Mayo Clinic lost a law suit against the government in which Mayo tried to argue that housestaff, or physicians completing residency training, are students under the law rather than employees, or workers.
The case wended its way through the legal system, all the way up to the Supreme Court, which made a 8-0 ruling on January 11th, against Mayo Clinic, firmly establishing housestaff as employees rather than students. An interesting editorial on the events leading to the decision is available at the New England Journal of Medicine.
Showing posts with label medicine. Show all posts
Showing posts with label medicine. Show all posts
Friday, January 14, 2011
Thursday, January 06, 2011
ICDs: non-evidence-based implantation
Important study in JAMA revealed that 1 in 5 ICDs are being implanted against the recommendations of current guidelines. ICDs are basically mini defibrillators that are put into your chest wall, with leads going directly to your heart, to provide potentially life-saving shocks if you develop a life-threatening arrhythmia.
There is plenty of evidence about which patients benefit from these devices, but also clear evidence about those who do not benefit. What was surprising about the study is the number of people getting the ICD implanted in groups that are known not to benefit from it.
A really good perspective on why this might be the case is offered by Harlan Krumholz, a cardiologist on the Board of Trustees at the American College of Cardiology. Of course, guidelines cannot cover all circumstances, and there are cases where going against guidelines could be a reasonable decision if the patient is given full disclosure and understands the risks and benefits.
This study also highlights how important patient registries are becoming in monitoring outcomes. The federal government, through Medicare/Medicaid, pays for a lot of ICD implantations and thus required the formation of a registry to track these outcomes.
The results of the study may prompt stricter criteria from CMS on the implantation of ICDs or perhaps stricter controls on who can implant them. I assumed the majority of ICDs were being implanted by electrophysiologists, but it turns out quite a few cardiologists, thoracic surgeons and even other specialists are implanting them.
As with any procedure, it is always best to go to someone who does a high volume of cases. Ultimately, the decision to implant an ICD is best made in consultation with a physician who knows you well and when you are clear on the risks and benefits of the procedure given your particular situation.
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| via NHLBI website; image on left is an ICD, right is pacemaker |
There is plenty of evidence about which patients benefit from these devices, but also clear evidence about those who do not benefit. What was surprising about the study is the number of people getting the ICD implanted in groups that are known not to benefit from it.
A really good perspective on why this might be the case is offered by Harlan Krumholz, a cardiologist on the Board of Trustees at the American College of Cardiology. Of course, guidelines cannot cover all circumstances, and there are cases where going against guidelines could be a reasonable decision if the patient is given full disclosure and understands the risks and benefits.
This study also highlights how important patient registries are becoming in monitoring outcomes. The federal government, through Medicare/Medicaid, pays for a lot of ICD implantations and thus required the formation of a registry to track these outcomes.
The results of the study may prompt stricter criteria from CMS on the implantation of ICDs or perhaps stricter controls on who can implant them. I assumed the majority of ICDs were being implanted by electrophysiologists, but it turns out quite a few cardiologists, thoracic surgeons and even other specialists are implanting them.
As with any procedure, it is always best to go to someone who does a high volume of cases. Ultimately, the decision to implant an ICD is best made in consultation with a physician who knows you well and when you are clear on the risks and benefits of the procedure given your particular situation.
Saturday, December 25, 2010
Happy Holidays!
Ah, digital media.
So, one post-call day, my very sleep deprived intern decided he wanted to take pictures of the ward team, apparently to help him remember a very memorable call night. He got his pictures, which were actually quite nice, and later, an intrepid, and digitally savvy, medical student used the pics to create this, um, fascinating video clip:
Who says medicine isn't fun? Just for the record, I have never participated in any 80s-style rock band groups...
So, one post-call day, my very sleep deprived intern decided he wanted to take pictures of the ward team, apparently to help him remember a very memorable call night. He got his pictures, which were actually quite nice, and later, an intrepid, and digitally savvy, medical student used the pics to create this, um, fascinating video clip:
Personalize funny videos and birthday eCards at JibJab!
Who says medicine isn't fun? Just for the record, I have never participated in any 80s-style rock band groups...
Friday, December 24, 2010
WorldScopes
WorldScopes is a worthwhile charity, sponsored by the American Medical Association, that seeks to provide doctors all over the world with stethoscopes. If you have an extra one lying around, consider making a donation today.
Wednesday, September 22, 2010
Pioglitazone (Actos) under FDA review
The FDA is now reviewing pioglitazone (Actos), a popular drug for the treatment of diabetes, for a possible link to bladder cancer. Pioglitazone has been gaining in popularity after a rival drug, rosiglitazone (Avandia), had been shown to increase cardiovascular risk. Pioglitazone sales top $3 billion annually, while rosiglitazone has fallen to less than $600 million annually due to the negative data on myocardial ischemia.
