>> screw the fda. i am going doa. >> that decision like it or not is left up to the people in this hospital. >> it's his body. >> why should the government stand in the way? >> there are cases in which individual benefit can be obtained by a drug not approved the fda. that is true. then it is up to the person who wants to gain access to it. >> sometimes people have to go out of the country to get things unfortunately that the fda may not have approved but in not approving it they are often reasons that deal with serious adverse health consequences for people taking the drug that hasn't begone through an approv process. >> let's go to the other side. >> 16-year-old austin and 12-year-old max have a form of muscular dystrophy that leads to muscular degeneration and eventually death. the by's mom heard about an ex p spur -- experimental drug that was going through fda trials that was told max could be in the study but austin could not. after 16 weeks jen could see the drug was working. max can walk. he ca

and the fda's campaign, which mr. seller can't talk about, but we are excited about the work that they have been doing is also laser focused on youth and trying to keep experimenters from consolidating. we are doing very good things. the other thing to keep in mind is both campaigns combined represent in terms of the amount of promotional effort that we are able to make about five days out of the year compared to what the tobacco companies are spending. >> you're talking about both combined? >> both the fda and cdc campaigns. the 365 that would be funded by the tobacco companies? >> right. >> just elaborate on the real cost. >> sure. unfortunately, too many kids experiment with cigarettes. over 700 -- each day. over each day they make the progression to becoming real smokers. compared to 20 years ago, those numbers are done. the bad news is those numbers are still unconscionably high from a public health perspective. their 25 million 12- to 1 in theolds country, and what we came to understand is there's about 10 milli

the problem is not with the fda. you already alluded to the fact that what happens more often is the problem rests with the sponsor, the company, the person who or whoever owns the drug not being or not willing to be able to provide that drug for those circumstances. let's focus on that. let's fix that problem and this legislation does not do that. >> stand by, everyone. david and then elizabeth. david, go ahead. >> yeah, what i was going to say is one also has to remember that giving unfettered access to experimental theorapeutics coul potentially damage the opportunity of other patients to be able to get access to that drug when it's approved. if there are very serious side effects that are detected with experimental use of drugs and there's a huge social media campaign around that patient getting the drug. if that patient's death is hastened, that could potentially create a firestorm that might influence fda's approval of that drug. >> yeah. and -- quickly, elizabeth, go ahead. >> one reason why the -- one reason

so thank goodness for the fda protecting us. but the fda grew like a tumor. getting a new drug approved now cost more than a billion dollars and takes up to 15 years. that caution kills people too. the fda once held a news conference and proudly announced this new heart drug will save 14,000 lives a year. jt up at the press conference to ask, excuse me, didn't this also mean you killed 14,000 people last year by delaying its approval? reporters don't ask that because reporters don't think that way. but it absolutely meant that. that year 14,000 americans died because of that delay. regulation can kill too, but a former congressman who served on a committee who oversaw the fda says this regulation is good and there should be more of it. dennis? >> i'm not making such a broad statement. we have to be careful about this jo to make sure people aren't going to be at risk to have side effects or consequences that haven't been reported properly before it goes on the market. >> do you disagree that the delay kills people too? >> delays can create problems. no questio

the problem is not with the fda. you already alluded to the fact that what happens more often is the problem rests with the sponsor, the company, the person who or whoever owns the drug not being or not willing to be able to provide that drug for those circumstances. let's focus on that. let's fix that problem and this legislation does not do that. >> stand by, everyone. david and then elizabeth. david, go ahead. >> yeah, what i was going to say is one also has to remember that giving unfettered access to experimental therapeutics could potentially damage the opportunity of other patients to be able to get access to that drug when it's approved. if there are very serious side effects that are detected with experimental use of drugs and there's a huge social media campaign around that patient getting the drug. if that patient's death is hastened, that could potentially create a firestorm that might influence fda's approval of that drug. >> yeah. and -- quickly, elizabeth, go ahead. >> one reason why the -- one reason

