Ask the Doc: Human Growth Hormone

On this site I’m unable to answer patient specific questions, but as time permits, may answer questions of a general interest.

Question:

I have been working out with a personal trainer with weight training and have been doing running on my own. I have been getting much stronger although I haven’t lost much weight. I asked the trainer why it takes longer to recover from a strenuous session at age 66 than it did when I was younger. She said that as we get older we have very little HGH in our system and that a small dose of HGH would help me recover quicker and she could push me harder. Would a small dose of HGH be beneficial for training? I know that testosterone creams etc. have a lot of side effects which are not good but how about HGH?

Answer:

Human Growth Hormone, or HGH, is a hormone that regulates growth, and decreases with age, as well as from obesity. It is one of many factors why, all other things equal,  66-year-olds aren’t as strong or fast, or recover as quickly, as when they were younger. With age lung function gradually declines, the cardiovascular system is less robust, testosterone levels fall in men, etc. In one of his movies, Warren Miller said something like, “If a 40-year-old says they sky as well as when they were 20, they are either lying, or they weren’t very good when they were 20!”

Human Growth Hormone is only approved by the FDA in limited circumstances, not including the normal decline with aging, and it’s expensive. It probably does build muscle, and for this reason is banned by the Olympics and some other sports institutions. It also has potential side effects.

Getting adequate sleep, regular exercise, eating healthy, and managing stress, are the most important things you can do to boost your growth hormone and improve your endurance.

Drug Shortages and the Joint Commission Stance

Periodically there have been drug shortages in the United States, which comes as a surprise to many. There are a number of reasons for this.

Recently one of my company’s pharmacists informed the physicians in my group of a nationwide shortage of bupivicaine and lidocaine, medications used for anesthesia, similar to what your dentist may give you before drilling your tooth.

I suggested that maybe we should be allowed to use such products past the expiration date until the shortage was resolved. They replied that they can’t do that because of Joint Commission standards.

So I wrote to the Joint Commission and eventually spoke with a nurse there. Their position was that it’s not safe to use a drug past its expiration date and they were just following guidelines by the Food and Drug Administration and others. I said that although I would generally agree that it is preferable not to use expired medications, in the case of shortages that may not be the case.

Imagine you have a life threatening infection with a bacterial organism resistant to all antibiotics but one, and there is a shortage of that antibiotic. In fact the hospital you are in has a box of antibiotics that expires at midnight tonight. They can give you only one dose then will have to throw away the rest, even though antibiotics would normally be given for 10 days and they don’t know when they will be able to get more.

Are you really safer as a result of throwing away the rest of the vials of the only antibiotic to treat your infection? In the interest of fair and balanced discussion I admit that I’ve eaten tuna fish after the date stamped on the can. But seriously, the risk of a complication from a slightly outdated medication is almost non-existent, and certainly less than the risk of going without.

Physicians going on medical missions to third world countries used to bring with them expired medications to administer to patients, the thought being that they were safe and better than nothing. Due to liability concerns, that pretty much doesn’t happen anymore, a fact said Joint Commission nurse brought up. In fact a 1997 article in the New England Journal of Medicine pointed out that at least half of the drugs donated to the Bosnian conflict were unusable because they had expired, and said pharmaceutical companies may have dumped the medications to get tax write offs and avoid disposal costs. That may have been the case, and could be addressed by not granting write offs for expired drugs, but that doesn’t mean they couldn’t have safely used the medications.

A 1979 law required pharmaceutical companies to give a date they guarantee the full potency and safety of a drug. They stand to gain financially when customers throw away good medicine because it has, “expired”. In fact the military conducted a study to see if they could extend how long they keep medications in order to cut back on the cost of destroying and replacing a billion dollars of inventory every 2-3 years. They found that 90% of the more than 100 drugs they tested were safe and effective up to 15 years after the expiration date. This program is now used by the Department of Defense, the Department of Veteran Affairs, the US Postal Service and the Bureau of Federal Prisons.

