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00:00The End
00:30A major city on the east coast of the United States, an FBI undercover operation is reaching
00:41a climax after months of surveillance.
00:44A meeting at a luxury hotel is being taped and monitored by a team of FBI agents.
00:51The target is not a mafia boss or a Colombian cartel peddling drugs.
01:07Instead, the merchandise is cutting edge scientific knowledge.
01:11What's on offer is a genetically engineered protein.
01:18One test tube can contain the blueprint for a pharmaceutical drug worth billions of dollars.
01:33A secret camera has been concealed in a hotel room, and it's recording the conversation
01:37as an undercover FBI agent is negotiating to buy priceless information.
01:42If my scientists in Moscow have trouble setting it up or maybe they don't understand something,
01:47maybe they want to invite you to come.
01:49The FBI agent is posing as a member of the Russian Foreign Intelligence Service.
01:54He's part of a new FBI unit set up to deal with a major threat to national security,
01:59the conspiracy to steal the nation's most valuable scientific secrets.
02:04Boston, Massachusetts is the center for many of America's most high-tech companies involved
02:20at the cutting edge of scientific and medical research.
02:23These centers are now surrounded by a new aura of secrecy.
02:27Corporations and universities have become the prime targets for a new breed of scientific spies.
02:34The free exchange of information that was once a cornerstone for scientific progress
02:38is under threat from unprecedented secrecy.
02:42For corporations, it's a billion dollar threat.
02:45But for individuals, it can be a matter of life and death.
02:49Subhu Kota, born in India but living in Boston, Massachusetts,
03:02has been under surveillance for years by the FBI.
03:05They believe he's been offering the former Soviet Union what it needs most,
03:09scientific and technological information which can be turned into profit.
03:14From the late 1980s through the early 1990s, Mr. Kota passed certain information
03:20to people that he knew were connected with the KGB.
03:24Sikorsky.
03:25Sikorsky.
03:26Helicopters.
03:27Helicopters.
03:28Helicopters.
03:29They have these advanced materials.
03:31Yes.
03:32You know, some of them which are more like a, you know, stealth kind of.
03:37I see.
03:38You know, stealth technologies.
03:40They were hard to get stealth technology.
03:42They were hard to get radar technology, jet engine technology.
03:46FBI Boston.
03:47Traditionally, the FBI has the task of counterintelligence.
03:51But in the new political climate, they're confronted by a different threat.
03:56The Cold War, as we've formerly known it, that started in the 50s or so
04:01and continued up to close to the present, has really ended as we've known it.
04:05But what's heated up is what we call the War of Industrial Espionage.
04:09And that's probably a loose term, but it covers a whole series of acts,
04:14including the sale of biotechnology, the sale of various products created in industry,
04:21and can continue all the way to the sale of military secrets as well.
04:24Each one is 10,000.
04:27So, okay, that's 10, 20, 30, 40, 80, 190, 200, 200, 200,000.
04:39Now, I think the Russians and others are interested in things that make money.
04:44And that's where we get into biotechnology.
04:47The pharmaceutical industry is among the most profitable enterprises in the world.
04:54It is from the new arena of biotechnology that the billion-dollar breakthrough drugs
04:59are expected to emerge.
05:01Combining genetics, animal research, and human proteins,
05:04biotechnology promises a holy grail for medical research.
05:08Fierce rivalry, secrecy, and competition has escalated in the global race
05:13to secure patents for breakthrough drugs that may offer miracle cures and miraculous profits.
05:19In the last two years, the number of UK biotech companies has doubled.
05:23The sector in the United Kingdom alone is worth an astonishing 5 billion pounds.
05:30Should that type of technology be compromised and sold to another country
05:36or a competitor within the United States,
05:39that's going to have a severe negative economic impact
05:43on the company that produced it, on the company that owns the patent.
05:47Subu Kota was planning to sell a genetically engineered protein for $300,000
05:53that had the potential to make millions, the product of an American biotech company.
05:58Kota believed his customers were the Russian intelligence service.
06:02In fact, they were the...
06:08The stolen property was a drug, or a cell line for a drug,
06:13known as erythropoietin, or EPO, or EPO, as it's more commonly known,
06:17which is a drug that stimulates the production of red blood cells.
06:22Epigen has significantly impacted the treatment and quality of life
06:27for people with chronic kidney failure on dialysis.
06:30When kidneys fail, they lose their ability to produce adequate amounts of erythropoietin,
06:35an important hormone that stimulates bone marrow to produce the red blood cells that carry oxygen.
06:40Without enough erythropoietin, the production of red blood cells declines.
