The Washington Post (and others) reported recently on a study in the recent Annals of Internal Medicine that showed diuretics were just as good as preventing heart attacks or strokes in patients with metabolic syndrome (pre-diabetes condition) than other agents, and was better in preventing heart failure in this group. The authors considered this important because new drugs like calcium channel blockers and ACE inhibitors are often used in these patients because diuretics can increase sugar and elevate cholesterol.
Bottom Line: Though the study did show an advantage to diuretics, it also showed they were more likely to increase sugar levels, possibly leading to diabetes. It is not clear which pressure medicine is best.
More if you are interested: This new study is part of a larger study called ALLHAT that examined patients with and without metabolic syndrome designed to look at the same question: do new more expensive drugs have any benefit than the older, cheaper diuretics? Answer: The diuretics acutally did better!
The current US hypertension guidlines (based on ALLHAT and other studies) recommend diuretics as first line therapy for most patients.
So everyone shoud be on a diuretic, right?????.
First, the US guidelines were published right before another big study, very similar to ALLHAT called ASCOT that found just the opposite, that calcium channel blockers and ACE inhibitors did better than diuretics. In fact, the European guidelines , which are more recent, recommend an ACE inhibitor for patients younger than 55 and a diuretic or calcium channel blocker to patients older than 55.
1. Why the discrepancy in studies and guidelines?
2. Which pressure medication should I take?
Guidelines are based on more than just how good a drug works.
Part of the US recommendations are based on cost. At the time of the studies, diuretics (like hydrochlorothiazide or HCTZ) had been generic for some time. ACE inhibitors (lisinopril) and calcium channel blockers (amlodipine), once blockbuster expensive drugs are now generic. Without looking at ASCOT, and looking at prices at the time, the NIH basically recommended diuretics for all.
Blood pressure control, not choice of drug is probably most important. ASCOT was a more Anglo poputlation, and ACE inhibitors tend to work better on whites. In ASCOT, ACE and calcium channel blockers lowered blood pressure better than diuretics, and had fewer heart attacks and strokes. In ALLHAT, the diuretics did a better job on blood pressure, and also on heart attacks and strokes. The key then is lowering blood pressure.
Diuretics may lead to diabetes. The recent report shows that diuretics did increase sugar more. The authors argue that despite this, there was no worsening of heart attacks and stroke. However, it takes years for people with pre-diabetes to develop substantially increased risk for a heart attacks and stroke. If the trial would have gone longer, you would probably see more diabetes in the diueretic group, and likely more heart atttacks and strokes. An interesting article last year in the Lancet analyzed all the large studies that looked for new onset diabetes. They found that ACE inhibitors were less likely to cause diabetes compared to other drugs, especially diuretics. In fact, diuretics were more likely to cause new diabetes compared to placebo!
Most patients need more than one drug. In both ASCOT and ALLHAT, almost all patients needed more than one drug to control their pressure, and many patients needed three or four. Thus, which is the best drug probably doesn't matter Fortunately, there are multiple combinations of old and new drugs that are now available as a generics: (lisinopril/HCTZ, amlodipine/benazapril, atenolol/chlorthalidone).
Chose the drug that's right for you. Look at side effects and benefits. Take what works to keep your blood pressure under control. Consider taking combination pills if needed.
Diuretics (hydrochorothiazide) - best studied, cheapest. May increase risk of diabetes, can cause frequent urination. Reduces risk of heart failure
ACE inhibitors (lisinopril)- fewest side effects (small chance of chronic cough which stops when drug is discontinued), won't increase risk of diabetes, protects the kidney. May not be as effective in black patients
Calcium channel blockers (amlodipine)- generally tolerated well, but can cause edema (swelling in the legs). May be more effective in black patients.
Beta-blockers- (atenolol, metoprolol) also best studied. Tend to cause more dizziness and tiredness. Excellent for patients with known coronary artery disease, and mandatory after a heart attack.
Wednesday, January 30, 2008
Friday, January 25, 2008
Dear Doctor: Vytorin
Vytorin continues to get hit hard. Information they released today to calm critics seemed to only intensify the scrutiny, with the FDA announcing they plan to review the safety and efficacy of ezetimibe (Zetia) which is also in Vytorin.
I have previously blogged about not taking an alarmest view on Vytorin (Vytorin and Zetia: What to do now? ) since it may be appropriate for some patients (though not likely most). However, I received a "Dear Doctor" letter today regarding the ENHANCE study that I thought non-recipients might be interested in.
"Dear Doctor" letters are often required by the FDA when there is a label change to a drug or signifcant concern. This is usually, but not always bad news. I have received many of these letters over the years, which have always beed delivered by my US postal carrier, but today's letter was delivered by UPS. It appears today's letter was not prompted by the FDA, but a proactive approach by Merck/Schering to ensure I don't stop writing prescriptions for Vytorin. Unfortunately, the letter is not yet posted on their web site. However, below are direct "several key points to consider" that appear in bold, with my interpretation (in italics) of what they are really trying to tell me below (capital letters Merk's editing not mine):
Lowering LDL-C remains the primary target of lipid-modifying therapy.
Just because our study showed that lowering the LDL didn't make a difference, doesn't mean you shouldn't follow guidelines that recommend lowering the LDL! Of course, the latest update to these guidelines were written in 2004. It is likely that they will change based on this study. The Medical Letter (non-comerically biased source of drug information for clinicians) just came out with its guidelines yesterday and recommended limited use of Vytorin and Zetia.
ENHANCE was an imaging study; it was not designed to examine differences in clinical outcomes, such as reductions in heart attacks or strokes.
Just because our drugs didn't prevent artery clogging doesn't' mean that they won't prevent heart attacks and strokes! Of course if there study did show that it prevented artery clogging, I guarantee Merk reps would be in my office the next day telling me that this data suggested Vytorin would likely prevent heart attacks and strokes. You can't have it both ways. Also, Lipitor has show to both reduce plaque build up and prevent heart attacks and strokes.
A Clinical Outcomes Study Comparing VYTORIN and Simvastatin is Under Way.
Don't draw any conclusions until the real study comes out. Of course, it will take a few years until these results are public. That's millions of prescriptions they hope we doctors write until their study (which will likely show similar disappointing results) is done.
What should you tell your patients who are taking VYTORIN (ezetimibe/simvistatin)?
When counselling your patients on VYTORIN or ZETIA, we would encourage you to respond based on your independent clinical judgement about the importance of lowering LDL-C by eating right, staying active, and following recommended prescribed medications.
