Close Concerns Weblog

Three cheers for pharmacists ~ and the visionaries behind the Asheville Project

Ian Urbina of the New York Times wrote one of the best stories early this year in the landmark series "Bad Blood" - that piece was "In the Treatment of Diabetes, Success Often Does Not Pay" and it did a piercing job of showing that, at least in New York City (but probably most places in the US), prevention doesn't pay - i.e., prevention of diabetes complications and prevention of type 2 diabetes itself. In two memorable graphics in that piece, he showed that the costs of basics ("good care, bad business") - diabetes educators, nutritionists, etc - were not covered, giving a disincentive to patients to seek this care, while by contrast, payments for other acute services (say, amputations) resulted in sometimes sizable profits to the hospital ("bad health, good business"). Of course it's easy to make it all quite reductive and paint hospitals and payors as the bad guys - that's not the point here, just to highlight Urbina's thought-provoking piece and to point to another one, in this morning's New York Times, that is by contrast to last January's piece, actually very encouraging.

Today's piece is all about pharmacists and how they are basically becoming stand-in diabetes specialists. (We know many have been for years.) In one NC town called Ashville (pop. 75,000), city government gives free diabetes medicines and supplies to diabetic municipal workers who agree to monthly counseling from trained pharmacists. Who better to help patients that those who are expert on medicine and who have some extra time to meet with patients? The results have been striking - costs for patients with diabetes are down in Ashvile over 50%, having dropped in the first year to $3,554 from $6,127, far below the national average (over $10,000) for a patient with diabetes. Much of the success seems to relate to ongoing help with adhering to the huge hassle of drugs, testing, etc - Urbina characterizes the job as part coach, part healthcare provider, part cheerleader - that completely makes sense that if you have someone to advise you, you'll be more motivated and do better - especially (or even in spite of) if you have someone at home to help. I love talking to pharmacists because they tend to really know what they are doing but they aren't too judgmental - for me, this has been a perfect combo. The fact that we also have two 24-hour pharmacies with 24/7 pharmacists nearby also helps - in my experience, pharmacists especially love talking about diabetes after 10 pm, when few others are around or asking any questions! Actually, that just might be urban San Francisco, but in Asheville, the pharmacists are also paid to sit down and discuss diabetes with the patients in the program. To me, this is the modern-day doctor - while at HMOs, doctors often only have eight minutes to spend with each patient (or they go broke), these pharmacists have more time and are probably incredibly knowledgable about the treatments, given their roles as experts on medications.

I love reading success stories. Clearly, one thing the city did right is also invest in quantifying and publishing its results. A quick search of Ashvile and diabetes on the net yields a powerpoint presentation by John Miall, the former Director of Risk Management for the City of Asheville. Miall was one of the visionaries behind what's called The Asheville Project - I heard Mr. Miall speak at Duke University last year at a fantastic diabetes conference put together by a bright young venture capitalist (then a business school student) called Nancy Lynch. (Nancy's story itself is very inspiring - a former orthopedic surgeon, she quit her field while at the top of her game and turned toward other healthcare work she found more inspiring - she has much experience of diabetes in her family.)

There is actually a video of the panel that John Miall spoke in - it was the best panel of many great ones throughout the day (see website below for agenda) and was led by Dr. Orville Kolterman of Amylin Pharmaceuticals and had lots of brainpower on employer power in healthcare.
http://mbaa.fuqua.duke.edu/hcc/conf_agenda_s2006.htm

What I find inspiring about about the Asheville Project is that it seems reproducible. It seems a very smart way to align interests of patients, pharmacists, healthcare providers, employers, and everyday taxpayers. Many thanks to Ian Urbina and everyone who helped him on this story for highlighting this innovative work. I wrote Mr Miall this morning to try to find out what journal documents the best the Asheville success and if I hear back, I'll post the citation and then send it to Mayor Gavin Newsom in San Francisco and all the pharmacy chains - here's hoping some education on such an inspiring program can help - we certainly need it!

The only unsettling thing about this article, having done a little more research on Asheville - why have only 40 employers begun similar programs? The benefits of the program were well documented starting in 2003 (search on Google for John Miall and you can see a 2003 powerpoint documenting impressive savings the first year.) Not to be too formulaic, but this seems a perfect win-win-win-win-win. Isn't this right? Patients get more attention, have lower costs, and happier lives, employers have lower costs and happier and more productive workforce, families worry less, doctors and nurses have more educated and motivated patients, pharmacists spend their time even more productively and are paid more [one hopes], payors have lower costs long term, taxpayers pay less....and even big pharma wins as they MUST sell more drugs if patients are more engaged.

Yes, 40 seems too low a number for the employers who have copied this. I hope America can think bigger. And how about the city governments - more could SO benefit by taking action. I'm not sure what the start up costs are for this program, but am looking into this now. Any other questions, please let me know. Mr. Miall and others involved in the Asheville Project have started a quiet revolution and it would be excellent to see it spread.

So many thanks to the New York Times for continuing to cover diabetes so intelligently. Full story is below.

**********
New Job Title for Druggists: Diabetes Coach

By IAN URBINA
Published: December 30, 2006
ASHEVILLE, N.C. — In an office behind the Hershey’s candy rack at a Kerr Drug here, Stuart Rohrbaugh shifts in his chair as his pharmacist stares at a dangerously high blood sugar reading from last month.

Diabetes
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“I think that was the day a buddy of mine brought over his home-brew beer,” stammers Mr. Rohrbaugh, whose diabetes was diagnosed six years ago.

Silently, the pharmacist lifts her eyes, sending Mr. Rohrbaugh’s gaze to the floor.

“I know, I know,” he says.

Mr. Rohrbaugh, 37, learned relatively late in life that he had Type 1 diabetes, a malfunction of the immune system that usually surfaces in childhood. There are hundreds in Asheville with that type, and even more with the more prevalent Type 2, which often hits as a consequence of obesity or age.

And so in this town of 75,000, where people like to use sugar in their coffee and in their iced tea, and as a term of endearment, Mr. Rohrbaugh and the others face the formidable challenge of either managing their diabetes or suffering its potential ravages: blindness, organ failure, stroke.

In trying to meet that challenge, the kind of polite browbeating that Mr. Rohrbaugh faced at his local pharmacy seems to be paying off.

For the past 10 years, the city of Asheville has given free diabetes medicines and supplies to municipal workers who have the disease if they agree to monthly counseling from specially trained pharmacists. The results, city officials say, have been dramatic: Within months of enrolling in the program, almost twice as many have their blood sugar levels under control. In addition, the city’s health plan has saved more than $2,000 in medical costs per patient each year.

There are at least 21 million diabetics in the United States, and health officials have begun to despair of combating the disease because it involves getting people to do something much more difficult than taking their medicine or having surgery: altering their daily behavior, like their eating and exercise habits.

But amid this gloom, Asheville’s public health experiment is something of a ray of hope, an example, however modest, of the kind of house-to-house, block-to-block battle that can win results and save lives in the face of a disease that has resisted quick-fix solutions.

Indeed, in recent years, about 40 other employers across the country — private companies or municipalities — have adopted versions of the program.

“We get a four-to-one return on investment,” said Barry Bunting, pharmacy director at Mission Hospitals, which runs the program in Asheville for about 450 city and hospital employees. For every dollar spent on medicines or counseling about diet, exercise and lifestyle, he said, the city saves $4 by preventing emergency room visits, dialysis, amputations or other common complications of diabetes.

During the first five years of the program, participants took an average of six sick days from work a year, half the number of previous years. Within three years of enrolling in the program, patients had halved their chances of going blind or needing dialysis or an amputation, a founder of the program said.

“When you have to answer to someone each month, you think twice before eating what you shouldn’t,” said George Ledford, 69, who joined the program five years ago.

The fifth deadliest disease in the nation, diabetes costs more than $130 billion per year in medical expenses and lost productivity in the workplace. While there is no cure, patients can delay or prevent complications by using medications properly and adjusting their diet and exercise routines.

But the efforts to help people change their lifestyles are complicated by a health care system in which insurers typically do not reimburse doctors for the kinds of counseling and monitoring that might keep patients on track.

So the Asheville experiment has enlisted pharmacists in its model. They serve as coach, clinician and cheerleader for patients, and they earn a fee for each session.

“Once you have a sense of what motivates them, you set little goals each visit and then build on them,” said Dana K. Arrington, a clinical pharmacist at Kerr Drug who sees at least one diabetes patient a day.

“This month, get on the treadmill once a week for 15 minutes. Next month, we write down each time you take your pills. Then switch from whole to skim milk. It’s a slow process if you want it to stick.”

While diabetics have often shown significant improvements in controlling their blood sugar soon after taking diabetes education classes, they typically relapse within three months, according to a study released in March 2003 by the Journal of the American Pharmaceutical Association. The report was co-written by Carole W. Cranor, a pharmacoeconomist who was then at the University of North Carolina, Chapel Hill.

What makes the Asheville Project unusual, the study found, is that at the end of the first year of the program, half the participants had their blood sugar under control. That number increased to two-thirds of the original group at the end of the program’s third year.

“Asheville had unusually long-term successes because of the distinct role played by pharmacists, who have at least five years of academic training and who are more rooted and accessible in communities than doctors,” said Ms. Cranor, who is now a clinical pharmacist at Dorothea Dix Hospital in Raleigh, N.C.

Aside from Asheville’s successes, the popularity of the program is being driven by pharmaceutical companies.

GlaxoSmithKline and Sanofi-Aventis, which make diabetes drugs, have jointly given about a million dollars in the past five years to the American Pharmacists Association Foundation, a nonprofit research group, to help promote and replicate the program, said Dan Garrett, one of the founders of the Asheville Project and a director at the foundation.

Diabetics frequently fail to take their medications consistently, studies show, so these drugmakers stand to profit from better patient compliance. None of the employers or cities that adopt the program are obligated to buy from these companies, though.

The frequency of consultations is the reason the Asheville Project has shown such long-term benefits, Mr. Garrett said.

For patients struggling to adjust their daily habits, it is the little questions — those too small and too numerous to justify an appointment with a doctor—that make the disease so difficult to manage and pharmacists’ involvement so invaluable, patients said.

When Mr. Ledford kept getting sores on his feet, a common diabetes complication, his pharmacist ventured into the aisles to help him find a lotion that worked. When Mr. Ledford’s blood sugar levels spiked mysteriously, the pharmacist questioned him about any changes in his routine. “The new cup I was using for my cornflakes was the wrong size,” recounted Mr. Ledford, explaining that this mistake in figuring his carbohydrate consumption was throwing off his insulin dosage calculations.

Despite his occasional lapses, Mr. Rohrbaugh said that without frequent feedback from his pharmacist and the program’s nutritionist, he would never have been able to learn how to count his carbohydrates, drop the necessary 20 pounds and administer his insulin. “I also was struggling to afford it all,” said Mr. Rohrbaugh, a worker in city planning who was paying more than $300 per month for medicines and supplies before joining the program two years ago.

