Latest Drugwonks' Blog
Let me respond to the latest tut-tut from Roy Poses who insist he isn’t calling physicians who work for drug companies or consult for them prostitutes but just wants transparency about their funding sources. I see a backtracking big time, much hypocrisy and huge bias. There is no doubt Poses is part of the “I hate Pharma†crowd along with many in the blogosphere. And he presumes that the only source of bias that affects the public health adversely – mostly without empirical evidence – is financial inducements from drug companies. He even uses the pejorative term “collaboration†as in drug companies are “now are the largest collective source of medical research money, they are thus under great pressure to collaborate with these companies. An academic trying to raise research money from one such company might find it hard to resist offers of consulting fees, speaker’s honoraria, advisory board positions, etc from that company. But once the academic thus starts to work part time for the company, who knows where his or her interests lie?â€
So for Poses the mere receipt for pharmaceutical research dollars is like alchemy, transforming the pure, virginal scientist into someone who – along with his or her results – can be twisted into something that reflects the desire for profits, not the public health. By his standards Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses just got one Merck grant back in 1997-1999 (which he never declared on his blog).
He gives two examples
“For the final words, let me quote Dr Stefan Kertesz, who was commenting on the pervasiveness of conflicts of interest affecting the 2004 National Cholesterol Education Panel guidelines that suggested drastic lowering of cholesterol for patients with heart disease and diabetes. (Hat tip for this to DB's Medical Rants.) These controversial guidelines may be one reason physicians feel compelled to use drugs to lower cholesterol which have, like ezetimibe, no proven independent benefits for their patients.â€
Controversial? Most of the people who Poses and Kertesz slime by association did the original work to establish the value of statins in the 1980’s. Does Poses not prescribe statins to people with high LDL and low HDL. And for him to say he won’t prescribe Vytorin because it has not proven independent benefit is shocking. It is both wrong and demonstrates he practices political science, a science driven by his guilt by association mentality.
Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to “natural†cholesterol lowering products that they sell, etc. No conflict there? Is it ok for physicians to promote and consult for companies pushing this approach?
Let us go further. So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind or biased eye towards other sources of conflict. Indeed, he ignores his own position stated in another post: “I think Anaissie et al have demonstrated the glaring need for tough regulations requiring disclosure of all financial (and probably political) conflicts of interest affecting anyone who can make decisions, for individuals or organizations, in health care. Basically similar regulations should apply not only to government agencies and academic medical institutions, but also all other health care organizations, not-for-profit and for-profit included.â€
Indeed, by focusing exclusively on financial conflicts and indeed only one subset of such monetary influences – ignoring funding from foundations, government business grants such as SBIR funds, money from consulting for trial attorneys or tort settlements, -- Poses and others ignore other forms of biases that can be as or more dangerous. As John P. A. Ioannidis wrote in Why Most Published Research Findings Are False:
“Conflicts of interest and prejudice may increase bias, u. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Prejudice may not necessarily have financial roots. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings. Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations. Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable].
But let us focus on other forms of bias.
For instance, the Prescription Project, which according to it’s website seek to ensure that “ industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information is essential to promoting sound and cost effective health care.â€
The Prescription Project has advisory committee members that consult for or work for the largest HMOs and the generic lobbying group. It obtains substantial funding from George Soros, as do many other organizations intertwined with The Prescription Project. The PP also “collaborates†with the Community Catalyst Group, another leftist organization that receives support from the Prescription Access Litigation Project. So the Prescription Project benefits indirectly from an organization that receives funding from trial lawyers.
Should Poses be suspicious about the choice of drugs made by The Prescription Project based on their source of funding? Not a peep.
In the end, Poses may be right to be cautious but the caution should be comprehensive or it is simply part of an ideological push or grab for power.
The point is, conflicts are a problem but ideological agendas and professional hubris can be deadly or truly damaging. I have not even touched the human cost of Steve Nissen’s attack on ADHD medicines, Avandia, etc. or the hype surrounding vaccines or SSRIs. I will only quote Marcia Angell who noted:
“Modern history is replete with instances of fervent beliefs or conventional wisdom being proved wrong by scientific research. Only a commitment to evidence can test the hopes, fears and biases that otherwise would have full sway. Science is sometimes messy and slow, but it’s the only method we have to answer questions about the material world and to evaluate the many health scares that recurrently sweep across the country. Like democracy, it’s better than whatever is second best, and we ignore it at our peril.â€
So for Poses the mere receipt for pharmaceutical research dollars is like alchemy, transforming the pure, virginal scientist into someone who – along with his or her results – can be twisted into something that reflects the desire for profits, not the public health. By his standards Gertrude Elion, Louis Pasteur, Josh Lederberg, Joseph Goldstein, Phil Sharp, Nobel Laureates all, are untrustworthy tools while Poses is the trusted one because they take or took drug money or worked for drug companies while he Poses just got one Merck grant back in 1997-1999 (which he never declared on his blog).
