Data Extraction: An iterative case-study process of review, discussion, and re-review of documents to identify themes relevant to the design and conduct of ADVANTAGE. To supplement the case-study review, the authors did a systematic review of the literature to identify published manuscripts focused on seeding trials and their conduct.
Data Synthesis: Review of the documents revealed 3 key themes: The trial was designed by Merck's marketing division to fulfill a marketing objective; Merck's marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination; and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members. Although the systematic review of the literature identified 6 articles that focused on the practice of seeding trials, none provided documentary evidence of their existence or conduct.
Limitations: The legal documents in these cases provide useful, but limited, information about the practices of the pharmaceutical industry. This description of 1 company's actions is incomplete and may have limited generalizability.
Conclusion: Documentary evidence shows that ADVANTAGE is an example of marketing framed as science. The documents indicate that ADVANTAGE was a seeding trial developed by Merck's marketing division to promote prescription of Vioxx (rofecoxib) when it became available on the market in 1999.
Source
Thursday, April 24, 2008
Looks like Dick Clark might be learning from recent history
"I think everyone has a lesson to be learned from this," Clark said. Drug companies may have to become more transparent about their external spending, as well as their relationships with physicians, he said.
"There is," he said, "a trust deficit we have to fix."
Source
"There is," he said, "a trust deficit we have to fix."
Source
Monday, April 21, 2008
Friday, April 18, 2008
The Star Ledger on the triumph of marketing over science in Big Pharma
Of all the black eyes the Merck pharmaceutical company has inflicted upon itself, the biggest shiner yet may come from new allegations in the current Journal of the American Medical Association.
Two JAMA articles say Merck misrepresented the death risks in one study and routinely stuck the names of top researchers onto ghostwritten scientific reports.
Once again, at the center of Merck's mess is Vioxx, the painkiller Merck withdrew from the market after finally acknowledging a cardiovascular risk for those taking the top-selling drug.
Documents related to the thousands of Vioxx lawsuits were reviewed by experts, who published their results in JAMA. They paint a damning picture of a company willing to buy the science required to support its marketing plans. In fact, one JAMA article says Merck's marketing staff planned some of the scientific studies and contracted to have them written, leaving a blank for the names of the researchers who would be recruited to serve as "authors."
If Merck is guilty, is there any reason to believe it is the only company that has done this? The JAMA editors raise that very good question.
JAMA, Consumers Union and others are calling for full disclosure of the financial links between pharmaceutical companies and research study authors, journal editors and reviewers as well as more disclosure about the role anyone listed on a scientific paper played in the research.
Those reforms would build a higher wall between science and pretense. Yet, if a company or individual is willing to tell the kind of lies the JAMA articles say were told, would the proposed safeguards be enough to prevent even bigger lies about vested interests and role-playing for pay?
A number of the implicated researchers have denied any misdeeds. So has Merck, which says the JAMA article authors have their own conflicts of interest because they previously worked for some of the litigants suing Merck over Vioxx.
Congress needs to order an investigation to sort fact from fiction in this matter. The shameful thing is that the Food and Drug Administration, understaffed and underfunded, is the least likely to do an effective job of answering the questions.
Some independent agent, such as the Government Accountability Office or the Institutes of Medicine, should be assigned to review the Vioxx documents and look into the growing list of questions about the legitimacy and integrity of the research on which patients bet their health.
Many experts stress that most of what we know about any medication is based on research sponsored by the very company with a fortune riding on the results. Is it possible to change that? It is certainly time to consider how it might be done.
The perception that pharmaceutical marketing has overtaken science seems like more than just a notion.
Source
Insider's view: Hear hear! Big Pharma spends twice as much on sales and marketing as it does on R&D. No wonder they are in the mess they're in.
How about this for a strategic idea: reverse that ratio and they might just come up with some novel compounds that will help get them out of this mess of their own making.
Two JAMA articles say Merck misrepresented the death risks in one study and routinely stuck the names of top researchers onto ghostwritten scientific reports.
