Late this morning, results from the APPROACH study were presented at the American Heart Association. Unlike the JUPITER study which I blogged about the other day, this study seems to have generated little press (at the time of this posting only AP press and MSNBC). However, already the press makes it seem like Avandia remains a bad drug, with headlines stating:
"Controversial diabetes med doesn't slow plaque"
I recently posted (The Diabetes Conspiracy (Part I) ) that Avandia and Januvia were taking the heat for increasing the cost of diabetes care, yet no one seemed to comment on the newer insulins which in addition to contributing about equally to the increase in cost of diabetes care, were being prescribed at a much faster pace then either of the two newer diabetes pills.
I have previously blogged about the Avandia scare (for details see Avandia Vindicated! ). Briefly, in May 2007, Dr. Steve Nissen published a highly publicized, as well as highly criticized meta-analysis of 42 studies stating that Avandia caused heart attacks. The study was published ahead of press in unprecedented fashion, and congressional calls for investigation were sounded immediately (almost as if the politicians knew in advance). The FDA found something different. Though their similar analysis did find an association with myocardial ischemia (not heart attack) with Avandia, it was only when Avandia was compared to placebo and not other diabetes drugs. In addition, their analysis of three large, randomized prospective studies (RECORD, ADOPT, DREAM) and several large databases of patients showed no evidence of a problem. Since the FDA's analysis, several other large diabetes studies in which patients took Avandia have been published, all showing no risk of heart attack with Avandia. We now have randomized studies where over 26,000 patients have been studied for over 3.5 years, of which more than 15,000 patients took Avandia and showed absolutely no difference in heart attacks or myocardial ischemia.
The APPROACH study was a prospective, randomized, double-blind study which looked at 672 diabetic patients who needed to have an angiogram or angioplasty (thus, high risk for heart attack). They looked at one of the coronary vessels that was not going to be intervened on and measured the amount of plaque build up. Half the patients got Avandia and the other half got glipizide, an older, generic diabetes medication. Patients took either drug for 18 months, and by the end of the study, compared to glipizide, patients on Avandia had an increase in their high-density lipoprotein (HDL) (or good cholesterol), lowering of their blood pressure, lowering of their triglycerides and lowering of their CRP (which thanks to JUPITER seems even more important). There was a small increase in low-density lipoprotein (LDL, “bad” cholesterol) in patients taking Avandia. The investigators used intravascular ultrasound (IVUS) to measure the buid up of plaque. They looked at change in % atheroma volume (primary endpoint) as well as change in total volume, and change in the worse segment. The patients taking the older diabetes medicine had an increase in there % atheroma volume (0.42%) (more plaque= bad) where the patients taking Avandia had a decrease in their % atheroma volume (-0.22%), but this was not statistically significant (p=0.12). Though there was similar non-significant reductions in the worst segment, there was a decrease in the total atheroma volume which as statistically significant.
Technically, this is a "negative" study because the primary endpoint was not found to be statistically significant. However, this is not "bad news" for Avandia, nor does it mean it is a bad drug.
1. Patients on the older generic drugs had increase in plaque build up, Avandia patients did not. The p value of 0.12 means there is an 88% chance these findings are true. By convention, we only accept the results if there is more than 95% chance. However, given the statistically significant decrease in atheroma volume as well as positive changes in in BP, CRP, etc. if anything it would appear that Avandia leans toward reducing risks for heart attacks. Though this study was small, these patient were all at high risk for heart attacks (they were having angioplasties!). Yet, there was no difference in heart attacks in patients taking Avandia. Thus, this study provides even more evidence that Dr. Nissen's flawed meta-analysis was completely wrong!
2. The patients on the older diabetes drugs had more hypoglycemia. I will blog on this in more detail, but hypoglycemia is not trivial. It can be life threatening. Avandia does not cause hypoglyccemia.
3. A virtually identical study was done with the other TZD on the market, Actos. The PERISCOPE study had almost identical findings. In that study, the patients on Actos had a 0.16% decrease in their % atheroma volume (numerically not as good as Avandia, but probably the same). However, the patients taking glimepiride (a similar, older, generic diabetes medicine) has a 0.73% increase in % atheroma volume (the patients on the generic diabetes medicine in PERISCOPE had more plaque build up the the patients taking the generic medications in APPROACH). However, this difference was statistically significant. It is possible that APPROACH was a "negative" study and PERISCOPE was "positive" because the patients on the older medicines did worse in PERISCOPE. Drug companies and diabetes experts will likely debate this for years. The PROACTIVE study showed that Actos actually prevented heart attacks in strokes in patients with high risks for diabetes. My point is not to say whether Actos is or is not different from Avandia. The point is that the study designs and findings of both studies were similar, suggesting that if anything both Actos and Avandia would protect you from having a heart attack, and not cause one.
Already, the media is quoting our old friend Dr. Steven Nissen on the findings of APPROACH. He claims that these results "give one more reason" to use Avandia with caution. Oh, by the way, do you know who the lead investigator for the PERISCOPE study was? Yep, Dr. Nissen. Guess who funded his research? (Hint: Takeda makes Actos). Nissen did another meta-analysis on Actos published in JAMA that unlike his NEJM Avandia meta-analysis, found no problem with Actos. Many of those patients in that analysis came from the PROACTIVE study. Please note that Takeda gave Dr. Nissen and friends $25,000 to help analyze the results.
Bottom Line: It's too early as I blog to judge media reaction. They may give this study very little attention. What attention this study does get will make it sound like this is yet another problem for Avandia, which will be reinforced by comments by Dr. Nissen. The reality is that though the primary endpoint of APPROACH was not statistically significant, both Avandia and Actos likely prevent, not cause heart attacks. One should be very skeptical of Dr. Nissen's determination to take down Avandia. He is just one of several players in the Diabetes Conspiracy.
