Monday, February 25, 2008
Pfizer pulls Jarvik TV Ad
It was only a matter of time. Criticism started to mount back in March with Pfizer's use of Dr. Robert Jarvik, inventor of the artificial heart, to promote their #1 selling drug Lipitor. The issue at hand was that the advertisement implied that Dr. Jarvik was a medical doctor that prescribed Lipitor for his patients. Though Dr. Jarvik did get an MD, he is primarily an inventor and researcher and does not practice clinically. In January, congress looked into this potential misrepresentation. Though Pfizer initially stood by Dr. Jarvik and the ad, continuing criticism forced them to pull the ad today.
The bigger issue here is not the use of celebrity endorsements to sell pharmaceuticals or even whether or not Pfizer should of been more clear about the fact that Dr. Jarvik can not legally write a prescription. Though promotion of pharmaceuticals on television is already a complicated issue, the use of a physician pitchman makes this more complicated. The public is likely very aware that when Sally Field promotes Boniva for osteoporosis, she is a paid celebrity endorser of the product. However, physicians have an primary obligation to their patient's best interest, which is compromised by a paid endorsement (Jarvik made $1.35 million). Though Dr. Jarvik does not treat patients, by promoting a product to the public who migh use this product, he is making a medical recommendation. As medicine and the media continue to mix, industry and consumers must be very careful about this ethical line. What about celebrity physicians that are real MD's? Would it have been better or worse if cardiologist Dr. Steven Nissen (who himself is becoming a media celebrity) had been in the ad instead of Dr. Jarvik?
Antibiotics overused in dementia patients
Several sources are reporting on a study in the Archives of Internal Medicine regarding the overuse of antibiotics in the nursing home setting. This study looked at 214 nursing home patients with advanced dementia for a year and a half and found that two-thirds were treated with antibiotics. More importantly, the closer the patients came to death, the more antibiotics were used.
Much of the discussion regarding these findings is focusing on the concern about overusing antibiotics leading to the development of infectious agents that are resistant to the antibiotics we commonly use. This is indeed important, but the bigger issue is here regards over-treatment in general. The politicians can debate the merits of mandates or whether tax incentives should be used to help pay for health care. However, the biggest driver of cost is use of medical services such as prescriptions, diagnostic tests and procedures. Everyone wants the best possible medical care, but we simply can not afford this for everyone. We spend a substantial portion of our country's health care dollar on the first and last days of life. Advanced stage dementia is a terminal illness. As one physician commented, “If we substituted ’end-stage cancer’ for ’advanced dementia,’ I don’t think people would have any problem understanding this.” It's one thing for a family to choose not to insert a feeding tube to their loved one dying of cancer. It's quite another not to give grandma some antibiotics when she has a fever. (Antibiotics in advanced dementia do not prolong life, may not improve suffering, and are likely harmful by increasing resistant organisms). If we are going to solve our health care crisis, we are going to have to discuss what we are willing to pay for, and what may not be worthwhile. Our "please do everything you can doctor," society may not be ready to handle this.
Friday, February 22, 2008
As reported in the Annals of Internal medicine, a study in the Netherlands involving 222 patients with hip osteoarthritis showed no difference in pain relief and function when taking glucosamine sulfate.
Though these results are disappointing, don't throw out your glucosamine just yet. These studies are hard to do, because measuring pain has some degree of subjectivity to it. The study was also small. An earlier Meta-analysis of several glucosamine studies found it to be affective. However, a more recent large NIH sponsored trial of 1583 patients with symptomatic knee osteoarthritis published in the New England Journal found no improvement. Given that glucosamine is relatively safe, if you have osteoarthritis and paying for this won't set you back too much, then trying it may be worthwhile. However, if you are not seeing any major improvement, there is evidence to suggest it may not work.
Just 1 in 4 know heart attack signs
Several sources are mentioning on a report from the CDC that only about one-third of U.S. adults are aware of the five major warning signs of heart attacks. This study conducted interviews over the telphone in 72,000 people and found:
48% recognize pain or discomfort in the jaw, neck, or back as a warning sign;
62%, feeling weak, lightheaded, or faint;
85%, pain or discomfort in the arms or shoulder;
92%, chest pain or discomfort;
93%, shortness of breath.