06:45A patient's oxygen-carrying capacity is severely reduced, resulting in a condition called anemia.
06:51Just one gram of epigen can be worth $2,000.
06:56With that particular substance, and that small amount of it,
07:00and a million dollars in the wherewithal to reproduce it,
07:04a company could realize, in fact, a $100 million profit at the end of one year.
07:08The FBI had to make sure that Cota never suspected the real identity of his potential client.
07:14Several meetings over a period of time were the basis for an elaborate sting operation.
07:19The strategy which was quite successfully implemented was, in fact,
07:26to utilize an FBI agent posing undercover as a KGB agent
07:30to reinvigorate the relationship with the primary subject,
07:34and that, in fact, did prove successful.
07:37Very good. Thank you.
07:38Mr. Cota, I like the way you operate.
07:41Very good.
07:43Cota, seen here on the left in this undercover video,
07:46claimed that his contacts in the scientific community
07:49could provide him with unique access to valuable biotechnology secrets.
07:53In a series of meetings, he promised to hand over a sample.
07:56Some of them would take a long time to outside to go and see them.
08:00But these are classified just as classified.
08:02Not like last time. I thought that I was going to bring a sample.
08:06I will get it to you. There's no problem.
08:08But mainly we have some understanding, you know, that that's...
08:11Well, I could talk to you on the phone this much, you know.
08:14Right, right.
08:15But I thought, yeah, I came here because I thought I was going to bring a sample.
08:19That's what my superiors did.
08:21The FBI is the largest law enforcement agency
08:26operation in the world.
08:28In undercover operations, they draw on an extraordinary range of resources,
08:32including private aircraft, millions of dollars,
08:35front companies, and Russian-speaking agents.
08:38But even the FBI is finding itself on a learning curve
08:41as it confronts the new threat from scientific spies.
08:45The course of fire we'll be shooting here today
08:48as a familiarization course for our street agents.
08:52And we'll be using a Hecker & Koch MP5 in the 10-millimeter version.
08:58As well as machine guns, FBI agents now need a new armory
09:02to meet the threat from a new breed of criminal.
09:05Scientists and businessmen who use their minds rather than force
09:08to commit crimes of a highly sophisticated nature.
09:11If somebody is shooting at us,
09:15our firearm policy is that we return fire to kill.
09:19Street agents are now having to acquire new skills
09:22in the area of science and technology.
09:24Mike Rollins.
09:27Mike Rollins.
09:28Mike Rollins is in charge of the Boston Division of the FBI,
09:31and armed with new legislation to counter the threat to trade secrets,
09:35he's in a new line of business.
09:37It's a brand new field.
09:39The law has only been on the books 18 months or less.
09:42So it's going to take us a while to get our agents to a level
09:46that we're confident that no violations are going to slip through the cracks
09:52because of an inability to understand what was brought to us.
09:57And I'm confident that we will get there,
09:59just as we have with health care fraud,
10:01investigating the Mafia,
10:03and going all the way back to the traditional bank robbery
10:06and theft from interstate shipment cases.
10:10Currently, the FBI has over 800 cases of trade secret theft on their books.
10:15It's a crime that is growing in popularity.
10:18The sector most under attack is biotechnology.
10:21Up off the hood. Don't hit the hood.
10:25Corporations risk the loss of hundreds of millions of dollars
10:28in lost sales and squandered research and development.
10:32Companies, particularly those in the biotech field like Genzyme,
10:36spend anywhere between 10 and 12 years developing their products
10:40from the time they start out in the research and development lab
10:43to the time they make it to market.
10:45And that represents an investment of anywhere between $100 to $150 million of work.
10:50Before that product actually gets out and produces any revenue for the company.
10:55Through that 10 year period is a tremendous opportunity for people outside the business
11:00to come in and steal the work that really represents the future competitive advantage of that business.
11:06It's really their future lifeblood.
11:08Subu Kota was attempting to siphon that lifeblood from a company called Integrated Genetics,
11:15which has since merged with Genzyme.
11:17Integrated Genetics had spent hundreds of thousands of dollars in the race
11:21to develop the new generation of genetically engineered drugs to treat anemia.
11:25Kota had claimed he could get samples.
11:28Inside the company his contact was Bhaskar Reddy,
11:31a biochemist seen here on the left,
11:33who worked on the development of erythropoietin.
11:36This developed company, how it was within you personally?
11:42I made it in a company.
11:43You developed it?
11:44You worked on it?
11:45Yes.
11:46You personally worked on it?
11:47Yes.
11:48Where did you work on it?
11:49In here, Birmingham.
11:50Yes.
11:51In which?
