Latest Drugwonks' Blog
Whether it’s said in an American accent or a more refined British one, what's most important is to accent the truth – comparative effectiveness is bad medicine when you use healthcare technology assessment (HTA) tools (aka "Evidence-based Medicine") that misuse and misrepresent data derived from RCTs. Doing so yields results that budget managers want – regardless of whether or not it yields what’s best for the patient.
It’s the choice of short-term, short-sighted politicians.
Consider what’s going on in the UK.
The Association of the British Pharmaceutical is fighting proposals by the Office of Fair Trading to overhaul the pharmaceutical price regulation scheme so drugs companies will be forced to evaluate the benefit to the patient and the National Health Service when they set the prices.
Richard Barker, ABPI director-general, called the OFT's proposals "dangerous and anti-innovative". "The OFT has failed to understand the nature of scientific progress is step by step," he said, arguing that without a commercial incentive to introduce incremental improvements, more significant breakthroughs in new medicines would not take place.
He said the industry's two principal demands were to enhance the methods used for "health technology assessment", which would scrutinize the efficacy and cost benefits of new medicines; and to boost the often poor "uptake" of new medicines recommended by the National Institute for Clinical Excellence, the medicines advisory body.
His comments came ahead of hearings set to begin in the coming weeks by the Commons' health committee on the operation of the institute, which is studying why the agency's decisions are increasingly being questioned and whether public confidence in the organization is waning.
MPs will discuss the evaluation process and whether any particular groups are disadvantaged by the process, the speed of publishing guidance, the appeal system, comparison with the work of its Scottish counterpart, and implementation of its guidance.
Here’s the full story from the Financial Times:
http://www.ft.com/cms/s/88cd12b8-f2c8-11db-a454-000b5df10621.html
It’s the choice of short-term, short-sighted politicians.
Consider what’s going on in the UK.
The Association of the British Pharmaceutical is fighting proposals by the Office of Fair Trading to overhaul the pharmaceutical price regulation scheme so drugs companies will be forced to evaluate the benefit to the patient and the National Health Service when they set the prices.
Richard Barker, ABPI director-general, called the OFT's proposals "dangerous and anti-innovative". "The OFT has failed to understand the nature of scientific progress is step by step," he said, arguing that without a commercial incentive to introduce incremental improvements, more significant breakthroughs in new medicines would not take place.
He said the industry's two principal demands were to enhance the methods used for "health technology assessment", which would scrutinize the efficacy and cost benefits of new medicines; and to boost the often poor "uptake" of new medicines recommended by the National Institute for Clinical Excellence, the medicines advisory body.
His comments came ahead of hearings set to begin in the coming weeks by the Commons' health committee on the operation of the institute, which is studying why the agency's decisions are increasingly being questioned and whether public confidence in the organization is waning.
MPs will discuss the evaluation process and whether any particular groups are disadvantaged by the process, the speed of publishing guidance, the appeal system, comparison with the work of its Scottish counterpart, and implementation of its guidance.
Here’s the full story from the Financial Times:
http://www.ft.com/cms/s/88cd12b8-f2c8-11db-a454-000b5df10621.html
There is an old joke about the definition of chutzpah being someone who kills his parents and then asks for mercy from the judge because he's an orphan.
Now we have the journalist equivalent. Alex Berenson has an article in today's NYT: "US Wonders If Drug Data Was Accurate." You might recall Berenson helped ferret documents in violation of a court order to help build a biased case against Eli Lilly about well known side effects about Zyprexa and who was slammed by Judge Harvey Weinstein for doing so. And now he is writing about Zyprexa using the same documents he stole. Once again, Berenson uses the "one paper out of several thousands of documents" approach to depict Lilly as a criminal corporation.
And then at the end of the article Berenson writes: "A federal judge has criticized The Times for violating a protective order that covered the documents."
C'mon Alex we can be more accurate. We have the actual transcript describing YOUR behavior without violating the protective order. Didn't Judge Weinstein describe what you did as conspiring " to obtain and publish documents in knowing violation of a court order not to do so, and that they executed the conspiracy using other people as their agents in crime."
And as another report noted, Weinstein further described the actions of the men as "illegal," "stealing," a "brazen flouting" of his order and, in the case of Berenson, "reprehensible." He took occasion to quote from a 2004 version of the Times' handbook on ethical journalism: "Staff members must obey the law in pursuit of news."
On the heels of intense criticism of the NYT coverage of the Duke rape case and the paper's falling earnings, the Berenson reporting is another example of the Times decline.