So far, the FDA is not recommending discontinuation of pioglitazone, as the association with bladder cancer comes from an interim analysis of a 10-year study being performed by the drug's manufacturer, Takeda.
The entire drug class of TZDs has come under increasing scrutiny over safety. I am beginning to think that the entire class of medication should be avoided and other means of controlling hyperglycemia in diabetics should be pursued.
Will be interesting to see what future data will reveal about pioglitazone.
So far, the FDA is not recommending discontinuation of pioglitazone, as the association with bladder cancer comes from an interim analysis of a 10-year study being performed by the drug's manufacturer, Takeda.
The entire drug class of TZDs has come under increasing scrutiny over safety. I am beginning to think that the entire class of medication should be avoided and other means of controlling hyperglycemia in diabetics should be pursued.
Will be interesting to see what future data will reveal about pioglitazone.
Wednesday, September 08, 2010
Rosiglitazone
The chairman of the FDA's advisory committee, Dr. Clifford Rosen, finally comes out to say that rosiglitazone (Avandia) should either be restricted to compassionate use or taken off the market. It's about time! Numerous studies have reinforced the risk of myocardial ischemia with Avandia, yet there continues to be robust use of the drug in the United States.
UK regulators have already recommended pulling rosiglitazone off the market as well. If you are a patient, or know a patient, who takes rosiglitazone (Avandia), you should talk to your physician about switching to another agent. Pioglitazone (Actos) is a drug that is similar to Avandia but does not have the same cardiovascular risk.
Of course, everyone's medical situation is different and you should make any decisions about treatment in consultation with a physician who knows you well. You should not discontinue any medications without consulting your physician. I do not have any conflict of interest or ownership in either company.
UK regulators have already recommended pulling rosiglitazone off the market as well. If you are a patient, or know a patient, who takes rosiglitazone (Avandia), you should talk to your physician about switching to another agent. Pioglitazone (Actos) is a drug that is similar to Avandia but does not have the same cardiovascular risk.
Of course, everyone's medical situation is different and you should make any decisions about treatment in consultation with a physician who knows you well. You should not discontinue any medications without consulting your physician. I do not have any conflict of interest or ownership in either company.
Friday, July 30, 2010
Preventing Heart Attacks: Is Crestor the answer?
In 2008, Dr. Paul Ridker, a physician-scientist from Harvard, published a study known as JUPITER, which found that Crestor (rosuvastatin) is beneficial in the primary prevention of cardiovascular disease, as it reduced the risk of MI, CVA and death.
The trial studied males over 50 and women over 60 years of age. Both groups had LDL (bad) cholesterol <130, but they had to have one important risk factor: hs-CRP>2.
Dr. Ridker believes that there is an important inflammatory component to coronary heart disease and pioneered the development of CRP, an inflammatory marker that is elevated in people at higher risk for cardiovascular disease. His theory was that this inflammation often precedes the hardening of the arteries, which is indirectly measured by cholesterol levels.
The JUPITER trial was gutsy, because it was going to test whether or not this theory actually holds. What if you took people with normal cholesterol levels, but elevated inflammatory markers (in the form of CRP) and treated them with a statin? Would that reduce the development of cardiovascular disease?
If so, it could be important proof that inflammation is a major driver of cardiovascular disease. A corollary would be that waiting to treat until the cholesterol levels are high, might be waiting too long and that intervention should take place when the inflammatory process has begun.
The results of the JUPITER trial seemed to come out strongly in favor of Dr. Ridker's theory. Earlier this year, the FDA was also convinced and decided to grant permission for Crestor's use in primary prevention of cardiovascular disease. It suggested 3 criteria for use:
- Age (> 50 years in men; > 60 years in women), and
- An elevated high-sensitivity C-reactive protein level (> 2 mg/L), and
- Presence of at least one additional cardiovascular risk factor (e.g., high blood pressure, low HDL-C, smoking, or a family history of premature heart disease).
No other statin, such as Lipitor, has this permission. Besides low-dose aspirin in men, no other drug is currently approved for primary prevention of cardiovascular disease.
There have, however, been a lot of criticisms of the study. Late in June, four papers came out in the Archives of Internal Medicine, all of which criticized the notion that statins are useful in primary prevention. One of the studies, by Dr. de Lorgeril, targeted the JUPITER trial claiming it was flawed and that, "[t]he results of the trial do not support the use of statin treatment for primary prevention of cardiovascular diseases and raise troubling questions concerning the role of commercial sponsors."
These papers have sparked a lot of controversy in the cardiovascular community, which is well summarized by this article on theheart.org. What is interesting about the de Lorgeril paper is that it seems to personally attack Dr. Ridker and another physician, Dr. Rory Collins, which is unusual for someone to do in a scholarly paper.