We hope you will blow off this study and tell your patients everything's OK.
Merck/Schering -Plough hopes to present addtional results of the ENHANCE trial at the American College of Cardiology in March.
Pay attention to this one folks! They have just told you there next step in how they will try to persuade doctors, patients and legistlators that these results should not be taken seriously. Basically, their premise is that the results don't make sense, since other studies have shown that simvistatin does indeed decrease artery clogging. They have already used this as their rationale for delaying the results. What they will likely do at the big cardiology meeting is show (with lots of graphs, tables and images) how bad their data was, how inaccurate the ultrasound readings were, and how none of the results can be trusted. They were hoping to have all of this evidence ready when the results were announced, but the media and public forced their hand in presenting the data early.
I have previously blogged about not taking an alarmest view on Vytorin (Vytorin and Zetia: What to do now? ) since it may be appropriate for some patients (though not likely most). However, I received a "Dear Doctor" letter today regarding the ENHANCE study that I thought non-recipients might be interested in.
"Dear Doctor" letters are often required by the FDA when there is a label change to a drug or signifcant concern. This is usually, but not always bad news. I have received many of these letters over the years, which have always beed delivered by my US postal carrier, but today's letter was delivered by UPS. It appears today's letter was not prompted by the FDA, but a proactive approach by Merck/Schering to ensure I don't stop writing prescriptions for Vytorin. Unfortunately, the letter is not yet posted on their web site. However, below are direct "several key points to consider" that appear in bold, with my interpretation (in italics) of what they are really trying to tell me below (capital letters Merk's editing not mine):
Lowering LDL-C remains the primary target of lipid-modifying therapy.
Just because our study showed that lowering the LDL didn't make a difference, doesn't mean you shouldn't follow guidelines that recommend lowering the LDL! Of course, the latest update to these guidelines were written in 2004. It is likely that they will change based on this study. The Medical Letter (non-comerically biased source of drug information for clinicians) just came out with its guidelines yesterday and recommended limited use of Vytorin and Zetia.
ENHANCE was an imaging study; it was not designed to examine differences in clinical outcomes, such as reductions in heart attacks or strokes.
Just because our drugs didn't prevent artery clogging doesn't' mean that they won't prevent heart attacks and strokes! Of course if there study did show that it prevented artery clogging, I guarantee Merk reps would be in my office the next day telling me that this data suggested Vytorin would likely prevent heart attacks and strokes. You can't have it both ways. Also, Lipitor has show to both reduce plaque build up and prevent heart attacks and strokes.
A Clinical Outcomes Study Comparing VYTORIN and Simvastatin is Under Way.
Don't draw any conclusions until the real study comes out. Of course, it will take a few years until these results are public. That's millions of prescriptions they hope we doctors write until their study (which will likely show similar disappointing results) is done.
What should you tell your patients who are taking VYTORIN (ezetimibe/simvistatin)?
When counselling your patients on VYTORIN or ZETIA, we would encourage you to respond based on your independent clinical judgement about the importance of lowering LDL-C by eating right, staying active, and following recommended prescribed medications.
We hope you will blow off this study and tell your patients everything's OK.
Merck/Schering -Plough hopes to present addtional results of the ENHANCE trial at the American College of Cardiology in March.
Pay attention to this one folks! They have just told you there next step in how they will try to persuade doctors, patients and legistlators that these results should not be taken seriously. Basically, their premise is that the results don't make sense, since other studies have shown that simvistatin does indeed decrease artery clogging. They have already used this as their rationale for delaying the results. What they will likely do at the big cardiology meeting is show (with lots of graphs, tables and images) how bad their data was, how inaccurate the ultrasound readings were, and how none of the results can be trusted. They were hoping to have all of this evidence ready when the results were announced, but the media and public forced their hand in presenting the data early.
Wednesday, January 23, 2008
To cut is to cure? Caution regarding surgical cure for obesity
Significant buzz has been generated in the press (NY times) and on the Net (KevinMD) regarding a recent study in JAMA that showed that 2 years after surgery ( a lap band procedure) most (73%) of Type 2 diabetics were off all diabetes treatments, compared to 13% of the patients with diet and exercise. The authors used the term "remission", though some media (AP wire) are reporting this as a diabetes cure.
It should not be surprising that more patients who got the surgery were able to get off their diabetes medications because the patients with the surgery lost substantially more weight. Other published studies show the superiority of bariatric surgery over conventional methods for sustainable weight loss. However, before you consider asking your physician for a surgery referral to cure your diabetes, consider the following:
1. This study was done in patients who had diabetes less than 2 years. The longer you have diabetes, the more the cells in your pancreas that produce insulin (beta cells) die off. You can't regain these, even after weight loss. I have many patients who have had successful bariatric surgery but were unable to get off all their diabetes medicine, because their diabetes had already progressed too far.
2. Sustained weight loss beyond two years after bariatric surgery has not been fully established. Certain patients do quite well for years after surgery, but some patients do gain this weight back. Obesity is a major problem for our country, and the internal (genes, hormones) and external (poor diet, stress, lack of exercise) forces that contribute to obesity are quite powerful, particularly for the American lifestyle. Though surgery may be an excellent tool that can lead to successful weight loss, it is no more a cure for obesity than it is for diabetes.
Medications for obesity have been disappointing thusfar. It is possible that a combination of current and soon to be available medications may do better. However, nothing works without agressive lifestyle changes that must be sustained over years.
If you are obese (BMI of >40 or BMI >35 with conditions like diabetes- calculate yours here ), you may be a good candidate for surgery. Do everything you can to lose weight with diet and exercise. If that doesn't work, IN ADDITION to diet and exercise (and possibly medication), surgery may be a good option for you. This study suggests that if you have only had diabetes for a few years, you may be able to get off some medications. However, to prevent the weight from coming back and re-developing diabetes, you must keep up with a healthy lifestyle.
It should not be surprising that more patients who got the surgery were able to get off their diabetes medications because the patients with the surgery lost substantially more weight. Other published studies show the superiority of bariatric surgery over conventional methods for sustainable weight loss. However, before you consider asking your physician for a surgery referral to cure your diabetes, consider the following:
1. This study was done in patients who had diabetes less than 2 years. The longer you have diabetes, the more the cells in your pancreas that produce insulin (beta cells) die off. You can't regain these, even after weight loss. I have many patients who have had successful bariatric surgery but were unable to get off all their diabetes medicine, because their diabetes had already progressed too far.