John Miall, one of the founders of the Asheville program, who recently retired as the city’s director of risk management, said that within its first year the average annual health care cost for diabetic employees dropped to $3,554 from $6,127.

“Do the math,” he said. “If just one employee is kept off dialysis, that is a $100,000 net savings for the year. That pays for a heck of a lot of preventative medicine and supplies.”

Sontra closes down, still amidst revolutionary claims ...

A matter-of-fact press release went out yesterday from Sontra announcing that it would cease operations. The troubled device manufacturer had all but announced this last quarter when it said it would run out of funds at the end of this year. This is another reminder of how difficult the non-invasive monitoring market is - the company has over time said that various products were in development (non invasive and continuous) for various markets (consumer, ICU) ... early results from nine highly-trumpeted (by the company) trials did not progress well.

We have utmost respect for ongoing research in diabetes, but we don't think it's right when companies raise patient expectations too early. It has been stated on the Sontra website for some time for example, that continuous monitoring for diabetes self testing should exceed 20% market penetration by 2009. Estimates that three million people in the US alone will be using continuous monitors in two years when major reimbursement challenges remain is irrresponsible, because it implies to patients that coverage will not be an issue. It's also an overstatement to claim market growth in a category (blood glucose monitoring) at 15%.

The Sontra website characterizes its product in development as revolutionary and notes that there is large potential upside to the company's market valuation. This makes it easy to understand why most prefer the more under-the-radar companies that don't make big claims too early.

Sontra Medical Corporation Announces Plan to Cease
Operations and to Voluntarily Delist From Nasdaq
FRANKLIN, Mass., Dec. 27, 2006 -- Sontra Medical Corporation (Nasdaq:
SONT) today announced that it will cease operations because it has been unable
to raise additional capital. Sontra previously announced that it had sufficient cash
to continue operations until December 31, 2006. The Company had been
working on seeking additional capital and the possible completion of a merger
transaction; however, the Company has not been successful in completing a
financing or transaction. The Company intends to terminate all employees, and
through an orderly wind-down of its operations, pay its current liabilities and
make appropriate accommodations for creditors. The Company's Chief
Executive Officer, Thomas Davison, will continue as Acting Chief Executive
Officer on a part-time consulting basis, and the Company's Chief Financial
Officer, Harry G. Mitchell, will continue as Acting Chief Financial Officer on a
part-time consulting basis. Messrs. Davison and Mitchell intend to continue to
pursue financing for the Company, while exploring the sale of the Company's
remaining assets, including its intellectual property portfolio.
In connection with Sontra's decision to cease operations, Sontra has elected to
voluntarily delist from the Nasdaq Capital Market. The Company has provided a
voluntary delisting notice to the Nasdaq Stock Market. On November 22, 2006,
the Company received a notice from the Nasdaq Stock Market indicating that
the Company was not in compliance with Nasdaq's requirements for continued
listing under Marketplace Rule 4310(c)(2)(B) because the Company did not have
either: (i) a minimum of $2,500,000 in stockholders' equity as of September 30,
2006, (ii) at least $35,000,000 market value of listed securities, or (iii) at least
$500,000 of net income from continuing operations for the most recently
completed fiscal year or two of the three most recently completed fiscal years.
On December 7, 2006, the Company submitted a plan to Nasdaq explaining how
it intended to achieve and sustain compliance with all the Nasdaq Capital Market
listing requirements. As of this time, the Company has been unable to complete
its plan, which included completing a financing or merger transaction, and has
therefore not regained compliance with Marketplace Rule 4310(c)(2)(B).

In addition, on October 17, 2006, the Company received a deficiency letter from
the Nasdaq Stock Market indicating that the Company was not in compliance
with Marketplace Rule 4310(c)(4) because for the previous 30 consecutive
business days, the bid price had closed below the $1.00 minimum per share
requirement for continued listing set forth in Marketplace Rule 4310(c)(4). The
Company has not regained compliance with Marketplace Rule 4310(c)(4).
Sontra has not arranged for the listing of its common stock on another national
securities exchange or for the quotation of its common stock in a quotation
medium. The Company's quotation for its common stock is expected to appear
in the "Pink Sheets" under the symbol "SONT." The Company's common stock
may also be quoted in the future on the OTC Bulletin Board provided a market
maker files the necessary application with the NASD and such application is
cleared.
About Sontra Medical Corporation (http://www.sontra.com)
Sontra Medical Corporation is a technology leader in transdermal science and is
developing a non-invasive, continuous transdermal glucose monitor ("CTGM")
for principal use in the Intensive Care Market. Through its platform technology,
the SonoPrep® Permeation System, combined with technical competencies in
transdermal drug formulation, analysis, delivery systems and biosensors, the
Company is creating a new paradigm in transdermal drug delivery and diagnosis.
The CTGM and other company products are being developed for several billion
dollar market opportunities, all utilizing skin permeation, chemistry and
biosensor technology developed by the Company. In addition, the Company
owns technology for transdermal delivery of large molecule drugs and vaccines.
# # #
Any statements contained in this press release that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.
Any forward-looking statements contained herein are based on current expectations, but are subject to a number of risks and uncertainties. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, a determination by the Company to wind down its business or file for bankruptcy; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; the Company's business, research, product development, regulatory approval, marketing and distribution plans and strategies; risks and uncertainties relating to the Company's ability to develop, market and sell products based on its technology, including a continuous transdermal glucose monitor for the hospital ICU market; the expected size of the market for the continuous transdermal
glucose monitor for the hospital ICU market; the expected benefits and efficacy of the SonoPrep device in connection with diagnostics, vaccine delivery, glucose monitoring and transdermal science. These and
other factors are identified and described in more detail in our filings with the SEC, including, without
limitation, our respective annual reports on Form 10-KSB for the year ended December 31, 2005, our
most recent quarterly reports on Form 10-QSB, and our current reports on Form 8-K. We do not
undertake to update these forward-looking statements made by us.
# # #
SonoPrep is a registered trademark of Sontra Medical Corporation. All other
company, product or service names mentioned herein are the trademarks or
registered trademarks of their respective owners.

The trendiest cardiometabolic risk factor

When Body Mass Index, or BMI, gets face time in the Fashion & Style section of the Times, as it did today, you know something’s up. Along with blood glucose, waist circumference, blood pressure, and others, BMI is a measurement that helps identify cardiometabolic risk. If one of these measurements is abnormal, there is an increased chance that another is too. Therefore, BMI is a very important measurement for the many Americans who have or are at risk for type 2 diabetes. But, for schoolchildren, adoptive parents, models???

We can only think that those for whom a low BMI is really important are so numerous now that everyone wants one! Indeed, once only a measurement important for health agencies, BMI is now appearing all over the place. This article discusses the September ban on runway models in Madrid whose BMI was below 18.5, China’s recent mandate that prospective adoptive parents for Chinese children have, among other things, a BMI under 40, and the report cards in Arkansas and Tennessee that include childrens’ BMIs. One calculates a BMI by dividing a person’s weight in kilograms by his or her height in meters squared (try it yourself – with pounds and feet – at www.nhlbisupport.com/bmi/).

The truth is, the article points out, BMI alone is not really a good gauge for general metabolic health: “The number should not be the final word for measuring whether a person is under- or overweight to an unhealthy degree, some experts say.” BMI is really only one of several measurements that matter. It does not distinguish between fat and muscle mass, the article points out, so that Arnold Schwarzenegger as Mr. Universe was technically obese (with a BMI of 33). Some studies show that sedentary people with lower BMIs are actually at greater risk for diabetes and heart attacks than fit people with higher BMIs. Part of why BMI remains an accepted gauge of health is because it’s easy to calculate and cheap, Ellin writes. Read the article below:

Second in a series: grim thoughts on dialysis

The New York Times has another front-page piece on diabetes tomorrow, this one about dialysis. When the article yesterday popped up on diabetes and discrimination, I thought immediately of Bad Blood, the hard-hitting series earlier this year (24,000 words!) and when I saw this piece, I knew it must be another series to end the year. And, there is now a posting that articles in this series are exploring the widening impact of the Type 2 diabetes epidemic.

Well, this does it all right. My take on this piece is that prevention doesn't pay - that's what I learned from Bad Blood earlier this year. The article is about the quality of the dialysis centers in New York - bottom line, there is so much demand that none can close, even if they need to or should to. Can't - too much demand. Of course, there is no problem, seemingly, with reimbursement for dialysis - Medicare pays for 90% of it. From the math in this piece, it sounds like over 40% of those on dialysis have diabetes (in 1980, it was only about 12%, of a far, far lower number - just 24,000). Oh, if Medicare would just reimburse all the education on diabetes that was needed, and all the therapies, how much dialysis would they need to pay for? And how much cheaper is early education and early therapy? Dialysis is nearly $25,000 per year in costs to the center - and what about the 12-15 hours of week of the lives of patients it takes? Oh that is extra.

The point of this article really centers on how tough it is for big dialysis chains to open in New York - the piece cites studies that show care at a big center is better on average than care at a small center, and this seems easy to understand - just chalk it up to economies of scale, with exceptions coming with incredible owners. What interested me most wasn't who is giving the dialysis in terms of companies, but rather, how did 24,000 people in New York come to need dialysis, particularly the ~ 10,000 people with diabetes, and how can we prevent this from coming a (sorry, more of a) runaway problem?

Thank you very much to the NYT for continuing an excellent series.

***** (article below)
Dialysis in N.Y. Lags as Diabetes Ruins Kidneys

By RICHARD PÉREZ-PEÑA
Published: December 28, 2006
Tens of thousands of people across the country, their kidneys ruined by Type 2 diabetes, have been forced into the grim routine of dialysis care, and in New York, those patients routinely receive some of the worst treatment, government records show.

At New York dialysis centers, those being treated are more likely to suffer from anemia and are less likely to have enough impurities and excess fluid removed from their blood, allowing more damage to their bodies, according to the records.

Experts say the disparity is caused in part by the fact that New York is dominated by small dialysis providers, many of them run by people with little background in medicine who entered the business to meet the surging demand.

Many of the smaller centers provide good care, experts say, but a lot also lack the money and staff training to compete on a quality-of-care basis with the national dialysis chains that dominate the market across the rest of the country.

Newly released patient data show that people who receive their dialysis from a national chain generally fare better than those treated by an independent provider.

But the chains are largely blocked from operating in New York by a state law that effectively bars publicly traded companies from owning health care facilities in the state.

“With the need for dialysis on the rise, the department is questioning whether it makes sense not to allow these large corporations to participate,” said Jeffrey W. Hammond, a Department of Health spokesman.

In 1980, fewer than 50,000 people in the United States needed dialysis to do the work of their kidneys; today, there are more than 350,000, including roughly 24,000 in New York. In 1980, diabetes was the primary cause of kidney failure for fewer than 6,000 dialysis patients; today, the figure is about 150,000.

