Editor of journal Tobacco Control refuses to discuss the issues

[Vocalek]

The FDA will be holding a public workshop in March on "Third party governance". This refers to a section of the Institute of Medicine's report on regulation of Modified Risk tobacco Products (MRTPs) that urged the FDA to require objective third parties to oversee any testing and clinical trials that tobacco companies perform, or have performed, on products they want to submit for approval as MRTPs. Approval would allow them to make marketing claims that their product reduces risks of smoking-related diseases.

Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

A major problem with complying with any of this is that most organizations that conduct clinical trials (e.g., universities, hospital centers, private research organizations, etc.) have instituted policies against accepting funds from tobacco companies. Even if the tobacco companies could organize and conduct the testing themselves, their institution's prohibition against accepting tobacco company money would effectively prevent reputable "third parties" from conducting the oversight.

The editor of the Tobacco Control, Ruth Malone, was invited to be a speaker at the workshop. This was her response.

BMJ Group blogs: TC News and Views Online » Blog Archive » A letter to the US FDA from Tobacco Control Editor, Ruth Malone

I would disagree with this assertion: "Public health advocates (and presumably the FDA) have a stake in saving lives." IMO, consumers have a stake in saving lives. So-called public health advocates such as Ms. Malone have a stake in insisting things be done "my way or the highway." Frankly, I'm not sure what the FDA's Center for Tobacco Products has a stake in. So far I am not convinced that it is in saving lives.

Malone further states, "Tobacco companies have a stake in protecting profits." This is true. However, has it occurred to Ms. Malone that tobacco companies must have a stake in saving lives? Saving lives works to keep their customer-base from dying off. Dead customers don't buy anything.

How confident does Ms. Malone's letter to the FDA make you feel that we will ever be seeing honest and accurate labeling of tobacco products? How confident does this make you feel that smokers will ever be offered a third choice, beyond "quit or die"?

 

[sonicdsl]

Malone further states, "Tobacco companies have a stake in protecting profits."

By that logic, they should not receive funds from BP either, as they also have a stake in protecting profits.

 

[Hulamoon]

In addition to having their so-called 3rd party tests and supposedly clinical trials in Africa and other out of the way locations. ...But that's OK to Malone, eh?

By that logic, they should not receive funds from BP either, as they also have a stake in protecting profits.

 

[mssam]

"Public health advocates (and presumably the FDA) have a stake in saving lives." IMO, consumers have a stake in saving lives. So-called public health advocates such as Ms. Malone have a stake in insisting things be done "my way or the highway."

I'm not sure I would agree that Ms. Malone has a stake in insisting things be done 'my way or the highway.' She seems to have a clear understanding about who she is playing ball with. She clearly states "I would be very willing to come to Rockville and share my perspectives with the FDA on the issue of third parties and tobacco products research. However, I cannot in good conscience participate as a panelist in this “Facilitated Dialogue” with the tobacco industry. Further, I strongly urge that other researchers from the public health community decline participation on such panels. The FDA should consider other means of determining a suitable framework for addressing the many issues related to industry-funded research." This shows she is open to other alternatives than the one she was offered. An offer that was probably originally concocted by BT and whispered in the FDA's ear.

Also, one of her supporting reasons for this decision was "any such discussion among “stakeholders” would require a minimal level of mutual understanding about the nature and purpose of science. However, a large body of academic research based on the industry’s own internal documents, as well as federal Judge Gladys Kessler’s extensive findings of fact in the successful U.S Department of Justice racketeering case against the major tobacco companies, [3] demonstrates that research is an arena in which the tobacco industry is particularly untrustworthy. This fact was also repeatedly noted in the Institute of Medicine (IOM) Report on Scientific Standards for Studies on Modified Risk Tobacco Products.[4] As the Kessler decision found, the tobacco industry engaged in a conspiracy to cover up and distort the evidence of their products’ harmfulness, and they have a long track record of egregious manipulation of science. The courts also found that this behavior is continuing and likely to continue in the future; I see no reason to differ with this conclusion."

Now, considering the FDA is usually a marionette puppet for BT and research is funded by BT; the consumer will not be offered a third choice if BT remains a major stakeholder imo.

