Shhh! Can't say who!
Thursday, January 31, 2008
Vytorin - There's none so blind....
As those who choose not to see!
If the treatment effect was nil, would the blinded data from ENHANCE have foretold the results of the surrogate-end-point trial?
Some imaging experts say yes!
If the treatment effect was nil, would the blinded data from ENHANCE have foretold the results of the surrogate-end-point trial?
Some imaging experts say yes!
Sanofi Aventis - Ketek: subpoenas ahoy!
Another chapter in the tale of Sanofi-Aventis’ Ketek has opened with the news that the US Congress is to subpoena documents from members of the government and the Food and Drug Administration in connection with a review of the controversial antibiotic.
The House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations has voted 12-0 to approve a motion to subpoena FDA officials over clinical trial data for Ketek (telithromycin), which the agency approved in 2004 despite claims that a key safety trial, known as Study 3014, involved fraudulent data.
Reports of severe liver damage and death in some Ketek users emerged in 2006 and the FDA withdrew Ketek's approval for sinusitis and bronchitis in 2007. However, Sanofi still sells the drug as a treatment for pneumonia.
The subcommittee also unanimously approved a subpoena to the Secretary of the Department of Health and Human Resources Michael Leavitt, for documents related to the briefing book and other materials used to prepare FDA Commissioner Andrew von Eschenbach for testimony given on March 22, 2007. John Dingell (Republican), chairman of the Committee on Energy and Commerce, said that officials at the HHS and FDA “failed to identify a single legal argument to support their attempt to limit the committee’s ability to conduct a thorough and fair investigation of the Ketek matter”.
Chairman of the subcommittee Bart Stupak (Democrat) added that it is important to ascertain what the FDA and Sanofi knew “and when they knew it regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake”.
He added that “the accuracy of testimony by Commissioner von Eschenbach last year regarding the approval of Ketek must also be answered”, claiming that “one would think the Commissioner would be eager to discover the truth, but instead, he has resisted our request for his briefing documents”.
Source:PharmaTimes
The House Energy and Commerce Committee’s Subcommittee on Oversight and Investigations has voted 12-0 to approve a motion to subpoena FDA officials over clinical trial data for Ketek (telithromycin), which the agency approved in 2004 despite claims that a key safety trial, known as Study 3014, involved fraudulent data.
Reports of severe liver damage and death in some Ketek users emerged in 2006 and the FDA withdrew Ketek's approval for sinusitis and bronchitis in 2007. However, Sanofi still sells the drug as a treatment for pneumonia.
The subcommittee also unanimously approved a subpoena to the Secretary of the Department of Health and Human Resources Michael Leavitt, for documents related to the briefing book and other materials used to prepare FDA Commissioner Andrew von Eschenbach for testimony given on March 22, 2007. John Dingell (Republican), chairman of the Committee on Energy and Commerce, said that officials at the HHS and FDA “failed to identify a single legal argument to support their attempt to limit the committee’s ability to conduct a thorough and fair investigation of the Ketek matter”.
Chairman of the subcommittee Bart Stupak (Democrat) added that it is important to ascertain what the FDA and Sanofi knew “and when they knew it regarding fraud in the pivotal safety trial for Ketek. The integrity of the drug approval process is at stake”.
He added that “the accuracy of testimony by Commissioner von Eschenbach last year regarding the approval of Ketek must also be answered”, claiming that “one would think the Commissioner would be eager to discover the truth, but instead, he has resisted our request for his briefing documents”.
Source:PharmaTimes
Just to avoid confusion
The story seems to be very popular with US medical school departments, judging by PharmaGossip's stat counter!
Viva Zyprexa! - Lilly have some nerve
How might one define hypocrisy?
Lilly's CEO-in-waiting chides the NYT whilst at the same time trying to settle with federal prosecutors for $1 billion!
Lilly's CEO-in-waiting chides the NYT whilst at the same time trying to settle with federal prosecutors for $1 billion!
GSK - Avandia: Dr Haffner is busted
A leading member of the Senate said Wednesday that a prominent diabetes expert had leaked an unpublished and confidential medical journal article to GlaxoSmithKline last year, tipping the company to the imminent publication of safety questions involving the company’s diabetes drug Avandia.The expert, Dr. Steven M. Haffner of the University of Texas Health Science Center in San Antonio, faxed the article to the drug maker after agreeing to read it as part of the peer-review process for The New England Journal of Medicine, according to a statement Wednesday by Senator Charles E. Grassley, Republican of Iowa.
“The most troubling aspect of this situation is that the integrity of another aspect of the scientific process is called into question — scientific peer review,” Mr. Grassley’s statement said. The peer-review process, he said, is meant to ensure “that other scientists will judge a study’s quality before it is made public.”
Read more from Stephanie Saul at the NYT here.
“The three major medical journals are becoming more like British tabloid newspapers. All they lack is a bare-chested woman on Page 3,” Dr. Haffner was quoted as saying.
In San Antonio, medical school dean William L. Henrich also issued a statement, saying: "This issue has just come to light on our campus. We are embarking on a complete investigation of the facts. Once the facts are understood, we will take swift and appropriate action."
Haffner was a co-author of a 2006 New England Journal article that was highly supportive of Avandia. In that study, financed by GlaxoSmithKline, Haffner reported receiving grant support and consulting and lecture fees from the company.
Busted - Dr Haffner!
Wednesday, January 30, 2008
Vytorin contd. - Merck's Dick Clark has a message
The chief executive of Merck has told Reuters that negative media coverage of the ENHANCE trial of the company's blockbuster Vytorin cholesterol drug has unfairly overlooked benefits of the medicine.
"With media hype, there is a great deal of confusion," Richard Clark told analysts in a conference call after release of the drugmaker's fourth-quarter earnings.
"There are no better products in lowering LDL than Vytorin and Zetia," Clark said.
"With media hype, there is a great deal of confusion," Richard Clark told analysts in a conference call after release of the drugmaker's fourth-quarter earnings.
"There are no better products in lowering LDL than Vytorin and Zetia," Clark said.
Insider's view: thanks Dick. Now please explain what exactly the benefits of Vytorin are?
In Insider's book there is a pecking order of clinical trial end points:
Top: Hard end points ( like death, heart attacks and strokes - you know, Dick, like the ones Vioxx caused). Good data - but long studies. We dont know what Vytorin does for these end points.
Middle: Surrogate end points ( like the ones in ENHANCE ) - often used to get indicative data of positive effects faster. We know know that the ezetimibe in Vytorin HAS FAILED to improve these any more than simvastatin alone.
Bottom: Biomarker end points (like BP, blood cholesterol levels etc.) - this was all that Vytorin was shown to improve when it got a licence from the FDA. Maybe they should reconsider that?
So, Dick, tell me the benefits of Vytorin! Other than it's sales might help Merck pay off the Vioxx settlements!
Statins - who needs them and why?
The NYT's Tara Parker Pope investigates:
But many statin users don’t have established heart disease; they simply have high cholesterol. For healthy men, for women with or without heart disease and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.
“High-risk groups have a lot to gain,” said Dr. Mark H. Ebell, a professor at the University of Georgia who is deputy editor of the journal American Family Physician. “But patients at low risk benefit very little if at all. We end up overtreating a lot of patients.” (Like the other doctors quoted in this column, Dr. Ebell has no ties to drug makers.)
How is this possible, if statins lower the risk of heart attack? Because preventing a heart attack is not the same thing as saving a life. In many statin studies that show lower heart attack risk, the same number of patients end up dying, whether they are taking statins or not.
“You may have helped the heart, but you haven’t helped the patient,” said Dr. Beatrice Golomb, an associate professor of medicine at the University of California, San Diego, and a co-author of a 2004 editorial in The Journal of the American College of Cardiology questioning the data on statins. “You still have to look at the impact on the patient over all.”
A 2006 study in The Archives of Internal Medicine looked at seven trials of statin use in nearly 43,000 patients, mostly middle-aged men without heart disease. In that review, statins didn’t lower mortality.
Nor did they in a study called PROSPER, published in The Lancet in 2002, which studied statin use in people 70 and older. Nor did they in a 2004 review in The Journal of the American Medical Association, which looked at 13 studies of nearly 20,000 women, both healthy and with established heart disease.
More
Let's put it another way.
Do you like to gamble?
“What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising?” asks Jerome Hoffman, professor of clinical medicine at the University of California at Los Angeles.
“How many would take that?”
How many indeed?
Finally take a look at this:
Dr Malcolm Kendrick is a controversial "cholesterol theory sceptic".
Bottom line. Insider thinks that statins might help some people. But they certainly should not be put in the tapwater!
He also is open to argument and discussion.
But many statin users don’t have established heart disease; they simply have high cholesterol. For healthy men, for women with or without heart disease and for people over 70, there is little evidence, if any, that taking a statin will make a meaningful difference in how long they live.
“High-risk groups have a lot to gain,” said Dr. Mark H. Ebell, a professor at the University of Georgia who is deputy editor of the journal American Family Physician. “But patients at low risk benefit very little if at all. We end up overtreating a lot of patients.” (Like the other doctors quoted in this column, Dr. Ebell has no ties to drug makers.)
How is this possible, if statins lower the risk of heart attack? Because preventing a heart attack is not the same thing as saving a life. In many statin studies that show lower heart attack risk, the same number of patients end up dying, whether they are taking statins or not.
“You may have helped the heart, but you haven’t helped the patient,” said Dr. Beatrice Golomb, an associate professor of medicine at the University of California, San Diego, and a co-author of a 2004 editorial in The Journal of the American College of Cardiology questioning the data on statins. “You still have to look at the impact on the patient over all.”
A 2006 study in The Archives of Internal Medicine looked at seven trials of statin use in nearly 43,000 patients, mostly middle-aged men without heart disease. In that review, statins didn’t lower mortality.
