Latest Drugwonks' Blog
"Drug Pirates Leave Death in their Wake." So reads the headline from the Guardian (of London). It's the most recent report on China's role in the growing global threat of counterfeit medicines -- and it's nothing short of international health care terrorism.
Some relevant snippets:
* Last month Peter Mandelson, the EU trade commissioner, revealed that fake birth control pills and HIV retroviral drugs from China had been seized by European customs officers.
* According to Mr. Mandelson, half of all counterfeit pharmaceuticals found inthe EU originate in China.
* The article cites the CMPI report to the effect that that global sales of counterfeit drugs will reach $75bn (£38bn) in 2010 - an increase of more than 90% from 2005.
* Henk Bekedam, representative for WHO in Beijing, said, "Fake drugs are a global problem and there is no reason to believe China is an exception. Piracy is a disease ... we need to report on it, find out where it is coming from, and go and deal with it."
Here's a link to the complete article:
http://business.guardian.co.uk/story/0,,1963095,00.html
And the closing sentence of the story is worth sharing:
"The worst consequences will be a lot more serious than erectile dysfunction."
Some relevant snippets:
* Last month Peter Mandelson, the EU trade commissioner, revealed that fake birth control pills and HIV retroviral drugs from China had been seized by European customs officers.
* According to Mr. Mandelson, half of all counterfeit pharmaceuticals found inthe EU originate in China.
* The article cites the CMPI report to the effect that that global sales of counterfeit drugs will reach $75bn (£38bn) in 2010 - an increase of more than 90% from 2005.
* Henk Bekedam, representative for WHO in Beijing, said, "Fake drugs are a global problem and there is no reason to believe China is an exception. Piracy is a disease ... we need to report on it, find out where it is coming from, and go and deal with it."
Here's a link to the complete article:
http://business.guardian.co.uk/story/0,,1963095,00.html
And the closing sentence of the story is worth sharing:
"The worst consequences will be a lot more serious than erectile dysfunction."
Interesting/disturbing article in Sunday's edition of the Washington Times on the growing trend of "medical tourism" -- Americans traveling abroad for surgeries. And this doesn't mean spending a relaxing week in Paris. Hardly. It's more likely a trek to India or Thailand.
Joshua Goldberg, 23, a California man who went to Thailand to be ordained as a Buddhist monk, died at Bumrungrad Hospital in Bangkok after being bitten by a snake. Reports indicated Mr. Goldberg was "simultaneously administered ... six contraindicated and lethal medications," despite warnings to doctors from his father about his allergies to certain drugs.
But our pal Uwe Reinhardt, a health economist at Princeton University, has not heard "one horror story" involving a medical tourist.
Well ignorance is no excuse. Nor is naivete. According to Uwe, "A lot of surgery is just plumbing that requires skill. Given circumstances today, it's much harder to run a hospital in Los Angeles than in India. And while things could go wrong in a hospital in India or another Asian country, they would probably turn out just as well there as here."
Doesn't that make you all warm and fuzzy?
A better, wiser, safer, more practical, and less expensive alternative is to strive to avoid surgery altogether. And the best way to avoid many surgeries is to diagnose disease earlier and provide treatment through non-invasive, domestic pharmaceutical intervention.
Americans would be far better off with proper medication today than a passage to India tomorrow.
Joshua Goldberg, 23, a California man who went to Thailand to be ordained as a Buddhist monk, died at Bumrungrad Hospital in Bangkok after being bitten by a snake. Reports indicated Mr. Goldberg was "simultaneously administered ... six contraindicated and lethal medications," despite warnings to doctors from his father about his allergies to certain drugs.
But our pal Uwe Reinhardt, a health economist at Princeton University, has not heard "one horror story" involving a medical tourist.
Well ignorance is no excuse. Nor is naivete. According to Uwe, "A lot of surgery is just plumbing that requires skill. Given circumstances today, it's much harder to run a hospital in Los Angeles than in India. And while things could go wrong in a hospital in India or another Asian country, they would probably turn out just as well there as here."
Doesn't that make you all warm and fuzzy?
A better, wiser, safer, more practical, and less expensive alternative is to strive to avoid surgery altogether. And the best way to avoid many surgeries is to diagnose disease earlier and provide treatment through non-invasive, domestic pharmaceutical intervention.
Americans would be far better off with proper medication today than a passage to India tomorrow.
