>> so we had july the 17th and fda meeting that was our first meeting with the fda. we were able to introduce two new outcome measures for our trials, and the fda was quite positive that we can run a phase two trial in the u.s. and we also got an approval by the european agencies in uk, spain and the netherlands which were quite enthusiastic. in particular that this drug has an excellent safety profile, it's well-tolerated. and by the way, hundreds of patients take the drug now worldwide off-label, of course, from the philippines, india, latin america and also in the u.s. >> thank you. since aborted broken the rules and a senator casey testily, you want to interject with the question before you leave? >> i'll wait for the testimony of the others. >> that's fine. our next testimony will come from lincoln tsang, a partner at arnold porter in london. >> mr. chairman, ranking member and establishment of the committee my name is lincoln tsang. i'm grateful for the opportunity to discuss certain technical and regulatory issues relevant to facilitating research and developm

and we said the fda is killing us. and in a certain sense we wanted the drugs out on the market faster and we wanted smart trials, we wanted humane trials and we wanted access and answers, but something else was listening. that brings us to a historical moment, but it is the people who are in power now who have been sort of enemies of the regulatory state since the reagan administration. who think the fda should be small enough to strangle in the bathtub. and this is not under the trump administration, there is the 21st century cures that passed last year, side by obama in his last months in office. it takes all the reforms we asked for and pushes it to the verdict extreme. so we see shorter trials, smaller trials, less information about the drugs we put in our bodies, and it costs more and more. so we opened up a pandora's box back then, because we were desperate. there were people from the manhattan institute and other think tanks, but right to try is nothing like parallel track, where we asked for clinical research

the fda make that determination, and where there are products that don't meet fda standards, we don't believe that they should be appropriately termed as medication. >> i want to congratulate you for what you have done, this is a compassionate use drug you worked hard and got it done and you've done a great job for shareholders >> thank you, jim. >> that the ceo of g w pharmaceuticals. this is a real company with the kind of science you need if you're going to go after these tough illnesses. "mad money" is back after the break. the nature of a virus is to change. move. mutate. today, life-changing technology from abbott is helping hunt them down at their source. because the faster we can identify new viruses, the faster we can get to stopping them. the most personal technology, is technology with the power to change your life. life. to the fullest. >>> now that the dust seems to have settled, i think it's worth circling back to some of the companies that had the misfortune of reporting when everyone was reporting here's a stock that's been getting slammed since the summer the actual n

are many other companies that have not gone through the fda. and some of those claims, i cannot speak about the fda, but some claims have caused concern. they have caused concern for our scientists. so we are a strong advocate. the fda has the potential for innovating and there needs to be one system that regulates all of these companies. emily: one last question. you work so closely with the government and you probably have more insight into this bridge between silicon valley and washington, more than other companies might, how has that relationship changed under the trump administration for better or for worse? are you concerned about the future of technological research, or no? anne: that is a great question. in some ways it is hard to look at the specific political environment for me because there are a couple things that have happened. it is clear this is an administration that is not want to regulate. that is very clear. at the same time we have had issues that have come up with facebook, google, etc., that clearly show that there are uni

are many other companies that have not gone through the fda. and some of those claims, i cannot speak about the fda, but some claims have caused concern. they have caused concern for our scientists. so we are a strong advocate. the fda has the potential for innovating and there needs to be one system that regulates all of these companies. emily: one last question. you work so closely with the government and you probably have more insight into this bridge between silicon valley and washington, more than other companies might, how has that relationship changed under the trump administration for better or for worse? are you concerned about the future of technological research, or no? anne: that is a great question. to lookways it is hard at the specific political environment for me because there are a couple things that have happened. it is clear this is an administration that is not want to regulate. that is very clear. at the same time we have had issues that have come up with thatook, google, etc., clearly show that there are unintended consequ

we will have to do more work with the fda. but it's an incredible step forward and i think my hope is that when i think about my dreams in five years, every drug coming onto the market should have a pharmacogenetics component. right now you see that in cancer therapies, but you don't see it in any others. emily: what drugs are we talking about here? >> we're talking about things like plavix, which is common. some people can take a staten and they get muscle pain. psychiatric is one of the biggest areas. there are a lot of medications that have already known association. plavix is interesting, because the state of hawaii came out and changed some of their reimbursement laws because so much of the hawaiian population does not genetically respond, so they made some statements about it. that was one of the most interesting cases for me. but there are a lot of medications -- when we look at numbers, when we have the tests, we can see 30% of customers all had a significant response. emily: what is your response to the controversy? t

