FDA Concerns About Zocor/simvastatin in the 80 mg dose

The Food and Drug Administration (FDA) announced concerns yesterday about the risk of muscle injury specifically around Zocor or generic simvastatin in the 80 mg dose.

Statins have been widely used since the 1980's for reduction of cholesterol and reduction in the occurrence of sudden deaths from cardiac arrest, heart attacks and strokes. Muscle injury is known to be an uncommon side-effect of the statins and is proportional to the potency ("strength") and dosage ("size") of the particular statin.

Simvastatin is the most potent of the generically available statins, and the 80 mg dose is the highest dose made for it.

The FDA is concerned (this link is technically worded) that the risk of muscle injury with 80 mg a day of simvastatin is higher than for comparable doses of other statins. Specifically, they are recommending that doctors not start patients on this dose, or increase patients already on lower doses to this dose.

This concern is based on a recently completed medical study comparing the effects of simvastatin in 20 mg and 80 mg doses with and without supplemental Vitamin B12 and folic acid after heart attack.

One of the findings from this study was that the risk of muscle injury with the 80 mg dose was 0.9%, and 0.02% with the 20 mg dose. Prior to this test, the risk with the 80 mg dose had been reported as 0.53%. Hence, the warning.

Please note that if you already are on simvastatin at 80 mg a day for a year or more and not having side effects (such as persistent muscle or joint pain, or weakness), there is no need of concern.

News announcements suggest switching to other medicines that are as effective as 80 mg of simvastatin. The problem with this is that the only medicines that are equally effective are Lipitor 40 mg and Crestor 20 mg. Neither of these is generic, so they are often much more expensive.

If you would like us to switch you to one of these, let us know. Please check your insurance formulary to see which of these you would prefer so you can let us know which one to switch you to.

Can I split this pill?

We often get asked whether it's okay to split or crush a pill. This might come up because of a need to reduce the dose, or because of difficulty swallowing the pill whole (think sulfa antibiotic or potassium replacement).

Generally, pills that have a score or line imprinted into them are intended by the manufacturer to be safely and easily splittable. Also, pharmacies will put an easily visible sticker on the bottle telling you not to crush or split the medication if this is an issue.

Pill splitting devices are easily and cheaply obtained at supermarkets, drug stores and pharmacies and are much easier to use than using a kitchen knife on the counter-tops!

If it interests you to know why some pills should not be crushed or split, there are a number of reasons (h/t Art Gonzalez, Pharm.D., Marshall Hospital Pharmacy Department):

• Crushing pills meant to dissolve under the tongue (sub-lingual) such as nitroglycerin for chest pain or angina can cause them not to work.
• Extended-release formulations of medicines often are designed to have an outer coating that allows the medicine inside to be slowly absorbed into your bloodstream over a long period of time. Spitting or crushing these can allow 12-24 hours worth of that medicine to get into you in a few hours: this would not be good. Often, these medicines have abbreviations after their names such as CR, LA, SR, XL, XR, CD, etc.
• Crushing or splitting pills with potential to be cancer-causing (carcinogenic) or birth-defect causing (teratogenic) can cause the medicine to be released into the air and can be positively dangerous to patients and their family members. Examples would include chemotherapy pills and hormonal pills.
• Sometimes the pill bottle will be labelled not to crush or split the pills because they are fragile, taste bitter, or might stain your teeth or irritate your throat.
  

Is there a link between cell phone use and cancer (v. 2.0)?

I posted on this topic a few months back, and noted that there was no compelling evidence to suggest that cell phone use was linked to brain cancers. Certainly, the occurrence of the types of brain cancer in question (gliomas and acoustic neuromas) has remained pretty much the same over the last decade or two, even though cell phone use has escalated very rapidly.

The World Health Organization (WHO) announced concerns of a potential risk in heavy cell phone use for developing gliomas and acoustic neuromas.

If you've been looking for a good excuse to stop answering your cell phone or to spend money on hands-free headsets, then now's the time!

However, if you are wondering how safe or unsafe cell phone use may be from the standpoint of brain cancer risk it's worth noting that the WHO's findings are far from conclusive.

• The level of risk is not new compared to earlier studies, and is assigned a level of 2B. This means a possible risk of cancer in humans, but with very limited evidence.
  
• Note that other possible carcinogens in the 2B category include carpentry, coffee and pickles.
• Even if this finding is taken at full face value, we are still talking about an uncommon form of cancer which means that the risk in any individual of developing a brain cancer from using a cell phone regularly is still very low.

To me, this is also interesting as telecom industry studies show that cell phone users are using there phones less for actual voice phone calls and more for texting, email and data transmission such as smart phone apps.