>> we heard from the fda in simplest terms, no. what they basically said to us, in the risk/benefit evaluation they felt the ben fit was modest and didn't give us an approval. >> reporter: the rejection ignited a storm of controversy with many crying sexism. the agency barraged with letters in support of the drug from prominent women's groups and even a handful of congresswomen. when you look at how many options there are for male sexual dysfunction, talking medical options, more than 20. and that we have zero fda approved for women's use. what do you think is going on there? >> first of all i think there is sexism at play. no one is making this up. not a hallmark holiday that someone decided to invent something to solve more of something. >> reporter: the fda denied our request to be interviewed about the drug or comments about the drug, but they are committed to advancing treatments for female sexual dysfunction and denied any allegations of gender bias. >> it is not sexist for the fda not to approve a drug that it doesn't believ

she's been fighting for fda approval for three years. >> what did you hear from the fda? >> we heard from the fda in the simplest term no. but they basically said to us is in a risk-benefit evaluation they felt that the effect was only modest and therefore they didn't give us approval. >> reporter: the fda denied our request to be interviewed or comment specifically on the drug, but they are denying any allegations of gender bias. >> it is not sexist for the fda not to approve a dug it doesn't >> reporter: some doctors say it was rejected for a simple reason, it's an ineffective drug for a non-existent problem. >> it's a classic marketing technique to first create a problem and then sell a solution. and that's what is going on here. sexual desire varies by person and varies by phase of life, but that doesn't make it a disease. >> reporter: cindy whitehead and sprout pharmaceuticals are appealing the fda's decision. if sprout wins the appeal it could be available as early as next year. it's a ruling women like amanda parish are eagerly waiting for. for "nightline" i'm mara

lyrica is fda-approved to treat diabetic nerve pain. lyrica is not for everyone. it may cause serious allergic reactions or suicidal thoughts or actions. tell your doctor right away if you have these, new or worsening depression, or unusual changes in mood or behavior. or, swelling, trouble breathing, rash, hives, blisters, changes in eyesight, including blurry vision, muscle pain with fever, tired feeling or skin sores from diabetes. common side effects are dizziness, sleepiness, weight gain and swelling of hands, legs and feet. don't drink alcohol while taking lyrica. don't drive or use machinery until you know how lyrica affects you. those who have had a drug or alcohol problem may be more likely to misuse lyrica. having reduced pain is great and i'm grateful for it. [ male announcer ] ask your doctor about lyrica today. it's specific treatment for diabetic nerve pain. to hear more of michael's story, visit lyrica.com. test. i make a lot of purchases for my business. and i get a lot in return with ink plus from chase like 60,000 bonus points when i spent $5,000

this is all serious fda and white house and congress and stuff. it's summertime so what i'm going to say is uva more dangerous or uvb? which one is more dangerous? which one can cause more cancer? >> i think "b." >> uva has more penetration and uvb causes sunburn. both are dangerous so get a broad spectrum sunscreen, that's important, to cover both. number two, sfp 15, spf 30, is spf 30 double the coverage or not? >> no. >> not case. those numbers are different. sp f-15 covers you 92% and spf 30 is 98% so never buy anything over sp f-15. >> remember the a, b, c, d and e. >> reamie it every two hours. reapply it every two hours because it washes off. >> it's not waterproof. >> thank you. >> good to know, guys. >> we have to interrupt a little bit because we have a fox news alert the president making a surprise visit to afghanistan there to meet with the troops on this memorial day weekend, and we're showing you pictures right now of brad paisley performing for the troops, and getting them jazzed up on this weekend here, and the president, by the wa

but tonight there's a new word of caution from the fda. >>> and later, hot wheels. the experiment that started in a toy store now making a difference for a lot of inspirational kids. >>> our health news story tonight will likely be of concern to all of us who take some form of aspirin every day. and those estimates start at somewhere north of 40 million americans. tonight the fda is warning that a daily dose is not for everyone, and taking aspirin needlessly may actually put them at significant risk. our report tonight from nbc's tom costello. >> reporter: for years, thanks in part to heavy advertising, many americans have believed aspirin is just what the doctor ordered to prevent heart disease. but leading doctors have long been concerned about patients without heart disease taking an aspirin a day. >> i think a lot of people think that because it is over the counter, that it has no side effects. and we've often said that if aspirin were invented today, it would actually be much more strictly regulated by the fda. >> reporter: aspirin thins the blood. it also carr

>> the fda will tell you today you don't need to take aspirin. you should have a full checkup, look at your heart, look at your ekg, your cholesterol and then as a whole we can decide whether you should be on it. but just having a family member now is not -- >> good to stay on top of it. >> prevention is the way. >> doc, thank you. see you again tomorrow morning. i'm kelly wright. >> i'm julie van daris. unlimited. as in, no limits on your hard-earned cash back. as in no more dealing with those rotating categories. the quicksilver card from capital one. unlimited 1.5% cash back on everything you purchase, every day. don't settle for anything less. i'll keep asking. what's in your wallet? i'll keep asking. my dad has aor afib.brillation, he has the most common kind... ...it's not caused by a heart valve problem. dad, it says your afib puts you at 5 times greater risk of a stroke. that's why i take my warfarin every day. but it looks like maybe we should ask your doctor about pradaxa. in a clinical trial, pradaxa® (dabigatran etexilate mesylate)..

