Tag Archives: FDA

Updates: FDA, ACS, and CASAA

Posted on 25 May 2013 by | 2 Comments

by Carl V Phillips

A few days ago, we reported about FDA CTP’s moves toward reducing the anti-THR lies in their public statements and otherwise shifting toward supporting the public interest.  I missed an important change that had appeared a week before, the elimination of one of the most blatant anti-THR lies to appear in FDA materials, one that stated an out-and-out falsehood that could not be cloaked in terms of being technically true like the “tobacco” conjunction lie emphasized in the previous post.

(The conjunction lie is to create a list that includes one bad exposure and implicitly blame everything on the list.  Example:  “Car and plane crashes are the leading killer of young people in America.”  Of course that toll is approximately 100% from car crashes, so it is a lie because it implies that plane crashes contribute importantly.  Similarly, anytime “tobacco” or some other conjunction of products is blamed for the toll from inhaling smoke, it constitutes the most common anti-THR lie.)

At this page, this older statement:

 To date, no tobacco products have been scientifically proven to reduce risk of tobacco-related disease, improve safety or cause less harm than other tobacco products.

was replaced with this:

To date, no tobacco products have met the requirements that would permit them to make claims of reduced risk or harm to users and nonusers of their regulated tobacco products. These requirements were put in place so that American tobacco consumers are not misled about the harms of tobacco products.

To provide context, this appears on a page title “Health Fraud” — rather ironically, given that the old statement was about as clear a fraud against health that someone could ever perpetuate — which contains information that is really directed at merchants of low-risk tobacco products.  It tells them that they are forbidden from telling anyone that everyone with half a clue knows that those products are much less risky than smoking.  That is obviously bad for public health, but it is true — they are forbidden.  However, this is presented in a child-friendly format that seems to be directed at consumers.  Given the “if you see… contact us” statement at the bottom, it seems that FDA is channeling the Stasi.

But though it seems unlikely they recruited any informants that are not already paid by the tobacco control industry, they did succeed in misleading a lot of consumers.  In fairness, it seems reasonably likely that whoever wrote the first version of this page was trying to communicate the message that was properly clarified in the second version.  But obviously the original author failed to communicate the truth to an unforgivable degree.  (Unforgivable, but not difficult to explain:  Many FDA careerists clearly do not understand the fact that there is a huge difference between “no scientific evidence” and “no FDA approval”, nor do they understand that “FDA approval” is not the same as “proof” of anything.)

Some observers still do not like the new message.  It would certainly be more precise and truthful to say “we have not approved any ‘modified risk tobacco product’ applications” or “we have not agreed to accept any such claim.”  The actor-free version of the statement, as if the institutional author of the web page is not the one making the decision and it is somehow an existential phenomenon, is rather misleading.

Also, attributing the MRTP requirement to a genuine concern about public health seems like rather a stretch, given that it was crafted by a coalition of cigarette manufacturers and anti-tobacco extremists.  But I trust that anyone seeking the truth already knows to pay no attention to “we were doing this to protect Americans” claims, whether about “public health” efforts to tax soda, ban salt, or ban e-cigarettes, or about drone aircraft assassinations, or subsidizing alternative electricity generation, or reading people’s emails; so that is kind of just a throw away.  (Note to readers: If you find yourself having a conversation with someone from another political “tribe” about such points, you should be able to identify something from this list where they agree that the government claims about doing something to protect us are bullshit.  Use that!)

But to circle back, let’s not let the details of the analysis distract from the main point:  FDA replaced a prominent, explicit anti-THR lie with something that is basically accurate.  Kudos.

By contrast, the American Cancer Society continues to damage public health.  As explored here extensively (like back from here), ACS is leading the fight to block state laws that would ban the sales of e-cigarettes to minors.  This seems to be because they want to create a situation where lots of kids are using them as an excuse for restricting adult access to these lifesaving (and cancer-eliminating) products.