Nor did they in a study called PROSPER, published in The Lancet in 2002, which studied statin use in people 70 and older. Nor did they in a 2004 review in The Journal of the American Medical Association, which looked at 13 studies of nearly 20,000 women, both healthy and with established heart disease.
More
Let's put it another way.
Do you like to gamble?
“What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising?” asks Jerome Hoffman, professor of clinical medicine at the University of California at Los Angeles.
“How many would take that?”
How many indeed?
Finally take a look at this:
Dr Malcolm Kendrick is a controversial "cholesterol theory sceptic".
Bottom line. Insider thinks that statins might help some people. But they certainly should not be put in the tapwater!
He also is open to argument and discussion.
Homoeopathy - the end is nigh!
At long last UK NHS primary care trusts are slashing funding for homoeopathic treatment amid debate about its efficacy and the drive to cuts costs, a study has suggested.
More than a quarter have stopped or cut funding for such services, research by the GP magazine Pulse has found.
The Royal London Homoeopathic Hospital, the country's largest, confirms it has lost eight contracts in a year and referrals are down by 20%.
The investigation into 132 primary care trusts found only 37% still have contracts for homoeopathic services and referrals are decreasing.
More at the BBC
Insider's view: Great, let's get this mumbo jumbo out of the NHS. Patients should feel free to waste their own private funds if they wish - but not public funds!
More than a quarter have stopped or cut funding for such services, research by the GP magazine Pulse has found.
The Royal London Homoeopathic Hospital, the country's largest, confirms it has lost eight contracts in a year and referrals are down by 20%.
The investigation into 132 primary care trusts found only 37% still have contracts for homoeopathic services and referrals are decreasing.
More at the BBC
Insider's view: Great, let's get this mumbo jumbo out of the NHS. Patients should feel free to waste their own private funds if they wish - but not public funds!
FDA - Hear hear!
All is not well at the FDA.
Commish Andy had to listen to four hours of "critique".
“I think we’ve had a cascade of serious warning signs that the levies are leaking,” Garret. FitzGerald of the University of Pennsylvania, a member of the agency’s Science Board, tells the paper. “We need to respond to these warnings before the hurricane hits.”
The possibility of dangerous side effects from medications is too strong to continue to ignore. This is the life-saving truth the Food and Drug Administration has finally acknowledged, after years of significant anecdotal evidence.
Drug makers are now being required to follow a specific regimen to determine if patients become suicidal during clinical trials, the ground zero for pre-market testing.
Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and other conditions will be required to perform a comprehensive assessment to determine suicide predictability.
The assessment was developed after top agency officials discounted claims that antidepressants cause some children and teenagers to become suicidal. But a lingering unease developed as cases have grown in recent years. Columbia University's department of psychiatry was commissioned to reanalyze the clinical trials of specific drugs. The possibility of a link was impossible to ignore.
Determining the predictability of the side effects will not only provide a chance to deter their occurrence. It also shifts the costs of averting the problem to manufacturers.
Source
Insider's view: Cheer up Andy. Insider has a plan.
Commish Andy had to listen to four hours of "critique".
“I think we’ve had a cascade of serious warning signs that the levies are leaking,” Garret. FitzGerald of the University of Pennsylvania, a member of the agency’s Science Board, tells the paper. “We need to respond to these warnings before the hurricane hits.”
The possibility of dangerous side effects from medications is too strong to continue to ignore. This is the life-saving truth the Food and Drug Administration has finally acknowledged, after years of significant anecdotal evidence.
Drug makers are now being required to follow a specific regimen to determine if patients become suicidal during clinical trials, the ground zero for pre-market testing.
Makers of drugs to treat obesity, urinary incontinence, epilepsy, smoking cessation, depression and other conditions will be required to perform a comprehensive assessment to determine suicide predictability.
The assessment was developed after top agency officials discounted claims that antidepressants cause some children and teenagers to become suicidal. But a lingering unease developed as cases have grown in recent years. Columbia University's department of psychiatry was commissioned to reanalyze the clinical trials of specific drugs. The possibility of a link was impossible to ignore.
Determining the predictability of the side effects will not only provide a chance to deter their occurrence. It also shifts the costs of averting the problem to manufacturers.
Source
Insider's view: Cheer up Andy. Insider has a plan.
Tuesday, January 29, 2008
Crestor vs Vytorin - John Mack spots the irony
Who says Americans can't "do irony"!
John Mack has a great post about AZ trying to replace Vytorin with Crestor!
The irony:
The ENHANCE and METEOR studies are similar in one respect: each studied only a few hundred people over a limited time period. Merck and Schering-Plough are trying to say we shouldn't place too much emphasis on a clinical trial involving only a few hundred people. Yet, a clinical trial involving only a few hundred people was good enough for the FDA to approve a new Crestor indication worth hundred of millions of dollars to AstraZeneca!
Hmm!
Maybe the FDA should rethink that Crestor indication!
John Mack has a great post about AZ trying to replace Vytorin with Crestor!
The irony:
The ENHANCE and METEOR studies are similar in one respect: each studied only a few hundred people over a limited time period. Merck and Schering-Plough are trying to say we shouldn't place too much emphasis on a clinical trial involving only a few hundred people. Yet, a clinical trial involving only a few hundred people was good enough for the FDA to approve a new Crestor indication worth hundred of millions of dollars to AstraZeneca!
Hmm!
Maybe the FDA should rethink that Crestor indication!
Atrazine - the truth now has it's boots on
Fascinating!
"From Silent Spring to Silent Night," a talk by Prof. Tyrone Hayes, Department of Integrative Biology,University of California, Berkeley, given at Humphrey Institute in Minneapolis on March 23, 2007.
Dr. Hayes is an authority on the effects of the pesticide atrazine on frogs, and is not popular with chemical companies for his views and proven research.
Hat tip: http://leiaorotulo.blogspot.com/
Schering Plough - Peter Rost is "smokin'"
This is a "must read"!
Schering-Plough’s CEO Fred Hassan has two years left to retirement as he faces the most serious challenge to his personal legacy: One failed trial, two Congressional investigations, subpoenas from the New York State Attorney General, an SEC investigation, and a brutal 40% drop in Schering-Plough stock price from its peak.
Until a few weeks ago Hassan was God's gift to the pharmaceutical industry (according to Forbes).
But was it all just a mirage--a skillfully played con-game?
More
Schering-Plough’s CEO Fred Hassan has two years left to retirement as he faces the most serious challenge to his personal legacy: One failed trial, two Congressional investigations, subpoenas from the New York State Attorney General, an SEC investigation, and a brutal 40% drop in Schering-Plough stock price from its peak.
Until a few weeks ago Hassan was God's gift to the pharmaceutical industry (according to Forbes).
But was it all just a mirage--a skillfully played con-game?
More
Shire - Vyvance: a lack of attention?
Shire, Britain’s third largest drug-maker, slid to a two-year low on the back of concerns about demand for Vyvanse, its treatment for attention deficit hyperactivity disorder in children.
Investment research house Sanford Bernstein cut its recommendation to “underperform” from “market perform” and slashed its target price to 910p from £11.20. Analyst Jack Scannell noted that Vyvanse held the key to the company’s future prospects, as it was likely to generate around a third of revenues by 2011.
“However, consensus numbers are only achievable if the Vyvanse launch accelerates substantially after a relatively slow first seven months,” he noted. Shire’s shares ended down 43½ at 946½p.
Daily Telegraph
Investment research house Sanford Bernstein cut its recommendation to “underperform” from “market perform” and slashed its target price to 910p from £11.20. Analyst Jack Scannell noted that Vyvanse held the key to the company’s future prospects, as it was likely to generate around a third of revenues by 2011.
“However, consensus numbers are only achievable if the Vyvanse launch accelerates substantially after a relatively slow first seven months,” he noted. Shire’s shares ended down 43½ at 946½p.
Daily Telegraph
Big Pharma's Big Problem contd. - "an entire generation" laid off
2007 was a brutal one for layoffs in Big Pharma.
With revenues under pressure across the sector, expect those big job cuts to continue, said Regent Atlantic Capital in a recent report, "The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities." "No one can precisely predict how many additional people will be displaced," the report states.
Two pharmaceutical industry CEOs interviewed for the report (and granted anonymity) believe that "an entire generation" of upper-middle and senior-level executives -- as many as 50,000 individuals -- will be displaced. Add that number to the 86,000 layoffs the pharma industry witnessed from 2003 to 2006.
More
With revenues under pressure across the sector, expect those big job cuts to continue, said Regent Atlantic Capital in a recent report, "The Continuing Evolution of the Pharmaceutical Industry: Career Challenges and Opportunities." "No one can precisely predict how many additional people will be displaced," the report states.
Two pharmaceutical industry CEOs interviewed for the report (and granted anonymity) believe that "an entire generation" of upper-middle and senior-level executives -- as many as 50,000 individuals -- will be displaced. Add that number to the 86,000 layoffs the pharma industry witnessed from 2003 to 2006.
More
Vytorin - all aboard the bandwaggon
Connecticut Attorney General Richard Blumenthal (right) announced that his state will also be investigating Merck and Schering-Plough's behavior relating to cholesterol blockbuster Vytorin, adding to the list of government entities probing aspects of the drug's marketing.
Monday, January 28, 2008
Great quote
Sometimes I think the surest sign that intelligent life exists elsewhere in the universe is that none of it has tried to contact us.
Bill Watterson
Bill Watterson
Sanofi - Aventis - idraparinux: bleeding clinical trials
Sanofi-Aventis' experimental stroke drug idraparinux caused more bleeding in some patients than a standard treatment in a study stopped ahead of schedule in 2005, researchers writing in The Lancet said.
Patients in the late-stage trial had ``significantly'' more bleeding after an injection of the medicine than those taking a standard oral blood-thinner, scientist Harry Bueller from the Academic Medical Centre in Amsterdam said in The Lancet. France's largest drugmaker has adapted the therapy to address the problem.
