lock down. now. >> tonight, a heated hidden camera investigation. >> dangerous drugs get in the market. 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? >> changed my mom's life forever. she did nothing to deserve this. >> how can drugs link to illness and even death make it to market? >> we have no idea what's going on in these clinical trials. >> there are drugs where i say, i can't believe they approved this. >> who okays drug testing? >> we wanted to ask you how that can be improved.

>> and just where are some of those tests taking place. some people didn't like our questions. >> you realize you are keeping this -- >> you may not like the answers. chris hansen with another hidden camera case from "the hansen files." thanks for joining us. i'm lester holt. from crooked lottery clerks to criminal daycare providers, over the years, "dateline's" hidden cameras have exposed all sorts of wrongdoing. now chris hansen is opening up "the hansen files again" which could change the way you look at drugs in your medicine cabinet. >> nearly half of all americans report taking a prescription drug within the last month. 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 grown accustomed to seeing shelves lined with every day wonder drugs, drugs that save and prolong countless lives. whether it's 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 meridia is off the shovels. >> worldwide withdrawal of vioxx. >> drugs preskrcribed to millio, pulled off the market because of serious, sometimes deadly side effects. >> that's for my seizures. >> it is a story pam knows all too well. active and in good health, pam suffered a debilitating stroke at the age of 43. >> and i kept saying, this is

wrong. >> for years pam had taken the popular painkiller vioxx for her mild arthritis. three months after her stroke in 2004, vioxx's manufacturer, merck, pulled the drug from the market. pam became convinced that 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 wri writing and social science. >> 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. >> changed my mom's life forever. she did nothing to deserve this. >> merck is in the process of settling a lawsuit filed by pam and hundreds of others. the company has already paid nearly $5 billion to end thousands of other vioxx lawsuits. merck says it acted responsibly. it has admitted no wrongdoing in its settlements. critics say it is not surprising 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 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 and they do work around the clock, but they are 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 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. but the controversy surrounding vioxx and other drugs got us wondering -- how strong is the safety net that's supposed to make sure the 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? and who are they being tested on? >> translator: i feel desperation. i have to participate in the study. >> are there companies out there that would be willing to help us get approval to test a drug as unsafe as vioxx?

coming up -- we set up a fictitious company and we got the okay to test a drug already taken off the market. happy birthday! thank you, nana

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the fda approves about 65 new drugs for sale every year, and nearly every year, an approved drug is pulled off the market because of potentially life threatening side effects. how could a bad drug end up in our medicine cabinets? to understand that, you need to know how drug testing works. first stage of development happens in a lab. then animal test something done to see if a drug works and is safe. finally, testing on humans. that's done in clinical trials where groups of volunteers are

given experimental drugs to see how they react. you might think that the government is overseeing all of these important clinical trials, but that's not the case. >> here's the thing that i think most people don't know. the fda inspects about 1% of clinical trials. >> 1%. >> dr. carl elliott is a bioethicist at the university of minnesota. >> we have no idea what's going on in these clinical trials. >> elliott says that's a problem, because many clinical drug trials, once overseen by university medical researchers, are now often run by big drug companies with a financial stake in the outcome. >> we can no longer simply trust the clinical research business to operate on the honor system. it's a business. >> so how much trust can we put in the system that is supposed to keep harmful drugs off the market? to find out, we created

fictitious pharmaceutical company. we establish a prestigious new york city address. really, just a small post office box. it's a low-budget operation. a $13 a month homemade website, business cards, cell phones and an answering machine. with our company up and running, we'll try to get approval to test a drug already pulled off the market. one with potentially dangerous side effects. 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 sure. the executive director of the association for clinical research organizations says irbs serve as human drug testing gate keepers. >> the irb should look at the scientific validity of that study and should look at the ways in which 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 ross. >> the irbs are being paid by the same people who have 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. >> the findings raise serious questions with the entire system for approving experimental testing on human beings. >> but has that government investigation made review boards more careful? would any review board still 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 responsibilities is to make sure the science behind our plan is safe. the documents we're going to submit are based on merck's own study to see if vioxx could shrink colon polyps. we removed vioxx's brand and generic names but we leave lots of other red flags that clearly identify what our drug really is, like the original drugmaker's abbreviation for vioxx -- mk-0966. review boards are also supposed to make sure that doctors supervising clinical trials are qualified. to see how careful they are, we use the same fictitious doctor and same fake medical license and office address gao used for its investigation. then we mail our proposed study to three commercial review