This sounds pretty good, says Christopher P. Cannon, a cardiologist at Brigham & Women's Hospital in Boston. He notes that in the data that are available, torcetrapib consistently raises blood pressure, but the change is small and might be treated with other medications. On the other hand, he says, increases in HDL are unparalleled.He says that if studies show the drug clears plaque out of the arteries, it could be very important. This medication would help address a huge unmet need, he says.
http://www.forbes.com/2006/11/30/pfizer-cholesterol-drug-biz-cz_mh_1201pfizer.html?partner=alerts
http://www.forbes.com/2006/11/30/pfizer-cholesterol-drug-biz-cz_mh_1201pfizer.html?partner=alerts
From AP According to Pfizer spokesman Paul Fitzhenry, 82 patients taking the combination of torcetrapib died, compared to 51 deaths in the arm of the study where patients were taking Lipitor alone. Each arm of the study had 7,500 patients. Pfizer said that the study didn't raise any questions about Lipitor's safety.
Dr. Philip Barter, chairman of the steering committee overseeing the study, said in Pfizer's release that the findings of the data safety monitoring board Torcetrapib were a surprise "in light of prior study results."
We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Barter, Director of the Heart Research Institute in Australia.
Only three patients, all on the combo pill, stopped taking their medicine because of a blood pressure increase. However, a total of 14 patients stopped taking the combo pill for any reason, twice as many as on Lipitor alone..."
Dr. Philip Barter, chairman of the steering committee overseeing the study, said in Pfizer's release that the findings of the data safety monitoring board Torcetrapib were a surprise "in light of prior study results."
We believed that the study was coming along as expected, and this new information was totally unexpected and disappointing, given the potential benefits of this drug," said Barter, Director of the Heart Research Institute in Australia.
Only three patients, all on the combo pill, stopped taking their medicine because of a blood pressure increase. However, a total of 14 patients stopped taking the combo pill for any reason, twice as many as on Lipitor alone..."
A factoid (courtesy of Gabriel Calzada, director of Madrid's well-regarded Instituto Juan de Mariana) for those who think that government control of health care leads to Nirvana:
In a classic case of "do as I say, not as I do," 86% of Spain's bureaucrats opt for private health care versus that provided by their employer, the government.
And, yes, Generalissimo Francisco Franco is still dead.
In a classic case of "do as I say, not as I do," 86% of Spain's bureaucrats opt for private health care versus that provided by their employer, the government.
And, yes, Generalissimo Francisco Franco is still dead.
Days before the advisory committee hearing on Ketek's risk/benefit profile guess who sends a letter to the NEJM claiming that the FDA's use of post market safety data in approving the drug was inappropriate?
David Graham.
But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.
I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.
I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.
He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...
If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.
David Graham.
But I thought that using observational databases were the key to identifying safety signals like those he found with Vioxx.
I guess they are only good if you find what you are looking for. Or if your sponsor Senator Grassley wants to put pressure on the FDA commissioner to politicize the review of Ketek by conducting a political show trial instead of a scientific inquiry.
I said I would criticize Graham and I will. He is nothing but a hack who will twist science to curry favor with his political patrons.
He also twists the truth. Ketek use is just not limited to sinus infections. Or maybe Graham and Grassley failed to read the medical literature about the use of ketek in treating COPD as well as community acquired pneumonia and the role the drug plays in reducing the risk of developing drug resistant bacterial strains...
If Andy doesn't get confirmed because he doesn't cave into Grassley's bullying and Graham's zealotry, good for him. It will make the FDA a stronger and saner place. Someone should drawn the line.
Let me remind everyone that Dr. Graham's famous memo on Vioxx did not adequately control for prior cardiovascular illness, obesity, hypertension or mixture thereof and that notwithstanding Grahama found a 1.47 relative risk of a significant cardiac event for low-dose Vioxx usage and 3.58 for high-dose Vioxx usage compared to current use of celecoxib, though the smaller number was not statistically significant, and relative risk compared to other populations was not statistically significance.
Further, it should be pointed that two advisory committees, one conducted by the FDA and another in Canada determined that Vioxx be returned to market. Dr. Graham's presentation at the FDA advisory committee was not as warmly received as the posterior polishing he received during his Senate presentation.
Do I apologize for logging on to our site to see the fake Graham posting and then responding from Israel and then rushing out to spend time with my family without reading the subsequent correction? Absolutely. Do I apologize for calling him a sad sick individual for equating the FDA with Nazi's when in fact he did nothing of the sort. Of course and it sickens me that someone would write some that disgusting using his name or anyone elses. While I strongly disagree with Graham and his approach, no one deserves such treatmen.