 

[Vocalek]

Now, considering the FDA is usually a marionette puppet for BT and research is funded by BT; the consumer will not be offered a third choice if BT remains a major stakeholder imo.

Oh really? That's quite interesting. Where did you learn that? Can you provide links to reports on this collusion between the FDA and Big Tobacco?

Keep in mind that that the goal of this meeting is to determine how best to regulate the development of modified risk tobacco products, as specified in Section 911 of the Family Smoking Prevention and Tobacco Control Act. Link to full text: Full Text of H.R. 1256 (111th): Family Smoking Prevention and Tobacco Control Act - GovTrack.us

The purpose of the workshop is to discuss the recommendation in the Institute of Medicine’s report, “Scientific Standards for Studies on Modified Risk Tobacco Products,” that sponsors of Modified Risk Tobacco Product (MRTP) applications use independent third parties to undertake one or more key functions in tobacco product research (third party governance). FDA is also considering third party governance as it relates more generally to tobacco research. Our goal is to receive input from interested stakeholders regarding features from existing third party governance models that may be applicable to tobacco product research.

Third Party Governance of Industry-Sponsored Tobacco Product Research - A Public Workshop

The law required the FDA to consult the Institute of Medicine regarding what scientific standards should be applied to determining whether a products would reduce the user's risks of disease and death. IOM responded with a detailed report: Scientific Standards for Studies on Modified Risk Tobacco Products

One thing that the IOM report recommended was that the tobacco companies accept independent oversight of their studies to guard against any attempts to "distort the evidence of their products’ harmfulness." This requirement would effectively shoot down Malone's accusations that all the scientists employed by tobacco firms are liars and cheats. Even if they were, the independent oversight (referred to as "third party governance" by the FDA) would prevent such shenanigans.

The main purpose of the FDA's workshop is to overcome the barriers that currently exist to implementing the IOM's recommendations. Malone admits, "Tobacco Control, the journal that I edit, and other reputable scientific journals including PLoS Medicine no longer publish tobacco industry-funded research." So apparently these books don't trust the scientists they select as peer reviewers to do an adequate job.

Results would be even more trustworthy if instead of conducting research themselves, the tobacco companies hired reputable scientific research centers (e.g., universities, hospital groups, professional scientific research organizations such as Battelle or RTI) to conduct the research. However, most of these institutions have implemented a policy against accepting any funding from tobacco companies. So they will also not be accepting tobacco money to conduct the oversight recommended by the IOM.

So where does that leave smokers? If the research never gets done, smokers will never learn that there are tobacco products (they exist today) that carry less than 1% of the health risks of smoking. They will continue smoking, and more than 50% will die of a smoking-related disease.

And not trusting the people that work for tobacco companies is not the real reason Malone doesn't want to participate in a dialog. In her own words:

Fourth, tobacco industry denormalization is a key part of successful tobacco control efforts. Convening a meeting of this sort undermines those critically important efforts by creating a forum for re-legitimation through association with respected public health agencies and leaders. Lending the FDA imprimatur to a public meeting featuring tobacco company speakers suggests that something has indeed changed and the industry is no longer harming people through its promotion of deadly products. But this is patently untrue. And, as we recently showed in an extensive review, a robust body of evidence supports tobacco industry denormalization as an effective population-level tobacco control strategy that contributes to reduced smoking prevalence among young people, reduced youth smoking initiation, increased intentions to quit and reduced perceived peer smoking prevalence. [7] It is very puzzling that the FDA would act in a way that undermines this important work.

The tobacco control cabal has spent considerable effort to completely demonize the tobacco industry, tobacco itself in any form, and tobacco consumers. Their public information campaign has succeeded beyond their wildest dreams. "Smoke-free zones" have become "tobacco-free zones." Where previously laws and regulations prohibited smoking, they are now prohibiting all tobacco use and specifying e-cigarettes are included.

