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Here's How Lee Iacocca Wants To Cure Diabetes
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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.”
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© Andrew HarnikThe American flag is lowered to half-staff above the White House in Washington, Tuesday, July 21, 2015, to honor the five U.S. service members who were killed by a gunman in Chattanooga, Tenn. last week.
PITTSBURGH — President Obama, facing growing criticism from conservatives and some veterans, ordered all American flags on federal grounds to be lowered to half-staff for the remainder of the week to honor the five service members killed at a naval reserve center in Chattanooga, Tenn.
The move was announced Tuesday, five days after the shooting rampage and just minutes after Obama delivered a speech here at the Veterans of Foreign Wars convention in which he defended his Iran nuclear deal, called for more military spending, and criticized Republicans for relying too heavily on military force and threats instead of diplomacy.
Standing before a crowded hall of aging veterans, Obama eulogized each of the four Marines and the one sailor killed by a gunman in Chattanooga. Tom Sullivan was “everything that a Marine should be,” Obama said. Skip Wells was so devoted to the Marine Corps that he wore his dress blues to his home town’s Fourth of July parade. David Wyatt led with courage in Afghanistan and mentored comrades with post-traumatic stress disorder. Carson Holmquist loved his wife, Jasmine, and their 2-year-old son. Randall Smith, the lone sailor, was a high school baseball star with two young daughters he called “little princesses.”
But even as he spoke, the president faced stinging criticism that he hadn’t acted swiftly enough to honor the dead by lowering the flag at the White House and federal buildings around the country.
“Oh one more thing, lower the FLAG!!!!!!!! Sir,” former Navy SEAL Marcus Luttrell, author of the best-selling book “Lone Survivor,” wrote on his Facebook page.
That critique was then echoed on Capitol Hill, where House Speaker John A. Boehner (R-Ohio) and Senate Majority Leader Mitch McConnell (R-Ky.) moved quickly to lower the flag to half-staff on the Capitol grounds.
The midsummer tempest highlighted how Obama — six years into his tenure as commander in chief — continues to be pressed to defend his patriotism, his support for the military and his toughness.
Those questions have grown especially pointed in the wake of the agreement with Iran to limit its nuclear program. Republican critics of the deal have blasted it as too weak and conciliatory, and insisted that tougher sanctions and threats of force would have been more effective in bending Iranian will.
In his VFW speech, Obama fired back, saying his more measured and diplomatic approach had produced results. “Instead of chest-beating that rejects even the idea of talking to our adversaries — which sometimes sounds good in sound bites, but accomplishes nothing — we’re seeing that strong and principled diplomacy can give hope of actually resolving a problem peacefully,” Obama said.
Obama also sought to demonstrate his toughness. In one of the speech’s most striking moments, he said he would not hesitate to use force against those who threatened the United States, and then he read off a list of al-Qaeda leaders killed on his watch.
“Osama bin Laden is gone,” Obama said. “Anwar Awlaki, a leader of the al-Qaeda affiliate in Yemen, gone. Many of al-Qaeda’s deputies and their replacements, gone. Ahmed Abdi Godane, the leader of the al-Qaeda affiliate in Somalia, gone. . . . The list goes on. If you target Americans, you will have no safe haven.”
The VFW crowd applauded heartily for that list, but the reception overall was cool, if respectful.
Obama also struck a hawkish pose in blasting Republicans for backing automatic cuts — known as sequestration — that would pare back defense spending. He accused the Republicans of “trying to fund our military with gimmicks” that would “shortchange national security programs like counterterrorism” and “increase risk to our troops.”
“I’ve got a better idea, which is to end sequestration, increase the defense budget, invest in America’s strengths,” Obama said. “We shouldn’t be playing partisan politics when it comes to national security.”
“These mindless cuts have to end,” he said.
Obama vowed to veto any “bill that locks in” the automatic cuts. That sets up a clash with Republicans who have pressed for more defense spending — without the matching increases to domestic programs that Democrats are demanding. Republicans believe those domestic spending hikes are too costly.
On the issue of lowering the flags, Obama seemed to hear the mounting Republican criticism and respond to it. There are no clear or consistent rules that apply to lowering flags to half-staff. Obama ordered flags lowered after the mass shooting at Fort Hood in 2009 but didn’t lower them when a gunman struck last year at the Army post in Texas.
He has lowered flags almost immediately after mass shootings in Tucson; Aurora, Colo.; Newtown, Conn.; Oak Creek, Wis.; and the Washington Navy Yard.
He has ordered flags to half-staff after the deaths of American icons such as Neil Armstrong, Edward Kennedy, Dorothy Height and Frank Buckles, America’s last surviving World War I veteran.
But he didn’t lower the flag after last month’s shooting in Charleston, S.C.
Obama focused most of Tuesday’s VFW speech on defending his foreign policy record and detailing improvements made to the Department of Veterans Affairs after last year’s scandal in which VA officials were found to have falsified records to cover up the long waits that many veterans faced to get basic medical care.
VA is now handling millions more appointments, and waiting times for veterans have fallen, Obama said. But he also acknowledged that VA continues to struggle with a surge of aging veterans as well as younger veterans of the long wars in Iraq and Afghanistan.
“You put it all together, and in some places, wait times are higher than they were last year,” he said.
The best way to honor all veterans, Obama said, was through a foreign policy that focused first on diplomacy and turned to war only as a last resort.
“I’m hearing echoes of some of the same policies and mind-set that failed us in the past,” Obama said. He said the critics of the Iran deal include “some of the same folks who were so quick to go to war in Iraq . . . [who] said it would only take a few months.”
Although Obama did not mention former president George W. Bush, Obama said past administrations were guilty of “rushing into war without thinking through the consequences.”
“Who paid the price?” Obama asked. “Our men and women in uniform.”
