Latest Drugwonks' Blog
The new standard for David Graham and his ilk: "As long as we have the evidence we want, we have the evidence we need. "
To wit: If we have evidence of harm of one drugs from a meta-analyses but measly evidence of other drugs then by definition the other drugs are safe...
Or: "The safest drug to take for diabetes is placebo."
To wit: If we have evidence of harm of one drugs from a meta-analyses but measly evidence of other drugs then by definition the other drugs are safe...
Or: "The safest drug to take for diabetes is placebo."
"There are people with so much antipathy for companies making money from drugs that they would rather people die than be helped from a new medicine"
The politicization of medicine. Why are such tactics necessary if the science speaks for itself. Why do how researchers who employ those tactics be relied upon as reliably as those that do not. "
Editorials that are one sided that give the media a field day for bashing. This is not a civilized world. Bashing should not be part of our culture. I heard today that A1C is not the gold standard but it is associated with a decrease in duration...so why is that now a problem. Why was there no evidence on statin use?
Charlie Steele, diabetes patient. Focuses on limb losses. 225 a day lose their leg because of diabetes. My A1C is creeping up. The longer you have diabetes the more likely this will happen. As a patient I want as many drugs. I am concerned about the hype. It makes one head spin. We need all the weapons we need. The 84 year old mother. She tried diabetic meds and could not tolerate them.. Avandia worked but now she doesn't take it because of the Nissen study.
Jerome Tolbott, endocrinologist. Had a patient demand to be taken off Avandia. Family demanded he be taken off the Avandia because of the media report. Doctors are just stopping the medication and it will worsen the diabetes problem. The TZDs are the only drugs that target insulin resistance. I have treated many patients with Avandia. Longshoreman was afraid to use a needle. After about five years with Avandia and two other oral agents his diabetes is under control. Two third of patients fail to control their A1C properly. The result is blindness, kidney failure, amputation. I need Avandia to help my patients. The media is terrorizing my patients.
We have set meta analysis up as a quasi null hypothesis that clinical data cannot refute..".J Richard Turner. PhD (Meanwhile, David Graham based on relatively little data claims Actos is a safer and better drug)
A physician survey showed that 75 percent of all diabetes doctors have seen reduced compliance or abandonment of Avandia.
The politicization of medicine. Why are such tactics necessary if the science speaks for itself. Why do how researchers who employ those tactics be relied upon as reliably as those that do not. "
Editorials that are one sided that give the media a field day for bashing. This is not a civilized world. Bashing should not be part of our culture. I heard today that A1C is not the gold standard but it is associated with a decrease in duration...so why is that now a problem. Why was there no evidence on statin use?
Charlie Steele, diabetes patient. Focuses on limb losses. 225 a day lose their leg because of diabetes. My A1C is creeping up. The longer you have diabetes the more likely this will happen. As a patient I want as many drugs. I am concerned about the hype. It makes one head spin. We need all the weapons we need. The 84 year old mother. She tried diabetic meds and could not tolerate them.. Avandia worked but now she doesn't take it because of the Nissen study.
Jerome Tolbott, endocrinologist. Had a patient demand to be taken off Avandia. Family demanded he be taken off the Avandia because of the media report. Doctors are just stopping the medication and it will worsen the diabetes problem. The TZDs are the only drugs that target insulin resistance. I have treated many patients with Avandia. Longshoreman was afraid to use a needle. After about five years with Avandia and two other oral agents his diabetes is under control. Two third of patients fail to control their A1C properly. The result is blindness, kidney failure, amputation. I need Avandia to help my patients. The media is terrorizing my patients.
We have set meta analysis up as a quasi null hypothesis that clinical data cannot refute..".J Richard Turner. PhD (Meanwhile, David Graham based on relatively little data claims Actos is a safer and better drug)
A physician survey showed that 75 percent of all diabetes doctors have seen reduced compliance or abandonment of Avandia.
Robert Meyer of the FDA slammed David Graham for ignoring other risks and problems that diabetics have.
Now the Wellpoint observational data shows that Avandia patients were twice as likely to have a prior heart problem.... oh.
No statistical signficance associated with either TZD...
Subgroup analysis of monotherapy..no statistical significance.
Now the Wellpoint observational data shows that Avandia patients were twice as likely to have a prior heart problem.... oh.
No statistical signficance associated with either TZD...
Subgroup analysis of monotherapy..no statistical significance.
Dr. David Graham of the tort lawer funded Goverment Accountability Project told the FDA that Avandia, along with "one meelion" other drugs should be yanked from the market.