Survival for them is an ordeal, at best.

At a typical dialysis center, patients come in three times a week, typically for four hours at a time. They sit in rows of recliners, dozing, watching television — anything to take their minds off the machines, needles and tubes that siphon blood from their bodies, clean it of impurities like urea, and pump it back in. It is surprisingly quiet; patients are so beset by side effects like fatigue, cramps or thirst, that mere conversation seems like an effort.

For all but a few, holding a job is out of the question. Most will never be healthy enough to qualify for a transplant that would free them of this burden, and there are far too few donated kidneys, anyway.

New drugs and dialysis techniques have improved their chances of survival since the 1980s, despite the fact that patients today are older, heavier and sicker. Even so, the average dialysis patient spends 15 days a year hospitalized, and the death rate is about one in five each year.

“I want to say it’s a rough life, but it hardly is a life,” said Denise Bembury, a dialysis patient who lives in Brooklyn. “I wouldn’t put this on anybody.”

Across the country, five companies own or operate almost two-thirds of the 4,800 dialysis units. Two of them, Fresenius Medical Care and DaVita, have more than half the market. But in New York, the big five run about 20 percent of the roughly 250 centers, by far their lowest share in any state.

The State Department of Health has helped the national chains work around the law that bars publicly traded companies from owning health facilities. This has allowed them to open some centers here, but the companies say the approval process remains long and difficult, dampening their interest.

The ownership restriction, in place for at least 50 years, state officials said, was enacted when there was no such thing as a dialysis center, and was intended to ensure that hospitals are responsive to local concerns, not to far-flung shareholders. Though the Health Department talks of changing the law, no one has made it a priority, and not even the large chains have pushed the issue in Albany.

Recent reports on the quality of dialysis care by the federal Centers for Medicare and Medicaid illustrate New York’s cause for concern. The centers examined a sampling of Medicare patients’ dialysis records in each of 18 regions, one of them New York State.

Medicare pays for almost 90 percent of dialysis in this country, and in the reports, for 2003 and 2004, New York ranked worst in all three of the most commonly used quality measures. Those measures are how likely patients are to have enough excess fluid like water removed from their blood during dialysis, how likely they are to have enough impurities like urea removed, and how likely they are to be anemic or severely anemic because of the treatment.

Those scores have improved in New York over the last decade, but not as quickly as they have nationwide, and New York’s numbers were actually worse in 2004 than in 2003.

The federal agency does limited comparisons of individual dialysis centers, which show that nationally, 4 percent of them have unusually poor patient survival rates, defined as at least 20 percent below average. In New York, 12 percent do. Federal officials caution against putting much stock in any one center’s numbers, but they say the regional picture clearly shows a problem.

The federal data do not draw any conclusions about the cause of the disparity. But experts said they believed the quality of care was affected by the high number of smaller, less experienced providers in the New York market. In fact, in New York City, one-fifth of the centers operating earlier this year had existed for less than five years.

A recent report by the United States Renal Data System Coordinating Center, a quasi-governmental agency that compiles the records of most dialysis patients, shows that patients at the major chains were less likely to die than those treated by smaller companies.

According to the center, the numbers were adjusted to account for differences that might affect patients’ risk, like age and sex, whether they had an underlying disease like diabetes and how long they had been on dialysis. The independents were defined as not being part of a major chain or a hospital.

Four of the five largest chains had adjusted death rates 7 percent to 10 percent lower than the independents had as a group in 2004, and one chain had higher rates, according to the center’s most recent annual report. Since then, two major chains, including the one with the highest death rate, have left the business, and two new ones have been formed.

Patients at the small companies were much more prone to infections that led to hospitalization or death. The small companies also lagged in nondialysis care that dialysis centers usually take over, like ensuring that patients get vaccinations for influenza, pneumonia and hepatitis B. Their diabetic patients were less likely to have tests that monitor blood sugar control.

Some independent operators say that large companies can “cherry pick” healthier clients. But the government’s figures show that the national chains’ patients are actually sicker when they begin dialysis — more anemic, more overweight, and with more advanced kidney disease.

Researchers and state and federal officials say they have known, or at least suspected, for years that patients fare better at the major chains, but they cannot be sure why.

One factor believed to play a role is that the average Medicare reimbursement rate for a dialysis session, $140 to $150, has changed little since the 1970s, making it difficult for the smaller operators who cannot realize economies of scale. Tight operating margins have left fewer small providers nationwide, although their numbers have grown in New York, where the chains have not been able to operate freely.

Dr. Allan J. Collins, director of the United States Renal Data System Coordinating Center, said: “We do know that the large organizations have an enormous advantage in resources because they can demand discounts from suppliers on drugs and equipment, and that can translate to better staffing, better training. The chains also tend to be more systematic and standardized in their procedures.”

Michael Paget, executive director of the National Renal Administrators Association, which represents large and small dialysis companies, said he was not familiar with the Coordinating Center’s research that indicates one group performs better than the other. The center first included those comparisons in a report last year, and first included the mortality and hospitalization breakdowns this year.

“I don’t think you can generalize about the independents, and there are many that do an excellent job,” outperforming even the best of the major chains, he said. But he acknowledged that bigger companies probably had an edge in training.

The federal government and most states, including New York, do not set training or educational standards for dialysis technicians, the workhorses of a dialysis center. (Federal rules require only that the centers have full-time or part-time doctors, social workers and nurses on staff.)

National chains customarily provide technicians and other staff members with months of initial training and occasional re-training, instruction that can boost the quality of care and that independent companies, with their tighter operating margins, have a hard time affording, experts say.

Ms. Bembury, 44, uses an independent center, Nephrocare, a three-year-old unit on Atlantic Avenue, in the Weeksville section of Brooklyn. She goes there, she said, because her doctors referred her there. Like many patients, she has no idea how it compares with other centers, or how to find out.

Until earlier this year, she was a social worker and an avid cook. Now, she is on disability, and her companion of more than 30 years prepares meals. They have six children, and she wonders how the four youngest, all teenagers, will manage.

“I’m thirsty all the time, and tired,” she said.

Nephrocare was one of a few dozen centers in New York with an abnormally high death rate in 2004, though not in 2005, and in both years, it had an unusually high number of patients with uncontrolled anemia, Medicare records show. An administrator at Nephrocare said that none of the owners or staff would be interviewed, and several other large, independent centers around the city gave the same response.

There are no rules as to who can own or manage a dialysis center. Doctors control some. Others are run by people with no background in health care. State officials say they conduct a “character and competence” review, and look at owners’ finances.

Under Medicare rules, states must inspect most centers every three years, though troubled centers are visited more often. Even when there are persistent problems, regulators would rather coax a center into improving than shut it, even temporarily, because the dialysis supply barely keeps up with demand.

State officials said they could recall only one center being forced to close this decade, and Medicare gave that order, not the state. The experience was painful, they said, as patients had trouble finding other centers nearby with spaces, or stations, available.

“We had 403 people who had to find other stations in New York City,” said Mr. Hammond, the department spokesman, “and that is not something we encourage or want to happen.”

More on diabetes and disability

We just wanted to point out how pervasive diabetes is. As if you didn't know, we know, but here's one more point -- the article in today's New York Times "Costs of a Crisis: Diabetics Confront a Tangle of Workplace Laws" (see yesterday's blog for our take on the piece) is the top most-emailed article right now (right ahead of a much less important but also fantastic piece, "Say Yes to Mess").

Postscript - 12 hours later, still the top emailed piece...

Medical care - pay for performance?

Here's hoping we are nearing pay for performance for medical care - and how about pay for performance for paitents? There are a thousand reasons why this is difficult (what about the doctors that get the hardest to treat patients? what about the doctors that get only patients with complications, like very good endos sometimes do?) I'm not in favor of losing ourselves completely in paperwork, but doesn't it seem logical that practices with lower average a1cs and healthier patients deserve some reward - or at least, like below, that there is some way to make sure the feet of an average patient with diabetes are checked? Seems like we can't afford not to do this?!

Editorial, New York Times
Paying Doctors for Better Care

Published: December 26, 2006
Should doctors be paid in accord with how often they treat you — or how well they treat you? The answer presumably is a bit of both. Yet the current fee-for-service reimbursement systems used by Medicare and other insurance programs perversely reward doctors for the volume of services they provide and pay little or no attention to the quality of those services.

Indeed, a doctor who botches a surgical procedure, diagnostic test or drug prescription and then has to follow up with corrective action actually profits from his mistake. He gets paid for the botch-up and then again for mitigating the mistake.

Thus it is salutary that the last Congress, in its waning days, passed legislation that takes a modest step toward the goal of paying doctors based on the quality of their treatment. It authorizes Medicare to pay doctors a small bonus if they voluntarily report data on the quality of their care, like whether they prescribe recommended medications to heart attack victims or examine the feet of diabetic patients. If Congress decides to move the program forward, such data might in time be used to reward doctors who practice the best medicine.

Even this first step had some critics accusing Congress of trying to impose federally regulated “cookbook” medicine. But the notion of pegging reimbursement to performance has strong support from leaders in clinical and academic medicine, provided it is done carefully and in collaboration with credible experts who know good medicine from bad when they see it.

More than 100 pay-for-performance programs already exist, sponsored by health plans, employer groups and Medicare. Many take a graded approach: first paying doctors to report treatment data, then paying extra if they follow professionally derived standards of care, and finally paying more if they achieve successful outcomes — measured, for example, by patient satisfaction or by keeping people healthy enough to avoid hospitalization.

Patient advocacy groups like AARP and the Medicare Rights Center favor the approach. Some medical societies, like those representing anesthesiologists and thoracic surgeons, have been working on their own quality standards. A 2004 poll found that a large majority of practicing physicians supported payments based on quality of care.

There is a clear need to improve the quality of care in a medical system that — despite excellence at the very highest levels — permits an alarmingly high rate of medical errors that harm tens of thousands of patients and drive up costs substantially. We can only hope that this is a real reform in the making, not a passing fad in the endless struggle to improve the health care system.

NYT, Sonny Kleinfield on diabetes and laws

Very intriguing piece by legendary report NR "Sonny" Kleinfeld in tomorrow's NYT, mostly about how complicated companies are finding hiring people with diabetes. I get that it can be complicated and I find the story about Mr. Steigauf, who works at UPS, literally tragic.

I was a little disappointed that there was no mention that it is sometimes an advantage to companies to have someone on staff with diabetes because some actually figure a way to take better care of themselves than the would if they didn't have diabetes. True the insurance still has to cover insulin, glucose testing, etc.

