the fda has been without a fullrs worely on the fda to permanent . >> i see i've >> absolutely.120,000 workers. it's it's an extremely important agency. do you think it's unconchenable our legislature has not solved that problem? >> we have to understand that there is some really good career civil servants who probably are making sure that agencyre >>> are drug manufacturers raising the price in the very clutch at the end? >> we do see some raising the price in the 6-9 months before the patent expires. >> does that defeat the alleged massive savings to the consumer from ger nark drugs? >> not at all. the opportunity is enormous. we know that if the country used anti-inflammatoriy drugs the way doctors and kaiser did rather than celebrex and vioxx, the country would have saved 5 billion dollars. >> i'm sorry we are out of time dr. sharon levine. dr. sharon levine. >> rose: welcome to the program. a subject tonight is the aftermath to the deadly shooting in connecticut. we begin with mayor michael bloomberg of new york. >> shame on me if i am, as an american, with the wherewithal to do s

unsafe because it's not fda-approved. a letter was sent to the doctors saying, the fda is very concerned that products distributed by the suppliers may cause harm to patients because they may be unsafe or ineffective. for peter, a century city plastic surgeon and expert on botox, he says using nonfda- approved injectibles can be dangerous. >> very specifically when it comes to botox, this is a very, very potentially poisonous material. use it in tiny doses on patients. but it's an agent used in chemical warfare and it can permanently paralyze you. >> reporter: he says he is shocked and saddened to hear there's a large list of medical offices buying botox through a non--approved fda sort. >> my advice to be very cautious maybe even confront the physician and say, you know, this is my understanding that you might be getting medication from a source that's not fda-approved. can you talk to me about it? >> that was amber lee reporting. doctors say patients can request to see the bottle and the box that the botox was drawn fro

well, fda scientists say it's safe to eat. but would you take a bite? abc's jim avila traveled to a secret location in central america for this "nightline" investigates. >> reporter: deep in the rain forests of panama, in a secret location, behind padlocked gates, barbedwire fences, and over a rickety wooden bridge, grows what could be the most-debated food product of our time. shades of "jurassic park" this is a freshwater farm, altering the genes, not of dinosaurs. but growing a new dna-altered saltwater fish. in the mountains, far from the sea, a salmon that could be the first genetically all teared animal protein approved for the world to eat. a landmark change for human food. critics call them frankenfish. >> the idea of changing an animal farm is creepy. when you move the dna of a species into another species, you create a new life form that's so new and so unique you can get a patent for it. >> reporter: until now, aqua bounty, the multi national company that for ten years has been developing this fish, has been keeping it under close wraps. the

fda acknowledges thousands of complaints.sked to consider halting production until the fda can determine whether or not the products contain tainted materials chinese government wrote back slamming the fda. the cause of the deaths have not been determined. wrote from the perspective of thew76: chinese side there might be something wrong with the fda investigation guidance. >> i don't believe that. they're one of the top scientists. >> the letter from the people's republic of china warned not to influence public opinion ask z.to clear the q eliminate the negative impact m they will be receiving several feet of snow f you have travel plans to head out there, winter storm watch going up friday morning. thank you to our transmission control for that view. we zr r r do have clear skies. we have our own radar in combination with national weather service radar will be watching for next storm. our radar tracking next storm first. it's coming in from northwest. temperatures falling and it's going to be a cold night. 44 degrees in fai

the fda's review of company data found those concerns unfounded. is this something i should be afraid of? >> man has been altering the nature of animals since man walked upright and began domesticating animals. >> reporter: a new lab-created meat in the pipeline for fda approval that is at once very different and just the same as america's favorite dish for dinner. same texture. eating frankenfish. >> please don't use that term. >> and jim avila with us now. so, jim, how soon could this be approved and in supermarkets? >> reporter: well, that's the latest mystery about this fish, diane. the fda just won't say. its scientists approved it as safe two years ago. the company says they may go out of business before the fda actually approves it. >> and will there be a label on it? is it a required -- is it a requirement that there be a label on it if it's in the supermarkets? >> if this fish is approved, it will not be labeled separately from farmed atlantic salmon so you will not know unless you buy organic or you buy a wild salmon. if you buy farm salm

