Free Speech and Off-Label Drug Use

When pharmaceutical representatives talk to physicians and others about their products, they are only allowed to talk about indications (reasons) to use the product as approved by the Food and Drug Administration. Doctors are free to prescribe for other reasons, and often do so for good reasons.  Drug companies may pay dearly if they break the rules. Pfizer paid 2.3 billion due to promoting Bextra for off-label use, for example.

This rule was put into effect decades ago to protect consumers. Since then there have been a number of examples of products promoted for things that in retrospect didn’t work as advertized. If you’re old enough, you’ve probably heard the term snake oil.

According to the Wall Street Journal there are now several court cases that may change these rules. In June the U.S. Supreme Court struck down a Vermont law and cited the First Amendment in a case involving pharmacies sharing data with pharmaceutical companies to help them market their drugs to doctors. That has opened the door for the companies to now claim the same free speech rights to market drugs off-label.

If the companies gain this ability, it would be bad for patients. Basically they could say whatever they want. Besides talking about off label use where there is legitimate reasons to use their product, they could claim anything they wanted to say. “Our drug is more effective than our competitor,” even if it’s not. “Our drug is perfectly safe,” even if it’s not. “Our drug will make you lose weight, increase your IQ, improve your looks, and make you live 10 years longer, “even if it won’t, but if you believe it, let me tell you about a bridge for sale.

I learn about a lot of new drugs because the sales reps come to my office to tell me about their product. As it is, I listen to them skeptically and off challenge what they say. Although they are restricted on what they can say, they can choose what information to emphasize and how to make their product look good without actually lying. If they can promote off label, I won’t know what to believe. Then my strategy might be to stop seeing reps.

An Apple A Day

You’re familiar with the first part, or a variation of it, but did you know the rest of this Mother Goose nursery rhyme?

An apple a day
Sends the doctor away.

Apple in the morning,
Doctor’s warning.

Roast apple at night
Starves the doctor outright.

Eat an apple going to bed,
Knock the doctor on the head.

Three each day, seven days a week,
Ruddy apple, ruddy cheek.

100-Year-Old Marathoner

Fauja Singh completes Toronto marathon.

According to the Wall Street Journal, on 10/16/11 Fauja Singh completed the Toronto marathon, finishing the 26.2 mile race in over 8 hours. I hope that will inspire my patients to exercise. I’ve started telling my octogenarians to start training for a half marathon. Heck, I’m letting them off easy.

How Primary Care Docs Became Assistant Shoe Salesmen

Nurse practitioners, physician assistants, pharmacists and naturopaths have gained the right to prescribe medications traditionally only done by a physician. But the Medicare Therapeutic Shoe Bill requires that the physician managing the diabetic condition certify the need for footwear and inserts.

So although the podiatrist truly has the expertise in this arena, it falls on the patient’s primary care physician or endocrinologist to do the paperwork. Congress might have been concerned that because podiatrists profit from selling inserts or shoes, that someone else should determine whether it’s really needed. In fact, though, us primary care docs are overworked and don’t have much time to deal with such paperwork. If we deny that the patient needs it, especially after their podiatrist already told them they do, the patients get mad at us.

I think the best way to minimize fraud would be to have patients pay a portion of the cost, say 25%. That way they are less likely to get a shoe or insert unless they feel they really need it. Actually Medicare pays 80% of the allowable amount so patients pay up to 20% if they don’t have secondary insurance. Since most patients are going to buy a pair of shoes in any case, I think they should pay what a similar non-medical shoe would cost, and Medicare would pick up the difference. That way there would be no financial incentive for patients to get shoes they don’t really need, and doctors could stop being the watchdog.

At the very least, Congress should allow nurse practitioners and physician assistants to do the paperwork.

Prior Authorization – License to Kill (our time)

A patient of mine informed me that her insurance didn’t want to cover a medication, and preferred a similar generic medication, which she previously tried but did not tolerate. She asked me to Call Humana’s  pharmacy review board. I usually leave such things to my nurse, but called them myself. A voice recognition system asked me for the patient’s account number and date of birth. After providing these, I was connected to a human, who asked for the same information. When I pointed out that I had just supplied the information, she said it didn’t come through, but made no offer to investigate why not.

If their menu system is not capable of transmitting such information to the computer screen of the people working for them, then they should not ask for the information using the automated system in the first place. This was not a onetime glitch, but something the nurses in my office encounter regularly. Our time is valuable. It’s bad enough that we have to justify our prescriptions, but it’s disrespectful of our time when we have to repeat ourselves with patient identification information. We have better things to do with our time.

Before deciding to post this, I decided to call again and give them a chance to say they would try and improve things. First I went to their website and clicked the For Providers link. I didn’t want to have to register, so I clicked the Customer Support button. Next I clicked the Contact Humana button. At the top it said they welcomed email, but one had to register to send messages securely. So I called their phone number for providers. Someone answered and wanted my patients ID number and date of birth. I informed I just had a question about the pre-authorization process, and not about a particular patient. She said that was another department and she transferred me, but not before asking for my name and call back number (I gave her my name, but told her I didn’t want a call back).

The next person again asked for my name and call back number. I explained my concern about being asked for the same patient information more than once. “That’s the process we’re required to follow,” she replied. I asked if they were interested in improving how they do things and she repeated what she had said. I asked if I could talk to someone who could improve the process. She told me they don’t have such a person!

I hope Humana and other pharmacy benefit managers take note. It may be your job to save your customers money, but you don’t have to waste physician’s and their office staff’s time. I hope the cynical view, that you do on it purpose to discourage prior authorizations, is not true.

Medication Errors

Not infrequently Express Scripts, Medco, or other similar companies send a fax to alert me that my patient is taking two similar medications. Occasionally it’s intentional, but most of the time it means something went wrong.