11:52Integrated Genetics.
11:53Integrated Genetics.
11:54That's the name of the company?
11:55Right.
11:56But it's no longer there.
11:57It is now part of Genzyme.
11:58Genzyme?
11:59Genzyme.
12:00Gen-
12:01Genzyme.
12:02Genzyme.
12:03Genzyme.
12:04Genzyme.
12:05Reddy's position in the company meant that he had access to samples
12:08and the formula for erythropoietin.
12:11It has become one of the most successful products of biotechnology.
12:15Erythropoietin, which is a red blood cell enhancer,
12:20the domestic market in America is in excess of a billion dollars.
12:25I was calculating last night.
12:27He's saying one gram.
12:28Yes.
12:29Okay.
12:30One gram is equivalent to three doses you need to have for one or two weeks.
12:36That can go up to 6,000 patients.
12:39So, three shots?
12:40Three shots.
12:41It's a series?
12:42Yes.
12:43One, two, three.
12:44One is not enough.
12:45And the three shots cost $2,000?
12:46Two, two.
12:47Or each one?
12:48Each one cost $2,000.
12:49So, $6,000 for one dose.
12:51Yeah.
12:52This commanded tens of millions of dollars in profits each year
12:55for the company that holds a patent on it here in the United States.
12:59That doesn't even count what it could be worth on a worldwide market.
13:03Once the FBI had their hands on Cota's sample, they needed the help of Genzyme's scientists
13:08to discover whether the allegedly stolen erythropoietin was identical to the product they'd been developing.
13:14So, the person who worked with them, while they're developing this particular product,
13:20he knows and he kept some bugs with them in the lab.
13:24Oh.
13:25So, they're right in here.
13:27Sure.
13:28He kept it.
13:29He kept it.
13:30He kept it.
13:31I see.
13:32He incubated them in a couple of universities.
13:35Three, four places he kept, you know, something like that.
13:39When I give you the go signal, I want you to run to the rear of the vehicle and engage those
13:45steel targets, the three targets.
13:47For 25 years, Eric Begg has worked as a street agent in the counterintelligence division of the FBI.
13:53As the case agent, he helped to develop the scientific evidence to be used in the trial.
13:58The complex nature of the case required a knowledge of the underlying science of biotechnology.
14:07I went to one of the universities here and sat down with one of their molecular biologists
14:11and asked him to tell me what it took to develop a cell line that would produce erythropoietin.
14:18And it took a long time for me to understand how that came about.
14:22And I have a little bit of a scientific background, but it's so old it is not to really bear on what he was talking about.
14:33Good.
14:34Dekak and Holster.
14:36Developing that particular bug is the time-consuming process.
14:41Like, we all have immune systems.
14:43Somebody got to develop that immune system in a lab.
14:46Yes.
14:47So once that is done, all we got to get is the original bug.
14:50We can multiply that again and again and again.
14:52Right.
14:53And I'm not saying I understood the chemistry of it all, but I think in general terms I did understand it.
15:00Which is, after all, what we're trying to convey to a jury.
15:03We need to know the truth so that my scientists know exactly where it came from, what it is, you know.
15:09So, oh, this question, number seven.
15:12Is it from Master Cell Bank or Working Cell Bank?
15:17Master Cell.
15:18Master Cell Bank.
15:19Okay.
15:20Good.
15:21With access to the Master Cell line, the purchasers were able to reproduce the protein in any quantity.
15:26A legal manufacturer on industrial scale offered a potential reward of hundreds of millions of dollars on the black market.
15:33But as in any illicit deal, the buyer kept hold of the money until Kota could prove that he was selling the genuine article.
15:43The person that was offering it was not going to give us the cell line itself.
15:48He was going to give us the liquid in which the cell line was nurtured.
15:54And that liquid would have in it the protein that we were interested in producing.
15:59In other words, the cell line expressed the protein into the liquid medium.
16:03They siphoned off the liquid medium, gave the liquid medium to us,
16:07and there was a test that we could buy and perform on this liquid medium
16:11to see that there actually was erythropoietin in it.
16:14Once we'd done that, we told him that we believed that he actually did have the cell line and wanted to purchase it.
16:20So we knew what we were purchasing.
16:23And once we'd done that, I think the most important thing from a legal standpoint
16:26was to prove that this particular cell line was not something that was created independently,
16:32but actually did belong to a specific company.
16:35I just thought of something. Did you have a gun or anything?
16:38No.
16:39For protection? No, no. You don't carry anything.
16:42You don't have anything at all.
16:44I thought maybe because there would be much money if you bring something with you.
16:47I carry bigger than anything.