``There was some imbalance in the safety aspects, but also a lower-than-expected event rate in the group taking the medicine,'' Salah Mahyaoui, a Sanofi spokesman, said yesterday in a telephone interview from Paris. ``Altogether this led to the safety board to recommend an earlier termination.''
Paris-based Sanofi is adjusting the dosing to tackle the bleeding problems that emerged primarily in older patients and in those with kidney problems. They've also added a substance, which doesn't change the structure of idraparinux or the way it works, that will enable doctors to switch off the treatment's anti-clotting mechanism. Sanofi needs products to spur growth after U.S. regulators rejected its Acomplia obesity medicine and as older products face generic competition.
More at Bloomberg
Patients in the late-stage trial had ``significantly'' more bleeding after an injection of the medicine than those taking a standard oral blood-thinner, scientist Harry Bueller from the Academic Medical Centre in Amsterdam said in The Lancet. France's largest drugmaker has adapted the therapy to address the problem.
``There was some imbalance in the safety aspects, but also a lower-than-expected event rate in the group taking the medicine,'' Salah Mahyaoui, a Sanofi spokesman, said yesterday in a telephone interview from Paris. ``Altogether this led to the safety board to recommend an earlier termination.''
Paris-based Sanofi is adjusting the dosing to tackle the bleeding problems that emerged primarily in older patients and in those with kidney problems. They've also added a substance, which doesn't change the structure of idraparinux or the way it works, that will enable doctors to switch off the treatment's anti-clotting mechanism. Sanofi needs products to spur growth after U.S. regulators rejected its Acomplia obesity medicine and as older products face generic competition.
More at Bloomberg
Séance - Feb 27th, London
European Medical Writers Association and Institute of Clinical Research are delighted to invite you to their first joint symposium. The theme is the “hot topic” of the ethical minefield of publishing clinical trial results.
Patients nowadays wish to have more and more information about their medicines, and the pharmaceutical industry is obliged to improve transparency regarding clinical research programmes. It is more important than ever for pharmaceutical companies to understand their ethical imperatives.
Journal editors are faced with the constant challenge of ensuring that high standards of ethicsand transparency are met. Recent guidelines have helped to define the role of medical writers, but their involvement remains controversial. These are just some of the topics that will be presented and discussed during this exciting one-day event.
The Programme
9.15 Registration
9.45-10.10 Publications: Purpose and Process
Dr Julia Donnelly, Julia Donnelly Solutions Ltd
10.10-10.40 Fraud in Publications
Dr Harvey Marcovitch,
Chairman, Committee on Publication Ethics
10.40-11.10 Authorship, Guests and Ghosts
Elise Langdon-Neuner, Director of Preclinical
Documents & Scientific Communications,
Baxter BioScience, Austria
11.10-11.30 Break
11.30-12:00 Ghostwriting: What’s the Problem?
Professor David Healey, Professor of Psychiatry,
Cardiff University
12.00-12.30 Panel discussion with Q&A
12.30-14.00 Lunch
14.00-14.30 A Journal Editor’s Perspective of Industry
Practices
Dr Trish Groves, Deputy Editor, British Medical
Journal
14.30-15.00 Publication Policies: Why Every Company
Needs One
Liz Wager, Publications Consultant, Sideview
15.00-15.20 Break
15.20-15.50 The View from ‘Big Pharma’
Dr Valerie Siddall, Global Director of Publications,
AstraZeneca
15.50-16.20 Panel discussion with Q&A
16.20-16.30 Conference wrap up
Adam Jacobs, Director, Dianthus Medical Ltd
Bring your own Ouija Board.
Patients nowadays wish to have more and more information about their medicines, and the pharmaceutical industry is obliged to improve transparency regarding clinical research programmes. It is more important than ever for pharmaceutical companies to understand their ethical imperatives.
Journal editors are faced with the constant challenge of ensuring that high standards of ethicsand transparency are met. Recent guidelines have helped to define the role of medical writers, but their involvement remains controversial. These are just some of the topics that will be presented and discussed during this exciting one-day event.
The Programme
9.15 Registration
9.45-10.10 Publications: Purpose and Process
Dr Julia Donnelly, Julia Donnelly Solutions Ltd
10.10-10.40 Fraud in Publications
Dr Harvey Marcovitch,
Chairman, Committee on Publication Ethics
10.40-11.10 Authorship, Guests and Ghosts
Elise Langdon-Neuner, Director of Preclinical
Documents & Scientific Communications,
Baxter BioScience, Austria
11.10-11.30 Break
11.30-12:00 Ghostwriting: What’s the Problem?
Professor David Healey, Professor of Psychiatry,
Cardiff University
12.00-12.30 Panel discussion with Q&A
12.30-14.00 Lunch
14.00-14.30 A Journal Editor’s Perspective of Industry
Practices
Dr Trish Groves, Deputy Editor, British Medical
Journal
14.30-15.00 Publication Policies: Why Every Company
Needs One
Liz Wager, Publications Consultant, Sideview
15.00-15.20 Break
15.20-15.50 The View from ‘Big Pharma’
Dr Valerie Siddall, Global Director of Publications,
AstraZeneca
15.50-16.20 Panel discussion with Q&A
16.20-16.30 Conference wrap up
Adam Jacobs, Director, Dianthus Medical Ltd
Bring your own Ouija Board.
The Whytorin Saga - Forbes' Matt Herper gets a letter
Here is a letter Schering Plough's Ken Banta sent on Friday to Matt Herper, Associate Editor at Forbes demanding corrections and apologies for this story that ran in the magazine about the ENHANCE study, Schering-Plough, and CEO Fred Hassan.
Matt,
Thanks for discussing the articles on Schering-Plough and our CEO that ran today in Forbes.
From our call this morning, you know how disturbed we are about some inaccuracies and unfair portrayals in the piece -- and I appreciate after talking with you that many of these were the result of editing decisions that you did not control.
These wrongly damage our company reputation and the reputation of our CEO.
They also misinform your readers on medical matters, many of whom are surely taking cholesterol medications and could be frightened into bad decisions.
I know you were on the FDA call this afternoon. I think what those experts had to say was an eloquent and authoritative answer to a lot of the criticisms and tonalities in the Forbes story.
I assume you will get the transcript of that FDA discussion and can compare what those experts said point by point with what your story said.
In brief I heard unequivocally - Lower LDL IS better, -it is not at all uncommon for a complex trial to take a long time to read out, -it is not uncommon or wrong for there to be contemplation of an endpoint change or an actual change in endpoint before a trial is unblinded,
-that there are lots of reasons to question the validity of imaging studies given the contradictory results of these studies with statins which have a proven cardiovascular outcomes benefit,
-that it is outcomes studies that matter and that is why IMPROVE-IT is the study that will matter.
Let me summarize the main concerns that we feel should be redressed immediately in online form and as corrections and amplifications in the next print issue.
Starting with the second paragraph and throughout the piece, the story wrongly states or implies that the Enhance trial and its handling were the sole responsibility of our CEO Fred Hassan (as in 'Then he botched the handling of a study…') when in fact this trial and every aspect of its handling are the joint responsibility of Merck and its CEO and Schering-Plough through their joint venture, including the funding and supervision and 'handling' of the Enhance study. Nowhere in the story is the joint-venture relationship properly stated. It is my understanding that language clarifying this that may have been in a previous draft of the story was deleted by editors. This needs a correction and an amplification.
Your story says the study raises doubts about Zetia's effectiveness. The study does not raise doubts about Zetia's effectiveness. Your story is incorrect and misleading and as the FDA panel stated the effectiveness of Zetia and Vytorin in lowering LDL cholesterol is demonstrated. What the study is inconclusive on is effect on thickness of the arterial wall -- which may have no correlation to cardiovascular events. This needs a correction.
' The excuses are thin. Either..or" There was not an either or. There were many, many possible reasons why the study did not happen on the anticipated time frame. Read the FDA transcript for details. This needs a correction.
"..case reveals the ugly reality of the pharma business…" This paragraph is unsupported by anything in the article and is not even supported by the casual references to other drugs mentioned. I.E. Zetia and Vytorin are based on new high innovation and Detrol was also a breakthrough new molecule, and so is Sugammadex featured in the sidebar story. I can only assume it was not written by you -- but it did appear in this article and it hurts us. This needs a correction and amplification as an editing error or misstatement.
"Now this delayed study shows that even pharma's Mr. Fix-It can't run a straightforward operation." This is incorrect and unfair -- as the FDA commentary reflects there is no reason to believe the time it took to report topline findings was out of line and it is accusing our CEO of running deliberately deceptive organization. This is unacceptable and it needs a correction and an apology.
Matt, those are the specific points. More broadly I would also say that I was surprised by the tone of some of this piece that again, seemed out of character with your usually careful and balanced tone. There is a cavalier and dismissive tone to many of the sentences and paragraphs that is inappropriate, and I think you can understand why Fred Hassan would be personally disturbed by this treatment of comments that he made to you in good faith.
Matt, I would also appreciate knowing whom to contact on this at the editorial level.
Your response and that of your editors meantime to these points and the actions Forbes will take to correct and improve and apologize will be appreciated.
Sincerely
Ken Banta
Strategic Affairs
Schering-Plough Corporation
Insider's view: Wow! Looks like a nerve was touched.
Let's just contemplate on what Schering Plough would have been saying about ENHANCE had the result been positive for Vytorin.
Insider guesses there could be documents and meeting notes inside S-P and Merck that might help us with that thought!
Matt,
Thanks for discussing the articles on Schering-Plough and our CEO that ran today in Forbes.
From our call this morning, you know how disturbed we are about some inaccuracies and unfair portrayals in the piece -- and I appreciate after talking with you that many of these were the result of editing decisions that you did not control.
