Saturday, June 19, 2010

Boston Doctors Getting Paid to Switch Patients to Generics

Interesting video from WCVB in Boston about doctors getting kick backs from the insurance company to switch patients from branded medications to generic medications. New Rules To Protect Prescription Drug Customers

If people were concerned about undue influence when drug companies used to give physicians pens and other novelties (now currently banned by most companies), they should really be concerned about actually monetary payments. The patient interviewed in the Boston piece stated his doctor wanted to switch him from Lipitor to generic simvastatin (cholesterol lowering medications) but did not mention that he was being payed by his insurance company to do so.

Though this is the first case I have heard of doctors being incentivized to switch patients to generics, it happens in pharmacies all the time. What is horrible is that some pharmacies may switch patients to alternative medications even if that switch costs the patient more money. The example I am familiar with is albuterol inhalers (see FDA Announces End for CFC-Propelled Inhalers).

Switching to generics is itself not a bad things. I have blogged before that, for most medicines, generics are just as good as brand name medicines. For example, if the patient were on Zocor, a switch to the generic simvastatin would probably make a lot of sense, since the medications are basically equivalent and it would likely save the patient some money. However, in some cases, the small differences may actually make a difference. Back in November, I discussed this in more detail (see Generic and Therapeutic Substitutions ).

In this particular case, the therapeutic switch from Lipitor to simvastatin might have been devastating since Lipitor is a much stronger medication. The piece does not say what dose the patient was on, but if the patient required Lipitor 40mg or 80mg, no dose of simvastatin would have given him the cholesterol lowering he needed.

What should you do?
1. If you are on a branded medication, ask your doctor if there is a generic equivalent of the exact same medicine, or one that works just as well.
2. If you are on a branded medicine and asked to switch to a generic by your doctor, find out why he or she wants to switch.
3. If you are on a branded medicine and asked to switch to a generic by your pharmacy, find out why they want you to switch. Is your insurance company asking for the switch? Is the medicine the same (generic substitution) or slightly different (therapeutic substitution)? Regardless, make sure that you check with your doctor before switching any medicine.

Tuesday, June 15, 2010

Watch Your Step When Changing Asthma Medications

Back in February, I blogged about the FDA's recommendations regarding long acting beta agonist (LABA) safety (see FDA Blows it on LABA Safety ). A few weeks ago the FDA finalized these recommendations. Though some make sense, such as not taking a LABA without an inhaled corticosteroid (ICS), the main one I have a problem with is the following recommendation for patients controlled on an ICS/LABA combo like Advair or Symbicort:

"Once asthma control is achieved and maintained, patients should be assessed at regular intervals and step down therapy should begin (e.g., discontinue LABA), if possible without loss of asthma control, and the patient should continue to be treated with a long-term asthma control medication, such as an inhaled corticosteroid."

Though the language is a little better than the original version which stated that "LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma control is achieved," The notion that stepping down the LABA is preferred to stepping down the dose of the ICS is not evidence based.

As mentioned previously, all the controversy come from the SMART study published back in 2006 which looked at the safety of salmeterol. The study was stopped early because certain subsets of patients, particularly African Americans, seemed to have increased risk, including asthma death. However, the data from the SMART study was very clear that most of the problems came from asthmatics taking LABA's alone. More importantly, there were no increased problems (regardless of ethnicity) when using a LABA with and ICS. The ICS seems to protect against rare, but serious problems associated with LABAs. In fact, no one taking Advair or Symbicort equivalents in the SMART study died.

The FDA, acknowledging that some patients need ICS/LABA's to control their asthma, but concerned about any potential LABA safety issue, recommend step down care for those on combination therapy that are now controlled. Interestingly, the NIH guidelines when discussing step down therapy not only mention that it should be done carefully, as it might risk worsening asthma, but also focus on reducing the dose of the ICS, and not discontinuing the LABA.

The fact the FDA (whose job it should be to tell whether or not a drug is safe or effective) has clinical recommendations that seem to contradict the NIH (whose job it is to make clinical recommendations) is enough to cause concern. However, even more startling is that fact that the data shows that the FDA is clearly wrong. As mentioned in my previous post,
one study in the US of 647 patients controlled on Advair did worse when stepped down to ICS alone, and another French study of 467 asthmatics studied over 6 months showed that stepping down to a lower dose of Advair was fine, but stepping down to ICS alone (what the FDA recommends) caused problems. Today, a new study was just published confirming the same thing: stepping down the LABA is ill advised in a well controlled asthmatic. The study, published ahead of print online, looked at two large managed care databases over several years. They found 4350 asthmatics who stepped down from Advair: 3881 stepped down to a lower dose of Advair and 469 stepped down to the ICS alone (what the FDA recommends). When they matched the patients for age, demographics, etc. they found that the asthmatics stepping down to the lower dose of Advair had 30% fewer prescriptions for short-acting beta-agonists, a 26% lower risk of receiving systemic corticosteroids, and a 48% lower risk of asthma-related hospitalization or Emergency Department visit during follow-up.