I also have to say that I was pretty dispirited by Fran Carpentier's provocative statement that she'd think twice about hiring someone with diabetes. She's one of the most visible people with diabetes in media and if she says this, what does that say for people with diabetes? I personally would say, if there are problems, the workplace should figure it out, not just avoid hiring PWD - that's a better long term solution, especially since it won't really help to just avoid hiring diabetics (though that will probably happen more as a result of her statement) - workplaces will still have plenty of people develop diabetes while there and firing them really isn't an option. Would Carpentier also avoid anyone at risk? How would risk be assessed? Is it starting to feel like Big Brother? Here was her quote: 'Even an outspoken advocate for diabetics like Fran Carpentier, a Type 1 diabetic and a senior editor at Parade magazine, understands the implications for business. “Knowing what it’s like to live with the disease hour by hour, day by day, I wonder if I owned my own company if I would hire someone with diabetes,” she said. “I’m being bluntly honest. And it kills me to say this.”'

Kills her to say it? I wonder what her full quote was, it's possible it was taken a bit out of context ... but, I also know with quotes like that out there, I sure hope I'll never be applying for another job. But who cares about one person, I don't... the real point was that other employers could be pretty negatively influenced by that quote and that might be wrong. People will laud her for being open and honest - but what if someone had said that to people that hired her along the way? No question that some people with diabetes will be more expensive than others and no question that on average, people with diabetes are LOTs more expensive. That is a largely a system problem, rather than a problem that can be solved by individuals. Why not make a suggestion that could make a difference rather than essentially encourage employers to discriminate?

Sublimely depressing.

************

Costs of a Crisis - Diabetics in the Workplace Confront a Tangle of Laws

By N. R. KLEINFIELD
Published: December 26, 2006
MINNEAPOLIS — John Steigauf spent more than a decade fiddling with the innards of those huge United Parcel Service trucks until an icy day two years ago when the company put him on leave from his mechanic’s job. A supervisor escorted him off the premises.

Jamie Rose for The New York Times
A Fight for Fairness Shereen Arent, the director of legal advocacy for the American Diabetes Association, says confusion about the disease itself is a big part of the problem: “It’s not all about ignorance, but if I can get rid of ignorance, I can get rid of a lot of discrimination.”
Costs of a Crisis
Business Implications
Articles in this series are exploring the widening impact of the Type 2 diabetes epidemic.

Diabetes
Go to Complete Coverage »

James Estrin/The New York Times
Tainted by a Condition John Steigauf, a United Parcel Service mechanic in Minnesota, learned that he had diabetes five years ago and started using insulin two years ago. He was put on leave by U.P.S., which he considered discrimination.
His work was good. He hadn’t socked the boss or embezzled money. It had to do with what was inside him: diabetes.

U.P.S. framed it as a safety issue: Mr. Steigauf’s blood sugar might suddenly plummet while he tested a truck, causing him to slam into someone.

Mr. Steigauf considered it discrimination, a taint that diabetes can carry. “I was regarded as a damaged piece of meat,” he said. “It was like, ‘You’re one of those, and we can’t have one of those.’ ”

With 21 million American diabetics, disputes like this have increasingly rippled through the workplace:

¶A mortgage loan officer in Oregon was denied permission to eat at her desk to stanch her sugar fluctuations, and eventually was fired.

¶A Sears lingerie saleswoman in Illinois with nerve damage in her leg quit after being told she could not cut through a stockroom to reach her department.

¶A worker at a candy company in Wisconsin was fired after asking where he could dispose of his insulin needles.

In each instance, diabetics contend that they are being blocked by their employers from the near-normal lives their doctors say are possible. But the companies say they are struggling, too, with confusion about whether diabetes is a legitimate disability and with concern about whether it is overly expensive, hazardous and disruptive to accommodate the illness.

The debate will probably intensify. The number of diabetics in America swelled by 80 percent in the past decade. Experts say the disease is on its way to becoming a conspicuous fact of life in the nation’s labor force, raising all sorts of issues for workers and managers.

Even an outspoken advocate for diabetics like Fran Carpentier, a Type 1 diabetic and a senior editor at Parade magazine, understands the implications for business. “Knowing what it’s like to live with the disease hour by hour, day by day, I wonder if I owned my own company if I would hire someone with diabetes,” she said. “I’m being bluntly honest. And it kills me to say this.”

Doctors, though, say that with improved medications and methods of self-testing blood sugar, most diabetics can do almost any job if they properly manage their illness. Yet myths about the disease persist, advocates say, leading many companies to shun diabetic employees.

“It’s not all about ignorance, but if I can get rid of ignorance, I can get rid of a lot of discrimination,” said Shereen Arent, the director of legal advocacy for the American Diabetes Association.

Part of the confusion is a byproduct of the disease itself, a capricious illness of elevated, damaging levels of sugar in the blood. Type 1 is a malfunction of the immune system that usually appears in childhood, while the far more prevalent Type 2 is closely associated with obesity and inactivity. Many people with diabetes will face withering complications like blindness, amputations and heart disease. Others will not.

For some, particularly insulin users prone to the abnormal drops in blood sugar known as hypoglycemia, the illness can cause dizziness, fainting or muddled judgment. Doctors, however, say those constitute a tiny number of readily identifiable cases.

Nonetheless, the risk of plunging blood sugars has fueled a longstanding reluctance to employ diabetics in jobs like those of truck driver or police officer, if they are on insulin. Until this summer, the National Fire Protection Association cautioned against making it too easy for even non-insulin-dependent diabetics to become firefighters. Now the association recommends an individual assessment.

Federal law bars diabetics from joining the armed services and prevents diabetics on insulin from becoming commercial pilots.

Innumerable diabetics, though, are engaged in more mundane jobs uninvolved in matters of life and death. For these people, secretaries and factory workers and programmers, a “reasonable accommodation,” like permission to eat at one’s desk or to be excused from fluctuating shifts, can make the difference in whether they can function.

When disputes can’t be resolved, the cases often land in court or before the Equal Employment Opportunity Commission. The commission, which enforces the Americans With Disabilities Act of 1990, says diabetes-related complaints have been on the rise, one of the few conditions generally showing an increase in complaints. Diabetes accounts for nearly 5 percent of the 15,000 annual allegations that the commission gets under that act, trailing only back impairment, other orthopedic injuries and depression.

Often the courts are of scant help in bringing clarity. Mr. Steigauf has spent two years trying to thread his way through the disability discrimination law. The federal law can be fuzzy, for it mentions no illness or handicap by name but supplies a legal test under which plaintiffs must usually demonstrate that a “major life activity,” like walking or vision, is “substantially limited.”

This is easy enough for anyone who has lost sight or a limb. But the restrictions of diabetes are often invisible. Diabetics thus can find themselves teetering on a balance beam, needing to prove they are disabled enough to fit under the law but not so impaired that they can’t do a job.

Judges in nearly identical cases have ruled in completely opposite ways, leaving diabetics bewildered and businesses unsure what, if anything, they should do. While some courts, for example, have held that the eating restrictions diabetics face satisfy the substantial limitation, others have disagreed.

“Usually the battle is over that word, ‘substantially,’ ” said Craig A. Crispin, an Oregon employment lawyer. “If you say the person is disabled because of the impact on eating, the other side will say: ‘Hey, look, she’s eating a sandwich. Where’s the disability?’ ”

Seeking Accommodations

The quarrels are as varied as working life: a musician rejected for a cruise ship’s cabaret band, baggage handlers and plane cleaners fired by an airline, a blackjack dealer dismissed by a casino.

The American Diabetes Association fields about 100 calls a month about workplace tussles like these. Many of them revolve around accommodations, though the changes sought tend to be modest: predictable hours, a place to test blood, freedom to snack when sugars get unbalanced.

Companies often cite workplace safety as their paramount concern, though there is little hard evidence to suggest that diabetics are a risk.

In one case in 2002, ConAgra Foods withdrew a job offer to Rudy Rodriguez at a Texas baked bean plant after a physical suggested that his Type 2 diabetes was so out of control that he was a hazard. Mr. Rodriguez had performed fine as an interim laborer, but the examining doctor declared there was nowhere he could safely work “outside of a padded room where he could even then fall and break his neck from dizziness or fainting.”

An appeals court found otherwise and held that ConAgra had violated the law. The case was settled, and Mr. Rodriguez now works for a printer.

“Some people who have a problem with hypoglycemia should not be doing public safety-type jobs,” said John W. Griffin Jr., a lawyer from Texas with Type 2 diabetes who handles discrimination cases. “But I guarantee you that that baked bean factory was not public safety.”

There has been other progress for diabetics: the San Antonio Police Department’s barring of diabetics on insulin was struck down. Insulin-using diabetics in good control of their illness can get private pilot’s licenses.

In the lingerie saleswoman’s case, Sears agreed to a consent decree awarding the woman $150,000 and stipulating that the store train supervisors about disability discrimination.

Employers, however, prevail in a vast majority of cases (many are settled). It is hard even to get lawyers to pursue complaints since prejudice is tricky to prove. Establishing discrimination has become harder since 1999, when the Supreme Court held that if a disability can be corrected with medicine or things like prostheses, it is not necessarily protected. Advocates for the disabled say the ruling warped the intent of Congress.

Ruth Colker, a law professor at Ohio State University who studies disability discrimination, said that very few working people with diabetes now find themselves guarded by the law.

Judges, in fact, have deemed these diabetics not disabled: a Maine store manager who had trouble walking because of poor circulation, and a New York security guard without vision in one eye and declining vision in the other who had four episodes of hypoglycemia in two years.

In some instances, employers have said they took action against an employee because of diabetes, but the court still found that the worker was not disabled and threw out the case.

“There’s not a remedy for every wrong,” said David A. Copus, a lawyer who represents employers and specializes in disability issues. “There are employers who don’t like ugly people. They’re not protected by the law.”

Mr. Copus said he was not unsympathetic. His father had diabetes; it was very debilitating.

Wary of bad outcomes, many diabetics conceal their illness on the job. Brian T. McMahon, a professor at Virginia Commonwealth University who studies workplace discrimination, said: “You get to the question of whether or not to disclose you have diabetes. Most people opt not to, for they fear: Am I inviting more trouble?”

Figuring Employer Costs

There was a time, four or five decades ago, when you wouldn’t find one diabetic on the entire floor of a factory. Now, Type 2 diabetics are commonplace. It is not only the ascendancy of the disease, but also the fact that a condition once considered a corollary to old age is striking people sooner, catching them long before retirement. And this comes as companies are already struggling to balance productivity in the workplace with soaring medical costs.

To understand the brutal math of diabetes, all a business has to do is consult the Web site diabetesatwork.org, set up by the government to furnish advice on addressing diabetes in the workplace. One of its tools is a calculator that uses rough assumptions to suggest what costs might be involved.

Businesses plug in the number of employees, the tally is multiplied by 8.2 percent (a slightly dated national prevalence rate for diabetes), then that figure is multiplied by $13,243, an estimate for yearly medical costs of a diabetic. Voilà: the price tag of diabetes. It is a burden more than five times that of workers without diabetes.