today the fda said sun lamps must carry the kind of black box warnings you've seen on cigarettes. these aimed at young americans and abc's rebecca jarvis has the story. >> reporter: for years doctors have urged the u.s. government to take action on tanning beds, but tonight for the first time, new rules. tanning beds must now carry a visible warning, cautioning anyone under 18 not to use them. >> we as dermatologists have been trying to deal with this issue for the last 20 years with the fda. >> reporter: the tanning industry calls the rules exce excessive and say their products, if used properly, are safe. 1 million americans tan every day, especially young people. in fact, by 12th grade, 32% of girls say they've used a tanning bed. using an indoor tanning salon increases the risk of melanoma, the deadliest of all skin cancers by 59%. katie is a survivor, she started tanning when she was in 6th grade. >> i thought there's no way as a 17-year-old i can have melanoma. >> reporter: a 2012 "20/20" investigate of tanning salons showed many salon worker denying their machines can be ha

what should the fda do? what should consumers do? even if the fda changed its mind nothing would change quickly? >> this has been an issue for a long time. for decade the fda is afraid to take on food processors and take action on this. they should start to look at this word. there has been so many lawsuits that a few months ago some of the judges in a different lawsuit urged fda to look at this because there is such confusion and really being worked out in the courts. fda said, oh, we don't know if we're going to touch it. we need fda not allow the use of word, that is one option, use natural on processed foods or set terms that people can rely, i know it means this, this and this. you may not agree with the terms but at least you know what they are but now it is chaos. gerri: it is chaos and it will not change anytime soon i don't think. what should consumers do when they go shopping and see word, organic nick? what claims can you believe? >> that is good point. organic is much more regulated. usda organic in green and white circle

there's a drug cam ambien that the fda last year said this is affecting people the next day. they are tracking ten milligrams, next day they canned drive, are groggy and can't wake up from them, don't know what happened and same condition with lieutenanta which is even longer acting so the fda is wisely suggesting instead of taking three milligrams a night use one milligram, maybe two milligrams. >> cut it in half. >> you can also get it in the one milligram dose. start with the lower dose and try not to take it every night. work on sleep hygiene first and get your doctor in the loop and doctors out there stop prescribing so much of this stuff. that's my message. >> a strong message. dr. samadi, what do you think about taking lunesta or the sleep aids? are you for it, or do you agree with dr. siegel? >> i think we have encouraged people to be able to sleep seven hours at least because if you really have insomnia and you can't sleep well, the health hazard is tremendous and it can affect you, but i agree with marc, that you should not take these medications. somewhere between

why won't the fda approve it? do you buy their argument? >>> starry night, the spectacular show in the sky overnight. will there be an even better show tonight? >>> good evening and thanks for joining us on a saturday night. we do begin with that deadly rampage. tonight police calling it a premeditated mass murder. it lasted several minutes. shaken young people, witnessing it all in the street, stunned when it was finally over. authorities say this is the gunman's bmw where it crashed to a stop, the windshields shattered after shootouts with police. the bodies covered in sheets on the ground, six victims. tonight there is an intense focus on a hollywood director's son believed to have been driving that car. his videos posted on youtube, many of them could hold chilling clues. listen. >> i've been doing a lot of thinking about how sad and unfair my life has been all because girls haven't been attracted to me. >> we have team coverage tonight, what do the experts see in those tapes. were many warning signs missed? first we begin with bazi kan

all of that is overseen by the fda, who i think has done in general a good job here. not perfect but a very good job. and we shouldn't disrupt that. we've gotten a lot of new drugs over the past few years precisely because we follow this orderly process. and also, we have a lot of therapies for aids precisely because we follow this same orderly process. >> so frank, let me get your thoughts on that. and also speak to what the fda says here, which they already allow access to these kind of investigative drugs. outside of clinical trials they have something as you know that they call the expanded access or compassionate use provision. and it basically allows for access to experimental drugs outside of a clinical trial. the patients must have a life-threatening disease or condition and no therapeutic alternatives. a manufacturer and the doctor then would make special arrangements. why isn't that enough if that's current federal law? >> well, we've got two questions there. so i'll try to go with the first one. and first of all, no one was listening to what i was saying wh