Once again, at the center of Merck's mess is Vioxx, the painkiller Merck withdrew from the market after finally acknowledging a cardiovascular risk for those taking the top-selling drug.
Documents related to the thousands of Vioxx lawsuits were reviewed by experts, who published their results in JAMA. They paint a damning picture of a company willing to buy the science required to support its marketing plans. In fact, one JAMA article says Merck's marketing staff planned some of the scientific studies and contracted to have them written, leaving a blank for the names of the researchers who would be recruited to serve as "authors."
If Merck is guilty, is there any reason to believe it is the only company that has done this? The JAMA editors raise that very good question.
JAMA, Consumers Union and others are calling for full disclosure of the financial links between pharmaceutical companies and research study authors, journal editors and reviewers as well as more disclosure about the role anyone listed on a scientific paper played in the research.
Those reforms would build a higher wall between science and pretense. Yet, if a company or individual is willing to tell the kind of lies the JAMA articles say were told, would the proposed safeguards be enough to prevent even bigger lies about vested interests and role-playing for pay?
A number of the implicated researchers have denied any misdeeds. So has Merck, which says the JAMA article authors have their own conflicts of interest because they previously worked for some of the litigants suing Merck over Vioxx.
Congress needs to order an investigation to sort fact from fiction in this matter. The shameful thing is that the Food and Drug Administration, understaffed and underfunded, is the least likely to do an effective job of answering the questions.
Some independent agent, such as the Government Accountability Office or the Institutes of Medicine, should be assigned to review the Vioxx documents and look into the growing list of questions about the legitimacy and integrity of the research on which patients bet their health.
Many experts stress that most of what we know about any medication is based on research sponsored by the very company with a fortune riding on the results. Is it possible to change that? It is certainly time to consider how it might be done.
The perception that pharmaceutical marketing has overtaken science seems like more than just a notion.
Source
Insider's view: Hear hear! Big Pharma spends twice as much on sales and marketing as it does on R&D. No wonder they are in the mess they're in.
How about this for a strategic idea: reverse that ratio and they might just come up with some novel compounds that will help get them out of this mess of their own making.
Wednesday, April 16, 2008
Merck - Vioxx: Psaty speaks
" In April 2001, Merck conducted high-quality analyses that identified a three-fold increase in the risk of deaths for patients taking Vioxx compared to those taking placebo. These analyses were not submitted to the FDA or made public. When Merck submitted data to the FDA in July 2001, they used a counting method that minimized the appearance of any risk. The FDA looked at the data that was submitted in July and it was still of concern. In December, the FDA raised questions about the mortality findings. Merck simply dismissed the FDA concerns and was unable to discern any “compelling or clear safety issue” here.
By conventional scientific standards, a three-fold increase in death is a major safety issue. And failure of a sponsor to inform participants, investigators, the subjects of the study, the FDA, of the mortality findings violates the trust of the human subjects.
This information may well have been important to thousands of patients in April of 2001 who were taking Vioxx.
They may have decided not to take it. "
MSNBC
Tuesday, April 15, 2008
Merck - Vioxx: it just won't go away
Merck suppressed evidence that its withdrawn arthritis pill Vioxx could harm patients, U.S. researchers charged on Tuesday.
An analysis of court documents suggests Merck knew about the problems years before it acted, the researchers report in the Journal of the American Medical Association.
They charge that Merck failed to disclose an internal analysis that found Alzheimer's patients taking Vioxx had a three times greater risk of death than patients taking a placebo.
"This is a major, serious safety signal," said Dr. Bruce Psaty of the University of Washington in Seattle, whose study compared internal Merck documents with data submitted to the U.S. Food and Drug Administration and published research.
"If these findings had been reported publicly in April of 2001, it is likely that many fewer patients would have chosen to use Vioxx and probably many fewer would have been injured," Psaty said in a telephone interview.
More at Reuters
An analysis of court documents suggests Merck knew about the problems years before it acted, the researchers report in the Journal of the American Medical Association.
They charge that Merck failed to disclose an internal analysis that found Alzheimer's patients taking Vioxx had a three times greater risk of death than patients taking a placebo.