Does it bother me that Graham's lawyer implies that I had reckless disregard for the facts and didn't take the time to see if there were an explanation instead of posturing like an aggrieved victim...kind of. Will the threat of a lawsuit stop me from criticizing Dr. Graham in the future if that was the goal?
You be the judge.
Further, it should be pointed that two advisory committees, one conducted by the FDA and another in Canada determined that Vioxx be returned to market. Dr. Graham's presentation at the FDA advisory committee was not as warmly received as the posterior polishing he received during his Senate presentation.
Do I apologize for logging on to our site to see the fake Graham posting and then responding from Israel and then rushing out to spend time with my family without reading the subsequent correction? Absolutely. Do I apologize for calling him a sad sick individual for equating the FDA with Nazi's when in fact he did nothing of the sort. Of course and it sickens me that someone would write some that disgusting using his name or anyone elses. While I strongly disagree with Graham and his approach, no one deserves such treatmen.
Does it bother me that Graham's lawyer implies that I had reckless disregard for the facts and didn't take the time to see if there were an explanation instead of posturing like an aggrieved victim...kind of. Will the threat of a lawsuit stop me from criticizing Dr. Graham in the future if that was the goal?
You be the judge.
Just received this letter from David Graham's attorney:
Dear Center for Medicine in the Public Interest:
First, thank you for acknowledging on DrugWonks.com that the opinion piece entitled “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†was not, in fact, authored by Dr. David Graham.
Having so acknowledged this fact, we would assume that DrugWonks.com would take the honorable and, we believe, legally mandated step of removing all the postings related to this matter that defame Dr. Graham. Not only did this not happen, DrugWonks.com actually posted an item, “My PS to David Graham†by Robert Goldberg, describing Dr. Graham, among other things as “a sad, sick individual,†after acknowledging that Dr. Graham was not the author of the aforementioned opinion piece.
In our view this Goldberg posting, and the failure to remove the prior postings by Peter Pittts related to this matter, exhibit actual malice toward Dr. Graham and an intentional or reckless disregard for the truth or falsity of these postings. Bluntly, they meet the legal standard of defamation.
Therefore, we must demand that, by 4 pm EST today (Tuesday, November 21, 2006):
(1) DrugWonks.com remove all postings associating Dr. Graham with “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†and any negative insinuations about Dr. Graham related to this matter;
(2) Publish, at the top of the home page of DrugWonks.com, a bold-face, unqualified apology to Dr. Graham as follows: “DrugWonks.com, the Center for Medicine in the Public Interest, Peter Pitts and Robert Goldberg apologize to Dr. David Graham for posting intemperate and insulting comments about Dr. Graham, wrongly attributing to him the authorship of “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity.†We regret any inconvenience or harm this has caused Dr. Graham.â€
Well, we want to do the right thing. And we certainly want Dr. Graham and his lawyers to think we're honorable. And, of course, we'd never want to be intemperate and insulting! Furtherest thing from our minds. But, David, you were also clearly inflamed by the article , so we hope you can see where we were coming from.
Please accept our most sincere apologies. And we regret any inconvenience this has caused you.
And, here's an open offer -- please send us your thoughts on the article that you didn't write and we will run it on drugwonks.com. Since it evidently caused you such grief, we'd like to give you the opportunity to set the record straight.
Your lawyer knows how to reach us.
Dear Center for Medicine in the Public Interest:
First, thank you for acknowledging on DrugWonks.com that the opinion piece entitled “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†was not, in fact, authored by Dr. David Graham.
Having so acknowledged this fact, we would assume that DrugWonks.com would take the honorable and, we believe, legally mandated step of removing all the postings related to this matter that defame Dr. Graham. Not only did this not happen, DrugWonks.com actually posted an item, “My PS to David Graham†by Robert Goldberg, describing Dr. Graham, among other things as “a sad, sick individual,†after acknowledging that Dr. Graham was not the author of the aforementioned opinion piece.
In our view this Goldberg posting, and the failure to remove the prior postings by Peter Pittts related to this matter, exhibit actual malice toward Dr. Graham and an intentional or reckless disregard for the truth or falsity of these postings. Bluntly, they meet the legal standard of defamation.