i don't believe the fda killed all those people. but i do believe that our bad policies contributed to this outcome. and how many of these illnesseses and deaths -- and think of the money involved, the billions of dollars in health care costs that we just wasted simply because we weren't prepared in 2009 to deal with the h1n1 influenza pandemic. before we go back to more barack obama, let's stop and recall president george w. bush who was regularly accused of manipulating scientific data often by barack obama himself. promoting science is about insuring that scientific data is never distorted or concealed to serve a political agenda and that we make scientific decisions base withed on facts, not ideology. president barack obama, march 9, 2009. well, did he live up to that? the bp oil spill was one of the biggest global oil spills in world history. how did the obama administration respond to this tragedy? quoting from the los angeles times, taken together two of the reports paint a picture of a government that was as unprepared to de

the fda taking its time in getting to the issue. think most people are at home going ew. >> i don't have a problem necessarily with steroid being injected into the chicken to make them larger. there's a reason that animals were created and supposed to stay exactly how they are. no cross-pollination here. interesting, little chance a salmon could escape and breed. if that happens, bred with wild fish they could disrupt everything. but there's -- >>> if the frankenfish got together with other fish. freaky fish! >> chaos. a freak every now and then. i knew willis would enjoy that. >>> still to come, getting ready for the end of the world. >>> as the countdown to the end of the mayan calendar draws near, we'll meet a man who is making sure he is ultra prepared, maybe even a little weird. >> announcer: "world news now" continues after this from our abc stations. >>> very important. very good news to report this morning. the u.s. government has confirmed the world is not going to end on the 21st of this month. >> thank god. >> whew. all r

you don't trust what the fda says? >> no, i do.ly for the, for the conspiracy theorists out there i suppose i put that in. these folks do a good job and they have been charged with our safety. so they have done the study, they have done the research and they believe it is safe. melissa: do you think they have done enough research over time? this strikes me as one of those things that comes back years later, the same way things leaching off plastic putting into the microwave. things considered safe for a long period of time and then they go back and say oops. that wasn't the case. you feel confident this wouldn't be one those? >> reasonably confident, yes, within the realm of probability, yeah. i mean this has been going on for over 10 years now and so i think within the realm of probability it's safe. is it possible something will happen? sure, absolutely. but i think you have to weigh the benefits against the side-effects. the other issue that should be mentioned, as we move forward is, the ethical and moral issue of genetically a

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fda won't say when it will give final approval. company says it could good out of business before it does. jim avila, abc news washington. >> well it is not often you hear about people in their 20's suffering a stroke but that is what happened to the star of the old show melt on in the middle. actor frank nunez tweet dad that he was hospitalized last we can after suffering a ministroke young man. clinic says a ministroke doesn't december industry brain cell or cause permanent disability lake major stroke does. he turns 27 tomorrow. awfully young to have that happen. >>> now to incredible police dash video out of texas. begins as traffic stop until the officers hear a scream from the trunk of the car. the arrest, rescue all caught on tape. l john reports this. >>reporter: newly released police dash cam video capturing routine traffic stop that business to become anything but routine. what cops doptd know yet there's a man tied up in that trunk. fearing for his life. that man 22-year-old shawn bloom seen her in the twitter picture. >

if the fda says that it is safe, it can just be sold as salmon.ould go out and buy it and eat it and not even know. if the fda says it is okay, i could be eating it without even knowing it. >> you need to inform the public. like anything else, if it is said to be safe and it is priced competitively, people will eventually eat it. the issue is, we have got to increase our product dimity. we are in trouble in the future. melissa: there are already a lot of things that we eat that have been genetically enhanced. there are plenty of vegetables out there that have been changed. this is the first animal. that is what makeseople a little uneasy. thank you. happy holidays. >> merry christmas to you. going from -- we give our 2012 to the masterminds of marketing. plus, running shoes. a former u.s. olympian turned high-priced hooker. the business is virtually untouched by the law. more "money" coming up. ♪ ♪ melissa: making good progress. so who could forget fearless felix, the skydiver who broke the sound barrier while wearing a red ball logo. the world re