These wrongly damage our company reputation and the reputation of our CEO.
They also misinform your readers on medical matters, many of whom are surely taking cholesterol medications and could be frightened into bad decisions.
I know you were on the FDA call this afternoon. I think what those experts had to say was an eloquent and authoritative answer to a lot of the criticisms and tonalities in the Forbes story.
I assume you will get the transcript of that FDA discussion and can compare what those experts said point by point with what your story said.
In brief I heard unequivocally - Lower LDL IS better, -it is not at all uncommon for a complex trial to take a long time to read out, -it is not uncommon or wrong for there to be contemplation of an endpoint change or an actual change in endpoint before a trial is unblinded,
-that there are lots of reasons to question the validity of imaging studies given the contradictory results of these studies with statins which have a proven cardiovascular outcomes benefit,
-that it is outcomes studies that matter and that is why IMPROVE-IT is the study that will matter.
Let me summarize the main concerns that we feel should be redressed immediately in online form and as corrections and amplifications in the next print issue.
Starting with the second paragraph and throughout the piece, the story wrongly states or implies that the Enhance trial and its handling were the sole responsibility of our CEO Fred Hassan (as in 'Then he botched the handling of a study…') when in fact this trial and every aspect of its handling are the joint responsibility of Merck and its CEO and Schering-Plough through their joint venture, including the funding and supervision and 'handling' of the Enhance study. Nowhere in the story is the joint-venture relationship properly stated. It is my understanding that language clarifying this that may have been in a previous draft of the story was deleted by editors. This needs a correction and an amplification.
Your story says the study raises doubts about Zetia's effectiveness. The study does not raise doubts about Zetia's effectiveness. Your story is incorrect and misleading and as the FDA panel stated the effectiveness of Zetia and Vytorin in lowering LDL cholesterol is demonstrated. What the study is inconclusive on is effect on thickness of the arterial wall -- which may have no correlation to cardiovascular events. This needs a correction.
' The excuses are thin. Either..or" There was not an either or. There were many, many possible reasons why the study did not happen on the anticipated time frame. Read the FDA transcript for details. This needs a correction.
"..case reveals the ugly reality of the pharma business…" This paragraph is unsupported by anything in the article and is not even supported by the casual references to other drugs mentioned. I.E. Zetia and Vytorin are based on new high innovation and Detrol was also a breakthrough new molecule, and so is Sugammadex featured in the sidebar story. I can only assume it was not written by you -- but it did appear in this article and it hurts us. This needs a correction and amplification as an editing error or misstatement.
"Now this delayed study shows that even pharma's Mr. Fix-It can't run a straightforward operation." This is incorrect and unfair -- as the FDA commentary reflects there is no reason to believe the time it took to report topline findings was out of line and it is accusing our CEO of running deliberately deceptive organization. This is unacceptable and it needs a correction and an apology.
Matt, those are the specific points. More broadly I would also say that I was surprised by the tone of some of this piece that again, seemed out of character with your usually careful and balanced tone. There is a cavalier and dismissive tone to many of the sentences and paragraphs that is inappropriate, and I think you can understand why Fred Hassan would be personally disturbed by this treatment of comments that he made to you in good faith.
Matt, I would also appreciate knowing whom to contact on this at the editorial level.
Your response and that of your editors meantime to these points and the actions Forbes will take to correct and improve and apologize will be appreciated.
Sincerely
Ken Banta
Strategic Affairs
Schering-Plough Corporation
Insider's view: Wow! Looks like a nerve was touched.
Let's just contemplate on what Schering Plough would have been saying about ENHANCE had the result been positive for Vytorin.
Insider guesses there could be documents and meeting notes inside S-P and Merck that might help us with that thought!
Sunday, January 27, 2008
PhRMA's Johnson admits to "backlash"
"In a number of states across the country, there is backlash building against [pharma] sales and marketing," said Ken Johnson, senior VP for the Pharmaceutical Research and Manufacturers of America. "This isn't five years ago. There are new challenges with respect to safety, to sales and marketing, to a wide range of issues. We represent some very smart people that recognize the world doesn't stand still."
The pharmaceutical industry is finally acknowledging that it needs a new marketing prescription after a perfect storm of waning patience in Congress, incredulousness from the medical community and growing angst among a skeptical public.
It's all led the $5 billion direct-to-consumer ad business to concede it has a drug problem.
Big Pharma's Big Problem contd - a Hollywood view
For 25 years, the drug industry has imitated the basic business model of Hollywood. Pharmaceutical executives, like movie moguls, have focused on creating blockbusters. They introduce products that they hope will appeal to the masses, and then they promote them like mad. The strategy has created not only Fosamax and Lipitor but Prozac for depression, Nexium for heartburn and Viagra for sex.
Only now is it becoming clear that this business model couldn't work forever. The strategy had a flaw that executives have long ignored: It required extraordinary amounts of promotion at the expense of scientific creativity.
To make the strategy work, the drug industry put its marketers in charge; scientists were given a back seat. Is it any wonder that executives at many companies have watched their pipelines of new drugs slow to a trickle?
Melody Petersen in the LA Times
Only now is it becoming clear that this business model couldn't work forever. The strategy had a flaw that executives have long ignored: It required extraordinary amounts of promotion at the expense of scientific creativity.
To make the strategy work, the drug industry put its marketers in charge; scientists were given a back seat. Is it any wonder that executives at many companies have watched their pipelines of new drugs slow to a trickle?
Melody Petersen in the LA Times
Is the answer to put the scientists in charge, Insider asks?
Saturday, January 26, 2008
SiCKO gets Oscar nomination - a letter from Michael Moore
"Sicko" Gets the Oscar High-Five ...a note from Michael Moore
January 25, 2008
Friends,
I just wanted to drop you a note to let you know (if you didn't already) the good news that "Sicko" has been nominated for this year's Academy Award for Best Documentary. It was a pleasant surprise when we got the news on Tuesday.
Of course, every reporter who's called me in the past few days wanted to know if I plan on giving an "anti-war" or "anti-Bush" speech, should "Sicko" win, as I did when we won the Oscar for "Bowling for Columbine" in 2003.
(As you may recall, it was the 5th day of the war when those Oscars were held, and I said from the stage that, while I enjoy making nonfiction films, we live in fictitious times with a man of fiction in the White House. A ruckus ensued with a loud roar of cheers and boos, then someone cued the band to get me off the stage. As host Steve Martin said a few moments later, Teamsters were out back loading me into the trunk of a car.)
Well it's five years later and we are still at war. But there's no booing these days. 65% of the public is now opposed to the war and to Mr. Bush. The Academy, instead of cutting off the microphone, now nominates anti-war films for Best Documentary. That's right, three of the five nominees this year are Iraq War films!
I am very honored to be in this group of documentaries, three of which I brought last summer to our film festival in northern Michigan. "Taxi to the Dark Side" is a brutal examination of U.S. torture in Iraq and Afghanistan. "Operation Homecoming" has actors reading letters from soldiers in Iraq. "No End in Sight" has ex-Bush administration officials admitting how they messed up the occupation, lamenting how things would have been so much better if only Bush had put people in Baghdad who knew what they were doing (and wouldn't we all have loved to see THAT? Hahaha). And "War/Dance" tells the moving story of kids in a dance competition in war-torn Africa. A diverse group of films, and proof that nonfiction movies are stronger than ever.
A lot of people ask me, 'how does this whole Oscar voting thing work?' Well, actors nominate actors, directors nominate directors -- every branch essentially votes to nominate their own (including documentary filmmakers in my branch) -- and then all 6,000 Academy members vote for the Best Picture nominees. After the nominations are announced, then all 6,000 vote for all the categories.
Documentaries, though, have one special rule: The voters have to verify they have seen all five nominated films. As some of these films, unfortunately, don't have the distribution they deserve, special Academy members-only screenings of all five nominees are set up for this very purpose in the next few days in New York, and in the next couple of weeks in L.A. and elsewhere, and that's when any Academy member can vote for Best Documentary.
But will there be an Oscar show this year? As you know, the Writers Guild (of which I am a member) is on strike and the Oscars are a union show. If the strike isn't settled, they won't be able to put on the typical telecast as no actor, writer or anyone I know will cross the picket line. This is all happening because a couple of hotheads at the studios (some would say union-busting knuckleheads) have walked away from the negotiating table in what seems like an attempt to simply get rid of the union. What do they think we are, air traffic controllers?
The writers are only asking for about 2.5 cents out of every dollar made on Internet sales (that's right, not even 3 pennies!), a small pittance compared to what the studios or networks rake in. That's it. The union has dropped the demand to unionize the reality shows (in 1993, I created the first unionized reality show, "TV Nation," but the Writers Guild unfortunately wasn't able to build on this).
I would like to believe that the honchos will come to their senses and settle this strike.
Otherwise, I won't be able to talk to Joan Rivers on the red carpet or attend all those Oscar parties afterward! Don't make me suffer like this! My wardrobe and stylist people are already in tears.
In the meantime, I'll send you some pre-Super Tuesday thoughts next week. Thanks again for all your nice comments on the Oscar nod and I hope this extra attention on "Sicko" will help to push for the day when every American can go to the doctor or the hospital and never be asked "what's in your wallet?"
Yours,
Michael Moore
MMFlint@aol.com
MichaelMoore.com
January 25, 2008
Friends,
I just wanted to drop you a note to let you know (if you didn't already) the good news that "Sicko" has been nominated for this year's Academy Award for Best Documentary. It was a pleasant surprise when we got the news on Tuesday.
Of course, every reporter who's called me in the past few days wanted to know if I plan on giving an "anti-war" or "anti-Bush" speech, should "Sicko" win, as I did when we won the Oscar for "Bowling for Columbine" in 2003.