2. Sustained weight loss beyond two years after bariatric surgery has not been fully established. Certain patients do quite well for years after surgery, but some patients do gain this weight back. Obesity is a major problem for our country, and the internal (genes, hormones) and external (poor diet, stress, lack of exercise) forces that contribute to obesity are quite powerful, particularly for the American lifestyle. Though surgery may be an excellent tool that can lead to successful weight loss, it is no more a cure for obesity than it is for diabetes.
Medications for obesity have been disappointing thusfar. It is possible that a combination of current and soon to be available medications may do better. However, nothing works without agressive lifestyle changes that must be sustained over years.
If you are obese (BMI of >40 or BMI >35 with conditions like diabetes- calculate yours here ), you may be a good candidate for surgery. Do everything you can to lose weight with diet and exercise. If that doesn't work, IN ADDITION to diet and exercise (and possibly medication), surgery may be a good option for you. This study suggests that if you have only had diabetes for a few years, you may be able to get off some medications. However, to prevent the weight from coming back and re-developing diabetes, you must keep up with a healthy lifestyle.
Friday, January 18, 2008
Risk of Smoking Trumps Drug's Warning
Any time the FDA adds a warning to a new drug, the media tends to portray this as a serious danger patients should be on the look out for. Sometimes this may in fact be the case, but usually this is just additional information, as is the case for Pfizer's smoking cessation drug Chantix. Most headlines highlight the word "warning", but particularly scary is CNBC's "Hazardous to Mental Health."
Essentially, now that the drug has been on the market for a while, there have been observations of worsening of mental health conditions, like depression and anxiety, including suicidal thoughts. Though this is a serious concern, it is not clear that this is linked to the drug, since these can occur with quitting smoking without the drug.
Bottom Line: The FDA appropriately added language to the drug's label to inform doctors that prescribing the drug may potentially cause psychiatric symptoms, especially in patients who have these underlying conditions. However, more than 430,000 deaths a year are attributable to smoking. Chantix has been shown to be the most effective drug to help patients stop smoking that is currently available. If you smoke, you should quit. Since most people need help, talk to your doctor, ask about Chantix, and if you have a mental health condition, let your doctor know.
More (if you are interested); There are several issues here that have little to do with smoking. The first is the way that the media hypes anything bad about a drug. The media has the potential to serve the public by warning of serious, life threatening effects of medications. However, most often the media scares and confuses patients about trivial issues or inconclusive evidence. Chantix is currently the most effective agent available for smoking cessation. I know I will get calls from my patients who I have prescribed it for asking about whether it is safe to take. Worse, some patients may just stop. In addition, I am sure that future patients will be reluctant to take this (or other medications) because they "heard something." Smoking cessation guidelines (which came out before Chantix was available) recommend that every patient interested in stopping smoking be offered medication, because it doubles their success rate.
The other issue is the safety monitoring for drugs. The media would not hype every label change if we had a better system in place to ensure drug safety. Some side effects are so uncommon it would take tens of thousands of patients to test a drug on before that drug could be approved. Because of this, drugs are tested on a few thousand patients, and then approved if safe and effective. Once prescriptions are being used in the public, the FDA monitors side effects reported by doctors and patients. This is called post-marketing surveillance. The problem is that this system is voluntary. More effort should be made by the FDA to watch a drug closely in its first year on the market. One idea would be to track patients taking new drugs and proactively ask them about any side effects. Of course this would take a significant amount of resources, but would certainly be worthwhile.
In the case of Chantix, post-marketing surveillance showed changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior. These things also happen when you stop smoking, so the link is not clear. Interestingly, though only about 21% of adult Americans smoke, a disproportionate amount of smokers have mental health illness. There are some theories that patients are able actually treat their mental illness with tobacco. Bupropion, another smoking cessation medication, also works for depression. It is possible the Chantix, because of its effect on nicotine receptors, may actually cause or exacerbate some of these symptoms. However, quitting smoking is the single most important thing anyone can do for their health. The benefits of the drug clearly outweigh the risks, but caution should be used in patients with known mental health conditions.
Below is the exact wording of Pfizer's label change.
WARNINGS
Neuropsychiatric Symptoms
Serious neuropsychiatric symptoms have occurred in patients being treated with Chantix. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however some of these symptoms have occurred in patients who continued to smoke. All patients being treated with Chantix should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior. These
symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking Chantix in the post-marketing experience. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder
did not participate in the pre-marketing studies of Chantix and the safety and efficacy of Chantix in such patients has not been established. Patients attempting to quit smoking with Chantix and their families and caregivers should be alerted about the need to monitor for these symptoms and to
report such symptoms immediately to the patient’s healthcare provider.
Essentially, now that the drug has been on the market for a while, there have been observations of worsening of mental health conditions, like depression and anxiety, including suicidal thoughts. Though this is a serious concern, it is not clear that this is linked to the drug, since these can occur with quitting smoking without the drug.
Bottom Line: The FDA appropriately added language to the drug's label to inform doctors that prescribing the drug may potentially cause psychiatric symptoms, especially in patients who have these underlying conditions. However, more than 430,000 deaths a year are attributable to smoking. Chantix has been shown to be the most effective drug to help patients stop smoking that is currently available. If you smoke, you should quit. Since most people need help, talk to your doctor, ask about Chantix, and if you have a mental health condition, let your doctor know.
More (if you are interested); There are several issues here that have little to do with smoking. The first is the way that the media hypes anything bad about a drug. The media has the potential to serve the public by warning of serious, life threatening effects of medications. However, most often the media scares and confuses patients about trivial issues or inconclusive evidence. Chantix is currently the most effective agent available for smoking cessation. I know I will get calls from my patients who I have prescribed it for asking about whether it is safe to take. Worse, some patients may just stop. In addition, I am sure that future patients will be reluctant to take this (or other medications) because they "heard something." Smoking cessation guidelines (which came out before Chantix was available) recommend that every patient interested in stopping smoking be offered medication, because it doubles their success rate.
The other issue is the safety monitoring for drugs. The media would not hype every label change if we had a better system in place to ensure drug safety. Some side effects are so uncommon it would take tens of thousands of patients to test a drug on before that drug could be approved. Because of this, drugs are tested on a few thousand patients, and then approved if safe and effective. Once prescriptions are being used in the public, the FDA monitors side effects reported by doctors and patients. This is called post-marketing surveillance. The problem is that this system is voluntary. More effort should be made by the FDA to watch a drug closely in its first year on the market. One idea would be to track patients taking new drugs and proactively ask them about any side effects. Of course this would take a significant amount of resources, but would certainly be worthwhile.