Wednesday, November 12, 2008
Sunday, November 9, 2008
Jupiter is Out, and the News is Good!
I am writing this within hours of the release of the Jupiter study. Already, this is hitting the media at WSJ and CNN, but expect more because this is big news. Looks like DB beat me to the punch, but he seems equally impressed
We participated in this study, so I may be a little biased, but the results are pretty impressive. The study looked at 17,802 patients from all over the world (including the US). The study gave half the patients 20mg of Crestor and the other half placebo. These patients relatively normal cholesterol levels and normal risk for heart attacks, except for an elevated C-reactive protein, or CRP, which is known to be associated with an increased risk of heart attack and stroke. The study was planned for 4 years, but stopped early at 1.9 years when the found that there was a clear benefit for those taking Crestor, and continuing the study would be unethical. The study was stopped a few months ago but the results were presented today and released ahead of press in the New England Journal.
The study found that Crestor reduced the risk of heart-related death, heart attacks and other serious cardiac problems by 44%. This pretty impressive given that these patients under current guidelines would not normally be candidates for taking cholesterol medication.
As evidenced already by the WSJ and CNN post, the message to the public will be 1) this may expand the use of statin medications for people who would otherwise not take them and 2) we need to be cautious before we do this.
Here's a few interesting things that have/may not come out.
1. Crestor is safe. Crestor, which is the most potent statin available on the market had the misfortune of launching just as Vioxx was pulled from the market. When David Graham from the FDA testified in front of congress, he named 5 drugs to potentially be worried about, Crestor being one of them. Dr. Sidney Wolfe, from Public Citizen had already petitioned the FDA not to approve Crestor, and asked for its immediate withdrawal from the market soon after launch. In a 36 page document, the FDA responded to Dr. Wolfe, essentially stating that Crestor was safe. However, the group continues to list Crestor among the worst pills to take.
If anything, this study clearly shows that Crestor is safe. Despite its potency, in a study of almost 18,000 patients, there were no differences in side effects between those that took 20mg and those taking placebo. You read that correctly, no differences. No differences in myopathy, elevated liver enzymes, kidney problems, etc. There was one patient that died of rhabdomyolysis (a very rare, but severe complication of statin medications). However, this patient was 90-years-old and had influenza, pneumonia, and trauma-induced myopathy; and this occured after the study was over.
2. Benefit of treating CRP alone was substantial. There were 142 heart attacks or cardiovascular related envents in the almost 9000 patients given Crestor 20mg, and 251 in the placebo group. This translates in to a number needed to treat (NNT) of 82. In otherwords, you would have to give Crestor 20mg to 82 patients with normal cholesterol but a high CRP for nearly 2 years in order to prevent one of these events. Some will argue that this impact was not substantial. With Crestor at about $3.45 a day, it would cost almost $200,000 over 2 years to prevent such an event. This may seem like a lot, but for mammography, some have calculated the number needed to screen to prevent one death is 781 women, and at a cost of $150 per mammogram, this comes to almost $120,000 which is not that far off.
3. These patients had a low risk for heart attack or stroke. The patients in this study had about a 6% risk of having a heart attack or stroke in 5 years using Framingham calculations. Indeed, the placebo group was found to have a risk of heart attack of less than 1% in the 1.9 years of the study. The mean LDL at baseline was 108mg/dL and current guidelines would have recommended an LDL less than 130mg/dL, with an option of lower than 100. Most physicians would not treat these patients with a medication. Thus, a 44% reduction (absolute reduction about 4%) is pretty impressive and does indeed suggest an expanded role for statins, or at least the need to check CRP.
4. Would a generic be just a good? One could extrapolate that using a generic statin such as simvastatin (generic for Zocor) could do just as well, but at a lower cost ($1 a day). There are several problems with this. First, patients in the study got a 50% reduction in their LDL cholesterol and a 37% reduction in their CRP with 20mg of Crestor. Best case scenario for simivastatin would be 80mg with up to a 47% reduction. However, one thing to consider is that the higher you go in dose, the more likely you are to get side effects with medicine. 20mg of Crestor is half the maximal dose (much of Dr. Wolfe's concern arose from 80mg of Crestor, which did have some side effects, and is why it is not available). 80mg of simvastatin is the maximal dose and very likely to cause side effects. Interestingly, all the studies looking at CRP and vascular changes seem to be in the studies using the higher doses of the potent statins like Lipitor and Crestor. Thus, though a few dollars might be saved, it is not clear that the benefit would be the same and you would likely end up with more side effects.
5. What about diabetes? Not sure whether the media will pick up on this, but they did find that physician report of diabetes was increased in the Crestor group (270 reports of diabetes, vs. 216 in the placebo group; P=0.01). This might seem a concern; however, these were physician reports without confirmation. When looking at the study lab values, there were no significant differences with respect to the fasting blood glucose level, and the A1c level was pretty much the same (5.9% and 5.8%). There is no biologically plausible reason to suspect Crestor as a cause of diabetes. However, both groups had a 41% prevalence of metabolic syndrome, which is a pre-diabetic state. Thus, it is not surprising to find an increase in diabetes in both groups.
Bottom Line
This is compelling data and will likely change guidelines. The anti-statin, anti-pharma folks will try to shoot this one down, but the data is pretty solid. If you are a man over 50 or a woman over 60, you should definitely ask your doctor to check your CRP if you cholesterol is relatively normal, and you would not otherwise be a candidate for cholesterol lowering medication. If your CRP is elevated, I think Crestor 20mg is a good option, since it is not clear that other medications (specifically simvastatin) would provide similar benefit.
