Dialysis in N.Y. Lags as Diabetes Ruins Kidneys

Another depressing article in the series on diabetes being run in this week's New York Times, this one focuses on dialysis centers in New York, and how patient outcomes are worse at the many, small dialysis centers which operate in New York than they are nationwide. Apparently, small centers provide generally worse levels of care in part, because they cannot compete with large, nationwide chains who can survive successfully on smaller margins. Medicare pays for 90% of dialysis in the U.S. because people become automatically eligible for Medicare when diagnosed with End Stage Renal Disease, and dictates what they pay for treatment. Dialysis patients in New York suffer from higher rates of anemia, and a larger percentage suffer from infections, leading to a higher death rate, much of which seems to be caused by New York State regulations which more or less prohibit large, national dialysis chains from operating in the state.

If public health officials like the New York City Department of Health and Mental Hygiene really want to do something useful, perhaps they should consider lobbying in Albany for updated legislation which fixes this problem by making it easier for large, well-capitalized dialysis chains to move into New York. Instead, they are forcing patients with diabetes to be in an involuntary glycosated hemoglobin (HbA1c) registry which seems destined to go to court, but do little to improve patient outcomes. So much for their goal to improve the health of all New Yorkers!

BTW, on a note related to this NYT article (hopefully none of my readers will ever require dialysis, but just in case): an October 2, 2003 Wall Street Journal article reported that the rate of survival among patients with renal failure increased significantly for patients who were given a portable dialysis machine to use at home for six nights a week, eight hours each night. (Usually, patients go to a dialysis center three times a week, for four hours a day.) So-called "intensive" dialysis treatment has been proven to significantly improve survival rates and overall health among those with renal failure, and has shown excellent results where it has been tried.

Just like the argument used for keeping blood glucose levels as close to normal as possible in patients with diabetes, the logical conclusion is that the body does significantly better when the blood is cleaned daily (closer to what functioning kidneys would do). But most patients in the U.S., Canada and elsewhere get treatments only 3 times a week because that's all the government in each country will pay for. In between, wastes build up and make patients fatigued, and are generally in poorer health, thus the lower rate of survival.

At present, wealthier patients who can afford intensive dialysis treatment for themselves, or a handful of "selected" patients (usually those who are younger and in better health otherwise) selected by nonprofit centers may receive intensive dialysis treatment. But patients must find out about the intensive dialysis program by themselves, therefore few receive it.

Dialysis in N.Y. Lags as Diabetes Ruins Kidneys
By Richard Pérez-Peña, The New York Times
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% 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% 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% of them have unusually poor patient survival rates, defined as at least 20% below average. In New York, 12% 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% to 10% 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."

URL for this article:
http://www.nytimes.com/2006/12/28/nyregion/28dialysis.html

Divine Inspiration

Well, Scott has inspired me (and inspiration doesn't happen all the time with me) with his holiday gift idea. I wanted to do something similar, but instead of giving everyone a token, I thought going the route of a Monopoly-inspired Community Chest card would better match my personal style. Its only for you, my readers!

It works just like a "Get Out of Jail Free" card in the game Monopoly. Redeem this card wherever you want or need it, whenever you need that target blood sugar level and everything you try fails to work. I bet your CDE is probably not giving any of these out this year!

Anyway, this will be my last post until after Christmas since I'm going to my parent's house for the holiday, and they have dial-up, so I don't expect to be logged in much until I return on December 27th.

Best wishes for a very happy holiday!

Tag - You're It!

OK, I was tagged by Barry for my top 5 holiday song picks, so here they are:

1. "Have Yourself A Merry Little Christmas" by The Pretenders. I love this song, and this version is great. BTW, Chrissie Hynde is a truly amazing performer, and if you ever have the chance to see her sing live, its worth going. She's one of the few performers I've seen live that I can say is even better in person than her recordings are!

2. "Do They Know its Christmas" (original version) by Band Aid. This song is still great, although its hard to believe the song is now 22 years old! How old does that make me?