Graham ostensibly "works" for the FDA but splits his time between GAP, having lunch with Senator Charles Grassley and talking to reporters. In his presentation to the FDA Graham never quite explained how a the RECORD study on Avandia, a prospective, observational study with defined endpoints that was reviewed and approved by the European Medicines Evaluation Agency could be considered inferior data to the retrospective Kaiser database he used to deem Vioxx dangerous.
http://news.yahoo.com/s/ap/20070730/ap_on_he_me/diabetes_drug
PS...Karen Mahoney of the FDA dumped all over Graham and Del Pan's rationale for rejecting RECORD namely that it was designed to capture how diabetes is actually treated. Of course the media will not capture this important difference.
Graham ostensibly "works" for the FDA but splits his time between GAP, having lunch with Senator Charles Grassley and talking to reporters. In his presentation to the FDA Graham never quite explained how a the RECORD study on Avandia, a prospective, observational study with defined endpoints that was reviewed and approved by the European Medicines Evaluation Agency could be considered inferior data to the retrospective Kaiser database he used to deem Vioxx dangerous.
http://news.yahoo.com/s/ap/20070730/ap_on_he_me/diabetes_drug
PS...Karen Mahoney of the FDA dumped all over Graham and Del Pan's rationale for rejecting RECORD namely that it was designed to capture how diabetes is actually treated. Of course the media will not capture this important difference.
From today's edition of the Washington Times ...
Dingell, Stark and Medi-scare
There is no truth to the rumors that Democratic Reps. Fortney "Pete" Stark of California and John Dingell of Michigan secretly jumped ship and are helping Republicans recapture the majority in the House. But you would never know it based on their health-care agenda. The two liberal old bulls who face little-to-no personal electoral vulnerability seem determined to march their caucus back to minority status by forcing them to cast a highly unpopular vote to cut Medicare.
A peak below the surface reveals why these two lawmakers' ideological crusade could put House Speaker Nancy Pelosi back in the minority leader's suite. This week, two House committees began consideration of legislation to reauthorize and expand the State Children's Health Initiative Program. Predictably, Democrats want to balloon it into a massive Leviathan costing more than $50 billion over the next five years. This large an expansion will induce millions to drop their private insurance coverage to feast at the taxpayer's expense. The program could accomplish its objectives with a lot less money, but consider who is in charge of Congress now.
But here's the kicker. To pay for this new largesse, Messrs. Stark and Dingell set their sights on cutting Medicare Advantage — a popular alternative to traditional fee-for-service. Medicare Advantage offers seniors an option of lower costs and more benefits in a managed-care setting. For over 8 million people in this rapidly growing program — nearly one out of every five seniors — this is their Medicare. For them, reducing funding means higher health-care costs and fewer benefits.
A recent national survey by Democratic pollster Mark Mellman underscores this point, noting "a vote to cut Medicare Advantage will elicit major negative political consequences." Mr. Mellman's data shows over half (52 percent) believe "a member of Congress who promised not to cut Medicare would be breaking their promise if they voted to cut Medicare Advantage." It's now Messrs. Stark and Dingell who want to "end Medicare as we know it" for a good number of seniors.
And while they will claim cuts to Medicare Advantage simply bring the program's funding into parity with fee-for-service, the real motivation is different. This alternative to traditional Medicare is one of the only hopes of reforming this exploding entitlement program. It provides seniors choices in health care and uses private -sector competition to drive down costs. But its biggest offense in eyes of the left is it doesn't fit their one-size-fits-all ideology. The Democrats should beware following Messrs. Stark and Dingell's ideologically driven lead. They are marching their party back to minority status while by breaking promises to seniors.
Dingell, Stark and Medi-scare
There is no truth to the rumors that Democratic Reps. Fortney "Pete" Stark of California and John Dingell of Michigan secretly jumped ship and are helping Republicans recapture the majority in the House. But you would never know it based on their health-care agenda. The two liberal old bulls who face little-to-no personal electoral vulnerability seem determined to march their caucus back to minority status by forcing them to cast a highly unpopular vote to cut Medicare.
A peak below the surface reveals why these two lawmakers' ideological crusade could put House Speaker Nancy Pelosi back in the minority leader's suite. This week, two House committees began consideration of legislation to reauthorize and expand the State Children's Health Initiative Program. Predictably, Democrats want to balloon it into a massive Leviathan costing more than $50 billion over the next five years. This large an expansion will induce millions to drop their private insurance coverage to feast at the taxpayer's expense. The program could accomplish its objectives with a lot less money, but consider who is in charge of Congress now.
But here's the kicker. To pay for this new largesse, Messrs. Stark and Dingell set their sights on cutting Medicare Advantage — a popular alternative to traditional fee-for-service. Medicare Advantage offers seniors an option of lower costs and more benefits in a managed-care setting. For over 8 million people in this rapidly growing program — nearly one out of every five seniors — this is their Medicare. For them, reducing funding means higher health-care costs and fewer benefits.
