Transcripts For CSPAN2 Tobacco Use And Regulation 20140826

Finally the committee on health, education, labor, and pensions will come to order. I think everyone for their patience. We have a lot of votes on the senate floor. Reconvene this hearing. Of the extraordinary publichealth efforts that have driven down tobacco use and the enormous challenges that remain. The nation has made remarkable progress in the 50 years as the first Surgeon Generals report on smoking and health. That time does not carry has been cut by more than half. We have learned what works from smoke free workplace is to access to free Cessation Services from meaningful tobacco taxes to robust regulations to Media Campaigns led a wildly successful tips from a former smoker to commonsense marketing restrictions. We know what works. Yes, despite all these efforts and successes tobacco use remains the leading preventable cause of death and the u. S. Let me repeat that. Tobacco use remains the number one preventable cause of death in the u. S. Right now 16 million americans are suffering from smoking caused illness, and over five and a half million kids alive today will ultimately die from smoking. Today nearly one in four Highschool Seniors smoke. Sadly, most young smokers become adult smokers. The problem is not just cigarettes. Last fall the centers for Disease Control and prevention reported that the use of Electronic Cigarettes were ecigarette and i will have more to say about those after a bit because i have an array of them appeared. The cdc reports the use of these Electronic Cigarettes are run to of among middle and i School Students more than doubled in one year. This is because of statistics like these that the Public Health efforts to combat tobacco have been among my top priority since i came here. In responding to the hundreds of thousands who die every year, in 1998 and introduced the First Comprehensive bipartisan bill to give the fda authority to regulate tobacco. Well, it took awhile but that finally became a reality five years ago with passage of the family smoking prevention and Tobacco Control act. Today we want to examine some of that, the implementation of that long. More recently in light of the fact that some 3500 children try smoking for the first time each state aisle for provisions in the Affordable Care act assures every american has access to tobacco Cessation Services without copays of deductibles. Also in the provisions i put in on the prevention of Public Health, investing more than 300 million in communitybased Public Health efforts to curb tobacco use. Last month confronted with the big prospect of a whole new generation becoming addicted to nicotine by way of ecigarette had joined with ten of my colleagues to release an Investigative Reporter feeling that manufacturers are devoting massive resources to the marketing of ecigarette and the Marketing Strategies are requested designed to appeal to kids. I urge everyone to read the report. I will share one example of the many graphics that contains. This chart you see a pair is an animated cartoon video game, video game through which players earn ecigarette coupons to redeem on facebook. Kids play these games. Then they get on facebook and they can redeem coupons. Cartoons, video games, social media, can the fivers. The ones i got here. Lets see. Ive got come ibert. That is one. That appeals to adults, right . Of a bear. And here is one. Any popsicle front of it. Cotton candy. Concentrated nicotine. Ive got another one here, crandall. Hello, ive got a strawberry. I did not want to leave out strawberry. Again, it is the same thing we used to see with clever cigarettes. The same thing. Again, they are pulling out all the stops to target children. It is absolutely shameful. A disgusting throwback to big tobacco playbook to promote traditional cigarettes to kids before restrictions were in place. I know that some believe that ecigarette era promising alternative to cigarettes. But hopefully we can all agree these products dont belong in the hands of kids. Keep in mind, this is a Drug Delivery device. Delivers nicotine. Nicotine is an addictive drug. And so i look forward to hearing more today from the fda about their new proposal to regulate these ecigarette and other Tobacco Products of the authority of the familys blocking prevention and control act. Well, that is what is this one called . Oh, jerry crash. That is not mentally that out. That is for the refills. You can refill it. Anyway, the ecigarette phenomenon has created a regulatory black hole that has gone on too long. Todays hearing is congresss first examination of a proposal which has extraordinary consequences for publichealth. So we are pleased today to have dr. Tim mcafee of the cdc office on smoking and health, mr. Mrs. Heller of the fdas center for tobacco parts to talk about the ongoing Public Health challenge posed by both. They will also report on the board communitybased and regulatory work in those agencies that are engaged in this. And now i will turn to senator alexander for his Opening Statement. Thank you, mr. Chairman. Welcome to the witnesses. Congress passed the law to which senator harkin referred, the family smoking prevention and Tobacco Control act almost five years ago. It clearly was taking a position to discourage the use of Tobacco Products. What has happened since then, run 18 percent of adults still smokes cigarettes, that is down from 20 in 2010. Smoking among youth continues to decline. Electronic cigarettes have grown rapidly. The number of adult smokers who tried ecigarette doubled between 2010 and 11. I am going to focus mostly on the socalled teaming regulation proposed two weeks ago by the fda, but i did want to first read some statistics about the center for Tobacco Products. The fda spin nearly 80 of the user fees collected. More than half of the spending to make under 68 million occur during fiscal year 2013. The fda has received only four premarket tobacco product applications which would have to be filed for any normal product put on the market after february 2,007 if deeming is finalized as it is. All four were rejected as a complete. There are over 4,000 such as liquid applications pending for Tobacco Products. The fda has decided on 34 of the over 4500 that the agency received. I believe the statistics reflect the poor performance, and i think it is important to college your attention. Now, appreciate being informed about the proposed regulation. I want to articulate my strong support for the alternative exempting premium cigars from fda regulation. I have some concerns about that, but i will followup with questions on how the works. The fda regulation should fit the product proposed by the product. And throughout the proposed regulation the fta talks about a somewhat controversial idea of farm reaction. For the 42 million americans currently smoke the fda should enable companies to find creative ways to reduce the negative Health Effects of nicotine addiction, not regulate that innovation out of existence. Most of the discussion around the deeming regulation and tobacco seems to be about ecigarette. I am here to listen. I understand there are competing points of view. Some Public Health experts such as david adams, american legacy foundation, the largest nonprofit public of charity in the nation devoted specifically to Tobacco Control has said this could be the single biggest opportunity that has come along in a century to make of the cigarette obsolete. That is one view. On the other hand, the cdc director has been quoted as stating that many kids are starting out with the cigarettes and then going on to smoke conventional cigarettes. So what are would like to understand is what research have we done to answer those questions. There are reports from countries overseas that some of these new products do not seem to be a gateway to traditional cigarette use, but we dont know that. We dont know that yet. So the purpose of a hearing such as this and a thank the chairman for calling it, is not to presuppose an answer but to find from experts in our government with their opinion is and what i would like to know is which of those points of view is prescribed to. Here is where i think we have agreement on. Regulations should be based in data and sound science. S. Sales to anyone under 18. Any child beginning to use a tobacco or nicotine product is bad for Public Health. Number three toy manufacturers should register at least approach to make ingredients to use with the fda. After that i think what we need to focus on is