We participated in this study, so I may be a little biased, but the results are pretty impressive. The study looked at 17,802 patients from all over the world (including the US). The study gave half the patients 20mg of Crestor and the other half placebo. These patients relatively normal cholesterol levels and normal risk for heart attacks, except for an elevated C-reactive protein, or CRP, which is known to be associated with an increased risk of heart attack and stroke. The study was planned for 4 years, but stopped early at 1.9 years when the found that there was a clear benefit for those taking Crestor, and continuing the study would be unethical. The study was stopped a few months ago but the results were presented today and released ahead of press in the New England Journal.
The study found that Crestor reduced the risk of heart-related death, heart attacks and other serious cardiac problems by 44%. This pretty impressive given that these patients under current guidelines would not normally be candidates for taking cholesterol medication.
As evidenced already by the WSJ and CNN post, the message to the public will be 1) this may expand the use of statin medications for people who would otherwise not take them and 2) we need to be cautious before we do this.
Here's a few interesting things that have/may not come out.
1. Crestor is safe. Crestor, which is the most potent statin available on the market had the misfortune of launching just as Vioxx was pulled from the market. When David Graham from the FDA testified in front of congress, he named 5 drugs to potentially be worried about, Crestor being one of them. Dr. Sidney Wolfe, from Public Citizen had already petitioned the FDA not to approve Crestor, and asked for its immediate withdrawal from the market soon after launch. In a 36 page document, the FDA responded to Dr. Wolfe, essentially stating that Crestor was safe. However, the group continues to list Crestor among the worst pills to take.
If anything, this study clearly shows that Crestor is safe. Despite its potency, in a study of almost 18,000 patients, there were no differences in side effects between those that took 20mg and those taking placebo. You read that correctly, no differences. No differences in myopathy, elevated liver enzymes, kidney problems, etc. There was one patient that died of rhabdomyolysis (a very rare, but severe complication of statin medications). However, this patient was 90-years-old and had influenza, pneumonia, and trauma-induced myopathy; and this occured after the study was over.
2. Benefit of treating CRP alone was substantial. There were 142 heart attacks or cardiovascular related envents in the almost 9000 patients given Crestor 20mg, and 251 in the placebo group. This translates in to a number needed to treat (NNT) of 82. In otherwords, you would have to give Crestor 20mg to 82 patients with normal cholesterol but a high CRP for nearly 2 years in order to prevent one of these events. Some will argue that this impact was not substantial. With Crestor at about $3.45 a day, it would cost almost $200,000 over 2 years to prevent such an event. This may seem like a lot, but for mammography, some have calculated the number needed to screen to prevent one death is 781 women, and at a cost of $150 per mammogram, this comes to almost $120,000 which is not that far off.
3. These patients had a low risk for heart attack or stroke. The patients in this study had about a 6% risk of having a heart attack or stroke in 5 years using Framingham calculations. Indeed, the placebo group was found to have a risk of heart attack of less than 1% in the 1.9 years of the study. The mean LDL at baseline was 108mg/dL and current guidelines would have recommended an LDL less than 130mg/dL, with an option of lower than 100. Most physicians would not treat these patients with a medication. Thus, a 44% reduction (absolute reduction about 4%) is pretty impressive and does indeed suggest an expanded role for statins, or at least the need to check CRP.
4. Would a generic be just a good? One could extrapolate that using a generic statin such as simvastatin (generic for Zocor) could do just as well, but at a lower cost ($1 a day). There are several problems with this. First, patients in the study got a 50% reduction in their LDL cholesterol and a 37% reduction in their CRP with 20mg of Crestor. Best case scenario for simivastatin would be 80mg with up to a 47% reduction. However, one thing to consider is that the higher you go in dose, the more likely you are to get side effects with medicine. 20mg of Crestor is half the maximal dose (much of Dr. Wolfe's concern arose from 80mg of Crestor, which did have some side effects, and is why it is not available). 80mg of simvastatin is the maximal dose and very likely to cause side effects. Interestingly, all the studies looking at CRP and vascular changes seem to be in the studies using the higher doses of the potent statins like Lipitor and Crestor. Thus, though a few dollars might be saved, it is not clear that the benefit would be the same and you would likely end up with more side effects.
5. What about diabetes? Not sure whether the media will pick up on this, but they did find that physician report of diabetes was increased in the Crestor group (270 reports of diabetes, vs. 216 in the placebo group; P=0.01). This might seem a concern; however, these were physician reports without confirmation. When looking at the study lab values, there were no significant differences with respect to the fasting blood glucose level, and the A1c level was pretty much the same (5.9% and 5.8%). There is no biologically plausible reason to suspect Crestor as a cause of diabetes. However, both groups had a 41% prevalence of metabolic syndrome, which is a pre-diabetic state. Thus, it is not surprising to find an increase in diabetes in both groups.
Bottom Line
This is compelling data and will likely change guidelines. The anti-statin, anti-pharma folks will try to shoot this one down, but the data is pretty solid. If you are a man over 50 or a woman over 60, you should definitely ask your doctor to check your CRP if you cholesterol is relatively normal, and you would not otherwise be a candidate for cholesterol lowering medication. If your CRP is elevated, I think Crestor 20mg is a good option, since it is not clear that other medications (specifically simvastatin) would provide similar benefit.
Wednesday, November 5, 2008
The Diabetes Conspiracy (Part I)
Avandia continues to get bashed by the press, though I have tried hard to defend it. Today's firing of 1800 GSK employees may have something to do with the declining sales of this product.
The latest bashing has to due with cost, and comes from a study in the Archives of Internal Medicine that revealed spending on diabetes medication has increased by 87% (almost double) in the past six years, from $6.7 Billion in 2001 to $12.5 Billion in 2007.
This was not only picked up by the mainstream media (MSNBC) but the medical blogsphere as well. Dr. Kevin Pho of Kevin MD noted that:
"these drugs (Avandia and Januvia) are markedly more expensive than the recommended first-line generic medication metformin.It's no wonder than spending on diabetes drugs has doubled to $12.5 billion over the past 6 years. Unless there's a medical contrindication, doctors shouldn't be reaching for these brand name medications first."