He gives two examples
“For the final words, let me quote Dr Stefan Kertesz, who was commenting on the pervasiveness of conflicts of interest affecting the 2004 National Cholesterol Education Panel guidelines that suggested drastic lowering of cholesterol for patients with heart disease and diabetes. (Hat tip for this to DB's Medical Rants.) These controversial guidelines may be one reason physicians feel compelled to use drugs to lower cholesterol which have, like ezetimibe, no proven independent benefits for their patients.â€
Controversial? Most of the people who Poses and Kertesz slime by association did the original work to establish the value of statins in the 1980’s. Does Poses not prescribe statins to people with high LDL and low HDL. And for him to say he won’t prescribe Vytorin because it has not proven independent benefit is shocking. It is both wrong and demonstrates he practices political science, a science driven by his guilt by association mentality.
Poses has also remained silent about the rash of websites that have popped up urging people to sue Merck and Schering for false claims, to stop taking Vytorin and switch to “natural†cholesterol lowering products that they sell, etc. No conflict there? Is it ok for physicians to promote and consult for companies pushing this approach?
Let us go further. So obsessed is he with the fear of pharma infiltration of medicine and science that he casts a blind or biased eye towards other sources of conflict. Indeed, he ignores his own position stated in another post: “I think Anaissie et al have demonstrated the glaring need for tough regulations requiring disclosure of all financial (and probably political) conflicts of interest affecting anyone who can make decisions, for individuals or organizations, in health care. Basically similar regulations should apply not only to government agencies and academic medical institutions, but also all other health care organizations, not-for-profit and for-profit included.â€
Indeed, by focusing exclusively on financial conflicts and indeed only one subset of such monetary influences – ignoring funding from foundations, government business grants such as SBIR funds, money from consulting for trial attorneys or tort settlements, -- Poses and others ignore other forms of biases that can be as or more dangerous. As John P. A. Ioannidis wrote in Why Most Published Research Findings Are False:
“Conflicts of interest and prejudice may increase bias, u. Conflicts of interest are very common in biomedical research, and typically they are inadequately and sparsely reported. Prejudice may not necessarily have financial roots. Scientists in a given field may be prejudiced purely because of their belief in a scientific theory or commitment to their own findings. Many otherwise seemingly independent, university-based studies may be conducted for no other reason than to give physicians and researchers qualifications for promotion or tenure. Such nonfinancial conflicts may also lead to distorted reported results and interpretations. Prestigious investigators may suppress via the peer review process the appearance and dissemination of findings that refute their findings, thus condemning their field to perpetuate false dogma. Empirical evidence on expert opinion shows that it is extremely unreliable].
But let us focus on other forms of bias.
For instance, the Prescription Project, which according to it’s website seek to ensure that “ industry-physician relationships are free of conflicts of interest and that physicians base their prescribing decisions on accurate and unbiased information is essential to promoting sound and cost effective health care.â€
The Prescription Project has advisory committee members that consult for or work for the largest HMOs and the generic lobbying group. It obtains substantial funding from George Soros, as do many other organizations intertwined with The Prescription Project. The PP also “collaborates†with the Community Catalyst Group, another leftist organization that receives support from the Prescription Access Litigation Project. So the Prescription Project benefits indirectly from an organization that receives funding from trial lawyers.
Should Poses be suspicious about the choice of drugs made by The Prescription Project based on their source of funding? Not a peep.
In the end, Poses may be right to be cautious but the caution should be comprehensive or it is simply part of an ideological push or grab for power.
The point is, conflicts are a problem but ideological agendas and professional hubris can be deadly or truly damaging. I have not even touched the human cost of Steve Nissen’s attack on ADHD medicines, Avandia, etc. or the hype surrounding vaccines or SSRIs. I will only quote Marcia Angell who noted:
“Modern history is replete with instances of fervent beliefs or conventional wisdom being proved wrong by scientific research. Only a commitment to evidence can test the hopes, fears and biases that otherwise would have full sway. Science is sometimes messy and slow, but it’s the only method we have to answer questions about the material world and to evaluate the many health scares that recurrently sweep across the country. Like democracy, it’s better than whatever is second best, and we ignore it at our peril.â€
Should Vytorin continue to advertise? What impact, if any, will this question have on the larger issue of DTC regulation? These and other questions are discussed in a worthwhile article in this week’s edition of Advertising Age.
Here’s a link to the article:
http://adage.com/article?article_id==123228
And a few paragraphs to whet your appetite:
"Unlike Merck's Vioxx, which in 2004 was found to contribute to heart attacks in some patients and was pulled off the market, Vytorin is safe and can still be sold. It does, the study found, reduce the levels of LDL in patients. It just doesn't, according to the study, live up to its claim of reducing plaque build-up. That's why Peter Pitts, a former associate commissioner for the FDA and now the president of New York-based Center for Medicine in the Public Interest, says this won't be the death knell for DTC that some think it is.
Just because a congressman sneezes doesn't mean pharmaceutical companies will catch a cold, Mr. Pitts said. DTC is heavily regulated and the question becomes 'What does the study tell us and how is it relevant to DTC?' It's a small study and a study based on certain genotypes. If you're currently on Vytorin, you don't have to stop taking it.