boards that have worked for big drug temperatures. 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 bio ethicist carl elliott says a couple of rejections doesn't necessarily mean the safety net isn't working perfectly. >> now the dangerous thing about it is that if one for-profit irb says that a trial is unethical or it's too risky, you just take it severe weather else. >> you can shop it around. >> you can shop it around until you get the answer that you want. >> in fact, our application is being reviewed by a third company, essex irb. and so far they're not mentioning any serious problems. this company only asks us to make some revisions on a consent form that study volunteers would

have to sign. we make those changes, and in a matter of weeks, we get our final answer in the mail. essex approves our trial, saying risks to subjects were determined to be reasonable and minimized. essex irb's bill for its services -- $1,800. this private review board has now given us the green light to begin human testing with one of the riskiest drugs to ever hit the market. that alarms former senior fda drug researcher dr. david ross. >> it's petrifying because it suggests there may be many, many others. >> petrifying. >> petrifying. >> that's a strong word. >> it is a strong word, 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 [ laughter ] [ girl ] wow. you guys have it easy. i wish i had u-verse when i was your age. in my day, we didn't have these fancy wireless receivers.

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our fictitious pharmaceutical company has official approval to test a drug identical to one already pulled off the market -- vioxx. how could this happen? well, 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 in new jersey. the company, essex irb, is supposed to be in the business of making sure drug trials are run by qualified doctors, backed by science, and protecting patients from unnecessary safety risk. is there lambert in? so why would they approve such an obviously risky plan? we're here to find out. hi, dr. lambert? dr. glen lack bert, the chairman of essex irb, is a retired pediatrician. has signature gave us the go-ahead to begin human testing. you recently approved a trial for a company called mallum kinetics. >> okay. >> i need to let you know that mallum kinetics is really "dateline" nbc. >> oh. >> i told dr. lambert that the test plan his board approved was for a drug identical to vioxx. how could you aof propprove a pl that's already been known to be

pulled off the market and have been been linked to deaths, strokes and heart attacks? >> i don't know. i really do not know how that could have occurred. we're very thorough in our reviews of protocols. >> but if excess 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, mk-0966, as merck did for vioxx. the reality doctor, is this, had you just used google you would have figured this out. review boards are 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 office supervisor tried to call a cell phone to verify his contact information but she says the staff does not routinely check medical credentials. >> unless we have some sort of suspicious to look them up online, we accept that these doctors are legitimate, they are doing studies. >> but don't you have a responsibility to verify that -- >> that's how we verify. >> by just having the documents sent to you? >> yes. yes. >> and 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 approved? >> knot 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 actions 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 the fda has approved. >> still, kessler says essex irb's approval of a plan to test a drug identical to vioxx on humans shows a serious weakness in the safety net. >> those review board 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 is not required. >> months after we told the fda what we found, it sent a warning letter to essex saying it violating laws. it turns out two other serious warning letters from issued to essex dating back to 1998. essex resolved those problems with the fda. the fda has the power to shut down review board, 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 approved? >> oh, yes. >> so you'll change the way you do business here? >> oh, yes. >> if we were a real pharmaceutical company with a real drug, we could already be testing an unsafe drug on humans. something, of course, we never actually planned on doing. but questions aren't just being raised about drugs tested in the

united states. next, our investigation takes us overseas. pharmaceutical companies can save millions of dollars, face less 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 hansen files"" continues. ask me what it's like when my tempur-pedic moves.

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our fictitious pharmaceutical company, mallum kinetics, has the go-ahead to test a drug in the u.s., a drug that's already been pulled off the market in the u.s. -- vioxx. but there's much more to the story. drugs that reach our medicine cabinet aren't only tests here in the u.s. in fact, 80% of the medicines the fda reviews for approval rely on tests conducted on foreign soil. medical ethicist dr. carl elliott says one big reason for that trend is, it is easier to find people, test subjects, willing to take the drugs. >> the faster you can get the subjects, the faster you can do the trials, the faster you do the trials, the faster you get the drug approved.

faster you get the drug approved, sooner it goes on the market and the more money it makes. >> and now drug companies are often relying on foreign middlemen to help them get approval of their drugs. they do much more than just give the go-ahead for human testing. these companies take care of everything from recruiting patients, to giving them test drugs, to analyzing data that will be submitted to the fda. so can we rely on those tests and the people running them? could we get our unsafe drug identical to vioxx tests overseas? to find out, we traveled here, to india, one of the new hubs of human drug trials. we make our way to a city quietly emerging as a clinical trial hotspot. it's in the slums of this city that we see firsthand what is truly powering this growth industry.