Kevin's comment seems to make sense. On his blog he also linked to Pizaazz' post Diabetes Drug Costs on the Rise which stated:
"The study investigators noted that the newer drugs Januvia, Avandia and the wildly popular Actos were prescribed in 28% of all doctor visits by the end of the study period." Pizaazz included this quote from Dr. David Nathan, who is Chief of the Diabetes Unit at Massachusetts General Hospital:
“We need to pay attention to this...if you can achieve the same glucose control at lower cost and lower side effects, that’s what you want to do.”
Sounds like expensive drugs such as Januvia and the thiazolidinediones (TZD's) like Actos and Avandia are just expensive pills made by the evil drug companies, which are doing nothing more than doubling the cost of medicines for diabetes. But hold on....
Before we (once again) malign branded prescription pills for diabetes, lets look beyond the sound bites and see what the data is really telling us about the changes in diabetes and diabetes care.
First, the number of patients with diabetes in the United States has increased. The study quotes 14 million diabetics in 2000 which increased to 19 million in 2007. This is due to the fact that as a nation we are becoming more and more overweight and obese, and thus more likely to get diabetes. Thus, an 87% increase in spending can be partially accounted for by the 36% increase in incidence of diabetes. If we are going to start throwing around blame, then we need to include McDonalds, Starbucks, Microsoft, etc.
Second, we need to look at the overall trends in diabetes. Metformin has replaced sulfonylurea as the most commonly prescribed pill for diabetes, likely due to better results with fewer side effects. The TZD's are a new class of medications that have slowly risen since their introduction, but are still prescribed less the the other two medications. Another less mentioned trend is the use of insulin, which started to decline a few years ago, but it has recently made a resurgence. More importantly the older (cheaper, generic) insulins have been almost entirely replaced by the newer, more expensive insulins. Finally, two new drugs (Byetta and Januvia) have been more recently introduced to market and are starting to gain acceptance.
Let's looks at the trends and costs of ALL of these products over the last 6 years, based on the data from the study.
Lispro (a very short acting insulin) increased from 2% of visits in 2001 and $0.4 Billion, to 7% and $1.4 Billion in 2007 (more than triple the use and cost)
Lantus (a very long acting insulin) increased from 2% and $0.1 Billion in 2001 to 12% and $2 billion in 2007 (six times the use and 10 times the cost)
The TZDs (Avandia and Actos) did peak in 2005 at 34%, but their use in 2007 is now the same as it was back in 2001 and prescribed at 28% of visits. The money spent doubled from about $1.9 billion in 2001 to $4.2 billion in 2007.
Per the study's estimates TZD's, Lispro and Lantus all cost $160, $156 and $123 respectively, which is not that much different. Thus, of the extra $5.8 billion dollars we are paying more for diabetes, $2.3 billion is coming from the TZD's, and $1.9 billion is coming from the newer insulins.
Januvia and Byetta, new types of drugs which I am calling (and thus hopefully coining the term) glucose regulators were new or non-existent in 2001 and they are now prescribed at 10% and 3% visits respectively for a combined additional $1.5 billion. Though Januvia is prescribed three times more often than Byetta, Byetta ($205) costs about 30% more than Januvia ($160-about the same price as new insulins and TZD's). Of note, Byetta is currently a twice daily injection, but will soon be available as a once weekly injection which may increase demand for this product incredibly.
Thus, though spending on diabetes medications has nearly doubled in the last six years (in part due to increased number of Americans with diabetes), the newer and more expensive insulins have contributed about as much to this as the TZD's like Avandia. However, unlike the TZD's of which overall prescribing hasn't changed, the newer insulins are being used 3 to 6 times more and that trend is likely to continue to rise. Furthermore, the introduction of Januvia and Byetta combined is still less of a factor than the newer insulins.
Where's all the negative press about insulin? Why does Avandia always get the bad rap? Why are the experts (like Dr. Nathan) not also calling for an immediate reduction in these newer insulins since they are equal contributors to the rising cost of diabetes, are rapidly increasing in their number of prescriptions where Actos and Avandia are stable, and they are no more effective (though they do have fewer side effects) then the older, generic insulins? Is Dr. Nathan "paying attention?"
More to come........
The latest bashing has to due with cost, and comes from a study in the Archives of Internal Medicine that revealed spending on diabetes medication has increased by 87% (almost double) in the past six years, from $6.7 Billion in 2001 to $12.5 Billion in 2007.
This was not only picked up by the mainstream media (MSNBC) but the medical blogsphere as well. Dr. Kevin Pho of Kevin MD noted that:
"these drugs (Avandia and Januvia) are markedly more expensive than the recommended first-line generic medication metformin.It's no wonder than spending on diabetes drugs has doubled to $12.5 billion over the past 6 years. Unless there's a medical contrindication, doctors shouldn't be reaching for these brand name medications first."
Kevin's comment seems to make sense. On his blog he also linked to Pizaazz' post Diabetes Drug Costs on the Rise which stated:
"The study investigators noted that the newer drugs Januvia, Avandia and the wildly popular Actos were prescribed in 28% of all doctor visits by the end of the study period." Pizaazz included this quote from Dr. David Nathan, who is Chief of the Diabetes Unit at Massachusetts General Hospital:
“We need to pay attention to this...if you can achieve the same glucose control at lower cost and lower side effects, that’s what you want to do.”
Sounds like expensive drugs such as Januvia and the thiazolidinediones (TZD's) like Actos and Avandia are just expensive pills made by the evil drug companies, which are doing nothing more than doubling the cost of medicines for diabetes. But hold on....
Before we (once again) malign branded prescription pills for diabetes, lets look beyond the sound bites and see what the data is really telling us about the changes in diabetes and diabetes care.