Their most recent “victory” came in Oklahoma on Thursday, when such a bill was voted down.  This case is a bit more complicated than the Rhode Island or Arizona cases noted in the previous posts — there was some tinkering with the tax laws built into the bill also.  This bill was originally written by R.J. Reynolds and included provisions that would have given them a competitive advantage over other e-cigarette merchants (which CASAA opposed because we believe diversity in the marketplace is in the best interests of the consumer). CASAA worked closely with the sponsor to remove the provisions that would have favored RJR over its competitors.  (For those who do not know, this is typical — most bills are crafted by stakeholders and other interested parties, not by lawmakers themselves.  Though many merchants do support consumer-friendly bills in this arena, it is CASAA that is actually working in the legislative process to make sure bills are in consumers’ interests.)

Those of us who had the misfortune to watch the floor debate heard the opponents repeatedly identify nothing bad about the bill, but rather just kept repeating that ACS (and the American Lung Association and the American Heart Association) opposed it, so it must be bad.  After all, we should all trust them, right?

Obviously not.  They are liars who are willing to sacrifice children in order to impose harmful restrictions on adults in a free society.  Something really needs to be done about them.

So, to recap, the scoreboard for the week:

Government: removing lies, moving toward real public-interest stakeholder involvement.

Private “public health” charities: blatantly lying, ensuring children’s access to nicotine, trying to create harm in order to impose severe restrictions on the public.

CASAA and other real public health consumer advocates:  Got FDA’s attention and action.  Lost the final vote in Oklahoma, but killed the anti-competitive original version which mattered more in the long run.

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Credit where due: FDA

Posted on 22 May 2013 by | 5 Comments

by Carl V Phillips

I’m back.  Sorry for the long absence — for obvious reasons, the blog loses out to paid work, family vacation, and (the only bit that is actually of interest to you) preparing a presentation for and attending the Tobacco Merchants Association meeting last week.  A bit more about TMA in a later post.  Today I want to focus on what was said about and by FDA at that meeting.

First, the good news:  In a presentation at the meeting, the head of TMA, Farrell Delman, pointed out that FDA had changed their website in a few places to make clear that the CDC estimated deaths from smoking are from smoking and not tobacco.  (I did not note which specific pages Farrell showed in his talk, but here (pdf) is one example I just found.)  As regular readers know, blaming “tobacco” or “tobacco products” for the risks from smoking is probably the most pervasive anti-THR lie.  It perpetuates the misperception that smoke-free tobacco/nicotine products create a substantial health risk.

Unfortunately, the change is not universal, but I will choose to embrace Farrell’s optimism for the moment.  We can hope that the remaining instances of the misleading “tobacco” bundling language are either dated info releases that would not be appropriate to change (the government is really not allowed to memory hole past statements) or places where they have just not yet noticed they need to make the change (like here or the sidebar here — hint, hint!).

And, of course, no doubt if you followed those links you noticed various other bits of anti-THR misinformation that still remain.  But any steps in the right direction are good news.  Pervasive myths are not fixed in a day.

Also on the frustrating side was the continued emphasis, as seen in the presentation of David Ashley, the CTP science chief, of the supposed possibility that low-risk products could lead to an increase in total population health risk by attracting new users who avoid smoking because of the risks (my liberal paraphrase of a couple of much less detailed bullet points).  Simple arithmetic shows that is impossible, but FDA has to emphasize it because it is so clearly enshrined in their enabling legislation.  This relates closely to my presentation at TMA, so I will comment more in a post about that (probably at EP-ology, but I will cross-post something here).

Back to the good news:  Mitch Zeller, the new head of the FDA’s tobacco unit (CTP) presented at the meeting and took questions.  So did Ashley.  Kathy Crosby, the new head of communications, had a prominent role in a panel.  The significance of this should not be underestimated.

During the Q&A for Zeller’s presentation, CASAA questioned CTP about the lack of consumer (i.e., the primary stakeholders in all of this) representation in their proceedings.  He invited us to submit a formal request, which we will send today or tomorrow.  It appears certain that this will give us a chance to present the consumer views to CTP in a special meeting.  It is less certain whether we will have a spot on the agenda for future hearings where other stakeholder presentations (industry, etc.) are included, but we are making every effort to ensure that consumers are given a place at the table.  We will keep you posted (and might recruit you to support our request should it seem useful).