The nurse at the Joint Commission pointed out that I could decide whether the risk was warranted to use an expired drug. But in reality, I don’t get the chance to even discuss it with a patient to give them a choice. Hospitals risk a large financial penalty, and potentially even being shut down, for violating Joint Commission standards. Those drugs are going to go in the trash the day before they expire, shortage or no shortage.

I think the Joint Commission should modify their standards. At the least it should say that drugs should not be used after the expiration date unless their are shortages, or delivery problems due to disaster, in which case the medications should only be used if there are not suitable alternatives, and it’s felt that the benefits exceed the risks.

Ask the Doc: Statins and Exercise

On this site I’m unable to answer patient specific questions, but as time permits, may answer questions of a general interest.

Question:

Let me know what you think of this article. Strenuous exercise has not seemed to bother me taking Lipitor 20 mg for several years. However, I am wondering about the effects on my muscles as I am currently ramping up exercise both running and weight lifting. Will enough exercise improve my cholesterol level enough to quit taking Lipitor? Long term effects of Lipitor? I don’t know.
http://well.blogs.nytimes.com/2012/03/14/do-statins-make-it-tough-to-exercise/

Answer:

As the article points out, about 10% of people may experience muscle aches from taking statin medications such as Lipitor. It referenced an article that showed that rats were not able to exercise as long if taking atorvastatin (Lipitor), and they showed increased oxidative stress and problems with mitochondria, cell’s powerhouses.

You should always be careful when evaluating animal studies, as they may not apply to humans. Given other data, however, it would not be surprising if there was a similar problem in people who exercise and take statins.

The questions is what to do. As with most medications, one needs to balance the risks versus the benefits. Statins clearly save lives, but the degree of benefit depends on one’s risk. The more cardiovascular risk factors one has (hypertension, diabetes, hyperlipidemia (high cholesterol), smoking, family history, etc.), the more one has to gain from medication, and the more likely I would recommend patients tolerate side effects if we couldn’t come up with a better option. For someone at relatively low risk, a statin may not be worth taking if causing side effects.

I certainly always advocate diet and exercise to manage problems with cholesterol and triglycerides (fats). The problem is that for most people, it’s easier said than done, and people either just don’t make sufficient changes, or they don’t maintain them. Also for some people, their genetics are just too strong. With the wrong genes you may have a high cholesterol despite being thin, eating vegetarian, and exercising regularly.

Another option is to take coenzyme Q10 (CoQ10) or ubiquinone if you are taking a statin. It’s known that statins decrease this enzyme in the mitochondria and it may be the reason statins cause muscle pain and weakness. It is not proven to work, though the supplements appear to be safe. A study in Japan showed that pitavastatin (Livalo) did not decrease coenzyme Q10 nearly as much as atorvastatin (Lipitor). Whether it causes less muscle problems is unknown at this time.

For patients that I feel need medications to lower their cholesterol, yet are unable to tolerate a statin, or refuse to take one, I offer other alternatives, such as niacin (Niaspan, Endur-Acin, Slo-Niacin), colesevelam (WelChol) or ezetimibe (Zetia). There are pros and cons for each option. Sometimes people tolerate one statin, and not another, or may do better with a combination of a low dose statin and another agent.

So there’s no easy answer to your question. Different patients have different solutions.

Let the Sunshine In, Let the Sunshine In

A GlaxoSmithKline representative came by to drop off samples in my office and asked if there was anything else they could do for us. GSK makes some inhalers so I asked if they could supply spacers to give to patients, something they used to do. Spacers come in different designs, but basically it’s a plastic tube that fits between an inhaler, such as albuterol, and the mouth. The extra distance causes the medication particles to get smaller, so they deposit deeper in the lungs. The spacers are relatively inexpensive, probably less than the cost of the inhaler for a week, and can last years, but because insurance companies usually don’t cover them, patient’s usually don’t get them. Handing one out in the physician office is a good way to get patients to use one, plus the proper use can be demonstrated in the office.

The representative said that his company was not giving the spacers, and in light of the Physician Payment Sunshine Act, doubted they would. This proposed regulation of the Centers for Medicare and Medicaid Services (CMS), part of Section 6002 of the Affordable Care Act, stipulates that, effective 3/1/12, that pharmaceutical companies report payments to physicians over $10. It makes no difference whether the spacers are for the physician, or their patients.

