the fda is also not commenting on what they have or have no doubt.e know that the fda does not require regulation of diagnostic test. but in recent years they have been stepping up their oversight more and more because they are starting to go direct to consumers and that is when the fda gets concerned. emily: we spoke to a leading endocrinologist who is very sort -- smart about blood testing. he was very skeptical. we realized he works for intermountain. he is negative on the company and technology despite the fact that his employer seems to approve of it. listen to a quote from that interview. >> senior doctors and biotech scientists have been paying attention for a long time because their claim of it too true.nd too great to be i've been asking them for their data. they refused to provide it. they do not play by the rules of science or medicine. they are not transparent. emily: he went on to say that the numbers, in terms of the and -- amount of blood used to be tested for inaccurate result in the adult. what do you make of this? >> on hospital sys

michael taylor is the fda deputy commissioner for foods. do the current laws do enough to protect the most vulnerable americans. >> we don't think they do enough to protect all americans. that's why we have the 3,000 deaths annually from a wide range of pathogens. >> reporter: taylor says that will change with the implay men taegs of the food safety modernization act, the first overall of u.s. food safety laws in more than 70 years. the kind of practices we saw in the facility are what the new food safety law is intended to prevent. >> reporter: you are going from reactivity to prevention. >> exactly. that's the shift. >> reporter: the shift started this fall when the fda began implementing rules. with 1,000 inspectors for 100,000 facilities. taylor says they can't do it alone. >> the companies have to take responsibility for understanding the hazard in their facilities. >> reporter: you will never have the resources to be in every production facility every day. >> we have got to have a system that creates real accountability on the compani

michael taylor is the fda deputy commissioner for foods. do the current laws do enough to protect the most vulnerable americans. >> we don' think they do enough to protect all americans. that's why we have the 3,000 deaths annually from a wide range of pathogens. >> reporter: taylor says that will change with the implay men taegs of the food safety modernization act, the first overall of u.s. food safety laws in more than 70 years. the kind of practices we saw in the facility are what the new food safety law is intended to prevent. >> reporter: you are going from reactivity to prevention. >> exactly. that's the shift. >> reporter: the shift started this fall when the fda began implementing rules. with 1,000 inspectors for 100,000 facilities. taylor says they can't do it alone. >> the companies have to take responsibility for understanding the hazard in their facilities. >> reporter: you will never have the resources to be in every production facility every day. >> we have got to have a system that creates real accountability on the companie

>> they're fda-registered generic drugs. they're produced in fda-inspected facilities. and we buy them. and our facilities are inspected by the fda as well. >> so then explain to me how this is possible from a market perspective. a company buys this drug and essentially has a monopoly on that drug as far as i understand it, right? they purchase the drug. not a legal monopoly because it's out of patent, right? i think i misspoke before and said patent. but they have this drug. they're going to jack up the price. you come in and say we'll sell it for a dollar. like how can you afford to sell it for a dollar if they're selling it for $750? >> well, first of all, you know, when you talk about the drug you talk about daraprim. everybody talks about daraprim. but daraprim is really a name in advertising. it's a brand name. the underlying chemical that makes up daraprim happens to be very inexpensive. and so what we are able to do is to buy that chemical. and let me be clear. we are not legally allowed to copy that drug. the fda will prevent us from doing that. and we will not

with tests running on our proprietary those through the fda's submission process. every test that we offer in our laboratory can run on our proprietary devices we bring tests up on our proprietary devices based on the frequency with which they're run. so at any given point in time we're running the tests that are most commonly ordered, but we've also done a lot of work as part of this commitment that we've made. and it's been very controversial that we've actually become the first company advocating for fda regulation of lab-developed tests. and as part of that we have said that we think that every lab-developed test really should go through the fda submission process. and so we've been consistent with it. and in fact we even just recently took our nanotainors through the fda clearance process and sent submissions and for those and as part of that process we're not even using our nanotainers except for fda cleared so everything run on our platform getting to the point that is fda cleared. >> one last question. obviously there's some dispute here. the journal doesn'