But even Mr. Pitts, a strong advocate for DTC, admits drug companies need an image boost. The industry should absolutely explain to the general population where drugs come from and how they're made," he said. “It's going to be hard. It's going to be a long-term proposition. But it's important for the viability of its image with consumers, not to mention the people on Capitol Hill."
That being said, it’s good news that, in yesterday’s edition of the New York Times (and elsewhere) there was a Vytorin ad that tried to put the current study into perspective.
Nice start – but more needs to be done. Vioxx was a missed opportunity to talk (soberly and sensibly) about safety (risk/benefit). Let’s not let Vytorin be a missed opportunity to talk about what clinical trials can tell us – and what they cannot.
This is an important teaching moment -- and can show the potency of DTC advertising and, more broadly, DTC² (direct to consumer communications) as a way to educate the public (yes -- politicians too) about the urgency of personalized medicine and 21st century clinical trial design.
Tough and complicated topics? You bet. But (as Tom Hanks said in A League of Their Own) "If it was easy, anyone could do it."
Here’s a link to the article:
http://adage.com/article?article_id==123228
And a few paragraphs to whet your appetite:
"Unlike Merck's Vioxx, which in 2004 was found to contribute to heart attacks in some patients and was pulled off the market, Vytorin is safe and can still be sold. It does, the study found, reduce the levels of LDL in patients. It just doesn't, according to the study, live up to its claim of reducing plaque build-up. That's why Peter Pitts, a former associate commissioner for the FDA and now the president of New York-based Center for Medicine in the Public Interest, says this won't be the death knell for DTC that some think it is.
Just because a congressman sneezes doesn't mean pharmaceutical companies will catch a cold, Mr. Pitts said. DTC is heavily regulated and the question becomes 'What does the study tell us and how is it relevant to DTC?' It's a small study and a study based on certain genotypes. If you're currently on Vytorin, you don't have to stop taking it.
But even Mr. Pitts, a strong advocate for DTC, admits drug companies need an image boost. The industry should absolutely explain to the general population where drugs come from and how they're made," he said. “It's going to be hard. It's going to be a long-term proposition. But it's important for the viability of its image with consumers, not to mention the people on Capitol Hill."
That being said, it’s good news that, in yesterday’s edition of the New York Times (and elsewhere) there was a Vytorin ad that tried to put the current study into perspective.
Nice start – but more needs to be done. Vioxx was a missed opportunity to talk (soberly and sensibly) about safety (risk/benefit). Let’s not let Vytorin be a missed opportunity to talk about what clinical trials can tell us – and what they cannot.
This is an important teaching moment -- and can show the potency of DTC advertising and, more broadly, DTC² (direct to consumer communications) as a way to educate the public (yes -- politicians too) about the urgency of personalized medicine and 21st century clinical trial design.
Tough and complicated topics? You bet. But (as Tom Hanks said in A League of Their Own) "If it was easy, anyone could do it."
Have a look at today’s New York Times editorial,“The Real Price of Fakes.â€
Here’s a link:
http://www.nytimes.com/2008/01/20/opinion/20sun3.html?_r=1&ref=opinion&oref=slogin
And here’s the concluding paragraph:
“Some people in Congress want to tighten penalties on counterfeiters, a good but modest move. More to the point, the Consumer Product Safety Commission and the Food and Drug Administration need more money. And businesses that often avoid acknowledging the fake trade, for fear of damaging their brand, should be more open with consumers about how to tell the difference between real and unreal. Until then, buyer beware.â€
A few points. First is that, absolutely, penalties must be significantly enhanced. Today the risks are too low and the rewards too high – and that will only lead to exponential growth in the counterfeiting of prescription medicines. According to the WHO, “The US based Centre for Medicine in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.â€
Willy Sutton, the depression-era criminal, when asked why he robbed, replied “because that’s where the money is.†If Willy Sutton were alive today, he’s be in the counterfeit drugs business – because that’s where the money is.
Second – and speaking of money – glad to see that the Times is calling on Congress to give the FDA more money to combat prescription medicine counterfeiting. And while they’re at it, the Times editorialists should also call out those members of Congress who want to actually tie FDA’s hands in dealing with this menace.
In 2006, the federal Joint Terrorism Task Force unsealed an indictment charging 19 persons with operating a global crime and terrorism ring spanning Lebanon, Canada, China, Brazil, Paraguay and the United States. The ring sold counterfeit drugs and other contraband materials, largely through direct consumer shipment from Canada, to Americans seeking cheaper drugs. It, in turn, directed its profits to support of the criminal terrorist group Hezbollah.
Less than four months later, as Hezbollah rockets rained down on Israel, the Senate voted for an amendment offered by David Vitter of Louisiana to ban U.S. Customs and Border Protection agents from seizing prescription drugs that Americans import from Canada. For Mr. Vitter, the passage was a defeat of sorts: He wanted to ban Customs agents from seizing medicines imported from anywhere, which suggests that the politicians who voted for the measure knew that dangerous people were trying to sell fake drugs in America.