we will have to do more work with the fda. but it's an incredible step forward and i think my hope is that when i think about my dreams in five years, every drug coming onto the market should have a pharmacogenetics component. right now you see that in cancer therapies, but you don't see it in any others. emily: what drugs are we talking about here? >> we're talking about things like plavix, which is common. depressants, some people can take a staten and they get muscle pain. psychiatric is one of the biggest areas. there are a lot of medications that have already known association. plavix is interesting, because the state of hawaii came out and changed some of their reimbursement laws because so much of the hawaiian population does not genetically respond, so they made some statements about it. that was one of the most interesting cases for me. but there are a lot of medications -- when we look at numbers, when we have the tests, we can see 30% of customers all had a significant response. emily: what is your response to the c

fda available by prescription in all 50 states. it treats sere forms of epilepsy and based on a chemical component found in marijuana that does not get uss high. >>> we turn to a story hitting home for so many families, perhaps yours. noveer is alzheimer's awareness and millions of family members who care for loved ones with alzheimer's are recognized for a job that can take a serious toll on their health. nbc news maria has more. >> reporr: for 14-year-old hailey and her mom robin balancing work, school and care giving has become a daily labor of love. their 82-year-old father and grandfather jim has alzheimer's. >> love you, grandpa. >> reporter: a former naval officer who lost his leg, jim was diagnosed with alzheimer's last year so robin had to move him and her mom into e tiny apartment she shares with her boyfriend and her daughter. >> not that shirt, dad. >> reporter: every morning and evening they dress jim, make his meals, give him meds and keep him safe as he slips into the cognitive fog of alzheimer's. >> i worry aboutalt

explain the process of getting a gene therapy developed and approved by the fda. how long does it take typically? how much does it cost? guest: gene therapies are moving pretty quickly. the reason is that sometimes they can be extremely effective. a child can get a dose of a gene therapy, there is a disease called spinal muscular atrophy, and it is really kind of speeding up the approval process. in that case, they only treated about 15 children before they were almost ready to go to the fda and ask permission to market it, something they have now done. so kind of comparison, treat 15 gives with gene therapy versus a save forlinical trial, a cancer drug, where you may see hundreds of thousands of people in a really long development time. it can be faster, but it is complex science. the gene therapies are delivered with science, bio particles, but the whole way to produce the gene therapy, sort cown bags of cowboy, is -- of located, but you make millions of particles, and if viruses go to the sales and basically deliver the new dna. we take a look at the calculus f

eliquis is fda approved and has both. don't stop eliquis unless your doctor tells you to. eliquis can cause serious and in rare cases fatal bleeding. don't take eliquis if you have an artificial heart valve or abnormal bleeding. if you had a spinal injection while on eliquis call your doctor right away if you have tingling, numbness, or muscle weakness. while taking eliquis, you may bruise more easily... and it may take longer than usual for bleeding to stop. seek immediate medical care for sudden signs of bleeding, like unusual bruising. eliquis may increase your bleeding risk if you take certain medicines. tell your doctor about all planned medical or dental procedures. what's around the corner could be surprising. ask your doctor about eliquis. >>> finally tonight, this thanksgiving took on special significance for a man who spent decades in prison and was finally released last year after he was pardoned. as we hear from nbc's steve patterson, it was result of an unlikely friendship that developed over the years. >> this is my favorite place in the house right here. >>

we may see more from the fda. the question of social media marketing but as of now, the fda has said anyone the markets to kids, the products will be removed from the market. --ot of e-cigarette managers manufacturers have tried to tackle this problem of teen use. some are voluntarily taking steps such as removing certain somects from stores or in cases no mother using social media influencers. voluntarily took a number of steps to no longer use younger people and their images. they don't use models anymore. they only use former adult cigarette smokers who have switched. host: in the days of cigarettes, marlborough and the like, you'd see some type of disclaimer put on packages. you see the same amongst e-cigarettes? jennifer: e-cigarette billboards and newspaper ads say nicotine is an addictive chemical, and they know it is intended for adults and generally intended for adult cigarette smokers to switch. host: our guest is with us until 9:30. about want to ask her questions. if you live in the eastern and central

the fda will weigh in soon. lester? >> cynthia mcfadden , thank you. >>> the first cannabis-based medication was just approved by the fda available by prescription in all 50 states. it treats severe forms of epilepsy and based on a chemical component found in marijuana that does not get users high. >>> we turn to a story hitting home for so many families, perhaps yours. november is alzheimer's awareness and family care givers month, where the millions of family members who care for loved ones with alzheimer's are recognized for a job that can take a serious toll on their health. nbc news anchor maria shriver has more on what she knows all too well. >> reporter: for 14-year-old hailey and her mom robin balancing work, school and care giving has become a daily labor of love. their 82-year-old father and grandfather jim has alzheimer's. >> love you, grandpa. >> reporter: a former naval officer who lost his leg, jim was diagnosed with alzheimer's last year so robin had to move him and her mom into the tiny apartment she sha

