I'm Your Cook, Not Your Doctor

Today on NBC's today show, celebrity chef Paula Deen confirmed she had Type 2 diabetes.  She was diagnosed 3 years ago, but only decided to come out today.  She also mentioned that she is a paid spokesperson for drug company Novo Nordisk, maker of several diabetes drugs. (Click here to view Al Roker's interview).

When the news started breaking earlier this week, I had mixed emotions about Deen as a spokesperson for diabetes. Blogger and health care marketer Richard Meyer at worldofdtcmarketing.com  posted This is a spokesperson for Novo?  Deen is of course known for her southern style of cooking, which typically involves very fattening ingredients. At one her restaurants she famously serves a hamburger with bacon and egg on a donut instead of a bun.

Rich correctly asks, "What message does this send to people ? That it’s OK to eat really bad food because diabetes can be treated with Rx drugs ?"


I commented on his blog that if Dean actually changes her ways, and focuses on healthier cooking, providing healthier recipes to her fans and other diabetics, she might actually make the perfect spokesperson.  Americans have not been paying attention to what we eat and obesity has now become an epidemic, leading to increasing numbers of patients with type 2 diabetes.


After seeing the Today show video, I remain on the fence.  Her interview was not the redemption story I was hoping for.  Give journalistic kudos to Al Roker who pressed Deen on whether she had changed her ways or changed her cooking. She responded essentially stating that she has always eaten (and suggested others eat) in moderation, claiming that her weekly cooking show is only 30 days out of a full year and that no one should eat that kind of food every day. According to Deen, when asked a similar line of questions from Oprah, she responded, "I'm your cook, not your doctor."


Deen did state that she and her sons would work to come up with lighter recipes (available on Novo's web site) and recommended people go to their doctor, get tested and "get on a program."   On the website diabetes in a new light,  Deen does say that she had to give up sweet tea.  In fact, rigid diet and exercise programs do not work all that well in reducing weight or improving diabetes, since patients have a hard time sticking to them, so her mantra "I wasn't about to change my life, but I have made simple changes in my life" may have some merit.


However, I believe there is still a difference between promotion of healthy lifestyle and realistic changes in diet and exercise and "everything in moderation" and "it's OK to have that little piece of pie." Paula doesn't have to become the next Richard Simmons or Jillian Michaels, but I would have liked to seen a little more "mea culpa." 
I am interested to see how this plays out in the media and in public opinion. This is a terrible disease and the prevalence is getting worse.  Ms. Deen has the potential to make a major impact.  I hope she takes her spokesperson role seriously. 

Nicotine Patches Do Work!

Here is another example of less than responsible journalism. Both the Wall Street Journal and Fox News report "Quit smoking: A new case for going cold turkey." Even NPR asked Do Nicotine Patches And Gum Help Smokers Quit? Other reports similarly headline with questions regarding the effectiveness of the nicotine patch, which has been a tried and true treatment to help smokers quit. All these reports stem from a study done by researchers at the Harvard School of Public Health and the University of Massachusetts in Boston and published online in the journal Tobacco Control, that found that over a 5-year period, former smokers who used nicotine-replacement products were just as likely to relapse as those who quit on their own.


This is indeed an important study because it shows that relapse rates are high, and nicotine patches may be insufficient to prevent quitters from relapsing.  Indeed, other methods should be sought for recent quitters to prevent them from relapsing. 


The problem with the way the media is reporting the study is that it is confusing quitting and relapse.  Countless studies show that nicotine replacement about doubles the chance that you will successful quit, which is usually defined as not one cigarette for 12 weeks (though better studies use 52 weeks to define quitting).  In this study, all the people studied had recently quit.  
This study was not measuring whether or not the patch helped these folks quit, but whether people who had quit using the patch were any different than people who had quit without the patch in terms of relapse several years down the road.  


People interested in quitting smoking should not be confused by the reports in the media.  Nicotine replacement will help you quit. The evidence for using medication (nicotine, bupropion, varenicline) is so strong that the US Surgeon General's guidelines recommends that all smokers (even those at risk to medication side effects such as heart patients and pregnant women) be offered some form of medication, since it is so effective. 
Again, the study is an important one because it shows we need to look beyond nicotine replacement to prevent long term relapse.  However, the journalists who reported on this study shouldn't have suggested that smokers consider going cold turkey. 

