Thursday, June 22, 2017

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!

Saturday, June 10, 2017

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.

Sunday, June 4, 2017

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?

Thursday, May 25, 2017

Sunscreen Use in Schools

Did you know that in most states, teachers and school nurses in public schools cannot apply sunscreen to students? That's because the FDA classifies sunscreen as an over-the-counter drug. Technically, students can't even apply sunscreen themselves unless they have a signed note from a doctor and their parents.

The rule strikes most parents and school administrators as odd. It's hard to see who could be harmed by applying sunscreen to a child who needs it, unless of course the child were allergic to an ingredient in the sunscreen. And that would be an unrelated problem entirely.

A bill to allow students to use sunscreen in schools stalled in Congress last year. Not willing to wait for Congress, some states are taking action. Seven states have already passed laws that allow students to use sunscreen in school, and eight more states are considering such laws, according to a CBS news report. It makes sense; Congress has a lot on its plate, and this is something states can deal with on their own.

Sunday, May 21, 2017

A New Outbreak of the Ebola Virus in 2017

On April 22 a 45-year-old man in a remote area of the Democratic Republic of the Congo (DRC) was diagnosed with the Ebola virus; call him the new "patient zero". In less than a month there were 20 more suspected cases and three deaths. Is this the start of a new outbreak? And if so, what is being done to prevent another outbreak like the 2014-2016 outbreak that killed over 11,000 people in Guinea, Sierra Leone, and Liberia?

It would be encouraging to think that "it'll be different this time", and maybe it will. For one thing, Merck has developed a vaccine that appears to be effective against the 2014-2016 strain of Ebola. There are already stockpiles of the vaccine on ice. But the vaccine is still considered "experimental". It has not yet been approved by the FDA, and so it can only be used in carefully monitored clinical study protocols designed to document the vaccine's safety and effectiveness. The DRC does not yet have an approved clinical study protocol on file, according to an article in Science. The government will need to decide whether standard containment strategies are likely to suffice, or whether it can establish an approved study protocol quickly enough to be able to vaccinate people at risk before the outbreak gets much worse.

You might think it would be a no-brainer to establish a clinical study protocol. It is not. Requirements would include the ability to keep the vaccine refrigerated the vaccine at all times - no small task in remote region of the country. Furthermore, an approved clinical study protocol would require extensive record-keeping, including follow-up of all vaccine recipients for an extended period of time. There's even a requirement for ethical oversight and for obtaining informed consent from all vaccine recipients.

And so we wait. We wait to see what the DRC does about this latest outbreak, and whether the outbreak spreads.

Friday, May 19, 2017

Creating Eggs From Skin Cells

Some day it may be possible to produce human babies from skin cells, according to an editorial in Science Translational Medicine.  It's all due to a new technique called in vitro gametogenesis (IVG).

IVG refers to the technique for producing eggs or sperm (gametogenesis) outside the body (in vitro). The technique only became possible because, a decade or so ago, scientists learned how to produce undifferentiated stem cells known as induced pluripotent stem cells (iPSPs) from mature somatic cells.  Since that time iPSCs have been used to create various kinds of specialized somatic cells, including neurons to heart muscle cells.  And just recently, iPSCs derived from mouse tail cells were used to create fully functional gametes (eggs).  When fertilized with sperm, these eggs created by IVG were able to develop into healthy baby mice.  Sperm have not yet been fully developed from iPSCs, but surely they will be.

The ability to produce eggs and/or sperm from somatic cells raises all kinds of possibilities for how the procedure might be used (or misused, depending on your perspective).  If an egg could be grown from a male's skin cell and then fertilized by IVF with sperm from a male partner, gay couples could have babies that were genetically related to both of the males.  Of course a female surrogate mother would be necessary to carry the embryo to term, but surrogate mothers are not uncommon these days. Taking it one step further, if both eggs and sperm could be created from a male's skin cells, the male could (again, with the help of a surrogate) have a child that was entirely genetically his. These are scenarios that may need to be dealt with in your lifetime.  (Note that since females have no Y chromosome, IVG could only produce eggs from a female; never sperm.)

On the positive side, the ability to produce eggs from skin cells could mean that overcoming infertility would become easier and cheaper.  Right now, women undergoing an IVF procedure must undergo a complicated cycle of ovary stimulation and egg retrieval; with IVG, that would be unnecessary.  Furthermore, IVG could be used to produce an almost infinite supply of eggs, whereas only a few eggs are produced with each IVF cycle.

How do you think IVG should be used?

Thursday, May 11, 2017

A Second Drug is Approved to Treat ALS

The FDA has approved a second drug to treat amyotropic lateral sclerosis (ALS), also known as Lou Gehrig's disease. ALS is a progressive, debilitating, neurodegenerative disease that is usually fatal within 3-5 years. The new drug, called Radicava, slows the progression of the disease somewhat after six months of use; apparently that was enough for the FDA to approve the drug.

Before you get too excited, though, here are some facts about the new drug; 1) It must be given intravenously. That means that the patient must have a permanent IV port installed, which poses an infection risk. 2) The drug is only partially effective. Patients using the drug won't feel better; their health will just decline less rapidly. 3) It's expensive - $146,000 a year, according to its manufacturer.

The first drug to treat ALS, called riluzole, costs only about a tenth as much as Radicava.  Riluzole extends the life of ALS patients by 2 or 3 months; whether Radicava does the same isn't yet known.

If you had a fatal disease and were expected to live only 5 more years, would you pay $146,000 per year to slow the rate of disease progression just a little, or to live an extra 2-3 months? That's a judgment call only you can make. But your insurance company might balk at the price of this drug, considering its minimal effectiveness.