FDA shuts down 23andMe

November 25, 2013

Wow!

The Food and Drug Administration has ordered DNA testing company 23andMe to stop marketing its over-the-counter genetic test, saying it’s being sold illegally to diagnose diseases, and with no proof it actually works.

I did not see this coming at all. Guess I was too focused on thinking about informed consent issues.

I originally posted this Jan 09, 2008 on the old blog and reposted it 12/12/2008 with small improvements over the prior version. It has been one of my more popular posts when it comes to Google hits. You might want to check out a personal recipe for opiate based cough remedy as well.


The US Food and Drug Administration (FDA) began sending warning letters to sellers of so called “bio-identical hormone replacement therapy” today according to an AP report. Apparently the claims for alleviating menopausal symptoms are

not supported by medical evidence and are considered false and misleading.

Needless to say, these “compounded” products are being sold without FDA approval. It’s all a conspiracy man! Dang FDA is a tool of BigPharma trying to keep cheap and effective remedies from the public. Noted tool of TheMan(BigPharmaDivision) Abel Pharmboy has a recent post in which he touches on “cosmeceutical” marketing of drugs and the FDA’s authority to regulate cosmetics under

their regulatory authority is in part ordered by the Federal Food, Drug, and Cosmetic Act of 1938 (and subsequent legislation).

soothingsyrup.jpg
source
This reminds me of the glory days of the quack remedy / patent medicine era and today, from the mouldering archives, we take up a Case Report published by A. B. Hirsch, M.D. [“Mrs. Winslow’s Soothing Syrup. American Medical Journal, 1884, 12(11):504-506] which is available from Google Books here. A footnote indicates that this Abstract was read before the Philadelphia County Medical Society on Sept 17, 1884. Ahh, Mrs. Winslow’s . Used for over 60 years by mothers for their teething children.

Read the rest of this entry »

The ONDCP has been twittering up a storm about the release of the latest National Drug Control Strategy document [ PDF ].

The website touts five bullet points:

  • Prevent drug use before it ever begins through education
  • Expand access to treatment for Americans struggling with addiction
  • Reform our criminal justice system
  • Support Americans in recovery

Whether you think the Obama ONDCP has changed quickly enough for your liking or not, there has clearly been a change in the rhetoric compared with past…all the way back to the Reagan ONDCP. Rhetoric such as this….

While law enforcement will always play a vital role in protecting our communities from drug-related crime and violence, we simply cannot incarcerate our way out of the drug problem. Put simply, an enforcement-centric “war on drugs” approach to drug policy is counterproductive, inefficient, and costly. At the other extreme, drug legalization also runs counter to a public health and safety approach to drug policy. The more Americans use drugs, the higher the health, safety, productivity, and criminal justice costs we all have to bear.

…differs very clearly from the prior ONDCP approaches. Even McCaffrey, as conversant as he was with the science*, still leaned heavily toward the punitive side.

Naturally, I am best pleased that they have a section entitled “The Science”:

Throughout much of the last century, scientists studying drug abuse labored in the shadows of powerful myths and misconceptions about the nature of addiction. When science began to study addictive behavior in the 1930s, people addicted to drugs were thought to be morally flawed and lacking in willpower. Those views shaped society’s responses to drug abuse, treating it as a moral failing rather than a health problem, which led to an emphasis on punitive rather than preventative and therapeutic responses.

And I would say that we still labor under a great deal of resistance, even though the hard edges may have morphed. We hear people trying to parse “only psychological” addiction from “physiological” addiction…what is this if not more of the “moral failing” argument? We also have attempts to define some substances (and non-substance reinforcers) as being out of consideration for genuine addiction…..again, a similar discounting of the science related to addiction. If you grasp the fact that addictions are disruptions of reward pathways, and that there are a limited set of final-common-mechanisms for reward in the brain then it is no surprise that anything which trips the reward triggers has the potential to cause disruption.

Today, thanks to significant advances in neuroscience, our Nation’s responses to drug abuse have begun to change. Groundbreaking discoveries about the brain have revolutionized our understanding of drug addiction, enabling us to respond more effectively to the problem.

Science demonstrates that addiction is a disease of the brain—a disease that can be prevented and treated, and from which people can recover.

Well yes…buuuuuut. Our ability to prevent and treat still has a long way to go. And this, I recognize fully, contributes to public misunderstanding. After all, if it is a disease, surely we must have very specific and mechanistically coherent treatments, right? We don’t, for the most part, and so skepticism over the assertion of “a disease of the brain” will continue.

__
*He was the first Drug Czar I heard address a scientific audience. He was impressive. They guy that came after him during the Bush administration was…not.

Fascinating.

The dog botherers always insist the dog attacks are due to “bad owners”. And that presumptively “good owners” will never have a dog that attacks or kills anyone.

We’ll leave aside their denialism about their own doggy’s noninjurious but threatening behavior and the inherent circularity of their argument for now.

The interesting point is what it takes to be a “good” owner. You have to train and “socialize” the dog. Control it. Keep it in the right circumstances. Train toddlers how to “approach it properly”. Leash it. Lock the gate. Etc. never let down your vigilance for one little second.

What is all of this but a frank admission that these alleged domesticated animals are INHERENTLY dangerous to other citizens? If they weren’t, the only problem would be “bad owners” who actively train the dog to aggress.

R.I.P. C. Everett Koop

February 25, 2013

via Wikipedia

For those of us of a certain age, Dr. C. Everett Koop will always be the iconic Surgeon General of the United States of America.

For me, the reasons that he was also a great Surgeon General is summed up in these few lines in the ABC News item on Koop’s passing.

Koop carried out a crusade to end smoking in the United States; his goal had been to do so by 2000. He said cigarettes were as addictive as heroin and cocaine. And he shocked his conservative supporters when he endorsed condoms and sex education to stop the spread of AIDS.

These were both very, very important things for the nation’s top health official to do at the time. Especially when the President himself couldn’t bear to say “AIDS” in public and many people still believed that smoking was just a ‘habit’, that low-tar and filtered cigarettes were safer and that the link to cancer had never been “scientifically proven” anyway.

RIP Dr. Koop

Go Team!!!!!

February 3, 2013

I’ve decided I am rooting for neuronal survival during the NFL SuperBowl today.

Go #teamneuron!

Via the New Zealand Herald:

A boy who almost died of tetanus before Christmas is home and on the mend, but his parents are desperate for others to vaccinate their children after they did not.

Auckland couple Ian and Linda Williams thought they had made an informed decision against immunising their three children because of concerns over adverse reactions.

But they regretted their decision when middle child Alijah contracted the potentially fatal disease just before Christmas, and was put in an induced coma on life support at Starship hospital.

They immediately immunised their other children and wrote to Alijah’s school to warn parents who had not vaccinated against the disease and others such as whooping cough.

“It was me that put my son in this situation,” Mr Williams said.

Yes, yes it was. Don’t let it be you who does the same, people. Vaccinate, vaccinate, vaccinate.

h/t: bengoldacre

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