Wednesday, October 22, 2008

Pharma & Pharmacy: CVS and Merck Team Up to Sell Drugs!

Let me start off this post by stating though I may be critical of certain practices of certain drug companies, I am by no means anti-pharma. Though the pharmaceutical industry is one of the most profitable industries, they bring valuable products and research to the public and the issues surrounding big pharma are far more grey then black and white in my opinion.

That said, I was somewhat shocked when I received a letter from CVS/Caremark about one of my patients. The patient was identified by name, date of birth and medication. The letter stated that this patient was identified by "through CVS Caremarks prescription claims data as having one or more prescriptions filled for metformin or a thaizolidinedione as their only treatment for diabetes." Actos and Avandia are the two thaizolidinedione availabe in the US, and metformin is the most commonly prescribed diabetes pill.

I have received similar notifications before, but usually because patients had only filled one or two prescriptions in a 12 month period for a medication (like the ones above) that they are supposed to be taking every day, thus alerting me to the possibility that my patient may not be taking their medications.

However, this letter was different, because I knew this patient was very compliant with all of his pills. This letter went on to say that I should consider prescribing Januvia for my patients (like the one listed) whose diabetes may not be under control. The bulk of the letter discussed information about Januvia. In very small print at the bottom of the page, it said "funding for this communication was provided by Merck & Co." You don't have to by a doctor or health care industry insider to figure out which company make Januvia.

I have no problems with Januvia. I actually will add this medications to my patients who are on metformin and/or a thaizolidinedione, who are not at a goal hemoglobin A1c of less than 7%. However, it is disturbing that the pharmacy is pushing a drug on behalf of a drug company. CVS/Caremark fills or manages more than 1 billion prescriptions annually through its approximately 6,300 CVS/pharmacy stores across the country. Ironically, the Wall Street Journal just reported that Merck just cut 7200 jobs. Perhaps they feel they can fire their reps, and let CVS and their employees sell their products. This is a bad mix, because both companies profit from prescriptions filled.

It is now well known that the drug companies collect prescribing data on physicians, but they only know what drugs physicians are prescribing and not who they are prescribing them for. Pharmacies obviously know what the doctor prescribes and which patients get it, but it is a privacy violation to share this with the drug companies. By funding promotional material through the pharmacies, the drug companies can target physicians at a patient specific level, bypassing patient confidentiality issues.

Though today it was only a letter promoting a drug attached to a patient who might potentially need it, what's next? Will I be receiving promotional calls from my local CVS pharmacy which seems like a professional to professional communication, but is really a disguised sales pitch? Will the retail pharmacist get a pop-up message when a patient is refilling a certain medication to ask their doctor to prescribe another? We are a free market society, and drug companies have a right to market their products, but the letter I received today is just plain wrong. It might even be illegal.

Tuesday, October 14, 2008

Open Enrollment Tip: Make Sure Your Doctor Can Still See You

A pair of articles in the Wall Street Journal and the Washington Post talk about and tips on saving money spent on health care and advice for open enrollment respectively.

I basically agree with all suggestions. WSJ's four tips include paying attention to open enrollment info at work (don't assume you will automatically keep your coverage by doing nothing), consider opting for higher co-pays and lower premiums if you don't see the doctor that often, signing up for a flexible spending account if offered, and inquiring about any company wellness incentives. The Post similarly suggests not to shop on premium alone and looking into wellness programs as well as figuring out your yearly out of pocket expenses, understanding your plan such as savings for in-network providers, and saving money by using mail order prescriptions.

However, one thing not mentioned in either story relates to changing insurances and still seeing your same doctor. The medical blogsphere (and even mainstream media) is filled with stories about how difficult it can be to find a primary care physician. One of the reasons is that many physicians, especially in metropolitan areas, have stopped taking some or all insurances. This is due to that fact that for some insurances the reimbursement rates are so low, physicians actually lose money by seeing patients in certain plans. As a physician in a university faculty practice that takes virtually all insurances, so many of my newer patients are from physicians just blocks away that simply stopped accepting these patients' insurances. Our division of General Internal Medicine has actually been closed to new patients for almost two years, simply because we don't have enough doctors to see all the patients we currently are responsible. (A closed university practice was once unthinkable and is a strong indicator of what a true primary crisis we currently have).