so everything run on our platform getting to the point that is fda cleared. >> one last question. obviously there's some dispute here. the journal doesn't make stuff up. why not just have the study of hundreds of people theranos versus lab corp. say, listen, we're willing to do it, we're willing to do it now as lab corp is quest. just say it right now on air quest, lab corp, we want to do a head-to-head 200, 300, 400 patients. what do you say? yes. >> we've already done it. absolutely. and it's actually even published in our fda decision summary from the summer from a 900-patient study where we got fda clearance of the exact system that the journal is questioning and demonstrated venous versus finger stick across a huge number of patients. it was 889, i think, for that test. and we've done that over and over again for every single test. >> excellent. elizabeth holmes, founder, chair and ceo of theranos. thank you for coming on "mad money." good to see you. >> good to see you too. >>> read the journal, listen to our interview. you make up your mind. stick with cramer.se bbq trophie

fda isn, the role of the unclear, they say that they went to the fda to approve all things they thinkt maybe they cannot do all the things they think they can do. it is also important to look at the way that the farming of technology has been, falling in love with this story and running with it without asking basic questions. this is a business with a secret black box, they are not sharing and saying that they can do something that has never been done before. and people run out and believe it and tries to get more access to this great company and this ceo james -- who seems to have this fantastic solution. i think that there are a lot of farming coverage that looks at these companies in silicon valley. betty: i agree. thank you, corey. now some good news about consumer confidence. preliminary consumer sentiment is up this month, final numbers later this month. this is the first time that the index has moved higher since early summer, wait i -- wage hikes are on the way and lower gas prices. joe weisenthal is here, what did you make of these numbers? i think the volatility that a big e

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the results from this study will be submitted to the fda. their long term goal is to study whether mdma should be re-classified by the fda so it becomes legal for medicinal uses. >> i think the rational thing to do is to learn everything we can about the possible risks and benefits and act accordingly. not to put it in a separate category just because it's been used recreationally. >> coming up on "techknow", the u.s. military's secret roll in psychedelic drug testing. >> we want to hear what you think about these stories. join the conversation by following us on twitter and at aljazeera.com/techknow. >> the money fell victim to the politics. >> they're more focused on getting jobs than our education. >> the drug was given orally to the men in the hospital ward at 11:15 and they immediately em-bussed, arriving at the exercise area ten minutes later. at 11:40 the first affects of the drug make their appearance the men no longer take cover they relax and begin to giggle. >> this british army experiment was filmed in 1964. the effects of psyche

fda has said in given content are fine and safe. fda is part of the h hrk s process. >> how did they impact the final recommendation? >> something that we are reviewing but our own experts, not just fda for us and nhs as well, the whole department is part of the process, reviews everything together, that forms the recommendations that we will be receive from our department collectively together. >> okay. additionally recommends replace sugared beverages or low-fat milk only for guidelines to be effective. in your final recommendations how do you intend to balance ideals that are idealistic on recommendations? >> you are getting ahead and wouldn't be able to comment on specifics. when we say balance, it's also about the issue the secretary raised of nutritional value. when you're trying to have a set number of calories and certain numbers of nutrition, how you can get the puz -- puzzles together is something we will put together. >> thank you, recommendations were voted and discussion of red, versus lien and packaged meat, recognized

. >> a meeting about the possible consequences of a new fda regulation to allow oxycontin prescriptions for children as young as 11. opioid addiction. s according to the state rep who filed a bill awarding the fda. her legislation would bands -- prescriptions of oxycontin for anyone under the age of 11. >> we are in the middle of an epidemic. >> the fda made the change back in august. >> it' s addictive. >> this is about the war on addiction. >> a slew of witnesses testified or the joint committee on mental health substance abuse that the move could be a band-aid >> please know mine and other people' s stories. we know firsthand what this drug does to people. -- the american cancer society and cancer action network filed this letter in opposition to the bill saying in essence, some patients need the strongest possible pain medication. >> we want to make sure that barriers are not put in place for cancer patients and others suffering from pain from getting the medication that they need to manage their pain. phil: a bird that has managed to elude capture is finally caught after terrorizin

