tonight. for all of us here at nbc news, good night. -- captions by vitac -- www.vitac.com lock the doors. >> lock down, now. >> foent aa hated he had hidden camera information. >> dangerous drugs on the market? is that fair to say? >> we go undercover to investigate the safety net to protect you from unsafe prescription drugs. are there holes in it? ones that potentially dangerous drugs can slip through. >> it changed my mom's life forever. she did nothing to deserve this. >> how can can drugs linked to ill illness and death make it to market. >> we have no idea what's going on the in clinical trials. >> there are drugs i can't believe they aapprove.

>> who okays drug testing? >> we want to ask how that's approved. >> where are some of those testing taking place. some people didn't like our questions. you may not like the answers. chris hansen with another hidden camera case from the hansen files. welcome to "dateline," everyone. i'm lester holt. from crooked lottery clerks on to criminal day care providers, over the years "dateline's" hidden cameras have exposed all sorts wrongdoing. now chris hansen is opening up the hansen files again with an investigation that could change the way you look at the drugs in your medicine cabinet. what have you uncovered? >> nearly half of all american report taking a prescription drug within the last month, so he we wondered how good is the system that makes sure those drugs are safe? as our hidden camera investigation found out, not

good enough. americans fill a stunning 4 billion prescriptions a year, and each time we go to the pharmacy, we've gron accustomed of seeing shelves lined with everyday wonder drugs, drugs that save and prolong countless lives. whether its for heart disease, breast cancer, hiv or diabetes, we trust that the pills we're taking are safe, and most are safe and effective. still, nearly every year we hear news like this. >> the diet drug maridia is off the shelves. >> a worldwide withdrawal of vioxx. >> the maker of bacal has pulled it off the market. >> drugs prescribed to millions and pulled off the market because of serious and deadly side effects. it's a story pam cunningham knows all too well.

active and in good health, pam surgeoned a debil suffered a debilitating stroke at 43. >> i kept saying this is wrong. >> for years she took vioxx for her mild arthritis. three months after her stroke in 2004, vioxx's manufacturer, merck, pulled the drug from the market. pam became convince that had vioxx caused her stroke. studies have since linked it to tens of thousands of strokes, heart attacks and deaths, but merck says the weight of scientific evidence does not support claims that vioxx causes strokes, including pam's. >> now. >> now. now. >> today the once energetic canadian teacher struggles with permanent memory and speech loss, relearning what she used to teach. what did you like most about teaching? >> reading with the kids and writing and social science. >> social science? >> yes. >> is your mother the same woman she was before the stroke?

>> not at all. >> will she ever be? >> no. no, she won't. >> pam's daughter, whitney, says watching her mother lose her health and independence is heart-breaking. >> it changed my mom's life forever, and she did nothing to deserve this. >> merck is in the lawsuit of settling a lawsuit filed by pam cunningham and hundreds of others. they paid 5$5 billion. mercked it acted responsibly and admitted no wrongdoing in the settlements. critics say it's not surprised that a drug as risky as vioxx was approved for sale. >> having seen what the process is like, there are drugs where i look at it and say, i can't believe they approved this. >> dr. david ross was a top drug safety reviewer for the food and drug administration. he left the agency after ten years frustrated that it had approved drugs he says put

patients at risk. ross says the fda's drug safety testing is not what you might think. >> i think the average person imagines the fda has a place where all these scientists are working, you know, sometimes around the clock testing drugs to make sure they're safe. is that the way it works? >> no. there are a large number of scientists that work around the clock, but they're not themselves testing the drugs. >> so who is responsible for getting the drugs tested for safety? it's actually the pharmaceutical companies themselves, and the fda often doesn't see the results of those tests until drug companies up want approval to sell their products. with thousands of drugs on the market, most of the time that system works. even so, ross says there are still serious flaws. >> it's not that every new drug is going to develop a problem,

but we have no way of knowing when something is going to go bad. >> even when the fda does learn about a drug's risks, can it be counted on to act quickly? in the case of vioxx, a senior fda scientist said his top managers dismissed his warnings about the evidence linking vioxx to heart attacks. the fda denies it ignored the warning. the controversy surrounding vioxx and other drugs got us wondering, how strong is the safety net that is supposed to make sure that billion dollar blockbuster drug of today won't be the dangerous drug of tomorrow? tonight, we go undercover taking our hidden cameras as we investigate just how reliably drugs are tested before they reach our pharmacy shelves. who actually tests the drugs you take? who are they being tested on? >> translator: out of desperation i had to participate in the study. >> are there companies out there that would be willing to help us

get approval to test aa drug as unsafe as vioxx? >> we can do that. >> coming up, we set up a fictitious company and got the okay to test a drug already taken off the market. >> it's petrifying. >> that's a strong word. >> we're talking about people's lives here. >> when the hansen files continues. whee! whee! wheeeeeeeee! ah heads up. wheeeeeeeeeeee! everything you love about geico, now mobile. download the new geico app today.