the advisory committee to the fda voted 11-2 against releasing that jug. yet it was released by the fda. that is puzzling. >> are you going to do something about it? >> we're going to try. i have had long conversations with the fda about it. the country is alarmed over it. zar and, the drugs c so on along with attorney generals and social workers and the like. movement orming fear in that group was this a new drug. that you would reconsider the decision and reconvene the advisory committee. these are the experts that nowkw drugs. i hope should reconvene to reconsider this drug now. especially since the company that makes it now says it will not take into long to perfect a pill that is abuse deterrent, that cannot be crushed. ould at least wait until that time comes. chairman rogers, thank you very much for being with us on "newsmakers." andrew, let me begin with you. they are working on this 12 spending bills to fund the federal government. it sounds like positive. sounding a lot of positive things. you do not really respond when push themna tried to into

por la administraciÓn de medicamentos y alimentos, mejor conocida por sus siglas en en inglÉs como fda. >> ofrecen cosas que en realidad no son. >> cÓmo quÉ? >> adelgazar sin hacer nieta ni nada y nada de eso es posible. >> no pueden creer todo lo que ven en la televisiÓn. >> segÚn la fda, varias usuarios de los productos han manifestado tener palpitaciones, taquicardia, baja de precio entre otros. fuimos a preguntar por algÚn remedio para adelgazar, para que me vendieran esas son las de polen a un premio de 25 $, asegurÁndome que me estaba llevando el producto mÁs popular y eficaz del mercado. los mÉdicos aseguran que en el pasado otras pastillas para adelgazar fueron removidas del mercado por su peligroso contenido. >> se usaba para adelgazar, pero se comprobÓ en estudios cientÍficos que es daÑino para el corazÓn. >> el mÉdico aconseja jamÁs comprar un producto que no enumere sus ingredientes, ni tampoco aquellos no aprobados por la fda, para asegurarse de que el contenido que anuncia sea verÍdico. >> dan el Último adiÓs en nuevo leÓn, al mexicano que llegó a ser e

thinks confirmed by the fda looking at our clinical trial. looking at the data submitted to them and part of the approval agreement. >>reporter: still complaints continue to come in to patient web sites including women who say they have been forced to undergo reversal surgery to remove the device. gabby says she is scheduled to upped go surgery this week and believes the device should be removed from the market until the safety concerns are better understood. >> i think the device has a reason hat a purpose and can be effective but if all those piece office that puzzle don't come together correctly, there can be some terrible terrible fall out from that. >>reporter: kristen z abc 7 news. >> in and out assure device also approved in canada and about to begin clinical trial in europe. american college of ob-gyn compared data on the effectiveness of this and other method of birth control but no current advice regarding the complaints collected on patient web sites. >> all right let's tour our attention to the weather forecast which may believe i

thinks confirmed by the fda looking at our clinical trial. looking at the data submitted to them and part of the approval agreement. >>reporter: still complaints continue to come in to patient web sites including women who say they have been forced to undergo reversal surgery to remove the device. gabby says she is scheduled to upped go surgery this week and believes the device should be removed from the market until the safety concerns are better understood. >> i think the device has a reason hat a purpose and can be effective but if all those piece office that puzzle don't come together correctly, there can be some terrible terrible fall out from that. >>reporter: kristen z abc 7 news. >> in and out assure device also approved in canada and about to begin clinical trial in europe. american college of ob-gyn compared data on the effectiveness of this and other method of birth control but no current advice regarding the complaints collected on patient web sites. >> all right let's tour our attention to the weather forecast which may believe i

and you will oversee the fda. i believe that the fda should get involved. it is our premier consumer agency. and i hope they can investigate this new substance just as they ,id with four logo -- loco which was alcohol and caffeine makes, and they banned it. that was proven unsafe and i believe this will. all i'm asking is whether you will commit to having the fda look into this new how call product -- alcohol product for health and safety reasons. >> this is a new issue. it is one i would want to understand better and i would want to know which jurisdiction and exactly why. as far as it being a tax issue, understand that, but why it has not been previously looked at by fta. >> they haven't looked at it, and i urge you to do them -- to do so. >> i will look at it further if i'm am confirmed. >> thank you. the other issue of concern is a hydra, where the fda has been worse. we have opioid abuse all over the country in urban and suburban and rural areas. powerful version of hydrocodone was approved for the market without the same temper tamperproof preventions