3. "A Holly Jolly Christmas" by Burl Ives. Whenever I hear this song, I feel like a kid again. Also, I can't help but imagine the Saturday Night Live parody of the Snowman from Rudolph on Saturday Night Live's TV Funhouse (The Narrator Who Ruined Christmas).

4. "Santa Baby" by Madonna. Its a very funny remake of a 1950's holiday song, and I like the material girl's version much better than Kylie Minogue's.

5. "Merry Christmas, Darling" by The Carpenters. This song is kind of sad, but its so fitting for the many people who are separated by distance at the holidays. I remember hearing it when I first moved to California in 1993 and wasn't able to come home for the holidays.

Its a bit late in the game, so I hope my nominees haven't been tagged already (I don't think so), so I'm tagging the following:

Gina (hopefully she's reading!)
Kassie
Sandra
Elizabeth (maybe she's reading even if she's not posting)
Jay

By the way, if you don't celebrate Chrismas, please don't be offended (consider it a compliment that you were tagged).

Whatever Became of Stem Cells?

Although I had planned to let it slip by without caving into the frenzy, I felt some sense that I should at least acknowledge the news from last week that scientists at a Toronto hospital reported that they now have proof the body's nervous system helps trigger type 1 diabetes, thus opening the door to potential new ways to cure the disease. My reasoning has more to do with having some historical documentation on my blog rather than overwhelming excitement over the announcement itself. While promising, as I've said many times before, if I were a mouse, I'd have a choice of maybe a dozen different "cures," but so far, not one of these miracle treatments has translated into success in humans, so while there is reason to be optimistic, I've learned to contain my excitement until we see proof in humans. I'm taking a wait-and-see approach. I feel very much the same way about stem cell research.

The field is divided mainly by the type of cells used; research using embryonic stem cells is the most contoversial since it involves the destruction of a blastocyst which, if implanted into a human uterus, has potential to become life. These are routinely discarded as medical waste without any threat of criminal prosecution under current U.S. law. (It seems inconsistent to ban medical research on all but a few cell lines created before August 9, 2001, yet simultaneously permit thousands to be tossed into the trash.) Anyway, this branch of science holds tremendous potential for a wide range of diseases, including type 1 diabetes, but in recent years, the field has been stifled by political arguments that have little to do with the actual science. This month, however, there were several positive developments.

As I wrote back in 2004, when California voters passed proposition 71, "Regardless of what happens on a Federal level, the passing of Proposition 71 has ensured that progress will be made in California and very possibly other states which follow suit. This state roposition may be the critical junction that leads researchers forward on the road to a cure."

Today, The Boston Globe reported that New Jersey Governor Jon S. Corzine announced $7 million in grant money for construction of facilities for embryonic stem-cell research and $3 million for adult stem-cell research grants. Last week, state lawmakers approved $270 million to build stem-cell research centers -- double what the state spent last year.

"Corzine has, quite literally, redoubled our efforts to encourage the best and brightest minds in the state to pursue stem-cell research," said N.J. Assemblyman Neil Cohen, sponsor of the 2004 law legalizing embryonic and adult stem-cell research in New Jersey.

At the present time, California, New Jersey, Illinois and Connecticut fund stem cell research, and it seems likely that Massachusetts may join them after newly-elected Democratic Governor Deval Patrick takes office. Although dLife rated the President, Senate, and Congress the second-biggest disappointment of 2006 "for their handling of stem cell research and the art of arguing the argument and not looking for viable solutions," Democrats have vowed to revisit the stem cell issue in Congress next year. But with a President unwilling to negotiate, they may have difficulty in accomplishing much on the issue. While progress will be made in U.S. states that are supporting this research, the big news on this topic is coming from across the Pacific. No, not South Korea, but Australia.

In early December, the Australian press reported that the Australian Parliament had passed legislation overturning a ban on therapeutic cloning, paving the way for scientists to pursue the field of regenerative medicine in that country. One of the first targets for embryonic stem cell research in Australia will likely be a cure for type 1 diabetes, with a top Australian researcher predicting major progress within four years.