"This is a major, serious safety signal," said Dr. Bruce Psaty of the University of Washington in Seattle, whose study compared internal Merck documents with data submitted to the U.S. Food and Drug Administration and published research.
"If these findings had been reported publicly in April of 2001, it is likely that many fewer patients would have chosen to use Vioxx and probably many fewer would have been injured," Psaty said in a telephone interview.
More at Reuters
Monday, April 16, 2007
Merck - Arcoxia: "clearly killing people" in Europe says Graham
Food and Drug Administration whistle-blower David Graham isn't giving up.
He's not content with helping to keep Merck's drug Arcoxia (the son or daughter Vioxx, depending upon who you read) off just the U.S. market, because that still leaves 63 countries in which the arthritis medication is sold.
Graham, of the agency's Office of Surveillance and Epidemiology, warned an FDA advisory panel Thursday that Arcoxia would be "a potential public-health disaster" because it raises heart attack and stroke risk. The panel voted 20 to 1 against recommending approval of Arcoxia, which critics have likened to Vioxx, the arthritis drug Merck withdrew in September 2004 because of cardiovascular safety concerns.
The FDA typically follows the advice of its advisory panels.
Graham said Friday that he wants to figure out how many extra strokes and heart attacks may have occurred in Europe since Arcoxia went on the market there in 2004. "I'm hoping that in Europe they reconsider this drug," he said. "It's clearly killing people."
More from Rita Rubin in USA Today
Graham, of the agency's Office of Surveillance and Epidemiology, warned an FDA advisory panel Thursday that Arcoxia would be "a potential public-health disaster" because it raises heart attack and stroke risk. The panel voted 20 to 1 against recommending approval of Arcoxia, which critics have likened to Vioxx, the arthritis drug Merck withdrew in September 2004 because of cardiovascular safety concerns.
The FDA typically follows the advice of its advisory panels.
Graham said Friday that he wants to figure out how many extra strokes and heart attacks may have occurred in Europe since Arcoxia went on the market there in 2004. "I'm hoping that in Europe they reconsider this drug," he said. "It's clearly killing people."
More from Rita Rubin in USA Today
Monday, October 02, 2006
Merck - Vioxx/Arcoxia:busted again!
The UK wing of drugmaker Merck has been reprimanded for breaching industry ethical guidelines by entertaining a group of healthcare professionals at a Chinese restaurant.
Photographs from an anonymous complainant showed a representative from Merck Sharp & Dohme dining with nine doctors and a pharmacist on a Friday evening. Two of the doctors' wives were also present.
The 'meeting' drew admonishment from the Prescription Medicines Code of Practice Authority. Its panel questioned Merck's claims that the discussion concerned guidelines dealing with non-steroidal anti-inflammatories and Cox-2 inhibitors.
It judged that the session had no "clear educational content" and that it was conducted in "an unsuitable venue". Details of the indiscretion have been advertised in the trade press in the first use of new PMCPA sanctions introduced this year.
Insider's view: Busted again! And this on the day they've been drummed out of their own club!
It makes Insider wonder if we are dealing with more than just a few bad apples here! This is the usual excuse that companies put forward to protect the "higher-ups".
Monday, September 18, 2006
Merck - Vioxx: no reserves for liability SEC told
Merck has told the SEC that it has not established any reserves for potential liability relating to Vioxx lawsuits or investigations, including for those cases in which a verdict has been entered against the company and which are now in post-verdict proceedings or on appeal.
The company has filed with SEC on August 7, 2006, that its insurance coverage with respect to Vioxx lawsuits will not be adequate to cover defense costs and any losses.
Merck has product liability insurance for claims brought in Vioxx Product Liability Lawsuits with upper limits of about $630 million after deductibles and co-insurance.
Source
The company has filed with SEC on August 7, 2006, that its insurance coverage with respect to Vioxx lawsuits will not be adequate to cover defense costs and any losses.
Merck has product liability insurance for claims brought in Vioxx Product Liability Lawsuits with upper limits of about $630 million after deductibles and co-insurance.
Source
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