the old fda is awesome and the new fda is awesome. part of the program that is really novel, our continuous glucose partner now has an icgm system which is really novel. what the fda is doing is recognizing that software isn't a pill. it's hard to change a pill once it's in the market. you can change and update software. that knowledge has led to really great innovations through the fda, and i think it is the right mix of being safe and secure as well as being innovative. and the other thing that really surprised me is just how human the fda is. for any of you who have been involved, if you haven't, i highly encourage you to figure out a way to work with a company that submits. they meet with you in person. they give you advice. it's actually a pretty wonderful organization to work with. now, the flipside, just because you asked about government. medicare/medicaid, i think they have a greatest need for programs like ours. so the average commercial payer might only have an employer might have an insured for three to five years. if medi

the fda's new rules leave glaring gaps. >> their plans do not include restricting the sale of mental and mint and does not apply to the open tank cigarettes. >> even with the restrictions there is a loophole. >> reporter: this senior wants to see the fda implement tougher policies. until then, he is focused on educating his classmates. >> i know students who after they heard about what actually is in these products they started to like consider quitting. >> reporter: the fda's new policy is expected to be phased in over the next few months. in fremont, kpix5. >>> there is look at sfo right now as -- oh still hazy there. as travel season approaches. there is a dangerous. cabin air can get contaminated and make you very sick. >> this problem was reported on earlier this year and we have more now with the latest. >> reporter: we discovered a flawed design in almost all planes can cause toxic fumes to enter the cabin. our investigation revealed that the industry and the agencies have missed several opportunities to protect both their employees and the public. >> it effected my entire lif

the fda's new rules leave glaring gaps. >> their plans do not include restricting the sale of mental and mint and does not apply to the open tank cigarettes. >> even with the restrictions there is a loophole. >> reporter: this senior wants to see the fda implement tougher policies. until then, he is focused on educating his classmates. >> i know students who after they heard about what actually is in these products they started to like consider quitting. >> reporter: the fda's new policy is expected to be phased in over the next few months. in fremont, kpix5. >>> there is a live look at sfo there. as the holiday travel season approaches. there is a dangerous. cabin air can get contaminated and make you very sick. >> this problem was reported on earlier this year and we have more now with the latest. >> reporter: we discovered a flawed design in almost all planes can cause toxic fumes to enter the cabin. our investigation revealed that the industry and the agencies have missed several opportunities to protect both their employees and the public. >> it effected my entire life, my husba

since the release of the blueprint fda has approved the first generic version of the epipen. the bio similars and the first three generic drugs under a new pathway drug to support competition. fda's success is in large part due to the action plan that the commissioner unveiled last year. one element has been cracking down on drug manufacturers abuse of fda programs that were intended to protect the public health to pad profits instead. we appreciate the recommendation from nam on this front in the drug rising report. already fda has gone after a number of ways that manufacturers game the system including the use of programs to didn't -- to delay generic competition. just last week we issued new draft guidance making it clear that manufacturers should not be misusing the system to block generic competition and noting that abuse of the system could and would be referred to the ftc as anticompetitive behavior. the complement -- this summer fda announced a bio similar action plan -- is a market for biological projects just as there are four small molecule generic drugs today. as

eliquis is fda-approved and has both. what's next? reeling in a nice one. don't stop taking eliquis unless your doctor tells you to, as stopping increases your risk of having a stroke. eliquis can cause serious and in rare cases fatal bleeding. don't take eliquis if you have an artificial heart valve or abnormal bleeding. while taking eliquis, you may bruise more easily and it may take longer than usual for any bleeding to stop. seek immediate medical care for sudden sign of bleeding, like unusual bruising. eliquis may increase your bleeding risk if you take certain medicines. tell your doctor about all planned medical or dental procedures. eliquis, the number one cardiologist-prescribed blood thinner. ask your doctor if eliquis is what's next for you. >>> in tonight's those stop that turned into a special delivery in north carolina. here is kristen dahlgren. >> reporter: when sergeant brian mayna pulled over this driver, it wasn't just >> he got out and said my wife is in labor. i said right now? he said right now. >> reporr: ready or not, their little gir