(As you may recall, it was the 5th day of the war when those Oscars were held, and I said from the stage that, while I enjoy making nonfiction films, we live in fictitious times with a man of fiction in the White House. A ruckus ensued with a loud roar of cheers and boos, then someone cued the band to get me off the stage. As host Steve Martin said a few moments later, Teamsters were out back loading me into the trunk of a car.)
Well it's five years later and we are still at war. But there's no booing these days. 65% of the public is now opposed to the war and to Mr. Bush. The Academy, instead of cutting off the microphone, now nominates anti-war films for Best Documentary. That's right, three of the five nominees this year are Iraq War films!
I am very honored to be in this group of documentaries, three of which I brought last summer to our film festival in northern Michigan. "Taxi to the Dark Side" is a brutal examination of U.S. torture in Iraq and Afghanistan. "Operation Homecoming" has actors reading letters from soldiers in Iraq. "No End in Sight" has ex-Bush administration officials admitting how they messed up the occupation, lamenting how things would have been so much better if only Bush had put people in Baghdad who knew what they were doing (and wouldn't we all have loved to see THAT? Hahaha). And "War/Dance" tells the moving story of kids in a dance competition in war-torn Africa. A diverse group of films, and proof that nonfiction movies are stronger than ever.
A lot of people ask me, 'how does this whole Oscar voting thing work?' Well, actors nominate actors, directors nominate directors -- every branch essentially votes to nominate their own (including documentary filmmakers in my branch) -- and then all 6,000 Academy members vote for the Best Picture nominees. After the nominations are announced, then all 6,000 vote for all the categories.
Documentaries, though, have one special rule: The voters have to verify they have seen all five nominated films. As some of these films, unfortunately, don't have the distribution they deserve, special Academy members-only screenings of all five nominees are set up for this very purpose in the next few days in New York, and in the next couple of weeks in L.A. and elsewhere, and that's when any Academy member can vote for Best Documentary.
But will there be an Oscar show this year? As you know, the Writers Guild (of which I am a member) is on strike and the Oscars are a union show. If the strike isn't settled, they won't be able to put on the typical telecast as no actor, writer or anyone I know will cross the picket line. This is all happening because a couple of hotheads at the studios (some would say union-busting knuckleheads) have walked away from the negotiating table in what seems like an attempt to simply get rid of the union. What do they think we are, air traffic controllers?
The writers are only asking for about 2.5 cents out of every dollar made on Internet sales (that's right, not even 3 pennies!), a small pittance compared to what the studios or networks rake in. That's it. The union has dropped the demand to unionize the reality shows (in 1993, I created the first unionized reality show, "TV Nation," but the Writers Guild unfortunately wasn't able to build on this).
I would like to believe that the honchos will come to their senses and settle this strike.
Otherwise, I won't be able to talk to Joan Rivers on the red carpet or attend all those Oscar parties afterward! Don't make me suffer like this! My wardrobe and stylist people are already in tears.
In the meantime, I'll send you some pre-Super Tuesday thoughts next week. Thanks again for all your nice comments on the Oscar nod and I hope this extra attention on "Sicko" will help to push for the day when every American can go to the doctor or the hospital and never be asked "what's in your wallet?"
Yours,
Michael Moore
MMFlint@aol.com
MichaelMoore.com
Friday, January 25, 2008
Whytorin - Spotlight on Schering Plough's Fred Hassan
Forbes' Matt Herper looks closely at Fred "Mr Fix It" Hassan, Schering Plough's mercurial CEO - and why the ENHANCE data took two years to surface.
Hassan's defense?
Schering didn't mean to do anything wrong, and he doesn't know exactly what went wrong. "I'm quite sure nobody had bad intentions," says Hassan, 62. "Why didn't it happen on time as it should have? I don't have the answers."
The excuses are thin.
Either Schering deliberately delayed a result it suspected would be bad or Hassan's team incompetently failed to realize that they were sitting on a time bomb. Since FORBES' first report on Nov. 19, Schering shares have given up 12 months of gains.
Forbes
Hassan's defense?
Schering didn't mean to do anything wrong, and he doesn't know exactly what went wrong. "I'm quite sure nobody had bad intentions," says Hassan, 62. "Why didn't it happen on time as it should have? I don't have the answers."
The excuses are thin.
Either Schering deliberately delayed a result it suspected would be bad or Hassan's team incompetently failed to realize that they were sitting on a time bomb. Since FORBES' first report on Nov. 19, Schering shares have given up 12 months of gains.
Forbes
pic - apologies to Chris Mueller/Redux for Forbes
Vytorin - how will the FDA react?
U.S. regulators said on Friday they would review whether to take action over Merck & Co Inc's and Schering-Plough Corp's popular cholesterol drug Vytorin after a study showed it was no better than a generic in preventing the build-up of fatty plaque.The Food and Drug Administration said it had not yet received a final report on the study, called ENHANCE. The agency's review of Vytorin will take about six months after final results are received, the FDA said.
More at Reuters
Freakonomics - learn more about Big Pharma
Freakonomics has regularly featured items on the pharmaceutical industry, including posts here, here, and here.
It was this post in particular, highlighting an interview with the CEO of Genentech, that made Stephen Dubner want to post a quorum on the subject.
So he gathered up some willing and able candidates — Dr. Stuart Apfel, Zola P. Horovitz, Dr. Harlan Krumholz, Ray Moynihan, and Dr. Cyril Wolf — and asked them the following question:
What’s something that most people don’t know, pro or con, about the pharmaceutical business, whether from an R&D, economic, or political perspective?
Here are the answers.
It was this post in particular, highlighting an interview with the CEO of Genentech, that made Stephen Dubner want to post a quorum on the subject.
So he gathered up some willing and able candidates — Dr. Stuart Apfel, Zola P. Horovitz, Dr. Harlan Krumholz, Ray Moynihan, and Dr. Cyril Wolf — and asked them the following question:
What’s something that most people don’t know, pro or con, about the pharmaceutical business, whether from an R&D, economic, or political perspective?
Here are the answers.
GSK - Avandia: more limits
GlaxoSmithKline, the UK-based pharmaceutical company headed by Jean-Pierre Garnier, has received a fresh blow to the prospects for Avandia, its diabetes drug, with European regulators imposing tighter restrictions on its use.
The European Medicines Agency (EMEA) warned that the drug, among the most important in GSK's portfolio, should only be prescribed after careful evaluation to patients suffering from ischaemic heart disease, or reduced blood supply to the heart muscle. It added that it should only be used in combination with insulin "in exceptional cases and under close supervision".
More at the FT
Insider's view: the Avandia users club will soon be holding their annual general meeting in a phone box near you!
Hat tip: Jimmie
The European Medicines Agency (EMEA) warned that the drug, among the most important in GSK's portfolio, should only be prescribed after careful evaluation to patients suffering from ischaemic heart disease, or reduced blood supply to the heart muscle. It added that it should only be used in combination with insulin "in exceptional cases and under close supervision".
More at the FT
Insider's view: the Avandia users club will soon be holding their annual general meeting in a phone box near you!
Hat tip: Jimmie
Gardasil - risk benefit analysis
Sanofi Pasteur MSD’s top-selling Gardasil has been thrust into the spotlight again after the European Medicines Agency said there have been two sudden and unexpected deaths in young women who had received the vaccine as a prevention against developing cervical cancer.
However, within the context of the 1.5 million women who have already been vaccinated on the continent, and because no causal relationship between the vaccine and the two fatalities has been established, the EMEA has decided that the benefits of Gardasil outweigh its risks.
There will be no changes to the product information. One of the deaths occurred in Austria and the other in Germany. In both cases, the cause of death could not be identified, says the agency.
However, Gardasil’s safety will continue to be monitored. Two cervical cancer vaccines are currently approved in Europe – Sanofi Pasteur MSD’s Gardasil and GlaxoSmithKline’s Cervarix – and both offer protection against HPV types 16 and 18, which collectively account for around 73% of cases on the continent.
However, in the USA, Cervarix has come up against a stumbling block in the shape of the country’s drug regulator, which in December requested additional information prior to approval, putting it even further behind its rival. Indeed Merck’s vaccines unit looks set to put in a star turn in 2008, with unit expected to reel in $4.8-$5.2 billion, boosted by Gardasil.
The introduction onto the market of innovative, high price vaccines is expected to quadruple the sector to $16 billion by 2016, according to a recent report by market analyst Datamonitor.
Whether the emergence of more unexplained deaths will limit Gardasil’s huge potential remains to be seen. It had previously been spotlighted by US pressure group Judicial Watch, which in October reported 11 fatalities amongst young women who had received the vaccine plus more than 1800 adverse events.
Source: PharmaTimes
However, within the context of the 1.5 million women who have already been vaccinated on the continent, and because no causal relationship between the vaccine and the two fatalities has been established, the EMEA has decided that the benefits of Gardasil outweigh its risks.
There will be no changes to the product information. One of the deaths occurred in Austria and the other in Germany. In both cases, the cause of death could not be identified, says the agency.
However, Gardasil’s safety will continue to be monitored. Two cervical cancer vaccines are currently approved in Europe – Sanofi Pasteur MSD’s Gardasil and GlaxoSmithKline’s Cervarix – and both offer protection against HPV types 16 and 18, which collectively account for around 73% of cases on the continent.
However, in the USA, Cervarix has come up against a stumbling block in the shape of the country’s drug regulator, which in December requested additional information prior to approval, putting it even further behind its rival. Indeed Merck’s vaccines unit looks set to put in a star turn in 2008, with unit expected to reel in $4.8-$5.2 billion, boosted by Gardasil.
The introduction onto the market of innovative, high price vaccines is expected to quadruple the sector to $16 billion by 2016, according to a recent report by market analyst Datamonitor.
Whether the emergence of more unexplained deaths will limit Gardasil’s huge potential remains to be seen. It had previously been spotlighted by US pressure group Judicial Watch, which in October reported 11 fatalities amongst young women who had received the vaccine plus more than 1800 adverse events.
