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Mexico Drug Lord’s Escape Was Foretold
Signs that Guzmán was to flee were abundant, including U.S. intelligence shared with local officials
ENLARGE
Soldiers guard a house near the Altiplano maximum security prison where Mr. Guzmán escaped. PHOTO: MARCO UGARTE/ASSOCIATED PRESS
By DUDLEY ALTHAUS in Mexico City, and DEVLIN BARRETT in Washington
Updated July 13, 2015 11:46 p.m. ET
42 COMMENTS
In the months before Mexico’s most infamous drug lord scurried to freedom through a mile-long tunnel, neighbors of the maximum security prison holding him witnessed dump trucks carting away thousands of tons of rubble from a humble house set in a nearby pasture.
U.S. intelligence agents had also picked up chatter on several occasions that Joaquin “El Chapo” Guzmán might be planning a breakout, and shared the tips with their Mexican counterparts, U.S. officials said on Monday.
Related Videos
0:00 / 0:00
The Mexican government is offering $3.8 million as a reward for the capture of the country’s top drug lord, Joaquín “El Chapo” Guzmán, who escaped from a maximum security prison on Saturday night. Photo: AP
0:00 / 0:00
Mexican drug lord Joaquín “El Chapo” Guzmán was found missing from his prison cell Saturday night. This is the second time in 15 years he has escaped. Photo: AP
There was even a heads-up of sorts on Twitter. An account widely believed to belong to the crime lord’s son assured followers in May that the “General will soon be back.”
Despite those warning signs, no one in Mexico’s government either connected the dots or did much to prevent Mr. Guzmán’s second jailbreak in the past 14 years, raising troubling questions about gross incompetence in Mexico’s security institutions, outright corruption, or a toxic combination of both.
“It’s profoundly worrying to think that corruption could reach this high,” said Ernesto Lopez Portillo, a Mexican law-enforcement expert. “At the same time, it’s profoundly worrying that there is incompetence of such magnitude that they couldn’t stop it. Either way, it’s bad.”
The escape has prompted angry questions inside the U.S. government—which twice helped painstakingly gather intelligence to help capture the drug lord only to see him get away—about how to proceed now that Mr. Guzmán is again free, said current and former American officials.
While U.S. authorities immediately pledged to help Mexico recapture him, some American law-enforcement officials believe the escape should prompt changes in how the two countries coordinate on anticartel efforts, and a stronger push by U.S. diplomats to quickly extradite senior cartel bosses when they are captured, the current and former officials said.
At the time of his escape, Mr. Guzmán was awaiting trial in Mexico, but U.S. authorities had also filed multiple indictments against him.
“What it does is strain the relationship between U.S. and Mexican law enforcement on sharing of intelligence,” said Jimmy Gurulé, a University of Notre Dame law professor and former federal prosecutor in Los Angeles who helped pursue Mexican crime bosses.
“At the core of El Chapo’s escape is this underlying concern of government corruption, of officials looking the other way or even assisting him,” he said. “As long as that is a viable concern, the U.S. will be reluctant to share as fully as they would like.”
The Drug Lord Who Got Away – Twice
Mexican police and soldiers were searching Monday for reputed Sinaloa cartel leader Joaquín Guzmán Loera after he fled the maximum-security Altiplano Prison near Mexico City.
ENLARGE
Michael Braun, a former head of intelligence at U.S. Drug Enforcement Administration, predicted that if Mr. Guzmán is captured again, Mexico will quickly agree to extradite him to the U.S.
“If he’s taken alive, then I believe the president of Mexico will turn him over pretty quickly,’’ said Mr. Braun, now at SGI Global, a security and intelligence consultancy firm. But Mr. Braun also said it was likely to be harder to capture him again because his cartel will have learned from mistakes that led to his previous arrests.
On Monday, Mexican officials said they were scouring the countryside for Mr. Guzmán, who is believed to be 58, and trying to figure whether and how corrupt jailers or others aided his Saturday night flight. Some 49 officials, mostly officials from the Altiplano prison, had been hauled in for questioning, the Interior Ministry and Attorney General’s Office said in a joint statement.
Attorney General Arely Gómez announced a $4 million reward for information leading to Mr. Guzmán’s capture. Interior Minister Miguel Angel Osorio Chong said he had fired the penitentiary’s warden and two more senior prison system officials. “There will be no place for impunity,” Mr. Osorio Chong said at a news conference announcing the firings. “Everyone involved in this escape will fall.”