thinks confirmed by the fda looking at our clinical trial. looking at the data submitted to them and part of the approval agreement. >>reporter: still complaints continue to come in to patient web sites including women who say they have been forced to undergo reversal surgery to remove the device. gabby says she is scheduled to upped go surgery this week and believes the device should be removed from the market until the safety concerns are better understood. >> i think the device has a reason hat a purpose and can be effective but if all those piece office that puzzle don't come together correctly, there can be some terrible terrible fall out from that. >>reporter: kristen z abc 7 news. >> in and out assure device also approved in canada and about to begin clinical trial in europe. american college of ob-gyn compared data on the effectiveness of this and other method of birth control but no current advice regarding the complaints collected on patient web sites. >> all right let's tour our attention to the weather forecast which may believe i

a wake-up call from the fda. the experts worry that the starting dose of a popular sleep aid, lunesta is too big for many people. o the results can affect your life and abc's chief medical director is here to break it down for us. >> basically the fda is saying anyone starting on the drug lunesta or generic should start at half the dose recommended. instead of two milligrams, it's one. the reason for that is the effect of the drug lasts into the morning. take a look at the recent study. 7.5 hours after taking it, many people impaired. problems with memory, coordination. you wouldn't want to be driving. it continues past that at 11.5 hours. some people still impaired and didn't know it. >> at 11.5 hours. >> that far out. >> so the bottom line for everyone tonight? >> start with as low dose as possible. for many people that tiny dose is all they're going to need. >>> now we turn to the nationwide out cry on sexual assault on college campuses.ÑmmÑ so many allegations that tonight a kind of secret avenger is on the

it's the magic drug and now the fda says what? >> first of all, i want to start off by agreeing with the fda for a strange reason. i don't think anybody should go to their pharmacy and pick up an aspirin, which is a very active chemical, and decide they'll treat themselves with it. i think they have to go to their doctors and doctors will hopefully be following the guidelines of the american heart association who says people at very high risk should be on aspirin. it's been shown by studies, eric, that 17% decrease in women for stroke over the ages of 55 on aspirin, over 30% decrease of heart attack in men over the age of 45 in aspirin, but we have to see it in conjunction with what are your risks of bleeding and risks of having stomach problems, if you have high blood pressure and that's one of your risk factors, is your high blood pressure under control. i have to look at a patient and judge the risks, what's the risks of bleeding because over 100,000 people go to the hospital every year from aspirin-induced bleeding. >> even th

. >> the fda keeps drug companies on the honor system. these drug companies violated the honor system. ultimately, destroyed documents. it kept them out of the legal system. stuart: this was testing on children. that is not allowed in america. >> the fda said you could not do it safely because of bladder cancer concerns. they said that they would just go to europe to do the test without telling the fda. they wanted to do the test on kids because they thought it would make them 2 billion more dollars. stuart: what happened to the children? >> at this point we do not have the documents and we do not know. there were basically nine different areas that i addressed with the jury. nine different areas of agree just comments that not only put at risk the people, but so unfair to the other good drug companies. they should be outraged. stuart: you do not think that the 9 billion will stand. you think that will be reduced? >> of course. the appellate courts will also reduce it. the jury was not out to see that 9 billion was collect it. they were o

and here's what the fda said. they say it is not used were supposed to be used as preventative medicine and those who don't have a history of heart attack or stroke. >> exactly. it is waiting the benefit and the rest. even though it's over-the-counter, even intracerebral, there's allergic reactions and you just have to be aware of that. in an older patient population, there are those that are at risk of following in hitting their heads. so needs to be weighed by the doctor. but what we do is focus and try to really determine the risk with various types of testing. gerri: this is all brought up because they're aspirin wanted to really market itself. do you agree with what the fda did? >> they did a very nice analysis relating to this and it clearly shows that there's no great benefit to that group of people. they did leave the door open saying that there's ongoing studies and let's see what happens over time. at the present time we cannot recommend as preventative way for people who have an increased risk of heart

we're close to filing that documentation with the fda. getting it to them. they'll have about six months to review it and hopefully get the drug approved and launch the product as early as first quarter of next year. that's where our focus is. we're very excited to finally after ten years to be able to bring perhaps the first drug ever for this uniformly fatal lung disease and we're focused on that. >> as i studied i was not able to find necessarily other drugs that i thought would be in the pipe. but it does seem this particular drug might have more uses than just the one you're talking about. >> that's right. it could be a portfolio within product for example. there's another disease called scleroderma which is a terrible disease. it's about as large as ipf and like ipf there's no drug approved and it's caused by fibrosis. so it is a drug that slows the process of scarring. so scleroderma is caused by scarring and it could work there. we have an on going phase 2 study we're excited back and further back in our research we have a number of antiscarring medi