and it has to be fda approved. so some doctors are receiving botox that's not been fda approved.ved botox and nonfda botox and we don't know what's in that. it hadn't been tested. >> this is not that you're going to somebody's home or garage to get botox injections. you're going to a doctor's office and you think that you're safe. >> right. >> and then i think the other thing, too, is that especially right how with financial times, people want things and they want them cheaper. >> everybody is looking for discounts for price point. but with botox, it has to be fda approved. this is a poison. it's not just botox. it's cancer drugs that are counterfeit and people's live we're talking about. there was an episode in florida where people had counterfeit botox and ended up in the intensive care unit so it's serious. most of the time i think the problem is it doesn't work or it's very diluted and it may well be botox but nobody knows. it hadn't been tested. >> we talked about the severity of this but how do we avoid this? how do we avoid the risks? what do we do to keep ourselves if we

cymbalta is fda-approved to manage chronic musculoskeletal pain. one non-narcotic pill a day, every day, can help reduce this pain. tell your doctor right away if your mood worsens, you have unusual changes in mood or behavior or thoughts of suicide. antidepressants can increase these in children, teens, and young adults. cymbalta is not approved for children under 18. people taking maois or thioridazine or with uncontrolled glaucoma should not take cymbalta. taking it with nsaid pain relievers, aspirin, or blood thinners may increase bleeding risk. severe liver problems, some fatal, were reported. signs include abdominal pain and yellowing skin or eyes. tell your doctor about all your medicines, including those for migraine and while on cymbalta, call right away if you have high fever, confusion and stiff muscles or serious allergic skin reactions like blisters, peeling rash, hives, or mouth sores to address possible life-threatening conditions. talk about your alcohol use, liver disease

the number of drugs on the fda's shortage list has more than triples. >> reporter: how concerned are i think the public needs to be concerned but not pan pinged virtually every hospital in the country is facing the difficulty. >> reporter: manufacturing problems, drug companies eliminating older drugs in favor of more profitable one, and middle-man companies that buy up drugs in short supply and reselling them at huge markups. it gained big attention after brenda freese and her husband spoke out about a drug that her son needed to survive was in short supply. >> i think if it's not criminal, it should be made a crime, because what you're dealing is stealing somebody's life. >> reporter: derek malcort, wjz eyewitness news. >> the fda has tightened rules on drug manufacturers. >>> the national hurricane center is changing its warning system after superstorm sandy caught many off-guard. they are changing the definitions so people will be ready for extreme conditions. >>> people in krisfield are still suffering from sandy's damage after a federal decision not to provide aid to storm- bat

so the fda are charged with protecting the food supply. an 8.2% budget cut translates to a combined $157 million. >> there's no word exactly what cuts would mean to inspector staffing. >> both the fda and usda-already stretched thin when it comes to inspection activities. they need increased resources, not fewer resources. >> agencies all say they're stretched. >> he is with freedom works and that's the cuts leave nothing to fear. >> arguing that getting spending under control endangers public health and safety is a really irresponsible scare tactic. especially when you realize that these aren't real cuts. these are reductions from anticipated increases in spending. >> cut the budget for the work these agencies do, it's going to signaturancely impact them today. going to significantly impact them tomorrow. >> you made that one. >> theresa and her kids are now healthy and food safety advocates. >> remember, we all have to eat. >> and they say nobody should have to fear what they eat. >> ama: a company that tracks food recalls says there war