Until I am convinced otherwise I plan to continue to use my cell phone, start off my day with a mug of coffee, and eat pickles or kim-chee when the mood strikes me. However, I will continue to defer carpentry to my wife since she is far better at it than me!

Travel Preparations

Summer is fast approaching, and we often get questions about travel abroad.

The idea here is to have a great time, but also be able to avoid or deal with health-related problems that may arise.

First, don't forget the basics.

• Bring things you already use such as spare glasses or contact lenses, sunglasses and prescription medicines you normally take. I suggest you bring controlled substances such as sedatives and pain-killers in the original pharmacy-issued containers. You might also want to make sure that such medicines are legal to possess on entering the countries in which you will be traveling.
• Bring normal first aid supplies such as lip balm, insect repellent, eye drops, band-aids, athlete's foot cream, Neosporin, and Tylenol or Advil.
• Pack for the kind of activities you will be doing. Rick Steves has a lot of great advice on this!

Feel free to see us if you have further questions or concerns. Also, we can help you with specific medical needs such as:

• Hepatitis shots
• prescription medicines to prevent malaria
  
• Tetanus shots
• prescription medicines in case of travelers' diarrhea
• prescription medicines for "jet lag"
• prescription medicines for flying-related panic attacks

Travel Med is a good resource for those unusual immunizations that doctor offices and public health departments do not carry, such as yellow fever vaccine. They have a Sacramento location at:
4250 H Street, Suite 4
Sacramento, CA 95819
916/254-2100

The Centers for Disease Control (CDC) have a lot of information for travelers, including specific concerns about your destination.

Also, don't forget to check the U.S. Department of State for information on travel such as passport requirements and crisis situations in your destination.

Bon Voyage!

Preventing Kidney Stones

Kidney stones are a relatively common problem, and a very painful one to have.

Lifetime risk of ever having one in both men and women is 5%. Fortunately, the risk isn't higher since passing a stone can be more painful than childbirth (or so every female patient who has had both has told me).

80% of stones contain calcium. Out of these, 80% are made of a chemical called calcium oxalate.

Happily, these kinds of stones may be prevented by some dietary suggestions:

• avoid high protein, high salt diets
• avoid Pepsi, Coca-Cola, tea and iced tea
• avoid excessive cheese and dairy products in your diet
• drink lemonade regularly (or, 8-10 ounces of lemon juice in 64 ounces of water)
• drink "reverse osmosis" water such as Aquafina, Dasari, or Alhambra instead of tap or well water
• if you take calcium supplements, use the ones that contain calcium citrate and not calcium carbonate (such as TUMS, RolAids or "natural" calcium)

(h/t Dr. Kash Desai, a local urologist)

Discount Prescription Drug Program

While the rest of California is participating in the economic recovery (jobs, home prices; that sort of thing), unfortunately the Sacramento area is not.

A patient recommended this website for a California discount drug card. He tells me it's pretty much as billed: no application or registration, and accepted in many local pharmacies.

Check it out if you'd like to pay less for prescription medications.

Do Cell Phones Cause Cancer? (No, not likely.)

Certainly, holding an emitter of electromagnetic radiation close to your head frequently should raise some question as to whether this could be harmful. However, cancers that could be caused by such EMR are occurring less frequently even as cell phone use is becoming more and more common. The best medical studies to date do not show a link, either.

This article (h/t New York Times) does an elegant job of bringing together the concerns and the most reliable information to date. For those avoiding the NYT paywall, this article (h/t BoingBoing) summarizes it quite nicely.

A Couple of Interesting Notes

Are lucky people really lucky, or just more flexible and open to opportunity? (h/t to Lifehacker)

It's pretty shocking to put the recommended evacuation areas around the Fukushima reactor near Tokyo into perspective. Gizmodo provides some maps of the same sized zones around reactors in L.A. (and also New York and Chicago). Ouch.

A Few Interesting Reads

• From Wired magazine, an interesting re-do on the famous Milgram experiments from back in the day. If asked, do you think you would deliver electrical shocks to a stranger for money? If actually offered money and provided with a real person, would you still?
• In Vanity Fair, a famous economist writes on the effects on our country of having 40% of the country's wealth in the control of 1% of its people.
• Ted Rall's cartoon: Terrorist Plots We Could Really Use.
  

Why did some pills suddenly get so expensive?

Well, I had been wondering that myself.

It appears that the FDA is trying to eliminate very old drugs that are widely used in conditions for which they were actually never proved to be safe and effective.