what is the research and what does it tell us . Of the torch to the testimony. Thank you. I know that Center White House has to leave shortly. If you want to make a short statement. I appreciate the chair recognizing me for one minute. We have two wonderful witnesses, one from the fda and one from the cdc. Wanted to make the point as a senator from rhode island that there has been important corporate in this area of reducing access to the number one cause of preventable death which is tobacco. And that comes from a company headquartered in rhode island. A very significant pharmacy chain across the country. And the ceo and his Management Team had made the decision to phase out the sales of tobacco product by october 1st of this year. That is an important commendable step. I just wanted that to be a part of the record of this hearing. Thank you very much. Mr. Chairman, i never miss some of which ended this is something when given the of the kennedy. Since i feel like and have lived with this issue as long as anybody in congress, and thank you for the job your doing of it eric when newly created agency. Very tough to get up and running mr. Chairman, i can remember when opportunities for Harm Reduction were the goal. Could not be achieved because technology did not allow us to get there. I remember when r. J. Reynolds expand several decades and came out with the product that to my desk was a precursor to some degree of the electronics cigarette even though it operated differently. You might remember that and there became a real opportunity for individuals to use the product that tell what they were looking for without a combustible. And how quickly we have moved to a point where no Harm Reduction is no longer gold we can work out these things about flavors. Americans. Look at the pool that was available. The cycle of combustible tobacco. Residents than careless befall we know we got in the right with the children attempting to do that. Another job the above the statutory requirements. Lets let him do it, but was not condemned where the technology has gone before we ever had an opportunity to see. In fact what effect this can have on pulling people off of combustible Tobacco Products. The committee, nova i hope the fda puts as much stock in Harm Reduction and now we get people off of something that is not as safe to a product is safer. This is, for some people, not eliminating access but a product category. Has been for 20 years, and nothing changed. That is fine. But as far as long as i am a member of the committee will fight for the American People to have a right to make a choice. And for mr. Mitch zeller to determine what those choices will be within reason. And i encourage you to continue the job is youre doing. Arrow that our policies reflect an opportunity for the American People to make a decision based upon what technology is available to choose a reduced farm product which i think many of the categories we see today are beginning to move toward. A think the chairman. Thank you. We will start to with our first witness, dr. Kim tim mcafee. The National Center for chronic disease prevention and health promotion. All science policy in programming and Tobacco Control and prevention. A family physician who practiced for more than a decade and served as a clinical faculty member at the university of washington Family Medicine and school of Public Health. Also offering the World Health Organization tobacco manual for low and middle income countries. Thank you for being here. And then after we will recognize mr. Sellars who is the director of the center for Tobacco Products wary the leaves the fda efforts to reduce disease, tobacco use and to develop regulations for the authority of a variety of products. Working on f. D. A. Issues for more than 30 years. He served as assistant commissioner director of the fda first office of tobacco programs prior to rejoining the fda in 2013 he worked on Tobacco Control as executive Vice President of the american legacy foundation. The taft. Thank you very much. And members of the committee for their statements previously. It is an honor to provide this statement. I wanted thank the chairman for his lead and also recognize this committees bipartisan history of support on Tobacco Control. As noted, i serve as the director of the office on smoking and health at the centers for Disease Controland prevention, and i am also a physician. Today and will discuss briefly the past, present, and future Tobacco Control trying on findings and recommendations primarily from the 50th anniversary Surgeon Generals report on tobacco and health. Fifty years ago half man and a third of the women in this country smokes cigarettes. Tobacco companies could advertise everywhere, including tv. And School Children carry lunch boxes with cigarette logos paris market was common in public places. Today the landscape is already dramatically different to me at all cigarette smoking has fallen from 42 in 1965 and 18 percent today and tobacco prevention and control measures save 8 million lives platinum over the last 50 years. Today half of our states prohibit smoking in work sites, restaurants, and bars and we now see the real consequences of smoking. Have these have had so real people fighting serious disease and disability. In the first year the ads hall lead over onehalf million to make a quick attempt. Despite enormous progress every day over 3,000 children to appear for Cigarette Companies smokingrelated deaths approach half a million a year and another 16 million americans suffer from serious smokingrelated disease. The 2014 Surgeon Generals report concluded that was initiated in sustained by the aggressive strategies of the Tobacco Industry was deliberately misled the public. In addition to making their products powerfully addictive the Tobacco Industry spends nearly a Million Dollars now are on promotions to developing products such as fruit and canned beef liver cigars and electronics cigarettes. The o. C. Are similar in size and shape to cigarettes appeal even more to you if than adults because of the flavors and lower prices. Responses to a large survey to five survey shows serious is nearly double the rate. And among 12th graders and surge to levels that we have not seen in over a decade. And ecigarette are heavily marketed on tv and radio some including Unproven Health claims that are proven to appeal to youth. As a result since reporter trying cigarettes. There are now hundreds of products ranging from disposables to tanked devices that are refillable, adjustable, and allow for use of other jurors the seismic in. Could propose an important regulatory requirements and allow for a comprehensive protection as we move forward. However, fda regulation alone is insufficient for this process. That is why states and cities across the country are falling these cigarettes enacting bans. Now, when the fact that they exist and there being marketed as the same as cigarettes but safer is a dramatic shift. According to the Surgeon General report a ecigarette could be beneficial if completely substituted for burns tobacco and could assist in a rapid transition to a society with little or no use of burns Tobacco Products. As we consider these issues we must not forget that burns Tobacco Products are overwhelmingly responsible for tobacco related death and disease. The appeal to children, half of longtime users and are addicted by design. If current rates continue or five and half million children under the age of 18 will tire of it because of smoking. The good news is we know a great deal of words and have a Regulatory Framework to its own rita progress. The bad news is in not doing enough of what works. Higher prices, access to cessation treatments, hardhitting media and state based Tobacco Control programs. The progress made is due to efforts from across society including as from Companies Like cbs would stop selling Tobacco Products. The thousands of businesses are helping employees quit smoking. Working together we can help americas of longer, healthier lives, prevent one in three cancer deaths, save our economy 300 billion annually in prevent half of premature deaths a year. Thank you for your attention to this important matter. An average answer any questions you may have. Thank you. Please proceed. Thank you, chairman, ranking member, senator, other members of the committee, the aborigines is testify. And director of fdas center for Tobacco Products or see tepee as we call it. I am honored to be here today to discuss the fda activities in implementing the