an unlimited supply of people so desperate that 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 drug. is this your only study? >> translator: no. three times. >> you just got back from one of the trials. this young man shows us fresh needle marks on his arm from drug drawn during a weight loss trial. >> the pill they're testing is to reduce fat. >> you had you had. >> you don't look that fat to me. with each person we speak to, we begin to see a pattern. they'renot signing up because they're sick. they're signing up because they get paid. this woman says she enrolled in two trials that paid her the equivalent $2600 and $400. a lot of money when you consider the average person in these slums makes 50 cents a day. one trial she says was to test 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 money for his treatment. >> medical debt also drove this mother 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 fingerprint. >> why no signature? >> translator: i can't sign. i don't even know how to read the time on a watch. >> but do you worry that because you couldn't read this consent form that maybe you didn't understand the real risks involved here? >> translator: they did explain it to me but i can't read or write so it doesn't matter

anyway. >> if they don't understand, that is both unethical and unlawful. >> 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 in to drug studies. does that violate the law, do you think? >> of course it violates the law. >> but some don't find out about the risks until it is too late. the 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 lost his life. >> his uncle, like the rest of the family, still grieves. the indian government reports that more than 1,500 people have died in clinical trials here since 2002008. but that 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 the supply of human guinea pigs than this man. that's because he recruits them. he's paid about $12 for every person he brings into a clinical trial. it is a good living, he says. but he goes on to tell 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? >> translator: it happens. lots of people do that. >> taking more than one drug at a time is not only potentially dangerous to them but could change the outcome of a safety trial. he says the company they've recruited for test many things. >> companies call me or send mees teme

text messages. >> but they're not pharmaceutical companies. he works for middlemen hired by drugmakers to recruit patients and conduct drug tests for them. they're contract research organizations, cros for short. and cros are everywhere in india. that worries medical ethicists because anybody can open a cro here. i don't need a license, i don't need doctors. so how much faith can we put in these unregulated companies whose tests help us decide if the drugs that end up in our medicine cabinets are safe. to find out, malum kinetics sends the same test plan we got approved in the u.s. to two prominent indian contract research companies. both do business with with big drug firms pa. and remember, our product is identical to vioxx but we've 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 from is s synchron services. with hidden cameras rolling, we meet with the director of clinical operations. he thinks i'm malum kinetic's ceo. he leads us to a conference room for a presentation. >> personally, i welcome you to synchron. >> he tells us they can manage a drug company's testing from start to finish. 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. and he tells us those same doctors will have no trouble recruiting their own patients -- four patients who get free

treatment and follow doctor's orders. >> doctor is god. if i go to him, i follow palestinely what he says. >> he says they're eager to test our drug on humans as long as it gets approval from an indian ethics committee. >> i'm confident that we can. >> reporter: the 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 -- synchron 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 whoever said that "less is more"

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hey, how are you? >> malum kinetics, our fictitious pharmaceutical upstart is in talks to do human testing. 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, synchron,

told us he team saw no safety issues and would take on our entire project for $1 million. >> it is one-stop shop. >> what will he say once we tell him what our drug really is? the next time we meet it is here in chicago at a huge expo where drug company contractors from around the world are gathered. the fda even has a booth here. and so does synchron. that same executive told us he'd be here promoting the company. i take the opportunity to talk with him again. he seems glad to see me. until i let him know that i'm not really the ceo of a drug company. >> as you see from these cameras, we are not a pharmaceutical company. i'm chris hansen. i'm a journalist with a program called "dateline" nbc and we're doing a story on how these drug trials are run.

i ask him how it is possible that synchron didn't detect that our product was actually vioxx. he says they'd have discovered it later, but then he says they knew it all along. he's talking about our meetingy india, a meeting he didn't know was being recorded with hidden cameras. synchron certainly didn't act like a company with reservations about our drug trial then. >> we can do. i'm confident we can do. >> and 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 the trial? we wouldn't have taken it up. >> you would not have.

>> no. >> and with that, our meeting with synchron comes to an end. but our journey in the world of overseas drug testing wasn't over. there was another company interested in testing our drug on humans, a company well known to the drug trial recruits we spoke with in the slums. lambda share ptherapeutic resea. our fictitious company send lambda the same plan to test the identical drug to vioxx, even though our plan shows red flags showing this is an unsafe drug, lambda doesn't appear to notice. they are interested in doing business with us. we set up a meeting with lambda executives and with hidden cameras recording, we were on our way. armed guards greet us at the gate and direct us inside, and it's clear from the start lambda wants to impress us. we meet with a team of doctors