Retainer, Concierge and Boutique Medicine are Not the Same Thing

Health care is in crisis. Reimbursements from insurance companies continue to dwindle, while the expenses of running an office continue to rise.  Looming cuts in Medicare are only weeks away, and many physicians may stop taking Medicare.  If these cuts go into affect, it is possible that primary care physicians could lose up to 50% of their salary.  Just recently CNN reported that some doctors are going bankrupt.

How to fix our health care system is an ongoing debate, but not surprisingly, many physicians have decided not to wait for the government to solve this problem and have taken matters into their own hands. One solution is to simply stop taking insurance altogether.  “Cash only” doctors are now commonplace in many major metropolitan areas.  Another solution is charging a regular, out of pocket fee (usually) in addition to what insurance will pay for treatment.  A version of this model that is becoming popular is called retainer medicine.  Sometimes, retainer medicine is referred to a “boutique” or “concierge” even by physicians and others involved in health care (as evidenced by this article in the AMA News, which prompted me to post on this topic).

However, “retainer”, “concierge” and “boutique” are not the same thing. Names are important, and the terms “concierge” and “boutique” tend to have negative connotations. Thus, it is important to describe the differences.

In a retainer model, patients pay a fee (not covered by insurance) to be part of a physician’s practice.  This is similar to clients paying a retainer fee to hire a specific lawyer.  With reimbursements from insurance companies being so low, the only way an insurance based physician can increase revenues is to increase the volume of patients they see.  Unfortunately, when physicians increase the number of patients they see, it leads to rushed patient visits, long waits in the waiting room, and decreased access to physicians including difficulty in getting appointments or responses phone call messages.  By accepting a retainer fee, the physician no longer needs to rely on insurance revenue alone, and in fact can decrease the amount of patients he or she sees on a regular basis. This allows for increased access (usually same day or next day appointments and 24/7 phone access) and longer appointment times (usually 30-60 minutes) for patients willing to pay a retainer fee.  The typical insurance based primary care physician has about 2500-3000 patients in their practice, and sees about 25 patients a day.  The typical retainer physician has about 500 patients and sees only a handful of patients each day.  Retainer fees and the amount of access patients get for what they pay vary widely, but the average retainer fee is about $1500 per year. 

Some have argued that retainer medicine is unethical because not everyone can afford $1500 a year.  First, the typical retainer fee amounts to about $4 a day, which is what many Americans pay (or more) for a Starbucks coffee. Secondly, one could also argue that it is also unethical for insurance based physicians to see complex patients in brief visits and/or not being able to see them in a timely fashion due to lack of access. 

Concierge medicine is somewhat different, and in my opinion, should not be used synonymously with retainer medicine. 

According to Wikipedia;

“A concierge is an employee who either works in shifts within, or lives on the premises of an apartment building or a hotel and serves guests with duties similar to those of a butler. The term "concierge" evolved from the French Comte Des Cierges, The Keeper of the Candles, who tended to visiting nobles in castles of the medieval era.”

Just like the concierge at a hotel, who can get you good seats at a ticketed event, a reservation at a popular restaurant, or even run an errand; a concierge physician can get you timely appointments with the best specialists, usually doing the scheduling themselves.  Many concierge physicians will even accompany patients to procedures or diagnostics tests, and some will even make house calls. Though some retainer practice physicians may perform concierge services (usually the ones charging well over the usual $1500 fee), the terms are not the same.  Many retainer physicians will assist in coordinating specialist appointments, but this is as far as they go. In fact, some “cash only” physicians perform concierge services to attract more patients, and some doctors (even insurances based physicians) will charge an extra-fee for some concierge services, such as a house call.

Boutique medicine is also completely different. Again, from Wikipedia:

“A boutique is a small shopping outlet, especially one that specializes in elite and fashionable items such as clothing and jewelry. It can also refer to a specialised firm such as a boutique investment bank or boutique law firm. In the strictest sense of the word, boutiques would be one-of-a-kind but more generally speaking, some chains can be referred to as boutiques if they specialize in particularly stylish offerings.”