Canada is already the favorite port of call for fake medicines. According to customs, most of these drugs are not shipped through wholesale distribution channels but are shipped directly to consumers, with Canada being the major transshipment point because of its access to the U.S. market.
Here’s a link:
http://www.nytimes.com/2008/01/20/opinion/20sun3.html?_r=1&ref=opinion&oref=slogin
And here’s the concluding paragraph:
“Some people in Congress want to tighten penalties on counterfeiters, a good but modest move. More to the point, the Consumer Product Safety Commission and the Food and Drug Administration need more money. And businesses that often avoid acknowledging the fake trade, for fear of damaging their brand, should be more open with consumers about how to tell the difference between real and unreal. Until then, buyer beware.â€
A few points. First is that, absolutely, penalties must be significantly enhanced. Today the risks are too low and the rewards too high – and that will only lead to exponential growth in the counterfeiting of prescription medicines. According to the WHO, “The US based Centre for Medicine in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.â€
Willy Sutton, the depression-era criminal, when asked why he robbed, replied “because that’s where the money is.†If Willy Sutton were alive today, he’s be in the counterfeit drugs business – because that’s where the money is.
Second – and speaking of money – glad to see that the Times is calling on Congress to give the FDA more money to combat prescription medicine counterfeiting. And while they’re at it, the Times editorialists should also call out those members of Congress who want to actually tie FDA’s hands in dealing with this menace.
In 2006, the federal Joint Terrorism Task Force unsealed an indictment charging 19 persons with operating a global crime and terrorism ring spanning Lebanon, Canada, China, Brazil, Paraguay and the United States. The ring sold counterfeit drugs and other contraband materials, largely through direct consumer shipment from Canada, to Americans seeking cheaper drugs. It, in turn, directed its profits to support of the criminal terrorist group Hezbollah.
Less than four months later, as Hezbollah rockets rained down on Israel, the Senate voted for an amendment offered by David Vitter of Louisiana to ban U.S. Customs and Border Protection agents from seizing prescription drugs that Americans import from Canada. For Mr. Vitter, the passage was a defeat of sorts: He wanted to ban Customs agents from seizing medicines imported from anywhere, which suggests that the politicians who voted for the measure knew that dangerous people were trying to sell fake drugs in America.
Canada is already the favorite port of call for fake medicines. According to customs, most of these drugs are not shipped through wholesale distribution channels but are shipped directly to consumers, with Canada being the major transshipment point because of its access to the U.S. market.
I have a lot of respect for John McCain but I wonder about what Leon Wieseltier of the New Republic praised and referred to as his "contempt for drug companies."
His contempt is getting in the way of clear thinking and good policy. And at time when we will need all the high paying, green jobs we can get, McCain's stance on pharmaceutical innovation -- where most of those jobs will be created worldwide -- is downright regressive and is at odds with his claim to be a pro growth Republican. If there has been a Republican, nay a member of Congress, with more pronounced and persistent antipathy to the pharmaceutical or biotech industry than John McCain, I can't think of one with the exception of New York’s two senator’s Charles Schumer or Hillary Clinton.
If he took the same position on the auto or housing industry he has on pharmaceuticals and biotech, he would shove the nation into an instant depression.
His contempt has been on display throughout the campaign, most notably in the New Hampshire debate when he call them "the bad guys". Why? From the straight talk express we never seem to get a straight answer. Seems to be related to his belief that drug companies inflate drug costs at government expense and artificial monopolies.
If drug costs reflects value, fine," "But if there are ways to bring greater competition to our drug markets by safe re-importation of drugs, by faster introduction of generic drugs, or by any other means we should do so. If I'm elected President, we will."
McCain has said: Problems with costs are created when market forces are replaced by government regulated prices.."
Yet he has aggressively pushed importation of drugs from foreign countries where "market forces are replaced by government regulated prices." And his legislation would force drug companies to sell as much of their price controlled product that is made to foreign spec -- not US spec -- as distributors would order and then would force the FDA to approve it instantly as safe and effective for the US market. Imagine forcing car, timber, building product, and steel companies to do the same! Meanwhile, Canada is the transhipment point for drugs from Iran, Pakistan, China, Venezuela..all our friends. The ultimate destination. America. McCain has no problem with letting Canada's lax importation policy stand as a surrogate for our drug and homeland security.
What are the “other means?†McCain voted for price controls and government run drug formularies for Medicare, especially when an HMO wanted to save money and pass it on to the government. This approach is used at the VA to restrict access to newer drugs and has actually shortened the lives of veterans. If imposed on Medicare and Medicaid it would mean seniors and the poor would be the last to the get what newer medicines are developed, if any are left.