family smoking prevention and Tobacco Control activists since it was signed in the law in june 2009. Next month marks the fiveyear anniversary of the Tobacco Control act, the law that gave fta comprehensive tools to protect the public from bobble effects of tobacco use through science based Tobacco Products regulation. Since the act became law in 2009 we have made significant progress toward establishing a comprehensive, effective, and sustainable from work for Tobacco Products regulation. Our first party was the creation of the center for Tobacco Products, the first is center at fda in 21 years. Groan a handful of employees in the fall of 2009 to nearly 500 employees today. During our startup phase even as the center was establishing itself, creating infrastructure cabiri appropriate personnel, we were required by law to make more than 20 mandatory statutory deadlines. We were also required to assess user fees, establish the Tobacco Product Scientific Advisory Committee that as tips sec and refer initial issues for consideration. In the center met nearly all of these many deadlines. Act p Main Responsibilities include reviewing the product submissions, developer of a science base for product regulation and enforcing the law to my issue regulations and guidance for industry and in educating the public about the risks associated with Tobacco Products used. I would like to briefly touch on each of these. See tipi is committed to carefully and thoroughly reviewing all Tobacco Products emissions in a consistent, transparent, predictable, and timely way. We recently established Performance Measures that include time trans for review of many of the submissions were received a. As a Regulatory Agency we can only go as far as the regulatory science will take us. C t p vons and uses Scientific Research to better understand tobacco problems, of the differences in product change the behavior of users and nonusers and how to best reduced optimism products. We partner with the National Institutes of health and the centers for Disease Control and prevention has well as with fdas center for Toxicological Research to advance the regulatory science base. Vigorous enforcement of the Tobacco Control act and implementing regulations is carried out through to becker regional compliance check inspections, inspections of domestic manufacturers and imported Tobacco Products and review of tobacco promotions, advertising demand labeling. C t p also provides compliance education and training on in february we launched the National Public Education Campaign to prevent use tobacco use and reduce the number of teams to become regular smokers. The campaign uses compelling facts and vivid imagery to a change police and behaviors over time, to educate you about the dangers of tobacco use, and to encourage them to be tobacco free. We have faced some challenges in the five years since see tepee was created, including the growing pains inherent in building a regulatory body from the ground up. We have worked through the logistical challenges of creating a brand new organizational structure, hiring qualified staff, developing the processes, procedures, and even the dedicated 90 resources to carry out the important regulatory function regulating Tobacco Products is markedly different from other products traditionally regulated by the fda. Our responsibility is unprecedented. No other country has cast a Regulatory Agency to evaluate new Tobacco Products before marketing based on Public Health criteria. We have also had to create a tobacco ridge of Compliance Program that is unique even within the fda. Moving forward, we intend to sustain the momentum needed to achieve our goal of reducing the arms and risks associated with Tobacco Products use. I would like to close on a more personal note. After 13 years out of government i return to Public Service in march of last year. The main reason i returned was the Public Health of which entity to help use the product regulation tools congress and the president granted the agency in the Tobacco Control act to help reduce the death and disease from tobacco use. The reality is that roughly one in five adults still smoke and we will explore all available regulatory options to reduce the harm caused by Tobacco Products. Perhaps our greatest opportunity to overcome this press and Public Health problem is to dramatically decrease the access and appeal of Tobacco Products chief. We intend to use the many tools at our disposal to help make the next generation tobacco free. I think the committee for its efforts and employees to answer any questions. Thank you. Think you very much. Now we will open four rows of five minute questions. I will start with you. We both already mentioned the hard hitting an incredibly effective tips from the former smoker campaign that created using resources from the 40 care act. I mention that in my statement. The outcomes of this campaign, at least what i have seen, have been extraordinary. You mentioned more calls to the quick lines. I wrote down over one half million calls were acquitted stamps. Can you just elaborate on the cdc work on his campaign, what evidence you have a your messages effective . And the last, i difference between the cdc Media Campaign tips from a former smoker and fda Media Campaign the real cost . Thank you very much. And i please feel free, if i bell regional of the was the last about, refresh my memory. As you noted, chairman, the campaign has been remarkably successful. If this figure who made a quick attempt. We also saw concurrently we are now in our third year. We have also seen doubling in calls to the national 1800 quit now telephone number. As much as a fivefold increase in visits to the website of a campaign. So we are very excited. We are particularly excited about the very specific information about quit a tent that we saw with the campaign. We also saw increases in nonsmokers, millions of homes said that they have actually talked to a loved one who smoked and encourage them to get help quitting. And i think one of the reasons that we were not surprised by these results is that we put a lot of work in up front, first reviewing all the information from other countries and states to my experiences, and then working with the chilly thousand smokers has king then, what would be most helpful to you to make a quick attempt, to be successful . And we designed the campaign through several cycles of trying out our ideas and then checking back with smokers to see what they said. They were firm that this was the type of campaign that they wanted. We have also seen 80 to 90 percent of smokers say that they have seen the ads. So we are feeling very strong about the response we have had. I would also mention that jerry hall up in North Carolina who died in september was a poster child. Americans stepped up to show, put a face on what the arms smoking will cause. In terms of your question about the fda in the cdc, two different approaches. Yes. We were really in different lines because the cdc program is focusing on adult smokers and encouraging them to quit. That is its laser focus. The f. D. A. Campaign, we are actually quite excited about the work that they have been doing all so laser focused on youth and initiation and trying to keep experimenters from consolidating. So doing very different things. The other thing to keep in mind is both campaigns combined represent in terms of the amount of promotional effort that we are able to make, represents about five days compared out of the year of with the Tobacco Companies are spending. Your talking about combined . Yes. Ours is out of the inner in 65. Right. Elaborate a little bit on the real cost. Sure. Unfortunately too many kids experiment with cigarettes for the first time over 3,000. Today. Each day. Indeed stay over 700 kismet the progression from experimentation to become regular smokers. The good news is compared to 20 years ago those numbers are down the bad days is, those numbers are still unconscionably high from a Public Health perspective there are 2500001217euros and our entire country. From their research that we did command we spent two years doing research before we launched the Real Cost Campaign in february, will we cant understand is, there are about 10 million of those 25 million who are at risk. We call them the one party away from taking that first spot. They already started to smoke a few and are on that trajectory to become regular smokers. And from our research we developed insights into how to communicate to these kids in ways that will break through the initial loss of the campaign focused on the Health Consequences of smoking and addiction. We dont talk to them like in a bowl lecturing a child about all smoke and here are the longterm risks. Turns out that if you talk that risk kids about premature skin wrinkling or gum disease and tooth loss and if instead of talking to them about nicotine and addiction you talk to them about loss of control if they become addicted to cigarettes, that enables them to hit the pause button play that enables them to rethink their relationship with the syrian. We also made a major investment in the evaluation, so we will see how were doing overtime. Stars with building awareness which leads to changes in attitudes and beliefs and then ultimately changes in behavior of intent and behavior. We made the investment in the valuation to follow 8,000 of our targets of the next couple of years to see how were doing. Misters seller, i think you are correct. Premium cigar should be treated differently. As a party upton of regulation that would exempt premium cigars. I introduced legislation like that some time ago i believe adults ought to the will to make their own sources. Had a cup of questions how would this price of 10 or . What if one retailer sold a cigarette 9. 