One Dead Guinea Pig

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Vladimir Yuri Zhirakarov first appeared on the streets of Houston around 1997, when he joined the faceless ranks of the city's burgeoning homeless population. He fell in quickly with the Impact Church of Christ just north of downtown near White Oak Bayou. He took irregular showers at the shelter. He took meals there, too. And he camped out on a wooded lot nearby.

But he didn't wander the way many of the others did. He stayed busy with odd jobs, routinely doing volunteer work at the church's food-and-clothing distribution center. When there was no work, he lifted weights.

He was likable, but secretive and prone to binge drinking. His English was hindered by heavy Slavic inflections, though he refused to speak what he said was his native language. He claimed to be a Russian political exile and warned that discovery would mean big trouble back in the mother country, where his father held a lofty political appointment.

While this could have explained his stash of identification papers unearthed by campmates after he died in 2002, it didn't. He was wanted, but not by the former Soviet state. The man who passed himself off as a Russian on the run was finally exposed by a horrific death equally as strange as his life.

He had been born Garry Allen Polsgrove in Campbell, Missouri.

Zhirakarov/Polsgrove died in an experimental drug trial in a private clinic near the Texas Medical Center.

His death ended a 30-year investigation by the U.S. Federal Bureau of Investigation. But it sparked an investigation of another sort entirely when the initial details of his death began unraveling, prompting authorities to take a closer look at the Fabre Research Clinic and its owner and founder, Dr. Louis Fernand Fabre.

Like many of his fellow soup-kitchen visitors, Zhirakarov was a professional human guinea pig, Impact pastor Ron Sellers says. Becoming part of a drug trial meant not only pocket money but a stay in an air-conditioned clinic with free meals between injections.

Men like Zhirakarov didn't brag about such forays, for fear that others would expose the lies they often told to qualify for the various drug trials, Sellers says.

"Desperate people do desperate things," says the pastor. "They learn the system of how to get into these trials."

In Zhirakarov's case, it got him into a trial for schizophrenics with the accompanying powerful drugs.

Zhirakarov began to show signs of an adverse drug reaction the first day he was included in the trial, April 11, 2002. Clinic staff documented he had a rapid heart rate. At this earliest of stages, clinicians should have taken him out of the trial and checked his heart for abnormalities, according to investigators. Instead, another dose was scheduled.

Eight days later, as the rapid heart rate continued, diarrhea began. Clinic staff attributed this development to a viral illness and recommended an over-the-counter antidiarrheal. Then, on April 24, his white blood cell count began to drop, according to data recorded by clinic staff. His blood pressure began to crash soon after, and laboratory findings indicated a "life-threatening" electrolyte imbalance and acute kidney failure were under way. But Fabre wouldn't review those findings until four days later, according to the U.S. Food and Drug Administration.

"At a minimum, the subject should have received intravenous rehydration, continuous cardiac monitoring, and a comprehensive evaluation of his acute renal failure," investigators wrote. "The patient's severely compromised renal function should have prompted major concern since it was potentially life threatening and because clozapine is primarily excreted through the kidney."

When Fabre did look over the patient's chart, he wrote the results were "not clinically significant."

Two days later an electrocardiogram was done, showing a clearly inflamed heart. The levels of clozapine accumulating in his bloodstream were three and four times greater than those found in the other patients, an autopsy would later reveal.

Fabre's first progress note appears in the patient's file on this day and is recorded at 3:15 in the afternoon. It reads: "Patient was exam for complaints of diarrhea… [I] ordered study meds to be discontinued (abnormal electrolyte results) diet clear fluids and lomotil as instructed."

The next day, Patient 059 died.

Dr. Louis Fernand Fabre should have been at the top of his game and feeling no pain. After 31 years of practicing mind medicine in Houston, he had just been named a Life Member of the Texas Society of Psychiatric Physicians. He'd been published in the Journal of Clinical Psychiatry and the British Journal of Psychiatry. And, more important, the big pharmaceutical companies had been leaning on him for decades to test out their experimental drugs on human subjects at his two community clinics near the Texas Medical Center.

But on a strangely warm January day earlier this year, a two-year-old skeleton named Zhirakarov came back to haunt the 1969 Baylor medical school graduate. A seven-page registered letter let him know, in no uncertain terms, that he was on the verge of losing his profitable drug-testing business. The small matter of a dead patient and allegations of a cover-up had put the senior psychiatrist on bad footing with inspectors from the FDA.