"There is no safe tobacco product" is repeated across the health-related web sites of governments world-wide and those of non-profits that claim to be in favor of preventing diseases associated with smoking. Only now, they claim that "tobacco" causes lung disease, cardiovascular disease, and cancers -- even though there is solid scientific evidence that substituting smokeless tobacco products for smoking reduces the risks of these diseases to the point of being immeasurably small. Furthermore, they managed to manipulate the Affordable Healthcare Act to encourage insurance companies to charge a 50% premium surcharge to "tobacco users," ignoring the fact that there is no actuarial evidence that non-smoked tobacco or use of NRTs or electronic cigarettes increases healthcare costs. Tobacco consumers are considered on par with addicts that populate "shooting galleries" if you get my drift. And judging from some of the comments on stories about e-cigarettes left by non-tobacco users or former smokers that quit cold turkey, this hatred of tobacco consumers is transferred to you and to me.

Admitting that there was a product made by a tobacco company that could serve as a low-risk alternative to smoking would crush not only Malone, but most of her co-conspirators as well.

Our government believes that the companies that might profit from these products should be the ones that pay. If not them, who would you suggest should pay for the research? You?

 

[VapApe]

To mod a quot from the the book Animal Farm all companies are created equal. But some are more equal than others.

Shouldn't BP be held to same standard as BT or higher. We know they don't have a perfect track record.
Pay for a stacked in their favor study.

Market the heck out of it, and settle out of court claiming no wrong doing, and repeat.

 

[someone3x7]

When I read about stuff like this I have to wonder in pure frustration the feasibility of separating the industry from the word Tobacco. Which is to say the feasibility of starting a farm for extracting nicotine from something else. Like belladonna perhaps.

 

[mssam]

Oh really? That's quite interesting. Where did you learn that? Can you provide links to reports on this collusion between the FDA and Big Tobacco?

Of course, go the gas station and buy a pack of marlbro's, newport's or whatever you used to smoke. Now, once you've done that, if you can't see the LINK then let me know. It only requires a little common sense to see that BT is legally allowed to sell a product that kills thousands on an annual basis, and that can only occur if the FDA, which is supposed to have the public's safety at the heart of the their decisions, allows it to happen...

Keep in mind that that the goal of this meeting is to determine how best to regulate the development of modified risk tobacco products, as specified in Section 911 of the Family Smoking Prevention and Tobacco Control Act. Link to full text: Full Text of H.R. 1256 (111th): Family Smoking Prevention and Tobacco Control Act - GovTrack.us

...this is where I think Ms. Malone, and myself, would disagree with you. That may have been the STATED purpose, but it doesn't appear to me to be the real intention. Furthermore, Ms. Malone has the right to refuse to participate in a "facilitated dialogue" with BT and the FDA all in one setting. She clearly stated her reasons for doing so as well. Now, whether you agree with what she chooses to do is entirely separate and your own personal opinion, but the title of the op is a little misleading in that she didn't refuse to discuss the issues. She refuse to sit in a rigged playing field with BT and the FDA. She stated "I would be very willing to come to Rockville and share my perspectives with the FDA on the issue of third parties and tobacco products research."...

Results would be even more trustworthy if instead of conducting research themselves, the tobacco companies hired reputable scientific research centers (e.g., universities, hospital groups, professional scientific research organizations such as Battelle or RTI) to conduct the research. However, most of these institutions have implemented a policy against accepting any funding from tobacco companies. So they will also not be accepting tobacco money to conduct the oversight recommended by the IOM.

So where does that leave smokers? If the research never gets done, smokers will never learn that there are tobacco products (they exist today) that carry less than 1% of the health risks of smoking. They will continue smoking, and more than 50% will die of a smoking-related disease.

...I agree 100%...

The tobacco control cabal has spent considerable effort to completely demonize the tobacco industry, tobacco itself in any form, and tobacco consumers. Their public information campaign has succeeded beyond their wildest dreams. "Smoke-free zones" have become "tobacco-free zones." Where previously laws and regulations prohibited smoking, they are now prohibiting all tobacco use and specifying e-cigarettes are included.

"There is no safe tobacco product" is repeated across the health-related web sites of governments world-wide and those of non-profits that claim to be in favor of preventing diseases associated with smoking. Only now, they claim that "tobacco" causes lung disease, cardiovascular disease, and cancers -- even though there is solid scientific evidence that substituting smokeless tobacco products for smoking reduces the risks of these diseases to the point of being immeasurably small. Furthermore, they managed to manipulate the Affordable Healthcare Act to encourage insurance companies to charge a 50% premium surcharge to "tobacco users," ignoring the fact that there is no actuarial evidence that non-smoked tobacco or use of NRTs or electronic cigarettes increases healthcare costs. Tobacco consumers are considered on par with addicts that populate "shooting galleries" if you get my drift. And judging from some of the comments on stories about e-cigarettes left by non-tobacco users or former smokers that quit cold turkey, this hatred of tobacco consumers is transferred to you and to me.