the fda says that the tightest see drug is tied to a serious liver injury.ust coming off of the bottom. sally and pharmaceuticals explanation of the relationship with pharmacies that distributed drugs have not satisfied investors. this is a cornering to a scathing report yesterday equating the company to a pharmaceutical enron. we sat down with andron left. >> pharmacies are outsourcing their chief privacy officer. none of it makes sense. i'vematter of fact, and will do this in the next few days, if i take all the responses from all of the silicide and include with it responses from the companies, you will see three different responses. the responses are amateurish. they are acting the way they are because the shares are still feeling the pain or a second day in a row. they will hold an investor call on monday to address all of the allegations. here to talk about what he ainks for this report is neutral rating on valiant. you are not changing the rating echoplex know, i am not. i have been agnostic on the stock for quite some time for reasons that have nothi

anna: there are fda inspectors on the ground.have been trying to build a better relationship with the chinese authorities there, china's fda. the u.s. fda is able to do their own inspections at some of these plants, though they don't have a ton of people. they have some trouble getting visas, so they don't have a lot of people on the ground, but they do send inspectors, and they are able to look and see how the factory is kept, whether they are meeting sanitation goals, but also whether they are manufacturing drugs the way we expect them to be manufactured here. they are finding that a lot of times, they are not meeting the protocol, they are not doing the right processes to ensure that the drugs we are getting from them are of a high enough quality. david: this is obviously worrisome. what are pharmaceutical manufacturers saying about these allegations? anna: some of the companies that we noted had bought from these chinese drug makers, pfizer, novartis, merck, some have said they test those products when they get them in the u.

century cure bill, we embodied the software act that deals with these provisions and would put the fdan the right lane when it comes to dealing with health care and software. this is such an exciting field. when you look at the m-health app, what it will do is to say, fda, if something has a life or death consequence, and you are looking at software that is embedded into a defibilator or implant that needs to go to the fda for oversight. if it is there for informational purpose, we will send it over here to the marketplace because it requires a learned int intermediary. as we move forward with precision medicine that is directed more specifically to the individual for their health and wellness, you have the utilization of ipad for that patient and capturing data and information and doing predictive diagnose for how someone is going to handle certainly protocols or therapy and what is the next step. there is a whole new usage and utilization there that will bring about more possibilities for better outcomes. when you look at just the internet there, with that health information, you are

testing our health with fda approval. for $199, 23 and me can test you for 36 conditions while giving you information about your genetic background. >> genetics can help us learn about ourselves in so many ways. this has to do with our identity and the way we relate to our families through to the choices we make on a daily basis and some serious health considerations. >> now, from its brand-new mountain view headquarters, 23 and me can tell you if you have a genetic predisposition for a specific duzees, but with high-tech testing in the spotlight, after reports it's not as accurate as it claims, 23 and me is moving slowly towards more information for its users. >> taking something that's complicated and making it simple and something that's abstract and sciency and microscopic and isn't really human relatable. >> it's a field that's very sciency, and new to most of us, with a growing number of people working to make things easier. you can get the $199 saliva test on the 23 and me website, and if you have done the test pre

and we put the fda in the right lane when it comes to dealing with health care software. this is such an exciting field when you look at the m-health apps. what it will do is to say, okay, fda, if something has a life or death consequence and you're looking at software that is embedded into a defibrillator or an implant, then that needs to go to the fda for oversight. if it is something that is there for an informational purpose, no, we're going to send it over here to the marketplace, because it requires a learned intermediary. but think about how that engages individuals in the maintenance of their health care and looking at disease management. also as we move forward with precision medicine, medicine, therapies, practices that are directed more specifically to the individual for their health and wellness. and you have the utilization of an ipad or a tablet for that participation and capturing data, capturing information and doing predictive diagnosis for how someone is going to handle certain protocols or therapies and what will be the next step for them. there is a wh

>> i think what's important is that we put fda, and i know that's the fda's mission and it's our mission as well. we have to put patients first, our philosophy is when we put patients first, we're going to win as a public, we're a public company. we have shareholders to account to, we're committed to putting patients first. that's what the fda wants to do, we're aligned in that regard. we need to work cooperatively with them to make sure we can act as a counterbalance to this situation as well as many others that we'll soon talk about. deirdre: mark baum, thank you for your time. we like to root for people taking the high road. thank you. >> thank you, deirdre. deirdre: too close for comfort, an amazing midair close call. we'll bring you more details. what is behind this brush with a huge jetliner? >>> actor seth rogen joining me to talk about his new movie. it is called "steve jobs." he played the role of steve wozniak, the co-founder of apple and talk about sony's hack attack and hollywood's challenge with equal pay. >>> then a jilted lover smashing her husband's bmw. that is video tha

