Do Not Stop Your Statins

As my tween daughter would say, "OMG!"
The media is a buzz with the news that the FDA is changing the warnings on statins.
The New York Times claims "Safety Alerts Cite Cholesterol Drugs’ Side Effects."
According to the Wall Street Journal "FDA Warns on Statin Drugs."
And the text on the bottom of the CNN report states "FDA places warning on statin labels."

Statins, which are cholesterol lowering medications are now one of the most commonly prescribed medications in the US. If I were one of the millions of patients taking a statin, I would be pretty worried based on what I am hearing from the media. 

Fear Not!  There is Nothing to Worry About.  Do Not Stop Your Statins!

Before getting in the details, it is important to note:

1. It is pretty irresponsible of the media to use scary headlines, when the warnings from the FDA weren't really that bad.  In addition, the warnings about liver problems (the one you hear about in all those TV commercials) were actually downgraded. 

2. It is not entirely the media's fault.  The FDA does a very poor job when releasing information.  When they update something, they should make it clear to physicians and patients what the real risk is.  Once again, the FDA failed miserably.

3. Statins are probably some of the safest medications we have. If patients could easily perform and interpret their own blood work, these might even be over the counter.  Some have suggested that this might be a good idea. Moreover, statins reduce heart attacks and strokes (#1 and #4 killer in the US). Though no medication is perfectly safe, I can think of no other long term medication where the risk benefit ratio is so far in favor of the drug. Cardiologist John Mandrola put this best in his post (via KevinMD) "Let's close the chapter on statin safety." 

Ok, now for the details. 

Today the FDA released information that they were updating warning information on statins. Essentially, there are three areas where safety data was updated: liver enzymes, memory impairment and diabetes.

Liver enzymes- This one is actually good news. Earlier statins caused some elevations in liver enzymes which were feared to potentially cause liver damage.  After many years of usage, it doesn't seem this fear is warranted.  Because they can affect the liver, patients with pre-existing liver disease should use statins cautiously. Even though statins can cause liver enzyme elevation, it is usually at the highest doses and usually returns to normal when the statin is stopped of the dosage is lowered. The routine monitoring of liver enzymes that was once recommended is now no longer required. 

Memory Loss- This is the one that makes me the most annoyed. First, because it really isn't true and second because the way the FDA communicated the data is useless at best and harmful at worst, since patients may stop taking statins because they are afraid that they will get Alzheimer's. 

According to the release the

"FDA reviewed the AERS database, the published medical literature (case reports and observational studies),^4-13 and randomized clinical trials to evaluate the effect of statins on cognition.^14-17"  

The numbers above refer to references of studies they looked at. However, of the 13 studies they analyzed "did not suggest that cognitive changes associated with statin use are common or lead to clinically significant cognitive decline." In fact, most of these studies were looking at use of statins to PREVENT Alzheimer's. Thus, most of the data they used to make this recommendation was from their own AERS database.  It would have been really nice to release this data! However, one of the mentioned publications did look at MedWatch drug surveillance system of the Food and Drug Administration (FDA) from November 1997–February 2002 for reports of statin-associated memory loss.  Of course we don't know the exact number of patients that took a statin during those 5 years, but it was in the millions.  The authors were only able to find 60 reports, of which none was truly confirmed (just patient report) and more than half noted improvement when the statin was stopped. 

I have previously blogged about this issue back in 2008 in my post Lipitor and Memory Loss as well as another post Lipitor: Responding to Spacedoc. Spacedoc is really Dr. Duane Graveline, MD, MPH, a family physician who became a NASA's scientist, but is better known for his book "Lipitor, Thief of Memory" which he wrote after having two episodes of something called transient global amnesia (TGA) which he states was associated with his use of Lipitor from 1999 - 2000. In fact, I actually became aware of TGA because the mother of a close friend had the exact same thing. 

Bottom Line- There may be some connection between Lipitor and memory loss. However, even if there is, it is extremely rare (you have a better chance of winning the lottery) and even if you get it, it usually goes away if you stop the medication. In other words, there is absolutely no reason to be alarmed, and no reason not to take the drug if you need it to control your cholesterol. 