and then the other thing that really surprised me is just how human the fda is. for any of you who have been involved, if you have, and i highly encourage you to figure out a way to work with the company that submits, they meet with you in person, they give you advice. it's actually pretty wonderful organization to work with. now, the flip side, just because you asked about government, medicare, medicaid, i think they have the greatest need for programs like ours. so, the average commercial payer might only have an employer might have an insured for three to five years. it's medicare where we're all going to pay for if we don't manage prediabetes now or people with diabetes today. and so, it's government reimbursement for medicare and medicaid programs that that's where i think is the holy grail for -- >> and do you see your company or are you already approaching them or do you figure you will after you have more data? >> no, it's a little bit a combination -- we're a start-up, granted, you know, a decently funded start-up. we're going through the process now and

now we have these companies that have no fda. the fda has no say in their safety. they determine the safety they do short-term studies and they put products on market and bio politicians are along the way. so how are we any better off today than when doctor wiley was making these changes? >> that's easy to raise that. you have some legitimate issues. first of course we are better off than we were when there was no safety testing. no requirement to safety test no labels and people could put things like formaldehyde into our food with impunity and children would die and not be prosecuted. we have moved hugely forward from that. you heard me rant about labels, but at least we have them. in that sense we have a safer food supply and indeed if you look at and then i'm gonna talk about additives. but if you looked at something like bad food manufacturer that kill people in recent years an example of where we have performed to a much higher level would be the peanut corporation of america scandal which was six or seven years ago and if you don't know it i think his name w

we appreciate the fda report. already the fda has gone after ways of turning off the system. >> that manufacturers should not be using the citizen prescription and nks that an abuse to say this system wool. to complement the work in the generic drug space, this summer fda also launched a bio similars action plan, to help build a market for bioproducts just like there are small generic drugs today. but even as we endeavor to build a real drug marketplace, there are still sources where sole source manufacturers of off patent, off the standards. i taught a safe group on how to safely import full force drugs that have no patent or exclusivity protections. [ applause ] >> this was not ant idea in the blueprint, but it followed the blueprint in that it could bring down costs for the patient. they also took advantage of well-meaning rules including orphan drug rules on drug pricing. earlier this year the fda finalized a guidance on orphan drug regulation requirements, making clear we will no longer grant orphan designati

first i will be joined by the fda -- the fda commissioner scott gottlieb to discuss the opioid crisis in the united states from the perspective of the federal government and the fda. he has been an active commissioner. we just had an interesting conversation. >>> next a panel of health and technology experts including clinicians to talk about what is working and what is still needed. then my friend and colleague the el editor will be joined by a panel of health experts to explore the role of digital help in dieting -- diabetes technology to improve prevention and treatment of diabetes. as you follow this on stage join the conversation using the hashtag politohealth. before we begin i would like to thank our sponsor, anthem, in their support for making this possible. here to stay -- to say a few words is doctor friedhoff -- welcome. >>> good morning, everyone. on behalf of and some i want to welcome you to our discussion on a tale of two crises -- on doctor stephen friedhoff. we are talking about how to use technology to combat two of the most complex challenges in healthcare -- the gr

. >>> tonight, the fda says it's taking drastic action to stop the spread of a national epidemic. the skyrocketing s number of teenager who are vaping, using e-cigarettes and the y feds say thent to ban menthol cigarettes all together. we get more from nbc's tom costello. >> reporter: in boulder, colorado, school nse liz blackwell is on the front lines of an exploding e-cigarette epidemic. >> it's an impact on whether or not they can participate in sports. >> reporter: the problem is natnwide. the fda said it's taking action. >> what is at risk i we'll reverse the gains in recent years of trying to bring down smoking rates ormong adults and kids. >> rr: the fruity flavors in e-cigarettes target teens. now the fda is itrdering stores that sell f e-cigarettes to physically wall them off from teens, and verify every customer is at least 18.'s itlso moving to ban menthol cigarettes and flavored cigars. the stats are arming. a stunning 78% increase in e-cigarette use among high schoolers in one year. a 48% jump among middle schoolers. the vaping industry says it supports raising the le

and companies that have no fda -- the fda has no say in what they and their safety, they determine the safety, they do short-term studies, and they rush products on to market, and they buy off politicians along the we that won't give us labels. so how are we better off today thanan way were when dr. wile, i was making changes? >> it's easy to co. rate that point and you have very legitimate issues there. first i want to say of course we're a lot better off than we were when there was no safety testing. there was no requirement to safety test. fithere were no labels, and peoe could put things like formaldehyde into our foods with impunity, and children would die and they would not be prosecuted. we've moved hugely forward from that. you heard from v me rant about labels but at least we have them. let me say in that sense we have a much safer food supply, and indeed if you look at some of the and then i'm going to talk about additives in some of the other things. but if you looked at something like food bad food manufacturing that had killed people, in recent years, an example of where w