Source: PharmaTimes
Vytorin - FAO Skip, Lee, AZ and Abbott
The chief financial officer of Pfizer said on Wednesday data from a large trial of Schering-Plough Corp's rival Vytorin cholesterol drug could provide more clout in the marketing of Pfizer's best-selling Lipitor.
Prescriptions for Vytorin, which Schering-Plough sells in partnership with Merck, have fallen since mixed findings from the so-called ENHANCE trial of Vytorin were unveiled by the two drugmakers on Jan. 14.
Vytorin failed to prevent further buildup of fatty plaque in the carotid artery when compared with simvastatin alone during the two-year study.
"It allows us to make our case the way we've been making it, and quite frankly gives it more teeth in terms of the clinical impact of our product," Pfizer Chief Financial Officer Frank D'Amelio told Reuters in an interview.
"Our product is proven not only to reduce 'bad' LDL cholesterol, but also to reduce plaque in arteries," D'Amelio said. "These other (Vytorin) clinical results clearly don't hurt us; they allow us to make our points about our product."
Hey Skip and Lee!
Prescriptions for Vytorin, which Schering-Plough sells in partnership with Merck, have fallen since mixed findings from the so-called ENHANCE trial of Vytorin were unveiled by the two drugmakers on Jan. 14.
Vytorin failed to prevent further buildup of fatty plaque in the carotid artery when compared with simvastatin alone during the two-year study.
"It allows us to make our case the way we've been making it, and quite frankly gives it more teeth in terms of the clinical impact of our product," Pfizer Chief Financial Officer Frank D'Amelio told Reuters in an interview.
"Our product is proven not only to reduce 'bad' LDL cholesterol, but also to reduce plaque in arteries," D'Amelio said. "These other (Vytorin) clinical results clearly don't hurt us; they allow us to make our points about our product."
Hey Skip and Lee!
Would you care to reconsider your recent words on Son of Whytorin !
A Lipitor/ezetemibe combo!
LOL
Oh. And while we are on the "combo" theme.
Insider suspects the "Son of Crestor" Abbott/AstraZeneca team will be having some interesting meetings at the moment! Insider wonders what data the FDA might now want to approve such combos in a post- ENHANCE world!
ROFL
Thursday, January 24, 2008
Vytorin - here come the lawyers
A Florida grandmother is suing the makers of cholesterol drug Vytorin, claiming that Merck & Co. and Schering-Plough Corp. misled consumers into thinking Vytorin was more effective than generic drugs.
The lawsuit, announced Thursday, seeks class action status and comes a week after the companies released a controversial study that raised questions about the expensive drug's effectiveness.
Vytorin combines Merck's Zocor and Schering-Plough's Zetia. The companies have a joint venture that markets Vytorin.
Filed in U.S. District Court in Jacksonville, Fla., on behalf of Marion J. Greene, 72, the lawsuit alleges violations of state consumer protection laws, breach of warranty and unjust enrichment in the companies' marketing and sale of Vytorin and Zetia.
Greene, who took the $100-a-month Vytorin, was reimbursed for at least part of the cost through the federal Medicare and Veterans Administration drug programs, according to her lawyers.
The attorneys are seeking refunds of what they call overpayments, because generic cholesterol drugs are available for about one-third as much as Vytorin and Zetia.
More
The lawsuit, announced Thursday, seeks class action status and comes a week after the companies released a controversial study that raised questions about the expensive drug's effectiveness.
Vytorin combines Merck's Zocor and Schering-Plough's Zetia. The companies have a joint venture that markets Vytorin.
Filed in U.S. District Court in Jacksonville, Fla., on behalf of Marion J. Greene, 72, the lawsuit alleges violations of state consumer protection laws, breach of warranty and unjust enrichment in the companies' marketing and sale of Vytorin and Zetia.
Greene, who took the $100-a-month Vytorin, was reimbursed for at least part of the cost through the federal Medicare and Veterans Administration drug programs, according to her lawyers.
The attorneys are seeking refunds of what they call overpayments, because generic cholesterol drugs are available for about one-third as much as Vytorin and Zetia.
More
Drug reps - one in five MD's just say no
Nineteen percent of US office-based physicians refuse to see drug and device industry sales reps, according to a recent analysis conducted by healthcare marketing firm SK&A Information Services.
Another 22.7% require reps to set an appointment, the survey found.
“The old days of walking into an office and bumping into the doctor are waning,” said Dave Escalante, SK&A president.
More
Another 22.7% require reps to set an appointment, the survey found.
“The old days of walking into an office and bumping into the doctor are waning,” said Dave Escalante, SK&A president.
More
Cosmoceuticals - Allergan and Estee Lauder team up
Can't wait to see the drug reps!
Coming this fall to certain doctors' offices: A new upscale skin-care line from Estée Lauder Cos.' Clinique Laboratories and Botox-maker Allergan that won't be available from retailers and represents the next step in the blending of cosmetics and aesthetic medicine.
Today the firms are set to announce a partnership that will combine Clinique's product-formulation expertise with Allergan's clout among dermatologists, plastic surgeons and other doctors specializing in aesthetic treatments. The products will be sold exclusively through physicians, a strategy reflecting the increasing importance of doctors' offices as retail space.
That trend is particularly robust in dermatology. Consumers are increasingly consulting physicians for product recommendations in hopes of getting more science-based advice than is readily available online or at cosmetics counters.
Coming this fall to certain doctors' offices: A new upscale skin-care line from Estée Lauder Cos.' Clinique Laboratories and Botox-maker Allergan that won't be available from retailers and represents the next step in the blending of cosmetics and aesthetic medicine.
Today the firms are set to announce a partnership that will combine Clinique's product-formulation expertise with Allergan's clout among dermatologists, plastic surgeons and other doctors specializing in aesthetic treatments. The products will be sold exclusively through physicians, a strategy reflecting the increasing importance of doctors' offices as retail space.
That trend is particularly robust in dermatology. Consumers are increasingly consulting physicians for product recommendations in hopes of getting more science-based advice than is readily available online or at cosmetics counters.
Physicians, for their part, are seizing on product sales to bolster their practice income.
More at the WSJ
More at the WSJ
Wednesday, January 23, 2008
Quote of the week
“I want to show how they manipulate the data and why we have to be so cynical about them.”
Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, says she has more articles on the drug industry’s role in research coming soon.
Source
Catherine DeAngelis, editor in chief of the Journal of the American Medical Association, says she has more articles on the drug industry’s role in research coming soon.
Source
Vytorin - a cardiologist's view
Dr. Jonathan Fialkow, a cardiologist in Miami, gives his view on Vytorin.
Nycomed UK - swingeing cuts
Insider has been told that Nycomed UK has cut its workforce from 110 to 40 today. Its whole primary care team (reps and managers) has been axed. There has also been a thinning out of senior management and head office workers.
The Whytorin Saga contd. - more from Skip
Well, he's back!
Merck and Schering-Plough said Tuesday they have suspended TV ads for Vytorin, a week after a study revealed the cholesterol drug is no more effective than a high dose of one of its components available generically at a third of the cost.
Vytorin, developed by Merck and Schering-Plough, is a combination of Zetia and Merck's Zocor, which lost patent protection in 2006.
The companies market Zetia and Vytorin jointly and split the profits. Shares of both companies fell Tuesday.
The ads tell viewers that about the genetic and dietary causes of high cholesterol — "food and family" — and show "family members" interspersed with food.
Ads have also been pulled for Zetia, said Skip Irvine, a spokesman for Merck/Schering-Plough Pharmaceuticals.
"We've made the decision to voluntarily and temporarily suspend direct-to-consumer broadcast advertising in light of mischaracterization and misinterpretation of the ENHANCE trial results," he said, declining to elaborate or comment on the data.
More
Tuesday, January 22, 2008
Adriane Fugh-Berman - what a woman!
Adriane Fugh-Berman wants to imbue the next generation of doctors with a healthy dose of skepticism toward pharmaceutical companies' marketing tactics. So Fugh-Berman, associate professor of physiology and biophysics at Georgetown University, has spent the last six months lecturing medical students at Georgetown and neighboring schools on the various tools drug salespeople use to get doctors to prescribe their products—from bringing lunch for the office staff to dropping off free samples of new products.
At first, the students are belligerent. "They say: 'I'm too smart to be bought by a slice of pizza,'" Fugh-Berman says.
She counters with a litany of statistics: A doctor who spends just one minute with a drug rep ends up prescribing 16% more of the medicine the rep is selling. A four-minute encounter prompts a 52% jump in prescriptions. At the end of her talk, Fugh-Berman gives the students a quiz, partly to gauge whether their attitudes have changed. "In the margins, they write stuff like 'No more drug reps!'" she reports.
Programs such as Fugh-Berman's are rolling out at medical and nursing schools across the country, funded by $21 million in grants from a consortium of state attorneys general. The money came out of a $430 million settlement that Pfizer (PFE) reached with state and federal legislators in 2004 over allegations that its Warner-Lambert division had improperly marketed the epilepsy drug Neurontin for uses not approved by the Food & Drug Administration.
More than 30 educators won grants to develop for-credit courses, role-playing exercises, and other educational programs designed to arm future prescribers with the ability to counteract drug company sales pitches. To give the students a realistic depiction of the drug industry, many educators incorporate actual drug reps into their programs.
Fugh-Berman's Web site, pharmedout.org, posts seven YouTube videos of former and current salespeople confessing to bad behavior. In one, a rep says that his strategy for using free samples is much the same as what "your typical street dealer employs on the corner when he's selling crack. The first one's free, then you pay, then you're hooked." The rep, who appears in shadow to conceal his identity, goes on to explain how easy it is to coax doctors to write prescriptions for new drugs in return for a handful of free samples.