I do think these papers make an important point, which is that previous statin trials have not demonstrated benefit in primary prevention of cardiovascular disease. Also, there was a slight increase in diabetes seen in patients on Crestor. Lastly, the JUPITER trial was stopped after less than 2 years, so we don't have real long-term data on how these patients will do. It may be that the benefit from Crestor is short-term and not durable.
It is also possible, however, that Crestor has unique properties that make it different from previous statins (it is far more potent than previous statins, for instance) and why it is able to show some benefit in this area. In addition, it is important to remember that JUPITER did not take anyone with low cholesterol into the trial, only patients with low cholesterol and high CRP levels. This kind of stratification hadn't really been done so explicitly in previous trials.
At the end of the day, everyone agrees that diet, exercise and smoking cessation should be the initial interventions in people hoping to reduce cardiovascular risk. Add in a baby aspirin if you are a high-risk male between 45 to 79 years old.
As far as my own practice, I may consider Crestor for primary prevention in patients who meet the FDA prescribing guidelines (age, hs-CRP>2 and one other risk factor), but I may limit treatment to 2 years (as there is no data for treating patients longer). In addition, I would counsel patients on the cost and side effect profile of Crestor and ensure they have already made therapeutic lifestyle changes.
Of course, everyone is different and your decision should be made in consultation with a physician who knows your personal and family medical history.
Monday, July 26, 2010
Enrollment in TIDE trial halted by FDA
The FDA has decided to halt further enrollment in the TIDE trial, a clinical trial sponsored by GlaxoSmithKline (GSK) to compare Avandia (rosiglitazone) to Actos (pioglitazone). Avandia has come under a lot of fire recently, due to safety concerns, including increasing Congressional scrutiny.
The FDA released the following statement, which reads, in part:
The FDA has instructed GSK to update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial regarding new safety information presented at the joint FDA Advisory Committee meeting held on July 13 and 14, 2010, along with information regarding the deliberations and votes of that meeting.
The decision by the FDA is somewhat surprising given that the same FDA Advisory Committee meeting suggested keeping Avandia on the market, despite uncertainty over its safety profile.
All in all, I think this is a smart, and surprisingly bold, move by the FDA. It is really advocating for patient safety, though a lot of this may be directly related to bi-partisan pressure from Congress and public perception that the FDA is too closely aligned with the pharmaceutical and medical device industries.
The FDA released the following statement, which reads, in part:
The FDA has instructed GSK to update investigators, institutional review boards (IRBs) and ethics committees involved in the TIDE trial regarding new safety information presented at the joint FDA Advisory Committee meeting held on July 13 and 14, 2010, along with information regarding the deliberations and votes of that meeting.
The decision by the FDA is somewhat surprising given that the same FDA Advisory Committee meeting suggested keeping Avandia on the market, despite uncertainty over its safety profile.
All in all, I think this is a smart, and surprisingly bold, move by the FDA. It is really advocating for patient safety, though a lot of this may be directly related to bi-partisan pressure from Congress and public perception that the FDA is too closely aligned with the pharmaceutical and medical device industries.
Caffeine and Pregnancy
There is apparently a lot of debate in the ob/gyn community about how caffeine consumption affects pregnancy. The American College of Obstetrics and Gynecology (ACOG) just released an opinion stating that <200mg (about one cup of coffee) per day does not increase the risk for miscarriage or preterm birth. No conclusion could be made about the relationship between caffeine and intrauterine growth.
Dr. Barth, Chair of the Committee on Obstetric Practice, was quoted as saying, "Given the evidence, we should reassure our pregnant patients and let them know that it's OK to have a cup of coffee."
I'm not too surprised about ACOG's opinion, given the amount of tea South Asians drink, and I can't imagine all of our women giving up chai during pregnancy! Tea also has less caffeine content, about 100mg, than coffee, which may help. A reminder to pick your addictions wisely! :-)
Of course, one should always make any decisions regarding pregnancy and caffeine intake with one's physician, as every situation is different and depends on any underlying medical conditions.
Dr. Barth, Chair of the Committee on Obstetric Practice, was quoted as saying, "Given the evidence, we should reassure our pregnant patients and let them know that it's OK to have a cup of coffee."
I'm not too surprised about ACOG's opinion, given the amount of tea South Asians drink, and I can't imagine all of our women giving up chai during pregnancy! Tea also has less caffeine content, about 100mg, than coffee, which may help. A reminder to pick your addictions wisely! :-)
Of course, one should always make any decisions regarding pregnancy and caffeine intake with one's physician, as every situation is different and depends on any underlying medical conditions.
Friday, July 23, 2010
Money and Medicine: The Story of Avandia
Nice piece on the controversy surrounding Avandia, or rosiglitazone. I think it should be pulled from the market or that additional black box warnings accompany the medication. Risk-benefit ratio just doesn't add up to me.