This is actually WORSE than a few years ago, when 1 in 3 Americans could recognize all of these as heart attack warnings. We need to do a better job or educating patients about the warning signs of a heart attack and what to do. In the survey 86% said they would dial 911 if they thought someone was having a heart attack or stroke. This means that 14% wouldn't know to do this!
Google gets into health care
The NY Times reported today that Google was partnering with the Cleveland Clinic and implementing Google's version of a personal health record where patients can keep track of medications, illnesses,etc. and which could be accessed by physicians and pharmacists.
There are certainly privacy issues that need to be dealt with here, but this is a step in the right direction. For patients with chronic illnesses on multiple medications, it is difficult to keep track of what medicines to take and when, let alone things like home blood pressure readings, laboratory results, medication allergies, etc. Though I think these will ultimately be helpful, Google (and others) need to make sure these integrate with Electronic Medical Records used by physicians and hospitals. In addition, the digital divide still exists in this country, so we need to make sure that the underserved have access to the Internet.
For more information on personal health records, Medline Plus has several excellent resources. If you can't wait for Google's version to come to you, you can try the Microsoft product or myPHR or iHealthRecord (this is not an endorsement, since I haven't used these myself or had feedback from any patients).
Tuesday, February 19, 2008
Factually, there is nothing wrong about this piece on some recent surprising findings from studies that according to Stein "has renewed debate about how aggressively doctors use drugs to prevent and treat some of the nation's leading health problems." Stein also does a good job at presenting both sides of the story. My only true objections (other than the way the headlines and subtitles seem to imply that patients should question taking their medications) are:
1. In the beginning of the article, when referencing the ACCORD study, Stein specifically highlights Avandia, which has been in the media a lot lately. Though we know very little about what caused people to die in this study, the ONLY thing we know is that (according to the NIH), it was NOT Avandia.
2. Second person quoted is Dr. Steven E. Nissen from the Cleveland Clinic who seems to be making a career of being quoted in the press on how certain drugs can be dangerous.
3. Under the section "Pushing Pills" there is an opinion from some industry critics that "more emphasis should be placed on improving cholesterol, blood pressure, blood sugar and other risk factors through lifestyle changes, such as eating better, maintaining a healthy weight and exercising more." This is absolutely true. However, it implies that we should put more emphasis on this and save drugs for only the very worst cases. Furthermore, there is no mention of the data on diet and exercise (more on that later).
The article discusses the "suprising" findings of two recent studies.
1. ACCORD- I explain this in detail in a previous post. Briefly, this NIH study on aggressive management of diabetes was stopped early because diabetics treated more aggressively had a greater chance of dying. I warned people not to stop taking their diabetes medications, because in this study patients were likely treated too aggressively. Because of these findings, a similar international study decided to make sure that they weren't harming anyone, and found no differences. Why the discrepancy? Because the international study was aiming for a target of less than 6.5% (guideline recommended) and the NIH study was trying to get patient to normal, or less than 6.0% (which no one recommends).
2. ENHANCE- also discussed in a previous post showed that the addition of zetia to simvistain (Vytorin) was no better at preventing aretery clogging then simvistatin alone. Again, findings were surprising, but not shocking, since there were no outcomes data yet on Zetia. Seems clear that there is likely more to heart disease than just lowering the ldl. However, the patients in this trial had extremely high cholesterol, and it is possible that neither drug was powerful enough to make a major difference.
Efficacy of Lifesytle Modifications
There is no question that we need to focus more on diet and exercise. Diet and exercise is generally cheap and benefits multiple factors. However, in many cases, diet and exercise will not be enough. This is why physicians prescribe medications IN ADDITION TO diet and exercise. Though diet and exercise is the first-line therapy for hypertension, high cholesterol and diabetes, the data on their efficacy alone are not all that impressive.
For prevention of diabetes, one study actually showed that diet and exercise did BETTER than metformin, a diabetes medication. However, the regimen that patients got was quite extreme including prepared meals, personal trainers and even Nike sneakers provided at no cost. Though diet and exercise works to prevent diabetes in patients at risk, it may not be reasonable for many, which is why the ADA last month (for the first time) recommended that physicians consider medications to prevent diabetes.
