Regulatory activities

We have a scheduling conflict


This HND piece examines the murky world of Drug Scheduling. While many abuses and inconsistencies could be discussed, we focus on the insane treatment of cannabis—presently part of the dreaded Schedule I. Bear in mind that to be in Schedule I, the drug has "no currently accepted medical use and a high potential for abuse.'

But wait, you say. Everyone has heard of the medical benefits of cannabis extracts. Only that does not really matter, as you will discover. And, that's only the tip of the iceberg. You will also discover how a natural product, CBD, can be shown to have numerous benefits, but is only so recognized if it goes through clinical trials.

Read the complete article.

EPA appears to be backing off from the discredited linear no threshold theory


This HND piece explains the Linear No Threshold Model (LNT), as it is applied to radiation and chemical exposure. This model has been consistently disproven based on practical experience, and—as we describe—ending up being a sort of "fruit of the poisonous tree." That's because when the guy behind this theory was starting to advance it, he already knew that it was bogus.

Neat, huh, especially considering that LNT was advanced during his Nobel lecture, and people who have studied the matter are quite confident that even then he was lying through his teeth. We cite examples of how LNT cannot possibly be true, and evidently, EPA's Science Advisory Board agrees. This bodes well for the future. Or putting it another way, better late than never.

Read the complete article.

E-cigarettes are not a gateway to smoking--they replace smoking

E-cigs_vapingThis HND piece debunks the pernicious nonsense pushed by the prohibitionists that vaping is a "gateway" to smoking. And you thought that the government wanted people to quit smoking. Completely ignoring science (OMG, are they vaping deniers?), they continue to attack e-cigs. Heck, the "enlightened" city of San Francisco has flat-out banned the sale of e-cigs because they know better. So...a city that can't keep human feces and discarded syringes off the streets has a better way. Riiight.

This story brings you the real story, citing numerous studies, and gives the facts behind the findings. As you might expect, the prohibitionists wildly distort the statistics, with all their slicing, dicing, and conflating.

Read the complete article.

Keeping track of toxic exposure

This HND piece examines the activities and technology involved in monitoring exposure to toxic substances. Pioneers of public health introduced this concept around 100 years ago, but it would take official government agencies such as EPA and OSHA to take it to the next level.

OSHA promulgates Permissible Exposure Limits for more than 500 substances, and most of these are based on an 8-hour time-weighted average exposure. Thus, some means of recording this data and calculating such averages is implied--even if such technology was not readily available when these limits were first introduced.

We then segue into some current products for data logging and new developments.

Read the complete article.

A look at drug testing

This HND piece delves into the matter of drug testing, from its beginnings to the present. Millions of such tests are run each year in private industry, sports teams, and for compliance with government regulations. There are some who think it is pointless, but ask them how they would feel if all such DOT tests were eliminated? They would have no problem with an impaired pilot, right?

False positives can still be a problem, including the fabled poppy seeds/opioid detection issue. In rare cases, lab errors can occur. Lab certification is great, but proper education of the employees is also essential.

Read the complete article.

Controlled substances: Who's watching the controllers?

This HND piece focuses on serious vagaries in how a particular controlled substance, CBD, is regulated. The case discussed involves Epidiolex, a CBD isolate recently FDA-approved for certain seizure disorders.

CBD is considered a Schedule I substance, which means that it has no approved medical usage. But, I guess it now does, so what is to be done? Let's just say that what the Feds did pleased the makers of Epidiolex...and no one else. Regulatory politics at its absolute worst.

Read the complete article.

Surrogate calibration in environmental air monitoring? No thanks

This HND piece digs into the matter of calibrating environmental air monitoring instruments. We detail why it's needed, along with the common calibration modalities. After that, we segue into the faulty notion of surrogate calibration.

Unfortunately, surrogate calibration has gained some popularity because it is...expedient. When it's used, it is inevitably because doing the calibration properly is a bit more difficult than the practitioners would like. Trouble is, surrogate calibration can introduce significant error into these measurements.

Read the complete article.

Tampering with tamiflu

This HND piece goes into the sordid tale of how a mediocre antiviral got stockpiled to the tune of billions of dollars, during the past flu scares. What's more, it was added to, and then removed from, the WHO Essential Medicines core list.

Credit the BMJ for keeping up the pressure to get the facts out. The only trouble is that it took several years to persuade Roche to come clean with its "hidden" clinical trials.

Read the complete article.

When institutions fail, whom will you call?

This HND piece describes the continuing failure of such agencies as FDA and CDC to protect the public. Among other things, we quote good friend Lawrence Muscarella on the horrible problem with heater-cooler devices, as used in many open heart procedures.

The inescapable concussion is that if institutions fail, then our last line of defense is...plaintiff's attorneys. But, wouldn't it be better if these bloated agencies actually did their job in the first place?

Read the complete article.

A look at ibogaine

This HND piece puts the spotlight on Ibogaine, a hallucinogenic drug with demonstrated anti-addictive properties. Not surprisingly, these properties were discovered inadvertently by a heroin addict, as he and a group of friends were experimenting with other drugs.

They were astonished to find that they lost their cravings for heroin, and had no withdrawal symptoms, either.

However, being classified as a Schedule I drug, ibogaine is stigmatized, and even if it weren't, ti is a naturally-occurring substance, so there is no inherent interest by Big Pharma. Fortunately, there is plenty of positive literature on the matter, and the powers-that-be are finally taking an interest.

Read the complete article.