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but fortunately, somebody else was. at usaa we provide retirement planning for our military, veterans and their families. now more than ever it's important to get financial advice from people who share your military values. call now for our free guide and tips on planning for your retirement this tax season. the fda approves about 65 new drugs for sale every year, and nearly every year an

fictitious pharmaceutical call company. we establish a prestigious new york city address. really just a small post office box. it's a low-budget operation, a ando. 13 dpol$13 a month homemade website, business cards, cell phones and an answering machine. with our company up and running, we'll try to get approve to test drug already pulled off the market, vioxx. to begin human testing, we'll need approval. you might think the government has the final word on something so serious, but that authority now often rests with private

for-profit institutional review boards, irbs for short. doug peddicord says irbs serve as human drug testing gatekeepers. >> the irbs should look at the scientific validity of that study and should look at ways in which the safety and the welfare of the people who may volunteer to be in that study will be protected. >> but critics say some review boards have a conflict of interest because their survival depends on money from the pharmaceutical industry. former senior fda drug safety researcher dr. david pros. >> the irbs are paid by the stamame people with a financial stake in the outcome. >> investigators at the government accountability office had the same concerns three years ago. they set up a sting operation using a bogus company looking for approval to test a clearly dangerous product. one of the three review boards

they approached actually approved it. the investigation sparked outrage in congress. >> gao's findings raise serious questions with the entire system of approving experimental testing on human beings. >> has that government investigation made review boards more careful? would any review board approve something so risky? to find out we used publicly available information to put together a plan to see if we could get approval to test a drug identical to vioxx. remember, one of the review board's sponltresponsibilities is it to make sure the science behind our plans are safe. it's based on merck's own study to see if vioxx could shrink colon pole lipyps. we keep the original drug make

maker's number for vioxx. review boards are supposed to make sure doctors supervised are qualified. to see how careful we use the same if i can tishgs doctor and same fake medical license and office address that the gao used for its investigation. then we mail our proposed study to three commercial review board that is work for big drug companies. two of them, sterling irb and western irb, spot the red flags. they recognize our dangerous product and figure out that our study doctor is fake. sterling rejects our plan citing serious safety concerns. western does, too. they're so alarmed they alert the fda. but carl elliott says a couple of rejections doesn't necessarily mean the safety net is working perfectly. >> now, the dangerous thing about is that if one for-profit irb says that a trial is

unethical or it's too risky, you just take it somewhere else. >> you can shop it around? >> you can shop it around until you get the answer you want. >> in fact, our application is being reviewed by a third compan essex irb, and to far they're not mentioning any serious problems. this company only asks us to make some revisions to a consent form that study volunteers would center to sign. we make those changes, and in a manner of weeks we get our final answer in the mail. essex approves our trial saying risks too subject were determined to be reasonable and minimized. essex irb's big for services? $1800. this private review board has given us the green light to begin human testing with one of the riskiest drugs to ever hit the market. na alarms former senior fda drug researcher dr. david ross. >> it's petrifying, because it suggests there may be many, many

others out there. >> petrifying is a strong word. >> it is but we're talking about people's lives here. >> coming up, how could a business whose job it is to protect people miss so many warning signs? we wanted to ask you how that could get approved. when "dateline" continues. [ gasps ] ♪ ♪ [ laughs ] ♪ ♪ [ female announcer ] mcdonald's happy meal has really blossomed with big, new changes like juicy, wholesome apple slices plus special kids fries in every box. it's a meal you'll both love. the simple joy of fresh, new changes. ♪ ♪ [ white ] in my kitchen, the heart of a great dish is a great tasting stock. new knorr homestyle stock. it's concentrated, with just the right ingredients, simmered to perfection. delicious. new knorr homestyle stock. tastes like stock made from scratch.