Admitting that there was a product made by a tobacco company that could serve as a low-risk alternative to smoking would crush not only Malone, but most of her co-conspirators as well.

Our government believes that the companies that might profit from these products should be the ones that pay. If not them, who would you suggest should pay for the research? You?

...yeah, yeah, yeah. I don't consider e-cigarettes tobacco products simple because there is nicotine in the e-liquid that is a part of a personal vaporizer. I would agree with someone3x7, in that the word tobacco should be removed and separated from e-cigarettes. E-cigarettes should probably be classified as vaporizers, or personal vaporizers, and left at that. There are plenty of products on the market that have an ingredient from a plant, but are not considered the plant itself. To consider e-cigarettes a tobacco product is to tip the scale in favor of BT...

 

[Vocalek]

I'm sorry, my dear, but the fact that the FDA hasn't banned the sale of tobacco cigarettes at your corner gas station does NOT prove that the agency is in cahoots with the tobacco industry. Far from it. The FDA is doing its best to prevent smokers from being able to switch to less hazardous products such as snus, dissolvables, and e-cigarettes. Somehow it doesn't occur to the FDA, or to the Malones of the world, that keeping the fact that there are lower risks products a big fat secret perpetuates smoking and thereby perpetuates the sickness and death related to smoking.

I suggest that you (and Ms. Malone) read the Tobacco Control Act carefully. Full Text of H.R. 1256 (111th): Family Smoking Prevention and Tobacco Control Act - GovTrack.us

The FDA is following the law that they have been given. The Tobacco Act does not permit the FDA to ban all tobacco cigarettes or to reduce their nicotine content to zero.

Given the guidance that the FDA issued for approval of MRTPs, I believe that the FDA is very cleverly avoiding the intention of the law to provide smokers with less hazardous options. If Ms. Malone doesn't see that, they she has not read the FDA's Draft Guidance Document. Modified Risk Tobacco Product Applications: Draft Guidance for Industry

Since FDA has made the requirements so complex, they can smile and tell Congress, "Yes, of course we are following the law" while they chuckle as they pass the "Tobacco-free Zone" signs posted all over the FDA offices. Those signs, by the way, also specify that use of e-cigarettes is prohibited, along with smokeless products. They haven't started to institute mouth inspections of staff and visitors yet, so I'm no sure how they can enforce their prohibition.

If Ms. Malone can't see that, she is blind as a bat.

You realize, of course, that even though the tobacco industry has 3 seats on the Tobacco Products Scientific Advisory Committee, they do not have voting rights. They are there mostly to answer any questions the FDA might have about their products.

Even though you don't consider e-cigarettes to be tobacco products, Ms. Malone does and so does the FDA. They are adamantly opposed to e-cigarettes because allowing smokers to switch to ecigs upset their master plan to keep kids from starting to smoke by killing off their parents, grandparents, aunts, and uncles who smoke. They plan to accomplish this by:

• Keeping the information about lower risk products a big secret from smokers
• Lowering nicotine levels as much as they can, making tobacco cigarettes even more hazardous because smokers smoke harder and faster to get the nicotine they need.
• Once all the smokers are dead, their problem is solved.

And you think the tobacco companies are evil! Hah!

P.S. The playing field is rigged all right. It is rigged against consumers of tobacco and nicotine products.

 

[teissenb]

For the record, it is Dr. Malone.

 

[mssam]

My apologies, Dr. Malone...

 

[the_vape_nerd]

vocalek and mssam...i think this back and forth between you two is informative..kudos to you both for keeping your disagreement respectable and not getting personal

 

[Petrodus]

Since FDA has made the requirements so complex, they can smile and tell Congress, "Yes, of course we are following the law" while they chuckle as they pass the "Tobacco-free Zone" signs posted all over the FDA offices. Those signs, by the way, also specify that use of e-cigarettes is prohibited, along with smokeless products. They haven't started to institute mouth inspections of staff and visitors yet, so I'm no sure how they can enforce their prohibition.