At 64, Fabre has long been one of the smaller names behind the success of the wave of new behavioral drugs that has so defined decades of millennial anxiety. Prozac became a national phenomenon when it was first approved in the late '80s, the subject of talk shows and best-selling books. Drugs like Prozac changed the way Americans thought about themselves and their relationship with the medicine cabinet. And Fabre's clinical trials played a key role in making that relationship possible.

While Fabre has faced public criticism before, particularly for his involvement in drug trials for Prozac and Halcion, his close relationship with big pharma also ensured him a profitable career.

In some ways, it wasn't such an easy road. At least three marriages imploded, and the custody battle with his latest ex-wife for his seven-year-old daughter got pretty nasty. But as court papers showed, Fabre was doing well financially with properties around Houston and Travis County, a Merlin III executive airplane, and an assortment of stocks and bonds in his various research endeavors. His ex-wife Pamela Waller got a million dollars, a Mercedes and a Land Rover in the divorce. Both kept their memberships at the prestigious Houstonian Club.

In contrast, Zhirakarov's life had no such perks. Before he took on the mysterious identity of a Russian drifter, Zhirakarov joined the U.S. Marine Corps to escape the poverty of Campbell's cotton patch. His sister, Nancy Gatlin, says he served two tours in Vietnam, earning two Purple Hearts and his sergeant stripes. It was after he settled into a desk job stateside and started handling payroll accounts that he ran into trouble with Uncle Sam. Doing what any reasonable outlaw would, he went for a jog on a California beach and never came back.

Several identity changes followed. Gatlin says he forged birth certificates and driver's licenses. He worked briefly as a nurse in Louisiana, then on barges along the Mississippi River. All the while, he was perfecting his Russian accent while keeping one eye over his shoulder.

It is unclear when Fabre and Zhirakarov met or how many trials the 55-year-old homeless man participated in. But his supervised death has all but destroyed Fabre's Houston business.

The drug business is huge. Worldwide it is worth almost $400 billion. But bringing new products to market can also be a billion-dollar endeavor. Getting just one new drug through the research and production phases and onto the shelves is estimated to cost between $800 million and $1.7 billion. But the payoffs are hard to ignore. A truly blockbuster drug can pay for itself in just two short years.

Fabre didn't shy from using his proximity to pharma wealth when he went bride-shopping in 2003.

"I am fairly famous for being responsible for approval of drugs like fluoxetine (Prozac), sertraline (Zoloft), olanzapine (Zyprexa) and many, many others. I am quite wealthy and have houses in Houston, Austin, and in the Bahamas. I fly my own jet airplane," he wrote to at least one online Russian a fraction of his age.

He also noted he was "responsible for getting these drugs approved in the United States, and the European Union."

The drug approval process is also desperately dependent upon the dutiful throngs of men, women and children who line up and lie down to swallow or get stuck with thousands of newly created substances every year. They may be hoping to find a cure for their own conditions. Perhaps some have the betterment of the human race in mind. Most are in it for the money.

Extended drug trials can pay hundreds or thousands of dollars in exchange for a few weekends of one's life and exposure to usually minimal risks. While the vast majority of new drug trials occur in hospital and university settings, there is a thriving network of smaller clinics in the game, too. Clinics that blare their message from billboards, newspapers and radios. Clinics where you can be fed and housed between blood pressure checks. Clinics like the one Fabre founded.

Human guinea pigs have a variety of laws and regulations on their side, even as they rent out their bodies and minds. Critics of the system complain that while subjects are supposed to be shielded from abuse by various federal protections, pharmaceutical money may be corrupting the process and putting lives at risk.

"The most dangerous thing to do is to give your body off to clinical trials. Your chances for getting harmed are pretty great," says Vera Sharav, president of the Alliance for Human Research Protection, a nonprofit collection of doctors and health advocates dedicated to limiting the risk medical research brings to human test subjects. "It's far worse than playing Russian roulette."

No matter how good regulations or trials appear on paper, experiments, by their very nature, represent risk. As the results are often not apparent until years down the road, potential health shocks are hard to trace back to their roots, Sharav says.

A U.S. General Accounting Office report in 1990 found that of the 198 new drugs released between 1976 and 1985, more than half resulted in bad reactions that weren't predicted by initial studies.

The Cleveland Plain Dealer reported in 1996 that of the "4,154 FDA inspections of researchers testing new drugs on people" since 1977, "more than half the researchers were cited by FDA inspectors for failing to clearly disclose the experimental nature of their work."