In the case of Chantix, post-marketing surveillance showed changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior. These things also happen when you stop smoking, so the link is not clear. Interestingly, though only about 21% of adult Americans smoke, a disproportionate amount of smokers have mental health illness. There are some theories that patients are able actually treat their mental illness with tobacco. Bupropion, another smoking cessation medication, also works for depression. It is possible the Chantix, because of its effect on nicotine receptors, may actually cause or exacerbate some of these symptoms. However, quitting smoking is the single most important thing anyone can do for their health. The benefits of the drug clearly outweigh the risks, but caution should be used in patients with known mental health conditions.
Below is the exact wording of Pfizer's label change.
WARNINGS
Neuropsychiatric Symptoms
Serious neuropsychiatric symptoms have occurred in patients being treated with Chantix. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however some of these symptoms have occurred in patients who continued to smoke. All patients being treated with Chantix should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation, and suicidal behavior. These
symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking Chantix in the post-marketing experience. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder
did not participate in the pre-marketing studies of Chantix and the safety and efficacy of Chantix in such patients has not been established. Patients attempting to quit smoking with Chantix and their families and caregivers should be alerted about the need to monitor for these symptoms and to
report such symptoms immediately to the patient’s healthcare provider.
Monday, January 14, 2008
Vytorin and Zetia: What to do now?
The news broke pretty rapidly today. The NY times is probably the most cited, but the scariest headline belongs to the Washington Post which might scare some patients stating "Cholesterol Drug Zetia Doesn't Benefit Health." Essentially, Merck and Schering-Plough, the companies that make Zetia and Vytorin (a combination of Zetia and Zocor), released the results of a study they funded called ENHANCE which compared Vytorin to Zocor alone in 720 patients with an inherited type of high cholesterol, and showed no benefit in the progression of atherosclerosis after 2 years of treatment.
Bottom Line (for those who want a quick opinion): Prevention of heart attacks and strokes may be more about the cholesterol medicine you take then how much your cholesterol is actually lowered. Based on this study and others, patients at risk for heart disease that require medications to lower cholesterol should be on a statin (Crestor, Lipitor, Zocor) at the dose which gets their cholesterol down. Zetia should probably be reserved for patients who can not take a statin due to side effects, or who need additional cholesterol lowering after taking the highest dose of a statin. Patients on Vytorin should not stop taking it (study showed no additional benefit, not that Vytorin didn't work), but might want to discuss with their doctor about taking a different kind of statin.
Details (for those that are interested).
First, don't be scared by the headline. Zetia is a good drug and does work. The problem is the benefit of Vytorin (two drugs: Zocor or simvistatin +Zetia). You have seen the clever TV ads about the two sources of cholesterol. Problem is that though cholesterol does come from two sources, there was never any proven benefit in treating those two sources over that standard approach which is using a statin alone.
When the drug reps initially promoted Vytorin, the pitch they would use implied that you could get the same results with a lower amount of statin, suggesting some safety benefit, since statins can and do cause side effects. (They had to back off of this approach when safety concerns with Zetia emerged, and the ENHANCE trial confirms there is really no safety differences).
The issue here has to due with outcomes, surrogate endpoints and surrogate markers. When you take a drug to prevent a heart attack or stroke, you want to know whether that drug actually resutls in decreases in heart attacks or strokes (outcomes). We have definitive evidence that taking statins lowers the risk for heart attacks and strokes. This is true even in high risk patients with normal cholesterol levels, such as diabetics, (which already suggests it may be the statin and not the actual amount of cholesterol reduced). The problem is that doing these types of studies requires a lot of patients over a long period of time, which is difficult and costly.
The ENHANCE trial looked at plaque build up (thickness) in the carotid arteries (arteries that supply blood to the brain). Clogging of the arterties has been shown to correlate well with heart attacks and strokes, but this is not the same thing.
Most trials look at cholesterol lowering. Cholesterol (specifically the bad cholesterol or LDL) is what is known as a surrogate marker for heart attack and stroke. We know the higher your cholesterol, the greater the chance of getting a heart attack. We also know that statins and even Zetia can lower the cholesterol. But does that mean that if you lower the cholesterol (surrogate marker) with a statin, Zetia or a statin plus Zetia; that you decrease your risk of heart attack and stroke (outcomes)? The answer is "yes" for statins, and (now after ENHANCE) possibly not with Zetia and Zetia plus statin.
We have been burned by surrogate markers before. I have mentioned use of folate to lower homocysteine levels in my previous post about Vitamin D. Lowering antioxidants with Vitamin E is another example (patients taking Vitamin E actually had more heart attacks).
In the ENHANCE study, the Vytorin did lower the cholesterol to a greater degree than the Zocor alone. However, this didn't show any differences in thickness of the carotid arteries. We know that when you lower LDL cholesterol with a statin, lower is better. The question is whether reaching your cholesterol goal with a statin (say 40mg of Zocor) has a difference in benefit with a combination of a lower dose of statin plus another drug (Zetia plus Zocor 20mg = Vytorin 10/20)? There has never been any evidence that treating those two sources of cholesterol showed any benefit. Safety (which was the intial promotional message) does not seem to be a reason. Additionally, Zocor is now generic (simvistatin) and Vytorin now costs more. Now with ENHANCE, there is evidence that by using a drug like Vytorin we may be denying a patient the dose of statin they need. DB suggests that we consider using only high dose statins, and pay less attention to the LDL number, and there is plenty of evidence to back up this claim.
I would recommend using a potent statin (Crestor, Lipitor, and possibly higher doses of simvistatin) that acheives your LDL goal. If that goal can't be achieved by the highest dose of statin or you have side effects at the statin dose that achieves this goal, then I would add Zetia to the statin.
Since this post has gotten way to lenghty, I won't even go into the scandal about the drug companies trying to delay and even change the way the ENHANCE data was presented so it didn't look as bad. This has been documented elsewhere.
Bottom Line (for those who want a quick opinion): Prevention of heart attacks and strokes may be more about the cholesterol medicine you take then how much your cholesterol is actually lowered. Based on this study and others, patients at risk for heart disease that require medications to lower cholesterol should be on a statin (Crestor, Lipitor, Zocor) at the dose which gets their cholesterol down. Zetia should probably be reserved for patients who can not take a statin due to side effects, or who need additional cholesterol lowering after taking the highest dose of a statin. Patients on Vytorin should not stop taking it (study showed no additional benefit, not that Vytorin didn't work), but might want to discuss with their doctor about taking a different kind of statin.