Before switching insurances, make sure your physician takes that insurance. Don't trust the information that the health insurance company hands out via your HR informational session. These paper copies are typically out of date. Call your physician's office business manager directly. Even if they currently accept the insurance, ask if they have any plans to drop it in the near future, as well as if they are currently accepting new patients on this insurance and if not, will they "grandfather" you in. When you sign up for a new insurance, you are considered a new patient. Though your doctor is legally obligated to continue your care, he or she is not legally obligated to accept your new insurance if they are closed to new patients. Though most physicians would unlikely "drop" current longstanding patients who switch to a cheaper insurance plan, it doesn't hurt to ask before you switch.

Wednesday, October 8, 2008

Over the Counter Cold Medicines and Children

The NY Times reported yesterday that the manufactures of children's cough and cold medicines will voluntarily put on their label that these medicines should not be used in children under 4. Generally, when a company does something voluntarily, it is done to avoid a worse penalty that will be mandated on them, such as recommendations from some FDA officials to ban these medications altogether for children under six. Earlier this year, the FDA released a public advisory that OTC cold medicines should not be used in children under 2, and these medications are now off the shelf. This issue is what to do with liquid formulas that are commonly taken by much older children. On the one hand, these medicines haven't proven any major scientific benefit, and might in fact cause harm. On the other hand, many children find symptomatic relief, and there is really very limited data to determine whether or not the risks outweigh the benefits.

Bottom Line:
Most upper respiratory infections in children are caused by viruses. These do not require antibiotics and will resolve on their own. Cold medicines generally contain some combination of antihistamines, decongestants, expectorants, and cough suppressants. Antihistamines are really for allergies, and can potentially make upper respiratory infections worse by thickening secretions The expectorants are common, it is unclear exactly whether or not they help. Decongestants are probably the most effective agents to improve symptoms in children and are likely safe in children over 6. Cough suppressants may also help and are also likely safe.
For children younger than 6, caution is likely warranted; though if your child is miserable medications a decongestant or cough suppressant may be helpful and the risk is fairly low. The American Academy of Pediatrics has some good information on their web site.

Sunday, October 5, 2008

UPLIFTing News for COPD

COPD (Chronic Obstructive Pulmonary Disease also known as chronic bronchitis and/or emphysema) has certainly been in the news lately. I have recently blogged about both good news and bad news for COPD. Now, the New England Journal of Medicine has recently released the UPLIFT study ahead of press, a third study which in combination with the TORCH study I believe helps but everything into perspective.

There are currently a few types of medications used to treat COPD. Bronchodilators do what they sound like they would, open up the airways. There are two types: anit-cholinergics and beta agonists that work by different mechanisms. Each type has a short acting version lasting a few hours and taken several times a day and a long acting version lasting 12 hours and taken twice a day. In the US, the short acting bronchodilator (SABA) used is albuterol and common long acting bronchodilators (LABA) are salmeterol (Serevent) and formoterol (Foradil). The short acting anticholinergic used is ipratriopum and te long acting anti-cholinergic is tiotropium (TIO) sold as Spiriva. Another common bronchodilator is a combination of ipratropium and albuterol sold as Combivent (there is not yet a combination of the long acting bronchodilators). In addition, inhaled corticosteroids (ICS) have been used to treat COPD, usually in combination with a LABA, such as Advair and more recently Symbicort.

With all of these medications, which one should be used and when? According to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (jointly sponsored by the NIH and the World Health Organization), in addition to smoking cessation and other preventative measures such as flu shots, patients are initially to use SABA or ipratropium, and when lung function becomes decreased to add LABA and/or TIO, and reserve adding an ICS for when lung function is worse that 50% of what it should be, especially if there are frequent exacerbations.

So what do the new studies show?

As mentioned previously, the first study published in the Annals of Internal Medicine studied a VA population and found that patients taking ipratropium had significantly higher death rate of about 11%. This was the headline in the media, but the study also found a 20% lower risk of death for patients on ICS and an 8% lower risk of death for patients on LABA.

The second study was a meta-analysis published in JAMA that analysed date from 14,783 patients with COPD and found that patients taking either ipratropium or TIO (or both) had a 58% increase in cardiovascular death, heart attack or stroke when compared to patients taking other meds (Advair, albuterol or placebo). As I mentioned in this post meta-analysis need to be interpreted with caution, using the Avandia meta-analysis as an example, since the more scientifically rigorous long-term, large randomized controlled trials have not showed similar results.