99 . It would just clarify one thing. We have proposed regulatory actions on cigars. One of the options is to be exempt. Cigars. The other is to include them. We are in rulemaking now and we need to wait for all of the comments to come in. We will then consider our regulatory options in large part and forms. Would you cant come in and out what would work. I just want to say, i dont want to prejudge what the outcome would be. I was trying to prejudge a little bit. Which you are free to do, and i am not. But to your question about the price point command the option that will lead out reprimands the bears would be accepted, there would have to be a definition so that we would know. Of price plus instant the that might not work very well. The last for comment on every aspect including the price point. And people have a better way of us doing it than what we propose to which is 10 per cigar, we welcome. Absolutely. Are you open to considering extending the comment . We have received multiple requests for extensions, which we are reviewing the chilly as we speak. I encourage you to do that. It is more important to do this right. This is an extensive complex area. Let me ask you a broader question. Whittier come down on this difference of opinion . David adams at the american legacy foundation, the single biggest of which entity that has come along in a century to make the cigarette obsolete. That is one point. Many kids are starting out with ecigarette perris you will know enough to know yet what the impact of ecigarette is . I need to answer as a regulator. We have proposed to extend our jurisdiction over Electronic Cigarettes that meet the statutory definition of a tobacco product. We are also finding little chilly dozens of studies to answer all the questions that we have about ecigarette. Right now we have far more questions than answers of the safety of the product, about what is in the product, what is in the vapor. We have questions about who was using the product and how theyre being used. It is a complicated are you dont come down on either side. Yes. As to whether it is a tool to help those who are already smoking cigarettes to stop smoking or more dangerous as a tool to encourage kids to start smoking. I think the only appropriate position for the fda to take is, they have the potential to do good and harm. We need answers to questions which were funding for research. Dont you have to have carper when would you have enough answers to be able to make the kind of decisions are expected to make your . Rudd, the first up in the process is having regulatory authority. We dont need the answers to those questions to the conclude the deeming rulemaking. But as we go forward in terms of figuring out what regulatory policies and approaches to be applied when they come within our regulatory reach, we need answers to those questions. Let me give you an example. We are spending a lot of money on what is called a longitudinal study following the same people over time. The population assessment of tobacco and Health Following literally tens of thousands of adolescents and adults. Over time studies like that will begin to give us an affirmation that answers some of the behavioral questions. Where is using the product, how theyre being used. We then need additional studies on the products themselves. There are a series of questions that have been raised about these liquid Nicotine Products and exposure to the nicotine in these liquid Nicotine Products. When we have answers to those kinds of questions reconfigure out how to use the many regulatory tools that turner says given the agency to figure out an appropriate Regulatory Framework to regulate every is starts with having the authority to regulate them which is what the proposal is all about. My time is up. Senator. Thank you, mr. Chairman. Do you believe that some Tobacco Products present greater rest to individuals and other products to back. Yes. Okay. On the continual of risk to monday believe noncombustible Tobacco Products are more likely to reduce harm than as smoke form of tobacco for individuals who would otherwise be using a conventional cigarette . The answer is it depends on who was using the product and how theyre being used. You can take any not combustion product whether it is a smokeless Tobacco Products, a ecigarette kaj and it really depends on who is using them and how theyre being used. If elected a subset of smokers who are otherwise unable or unwilling declared they will continue to smoke a cigarette. Half of them will die prematurely later in life from that decision if we could get all of those people to completely switch all of their cigarettes from one of these non combustible products that would be good for Public Health. Our job as the regulators to figure out what is going on at the population level and it includes a much larger group of smokers, like the first group, a much larger group who are concerned about their ralph and you are interested in cutting the dividend what happens instead of those people completely substituting with a non combustible products . They start using both. And then along the way they wind up being less interested in putting. Then we would say that that might not be good for Public Health. Our job is to figure out what the net of all those possible behaviors including any initiation which would not be good for Public Health and then try to make regulatory policy at top of that. So much for the adult that chosen the correct five years ago. They cheered saddam and then they went out back and have a cigarette does that mean that new credit is not a useful tool . It is only a useful tool if that individual uses it to quick. I would absolutely concede that any of these products at an individual level can do good. What is challenging for all of us dealing with the law that you gave us the responsibility to implement and enforce is the decisions that we have to make are not going to be made about what might be good for the theoretical individual. We have to have regulatory science support decisions that inform what is happening and a population level. We have to look at all possible behaviors. If your term line is this white then the Public Health effects is better. You have less people using combustible products. You have more of those individuals who have quit or go to a reduced farm product. You know, let me just say for the record, cvs limited to their cigarettes. Cigarettes still sells patches of the metric gum. Probably all of the pharmaceutical products that aid in eliminating or reducing the rate of smoking. It is not like the throughout the whole category. Sector retailer that sacrifice some large amount of sales. They still believe that the Risk Reduction is an important thing to endorse. Would you agree . I would answer it in this way the products you are refering to have been approved by the fda as safe and effective medications and have been on the market for over 30 years. Theyre is a robust seven space to know that those products work to help smokers stop smoking permitted they are actually not approve for reduction hinman for abrupt cessation. But theyre is a robust seven spaces shows that when market to help smokers quit and used properly people can succeed in one. By contrast, to go to the questions