Details (for those that are interested).
First, don't be scared by the headline. Zetia is a good drug and does work. The problem is the benefit of Vytorin (two drugs: Zocor or simvistatin +Zetia). You have seen the clever TV ads about the two sources of cholesterol. Problem is that though cholesterol does come from two sources, there was never any proven benefit in treating those two sources over that standard approach which is using a statin alone.
When the drug reps initially promoted Vytorin, the pitch they would use implied that you could get the same results with a lower amount of statin, suggesting some safety benefit, since statins can and do cause side effects. (They had to back off of this approach when safety concerns with Zetia emerged, and the ENHANCE trial confirms there is really no safety differences).
The issue here has to due with outcomes, surrogate endpoints and surrogate markers. When you take a drug to prevent a heart attack or stroke, you want to know whether that drug actually resutls in decreases in heart attacks or strokes (outcomes). We have definitive evidence that taking statins lowers the risk for heart attacks and strokes. This is true even in high risk patients with normal cholesterol levels, such as diabetics, (which already suggests it may be the statin and not the actual amount of cholesterol reduced). The problem is that doing these types of studies requires a lot of patients over a long period of time, which is difficult and costly.
The ENHANCE trial looked at plaque build up (thickness) in the carotid arteries (arteries that supply blood to the brain). Clogging of the arterties has been shown to correlate well with heart attacks and strokes, but this is not the same thing.
Most trials look at cholesterol lowering. Cholesterol (specifically the bad cholesterol or LDL) is what is known as a surrogate marker for heart attack and stroke. We know the higher your cholesterol, the greater the chance of getting a heart attack. We also know that statins and even Zetia can lower the cholesterol. But does that mean that if you lower the cholesterol (surrogate marker) with a statin, Zetia or a statin plus Zetia; that you decrease your risk of heart attack and stroke (outcomes)? The answer is "yes" for statins, and (now after ENHANCE) possibly not with Zetia and Zetia plus statin.
We have been burned by surrogate markers before. I have mentioned use of folate to lower homocysteine levels in my previous post about Vitamin D. Lowering antioxidants with Vitamin E is another example (patients taking Vitamin E actually had more heart attacks).
In the ENHANCE study, the Vytorin did lower the cholesterol to a greater degree than the Zocor alone. However, this didn't show any differences in thickness of the carotid arteries. We know that when you lower LDL cholesterol with a statin, lower is better. The question is whether reaching your cholesterol goal with a statin (say 40mg of Zocor) has a difference in benefit with a combination of a lower dose of statin plus another drug (Zetia plus Zocor 20mg = Vytorin 10/20)? There has never been any evidence that treating those two sources of cholesterol showed any benefit. Safety (which was the intial promotional message) does not seem to be a reason. Additionally, Zocor is now generic (simvistatin) and Vytorin now costs more. Now with ENHANCE, there is evidence that by using a drug like Vytorin we may be denying a patient the dose of statin they need. DB suggests that we consider using only high dose statins, and pay less attention to the LDL number, and there is plenty of evidence to back up this claim.
I would recommend using a potent statin (Crestor, Lipitor, and possibly higher doses of simvistatin) that acheives your LDL goal. If that goal can't be achieved by the highest dose of statin or you have side effects at the statin dose that achieves this goal, then I would add Zetia to the statin.
Since this post has gotten way to lenghty, I won't even go into the scandal about the drug companies trying to delay and even change the way the ENHANCE data was presented so it didn't look as bad. This has been documented elsewhere.
Fibromyalgia is Real
An article in today's NY Times Health Section that mentions Pfizer's drug Lyrica, which was recently approved for the treatment of fibromyalgia also discusses some of the controversies regarding the diagnosis. There are some experts that don't believe that fibromyalgia is real, stating that the pain patients feel all over their bodies results from an their inability to “get through life with some vicissitudes." As a practicing internist with many patients who suffer from this condition, I can tell you that the disease is real. There are many illnesses where stress and other psychosocial factors exacerbate a condition; migraine headaches, irritable bowel syndrome, depression to name a few. Though stress management and relaxation techniques can be quite effective in the management of fibromyalgia, this does not make it less real of a disease. Patients' lives are severely impacted, and some of the strongest pain medications often will have no effect. Their pattern of pain is also quite characteristic. We need to continue to research this disease to find out why patients get these pain symptoms in order to find more effective treatments. The approval of Lyrica for fibromyalgia is welcome news for many patients and physicians. All one has to do is either experience fibromyalgia or treat several patients with the conditions to know that the condition is real.
Saturday, January 12, 2008
Physician Owned Hospitals
One of the goals of this blog is to provide physician insight into some of the top media healthcare stories in order to help patients and consumers make informed decisions. However, sometimes there are important stories that don't gain a lot of attention, that should also be pointed out.
One such story is a recent report in the Washington Post regarding physician owned hospitals and how they were poorly able to handle emergencies. The report stated that only about half of the 109 physician owned hospitals they surveyed had emergency rooms, and those that did were barely adequate. About one third of the hospitals studied called 911 when there was an emergency. Certainly, at face value, this report call into question the capability of such hospitals to provide adequate care in the event of an emergency. It also add fuel to those against physician owned hospitals who worry that "doctors who own hospitals are more likely to refer patients to those hospitals, have an incentive to put profits above the patient's health." However, in my opinion the importance of the story is that it exemplifies how having 47 million Americans without health insurance potentially affects the health care for those with coverage.
Proponents of physician owned hospitals claim that they offer high-quality specialized care by focusing on certain groups of patients. However, these groups of patients tend to be the most profitable to treat, such as orthopedics and cardiac care. But another advantages that physician owned hospitals have is that they aren't required to have an emergency room. A private practice in the outpatient setting or a privately owned hospital can refuse care to any patient they want. However, once you put up a sign that says "emergency room," you are legally obligated to treat that patient, regardless of who they are or more importantly their ability to pay. There are also laws in place that prevent hositals from diverting patients who can't pay to other hospitals. Thus, hospitals have to eat the cost of patients without insurance, and that loss usually is passed on to patients with insurance. Why to you think the hospital charges $5 a pill for Tyelenol?
