Monthly Archives: August 2014

FDA signals that nothing is ever “substantially equivalent”

by Carl V Phillips

The FDA Center for Tobacco Products (CTP) recently ruled on “Substantial Equivalence” (SE) applications about a group of smokeless tobacco products in the Ariva/Stonewall family. They ruled that these are not substantially equivalent to predicate products, which is an Orwellian way of saying they are banning them. In a week filled with bad news about supposedly health-oriented organizations threatening people’s health and welfare with anti-THR lies, this perhaps passed unnoticed by many. It should not have. It is by far the worst news of the week for Americans. We are still trying to make sense of the details as they relate to the particular products (note all the complexities below), but one implication is clear: FDA plans to use the SE process to block the introduction of THR products. Continue reading

The biggest victims of WHO’s anti-harm-reduction efforts are in India

by Carl V Phillips

Tobacco harm reduction supporters and vapers have been (rightly) incensed by the World Health Organization’s (aka The Organization WHO Must Not Be Named) recent disinformation about e-cigarettes and proposed policies that would inappropriately restrict them. But there is good news for >99% of those of you speaking up about this: You live in a country where an extremist cabal at the WHO has limited influence. Not so for the unfortunate citizens of India and neighboring countries. Continue reading

WHO responds to criticism over e-cigarettes with attempted censorship

by Carl V Phillips

My previous post should have sat at the top of the page for the rest of the day, or two, because it is important (so please read it), but this is breaking news that I wanted to report on.

As many readers know, the World Health Organization (WHO) came out this week with an attack on e-cigarettes which presages them trying to pressure governments into acting against e-cigarettes. CASAA has not tried to address this in detail because (a) most of what we would have to say is generic observations of how many of the claims are wrong and proposed policies are bad, and we have already done that in other contexts, and (b) it seemed a reasonable division of labor to leave this to European supporters of tobacco harm reduction because we had to deal with the CDC and FDA this week. One of the Europeans who took on the WHO was Clive Bates, including with these posts. In response to Bates’s challenge to them, WHO did not pause to consider that they might be wrong and doing harm, nor did they try to defend themselves substantively. Instead, they threatened legal action against Bates. Continue reading

FDA is complicit in CDC’s lies; grossly inappropriate behavior for a regulator

by Carl V Phillips

The neglected half of the story about CDC’s latest lies about e-cigarettes — and it is fully half of what is important, at least — is FDA’s complicity in it. As I recounted in the last two posts, and Brad Rodu expanded upon, the latest CDC claims about kids’ use of e-cigarettes are based on a shoddy and misleading study (presumably intentionally so). It is full of lies in itself, and those were then further exaggerated and made more inaccurate in CDC’s press release. It is certainly not acceptable that our government officials at CDC are acting as blatant propagandists for a special-interest position. It is probably illegal and is certainly unethical. But we have come to expect this from CDC — they have been one of the leading anti-THR liars for 15 years. It is far more troubling that the agency that is supposed to be the impartial regulator of such products, FDA, is complicit in the lies. Continue reading

CDC press release about e-cigarettes: blatant lying by government officials

by Carl V Phillips

Yesterday I peer reviewed the latest journal article about by CDC and FDA about kids’ use of e-cigarettes, pointing out the massive methodological flaws, inaccurate conclusions, Orwellian language, and overt political advocacy that it contained. I mentioned CDC’s associated press release, but did not go into details. But the press release is arguably a far greater crime (and that is not hyperbole — it is criminal for the US government to lie to the people), and calls for a post of its own. Continue reading

CDC refines their lies about kids and e-cigarettes

by Carl V Phillips

I will interrupt my series on the failures of peer review to look at a great example of the failures of peer review, a new broadside (I hesitate to call it a study) from the CDC that appears in Nicotine and Tobacco Research, an alarmist piece about kids’ reported use of e-cigarettes.  Here is the official abstract at the paywalled journal page.  And here is a bootleg copy of the full manuscript (the US government does not let you hide your work behind paywalls if it comes from taxpayer-funded grants, and so I am not going to let them do it when we are paying for it directly). Continue reading

What is peer review really? (part 2)

by Carl V Phillips

In the previous post, I pointed out how the system of journal peer review that dominates in health sciences is a relatively new invention that is already obsolete and has been abandoned by more serious sciences.  In spite of that, there is an idolatry of that system results in a lot of harm, caused by those who mistakenly believe that “in a peer-reviewed journal” means “correct”.  While it genuinely baffles me that anyone needs to have the falsity of that equivalence explained, the reality on the ground shows it is apparently needed.  In this post I will start to make more concrete the observations about the limitations of the system in the form of a series of myths. Continue reading

What is peer review really? (part 1)

by Carl V Phillips

[Update: Index of this series:

Some related posts:

You can also click on the “peer review” tag for more still.]

In this series I am going to jot down some observations I am building into more formal presentations about the nature of peer review in the health sciences, and in to tobacco subfield in particular.  This is, in part, motivated by my observations about the FDA’s apparent relationship with the corpus of scientific evidence in CASAA’s comment on the e-cigarette deeming regulation, in which they acted as if anything stated in a peer-reviewed journal article must be true, whereas the rest of human knowledge does not even exist.  This is not just a problem of false negatives (failing to recognize the vast majority of the useful scientific information that does not appear in journals), though that is the worst problem.  It is also a matter of false positives — they apparently believe that publication in a “peer-reviewed journal” confers some claim of accuracy — on not only the research results but every last offhand opinion in the introduction — that excuses them from acquiring real expertise. Continue reading