For high blood pressure, there is some evidence that diet and exercise is effective. Below is a table from the NIH's Hypertension Guidelines that includes the effect of various lifestyle interventions. Please note that doing more than one thing can add up, but the results are not additive. Life Style Modifications
You can see that there is definitely evidence that if you do things like exercise, stop smoking and eat a healthy diet you can have a substantial impact. The best studied diet is the DASH diet, which is very similar to a Mediterranean diet. It showed a significant improvement in lowering blood pressure than just a lower calorie diet with an impressive 11 points off the top number (systolic) and 5 points off the bottome number (diastolic). Though these numbers are meaningful and important, if your blood pressure is 160/100, it is likely that no amount of diet and exercise will be able to get your blood pressure under control.
Diet and exercise is key and critical for treating chronic diseases like hypertension and diabetes. Furthermore, there is much more to learn about which medications to give to which patients in treating these conditions. There are currently good medications available (many generic) that have not only shown substantial improvement in blood pressure, sugar and cholesterol control above and beyond what lifestyle modication can acheive, but also have prevented outcomes like heart attacks and strokes and have even saved lives. Should we continue to look carefully at medical treatment? Certainly. Do we need to focus more on diet and exercise? Absolutely! Should we (based on some recent studies) call into question the notion of treating these serious illnesses with medications? Certainly not.
Friday, February 15, 2008
Why the confusion? The reason has to do with a product's indication. When a product is approved by the FDA as being both safe and effective, it is only approved for a specified indication. A good example of an indications would be age. When GSK first approved Advair (the #1 selling asthma drug), it was indicated for adults or children over 12 years of age. The reason for this indication is that the studies that GSK submitted to the FDA for approval were only done in children 12 years and older. But what if you are a 10 year old asthmatic that could really benefit from Advair? Your physician, if he or she felt comfortable could still prescribe it because a physician can use any approved drug for any patient in whom he or she feels is appropriate. The difference is that the drug companies can only promote their products to patients and physicians for its indicated use. In fact many drugs are used for "off-label" indications. This is especially true in Pediatrics, where it might take years before the company does the studies to get approval in younger children (Advair is now approved for 4 and up). In fact, drug companies will often use their indications for a competitive advantage over similar drugs that may not have that indication (like Zyrtec and Lyrica).
Going back to fibromyalgia, before Lyrica, many physicians (myself included) used Neurontin (indicated for seizures) for fibromyalgia pain (Lyrica and Neurontin are similar drugs), and it is still used today, though it use is considered off-label. In fact Pfizer (who also makes Neurontin) settled a case regarding Neurontin in 2004 for $430 million. The crime: promoting Neurontin for off label use. The FDA has been cracking down on drug companies to ensure that they are only marketing their drugs for their specificied uses. However, off-label promotion continues to be a common occurence.
This may be about to change.
As reported in the Wall Street Jounrnal today, the FDA announced it is considering lifting some of its restrictions on drug companies for off-label promotions to physicians. Specifically, drug companies through their representative may now be allowed to give a physician an article published from a peer-reviewed journal on their drug, even if the drug has not been approved for that indication. According to the FDA:
"Articles that discuss unapproved uses of FDA-approved drugs and devices can contribute to the practice of medicine and may even constitute a medically recognized standard of care," said Randall Lutter, FDA deputy commissioner for policy. "This guidance also safeguards against off-label promotion."
Off-label use can be very important for certain drugs where an approved treatment does not exist. In fact many discoveries regarding drugs were made initially using the drugs off-label. If physicians want to be up to date on the latest information, it would be important for them to know about studies on a product, even if the use is off-label. It may take years before the company gets approval for the indication that is clearly effective based on published research. In fact, many times the company does not even seek the indication because the cost of the approval process is quite high, and (especially if there are good studies to support its use) doctors will often start using drugs for off-label indications well before the product gets approved for that use.