Diabetes- This is another topic that I have blogged about, and one that seems not to want to go away.  You can see my post "Statins Don't Cause Diabetes" for all the details.  Much of the concern came from a Crestor trial which actually showed Crestor to cut heart attack risk in half in patients that had relatively normal cholesterol.  This study used a particularly high dose of Crestor, and the FDA warnings point to other studies using high dose statins with similar findings.  It is important to note that in the Crestor study, about 40% of the patients were at risk for developing diabetes in the first place, that measures of diabetes in the study were really no different, but the physician reported (i.e. unconfirmed) rates of diabetes were increased.   However, more importantly, if you look at the actual rates of developing diabetes it was 3% in the Crestor group an  2.4% in the placebo group.  In other words, if statins increase your risk of developing diabetes, it increases it only by 6/10 of a percent (not as low a winning the lottery/memory loss, but pretty darn low). However, with millions taking a statin, even a small risk is something to consider.  However, one must also note that diabetes is a disease process more than just an isolated sugar number, and it is unclear what actual risk a statin would cause by turning a pre-diabetic patient into a diabetic one.  In fact, patients who are pre-diabetic have a 4 to 6 times greater risk of heart attacks and strokes, and statins have been used in pre-diabetic patients and shown to reduce their risk of heart attack and strokes.  Conversely, no study has shown that reducing sugar in a diabetic reduces their risk of heart attack and stroke. 


Bottom Line-statins may raise your sugar a tiny bit, and for those patients who are at risk for developing diabetes, taking a high dose statin may "push" that patient into having diabetes sooner than expected.  However, even in that circumstance, the statin is probably still well worth the risk since it is potentially preventing a heart attack or stroke and slightly increasing the sugar probably has no clinical ramifications. 

Your Fired! Can Doctors Fire Their Patients?

In today’s Wall Street Journal, and article that is getting a lot of attention is More Doctors 'Fire' Vaccine Refusers. The article discussing the increasing frequency of pediatricians who are “firing” patients/families from their practices because they refuse to take recommended vaccines for fear of autism or other concerns (rampant on the internet, but all proven untrue). Many have started to blog or tweet about this. Richard Meyer at World of DTC Marketing.com poses the question Should doctors be able to fire patients ? This is an interesting question that I will attempt to answer.


It is important to note that not only should physicians be able to fire patients, they must be able to fire patients. Physicians are allowed to choose which patients they accept (unless they work in the emergency room). This happens every day, when a physician refuses to accept a patient that does not have an insurance they contract with. However, it would not be illegal (or even unprofessional) for a physician to for example, not accept any patients who currently smoke. Many primary care physicians will not accept a new patient who is a chronic opioid user (or will only accept them under the circumstances that another provider manages their narcotic prescriptions).

However, once a physician sees a patient, she has established a doctor-patient relationship. This is a legal and binding contract that comes with rights and responsibilities, such as confidentiality. In addition, if a doctor-patient relationship starts to sour, the physician cannot simply one day refuse to see the patient. This is called "abandonment" and is subject to legal action. Thus, physicians need to have a process to “fire” (terminate is the technical term) a patient from their practice, or they would become indentured to their patients indefinitely. The process of terminating a patient usually involves timeliness of notifying the patient, provision of care until a new provider is found in a reasonable amount of time, and assistance with finding a new provider (such as providing recommendations).

The issue of pediatricians firing vaccine refusers is an interesting one, since the typical splits between doctors and patients are usually related to disruptive patients, unhappy patients or patients inability to pay. The issue of vaccine refusal is more of a philosophical one, though concern for the health and safety of other patients and staff is certainly a reasonable concern.

However, another twist to this issue involves new models of health care where providers are rewarded for improvements in quality of care. Known as “pay for performance”, physicians get a bonus if they can deliver better quality. These bonuses are generally delivered on patient population data. For example, a target might be having 90% of diabetic patients getting annual eye exams or checking blood sugar control. Would it be acceptable/reasonable for a physician to “fire” a patient who refuses to follow the recommendation that the physician is being measured on? Patient satisfaction is also becoming a popular measure. Would it be acceptable/reasonable for a physician to “fire” a patient who is constantly unhappy and likely to give the physician a poor satisfaction rating that he or she is being measured on? Should there be laws against physicians firing non-adherent or unhappy patients? If not, and assuming most physicians will wind up incentivized by such measures, which physician would accept a known unhappy or non-adherent patient?

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.