But hospitals also make up for this loss by providing some of the more lucrative services for covered patients such as orthopedics and cardiac care. If physician owned hospitals start providing these services alone, and start taking away this business from the city and community hospitals, these hospitals will not be able to survive. Many will close. This means that even if you have excellent health insurance, therer might not be an adequate number of hosptials with emergency services when you need it the most!
One solution could be to require any physician owned hospital to have emergency room services, but the recent study shows that even those that had them were inadequate. The real solution is finding health care coverage for everyone.
One such story is a recent report in the Washington Post regarding physician owned hospitals and how they were poorly able to handle emergencies. The report stated that only about half of the 109 physician owned hospitals they surveyed had emergency rooms, and those that did were barely adequate. About one third of the hospitals studied called 911 when there was an emergency. Certainly, at face value, this report call into question the capability of such hospitals to provide adequate care in the event of an emergency. It also add fuel to those against physician owned hospitals who worry that "doctors who own hospitals are more likely to refer patients to those hospitals, have an incentive to put profits above the patient's health." However, in my opinion the importance of the story is that it exemplifies how having 47 million Americans without health insurance potentially affects the health care for those with coverage.
Proponents of physician owned hospitals claim that they offer high-quality specialized care by focusing on certain groups of patients. However, these groups of patients tend to be the most profitable to treat, such as orthopedics and cardiac care. But another advantages that physician owned hospitals have is that they aren't required to have an emergency room. A private practice in the outpatient setting or a privately owned hospital can refuse care to any patient they want. However, once you put up a sign that says "emergency room," you are legally obligated to treat that patient, regardless of who they are or more importantly their ability to pay. There are also laws in place that prevent hositals from diverting patients who can't pay to other hospitals. Thus, hospitals have to eat the cost of patients without insurance, and that loss usually is passed on to patients with insurance. Why to you think the hospital charges $5 a pill for Tyelenol?
But hospitals also make up for this loss by providing some of the more lucrative services for covered patients such as orthopedics and cardiac care. If physician owned hospitals start providing these services alone, and start taking away this business from the city and community hospitals, these hospitals will not be able to survive. Many will close. This means that even if you have excellent health insurance, therer might not be an adequate number of hosptials with emergency services when you need it the most!
One solution could be to require any physician owned hospital to have emergency room services, but the recent study shows that even those that had them were inadequate. The real solution is finding health care coverage for everyone.
Tuesday, January 8, 2008
Vitamin D tied to Heart Attacks - A prescription to sunbathe?
A recent study that is prevalent on the Internet related to Vitamin D and Heart Attacks. Published online, ahead of print in the American Hear Association's journal Circulation, the study looks at the sons and daughters from the famous Framingham study who had not a heart attack and measured their levels of vitamin D. They found that of 1739 patients studied over 5 years, there were 120 heart attacks. People with low levels of vitamin D were 62% more likely to get a heart attack than people with normal levels of vitamin D. Does this mean that you should book your next trip to the Caribbean to soak in the rays?
One of the problems with medical news in the media is confusion between association and causation. This study showed that people with heart attacks are more likely to low levels of vitamin D, not that taking in more vitamin D will prevent heart attacks. Physicians have been burned by this in the past. With regards to heart attacks, homocysteine is a great example. Observational studies like the vitamin D study showed that low levels of homocysteine were associated with increased heart attacks. In addition, we new that taking folic acid (which is very important in preventing birth defects in pregnant women) increases levels of homocysteine. So naturally, taking folic acid prevents heart attacks, right? Wrong. When studied prospectively (given half the agent and half a placebo), though folic acid raised homocysteine, it did not prevent heart attacks, and in fact may have increased the risk.
The same is true of other supplements, which I have mentioned on this blog previously.
So why would low levels of vitamin D be associated with heart attacks if they don't cause them? This is known as a marker for disease. One of the ways we get vitamin D is by exposure to sunlight. Perhaps people who were more active, and more likely to be outside, had higher levels of vitamin D and lower risks of heart attacks?
The point is that just because a study says that something is associated with a disease doesn't mean that it will cause/prevent it. Vitamin D (and calcium) are very important for bone health. The National Osteoporosis Foundation has a great page on recommended daily amounts of vitamin D and calcium. As far as preventing heart attacks, you need to stop smoking, become physically active, lower your blood cholesterol, and control diabetes and high blood pressure if you have it. For patients at high risks medications to lower cholesterol and aspirin are very helpful. The American Heart Association has very good information on this.
One of the problems with medical news in the media is confusion between association and causation. This study showed that people with heart attacks are more likely to low levels of vitamin D, not that taking in more vitamin D will prevent heart attacks. Physicians have been burned by this in the past. With regards to heart attacks, homocysteine is a great example. Observational studies like the vitamin D study showed that low levels of homocysteine were associated with increased heart attacks. In addition, we new that taking folic acid (which is very important in preventing birth defects in pregnant women) increases levels of homocysteine. So naturally, taking folic acid prevents heart attacks, right? Wrong. When studied prospectively (given half the agent and half a placebo), though folic acid raised homocysteine, it did not prevent heart attacks, and in fact may have increased the risk.
The same is true of other supplements, which I have mentioned on this blog previously.
So why would low levels of vitamin D be associated with heart attacks if they don't cause them? This is known as a marker for disease. One of the ways we get vitamin D is by exposure to sunlight. Perhaps people who were more active, and more likely to be outside, had higher levels of vitamin D and lower risks of heart attacks?
The point is that just because a study says that something is associated with a disease doesn't mean that it will cause/prevent it. Vitamin D (and calcium) are very important for bone health. The National Osteoporosis Foundation has a great page on recommended daily amounts of vitamin D and calcium. As far as preventing heart attacks, you need to stop smoking, become physically active, lower your blood cholesterol, and control diabetes and high blood pressure if you have it. For patients at high risks medications to lower cholesterol and aspirin are very helpful. The American Heart Association has very good information on this.
Saturday, January 5, 2008
Free Drug Samples Not Going to the Poor. Does this mean we should abandon them?
A recent story from the Amercian Journal of Public Health has gained some attention ( see US News, MSNBC, and NPR). The study shows that wealthier and insured patients were more likely to get free drug samples (which the pharmaceutical industry spends billions on) then the poor and uninsured. This certainly does put a damper on the drug industry's claim that samples help the poor and insured. Combined with data showing that samples increase the likelihood that physicians will use more expensive drugs and therefore drive up health care costs, this suggest maybe we should abandon samples altogether. Consumer groups and others have called this practice into question, and some major medical institutions have stopped the practice altogether.