First, the number of patients with diabetes in the United States has increased. The study quotes 14 million diabetics in 2000 which increased to 19 million in 2007. This is due to the fact that as a nation we are becoming more and more overweight and obese, and thus more likely to get diabetes. Thus, an 87% increase in spending can be partially accounted for by the 36% increase in incidence of diabetes. If we are going to start throwing around blame, then we need to include McDonalds, Starbucks, Microsoft, etc.
Second, we need to look at the overall trends in diabetes. Metformin has replaced sulfonylurea as the most commonly prescribed pill for diabetes, likely due to better results with fewer side effects. The TZD's are a new class of medications that have slowly risen since their introduction, but are still prescribed less the the other two medications. Another less mentioned trend is the use of insulin, which started to decline a few years ago, but it has recently made a resurgence. More importantly the older (cheaper, generic) insulins have been almost entirely replaced by the newer, more expensive insulins. Finally, two new drugs (Byetta and Januvia) have been more recently introduced to market and are starting to gain acceptance.
Let's looks at the trends and costs of ALL of these products over the last 6 years, based on the data from the study.
Lispro (a very short acting insulin) increased from 2% of visits in 2001 and $0.4 Billion, to 7% and $1.4 Billion in 2007 (more than triple the use and cost)
Lantus (a very long acting insulin) increased from 2% and $0.1 Billion in 2001 to 12% and $2 billion in 2007 (six times the use and 10 times the cost)
The TZDs (Avandia and Actos) did peak in 2005 at 34%, but their use in 2007 is now the same as it was back in 2001 and prescribed at 28% of visits. The money spent doubled from about $1.9 billion in 2001 to $4.2 billion in 2007.
Per the study's estimates TZD's, Lispro and Lantus all cost $160, $156 and $123 respectively, which is not that much different. Thus, of the extra $5.8 billion dollars we are paying more for diabetes, $2.3 billion is coming from the TZD's, and $1.9 billion is coming from the newer insulins.
Januvia and Byetta, new types of drugs which I am calling (and thus hopefully coining the term) glucose regulators were new or non-existent in 2001 and they are now prescribed at 10% and 3% visits respectively for a combined additional $1.5 billion. Though Januvia is prescribed three times more often than Byetta, Byetta ($205) costs about 30% more than Januvia ($160-about the same price as new insulins and TZD's). Of note, Byetta is currently a twice daily injection, but will soon be available as a once weekly injection which may increase demand for this product incredibly.
Thus, though spending on diabetes medications has nearly doubled in the last six years (in part due to increased number of Americans with diabetes), the newer and more expensive insulins have contributed about as much to this as the TZD's like Avandia. However, unlike the TZD's of which overall prescribing hasn't changed, the newer insulins are being used 3 to 6 times more and that trend is likely to continue to rise. Furthermore, the introduction of Januvia and Byetta combined is still less of a factor than the newer insulins.
Where's all the negative press about insulin? Why does Avandia always get the bad rap? Why are the experts (like Dr. Nathan) not also calling for an immediate reduction in these newer insulins since they are equal contributors to the rising cost of diabetes, are rapidly increasing in their number of prescriptions where Actos and Avandia are stable, and they are no more effective (though they do have fewer side effects) then the older, generic insulins? Is Dr. Nathan "paying attention?"
More to come........
What can President Obama do about health care right now?
The results of yesterday's election were stunning. Regardless of who you supported, most should be able to appreciate the historic moment that just occurred. President Obama will have many daunting challenges ahead, including fixing our broken health care system. Not only will this not be a difficult task, but it will also not occur overnight. However, doctors and patients are struggling now. With changes in the make up of congress and the momentum from the election, here are three things that President Obama could do immediately after January's Inauguration to make some substantial changes right now.
1. Pay physicians for talking to patients. Our study which looked at factors associated with medical students career choices showed that only 2% wanted to go into primary care internal medicine. Though huge student debt and lucrative salaries in fields like dermatology and radiology may contribute, most students who applied to medical school did not do so in order to drive a Mercedes or live in a mansion. One of the main reasons that students shy away from primary care has to do with the burdens of practice, which is largely due to the way in which primary care is reimbursed. The medical home has been proposed as one method to deliver coordinated care, improve quality as well as change the way primary care services are reimbursed. However, agreeing on exactly what this will look like and how it will become mainstay practice may take some time. In the mean time, how about some immediate legislation that increased the amount of money physicians get for the time time they spend with patients, without ridiculous codes and other documentation requirements to get reimbursed. This should also apply for non-visit related time such as emails, phone calls, and filling out forms/paper work. This is not a solution for solving our delivery system crisis, but would have an immediate impact.
2. Tort reform. There is agreement on both sides of the aisle on this issue, so let's pass something quickly. The main problem is that bad outcomes do not generally result from malpractice, but patients need some kind of compensation when things do go wrong. Doctors order more tests because of malpractice fears. Not only does this increase the cost health care, but probably results in more harm to patients, since added testing (especially in patients who don't really need it) usually leads to complications from further testing and treatment. No-fault insurance and/or an impartial hearing before a case goes forward have been proposed solutions. Even if a long term solution takes some time, immediate caps on pain and suffering could help now.
3. National formulary. Whether you favor universal health care, or fear "government run" health care, negotiating drug prices with the pharmaceutical industry is a no brainer. Medicare, Medicaid and the VA get the best deals on drug prices because they have the volume of patients that the government can use in their negotiations with the drug companies. You could even keep your private, for-profit health insurance, but have your drug benefits "carved out." Allowing the government to negotiate drug prices on your behalf could immediately cut the price we spend on pharmaceuticals. We could create a sliding scale based on income regarding what an individual would pay for generic and brand named drugs. Even if it takes some time to cover the 47 million Americans without health care, we should be able to get them prescriptions pretty quickly.