I think the key words in this definition are “specilalized” “stylish” and “elite.” The first word is something commonplace in medicine, but the later two words are something usually not associated with medical practice. “Luxury” is also implied in the word “botique.”  Thus, in my opinion, a boutique doctor is one that specializes in unique, often luxurious services, that are not offered by others and which will therefore cost a little extra.  These services include, but are not limited to, cosmetic procedures (botox, laser hair removal), medical spa services, comprehensive screenings (i.e. body scans), and herbs or supplements.  Though both retainer and concierge physicians may provide boutique services, this is generally not the norm.  In fact, many insurance based primary care physicians have started to add these services as a way of keeping their practice running. (Ethics could be questioned here as well).

I am not arguing that retainer medicine is the solution for all of our nation’s health care woes. It certainly is not.  However, given that it solves some of the issues with 3^rd party payors, is a model that continues to grow, and patients and providers enrolled seem to be very satisfied; it is something that deserves attention.  Another model that is garnering some attention is direct access primary care.  In this model, patients pay a monthly fee (usually about $70/month) and receive enhanced access and communication as well as primary care and urgent care services. Though the cost is slightly less ($1500/yr vs. $840/yr) and access to your personal may not be 24/7, this is a similar model to the retainer concept. (Proponents have called this retainer medicine for the masses).

Thus, using terms “concierge” and “boutique” that have connotations of elitism, luxury and unnecessary care synonymously with retainer medicine discredits a potentially viable health care model for many Americans.  I would request that physicians, policy makers and journalists no longer use these terms as if they were the same. 

Statins and Prostate Cancer

The Wall Street Journal is reporting on a study published in the journal Cancer, and described by Reuters that links statins to reducing the risk of prostate cancer.  According to the report:

The researchers found that men who died of prostate cancer were half as likely to have taken a statin at any time, and for any duration, than men in the "control" group.  Those with fatal cancers were 63 percent less likely to have ever taken a statin, according to findings published in Cancer.

 I would love for statins to reduce the risk of prostate cancer. Readers of this blog know I am relatively pro-statin, in the right patient population. However, this study is too limited to make an actual connection, and I would not recommend taking statins solely for prostate cancer prevention.

What did the researchers do? The looked at the medical records of 380 men who died of prostate cancer and matched them with the records of another 380 men who did not have prostate cancer.  They use statistical techniques to adjust for difference such as age, weight and other medications.

What's the problem with the study? First, if the study findings are correct, such a study that uses medical  records and then looks back in time can not prove causation.  It only proves association.  This means that the study doesn't prove that taking a statin will ward off prostate cancer. Rather, the results mean that men who had died of prostate cancer were less likely to take a statin.  This is a big difference.  There are multiple examples where a confirmed association did not result into a confirmed causation (Vitamin E/C and  Folic Acid for preventing heart attacks).  In addition, there are many reasons that the association is in fact not correct.  Perhaps men who had been diagnosed with prostate cancer chose not to take statins, even if their doctors recommended it, because they were more concerned about the prostate cancer?  Perhaps men who did not have prostate cancer were extremely health conscious and were more aggressive about both doing things to prevent cancer (exercise, diet, etc.) as well as being more aggressive about  taking statin medications for high cholesterol?

Why this might be true? The only way to truly determine causation is to perform a randomized clinical trial (RCT).  Only a RCT can both eliminate some of the confounding variables (i.e. were the men without prostate cancer more aggressive about their overall health) and demonstrate the primary ingredient for causation: that exposure always precedes the outcome.  If factor "A" is believed to cause a disease,  then it is clear that factor "A" must necessarily always precede the occurrence of the disease. 

However, there are two findings from this study that support causation.  First, is dose-response relationship.  Only the newer, more potent statins showed benefit. Taking a lower potency statin was not protective.  The second is biologic plausibility. According to the Reuters report, Dr. Stephen Freedland, who studies prostate cancer at the Duke University Medical Center in Durham, but wasn't involved in the new study was quoted as stating that statins may protect against fatal prostate cancer through their known cholesterol-lowering effects, mentioning that cholesterol is a "key nutrient" for cancer cells, so lower cholesterol levels in the body could prevent more aggressive forms of cancer from developing.

Bottom Line: This study is exciting and will hopefully lead to randomized trials which can prove whether or not taking a statin will prevent prostate cancer.  For now, there is very limited evidence to suggest this would actually work, and men should not start taking a statin just to lower their risk of prostate cancer.

