New Yorker magazine carries an article (full text available to all) about a young self-made billionaire whose success was partly due to having put in the effort to learn Mandarin while in high school.
Separately, the article covers the question of whether people will benefit from being able to get blood tests more easily and cheaply, e.g., without having to first visit a physician and without having a vein opened up. A doctor friend says “Never order a test unless you know what you’re going to do with the answer.” If he is correct then generally we will not be healthier if we get more numbers more frequently. The article also covers the question of the extent to which the FDA will regulate vertically integrated blood testing labs differently than labs who buy their machines from third-party vendors.
Regarding the second question, I queried a friend in the pharma industry. Here’s what she had to say…
A couple of things struck me, the first being the powerful friends/supporters that she has on her Board. I really do believe that this has insulated her from some rather obvious scrutiny. The second was the FDA representatives who appear to not have a clue regarding their own regulations.
If a product is labeled, promoted or used in a manner that meets the following definition in section 201(h) of the Federal Food Drug & Cosmetic (FD&C) Act it will be regulated by the Food and Drug Administration (FDA) as a medical device and is subject to premarketing and postmarketing regulatory controls.
A device is:
“an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:
- recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
- intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
- intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes.”
This part of the CFR details the Quality System Requirements for all Medical Devices. In the scope section it states: “(a) Applicability. (1) Current good manufacturing practice (CGMP) requirements are set forth in this quality system regulation. The requirements in this part govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use.” (Theranos is utilizing these devices for the diagnoses of human ailments, so this should be applicable.)
This section of the Code of Federal Regulations discusses exemptions for diagnostic devices, and specifically states: “…must still submit a premarket notification to FDA before introducing or delivering for introduction into interstate commerce for commercial distribution the device…” and goes on to list circumstances and applications which appear to fit the description of this application.
I think the crux of the argument here is the interstate commerce clause, however the argument could certainly be made, and I think effectively, that because this device is being utilized as a diagnostic tool in multiple states, Theranos has definitely crossed the line into interstate commerce.
Related:
My son is a pretty fluent Mandarin speaker – he studied it in high school and college and lived in Shanghai for a year. However, he has not found a way to monetize it. We get great service at Chinese restaurants but it hasn’t turned out to be a way to make a living (for him). After all, there are a billion people who speak Mandarin, so it is not exactly a rare skill. Even the number of people who speak both Mandarin and English (or Engrish) must be in the millions. Westerners who speak Mandarin are more rare but there are lots of Chinese-Americans who speak both languages.
A former co-worker, a Windows sysadmin, spent his days in a windowless room, ate exclusively from fast food or cellophane wrappers, and smoked. He told his doctor that he felt listless and requested a check of his Vitamin D. The doctor diagnosed him with depression and recommended psychoactive medication. The co-worker said “Humor me: just test my Vitamin D”. It came back extremely low, so he started taking vitamins and feeling dramatically better.
” If he is correct then generally we will not be healthier if we get more numbers more frequently. ”
I don’t think the point is for individuals to get tested more frequently but that the fraction of people in the population who get tested increases. At the simplest level, the test results are simple to understand. Every test I have had always gives an OK range and will flag the parameters that are out of range. So, what you do with the test results is if you are out of range go see a doctor.
I had been feeling less energetic for a few months before a recent check-up with my doc. I asked him to check my testosterone. He did and said the results show that I have the testosterone of a teenager! He advised that I increase my protein intake and reduce my sugar intake. It seems to be working.
To get meaningful measures of most vitamin and hormone levels you have to take multiple samples at different times over days. Also, the quality of many lab results are highly questionable. People draw blood and send the vials to multiple labs and get back dramatically different assays.
Bloodwork is much harder to use than people think. If you’re curious the people who have all this stuff figured out and written up are drug using body builders.
For a fluent English speaker, the expected financial return of learning another language is very small. The numbers I saw (sorry, no cite at hand) were persuasive–as in persuaded me not to consider learning Mandarin or Arabic just to have them in inventory on the off chance that I could sell that shipload of widgets to a foreign buyer.
This comment assumes there is not an expected need to know a certain language.
If you’re going to be dealing with Shanghai on a regular basis, that’s a different situation.
From the ages of 26 to 28, I faithfully studied Spanish about one hour per day on my own, plus several night classes, several months with a private tutor, and 8 weeks at a full-time in-residence total immersion program. After two years, I tested at a Level 2 (out of 5) on a government aptitude test. That’s not very good, but passable. After the total immersion program, I was actually beginning to dream in Spanish, and the first words out of my mouth were in Spanish upon a visit to my mother. It’s been over twenty years since then and I haven’t kept up with the training and have lost much of my limited ability.