1. Pay physicians for talking to patients. Our study which looked at factors associated with medical students career choices showed that only 2% wanted to go into primary care internal medicine. Though huge student debt and lucrative salaries in fields like dermatology and radiology may contribute, most students who applied to medical school did not do so in order to drive a Mercedes or live in a mansion. One of the main reasons that students shy away from primary care has to do with the burdens of practice, which is largely due to the way in which primary care is reimbursed. The medical home has been proposed as one method to deliver coordinated care, improve quality as well as change the way primary care services are reimbursed. However, agreeing on exactly what this will look like and how it will become mainstay practice may take some time. In the mean time, how about some immediate legislation that increased the amount of money physicians get for the time time they spend with patients, without ridiculous codes and other documentation requirements to get reimbursed. This should also apply for non-visit related time such as emails, phone calls, and filling out forms/paper work. This is not a solution for solving our delivery system crisis, but would have an immediate impact.
2. Tort reform. There is agreement on both sides of the aisle on this issue, so let's pass something quickly. The main problem is that bad outcomes do not generally result from malpractice, but patients need some kind of compensation when things do go wrong. Doctors order more tests because of malpractice fears. Not only does this increase the cost health care, but probably results in more harm to patients, since added testing (especially in patients who don't really need it) usually leads to complications from further testing and treatment. No-fault insurance and/or an impartial hearing before a case goes forward have been proposed solutions. Even if a long term solution takes some time, immediate caps on pain and suffering could help now.
3. National formulary. Whether you favor universal health care, or fear "government run" health care, negotiating drug prices with the pharmaceutical industry is a no brainer. Medicare, Medicaid and the VA get the best deals on drug prices because they have the volume of patients that the government can use in their negotiations with the drug companies. You could even keep your private, for-profit health insurance, but have your drug benefits "carved out." Allowing the government to negotiate drug prices on your behalf could immediately cut the price we spend on pharmaceuticals. We could create a sliding scale based on income regarding what an individual would pay for generic and brand named drugs. Even if it takes some time to cover the 47 million Americans without health care, we should be able to get them prescriptions pretty quickly.
Monday, November 3, 2008
Did Your Doctor Get it Right?
The latest from MSNBC is an article about questioning your physicians diagnosis called Did your doctor get it right? The premise is that commonly presenting symptoms are not always what they seem and your physician may mistakenly treat the wrong condition. Persistent cough vs. asthma, anxiety vs. arrhythmia, sinus infection vs. migraine, post nasal drip vs. Laryngopharyngeal reflux and urinary tract infection vs. interstitial cystitis are the five diagnosis that are discussed.
Stacey Colino, the author of the piece who is not listed as a physician or health care professional invites patients to "sleuth out what’s actually making you sick so you can find the right remedy and feel better fast."
I don't have any problems with the factual material of the article, other than the weight of the evidence (migraines and laryngopharyngeal reflux are probably missed more frequently, whereas most persistent coughs in adults are not likely new onset asthma). However, the notion that your doctor has no clue, and you should be your own detective is a unwise suggestion.
Physicians, myself included, do not get all diagnoses right the first time. That said, figuring out your own disease on your own is probably not the best alternative. Medicine is tricky. I see sinusitis and upper respiratory tract infections every single day, and they all present slightly differently in different patients. One of the interesting things about primary care is how unique everyone's "common" illnesses are; both the diagnosis and how the illness affects patients' lives. In addition to years of training, what a physician has is the years of experience to sort out what the actual problem may be. This experience can not be learned just by completing medical school, and certainly not on the Internet.
Instead of trying to "solve the case" case as "doctor" Colino suggests, here are some tips to help you and your physician arrive at the correct diagnosis when you have a medical problem.
1. Don't leave anything out. In medical school, we train our students to ask the right questions to help ascertain all the clues to determine the correct diagnosis. However, we can not read minds. If there is something else bothering you, regardless of whether or not you may believe it is connected, please mention this. This could be as simple as stress at work, a change in diet, a seemingly mild and unrelated symptom. Your physician may reassure you that indeed this is not likely related, but it is important to mention everything that is going on.
2. Understand your diagnosis. Once a diagnosis is made, you should not only understand what you have, but why your physician feels this way and why he or she is recommending the treatment given. Not only is this important so you can understand what is happening, but also because a misunderstanding or correcting the physician's perceptions of your illness may lead to the correct diagnosis.
3. Have a plan. Your physician should not only tell you what you have, but also when you should expect to feel better and what things to look out for that could possibly go wrong or lead to a different diagnosis. Antibiotics typically work in a day or two, so if you are not feeling substantially better, there could be a problem. Conversely, upper respiratory infections caused by viruses can take up to two weeks (sometimes longer) to resolve. If patients know what to expect, they won't be trying to solve their own medical mystery when things haven't improved quickly.
4. Communicate. Problems occur when patients don't communicate with their doctors. The article would suggest for example that if your cough isn't going away you might have asthma. You might look this up on the Internet and then either try a relative's medicine or take some over the counter Primatene Mist. This would be a huge mistake. As above, you should have a plan. When that plan doesn't go as expected, don't just ditch your doctor and solve your own problem. Call the physician and let them know you are not getting better. Response to treatment helps confirm a diagnosis or suggest a new one. In this specific case, I would probably re-evaluate the patient, possibly order more tests such as a chest X-ray, and try alternative medications (which are generally safer then over the counter meds and using someone else's prescriptions).
Stacey Colino, the author of the piece who is not listed as a physician or health care professional invites patients to "sleuth out what’s actually making you sick so you can find the right remedy and feel better fast."
I don't have any problems with the factual material of the article, other than the weight of the evidence (migraines and laryngopharyngeal reflux are probably missed more frequently, whereas most persistent coughs in adults are not likely new onset asthma). However, the notion that your doctor has no clue, and you should be your own detective is a unwise suggestion.
