Tuesday, July 5, 2011

Chantix should not be withdrawn.

Despite the rising rates of obesity, smoking is still the single leading cause of preventable death in the US.  Quitting smoking is very difficult because one needs to address both the behavioral and pharmacologic aspects of nicotine addiction  Though other agents are available, Chantix or varenicline is the most effective agent to assist in smoking cessation.  This has been proven in several large, randomized clinical controlled trials (RCT's). RCT's are the gold standard when it comes to scientific proof. (More on that in a minute).

Chantix is not without issues.  The main side effect is nausea, which about 30% of users will get.  It is usually mild and usually goes away, though a small percent of people will not tolerate this.  The more recent concern with Chantix was exacerbations of neuropsychiatric symptoms: depression, anxiety, and suicidal ideation.  These side effects were not seen in many of the initial studies, but in later on via reports by doctors and patients after the drug was on the market.  This method is called post-market surveillance. Post-market surveillance is critical in determining drug safety, because rare but serious side effects may not be seen when you only study thousands not millions of patients.  However, unlike RCT's , proving cause and effect can not be determined. In regards to psychiatric symptoms, in the original studies that the Pfizer submitted to the FDA, Chantix had few interactions and did not show any. However, because Pfizer compared Chantix to bupropion (the only other pill indicated for smoking cessation, but also used for depression), patients with mental illness were purposely excluded from the study. (See more about this in Where's the Good News about Chantix? and More FDA warnings should not be cause for worry.) In fact, since these warnings first appeared, further studies seem to indicate that just stopping smoking, not necessarily Chantix, can cause these problems.  Furthermore, warnings were not just added to Chantix but also to bupropion. Regardless or whether symptoms like depression or even suicidal thoughts is linked to Chantix or stopping smoking, doctors and patients should be aware of this concern for any patient quitting tobacco. 

Now we have a new concern regarding Chantix causing cardiovascular events.  The initial concern was raised by the FDA in their review of a study of 700 patients with known cardiovascular disease randomized to Chantix or placebo. Though Chantix was far more effective in helping these patients with known heart disease quit tobacco, there was a small number of increased cardiovascular events, more in the Chantix group than placebo. The total number of events was 28 in the Chantix group vs. 17 in the placebo.  The study was not designed to show whether or not this number was statistically significant (was really true), but the FDA added a warning to Chantix' label.

However, a new study raises questions about Chantix and people without heart disease.  This is being blasted all over the media.  The Wall Street Journal reports "Drug Tied to Heart Risks."  The New York Times reports "Study Links Smoking Drug to Cardiovascular Problems."  ABC News states "Chantix: Quit Smoking, But Risk Your Heart?" All of them have similar language to the ABC news site stating:

Study authors looked at 14 past studies of Chantix and found that overall, people on the drug had a 72 percent increased risk of being hospitalized with a heart attack or other serious heart problems when compared with those taking a placebo.

That seems pretty bad! Unless, of course, you look at the actual data. The new study is a meta-analysis of studies looking at patients on Chantix without cardiovascular disease.  The study is from the Canadian Medical Association Journal.  They looked at data from 14 RCT's 8216 participants. They found that Chantix was associated with a significantly increased risk of serious adverse cardiovascular events compared with placebo on 1.06% [52/4908] in varenicline group compared to  0.82% [27/3308] in placebo group.  In other words, the absolute difference between Chantix and placebo is 0.24% or 24/10,000. This sounds a lot less scary than 72% increase (relative increase) being reported in the media.  It is also very, very important to note that the technique used to derive these numbers is a statistical technique, a meta-analysis, which is not nearly as rigorous as an RCT.  Meta-analysis are designed to ask questions, not to answer them.  ( I have blogged previously about the pros and cons of meta-analysis). Furthermore, even patients without a history of cardiovascular disease who smoke, have a risk for cardiovascular disease, which is why they need to stop in the first place.

Bottom Line: One must always question 1) the results of a meta-analysis because it has many limitations and 2) any non-RCT, especially a meta-analysis, with a very small absolute risk (i.e. 0.24%) especially if the authors/journalists are trumpeting a large relative risk (i.e. 72%) and  also 3) take into account the context of the situation, i.e. the single best agent we have available for the leading preventable cause of death in the United States, might possibly have an associated very small increase in heart disease in smokers that will likely have a much greater risk of heart disease if they don't stop smoking. While I agree more research is needed, and warnings about a possibly increased cardiovascular risk are not inappropriate, pulling Chantix from the market would be a huge mistake.

Friday, July 1, 2011

Paying For Your Time

There has been a lot of Internet/Twitter buzz regarding a recent CNN article "Would your doctor pay for wasted time?" by Elizabeth Cohen.  The premise of the article is that a patient's time is valuable, and if the doctor keeps a patient waiting for longer than anticipated, it should be the doctor that pays the patient, since the patient's time is valuable too.  She describes the story of patient Elaine Farstad waited over two hours to see her physician.