. >>> the fda has approved a new opioid that's more potent than the dangerous pain killer fept nil. we probably don't have to tell that you 50,000 people are dying every year in the u.s. after an open poid ov -- after an opioid overdose and many are wondering if the new drug could do more harm than good. >> reporter: for those fighting the opioid epidemic it's a hard pill to swallow. the fda's approval of the drug, an opioid pain killer ten times as poe temp as fentanyl throws more fuel on the raging fires of america's opioid crisis. massachusetts senator edward markey and three other senators signed a letter last week demanding the fda not green light the drug. >> what the fda is doing by ought rising the drug to go into the market is supercharging an already deadly problem that we have in our country. >> reporter: for the senator it's perm. opioid deaths in massachusetts are more than twice the national average, but the fda says it has safety measures in place and that the drug is restricted to use in certified, medically certified healthcare settings such as hospitals, surgical c

eliquis is fda approved and has both. don't stop eliquis unless your doctor tells you to. eliquis can cause serious and in rare cases fatal bleeding. don't take eliquis if you have an artificial heart valve or abnormal bleeding. if you had a spinal injection while on eliquis call your doctor right away if you have tingling, numbness, or muscle weakness. while taking eliquis, you may bruise more easily... and it may take longer than usual for bleeding to stop. seek immediate medical care for sudden signs of bleeding, like unusual bruising. eliquis may increase your bleeding risk if you take certain medicines. tell your doctor about all planned medical or dental procedures. what's around the corner could be surprising. ask your doctor about eliquis. >>> finally tonight, took thanksgivin on special significance for a man who spent decades in prison and was finally released last year after he was pardoned. as we hear from nbc's steve patterson, it was result of an unlikely friendship that developed over the years. >> this is my favorite place in the house right here. ep >>rter

the fda is saying only certain types of romaine lettuce should be avoided in the midst of the efx co e. coli outbreak. lettuce appears to be from the central coast. lettuce from elsewhere and labeled as such should be okay. if you don't know where your romaine lettuce came from, don't eat it. the exact source of the contamination is still unclear. 43 people have gotten sick in 12 states. >>> almost 500,000 women in the u.s. get them yearly, but there's alarming news about breast implants. there's new evidence a particular implant could be link told a deadly cancer, that has women and the medical community taking another look at the procedure. for three excruciating years, michelle suffered from painful swelling around her breast and constant fatigue. >> i probably went to the doctor six times, nothing was working. >> she suspected the breast implant she got 20 years ago, but the mammograms came back normal. she had them removed any way. >> my scar capsule was fuel of disease. >> reporter: she was diagnosed with a cancer of the immune system linked to breast implants called alcl, firs

the fda announced new proposals to cut down on underage use today. walk us through those proposals. >> well, the overarching theme is they basically want to make it much harder for young people, kids, to actually be -- have these things available to them so that's really what the focus is on, and part of it is looking at the flavored e-cigs which think truly believe have been used to get the young people to start using e-cigarettes so they want to ban the flavors and make the flavors harder to get. if people will buy the e-craig let's at all. you'll buy them from a vaporing store that has age restrictions in place. can't buy them from everywhere. they also want to ban menthol cigarettes. they want to ban flavored cigars. these are parts of the recommendations that will made now. still going to the comment people and it's going to be a contentious debate and the fda is very clear now on what they are trying to do. >> and the idea here, corporations are preying on children and get them hooked on something that will ultimately in all likelihood lead to

reports say the fda is looking at restricting sales of menthol cigarettes. the stock is heading for its worst day in 19 years. let's take a look at how the european markets are performing and show some numbers. down by 8/10 of 1%. we are trading with

. >>> tonight, the fda says it's taking drastic action to stop the spread of a national epidemic. the skyrocketing number of teenagers who are vaping, using e-cigarettes and the feds say they want to ban menthol cigarettes all together. we get more from nbc's costello. >> reporter: in boulder, colorado, school nurse liz blackwell is on the front lines of an exploding e-cigarette epidemic. >> it's having an impact on whether or not they can participate in sports. it's having an impact on the relationships within their families. >> reporter: the problem is nationwide. the fda said it's taking action. >> what is at risk is we'll reverse the gains in recent years of trying to bring down smoking rates among adults and kids. >> reporter: the fruity flavors in e-cigarettes target teens. now the fda is ordering stores that sell fruity e-cigarettes to physically wall them off from teens, and verify every customer is at least 18. it's also moving to ban menthol cigarettes and flavored cigars. the stats are alarming. a stunning 78% increase in e-cigarette use among high schoolers in one year