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our fictitious pharmaceutical company, malum kinetics has official approval to test a drug pulled off the market, vioxx. how could this happen? the approval wasn't granted by government regulators like you might think. instead it came from a private company whose board meets every week inside this small brick building pin new jersey.

the company essex irp is supposed fob in the business of making sure drug trials are run by qualified doctors, backed by science and protecting patients from unnecessary safety risks. is dr. lambert in? why would they approve such an obviously risky plan? we're here to find out. hi, dr. lambert. dr. glenn lambert is a retired pediatrician. his signature gave us the go-ahead to begin human tests. he recently approve ail fril for a company called malu mi kinetics. i need to let you know malum kinetics was "dateline nbc"." >> oh. i told him the test plan they approved was for a drug eiffel cal to vioxx. how could you approve a proet squall for a drug already known to be pulled off the market and have been linked to deaths, strokes and heart attacks? >> hmm. i don't know.

i really do not know how that could have occurred. we're very thorough in our reviews of protocols. >> if essex really did thoroughly review the safety of our plan, like review boards are supposed to, an easy internet search would have shown our drug wasn't safe because we used the same abbreviation, mk0966 as merck did for vioxx. the reality is had you just used google, you would have figured this ouchlt review boards areal also supposed to make sure the doctor running a study is qualified. remember, the doctor leading our study and his medical certificate were fabricated by the government accountability office for its own sting. did you check independently to see if, in fact, he had a medical license. >> we probably did get a copy of a medical license. >> well, it doesn't exist. >> essex's office supervisor did try to call a cell phone we used for dr. kruger to verify his contact information, but she

tells us that the staff doesn't routinely check research doctor's medical credentials. >> like i said, unless we have a suspicion to look them up online, we accept that these doctors are legitimate, they are doing studies. zoop >> don't you have an responsibility to verify? >> that's how we verify? we ask them. >> just having the document sent to you? >> yes, yes. >> essex has approved hundreds of research studies. if you approved a protocol for a drug that is linked to thousands of deaths in this case, how many others have you aapprovedapproved? >> none that we know of. >> we wanted to talk with the fda about essex's approval. the agency wouldn't speak to us on camera but said in a statement that essex's action are not a reflection on the entire irb system. we did, however, talk with someone who knows a lot about the fda, dr. david kessler,

former fda commissioner in the first bush and clinton administrations. overall, he says, prescription drugs in this country are safe. >> if you get sick with a serious and life-threatening disease, i'd rather be living here in the united states and have access to the drugs that fda has approved. >> still, kessler says essex erb's approve of a plan to test a drug identical to vioxx on humans shows a serious weakness in the safety net. >> those have a special responsibility. that is one of the important layers of consumer protection. any hole in any of those layers could mean disaster. >> the problem with the review board system, he says, is that there are no universal standards. >> there's voluntary certification, but it's not required. >> months after we told the fda what we found, it sent a warning

letter to essex saying it violated laws when it approved our study and two others involving children can and it turns out two other serious warning letters were issued to essex dating back to 1998. essex resolved the problems with the fda. the fda has the power to shut down review boards, but it never has. the agency says the essex case is still open. meanwhile, the company is still in business. do you see why this would be alarming that something like this could be aapprovepprovedapproved? >> oh, yes. >> you'll change how you do business here a little bit? >> oh, yes. >> if malum kinetics was a real pharmaceutical company, we could test an unsafe drug on humans, something we never planned on doing. but questions aren't just being raised about drugs tested in the united states. next, our investigation takes us over overseas, pharmaceutical

companies can save millions of dollars, face leg regulatory scrutiny and find people desperate enough to become human guinea pigs. >> translator: i am helpless. i have to do this. >> coming up, could our fictitious company get the help we need to test a potentially dangerous drug overseas? when the han"the hansen files" continues. ir whole careers here. [ charlie ] we're the heartbeat of this place, the . we take pride in what we do. when that refrigerator ships out the door it's us that work out here. [ michael ] we're on the forefront of revitalizing manufacturing. we're proving that it can be done here, and it can be done well. [ ilona ] i came to ge after the plant i was working at closed after 33 years. ge's giving me the chance to start back over. [ cindy ] there's construction workers everywhere. so what does that mean? it means work. it means work for more people. [ brian ] there's a bright future here and there's a chance to get on the ground floor of something big something that will bring us back. not only

