we wish the fda would do more of that. what we did at the goldwater institute under freedom of information act to tell us of the decisionmaking process they used to judge that ebola was such an emergency that all rules were off the table to immediately give something to people that had never even been tested in human beings but baldis patients with terminal illnesses cannot access these medicines to save their life. the mother that we talked about with the two boys with muscular dystrophy said that is an emergency to my son and if you have a brain cancer that is an emergency for you in your family and it is the same as ebola your life is on the line. the fda refused to share their decision making process with us so we have taken them to court to force their hands. the fda has the power literally of life and death over american citizens. regardless of what you think of the policies the american people have a right to know how the fda is making decisions that will leave some people to live and others to die. >> host: the ebo

there is an indictment of what the fda has been doing for 50 years because fda clinical trials our population-based trials, overwhelmed with based just looking for empirical correlations. if you've got pancreatic cancer, let's throw this drug at you, if you do better, good. but, of course, is what you define as a disease is 25 different diseases, you fail to cure. there is a core problem with the fda existing trial protocols which statisticians call the reference class problem. if each of you represents 1000 patients, the simple question is, let's to pancreatic cancer, that's her favorite cancer today. this row here, if around you all of which are pancreatic cancer, 15,000 or so and test the drug in all of you, who is to say your predictive of the rest of the people in this room? if pancreatic cancer is an absolutely identical disease, that's a good sample. we know today modern genomics issue and there's enormous amounts of variations in genes and, therefore, the proteins that they code for. the saddest part of this to my mind is the fda issued its first guidance as they called for far more genomic

frankly, there is no role for the fda and administering compassionate use. it's not for the agency was designed to do nor is it something the agency truly desires to do. when i was conducting interviews for this the interview with the head of the center for new drug development at the fda. and we asked a theoretical question of what you in theory like to see tens of thousands of patients accessing compassionate youth given the chance to try some of these promising and border cutting-edge treatments and she said well it would be another burden on the healthcare system and that attitude is quite prevalent throughout the bureaucracy. i'm not saying everyone had that attitude. there are some incredible people fighting for patients. but as an agency commits job isn't to treat patients. its job is to approve medicines and products for the u.s. market. it's for physicians to decide whether to help you through other treatments so we would like to see the fda not even have a role in this particular aspect of compassionate use. it should be about the physicians and pa

in 2013, the fda yanked 23 products off the market. anne wojcicki had to face a very public divorce from her husband, google cofounder sergey brin. she has made a remarkable comeback with a first fda approved consumer product. new funding. joining me today is anne wojcicki. it is so great to have you here. the last two years have been crazy. it could have been disastrous for the company. now you are back on good terms. with the fda. how do you feel about where you are right now? anne: i feel great. i am proud of the company and what we have accomplished. when you have to slog through and put your head down and there is a lot of work ahead of you and you're not going to see a reward for a couple of years, it's hard. i feel like we just climbed the first flight of stairs, but we're still climbing the empire state building. there is a lot more to go. we are back on the market. we have an incredible product. we have redesigned everything. this is the first chapter and a whole new book for 23andme. emily: you have the first fda approved con

fda reform.hat is one of the most productive areas at the manhattan institute. i don't know of any other think tank to bring the kind of work the manhattan institute's is doing on this issue. the question we will talk about today is the most interesting area talking about how to reform the fda. talking about innovative new treatments and recently precision of a storm. there are a thing as called by markers if you get checked at the doctor's office that is a by a marker it is a lab test it is something that we use to correlate what is going on in your body with a particular outcome of disease high cholesterol levels or low density or high ldl is correlated to heart problems that is day by a marker. 50 years ago we had a couple dozen by a marker is but the cousin of the the answer is a genetic science and as human genome project how zero different genes in our body regulates different proteins in the chemical process for diseases we're on the verge of having hundreds of thousands of these lab test