The escape of Mexico’s most notorious crime boss deepens the cynicism that most Mexicans have toward their government, especially when it comes to issues of corruption, policing and a prison system that is widely believed to be in the hands of criminals rather than wardens.
One social-media post making the rounds in Mexico City showed a thick wad of dollar bills rolled up, and said: “The tunnel through which El Chapo escaped.” Other posts likened Mr. Guzmán’s burrowing skills to those of Super Mario or Bugs Bunny.
Mr. Guzmán, first captured in Guatemala in 1993, busted out of another maximum security prison in 2001, hidden in a laundry cart that was calmly wheeled outside by a prison janitor. Several guards were later convicted of having taken bribes to look the other way.
He went on to become the country’s most important drug lord as leader of the powerful Sinaloa cartel, and was finally recaptured early last year for a second time in the Mexican port city of Mazatlán.
But it didn’t take long for reports to surface that El Chapo was trying to bust out again. Last summer, DEA agents in Los Angeles received information that Mr. Guzmán’s son, Ivan Archivaldo Guzmán, had hired lawyers and people with backgrounds in the Mexican military to devise a plan to free his father, U.S. officials said.
Earlier that year, DEA agents on the same case were also told another gang linked to the cartel might try to bribe or threaten prison workers into helping Mr. Guzmán escape, these officials said. In December 2014, DEA agents in Houston were told of a possible deal to release Mr. Guzmán and another senior drug trafficking suspect held in Mexico, U.S. officials said.
Those tips were all shared with Mexican authorities, officials said. Even without the tips, U.S. and Mexican law-enforcement agencies were aware Mr. Guzmán would likely try to escape, since he had done so before.
Even Mr. Guzmán’s use of a tunnel should not have been a surprise since he is widely credited with having pioneered the use of drug-smuggling tunnels as well as used elaborate tunnels to elude capture during his 13 years on the run following his first escape.
While Mr. Guzmán is the most high-profile prisoner to have escaped from Mexican penitentiaries, he is far from alone.
At least 132 alleged members of the Zetas gang broke out of a prison in the city of Piedras Negras in late 2012, also using a tunnel from a prison carpentry shop. Another 191 men escaped from another state jail in the city of Nuevo Laredo in 2010, out the back gate.
Federal police in 2010 arrested the warden and a number of guards of a maximum-security prison in the northern city of Gomez Palacio, charging them with allowing the jailed members of a gang affiliated with Mr. Guzmán to slip out at night to kill gangland rivals.
Two years later, police detained jailers in a state prison outside the city of Monterrey, accusing them of leading members of one drug trafficking group into the prison yard to be slaughtered by those of another.
The Altiplano federal prison, on the barren highland plains near Mr. Pena Nieto’s hometown west of Mexico City, was thought to be as secure as any in the world. Most of Mexico’s top crime bosses have been imprisoned there for the past 25 years. Mr. Guzmán is the first known to have escaped.
CARTEL LEADER’S ELUSIVE PATH
Mid to late 1950s: Guzmán is born in La Tuna, Sinaloa.
November 1992: Now at the Sinaloa cartel, Guzmán orders his gunmen to target rivals from the Tijuana cartel in a Puerto Vallarta disco, killing five.
June 1993: Guzmán is arrested after surviving a Guadalajara airport ambush in which rivals gunning for him kill a Catholic cardinal instead.
Jan. 19, 2001: Guzmán escapes from prison and cements his control over the Sinaloa cartel.
2004-12: Guzmán wages war with rivals along U.S. border for smuggling routes and evades multiple attempts at capture in his native northwestern mountains.
May 2008: Guzmán’s rivals kill his son Edgar in Sinaloa’s capital, Culiacán.
March 2012: He escapes arrest attempt by minutes in Mexican beach resort Los Cabos.
Feb. 22, 2014: Guzmán repeatedly evades Mexican Marines using escape tunnels in Culiacán before his arrest in Mazatlán.
July 11, 2015: He escapes maximum-security prison through a tunnel.
Construction experts calculated that more than 1,300 metric tons of dirt—enough to fill nearly 400 dump trucks—had to be carried away from the house during the months of digging the sophisticated tunnel.