that's not what the fda did here in the u.s. the fda says two months after chapel's surgery it issued a safety communication about the metal on metal category of hip implants, b unlike those other countries it never issued a warning about the specific bio met device. jack mitchellreviously ersaw special investigations for the fda and now is a director at the national center for health research. he is critical of how many medical devices, including the bio met m 2 a, are cleared by the fda. >> i think for the average patient they think if there is an fda seal of approval on the drug or a medical device that means it's perfectly safe under any and all circumstances and that's simply not true. >> reporter: an nbc analysis at least five devices where other countries issued safety warnings but the fda never did the same, including a knee implant with au high f rate and a pregnancy test that gave false results. a key difference, how countries monitor device safety. the fda has an adverse event database where manufacturers, ctors, and

two panels and aids activists and medical experts discuss the events that led to the fda protest, and talk about the immediate impact on aids care and the legacy of the confrontation for the medical field. this is about 90 minutes. >> summit events are impactful in the moment, and some of them, their legacy becomes clearer overtime. was october 11, 1988, 30 years ago today. welcome to the johns hopkins bloomberg school of public health for an anniversary seizing control of the fda. i'm the vice dean of public health practice and community engagement here at the school, and the scenes that we sd

the fda just approved a drug >>> new at 11:00, a major milestone in the battle against cancer. the fda just approved a drug that targets a tumor based solely on its dna rather than its location in the body. nbc bay area's ian joins us now with this lifesaving treatment, ian. >> the drug focuses on tumors with a specific mutation seen in a small number of patients, only about 1%, but when successful, the results are astounding. rihanna is now a happy healthy girl after a rough first year of her life. she was born with a rare type of tumor on the outside of her arm. >> my whole world fell apart. i was like, oh, my god, like why did it have to be my daughter? >> reporter: chemotherapy didn't work. doctors said they would have to amputate. then they tried an experimental drug. within just three days, the tumor started to shrink. >> the mass went down drastically, and we were like, wow, this stuff is something else. >> reporter: the fda approved that drug this week, the first to treat at least 12 types of cancer that all have the same specific tumor mutation, including breast, lung,

. >>> the fda has approved a new opioid that's more potent than the dangerous pain killer fep nil. we probably don't have to tell that you 50,000 people are dying every year in the u.s. after an open poid ov -- after a opioid overdose and many are wondering if the new drug couldo more harm than good. >> reporter: for those fighting the opioid it's a hard pill to swallow. a'e fds approval of the drug, an opioid pain killer ten times as poe temp as fentanyl throws more fuel on ting fires of america's opioid crisis. massachusetts senator edward markey and three other senators rsigned a let last week demanding the fda not green light the drug >> what the fda is doing by ought rising arhe drug to go into the mt is supercharging an already deadly problem that we have in our country. >> reporter: for the senator it's perm. opioid death in massachusetts are more than twice the national average, but has fda says it safety measures in place and that the drug is restricted to use in certified, medically certified healthcare settings such as hospitals, surgical centers and emergency department

that's not what the fda did here in the u.s. two months before his surgery, they issued a safety recommendation. but unlike the other countries, it never issued a warning about the specific biomet device. jack mitchell oversaw investigations at the fda, now is the director for health research. he is critical how many medical devices, including the biomet m2a, are cleared by the fda. >> a patient, if they think the fda puts the seal on the device, that it's safe under all circumstances. that's not true. >> reporter: nbc analysis found five devices where other countries issued safety warnings but the fda never did the same. including a knee implant and a pregnancy test that gives false results. a see difference, how countries monitor device safety. the fda has what is called an adverse event database, where many doctors and patients can report injuries. but critics say the system is too slow. >> it sometimes takes them months, if not years, to discern that there is a major problem that requires action. >> reporter: but other count

only first identified by the fda in 2011. now, new fears it is an emerging risk. >> reporter: did you think to yourself this could be cancer? >> never, never. >> reporter: my plastic surgeon didn't bring it up to me. my ob/gyn n s f has 414 reported cases of alcl and believe it's caused at least nine deaths. they have considered it rare with odds as low as one in 30,000 women at risk. an nbc news investigation with the icij found data from other countries suggesting the risk could be as high as 1 in 10,000 or even 1 in 1,000. some countries may use different types of implants. the main concern is with textured implants said to remain more firmly in place than smooth though they carry a risk, too. >> it's an emerging crisis. >> reporter: eric swanson, author of two textbooks on cosmetic surgery, believe this is latest evidence shows textured implants are dangerous and should be banned. >> if you have an alternative that's safe, why would you recommend that he had textured implants until they were removed. one implant manufactu