16:49Yeah, yeah, no problem. Good.
16:51Once they had carried out the tests and satisfied themselves that they had enough evidence for a jury,
16:56the FBI arranged a final showdown.
16:58280, 290, 300.
17:04You're going to count it now? No, no.
17:08If you want to count it or if you want to look through it, you're welcome.
17:13It is all $100 bills.
17:17Just as he thought he was $300,000 richer, Mr. Kota received an unexpected surprise.
17:24Yes.
17:25Yes.
17:26Excuse me.
17:27Just close it up. Close it up.
17:28Just a minute.
17:29But despite all the evidence that was caught on camera, there was an unexpected result
17:43when the case finally came to trial in October of this year.
17:49Although Kota pleaded guilty, his co-defendant Reddy was acquitted.
17:54The jury accepted that Reddy hadn't stolen the protein and that he could have made it himself.
18:04But the FBI had at least successfully prevented the counterfeit production of epigen.
18:09And they would do even better in another case in New Jersey.
18:13This time, there would be more than a billion dollars at stake.
18:16In the United States, biotechnology is one of the fastest growing economic sectors.
18:34It's also the most competitive new frontier of medical science.
18:39It's an industry which is attracting massive sums of investment capital
18:43and is transforming an unprecedented number of scientists into multi-millionaires.
18:48Even companies that have not produced a single product can be worth hundreds of millions of dollars on the stock market.
18:55Just one formula can be worth billions.
18:59And the secrecy surrounding the work of these scientists is critical to protect future profits.
19:04There's so much money involved in biotechnology, so much investment, I think,
19:11because it's deemed that this is really the one and only way that we will combat the most serious health problems that still remain for humans.
19:22The rewards are significant, clearly.
19:26A new drug that adequately treats a previously untreatable or poorly treated disease can quite rapidly escalate to billions of dollars a year in annual sales.
19:38And clearly, a single product generating that volume of sales and profits can make a single company quite wealthy,
19:47as well as the investors in that company.
19:49It is these multi-million dollar profits which have attracted the attention of both unscrupulous competitors
19:56and the intelligence agencies of foreign governments.
20:03David Kent is the head of security at Genzyme.
20:06He's come across a variety of methods used to try to steal secrets.
20:10It would range from stealing documents that might have proprietary information about customers or customer lists.
20:18It may be stealing computer files that might have research information about future or current projects ready to launch.
20:25There's no bounds to human imagination when it comes to some sort of criminal enterprise.
20:30In 1996, the director of the FBI alerted Congress to the threat to national security from the growing number of cases involving the theft of commercial and scientific secrets.
20:52The criminals have ranged from French and Chinese spies through to discontented employees who would sell the secrets themselves.
20:59The FBI has analyzed the people involved and the cost to the country.
21:04I believe the numbers were 74% of the people involved in those incidents were people who were in a position of trust within those companies.
21:13So it's not just foreign involvement. In fact, I think only 21% of the subjects, if you will, represented foreign countries.
21:21And yet the dollar amount that they gave was $5.1 billion in admitted losses, which equates to roughly 9% of the United States gross national product.
21:34And the powers that be in Washington have come to the conclusion that our national security is inextricably intertwined with our economic prosperity.
21:46To safeguard that prosperity, the FBI has devised a new program for companies involved in scientific research to alert them to the dangers.
21:56Hi, I'm Ken Warner with the FBI. I'm here to see Dave Kent.
22:01Using intelligence from a variety of sources, the Bureau warns science-based companies if they're being targeted by foreign governments.
22:12Hi, Dave. Pleased to meet you.
22:14Hi, Dave. Thank you.
22:17Our goal is to get out there at least quarterly.
22:20With the cessation of the Cold War, if you will, we began to focus our efforts on the threat to our economic well-being.
22:28And it became very evident that we did not have the wherewithal by virtue of laws from an enforcement point of view to stop, essentially, economic espionage or the theft of trade secrets.
22:41Last year, in response to the threat, a new law was passed which revised the Espionage Act to include the theft of scientific secrets as well as classified military technology.
22:58The most dangerous activity for an FBI agent is working undercover.
23:09Until recently, these agents never appeared on television or gave interviews.
23:13Paul Hayes is one of the first to do so.
23:18He worked a case in New Jersey which involved the largest sums of money yet recorded in an attempt to steal scientific secrets.
23:33This kind of information had hundreds of millions of dollars worth of potential impact on the revenues and profits of each company.
23:43Paul Hayes masqueraded as a wheeler-dealer who specialized in bartering raw materials for hard currency, a black market operation known as counter-trade.