In his presentation, Zeller made clear that the top priorities for the CTP currently include the “deeming regulation” that would bring e-cigarettes and some other products under FDA jurisdiction.  (Contrary to what you sometimes read, they are not currently regulated by FDA as a tobacco product, but probably will be.)  Whether this is done in a way that makes e-cigarettes better (i.e., serves the consumers’ interest, as FDA regulation is supposed to do) or in a way that threatens innovation or their very existence (serving the interests of the anti-tobacco extremists, who want to prevent harm reduction) remains to be seen.

Another stated priority is to get through some of the backlog of applications.  Unfortunately this does not matter much for real consumer interests, since as far as we can tell the overwhelming majority of these are just “substantial equivalence” applications by cigarette makers who just want approval for some insignificant change of their products.  It does not appear that there are any “MRTP” applications pending.  (That is the misnamed category that would allow harm reduction claims about a product — it is “modified risk tobacco products”, though the products that really matter are not modifications of existing products, but entire categories that have always been very low risk compared to smoking.  The misnomer itself is an anti-THR lie because it is designed to hide the fact that different categories of products have hugely different risks, though that is not the fault of FDA, but rather of the ANTZ that wrote the legislation that created CTP and their mission.  At least lawmakers changed the ANTZ’s proposed wording that would have completely forbidden any claims comparing low risk products to smoking, an obvious attempt to prevent THR.)  We believe there is at least one MRTP application in the pipeline, though unfortunately it is not for a low-risk product.

And on a less recent note, many of you may recall that FDA rebuffed attempts by the ANTZ at University of California San Francisco to make CTP their own private activist organization by threatening to boycott if stakeholders (in that case, industry) were allowed to even present their views.  (Though, of course, they showed up at the hearing to announce they were not showing up at the hearing.  We cannot expect them to be honest even in their protests, after all.)  CTP did not make any public response to this attempt to subvert the American political system, but they clearly did not give in.

I guess the bottom line is that we are in far from a perfect world, with regard to THR-related regulation, but it looks like a much better world than existed a year ago.

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CASAA’s FDA testimony re “3rd Party Governance”

Posted on 3 April 2013 by | 4 Comments

In “response” to a report by the Institute of Medicine, the US FDA recently held hearings about whether to try to impose “third-party governance” of research.  (The scare quotes refer to the fact that the IOM report was conducted at the behest of FDA, so this is really a “response” to their own initiative.)  The concept is that certain parties cannot be trusted to do honest research, and therefore some more neutral third party should control the research.

This is not a bad idea at the simplistic level of political chatter, and there are efforts by independent parties to do genuine public-interest research (like recent initiatives by CASAA).  But the devil is in the details, and the details are indeed diabolical.  The neutral language is really a stalking horse for anti-tobacco extremists to try to control all of the research, furthering their efforts to censor consumer interests and all other voices in the discussion.  Of course, it is those ANTZ, not the modern tobacco and e-cigarettes industries, who consistently do extremely biased politicized junk science.

Thus, our comments, as presented at the FDA hearing by CASAA Legislative Director, Gregory Conley:

My name is Gregory Conley, and I am here on behalf of the Consumer Advocates for Smoke-free Alternatives Association, known as CASAA.  We are the leading US advocate that represents consumers of low-risk smoke-free alternatives to smoking, including electronic cigarettes and smokeless tobacco, and other consumers who might someday switch to such products.  We are an all-volunteer organization, funded entirely by donations.  Our organization does not take positions on the regulation of cigarettes or smoking, and therefore all of my remarks should be interpreted as referring to research and regulation of smoke-free products and research about tobacco harm reduction.

Research on tobacco harm reduction and smoke-free alternatives should focus on benefiting the primary stakeholder, the consumers.  Therefore, we support the principle of encouraging research that is controlled by third-parties who are primarily interested in informing and benefiting consumers.  However, we believe that the greatest concerns about research that is not done honestly, or is done in ways that do not support the public interest, do not relate to the tobacco or e-cigarette industries.  Recent research on these products – a significant body of which was conducted or directly funded by the tobacco and e-cigarette industries – has been in close alignment with the public interest.  Specifically, it has been honest research that pursued ways to improve the health and well-being of tobacco and nicotine consumers.