On the other hand, allowing drug companies to promote their products for uses that have not been approved by the FDA as being safe and effective is risky business. This may lead to inappropriate use of the drug. The measure proposed by the FDA has the potential advantage of allowing only good studies (peer-reviewed, published) to be used for off label promotion and not other data (non-published, not peer reviewed). Both types of data are currently used for off-label promotion by drug company representative despite this practice being against the policies of most major drug companies. Critics will argue that even these "good" studies are inherently biased. If the new policy is approved, it will be interesting to see whether this promotes scientific discussion and learning, or inappropriate use of medications. (Optimistically, I think it will do the former, but realistically I think it will do both).
One of the main issues is not so much whether to allow drug companies to show publically available articles to doctors regarding the off-label use of their drugs (if a study is published in the New England Journal of Medicine, why shouldn't a rep bring this to a physician's attention?). The real issue is the way studies on drugs are done and the way physicians learn about appropriate use of medications. Most studies done on pharmaceuticals are sponsored by the drug companies. All of the major medical journals that publish these studies are supported by advertising revenue from the drug companies. If a physician wants to learn more about a drug, they can go to live meetings, dinner programs, web programs, etc. which are (you guessed it) funded by the drug companies.
This is not a criticism of the drug companies. They have an obligation to their share holders to promote their products for their indicated use. In addition, the information they provide to physicians can be valuable for patient care. The problem is that their is very few ways for physicians to get truly unbiased information. The NIH or government does not fund many therapeutic trials. At the NIH, there is no Institute for Primary Care whose mission is to educate primary care physicians about evidence based treatments. If we as a society want to ensure that there is no conflict of interest in the research on therapeutic agents that improve our health, as well as the promotion of this research and information to the physicians that prescribe these products, then we are going to have to start paying for this. The drug industry has and will continue to fill this void, and at this point it doesn't look like our society is willing to spend the money on this when so many Americans still don't have health care coverage.
Wednesday, February 13, 2008
Bottom line: There are no perfectly safe drugs. Lipitor is one of the most prescribed drugs in the country, with approximately 18 million people currently taking it. Though there is little evidence for memory problems with Lipitor, a rare side effect (1/10,000) will occur in 1800 patients if 18 million are taking it. On the other hand, for certain people at high risk for heart attack and stroke, Lipitor can decrease these chances by 25% or more. If you are on Lipitor (or other cholesterol medications) don't stop taking them because of newspaper reports of rare and unconfirmed side effects. On the other hand if you notice anything strange after starting any new medication, talk to your physician.
More info: Statins clearly work. Though some may joke about putting them in the water, several have suggested that if every adult over 55 took a pill containing some statin, aspirin, and blood pressure medications (a polypill), this would prevent substantial numbers of heart attacks and strokes. On the other hand, some of the millions of Americans that might take such a pill would get side effects. The key is to balance the risks and benefits of the medication. Cost is a separate issue because you can consider either cost to you ($20 co-pay) or cost to society (thousands of dollars to prevent just one heart attack).
Regarding memory issues, these have been reported, but the link between memory disorders and Lipitor is unclear. Memory loss was not seen in the thousands of patients Lipitor was tested in prior to its approval. However, for a rare side effect, it may take tens of thousands of patients to take the medication before a side effect becomes apparent. There was some preliminary evidence that statins might prevent Alzheimer's disease. Unfortunately, this does not seem to be the case. However, in a recent study of almost 1000 elderly patients, statins were not associated with increases in Alzheimer's, dementia or decreased mental function. Yet, there continue to be reports of memory problems thought to be related to Lipitor, including a NASA astronaut who experienced transient global amnesia after starting the drug.
So how to you weight the risks and benefits?
You have to look at not just the side effects of the drug, but the chances you will get that side effect, and balance that with the chances the drug will actually improve your health, which is usually related to your base line risk.
The most common side effect of statins (including Lipitor) is muscle pain, which occurs in 2-3% of patients. It is usually mild and usually goes away.
Looking at one study (ASCOT-LLA), for patients without prior heart disease, but who had risk for heart attack and stroke (high blood pressure, plus 3 other risk factors such as family history, being overweight, high cholesterol), for every 100 patients who took Lipitor for 3 years, one heart attack or fatal heart attack or stroke was prevented.