23:52He pretended that his clients were former Eastern Bloc countries and set up a dummy company in the New York area.
24:01I suggested we try and operate as a counter-trade company or an individual operator as if they were a counter-trader for a company.
24:10So that would give us optimum reason to be in contact with various countries that might be trying to appropriate American technology illegally.
24:22The technology being offered for sale belonged to two of America's largest and most successful pharmaceutical companies, Shearing Plough and Merck.
24:31The first technology was to manufacture their breakthrough anti-cancer preparation, Interferon.
24:37The second was the fermentation process for Merck's Ivermectin, a cure for river blindness in Africa.
24:43Interferon was the result of over 20 years of research to develop a revolutionary anti-cancer treatment from a plant extract.
24:52Ivermectin was also the result of many years of research by Merck to treat a disease which had previously been incurable.
25:04With these two drugs each were pushing about one billion dollars in annual sales.
25:11The industry refers to them as blockbuster drugs and they were among their most successful and profitable products.
25:18In this case, those stealing the scientific information were not agents of a foreign power, but American citizens.
25:31One of them was a former research scientist who'd worked for Shearing Plough, Dr. Bernard Mayles, seen here on the left in a secretly filmed FBI tape.
25:41With him is his partner in crime, another scientist, Mario Missio, owner of a laboratory called Biofarm.
25:50Tipped off by the company itself, the FBI made their initial contact with Mario Missio on the pretext of translating Italian scientific documents into English.
26:00Obsessed with secrecy, they used a code name, BN25, for the drug that they were illegally trying to sell.
26:07A million dollars is a good increase in ballpark.
26:14Wow, that's like this.
26:16A wrap, nice and tight.
26:18One other thing, I need to discuss.
26:19Okay?
26:20Yeah.
26:21When you culled this BN25, it's always culled it there.
26:25Yes.
26:26He doesn't know anything about any of the business aspects that we've negotiated on, just that he's responsible for it.
26:36It was well over a nine-month period before we were able to consummate a deal whereby they would provide me the technology and, in this case, a particular mutant strain of microorganism utilized for the fermentation process in exchange for their choice of payment, which, in this case, was cash.
26:55Although not a scientist, Paul Hayes' cover as a crooked businessman proved a successful strategy.
27:02Trying to enhance credibility, I operated a FBI-run shell company.
27:09Everything that they would have checked on me and did check on me proved to be something that could corroborate.
27:15I had foreign currency in my possession quite often, which would indicate that I was traveling to various places.
27:22For instance, I had memorized the foreign exchange for a U.S. dollar transaction with numerous different countries so that I could cite them easily and interact as need be.
27:31Dr. Mayes indicated that he had all the technology and the microorganisms needed to set up a full industrial scale production of either one of these items.
27:44Anyone could easily be in competition with rightful owners, Merck or Shearing Plough, if they got their hands on what he had.
27:53As two of the world's best-selling drugs were involved, Paul Hayes had to come up with some serious money to support his cover.
28:01I told him that I would bet that I could get six or eight million dollars for the interferon process from the Soviet Union.
28:10What we did is we continued to negotiate on the ivermectin and through time we settled on a price of one and a half million dollars.
28:20They wanted it in cash and the deal was closed where they provided me the technology and the microorganism for 1.5 million dollars.
28:35Males revealed that the research and development costs alone were in the order of 850 million dollars.
28:41As the undercover case reached its final stages, it was arranged that the formula and the samples would be exchanged in return for over a million dollars in cash.
28:52Words may not be that accurate.
28:54But this is not inclusive of all that 850 million research because you have toxicity studies that you have to go through.
29:03You have pre-clinical studies that you have to go through.
29:06You have the animal studies that you have to go through.
29:09You have the clinical studies that you have to go through.
29:12A clinical study with a thousand patients may cost you three and a half million dollars.
29:20Obviously with a million dollars in cash, I did not want to be riding planes, wandering streets,
29:25or being in a public place where a million dollars in cash, which is quite bulky, would be exposed to theft or a problem,
29:33not knowing myself whether Males and Missio might have other individuals they would bring along with them.
29:42It was agreed that the handover would take place in a bank vault in Atlanta, Georgia.
29:47The FBI would secretly film them receiving the cash.
29:50I met them in the lobby of the bank and we proceeded where this conference room had already been arranged for.
29:57And I put the cash on the table, showed them that I was for real, and I was ready to do the business transaction.
30:04At that point, Bernard Males pulled the documentary technology he had out of his back pocket.
30:16And sometime shortly thereafter, Mario Missio went back out to a car and came in with a cooler
30:22where the microorganism for the production of fibromectin was kept supposedly within dry ice even though most of it had evaporated.