>> fda's only got one responsibility. it's john q.lic to protect the american public from safety and effectiveness. >> reporter: senator grassley told us the fda's response was incomplete. he had more questions as he decides what steps to take next. once again, bard declined our request for an on-camera interview, but told us while all medical devices carry some risk, its filters are an important clinical option for physicians, and that the company steadfastly believes in the safety and efficacy of these devices. >> we've got the bulk of that filter out. >> reporter: four days after chris' emergency surgery, he met with the doctor for a follow-up. >> this is a filter we removed. one of the broken arms is at the bottom of the jar. >> reporter: a patient grateful to be saved from a filter he thought was saving his life. you seem shaken to me. >> it's very difficult to think that you could have -- >> reporter: you caught it. >> luckily. >> reporter: the fda did not answer our question why bard's recovery and g2 filters were not recalled.

that's because fda says such products are not different from their non-engineered counterparts. that brings me back to frankenfish and consumers who fear there is something fishy about it. the companies won't have to disclose that its genes have been engineered. that is one issue raised by the first genetically altered animal heading our way. >> reporter: these fish are as fresh and wild as you will find in any shop. king salmon caught off the coast of a larks ska. there could be competition in the future. >>> i think in the pacific north-west where ground zero salmon company, we would have a hard time selling such fish to the public. >> reporter: aqua bowdy technologies has been working on this concept for 20 years, using the fish farms. the company claims its man made sterile modified salmon grow to maturity twice as fast as normal >>> maybe in the coscos, the big box retail organizations there may be a place for that. you have to address feeding everybody that has a price point >> reporter: this center for veterinry medicines, analysis has been made of aqua advantaged salmon

we talked to the fda. we talked to groups.became clear that there were not easy options forward. emily: did you consider selling? like seriously consider that? anne: the idea that genetic testing will be a foundation for health care in the future was core to my being. i am wedded to this company for the rest of my life. i was not interested in selling. i was not interested in closing up shop and saying this is too hard. we just need to say that we needed to refocus. we need to hire the right people. we have a major miscommunication. we need to make sure we are executing the right way. emily: it was an arduous process. you hired a regulation chief and people who could better interact with washington. how did you get there? anne: it was me picking up the phone and calling everyone i knew and said what are the right lawyers to talk to in d.c. or the heads the regulatory offices? how can we figure out the path moving forward? kathy had a tremendous amount of experience with genetic health. she understood genetics. she understood t

is it fda? >> yes, it's at the fda level for us to be able to say, what is consistent with label, no misleading, not misrerptipresen but most importantly what they need for their patients. so that's one. another issue is incentives, if you will. so if we're trying to talk to a pbm, their only measure is their drug cost. so they have very little interest in talking with us about outcomes-based contracting because they are not responsible for the medical piece. and the short-term incentives versus a long-term gain, not only is a problem today, but comes as a bigger problem later. we have a medication, cart 19, co-developed with the university of pennsylvania where for cll, a form of leukemia, where we have patients, children, who -- emily is one i remember, in particular, who was dying and she had gone through every other medication she did. she received immunotherapy, took her blood, rubbed up the t-cells and she's cured a few years later. we have many, many patients on the product already that's

and it's difficult because congress is separate from the fda. so a lot of this is through the regulatory process and the white house has already through the health care law, through other regulations, it has tightened some of the ways that fda works with these companies and approves the final medicine, but in 2014, we saw a record number of medicines approved, about 400 received final approval from the fda. and that is more than past years and it's showing that even though companies continue to say that there is too much regulation, there is a slow driven, dr drip, trdrip of drugs being approved, we are seeing some improvement. >> here is a chart showing the change in hospital care costs, 2013 gray, red is 15 da'15. you see here prescription drug. cynthia is up next, kansas city, missouri. line for republicans. good morning. >> reporter: good morning. my concern with the pharmaceutical industry is this, my mother is in her 80s on a statin drug and becomes diagnosed with pre-dit babetes. and this is a fairly active woman. and we find out one of t

last fall the fda recommended against it in most fibroid patients. an open letter has been published saying that the fda is wrong and the implement is still needed to save lives. next, blowing smoke, e cigarettes billed as the best way to quit and the warning that they have their own risks. keeping secrets. why that could be hazardous to your health. sure, tv has evolved over the years. it's gotten squarer. brighter. bigger. it's gotten thinner. even curvier. but what's next? for all binge watchers. movie geeks. sports freaks. x1 from xfinity will change the way you experience tv. tand that's what we're doings to chat xfinity.rself, we are challenging ourselves to improve every aspect of your experience. and this includes our commitment to being on time. every time. that's why if we're ever late for an appointment, we'll credit your account $20. it's our promise to you. we're doing everything we can to give you the best experience possible. because we should fit into your life. not the other way around. >>> one more story tonight about a cure that co