Sometimes I change a patients’ medication to something similar to achieve better efficacy, to minimize side effects, or due to cost. Although I always put the changes in writing for the patient, telling them what to start and what to stop, this doesn’t always work. Patients may get an automatic refill of the original medication from the pharmacy or call it in when they notice a pill bottle is almost empty. Sometimes they go by a medication list they’ve generated, but not updated, rather than the printout I give them.

Sometimes patients end up on two similar medications after getting one from a specialist who doesn’t realize a patient is taking something, because the patient didn’t bring the list I gave them, and they don’t remember everything they take. For example I might have the patient on lisinopril for hypertension, and their cardiologist prescribes the similar benazepril.

A similar medication error happens when we tell patients to stop a medication and they don’t for similar reasons as above.

So the faxes are helpful when these things are caught, but it would be better if it occurred at the the time the prescription is sent to the pharmacy.  Ideally the pharmacy computer would automatically connect to the physician’s electronic medical record (EMR), particularly the primary care doctor, and compare medication lists. If they had medications to refill that didn’t match the EMR record, they would call to double check if the patient could not give them a good reason for the discrepancy. In addition, the pharmacy computer could keep track of all the chronic medications a patient has filled. If the patient doesn’t get the prescription refilled in a timely manner, their computer would query the physician computer to make sure it was still an active medication. If so they would call the patient (and maybe in the future talk to the patient’s medication list carried on their computer/mobile device) and remind them to refill their medication, assuming someone hadn’t stopped it, the patient was taking samples, or some other good reason.

If you use a program such as Quicken, you can download credit card and other transactions and reconcile them with entries you’ve entered. Comparing medications would be a similar process.

There are certainly barriers to such a solution. Electronic health records would need to have medication fields standardized, and there would need to be protocols to exchange the information. I’m not sure, but I think some of this already exists. Of course there are legal issues such as HIPAA.

As John Lennon said, “You may say I’m a dreamer, but I’m not the only one. I hope someday you’ll join us, and the world will be as one.”

Right for the Wrong Reason?

In 2007, Texas Governor Rick Perry signed an executive order mandating that teenage girls be vaccinated with Gardasil, a vaccine that helps prevent cervical cancer by providing protection against Human Pappillomavirus, or HPV. This was subsequently overturned by the Texas legislature. Now it’s a matter of discussion among Republican presidential candidates. Representative Michelle Bachmann has criticized not only that, ““To have innocent little 12-year-old girls be forced to have a government injection …is just flat out wrong,” but has also suggested that he was motivated by political donations from pharmaceutical company Merck.

We’ll have to see how things play out in regards to whether Governor Perry made his initial decision because of political donations, but it least has the appearance of impropriety.

From a medical point of view, I think he was right to mandate vaccination against HPV, even if he did so for the wrong reason. According to the CDC and the American Cancer Society, at least half of sexually active people will get infected with HPV in their life. Half of those people are infected between 15 and 24 year of age.

In the United States, about 12,000 women are diagnosed with cervical cancer, and 4,000 die from it, each year. HPV causes most of these, as well as many cases of anal and oropharyngeal (mouth and throat) cancer, and genital warts.

As a father of daughters, I get that when they’re 10 to 12-years-old, you don’t want to think of them being sexually active. But most people eventually are, and you can’t be certain that it will only be with one uninfected person the rest of their life. Once they’re infected, it’s too late.

The policy for vaccination against HPV should not be different than for other infectious disease, such as tetanus, polio, measles and chicken pox. If you love your children, you should seriously consider vaccinating them. Even if he had ulterior motives, I think Governor Perry had the right idea.

Changing of the Guard

At the start of the 2011 Washington State Medical Association (WSMA) Annual Session in 2011, a list of member physicians who had died in the past year was read. Almost all of them were men. This was a poignant reminder of how much things have changed. Nowadays almost half of all medical school graduates are women.

Migraine or Sinus Disease?

A fractal suggestive of visual changes associated with migraines.

One of the more common reasons patients come to see me is because they think they have a sinus infection. Often they say they have pain in the sinus below their eye, nasal congestion, and may have drainage. They  tell me that they’ve had it before, and antibiotics help.

Careful questioning often reveals that they are really have a migraine headache. Typically they start as a teenager or young adult, and tend to decrease in frequency and severity in the 40’s to 50’s. They may occur on one or both sides of the head, and are often associated with nausea, sensitivity to light and sound, and sometimes people get blurred vision or see white spots or zigzag lines. Going to sleep helps. Migraines are more frequent in females and tend to run in families. If patients are unaware of a family history of headaches, I tell them to ask their mother, sister or daughter because they may just not have mentioned it.

Patients think antibiotics help because their headaches get better a few days after they start the medicine. But migraines generally only last 4 hours to 3 days if you don’t take anything. So the antibiotics get the credit, when none is due.

Sometimes the pain from a migraine goes into the neck, or it’s only felt there, and patients think they have a neck problem. They may go to a chiropractor or massage therapist before they see me.

Migraines are also confused for sinusitis because nerves from the brain that are activated with migraines can stimulate the nose to cause congestion. ‘Sinus Headaches’ was invented by Madison Avenue (or at least some advertising agency) to sell pills. Outside the United States, you won’t find such pills being advertized or sold. Some people truly have headaches from sinus infections, but many headaches thought to be sinusitis, are really migraines.

There are lots of ways to treat migraines, which I won’t discuss in this article, but first you have to get the diagnosis right.

If you have headaches or neck pain, be careful about telling your doctor that you think you have a sinus infection or neck arthritis. You may just convince them you’re right, when maybe you’re having a migraine.