from senator alexander of what you know and what you dont know when it comes especially to ecigarette there is a lot more that we need to know. I agree with you totally. But can you point to a new innovation where we know right at the beginning everything about it . We can come to an assessment. No, i am hopeful the three or studies you find this product is safe. We dont want an unsafe product upton if it contributes to a different problem. But if you find that it is safe, are we going to say the same thing about ecigarette three years and now . The body of evidence said that this is a tremendous thing to live in a couple of combustible Tobacco Products. Isnt that a good thing . If were going to regulate them, thats what the Tobacco Center has proposed to do apparently have to find that the claims, the new products are appropriate for the protection of the Public Health and not the safety and efficacy standard. Congress gave us a different standard to use when using the Tobacco Authority. And under the standard of public for the protection of the Public Health it is that makes a behaviorist that i was describing that we have to assess and then make regulatory policy based upon. I certainly look forward to the science that is produced on this. I just caution our friends at cdc. If we Kill Technology and innovation which is in essence of what some are attempting to do right at the beginning, just out, no more of an innovation is not going to play a role and reducing the amount of americans smoke. It is just not permitted at think it is safe to say that when i look at diabetes today i look at other things that we would consider a Public Health academic pahang innovation would give us the ability to do it. I dont think its going to be by going out and limiting whether they can go to mcdonalds and by the ots order. The cdc is not proposing that payment will be innovation, driving technology, coming up with products that will allow us to turn around the problem that theyve got. Think that is what were starting about here. I look forward to the work youre doing. Thank you, senator. But start another round. Last months proposal to expand the authority to include more Tobacco Products marked an essential step forward i was disappointed that the rule did not address some of the most egregious practices i mentioned in my Opening Statement that last month at finding was released into the marketing practices of nine commonly sold ecigarette ransom. To say those findings were disheartening for me is an understatement. Among those findings you will be surprised, six of the Companies Reported that the market ecigarette and flavors that appeal to children and teens to my flavors like cherry crash and chocolate treats and pitch joaquin and great meant. I would just say that anyone in crams of these products are expressly targeting kids is clearly blowing smoke. These are targeted to kids, not adults. Heres the refillable cherry cr. The one i had earlier was, what the heck was that . Apple cranberry. So, again, these are targeted to kids. So, again, congress knew what it was doing based upon, i think, evidence maybe we had that they were using flavors in cigarettes to go after kids. So, again, why forget about the prospect of whether ecigarettes are good or bad for adults, could this be a stopping, cessation we dont know all that yet. Thats got to be learned. But is it safe to say that when youre talking about kids that maybe there ought to be some restriction on these to kids . Dr. Mcafee or mr. Zeller, i guess, why did fda feel it was important to hold off on restrictions on ecigarette flavors and marketing when theyre clearly targeting kids . Why did fda hold off on that . I appreciate on the flavors. I appreciate the question and the perspective, mr. Chairman. And we share the concerns about any marketing of any of the currently unregulated products like ecigarettes that would have an appeal to kids. We need to have jurisdiction over them to do something about it. But in the preamble to the proposed deeming rule that would give us the authority to take regulatory action, we summed up all the evidence that we had about flavors, and we asked a series of what i think are very profound and farreaching questions about that we want comment from all points of view on what role the presence of flavors like this should play as an influence on the regulatory policies that the agency will be in a position to make when deeming is final and we have the ability to use all manner of tools. Technically, to ban flavors requires the issuance of something called a product standard under a different section of the statute. Its a desperate rulemaking. But its a separate rulemaking. We need answers to the questions posed about what roles these flavors play. Let me take a different line. Does fda have the authority to regulate Drug Delivery devices . Fda first try today regulate ecigarettes as Drug Delivery devices, and we were struck down by the courts. In the absence of a cessation claim. The very first action that fda tried to to take on ecigarettes back in 2008 and 2009 before the act passed was an enforcement action to prohibit the importation of ecigarettes as unapproved drugs is and devices. We were sued by an importer, and the importer won in court, and in 2011 we had to announce we would create a Regulatory Framework under these tobacco authorities in the absence of a cessation claim. I guess i dont understand, is nicotine generally recognized as a drug . Yes. Its an addictive drug, is it not . It is. Does not an ecigarette deliver a nicotine vapor to your body . We can make the assumption it does. We need more information about that, but we can make the assumption it does. What else would you do . You dont throw it on the ground. Its put in there, and you inhale it. I can only tell you what the courts ruled. We tried to regulate ecigarettes in exactly that way. And we were overruled by courts. In the absence of a claim, a medicinal claim, a therapeutic claim, the courts told fda the only way we could regulate nicotinecontaining ecigarettes was under the tobacco authorities. It has two parts, something thats either made or derived from tobacco and the nicotine in ecigarettes is derived from tobacco, and in the absence of a drug claim the only way we could regulate tobaccoderived nicotine this these products was under the tobacco authorities. The reason i had all these out here today is just to show the proliferation of the devices that are going to kids. Heres one thats 800 puffs. Delivers something thats a cranapple. Now, its interesting. They say on the back in fine print, it says electronic hookah, thats what this is called, is not approved by the United States food and drug administration. You must be of legal tobaccopurchase age according to state law to purchase and use these products. This product has not been tested or proven to aid in smoking cessation. And the product contains nicotine which is addictive and toxic substance and must not be used by pregnant or nursing women and nonsmokers. Keep this product out of reach of children. Laugh we laugh we know kids are getting them. Theyre buying them, theyre proliferating among high School Students, theyre buying these fancy things here. Theyve got a plug that goes into the wall, looks like a computer plug. Its got be the little computer device that goes in there, and you stick your thing in there and recharge it. Theyre rechargeable. I dont know what that costs. Im told this costs about 10, you get 800 puffs on 10. But these are all geared towards young people. And i had that out just to show that, you know, i heard say, well, we need a longer Comment Period. Well, i dont know about that. Somethings got to be done about this. Well, let me tell you other parts of the proposal that would address the issue of use of these products. We proposed extending the minimum age of sale that currently exists for cigarettes to ecigarettes, and so retailers who sold ecigarettes to minors if this proposal goes final would be violating our regulations in federal law. Weve proposed to ban the sale of any of these products in vending machines to the degree that there are vending Machine Sales unless its in an adultonly establishment. And on the issue of nicotine and addiction, we have proposed a warning label on all of these products that explains to the public that they contain nicotine and that nicotine is addictive. The Comment Period is the publics opportunity to make suggestions for additional things that we should be thinking of doing when