"Diabetes May Be Reversed by Long-Used Vaccine for TB..." Topic

Diabetes May Be Reversed by Long-Used Vaccine for TB by By Shannon Pettypiece – Aug 9, 2012 8:13 AM ET.

A tuberculosis vaccine in use for 90 years may help reverse Type 1 diabetes and eliminate the life- long need for insulin injections, say Harvard University researchers raising money to conduct large, human studies.

Patients with Type 1 diabetes must inject insulin daily to control their blood sugar because their bodies don't produce the hormone, the result of an errant immune system that destroys insulin-producing cells in the pancreas. The vaccine, called bacillus Calmette-Guérin, or BCG, stimulated production of a protein that killed the insulin-attacking cells, according to the findings of an early-stage study published yesterday in the journal PLOS One.

Insulin injections help control Type 1 diabetes for the 3 million Americans with the disease, though there is no cure for the condition usually diagnosed in childhood. Results of the trial showed that two of the three patients given BCG had signs of renewed insulin production. The researchers now plan a larger study that could yield results in three to five years.

"We think this can be taken all the way to the market and that is what we are trying to do." said Denise Faustman, director of Harvard-affiliated Massachusetts General Hospital's immunobiology laboratory, who led the study.

The vaccine, a weakened form of the tuberculosis bacteria, stimulates production of TNF, a cell-signaling protein that plays a role in cell death. With more TNF, the body can attack those harmful immune cells while leaving the rest of the body's defenses intact. The vaccine is approved by the U.S. Food and Drug Administration for tuberculosis though it isn't generally recommended for use in the U.S. The vaccine also is approved to fight bladder cancer.

Study Results

In the study, researchers administered two doses of the BCG vaccine to three patients who had been diagnosed with Type 1 diabetes. The patients were followed for 20 weeks and two of the three were found to have an increase in the death of the insulin-harming cells and a rise in elevation in C-peptide levels, suggesting the production of insulin.

"These patients have been told their pancreases were dead," Faustman said. "We can take those people, give them a very low dose twice and see their pancreases kick in and start to make small amounts of insulin."

To Market

Faustman and her colleagues at Massachusetts General in Boston are working to get the vaccine to market. After their early findings in studies with mice, she said they tried to interest every major drugmaker in developing the vaccine as a possible cure for diabetes. All told her there wasn't enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said.

So now, she is trying to raise money to pay for the expensive larger human trials. Her lab so far has received $11 USD million of the $25 USD million needed to pay for the next stage of testing. All of the money is coming from private donors, the largest of which is the Iacocca Family Foundation.

"It's a cheap man's approach in how to get in the clinic," she said.

The vaccine's ability to raise levels of cell-killing TNF also is being studied as a way to treat multiple sclerosis. In a study in Italy, researchers found the vaccine may prevent progressions of brain lesions in patients with advanced stages of MS, Faustman said.

Hope springs eternal.

That would be great.

Substitute a methyl- for an ethyl-, patent it, and Big Evil Pharma will be good to go!

Diabetes sufferers seem to be a rather large market…

>Diabetes sufferers seem to be a rather large market…

A large, steady, stream of income. This is the same reason they sell you printers cheap and whack up the cost of ink cartridges. They hate those refills, and try many tricks to get around them.

>All told her there wasn't enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said.

Yep, big Pharma looking after our interests.

OK, Chortle, you pay to run the trials (at least a million, possibly more) and then manufacture, distribute and sell the stuff. Yeah, nast old evil Big Pharma won't make and sell a product at a loss, how could they be so cold?

"… increase in the death …"

Just between you and me, this phrase doesn't really help sell me on the idea.

… increase in the death …

Just between you and me, this phrase doesn't really help sell me on the idea.

"increase in the death of the insulin-harming cells and a rise in elevation in C-peptide levels, suggesting the production of insulin."
How does this, when quoted in full, not sell you on the idea?

Yeah, nast old evil Big Pharma won't make and sell a product at a loss, how could they be so cold?