Physicians, myself included, do not get all diagnoses right the first time. That said, figuring out your own disease on your own is probably not the best alternative. Medicine is tricky. I see sinusitis and upper respiratory tract infections every single day, and they all present slightly differently in different patients. One of the interesting things about primary care is how unique everyone's "common" illnesses are; both the diagnosis and how the illness affects patients' lives. In addition to years of training, what a physician has is the years of experience to sort out what the actual problem may be. This experience can not be learned just by completing medical school, and certainly not on the Internet.
Instead of trying to "solve the case" case as "doctor" Colino suggests, here are some tips to help you and your physician arrive at the correct diagnosis when you have a medical problem.
1. Don't leave anything out. In medical school, we train our students to ask the right questions to help ascertain all the clues to determine the correct diagnosis. However, we can not read minds. If there is something else bothering you, regardless of whether or not you may believe it is connected, please mention this. This could be as simple as stress at work, a change in diet, a seemingly mild and unrelated symptom. Your physician may reassure you that indeed this is not likely related, but it is important to mention everything that is going on.
2. Understand your diagnosis. Once a diagnosis is made, you should not only understand what you have, but why your physician feels this way and why he or she is recommending the treatment given. Not only is this important so you can understand what is happening, but also because a misunderstanding or correcting the physician's perceptions of your illness may lead to the correct diagnosis.
3. Have a plan. Your physician should not only tell you what you have, but also when you should expect to feel better and what things to look out for that could possibly go wrong or lead to a different diagnosis. Antibiotics typically work in a day or two, so if you are not feeling substantially better, there could be a problem. Conversely, upper respiratory infections caused by viruses can take up to two weeks (sometimes longer) to resolve. If patients know what to expect, they won't be trying to solve their own medical mystery when things haven't improved quickly.
4. Communicate. Problems occur when patients don't communicate with their doctors. The article would suggest for example that if your cough isn't going away you might have asthma. You might look this up on the Internet and then either try a relative's medicine or take some over the counter Primatene Mist. This would be a huge mistake. As above, you should have a plan. When that plan doesn't go as expected, don't just ditch your doctor and solve your own problem. Call the physician and let them know you are not getting better. Response to treatment helps confirm a diagnosis or suggest a new one. In this specific case, I would probably re-evaluate the patient, possibly order more tests such as a chest X-ray, and try alternative medications (which are generally safer then over the counter meds and using someone else's prescriptions).
Wednesday, October 22, 2008
Pharma & Pharmacy: CVS and Merck Team Up to Sell Drugs!
Let me start off this post by stating though I may be critical of certain practices of certain drug companies, I am by no means anti-pharma. Though the pharmaceutical industry is one of the most profitable industries, they bring valuable products and research to the public and the issues surrounding big pharma are far more grey then black and white in my opinion.
That said, I was somewhat shocked when I received a letter from CVS/Caremark about one of my patients. The patient was identified by name, date of birth and medication. The letter stated that this patient was identified by "through CVS Caremarks prescription claims data as having one or more prescriptions filled for metformin or a thaizolidinedione as their only treatment for diabetes." Actos and Avandia are the two thaizolidinedione availabe in the US, and metformin is the most commonly prescribed diabetes pill.
I have received similar notifications before, but usually because patients had only filled one or two prescriptions in a 12 month period for a medication (like the ones above) that they are supposed to be taking every day, thus alerting me to the possibility that my patient may not be taking their medications.
However, this letter was different, because I knew this patient was very compliant with all of his pills. This letter went on to say that I should consider prescribing Januvia for my patients (like the one listed) whose diabetes may not be under control. The bulk of the letter discussed information about Januvia. In very small print at the bottom of the page, it said "funding for this communication was provided by Merck & Co." You don't have to by a doctor or health care industry insider to figure out which company make Januvia.
I have no problems with Januvia. I actually will add this medications to my patients who are on metformin and/or a thaizolidinedione, who are not at a goal hemoglobin A1c of less than 7%. However, it is disturbing that the pharmacy is pushing a drug on behalf of a drug company. CVS/Caremark fills or manages more than 1 billion prescriptions annually through its approximately 6,300 CVS/pharmacy stores across the country. Ironically, the Wall Street Journal just reported that Merck just cut 7200 jobs. Perhaps they feel they can fire their reps, and let CVS and their employees sell their products. This is a bad mix, because both companies profit from prescriptions filled.
It is now well known that the drug companies collect prescribing data on physicians, but they only know what drugs physicians are prescribing and not who they are prescribing them for. Pharmacies obviously know what the doctor prescribes and which patients get it, but it is a privacy violation to share this with the drug companies. By funding promotional material through the pharmacies, the drug companies can target physicians at a patient specific level, bypassing patient confidentiality issues.
Though today it was only a letter promoting a drug attached to a patient who might potentially need it, what's next? Will I be receiving promotional calls from my local CVS pharmacy which seems like a professional to professional communication, but is really a disguised sales pitch? Will the retail pharmacist get a pop-up message when a patient is refilling a certain medication to ask their doctor to prescribe another? We are a free market society, and drug companies have a right to market their products, but the letter I received today is just plain wrong. It might even be illegal.
That said, I was somewhat shocked when I received a letter from CVS/Caremark about one of my patients. The patient was identified by name, date of birth and medication. The letter stated that this patient was identified by "through CVS Caremarks prescription claims data as having one or more prescriptions filled for metformin or a thaizolidinedione as their only treatment for diabetes." Actos and Avandia are the two thaizolidinedione availabe in the US, and metformin is the most commonly prescribed diabetes pill.
I have received similar notifications before, but usually because patients had only filled one or two prescriptions in a 12 month period for a medication (like the ones above) that they are supposed to be taking every day, thus alerting me to the possibility that my patient may not be taking their medications.