30:32And they presented their side of the deal.
30:34If they'd not been arrested and convicted, the economic loss would have been enormous.
31:01The prosecution calculated that the value of the stolen information was greater than in any previous case.
31:08The judge gave the case at sentencing on both Males and Missio $750 million worth of economic loss prevented,
31:16which would be obviously a conservative number.
31:19He's just taking the research and development value and not trying to calculate in any sort of economic way
31:27the potential for lost sales or the marketplace issues that could occur in the future.
31:34One million dollars.
31:37What are we going to do when we have eight million for the interference?
31:42Well, if we get eight million for the interference, we're going to put it in the bag.
31:48The defendants were jailed for a total of 14 years.
31:51The stakes are now so high that it is possible that scientific crime could even involve murder.
31:58La Jolla, near San Diego, California.
32:13As the latest center for America's biotechnology, the area has attracted some of the world's leading scientists to work there.
32:21Sunayo Saito was renowned for his research into the complexities of Alzheimer's disease.
32:35The University of San Diego had received a $14 million grant to finance his research.
32:41If Saito could achieve a breakthrough in the treatment of Alzheimer's disease, it would have been worth millions of dollars.
32:48The rumour was that he was close.
32:51Last year, he drove his 13-year-old daughter home from school after helping her with a science project.
32:57Here we are, we're finally home here.
33:01Let's go look.
33:07The brutal murder of a scientist and his teenage daughter shocked the world.
33:33The motive remains a mystery.
33:37But scientists suspect that the murder may have been connected to Saito's specialized research.
33:44Tunao Saito, an Alzheimer's researcher at UCSD, and his 13-year-old daughter Luli, were shot down in the driveway of their home Tuesday night.
33:54There were no witnesses, there is no motive known, and there are no suspects.
34:00International media speculation has the murders committed by a professional.
34:04Some say over Professor Saito's work to find a way to detect the onset of Alzheimer's disease.
34:12Murder is the most extreme possibility in the brave new world of biotechnology.
34:18But the very idea that hit men could be involved illustrates an alarming change in the process of science.
34:25Secrecy and suppression of information are now the order of the day as scientific research becomes ever more jealously guarded.
34:32The effects are being felt not just on the flow of fundamental knowledge.
34:37For one of the world's foremost cancer specialists, working in the highly advanced field of cancer vaccine research, where a breakthrough can benefit millions of people, secrecy in science is literally a matter of life and death.
34:50Well, we run into this all the time in the kind of research that I do.
34:55I'm involved in cancer research, trying to find new cancer treatments.
34:59I'm trying to develop new cancer vaccines, a way to stimulate the body's immune system to fight cancer.
35:05And we're doing this from a variety of different directions.
35:07Now, this is a very cutting-edge area of modern technology, and it requires a whole variety of biologic reagents and information and cellular immunology.
35:17And very often, many of these reagents or biologic materials are developed by a biotechnology company.
35:24And so very frequently, I run into situations where a biotechnology company will not give me something that I need that's essential for performing experiments unless I agree to keep information that they send me confidential.
35:38But even worse, I agree to keep any results that I obtain confidential.
35:44And, for example, in the paper that I wrote in the New England Journal of Medicine, I cite an example and quote verbatim from an agreement that a very large biotechnology company asked me to sign,
35:55which said that they would send me that material, and I could use it in my experiments.
35:59But I could not tell anybody about the results of those experiments without their permission for 10 years after I did those experiments.
36:09Now, that's outrageous. I don't see how any scientist could sign such an agreement, and yet these kinds of agreements are insisted upon by biotechnology companies and pharmaceutical companies and are being signed quite frequently.
36:22For working doctors all over the United States, it's a disturbing trend.
36:40At Massachusetts General Hospital, David Blumenthal has been exploring the extent of the problem.
36:45We've actually done some studies that tried to quantify the frequency of secrecy or data withholding among scientists who are actively doing research in the U.S.
37:00And we found that about 20 percent of the respondents to our survey said that they had withheld research results for one reason or another,
37:09usually for some commercially related reason, in the previous three years.
37:13Secrecy strikes at the heart of the free exchange of information, a principle once regarded as the cornerstone of scientific progress.
37:24Einstein, and actually also some of his colleagues, Niels Bohr, for example, were very strong believers in the openness of science,
37:31and Einstein said, in effect, that the privilege of working in science and of knowing the truth carried with it the obligation never to withhold any portion of the truth.
37:42When one talks about medical research, we're not talking about an intellectual adventure, the way much of science is conducted.