By contrast, there is serious concern about research that is conducted and sponsored by another special-interest group, the tobacco control industry, the coalition of organizations and individuals who are dedicated to the elimination of all tobacco and nicotine use.  Because honest consumer-oriented research tends to support tobacco harm reduction, and because tobacco harm reduction is a threat to the tobacco control industry’s business model, they have actively promoted scientific disinformation to mislead consumers about smoke-free alternatives.  This has been documented by researchers for over a decade and our own current research and publications document that this disinformation campaign continues.

Thus, redirecting some research away from manufacturers’ control and to the control of those who are specifically concerned about consumers’ choices and welfare might theoretically offer some modest benefits for the public interest.  To facilitate this, it is important to push back against the efforts to vilify any honest independent researcher who accepts industry funding.  But redirecting research away from the control of the tobacco control industry would be enormously beneficial for consumers and the public interest.  The worst possible scenario would be to use the principle of third-party governance of research to put more research under the control of anti-tobacco researchers who support an extremist anti-tobacco-harm-reduction agenda that threatens the health and welfare of consumers.

The claims that the tobacco industry engages in dishonest research are based on ancient history.  Recent research conducted and sponsored by the several tobacco companies who are actively pursuing tobacco harm reduction, as well as e-cigarette companies that have started to support research, appears to be objective and honest science.  When someone makes claims about dishonest research from the tobacco industry, they never identify any recent example of ethical misconduct, or even bad research.  Instead, their claims are based entirely on events that occurred many years before I was born, actions taken by people who have long-since retired or died.

The industry’s interests are not perfectly aligned with those of consumers.  But the public interest can and should be served by the FSPTCA’s already extensive FDA regulatory oversight.  A large portion of industry-funded research can be carried out by independent researchers who are primarily concerned about consumers, and about doing the best possible honest science.  In addition, the few in-house industry research operations appear to be very interested in doing the best possible honest science, and in considering the health of consumers even when it does not align perfectly with maximizing profits.

Thus, we believe that the public interest could be served by the creation of some consumer-oriented third-party institutions that conducted research that was funded by the manufacturers.  However, the status quo with respect to manufacturer-sponsored research is closely aligned with the public interest, and thus no major changes are demanded.

By contrast, anti-tobacco activists have a consistent record of publishing false and misleading claims meant to discourage would-be smokers from using low-risk alternatives instead.  This extends to the scientific research they conduct or control through their vast funding network.  Unlike the allegations about manufacturers’ supposed hidden manipulation of science, which are based on speculation and innuendo, it is easy to observe misleading research coming from anti-tobacco activists.

Common tactics include:

  • suggesting that trivial risks and exposures from smoke-free products, which have no serious health consequences, are similar to the risks from smoking;
  • denying the existence the overwhelming evidence about the efficacy and effectiveness of tobacco harm reduction products;
  • starting with the premise that tobacco harm reduction is bad, and merely reporting that premise as if it were the result of a study.

Researchers have documented that these and other anti-harm-reduction lies from tobacco control were common a decade ago, and they have increased in volume since then.  Frequently they appear in journal articles and other research reports.  CASAA has a blog that is devoted to identifying this misleading research that runs contrary to the public interest.  We analyze several examples every week, and are forced to ignore many others due to the sheer volume.

The goal of third-party governance is to take control of research out of the hands of special interests who are likely to bias the science and otherwise act contrary to the public interest.  We understand that the FDA does not have any authority to redirect funds away from these misleading and harmful efforts by anti-harm-reduction activists, and we would not advocate for the violation of free-speech rights that such a government confiscation would entail.  However, the spirit of third-party governance says that FDA, and DHHS more generally, should avoid directing any additional research funding toward those activists and activist organizations.

If there is an opportunity to direct research funds, whether they come from manufacturers’ fees and contributions or some other source, to third parties who will do honest science in the interest of consumers and do not support an anti-harm-reduction or other anti-consumer prohibitionist agenda, this would probably have some benefit.  However, the current research practices of manufacturers are not actually very far from this scenario.  To reiterate, the worst possible scenario – in terms of public health, consumer well-being, and honest science – would be to transfer more research to the control of anti-tobacco activists.