This in itself is not a bad idea. For example, a look into whether childrens' over-the-counter cough and cold formulas really help or not has shown not only that they don't help to relieve cold symptoms in children, they can also cause serious side-effects such as seizures. This has led to efforts by family doctors and pediatricians to let parents know this and to use more supportive home treatment than over-the-counter medicines.

On the other hand, this has led drug companies to respond in unfortunately predictable ways. This story explains why colchicine (used for decades to relieve or prevent severe gout pain) went suddenly from 10 cents/pill to $5/pill.

It is also probably why you can't get quinine pills for leg cramps anymore. It was never actually tested for any condition but malaria. My guess is that the companies that make it don't want to go through the trouble and expense of testing it for leg cramps and simply withdrew it.

Radiation Exposure

While I trust that the fax from Grandpa's Pharmacy offering to sell me and my office staff much-sought-after potassium iodide at the bargain rate of $60 is well intended, I doubt that it will be necessary. Apparently, there's been a run on the supply in the US, especially on the West Coast.

Potassium iodide can help to displace radioactive iodine from being taken up by the thyroid gland in the event of exposure to it, but would have to be taken at least 6 hours before exposure. Even given the US NRC recommending US citizens in Japan evacuate from within 50 miles of the troubled reactor, the exposure levels on the US mainland over 5,000 miles away is going to be just about nil. Overall, the smart money in avoiding exposure to radioactive iodine will be avoiding drinking milk from northeast Japan.

Some interesting reading on the subject:

• ProPublica has a nice reading list from a variety of news sources covering basic background, up-to-the-minute liveblogs and twitter feeds, and the public health aspects of radiation exposure.
• MSNBC (h/t to Boing Boing) shows a ranking of US nuclear power plants at risk for quake damage causing a core meltdown. (Hint: the most at-risk are not in California)
• For those concerned about TEOTWAWKI (the end of the world as we know it), Medscape has a very technical discussion of nuclear and radiologic decontamination including a discussion of potassium iodide. Who knew Mylanta and Maalox can help to reduce absorption of strontium and radium? (Dose: 100cc by mouth ASAP upon exposure)
  
• For an interesting and lighter side note, Slate discusses why there is so little looting going on in Japan right now.
  

Interesting conversation over breakfast with my daughter this morning about how to decide on your livelihood. She is a high school freshman who wants to contribute to the world, have a comfortable salary, have a family, travel and enjoy what she does for a living. Indeed, don't we all?

Interesting she should ask (and believe me, I'm glad she's asking), since there have been some interesting reads in the news on this very subject.

This article in the Harvard Business Review questions the practice of "business as usual" and re-frames the question for the future as "Does what you do have a point- one that matters to people, society, nature and the future?"

The next people to be displaced by computerization (not so much by off-shoring) are attorneys. Wow. Just wow.

Staying cool under pressure is somewhat genetic, but more so environmental. And the good news is, it can be taught!

Here's a handy way to estimate portion sizes.

For those who struggle with trying to visualize diet recommendations such as "1 cup of pasta",

• 3 ounces of meat is the size of a deck of cards
• 1 and 1/2 ounces of cheese is the size of 4 dice
• 1 cup of cooked cereal or pasta is the size of a baseball.

(h/t to Consumer Reports magazine!)

A Clinician's Perspective on the Question of Violent Language in the Public Media

I agree with the author of this article (a practicing psychiatrist) that the link between violent acts and violent language used on TV and in talk radio cannot be so easily dismissed.

This is much discussed in the setting of the shootings in Tuscon by Jared Loughner; it is reasonable to suppose that Mr. Loughner did not get the idea to shoot Representative Giffords simply because he follows Sarah Palin's website. However, I'd say that it's hasty to say that no connection exists between his actions and the general tone of Ms. Palin and others like her. "Don't retreat: Reload" is not a peaceful or reasoned exhortation.

An Alternative to Coumadin (warfarin)

As many of you already seem to be aware, the FDA approved a medicine called Pradaxa in late October, 2010.

Currently, it is for use in patients who have a very common arrhythmia called atrial fibrillation (AFib) without any heart valve disease along with it. The purpose of the medication is to act as a "blood thinner" to prevent stroke due to the AFib.

Up until this time, the only way to do this was with a pill called Coumadin (warfarin). Aside from the 2% per year risk of serious bleeding due to the medication, it also requires frequent lab testing to be sure that the dose is adjusted correctly. Dose adjustments are common because many, many common foods and medicines can interfere with the metabolism of Coumadin.

The deal with Pradaxa, is that it works just as well as Coumadin in preventing AFib-related stroke, and is about the same in terms of side-effects and bleeding risks. However, the dose is largely the same for all patients, and does not require lab testing. Pradaxa can be used as a first medication, or as a change from Coumadin.

