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NEWS: Dean Clinic says diabetes patients may have been exposed to hepatitis, HIV

From Madison.com

RON SEELY | rseely@madison.com | 608-252-6131 | Posted: Monday, August 29, 2011 4:30 pm

As many as 2,345 Dean Clinic patients may have been exposed to the bloodborne illnesses hepatitis B and C and HIV because a diabetes nurse educator reused the handles of insulin demonstration pens and finger stick devices over a five-year period, from 2006 to 2011, clinic officials said Monday.

Both Craig Samitt, Dean's chief executive officer, and Mark Kaufman, chief medical officer, described the risk as "small" because the educator, who worked out of the Dean clinics on Stoughton Road and in Sun Prairie, did not re-use actual needles.

Even so, said Kaufman, it is possible that blood from patients contaminated the bases of the re-used demonstration pens, which are supposed to be used to show how to inject insulin and aren't intended for use on people, or the plastic handles of the finger stick devices.

"We're confident the person always changed needles between uses of the devices," said Kaufman. "But even if you're changing the needle, there is the possibility that the first person's blood could come in contact with the next person's blood."

Abigail Tumpey, a spokesperson for the federal Centers for Disease Control and Protection, said Dean has consulted with that agency about the incident. Craig said the clinic has also been in touch with the state Division of Public Health. Officials with both agencies were unsure Monday whether further investigations will be conducted. 

"We would agree that the risk is small," said Tumpey. Regardless, she added, most people in such education programs expect no risk. Tumpey said the CDC works with clinics in such situations to make sure patients are notified and that their needs and concerns are met.

"The goal is more health care transparency," said Tumpey. "It is a very scary time for many of these patients."

Samitt said this was an "isolated" incident involving the single educator, who has since been fired. He declined to identify the individual. Samitt said clinic officials learned of the potential exposure on August 10 from another employee and conducted an investigation. Monday, the clinic mailed letters to all 2,345 patients to inform them that they may be at increased risk.

Also, Samitt said, a team of 25 nurses is taking telephone calls from affected individuals to determine whether they should be tested for HIV, which is the virus that causes AIDS, or for either form of hepatitis, a disease that attacks the liver. He said calls were already being received Monday after stories about the possible exposure began appearing in the media.

"This is a very difficult situation for us at Dean," said Samitt. "I'd like to apologize for the concern this has caused patients and their families. We'll do whatever it takes to care for affected patients."

Kaufman said risk to individual patients depends on whether the nurse actually used one of the insulin devices on them. "Did the nurse use any sharp instrument on you? If the answer is 'No,' then there is no risk. If you don't remember, then we could assume there was a risk, no matter how small."

But Samitt said anybody who is concerned about exposure will be offered testing. He said while most of the involved patients are from Dane County, a handful from outside the county and even outside the state may have been referred to the educator. "We're casting a very broad net to include each and every patient the nurse could have seen," said Samitt.

As for how the misuse of the devices could have gone for so long without being detected, Samitt said the clinic is still trying to figure that out.

"We'd like to know the answer to that question as well," said Samitt. "This is an active investigation."

Samitt said the nurse was certified through state and federal programs, including the Association of Diabetic Educators, to work as a diabetes educator. Also, he said, the nurse went through Dean's own training program. An important part of that training, he said, is learning not to re-use the testing devices. The insulin demonstration pen, for example, is not supposed to be used on people but rather is used on oranges or pillows to show patients how to inject insulin.

"This is upsetting to us as well," Samitt said. "There is a basic standard  of care principle here."

Samitt added that it was unclear whether the nurse went through the clinic's refresher course on standard practices. He said there was apparently little oversight or evaluation of the nurse's work.

"There weren't regular, routine observations," said  Samitt.

Samitt said that in the wake of the incident the clinic is requiring staff to be retrained in the use of the devices, improving monitoring the use of the devices and also making sure that practices by clinic staff are routinely observed.

The state Department of Safety and Professional Services is also reviewing information about the case, according to John Murray, executive assistant at the agency.

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D Science

As a general rule I don’t repost stories about the latest diabetes “cure” that seem to be “almost” ready.  I mostly avoid doing this because I remember the first time I saw an article that claimed the researchers had cracked the code and just needed a few more dollars to cure us all. That first article came to my attention just weeks after Arden was diagnosed and it took me two days to realize that these “cures” have been pro ported to be just around the corner for decades. I believe that one of them will eventually break through but for me (or you) to emotionally chase each one of them, well that’s not a good idea. All of that doesn’t mean that I don’t follow along with what the scientific world is trying to do... Today, I’m reposting an article because this one seems a little different, just slightly more hopeful. It has no anti-rejection drugs that trade diabetes for cancer and it’s backed by a philanthropist with a strong personal connection and an eye for a good idea. In short this one seems doable to me. See what you think and comment if you’re so moved.

