A new study in the New England Journal of Medicine has generated a lot of media attention this week (such as this NY Times article).  The study pooled prior randomized studies that compared patients taking the diabetes medicine Avandia (rosiglitazone) to patients taking other diabetes medicines or placebo and looked for differences in rates of heart attack.

The worrisome result was a statistically significant increase in the number of heart attacks in patients taking Avandia compared to patients taking placebo or other diabetes medication.  The magnitude of this increase is difficult to ascertain from the information published in the paper.  Though the media is reporting that the study showed a 40% higher heart attack risk with Avandia, this number is not at all informative.  (For example if 10 in a million placebo patients had heart attacks compared to 14 in a million Avandia patients, that would be a 40% increased risk, but the actual magnitude of the risk is so tiny as to not deserve attention.  If, on the other hand, 10 out of 100 placebo patients had heart attacks compared to 14 out of 100 Avandia patients, that would also be a 40% increased risk, but the absolute magnitude of this risk would be much more worrisome.)

The study has led the FDA to issue this warning to patients and physicians.  The FDA warning notes that this study is very preliminary.  It’s pooled from other studies that weren’t designed to measure heart attack rates, and there are other, conflicting studies.  There are large ongoing trials that will answer this question definitively.  So the FDA isn’t recommending that patients stop Avandia, just that they have a conversation with their doctors.  After all, stopping a medicine that is controlling your diabetes is much more dangerous than any risk discovered in this study.

This is another example of a tiny number of irresponsible people imposing a lot of inconvenience on millions of others.  The Associated Press reports in this Forbes article that four East Coast supermarket chains will only sell products containing dextromethorphan (DXM) to customers over 18 years of age.  DXM is a cough suppressant and is very common in over-the-counter cough remedies.  I recommend it all the time.  Why the new restriction?  Apparently some teenagers have been taking DXM in extreme doses in attempts to get high, and five teenagers died in cases that may have been associated with DXM abuse.

This may not have merited my notice if it didn’t follow on the heels of another major cold medicine hassle.  Recently stores and pharmacies have made it necessary to show identification to buy pseudoephedrine, a very commonly used over-the-counter nasal decongestant (the ingredient in Sudafed).  The quantity of pseudoephedrine that can be bought at one time has also been severely limited.  You can imagine what an annoyance this is if you have a few young children at home who always have colds (and infect their parents).  Some winters my family goes through Sudafed by the bucketful, but now we can only buy it by the thimble.  Why would any organization stand between a cold sufferer and his nasal decongestant?  Because some people use pseudoephedrine in drug labs to make methamphetamine (crystal meth).  So because pseudoephedrine might be used to make an illegal drug, your nose has to run a little longer before you get relief. Has anyone done a study to check if this restriction has made crystal meth more difficult to obtain?  I doubt it.  But once in place restrictions like these are never lifted, even if they are totally ineffective.

So I beg all the irresponsible recreational drug using teenagers out there:  Before the next drug fad spreads, please let me know so I can stock up on whatever otherwise-harmless medicine you’re about to yank out of our hands.  Thank you.

Recently human papilomavirus (HPV) has been making a lot of news.  The story involves big business, cancer, government policy, and sex.  I’m surprised HBO hasn’t made a series about it.

HPV is a sexually transmitted virus that causes genital warts, cervical cancer, and has recently been associated with oral cancers.  Merck recently released Gardasil, a vaccine that protects against the strains of HPV that cause most (but not all) of the cases of cervical cancer and genital warts.  A vaccine to prevent cancer!  That alone was newsworthy.  The CDC recommended the vaccine for all girls and women 11 to 26 years of age.  Since then, some state legislatures have mandated vaccinating school-aged girls, which has led to noisy political battles between opponents and supporters of the legislation.

This issue of The New England Journal of Medicine is practically a wall-to-wall HPVfest: three scientific articles, three editorials, and two perspective articles all about HPV.  The studies prove that the vaccine decreases the risk of precancerous cervical abnormalities that eventually lead to cervical cancer, but the magnitude of the reduction was smaller than expected.  This LA Times article has an excellent summary of the issue.  The vaccine is safe, but cervical cancer takes years to develop, so the vaccine’s ability to prevent cervical cancer will be revealed by these ongoing studies years from now.

Meanwhile, until the next germ catches the spotlight, you can expect HPV and Gardasil to continue generating controversy.

Though heart attacks continue to be the number one cause of death in the United States, the news for treatment and prevention of heart disease keeps getting better.  An article in this issue of The Journal of the American Medical Association examines the rates of death in a multinational study of heart attacks and heart-related acute chest pain.  The study was also covered in this Reuters article.

The news is very encouraging.  As hospitals increasingly adopt evidence-based best practices for treating heart attacks, the rates of death and heart failure have dropped dramatically.  Best practices include immediate angioplasty for heart attacks and medications like beta blockers and aspirin that have been proven to improve survival.

As best practices spread, we can hope that these statistics will continue to improve and that the tragedy of sudden death in middle age from a heart attack will be almost unheard of.

Tangential Miscellany:

This LA Times article discusses the new FDA warning that will be applied to every antidepressant medication, warning of the potential for increased suicidal thoughts or behavior in patients between the ages of 18 and 24 taking antidepressants.  There are two striking things about this story.  This is the first FDA warning that will include explicit consideration of the benefit of the medications.  The warning will state “that depression and certain other serious psychiatric disorders are themselves the most important causes of suicide” and that the benefit of treating depression must be weighed against the risks.  The other surprising issue is that, as far as I know, this is the only time a warning has been issued for multiple different families of medications whose only common characteristic is that they are used to treat the same disease.  Different families of antidepressants work through different mechanisms, and have different side effects, but all of them will carry the new warning.