"Type 1 diabetes is the first port of call for us. Once we have the cells in the petri dish, we can see what regulates the disease, how we can understand the disease process and how we can go through drug discovery. We can do it in the petri dish, rather than in human or animal tests," according to Dr. Kuldip Sidhu, who is the diabetes transplant unit manager for Prince of Wales Hospital.

Professor Peter Schofield, a neuroscientist who was on the Lockhart committee which recommended that therapeutic cloning be adopted, said diseases and illnesses that have a focal cause would be the first to see results.

"Any disease that has a focal cause would be looked at first. For example Parkinsons' disease, where it is one small region of the brain that undergoes degeneration; diabetes, where you have the immune attack on the pancreatic beta cells; and spinal injury, where there is a lesion you're trying to get neurons to grow over," he said.

Australia joins several other countries, including the UK, Singapore, Israel and Sweden who all have what can be considered "hospitable" environments for stem cell researchers. Last year, opponents were predicting that the field would suffer irreparable damage when it was revealed that South Korean cloning scientist Hwang Woo-Suk committed science fraud regarding progress made on embryonic stem cell research.

However, with Australia's support, along with funding from several U.S. states who are contributing to the field, perhaps 2007 will be the year this field of research finally starts making some legitimate advances!

The Business of Diabetes: Recent Comments from Wall Street

This is my inaugural posting for what I am calling postings on the "Business of Diabetes". Many companies that sell their products and treatments to serve patients with diabetes are publicly held firms, therefore Wall Street expects regular updates from management on the state of affairs. Sometimes we can get a "sneak preview" of what's to come based on information senior management gives to investors. While people with investment accounts have access to this information (although they may still need to look for it), for others, unless the news is released to the general press, may never hear about it. That is my motivation behind this "series".

By the way, speaking of the business of diabetes, Close Concerns is a San Francisco-based consulting firm that provides consulting services on diabetes to a wide range of established and start-up corporate clients, including pharmaceutical, medical device, and biotechnology companies. Their focus is diabetes. One of the principals of the company is Kelly Close, someone I had the pleasure of meeting at their offices personally this past August.

Their consulting services are likely not directly relevant to patients since they do not work directly with diabetes patients. But its worth mentioning that Close Concerns very recently introduced a patient newsletter on diabetes which is called "diaTribe" which is out now and available on the company's new website for patients, http://www.diatribe.us. According to their website, "diaTribe examines the latest research and products that readers can apply to their own lives." A free sample of the diaTribe report is available now on the website. Readers can join their mailing list for free, and subscriptions to the newsletter itself are a reasonable $29 per year. I haven't subscribed yet, but its definitely worth looking into. Details are available on the diabTribe website noted above.

Anyway, back to my posting on the Business of Diabetes:

As some of my readers are aware, on August 2, 2006, Novo Nordisk had requested a preliminary injunction to keep Pfizer from selling Exubera® as part of a patent-infringement case the company brought against Pfizer. The company claims that Pfizer's Exubera infringes on its patents, which cover methods for administering inhaled insulin to patients with diabetes.

In an order made on December 14, 2006, U.S. District Judge Leonard B. Sand in Manhattan said he wouldn't grant a preliminary injunction to stop Pfizer from selling the inhalable insulin Exubera. The judge referred to "public health reasons" as one of the reasons for not granting a preliminary injunction. While I cannot see what kind of "public health reason" might exist, and patients aren't exactly beating down the doors to add Exubera to their treatment plans, I'm still pleased that the judge did not grant a preliminary injunction.

Novo Nordisk affirmed its committment to protecting its intellectual property following the denial of its motion for a preliminary injunction to prohibit Pfizer from marketing its inhaled insulin product Exubera in the U.S. The court stated that issues of infringement and validity "will be best served through closer inspection at trial." Novo Nordisk did not regard the ruling as impairing the strength of the underlying case, and also noted that the ruling involves only one of the five patents at issue.

Novo Nordisk says it remains confident in the strength of its patents and "looks forward" to a full trial on the merits of the infringement case against Pfizer. A company spokesperson said "We continue to believe that our commitment to changing diabetes, innovation, and to helping people with diabetes depends upon respect for patents." Of course, all pharmaceutical companies, including the plaintiff Pfizer, are very familiar with the courtroom, so the results of this case will be interesting.