last fall the fda recommended against it in most fibroid patients. an open letter has been published saying that the fda is wrong and the implement is still needed to save lives. next, blowing smoke, e cigarettes billed as the best way to quit and the warning that they have their own risks. keeping secrets. why that could be hazardous to your health. >>> coming up at the top of the hour on al jazeera america, secretary of state john kerry announces a third round of talks of ending the violence in syria will take place later this no in new york. a final push to end the fight against boko haram. donald trump follows back lash around the country in relation to his call to ban all muslims. >>> one more story tonight about a cure that comes with added risk, the e cigarette is an increasingly popular way for smokers to quit. studies have found respiratory disease linked to more than 25% of the chemicals. so they may suffer long damage. lung damage >> no-one know what the health effects are of puffing these things every day for 20 years. >> reporter: behind

new rules to ban anyone under 18 from using tanning beds which the fda said dramatically increased thekin cancer. the industry said consumers are already well aware of the risks. for 74,000 cases of melanoma this year, erica hill reports on this proposal the fda said will save lives. >> reporter: as skin cancer rates rise in the u.s., there is an urgent focus on a known cause. indoor tanning beds. >> we see women in their 20s with melanoma. almost every one of the young women has spent time in a tanning bed. >> the fda wanted to bar all minors under 18 from using indoor tanning beds and have adults sign consent forms acknowledging the risk. states regulate access for miners. states and the district of columbia ban the practice for those under 18. the indoor tanning industry said the decision should be left up to the person. doctors see this almost daily. >> is this enough? >> no. in my opinion, i wish we could shut down the tanning industry as a whole. i think these ultraviolet boxes are a proven carcinogen. >> at 24, this woman was diagnosed with melanoma. >> i was shocked. >> two yea

last fall the fda recommended against it in most fibroid patients. an open letter has been published saying that the fda is wrong and the implement is still needed to save lives. next, blowing smoke, e cigarettes billed as the best way to quit and the warning that they have their own risks. keeping secrets. why that could be hazardous to your health. >> i felt like i was just nothin'. >> for this young girl, times were hard. >> doris' years in a racist, impoverished setting had a major impact. >> but with looks, charm... >> i just wanted to take care of my mom. >> and no remorse... >> she giggles every time she steps into the revolving door of justice. >> she became legendary. >> the finer the store, the bigger the challenge. >>> one more story tonight about a cure that comes with added risk, the e cigarette is an increasingly popular way for smokers to quit. studies have found respiratory disease linked to more than 25% of the chemicals. so they may suffer long damage . lung damage >> no-one know what the health effects are of puffing these things e

last fall the fda recommended against it in most fibroid patients. an open letter has been published saying that the fda is wrong and the implement is still needed to save lives. next, blowing smoke, e cigarettes billed as the best way to quit and the warning that they have their own risks. keeping secrets. why that could be hazardous to your health. >> we're here to fully get into the nuances of everything that's going on, not just in this country, but around the world. getting the news from the people who are affected. >> people need to demand reform... >> ali velshi on target. >>> one more story tonight about a cure that comes with added risk, the e cigarette is an increasingly popular way for smokers to quit. studies have found respiratory disease linked to more than 25% of the chemicals. so they may suffer long damage . lung damage >> no-one know what the health effects are of puffing these things every day for 20 years. >> reporter: behind some of the toughest anti smoking laws in the country. >> we worked very hard to counteract the factor of

we had a filing to the fda. first timed the ever happened we've had a refusal to file. and i called the people together and there were 12 people and i said what happened? and when you talk to them, they said well, we knew it was a bad file. i said everybody individually knew it was a bad file but nobody spoke up? so that's when we started talking about straight top. get the coin out, say look, maybe not in your area but if you're uncomfortable about something you have to speak up and the coin is a mechanism, a symbol, it's a way of saying the coin is on the table, i'm protected and i want to tell you what i believe is wrong. >> so it's like the conch in lord of the flies. like this tool. >> this tool. [ laughter ] >> but i don't think people know what's on the coin. so could you knew miz matally -- i think that's the right word -- >> yeah, bring it up. >> everybody has this. we had a big fight with our cfo, he didn't want to pay for them. but cfos are like that. so it says straight talk which is what you can put down if you feel you here in an environment y things have