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our fictitious pharmaceutical company, malum kinetics has the go ahead to start human testing in the u.s. with a drug identical to one already pulled off the market, vioxx. there's much more to this story. drugs that reach our medicine cabinets aren't only tested here in the u.s. in fact, 80% of the medicines

the fda reviews for approval rely on tests conducted on foreign soils. dr. carl elliott says one big reason for that trend is it's easier to find people, test subjects willing to take the drugs. >> the faster you get the subjects subjects, the fast you are do the trials. the faster you get the drug approved it goes on the market and makes more money. >> now drug companies are often relying on foreign middlemen to help them get approval of their drugs. had they do much more than give the go-ahead for human testing. these contract companies can take care of everything from recruiting patients to giving them test drugs to analyzing data submitted for the fda. can we rely on those tests and the people running them? could we get our unsafe drug identical to vioxx tested overseas? to find out, we travel here to india, one of the new hubs of

human drug trials. we make our way to a city quiet quietly emerges as a clinical trial hot spot. it's in the slums of this city that we see firsthand what's powering this growth industry. an unlimited supply of people so desperate they're willing to become human guinea pigs. these two women show us forms consenting to be part of birth control tests. a birth control product. is this your only sfudy? >> translator: no. three times. >> so you just got back from one of the trials. this this young man shows us fresh needle marks on his arm from blood drawn during a weight loss trial. the pill they're testing is to reduce fat. >> uh-huh. >> you don't look that fat to me. >> with each person we speak to, we begin to see a pattern. they're not signing up because

they're sick. they're signing up because they get paid. therona enrolled in two trials that paid her the equivalent of $200 and $400, a lot of men when you consider the average person in slums makes about 50 cents a day. one trial, she says, was to test it a cancer pill. she says it made her sick. she does not have cancer. why did you do this? >> translator: helplessness. my husband died. he was sick. we had taken a lot of loans for his treatment. our money lender used to threaten to throw us out of the home. >> medical debt also drove rumba, meyer of three, to clinical trials after a government hospital couldn't cure her sick son, she borrowed heavily to pay a private doctor. >> translator: i was desperate. >> this is the consent agreement for one of the studies. i notice that your fingerprints

are here and not your signature. >> translator: yes, that's my finger frintprint fingerprint. >> why no signature? >> translator: i can't sign. i can't ride time on a watch. >> are you worried since you can't read this consent form you didn't understand the real risks involved here. >> translator: they did explain it to me, bit can't read or write so it doesn't matter anyway. >> this doctor is editor of an indian medical ethics journal. he says the problem isn't just with fingerprints on consent forms. it's also using money to draw desperate people into the drug studies. does that violate the law? >> of course it does. >> some don't find out about the risks until it's too late. this father of this 19-year-old believes his son died from being in a drug trial. >> translator: he went for the study and became weak. he was a healthy kid. he had no physical problems, and suddenly he lost his life.

p. >> his you thinkuncle, like the rest of the family still grieving. the indian government reports that more than 1500 people have died in clinical trials here since 2008, but that happen doesn't seem to stop people from flocking to them. >> translator: people are known to go and line up the night before often sleeping by the streets. >> few people know more about e supply of human guinea pigs than this man. that's because he recruits them. he's badpaid about $12 for every person he brings into a clinical trial. it's a good living he says. he tells us something alarming to anyone worried about how reliable some overseas tests are. are you aware of subjects taking part in more than one study at the same time? >> reporter: >> translator: it happens. lots of people do that. >> taking more than one drug fet is not only potentially danger to them, but could change the

outcome of a safety trial. he says the companies he recruits for have tested drugs to treat everything from diabetes to migraines to high blood pressure. so you don't work just for one company? >> translator: yeah. companies call me or send me text messages. >> but the companies he's talking about aren't pharmaceutical companies. he works for those middlemen hired by drug makers to recruit patients and conduct testing for them. they're called contract research organizations, cros for short. cros are everywhere in india. he says anyone can open a cocro here. how much faith can we put in these unregulated companies whose tests help decide whether the drugs that end up in our medicine cabinets are safe? to find out our fictitious drug

company sends the same test plan to two prominent indian contract research companies. both do business with big drug firms. remember, our product is identical to the unsafe drug vioxx. we removed the brand name from our plan and tell the companies we want them to do everything, recruit patients, get necessary approvals and finally run the actual tests. one company we hear is synchon research services, and it doesn't take long to set up a meeting with hidden cameras rolling we meet with the director of clinical operations. morthy thinks i'm malum kinetic's ceo. he leads us to a conference room. he says they can manage a drug company's testing from start to finish, and it appears he has no idea our product was already withdrawn from the market worldwide.