Although the biggest player in the insulin market today, Wall Street analysts have warned that Novo Nordisk is falling behind its competitors in the development of new type 2 diabetes treatments. The type 2 market is growing very rapidly on a worldwide basis, but Novo's GLP-1 medicine (Liraglutide) and its inhaled insulin (Aerx) aren't anticipated to reach the market until 2009.

The company has played down the issue, saying it isn't worried about the time lag. "We might not always be first, but we will always be best," Chief Executive Lars Rebien Sørensen said in September.

Separatly, Eli Lilly & Co. recently told investors about some type 2 diabetes medicines in late-stage development at an investor presentation. In the company's diabetes business, its main product is in development is Byetta (exenatide) LAR, a long-acting release formulation of its popular Byetta (a once-weekly injection for type 2 diabetes) and reported that Phase II results are "encouraging" (A1C levels improved ~2% vs. placebo, 12 out of 14 high-dose patients achieved A1C target of less than or equal to 7%, high-dose patients lost an average of 8.4 lbs vs. placebo, both doses were well tolerated with mild nausea being the most common adverse event, no severe hypoglycemia was reported). Lilly also stated it is working on "building out its manufacturing capabilities." As some people are aware, Lilly has struggled to meet unusually strong demand for Byetta, its jointly-marketed type 2 diabetes medicine with Amylin Pharmaceuticals. I would reiterate, however, that research has also suggested that Byetta may have some benefit to patients with type 1 diabetes, since it has been proven to increase beta cell mass, therefore trials are pending on both newly diagnosed type 1 patients, as well as among type 1 patients who recently underwent islet transplants.

Like Novo Nordisk's inhaled insulin product, Lilly's AIR inhaled insulin is also in phase III development. Enrollment in a major two-year safety trial is complete and there are seven clinical trials that are either ongoing or actively enrolling. Lilly believes that its easy to use delivery device will encourage "earlier, more appropriate" use in type 2 diabetes patients. Lilly expects to see equivalence in efficacy AIR to injectable Humalog. A filing is expected in 2009 in the U.S. and Europe.

Lilly also showed investors that Byetta ranks 4th (vs. 8th last year) in gaining new prescriptions among common branded type 2 diabetes medicines and stated that more than 65,000 physicians have prescribed at least one sample. The company made a point of noting that "the main hurdle lies in getting the first prescription to the patient, as uptake from that point on appears to be good."

Smith Barney analysts were quoted as saying "Our enthusiasm for Lilly is tempered by challenges to its in-line product portfolio (including Zyprexa, the insulin franchise, and Evista). We remain concerned about prescription trends for Zyprexa, the insulin franchise, and Evista, which comprise 54% of the company's worldwide pharmaceutical business in 2005."

The company's insulin franchise is also expected to face new competition from other inhaled insulins (notably, Pfizer's Exubera, as well as Novo's inhaled insulin product Aerx which is expected to be on the market around the same time as Lilly's) as well as increased competition from Sanofi's Apidra injectable rapid-acting insulin analog. To address these concerns, Lilly President John Lechleiter told Dow Jones Newswires on Deceber 7, 2006 that the company expects to increase the portion of its U.S. sales force marketing insulin products by 40% in 2007. The increased sales force "would support the launch of 5 new insulin pen-delivery products," he said. These "pen devices" would largely be for the new Humapen Memoir which I noted in my previous post following the ADA Scientific Sessions, as well as pen devices for Byetta and Symlin.

At the investor conference, Lilly affirmed its commitment to the insulin franchise and said it plans to increase sales rep support for that business by 40%. This was likely due to competitive pressures (Novo Nordisk is adding another 800 sales reps). Although Lilly remains one of the leading sellers of insulin, as I reported last year, Novo Nordisk and Sanofi-Aventis have aggressively taken market share from Lilly in recent years and in late 2005, Lilly lost its #1 market share position to Novo Nordisk. Dow Jones also noted that Lilly will modestly increase its worldwide diabetes sales force, mainly to try to fuel growth of Byetta, a newer treatment for type 2 diabetes jointly marketed with Amylin. Lilly has already doubled the sales force for the diabetes business in the UK and tripled its reach in Brazil.