Let's say that memory loss is caused by Lipitor (unclear) and happens for every 1/1000 patients (probably much less, like 1/100,000):
For every 1000 patients with high risk for heart attacks taking lipitor, 30 will get mild muscle pain, 10 will have a heart attack prevented, and 1 might have some memory loss. These numbers are still look pretty good (as long as you don't cost-about $1 million a year).
Use of expensive drugs (Celebrex), diagnostic tests (MRI's) and expensive surgeries (spinal fusion) are cited as the reasons for the cost increase. Yet these treatments don't seem to help any. The study looked at national survey of what people spend and how healthy they are. Despite the increase in spending on spinal problems, people with back and neck problems who reported physical, social and work limitations rose to 24.7 percent in 2005 from 20.7 percent in 1997.
Bottom Line: The bad news is that most of our current treatments for back and neck pain aren't that great. The good news is that most of these conditions resolve on their own. Before spending lots of money on medications, surgery and expensive tests; try good old fashion rest, heat and cheaper drugs like Tylenol and and Ibuprofen/Alleve.
More info: With the exception of one recent study (SPORT) which suggest spinal surgery might be more effective than conservative treatment, most reports show that when it comes to spinal pain, all treatments seem to work about equally effectively and don't help a great deal. An article on low back pain that I ask my students to read comes from American Family Physician that states:
"Acute low back pain with or without sciatica usually is self-limited and has no serious underlying pathology. For most patients, reassurance, pain medications, and advice to stay active are sufficient"
There are certain "red flag" coniditions associated with back pain that might require more agressive testing or treatment which include:
Age > 50 years, fevers/chills, recent infection, wound near spine, history of significant trauma, unrelenting night pain or pain at rest, worsening muscle weakness or nerve damage, difficulty urinating, fecal incontinence, unexplained weight loss, cancer or strong suspicion for current cancer, osteoporosis, depressed immune system from medications like oral steroids, and IV drug use.
However, absence of these conditions usually means not much more needs to be done. Most back or neck pain resolves in 4-6 weeks. If things don't get better, then more testing, referrals, etc. may be indicated.
One of the disturbing things about the report is that when it came to prescriptions, one of the biggest increases was with the drug Oxycontin. This is a narcotic medication that is extremely addicitive and can be quite dangerous. In general, it is not recommended in the treatment of chronic back and neck pain.
Also, general health and ergonomics are major contributors to spinal pain and are often overlooked. Many patients with back pain get substantial improvement from weight loss. Though weight loss is difficult for many, even a 5-10% decrease in body weight can lead to imrovements in back pain (in addition to overall health). Both back and neck pain can also be caused by poor seating, posture, and other work related conditions like driving for long periods of time. Simple adjustments of the works space are very cheap and often quite effective.
Wednesday, February 6, 2008
Bottom Line: Trying to get the sugar too low in these patients may have been harmful. However, most physicians don't even try to come close to getting the sugar this low. If you are diabetic, keeping your sugar under control is still extremely important. Also, it was made clear that Avandia was not a factor in these deaths.
For those who want to know more: We have known for some time that there is more to diabetes treatment than just the sugar. People with Type 2 diabetes don't die for high sugar, but rather suffer from the complications caused by diabetes- heart attack, stroke, kidney failure, blindness. One of the largest diabetes trials done in Europe (UKPDS) showed us that by treating diabetes more agressively, these complications were reduced. Recommendations to keep the hemoglobin A1c (measure of overall sugar control) under 7.0% was based on this study. However, though heart attacks were reduced in the UKPDS, this difference was only 95% certain (most scientist say you need more that 95% certainty to prove something). Thus, when it comes to heart attacks, there is something more than the sugar. The ACCORD study tried to get patients to a hemoglobin A1c under 6.0% (or normal) believing that more agressive care would benefit patients. Surprisingly, there were more deaths. The full report has not yet been released, but in order to get patients this close to normal, insulin was likely neededin many cases. Insulin can drop the sugar too low and has also been associated with an increase in cardiac risk. Interestingly, guidelines from the ADA suggest preferably using insulin to get patients under control, rather than use other (newer) agents because they are more expensive and don't work as well as insulin. (Perhaps this may not be the best approach).