Don't take my word for it
If you still remain skeptical, don't take my word for it. Look elsewhere. In Canada, where they have access to the exact same data, the label for Advair is completely different. You can access the full label by clicking here. However, the following excerpt says it all:

"Patients should be regularly reassessed so that the strength of ADVAIR® they are receiving remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose of fluticasone propionate at which effective control of symptoms is maintained."

In other words, the Canadian Advair label is consistent with what the evidence shows, and consistent with what our own NIH guidelines recommend. The FDA's versions is the opposite.
In the UK, the safety information not only has no mention of stepping down, but their is also no "black box" warning or even mention of the SMART study. The Brits only mention SMART when discussing Severent.

Bottom Line: The LABA safety issue is more about politics then science. LABA's should not be taken alone, but in combination with and ICS (like Advair and Symbicort) are the most effective agents for asthma and are completely safe. The goal for any physician is to have the patient on the lowest amount of medication possible to keep their condition under control. For asthmatics well controlled on ICS/LABA, the data is crystal clear. Despite what the FDA says, it is better to go to a lower dose ICS and remain on an ICS/LABA combo, then to go off the LABA and remain on the ICS alone.

Wednesday, June 9, 2010

Should You Friend Your Doctor??

My friend and colleague Katherine Chretien has a provocative Op-Ed in USA Today entitled A doctor's request: Please don't 'friend' me which asks the question whether doctors and patients should interact in social networking sites such as Facebook. Social networking has huge potential in health care regarding the sharing of information and ideas, and could possibly even enhance communication between doctors and patients. However, as Dr. Chretien points out, many physicians have steered clear of social networking sites, and those who do, "actively dread having a patient add them as a friend." The main problems with social networking and patient-physician interactions boils down to confidentiality/security and boundaries.

Confidentiality/security is less murky issue to deal with, and is applicable to all online communications between doctors and patients. First, there has to be privacy. If a patient wants to post their entire medical history to the world, they have every right to do this, but doctors have to ethically and legally maintain a patient's privacy. This should not be too difficult, but could get tricky in a social networking world. If a patient posts "Not feeling well today," a reply from their physician "don't forget to take your meds," would likely be a violation of privacy and confidentiality. In addition, all online communication must be secure. Regular email does not even meet that requirement. In fact, unlike email, both parties need to be logged in to Facebook to send and receive messages, making Facebook a better choice for direct communication between doctors and patient then regular email. Part of security also means encryption. According to Facebook they "always posts to a secure page when users are logging in and employs industry standard encryption."

The bigger problem has to do with boundaries. The doctor and patient relationship is unique in that is should be close and personal, but if too close, the doctor's objectivity could be compromised. This is why it is considered unwise (and sometimes unethical) for physicians to treat their relatives. According to Dr. Chretien, "the thought of opening up our personal pages filled with family photos, off-the-cuff remarks and potentially, relationship status and political and/or religious views to our patients gives us the heebie-jeebies." However, is having family photos online any different than having family photos in one's office? Does an off the cuff remark revealing a physician's political slant any different in the office than on the web? Physicians are often known to personalize their office space with items of personal importance and significance. Family photos, an artifact from a vacation, a golfing trophy, a treasured gift from a patient, etc. I believe this is a good thing. It humanizes physicians and hopefully assists patients in making connections with us.

The two problems with Facebook are controlling one's own privacy and the use of the word "friend." Facebook was founded by Mark Zuckerberg with his college roommates and fellow computer science students. In other words, it was invented by kids. The term used to link one another is "friend." However, this is not "friend" the noun which we are all familiar with, but rather "friend" the verb. Though "friend" the verb can theoretically used to mean "befriend," in conjunction with Facebook it is the mechanism by which one connects with another individual online. The confusion is not unique to the doctor-patient relationship. I am sure many young adults wonder what to do when a parent "friends" them. If instead of "friend", Zuckerberg and colleagues had used the word "connect', we would probably be less concerned about boundary issues. Is it wrong for a physician to "connect" with patients online?

The issue of controlling one's own privacy is likely what truly concerns many physicians when considering using social networking platforms like Facebook with patients. After all, the physician who personalizes his or her office space has carefully decided what he or she wants patients to know about them. Even if a physician is careful in posting information on Facebook knowing that patient-"friends" might see, other non-patient "friends" can tag the physician in a compromising photo or leave an inappropriate reply that could be easily viewed by the patient. This is obviously a barrier, but this barrier is easily overcome. The easiest way to avoid this problem is to have two separate Facebook accounts: a professional/patient account and a private/personal account. A variant of this would be setting up a "Fan" page. (Please feel free to click on the blue box with the "F" to the right to become a "fan" of Dr. Mintz). Finally, any Facebook user should be familiar with the privacy settings on Facebook. These can be customized. For example, you might create a groups called "patients", "relatives" and "close personal friends"; assigning different permissions to each of these groups.

As the Op-Ed points out, there are currently no national guidelines for social media use by physicians and, as mentioned above, confidentiality and boundary issues are difficult and controlling one's own privacy may not be easy for many physicians. However, most of the barriers for using social networking between doctors and patients can be overcome. Given that, and the potential uses and benefits social networking can provide, I would somewhat disagree with my friend (correct usage of the noun) that physicians shouldn't be "friends" on Facebook with patients. However, if they do, they should proceed with extreme caution.