some companies could find ways to avoid listing devices that would be subject to fda approval to avoidthe tax. experts say the fda may have to rely on complains from third parties to find out about -- companies that evading the requirements. ellen brightman, new york stock exchange. >>> everybody is hoping the rain holds off, it holds off today, better part of tomorrow, keep our fingers crossed. you can see some of the fog moving about this morning thickest north bay valleys, tiburon, belvedere over to about oakland this morning. clouds gone so is the rain, dry now rotating you can see it up there scan being the skies looking for that next storm from the west tomorrow afternoon. let's talk about right now. temperatures running mainly in the 40s and 50s out there. heads-up on guerneville and napa river, russian river guerneville and napa river at napa, for the most part crested starting to fall even with the extra rain i don't think there will be flooding concerns tomorrow into wednesday. 37 napa, santa rosa everybody else in the 40s, low to mid 40s monterey bay and inland. partly cloud

one drug stock part of the well performers despite some big news from the fda.und. [ malennouncer ] it's tt time of year again. time for citi price rewind. because your daughter really wants that pink castle thing. and you realldon't want to pay more than you have to. only citi price rewind automatically searches for the lowest price. and if it findone, you get refunded the difference. just use your citi card and register your purchase online. ave a super sparkly day! ok. [ male announcer ] now all youeed is a magic carriage. citi price rewind. start saving at citi.com/pricerewind. ashley: all right, alexa pharmaceuticals, one of the worst performing u.s. stocks today even though the drug developer got fda approval friday for mental health treatment drug. analysts say ther this seems toa disconnect between the realities of approval from the fda and exactly what that means. shares are down nearly 14% after having just jumped 50% in five weeks. shares are down more than 30% this year. there's been a wild ride to say the least. let's send it over to david asman and

a couple activists who used to work for the fda didn't like this really cool scientific process thatarates the beef trimmings and you get the remaining ground beef so they coined this term deliberately to hurt the company, and -- >> the company was doing something our instinct, taking the last bit bet of beef off the bone by trimming slightly and saved the money and saved the environment. >> anding for get just the environment. i get tired of hearing that argument. what about us? everybody on abc constantly saying, oh, you should eat leaner beef, worry about your health. so when we try to eat the leaper beef, they tack that away from us, too. >> and not using it wastes 5,000 companies a -- cows a day. >> they said the term pink slime 178 times either on their broadcast. >> then they started taking it back. >> there's a classic journalism. they said the term commonly used -- and then of course what you find, no, it's not. washington post, new york times, one or two times a most they ever used it prior to that. >> what's the agent? why? >> the agenda is all the activists who are pushin

if this goes through the fda budget will be cut by $350 million.ause a huge slowdown in their ability to help us get our drugs through and do what they're supposed to do. that is a big issue. tracy: the other issue we were just talking about is the investment in new drugs. we heard venture-capital lists are not coming to the mental device world because of the excise tax. you say they're slowing down in the drug creation world as well. >> the part of that and fda regulation was becoming inefficient enough that the time lines were increasing more and more. it takes 12 or more years on average to get a promising drug to market assuming that it works. the fda has been concerned and working on it and we have had some legislation passed by congress and signed by the administration this year that increases the efficiency of some of the processes. until recently venture-capital lists were slowing down their investments because they felt the risks were too high. they are starting to be more encouraged because of this increased efficiency but if the capital

so the fda and usda are charged with protecting the simply. an 8.2 budget cut translates to $157 million. there's no word exactly what cuts would mean to staffing. >> both fda and usda are stretched pretty thin when it comes to the activities they do. they need increased resources and not fewer. >> agencies always say they're stretched. >> dean clancy is with freedom works and says the cuts leave nothing to fear. >> arguing that getting spending under control endangers public health and safety is a really irresponsible scare tactic. especially when you realize that these aren't real cuts. these are reductions from anticipated increases in spending. >> cut the budget for the work these agencies do, it's going to significantly impact them today. tomorrow. >> you made that one, didn't you? >> tressa bennett and her kids are now healthy and food safety advocates. >> remember, we all have to eat. >> and they say nobody should have to fear what they eat. >> a company that tracks food recalls says there was 414 last quarter. the highest level in at l

