Compounding Pharmacy Executive Goes to Prison

The co-founder and head pharmacist of a now-bankrupt New England compounding pharmacy has finally been sentenced to prison. Under his direction the pharmacy failed to ensure the sterility and safety of its products, which ultimately killed 76 people (see this blog, Jan 2, 2015).

Although the executive's conviction and sentencing finally closes this unfortunate case, not everyone is satisfied with the verdict. The executive was cleared of charges of second-degree murder that might have resulted in a 35-year sentence. Instead, he was convicted of racketeering and fraud, for which he will spend only 9 years in prison.

Fear of Vaccines

Why does the notion that vaccines cause autism continue to persist, despite all the scientific evidence to the contrary? In a recent essay, a science writer and father argues that it's all about one of our most basic emotions - fear. According to the author of the article, fear is just too strong an emotion to be overcome by logic or evidence.

If he's right, then continuing to try to convince anti-vaccine advocates with more scientific evidence just isn't going to work. Their fear will have to be acknowledged and addressed. How to do that is a question for which the author doesn't yet have an answer.

New Treatment for Chronic Knee Pain

What are your options for reducing chronic pain? Certain drugs are good at reducing pain, of course, but some of the most effective ones are dangerously addictive when used for more than a few days. Cortisol injections can reduce the pain from certain types of arthritis. That used to be about it. But now there's a new method is called "cooled radiofrequency therapy", or CooliefTM for short.

Coolief is a non-invasive, outpatient technique designed to block pain for prolonged periods. Radiofrequency energy is applied to needles inserted into the site of pain. The radiofrequency energy heats sensory nerve endings, damaging them and blocking their ability to transmit pain signals. Because the radiofrequency energy heats up the needles, the needles are simultaneously cooled to avoid widespread tissue damage. The result is immediate relief from pain. And because damaged sensory nerve endings take a long time to heal, the pain relief can last for up to 24 months.

The technique is currently FDA-approved for the treatment of osteoarthritic knee pain, but it's been used to treat chronic back pain as well. It is likely that the technique will gain further FDA approvals in the not-too-distant future. The cost (about $4,000) is covered by some health insurance policies.

If the Coolief technique proves to be both safe and effective in treating different sources of chronic pain, some day physicians may be able to stop writing so many prescriptions for addictive pain-killers!

Chondroitin as a Treatment for Osteoarthritis

The dietary supplement chondroitin has been selling for a long time as a treatment for joint pain due to osteoarthritis.  Recently I've even seen advertisements promoting the use of glucosamine/chondroitin (chondroitin is almost always sold in combination with glucosamine) in pets.  I suppose the theory is that if works for humans, then it should work for pets.

And yet, chondroitin hasn't actually been shown convincingly to reduce joint pain (see this blog Oct. 6, 2010).  With that as background, a new study now purports to show that high-quality pharmaceutical-grade chondroitin (not the ordinary over-the-counter stuff) actually does reduce joint pain in people suffering from knee arthritis.  In fact, chondroitin allegedly worked as well as the popular prescription nonsteroidal anti-inflammatory drug, celecoxib.

So chondroitin works, right?  Not so fast. According to the footnotes in the article, the study was sponsored (i.e. funded) by a pharmacy company that makes pharmaceutical-grade chondroitin. It's not hard to imagine that the company has a financial interest in the study's outcome.  The company even provided "editorial assistance" to the author prior to the article's publication.

Putting all that possible bias aside for a moment, the data show a minimal effect of chondroitin at best.  According to Figure 1 in the article, at six months of treatment both chondroitin and celecoxib reduced patients' reported knee pain significantly. However, patients in the placebo group (receiving neither drug) also reported a reduction in pain, by nearly the same amount. In other words, most of the patients' reported pain reduction was caused just by being enrolled in the study and thinking that they might be receiving a drug that worked.

Before I accept that chondroitin definitively reduces the knee pain of arthritis, I'd want to see this study repeated in an independent study.

Advance Directives, and Suing for "Wrongful Life"

When it comes to their last moments, some medical patients would prefer to die gently without having their chest opened, their heart shocked, or their breathing taken over by a pump, especially if their chances of a meaningful recovery are low. To that end, many patients sign advance directives that are intended to provide a clear statement of their wishes. Hospitals often encourage patients to sign an advance directive because it can provide guidance to the medical team when (or if) patients can no longer speak for themselves.

But what happens when the medical team doesn't honor a patient's advance directive? This is not as far-fetched as it might seem. Physicians are trained to save lives, and it's difficult for them to watch a patient die when they know that a procedure might keep the patient alive, if even only for a while. If a patient is kept alive by medical measures specifically not wanted as documented by their advance directive, should damages be awarded for "wrongful life"? It all boils down to whether an advance directive should be viewed as only advisory, or whether it should be considered similar to a legal document.

This is a legal grey zone that is now being tested by several "wrongful-life" lawsuits. Traditionally, courts have been reluctant to punish doctors who aggressively work to save their patients. But recent court decisions suggest that the tide may be turning to favor the patient, according to an article in The New York Times. Time will tell.

Do you have an advance directive? You'll probably be asked that question the next time you visit an emergency room or are admitted to a hospital. The question is; even if you do, will it be honored?