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FDA almost kinda sorta following MHRA, almost recognizing THR

Posted on 2 April 2013 by | Leave a comment

by Carl V Phillips

Yesterday, in what was not nearly funny enough that it could be an April Fool’s joke, the US Food and Drug Administration issued a statement that they “may” allow changes to pharmaceutical nicotine product (NRT) labels to reflect a bit of reality.  In particular, the label would not be so restrictive about the period the products can be used and there would not be warnings about simultaneously using multiple tobacco/nicotine products.  Those warnings had many smokers and others convinced, for decades, that violating those protocols put them at dire risk.  Many were convinced that they might as well smoke rather than dare defy the label.

This comes following hearings a few months ago where several of us from CASAA found ourselves in the odd position of testifying on the same side as the pharmaceutical companies.  We were arguing in favor of explicitly allowing long-term use of low-risk nicotine products like their UK equivalent, the Medicines and Healthcare products Regulatory Agency (MHRA), already does, with the recognition that this would also tend to open the door for recognition of other THR options.

First, the bad news:  The unit of FDA that oversees NRT and made this move is the Center for Drug Evaluation and Research.  They are not the unit with the authority to regulate all other tobacco products, the Center for Tobacco Products, and so nothing about this extends beyond NRT except in spirit.  Additionally, the very weak move does not go nearly as far as the MHRA.  The language will still insist that the products should be used only in pursuit of nicotine abstinence.

By contrast, MHRA has approved one NRT product for use as a long-term substitute for smoking, perhaps with no intention of pursuing abstinence (i.e., THR).  This same approval is expected to be granted to other products, including particular e-cigarette products.  (However, though the application process for that is far easier than for a typical drug approval, it is still out of the reach of all but the larger manufacturers.)

Second, the lies:  I will not bother with the boilerplate lies about tobacco use that always show up in writings like this, focusing only on the substance of the statement itself.  FDA states that these particular products do not have “significant potential for abuse or dependence”.  Not only does this indicate their commitment to the bad old model of NRT (“if you use this to become abstinent, you have our blessing and sacred permission, but if you use it, say, just because the effects of nicotine improve your life, then you are abusing it, you evil degenerate”) but it also presents a backhanded indictment of other products by suggesting a contrast.  Since long-term NRT use seems to resemble use of any other tobacco product, particularly e-cigarettes, this implicit distinction is a lie.

The statement also nerfs the recognition that long-term use of these products poses no major health problem by stating, “Consumers are advised to consult their health care professional if they feel the need to use an [over the counter] NRT for longer than the time period recommended in the label.”  But if health care professionals generally had half a clue about this, the move by FDA would be moot.  Those that know the truth have been offering accurate advice about THR (using NRT and other low-risk alternatives) all along.  The others are not going to suddenly acquire any understanding that they currently lack.

Third, the good news.  This opens the door a crack toward the US government to recognizing THR.  It is an embarrassingly small crack, given the accumulated evidence and the move by the British, and is not nearly enough to end the US government’s reign as the worst anti-THR liar in the world, but it is something.

More interestingly, there is an official recognition that the favorite ANTZ bogeyman, “dual use”, poses no harm in itself.  The FDA admits the obvious, that there is “no significant concern” about using multiple products at once.  Of course, the ANTZ will cling to the specific wording:  Since this is a statement about just NRTs, the statement about using multiple products at the same time is phrased in terms of one of them being a pharmaceutical industry product.  Thus, the ANTZ will claim, if someone is using more than one product, and none are made by the pharma industry, then that is somehow still bad.

Yeah, right.

Of course they are going to try that.  It does not mean that the rest of us cannot keep hammering away at the message that the FDA has stated that the evidence does not suggest there is anything harmful about dual use.  (That is, of course, that there is no harm above and beyond any harm from the use of each product in itself, in whatever quantity is being used.  Smoking even a little bit is still far more harmful than just using smoke-free alternatives, though any reduction smoking due to use of the alternatives provides a health benefit.)

So, please recite it with me now, and repeat it often:

The FDA has stated that there is nothing harmful about dual use.

Of course, everyone who is not a liar or one of their useful idiots already knew that.  It is obvious, and there has never been any reason whatsoever to believe there was any harm generated by mixing products from two categories, any more than there was about mixing cigarettes from different packs.  Still, it is fun to say that this knowledge is now “FDA approved”.

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