However, as a physician that uses and would like to continue using samples, here's my take on the study and the issue.
1. It should be no suprise that physicians don't give samples to the poor and uninsured. Drug samples are usually for the newest and most expensive drugs, and usually only come in a 7 day supply. You could certainly give poor patients these medicines, but what happens after the first week or two when the samples run out? Even if poor patients have good insurance, they are often not able to pay the generally high co-pays associated with the newest medications. One smaller finding of the study was that patients who were uninsured at least part of the year were more likely to receive samples than patients who always had insurance. In other words, physicians were more likely to give samples to patients until they were able to get coverage. I have a patient who I gave samples for 6 months until he was able to get insurance. He would have surely suffered without these samples. Sounds like a good use to me.
2. Prescription drugs are a major investment for patients. Even if patients have insurance, co-pays on non-generics can reach hundreds of dollars a year, and that's just for one drug. Medicines are generally dispensed in 30 and 90 day supplies. The ability for a patient to try out a drug before they fully commit to taking it long term is a welcome opportunity. If the patient experiences a side effect (particularly important for drugs that are new to the market) then an entire co-pay an pricey medication bottle need not go to waste.
3. Samples are one way for physicians to get comfortable utilizing newer medications. Even if a patient has insurance, and even if there are no side effects from the medication, if the drug doesn't work the patient has wasted time and money (and possibly health). For a very new medication, the drug companies will often give doctors a few samples with a full one month's supply. These "starter packs" allow physicians to see how effective the medication is (which often takes more than a week) without the patient paying anything.
4. Certain non-pill samples are invaluable. I do a tremendous amount of asthma care. Using an inhaler takes some getting used to, and takes some time to explain to patients. With samples, I can not only demonstrate proper technique, but allow the patient to show me that they can use the device properly. This is true for different kinds of injectable medicines (like insulin) as well.
Bottom line: The study does shed light on the industry's claim that samples benefit the poor and needy. However, samples may actually be more beneficial to the insured and non-poor who can ultimately afford these newer medications, and can be important in filling a gap for those who are between jobs and in the process of getting insurance. The real issue is how to get affordable medications to all people who need them.
However, as a physician that uses and would like to continue using samples, here's my take on the study and the issue.
1. It should be no suprise that physicians don't give samples to the poor and uninsured. Drug samples are usually for the newest and most expensive drugs, and usually only come in a 7 day supply. You could certainly give poor patients these medicines, but what happens after the first week or two when the samples run out? Even if poor patients have good insurance, they are often not able to pay the generally high co-pays associated with the newest medications. One smaller finding of the study was that patients who were uninsured at least part of the year were more likely to receive samples than patients who always had insurance. In other words, physicians were more likely to give samples to patients until they were able to get coverage. I have a patient who I gave samples for 6 months until he was able to get insurance. He would have surely suffered without these samples. Sounds like a good use to me.
2. Prescription drugs are a major investment for patients. Even if patients have insurance, co-pays on non-generics can reach hundreds of dollars a year, and that's just for one drug. Medicines are generally dispensed in 30 and 90 day supplies. The ability for a patient to try out a drug before they fully commit to taking it long term is a welcome opportunity. If the patient experiences a side effect (particularly important for drugs that are new to the market) then an entire co-pay an pricey medication bottle need not go to waste.
3. Samples are one way for physicians to get comfortable utilizing newer medications. Even if a patient has insurance, and even if there are no side effects from the medication, if the drug doesn't work the patient has wasted time and money (and possibly health). For a very new medication, the drug companies will often give doctors a few samples with a full one month's supply. These "starter packs" allow physicians to see how effective the medication is (which often takes more than a week) without the patient paying anything.
4. Certain non-pill samples are invaluable. I do a tremendous amount of asthma care. Using an inhaler takes some getting used to, and takes some time to explain to patients. With samples, I can not only demonstrate proper technique, but allow the patient to show me that they can use the device properly. This is true for different kinds of injectable medicines (like insulin) as well.
Bottom line: The study does shed light on the industry's claim that samples benefit the poor and needy. However, samples may actually be more beneficial to the insured and non-poor who can ultimately afford these newer medications, and can be important in filling a gap for those who are between jobs and in the process of getting insurance. The real issue is how to get affordable medications to all people who need them.
Wednesday, January 2, 2008
Calories from Junk Food Are Cheap
The hot health news item today was as study done by Dr. Mark J. Pletcher, from UCSF in today's JAMA which showed that white patients are more likely to get strong pain medications in emergency rooms than African Americans, Asians, and Hispanics. We must work on eliminating racial disparities in health care. It is shocking that they exist today.
A less popular, but also very important study cited by MSNBC today comes from the University of Washington and published in The Journal of the American Dietetic Association which looked at grocery stores in Seattle and found that while the price of fruits and vegetables is climbing faster than inflation, the price of junk food is actually going down.
"Whereas the price of the lowest-calorie fruits and vegetables was more than $18.16 per 1,000 calories, the most calorie-rich foods cost $1.76 per 1,000 calories."
It should not be a surprise that we have such a horrible obesity epidemic when you can get more for your money by eating junk food. The two studies are actually related since minorities comprise a disproportionate amount of the socioeconomically disadvantaged, and obesity leads to multiple health problems. Perhaps (in addition to educational programs) if we subsidized healthy foods and taxed unhealthy foods, we could start to get a grip on our nation's obesity problem?
A less popular, but also very important study cited by MSNBC today comes from the University of Washington and published in The Journal of the American Dietetic Association which looked at grocery stores in Seattle and found that while the price of fruits and vegetables is climbing faster than inflation, the price of junk food is actually going down.
"Whereas the price of the lowest-calorie fruits and vegetables was more than $18.16 per 1,000 calories, the most calorie-rich foods cost $1.76 per 1,000 calories."
It should not be a surprise that we have such a horrible obesity epidemic when you can get more for your money by eating junk food. The two studies are actually related since minorities comprise a disproportionate amount of the socioeconomically disadvantaged, and obesity leads to multiple health problems. Perhaps (in addition to educational programs) if we subsidized healthy foods and taxed unhealthy foods, we could start to get a grip on our nation's obesity problem?
Tuesday, January 1, 2008
Best and Worst of 2007
Looking back at 2007, there were many ups and downs in the area of health and health care. Here are a few of the top items that kept my attention.