Meanwhile according to a study by the Milken Institute, the biotechnology industry generated more than 2.7 million jobs and $172 billion in real output in 2003. The average income of each “green: job? $60000 plus benefits. But leave it to McCain to be the sponsor of a bill this coming session of Congress that would give overseas generic drug firms an incentive to sue new biotech firms for their patents before they expire in order to create “competition.â€
His contempt is getting in the way of clear thinking and good policy. And at time when we will need all the high paying, green jobs we can get, McCain's stance on pharmaceutical innovation -- where most of those jobs will be created worldwide -- is downright regressive and is at odds with his claim to be a pro growth Republican. If there has been a Republican, nay a member of Congress, with more pronounced and persistent antipathy to the pharmaceutical or biotech industry than John McCain, I can't think of one with the exception of New York’s two senator’s Charles Schumer or Hillary Clinton.
If he took the same position on the auto or housing industry he has on pharmaceuticals and biotech, he would shove the nation into an instant depression.
His contempt has been on display throughout the campaign, most notably in the New Hampshire debate when he call them "the bad guys". Why? From the straight talk express we never seem to get a straight answer. Seems to be related to his belief that drug companies inflate drug costs at government expense and artificial monopolies.
If drug costs reflects value, fine," "But if there are ways to bring greater competition to our drug markets by safe re-importation of drugs, by faster introduction of generic drugs, or by any other means we should do so. If I'm elected President, we will."
McCain has said: Problems with costs are created when market forces are replaced by government regulated prices.."
Yet he has aggressively pushed importation of drugs from foreign countries where "market forces are replaced by government regulated prices." And his legislation would force drug companies to sell as much of their price controlled product that is made to foreign spec -- not US spec -- as distributors would order and then would force the FDA to approve it instantly as safe and effective for the US market. Imagine forcing car, timber, building product, and steel companies to do the same! Meanwhile, Canada is the transhipment point for drugs from Iran, Pakistan, China, Venezuela..all our friends. The ultimate destination. America. McCain has no problem with letting Canada's lax importation policy stand as a surrogate for our drug and homeland security.
What are the “other means?†McCain voted for price controls and government run drug formularies for Medicare, especially when an HMO wanted to save money and pass it on to the government. This approach is used at the VA to restrict access to newer drugs and has actually shortened the lives of veterans. If imposed on Medicare and Medicaid it would mean seniors and the poor would be the last to the get what newer medicines are developed, if any are left.
Meanwhile according to a study by the Milken Institute, the biotechnology industry generated more than 2.7 million jobs and $172 billion in real output in 2003. The average income of each “green: job? $60000 plus benefits. But leave it to McCain to be the sponsor of a bill this coming session of Congress that would give overseas generic drug firms an incentive to sue new biotech firms for their patents before they expire in order to create “competition.â€
Yesterday we commented on the New York Times neglecting to mention -- in a story about clinical trial transparency and Prozac (along with other drugs) that Eli Lilly & Co. posts its clinical trials on a public website.
Well, sins of omission are seldom fun.
Here's Lilly's response:
INDIANAPOLIS, Jan 18, 2008
"Eli Lilly and Company strongly objects to implications in a New York Times article published Thursday that the company has suppressed results of negative clinical trials.
The story, based on a separate article in The New England Journal of Medicine (NEJM), cited Prozac and Lilly as high-profile examples of how the industry purportedly suppresses negative clinical trial data. Not only was the Times' story inaccurate when it comes to Prozac -- the NEJM article didn't identify a single Prozac study as unpublished -- but it also likely created a strong false impression with readers that Lilly suppresses data.
Lilly is an industry leader in being transparent with our clinical trial data. We are committed to publicly disclosing medical research results -- whether favorable or unfavorable to a Lilly medicine -- in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products.
In December 2004, Lilly was widely recognized as the first pharmaceutical company to voluntarily launch a clinical trials registry, where we post the results of all Lilly sponsored registration clinical trials for all of our marketed products dating back to 1994, and all clinical trials for marketed products since December 2004.
In addition, the two Cymbalta studies listed in an appendix to the NEJM article as "unpublished" have, in fact, been published in peer-reviewed journals. The results of HMAT-A and HMAQ-B were published twice -- first in the Autumn 2002 issue of Psychopharmacology Bulletin, and again in the Primary Care Companion Journal of Clinical Psychiatry in 2003. In addition, these studies were presented at one or more medical congresses that require peer review of abstract submissions and they also have been available to the general public on LillyTrials.com since 2004.
The authors of the NEJM article decided not to count studies as "published" if the manuscript included data from two or more studies. While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data.
We clearly have been transparent. The data is publicly available online; we've presented it to health care professionals at major medical meetings; and we published it -- more than once -- in peer-reviewed medical journals. And we remain committed to transparency. All of which we would have told The New York Times ... if only they had called and asked."
Has the New York Times changed its motto from "All the news that's fit to print" to "Don't ask, don't tell?"
Well, sins of omission are seldom fun.
Here's Lilly's response:
INDIANAPOLIS, Jan 18, 2008
"Eli Lilly and Company strongly objects to implications in a New York Times article published Thursday that the company has suppressed results of negative clinical trials.
The story, based on a separate article in The New England Journal of Medicine (NEJM), cited Prozac and Lilly as high-profile examples of how the industry purportedly suppresses negative clinical trial data. Not only was the Times' story inaccurate when it comes to Prozac -- the NEJM article didn't identify a single Prozac study as unpublished -- but it also likely created a strong false impression with readers that Lilly suppresses data.