Now we have the journalist equivalent. Alex Berenson has an article in today's NYT: "US Wonders If Drug Data Was Accurate." You might recall Berenson helped ferret documents in violation of a court order to help build a biased case against Eli Lilly about well known side effects about Zyprexa and who was slammed by Judge Harvey Weinstein for doing so. And now he is writing about Zyprexa using the same documents he stole. Once again, Berenson uses the "one paper out of several thousands of documents" approach to depict Lilly as a criminal corporation.
And then at the end of the article Berenson writes: "A federal judge has criticized The Times for violating a protective order that covered the documents."
C'mon Alex we can be more accurate. We have the actual transcript describing YOUR behavior without violating the protective order. Didn't Judge Weinstein describe what you did as conspiring " to obtain and publish documents in knowing violation of a court order not to do so, and that they executed the conspiracy using other people as their agents in crime."
And as another report noted, Weinstein further described the actions of the men as "illegal," "stealing," a "brazen flouting" of his order and, in the case of Berenson, "reprehensible." He took occasion to quote from a 2004 version of the Times' handbook on ethical journalism: "Staff members must obey the law in pursuit of news."
On the heels of intense criticism of the NYT coverage of the Duke rape case and the paper's falling earnings, the Berenson reporting is another example of the Times decline.
Pfizer's New combo drug-diagnostic for HIV got through the FDA Adcomm... I still wonder what prompted the FDA to dump all the safety concerns ahead of the commitee meeting?
http://blogs.wsj.com/health/2007/04/24/pfizer-aids-drug-gets-fda-panel-support/
http://blogs.wsj.com/health/2007/04/24/pfizer-aids-drug-gets-fda-panel-support/
The FDA announced today that all supplements and products derived from kryptonite would have a black box warning. Dr. David Graham had pressured the agency after noting that the presence of kryptonite would pose a serious and life threatening danger to Superman, Supergirl and other survivors of the planet Krypton. Graham had been pushing Congress to expand it's drug safety program to move beyond "merely planetary surveillance activities" and into galactic exploration of pharmacovigilance matters. The FDA said in a press release " this pilot project is part of our effort to develop a global and indeed galactic risk management program." The agency had planned to establish this program in partnership with Luthor Industries and the Justice League of America but was attacked by members of Congress for being too "cozy" with special interests.
When it comes to what this Congress is trying to do to the public health, we refuse to sit by and take a postion of, er, non-intereference.
Here's a new piece from today's edition of the Chicago Tribune:
http://www.chicagotribune.com/news/opinion/chi-0704230346apr24,0,7088012.story?coll=chi-newsopinioncommentary-hed
Hopefully some prominent Chicago officials (like Barack Obama and Rahm Emanuel) will see this and see the light. But we'll keep our expectations realistic and just hope they see it.
Here's a new piece from today's edition of the Chicago Tribune:
http://www.chicagotribune.com/news/opinion/chi-0704230346apr24,0,7088012.story?coll=chi-newsopinioncommentary-hed
Hopefully some prominent Chicago officials (like Barack Obama and Rahm Emanuel) will see this and see the light. But we'll keep our expectations realistic and just hope they see it.
Again, I am not making this up.....
New breakthrough research demonstrates for the first time that spending 5 minutes with a drug rep alters the subconscious mind of doctors in subtle ways, causing them to prescribe drugs that no one really need or wants or even uses.
The survey of 116 visits to 97 doctors found that after a five minute "session" with a drug rep, doctors were 46 percent more likely to prescribe a drug or recommend it to their colleagues.
One of the author's of this groundbreaking study, Dr. Michael Steinman of the San Francisco Veteran's Affairs Hospital said: "The remarkable thing is how effective a very brief visit by a drug representative -- most often less than five minutes -- can be in influencing physicians' choices to use a drug for an unapproved indication,"
Besides free drug samples, salespeople often bring gifts, lunch for the doctor or office staff, new pens and coffee mugs. "The doctor feels subtly, even subconsciously, indebted to the representative," Steinman said.
The study appears in the April 24, 2007 issue of PLoS Medicine. Co-authors of the study were G. Michael Harper, MD, Mary-Margaret Chren, MD, and C. Seth Landefeld, MD, of SFVAMC and UCSF.
Steinman, Landefeld, and Chren served as unpaid expert witnesses for the plaintiff in the litigation from which the source data for the study was obtained.
What a surprise.