A recent national survey by Democratic pollster Mark Mellman underscores this point, noting "a vote to cut Medicare Advantage will elicit major negative political consequences." Mr. Mellman's data shows over half (52 percent) believe "a member of Congress who promised not to cut Medicare would be breaking their promise if they voted to cut Medicare Advantage." It's now Messrs. Stark and Dingell who want to "end Medicare as we know it" for a good number of seniors.
And while they will claim cuts to Medicare Advantage simply bring the program's funding into parity with fee-for-service, the real motivation is different. This alternative to traditional Medicare is one of the only hopes of reforming this exploding entitlement program. It provides seniors choices in health care and uses private -sector competition to drive down costs. But its biggest offense in eyes of the left is it doesn't fit their one-size-fits-all ideology. The Democrats should beware following Messrs. Stark and Dingell's ideologically driven lead. They are marching their party back to minority status while by breaking promises to seniors.
NASA to Investigate Report of Astronauts Boozing, Then Flying
By Marc Kaufman
Washington Post Staff Writer
Friday, July 27, 2007; A03
"NASA officials said yesterday that they will look into reports that astronauts were allowed to fly not long after drinking alcohol -- on several occasions after warnings that they were intoxicated and a potential flight-safety risk."
Well, at least there's not a lot of traffic.
http://www.washingtonpost.com/wp-dyn/content/article/2007/07/26/AR2007072602111_pf.html
By Marc Kaufman
Washington Post Staff Writer
Friday, July 27, 2007; A03
"NASA officials said yesterday that they will look into reports that astronauts were allowed to fly not long after drinking alcohol -- on several occasions after warnings that they were intoxicated and a potential flight-safety risk."
Well, at least there's not a lot of traffic.
http://www.washingtonpost.com/wp-dyn/content/article/2007/07/26/AR2007072602111_pf.html
Sara Lee's new EarthGrain bread gives a new meaning to the term Heavy Metal. I've heard of trying to compete with China but this might be taking it too far...
Sara Lee recalls bread that may have metal pieces
CHICAGO (Reuters) - Sara Lee Corp. is recalling bread sold under EarthGrains, Sara Lee Delightful Wheat and several other brands because the loaves may contain small pieces of metal, the company said on Friday.
The company decided to recall the bread after it discovered damage to a whole-wheat flower sifter during a routine inspection that indicated some metal might have made its way into the bread, Sara Lee spokesman Mark Goldman said.
What's next? Magnetic matza?
View Article
Sara Lee recalls bread that may have metal pieces
CHICAGO (Reuters) - Sara Lee Corp. is recalling bread sold under EarthGrains, Sara Lee Delightful Wheat and several other brands because the loaves may contain small pieces of metal, the company said on Friday.
The company decided to recall the bread after it discovered damage to a whole-wheat flower sifter during a routine inspection that indicated some metal might have made its way into the bread, Sara Lee spokesman Mark Goldman said.
What's next? Magnetic matza?
View Article
http://www.forbes.com/business/2007/07/26/glaxo-avandia-fda-biz-cx_mh_0726glaxo.html
Or why the blockbuster model of drug development and data collection is over.
Or why the blockbuster model of drug development and data collection is over.
I am adding a PS to my post. Vioxx was yanked by Merck because a pain killer was shown in a RCT to have a relative risk of MI events of 1.92 (rofecoxib 1.50 events vs placebo 0.78 events per 100 patient years). The results from the first 18 months of the APPROVe study did not show an increased relative risk of adverse cardiovascular events. All the problems cropped up after. And still both the FDA and Canadian Health advisory panels recommended returning Vioxx to the market for many patients under some conditions. In each case panelists believed that uncontrolled pain was a greater risk than the absolute risk of a heart attack from long term use associated with any NSAID.
In Avandia's case, we have no clear cut evidence of MI in any long term data except in the insulin population that doctors tend not to give Avandia to in the first place. So for the FDA to say Monday's meeting is not about Nissen is misleading. It is all about Nissen. It would not be meeting July 30 if not for his end run with his "study." More to the point, the FDA the failed to ask if uncontrolled glucose levels was a greater risk than the absolute risk of a heart attack from long term use associated with any oral diabetes drug.
That's the Nissen effect.
In Avandia's case, we have no clear cut evidence of MI in any long term data except in the insulin population that doctors tend not to give Avandia to in the first place. So for the FDA to say Monday's meeting is not about Nissen is misleading. It is all about Nissen. It would not be meeting July 30 if not for his end run with his "study." More to the point, the FDA the failed to ask if uncontrolled glucose levels was a greater risk than the absolute risk of a heart attack from long term use associated with any oral diabetes drug.
That's the Nissen effect.
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