Starting at the house in the pasture, the tunnel was drilled directly into the shower stall in Mr. Guzmán’s cell, an engineering feat that almost certainly required plans of the prison, analysts say.
“With all that security there had to be bribes,” said Mexico City security analyst Raúl Benítez. “It took a long time to dig that tunnel and nobody knew anything. Someone inside the prison received a lot of money.”
The house where Mr. Guzmán emerged from the tunnel sits within sight of the prison. A state police school and a military base sit nearby.
Neighbors said there were movements of pickups loaded with sand in recent months. They didn’t find it unusual, the men said, because workmen had been using heavy construction equipment on a nearby expansion of a drainage system.
“Who could think those trucks were related to the escape of El Chapo?,” asked Ricardo González.
President Enrique Peña Nieto and his top security aides has brushed aside U.S. back channel requests to extradite Mr. Guzmán to face trial in one or more of the seven federal courts where he faces indictments. The crime boss would be tried in Mexico, they said, and would spend decades in prison here.
But now he’s gone, again.
“Good things come to those who wait,” said a July 6 post on the Twitter site that experts believe belongs to Ivan Guzmán, the criminal’s son.
—Juan Montes in Almoloya de Juárez, Mexico, contributed to this article.
Write to Dudley Althaus at Dudley.Althaus@wsj.com and Devlin Barrett at devlin.barrett@wsj.com
Signs that Guzmán was to flee were abundant, including U.S. intelligence shared with local officials
ENLARGE
Soldiers guard a house near the Altiplano maximum security prison where Mr. Guzmán escaped. PHOTO: MARCO UGARTE/ASSOCIATED PRESS
By DUDLEY ALTHAUS in Mexico City, and DEVLIN BARRETT in Washington
Updated July 13, 2015 11:46 p.m. ET
42 COMMENTS
In the months before Mexico’s most infamous drug lord scurried to freedom through a mile-long tunnel, neighbors of the maximum security prison holding him witnessed dump trucks carting away thousands of tons of rubble from a humble house set in a nearby pasture.
U.S. intelligence agents had also picked up chatter on several occasions that Joaquin “El Chapo” Guzmán might be planning a breakout, and shared the tips with their Mexican counterparts, U.S. officials said on Monday.
Related Videos
0:00 / 0:00
The Mexican government is offering $3.8 million as a reward for the capture of the country’s top drug lord, Joaquín “El Chapo” Guzmán, who escaped from a maximum security prison on Saturday night. Photo: AP
0:00 / 0:00
Mexican drug lord Joaquín “El Chapo” Guzmán was found missing from his prison cell Saturday night. This is the second time in 15 years he has escaped. Photo: AP
There was even a heads-up of sorts on Twitter. An account widely believed to belong to the crime lord’s son assured followers in May that the “General will soon be back.”
Despite those warning signs, no one in Mexico’s government either connected the dots or did much to prevent Mr. Guzmán’s second jailbreak in the past 14 years, raising troubling questions about gross incompetence in Mexico’s security institutions, outright corruption, or a toxic combination of both.
“It’s profoundly worrying to think that corruption could reach this high,” said Ernesto Lopez Portillo, a Mexican law-enforcement expert. “At the same time, it’s profoundly worrying that there is incompetence of such magnitude that they couldn’t stop it. Either way, it’s bad.”
The escape has prompted angry questions inside the U.S. government—which twice helped painstakingly gather intelligence to help capture the drug lord only to see him get away—about how to proceed now that Mr. Guzmán is again free, said current and former American officials.
While U.S. authorities immediately pledged to help Mexico recapture him, some American law-enforcement officials believe the escape should prompt changes in how the two countries coordinate on anticartel efforts, and a stronger push by U.S. diplomats to quickly extradite senior cartel bosses when they are captured, the current and former officials said.
At the time of his escape, Mr. Guzmán was awaiting trial in Mexico, but U.S. authorities had also filed multiple indictments against him.
“What it does is strain the relationship between U.S. and Mexican law enforcement on sharing of intelligence,” said Jimmy Gurulé, a University of Notre Dame law professor and former federal prosecutor in Los Angeles who helped pursue Mexican crime bosses.
“At the core of El Chapo’s escape is this underlying concern of government corruption, of officials looking the other way or even assisting him,” he said. “As long as that is a viable concern, the U.S. will be reluctant to share as fully as they would like.”