This leads to the recent UPLIFT trial, which was a long-term, large randomized controlled trial (4 years, almost 6000 patients) looking at TIO and its ability do decrease that rate of lung function decline which normally accompanies COPD. The trial showed no difference in this outcome between patients taking TIO and placebo. However, there were fewer exacerbations and improved quality of life. Additionally, there was about 10% relatively fewer deaths, though this result did not reach statistical significance. Thus, though anti-cholinergic medicines may cause some harm, it appears that this is likely mainly for the short acting ipratropium and not for the long acting tiotropium.

Also important to understanding the implications of the results of these three studies, one has to consider the TORCH trial This was also another long term (3 year) large (over 6000 patients) in patients with COPD taking either ICS, LABA or both (Advair) that found a significant reduction in exacerbations and almost (like UPLIFT) decreased death. In addition, a recent analysis of this study showed what UPLIFT (and any other medication for COPD for that matter) could not: preventing the decline in lung function seen with COPD. One downside of TORCH was an increase in pneumonia in patients taking ICS (alone or in combination).

What to do now?

According to the GOLD guidelines, "the effects of oral and inhaled glucocorticosteroids in COPD are much less dramatic than in asthma" and "regular treatment with inhaled glucocorticosteroids does not modify the longterm decline of FEV1 in patients with COPD." The first statement does not seem very evidence based, especially in light of recent data and the later statement is now incorrect.

It is time to update COPD guidelines in light of the new data. Short acting bronchodilators should likely be used with caution given the risk of death, and inhaled corticosteroids (used in combination with a long acting beta agonist) should likely be given a more prominent role given robust exacerbation reduction, disease modifying properties and potential mortality benefit. The UPLIFT study is reassuring for patients using Spiriva.

Wednesday, October 1, 2008

JAMA study on News Media Misses the Bigger Problem

It is not surprising that there is limited media coverage of a JAMA article which criticizes the media for their coverage of medical studies. Specifically, of studies published in the major medical journals (New England Journal of Medicine, JAMA, Lancet, Annals of Internal Medicine, and Archives of Internal Medicine), that were covered in the media, 42%; did not report that the research had received company funding and of the studies on drugs with both a generic and brand name, 67% of the media reports mentioned the drug by brand name at least half of the time.

As mentioned, there is limited coverage of this study in the mainstream media, as well as little chatter on this in the blogsphere. Though most of the focus will be on the lack of reporting of industry funding, there are bigger issues here. I am not too bothered by the findings of the study because 1) most studies involving therapeutic agents are funded by the industry and 2) the public knows the medications by the brand name and not the generic. The real issues are regarding media coverage of medicine in general.

Dr. Kevin Pho of the blog KevinMD correctly points out that
Part of the problem is that some reporters cross-cover medical stories, and are
not specifically trained in the nuances that are unique to health reporting.
In addition, the shear volume of articles is worth mentioning as well. In the study, they looked at articles published over 4 years in the aforementioned journals regarding an industry sponsored drug study. Of the 358 studies they found, 117 were reported in the media using 306 unique reports. This means that over the course of 4 years, there was an article reported about every other week and mentioned three unique times. And this is only for the findings in the 5 biggest impact journals. This doesn't include articles coming out of specialty journals, which also get a lot of press (such as the recent study about Hep B and Pancreatic cancer reported in the NY Times and published in the Journal of Clinical Oncology). This doesn't include reports from agencies like the CDC (such as the report on Superbugs in the WSJ today). This doesn't include announcements from the FDA, which I have mentioned have increased in recent days. This doesn't include non-pharmaceutical reports (such as ABC News' piece on holistic ways to treat the common cold) and it doesn't include medical "buzz" reports such as CNN's reporting of celebrity Jenny McCarthy's crusade against vaccines because the may cause Autism (CDC says that they don't Jenny).

The public is inundated on a daily basis with medical information that is not always reported accurately, that often takes a negative spin (because scary things sell papers and thus advertising dollars), that leave the public and patients confused, and in many cases lead patients to distrust any product and even their own doctors. (My post on a Men's Health article regarding 8 drugs doctors would never take being a perfect example).

One of my main purposes for starting this blog was to help my patients and friends (as well as others) sort through the media mess. However, I am finding it is an uphill battle.