Therefore, we must demand that, by 4 pm EST today (Tuesday, November 21, 2006):
(1) DrugWonks.com remove all postings associating Dr. Graham with “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity†and any negative insinuations about Dr. Graham related to this matter;
(2) Publish, at the top of the home page of DrugWonks.com, a bold-face, unqualified apology to Dr. Graham as follows: “DrugWonks.com, the Center for Medicine in the Public Interest, Peter Pitts and Robert Goldberg apologize to Dr. David Graham for posting intemperate and insulting comments about Dr. Graham, wrongly attributing to him the authorship of “The lawlessness of the FDA, Big Pharma immunity, and crimes against humanity.†We regret any inconvenience or harm this has caused Dr. Graham.â€
Well, we want to do the right thing. And we certainly want Dr. Graham and his lawyers to think we're honorable. And, of course, we'd never want to be intemperate and insulting! Furtherest thing from our minds. But, David, you were also clearly inflamed by the article , so we hope you can see where we were coming from.
Please accept our most sincere apologies. And we regret any inconvenience this has caused you.
And, here's an open offer -- please send us your thoughts on the article that you didn't write and we will run it on drugwonks.com. Since it evidently caused you such grief, we'd like to give you the opportunity to set the record straight.
Your lawyer knows how to reach us.
While we are certainly drugwonks, it's important not to forget that one of the most important ways to achieve and maintain good health is through proper diet and nutrition.
Remember, it's the FDA.
I was proud to have been a part of the FDA's Task Force on Consumer Health Information for Better Nutrition. One of our recommendations was that the agency move more swiftly and aggressively to approve qualified health claims for food -- making their value to America's health more transparent and potent from a labeling perspective.
Today's news is that CFSAN (the Center for Food Safety and Applied Nutrition) has received OMB approval for a study on how to best communicate qualified health claims to consumers.
After all, information that isn't properly understood by the consumer isn't worth the label its written on.
Remember, it's the FDA.
I was proud to have been a part of the FDA's Task Force on Consumer Health Information for Better Nutrition. One of our recommendations was that the agency move more swiftly and aggressively to approve qualified health claims for food -- making their value to America's health more transparent and potent from a labeling perspective.
Today's news is that CFSAN (the Center for Food Safety and Applied Nutrition) has received OMB approval for a study on how to best communicate qualified health claims to consumers.
After all, information that isn't properly understood by the consumer isn't worth the label its written on.
USA Today reported yesterday that Medicaid spending as a whole actually declined for the first time since 1965. I have not looked at the data yet and plan to but at first glance it would seem to me that increased utilization of medications -- particularly among the dually eligible population and those in nursing homes -- might be saving money in the more labor intensive parts of the health care system.
ere's a link to the article.
http://www.usatoday.com/printedition/news/20061127/1a_lede27.art.htm
The article notes: "The changes include shifting the elderly from nursing homes to less-costly home health care, cracking down on fraud, refining the management of high-cost patients (such as those with AIDS or hemophilia) and cutting some payments to hospitals and doctors. " Unstated is the fact that such changes rely upon increased drug utilization via disease management programs. At the same time, the question has to be raised as to whether states are simply cutting costs by simply denying care in isolated instances. But then again, the Part D experience has moved control of the drug benefit into the hands of consumers and advocates, albeit with some initial bumps and disruptions which CMS and a motivated crew of stakeholders has promised to rectify this enrollment period. All the more reason to shift resources from providers to consumers...
If so, and I promise to follow up on this premise, it is yet another reason why restricting seniors choice of drugs to fill the dough nut hole for rich seniors makes no sense at all. And why the Part D experiment should be expanded to include Medicaid as a common sense coalition of Ds and Rs are proposing in Congress. The link to this article can be found here.
http://www.jsonline.com/story/index.aspx?id=535435
H
ere's a link to the article.
http://www.usatoday.com/printedition/news/20061127/1a_lede27.art.htm
The article notes: "The changes include shifting the elderly from nursing homes to less-costly home health care, cracking down on fraud, refining the management of high-cost patients (such as those with AIDS or hemophilia) and cutting some payments to hospitals and doctors. " Unstated is the fact that such changes rely upon increased drug utilization via disease management programs. At the same time, the question has to be raised as to whether states are simply cutting costs by simply denying care in isolated instances. But then again, the Part D experience has moved control of the drug benefit into the hands of consumers and advocates, albeit with some initial bumps and disruptions which CMS and a motivated crew of stakeholders has promised to rectify this enrollment period. All the more reason to shift resources from providers to consumers...
If so, and I promise to follow up on this premise, it is yet another reason why restricting seniors choice of drugs to fill the dough nut hole for rich seniors makes no sense at all. And why the Part D experiment should be expanded to include Medicaid as a common sense coalition of Ds and Rs are proposing in Congress. The link to this article can be found here.
http://www.jsonline.com/story/index.aspx?id=535435
H
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.