"I decided to bill the doctor," she says. "If you waste my time, you've bought my time."

Farstad mailed an invoice to her doctor based on her own hourly wage, and eventually received a $100 check in the mail.

As mentioned, this story has received considerable attention. Over at the blog Survivor: Pediatrics , Brandon Betancourt humorously counters "Why not bill everybody that wastes our time?" including the movie theaters that make us sit through commercials and previews before the movie we came to see, or even Disney for waiting in those long lines. 

However, the issue of why patients have to wait is an important one. Most patients recognize that emergencies do come up in medicine, which often causes doctors to run behind schedule.  However, medical emergencies are not the main reason why patients spend long waits in doctor's waiting rooms.  The answer can be found in a study published last year and discussed in the New York Times "Study Shows ‘Invisible’ Burden of Family Doctors."  Primary care physicians do a lot more during their day than just see patients.  However, they only get paid for seeing patients.  The actual study, published in the New England Journal of Medicine measured exactly what a group of family physicians did in a given day.

Family doctors are paid mainly for each visit by patients to their offices, typically about $70 a visit. In the practice in Philadelphia covered by the study, each full-time doctor had an average of 18 patient visits a day.

But each doctor also made 24 telephone calls a day to patients, specialists and others. And every day, each doctor wrote 12 drug prescriptions, read 20 laboratory reports, examined 14 consultation reports from specialists, reviewed 11 X-ray and other imaging reports, and wrote and sent 17 e-mail messages interpreting test results, consulting with other doctors or advising patients.

All of this unpaid work takes an incredible amount of time.  Also, assuming that the doctors were collecting 100% of their $70 per visit, at 18 visits a day, with 60% overhead  (often more for doctors), the doctor only takes home about $120,000 a year in salary.  Now that seems like a pretty good salary, and is certainly much more than most Americans make.  However, it is far lower than many other professionals with equal or less training (lawyers, accountants, dentists, college professors, etc.) and also doesn't take into account the enormous debt that medical students accumulate (in some cases close to $200,000 at graduation, adding up to  well over $1 million if paid over the course of a typical loan).   This is why our medical students are not going into primary care.

All this work can't be done in a given day, and the doctor can't see fewer patients to squeeze in this work because it will lower her salary even further. Another way to put this is that the doctor's time is valuable too, but she isn't get paid for her time. The doctor is getting less than what's it worth from the insurance companies for actually seeing patients and getting nothing from insurance for anything that's not face to face.

Thus, the doctor who is trying to see too many patients in too little time while simultaneously trying to get all the phone calls, lab results, etc. is going to run late. In my practice, with the exception of the first patient of a morning or afternoon session, I start each patient conversation with, "I am so sorry to keep you waiting."  There is only so much that can be accomplished in 15 minutes.   Primary care physicians who need to manage multiple complex medical issues have a choice: be good or be on time.  I choose to do the best job I can, which causes most of my patients to wait much longer than any of them should.

One solution to the problem is to have insurers properly reimburse primary care physicians for all the work that they do.  Unfortunately, regardless of who gets elected in 2012, this seems unlikely to happen.  Another solution is to get the insurance companies out of the mix all together.  This alternative solution is already starting to happen.  Retainer or concierge practices, which charge an annual fee (on average $1500/year) allowing doctors to have a very small number of patients who have instant access and no wait times, are gaining in popularity. Some have suggested that this is one solution for the primary care crisis.

However, many patients can not afford high retainer fees nor necessarily need this level or service.  For these patients, another solution is direct access primary care. Direct access primary care works more like a gym membership, where you pay a monthly fee for all of your basic primary care needs.  You can use your direct access primary care provider as little or as much as needed.  Qliance in Seattle, charges about $75/month.

There are a variety of other models that improve patient and physician satisfaction, and likely the actual quality of care.  However, the key ingredient in all of these models is cutting out the insurance companies to save money, hassle and overhead costs; and collecting money directly from patients to enhance revenue. This combination allows primary care physicians to spend more time with patients, have increased access, and subsequently low to no waiting for patients.

Bottom Line: The current insurance based system keeps primary care physicians on a treadmill, usually forcing them to choose quality of care over patient convenience. Though all patients deserve high quality, patient centered care that is convenient as well, the solution of higher reimbursements and decreased hassles for primary care physicians does not appear to be happening any time soon. Thus, as a patient, you have a choice. If your time is valuable, then you are going to have to pay extra for primary care services. If you choose to (or are only able to) rely on health insurance premiums and co-pays to cover the cost of your care, you should expect to wait. Expect to wait to get a timely appointment with your doctor. Expect to wait for the phone call with results of your recent tests. And, of course, expect to wait in your doctor's waiting room.