Common Sense: American Scientific

The Wall Street Journal on 12/4/2013 published a letter to the editor written by the Commissioner for Food And Drugs Administration, Ms. Margaret A. Hamburg, M.D.

Here is a salient excerpt (Emphasis added):

“The agency's desire to review these particular tests is solely to ensure that they are safe, do what they claim to do and that the results are communicated in a way that a consumer can understand. Without FDA review, any safety concerns are unknown and could potentially lead to patient harm, such as a consumer receiving a false positive or negative result that leads to an unnecessary treatment or delays care.”

So without doctor Hamburg’s review any safety concerns are unknown. What a nonsense! As if the private sector is completely incapable or unwilling to do such reviews as well. Such hypocrisy and pretense!

Big Government Paternalism In Action

An antiquated, Soviet-style agency, the FDA, has come out against 23andMe. See, e.g. here (Subscription only, Wall Street Journal). I could not verify it quickly, but I believe the germane letter from FDA to 23andMe is not published yet.

Authoritarian agency of the Progressive Era (early 20th century) collides with 21th century company!

Hundred thousands of the People of Declaration Of Independence fame have ordered such tests and why not! It is our right!

However, “public health experts worry about inaccurate results or the misuse of data outside of the guidance of doctors and genetic counselors” (emphasis added; see above Wall Street Journal article). Let them worry! This is so laughable in a country of the brave and free where individual liberty and responsibility combined with self-government is supposedly the highest ends of the U.S. Constitution as envisioned by the Founders.

The letter from FDA to the company stated something like “the company doesn’t have proper clearance to market the DNA testing kit, and that 23andMe hasn’t sufficiently worked with the agence [bully] to secure such approval. … [FDA] could take more serious regulatory action including product seizure” (emphasis added; see above Wall Street Journal article). The FDA should be shut down ASAP and a start over is necessary!

Scientific American In Defense Of The Nanny State

Just read this article titled “FDA Was Right to Block 23andMe”. What a sycophant (actually “the editor in charge of health and medicine features for SCIENTIFIC AMERICAN”) has written this article and Scientific American published it? Of course, everybody is entitled to their opinion!

Quotes from the above article (emphasis added):

“A few techno-libertarians are up in arms over the FDA’s letter warning the genetics company 23andMe to stop selling its personalized genome services kit. But a quick search of the Food and Drug Administration’s … website shows federal regulators have been targeting various low-cost genetic testing ventures to provide the necessary analysis that goes along with a proper genetic screening for at least the past three years.”
“At present, getting raw data about your personal genome is worse than useless, as Nancy Shute pointed out in a Scientific American article that I edited back in 2012.”
“Cheap sequence data from 23andMe and other gene testing companies has much greater potential to harm without the proper interpretation of the results, which is still quite difficult and expensive in most cases.”

What an incredible condescension “a few techno-libertarians” or “Cheap sequence data”!

Oh, the editor wrote an article back in 2012 which we are to believe is her qualification for her conclusion. 2012 is already stone age in terms of the Internet Age or genome science.

Genetic Testing Without Analysis

This is obviously a non sequitur argument!

I have no doubt that companies like 23andMe would provide any possible and reasonable analysis (perhaps at an extra price) any time.

Why can I as a customer not find someone to interpret the results for me? Why can I not try to interpret/analyse the results myself, because I am not a physician?

Too Many False Positives

This could possibly frighten or confuse customers so the pseudo justification by the FDA. First of all, is it really true? Sounds like typical paternalism to me!

New Territory And Trial And Error

Genetic sequencing and analysis is still in its infancy. This is only the beginning!

We are here in unprecedented, unknown territory with such affordable genetic tests. However, the more tests we have, the better, the cheaper, the higher the quality, the greater the probability we will be able to analyse them.

This is obviously a trial and error process! Big Government stay out of it as much as possible! Let the People decide!

It is probably imminent that computers will be able to analyse those test result for us!

As An Aside

23andMe is a company co-founded by two women. Someone may tell European politicians that gender quotas are stupid!

Thursday, November 07, 2013

Scientific American Is A Scaremonger

Update As Of 11/24/2013

Here is another one of those scare articles titled “Only Half of Drugs Removed by Sewage Treatment/

Only about half of the prescription drugs and other newly emerging contaminants in sewage are removed by treatment plants says a new report”. This one is from the same source again (see below), i.e. Environmental Health News (EHN).

Again, the underlying report is not linked in this article, but the original article by EHN contains a link to original source (here). However, the report is only available to subscribers.

The original EHN article contains a mix of information from interviews, different studies, but with a strong tendency to raise alarm.

Apparently from an interview with the lead author of the underlying study we learn “The compounds show up in low levels – parts per billion or parts per trillion”. We do not learn whether this extremely low level is above any legal or regulatory thresholds.

Somewhere in the middle of the EHN article it is mentioned “Chemicals’ showing up in wastewater effluent doesn’t necessarily mean they will be found in drinking water.”

More could be said about this Scientific American/Environmental Health News article, but for brevity sake I will stop here.

The detection of medical drugs or household chemicals etc. in water after sewage treatment has become a hot topic. Thus, vetting and due diligence in news reporting is paramount to avoid unnecessary alarmism and sensationalism.

A Remarkable History

This popular science magazine has an impressive history going back to 1845. It is owned since 1987 by the renowned German publisher Holtzbrinck group. Many famous scientists, including Albert Einstein, have contributed articles in the past.

Strongly Biased Towards Environmentalism

Over time, I have noticed multiple times that the online American Scientific has an environmentalism bias. A strong one too. If you don’t believe me check out this one.

Recently, I have come across these two alarmist articles in Scientific American:

Both are published by “Environmental Health News”. Both are intended to raise immediate fears by parents just by reading the strongly worded title. Both cited studies appear to have severe issues in terms of rigorous scientific methodology, e.g. representativeness (small sample size) and so on. Both do not link to the original study underlying the article by the “Environmental Health News” service. Both do not link back to the original article at the source (i.e. Environmental Health News).

For brevity sake, I will stop here even though more could be said about this shoddy, tendentious journalism.

Vetting And Double-Checking Sources

Any reputable publication should apply reasonable efforts and diligence to verify their sources and to properly cite sources.