Currently, the cost of this medicine is about $200/month since no insurance plans cover it (the exception to this is the military's TriCARE insurance which covers all but a $20/month co-payment). Depending on you financial state of affairs and the value you place on your time and co-pays for lab testing, you may still find this worthwhile.

News on the MediCare front

Thanks to everyone who read this or my letter to the editor of the Mountain Democrat, and especially if you contacted your senators to express concern!

At this time, a bipartisan bill has been passed that puts off a 25-30% reduction in reimbursement to doctors taking care of MediCare and TriCare patients until 1/1/2012. It awaits President Obama's signature, which he has said will be forthcoming.

In the meantime, please keep the pressure on Congress and Senators Boxer and Feinstein to use this time to find a different way for MediCare to determine physician reimbursement.

The current formula (the so-called Sustainable Growth Rate, or SGR) has been used for a decade or more, and ties physician reimbursement to various measures of cost including the rate of inflation. While I am fine with MediCare expenditures being contained, the problem here is that the costs of running a practice (payroll, insurance, rent, supplies) has steadily increased far faster than the rate of inflation). This results every year in the potential for a steep reduction in physician reimbursement. Congress has annually passed a last-minute measure putting it off until the next year.

By now, this has snowballed into a potential rate cut of 25-30%, which you have to admit is mighty steep. If this were to happen, older Americans and military patients would be depending on doctors wanting to take on the care for patients for whom they would be getting 70 cents or less on the dollar; all this while still trying to pay their employees generously and provide them with benefits during the worst economy since the Great Depression. Bit challenging, that.

Please keep Congress working on a better solution for this problem!

A Way to Track Your Blood Pressure

A patient recently gave me the link for a free on-line program for tracking and graphing your blood pressure over time.

I was seeing her over a concern for her blood pressure, and she showed me a graph of 6 months worth of averaged blood pressure measurements! This made it very easy to discuss her blood pressure, address concerns over it and come up with an agreeable plan of treatment and follow-up (diet, exercise and weight reduction, as it so happened).

Check it out!

Impending MediCare crisis!

This is a letter submitted to the editor of the Mountain Democrat. 'nuf said.

Dear Editor,

As a family doctor serving our community for the past 13 years, I want people to be aware that doctors who see MediCare and TriCare patients (the disabled, the elderly and the military and their families) face a 30% reduction in payment for their care to be phased in on December 1 and January 1.

To be clear, this is not related to recent health care reform legislation but rather to a payment method that MediCare has been using for years now called the Sustainable Growth Rate. This is supposed to reign in spending by MediCare (and TriCare, which is linked to it) by scaling payment to doctors based on local population and cost of running a business. This has typically been deferred at the last minute by Congress in order to avoid cuts to doctors and their patients.

Unfortunately, the currently convened "lame duck" session must act now to defer these cuts and hopefully to devise a better system of payment. If they do not, every doctor who sees disabled, older or military patients faces a loss of 30% in professional services given in service to these patients.

Speaking for myself, I do not plan to stop seeing patients with these insurances because I feel it is a duty and responsibility of doctors to see these patients who have given so much to our community. However, such large reductions in payment would certainly affect how many patients with these insurances I could see and would certainly have a stifling effect on the ability of elderly and military patients to find medical care.

If this concerns you, please urgently contact Senators Boxer and Feinstein to urge them to act now!

Yours truly,

Mark Tong, MD

Office of U.S. Senator Barbara Boxer
501 I Street, Suite 7-600
Sacramento, CA 95814
(916) 448-2787
(202) 228-3865 fax

Office of U.S. Senator Dianne Feinstein
One Post Street, Suite 2450
San Francisco, CA 94104
Phone: (415) 393-0707
Fax: (415) 393-0710

A Word on Whole-Body Scans (this time in airports)

I find it ironic at just the time that renewed concern is being expressed by both doctors and patients about radiation exposure in medical tests such as CT's and heart scans, we are evidently willing to accept what amounts to radiation exposure with unknown health risks in the interests of a virtual strip search to get on a plane. Given the way that medicines and tests often only reveal side-effects after widespread use, I hope that we don't see a rash of "problems" in pilots, flight crews and business travelers in the intermediate future.

I must say, I do find myself in agreement with Captain Smith that our response to the terrorist actions between 1985-89 was much more calm, determined and measured and less self-defeating.

Favorite Doctors of 2010

Hey, I'm very honored!

Thanks to everyone who voted for me in the Foothills Style magazine as among our communities favorite doctors. My staff and I do everything we can to give you excellent medical care and service, and look forward to continuing to do so for the future!