Latest Drugwonks' Blog
I got a kick at how the VA's flak-catcher tried to sidestep the fact that nearly 40 percent of it's hostages have bought Part D coverage in addition to holding on to VA coverage.
The AP's Kevin Freking has the VA spin doctors trying to establish the difference as follows: There are also differences in the list of drugs the VA covers compared with the list of drugs a typical Medicare plan covers. Leavitt described the VA's list, or formulary, as "among the most restrictive in the marketplace."
In Medicare, slightly more than half of enrollees are in plans that cover 1,000 to 1,500 medications. Another 35 percent are in plans that cover more than 1,500 drugs, Nelligan said.
Meanwhile, the Veteran's Administration plan covers about 1,300 drugs, Valentino said.
But, he calls the number of drugs on a formulary "almost irrelevant."
He said if a plan covers the top 200 selling drugs, then it's basically covering everyone's needs. When asked if the VA covers the top drugs used by seniors, Valentino said he was confident that it does. (Mike Valentino, VA's pharmacy director.)
"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.
Equally safe and effective?
Mr. Valentino should have heard the presentation by FDA's Janet Woodcock about the myth of therapeutic substitution at Windhover FDA/CMS Summit in Washington this past week.
Or he can ask some of the VA consumers who post about their experiences at the hadit.com Vets forum
You can always get a letter from a Doctor explaing what you need and why and than the VA will have to get it for you. There is a risk though. I tried it a number of years ago and was threatened with losing my fee services....
to get the VA to pay, I will have to schedule umteen appointments first, before approval. Sometimes I wonder if it's worth the hassle.
I simply recieved a call from my VA doc one day, saying the VA pharmacy no longer carries the slow release Oxycontin I had been taking for sometime. It's one of the few I found that works with neurological, (hot ice pick stabs) I get & chronic pain.
His message said they were stopping the med, "imediately" & prescribing "methadone".
I refused it & was told to come in & discuss it with the Doc. (Another 300 mile trip).
I was told by the Doc The VA no longer carries it in our region. This is sort of true, I found out.
The truth is, the "VA" Pharmacy @ the Spokane VAMC told me it's on the formulary list. Meaning, they stock it, but the Doc must specifically request it & it must be approved before you recieve it.
I went through sudden withdrawal symptoms & suffered from symptoms due to MS, Fibromyalgia, Spinal disorders & the list goes on for nearly 6 months, without being treated for neurological pain. The Doc said I can take Meth or do without, because "he" wasn't going to prescribe anything but Meth.
I was eventually put back on 5 mg of Oxycontin. Three, every six hours, as needed & Oxycodone for break through pain.
The doc has since cut the Oxycodone.
I am unable to take triptians such as imitrex, etc., Demerol and morphine. I am able to take Darvocet which helps a little but the best med for me is Stadol. The VA does not carry it! I have a private dr prescribe it and I use the nasal spray. Within 5 mins the pain is gone. Unfortunately, so am I for about 5 hours.
I have not been able to work since February 2004 since I have 3-5 attacks per week. I use ice packs on the top and sides of my head and heat on my neck and it seems to work.
Let me repeat what Mr. Valentino said:
"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.
And this is what the Dems want to inflict on all seniors.
But I guess 2 million VA consumers have signed up for Part D because they like paying twice for equally safe and effective drugs...
The AP's Kevin Freking has the VA spin doctors trying to establish the difference as follows: There are also differences in the list of drugs the VA covers compared with the list of drugs a typical Medicare plan covers. Leavitt described the VA's list, or formulary, as "among the most restrictive in the marketplace."
In Medicare, slightly more than half of enrollees are in plans that cover 1,000 to 1,500 medications. Another 35 percent are in plans that cover more than 1,500 drugs, Nelligan said.
Meanwhile, the Veteran's Administration plan covers about 1,300 drugs, Valentino said.
But, he calls the number of drugs on a formulary "almost irrelevant."
He said if a plan covers the top 200 selling drugs, then it's basically covering everyone's needs. When asked if the VA covers the top drugs used by seniors, Valentino said he was confident that it does. (Mike Valentino, VA's pharmacy director.)
"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.
Equally safe and effective?
Mr. Valentino should have heard the presentation by FDA's Janet Woodcock about the myth of therapeutic substitution at Windhover FDA/CMS Summit in Washington this past week.
Or he can ask some of the VA consumers who post about their experiences at the hadit.com Vets forum
You can always get a letter from a Doctor explaing what you need and why and than the VA will have to get it for you. There is a risk though. I tried it a number of years ago and was threatened with losing my fee services....
to get the VA to pay, I will have to schedule umteen appointments first, before approval. Sometimes I wonder if it's worth the hassle.
I simply recieved a call from my VA doc one day, saying the VA pharmacy no longer carries the slow release Oxycontin I had been taking for sometime. It's one of the few I found that works with neurological, (hot ice pick stabs) I get & chronic pain.
His message said they were stopping the med, "imediately" & prescribing "methadone".
I refused it & was told to come in & discuss it with the Doc. (Another 300 mile trip).
I was told by the Doc The VA no longer carries it in our region. This is sort of true, I found out.
The truth is, the "VA" Pharmacy @ the Spokane VAMC told me it's on the formulary list. Meaning, they stock it, but the Doc must specifically request it & it must be approved before you recieve it.
I went through sudden withdrawal symptoms & suffered from symptoms due to MS, Fibromyalgia, Spinal disorders & the list goes on for nearly 6 months, without being treated for neurological pain. The Doc said I can take Meth or do without, because "he" wasn't going to prescribe anything but Meth.
I was eventually put back on 5 mg of Oxycontin. Three, every six hours, as needed & Oxycodone for break through pain.
The doc has since cut the Oxycodone.
I am unable to take triptians such as imitrex, etc., Demerol and morphine. I am able to take Darvocet which helps a little but the best med for me is Stadol. The VA does not carry it! I have a private dr prescribe it and I use the nasal spray. Within 5 mins the pain is gone. Unfortunately, so am I for about 5 hours.
I have not been able to work since February 2004 since I have 3-5 attacks per week. I use ice packs on the top and sides of my head and heat on my neck and it seems to work.
Let me repeat what Mr. Valentino said:
"They are either on our formulary or we have an equally safe and effective drug in that class on our formulary," he said.
And this is what the Dems want to inflict on all seniors.
But I guess 2 million VA consumers have signed up for Part D because they like paying twice for equally safe and effective drugs...
"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.
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.