The Drug Lord Who Got Away – Twice
Mexican police and soldiers were searching Monday for reputed Sinaloa cartel leader Joaquín Guzmán Loera after he fled the maximum-security Altiplano Prison near Mexico City.
ENLARGE
Michael Braun, a former head of intelligence at U.S. Drug Enforcement Administration, predicted that if Mr. Guzmán is captured again, Mexico will quickly agree to extradite him to the U.S.
“If he’s taken alive, then I believe the president of Mexico will turn him over pretty quickly,’’ said Mr. Braun, now at SGI Global, a security and intelligence consultancy firm. But Mr. Braun also said it was likely to be harder to capture him again because his cartel will have learned from mistakes that led to his previous arrests.
On Monday, Mexican officials said they were scouring the countryside for Mr. Guzmán, who is believed to be 58, and trying to figure whether and how corrupt jailers or others aided his Saturday night flight. Some 49 officials, mostly officials from the Altiplano prison, had been hauled in for questioning, the Interior Ministry and Attorney General’s Office said in a joint statement.
Attorney General Arely Gómez announced a $4 million reward for information leading to Mr. Guzmán’s capture. Interior Minister Miguel Angel Osorio Chong said he had fired the penitentiary’s warden and two more senior prison system officials. “There will be no place for impunity,” Mr. Osorio Chong said at a news conference announcing the firings. “Everyone involved in this escape will fall.”
The escape of Mexico’s most notorious crime boss deepens the cynicism that most Mexicans have toward their government, especially when it comes to issues of corruption, policing and a prison system that is widely believed to be in the hands of criminals rather than wardens.
One social-media post making the rounds in Mexico City showed a thick wad of dollar bills rolled up, and said: “The tunnel through which El Chapo escaped.” Other posts likened Mr. Guzmán’s burrowing skills to those of Super Mario or Bugs Bunny.
Mr. Guzmán, first captured in Guatemala in 1993, busted out of another maximum security prison in 2001, hidden in a laundry cart that was calmly wheeled outside by a prison janitor. Several guards were later convicted of having taken bribes to look the other way.
He went on to become the country’s most important drug lord as leader of the powerful Sinaloa cartel, and was finally recaptured early last year for a second time in the Mexican port city of Mazatlán.
But it didn’t take long for reports to surface that El Chapo was trying to bust out again. Last summer, DEA agents in Los Angeles received information that Mr. Guzmán’s son, Ivan Archivaldo Guzmán, had hired lawyers and people with backgrounds in the Mexican military to devise a plan to free his father, U.S. officials said.
Earlier that year, DEA agents on the same case were also told another gang linked to the cartel might try to bribe or threaten prison workers into helping Mr. Guzmán escape, these officials said. In December 2014, DEA agents in Houston were told of a possible deal to release Mr. Guzmán and another senior drug trafficking suspect held in Mexico, U.S. officials said.
Those tips were all shared with Mexican authorities, officials said. Even without the tips, U.S. and Mexican law-enforcement agencies were aware Mr. Guzmán would likely try to escape, since he had done so before.
Even Mr. Guzmán’s use of a tunnel should not have been a surprise since he is widely credited with having pioneered the use of drug-smuggling tunnels as well as used elaborate tunnels to elude capture during his 13 years on the run following his first escape.
While Mr. Guzmán is the most high-profile prisoner to have escaped from Mexican penitentiaries, he is far from alone.
At least 132 alleged members of the Zetas gang broke out of a prison in the city of Piedras Negras in late 2012, also using a tunnel from a prison carpentry shop. Another 191 men escaped from another state jail in the city of Nuevo Laredo in 2010, out the back gate.
Federal police in 2010 arrested the warden and a number of guards of a maximum-security prison in the northern city of Gomez Palacio, charging them with allowing the jailed members of a gang affiliated with Mr. Guzmán to slip out at night to kill gangland rivals.
Two years later, police detained jailers in a state prison outside the city of Monterrey, accusing them of leading members of one drug trafficking group into the prison yard to be slaughtered by those of another.
The Altiplano federal prison, on the barren highland plains near Mr. Pena Nieto’s hometown west of Mexico City, was thought to be as secure as any in the world. Most of Mexico’s top crime bosses have been imprisoned there for the past 25 years. Mr. Guzmán is the first known to have escaped.