...of course, people should make their decisions in consultation with their physician, not my online musings...
This is a nice timeline of significant events with Avandia. Below is the video interview:
...of course, people should make their decisions in consultation with their physician, not my online musings...
This is a nice timeline of significant events with Avandia. Below is the video interview:
Watch the full episode. See more Need To Know.
Monday, May 10, 2010
Anesthesiologists: Lethal Injection Lethal for your Career
Very significant ethical decision by the American Board of Anesthesiologists - they have decided to revoke board certification for any anesthesiologist who participates in lethal injections.
The AMA has long opposed physician involvement in state executions, but no specialty in medicine has taken the step of revoking certification for physician members who participate in state executions.
This is a really big deal, a strong statement by a large specialty group to separate physicians from state executions. It also puts pressure on other healthcare professionals, like nurse practitioners and physician assistants who sometimes participate in state executions.
It will be interesting to see if other medical specialties follow suit...
The AMA has long opposed physician involvement in state executions, but no specialty in medicine has taken the step of revoking certification for physician members who participate in state executions.
This is a really big deal, a strong statement by a large specialty group to separate physicians from state executions. It also puts pressure on other healthcare professionals, like nurse practitioners and physician assistants who sometimes participate in state executions.
It will be interesting to see if other medical specialties follow suit...
Friday, April 30, 2010
Death of Traditional Internal Medicine
Interesting post by an internal medicine physician on the death of the traditional internist. In the old days, internists would take care of their patients both as outpatients (in clinic) and as inpatients (in the hospital).
Dr. Knope argues that this practice is essentially dead and I think he's right. In today's healthcare world, care is extremely fragmented. A typical internist sees 20-30 patients in clinic daily and seeing patients in the hospital is often impractical.
Moreover, access to one's internist is not always simple - patients can often wait a month or more for minor problems and thus visit urgent care centers or "minute clinics." The patient could be prescribed medications or interventions at these visits that get lost in follow up with the internist or when he or she gets hospitalized.
Dr. Knope chose to opt out of the mess by opening a "concierge" practice, where a few wealthy patients pay him to be at their beck and call for all problems, whether in the clinic or the hospital. This, however, is not a practical solution to the problem, which he admits.
I think the primary care specialties have recognized this problem and thus argued for the establishment of a "medical home" model, which would at least centralize all of the patient's medical information and allow for more efficient coordination of care. The ACP has done a lot of advocacy on this issue and I believe important measures supporting this process were passed with the new health care reform law.
I don't think the traditional internist will survive, except in rural areas or niche practices like concierge medicine, but the hope is that the new breed of internist will better utilize technology and performance improvement measures to deliver holistic care that results in better health for patients and society.
Dr. Knope argues that this practice is essentially dead and I think he's right. In today's healthcare world, care is extremely fragmented. A typical internist sees 20-30 patients in clinic daily and seeing patients in the hospital is often impractical.
Moreover, access to one's internist is not always simple - patients can often wait a month or more for minor problems and thus visit urgent care centers or "minute clinics." The patient could be prescribed medications or interventions at these visits that get lost in follow up with the internist or when he or she gets hospitalized.
Dr. Knope chose to opt out of the mess by opening a "concierge" practice, where a few wealthy patients pay him to be at their beck and call for all problems, whether in the clinic or the hospital. This, however, is not a practical solution to the problem, which he admits.
I think the primary care specialties have recognized this problem and thus argued for the establishment of a "medical home" model, which would at least centralize all of the patient's medical information and allow for more efficient coordination of care. The ACP has done a lot of advocacy on this issue and I believe important measures supporting this process were passed with the new health care reform law.
I don't think the traditional internist will survive, except in rural areas or niche practices like concierge medicine, but the hope is that the new breed of internist will better utilize technology and performance improvement measures to deliver holistic care that results in better health for patients and society.
Monday, January 07, 2008
Physicians and Execution
The New England Journal of Medicine published an important editorial today, voicing its opposition to the involvement of physicians in state executions. I totally agree with the editorial, I don't think it is the role of physicians to facilitate death, whether it is in the setting of capital punishment or assisted suicide (admittedly, a separate issue). The Journal states:
It will be interesting to see how the Court rules on this important issue.
Physicians and other health care providers should not be involved in capital punishment, even in an advisory capacity. A profession dedicated to healing the sick has no place in the process of execution.The editorial was issued in response to the Supreme Court's decision to hear the case Baze v. Rees about the constitutionality of lethal injection. I am not, in theory, opposed to capital punishment for certain crimes, but I do have a problem with the way it is practiced, because I think there are racial and economic factors that allow injustice to creep too easily into the system.
It will be interesting to see how the Court rules on this important issue.
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