the fda did propose these rules they were going to use to regulate this industry. they said they plan on doing that. they'll regulate e-cigarettes as well as the component parts, the batteries, the oil that people put in there. but there's no timetable. until then you're responsible for what happens. you need to watch out for your own safety, and the fda encourages you if you have adverse effects, you can report that on our website. >>> it's time for the weather, and we're keeping it close on showers that may affect briefly the ball game. >> just briefly. just briefly. we are attacking no showers on reboot. the skies look more threatening than they really are. this is our view from the rock camera on 30 rock. we can see the clouds rolling in just now. it was mostly clear, and approximately. later on tonight, though, it is going to get quite chilly. we zoomed in on queens to show you there's nothing happening. no rain. but it is moving to parts of new jersey. we're seeing thunderstorms pop up in wayne county, livingston county. there could be some downpours in there

actually the first laser we're using to melt fat (track) it's called sculpsure and it was recently fda-approved. in addition to all the tubes and without burning the skin. (natsot of dr. katz) this is the area, cold plate cools the skin, laser comes out and heats the skin track: those applicators are snapped into place. studies have shown a single treatment can remove up to 30 percent of the fat in the treated area. dr bruce katz / juva skin & laser center we need no anesthesia for the treatment, there's no downtime, people go right back to work after the session. they feel a little tender for a week or so but it's like having a big workout. track: before and after photos from the clinical trials show the device can treat almost any area where there's a fat pocket... painlessly. ( sot jackie akbar / sculpsure patient) i feel heat just a tad but the cooling that comes after feels pretty good. (track) and the whole process takes just

it used be before the fda stepped in. now $99. >> it's a complete experience as you're getting over 60 different reports about your health and ancestry as we believe that is providing a lot of value to the consumer. now that we are an fda and we meet their standards that there is just a lot of value in that testing. >> how do you acquire more information about 23 and me? >> the final information or to order a test go to www.23andme.com. >> we are cautious about putting our information out there. there are privacy settings? >> yes. we would review all the barriers to protect the customer data with a lot of control for each individual customer if they want to share their information or not that they could be control thed inside their account. >> all right, with 23 and me, thank you so much. >> thanks for having me. >>> we have learned a lot as thousands are making it on their own return. we're going to follow one man's trek. >>> let's give you a live look outside at highway 24. we've seen it a lot worse as we make our way i

fda asserted the safety of it.fd yet dgac used a dubious process to call into question its safety, citing weak science against the backdrop of decades of research that shows otherwise. now we're calling for more research in spite of the fact that fda spent over a decade studying this ingredient and safety and concluded there is no increased risk of cancer from aspertame. during your review of the guidelines, are you consulting with the fda on recommendations after they spent years reviewing the science? >> yes. fda is a part of process at hhs. with regard to the issue of the safety of aspartame -- there are basically five products that fda has said in gip contents are fine and safe. and so, yes, fda is a part of the hhs process. >> how do the inner agencies review impact the final recommendations? >> the review is an extremely important part of the process. i think both the secretary and i have indicated that the input of the advisory committee is something that we are reviewing. but our own experts across our depa

. >> reporter: approved by the fda, essure is used by 250,000 women.en, including kim hudak, are questioning the device's impact on their health. >> physically, it has completely compromised my health in almost every aspect. >> reporter: she says over 14 years, essure has led to a host of problems -- severe headaches, spasms, bleeding, and eventually two surgeries, including a hysterectomy. looking for answers online, kim discovered a facebook page about essure. >> at first, i was relieved, and then i was horrified that all these women had the same problems as i did. >> reporter: that group has more than 20,000 members with varying complaints. so, a device that women chose to avoid surgery may actually create a surgical need for them? >> absolutely. >> reporter: now a new study led by dr. art sedrakian of new york's medicine, says planting the essure in the fallopian tubes can lead to more complications than traditional surgery, a risk that he says is ten times greater with essure. >> in many instances, we believe this is a reflection of the device fai