our rule goes final. Its interesting. This has a lot of that stuff on the fine print in the back, but none of this does. And thats because theyre not currently regulated by fda. But its concentrated nicotine, an addictive drug. I went way over my time. Ill yield [laughter] ive got more. Thank you, mr. Chairman. I have no more questions, and i have an appointment that i have to go to, but i certainly have no objection to your continuing. No, sir. Okay, thank you very much. I want to change things here a little bit. Dr. Mcafee, one of the most startling findings was that cigarettes are more dangerous today than they were when the first Surgeon Generals report was issued 50 years ago. That was startling. The report indicates that cigarette smokers today have a higher risk for lung cancer than smokers in 1964 despite folk smoking fewer smoking fewer cigarettes and that some, if not all, of this increased risk is likely caused by changes in the composition and design of cigarettes. Can you explain ways in which these cigarettes are more dangerous . Sure. And i would add that the other thing that i think we have found very disturbing around this in some ways unexpected finding is that it does raise concerns about the ability of innovation to to automatically lead to improvements in Public Health without regulation. Because over the last 50 years until the fda got authority four and a half years ago, cigarettes were entirely unregulated, and the remarkable thing that happened was that the innovations that were put in place by apparently, some of the innovations that were put in place that affected composition and design of cigarettes did not lead to fewer deaths. Most of the innovations appear to have been more driven for other purposes. And the things that we have found and a lot of this is, basically, driven by end deem logic findings its that despite the fact that we are smoking fewer cigarettes, a person who smokes in the United States is more likely to develop lung cancer than they were 30 or 40 years ago. And theres been im sorry, excuse me. Sure, no problem. Theres been a specific change that we absolutely think is related to changes in the design and composition, and thats the type of cancer that people develop. The common lung cancer, way back when i was in medical school the most common form of lung cancer was sway now carcinoma which was found close in to the main branchings of the lung. And over the last few decades, this has shifted to the another kind of cancer called adno carcinoma which is located in the periphery of the lungs, and we believe this is due, essentially, to the fact that cigarettes over the last 30 or 40 years have become easier to ip hail due to changes inhale due to changes in their design and composition that may range everything from the light low mild changes in the nature of the, their composition to design changes like ventilation holes and filters. Were not entirely sure what it was, but the Surgeon General determined that this change was caused, was related to design and composition changes. So the technology was used to make a cigarette that was easier to inhale and contain substances that were more dangerous . Whether they contain more substances that are actually more dangerous or they literally just allowed a smoker to inhale them more deeply than they previously were inclined to do because of the cigarettes 50 years ago were harsher. So, again, what were viewing, what were seeing in terms of the numbers is very large increases in the risk of lung cancer. Larger in women than in men. But very large in both. So cigarettes have actually become or at least the way that cigarettes are being used and smoked in the United States have become more dangerous, not less dangerous. Mr. Zeller, again, five years since weve passed the family smoking prevention Tobacco Control act. Again, i think a truly historic achievement for Public Health, or but i know there have been some delays in implementing some provisions, but i also recognize that thanks to the ability of the, the da to the fda to regulate these products, strides have been made during that time. The center for Tobacco Products has been, obviously, key. Thats whos charged with this responsibility. What have been some of the best accomplishments, perhaps some of the Biggest Challenges confronting the center for Tobacco Products . In terms of accomplishments, it was no small task to start with literally two fulltime employees at the end of september of 2009. Two. Accompanied by about 20 other people who were temporarily on loan to this brand new center. So it was no small task to literally build the center into what it is today. It is a fullfledged regulatory entity doing compliance and enforcement, doing public education, doing major work in terms of reviewing product applications and overseeing investments in research. As i said in my remarks, were a Regulatory Agency. We can only go as far as the regulatory science will take us. It informs all the decisions we make on product applications, all the policies, guidances, regulations that we could be issuing. So on the accomplishment side of the ledger, having a fullyfunctioning center thats doing all of that and that has launched the Real Cost Campaign and that is doing a massive nationwide enforcement of youth access laws, making a major investment in research and making progress on the product review submissions would be the short list of accomplishments. There have been challenges. For the very same reason that we literally started from nothing in 2009, there were challenges with the product submissions. No question. Uhhuh. Now, we can look at it from both sides. There were problems with the submissions. Many of them were incomplete. But we have to own part of that as the regulator as well. It took us time to get up to speed. It took us time to hire all of the scientists and especially chemists and engineers. We really needed some specialized science capability to do the best possible product reviews. But weve made extraordinary progress in dealing with the queue of applications. So i would say on the challenges side its what comes with literally starting from nothing, inheriting, as i said, over 20 mandatory statutory deadlines and then doing the best possible job that we could with the product submissions. I can report that weve made extraordinary progress on the product submissions. Theres a concept known as substantial equivalence. Its one of the pathways to market that companies can submit applications for. And for the queue of substantial equivalence applications for products not currently on the market, review of new applications can begin as soon as an application is received. And we couldnt have said that a year ago, two years ago, three years ago. There is more progress to be made, but i think that we are meeting some of the greatest challenges that we have faced. I appreciate that. And lets talk a little bit about warning labels. One of the key provisions was calling for larger warping labels on warning labels on cigarettes and smokeless Tobacco Products. The smokeless warning labels requirement, i guess, has been implemented. However, the specific graphic warning levels proposed by the fda again were struck down by a court, u. S. Court of appeals for the d. C. Circuit on First Amendment grounds. After that decision i wrote to commissioner hamburg urging fda to develop and implement a strong new graphic warning labeling rule. Indeed, fdas General Authority to require graphic warning labels has been affirmed in the courts. So given the evidence that graphic warning labels encourage smokers to quit and prevent nonsmokers from starting to smoke, im hoping this is a high priority for fda. So is fda going to propose a new set of cigarette warning labels thats designed to withstand a constitutional challenge . The priority and were doing this is getting the Research Done to inform our ability to write a new rule to survive the likely litigation that would come. Getting that Research Done is one of our highest priorities. And armed with the results of that research and with paying attention to the Court Decisions that have come in in reviewing our first attempt which was struck down will require some careful deliberations. And we will do that just as soon as we can complete the research. But getting the Research Done to support a new graphic warning label rule is a very high priority of the center and the agency. I wish we had some labels like i see in our neighboring country to the north, in canada. Theyve got some pretty