37:51We're talking about attempts to solve desperate problems that cause a great deal of human suffering.
37:58And so I tend to think of medical research as somewhat different.
38:01It's not a search for truth. It's not an intellectual exercise.
38:04It's an attempt to solve problems that cause innocent people desperate suffering.
38:14Contrary to the public perception, a great deal of research is directed not towards curing the most common diseases,
38:21but rather in a direction which may profit a company at the expense of its rivals.
38:25I was involved with one company that wouldn't share information about a particular reagent we wanted to use in a clinical trial.
38:34I asked them why they wouldn't share that information, and they were worried that, in fact, another competing company might get that information,
38:41and therefore save a lot of time.
38:45And so they were willing to suppress information and allow another drug company to give ineffective and maybe even harmful doses of a drug to patients
38:55when they already knew what the appropriate doses were.
38:58And so this is happening very, very frequently, much more frequently than I think most people believe.
39:06And when I've talked about this to people who are not in medicine and science, they're dumbfounded.
39:12They say, how can this possibly go on when people are dying of cancer in the United States alone?
39:18560,000 innocent people died of cancer, and in Great Britain, one out of every six people now alive are going to die of cancer if we can't find better treatments.
39:27I don't see that it's reasonable, given those numbers, to do anything that might delay the time that we can develop information that might help those unfortunate people.
39:38Back even 20, 30 years ago, we thought that maybe the health and the scientific truth was something that everybody owned,
39:46and that medicines and other things were so important they were the property of all people.
39:52We have set up a system in which the engine of science is no longer the search for truth.
40:00The engine of science is the patent which gives someone the right to control a drug that may help millions of people,
40:07and interestingly enough, may harm an equal number.
40:13Controversy over the possible harmful effects of a drug recently arose over a treatment prescribed for heart patients
40:19to relieve the symptoms of high blood pressure.
40:23Calcium channel blockers have annual sales of 8 billion dollars.
40:28By regulating the body's flow of calcium, they dilate the arteries and can reduce blood pressure.
40:35They are the most important family of blood pressure drugs, and are taken by about 7 million people in the United States,
40:43and many, many more millions worldwide.
40:44They are probably the most widely used single family of drugs that we have.
40:51Although they've been on the market since the 1960s, no long-term studies have been done on those taking the drugs.
40:59Dr. Kurt Furberg was commissioned by a drug company to supervise a large-scale, three-year clinical study.
41:04It involved over 800 patients at nine centres.
41:09The aim was to compare the effectiveness of calcium channel blockers with alternative treatments.
41:17But the results, and those of his other studies, have alarming implications.
41:21When we combined the findings in a large number of studies, we observed an increase in mortality.
41:32A trend, which is a paradox, because we expected a decrease.
41:38Furberg was coordinating a research project known as the MIDAS study.
41:42The project was funded by pharmaceutical company Sandoz, one of the major manufacturers of calcium channel blockers.
41:50When the research results were not what they expected, the gap between completion of the study and its publication got longer and longer as the company contested the findings.
41:59The company, the sponsor, Sandoz, in my view, interfered with the process of analyzing, interpreting and publishing the findings.
42:14And I think, as part of that process, there was an effort on part of the company to make some of the investigators more friendly
42:27by offering generous financial support.
42:35Dr. Kurt Furberg and several of his colleagues were sufficiently upset by the conduct of the company
42:40to resign from the project and remove their names from the published article.
42:47One researcher who'd worked on the study became so concerned he sent Furberg a memo protesting at the behaviour of the company.
42:54One colleague received a call from Sandoz. It was just a few days before he was scheduled to attend a meeting where we would present the confidential data.
43:09And he was offered to be on a panel to work with the company and to present the findings, do some further analyses.
43:17And for that he was offered $30,000 a year for two years.
43:24The debate between the MIDAS investigators over the interpretation of the findings dragged on for two years.
43:31Meanwhile, another report by Dr. Bruce Persati and Dr. Furberg appeared, suggesting that calcium channel blockers were connected with an increase in heart attacks rather than the expected decrease.
43:42An editorial criticising the study appeared in the same journal.
43:47On the day before the study appeared, there was this, thousands of doctors got an express mail package containing the editorial and a letter that criticised the findings, but not even including the article so the reader could judge for themselves.
44:02So, you know, tens of thousands and hundreds of thousands of dollars can be expended to put spin on a scientific finding that drug companies consider to be a threat.
44:16Editorials such as this appear routinely in medical journals.
44:20They are a way of opening a debate between scientists about controversial or surprising research.
44:27In this case, Kurt Furberg believes the article served to highlight the problems which flow from the funding of medical research by pharmaceutical companies.