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it's the only fda-approved long-term implantable sensor that provides realtime data. it's implanted under your skin. in a fox business exclusive, sensionic ceo, the company that makes it, tim goodenow will show us how it works. 8% to 10% of the population suffers from diabetes. this could be an unbelievable game changer. how does it work? >> thanks for having us. it's very exciting technology, as you said. the thing to keep in mind about managing your disease, diabetes, is the fact that it is long-term and chronic. so any time you look for any improvement in that, you are trying to make people's lives easier. that's what we approach with the implantable product. the value behind it is just as you said, you put it under the skin and forget about it. that whole ability to make your life easier is what we're trying to enable with that sensor. liz: a doctor implants it and we will show all of this on camera. doctor implants it, then you put a sensor over it, is that correct? >> right. we call it transmitter. liz: does it hurt to be implanted? what's the size of it? >> ver

. >>> plus, we'll debate the fda's bold plan to restrict the sale of flavored ecigarettes. >>> going once, going twice, sold we'll go inside the most expensive house ever put up for auction. "ho "power lunch" starts right now >> welcome, everybody, to "power lunch. what a wonderful program that was on "fast money halftime. a great tribute to our servicemen and women welcome, everybody i'm tyler mathisen stocks moving lower and on pace for the worst day of the month the month is young, folks. it's the second straight down day for the s&p 500 and the nasdaq, at least as of now it'd be the first in five for the dow if we close on the red side oil, a big mover, down for a tenth straight day slipping further into bear market territory tech, materials, communication services, they're the worst performing sectors right now consumer staples is leading. everybody needs paper product, paper towels and that kind of stuff. movers today, activision blizzard calling yesterday yelp sinking as revenue was short of estimates dropbox moving higher. the company gave upbeat guidance let's send it to dom

it is fda-approved but not specifically for breast reconstruction. >> i was shocked. and i thought, well, you know, obviously i should have been told. >> reporter: connect says she wasn't told and she thinks money may be to blame. the doctor is a paid consultant and researcher for ail a allergan and owns stock in want compathe company. he earned more than $470,000 from the company doing consulting and research, something she says she only later learned online. >> in one way, it made me feel like, oh, that's why this happened, you know? maybe the doctor was being paid to use this. >> reporter: do you think the money tainted this doctor's medical judgment? >> in my opinion, yes. >> it was fda cleared. >> reporter: by law the doctor is not required to disclose his financial ties directly to the patient during treatment. no doctor is. physicians only have to report the money to the federal government. the information is publicly accessible but consumer watch dogs say patient harmed when doctors have a pecuniary interest in the medical devices or drugs that they're prescri

the fda is proposing a proposed ban on menthol cigarettes. they found they are harder to quit and likely pose a greater health risk than regular cigarettes it comes amid a crackdown on ecigs. the fda commissioner says that smoking is an epidemic now they're going to limit the flavors you can get at gas stations and convenience stores. >> you know what juuling. >> i've heard of it. >> you don't have kids, do you >> no. teenage kids, it's an epidemic. >> is that like vaping >> yeah, flavored. mango. >> it attracts kids. >> there you go. >> back to what you were talking about, the grinch stole the box office the latest take on the dr. seuss holiday classic scored number one in movie theaters. they say the grinch is estimated to have snagged nearly 79 million worldwide. i'm kind of like you i don't like the trees too early. i'm not a christmassy person. >> christmas burnout. >> it's not even thanksgiving. thanksgiving is early. >> don't steal our thunder. >> breakfast alert kfc rolling out chicken and waffles. the fast food chain spoofing the fam

the device never lost fda approval for sale outside the u.s. the maker says, today the pyrotitan meets all the regulatory safety and performance requirements. meanwhile, this man says it forced him to have a complete shoulder replacement. a tough prescription to swallow for a father of six. >> you sit here in my library and you can't do the things that you want to do. >> reporter: he trusted an american product and assumed its safety had u.s. approval. katie beck, nbc news. >>> stay with us for more on medical device dangers. our nbc news broadcast exclusive global investigation spanning 36 countries. visit nbc news.com and watch "nbc nightly news" tomorrow and monday. >>> one of this country's trailblazers has died. olivia hooker was one of the last survivors of the 1921 race massacre in tulsa, oklahoma. as many as 300 people were killed. hooker witnessed the violence as a 6-year-old girl. in 1945 she became the first african-american woman to enlist in the u.s. coast guard. she earned a doctorate in psychology and was a professor at fordham u