CARTEL LEADER’S ELUSIVE PATH
Mid to late 1950s: Guzmán is born in La Tuna, Sinaloa.
November 1992: Now at the Sinaloa cartel, Guzmán orders his gunmen to target rivals from the Tijuana cartel in a Puerto Vallarta disco, killing five.
June 1993: Guzmán is arrested after surviving a Guadalajara airport ambush in which rivals gunning for him kill a Catholic cardinal instead.
Jan. 19, 2001: Guzmán escapes from prison and cements his control over the Sinaloa cartel.
2004-12: Guzmán wages war with rivals along U.S. border for smuggling routes and evades multiple attempts at capture in his native northwestern mountains.
May 2008: Guzmán’s rivals kill his son Edgar in Sinaloa’s capital, Culiacán.
March 2012: He escapes arrest attempt by minutes in Mexican beach resort Los Cabos.
Feb. 22, 2014: Guzmán repeatedly evades Mexican Marines using escape tunnels in Culiacán before his arrest in Mazatlán.
July 11, 2015: He escapes maximum-security prison through a tunnel.
Construction experts calculated that more than 1,300 metric tons of dirt—enough to fill nearly 400 dump trucks—had to be carried away from the house during the months of digging the sophisticated tunnel.
Starting at the house in the pasture, the tunnel was drilled directly into the shower stall in Mr. Guzmán’s cell, an engineering feat that almost certainly required plans of the prison, analysts say.
“With all that security there had to be bribes,” said Mexico City security analyst Raúl Benítez. “It took a long time to dig that tunnel and nobody knew anything. Someone inside the prison received a lot of money.”
The house where Mr. Guzmán emerged from the tunnel sits within sight of the prison. A state police school and a military base sit nearby.
Neighbors said there were movements of pickups loaded with sand in recent months. They didn’t find it unusual, the men said, because workmen had been using heavy construction equipment on a nearby expansion of a drainage system.
“Who could think those trucks were related to the escape of El Chapo?,” asked Ricardo González.
President Enrique Peña Nieto and his top security aides has brushed aside U.S. back channel requests to extradite Mr. Guzmán to face trial in one or more of the seven federal courts where he faces indictments. The crime boss would be tried in Mexico, they said, and would spend decades in prison here.
But now he’s gone, again.
“Good things come to those who wait,” said a July 6 post on the Twitter site that experts believe belongs to Ivan Guzmán, the criminal’s son.
—Juan Montes in Almoloya de Juárez, Mexico, contributed to this article.
Write to Dudley Althaus at Dudley.Althaus@wsj.com and Devlin Barrett at devlin.barrett@wsj.com
In the late 1990s, former Chrysler CEO Lee Iacocca handed more than $10 million to Massachusetts General Hospital (MGH) scientist Denise Faustman and instructed her to transform an ancient tuberculosis vaccine into a cure for type 1 diabetes. Today Faustman announced the latest milestone in that project—FDA clearance to launch a large trial in people based on what her lab learned from that early research. And the 90-year-old auto magnate continues to fund her studies through the Iacocca Family Foundation, which he founded in 1984 in memory of his late wife, Mary, who died of complications from diabetes.
The trial, announced at the American Diabetes Association conference in Boston, will investigate whether treating patients with the vaccine, bacillus Calmette-Guérin (BCG), will improve natural insulin production in adult patients whose pancreases still produce small but detectable levels of the hormone. If it works, BCG might one day be used to essentially reverse the disease in some patients—even adults who have suffered from diabetes from childhood—says Faustman, director of MGH’s immunobiology laboratory and the study’s principal investigator. And it wouldn’t cost much, either, since BCG has been around for nearly a century and is available in generic form.
“We’re not only going for something cheap and safe, but also trying to figure out a good treatment that might reverse the most severe form of the disease in people who are 15 or 20 years out,” Faustman says.
Here’s how BCG works: The vaccine prompts the immune system to make tumor necrosis factor (TNF), a protein that destroys the abnormal T-cells that interfere with the pancreas’s ability to make insulin. That elevation of TNF has already been well-proven to be quite therapeutic in some settings—BCG, in fact, is approved by the FDA not only to prevent tuberculosis but also to treat bladder cancer.