Grant recipient Elissa Ladd features several former drug reps in four online documentaries she posted on her site, perxinfo.org. The films are part of a larger curriculum designed for advanced-practice nurses, who are licensed to prescribe drugs. When nurses see the confessionals, "they're often surprised," says Ladd, clinical assistant professor at the Massachusetts General Hospital Institute of Health Professions. There are 150,000 nurses licensed to prescribe drugs in this country, she says, but they receive virtually no training on dealing with drug company marketing practices.
Many of the new marketing-focused educational programs are designed as counterweights to the drug industry's strong presence in medical education. Guest speakers who appear in "grand rounds"—lecture series that residents and other medical trainees must attend—are often sponsored by drug companies. And the industry pays for most of the continuing medical education courses that doctors take throughout their careers. Critics say the companies influence the content of those courses to suit their marketing goals. That's why most courses funded via the Neurontin settlement don't allow for pharmaceutical companies to speak up in their own defense or to provide any other type of input. "The drug companies have dominated our culture," Ladd says. "Our goal is to change that."
A handful of grantees are placing future doctors in simulated sales scenarios. Richard Pinckney, assistant professor of medicine at the University of Vermont, runs a workshop in which an actress playing a sales rep makes a pitch to a crowd of med students. At the end, Pinckney deconstructs the pitch, pointing out common pitfalls that doctors can fall into. "Often the rep refers to an expert who she says used the product and liked it," Pinckney says. "I explain how the use of expert opinions can be swayed by the company." At the Mount Sinai School of Medicine in New York, med students spar one-on-one with an actress playing a patient. After complaining of heartburn, the actress whips out an ad for Nexium that she says she found at her hairdresser's salon. "I think this is the drug for me," she declares, reciting the ad's promise that the drug controls acid better than any other branded product. The students, armed with studies showing the drug is no better than cheaper over-the-counter alternatives, try to persuade the faux patient to try something else.
Lauren Peccoralo, a third-year resident at Mount Sinai, found the exercise invaluable. "This happens a lot with patients, where they bring in these ads," she says. "It's important for us to practice how to convince patients that they should trust what the doctor is recommending instead." With such programs now in full swing, it's clear the nation's drug reps will soon find themselves face-to-face with a whole new generation of skeptical doctors.
BusinessWeek
At first, the students are belligerent. "They say: 'I'm too smart to be bought by a slice of pizza,'" Fugh-Berman says.
She counters with a litany of statistics: A doctor who spends just one minute with a drug rep ends up prescribing 16% more of the medicine the rep is selling. A four-minute encounter prompts a 52% jump in prescriptions. At the end of her talk, Fugh-Berman gives the students a quiz, partly to gauge whether their attitudes have changed. "In the margins, they write stuff like 'No more drug reps!'" she reports.
Programs such as Fugh-Berman's are rolling out at medical and nursing schools across the country, funded by $21 million in grants from a consortium of state attorneys general. The money came out of a $430 million settlement that Pfizer (PFE) reached with state and federal legislators in 2004 over allegations that its Warner-Lambert division had improperly marketed the epilepsy drug Neurontin for uses not approved by the Food & Drug Administration.
More than 30 educators won grants to develop for-credit courses, role-playing exercises, and other educational programs designed to arm future prescribers with the ability to counteract drug company sales pitches. To give the students a realistic depiction of the drug industry, many educators incorporate actual drug reps into their programs.
Fugh-Berman's Web site, pharmedout.org, posts seven YouTube videos of former and current salespeople confessing to bad behavior. In one, a rep says that his strategy for using free samples is much the same as what "your typical street dealer employs on the corner when he's selling crack. The first one's free, then you pay, then you're hooked." The rep, who appears in shadow to conceal his identity, goes on to explain how easy it is to coax doctors to write prescriptions for new drugs in return for a handful of free samples.
Grant recipient Elissa Ladd features several former drug reps in four online documentaries she posted on her site, perxinfo.org. The films are part of a larger curriculum designed for advanced-practice nurses, who are licensed to prescribe drugs. When nurses see the confessionals, "they're often surprised," says Ladd, clinical assistant professor at the Massachusetts General Hospital Institute of Health Professions. There are 150,000 nurses licensed to prescribe drugs in this country, she says, but they receive virtually no training on dealing with drug company marketing practices.
Many of the new marketing-focused educational programs are designed as counterweights to the drug industry's strong presence in medical education. Guest speakers who appear in "grand rounds"—lecture series that residents and other medical trainees must attend—are often sponsored by drug companies. And the industry pays for most of the continuing medical education courses that doctors take throughout their careers. Critics say the companies influence the content of those courses to suit their marketing goals. That's why most courses funded via the Neurontin settlement don't allow for pharmaceutical companies to speak up in their own defense or to provide any other type of input. "The drug companies have dominated our culture," Ladd says. "Our goal is to change that."
A handful of grantees are placing future doctors in simulated sales scenarios. Richard Pinckney, assistant professor of medicine at the University of Vermont, runs a workshop in which an actress playing a sales rep makes a pitch to a crowd of med students. At the end, Pinckney deconstructs the pitch, pointing out common pitfalls that doctors can fall into. "Often the rep refers to an expert who she says used the product and liked it," Pinckney says. "I explain how the use of expert opinions can be swayed by the company." At the Mount Sinai School of Medicine in New York, med students spar one-on-one with an actress playing a patient. After complaining of heartburn, the actress whips out an ad for Nexium that she says she found at her hairdresser's salon. "I think this is the drug for me," she declares, reciting the ad's promise that the drug controls acid better than any other branded product. The students, armed with studies showing the drug is no better than cheaper over-the-counter alternatives, try to persuade the faux patient to try something else.
Lauren Peccoralo, a third-year resident at Mount Sinai, found the exercise invaluable. "This happens a lot with patients, where they bring in these ads," she says. "It's important for us to practice how to convince patients that they should trust what the doctor is recommending instead." With such programs now in full swing, it's clear the nation's drug reps will soon find themselves face-to-face with a whole new generation of skeptical doctors.
BusinessWeek
Teva buy biologics
The WSJ report that generic-drug giant Teva Pharmaceutical Industries Ltd. has agreed to acquire biopharmaceutical company CoGenesys Inc. for $400 million in cash.
The deal, which is expected to close by the end of June, is likely to stoke the debate about the role generic-drug makers should play in the emerging market for biological therapies.
The deal, which is expected to close by the end of June, is likely to stoke the debate about the role generic-drug makers should play in the emerging market for biological therapies.
Vytorin - The Street's Melissa Davis writes:
In the summer of 2006, Schering-Plough made a bold -- if premature -- call.
During a two-day strategy session, the company's latest proxy statement shows, Schering-Plough declared that its crisis period from recent years had come to an end. The company reached that conclusion shortly after the close of a key trial meant to further strengthen a booming cholesterol-drug franchise that it operates with Merck.
Not until last week, nearly a year and a half later, did the results of that trial finally emerge. The study, popularly known as ENHANCE, suggested that Schering-Plough's blockbuster cholesterol-lowering drugs work no better -- and could pose greater risks -- than the far cheaper generic Zocor.
Schering-Plough's shares plummeted 20% in a matter of days as a result. The stock couldn't even manage a rebound on Friday after CEO Fred Hassan announced plans to buy $2 million worth of the hammered shares.
"The media interpretations of the top-line ENHANCE results, and the resulting stock price reaction, have been deeply troubling," Hassan stated. "This investment in Schering-Plough reflects my long-term confidence in the company. ... There are still significant challenges facing Schering-Plough, but I firmly believe this company can be turned around."
More
During a two-day strategy session, the company's latest proxy statement shows, Schering-Plough declared that its crisis period from recent years had come to an end. The company reached that conclusion shortly after the close of a key trial meant to further strengthen a booming cholesterol-drug franchise that it operates with Merck.
Not until last week, nearly a year and a half later, did the results of that trial finally emerge. The study, popularly known as ENHANCE, suggested that Schering-Plough's blockbuster cholesterol-lowering drugs work no better -- and could pose greater risks -- than the far cheaper generic Zocor.
Schering-Plough's shares plummeted 20% in a matter of days as a result. The stock couldn't even manage a rebound on Friday after CEO Fred Hassan announced plans to buy $2 million worth of the hammered shares.
"The media interpretations of the top-line ENHANCE results, and the resulting stock price reaction, have been deeply troubling," Hassan stated. "This investment in Schering-Plough reflects my long-term confidence in the company. ... There are still significant challenges facing Schering-Plough, but I firmly believe this company can be turned around."
More
Monday, January 21, 2008
Parallel trade and "black propaganda"
The European Commission is to prioritise and speed up moves to deal with the issue of counterfeit drugs in parallel trade and will launch a legislative initiative on the issue after the summer break, Commission Vice President Guenter Verheugen has announced in the European Parliament.
At the end of December 2006, the Commission began a two-part study into pharmaceutical distribution channels. The first part of the study, dealing with safe medicines in parallel trade, was completed at the end of 2007 and the second, covering counterfeit medicines, was due to present this year.
However, Commissioner Verheugen told Parliament last week: “Unfortunately, the first results of the study show that parallel trade brings a considerable risk for the safety of the patients. The reasons for that are numerous - there are problems with the packaging and labelling of the products as well as with product recalls, the complexity of distribution channels and the supply. And finally it is difficult to effectively enforce the law.”
The Commission is now analysing these findings “in order to develop a coherent strategy to avoid these risks,” he told Parliament. Different political options are being examined in terms of their social, economical and ecological effects, but the issue is a priority for the Commission, given its importance for public health policies, and a decision on further procedure will be made in the near future, he said.This initiative will require a change to the work program of DG Enterprise and Industry, which is headed by Commissioner Verheugen and has responsibility for the pharmaceutical industry, he added.