More Evidence that Lantus Causes Cancer

There is a new study reported in Bloomberg this morning that Sanofi’s Lantus Doubled Cancer Risk in Study of Diabetics. The study, which was presented yesterday at the San Antonio Breast Cancer Symposium retrospecitvely evaluated medical records of 23,266 patients in southern Sweden and determined that diabetics who used Lantus had a 2.9-fold greater chance of cancer, while those who took the generic drug metformin had an 8 percent lower risk.

I have previously blogged about this back in 2009 when the first reports surfaced about the link between Lantus and cancer. (See A New Problem With Insulin: Cancer ,  Lantus Causes Cancer! Why Doesn't Anyone Seem Care? and Lantus and Cancer- A Closer Look Is Not Reassuring )

Back in 2009, when the story broke, the FDA acknowledged the potential link but stated that the data was insufficient and recommended that patients not stop taking Lantus, at least without discussing this with their physicians. They stated that they were "currently reviewing many sources of safety data for Lantus, including these newly published observational studies, data from all completed controlled clinical trials, and information about ongoing controlled clinical trials, to better understand the risk, if any, for cancer associated with use of Lantus." However, we didn't hear much until January, 2011 when they released an update declaring that they had reviewed the four 2009 studies and has "determined that the evidence presented in the studies is inconclusive", and in addition had reviewed results from a 5 year study (sponsored by the makers of Lantus) which did not show an increased risk but was  "not specifically designed to evaluate cancer outcomes," concluding, "at this time, FDA has not concluded that Lantus increases the risk of cancer. Our review is ongoing, including review of information from a current clinical trial." With the new study reported today, it will be interesting to see whether the FDA chooses to give and update or reveals and additional information, such as a VA data set they are supposed to be evaluating.

According to the Bloomberg article, a Sanofi study from Sweden, Norway, Finland, Denmark and Scotland is complete and will be submitted to health authorities this month.  In addition,  U.S. study will be finished in early 2012, while a final report from Europe will come later. All of these studies combined will involve more than a million patients, which will hopefully be enough to give a more conclusive answer.

To be clear, I am not 100% convinced that Lantus causes cancer.  However, there is another long acting insulin (Levemir) which has similar efficacy to Lantus, has not been associated with cancer, and has a substantially different affinity for the insulin like growth factor (IGF) receptors that are implicated in the possible connection.  Given the mounting evidence of a cancer link with an equally effective product that appears to be safer, I can't see any reason to prescribe Lantus when Levemir is available.

No Medicare "Doc Fix" Could Result in Over 50% Salary Cut to Primary Care Physicians

Fortunately, the 27% reduction in Medicare payments to physicians that is set to take place in a matter of weeks unless congress acts is getting some press.  Fox News published this piece yesterday, as did the Washington Post. Writer Merrill Goozner breaks things down nicely in his article, "Is There a Doctor Fix in the House...and Senate?"

However, one thing that seems to be getting confused in all the media reports is the difference between physician payments and physician salary. A doctor's income is what he takes in (payments) minus expenses or overhead. Physician overhead (staff, office space, electricity, malpractice, equipment,etc.) is very expensive. One of the reasons, but not the only reason, a doctor's overhead is so high is because we need to hire extra staff just to deal with the insurance bureaucracy.  (See "Your 10 minute office visit needs 8 people and 45 minutes of work" via KevinMD.) While payments from Medicare to physicians have not really increased over time, overhead has gone up dramatically.

Physicians, patients, and policy makers need to understand that a 27% cut in physician payment will have a far greater impact on physician salary because of this overhead. 

An article from the AMA News discussing the issue of the "doc fix" has an interesting table with current payments and proposed payments.  Let's say a family physician sees 25 Medicare patients a day, 5 days a week for 50 weeks out of the year. At the current rate of  $68.97 per visit, this generates $431,062 in revenue. At 60% overhead of $258,637, this family physician's income would be $172,425 per year. Now any doctor reading this will tell you that 1) no physician would see exclusively Medicare patients because they just don't pay enough (at current rates) to sustain a practice and 2) you can't see 25 Medicare patients in a day because patients 65 and up have multiple medical problems and you simple couldn't see them all in 15-20 minute visits. However, the income is very close to$168,550 which is the average salary for a family physician. Thus, the numbers are good for the purpose of discussing the impact of Medicare cuts on not just payments but salary.