Lilly is an industry leader in being transparent with our clinical trial data. We are committed to publicly disclosing medical research results -- whether favorable or unfavorable to a Lilly medicine -- in an accurate, objective and balanced manner in order for our customers to make more informed decisions about our products.
In December 2004, Lilly was widely recognized as the first pharmaceutical company to voluntarily launch a clinical trials registry, where we post the results of all Lilly sponsored registration clinical trials for all of our marketed products dating back to 1994, and all clinical trials for marketed products since December 2004.
In addition, the two Cymbalta studies listed in an appendix to the NEJM article as "unpublished" have, in fact, been published in peer-reviewed journals. The results of HMAT-A and HMAQ-B were published twice -- first in the Autumn 2002 issue of Psychopharmacology Bulletin, and again in the Primary Care Companion Journal of Clinical Psychiatry in 2003. In addition, these studies were presented at one or more medical congresses that require peer review of abstract submissions and they also have been available to the general public on LillyTrials.com since 2004.
The authors of the NEJM article decided not to count studies as "published" if the manuscript included data from two or more studies. While this methodology might be suitable for an academic discussion, it's clearly not the appropriate standard for determining whether a company has been transparent in disclosing its data.
We clearly have been transparent. The data is publicly available online; we've presented it to health care professionals at major medical meetings; and we published it -- more than once -- in peer-reviewed medical journals. And we remain committed to transparency. All of which we would have told The New York Times ... if only they had called and asked."
Has the New York Times changed its motto from "All the news that's fit to print" to "Don't ask, don't tell?"
The “authorized generics†debate has made it to the other side of the pond. The Financial Times reports that the EU Commission is concerned that the price of medicines is rising -- while innovation declines—and will investigate whether the pharmaceutical industry abuses patent rights to delay the introduction of low-cost generic alternatives.
The Financial Times writes, “The answer may be that collusion between companies keeps prices high. But the pricing of medicines in much of Europe is more government-controlled than in the US. Companies may profit from national pricing. In the UK, where there is a freer approach, competition is more intense and discounting heavy. Not enough deregulation may be the bigger problem.â€
Here is the complete Financial Times editorial:
http://www.ft.com/cms/s/0/75dbce42-c52c-11dc-811a-0000779fd2ac.html?nclick_check=1
For more discussion of the authorized generics issue, along with an economic analysis of the same, please see:
http://drugwonks.com/2007/05/rockys_racoon.html
The conclusion of the Financial Times editorial is spot on – and something we should take to heart on our side of the Atlantic as well – that we must be careful that “a consumer-first approach does not become a populist one.â€
And -- when you consider some of the health care rhetoric being bandied about by the Presidential candidates -- that’s a notion worthy of serious consideration.
The Financial Times writes, “The answer may be that collusion between companies keeps prices high. But the pricing of medicines in much of Europe is more government-controlled than in the US. Companies may profit from national pricing. In the UK, where there is a freer approach, competition is more intense and discounting heavy. Not enough deregulation may be the bigger problem.â€
Here is the complete Financial Times editorial:
http://www.ft.com/cms/s/0/75dbce42-c52c-11dc-811a-0000779fd2ac.html?nclick_check=1
For more discussion of the authorized generics issue, along with an economic analysis of the same, please see:
http://drugwonks.com/2007/05/rockys_racoon.html
The conclusion of the Financial Times editorial is spot on – and something we should take to heart on our side of the Atlantic as well – that we must be careful that “a consumer-first approach does not become a populist one.â€
And -- when you consider some of the health care rhetoric being bandied about by the Presidential candidates -- that’s a notion worthy of serious consideration.
A US study by the Banner Good Samaritan Medical Center in Phoenix, Arizona has found surgical residents performed better during simulated surgery after playing on the Wii for an hour beforehand.
"The whole point about surgery is to execute small, finely controlled movements with your hands, and that is exactly what you get playing Wii," Kanav Kahol, who conducted the study with colleague Marshall Smith, told New Scientist magazine.
Professor John Quin, executive director of surgical affairs at the Royal Australasian College of Surgeons, said the study was interesting and showed promise, but it was still not clear whether better performance in simulated surgery translated into better performance in surgery on a live patient.
"What it shows at the moment is only that if you repeatedly play video games you get better at playing video games," he said, adding the RACS was conducting a Federal Government-aided study to determine the effectiveness of simulated surgery.
Professor Quin said he hoped high-tech tools like the Wii and simulated surgery proved useful because "it's getting more and more difficult to train the full experience of the surgical operation".
The study found only those games requiring precise movements, like Marble Mania in which a player guides a marble through a 3D obstacle course using the Wii's motion-sensitive remote, are effective.
"You don't gain a lot from swinging an imaginary tennis racket," Kahol said.
Past research by other academics has similarly found video games requiring fine control can help build the skills surgeons need for operations like keyhole surgery.