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erica hill has more on the fda's proposal. >> reporter: as skin cancer rates rise dramatically in the, there's an urgent focus on a known cause, indoor tanning beds. >> we commonly see women in their 20s with melanoma. almost every one of those young women has spent extensive time in a tanning bed. >> reporter: the fda wants to bar all minors under 18 from using indoor tanning beds and would require adults to sign a consent form acknowledging the risks. a number of states already regulate access for minors while 13 states in the district of columbia ban the practice entirely for those under 18. the indoor tanning association says the decision should be left up to parents. dr. deborah sarnoff sees this daily. are these regulations enough? >> no. i wish we could shut down the tanning industry as a whole. i think these ultraviolet boxes, it's a proven carcinogen. >> reporter: at 24, melissa cohen was diagnosed with early stage melanoma. >> i was definitely shocked. >> reporter: two years later, this medical student sees tanning in a much different light. >> my message would be that tanni

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 only live national news show at 11:00 eastern. >> we start with breaking news. >> let's take a closer look. >> 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 effe

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. >> there is so many changes in my life... i was ready for adventures. >> from burlesque dancer to acclaimed artists. >> art saved my life. >> reflections from her new memoir. >> no no no no no... i'm way to dysfunctional to have an ordinary job. >> see what lies ahead for molly crabapple. >> who emerges from life unscathed? >> i lived that character. >> we will be able to see change. >> the drug was given orally to the men in the hospital ward

it's safe and good. our product will shine with that,"> usda specializes in meats and eggs but the fda has regulatory oversight over all other fish and fishery products. some feel the inspection process changes by organization.. and new inspection system may be costly.. besides new costs, gibbons argues the change only protects domestic producers and violates world trade organization rules. he worries the situation could bring retaliation and end up in court. and other commodities could be impacted. we don't export any for instance. in the end, trade retaliation is visited upon with u.s. ag exexrts. so this is a se, lose, lose," when it comes to his own industry, kyser isn't worried about new restrictions to domestic catfish producers. "federal regulation is not a problem for us in the catfish industry as long as its equauato everybody in the game. we grow a safe and healthy product. all we are asking for is equal playing field with competitors," in an industry thta's seen tough times, they hoho their industry can rebuild and continue in kyser's case, a lifelong legacy. "it's a lot to

>> at the fda level.what is consistent, not misleading, not misrepresenting but something that is proving value according to what the health insurance plan needs. so that is one. another issue is incentives, if you will. if we are trying to talk to a pbm they are only measure is the drug costs. so they have very little interest in talking with us about outcomes -based contracting because they are not responsible for the medical fees. the short-term incentives versus the long-term gain not only is a problem today the becomes a bigger problem later. we have a medication developed at the university of pennsylvania for a form of leukemia where we have patience children, emily is one of them in particular who was dying and she has gone through every other medication. she received immunotherapy where they took her blood, put it back in and she is cured a few years later. and so when you look at that we have many patients already. it is not yet marketed, not yet available, but it is life-saving. how do you charg

the fda pushed off a december 27th decision on the year to next month. a competing drug from smaller drugmaker ser represent ta faces an outside panel review january 22nd. both could be major stock movers. in the second week of the year, a major investor conference. the annual jpmorgan health care conference. hundreds of companies and thousands of investors executives and others head toe san francisco every january 11th to the 14th where celgene provide guidance for the year ahead. and finally, at the end of the month, an fda decision expected in hepatitis c merck may join gilead and abhave i with a new regimen north infection. michael yee says the fda's decision may have an impact as much as 5% on shares of gilead but price is a big question for these drugs. investors will be watching closely to see if merck offers a major discount to compete. investors hope the first month of the new year brings better news than the last six months of the old one. i'm meg terrell. >> did you ever wonder where all that money the movies make at the box office goes? we'll