Now, if the 27% Medicare costs go into effect, Medicare will only pay $51.07 for that same visit.  Using the same numbers, the revenue generated is only $319,187 (26% decrease in Medicare payments), but the $258,687 in overhead stays the same.  This leaves the primary care physicians with a $60,550 annual income. That's a 65% cut in physician salary.  Even if my numbers are off, its clearly more than a 27% cut to salary, and much greater than 50%.  The bottom line is that if these cuts take place, primary care physicians will certainly stop seeing new Medicare patients, and many will stop taking Medicare patients altogether.Many already have!!!

Now, most pundits seem to think that since seniors vote, and Medicare is a big issue for them, and that the election is less than a year away; Congress will find a way (like they have for the past few years) to find the money to cover the cuts for at least another year.  However, I wouldn't be so sure.  I would advise anyone who is on Medicare, has a loved on on Medicare, or who plans on having Medicare in the future to call their representatives and ask them to ensure that these payment cuts not go into affect.

Industry Funded Studies

One of the advantages of being a blogger is the comments, feedback and communications I receive from readers.  Though not all of it is positive, many of these interactions with people from across the globe that I do not know has been quite enjoyable for me personally.

One email I received from a reader had to do with industry funded studies.  This is not an uncommon concern, and one that frequently shows up on this blog and others.  The email encapsulates many people's concerns with industry funded studies.

Dear Dr. Mintz,

I am staring at my computer unable to formulate the words to express my opinion on a very important subject. I do not want to come across as rude, condemning or complaining, yet I am compelled to share with the medical community my honest patient perspective.


I view the medical profession as one of the most respected on earth. But it isn't perfect. As a patient I become very discouraged when I see a medical professional look towards industry funded drug studies to make medical decisions.


Now for the painfully honest part. When I see a Doctor subscribe to "results" from an industry funded drug study, my image of that physician goes to pot in a heartbeat. "How can he/she be so gullible" and "Incompetent" are thoughts that pass through my mind. I quickly lose trust in that physician's ability to make smart decisions in my health care, and the doctor loses my business.


On on the contrary, I asked a physician what he thought about industry funded drug studies, he answered "I ignore them." This doctor won me over in three words.


Obviously it takes excellent academic ability to become a physician, but I look for more than that. I look for wisdom and integrity when choosing a physician.


There is no question that industry studies are biased by nature.  The drug company is beholden to its stockholders to increase sales.  Therefore, they have a fiduciary obligation to make sure that their research puts their products in the best light.  This is not unlike any product in the US where a manufacturer does research stating that people prefer it or it works better than a competitor.  Unlike these products, medications are heavily regulated in the United States.  Thus, for a medication to get approval or to make any claims, all studies, including ones funded by the industry have to go through the FDA.

Here's the real problem:

Almost all research done on medications is funded by the industry. I would love it if instead of relying on industry sponsored studies, I could rely on non-biased information.  However, when it comes to medications, these studies are few and far between.  In 2005, the industry spent close to $40 billion dollars on research.  Compare this to the entire NIH budget that same year of less than $30 billion.  Also, understand that the NIH spends very little money on actual drug studies.  They focus more on finding a cure to cancer, not whether expensive medicine X is just as good as the older generic medication. 

When I want to know whether to buy product X vs. product Y, I can go to an independent source such as Consumer Reports, which does their own, independent research.  There is really no such independent source for drug information.  In fact, prescription drugs is one of the only areas that Consumer Reports does not do their own research.  All their recommendations on which medicine is "right for you" come from drug company sponsored studies.
If we ignored all industry funded studies, we be ignoring most of the data.  In addition, since these studies are heavily regulated, we would be ignoring mainly good, helpful data, even if biased.  The simple alternative is to fund the NIH or similar organization equally to the drug companies in order to do independent research.  Of course this would likely require significant government spending, which is likely a non-starter.

The good news is that independent comparisons of treatment, called comparative effective research, are starting to be done, and (whether you like health care reform or not), there is funding for this research in the Affordable Care Act.  Unfortunately, this funding is not nearly enough to compete with the drug companies.  Thus, unless you are willing to pay considerably more in taxes or drop some needed services, physicians and patients still need to rely on industry funded research. Many studies from the industry are actually quite good and useful, though, because of inherent bias, should always be looked at with a skeptical eye.