she points to the fda, and they say at this point -- >> does the fda have access to the technology reportedly -- >> i don't think they have access to the technology. >> who does? >> does anyone? >> it's my understanding they say that is their -- >> i understand that. i understand it's a trade secret. if someone besides the competitor ought to be able to see -- >> world of science you share your information. >> and has to be duplicated or we'd be all using cold fusion. >> what they're looking at is whether the finger prick tests are as accurate as the blood drawn from six viles in your arm. that's the big question. >> using standard equipment. >> jeff is from yale is here. one of the issues on that, you prick the finger, you take less blood, and they were diluting the blood by using all sorts of chemicals to create more volume or liquid. >> to run that in the old semen equipment, and the viles they used, and it's -- that's nothing proprietary about that, just a little thimble size vile. >> these are not gray areas -- is or isn't with molecular biology. you know. >> the -- i thought cramer's qu

not to say fda regulation is good or bad. the question i think we have to ask is who will it serve in this particular context through this particular legislation? that is the question. yes. right behind you. >> since there is no evidence that smoking tobacco can be used without producing this and norma's burden of disease, and there is all this evidence that it does produce this enormous burden of disease, why are we asking any other questions other than what is the most strategic way to put an end to smoking tobacco? >> i think that is the question we need to ask. what is the strategic and pragmatic approach to making societies genuinely smoke-free? one of the things i found in the book and i think this is one of the difficulties is, in many ways the cigarette was grandfathered. it was a historic product based on a crop that was grown before .uropeans even got here it became an incredible economic engine of the development of the early state. and so we are dealing with a product with this historical weight, and i don't think

periodista: estÁn en cualquier bodega a la visto del pÚblico, y aprecios bajos a pesar que la fda hao por los anteriores tres dÍas tabletas para mejorar el rentomiento sexual. ramÓn garcÍa dice haberlas usado, tiene 50 aÑos. ramÓn: se me ka lento aban las orejas y eso solamentemente un poco. periodista: pero aÚn asÍ las volviÓ a usar? ramÓn: si. periodista: multarÍa con mil dÓlares a los consumidores por primera vez, en la segunda vez 5.000, y despuÉs cerrarÍan en donde la venden. mis amigos que las usan dicen que han vomitado, el corazÓn fuertes latidos, es un peligro. periodista: la fda advirtiÓ que estos productos tienen 30 veces mÁs la dosis de la medicina que se vende con prescripciÓn mÉdica y tienen efectos alarmantes de presiÓn arterial. lourdes: no tienen la fecha de caducidad ni los efectos secundarios, es por eso que las autoridades han decidido intervenir. jorge: y ahora vamos a terminar con otra pÍldora, le llaman la pÍldora del ejercicio y estÁ en experimento, pero todavÍa estas pastillas son experimento, no hay nada que cambie el hacer ejercicio. marÍa elena: quÉ bien!

we spent a lot of time with the fda. they helped us out a lot.ey to the company, our belie belief is that getting drugs to market is one thing, but pricing is an issue. we've seen that the past a couple of weeks. the ability to get both of those drugs approved in one clinical trial gives us basically the ability to price it any way we want to. obviously we're not running a charity, we're here to sell drugs at a reasonable price. i think we can get there without price gouging. >> let's talk first about timetable. if you're watching at home, phase iii doesn't mean it's going to be this month, but it could be, what, within a couple of years? >> so the studies should get started hopefully in the next 30 to 60 days. we anticipate it will take about 18 to 24 months to enroll the trial. and then it could be within another, you know, six to 12 months after that, we could have an outcome. >> this is a fatal disease. i mean, how do you have trials that can last that long? how do you do that, knowing that people may not live long enough to be in the trial?

the claims manufacturers but on the product must note the fda has not approved them, unless the fda has approved the settlement. the fda urges if you've had a problem with a supplement that you have taken to contact them. jonathan: all across the world flights and passengers delay because of a glitch. -- customs computers shutdown overnight. lines stretched through terminals. the way together u.s. customs was 90 minutes. the issue is tracked public back way home and security computer system. it raised security questions but early indications are this glitch was not a hack. i'm not sure that supposed to make us feel better. around the commonwealth, the public information meeting about the insight about the project involves establishing toll lanes between the morning and evening rush hours. it begins of the farm will station the school cafeteria in ashburn, virginia. alison: but get a check on the traffic situation. robert is in the traffic center. robert: northbound lanes of 270 have stop and go traffic. that heavy traffic as of towards the frederick county line. 295, heavyd.c. traffic c