Kahol and Smith are now reportedly designing Wii software to accurately simulate surgical procedures. For developing countries unable to provide expensive professional training systems, the Wii could be used as a cheap and effective training tool.
In conducting their study, the pair called on eight trainee doctors to play the Wii for an hour before performing virtual surgery using a tool called ProMIS. The training tool provides a 3D simulation of a patient's body and tracks the surgeon's movements while they are "operating".
Movement data was then processed using an algorithm and the surgeons were given scores. Those who played the Wii scored 48 per cent higher on tool control and performance than those who didn't.
"The whole point about surgery is to execute small, finely controlled movements with your hands, and that is exactly what you get playing Wii," Kanav Kahol, who conducted the study with colleague Marshall Smith, told New Scientist magazine.
Professor John Quin, executive director of surgical affairs at the Royal Australasian College of Surgeons, said the study was interesting and showed promise, but it was still not clear whether better performance in simulated surgery translated into better performance in surgery on a live patient.
"What it shows at the moment is only that if you repeatedly play video games you get better at playing video games," he said, adding the RACS was conducting a Federal Government-aided study to determine the effectiveness of simulated surgery.
Professor Quin said he hoped high-tech tools like the Wii and simulated surgery proved useful because "it's getting more and more difficult to train the full experience of the surgical operation".
The study found only those games requiring precise movements, like Marble Mania in which a player guides a marble through a 3D obstacle course using the Wii's motion-sensitive remote, are effective.
"You don't gain a lot from swinging an imaginary tennis racket," Kahol said.
Past research by other academics has similarly found video games requiring fine control can help build the skills surgeons need for operations like keyhole surgery.
Kahol and Smith are now reportedly designing Wii software to accurately simulate surgical procedures. For developing countries unable to provide expensive professional training systems, the Wii could be used as a cheap and effective training tool.
In conducting their study, the pair called on eight trainee doctors to play the Wii for an hour before performing virtual surgery using a tool called ProMIS. The training tool provides a 3D simulation of a patient's body and tracks the surgeon's movements while they are "operating".
Movement data was then processed using an algorithm and the surgeons were given scores. Those who played the Wii scored 48 per cent higher on tool control and performance than those who didn't.
A combination of common and minor variations in five regions of DNA can help predict a man’s risk of getting prostate cancer, researchers reported Wednesday.
According to today's New York Times:
"A company formed by researchers at Wake Forest University School of Medicine is expected to make the test available in a few months, said Karen Richardson, a Wake Forest spokeswoman. It should cost less than $300.
This is, some medical experts say, a first taste of what is expected to be a revolution in medical prognostication. The results, they agree, are clear. But the question is what happens next."
Here’s a link to the complete story:
http://www.nytimes.com/2008/01/17/health/17cancer.html?scp=1&sq=medical+test
According to today's New York Times:
"A company formed by researchers at Wake Forest University School of Medicine is expected to make the test available in a few months, said Karen Richardson, a Wake Forest spokeswoman. It should cost less than $300.
This is, some medical experts say, a first taste of what is expected to be a revolution in medical prognostication. The results, they agree, are clear. But the question is what happens next."
Here’s a link to the complete story:
http://www.nytimes.com/2008/01/17/health/17cancer.html?scp=1&sq=medical+test
Predictably USA Today pushes the panic button on Vytorin
http://www.usatoday.com/news/health/2008-01-16-cholesterol-main_N.htm
But many doctors express frustration. They say they're increasingly asked to prescribe drugs like Vytorin, Zetia and Crestor though the drugs have never have been successfully tested in long-term trials. In the world of billion-dollar medicines, these have a nickname — "me-too" drugs, because they're purportedly like other drugs that have been more extensively tested.
Cholesterol-lowering drugs aren't the only culprits. A number of blood-pressure-lowering ACE-inhibitor drugs are riding on the coattails of the blockbuster Captopril. Zetia and Vytorin are me-too drugs that stretch the limits of the category. Although they were approved on the same basis as statins — for their power to lower bad cholesterol — they aren't statins. They work by an entirely new mechanism that Merck and Schering-Plough promote heavily to doctors and on television, though it's not as well-tested as the statin approach.
Doctors who prescribe them, and patients who use them, take it on faith that the drugs will protect them from heart attacks and prolong their lives, says Yale University cardiologist Harlan Krumholz.
"This is huge," he says. "It's a story of whether or not the profession is going to turn and say, 'We're not going to say me-too drugs are the same unless they prove it.' "
Meanwhile none of the articles picked up on the real reason why most drugs don't work for most people: genetic variations. Nor did they link this story to another important scientific one about cholesterol reported last week.
7 New Cholesterol Genes Found
Genes May Make Good Targets for New Cholesterol Drugs, Experts Say
By Miranda Hitti
WebMD Medical News
Reviewed by Louise Chang, MD
Jan. 14, 2008 -- Scientists have discovered seven genes that affect levels of HDL ("good") cholesterol, LDL ("bad") cholesterol, and triglycerides (another type of blood fat).
Several of those genes "are potentially attractive drug targets" to lower heart disease risk, write the University of Michigan's Cristen Willer, PhD, and colleagues.