However, this letter was different, because I knew this patient was very compliant with all of his pills. This letter went on to say that I should consider prescribing Januvia for my patients (like the one listed) whose diabetes may not be under control. The bulk of the letter discussed information about Januvia. In very small print at the bottom of the page, it said "funding for this communication was provided by Merck & Co." You don't have to by a doctor or health care industry insider to figure out which company make Januvia.
I have no problems with Januvia. I actually will add this medications to my patients who are on metformin and/or a thaizolidinedione, who are not at a goal hemoglobin A1c of less than 7%. However, it is disturbing that the pharmacy is pushing a drug on behalf of a drug company. CVS/Caremark fills or manages more than 1 billion prescriptions annually through its approximately 6,300 CVS/pharmacy stores across the country. Ironically, the Wall Street Journal just reported that Merck just cut 7200 jobs. Perhaps they feel they can fire their reps, and let CVS and their employees sell their products. This is a bad mix, because both companies profit from prescriptions filled.
It is now well known that the drug companies collect prescribing data on physicians, but they only know what drugs physicians are prescribing and not who they are prescribing them for. Pharmacies obviously know what the doctor prescribes and which patients get it, but it is a privacy violation to share this with the drug companies. By funding promotional material through the pharmacies, the drug companies can target physicians at a patient specific level, bypassing patient confidentiality issues.
Though today it was only a letter promoting a drug attached to a patient who might potentially need it, what's next? Will I be receiving promotional calls from my local CVS pharmacy which seems like a professional to professional communication, but is really a disguised sales pitch? Will the retail pharmacist get a pop-up message when a patient is refilling a certain medication to ask their doctor to prescribe another? We are a free market society, and drug companies have a right to market their products, but the letter I received today is just plain wrong. It might even be illegal.
Tuesday, October 14, 2008
Open Enrollment Tip: Make Sure Your Doctor Can Still See You
A pair of articles in the Wall Street Journal and the Washington Post talk about and tips on saving money spent on health care and advice for open enrollment respectively.
I basically agree with all suggestions. WSJ's four tips include paying attention to open enrollment info at work (don't assume you will automatically keep your coverage by doing nothing), consider opting for higher co-pays and lower premiums if you don't see the doctor that often, signing up for a flexible spending account if offered, and inquiring about any company wellness incentives. The Post similarly suggests not to shop on premium alone and looking into wellness programs as well as figuring out your yearly out of pocket expenses, understanding your plan such as savings for in-network providers, and saving money by using mail order prescriptions.
However, one thing not mentioned in either story relates to changing insurances and still seeing your same doctor. The medical blogsphere (and even mainstream media) is filled with stories about how difficult it can be to find a primary care physician. One of the reasons is that many physicians, especially in metropolitan areas, have stopped taking some or all insurances. This is due to that fact that for some insurances the reimbursement rates are so low, physicians actually lose money by seeing patients in certain plans. As a physician in a university faculty practice that takes virtually all insurances, so many of my newer patients are from physicians just blocks away that simply stopped accepting these patients' insurances. Our division of General Internal Medicine has actually been closed to new patients for almost two years, simply because we don't have enough doctors to see all the patients we currently are responsible. (A closed university practice was once unthinkable and is a strong indicator of what a true primary crisis we currently have).
Before switching insurances, make sure your physician takes that insurance. Don't trust the information that the health insurance company hands out via your HR informational session. These paper copies are typically out of date. Call your physician's office business manager directly. Even if they currently accept the insurance, ask if they have any plans to drop it in the near future, as well as if they are currently accepting new patients on this insurance and if not, will they "grandfather" you in. When you sign up for a new insurance, you are considered a new patient. Though your doctor is legally obligated to continue your care, he or she is not legally obligated to accept your new insurance if they are closed to new patients. Though most physicians would unlikely "drop" current longstanding patients who switch to a cheaper insurance plan, it doesn't hurt to ask before you switch.
I basically agree with all suggestions. WSJ's four tips include paying attention to open enrollment info at work (don't assume you will automatically keep your coverage by doing nothing), consider opting for higher co-pays and lower premiums if you don't see the doctor that often, signing up for a flexible spending account if offered, and inquiring about any company wellness incentives. The Post similarly suggests not to shop on premium alone and looking into wellness programs as well as figuring out your yearly out of pocket expenses, understanding your plan such as savings for in-network providers, and saving money by using mail order prescriptions.
However, one thing not mentioned in either story relates to changing insurances and still seeing your same doctor. The medical blogsphere (and even mainstream media) is filled with stories about how difficult it can be to find a primary care physician. One of the reasons is that many physicians, especially in metropolitan areas, have stopped taking some or all insurances. This is due to that fact that for some insurances the reimbursement rates are so low, physicians actually lose money by seeing patients in certain plans. As a physician in a university faculty practice that takes virtually all insurances, so many of my newer patients are from physicians just blocks away that simply stopped accepting these patients' insurances. Our division of General Internal Medicine has actually been closed to new patients for almost two years, simply because we don't have enough doctors to see all the patients we currently are responsible. (A closed university practice was once unthinkable and is a strong indicator of what a true primary crisis we currently have).
Before switching insurances, make sure your physician takes that insurance. Don't trust the information that the health insurance company hands out via your HR informational session. These paper copies are typically out of date. Call your physician's office business manager directly. Even if they currently accept the insurance, ask if they have any plans to drop it in the near future, as well as if they are currently accepting new patients on this insurance and if not, will they "grandfather" you in. When you sign up for a new insurance, you are considered a new patient. Though your doctor is legally obligated to continue your care, he or she is not legally obligated to accept your new insurance if they are closed to new patients. Though most physicians would unlikely "drop" current longstanding patients who switch to a cheaper insurance plan, it doesn't hurt to ask before you switch.
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