graphic and strong labels. Full package on it. I guess they dont have a constitution like we have. [laughter] they have to worry about. But theyre great warning labels. Does fda plan to exercise be its authority in the area of standards to require changes in ig relates and other Tobacco Products cigarettes and other Tobacco Products, for example, limiting tar and nicotine levels to headache them less addictive, harmful or less attractive . Youre referring to the authority in the law known as product standards . Thats right. Product standards product standards. Is one of the most powerful tools that Congress Gave the agency. It is the power, with one exception, it is the power to ban or restrict the allowable levels of ingredients constituents in the finished product. And we have been saying publicly that we are investing in research to explore potential product standards in three areas, and this is as far as i can go publicly. Uhhuh. We are supporting research to explore potential product standards in the areas of addiction, toxicity and appeal. And armed with that information we will then explore our regulatory options. Good. Good, good. My last question, dr. Mcafee, i want to talk about Cessation Services. Last year i wrote to secretary sebelius because i had concern that many private Health Insurance plans were not covering tobacco Cessation Services that are recommended by the u. S. Preventative Services Task force and required under provisions that i authored in the Affordable Care act. Earlier this month the department issued guidance clarifying for insurers exactly what evidencebased tobacco Cessation Services must be covered without copays or deductibles as the law requires. We know that a combination of medication and counseling is most effective at helping tobacco users quit. So could you elaborate on the role of Cessation Services in stemming the tide of tobacco use . And whether you expect this guidance to provide improved access to such services and, secondly, do you have any suggestions on the best way to increase the number of doctors who talk to their patients about quitting and increase the number of smokers who are covered under these Cessation Services . Well, thank you very much, chairman harkin, for that question. And a question that is near and dear to me because one of the things that i did prior to coming to cdc was to work very, very hard as a primary care doctor within an integrated Health Care System to, basically, to try to figure out how we could mobilize the engine of health care to help our patients quit smoking. And this is proven to be something that has both has lots of very strong potential but also lots of very strong challenges. And the potential is basically 75 of smokers see a doctor in a year, and doctors have a lot of respect, and they are also embedded in a system that increasingly knows how to adopt changes and influence behaviors. But on the flip side, there have been prodigious obstacles to moving forward around this including the lack of training that medical professionals get to help their patients and then particularly the lack of coverage and capacity to be able to provide Services Without it seeming like something that theyre doing just as on top of Everything Else as opposed to something thats integral to care. So i think the, and the short story that i learned from my decade of trying to do this is, yes, it is possible. It takes a lot of work. You have to make, you have to make Services Accessible so that clinicians can refer people out to get deeper or levels of service, so weve spent a lot of time trying to build up Services Like the 1800quitnow as an option for clinicians, and you have to figure out ways that they can have the time, get reimbursed for it, etc. And then it really does work. You can actually drop prevalence at a population level. There are some very, very exciting experiences in massachusetts in medicaid, for instance, where they were able to drop prevalence in just a few short years by major promotion of a very, of a good benefit. The exciting elements associated with the Affordable Care act are really that it has, as you noted, embedded in it requirements about barrierfree coverage. Theres been a devil in the details challenge around how that actually gets translated into language and guidance to health plans so that they are able to do that, encouraged to do that, required to do that. I do think that the guidance that hhs released last month gets a bit more specific around this. This is what the health plans actually were saying would be helpful to them and that many of them will move itll continue to be the process, but one that has hope. Weve tried to integrate that in with the tips from former Smokers Campaign that as gotten a lot of interest from health care organizations. I just guess i wish we had more emphasis, and im going to be looking at this too, that people who are covered under the Affordable Care act see their doctors on prevention and wellness with no copays, no deductibles, they go in and get their annual checkup that doctors have and their list of things that they do is to advise them on smoking, if they smoke, to advise them on not only why they should quit, but how they should quit. How, whats available to them to help them and refer them to the quit lines, refer them to other activities that they might do to cease, and then if they need medication or, you know, the patches or the gum and stuff like that, to be able to advise them ask and get them on those and get them on those. You know, thats what im hoping we do. I, i strongly agree. Weve actually done a rate good job over the last a pretty good job over the last 15 years, say, of getting it so is that people are asked about their fact use status and given brief advice by physicians, but we still have a ways to go to try to make it so that particularly if people are interested, which most people are, that they can gain access to help, everything from counseling right on the spot to referral for coming or phone coming or web coming phone counseling or web counseling into medications and having it more embedded the way we treat hypertension, cholesterol or the management of diabetes, having it just be part of service. I want to just add one more thing before i close up here, and that is the issue was raised earlier about premium cigars. And then i read somewhere about more and more kids are smoking. Not what you think of as a cigar, but theyre like little cigarettes, but theyre wrapped in cigars, and theyre little, small cigars. And those are also, i think, being flavored too, if im not mistaken. Yeah, some of those are being flavored. So theres a clear distinction between that and premium cigars, and i you said to me as you were working on a rule and how you define, right . What a premium cigar is. I dont know what it is either. But i just hope theres a clear delineation between those, between that which kids dont use and which they cant afford to buy, and theyre too expensive and the ones which they do can get hooked on, those little to your point on flavors, one of the elements of our proposed definition for a premium cigar is that the only flavor thats in there is tobacco. Well, are there premium cigars with flavor . Huh . [inaudible] oh, there are premium cigars with flavoring. Were proposing that the only flavor that can be in a premium cigar is tobacco, but were welcome to take comments on that. Yeah, i dont know that either. I just, its like that old saying, you know, i know it when i see it. Right. You know a premium cigar when you see it. Its hard for a regulator to take that approach though. [laughter] very true. I appreciate that. If i could just add a word or two armed that. Around that. I would want to make sure that we emphasized the reality that all cigars are dangerous. They all contain most of the same toxic substances. Theyre burning back in, and that creates thousands of tobacco, and that creates thousands of tobacco, and that includes 7080 carcinogens. Most of those worrisome ingredients are also present in premium cigars. There may be some differences in how theyre smoked, etc. , but if its its still a dangerous product, and the question of how it should be regulated is different from the question of whether it should be regulated, whether they should be regulated. Got that. Well, the other thing i just want to say is i had all this stuff on ecigarettes and, again, i just reemphasize that the way theyre being marketed, theyre being marketed to kids. And its nicotine. Nicotine is an addictive