The Fungal Meningitis Outbreak: Who's to Blame?

Whose fault was it that several batches of compounded drugs produced by a compounding pharmacy in Massachusetts led to hundreds of cases of fungal meningitis and 32 deaths in 19 states? Predictably, we’re now at the “blame-game” stage.  According to The Examiner, fingers are being pointed at the compounding pharmacy (for bad manufacturing practices); the Massachusetts state pharmacy board (responsible for oversight of the compounding pharmacy); poor communication between states; the FDA (for not fulfilling its mandate from Congress to “protect the public health”); even Congress itself (for enacting the laws under which the FDA operates).

Hopefully the various players will get beyond the blame game and come up with concrete solutions. This tragedy should be a wake-up call for regulators at all levels. We’ll be watching to see what (if anything) changes in the future.

Should Healthy People be Screened for HIV Infection?

According to the Centers for Disease Control (CDC), 25% of people who are infected with HIV do not know they are infected. Apparently these people are causing 80% of all new HIV infections. The available research suggests that if they knew they were infected they would make healthier choices in order to maintain their own health and protect the health of those they love. In the long run, that would reduce the rate of new HIV infections and ultimately lower our national health care costs.

At least that’s the logic behind the idea that all adults should routinely be tested for HIV infection. The American College of Physicians and Surgeons currently recommends that all persons older than 13 years should be tested. The CDC largely agrees, but adds that testing is not warranted in persons older than 64 or in populations with an HIV prevalence of less than 0.1%. However, the U.S. Preventive Services Task Force (USPSTF) does not yet recommend routine HIV screening of all persons; it recommends screening only patients “at increased risk”. As a result, routine screening for HIV infection is not yet commonplace.   It boils down to money; without a recommendation by the USPSTF, insurance companies are unlikely to pay for HIV tests in healthy people. 

Physicians groups and the CDC argue that patients don’t necessarily tell their physicians if they are at increased risk of HIV infection, so it’s nearly impossible to tell who is at increased risk. In addition, it’s hard for a physician to know the actual percentage of HIV in the patient’s population.

But now it appears that the USPSTF is considering changing its recommendation. The Task Force issued a draft document on Nov. 20 that, if approved, will recommend that all persons aged 15-65 be routinely screened for HIV infection. The draft document is available for public comment until Dec. 17.

Would routine screening for HIV infection be a good idea? You decide. You can comment on the USPSTF’s draft recommendation if you wish by going to to the USPSTF’s web page on the subject.

Repetitive Mild Brain Injury and CTE

The evidence that there is a link between repetitive mild traumatic brain injury and a degenerative brain disease called chronic traumatic encephalopathy (CTE) continues to build. In the most recent study, published in the journal Brain, evidence of CTE was found in the brains of 68 of 85 subjects with a history of mild traumatic brain injury, including 34 of 35 NFL players and four out of five hockey players. In contrast, there was no evidence of CTE in the brains of 18 normal control subjects.

These new data should not be taken to mean that nearly all NFL players and hockey players are destined to develop CTE. It’s important to recognize that the subjects who were chosen for inclusion in the study were chosen specifically because they had been exposed to repetitive mild brain injury during their careers. Nevertheless, the numbers are pretty shocking. No one is suggesting that we give up sports such as football and hockey. But as the dangers of repetitive brain injury become more and more apparent, sports federations and professional sports leagues will need to look closely at how to protect athletes from these kinds of injuries.

Oral Contraceptives Over-The-Counter?

A committee of the prestigious American College of Obstetrics and Gynecology (ACOG) issued a recommendation recently that oral contraceptives be made available over-the-counter (OTC). Currently, oral contraceptives are available only by prescription.

Some obstetricians and gynecologists benefit financially from the current prescription-only policy. Nevertheless, ACOG is advocating for OTC availability because it believes that the increased availability of oral contraceptives would go a long way toward reducing the high incidence of unwanted pregnancies in this country. The economic and social costs of unwanted pregnancies include costs for health care; costs associated with social welfare support for poor women and their infants; even the social costs of higher levels of domestic violence in families with unwanted children. According to ACOG, the added risks if oral contraceptives were available OTC would be minimal.

ACOG can only recommend, however. The FDA would have to approve the OTC sales of oral contraceptives, and so far, oral contraceptive manufacturers have not even applied for such approval. Perhaps with this recommendation they’ll be temped to do so.

Even if OTC sales of oral contraceptives are eventually approved, an age restriction could still apply, as it does for the “morning-after” pill (You must be 17 or older to purchase the morning-after pill over-the-counter.)