The Commission Vice President was responding to questions from Mairead McGuinness, Member of the European Parliament (MEP) for Ireland East. She asked him how the Commission planned to respond to last November’s report from the European Alliance for Access to Safe Medicines (EAASM), which warned that counterfeit and sub-standard medicines are now finding their way into the European Union (EU) supply chain.In particular, she asked, does the Commission plan to tackle this problem by reviewing parallel trade and promoting a genuine single market in pharmaceutical products which, she said, “is in the interests of consumers and appears essential to ensure that the benefits of the internal market, including affordable medicines, extend to all parts of Europe's economy?”
Commissioner Verheugen replied by outlining the plans to prioritise the issue of counterfeits, and continued that additional ways to address parallel trade are currently being explored, in particular with respect to pricing initiatives.
Revision of the transparency directive to include specific information on pricing would also be a possible way forward, he said, but added that the first thing to do is to clarify the situation, know exactly what is happening, and then examine whether EU legislation is able to change it.“The whole issue of pricing and reimbursement of medicines in the EU is under the full responsibility of the member states; we have no powers whatsoever, but it is obvious that we need to cooperate,” which is why pricing and reimbursement is a priority for the Commission, he said.
“I am well aware that, for citizens, the fact that the same medicine has completely different prices in different European member states is difficult to understand. It is also difficult for me to understand. The fact that these prices are regulated is only one factor. Another factor, of course, is that the pharmaceutical industry is part of the market economy. They are free to set their prices, but we are intensely studying the situation and I think that we will be able to present solutions," Commissioner Verheugen told Ms McGuinness.
In its response to the Commission’s call for evidence for its probe into safe medicines in parallel trade, the European Federation of Pharmaceutical Industries and Associations (EFPIA) had claimed that EU regulatory atuhorities “apply two sets of regulatory standardes, ie, one set for strict rules applied to the Marketing Authoirzation holder (or manufacturer) and a set of ‘substandard’ rules applied to parallel traders. This leads to the belief that the ‘free movements of goods’ principle appears to be the Commission’s overriding objective, superseding objectives such as patient safety or continued appropriate and balanced supplies of medicinal product to all the member states’ markets.”
The response to the Commission submitted by the European Association of Euro-Pharmaceutical Companies (EAEPC), which represents parallel traders, stated that: “parallel distribution, the only form of intrabrand price competition which exists in the pharmaceutical market, makes expensive, innovative medicines more affordable for patients and governments.” And last November, EAEPC attacked the EAASM report as “black propaganda” which was about “discrediting the legitimate and safe practice of EU-internal distribution of medicines which introduces price competition for manufacturers.”
By Lynne Taylor
Source: PharmaTimes
At the end of December 2006, the Commission began a two-part study into pharmaceutical distribution channels. The first part of the study, dealing with safe medicines in parallel trade, was completed at the end of 2007 and the second, covering counterfeit medicines, was due to present this year.
However, Commissioner Verheugen told Parliament last week: “Unfortunately, the first results of the study show that parallel trade brings a considerable risk for the safety of the patients. The reasons for that are numerous - there are problems with the packaging and labelling of the products as well as with product recalls, the complexity of distribution channels and the supply. And finally it is difficult to effectively enforce the law.”
The Commission is now analysing these findings “in order to develop a coherent strategy to avoid these risks,” he told Parliament. Different political options are being examined in terms of their social, economical and ecological effects, but the issue is a priority for the Commission, given its importance for public health policies, and a decision on further procedure will be made in the near future, he said.This initiative will require a change to the work program of DG Enterprise and Industry, which is headed by Commissioner Verheugen and has responsibility for the pharmaceutical industry, he added.
The Commission Vice President was responding to questions from Mairead McGuinness, Member of the European Parliament (MEP) for Ireland East. She asked him how the Commission planned to respond to last November’s report from the European Alliance for Access to Safe Medicines (EAASM), which warned that counterfeit and sub-standard medicines are now finding their way into the European Union (EU) supply chain.In particular, she asked, does the Commission plan to tackle this problem by reviewing parallel trade and promoting a genuine single market in pharmaceutical products which, she said, “is in the interests of consumers and appears essential to ensure that the benefits of the internal market, including affordable medicines, extend to all parts of Europe's economy?”
Commissioner Verheugen replied by outlining the plans to prioritise the issue of counterfeits, and continued that additional ways to address parallel trade are currently being explored, in particular with respect to pricing initiatives.
Revision of the transparency directive to include specific information on pricing would also be a possible way forward, he said, but added that the first thing to do is to clarify the situation, know exactly what is happening, and then examine whether EU legislation is able to change it.“The whole issue of pricing and reimbursement of medicines in the EU is under the full responsibility of the member states; we have no powers whatsoever, but it is obvious that we need to cooperate,” which is why pricing and reimbursement is a priority for the Commission, he said.
“I am well aware that, for citizens, the fact that the same medicine has completely different prices in different European member states is difficult to understand. It is also difficult for me to understand. The fact that these prices are regulated is only one factor. Another factor, of course, is that the pharmaceutical industry is part of the market economy. They are free to set their prices, but we are intensely studying the situation and I think that we will be able to present solutions," Commissioner Verheugen told Ms McGuinness.
In its response to the Commission’s call for evidence for its probe into safe medicines in parallel trade, the European Federation of Pharmaceutical Industries and Associations (EFPIA) had claimed that EU regulatory atuhorities “apply two sets of regulatory standardes, ie, one set for strict rules applied to the Marketing Authoirzation holder (or manufacturer) and a set of ‘substandard’ rules applied to parallel traders. This leads to the belief that the ‘free movements of goods’ principle appears to be the Commission’s overriding objective, superseding objectives such as patient safety or continued appropriate and balanced supplies of medicinal product to all the member states’ markets.”
The response to the Commission submitted by the European Association of Euro-Pharmaceutical Companies (EAEPC), which represents parallel traders, stated that: “parallel distribution, the only form of intrabrand price competition which exists in the pharmaceutical market, makes expensive, innovative medicines more affordable for patients and governments.” And last November, EAEPC attacked the EAASM report as “black propaganda” which was about “discrediting the legitimate and safe practice of EU-internal distribution of medicines which introduces price competition for manufacturers.”
By Lynne Taylor
Source: PharmaTimes
The Whytorin Saga contd. - Stefan Kertesz makes a great point
The recent news that Vytorin and its sister drug Zetia don't seem to help patients and might be harmful is not just about the toxicity of yet another drug. It's about the toxic interplay of the pharmaceutical industry and the experts who write the guidelines and set the benchmarks doctors aspire to.
To see how this works, let's look back to 2004.
On July 12 of that year, the federal National Cholesterol Education Panel made an announcement: For patients with heart disease or diabetes, doctors should consider an especially low goal for bad cholesterol of 70. Not all experts agreed. A lot of us thought it would be costly and risky to "do whatever it takes, just to get the cholesterol down."
But, doctors across the country gulped, reached for their prescription pads, and then realized that a lot of patients couldn't reach the new target without a new drug. Then, 11 days later, Merck and Schering Plough introduced Vytorin.
One inconvenient fact emerged soon thereafter:
Of the cholesterol guideline's nine authors, eight disclosed significant financial ties to the pharmaceutical industry, seven specifically to Merck and Schering Plough. I'm not suggesting that these experts have opinions for sale. The problem is that when data are conflicting, wishful thinking and commercial interests may supplant a rational consideration of the facts.
To protect patients we need to do two things:
We should demand entirely public disclosure of the financial ties for any expert who helps define the standards for quality in health care. And we should demand that at least some of our experts come from outside the industry, altogether.
The point is this:
The science of drug development and the science of quality in health care represent two very different enterprises. If we continue to let the drug developers have such a strong hand in defining quality, we will continue to fall prey to conjecture, to wishful thinking and hype. It would be best for our health to keep these two enterprises separate.
Sunday, January 20, 2008
The Whytorin Saga contd. - Sid Wolfe speaks
Ouch!
Users of the prescription cholesterol medicine Zetia and Vytorin received some troubling news from the makers of the drug on January 14: Although the pills they’re taking lower their cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting them at risk. In 2004, WorstPills.org - a project of Public Citizen's Health Research Group - warned subscribers not to take these drugs until more was known about them.
For a limited time, WorstPills.org is providing you with information about Vytorin at no charge.
Full statement: Drug companies, FDA lagged in warning public about Zetia, Vytorin
Our article warning consumers not to take Zetia (Ezetimibe) and Vytorin (Ezetimibe with Simvastatin)
Summaries of all of our work on high cholesterol, including information available to subscribers only
We have been advocating for drug safety for over 35 years, and in order to ensure our independence, we accept no corporate or government funding and take no advertising. Profiles of over 500 other drugs and 13 dietary supplements are available to subscribers. Other benefits of subscription include e-alerts warning you of breaking drug news and new drug articles each month.
Learn more
Users of the prescription cholesterol medicine Zetia and Vytorin received some troubling news from the makers of the drug on January 14: Although the pills they’re taking lower their cholesterol, there is no evidence that they reduce the risk of heart attacks and strokes, and may, in fact, be putting them at risk. In 2004, WorstPills.org - a project of Public Citizen's Health Research Group - warned subscribers not to take these drugs until more was known about them.
For a limited time, WorstPills.org is providing you with information about Vytorin at no charge.
Full statement: Drug companies, FDA lagged in warning public about Zetia, Vytorin
Our article warning consumers not to take Zetia (Ezetimibe) and Vytorin (Ezetimibe with Simvastatin)
Summaries of all of our work on high cholesterol, including information available to subscribers only
We have been advocating for drug safety for over 35 years, and in order to ensure our independence, we accept no corporate or government funding and take no advertising. Profiles of over 500 other drugs and 13 dietary supplements are available to subscribers. Other benefits of subscription include e-alerts warning you of breaking drug news and new drug articles each month.
Learn more
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