drug. So theyre marketing an addictive drugs to kids which gets them addicted on nicotine. And if they cant get ahold of one of these or one of those, theyll get ahold of cigarettes. So it just almost seems to me like this is almost like a gateway kind of an approach to cigarette smoking. So i urge you, i hope that again, i dont know about extending the Comment Period, whether that needs to be done. But, boy, i sure hope we dont kick this can down the road any more. Weve got to get a handle on this one and start nipping this in the bud. This ecigarette stuff. What you do on it with adults, im a little less clear on that. But for kids, as far as im concerned pretty clear whats happening here in how theyre marketing it. Now, do either one of you have anything else that we havent asked or covered that youd like to make for the record or have us think about . Its open to if theres anything that we havent asked or covered that youd like to id actually like to follow up on one of the things that you had said about ecigarettes. I think one of the things thats been misunderstood about our findings last september at cdc is that theres some implication that we have to prove that children who use ecigarettes will progress in some large, dramatic fashion automatically to cigarettes, and we think thats a red herring. And its, essentially, related to what you just said. Its an important thing to find out, and we look forward to the findings from the path. But the bottom line is for at least three reasons children should not be, they should be, they should not be using ecigarettes, and we as a society do not need theres no necessity for us to require marketing, sales and product characteristics that will result in millions of kids experimenting with ecigarettes. As you noted, nicotines addictive. The other thing that were worried about is even if kids were not to progress to cigarettes, we dont need to have ecigarettes to get kids to not smoke. We have plenty of other societal tools that have proven to be very effective. We can get youth use down into low Single Digits doing stuff. It is egregious to suggest that somehow we need to have kids do this in order for adults to quit. And were very worried because the Surgeon Generals, this most recent Surgeon Generals report, one of its findings around nicotine was that its strongly suggested that it has deleterious effects on the development of the adolescent brain. And this is not something that we need to or should fool around, fool around with. And then the last issue is, in fact, were not saying that it is a gateway, but we have ample reason to be anxious and concerned that one of the results of millions of kids if it becomes millions playing around with ecigarettes especially at the reason theyre fooling around with these cigarettes because theyre watching advertisement and promotion that is renormalizing tobacco use, is making it sexy, glamorous, using celebrity endorse canments on television endorsements on television, this is a huge experiment. And it is not fair to our children to ask them to pay a potential price around that for a hypothetical benefit to adult smokers. And we know that the tactics that are being used by, in the process of marketing ecigarettes, there are half a dozen characteristic of them that are very similar to to the same things that a 2007 Surgeon Generals report found that Tobacco Companies used to increase the chances that kids would smoke cigarettes. So we dont think we can afford to or that theres any necessity to literally spend five or ten years proving that a 13 beyearold using ecigarettes will lead the them using cigarettes. Its just, period, a bad idea. Youre saying, basically, theyre dangerous in and of themselves whether theyre a gateway or not. Correct. Even the idea of a gateway, its somewhat of a misnomer because a gateway in Substance Abuse treatment is if you use one drug, it will lead to another drug. Like if you use marijuana, maybe itll cause you to use cocaine or heroin. This is the same drug, its nicotine, its just a different delivery device, and the drug itself is intrinsically of concern in adolescents. Got it. Mr. Zeller . Just one closing thought. Absolutely understand the concerns that you and dr. Mcafee have expressed about ecigarettes and especially the degree to which, any degree to which they are enticing kids. Ill just leave you with one big picture thought. Lets not lose sight of the fact that this remains the leading cause of preventable death and disease in our country, principally because of come busting cigarettes combusting cigarettes x. The opportunity that congress has given the center for Tobacco Products with the authorities and the resources that youve given us is an opportunity to make a serious dent in that death and disease toll. Now that we can add the tools of product regulation and the impact a product regulation can have to National Comprehensive Tobacco Control efforts, lets not lose our focus on what that primary cause is for those now more than 480,000 avoidable deaths each year. And its primarily burning combusting cigarettes, and we need to redouble our efforts to focus on that. And if i might just reemphasize the very important point that mitch made, along these same lines the Surgeon Generals report really emphasized this point that we can argue, and we will, about how ecigarettes should be regulated, how hard velvet glove, iron fist, how should this happen and which particular policies. But the safest thing that we can do, the biggest way that we can minimize their dangers and potentially maximize any potential benefits they have is, and i quote the impact of the noncombustible aerosolized forms of nicotine delivery on Population Health is much more likely to be beneficial in an environment where the appeal, accessibility, promotion and use of cigarettes and other combusted Tobacco Products are being rapidly reduced especially among youth and young adults. In other words, if ecigarettes were marketed like the patch well, or if cigarettes were, if cigarettes if the appeal, accessibility and promotion and use of cigarettes were thumb screwed in a more dramatic fashion. The courts ruled the only way we could regulate the is cigarettes is under Tobacco Authority because nicotine is derived from tobacco that is a Regulatory Framework were trying to create. I have to think more about that. [inaudible conversations] yes. I guess you are right. Bad decision. Thank you both for your leadership in this area. You just cannot let up on the efforts. We have to figure out a way especially as it pertains to kids to get a handle on these cigarettes. I dont know if i am for extending the deadline or not. I dont know. All i know is there should be some compelling reasons to extend the deadline beyond 75 days. I dont know if there are or not. A aias the record be open for comments and suggestions and thank you for being so patient and thank you for your leadership. [inaudible conversations] [inaudible conversations] just under two hours. [inaudible conversations] the Senate Appropriations subcommittee on education related agencies please, to order. Todays hearing is the fifth held since 2000 focusing on alzheimers disease. The burden of the disease, a state of research and the challenges faced by caregivers. Going back many years we have heard predictions from experts for the far reaching consequences it will have on the quality of life for American Family and the burden placed on the economies in the years ahead. Last april a study predicted these consequences will be far greater than imagined. Well hear from the author of of that study today on the next panel. With this commanded the study of the nation and the subcommittee. Few americans whose lives have not been touched in some way whether a family or friend the most common form of dementia of older americans. For those living with the disease the ravages get worse over time and on society. And it has doubled and as the baby boom generation continues. The federal governments involvement with Research Began in 1976 when three institutes of National Institute of health invested 3. A Million Dollars for research into the cause of this disease. We now spend approximately half a billion dollars each year on research and alzheimers disease. And we had success along the way but the harsh reality is we dont know how to prevent or reverse or definitively diagnose alzheimers. More researches desperately and urgently needed. The subcommittee zero is a years a strict policy or definitively with the peer review process