And in an anonymous survey of 3,000 government-funded researchers, 15 percent of scientists questioned admitted they had changed how they did studies in response to "pressure from a funding source," The Boston Globe reported in June.

As Sharav puts it: "Just think about all those drugs that have recently been removed from the market. They were all subjected to clinical trials, too."

The U.S. Department of Health and Human Services, which invests billions every year in studies that involve human test subjects, has enacted numerous protections over the last half-century, though the darker side of research has repeatedly held our attention hostage with almost unbelievable tales of institutionalized victimization. Events like the Tuskegee syphilis trials, where more than 400 black sharecroppers had medication withheld for decades during the well-documented study, involved criminal abuse. "Patients" told they were receiving a special treatment were really being used to study the uninhibited progress of the disease.

Other offenses have included the injection of live cancer cells into patients in at least two hospitals, subjects unknowingly fed radioactive tracers during experiments by the Atomic Energy Commission, and numerous chemical and biological experiments on both enlisted and civilian populations by the U.S. military.

All of these cases -- and many others besides -- involved the type of secrecy and ethical breaches that current legislation has sought to address. Central to the issue is informed consent. Medical tests, first and foremost, must include the consent of the trial participant and spell out in clear language any potential health risks involved. How that is achieved, or not achieved, varies from trial to trial.

Playing into the problem is the fact that so many test subjects come from the most vulnerable of stock -- drug addicts, alcoholics, the homeless, the poor and the mentally ill -- those for whom it becomes increasingly difficult to turn down a $50 bill for a few (in most cases innocuous) proddings of the needle.

Zhirakarov's death was far from the only bad drug reaction recorded by the review board overseeing trials at Fabre's clinics. In a letter to the FDA earlier this year, Owen Reese Jr., executive director of the Western Institutional Review Board, wrote that his board received and reviewed 12,000 such reports in 2004 alone. These tend to be serious, including "death, life-threatening events, inpatient hospitalizations, significant disability or birth defects," he wrote.

Fabre's early research on Prozac is picked apart in the popular book Talking Back to Prozac. The study that had been pivotal in gaining FDA approval not only was skewed toward a favorable response to the drug but was incredibly limited in terms of participation, authors Peter and Ginger Breggin wrote. Only 11 participants who were actually fed Prozac completed the study, and they compared their experience with those who took the placebo. But it was the work Fabre did for the Upjohn Company on the sleeping pill Halcion that got him the closest he had yet come to serious legal trouble.

Though Fabre continued to work for Upjohn through the '80s, a suit brought by area families in December 1993 alleged he falsified data collected from 1973 to 1975 while getting started in the trial business. According to the suit, Fabre ran studies back to back, repeatedly used the same patients and offered no breaks between drugs to allow the subjects' systems to cleanse -- making accurate linkages of side effects impossible.

"He would simply assign the patient a new name on the next set of charts, to make it appear as though a different set of patients was taking the tests," the suit reads. "On one occasion, Upjohn sent some of its own staff to Fabre's Clinic to 'cleanse' the records prior to an expected FDA audit."

Sued for civil conspiracy, fraud, negligence and battery, Fabre cleared the rap after the Upjohn Company, which was also sued in the case, settled out of court in 1997 for a "substantial" sum of money, according to Paris, Texas, attorney Michael Mosher.

More recent investigations have cited Fabre for less dramatic problems such as record-keeping infractions. In 1999 inspectors issued Fabre a citation of "inspectional observations" and criticized his office's failure to record which patients were given drugs at which time. Fabre at first denied there was a problem, saying that he was "confident each subject received the correct [drug] at the correct time," even though the medications were administered by others.

"We explained," the FDA report reads, "that the word of the investigator must be supported by documentation…We informed Dr. Fabre that repeated or severe non-compliance…could form the basis for further agency actions such as Warning Letters, clinical holds, or disqualification."

He wouldn't have long to wait.

A 2002 investigation, completed less than two months prior to Zhirakarov's death, found that staff had not maintained good records of patient histories. Two patients had been included despite lacking the right medical condition for the study.

Fabre countered that while test subjects "often report erroneous information on their personal history" that may make them appear as if they didn't qualify, his staff was able to discern truth from untruth since so many of the patients were well-known repeat customers. Such group memory would seem invaluable considering the fact that inspectors characterized the clinic's medical files as incomplete, illegible and often undated.

But perhaps the most egregious finding was Fabre's delay in filing safety reports with the board overseeing the study in question. In one case, his lab took more than a year to forward the required notification, according to investigators.