The purpose of the Physician Payment Sunshine Act is to discourage physicians from making prescription decisions based on financial inducements. Just to be clear, pharmaceutical companies don’t just give physicians cash to prescribe their medications, which would clearly be immoral, if not illegal, but can give other incentives in the form of meals, books, speaking fees, etc. In this case, however, the reporting requirements are not consistent and don’t make sense. They don’t have to report leaving samples of their inhaler, which costs far more than a spacer, but they would have to report the spacer, even though it could be used with inhalers made by other manufacturers. Although in balance I like having samples, they tend to encourage one to prescribe them since we don’t have generic samples. I think insurance companies would save money providing free generic samples, but that’s another story.

The bill was introduced by senators Charles Grassley, R-Iowa, and Herb Kohl, D-Wisconsin. As recently reported by 60 Minutes, congressmen can legally trade on insider information, so this law was hypocritical (in fact I see that only 25% of the Sunshine Act sponsors senators are sponsoring the Stop Trading on Congressional Knowledge Act  S.1871 or S.1903 bills) . But as physicians we are ‘Hippocratical‘ and hold ourselves to a higher standard. That said, I think there are many instances where it’s legitimate for physicians to accept items of value from pharmaceutical companies.

The science of medicine advances at a fast rate, and it’s difficult, if not impossible, to keep up to date. This is true for specialists, and even more so for primary care physicians. The majority of medications I prescribe every day were not available when I was a resident in training. One way I help stay up to date is to listen to pharmaceutical representatives, or physicians they bring in, while I eat a meal they provide. There is no quid pro quo agreement to prescribe their medications, and many a rep can attest that I frequently challenge what they say. But what they do get is some of my time and a chance to present information that ultimately may benefit my patients. True, there are other ways to get the information, but time is the problem. I have to eat, so that’s a good time to talk. Listening to top physicians they’ve flown in, and having the opportunity to ask questions, is very valuable. I also participate in research trials (needed to create new medications), and those fees will show up in the database. The act would not make such payments illegal, but the concern is that the public will not be able to put the numbers in context and it may incorrectly imply impropriety.

Physicians and other providers do need to be careful they are not unduly biased by pharmaceutical companies, and I have a lot of concerns about pricing manipulations of medical drugs, but when it comes to the Physician Payment Sunshine Act, I think it’s pointing a light at the wrong place, or at least with too broad a beam.

Penny Wise, Pound Foolish

A patient of mine has been on cyclobenzaprine, a muscle relaxer, intermittently for over a year. Now her insurance, a Humana, Medicare plan, said they will no longer cover it. I pointed out to them that the medication is generic and at Costco one could purchase 100 pills for $9.93 without insurance. That would be enough to last her over 3 months. The Costco price for tizanidine they suggested I switch her to costs even more. They told me to check their website for what they cover, which I did. It said cyclobenzaprine is covered, though on some of their plans it requires prior authorization, which is what I tried to obtain. Besides the risk of switching a medication to something new, Humana wasted the time of my nurse and I for what would be a minuscule, if any savings. They would not budge other than saying she had to first try and fail tizanidine.

I understand the need to control costs, but forcing doctors to change from one cheap medication to another cheap one is not the way to do it. It doesn’t save significant amount of money, and it frustrates their customers (the patients) and their physicians.

Insurance companies such as Humana place no value on physicians time. I hope other physicians join me contesting such things from time to time. Don’t just accept the first no. Make them deal with extra phone calls and faxes when they are unreasonable. If enough of us protested, I think we could force them to change their ways. Occupy Medical Insurance Companies Movement, anyone?

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.”

Glazed Donuts

A couple of pharmaceutical reps brought us lunch to discuss their new product, a testosterone gel that’s more concentrated, and thus lower volume, and applied to the inner thighs. Referring to their main competitor, that uses a larger volume applied to the shoulders and upper arms, one of the reps said that by using his product instead, one could avoid, “that whole glazed doughnut thing.”

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