Faustman’s lab spent years doing basic science experiments to show TNF can temporarily eliminate the abnormal T-cells that cause type 1 diabetes. Iacocca’s foundation, which had been supporting some of that work since coming across the lab’s earliest studies, invited Faustman to present the results of her research at a board meeting in 1999, she recalls.
Iacocca asked Faustman why she wasn’t using BCG to cure diabetes in mouse models of the disease. “I said, ‘It’s too early. We need to do more basic science,’” Faustman recalls. “He looked at me and said, ‘You know, it’s my money.’ We made a deal that if I would aggressively go forward in the mouse he would support me. He gets the credit for supporting the basic science that led to the discovery that TNF is needed in type 1 diabetes.”
Lee Iacocca’s foundation has supported basic diabetes research at Massachusetts General Hospital (Credit: AP Photo/Paul Sancya)
With continued funding from the foundation and other supporters, Faustman launched a small phase 1 clinical trial in people designed to prove that BCG would kill the bad T-cells and stimulate good T-cells in a way that would restore insulin secretion. It worked, though the positive effects were transient. So Faustman started planning a larger phase 2 study to prove that regular injections of BCG, followed by periodic booster shots, would produce a sustained response, and to determine whether that response might improve over time as the pancreas regenerates.
Still, Faustman’s team had to overcome one big hurdle before the FDA would approve the phase 2 trial: a massive shortage of BCG. Two of the biggest producers of the vaccine, Merck and Sanofi , have suffered production problems, leading to huge manufacturing delays. The issue has left some bladder cancer patients in the lurch, as reported recently in the Wall Street Journal. Faustman and her colleagues, who had been using Sanofi’s vaccine, had to go looking for an alternate supplier.
Still, Faustman’s team had to overcome one big hurdle before the FDA would approve the phase 2 trial: a massive shortage of BCG. Two of the biggest producers of the vaccine, Merck and Sanofi , have suffered production problems, leading to huge manufacturing delays. The issue has left some bladder cancer patients in the lurch, as reported recently in the Wall Street Journal. Faustman and her colleagues, who had been using Sanofi’s vaccine, had to go looking for an alternate supplier.
So MGH collaborated with a division of the Bill & Melinda Gates Foundation and the World Health Organization to secure the vaccine for the trial from a drug manufacturer that’s run by the Japanese government, Faustman says. “We had to get the FDA to certify that [the manufacturer's] processes are up to U.S. standards so the BCG can be used for trials,” she says. “This is not something that academics normally do, but we were determined.”
Faustman’s team has raised $19 million of the $25 million needed to complete the phase 2 study, thanks largely to the Iococca Family Foundation, which continues to be the project’s biggest source of support. “I made a promise to my late wife to find a cure for type 1 diabetes,” Iococca said in a statement. “Now my family and I look forward to the continued progress and are proud to support this effort to get closer to that goal.”
Faustman’s plan is to enroll 150 adults with diabetes, some of whom will receive BCG, with the others getting a placebo. The patients will have two injections four weeks apart and then annual injections over four years. They will continue to take insulin, though the research team will be watching closely to see if the BCG reduces the amount of insulin needed to maintain blood-sugar control, Faustman says. “We expect the metabolic effect to occur gradually over five years,” she says.
However it turns out, Faustman says, she will always be grateful to Iacocca for having the patience to continue funding the BCG research. “Many other people support us now, but the Iacocca Foundation makes a huge contribution to these trials,” she says. “He sees the big picture and is willing to look for ways to change the paradigm.”
Also on Forbes:
In the late 1990s, former Chrysler CEO Lee Iacocca handed more than $10 million to Massachusetts General Hospital (MGH) scientist Denise Faustman and instructed her to transform an ancient tuberculosis vaccine into a cure for type 1 diabetes. Today Faustman announced the latest milestone in that project—FDA clearance to launch a large trial in people based on what her lab learned from that early research. And the 90-year-old auto magnate continues to fund her studies through the Iacocca Family Foundation, which he founded in 1984 in memory of his late wife, Mary, who died of complications from diabetes.
The trial, announced at the American Diabetes Association conference in Boston, will investigate whether treating patients with the vaccine, bacillus Calmette-Guérin (BCG), will improve natural insulin production in adult patients whose pancreases still produce small but detectable levels of the hormone. If it works, BCG might one day be used to essentially reverse the disease in some patients—even adults who have suffered from diabetes from childhood—says Faustman, director of MGH’s immunobiology laboratory and the study’s principal investigator. And it wouldn’t cost much, either, since BCG has been around for nearly a century and is available in generic form.