in fact, he says he's shown part of our plan to private doctors who would conduct our trial, and they didn't spot any safety issues. >> they have no issues. >> he tells us those same doctors have no trouble recruiting their own patients, poor patients who get free treatment and follow doctor's orders. >> if i go to him, i will blindly follow what he says. >> he says syncron is eager to move ahead as long as it gets approval from an indian ethics committee. >> i'm confident that we can. >> their price tag? a little over $1 million. we tell him we'll be in touch soon, and that's when we'll let him know who we really are. coming up, syncron isn't the only indian company that wants to do business with us. we set up another meeting, and it doesn't turn out quite the

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how are you? malum kinetics is in talks with two indian outsource companies to do human testing there. our product is mk-0966, which you can see with a simple google

search, is actually vioxx, a drug voluntarily pulled off the market because of its potentially dangerous side effects. they haven't figured that out yet. in fact, a top executive from one of the companies, syncron, told us his team saw no safetyish use and would take on our entire project forl a little over $1 million. >> it's a one-stop shop. >> what will he say once we tell him what our drug really is? the next time we meet it's here in chicago at a huge expo where drug company contractors from around the world gather. the fda even has a booth here. so does syncron. that same executive said he'll be here promoting the company. i take the opportunity it to talk with him again. he seems glad to see me. >> so nice to see you. >> until i let him know that i'm

not really the ceo of ia drug company. as you see from the cam ras, we're not a pharmaceutical company. i'm chris hanson and i'm a journalist with "dateline nbc." we're doing a story on how the drug trials are run. i ask how it was possible they didn't detect our product was the same as vioxx. at first he said they would have detected it after more research, but minutes later he said he knew what the drug was all the time. >> we did pick it up but didn't share it with you at that point in time. >> you picked it up? he's talking about our meeting in india, a meeting he didn't know was being recorded with hidden cameras and syncron didn't act like a company with reservations about our drug trial then. now he says he's sure an indian ethics committee would have found problems with our study.

what would have happened next? >> in the process of trial? he wouldn't have to tha that. >> that's not what you told us. >> we definite wouldn't do that. >> with that, our meeting with syncron comes to an end. our journey into the world oversees drug testing isn't over. there was another indian company interested in testing our drug on humans. a company well-known to the drug trial recruits we spoke with in the slums. lambda therapeutic reserchlt it's immaculate headquarters rise above the poor and desolate neighborhood surrounding it. our fictitious company sends lamda that same plan to test a drug identical to vioxx. own those our plan has red flags, lambda doesn't appear to notice. they're sfwed ininterested in doing business with us.

we set up a meeting with lambda a executives and we're on our way. armed guards meet us at the gate and direct us inside and it's xleer from the start lambda wants to impress us. we meet with a teamer erof doctors and ph.d.s. they're ran by clinical trials for a contract research company in the u.s. we put on lab coats, and he takes us on a tour. we go through rooms that look like sci-fi movie sets. in this waiting room lambda isn't short on recruits. the volunteers earn an average of $150 per study he says, a fraction of what it would cost us in the united states. >> that's sfwirtfor the entire study. >> our meeting is in this plush boardroom where we're given a slick power point presentation. they tell you that four specialists have reviewed our

plan. nose four doctors have thur he rowly gone through it? >> yes. >> lambda price tag is $775,000. we're well into our meeting when out of the blue dr. matthew announces his team just realized after months of talks that our product is actually the same as vioxx. >> it's withdrawn currently. it's not sold, and the it's not marketed. >> that's right. >> he knows vioxx's controversial history. we're convinced he's ready to pull the plug on the meeting, but then dr. matthew stuns us. he says they're interested in helping us get the trial started anyway. >> we have deliver the trial. we're in the business of doing research. that depends how challenging the project is. >> matthew and his team say they need to take precautions to

protect patients like monitoring those with cardiac risks and lowering dosages if necessary and the marnl challenge is getting an indian board to approve testing a drug like vioxx. >> we have a huge, huge scientific argument. >> to help us make the case toindian regulators, dr. matthew proposes a strategy. hire well-connected medical opinion leaders, consultants to persuade indian regulators to let us test our drug on humans. >> consultants from here and we'll see who can speak for the drug. >> how confident are you that we can do that? >> very confident, very confident. we can take whoever we want in india. >> with this strategy, dr. matthew says our odds for approval aren't in surmountable. >> that's because it's vioxx. >> he says getting approval may take more time, but he's optimistic. i want to make sure he's actually suggesting we could get a drug identical to vioxx