just this past month the fda said it had received 4800 illnesses of pets being sick. the cause of the illnesses are under investigation. >> the fda received more than a thousand reports of dog deaths. >> cnn lina matello talks to one woman who nearly lost her pet to these toxic treats. >> reporter: meet sadie from florida whose brush with death still haunts her owner. >> she started throwing up blood. she started passing blood. she actually was throwing up blood clots that looked like pieces of liver. >> reporter: sadie's vet thought it was due to the treats. >> i was devastated. i almost started crying in his office. i thought, i killed my dog. i had no way of knowing that. you go to the store, you look at chicken treats. they looked like something i would eat myself. >> reporter: it turns out sadie is not alone. the food & drug administration has received more than 4800 complaints over sick pets, including 1,000 dog deaths possibly linked to chicken, duck, or sweet potato jerky treats. >> it doesn't surprise me. that number is probably a lot more. the fda is only ab

despite the investigation, fda says it still can't figure out why the pets are getting sick. live in union city, terry, shoppers were clamoring for this change. >> clamoring for a change and tonight they got it in spades. not only is petco pulling the chinese doggy treats from the shelves by the end of the year but now we found out that pet smart will follow suit. this is two years too late for rachel chambers of morgan hill to save her dog, cally. >> good girl. can you sit? >> rachel chambers love hes her family's four dogs, just as she loved cally, a shepherd mix that died a painful death after eating chinese made dog jerky two years ago this month. >> important that more lives are saved. but incredibly sad the lives that are lost during the two years they should have done something. >> the fda hasn't identified the exact ingredient that has sickened and sometimes killed animals but petco decided now is the time to act. >> we decided at this point we want to good ahead and make this move even though the evidence is tlnt. because it is the best thing for our pests. >> i aske

however the specific warning labels proposed by fda, were struck down by a court, u.s. court of appeals over the d.c. circuit on first amendment grounds. after that decision, i wrote the commissioner to urge the fda to move quickly to implement a strong new graphic warning label and rule. given the evidence that graphic warning labels encourages smokers to quit, i'm hoping this is a high priority for fda. is fda going to propose a new set of cigarette warning labels that's designed to withstand a constitutional challenge? >> the priority and we're doing this is getting the research done to inform our ability to write a new rule. so survive the likely litigation that would come. getting that research done is one of our highest priorities. armed with the results of that research and with paying attention to the court decisions that have come in in reviewing our first attempt which was struck down. will require some careful deliberations. we will do that crust as soon as we can complete the research. getting the research done to support a new graphic warning label rule is

. >>> the fda is coming down hard on illegal on-line pharmacies, the fda partnering with other federal and international agencies, took action against websites that sell what it calls potentially dangerous and unapproved prescription medicines to u.s. consumers. this week, the fda detained or seized hundreds of packages at u.s. mail facilities containing illegal prescription drugs. >>> while those mail order pharmacies may be the only way some can afford their prescription medications as the price of drugs seems to climb higher and higher. so why do brand name drugs cost so much and can anything be done about it? meg terrell gets some answers. >> reporter: when it was approved in 2001, the cancer drug and others that followed enabled patients to live almost normal life spans, the price about $30,000 a year, now it tripled to $92,000 a year. everybody is taking notice. >> access really is a problem for a lot of patients in relation to these very costly medicines. we sometimes think well, people have insurance and under obamacare there is a lot more coverage. but what that does not take

it was fda approved for anemia due to chemotherapy. and gm tried to encourage doctors to think outside the box and give it to people who would need it for other reasons. they actually did a series of clinical trials to promote it for that. also to promote giving a erythropoitin. you have to understand bundling we in medical college make money by buying our chemotherapy wholesale and selling it at retail. and we make money on chemotherapy marco. while the cost of chemotherapy is actually the cost that we can charge the patient is actually set by governmental influences but the cost that we pay the company is determined by the company. bundling is the concept that was wal-marwal-mar t would call volume discounting. if i were in a four person ecology practice in the big city like atlanta or d.c. and our practice views a little bit of erythropoitin what we gave for erythropoietin and what we paid for erythropoietin we broke even but if we used a lot of erythropoietin there were four person practices that made for quarters of a million doll