44:35At the time that he wrote this editorial, he had a grant pending with the major manufacturer of calcium channel blockers in the United States.
44:50Realising the potential conflict of interest arising from the source of funding, the author declined the grant.
44:56Maybe there is a lesson there for people to be more careful and it's come up again repeatedly that they need to watch out for conflict of interest.
45:09The dispute over the MIDAS study's findings kept the controversy of calcium channel blockers away from the public arena for over two years.
45:18But when Persate and Furberg's paper was published, the worst fears of the drug companies were quickly realised.
45:23It was like a bombshell and suddenly in the United States there was like this panic because these millions of people were taking these drugs.
45:33And the newspaper summary of it said it might increase the risk of a heart attack by 60% when compared to beta blockers or diuretics.
45:42And so there was this brief firestorm of public concern about whether drugs so many people were taking were safe.
45:48Reports of an increased risk of heart attack associated with nifedipine caused many patients to stop taking their medication.
45:55But critics argue that the studies involve only the short acting form of the drug which is no longer widely used.
46:02Dr. Furberg and his colleagues at the University Hospital were afraid that such negative findings would frighten off industry funding.
46:10I was threatened that I would not get funding for my research.
46:17It's a lot of fairly unpleasant things.
46:23In July last year, another study was published.
46:27This time it pointed to a link between the use of calcium channel blockers and a risk of cancer.
46:32With the drugs still openly available, the concern is that it might actually be harmful for heart patients.
46:41The companies claim that the drugs are perfectly safe, although they are now promoting the longer acting brands of the drug in preference to the shorter acting ones.
46:49Although the jury is still out as to proof of their harmful potential, Dr. Furberg points out that there are many proven and safe alternatives to calcium channel blockers.
47:02And he remains convinced that there could still be a serious risk from both types.
47:06Dr. My assumption is that there will be thousands of patients dying every year unnecessarily.
47:15Dr. Thousands of lives could be at risk by using calcium channel blockers instead of more proven agents.
47:24But we don't have the definitive long-term study yet to answer that.
47:28But I think you have to look at the arithmetic of risk in drugs.
47:31You have seven million people taking calcium channel blockers.
47:36Suppose that only one tenth of one percent are injured.
47:40You still have thousands of people hurt.
47:46To me, the issue of secrecy in medicine is very clear.
47:50The ethics are very clear.
47:52If you keep secrets or don't share information, then you can delay progress.
47:56If you delay progress, then the time to developing new treatments will be prolonged.
48:02And if the time to develop new treatments are prolonged, then people, human beings, suffer and die who need not have done so.
48:09So to me, A equal B equal C.
48:12I think people who keep secrets don't mean for people to suffer and die.
48:15But in fact, in medical research, that is the consequence of their actions.
48:19And when looked at that way, it's clearly immoral to do that.
48:26Just last summer, a Taiwanese scientist was arrested in Philadelphia, attempting to steal secrets to set up a biotech industry in the Far East.
48:36A reminder that as technology advances, and as competition becomes even fiercer, the emphasis in science is increasingly on money.
48:44Commercial pressures can be an effective catalyst for the production of new and better drugs.
48:53And no one is suggesting that biotech companies shouldn't make profits.
48:59But the public has a right to ask what may be lost when science becomes the servant of secrecy and profit, rather than openness and knowledge.
49:08A reliable and bewusst in mortgage.
49:10To make a difference with this, it is no longer than that dangerous, but the company is probably because of the labor of the world.
49:13The federal government has a state of law on a law enforcement and for the reason.
49:15And the company is not only on the law enforcement, but of law enforcement and a law enforcement administration.
49:17In fact, it is a real major duty of the fact that the government is a general duty and responsible police in the south of the area of New York City.
49:19It's a general duty of law enforcement and the government is a federal government.
49:21And the government has a right to try to reach the state of the people to recycle.
49:23In fact, the government has a great debt that the government has been on the west.
49:24As the government has made the government's prime and the government's own, the government has made the republic for purchase.
49:25and the government has a lot of public attention.
49:26If you're concerned about calcium channel blockers and would like to find out more,
49:53or you can ring the Channel 4 information line on 0345 59 10 20.
49:59That's 0345 59 10 20.
50:04Details of next week's Equinox coming up in just a moment.
50:23What really happened on MIR?
50:43British astronaut Michael Fowl reveals the frightening truth exclusively to Channel 4.
50:50Science beyond the horizon next Monday at 9.
50:55As the net tightens on the killer, Fitz begins to crack.
50:59Transcription by CastingWords
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