 

Fromhttp://m.xconomy.com/3376/show/9afa00bb7aaa31f4ea0ec98fd59537aa/

 

Posted by Arlene Weintraub on Friday Jun 24th at 4:00pm

What happens when a guy who got wealthy selling cars hands millions of dollars to a scientist and tells her how to spend it? Folks attending the American Diabetes Association conference starting today in San Diego are getting a hint of the answer to that question. Denise Faustman, director of the Massachusetts General Hospital (MGH) immunobiology laboratory is presenting two abstracts from a clinical trial funded by the Boston-based Iacocca Family Foundation, established by former Chrysler CEO Lee Iacocca to support research aimed at curing type 1 diabetes.

Faustman’s data shows that low doses of an 80-year-old vaccine temporarily reversed type 1 diabetes in Phase 1 human trial. The vaccine is called bacillus Calmette-Guerin (BCG). It was developed to prevent tuberculosis and is now available as a generic drug. BCG induces the immune system to make tumor-necrosis factor (TNF), which kills the T-cells that cause the pancreas to stop producing insulin.

Faustman’s team went to Iacocca’s foundation for funding after repeatedly having the door slammed in their faces by drug companies. The MGH scientists had plenty of animal studies showing that it was possible to regenerate the pancreas, and therefore restore insulin production in diabetes models. But when MGH went to the pharmaceutical industry looking for funding to research a pancreas-regenerating drug, “everyone said, ‘you’re reversing the disease. How are we going to make money?’” Faustman says.

So MGH spent years looking for a generic drug that would stimulate the production of TNF. Iacocca’s foundation supported much of that work, which involved drawing blood from thousands of diabetes patients and proving that they could use TNF to kill the bad T-cells. “One day, Mr. Iacocca looked at me and said, ‘Denise, when are you going to cure diabetes?’” Faustman recalls.

Iacocca instructed Faustman to show the technique worked in a mouse study, so it could eventually be tried in humans. “No one had ever reversed diabetes in a mouse,” she says. “Philanthropy can take risks. He made it clear it was his money and he wanted risky therapies done.” Then the foundation put $10 million toward the Phase 1 human trial. All told, Iacocca’s group is the largest single donor to Faustman’s research.

MGH’s Phase 1 study was designed to answer four key questions about BCG, Faustman says. “Does it kill the bad T-cells? Does it induce the good T-cells? Does it change the pancreas? Does it restore insulin secretion?” The data, she says, “shows positive responses in all four outcomes.”

One caveat, Faustman says, is that the drug produces a transient effect. That means it will have to be given in repeated intervals, perhaps every four to six weeks. Still, says Faustman, “this will be the first data showing that the pancreas can be turned back on.”

Iacocca launched his foundation in 1984 in honor of his late wife, Mary, who died of complications from type 1 diabetes. The foundation declined to comment for this story. But Kathryn Iacocca Hentz—president of the foundation and Lee’s daughter–said in a statement “These results are very meaningful to the Iacocca Family. We have supported this work since the mouse studies first showed the reversal of longstanding diabetes.”

The foundation has made a gift of undisclosed size to MGH to support the Phase 2 program, which MGH is now planning. The hospital has raised $8.5 million of the $25 million it will need to support the trial over the next three years. Though Faustman says they’ll need other partners to kick in additional funding, she’s certain they couldn’t have come this far without the help of the former Chrysler CEO. “You have to wonder how a guy who built cars knew what we needed to do,” she says. “But he knew what risks to take.”

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Covey declines deal after diabetes diagnosis

Likely Type 1, Brewers' top pick opts for University of San Diego

MILWAUKEE -- For the first time in nearly two decades, the Brewers and a first-round Draft did not strike a deal. A stunning medical diagnosis got in the way.

 

Right-hander Dylan Covey, the 14th overall selection in June's First-Year Player Draft, woke up Friday thinking he was four days from signing his first professional baseball contract. He learned Friday afternoon that he was diabetic.

 

On Monday, only a few hours before the deadline for Major League teams and their picks to come to terms, came word with 95 percent certainty that it was Type 1 diabetes. Facing a lifetime of treatment and a major adjustment to his promising baseball career, Covey declined the Brewers' contract offer and said he would instead attend the University of San Diego.

 

The rest of the story is at the LINK

 

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The following are archived comments from this post. You can post new comments below.