Ron Z. Goetzel, a vice president for Thomson Medstat, which analyzes health care costs for businesses, said that if absenteeism and productivity losses are added, diabetes ranks third among major conditions as an economic cost to employers, after heart disease and hypertension.

Companies have only started to reckon with this, and with the disease’s ancillary concerns. Even if advocates say safety is rarely a factor, companies argue they cannot take chances with some types of workers, like school bus drivers or even pizza deliverers.

Concessions may seem small — for example, granting a bank teller more frequent breaks — but many employers contend that if rules bend for one person, then that breeds resentment among other employees. Co-workers cannot see the diabetes, and if an employer gives preferential treatment to a diabetic worker, it cannot legally tell other workers it is because of the diabetes. Companies feel that indulging all diabetics trivializes the meaning of disability and of fairness.

“It comes down to how many extra points do I give you,” said William J. Kilberg, a Washington employment lawyer. “Why is everybody a victim?”

He said too many people who are not disabled demand special favors. “I mean, I wear eyeglasses,” he said.

In addition to the threat of a suit under federal or state disability law, businesses must grapple with the Family and Medical Leave Act, which requires them to grant unpaid leave to ill workers. That can create scheduling difficulties.

“This whole area gets complicated, because the medical leave act can mean employees absent from the workplace for extended periods,” said Stephen A. Bokat, general counsel for the United States Chamber of Commerce. “That bothers employers even more than an employee needing a half-hour during the day to administer some insulin.”

Health care consultants urge companies to become proactive, try to use tools like wellness programs to forestall diabetes’ claim on their workers and install disease management programs to improve existing cases. And many do. Companies dangle $100 incentives (though more often a mug or a T-shirt) if an employee submits to a health assessment or accepts a phone call from a health coach.

But getting participation is hard. And the economic worth of these undertakings to a business is difficult to gauge with a progressive disease like diabetes. Sometimes the evident benefits of in-house health programs are years down the road, when an employee a business invested in may well be working elsewhere.

When Safety Comes First

John Steigauf’s fellow mechanics called him “Flunky.” The name caught on after Mr. Steigauf gave advice to a prickly supervisor, who thundered, “I’m not going to let some flunky mechanic tell me how to do my job.” Mr. Steigauf, 47, wanted it embroidered onto his uniform. Supervisors said forget it.

He joined United Parcel in Minneapolis in 1991, turning wrenches from the start. Five years ago, he learned that he had Type 2 diabetes. Though it often goes with being overweight, he had a wide receiver’s build: 6-foot-2, 193 pounds. But his mother had diabetes.

He was put on pills and watched his diet, abandoning his cherished hot chocolate. Yet his blood sugar remained high. If it didn’t drop, he would need insulin. That sent fear pumping through him.

U.P.S. requires mechanics, like its interstate drivers, to hold a commercial driver’s license and to be cleared to drive out of state so they can road-test trucks. In reality, mechanics could go weeks without leaving the yard, but those were the rules. And at the time, federal officials did not grant interstate licenses to insulin-using diabetics.

They did dispense a few exemptions. But Mr. Steigauf, who started using insulin only in 2004, stood no chance. The requirement was to have driven safely while on insulin for three years.

So Mr. Steigauf tried starving himself, slicing off 30 pounds. It made him crabby, fatigued and so thin “that if I stuck my tongue out, I looked like a zipper.”

His blood sugars did not budge. But after he took insulin, his diabetes settled down almost at once.

Later in 2004, he had to have a physical to renew his commercial license, a test he could no longer pass. Minnesota did not have the three-year rule, and since he had never had a hypoglycemic episode or other problems, Mr. Steigauf got an exemption to drive within the state. Given that he didn’t even leave the county while road-testing trucks, he hoped that would be good enough.

It wasn’t. For consistency, U.P.S. wanted all its mechanics to be certified to drive from state to state, whether they needed to or not. So Mr. Steigauf was sent home on disability, even though he felt fine.

Norman Black, a U.P.S. spokesman, said the company had always intended to find Mr. Steigauf another position. He said the company did not discriminate but was passionate about safety.

Studies tracking accident rates of diabetics are inconclusive; some indicate worse outcomes, others don’t. But either way, Mr. Steigauf’s direct supervisor at the time, Dan Welke, said he thought the company had gone too far, that somebody else could road-test the trucks repaired by Mr. Steigauf.

“It just seemed ridiculous,” Mr. Welke said.

Mr. Steigauf also had trouble making sense of this. When his diabetes raged out of control, it had been all right to fix trucks. Now, with the illness under control, it wasn’t.

When he spoke to someone in human resources, Mr. Steigauf said he was told that he would never come back. The notion that he was a human tinderbox punctuated his interactions. “I’d be told that I could pull a tractor up to a fuel pump and pass out and the thing would explode,” he said. “I was like a grenade and was going to kill people.”

At home in Bloomington, Minn., where Mr. Steigauf’s tidy ranch is bordered by a soupçon of lawn, he, his wife, Dawn, their twin daughters and their severely autistic son struggled on a weekly disability check of $431, about half his old pay.

To keep going, he did odd jobs. Friends at U.P.S. dug into their pockets. The family cut one another’s hair and skipped sending Christmas cards.

Finally, Mr. Steigauf asked U.P.S. to excuse him from interstate driving as a “reasonable accommodation” under disability law. After all, he had left the state for U.P.S. only once in 13 years. Some of his colleagues, he found out, did not even have commercial driver’s licenses.

But U.P.S. refused, saying he was not disabled under discrimination law, and thus not entitled to an accommodation.

So, in early 2005, he filed a complaint with the Equal Employment Opportunity Commission and waited, interned in his house, as if he had evaporated — all the while collecting disability from a company that said he was not disabled.

After seven months, U.P.S. offered him a lower-paying job, fixing trailers. He could not touch an engine or drive. But he took it while he battled for his former position.

Then he had some luck. Federal officials changed their rules on interstate licenses and Mr. Steigauf qualified for a waiver, allowing him to return to his old job. He is expected to start within a month or so.

This fall, the E.E.O.C. concluded that he had been discriminated against and that U.P.S. owed him relief. U.P.S. said it would contest the decision.

Mr. Steigauf is still bitter, not toward U.P.S. itself, but toward the way he believes it treats diabetics. Even now, he feels singled out.

“I’ve had unloaders at work say to me, ‘Are you that diabetic guy?’ ” he said. “I don’t know what they mean. Nothing? Or, ‘You shouldn’t be working here’?”

To keep his exemption, he must obey a complicated protocol to show the Federal Motor Carrier Safety Administration that he remains fit. Every three months, he has to report how much he drives and his sugar levels. If he has an accident, even if someone rams his car while he’s in a movie, he has two days to alert the government. He has seven days to let the government know if he has a new car or a new phone number.

“The exemption adds to the discrimination,” he said one afternoon at home. “It constantly reminds me that I’m different.”

His children skittered through the room.

“You become a show dog,” he said. “I fix engines. I don’t want to be a show dog.”

UN resolution on diabetes passed!

Novo Nordisk issued a press release earlier this week regarding the exciting news that the General Assembly of the United Nations (UN) adopted a Resolution on diabetes on December 20, 2006. We loved this news and give big credit to the IDF (international diabetes federation), diabetes advocates Kari and Clare Rosenfeld whose idea this was, and many doctors and researchers and workers in diabetes who helped make it happen, particularly incoming IDF President Dr. Martin Silink. What does this resolution do? It brings diabetes out of the shadows, as Clare told us in an interview earlier this week for Diabetes Close Up. Why? The Resolution recognized for the first time that this chronic disease is as serious a threat to global health as infectious epidemics. It designats the IDF World Diabetes Day, November 14, as a United Nations Day to be observed beginning in 2007. Finally, it calls on all nations to develop national policies for the prevention, treatment, and care of diabetes.

The IDF-led “Unite for Diabetes” campaign has been working since June 10, 2006 for the passage of this Resolution. The IDF launched the campaign at the 2006 ADA meeting, in Washington DC, on June 10, 2006. Top corporate sponsors for the campaign include GSK, J&J, Lilly, Merck, Novo Nordisk, and Pfizer as well as Bayer, Novartis, and Sanofi-Aventis and Abbott Diabetes Care. The People’s Republic of Bangladesh sponsored the Resolution at the UN until it was accepted by the G77 (a coalition of 133 developing and transitional countries led by the Republic of South Africa).

As we saw in Capetown earlier this month, the “Unite for Diabetes” campaign received a great deal of attention this year. Dr. Martin Slink devoted his inaugural address at the closing session of the conference to the importance of this campaign. Dr. Slink said that his first priority as IDF president would be the passage of this Resolution – we’re surprised and thrilled that it happened so quickly, which by most estimates was ahead of expectations.

This provides a good platform for diabetes we think and means more publicity for diabetes - just in time, as we also noted recently a more sobering fact - diabetes now takes more lives than AIDS. Sobering, indeed.

NYT on Lilly's Zyprexa - unsettling at best

Veteran New York Times reporter Alex Berenson wrote a piecing overview of Lilly in Sunday's paper, with another one following today (see both below) charging essentially that the insulin manufacturer ignored - and kept from doctors and nurses - the risks of Zyprexa and also that they encouraged broad off-label use of the medicne. I've always vaguely known about the association of Zyprexa and weight gain, but that 30% of those who take it gain 22 pounds or more - I had no idea the extent of the problem. That so many develop diabetes (direct effect assumed) on Zyprexa is bad but if Lilly tried to mask this, that is what is really unsettling. It will be interesting to see if another ax falls tomorrow.

December 17, 2006
Eli Lilly Said to Play Down Risk of Top Pill

By ALEX BERENSON
The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.

The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.

Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.

Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.

Critics, including the American Diabetes Association, have argued that Zyprexa, introduced in 1996, is more likely to cause diabetes than other widely used schizophrenia drugs. Lilly has consistently denied such a link, and did so again on Friday in a written response to questions about the documents. The company defended Zyprexa’s safety, and said the documents had been taken out of context.

But as early as 1999, the documents show that Lilly worried that side effects from Zyprexa, whose chemical name is olanzapine, would hurt sales.

“Olanzapine-associated weight gain and possible hyperglycemia is a major threat to the long-term success of this critically important molecule,” Dr. Alan Breier wrote in a November 1999 e-mail message to two-dozen Lilly employees that announced the formation of an “executive steering committee for olanzapine-associated weight changes and hyperglycemia.” Hyperglycemia is high blood sugar.

At the time Dr. Breier, who is now Lilly’s chief medical officer, was the chief scientist on the Zyprexa program.

In 2000, a group of diabetes doctors that Lilly had retained to consider potential links between Zyprexa and diabetes warned the company that “unless we come clean on this, it could get much more serious than we might anticipate,” according to an e-mail message from one Lilly manager to another.