It all earned Fabre another page and a half of inspectional observations, but studies at the clinics on Crawford and Austin streets continued. One study gearing up involved a powerful drug for schizophrenia treatment. It was to compare Novartis's trademarked Clozaril with its generic equivalent.

The trial represented significant risk, since about one of every 100 patients who take Clozaril develops a potentially fatal disease known as agranulocytosis. Of those who contract it, about 3 percent die, according to Novartis literature.

A far less common and more often fatal side effect known as myocarditis results in a weakened and inflamed heart in about 32 of every 100,000 patients on the drug. Of the 30 reports of myocarditis associated with the drug in the United States as of August 2000, 17 proved fatal. Other side effects include high fevers, seizures, hypotension and hyperglycemia.

When pharmaceutical companies discover a new drug, testing begins at the most elementary level, that of simple modeling and theoretical predictions. Then it winds its way through the animal kingdom. If no "profound toxicity" is experienced in rats, for instance, it may be time to try it out on chimps. If no primate pandemonium ensues, the testing moves on over to their human cousins.

David J. Hayes, clinical assistant professor of pharmacy at the University of Houston, says the first phase of human testing is also the most dangerous. For that reason, it involves only a handful of participants. The purpose is to observe the body's "natural responses" to the newly engineered compounds.

If successful, the trials may then go national and involve thousands of participants at dozens of clinics. Studies that originate in private industry are outlined by the drug developers and the FDA. But then they are turned over to an institutional review board, or IRB. Such boards are created to oversee projects involving human test subjects. They can be outgrowths of a university, hospital or even the pharmaceutical company itself.

When the Institute of Medicine of the National Academies warned in 2002 that conflicts of interest within the clinical testing industry were creating serious problems, overstretched review boards bore part of the blame. Add conflicts of interest to the equation, and cracks in the foundation of human medical testing start to appear.

While Hayes suggests that new investigatory pressures are creating an "overly cautious" pharmaceutical industry, he is willing to entertain the possibility there are still some bad apples in the biological barrel.

"I can be a little bit of a cynic in this life and say, you know, as much as you try to create a perfect system, there may be some imperfections," Hayes says. "Obviously, there's going to be."

He, like others in higher education, portrays the "mom and pop" clinics as the weak flank of the research industry.

More than 730 trials are under way or recruiting participants in Houston, according to a federal clearinghouse for trial information. But the FDA could not provide details regarding how many clinics it inspects each year.

"Maybe some of the smaller companies that are trying to get out there, you know, they maybe are more aggressive. They have a lot less to lose than a Pfizer or Merck," Hayes says.

While Fabre, his lawyers and his business partner refused to participate in this story, Dr. Daniel Vine recalls his days working at the Fabre Clinic in the early '80s with fondness. It was such a good experience that he went on to specialize in neurology and now runs his own research clinic in Utah. "Lou seemed to be on top of everything, as far as I remember, you know? We didn't have any problems."

When Zhirakarov died on May 3, 2002, and efforts to resuscitate him failed, a concerted campaign of self-preservation got under way. Fabre placed a final note in the patient's file that read, "this AM patient was awake and well at 7:30…We feel that this [death] is not related to medication."

Then he prepared the required Serious Adverse Event Report for the trial's sponsor, Zenith Goldline Pharmaceuticals, stating incorrectly that the electrocardiogram performed the day before the death failed to detect any serious abnormalities.

When Pastor Sellers called to ask what had happened, he didn't get very far.

"They were nice," Sellers says, "but there wasn't much information. As I recall, they just pretty much had the posture that what had happened didn't seem to have anything to do with the trial itself. And that he just had an apparent heart attack."

Slowly, things began to return to normal. New drug trials were begun.

FDA investigators showed up five months later and wrote up the death but did not shut down the clinic. Apparently, neither did they alert the review board or drug companies that used the clinic. And Fabre wasn't exactly trumpeting the fact he was under investigation.

In 2004, the Western Institutional Review Board, based in Olympia, Washington, approved two new studies for Fabre, according to Angela Brown, president of the board. Although Fabre would have been asked in each application if he was under investigation, he failed to reveal that fact.

"It appears there was not full disclosure in this case," Brown says.

It would be another two years and three months before the FDA finally began disqualification proceedings against Fabre, with a notice issued January 19. There appeared to be no immediate ramifications. The FDA says that research in such situations is usually not suspended until after a case is resolved at a final hearing, a process that can take years.

