Thursday, June 15, 2017

Over the Counter Hearing Aids? Sounds great (no pun intended)!




There has been ongoing discussion for some time over how to help people use devices to improve their hearing that is both easy to use and affordable.

One problem is that MediCare actually can't cover hearing aids, barring a literal Act of Congress making such coverage possible.  Additionally, hearing aid technology has been difficult and generally required several visits to a licensed audiologist (hearing specialist) to customize them to each individual user.

Fast-forwarding to the present, the electronics technology for hearing aids has advanced just like electronics and computers in everything else.  Hearing aids that can be fully set up and used by the individual users are now seen to work nearly as well as high-end audiologist adjusted ones, at a fraction of the price (say, $300 instead of $4,000).

Congress is getting set to vote on a piece of legislation that would give the FDA three years to devise a way for hearing aids to be available over the counter after being shown to be safe and effective.  When Elizabeth Warren and Chuck Grassley are supporting the same legislation, then something is definitely up.  Stay tuned for further developments over the next few years!

Thursday, June 8, 2017

More on Drugs (or, medications)


I've come across some interesting reading on the subject of drugs and medications, and thought you might be interested since they cover the gamut of pharmaceutical research, clinical medicine and medical ethics.

If you watch TV, you may have already seen ads for a new kind of cholesterol lowering medication called Repatha.  It is injected by the patient every two weeks, and is not a statin and therefore does not have statin side-effects.  So far, so good.  Thing is, while Repatha substantially lowers cholesterol, the reduction in likelihood of heart attack or stroke is minimal, and the reduction in death from heart attack or stroke is zero.  Oh; and it costs over $14,000 every year.  The cost and the number of people who would have to take the medication to improve health is much, much higher than for the statins, and Repatha so far does not appear to be as effective as statins, either.

Mind, the medication has only been around for two years, so it's possible that benefit may become clearer over a ten year period of time.  For now though, Repatha seems like it might mostly be of interest to those who are at high risk of heart attack or stroke and just cannot tolerate statins.

Vox does a good job of summarizing a recent study on Repatha.

On the other end of the spectrum, what about re-thinking placebos

We already know that placebos can be very effective.  If a doctor prescribes something and tells you that you'll feel better, there's at least a 30-50% chance you'll feel better.  If pain is involved, the odds improve to 60-75%.  If the treatment is a sham (fake) procedure or surgery for pain, the odds improve up to 90%.  If we reveal to you that the pill or procedure or surgery was fake, the improvement does not go away!

Morphine works 50% more effectively if you know you are receiving it, compared to if it's just in your intravenous line and you can't tell that your getting it.  It works even better if you yourself control giving it to yourself, rather than asking a nurse for it.

There is starting to be open discussion of the use of open-label placebo use for some conditions, in which both the patients and doctors are fully aware of the use of a placebo for treatment.  Certainly not for cancer or life-threatening infection, but for other conditions such as back pain, or irritable bowel syndrome.  If this is both effective and safe, should we really continue to consider placebo use unethical?

And now for something completely different.  Recent studies demonstrate that single or limited treatments with ketamine can result in remission in depression, with MDMA can treat PTSD, and with psyolcibin can significantly aid patients with terminal cancer diagnoses.

Thing is, these are all considered by the FDA to be drugs of abuse characterized by high potential fore abuse with no medical value. 

Additionally, these studies are often initiated based on reports of incidental improvements in medical conditions by recreational drug users.  This raises some interesting questions.

For example, if the only things we can say with any certainty about MDMA (a/k/a Ectasy, X, Molly...) are that it doesn't seem to cause organ damage, withdrawl or life-threatening problems and largely seems to result in the user experiencing a 4-6 hour period of feeling generally happy and trusting of everyone around them, how dangerous exactly is the abuse potential of this?  Should more structured medical study actually be done?

Should the FDA consider rescheduling some of these drugs, which would make clinical testing possible?  As researchers on the clinical benefits of psylocibin ("magic mushrooms") point out, getting research grants is easier with psylocibin because it's not spelled L-S-D.

For that matter, are we going about this research all wrong?  Depression and anxiety are very common.  Certainly, the pharmaceutical industry is researching newer drugs, but really nothing new has come out since Lexapro, which is simply another SSRI and has been out long enough to be generic.  This research is by definition going to be incremental, insofar as side effect potential is intended to be minimized.  The clinical experiences with ketamine, MDMA and psylocibin are incidental to people frankly using them because they have noticeable effects on the brain ("getting high").  The beneficial effects on depression, PTSD or fear of dying seem to be a side-effect, but a noticeable side-effect that may be a result of taking a substance expected to effect the brain in a noticeable way.  This is not to say legalize everything yesterday, but it may point out a different way of looking for effective treatments of common psychiatric problems.