The Best
1. Getting Rid of Trans-fats. Though the decision was made in the end of 2006, in wasn't until July 2007 when The New York City Board of Health's decision to adopt the nation’s first major ban on the use of trans fats in restaurant cooking took affect. This set off a chain reaction which is leading to some healthier food in restaurants across America.
2. Medicine just as good as procedures for stable angina. In this study published in the New England journal, over 2000 patients with stable angina (heart disease and chest pain, but no heart attack yet) were randomized to angioplasty (an invasive procedure) or just medications. There was no difference in death or heart attack rate at the end of the study.
3. New asthma guidelines available. Though this arrived with little fanfare in the press, the fully updated NIH asthma guidelines has been anticipated for a decade. The new guidelines give doctors a different approach to asthma focusing on disease control and risk for future events. I am hopeful that his new approach will help curtail the over 2 million ER visits a year due to asthma.
4. Breakthrough drug for muscular dystrophy. Also met with little fanfare, likely because it was just a safety study in 4 boys and didn't really change their disease, this recent study is the first real human trial of a drug that knocks out genetic defects. If successful, this approach may not only cure diseases like muscular dystrophy but could be used in other genetic diseases and even cancer.
5. Better ways to find breast cancer. A study published (again) in the New England journal took nearly 1000 women who had been diagnosed with breast cancer in one breast, looked at MRI's of the other breast where mammography was negative. They found lesions in over 100 women, 25% of which were cancer. This and other studies led to changes in guidelines from the American Cancer Society who recommends MRI for certain women at very high risk of breast cancer (20-25% life time risk- you can calculate your risk here).
The Worst
1. Pfizer pulls Exubera. So many of my diabetic patients who need insulin refuse to every try it because of the idea of injecting themselves. I was one of the first doctors to prescribe the new inhaled insulin, Exubera. Though not perfect, Exubera was a great additional tool in our battle to fight diabetes. Unfortunately, it wasn't making enough money, and Pfizer pulled the plug. I would understand if the company just stopped marketing it, but to stop making it was a hard hit for some patients who saw this product as a life saver.
2. Avandia scare. I put this on my worst list not because of that avandia was found to cause heart attacks (the FDA now says the data is inconclusive) or because of all the flaws found in the study that caused the controversy, but because of the many patients who were confused and scared by all the media hype, and stopped taking the drug, many without discussing it with their physician.
3. MRSA in the community. Up until recently, this scary bug was confined to hospitals. This will be an ongoing problem for 2008. The New York times has a great "What you need to know" piece on this.
4. No go on HDL drug. The cholesterol lowering drugs called "statins" are life savers, reducing heart attacks, strokes, etc. by 25-30%. However, this not 100% or even 50%. Low hdl (good cholesterol) has an even stronger association with heart disease then the ldl (bad cholesterol) that statins treat. There was great excitement about a new drug about to come to market that would dramatically improve hdl, but safety issues prevented this drug from being approved, and Pfizer's $1 billion investment went down the drain.
5. No go on obesity drug. Rimonabant was another highly anticipated drug that could help with smoking cessation, diabetes, and most importantly weight loss. Though the drug is currently available in Europe, the FDA did not approve this drug because of increased psychiatric side effects. Though likely the right decision, this very disappointing.
Happy New Year!
The Best
1. Getting Rid of Trans-fats. Though the decision was made in the end of 2006, in wasn't until July 2007 when The New York City Board of Health's decision to adopt the nation’s first major ban on the use of trans fats in restaurant cooking took affect. This set off a chain reaction which is leading to some healthier food in restaurants across America.
2. Medicine just as good as procedures for stable angina. In this study published in the New England journal, over 2000 patients with stable angina (heart disease and chest pain, but no heart attack yet) were randomized to angioplasty (an invasive procedure) or just medications. There was no difference in death or heart attack rate at the end of the study.
3. New asthma guidelines available. Though this arrived with little fanfare in the press, the fully updated NIH asthma guidelines has been anticipated for a decade. The new guidelines give doctors a different approach to asthma focusing on disease control and risk for future events. I am hopeful that his new approach will help curtail the over 2 million ER visits a year due to asthma.
4. Breakthrough drug for muscular dystrophy. Also met with little fanfare, likely because it was just a safety study in 4 boys and didn't really change their disease, this recent study is the first real human trial of a drug that knocks out genetic defects. If successful, this approach may not only cure diseases like muscular dystrophy but could be used in other genetic diseases and even cancer.
5. Better ways to find breast cancer. A study published (again) in the New England journal took nearly 1000 women who had been diagnosed with breast cancer in one breast, looked at MRI's of the other breast where mammography was negative. They found lesions in over 100 women, 25% of which were cancer. This and other studies led to changes in guidelines from the American Cancer Society who recommends MRI for certain women at very high risk of breast cancer (20-25% life time risk- you can calculate your risk here).
The Worst
1. Pfizer pulls Exubera. So many of my diabetic patients who need insulin refuse to every try it because of the idea of injecting themselves. I was one of the first doctors to prescribe the new inhaled insulin, Exubera. Though not perfect, Exubera was a great additional tool in our battle to fight diabetes. Unfortunately, it wasn't making enough money, and Pfizer pulled the plug. I would understand if the company just stopped marketing it, but to stop making it was a hard hit for some patients who saw this product as a life saver.
2. Avandia scare. I put this on my worst list not because of that avandia was found to cause heart attacks (the FDA now says the data is inconclusive) or because of all the flaws found in the study that caused the controversy, but because of the many patients who were confused and scared by all the media hype, and stopped taking the drug, many without discussing it with their physician.
3. MRSA in the community. Up until recently, this scary bug was confined to hospitals. This will be an ongoing problem for 2008. The New York times has a great "What you need to know" piece on this.
4. No go on HDL drug. The cholesterol lowering drugs called "statins" are life savers, reducing heart attacks, strokes, etc. by 25-30%. However, this not 100% or even 50%. Low hdl (good cholesterol) has an even stronger association with heart disease then the ldl (bad cholesterol) that statins treat. There was great excitement about a new drug about to come to market that would dramatically improve hdl, but safety issues prevented this drug from being approved, and Pfizer's $1 billion investment went down the drain.
5. No go on obesity drug. Rimonabant was another highly anticipated drug that could help with smoking cessation, diabetes, and most importantly weight loss. Though the drug is currently available in Europe, the FDA did not approve this drug because of increased psychiatric side effects. Though likely the right decision, this very disappointing.
Happy New Year!
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