Showing posts with label Off Label. Show all posts
Showing posts with label Off Label. Show all posts

Thursday, September 1, 2016

Personal Patient Experiences with Alpha Stim

Totals:

Responders:

On Label:

Off Label:
1) An older woman had the compulsion to climb the stairs precisely 60 times a day. She had severe back pain. She had a heart attack, with heart damage. She could potentially suffer heart failure. She got Alpha Stim 20 minutes day, set at 1 for one week, then at 2 for one week. Her compulsion was gone. I stopped the treatment for 2 weeks, and there was no return of her obsessive-compulsive disorder. There was no substitute compulsion, as sometimes occurs. The compulsion has not returned for 4 months. She requested to continue regular treatments for anxiety and for insomnia. I restarted treatment at her request.

2) An adolescent had a form of autism, once called Asperger Syndrome. He had a very high level of rage, despite high doses of a major tranquilizer, with high blood levels. If he did not get what he wanted, he jumped from a high balcony. I asked him what was the date today. He replied, that is a stupid question, and walked out. He had two treatments at a level of 1. He said, he would go to the pool, for the first time of the summer. The bus was 45 minutes late, but he just paced and waited. He went to the pool. He had two more treatments, and a home visit. Instead of being destructive and assaultive, his mother reported he started talking to her about his interests, such as computers and games. After a year, but only a month on Alpha Stim AID, he went home. He was asking for the treatment, and for an extension of the time to 30 minutes. It is unclear if he liked the treatment or access to the internet offered to him while on it.

3) A woman is received Alpha Stim M treatment for neck pain. After several treatments, she reported no improvement in her neck pain. However, her tinnitus (ringing in the ear) of many years was completely gone.


Non-Responders:


Bibliographies:

On label reports here.


Off label reports here

Tuesday, April 27, 2010

False Claim Act Attacks on Off Label Promotion

Click on title above for review of civil procedure defense, using Rule 9 (b).

Off label use represents about half of all prescriptions. Off label is the use of a medication for condition not approved by the FDA, after test data have been submitted by the drug companies. It is half of medicine, and can be as scientifically rigorous and prove as on label use.

Off label use represents a gold mine of medical advances at little or no cost. So the blood thinning effect of aspirin is a nuisance to the headache patient in whom it caused a bleeding ulcer. It is a great benefit to the heart patient who needs a mild blood thinner. Is aspirin a pain killer or a blood thinner? One patient's side effect is another's best treatment option.

Therefore, at the policy level, the lawsuits for any off label promotion should be dismissed as damaging to clinical care, by chilling the advocacy for innovative uses of cheap, older, often generic medication.

Beyond the appalling effects on clinical innovation, off label promotion is speech. The Free Speech Clause is a coin with two sides, the freedom to say speech, and the freedom to hear speech. Corporations may not have unlimited rights to free speech. However, doctors and patients have an unlimited right to hear free speech.