In addition, the company's pipeline appears uninspiring, but Smith Barney said it views "its most high-profile pipeline project, prasugrel, as a high risk/high reward opportunity." They wrote "All considered, we rate the shares of Lilly Hold, given a lackluster pipeline, challenges to its in-line product portfolio and the stock's valuation (~5% premium to 2008E drug's P/E [Price to Earnings ratio])."

VOTE for 2006 Dumbest Diabetes Research Study

Although voting for the 2nd Annual Diabetes O.C. Blog Awards is probably more noteworthy, in what has become something of a tradition, this year, I am again polling people to evaluate the "Dumbest Diabetes Research Study" award for 2006, and this is my second annual poll. Note that polling closes around 4:00 pm EST on New Years Eve. Last year, I did the same the same poll (see here for details), and the winner was a study that concluded "High Fasting Blood Glucose May Be a Risk Factor for Type 2 Diabetes" which was published in The New England Journal of Medicine. Not surprisingly, the winners never claimed their prize, a packet of Sweet & Low. Of course, I ask everyone to help me by calling attention to a sampling of truly "dumb diabetes research" (defined as having done little, if anything to improve the lives of people now suffering from diabetes) which is published in a scientific or medical journal if and when you learn about it. Please e-mail it to "DiabetesPortal-owner@yahoogroups.com".

Millions of dollars are wasted on foolish and unnecessary diabetes research each year, instead of spending money on research towards curing patients with diabetes. Most of these studies have only only served to keep researchers working, but have done little, if anything to improve the lives of people actually suffering from diabetes. The researchers and the medical establishment should really be ashamed of studies like these, as should the organization(s) who funded this research. Ask yourselves: were these studies really necessary? To vote, click on the title link (above) and you will be forwarded to DiabetesTalkFest.com to vote there.

Listed below are several diabetes studies that were done published in prominent medical and/or scientific journals during 2006 that quite frankly, were a complete waste of money to either prove the obvious, or worse, just plain dumb. Need an example? See below, as I have provided summaries (as well as the full journal publication if you're interested) and then vote for the study you believe was the dumbest. The winner will receive publicity on their accomplishments, and, if they want it, a packet of Sweet & Low.

1. Childhood obesity and type 1 diabetes
The results of a study conducted at Wake Forest University School of Medicine in the USA, published in the February 2006 issue of Diabetes Care, searched desparately to find a link between obesity in children and the younger average onset of type 1 diabetes. The relationship, however, was found only in children whose production of insulin had already been significantly reduced, and most patients diagnosed with type 1 were significantly below the average weight. Low birth-weight was also indicated as a possible factor in accelerating the development of type 1 diabetes. The study was part of the 'Search for Diabetes in Youth' initiative, which aims to identify the prevalence and incidence of childhood diabetes in the USA.
http://care.diabetesjournals.org/cgi/content/abstract/29/2/290

2. Cord blood islet autoantibodies are related to stress in the mother during pregnancy
The researchers' objective of this study were not disclosed in the extract, but it seems that they were trying to identify whether something that occurs during gestation might be responsible for the development of immune-mediated (type 1) diabetes. They conclude that "associations with increased worries by the mother remained in newborns with high type 1 diabetes mellitus (T1DM)-human leukocyte antigen (HLA) risk, but not in non-HLA risk children -- in other words, if there was a family history of type 1 diabetes, then stress appears likely to elevate the child's risk for type 1 diabetes, but it doesn't if there is no family history. The researchers note that prospective follow-up on these children will determine the importance of this early IA for postnatal islet autoimmunity, type 1 diabetes, or both. There are many "suspected" triggers for type 1, but seeking for blame of the mother without a means to correct the situation seems unworthy of this costly research.
http://www.annalsnyas.org/cgi/content/abstract/1079/1/345