Scott
If the type I is really the reason that he didn't sign, I think that he made a mistake - it's a mistake I understand but a mistake none-the-less.  I hope someone can show Dylan that he can play baseball just fine with type I.  My heart goes out to Dylan and his family, I know what is about to happen to them...
Wednesday, August 18, 2010 - 12:15 AM

 

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New gel could speed wound healing

In this Wednesday Aug. 4, 2010 photo a demonstration of how wound-healing gel is used on a leg wound is seen at University College London. British scientists are about to begin a final phase of testing on a new gel that heals wounds up to five times as fast as normal treatment. The gel, named Nexagon, works by interrupting how cells communicate and prevents the production of a protein that blocks healing. That allows cells to move faster to the wound to begin healing it. Though it has only been tested on about 100 people so far, experts say if it proves successful, the gel could have a major impact on treating chronic wounds, like leg or diabetes ulcers, and even common scrapes or injuries from accidents. (AP Photo/Kirsty Wigglesworth)

 

 

LONDON — For three years, Connie McPherson had debilitating leg ulcers that were so painful she sometimes couldn't sleep. Despite repeated surgery, antibiotics, steroids and other treatments, nothing helped.

 

Then last year, she took part in a trial for a new gel aimed at chronic wounds.

 

"It was the answer to my prayers," said McPherson, 58, a real estate agent in Tulsa, Oklahoma. Within weeks, McPherson said the ulcer treated was completely healed. "I tried everything possible and this is the only thing that worked."

 

The gel used to treat McPherson was developed by a team led by David Becker, a professor of cell and developmental biology at University College London. The gel, named Nexagon, works by interrupting how cells communicate and prevents the production of a protein that blocks healing. That allows cells to move faster to the wound to begin healing it.

 

Though it has only been tested on about 100 people so far, experts say if it proves successful, the gel could have a major impact on treating chronic wounds, like leg or diabetes ulcers, and even common scrapes or injuries from accidents.

 

In most chronic wounds, Becker said there is an abnormal amount of a protein involved in inflammation.

 

To reduce its amount, Becker and colleagues made Nexagon from bits of DNA that can block the protein's production. "As that protein is turned off, cells move in to close the wound," Becker said. The gel is clear and has the consistency of toothpaste.

 

http://www.msnbc.msn.com/id/38671775/ns/technology_and_science-science/

 

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Nanovaccine helped mice overcome type 1 diabetes

CHICAGO (Reuters) - An experimental vaccine containing tiny molecules of an immune-system protein was able to reverse type 1 diabetes in mice, raising hope that it might work in people, Canadian researchers said on Thursday.

Type 1 diabetes is caused when certain white blood cells, called T cells, go haywire and begin attacking insulin-producing cells in the pancreas.

 

But not all T cells cause harm, said Dr. Pere Santamaria of the University of Calgary in Alberta, whose study appears in the journal Immunity.

 

"Essentially, there is an internal tug-of-war between aggressive T cells that want to cause the disease and weaker T cells that want to stop it from occurring," Santamaria said in a statement.

 

Santamaria's team wanted to find a way to counteract the harmful autoimmune response without compromising general immunity.

 

They developed a so-called nanovaccine -- particles many times smaller than a cell and coated with protein fragments specific to type 1 diabetes. These were bound to molecules that play a critical role in presenting these protein fragments to T cells.

 

When the team gave the vaccine to mice with an early form of type 1 diabetes, they found the vaccine slowed the progression of the disease. And in mice that had full-blown diabetes, the vaccine helped restore normal blood sugar levels.

 

The team said the vaccine appears to work by expanding the number of T cells working to fight off the attack of aggressive T cells that destroy the insulin-producing beta cells.

 

And they said the findings may lend clues about how to reverse other autoimmune diseases, such as multiple sclerosis or rheumatoid arthritis.

 

Teodora Staeva of the Juvenile Diabetes Research Foundation said in a statement the study was promising because the treatment worked only on the immune cells specifically focused on aggressively destroying beta cells, without compromising the rest of the immune system.

Type 1, formerly called juvenile diabetes, represents about 10 percent of the estimated 180 million cases of diabetes globally. Most diabetics have type 2, the kind linked with a rich diet and lack of exercise.

(Editing by Eric Walsh)

 

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The following are archived comments from this post. You can post new comments below.

Barbara (Julia's grandma)
Thank you, Scott, for putting this report about the vaccine on your web-site.   It gives us hope that someday there WILL be a cure for our precious girls and the many others with type 1 diabetes.
Tuesday, April 13, 2010 - 07:13 PM

 

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