The study was supported by funds from the Veterans Health Administration, the National Institute on Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the John A. Hartford Foundation, and the California Tobacco-Related Disease Research Programs.
What is government money doing supporting such crap?
New breakthrough research demonstrates for the first time that spending 5 minutes with a drug rep alters the subconscious mind of doctors in subtle ways, causing them to prescribe drugs that no one really need or wants or even uses.
The survey of 116 visits to 97 doctors found that after a five minute "session" with a drug rep, doctors were 46 percent more likely to prescribe a drug or recommend it to their colleagues.
One of the author's of this groundbreaking study, Dr. Michael Steinman of the San Francisco Veteran's Affairs Hospital said: "The remarkable thing is how effective a very brief visit by a drug representative -- most often less than five minutes -- can be in influencing physicians' choices to use a drug for an unapproved indication,"
Besides free drug samples, salespeople often bring gifts, lunch for the doctor or office staff, new pens and coffee mugs. "The doctor feels subtly, even subconsciously, indebted to the representative," Steinman said.
The study appears in the April 24, 2007 issue of PLoS Medicine. Co-authors of the study were G. Michael Harper, MD, Mary-Margaret Chren, MD, and C. Seth Landefeld, MD, of SFVAMC and UCSF.
Steinman, Landefeld, and Chren served as unpaid expert witnesses for the plaintiff in the litigation from which the source data for the study was obtained.
What a surprise.
The study was supported by funds from the Veterans Health Administration, the National Institute on Arthritis and Musculoskeletal and Skin Diseases, the National Institute on Aging, the John A. Hartford Foundation, and the California Tobacco-Related Disease Research Programs.
What is government money doing supporting such crap?
The Thai dictatorship clearly has Abbott in is sights. Working hand in glove with NGOs it clearly picked a fight over the price of its HIV drugs to distract attention over the suspension of civil liberties. It is disturbing to see Oxfam -- which boycotts Israel over so-called human rights abuses -- working with Thailand's military junta to demonize drug companies yet again and get away with it. But that is how the media and most of the world sees things. So ultimately Abbott had no choice but to cave, at least for now.
Long term, drug companies need to rethink their approach to emerging markets. Time and the wealth are on the side of innovation and property rights, not the thugs and NGOs who prop them up. They would do well to increase investment in global health policy, entrepreneurship in middle markets, and support partnerships with people interested in delivering new products throughout the world at market relevant prices.
Long term, drug companies need to rethink their approach to emerging markets. Time and the wealth are on the side of innovation and property rights, not the thugs and NGOs who prop them up. They would do well to increase investment in global health policy, entrepreneurship in middle markets, and support partnerships with people interested in delivering new products throughout the world at market relevant prices.
AP's Andrew Bridges reports today that
" Health officials repeated safety concerns about an experimental group of HIV drugs Friday, days before government advisers will recommend whether the first drug from the class merits approval.
Pfizer Inc. seeks Food and Drug Administration approval for maraviroc, potentially the first in a novel group of drugs to fight HIV, the virus that causes AIDS. Pfizer proposes marketing maraviroc as Celsentri.
Pfizer believes there is a clear unmet need for new drugs to fight HIV in patients for whom other, older drugs no longer work. Celsentri is unlike any other HIV medicines now on the market in that it targets the cells of patients and not the virus itself.
The FDA has scheduled a Tuesday meeting of outside experts to discuss Pfizer's application for approval. The FDA has asked the experts whether Celsentri, if approved, would require special labeling or if further study of the drug's safety is needed before it can be sold. FDA also asked whether the drug should be studied further in women and blacks."
Is this a strategic attempt to get the "bad news" out ahead of the Adcomm meeting or an effort to scuttle the drug in order to avoid looking bad? CCR5 inhibitors have been associated with an increased risk of liver damage and lymphoma but I don't know what that risk is relative to other drugs such as tylenol or other viruses left untreated. More worrisome perhaps: Maraviroc not only targets specific cells, but it will be marketed with a protein assay that will identify which patients that are high responders. Personalized medicine. Which means that the risk benefit profile will be higher still. I don't get this need for studying African Americans and women when you have a genetic test. Why not study Ashkenazic Jews still suffering from last night's Yankee game who live in New Jersey while your at it?
A first in class personalized medicine for a fatal disease and still the agency is screwing around with safety issues. Just how high does the bar have to be to get a drug approved?
" Health officials repeated safety concerns about an experimental group of HIV drugs Friday, days before government advisers will recommend whether the first drug from the class merits approval.