eliquis is fda-approved and has both. so what's next? seeing these guys. don't stop taking eliquis unless your doctor tells you to, as stopping increases your risk of having a stroke. eliquis can cause serious and in rare cases fatal bleeding. don't take eliquis if you have an artificial heart valve or abnormal bleeding. while taking eliquis, you may bruise more easily and it may take longer than usual for any bleeding to stop. seek immediate medical care for sudden signs of bleeding, like unusual bruising. eliquis may increase your bleeding risk if you take certain medicines. tell your doctor about all planned medical or dental procedures. eliquis, the number one cardiologist-prescribed blood thinner. ask your doctor if eliquis is what's next for you. cardiologist-prescribed blood thinner. forget about vacuuming for weeks. the (new) roomba i7+ with clean base automatic dirt disposal empties the roomba bin for you. so dirt is off your hands. if it's not from irobot, it's not a roomba. with lindor. a milk chocolate shell with a smooth, melting center from t

the fda is getting slammed for approving a perful new pain drug. it's ten times more potent then fentanyl. some are wondering now if this new drug could do me harm than good. nbc's matt bradley has more. >> reporter: for those fightings americ opioid epidemic, it's a hard pill to swallow. politicians and drug safety advocates say the fda's ace approval of dsuvia, an opioid painkiller ten times as potent as fentanyl, throws more fuel on the raging fires of america's opioid crisis. massachusetts senator edward markey and three other senators signed a letter last week, demanding the n fda greenlight the drug. >> what the fda is doing, by authorizing dsuvia to go into the market is supercharging an already deadly problem that we have in our country. >> reporter: for the senator, it's personal. opioid deaths in massachusetts are more than twi the national average, but the fda says it has safety measures in place and that dsuvia is restricted to use in certified, medally supervised health care settings such as hospitals and emergencys sett they say it wo

any connected medical device has the potential for cyber threats to occur suzanne schwartz is an fda cybersecurity expert. she says implantable devices that send information to doctors, patients and healthcare providers could be at risk. pacemakers, difibulators, insulin pumps>there are also concerns hackers could target machines like mris, cat scans and ventilators. we are building information sharing platforms. that's really the key here, is that cybersecurity is a shared responsibilitythe fda has also enlisted so-called "white hat" hackers to help identify cyber weaknesses. (ken)the fda also recently developed a cyber security "playbook" for hospitals and healthcare systems(pam) the agency wants hospitals to put protections in place, do exercises and have response plans ready ... should a cyber attack occur. patients' health. > (ken) (ken)the fda also recently developed a cyber security "playboo

fda review. >> we're excited. it looks like it may get approved sometime next year. >> reporter: dr. june zang is an allergy immunologist with the south bay asthma group. here's how the pill works. it contains a peanut protein that. dose is increased over time -- protein. that dose is increased over time with the goal of building peanut tolerance. >> so it gives them some protection. it's desensitizing their bodies, so their body is not recognizing it. it's completely foreign. >> reporter: but dr. zang warns this is not a cure. >> they cannot eat as much as they want. they have to really still stay away, still carry their epipen every day. >> that's very exciting to know. i wish that would be approved immediately. >> reporter: still if approved by the fda, the drug would be the first of its kind prescription. amir says it would open doors to things and food he's avoided all his life. >> that would be life changing. that would be amazing. >> reporter: maria medina, kpix5. >> dr. zang said the pill would only be ava

joining us today i'm delighted to kick off with two very knowledgeable people and commissioner of the fda and with those challenges facing oncology today so thank you for joining me. so starting with the general question and with those changes of research and treatment recently winning the nobel prize in immunotherapy and actually today celebrating the nobel laureates at the embassy down the street. so starting with you that you are the most excited about and what is the most promising area in the next five or ten years? . >> the major change of cancer care from oncologist as a movement to treat every patient the same every best cancer patient - - breast cancer patient but that there are many different types. if not personalized therapy and then to go from treating everything to hire the fragmented is different provisions gives much better therapies. more effective treatments for lung cancer or bracts cancer or toxicity and then can be treated based on those results. so like in college he use for those that hive high recurrence like melanoma or other types like radio oncology works well.

the fda is working to ban menthol and min in cigarettes. a move that could take years to put in place. th'll also limit where flavored e-cigarettes can be purchased. those restrictions could kick in within a few months. the federal study found that 3 millio stountudents in middle o high school are using e-cigarettes. >> if you need more than one cup of coffee to get youray ing, it might be your dna's fault. the more sensitiveso a p is to the bitter taste of caffeine, the more coffee they drink.