And in that year and 2001, the documents show, Lilly’s own marketing research found that psychiatrists were consistently saying that many more of their patients developed high blood sugar or diabetes while taking Zyprexa than other antipsychotic drugs.

The documents were collected as part of lawsuits on behalf of mentally ill patients against the company. Last year, Lilly agreed to pay $750 million to settle suits by 8,000 people who claimed they developed diabetes or other medical problems after taking Zyprexa. Thousands more suits against the company are pending.

On Friday, in its written response, Lilly said that it believed that Zyprexa remained an important treatment for patients with schizophrenia and bipolar disorder. The company said it had given the Food and Drug Administration all its data from clinical trials and reports of adverse events, as it is legally required to do. Lilly also said it shared data from literature reviews and large studies of Zyprexa’s real-world use.

“In summary, there is no scientific evidence establishing that Zyprexa causes diabetes,” the company said.

Lilly also said the documents should not have been made public because they might “cause unwarranted fear among patients that will cause them to stop taking their medication.”

As did similar documents disclosed by the drug maker Merck last year in response to lawsuits over its painkiller Vioxx, the Lilly documents offer an inside look at how a company marketed a drug while seeking to play down its side effects. Lilly, based in Indianapolis, is the sixth-largest American drug maker, with $14 billion in revenue last year.

The documents — which include e-mail, marketing material, sales projections and scientific reports — are replete with references to Zyprexa’s importance to Lilly’s future and the need to keep concerns about diabetes and obesity from hurting sales. But that effort became increasingly difficult as doctors saw Zyprexa’s side effects, the documents show.

In 2002, for example, Lilly rejected plans to give psychiatrists guidance about how to treat diabetes, worrying that doing so would tarnish Zyprexa’s reputation. “Although M.D.’s like objective, educational materials, having our reps provide some with diabetes would further build its association to Zyprexa,” a Lilly manager wrote in a March 2002 e-mail message.

But Lilly did expand its marketing to primary care physicians, who its internal studies showed were less aware of Zyprexa’s side effects. Lilly sales material encouraged representatives to promote Zyprexa as a “safe, gentle psychotropic” suitable for people with mild mental illness.

Some top psychiatrists say that Zyprexa will continue to be widely used despite its side effects, because it works better than most other antipsychotic medicines in severely ill patients. But others say that Zyprexa appears no more effective overall than other medicines.

And some doctors who specialize in diabetes care dispute Lilly’s assertion that Zyprexa does not cause more cases of diabetes than other psychiatric drugs. “When somebody gains weight, they need more insulin, they become more insulin resistant,” Dr. Joel Zonszein, the director of the clinical diabetes center at Montefiore Medical Center in the Bronx, said when asked about the drug.

In 2003, after reviewing data provided by Lilly and other drug makers, the F.D.A. said that the current class of antipsychotic drugs may cause high blood sugar. It did not specifically single out Zyprexa, nor did it say that the drugs had been proven to cause diabetes.

The drugs are known as atypical antipsychotics and include Johnson & Johnson’s Risperdal and AstraZeneca’s Seroquel. When they were introduced in the mid-1990s, psychiatrists hoped they would relieve mental illness without the tremors and facial twitches associated with older drugs. But the new drugs have not proven significantly better and have their own side effects, said Dr. Jeffrey Lieberman, the lead investigator on a federally sponsored clinical trial that compared Zyprexa and other new drugs with one older one.

The Zyprexa documents were provided to the Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will. Mr. Gottstein said the information in the documents raised public health issues.

“Patients should be told the truth about drugs like Zyprexa,” Mr. Gottstein said.

Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits.

In its statement, Lilly called the release of the documents “illegal.” The company said it could not comment on specific documents because of the continuing product liability suits.

In some ways, the Zyprexa documents are reminiscent of those produced in litigation over Vioxx, which Merck stopped selling in 2004 after a clinical trial proved it caused heart problems. They treat very different conditions, but Zyprexa and Vioxx are not entirely dissimilar. Both were thought to be safer than older and cheaper drugs, becoming bestsellers as a result, but turned out to have serious side effects.

After being pressed by doctors and regulators, Merck eventually did test Vioxx’s cardiovascular risks and withdrew the drug after finding that Vioxx increased heart attacks and strokes.

Lilly has never conducted a clinical trial to determine exactly how much Zyprexa raises patients’ diabetes risks. But scientists say conducting such a study would be exceedingly difficult, because diabetes takes years to develop, and it can be hard to keep mentally ill patients enrolled in a clinical trial.

When it was introduced, Zyprexa was the third and most heralded of the atypical antipsychotics. With psychiatrists eager for new treatments for schizophrenia, bipolar disorder, and dementia, Zyprexa’s sales soared.

But as sales grew, reports rolled in to Lilly and drug regulators that the medicine caused massive weight gain in many patients and was associated with diabetes. For example, a California doctor reported that 8 of his 35 patients on Zyprexa had developed high blood sugar, including two who required hospitalization.

The documents show that Lilly encouraged its sales representatives to play down those effects when talking to doctors. In one 1998 presentation, for example, Lilly said its salespeople should be told, “Don’t introduce the issue!!!” Meanwhile, the company researched combinations of Zyprexa with several other drugs, hoping to alleviate the weight gain. But the combinations failed.

To reassure doctors, Lilly also publicly said that when it followed up with patients who had taken Zyprexa in a clinical trial for three years, it found that weight gain appeared to plateau after about nine months. But the company did not discuss a far less reassuring finding in early 1999, disclosed in the documents, that blood sugar levels in the patients increased steadily for three years.

In 2000 and 2001, more warning signs emerged, the documents show. In four surveys conducted by Lilly’s marketing department, the company found that 70 percent of psychiatrists polled had seen at least one of their patients develop high blood sugar or diabetes while taking Zyprexa, compared with about 20 percent for Risperdal or Seroquel. Lilly never disclosed those findings.

By mid-2003, Lilly began to change its stance somewhat, publicly acknowledging that Zyprexa can cause severe obesity. Marketing documents make clear that by then Lilly believed it had no choice. On June 23, 2003, an internal committee reported that Zyprexa sales were “below plan” and that doctors were “switching/avoiding Zyprexa.”

Since then, Lilly has acknowledged Zyprexa’s effect on weight but has argued that it does not necessarily correlate to diabetes. But Zyprexa’s share of antipsychotic drug prescriptions is falling, and some psychiatrists say they no longer believe the information Lilly offers.

“From my personal experience, at first my concerns about weight gain with this drug were very significantly downplayed by their field representatives,” said Dr. James Phelps, a psychiatrist in Corvallis, Or. ‘Their continued efforts to downplay that, I think in retrospect, was an embarrassment to the company.”

Dr. Phelps says that he tries to avoid Zyprexa because of its side effects but sometimes still prescribes it, especially when patients are acutely psychotic and considering suicide, because it works faster than other medicines.

“I wind up using it as an emergency medicine, where it’s superb,” he said. “But I’m trying to get my patients off of Zyprexa, not put them on.”

Drug Files Show Maker Promoted Unapproved Use

By ALEX BERENSON
Eli Lilly encouraged primary care physicians to use Zyprexa, a powerful drug for schizophrenia and bipolar disorder, in patients who did not have either condition, according to internal Lilly marketing materials.

The marketing documents, given to The New York Times by a lawyer representing mentally ill patients, detail a multiyear promotional campaign that Lilly began in Orlando, Fla., in late 2000. In the campaign, called Viva Zyprexa, Lilly told its sales representatives to suggest that doctors prescribe Zyprexa to older patients with symptoms of dementia.

A Lilly executive said that she could not comment on specific documents but that the company had never promoted Zyprexa for off-label uses and that it always showed the marketing materials used by its sales representatives to the Food and Drug Administration, as required by law.

“We have extensive training for sales reps to assure that they provide information to the doctors that’s within the scope of the prescribing information approved by the F.D.A.,” Anne Nobles, Lilly’s vice president for corporate affairs, said in an interview yesterday.

Zyprexa is not approved to treat dementia or dementia-related psychosis, and in fact carries a prominent warning from the F.D.A. that it increases the risk of death in older patients with dementia-related psychosis. Federal laws bar drug makers from promoting prescription drugs for conditions for which they have not been approved — a practice known as off-label prescription — although doctors can prescribe drugs to any patient they wish.

Yet in 1999 and 2000 Lilly considered ways to convince primary care doctors that they should use Zyprexa on their patients. In one document, an unnamed Lilly marketing executive wrote that these doctors “do treat dementia” but “do not treat bipolar; schizophrenia is handled by psychiatrists.”

As a result, “dementia should be first message,” of a campaign to primary doctors, according to the document, which appears to be part of a larger marketing presentation but is not marked more specifically.

Later, the same document says that some primary care doctors “might prescribe outside of label.”

Ms. Nobles said that the company had never promoted its drug for any conditions except schizophrenia and bipolar disorder. Older patients who seem to have dementia may actually have schizophrenia that has gone untreated, Ms. Nobles said.

Several psychiatrists outside the company said yesterday that they strongly disagreed with Lilly’s claim. Schizophrenia is a severe disease that is almost always diagnosed when patients are in their teens or 20s. Its symptoms could not be confused with mild dementia, these doctors said.

Zyprexa is by far Lilly’s best-selling product, with $4.2 billion in sales in 2005, 30 percent of its overall revenues. About two million people worldwide received it last year. Based in Indianapolis, Lilly is the sixth-largest American drug company.

The issue of off-label marketing is controversial in the drug industry. Nearly every company is under either civil or criminal investigation for alleged efforts to expand the use of its drugs beyond the specific illness or condition for which they are approved.

Lilly faces federal and state investigations over its marketing of Zyprexa. In its annual report for 2005, Lilly said that it faced an investigation by federal prosecutors in Pennsylvania and that the Florida attorney general’s office had subpoenaed the company “seeking production of documents relating to sales of Zyprexa and our marketing and promotional practices with respect to Zyprexa.”

Since Lilly introduced Zyprexa in 1996, about 20 million patients worldwide have received the drug, which helps control the hallucinations and delusions associated with schizophrenia and severe mania. But Zyprexa also causes weight gain in many patients, and the American Diabetes Association found in 2004 that Zyprexa was more likely to cause diabetes than other widely used drugs for schizophrenia.

Lilly says that no link between Zyprexa and diabetes has been proven.

As part of the “Viva Zyprexa” campaign, in packets for its sales representatives, Eli Lilly created the profiles of patients whom it said would be suitable candidates for Zyprexa. Representatives were told to discuss the patient profiles with doctors. One of the patients was a woman in her 20s who showed mild symptoms of schizophrenia, while another was a man in his 40s who appeared to have bipolar disorder.

The third patient was “Martha,” a widow with adult children “who lives independently and has been your patient for some time.” Martha was described as being agitated and having disturbed sleep, but without the symptoms of paranoia or mania that typically marked a person with schizophrenia or bipolar disorder.