Also released today, was a study in the New England Journal of Medicine that had absolutely no press. This was another agressive management study, but rather than try to get the sugar as low as possible, this study tried not lonly to get patients to an A1c below 6.5% ( a more reasonable target), but also their cholesterol less than 175, and blood pressure less than 130/80. Patients were treated for over seven years and then followed for more that 5 years after treatment. After 13 years, patients in the intensive treatment group had the total death rate cut in half, with over 40% lower rates of cardiac death and heart attacks, and almost half as many patients treated for eye complications. In order to achieve these goals, the patients in the intense group needed more medicine, including insulin, but likely not as much as those in the ACCORD study.
The implication of these two studies are that:
1) Diabetics should try to keep the sugar under control for as long as possible, at an A1c less than 6.5%
2) Going below 6.5% is probably not necessary, and going below 6.0% may be harmful.
3) Diabetics must also control blood pressure and cholesterol. (All diabetics should take a statin medication, even if their cholesterol is normal!)
Sunday, February 3, 2008
There are obviously many issues to vote on (the war, the economy), but as a health care provider, I am most interested in health care.
A few disclosures:
1. I am a Democrat and will likely support the Democratic nominee for President.
2. I feel that in order for real change, we need some type of mixed public private insurance that would allow for a single payor system to cover most needs for all.
3. I don't believe that any of the current candidates has an actual solution for true health care reform (though some are closer than others). Both of the major candidates on each side essentially keep private, for-profit health insurance intact, which I feel is a big part of the problem. Additionally, none of the candidates are truly addressing critically important issues. Many pay lip service to primary care, but no candidate discusses how many primary care physicians are leaving practice will few new physicians to fill their shoes. Some discuss the benefit of Electronic Medical Records, but no one has a plan to pay for the huge upfront costs.
That said, it's essentially down to Romney and McCain on the Republican side and Obama and Clinton for the Democrats. The Kaiser family foundation does a nice job on their web site to allow you to compare all of the candidates plans.
In general, the Republicans want to keep the private, for-profit insurance companies in tact, and allow tax credits to be used for purchasing health care. Personally, I think this is a mistake. Though competition may drive health care costs down, Americans don't always put their health first. If my neighbor chooses not to purchase home or fire insurance and his house burns down, it's his loss not mine. However, if someone chooses not to get a mammogram, and cancer is caught at a later stage that is more expensive to treat, this adds cost to the whole system. A recent study in the New England Journal showed that for patients in managed medicare plans, higher co-pays were associated with fewer covered patients getting mammograms.
In comparing McCain's and Romney's plan side by side, there are not substantial differences, but McCain seems to have more concrete ideas. Though both support malpractice reform, McCain mentions re-importation of prescription drugs and providing national (not state) insurance, as well as mentioning "invest in prevention and care of chronic illnesses."
Thus, if you are Republican and hope for some change in health care, I would recommend voting for McCain.
Deciding between Clinton and Obama on health care is a little trickier, since, as Obama pointed out in the last debate, that both health plans are “95%" similar, offering goverent sponsored insurance to all, but leaving private insurance in tact. Practicing in D.C. with many federal employees in my practice, I can tell you that government sponsored insurance would be great to have. Patients tend to have more services covered, and I have fewer hassles with prior authorizations.
The major difference between the two candidates is requiring that insurance be covered. Obama insists that if the cost for health care is low enough, people will sign up. Clinton states that there are many Americans currently who could afford insurance, but don't have it. She's right!
The best example is the State Children's Health Insurance Program (SCHIP) which both candidates are in favor of expanding. People might not know that there are many people who qualify for SCHIP (free health care) that simply don't get it. There are a variety of reasons for this, but the point is that even if you offered free health care for anyone making less then the median income of the country, there would still be some individuals that would remain uninsured. As above, using the home and fire insurance example; when people who choose not to have health insurance end up costing the system, it becomes my problem.
Since the only real difference is mandates for health care coverage, if you are a Democrat, I would recommend voting for Clinton.