Two of the newly identified genes only affect HDL cholesterol, one only affects LDL cholesterol, three only affect triglycerides, and one affects LDL cholesterol and triglycerides.....
....Willer and colleagues also noticed that genes for high LDL cholesterol levels were associated with greater risk of coronary artery disease, which makes heart attacks more likely.
"Nearly all of the gene regions that we found to be involved in higher LDL levels were also involved in coronary artery disease risk," Willer states in a news release. "This is a remarkable result and suggests that new drug therapies that target the genes in these regions will also help prevent coronary artery disease and allow people to live longer and healthier lives."
One day, it may be possible to tailor cholesterol and triglyceride treatments to a patient's gene profile, the researchers note.
Meanwhile, your doctor can check your cholesterol and triglyceride levels and give you advice about how to improve those levels through diet, exercise, and medication, if needed."
Not one article or news account discussed this important factor. It's easier just to make people panic and pick up on the old "me-too" drug issue.
http://www.webmd.com/heart/news/20080114/7-new-cholesterol-genes-found
http://www.usatoday.com/news/health/2008-01-16-cholesterol-main_N.htm
But many doctors express frustration. They say they're increasingly asked to prescribe drugs like Vytorin, Zetia and Crestor though the drugs have never have been successfully tested in long-term trials. In the world of billion-dollar medicines, these have a nickname — "me-too" drugs, because they're purportedly like other drugs that have been more extensively tested.
Cholesterol-lowering drugs aren't the only culprits. A number of blood-pressure-lowering ACE-inhibitor drugs are riding on the coattails of the blockbuster Captopril. Zetia and Vytorin are me-too drugs that stretch the limits of the category. Although they were approved on the same basis as statins — for their power to lower bad cholesterol — they aren't statins. They work by an entirely new mechanism that Merck and Schering-Plough promote heavily to doctors and on television, though it's not as well-tested as the statin approach.
Doctors who prescribe them, and patients who use them, take it on faith that the drugs will protect them from heart attacks and prolong their lives, says Yale University cardiologist Harlan Krumholz.
"This is huge," he says. "It's a story of whether or not the profession is going to turn and say, 'We're not going to say me-too drugs are the same unless they prove it.' "
Meanwhile none of the articles picked up on the real reason why most drugs don't work for most people: genetic variations. Nor did they link this story to another important scientific one about cholesterol reported last week.
7 New Cholesterol Genes Found
Genes May Make Good Targets for New Cholesterol Drugs, Experts Say
By Miranda Hitti
WebMD Medical News
Reviewed by Louise Chang, MD
Jan. 14, 2008 -- Scientists have discovered seven genes that affect levels of HDL ("good") cholesterol, LDL ("bad") cholesterol, and triglycerides (another type of blood fat).
Several of those genes "are potentially attractive drug targets" to lower heart disease risk, write the University of Michigan's Cristen Willer, PhD, and colleagues.
Two of the newly identified genes only affect HDL cholesterol, one only affects LDL cholesterol, three only affect triglycerides, and one affects LDL cholesterol and triglycerides.....
....Willer and colleagues also noticed that genes for high LDL cholesterol levels were associated with greater risk of coronary artery disease, which makes heart attacks more likely.
"Nearly all of the gene regions that we found to be involved in higher LDL levels were also involved in coronary artery disease risk," Willer states in a news release. "This is a remarkable result and suggests that new drug therapies that target the genes in these regions will also help prevent coronary artery disease and allow people to live longer and healthier lives."
One day, it may be possible to tailor cholesterol and triglyceride treatments to a patient's gene profile, the researchers note.
Meanwhile, your doctor can check your cholesterol and triglyceride levels and give you advice about how to improve those levels through diet, exercise, and medication, if needed."
Not one article or news account discussed this important factor. It's easier just to make people panic and pick up on the old "me-too" drug issue.
http://www.webmd.com/heart/news/20080114/7-new-cholesterol-genes-found
912 word story in today's edition of the New York Times under the headline, "Antidepressant Studies Unpublished."
Here's the first paragraph:
"The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found."
And later on:
"The finding is likely to inflame a continuing debate about how drug trial data is reported."
Here's the full story:
http://www.nytimes.com/2008/01/17/health/17depress.html?_r=1&oref=slogin
912 words and not a single one speaking to the fact that Lilly (per Prozac) was the first Pharma company to put all of its clinical trials on a public website.
Is Google blocked at the Grey Lady?
Here's the first paragraph:
"The makers of antidepressants like Prozac and Paxil never published the results of about a third of the drug trials that they conducted to win government approval, misleading doctors and consumers about the drugs’ true effectiveness, a new analysis has found."
And later on:
"The finding is likely to inflame a continuing debate about how drug trial data is reported."
Here's the full story:
http://www.nytimes.com/2008/01/17/health/17depress.html?_r=1&oref=slogin
912 words and not a single one speaking to the fact that Lilly (per Prozac) was the first Pharma company to put all of its clinical trials on a public website.
Is Google blocked at the Grey Lady?
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