3. Effect of Medication Nonadherence on Hospitalization and Mortality Among Patients With Diabetes Mellitus
The reported reasoning for this study was because "Medication nonadherence may reduce the effectiveness of therapies. To our knowledge, the association between medication nonadherence and mortality remains unexplored outside the context of clinical trials." The authors conclude that "Medication nonadherence is prevalent among patients with diabetes mellitus and is associated with adverse outcomes. Interventions are needed to increase medication adherence so that patients can realize the full benefit of prescribed therapies." Did we need a study to "prove" that people who don't take medicines prescribed will have worse outcomes?
http://archinte.ama-assn.org/cgi/content/abstract/166/17/1836

4. Effects of chili consumption on postprandial glucose, insulin, and energy metabolism
The reported objective of this study was to investigate the metabolic effects of a chili-containing meal after the consumption of a bland diet and a chili-blend supplemented diet. The authors in Australia studied 36 individuals, and concluded that regular consumption of chili may attenuate postprandial hyperinsulinemia.
http://www.ajcn.org/cgi/content/abstract/84/1/63

5. Idiosyncratic Personal Explanations for Blood Glucose Events Are Associated With Poorer Self-Management and Glycemic Control
The reported objective of this study was to examine whether spontaneous causal attributions for blood glucose events were associated with blood glucose control (HbA1c [A1C]), self-management, and adjustment to diabetes. Wasting money on the research seems to be all that was accomplished.
http://care.diabetesjournals.org/cgi/content/abstract/29/6/1208

6. Impact of Glycemic Control on Survival of Diabetic Patients on Chronic Regular Hemodialysis: A 7-year observational study
The reported objective for this study was "to investigate the impact of glycemic control during regular hemodialysis on the survival of diabetic patients with chronic kidney disease". However, while this sounds like a doctor-designed study, the reality is that maintaining glycemic control, especially among patients with type 1 diabetes, becomes notably more difficult without fully-functional kidneys because of significantly increased risk of hypoglycemia. Also, the idea of avoiding complications seems lost on patients already experiencing kidney failure.
http://care.diabetesjournals.org/cgi/content/abstract/29/7/1496

7. Lifestyle Intervention Is Associated With Lower Prevalence of Urinary Incontinence: The Diabetes Prevention Program
This study revealed that reducing the liklihood of developing urinary incontinence was a more powerful motivator for many obese women to lose weight than developing type 2 diabetes. Some researcher was up very late at night asking whether the threat of having to having to buy Depends was stronger than the threat of having to pierce your fingers to test for elevated blood glucose levels? But wait, this implies that many of these people would actually be motivated to control their diabetes, and the fact is that if someone who does not "feel" sick is motivated to take care of themselves, then there is less motivation than losing control over one's bladder. Again, common sense, not earthshattering research here. The real question we should be asking why did someone spend our money to study this? Was there a research grant from Depends?
http://care.diabetesjournals.org/cgi/content/abstract/29/2/385

8. Mealtime Interactions Relate to Dietary Adherence and Glycemic Control in Young Children With Type 1 Diabetes
This study's objective was to examine the relationships between parent-child mealtime interactions and dietary adherence and glycemic control in young children with type 1 diabetes. It was hypothesized that young children who exhibited disruptive mealtime behaviors would have more dietary deviations (poorer dietary adherence) and poor glycemic control. It was also hypothesized that parents of young children who used ineffective/coercive parenting strategies at mealtimes would have children with more dietary deviations and poor glycemic control.
http://care.diabetesjournals.org/cgi/content/abstract/29/5/1002

9. Obesity in Middle Age Raises Heart Disease and Diabetes Risk
The reported objective of this study was "to assess the relation of midlife body mass index with morbidity and mortality outcomes in older age among individuals without and with other major risk factors at baseline". Obesity at any age is a known risk factor for a wide variety of ailments. Was a research study really necessary to prove that even among people without apparent cardiovascular risk factors, obese people were at higher risk for cardiovascular disease and diabetes than people who are normal weight? Simply stated, it is well-known that obesity is not healthy. Did we really need yet another study to prove it?
http://jama.ama-assn.org/cgi/content/abstract/295/2/190