“We’re not only going for something cheap and safe, but also trying to figure out a good treatment that might reverse the most severe form of the disease in people who are 15 or 20 years out,” Faustman says.
Here’s how BCG works: The vaccine prompts the immune system to make tumor necrosis factor (TNF), a protein that destroys the abnormal T-cells that interfere with the pancreas’s ability to make insulin. That elevation of TNF has already been well-proven to be quite therapeutic in some settings—BCG, in fact, is approved by the FDA not only to prevent tuberculosis but also to treat bladder cancer.
Faustman’s lab spent years doing basic science experiments to show TNF can temporarily eliminate the abnormal T-cells that cause type 1 diabetes. Iacocca’s foundation, which had been supporting some of that work since coming across the lab’s earliest studies, invited Faustman to present the results of her research at a board meeting in 1999, she recalls.
Iacocca asked Faustman why she wasn’t using BCG to cure diabetes in mouse models of the disease. “I said, ‘It’s too early. We need to do more basic science,’” Faustman recalls. “He looked at me and said, ‘You know, it’s my money.’ We made a deal that if I would aggressively go forward in the mouse he would support me. He gets the credit for supporting the basic science that led to the discovery that TNF is needed in type 1 diabetes.”
Lee Iacocca’s foundation has supported basic diabetes research at Massachusetts General Hospital (Credit: AP Photo/Paul Sancya)
With continued funding from the foundation and other supporters, Faustman launched a small phase 1 clinical trial in people designed to prove that BCG would kill the bad T-cells and stimulate good T-cells in a way that would restore insulin secretion. It worked, though the positive effects were transient. So Faustman started planning a larger phase 2 study to prove that regular injections of BCG, followed by periodic booster shots, would produce a sustained response, and to determine whether that response might improve over time as the pancreas regenerates.
Still, Faustman’s team had to overcome one big hurdle before the FDA would approve the phase 2 trial: a massive shortage of BCG. Two of the biggest producers of the vaccine, Merck and Sanofi , have suffered production problems, leading to huge manufacturing delays. The issue has left some bladder cancer patients in the lurch, as reported recently in the Wall Street Journal. Faustman and her colleagues, who had been using Sanofi’s vaccine, had to go looking for an alternate supplier.
Still, Faustman’s team had to overcome one big hurdle before the FDA would approve the phase 2 trial: a massive shortage of BCG. Two of the biggest producers of the vaccine, Merck and Sanofi , have suffered production problems, leading to huge manufacturing delays. The issue has left some bladder cancer patients in the lurch, as reported recently in the Wall Street Journal. Faustman and her colleagues, who had been using Sanofi’s vaccine, had to go looking for an alternate supplier.
So MGH collaborated with a division of the Bill & Melinda Gates Foundation and the World Health Organization to secure the vaccine for the trial from a drug manufacturer that’s run by the Japanese government, Faustman says. “We had to get the FDA to certify that [the manufacturer's] processes are up to U.S. standards so the BCG can be used for trials,” she says. “This is not something that academics normally do, but we were determined.”
Faustman’s team has raised $19 million of the $25 million needed to complete the phase 2 study, thanks largely to the Iococca Family Foundation, which continues to be the project’s biggest source of support. “I made a promise to my late wife to find a cure for type 1 diabetes,” Iococca said in a statement. “Now my family and I look forward to the continued progress and are proud to support this effort to get closer to that goal.”
Faustman’s plan is to enroll 150 adults with diabetes, some of whom will receive BCG, with the others getting a placebo. The patients will have two injections four weeks apart and then annual injections over four years. They will continue to take insulin, though the research team will be watching closely to see if the BCG reduces the amount of insulin needed to maintain blood-sugar control, Faustman says. “We expect the metabolic effect to occur gradually over five years,” she says.
However it turns out, Faustman says, she will always be grateful to Iacocca for having the patience to continue funding the BCG research. “Many other people support us now, but the Iacocca Foundation makes a huge contribution to these trials,” she says. “He sees the big picture and is willing to look for ways to change the paradigm.”
Also on Forbes:
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