merck shares have rallied this year into the fda decision... the fcc thinks twice about net neutrality.new language out of the chairman's office comes after a considerable outcry over a proposal put forth last month. the original language proposed changes that would essentially allow the internet to be divided into a fast lane for content companies willing to pay for it and a slow lane for the rest. the new draft includes language about the f-c-c scrutinizing deals to insure that non-paying companies will not be at a disadvantage. a quick check of the latest round of earnings points to postive signs for the economy. around 453 companies in the s&p have reported results. according to bloomberg news. 76% turned in profits that topped analyst estimates. based on corporate projections-- profits are expected to rise 7.2% this year. walmart's banks are under fire for fee collection. according to the wall street journal ,banks under walmart's umbrella of services are some of the biggest collectors of fees in the country. out of 67-hundred banks in the

as marc mentioned, fda is right on this. not one size fits all, everybody go out and take baby aspirin is a huge mistake. it's very clear now you should not take it for high-risk patients. if you have not had heart attacks don't take aspirin, only if you have had heart attack as a recurrence. how do you know you're at risk? one of the things we've spoken about, believe me, i'm not a cardiologist but i read it a lot. you can go and get a quick test, show how much calcium in your arteries and vessels. if you have a high score, obviously you're on your way to having a heart attack. maybe taking aspirin in those patients can prevent clotting. to go there random, that's not a good call. >> finally, a study out of minnesota that shows if you have calcium in arteries and neck you have a greater chance of a heart attack. if we can identify you as a high-risk group, i say take aspirin. >> take carotid arteries. >> do you? >> yes. >> are you going to stop? >> no. >> what is the way to stop? immediately? >> he doesn't have any family w

regulation at all but in april, the fda proposes to change that. critics say that this was long overdue with a potential $3 billion business needed. dr. hamburg says the agency is working for more feedback before making a decision. we imposed a rule that would enable us to broaden our authority to regulate the full range of tobacco products including e-cigarettes. as is out for comment right now and a lot of interested stakeholders will move to the final ruling, and that will give us the foundation to regulate these other products that are in the marketplace, and be able to really assess what needs to be promote health and protect safety. >> i know you are still getting comments but what will change for this industry once the final ruling is adopted? what happens overnight, because there is no regulation right now? >> a couple of things will happen with the completion of the final rule. there will likely be other steps taken over time, but most importantly they will no longer be able to sell the e-cigarettes to youth under age 18. they will have to

fda. hrsa. i also have some of the highest rates of nobel prize winners and some of the highest rates of poverty. whether they're in baltimore city or mountain counties adjacent to west virginia. so i need a chief executive officer. we need someone who will bring executive skills to this job. 80,000 people work for hhs. you have the largest budget -- other than defense, the largest domestic budget. we see three issues. money, management and morale. money, that's our job. and sometimes we do it well. sometimes we don't. but we need someone in management who can tackle these tough problems, whether cleaning up the techno boondoggle of the health.gov to also going across the silos of agencies. and then we have a morale problem. because of the way they've been -- my federal employees have been battered by the budget and the uncertainty of funding and the trivializing of them and their work, you and i know that we have a morale problem. whether it's in fda or nih. and people are looking elsewhere rat

no duerme. >> pero para algunos tomarse la pastilla es la Única opciÓn, lo importante, como dice la fda ex empresa con la -es empezar con la dosis mÁs baja posible. >> hace unos dÍas una imagen dio la vuelta al mundo,unas gemelas en ohio que habÍan nacido tomadas de la mano, hoy los padres de las pequeÑas revelaron en una entrevista que todo se tratÓ de un montaje, porque el personal mÉdico que atendiÓ el parto las habÍa unido despuÉs de que nacieron, ahÍ tienen la verdad. este domingo, en la ediciÓn de "aquÍ y ahora" le sorprenderÁ saber que los exorcismos existen en realidad, aquÍ un adelanto. >> sesiones de exorcismo, demonios, o desequilibrios. >> llegaron a pensar que estaba loca, demente, quisieron encerrarme en un centro, una clÍnica psiquiÁtrica. >> tambiÉn el gran caza talentos de fÚtbol revela quÉ vio en neymar y robinho. ademÁs, tener un solo brazo no le impidiÓ ser campeón de artes marciales. y se confiesan las cuatro finalistas de nuestra belleza latina, quien se llevarÁ la corona? >> ya recorren las redes sociales el ví ♪ ♪ >> tÚnez era conscie

