Daytime Sleepiness vs Dementia and the Case of President Biden

Dementia is the permanent, irreversible loss of the ability to form new memories, for exaample, today's date.

Daytime sleepiness from inadequate amounts of REM and Stage IV deep sleep is as impairing as intoxication on illegal alcohol blood levels. All the above functions can be affected as well. However, the remedy to daytime sleepiness is a good night's sleep. Another is a 30 minute nap. That is the limit of time for a nap to refresh, but to avoid spoiling that night's sleep. The other remedy for daytime sleepiness is modafinil 200 mg, pproved for sleepiness associated with inadequately treated sleep apnea.

I reviewed the case against "Fit for Duty" requirement for the police, punishing sleepiness at work. An accommodation for daytime sleepiness is imperative, especially if the job has caused the daytime sleepiness. The best is a 30 minute nap. An alternative is to take modafinil 200 mg for wakefulness, without effect on emotions or on thinking.

Biden has sleep apnea. He might have daytime sleepiness in the absence of a review of his medical record. Please, stop saying, Biden is demented. Biden should consider coming out about his sleep apnea, to help the majority of those with it who are untreated. It is not a disqualifying condition if treated with regular use of CPAP, implants, naps shorter than 30 minutes, and modafinil 200 mg in the AM. His doctor should provide that medication to cover the hours when alertness will be important.

As to slowing, the human body loses 0.5% of its dopamine neurons each year from birth, and movement slows from age 2. If fast movement is a requirement, then a 5-year-old should be president. Performance on cognitive tests peaks at age 16. In order to give a 40-year-old an IQ of 100, one must allow 50% of the right answers required at 16. Same thing, make a 16-year-old President if performance on a cognitive test is relevant to political leadership. As to trouble with word finding, the most common causes do not include dementia, but aging, language processing problems, inattention and distraction, stress and fatigue.

Remarks about the mental performance of President Biden are ad hominem remarks. They commit the Fallacy of Irrelevance. Biden should be criticized about his policies. On the other hand, did Biden make any of his decisions while sleepy? If Biden mistakes were made while sleepy, add them to the list of historic disasters caused by sleepiness.

Letter Submitted to the Federal Trade Commission on the Inexplicably  High Price of Generic Modafinil Produced by Four Companies

        RE: Anomalous Higher Price of Generic Modafinil than Patented Metabolite, Nuvigil (Armodafinil)

Dear Madam or Sir:
Modafinil is a medication that effectively promotes wakefulness. It has found many uses on and off label. Its patent expired. Regulatory action took place after generic companies were paid to delay producing it, in the FTC’s Pay to Delay matter.  (https://www.ftc.gov/news-events/press-releases/2015/05/ftc-settlement-cephalon-pay-delay-case-ensures-12-billion-ill)

A metabolite (break down product), armodafinil, was patented, as Nuvigil. Its maker priced modafinil higher to promote the sales of Nuvigil. I understand the logic and their right to do so. Modafinil has longer action, and less of a crashing sleepiness effect than armodafinil. Thus, the longer half life of the original molecule, modafinil, may be more desirable to doctors and patients.

What I do not understand is why other companies making generic modafinil would also price it higher than Nuvigil, a product they do not make. Nuvigil (armodafinil) 150 mg has the same strength as Provigil (modafinil) 200 mg.

Prices for 30 pills (according to Giant Pharmacy, 9/21/15).

Modafinil 200 mg, by Par, Teva, Watson (Actavis), and Qualitest: all $1000.

Nuvigil 150 mg, (armodafinil): $670.

There appears to be a concerted effort to control the pricing of modafinil that violates the anti-trust laws.  Why would a competitor not price the perfectly equivalent, or even superior, modafinil a $1 less than Nuvigil and capture the large market for this medication?

Generic modafinil is also made in India. Its retail cost in a pharmacy in India  is 80 cents a pill. People who have taken it report it to be as good as the US medication. No doubt, maker and pharmacist are making a profit at that price.

I request an investigation into this anomalous pricing situation. The argument that these are different medications is specious. Modafinil is converted into armodafinil by the liver. 

I have standing to take the place of my patients in legal disputes (granted by the Third Circuit, in Behar v DOT)

Sincerely Yours,

David Behar, MD

Maker of Provigil and Nuvigil

Teva Pharmaceuticals
41 Moores Road
Frazer, PA 19355

Makers of Modafinil (generic Provigil)

Par

http://parpharm.com/

300 Tice Boulevard
Woodcliff Lake, NJ 07677
 (201) 802 4000

Teva

Teva North America
1090 Horsham Road
North Wales, PA 19454 USA
888-TEVA-USA (888-838-2872)

Watson (now Actavis)

 Morris Corporate Center III
 400 Interpace Parkway
 Parsippany, NJ 07054 USA

 862-261-7000
 Fax: +1-862-261-7914

Qualitest

3241 Woodpark Blvd
Charlotte, NC 28206
704-598-5011

On the 80 Working Hours a Week of Residents

Banned on left wing blog and propaganda outlet, KevinMD. A resident discussed limits of resident time. So here is a reply to this post.

http://www.kevinmd.com/blog/2016/04/how-duty-hour-restrictions-are-hurting-residency-training.html

The answer, as usual, is freedom and technology.

They say it takes 10,000 hours to become proficient at a skill. One may reach that time in 2.5 years or 5 years. If one's income as a surgeon is $400,000 a year, the difference is worth $million.

The best would be to allow a choice.

Being sleepy is as great an impairment as being drunk on the job.

Although I oppose regulation, I support a regulation making all employers provide places and times to take naps up to half an hour. The time should be returned to the employer by staying after others have gone home, or by coming in earlier.

I also support the provision of modafinil over the counter, so it may replace caffeine. It is 100 more effective at promoting productive wakefulness, and has 1/100 the side effect of caffeine. I intend to submit a Citizen Petition to the FDA to allow it over the counter.

I have filed a regulatory complaint because generic modafinil costs $30 a pill in the U.S., even though made by 4 companies. It costs 80 cents in India, and is over the counter. No doubt the pharmacy and the maker are still making a profit at that price.