Studies sponsored by Eli Lilly and Wyeth continued at the clinic. New trials were advertised in area papers. A call placed to Fabre Clinics in March revealed no openings for research subjects but indicated there are plans for a new trial to begin in April.

Fabre's lawyer complained about the timing of the disqualification notice, among other things.

"We believe that the agency's treatment of Dr. Fabre has been grossly unfair," wrote Douglas Farquhar on March 7 of this year. "FDA's actions have caused Dr. Fabre personal embarrassment and professional ruin, without due process."

When the review board did find out about the investigation, Brown says, it alerted Wyeth and Eli Lilly. Wyeth spokesperson Gerald Burr says the FDA should have alerted them when problems first developed. "We would have expected that ethically they would inform us of something like this, professionally and ethically," he says.

Wyeth officials then interrupted the trial under way. A clinical monitor for the company told Burr that at that point Fabre was "cooperative" and "stepped down."

"The patients who hadn't finished their course of the [drug] were tapered off," Burr says. "We're going to look at this data and have it audited and see if it's usable."

With his trials being canceled and calls from the media mounting, Fabre began his disappearing act. His company's Web site was taken offline and a business profile listing on Hoover's Web site also vanished. A "for rent" sign popped up outside his clinic on Calumet Street. The twin office on Austin a few blocks south was put on the market. Both are two-story brown brick buildings with iron gates. And both still boast the company slogan, "Advances in medicine enriching lives." A third property held on Crawford, to which Fabre's letter from the FDA was addressed, has already been leveled, town homes rising in its place.

While Fabre failed to reply to questions and messages delivered by telephone, e-mail and fax from the Houston Press (other than to say he would not respond), Fabre's D.C.-based attorney, a specialist in FDA investigations, wrote the FDA that Fabre had been misled about the severity of the allegations against him by FDA investigators. What's worse, "totally inconsistent with these assurances, the NIDPOE letter essentially falsely accuses Dr. Fabre of letting a patient die," Farquhar wrote on March 7. In all of Fabre's 400 clinical trials involving about 200,000 patients, the death of Zhirakarov was the "one and only untoward event of significance," he added.

Point by point, Farquhar's letter takes issue with the FDA's complaint. Patient 059 did not suffer prolonged hypertension, Farquhar wrote, and renal failure was not determined until after the autopsy. "The patient was appropriately evaluated and treated based on what was known at the time," he added.

A more contrite Fabre wrote the FDA on March 23, informing them of operational changes being made. Staff, for instance, had been instructed to alert him immediately if they ever observe the heart rate of a subject taking clozapine race past 120 beats per minute. But he went on to dispute the FDA's findings, stating that what problems do exist at his clinics are related to record keeping, not any lack of involvement on his part.

However, problems continued after the death, according to a March FDA inspection that found numerous failures to record or investigate adverse drug reactions that resulted in several hospitalizations in 2003.

So far, no lawsuits have been filed against Fabre in the case. But even if Fabre loses his testing credentials, it may not affect him all that much. For several years now he has been developing another side of his business in an attempt to make the transition from drug testing to drug manufacturing.

Two months after Zhirakarov's death California-based Questcor Pharmaceuticals announced its agreement with Fabre-Kramer Pharmaceuticals -- Fabre's partnership with Stephen Kramer, a local IRB member and fellow life member of the Texas Society of Psychiatric Physicians -- to develop and "commercialize" Hypnostat and Panistat, two drugs developed by Fabre-Kramer now in the early clinical trial stages.

Questcor received $250,000 up front in the deal and rights to half of all future revenues. But drug development is a fickle endeavor. Take, for instance, another promising drug F-K got involved with. Ariza was going to cut into Prozac's turf as a new treatment for major depressive disorders. Initial European market reports projected the new pill would be raking in as much as $360 million by 2010. However, the drug bombed when the FDA found it ultimately "not approvable." It's now being looked at by the National Institute on Drug Abuse for a less glamorous purpose: as a potential treatment for cocaine addicts.

Before Garry Polsgrove was Vladimir Yuri Zhirakarov, before he ever introduced himself as Paul Schroeder or Paul Steiner or Ernest J. Kowalski, he was a little boy growing up picking cotton in a speck of a town called Campbell, Missouri. The boy was different from the beginning, according to his sister. He never dreamed of being a fireman or a policeman, typical boyhood ambitions of his day. "No, he didn't want to do that," recalls Gatlin. "He wanted to go to Australia and raise mink…Have a mink farm, you know?"

