Regulatory activities

Cannabis and cancer

This HND piece continues the discussion of the medical effects of cannabis. In this piece, we examine Cannabis and cancer, and cite a few positive studies.

There are demonstrated anti-tumor properties, as well as effects against the nausea and vomiting often induced by chemotherapy. Ironically, there are two FDA-approved drugs for the nausea/vomiting indication, which are nothing more than synthetic versions of the naturally-occurring chemicals in Cannabis. Yet, Marijuana is a Schedule I drug (the worst classification), and one of the first drugs classified). Note that Schedule I drugs are so classified, in part, because they have "no currently accepted medical treatment use in the U.S."

Ah...but who determines what is "medically acceptable"? Surprise, surprise! The entire asinine classification system is 99% politics and 1% science.

Read the complete article.

Impaired driving, SAMHSA, and the DOT: It's...complicated

This HND piece delves into a brief history of how the trucking industry became regulated in 1935, which messed things up so badly that much of it became de-regulated in 1980. Of course, new regs would follow shortly.

This gets us into the bizarro world of required physical exams for truck drivers. Let's be kind and say that the integrity of these exams varies quite a bit. At the bottom are "doctors" who hang out a truck stops, and will basically pass anyone, to legit MDs who...yes...occasionally have to fail drivers, which unfortunately means that they cannot work as drivers anymore.

The other problem is the inconsistency of what drugs they test for, and what drugs are prohibited, but are not tested for.

Read the complete article.

Fixing the VA, fixing healthcare

This HND piece compares the overblown, incompetent management of our Department of Veterans Affairs (and the attendant problems) with overblown, overpaid, and incompetent management of private healthcare institutions.

Naturally, we discuss the absurd "Disney" comparisons made by VA Secretary Robert McDonald, and comment on his less than successful career as CEO of Procter & Gamble. We then segue into some hard-hitting commentary from healthcare reformer Roy M. Poses, MD.

Read the complete article.

FDA follies, part 2

This HND piece is a sequel to part 1.

FDA is one of those agencies that seems to retain a good reputation—outside the realm of people who are actually familiar with how it works. For most who have had the misfortune to deal with it, it is widely despised.

This article delves into the frankly horrific story of diabetes meds, and then segues into FDA's latest failure—the endoscope-related infections. In a sense, this is failure beyond failure, since FDA was finally starting to kick some butt in this affair, only to completely back off.

For an agency that STILL touts its thalidomide victory form the ealry 1960s (while keeping quite silent on the matter of American thalidomide babies), it's time for big changes.

Read the complete article.

Yet more on Chinese drywall

This HND piece starts with a walk down Chinese drywall memory lane, but ends up at a very current case.  An unfortunate Florida homeowner—and we are certain that there are many more like him—got caught up in the state's nonsensical criteria for tainted and corrosive drywall.

In defense of the Sunshine State, it simply went along with the absurd recommendations of the Consumer Product Safety Commission and ASTM.  CPSC chose orthorhombic sulfur (S8) as its qualifying standard, despite plenty of contrary data--and this was data that CPSC paid for, and represented superb analytical work.  Another epic fail from CPSC, and from the once-respected ASTM.  

Read the complete article.


An unethical clinical trial, a leading journal, and the sketchy motives of NGOs

This HND piece is a follow-up to an earlier story describing how three healthcare-related non-governmental organizations (NGOs) are conspiring to undo hard-fought improvements in work rules, pertaining to surgical resident physicians. The NGOs in question are the American Board of Surgery, the American College of Surgeons, and the Accreditation Council for Graduate Medical Education (ACGME).

Now, the research—such as it is—supporting more hours for the residents, has been published in no less than the New England Journal of Medicine.

Mark well that this is a double travesty, in that the research itself clearly violates long-established ethics guidelines, and it being published in NEJM violates the Journal's longstanding policies on accepting manuscripts from human subjects research. In short, this is failure beyond failure, only it doesn't seem to matter. Inasmuch as NEJM surely has no shortage of submissions, it is simply mind-boggling that they would fast-track such crapola.

God knows why the academic surgeon from Northwestern heading up the study would waste his time with this egregious nonsense, or why the editorial board of the Journal has turned into a bunch of feckless Kool-Aid drinkers.

Read the complete article.

Will the Patty Murray superbug/tainted scope report shake things up?

This HND piece covers the devastating report released a few days ago by Senator Patty Murray (D-WA). Murray was dragged into the world of endoscope reprocessing and infection control when famous Virginia Mason Medical Center of Seattle became one of the first hospitals to report deaths related to tainted endoscopes. Who knows how many went unreported?

Making matters worse is that the entire situation reveals epic failure at all levels, not the least of which is the good old FDA. Bear in mind that the processing (cleaning and sterilizing) of these scopes is left up to hospital employees who are among the lowest paid.

Murray's report proffers a number of recommendations, and we comment on these.

Read the complete article.

The only thing we have to fear...are the fear entrepreneurs themselves

This HND piece goes after the absurd—but widely publicized—IARC findings regarding red and processed meat products. Bear in mind that of the 985 substances IARC has tested for carcinogenicity, only one has been put into its Group 4 (Probably not carcinogenic to humans).

Note also that in epidemiological terms, relative risks of 1.18 and 1.17—as are indicated with processed meat products and red meat, respectively—are statistically insignificant, and one wonders why the "experts" at IARC ignored this. Indeed, as a rule of thumb, an RR of at least 2.0 is necessary to indicate a cause and effect relationship, and a RR of 3.0 is preferred.

Compounding this epic journey into junk science, IARC does almost nothing to change the public perception of its ratings. Its classification system does not assess the carcinogenic risk of the given agent, but rather, its rating of the quality of supporting evidence.

Thus, included in the dreaded Group 1 (Carcinogenic to humans) are alcoholic beverages, asbestos, benzene, diesel exhaust, mustard gas, tobacco products, and now...processed meat. However, this does not mean that processed meat is as carcinogenic as tobacco products or asbestos, even if that's what any number of bogus authorities and fear entrepreneurs are now claiming.

The irony here is that IARC has recently been mocked by real scientists for its nonsensical work on formaldehyde. Among other things, it based its cancer assessment on an unpublished and ridiculously flawed and inconsistent study from China. At least, formaldehyde is a chemical with known dangerous properties. But red meat?

Read the complete article.

Yet more mindless attacks on e-cigarettes

This HND piece picks up the baton from a few months ago. Only this time, the State of Indiana is complicit in a rotten crony capitalism scheme, which throws out the more popular closed e-cig systems, in favor of the old-school closed systems.

Surely, it is only by coincidence that the closed systems—favored by Big tobacco—are exempt from the legislation. Yep, just like it's a coincidence that the closed systems aren't quite as good as the open devices at helping people quit smoking.

Maybe some day, the public will connect the dots, and figure out that "public health" is the LAST thing on the minds of the ghouls in charge of government and private public health organizations.

Read the complete article.

Who's watching the watchers: Big problems with ERCP scopes

This HND piece returns to the sadly familiar matter of deaths from contaminated ERCP scopes.

This time, there is another wrongful death lawsuit, and perhaps more importantly, the FDA is now publicly getting involved. So, there's something for everyone! Regulatory screw-ups, manufacturers covering their rear end, and blame being thrown back and forth.

The sad part of this is that it is not exactly "rocket science" to determine—once and for all—the best method to process these scopes. all that's standing in the way is fear, corruption, and a whole lot of money.

Read the complete article.