and ph.ds. they're led by dr. phillip matthew, a lambda vice president who ran clinical trials for a contract research company in the u.s. 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 we see that lambda isn't short on recruits. >> volunteers. >> 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 for the entire study as opposed to say $150 a day which is what.s. rates are. >> our meeting is in this plush boardroom where we are given a slick power point presentation. they tell us that four specialists have reviewed our plan. >> those four doctors have thoroughly gone over? >> yes. >> lambda's price tag for our project -- $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. it's not sold, it's not marketed. >> 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 are in the business of doing research regardless of challenging the project is. we also have to be realistic. >> matthew and his team say they'll need to take precautions to protect patients, like monitoring those with cardiac risks and lowering doses, if necessary. and the major challenge, getting an indian regulatory board to approve testing a drug like vioxx. >> we have huge, huge scientific

argument to win the case for bringing a study to trials. >> to help us make the case to indian regulators, dr. matthew proposes a strategy -- hire well connected medical. opinion leader, consultants, to persuade indian regulators to let us test our drug on humans. how confident are you that it can be done? >> very confident. >> with this strategy, dr. matthew says our odds for approval aren't insur mountable. he says getting approval could 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. >> just so i understand clearly, you think this is more an issue of how long to get it done versus getting it done. >> yes. yes.

we would love to take on the challenge. >> lambda appears ready to accept our money and take our study to the next level. but before we leave, i pull dr. matthew aside. i let him know we are actually journalists. >> i'm chris hansen and i'm a reporter from "dateline" nbc, a news magazine in the united states. malum kinetics -- with our cameras now in the open, he backtracks on what he told us in the meeting. >> we are fully aware of risk of vioxx. we would never do a study. we want to discuss with you what this is all about. >> even after we talked about this being vioxx, you said that we could go ahead and very likely do a study. >> no. 50-50. >> he takes offense that anyone would question lambda's integrity. another lambda executives steps

in and declares the interview over. and the tension in the room quickly rises. if you want us to leave -- but leaving isn't going to be easy. when we try, the lambda executive blocks the doorway. >> please have a seat. coming up -- the situation goes from bad to worse. >> lock the doors. lock down! now! >> lambda executives call in security to guard the door. we're told we won't be leaving ♪

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our meeting with lambda, an indian company that conducts human testing for drug firms, has taken a turn for the worst. >> please have a seat! >> now that we told them we're journalists, not a pharmaceutical company. >> lock down! now! >> we're locked in for nearly five hours after police arrive and log complaints from both sides, they escort us to this small police station. the top police inspector tells lambda's executives that we haven't broken any laws. still, as a condition of our release, we hand over copies of tapes from the cameras they

could see. they didn't know about our hidden cameras. we're now free to leave this city. this hub of human drug testing. 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 going to increase. >> and kessler says the problem is not just with foreign drug testing, something we discovered when that new jersey review board approved our 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. >> so with all the holes we found in the drug safety net from the review board in new jersey, to the research companies in india can we still be confident the medicines we take are properly tests 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.

the director of the association of clinical research organizations also defends the industry's track record. >> concerns notwithstanding, on the whole, the clinical research enterprise is amazingly safe and amazingly productive. >> he says there is too much at stake for the industry to tolerate unethical behavior. >> in the instances where we have seen bad actors, we've often seen that those bad actors go out of business rather promptly. >> we also took our findings to u.s. senator charles grassley, an outspoken critic of the fda's oversight of pharmaceutical companies. he faults the agency for not exercising enough authority. >> fda is in the position of policing 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 are done. >> they don't oversee those clinical trials until most of 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 drugmakers and their contractors to monitoring drugs after they're approved for sale. the agency also said it's establishing international offices to improve its ability to oversee the growing number of foreign drug trials. former fda commissioner david kessler says the fda still sets the gold standard. >> can the average american trust the quality of the 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 foolproof? no. >> and kessler says the fda can do more to strengthen the safety net to avert a crisis. one way, he says -- hold drug industry extifls accountable when their companies or people at risk. >> they can send ceos to the court system. hold one responsible and it sends a pretty strong signal. >> more inspections are needed but kessler says they can only go so far. >> fda in its heart knows it can't be in 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 standards. i think any physician, any doctor, who runs a clinical

trial should be certified, should be trained. and i think that's true for the institutional review boards. >> reporter: whatever the solutions are, kessler says maintaining the status quo could have serious consequences. what are the possible ramifications of that? >> i think we've seen it. >> dangerous drugs getting on the market. is that fair to say? >> drugs that are contaminated. drugs are are adulterated. drugs that don't work. >> cukessler says tackling probm will give regulators more money, money that won't 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 prescribe to. >> what's going to happen -- and i can predict this -- i mean it's been the history over the last 100 years -- we don't act until there's a