Pfizer Inc. seeks Food and Drug Administration approval for maraviroc, potentially the first in a novel group of drugs to fight HIV, the virus that causes AIDS. Pfizer proposes marketing maraviroc as Celsentri.
Pfizer believes there is a clear unmet need for new drugs to fight HIV in patients for whom other, older drugs no longer work. Celsentri is unlike any other HIV medicines now on the market in that it targets the cells of patients and not the virus itself.
The FDA has scheduled a Tuesday meeting of outside experts to discuss Pfizer's application for approval. The FDA has asked the experts whether Celsentri, if approved, would require special labeling or if further study of the drug's safety is needed before it can be sold. FDA also asked whether the drug should be studied further in women and blacks."
Is this a strategic attempt to get the "bad news" out ahead of the Adcomm meeting or an effort to scuttle the drug in order to avoid looking bad? CCR5 inhibitors have been associated with an increased risk of liver damage and lymphoma but I don't know what that risk is relative to other drugs such as tylenol or other viruses left untreated. More worrisome perhaps: Maraviroc not only targets specific cells, but it will be marketed with a protein assay that will identify which patients that are high responders. Personalized medicine. Which means that the risk benefit profile will be higher still. I don't get this need for studying African Americans and women when you have a genetic test. Why not study Ashkenazic Jews still suffering from last night's Yankee game who live in New Jersey while your at it?
A first in class personalized medicine for a fatal disease and still the agency is screwing around with safety issues. Just how high does the bar have to be to get a drug approved?
Lots of folks exercising their right to free speech over the issue of limiting free speech, aka: DTC advertising. The latest is the legislative attempt to give the FDA authority to ban advertising for the first two years after a drug is approved.
Here’s Senator Kennedy’s perspective:
"What we are looking at is the very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA … wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs.â€
But FDA already negotiates such circumstances. That’s the key word, “negotiate.†And it’s not a finesse. Minus that word it’s … unconstitutional.
And there are many people, far less holy than Senator Kennedy, who see this as the first step towards banning pharmaceutical advertising altogether.
Consider what a Consumer Reports analyst said, "We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people. The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."
Drugwonks does not believe that less information makes anything or anyone safter.
Make no mistake – this is a battle not only over the future role of the empowered health care consumer – but for the First Amendment.
Others are now saying, based on this new negative momentum, that DTC television ads will need to be more than one minute long to appropriately convey fair balance and adequate provision.
But it’s not a question of the time – it’s a question of the presentation. Can ads do a better job properly balancing risk and benefit? Most certainly. But it’s not necessarily a question of “more†as much as it is a question of “better.†And that means the FDA and industry (along with their advertising agencies) need better social science to determine how to best communicate such information to consumers.
Sounds like a good opening assignment for the agency’s new advisory committee on risk communications.
If we truly want to create a situation where our medicines are “safer†we must learn how to better communicate risk and benefit – not limit it.
Otherwise the empowered health care consumer might very well be gone in 60 seconds.
Here’s Senator Kennedy’s perspective:
"What we are looking at is the very rare circumstance. It would be used in the most limited kinds of circumstances, where the FDA … wants to give approval for a drug but is not sure and fears advertising will lead to massive use of the drugs.â€
But FDA already negotiates such circumstances. That’s the key word, “negotiate.†And it’s not a finesse. Minus that word it’s … unconstitutional.
And there are many people, far less holy than Senator Kennedy, who see this as the first step towards banning pharmaceutical advertising altogether.
Consider what a Consumer Reports analyst said, "We don't know, and we won't know, how truly safe a drug is until it's been used in millions of people. The real testing of these drugs takes place after a pill hits the market, and that's why the advertising needs to be regulated."
Drugwonks does not believe that less information makes anything or anyone safter.
Make no mistake – this is a battle not only over the future role of the empowered health care consumer – but for the First Amendment.
Others are now saying, based on this new negative momentum, that DTC television ads will need to be more than one minute long to appropriately convey fair balance and adequate provision.
But it’s not a question of the time – it’s a question of the presentation. Can ads do a better job properly balancing risk and benefit? Most certainly. But it’s not necessarily a question of “more†as much as it is a question of “better.†And that means the FDA and industry (along with their advertising agencies) need better social science to determine how to best communicate such information to consumers.
Sounds like a good opening assignment for the agency’s new advisory committee on risk communications.
If we truly want to create a situation where our medicines are “safer†we must learn how to better communicate risk and benefit – not limit it.
Otherwise the empowered health care consumer might very well be gone in 60 seconds.
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.