10. Prevention of Hypoglycemia During Exercise in Children With Type 1 Diabetes by Suspending Basal Insulin
The reported objective of this study was to focus on this because strategies for preventing hypoglycemia during exercise in children with type 1 diabetes had not been well studied. This study was conducted to determine whether stopping basal insulin could reduce the frequency of hypoglycemia occurring during exercise. However, as the researchers should have expected, the risk of high blood sugar (hyperglycemia) increased.
http://care.diabetesjournals.org/cgi/content/abstract/29/10/2200

***** Editor's Note: The following study was the 2006 Winner! *****
11. Short legs related to excess weight and diabetes
Researchers from Johns Hopkins University conducted a cross-sectional analysis of 7,424 adults aged 40–74 years, from the third National Health and Nutrition Examination Survey (NHANES) and concluded that being short - specifically having short legs and a low leg length-to-height ratio - is linked to an increased type 2 diabetes and obesity risk in middle age. They recommend "early intervention" to improve childhood nutrition in diabetes prevention. While this was a meta analysis, it still suggests that the parents are to blame for adults getting type 2 diabetes, which may be a flawed conclusion.
http://care.diabetesjournals.org/cgi/content/abstract/29/7/1632

Interview with JDRF CEO Arnold W. Donald

Yesterday, the Internet was abuzz over Kelly Close's terrific interview with JDRF's CEO Arnold W. Donald. I have made several posts on various message boards regardling my impression that the jury is still out on Mr. Donald's leadership as CEO. However, Kelly did JDRF a huge favor by filling a much needed gap here by conducting the interview.

I do not wish to focus on strictly negative thoughts, but I do want to be something of an offsetting balance to strict praise CEO's routintely receive by calling attention to areas they need to focus on as well. For example, why did it take nearly 1 year for this CEO to "go public"? I suppose one could say his Congressional testimony to speak on the topic of the artificial pancreas project was his first public appearance on a national level, but that is not really meeting with his "shareholders" as a public interview is. (By the way, on the topic of artificial pancreas, be sure to join the December 12, 2006 online chat with Dr. Aaron Kowalski, Director of Strategic Research Projects at the JDRF to speak with him about that project. [Note: The transcript for that chat is available at DiabetesTalkFest.com.]

Back to Mr. Donald. After almost 1 year on the job, I found the interview to be more disturbing than impressive. Why? Well, under former CEO Peter Van Etten, JDRF had a very clear direction, and while there was some criticism of Mr. Van Etten's focus on stem cell research at the expense of other promising avenues towards a cure, so far, Mr. Donald has yet to show the same degree of focus. This organization was founded by parents of children with type 1 to find a cure for their children. To a large extent, that group remains their most important constituency, so the CEO must try and motivate them. Personally, I did not find this interview to be very motivating to myself as a fundraiser who has consistently raised several thousand dollars per year for the organization.

Another area we should question was his response to the following question: "There's been a lot of media attention on type 2 compared to type 1, and I wonder how the JDRF reminds decisionmakers that type 1 is also on the rise?"

His response was "While I have some empathy for those who feel a need to drive type 1 as an agenda item because I'm at JDRF, I think that some times we get caught up on the distinction that, number one, medically is not as clean as we may have thought it was in the past. And, number two, in terms of addressing the human impact, it may be more academic. So, my attitude is, look, type 1 is an autoimmune disease, and based on that, it requires certain types of research that may be unique. But the learnings from the research in both areas can lend a huge amount of benefit to the other, and so where I'm at is we need to eliminate diabetes. That's the deal."

Sorry, but no matter how you spin that, focusing on the areas of overlap between the major types of diabetes, rather than the unique distinctions is really not going to motivate JDRF's fundraisers (does it motivate you?). The NIH/NIDDK already does that. So does the ADA. If JDRF's role is to, as he says, "fill in the gaps," JDRF really does not need to duplicate that role.