The article doesn't mention anything about operating at a loss, just that "…there wasn't enough money to be made in a cure that used an inexpensive, generically available vaccine, Faustman said."

Diabetes sufferers seem to be a rather large market

Type I not quite to the extent as the great crashing wave of Type II sufferers we have and are going to keep having. If this also works on Type II Diabetes it will get a lot more attention. Type I is manageable long-term already and making insulin manufacturers plenty of money.

"Big Pharma" doesn't labor under the Hippocratic Oath. They have customers, not patients. That makes their response "correct", but not right.

"Big Pharma" doesn't labor under the Hippocratic Oath. They have customers, not patients. That makes their response "correct", but not right.

Should someone explain to me why Big Pharma SHOULD sell at a loss? What kind of company do YOU work for? What needed and necessary stuff do THEY sell at a loss?

It seems to me that one drug COINCIDENTALLY has other effects. It is quite likely that a similar one could very well do even better. And, one which can be patented. Then, that particula minion of Big Pharma could make some money, which is their primary purpose.
Don't blame Big Pharma for idiotic laws forced on them by hypocritical lawmakers, who pretend they are on your side. Tell me another one.

Who in their right mind would want to own a Big Pharma company, when every jackanapes of a politician or lawsuit hungry lawyer sees you as nothing but a target?
I would not blame a comaony like Merck in the least if they decided "Screw this! We're going to go make wine coolers instead. Let someone else handle this headache!"

More likely, though, the US FDA will hold it up for 10 years in endless trials, while it goes on sale in Slobbovia and Bongolesia.

It sounds hopeful, but…

Type I is manageable long-term already and making insulin manufacturers plenty of money.

And the test strip people. Does anyone really think they want to see a cure for diabetes, type I and/or II, anytime soon, if ever?

While I am immensely grateful for being able to live as a type I diabetic (diagnosed when I was 24 ending my military career) I have become very, very pessimistic about there ever being a cure for diabetes or any disease for that matter where large pharmaceutical companies are making billions from producing consumable products to control the symptoms.

As far as being manageable long term:

That's true, but it is very, very difficult to do so, thus the reason why the majority of people on dialysis when I was were diabetic. So it's very, very cruel to lessen any emphasis on type Is. Ask any parent who is dealing with a young child diagnosed.

You will find the vast majority of diabetics of type I or II do not consistently manage it well. Unfortunately I was one of those and am trying very hard to do so to honour the life of the dead person whose family gave me a second chance with a new kidney.
--
Tim

You do know you have public researchers to right?

People working for goverments, now that the cats out of the bag, lots public researchers will start to look at it.

As seen above, public researchers do not have the capital or resources to bring a drug to market. Nor do they have the experience to deal with regulators. The current group can benefit from the studies done to bring the TB drug to market, but they might not contain enough information to support its proposed use. TB drugs are intended for short term use, working up a safety profile for a drug that is used chronically is quite another task and the write up seems to indicate that the drug attacks the messengers of the immune system rather than stopping the immune response itself, hence it will have to be taken repeatedly. In the end, if the safety profile and efficacy are not as good or better than conventional medicine provides the FDA will say 'Thanks for the multimillion dollar workup, but the patients do just as well with conventional medicine, so, better luck next time.'

The "fault", if there is any, lies in the well-meaning laws that do not allow the evil Big Pharma to keep their patents long enough. Once the patent expires and it is no longer possible for a company to make a profit, they have no interest in pursuing further research on the drug.

Selling a drug for a use for which it is not "apporved" is a landmine of possible legal barriers, from "wrongful death" lawsuits to … you guess it.

the number one legal obligation of a publicly owned company is to make money for its stockholders. NOT to give things away, or to encourage experments that could bite them in the ass.

I blame over-eager regulators and the broken legal system in the US.

So the OFM is against a laissez-faire market…

Patent law, as is, in these United States favors big spenders and/or those with the loudest voice at the expense of innovation. Look at Apple vs. Samsung, with the former patenting or attempting to do such with concepts and hobby related, Battlefoam is back to its old tricks: link .