When he returned from his second tour of Vietnam, Polsgrove, by then a sergeant, was stationed at Camp Pendleton in Carlsbad, California. He worked long hours as a payroll clerk, according to a news article in the Campbell Citizen. Often he would report to work late at night to catch up when the workload was demanding. Gatlin believes he and some friends also were writing themselves checks under fictitious names.

After one late night of paper-pushing, Polsgrove put on his gray sweat suit and blue tennis shoes a little before 6 a.m. While his wife, Cindy, prepared breakfast, he went for a jog on the beach.

A fellow beachcomber spotted the tennis shoes and sweat suit, reporting them the next day after a missing person's report went out.

Zhirakarov had been up and had a shower at the Fabre Clinic's Austin Street center the morning of May 3, 2002, according to Farquhar's March 7 letter. However, a clinic nurse hunting down another blood sample later found him "unresponsive" in bed. She quickly called for an ambulance.

Paramedics performed CPR but couldn't reinspire his drug-damaged heart. At Park Plaza Hospital, ER staff went so far as to install a pacemaker, according to Farquhar.

The autopsy report states that Zhirakarov was at the hospital a total of 11 minutes before being pronounced dead. A tracheal tube hung from his throat. Defibrillator pads and electrocardiogram wires were still pasted to his chest.

Was he schizophrenic? Did he belong in the trial? Fabre cites client confidentiality in not responding to questions about the death. Though Gatlin hadn't seen her brother in more than a decade, she denies the diagnosis but readily admits he had problems. "I personally think, like, Vietnam messed him up mentally," she says. "He seemed, you know, okay. But I sometimes think you have to be around people for a period of time, and these were just short visits."

Sellers knew Zhirakarov as a dependable -- if excessively private -- individual. Both he and Gatlin say he was extremely intelligent and likable. But Sellers says the ego-grinding nature of street life affects all homeless people, eventually leading to some form of mental illness.

Fabre likes to keep his business in the family. Ex-wife Pamela Waller ran the Houston clinics after the office manager was driven out in a storm of claims and counterclaims that involved an $85,000 legal dispute with Fabre. Though her case was dismissed in July 1999, the former manager accused the doctor of failing to honor maternity leave and severance agreements.

Former wives also worked his clinical trials, Mosher says.

"You would have people that would give honest results and the drug would start looking bad, so he'd fire them and put his wife in there doing the readings even though she wasn't medical personnel," he says.

Fabre's partnership with a new wife -- a 33-year-old acupuncturist named Nataliya Kurgut, wooed from the Ukraine via an e-mail romance -- could see the husband-and-wife formula continue overseas.

Since their reported 2003 Caribbean marriage, a new line has appeared on Kurgut's résumé: vice president of Specialized Psychopharmacology, Ltd. in Abaco, Bahamas. While this suggests the pair may be performing trials in the Caribbean, Fabre is on the verge of venturing into Eastern Europe as well. New drug trials under Fabre's supervision are being planned for Kharkov, Ukraine, according to one Ukrainian source who asked not to be identified. Both countries offer populations who are in need of cash and less likely to drop out of the trials before their completion.

One of the great unanswered questions is why the FDA took more than two years to cite Fabre in Zhirakarov's death. While investigators and public relations flacks would not answer any questions directly, politics is the most likely culprit.

As the agency has come under increasing fire for failing to police drug companies adequately, old investigations are being picked up with new vigor, some suggest.

"They are simply now trying to do what they should have done all along, because everybody's coming around and finding all the things they didn't do when they were nothing but drug company whores," Mosher says. "They're trying to clean up their act just a little and look like they deserve to be the agency protecting us from drug companies."

The new frenzy of regulatory activity comes a little late for Zhirakarov and his sister.

When 61-year-old Gatlin thinks about why her last living relative is no longer, she looks back thoughtfully to those early decisions made by a marine she says was still shocked by the horrors of war.

"The choices he made when he was young affected the rest of his life. I mean, like, we couldn't even visit like a normal family, I mean, like normal families do. So…It's just, uh, I guess just one of them things. I mean, I might not have saw him for years, but, you know, that don't mean it didn't hurt any less."

But if there were any horrors haunting Polsgrove, they weren't Vietnamese in nature, according to a spokesman for the U.S. National Archives and Records Administration. Per his military records, Polsgrove spent his entire five-year service period stationed in Carlsbad, California, and never rose higher than the rank of corporal. Of course, his file also indicates he died in April 1970.

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