we have met with the fda and we have what's called a special protocol agreement, it's an spa. and this agreement is for the conduct of a pivotal phase three trial and we have one for hodgkin's lymphoma and an spa for t-cell lymphoma and the t-cell lymphoma trial should start within the next month or two and we're really excited to do those trials, get them done and then become the standard of care and really redefine front line therapy for all these patients with two different types of lymphoma. >> when you say front line therapy, how much is currently spent on the system, the frontline therapies and the cocktail that's used for the front line therapies? >> i can tell you about patient numbers. in front line hodgkin's lymphoma, it's about 9,000 patients a year just in the united states. and if you look at the t-cell lymphomas, it's roughly 5,000 to 6,000 patients in the united states. so that market opportunity is substantial. >> you have currently said, you went through your most recent conference call that you are going to have substantial sales next year, so i want to tell

have machines that can calibrate to kids, and then we have to see these changes with the laws so if fda has proposals out for medical imaging around kids so you know how to downsize a radiation dose for kids who is smaller, their physical size is narrower, and also to make machines more accountable and more clear in how they work. >> [inaudible]. >> it's very low doses but that's an excellent question and i thought somebody would probably ask that. so, the united states preventative services task force in 2009 came out with a proposal to revise guidelines saying that perhaps women aged 40 to 50, there's no cost benefit really for that age group in terms of having mammogram of average risk, so recommended that women start mammography at age ao where the benefits really out weigh the risk, you don't have 40 years left in your life span at that point perhaps, you have 30, you're at a less vulnerable stage of life so there are a lot more benefits for life, your breast cancer risks are higher, so you know, the age 40 to 50, there's still a lot of debate about that and women need to discuss t

they're often regulated by different federal agencies, the fda regulates cosmetics, the environmental protection agency, pesticides and most synthetic chemicals but it's all over the place, one chemical might be regulated by any number of agencies, you have to step back and say we need to make sure all chemicals are safe and they're screened carefully, the european union did this, at least there's movement in that direction, the united states has not yet done this. so, the law that currently regulates chemicals was passed two years after i was born and i'm sorry but i think a lot has changed in the world about what we know about chemicals and what chemicals are used in the duration of most of my lifetime so we could change the laws so that new knowledge is integrated in how we screen chemicals for safety. today we think about 84 thousand chemicals are out there and about 1 thousand more are added each year and most of these, we don't have any human health data for, 90%, no human health data at all and hundreds of these are in our bodies, we know from studies, so we need to pass compre

. >>> a company called aquabounty is waiting for final fda approval on what critics are calling their manmade fish. abc news got exclusive access to a facility in panama where the company is bioengineering atlantic salmon that grow a lot faster than natural salmon. basically, the company merges dna from chinook salmon and sea eels to produce its salmon. and our jim avila, he was brave enough to taste it. >> nothing's going to happen to me or my children if they eat this fish? >> it will make you healthier. man has been altering the nature of animals since man walked upright and began domesticating animals. the beef that we consume, the pork that we consume today, don't resemble their early ancestors at all. >> critics worry but have no proof that the new fish will increase allergies. an fda review of company information found that concern to be unfounded. >>> mcdonald's is the latest fast food chain with a special promotion this month. a cult favorite is returning, the mcrib pork sandwich. >> yes. >> saucey goodness. although the national launch is the 17th, it's already available in

disease control says contaminated food sickens about 48 million people a year, 3000 people die, so the fda the usda's food safety and inspection service are charged with protecting the food supply. an 8-point-2 percent budget cut translates to a combined $157 million dollars. there's no word exactly what cuts would mean to inspector staffing "both fda and usda are already stretched pretty thin when it comes to the inspection activities and the food safety work they do.they really need increased resources and not fewer resources." >> "agencies always say they're stretched". >> dean clancy is with freedomworks an organization that promotes smaller government, and he says the cuts leave nothing to fear. >> "arguing that getting spending under control endangers public health and safety is a really irresponsible scare tactic. especially when you realize that these aren't real cuts, these are reductions from anticipated increases in spending". >> "if you cut the budget for the work that these agencies do, it is going to significantly impact them today, its going to impact them tomorrow" "you mad