approved for testing on humans. so just so i understand clearly, you think this is more an issue of how long to get it done versus getting it done? >> yes. from our perspective, we would love to take on the challenge. >> lambda appears ready to take our money, but before we leave i pull dr. matthew aside and let him know we are actually journalists. i'm chris hansen, and i'm a reporter for "dateline nbc," a news magazine in the united states. malum kinetics -- >> i knew that. >> with our cameras now in the open, he backtracks on what he told us in the meeting. >> we never agreed to do your study wechlted to discuss with you what this is all about. zoop . >> even after we talked about it being vioxx, you said we could

go ahead and do a study. >> no. 50/50. >> he takes offense that anyone would question lambda's integrity. another lambda exactive steps in and declares the interview over. >> we can stop. >> and the tension in the room quickly rises. if you want us to leave, we will. leaving isn't going to be easy. when we try the lambda xex tichexecutive locks the doorway. >> please have a seat. >> coming up, the situation goes from bad to worse. >> lock down, now! >> lambda executives call in security to guard the door. we're told we won't be leaving anytime soon.

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our meeting with lambda, an 3 f1 indian company that conducts human testing for drug firms has

back in the u.s. we told former fda commissioner david kessler what we learned about india's drug research industry. >> you identified a real issue, a real problem that's only go to increase. >> and kessler says the problem is not just with foreign drug testing, something we discovered with that new jersey review board approved or plan to test a drug identical to vioxx on humans. >> this is as much an issue

sometimes in the united states. don't feel that there's no problem here at home. >> with all the holes we found until the drug safety net, from the review board in new jersey to the research companies in india, can we still be confident that the medicines we take are properly tested and safe? the pharmaceutical industry's lead trade group declined to talk to us, but in the past it's called the u.s. drug approval process second to none. doug peddicord the director of the association also defends the industry's track record. >> concerns notwithstanding on the whole the clinical research enterprise is amazingly safe and amazingly productive. >> peddicord says there's stootoo much at stake for the industry to tolerate unethical treatment. >> in the instances we've seen bad actors, we've often seize those bad actors go out of

business rather promptly. >> we took our findings to u.s. senator chuck grassley. he faults the agency for not exercising enough authority. >> fda is in the position of policing the entire operation. they are the 900-pound gorilla. they need to act like a 900-pound gorilla. >> grassley believes the fda needs to get involved early in the planning and supervising of clinical trials, not just review drug company test results after they're done. >> he they don't oversee those clinical trials until most them are completed. then they see the results. to what extent can they trust the results? >> the fda responded in a statement that it is already strongly engaged in the clinical research process from inspecting drug makers and their contractors to monitoring drugs after they're approved for safl. the agency is establishing

international offices to aapprove its ability to oversee the growing number of forler drug trials. former commissioner david kessler says the fda still sets the gold standard. can the average american trust the quality of a new medicine that they may be prescribed? >> you can probably trust drugs more in this country than any other place in the world. but is it fool-proof? no. >> kessler says the fda can do more to strengthen the safety net to avert a crisis. one way he says, hold drug industry executives accountable when their companies or contractors put people at risk. >> it can send ceos to jail through the court system. hold one ceo responsible, and it sends a pretty strong signal. >> more inspections are needed, too, kessler says, but they can only go is so far.

>> fda in its heart knows it can't be on every corner. it can't be at every site. >> but kessler says the fda can do something else. set up a system that rejects clinical trials run by unqualified doctors, no matter where the trials take place. >> i think we need to up our stand standards. i think any physician, any doctor who runs a clinical trial should be certified, should be trained. i think that's true for the institutional review boards. >> whatever the solutions are, kessler says maintaining the status quo could have serious consequences. what are the possible ramifications of that? >> i think swooeven it. >> dangerous drugs getting on the market? is that fair to say? >> drugs that are contaminated. drugs that are adulterated. drugs that don't work. >> ultimately kessler says tackling the problem will mean giving regular laltorteors more money,

money he doesn't expect will come soon enough. in the meantime he worries about the ongoing risks, risks for volunteers testing the drugs and for the people they're ultimately prescribed to. >> what's going to happen and i can prediblgtct this, it's been the history over the last 100 years, we don't act until there's a problem. >> until people die? >> regrettably. >> chris, i'm guessing there are people watching this now wondering about drugs they may currently have in their medicine cabinet. how do you feel find out if there's a problem with the certain drug? >> first off, let's remind everyone out of the 4 billion prescriptions filled every year the vast majority are drugs perfectly safe. those that may not be, the fda keeps a running list of drug recalls and alerts on its website. you can find a link to the fda site plus more information from our investigation on our website