The FDA is on a mission ... !!
I speculate the regulations they will reveal in April
were chiseled in stone ... Last year
and they were not happy when told they were
to hold off regulating until AFTER the Election !!

 

[TTK]

For the record, it is Dr. Malone.

Is it an MD, PhD,JD or EdD, or what? I don't much care for Dr. preceding a name in print because you can't tell just by that prefix. Malone, MD would be fine if that is true. I am a Dr too, but PhD, so I don't use the Dr. preceding my name because of the confusion factor. On any given subject, it can be important to know.

Edit just to add: Even for a person who has a doctorate, it is not improper to call them Ms. or Mr. or Mrs. etc.

 

[teissenb]

| UCSF School of Nursing

There is a long history of women in science being referred to without their titles while men frequently get their titles included. I think we need to be particularly careful in this regard.

 

[VapApe]

Still some one with a PHD in basket weaving can use the title DR.
So it never hurts to check.

I have seen my share of health care story's, by folks using the title DR. Who were not MDs or any where related to heath care.

 

[TTK]

Well, Ruth E. Malone, RN, PhD, FAAN is the most appropriate in my opinion.

 

[Vocalek]

To quote Jesse Kline, writer for the National Post, "Anti-tobacco advocates need to get over their deep-seated antipathy toward smokers."

As for the demonization practice, it just may be a dud when it comes to helping smokers.

Smoking dropped sharply after the Surgeon General’s landmark report on the dangers of tobacco was published in 1964, but rates have plateaued during the past two decades despite increasingly stringent measures to persuade people to quit. The study found biological evidence that may help explain why some people respond to anti-smoking inducements, such as higher taxes and the expansion of clean-air laws, and why others do not.

“We found that for people who are genetically predisposed to tobacco addiction, higher cigarette taxes were not enough to dissuade them from smoking,” said lead researcher Jason M. Fletcher, associate professor in the Department of Health Policy and Management at the Yale School of Public Health.

The “gene-policy interaction” study, the first of its kind, found that variations in the nicotine receptor were linked to the influence of higher taxes on multiple measures of tobacco use. Individuals with a specific genetic variant decreased their tobacco use by nearly 30 percent when facing high tobacco taxes, while individuals with an alternative genetic variant had no response.

“This study is an important first step in considering how to further reduce adult smoking rates,” said Fletcher. “We need to understand why existing policies do not work for everyone so that we can develop more effective approaches.”

The gap in the effectiveness of tobacco-control policies remains poorly understood. The findings suggest that strategies that do not rely on financial or social consequences may be needed to persuade a still-significant segment of the population to quit, notes Fletcher.

Study Shows that Genetics Play an Important Role in Anti-Tobacco Policies | SciTech Daily

Oh, but I am forgetting. It isn't about saving the lives of smokers.

 

[kristin]

To quote Dr. Carl Phillips about this topic:

"...those who advocate eliminating all tobacco use, or even all smoking, do not qualify as a third party. They are every bit as biased as the industry is. Indeed, it is almost impossible to find an example of a major tobacco company producing junk science or otherwise misleading the public and regulators about their research, whereas there are so many examples of anti-tobacco activist researchers doing so that it would be impossible to even begin to list them. If the [tobacco] industry is not trusted to control this research then they [anti-tobacco researchers] should not be trusted either."

Folks, PLEASE start reevaluating your long-held beliefs about "Big Tobacco." Think about it - everything you still think of as "known facts" was told to us by the same ANTZ who are now lying about e-cigarettes and low-risk smokeless tobacco products! Don't you think that at least makes those "known facts" worthy of review and doubt? Do you think they just lie about e-cigarettes (or just need to be "convinced") and everything they told us about Big Tobacco was not warped, twisted or downright lies but absolute truth? They really just learned how to lie so skillfully since e-cigarettes came on the market? The truth is that much of what we think we know about "Big Tobacco," smokeless tobacco, smoking and the benevolent mantle taken on by the ANTZ isn't "truth" at all.

 

[Petrodus]

Believe It OR Not
Kristin is speaking the truth