The other statement I would call attention to was when he was asked about the government relations front and if there was room for any improvements there. His response was "Again we've been incredibly successful, but there's more power to harness in the volunteer base and there are things to get front of. For example, the [closed loop] artificial pancreas."

However, I have a different impression of that. Previously, I hosted an online chat with Larry Soler, who is the VP for Government Relations for JDRF in Washington, DC. One issue we discussed was that there were many state-related initiatives (many of which were related to stem-cell research, either to fund or to ban it), and he told me that his perception was that JDRF was well able to handle issues on a federal level, but the local chapters need help from JDRF National in terms of organizing the database to identify people locally, etc. so that e-mail alerts could be targeted on a state level, or even by district level. Right now, everything JDRF Government Relations does (or nearly everything) is done on a federal level. JDRF needs to organize to be better able to handle things on a state level.

During the recent election, JDRF was not especially well-prepared in Mr. Donald's home state of Missouri, which had ballot measure on whether to allow stem cell research (amendment 2) which luckily passed, but that was largely thanks to the Michael J. Fox television commercials and the press garnered by Rush Limbaugh surrounding them, not due to JDRF. This is an example where the JDRF is not truly as prepared to handle initiatives on the state level as they need to be, yet for the new CEO to state "we've been incredibly successful" on the government relations front is overlooking an area that frankly, needs some improvement.

When all is said and done, the jury is still out on Mr. Donald's performance as JDRF's CEO, as he really has only had 1 year to move the organization. But its up to everyone who supports the organization to make it very clear where they are pleased, and where they want Mr. Donald to focus. Remember, we are all shareholders of the JDRF, and management has a fiduciary responsibilty to us as shareholders. My thanks again to Kelly Close for a great service to the JDRF and us as shareholders!

Cookie-scented bus stops are canned

Well, city officials in my former hometown of San Francisco (sometimes referred to as "the People's Republic of San Francisco" for the city's decidedly leftist ways, but since I've only lived in blue states, virtually all of them, I found it to be a virtue) have ordered the immediate removal of cookie-scented strips from bus shelters just one day after they went in as part of a marketing campaign to promote milk. Apparently, the request was made to CBS Outdoor, the company that holds the advertising contract for the city's bus shelters late yesterday night. The move came amid public concern over potential allergic reactions to scented products. Under the advertising contract, the Municipal Transportation Agency (better known as MUNI) can request the removal of ads deemed objectionable.

The gimmick was part of the California Milk Processor Board's wildly successful "Got Milk?" campaign. The idea was that once people got a smell of chocolate chip cookies, they'd get the urge for a glass of milk, too. Of course, some people don't like milk, with or without cookies, so the scents might just be seen as annoying.

"We got complaints," said Maggie Lynch, a spokesperson for MUNI. "It is controversial."

According to the San Francisco Chronicle, representatives from the California Milk Processor Board were not immediately available for comment.

Although NPR reported that the campaign was planned to be introduced elsewhere in 2007, including possibly Chicago and New York City, this raises questions about the future of this particular type of ad campaign. Had it been allowed to continue, this would have been the first-ever "olfactory-based" marketing plan (or scented outdoor advertising) in the U.S.

I would venture to guess that New York City Department of Health and Mental Hygiene would have opposed this ad campaign as well, since they voted to ban trans-fats, in a move that is being protested by the NYC restaurant industry not because they are unwilling to comply, but because they only have 18 months to find alternatives. They like to note that it took Wendy's two years to find an alternative oil for use in its fries (an alternative which Consumer Reports says still has trans fat in it, although far less than before).

Dan Fleshler, a spokesman for the National Restaurant Association, said "We don't think a local municipal health body has any business banning a product the FDA has already approved." Very well said, in my opinion.

NYC Health Officials might have claimed that the cookie-scents would turn everyone into type 2 diabetics, or some other unsubstantiated claim they have become known for making. Then again, the NYC Health Comissioner loves to appear on TV, and there isn't anything imminent to get his ugly mug on camera, but I guess the City by the Bay beat him to the punch! Speaking of punch, maybe they try to should ban that, too, it does contain a lot of sugar ...

What can I say, I'm a cynic, but that's why people like me!