Ms. Nobles said that Lilly had actually intended Martha’s profile to represent a patient with schizophrenia. But psychiatrists outside the company said this claim defied credibility, especially given Martha’s age. Instead, she appeared to have mild dementia, they said.

“It’d be very unusual for this to be a schizophrenic patient,” said Dr. John March, chief of child and adolescent psychiatry at Duke University medical center. “Schizophrenia is a disease of teenagers and young adults.” Dr. March serves on Lilly’s scientific advisory board.

Diagnostic criteria for schizophrenia include delusions, hallucinations, disorganized and incoherent speech, and grossly disorganized behavior. They also include so-called negative symptoms like social isolation and a flattening of the voice and facial expressions.

The documents also show that Lilly encouraged primary care doctors to treat the symptoms and behaviors of schizophrenia and bipolar disorder even if the doctors had not actually diagnosed those diseases in their patients. Lilly’s market research had found that many primary care doctors did not consider themselves qualified to treat people with schizophrenia or severe bipolar disorder.

The campaign was successful, the documents show. By March 2001, about three months after the start of Viva Zyprexa, the campaign had led to 49,000 new prescriptions, according to a presentation that Michael Bandick, the brand manager for Zyprexa, gave at a national meeting of Lilly sales representatives in Dallas. Mr. Bandick did not say how many of those new prescriptions were for older patients with dementia.

Over all, sales of Zyprexa doubled between 1999 and 2002, rising from $1.5 billion to $3 billion in the United States. In 2002, the company changed the name of the primary care campaign to “Zyprexa Limitless” and began to focus on people with mild bipolar disorder who had previously been diagnosed as depressed — even though Zyprexa has been approved only for the treatment of mania in bipolar disorder, not depression.

In a 2002 guide for representatives, Lilly presented the profile of “Donna,” a single mother in her mid-30s whose “chief complaint is, ‘I feel so anxious and irritable lately.’ ” Several doctors’ appointments earlier, she was “talkative, elated, and reported little need for sleep.”

Lilly’s efforts to promote Zyprexa to primary care doctors disturbed some physicians, the documents show. In August 2001, a doctor in Virginia sent an e-mail message to Lilly and the F.D.A., complaining about a presentation from a Lilly sales representative who had discussed the hypothetical Martha with him.

The representative “presented an elderly female patient who was presented to her physician by her family complaining of insomnia, agitation, slight confusion, and had no physical finding to explain her state,” the doctor wrote. The representative then suggested that the doctor prescribe Zyprexa.

“I inquired what Zyprexa was indicated for she then indicated that many physicians might prescribe an antipsychotic for this patient. I then asked for her package insert and read to her that her product was indicated for schizophrenia and bipolar mania — neither of which the presented patient had been diagnosed with,” the doctor wrote.

He added that he had never contacted the F.D.A. before but was “genuinely concerned about the promotion of this powerful drug to my peer community of primary care physicians outside of its approved and intended purpose.”

Tara Ryker, a spokeswoman for Lilly, said the company no longer uses “Martha” or “Donna” in its marketing. “We are constantly developing new promotional materials and new profiles,” she said.

The Zyprexa documents were provided to The Times by James B. Gottstein, a lawyer who represents mentally ill patients and has sued the state of Alaska over its efforts to force patients to take psychiatric medicines against their will.

Mr. Gottstein said yesterday that the information in the documents should be available to patients and doctors, as well as judges who oversee the hearings that are required before people can be forced to take psychiatric drugs.

“The courts should have this information before they order this stuff injected into people’s unwilling bodies,” Mr. Gottstein said.

Lilly originally provided the documents, under seal, to plaintiffs lawyers who sued the company claiming their clients developed diabetes from taking Zyprexa. Last year, Lilly agreed to pay $700 million to settle about 8,000 of the claims, but thousands more are pending. Mr. Gottstein, who is not subject to the confidentiality agreement that covers the product liability suits, subpoenaed the documents in early December from a person involved in the suits.

The “Viva Zyprexa” documents also provide color about Lilly’s efforts to motivate its sales force as they marketed Zyprexa — whose generic name is olanzapine — to primary care doctors.

At the 2001 meeting in Dallas with Zyprexa sales representatives, Mr. Bandick praised 16 representatives by name for the number of prescriptions they had convinced doctors to write, according to a script prepared in advance of the meeting. More than 100 other representatives had convinced doctors to write at least 16 extra prescriptions and thus “maxed out on a pretty sweet incentive,” he said.

“Olanzapine is the molecule that keeps on giving,” Mr. Bandick said.

Seattle Times on Medtronic - not a case...

There was an article in today's NYT about a woman who used a Medtronic pump but didn't have a safety feature set - see below. The article seems to imply that this is Medtronic's fault, which seems absurd. Anyone who gets a pump is responsible for knowing how it works and how it operates. Although doctors and nurses can help with that, in my view, it's part of the burden of being diabetic to figure out how to best take care of yourself. It's well-documented how having diabetes is so like walking a tightrope - ironically too much careful care can prompt serious hypoglycemia. For the Seattle Times to imply that it is Medtronic's fault that the woman slipped into a hypoglycemic coma is wrong - if more people are successful at sueing companies for behavior that went wrong that is ultimately their own responsibility, then pretty soon we'll have companies deem it not worth it to even make these devices. Similarly, is it the doctor's or nurse's fault? I don't think so. They can't foresee every problem - that's why the patients have instruction manuals. The companies do have a responsibility to make sure the manual is clear and understandable but beyond that, I think patients can take responsibility for their own care - they need t, no one else will, and resorting to suing seems going far too far ....

Your Courts, Their Secrets
Woman's coma leads to secrecy, silence
By Ken Armstrong and Justin Mayo

Sylvia Lane, a diabetic, lay in her apartment bed in Lynnwood, comatose and alone, her blood and brain in desperate need of sugar.

But the medical device she'd just received instead kept pumping insulin into her body, pumping and pumping, starving her brain and making it more unlikely she would ever wake up.

Lane was 17 weeks pregnant. Her husband was on an aircraft carrier, halfway round the world. Relatives were calling but getting no answer.

The pump, about the size of a cellphone, had a safety feature designed to stop the insulin flow in emergencies like this. But the feature wasn't on. The pump had been shipped to Lane with the option turned off, and the device's instructional video devoted only 15 seconds to it, saying nothing about why the feature should be used.

Ultimately, Lane suffered severe and permanent brain damage. Her family sued Medtronic Inc. — the parent company of the pump's manufacturer — alleging the pump was unsafe. Medtronic had already sold 150,000 insulin pumps in the United States.

A "defective" product — but what product?

Four years ago, a lawsuit alleged that a medical device was unsafe and that the University of Washington Medical Center had committed malpractice. But the whole file was sealed. Under a public-disclosure request, The Seattle Times got a copy of the complaint from the UW — but almost every meaningful detail was blacked out, including the name of the medical device.

What happened to Sylvia Lane could have yielded insight into the pump's design and instructions, alerting patients and health-care providers to the importance of this safety feature, originally called a "Deadman's Switch."

But when Medtronic settled the lawsuit three years ago, the entire court file was improperly sealed, hiding every allegation and discovery behind an electronic password.

What's more, Medtronic failed to disclose Lane's injury to the federal government, which uses such reports to spot problems with medical devices and to protect the public.

Lawsuits and regulatory reports allow patterns to emerge and warnings to sound. Here, there was merely secrecy and silence.

The Seattle Times got this file opened three months ago as part of a continuing investigation of improperly sealed court records.

Lane's family also sued the state of Washington, alleging the University of Washington Medical Center committed medical malpractice while instructing Sylvia on the pump's use. The state settled, using taxpayer dollars. But the UW, despite being asked for all its records a year ago, has yet to reveal the amount.

The following account relies on the court file. The lawyer for Lane's family said he cannot comment, nor can the family, because the parties agreed to confidentiality as a condition of settlement. Medtronic also declined comment, citing the settlement agreement and Lane's privacy.

A pump that mimics the pancreas

Michael Lane and Sylvia got married in 1989, then moved about as his Navy career dictated. In 1995, they were living in Naples, Italy. That's when Sylvia learned she had type 1 diabetes.

Her pancreas didn't work. It wasn't producing the insulin she needed.

Glossary

Diabetes: A disease in which the body cannot properly convert sugar, starches and other food into energy. An estimated 20.8 million adults and children in the United States are diabetic. Long-term complications include heart disease, blindness, kidney damage and amputations. There are three major types: type 1, type 2 and gestational diabetes.

Insulin: Insulin is a hormone normally produced by the pancreas that helps convert sugar from food into energy the body uses. The pancreas releases more insulin when blood sugar goes up, and less as blood sugar drops.

Type 1 diabetes: People with type 1 diabetes have a pancreas that doesn't produce insulin. To survive, type 1 diabetics must get insulin from daily injections or an insulin pump. An estimated 5 percent to 10 percent of Americans diagnosed with diabetes are type 1.

Hypoglycemia: Hypoglycemia is a condition in which blood sugar is too low. If untreated, it may lead to unconsciousness, coma or death. Diabetics that become hypoglycemic need to eat or drink something to raise their blood sugar.

Source: American Diabetes Association

Insulin, a hormone, counteracts rising blood sugar. When blood sugar goes up, a healthy pancreas releases more insulin. When blood sugar goes down — during sleep, for example — insulin production decreases. The pancreas acts as a regulator, keeping blood sugar from going too high or low, either of which can mean sickness or death.

Sylvia now needed to inject herself with insulin, using a syringe.

The couple moved to Washington in 2000. In August of that year, Sylvia, then 34, learned she was pregnant. Soon after, Michael, a lieutenant, left for duty in the Persian Gulf.

Sylvia lived alone in their Lynnwood apartment.

Because her blood sugar wasn't under control, Sylvia went to the UW's Diabetes in Pregnancy clinic. A doctor there prescribed an insulin pump. Sylvia's insurance helped her buy a pump, a model 508, for about $5,100. The pump arrived in October 2000.

Insulin pumps came onto the market in the 1980s. Today's models weigh just a few ounces and can hold a several-day supply of insulin. A thin tube runs from the pump, worn on a belt or in a pouch under clothes, into the user's stomach. Mimicking a pancreas, the pump steadily releases small amounts of insulin. It can also be programmed to release larger doses — to anticipate a meal, for instance.

Pumps help minimize the highs and lows, reducing diabetes' long-term effects, such as kidney failure, limb loss and blindness.

But pumps also carry risk. If someone's blood sugar drops too much, he can go into a hypoglycemic coma. Hypoglycemia demands sugar, not insulin. But the pump doesn't know that. It keeps pumping insulin — and the user, unconscious, can't turn it off.

MiniMed, the maker of Sylvia's pump, recognized this danger early on. It created a safety feature in the late 1980s that would stop the insulin flow if the user didn't press a button for a set number of hours. Company documents initially called it a "Deadman's Switch." It later became known as the "Auto-Off."