n a pill they get a bit of product. >> a number of groups launched a nationwide effort to pressure fda into reversing its decision and keep it off the market. the fda defended the decision and it is still available in limited supplies. >> we're feeling in prevention environment is that it has potential to be the next oxycontin. >> after months of pressure, the manufacturer has taken a major step that could address questions about safety, addressing it will sell a division dedicated to migraine treatment and focus on a version with abuse deterrents the company says it is investing tens of millions of dollars to develop an abuse to turn technology more effective than those on the market. the company says it's working to introduce the next generation as soon as possible. for some, it would be a beginning. >> it's important for all of the opioids out there to have that it take as way opportunity to crush and snort. >> they say they will continue the fight to combat the deadly misuse of prescription drugs. >> whatever i can do in the name of my beautiful son, joseph, i'm going to do, to hel

the fda will be notified then the fda will notify the vendor and they start working on a fix. >> the wheels of government turn so slowly, this is the kind of information that you want back to vendor very quickly. >> yes, exact. >> i. >> do you get the sense that it gets turned over rapidly. >> i think it does. the fixes do not get turned over very rapidly. so if we look at the historical, you know, context that we have for devices like this, it could take years for a software update to come out for a device like this. >> wow. >> so that's a big window. right? for any kind of devise, so hopefully things move faster in the future, but right now it is a slow process. >> well, unlikely allies are teaming up to protect you from potential internet bugs, up next we discuss the crucial market for hiring hackers. their employers might surprise you, plus we'll speak to a scientist and hacker who just hacked his own body to treat a chronic condition a few days ago, hear his bizarre story next. ♪ ♪ consider this. the news of the day plus so much more. answers to the questions no one else wil

the fda will be notified then the fda will notify the vendor and they start working on a fix. >> the wheels of government turn so slowly, this is the kind of information that you want back to vendor very quickly. >> yes, exact. >> i. >> do you get the sense that it gets turned over rapidly. >> i think it does. the fixes do not get turned over very rapidly. so if we look at the historical, you know, context that we have for devices like this, it could take years for a software update to come out for a device like this. >> wow. >> so that's a big window. right? for any kind of devise, so hopefully things move faster in the future, but right now it is a slow process. >> well, unlikely allies are teaming up to protect you from potential internet bugs, up next we discuss the crucial market for hiring hackers. their employers might surprise you, plus we'll speak to a scientist and hacker who just hacked his own body to treat a chronic condition a few days ago, hear his bizarre story next. ♪ ♪ >> award winning producer and director joe berlinger exposes the truth. >> our current system

these times of issues and the fda was present. and it was really a partner in trying to make sure the industry moves forward. >> did you a secondary and then it went very well. and then you brought 3.3 million shares. it is a very fine outfit. and people were surprised. why was not that part of the secondary? and some something we should worry about? >> we went through the process where we are private equity owned. we're still a controlled company at this point. and essentially, the secondary was very successful for our investors overall. we had a little extra cash in the books and we think it is very important to use our cash effectively. we could create a very effective transaction. tpg had a funneled open in 2003. intended for a ten-year life so they didn't have pressure on those shares. we're able to take care of that and create a win for the investors. >> that makes a ton of sense. it is good because -- we have a enough cash to do it. most companies do not. >> recommended right out of the chute because it's got a great busine

. >> contienen ingredientes que ya son aprobados por la fda, pero podrÍa haber mÁs? >> sabemos que nuestros productos hay ingredientes que pueden causar cÁncer a temperatura muy alta,y tiene otros efectos. >> la temperatura oscila entre 374 a 455 para el hyde, entre mÁs alta, más grueso es el vapor. ese un aumento de temperatura es lo que preocupa a los mÉdicos. pero esto no detiene a los aficionados como gonzalo, que hace aÑo y medio comenzÓ a "vapear". >> menos daÑino, pero es un vicio. >> o sea que tÚ necesitas tu nicotina. >> la nicotina, y detenerme a echar humo. >> la fda anunciÓ que van a regular los cigarrillos electrÓnicos como si fueran productos de tabaco, se prohibirÁ la venta a los menores y deberÁn tener etiquetas de emergencia que los catalogar como peligrosos para la salud. >> en nuestro final de impacto en el dÍa de las madres una madre tuvo doble regalo, nacieron gemelas idÉnticas, nacieron tomadas de las manos, ojalÁ que durante el resto de su >> asÍ nos despedimos gracias. ♪ ♪ >> es lunes 12 de mayo de 2014, esos son los titula