Medtronic, a multibillion-dollar company based in Minnesota, acquired MiniMed in 2001. This took place a year after Sylvia received her pump and a year before her family filed suit.

When Sylvia's pump arrived, the Auto-Off was deactivated. That's how the company ships all its pumps, to this day.

Sylvia's pump came with an instructional video. The video, 48 minutes long, devoted only 15 seconds to the Auto-Off, and that came more than a half-hour into the tape. "A safety feature which can be helpful for every pump user," the video called it. But the video didn't say why anyone might want the pump to stop pumping. It didn't say how the feature could save users from harm.

Medtronic Inc.

Headquarters: Minneapolis, Minn.

Employees: 37,000 worldwide

Annual sales: $11.3 billion

Products include: Implantable pacemakers and defibrillators for the heart; insulin pumps; stents for vascular diseases; devices to treat spinal pain

That video would become emblematic of this question:

Insulin pumps help diabetics. The 508 appears to be a good pump. The Auto-Off appears to be a smart feature. But how can it be a safety feature if many people don't know why they need it?

17 calls — and no answer

On Oct. 25, 2000, a Wednesday, Sylvia met with Emily Holing, a diabetes educator at the UW clinic. Holing hooked up Sylvia's pump and showed her how to use it.

This same afternoon, Holing documented two episodes of hypoglycemia for Sylvia, 15 minutes apart. Each time Sylvia needed to drink orange juice.

Holing didn't activate the Auto-Off on Sylvia's pump. She understood the feature, Holing said later, but didn't think Sylvia should use it. "I don't want the insulin interrupted during pregnancy," Holing said in a deposition. She advised Sylvia to use a "buddy system," with a friend or relative making regular checks on her.

Sylvia had pizza that evening, then drove home. She wouldn't be heard from for three days.

Friends and family tried calling Sylvia on Thursday, Friday and Saturday, leaving 17 messages. Sylvia's twin sister lived three hours away. On Saturday she traveled to Sylvia's and, with another relative, went inside. They found Sylvia on her bed, unconscious, lying in vomit. Her insulin pump was attached and running.

Sylvia was in a hypoglycemic coma. Paramedics injected her with sugar water and transported her to the hospital.

She gradually emerged from the coma but suffered permanent and severe brain damage. Memory, comprehension, reading, writing, walking, problem solving, judgment — all were impaired. Sylvia could speak only in combinations of two or three words, such as, "I'm fine." Medical experts said they expected little improvement. She would need round-the-clock care for the rest of her life.

Doctors terminated Sylvia's pregnancy Nov. 11, at 20 weeks, fearing the unborn child had suffered serious injury.

10 deaths — with few details

In May 2002, Michael Lane filed suit in King County Superior Court, on his and Sylvia's behalf.

The lawsuit named two sets of defendants.

Medtronic, the lawsuit alleged, violated Washington's product-liability law: The pump's warnings were insufficient and its design unsafe. The Auto-Off should be automatic, not an option, the lawsuit alleged. Had the feature been activated and the insulin cut off, Sylvia could have emerged from her coma and sought help before suffering brain damage, the lawsuit contended.

The lawsuit also accused the UW Medical Center of medical malpractice, saying Holing failed to advise Sylvia adequately on the pump's use and risks.

Christopher Otorowski, a Bainbridge Island lawyer, represented Michael Lane.

A year into the suit, Otorowski cited 15 reports filed with the U.S. Food and Drug Administration (FDA) for a nine-month period ending in March 2003. Although light on detail, the reports disclosed 10 deaths and five injuries suffered by people using Medtronic's insulin pumps.

The reports, Otorowski said, constituted "a trend or pattern of deaths." He said Medtronic should divulge more information about each case. The company, he wrote, was concealing information about the pump's risks "from the public, the medical community and the government."

Before approving a new medical device, the FDA requires clinical studies or testing for safety and effectiveness. But MiniMed had bypassed that step by saying the devices were "substantially equivalent" to a generic infusion pump used for medical fluids, Otorowski said. That general-purpose pump was approved before 1976.

The company made and sold insulin pumps "without anything more than a rubber stamp," Otorowski wrote.

Medtronic defended its pumps in general and the safety option in particular. The Auto-Off "is not some mysterious and nefarious device that dooms unsuspecting pump users to hypoglycemic comas," wrote Douglas Hofmann, a lawyer representing the company.

Medtronic said the role played by Holing, the UW diabetes educator, should free the company from any claims of liability. How could Medtronic be blamed for shipping the pump with the safety feature off, the company argued, when Holing had decided Sylvia shouldn't use it anyway?

The company also said the law does not require it to warn users about risks. The pump is available only by prescription, Medtronic said, so the company's duty is to ensure that health-care providers prescribing the pump understand its features. And in this case, Medtronic said, Holing understood the safety option and chose not to activate it.

Medtronic tested Sylvia's pump afterward and determined that it "performed flawlessly," Hofmann said. The company called any demand for a redesign "manifestly irresponsible."

Medtronic also challenged the relevance and reliability of the 15 reports to the FDA. The reports said little or nothing about the Auto-Off feature. Plus, none of the reports concluded that a pump had caused a death or injury, Medtronic said.

Motions that become moot

As the October 2003 trial date approached, Otorowski demanded more and more information from Medtronic. He wanted records of other lawsuits; customer complaints; details of adverse-event reports to the FDA; documents on the government-approval process.

Medtronic and Otorowski sparred over what documents the company would have to produce. Ultimately, the judge would have to decide.

In August 2003, the UW settled the claim against it. But the university has yet to disclose what it paid, even though that figure is a public record.

The same month, just before a hearing to determine if there was enough evidence to warrant trial, Medtronic and Michael Lane also settled. The judge had not yet ruled on Otorowski's demands for additional records — so those motions became moot.

Together, Lane, Medtronic and the UW asked for the entire file to be sealed. They said they wanted to keep private Sylvia's medical information and Medtronic's proprietary records; to protect the Lanes from financial predators; and to honor the parties' settlement agreement, which required that the amount remain confidential.

The joint sealing request also made one other argument — a perplexing one, given Otorowski's prior reference to the pump's "insidious danger."

"It is unlikely that the sealing of this court file would be of interest to any other individuals," the request said. "This is a unique case involving the claims of a single individual."

In October 2003, Judge Richard Jones sealed the file.

This year The Times challenged that order. Just because the parties want their settlement a secret is no grounds to seal an entire file, the newspaper argued. And where legitimate privacy concerns exist, limited parts of documents can be blacked out.

Jones opened the file back up.

"Tip of the iceberg"

Manufacturers must file reports with the FDA when they become aware that a medical device has malfunctioned or may have contributed to a death or serious injury.

The key word is "or." That's the word used in federal regulations: malfunction or injury.

In the Lane lawsuit, Medtronic acknowledged that it did not report Sylvia's injury to the FDA. A Medtronic director wrote in court documents that the company makes a report "if a malfunction is identified and it meets" reporting requirements.

He used the word "and."

"By making this convenient word substitution, the defendant has created an imaginary loophole," Otorowski wrote. Medtronic's interpretation requires a malfunction — in effect, erasing injury as grounds for reporting, he argued. Lane's lawsuit didn't claim malfunction. It alleged that Sylvia suffered severe brain damage because of a flawed design and insufficient warnings.

Otorowski said Medtronic's reporting practices were "deceptive" and put the company's "credibility squarely at issue."

One of Lane's experts, William Damaska, once directed the FDA's Division of Compliance Operations. The FDA uses "adverse-event" reports to issue recalls, safety alerts and labeling changes, Damaska wrote. Doctors use them to make choices about treatment and medical devices.

Sylvia's injury "clearly" met the reporting criteria, Damaska wrote. Medtronic's failure to alert the FDA, he said, suggested that "what is reported is only the tip of the iceberg."

Medtronic said any suggestion that it had not reported other events was "entirely speculative."

Nationally, other lawsuits have also accused Medtronic of reporting lapses. Medtronic, a Fortune 500 company with annual sales of $11 billion, makes all kinds of medical devices. Other lawsuits have alleged that Medtronic failed to make timely warnings to the public and physicians about problems with implantable heart defibrillators and with the tubing on insulin pumps.

In addition, the company agreed last summer to pay a $40 million fine to settle civil allegations that it provided kickbacks to doctors, to encourage them to use its spinal products. The kickbacks included sham consulting and royalty agreements, as well as lavish trips, the U.S. Justice Department said.

Which device? The words are blacked out

Some lawsuits allege a broad threat. But sealing the file can make it nearly impossible to figure out what happened.

When The Times began this investigation, it identified 420 sealed civil suits in King County. The names of the parties were available, but little else.

The Medtronic case stood out. The company sells pacemakers, defibrillators, insulin pumps, heart-valve products. Did the lawsuit claim some device was defective? And if so, which one?

Because the UW — a public entity — was also a defendant, The Times asked for its records from the lawsuit. A sealing order applies to the courts; it does not suspend open-records laws for other public entities.

In January the university turned over the complaint, a document that lays out the allegations. This provided a first glimpse inside the court file. But the university — citing patient privacy — had blacked out just about every meaningful detail in it.

The complaint said some medical device was unsafe. Which device? That information was marked out.

The newspaper contacted Medtronic. In February, a spokesman said the company couldn't comment on the lawsuit because the file was sealed. But his e-mail added:

"Medtronic and the entire medical technology industry follow strict guidelines and regulations stipulated by the FDA regarding product development, safety, effectiveness and quality. We take those guidelines and regulations very seriously, and must — by law — report any incidents that could potentially harm our patients. Medtronic would not intentionally hide information that could potentially jeopardize patient safety by sealing a court file."

Lawmakers do an about-face

The Washington Legislature passed two laws in 1993 to prevent secrecy in product-liability cases.

One barred parties from entering confidentiality agreements that concealed a public hazard. The other kept judges from signing orders that hid such dangers.

But in 1994, lawmakers did an about-face. The former law was repealed, and the latter, diluted.

Gone was the rousing endorsement of the public's right to know about hazards. The new law said the public has two interests: knowing about threats to safety — and making sure that businesses can keep trade secrets. A judge must balance the two before approving secrecy.

The new law has rarely, if ever, been used. A search of published appellate opinions failed to turn up even one case where it has been applied.

But the law still allowed an outsider to challenge a confidentiality agreement as contrary to the public interest. And that's what The Times is doing.

The newspaper has asked a judge to void the confidentiality agreement between Medtronic and Michael Lane. Doing so might free the parties to discuss the case and reveal how much Medtronic paid.

The newspaper's motion is still pending.

Ken Armstrong: 206-464-3730 or karmstrong@seattletimes.com; Justin Mayo: 206-464-3669 or jmayo@seattletimes.com

Copyright © 2006 The Seattle Times Company