American Cancer Society's Effort Could Also Benefit Diabetes

Can the American Cancer Society's marketing efforts benefit people with diabetes? We may find out next year. In what was arguably one of the biggest news stories in the nonprofit arena recently, The New York Times is reporting that next year, the American Cancer Society announced plans to devote its entire $15 million advertising budget to the consequences of inadequate health coverage.

Two 60-second television commercials that form the bulk of the campaign make that point readily apparent. One features images of uninsured cancer patients, appearing hollow and fearful. "This is what a health care crisis looks like to the American Cancer Society," the narrator begins. "We're making progress, but it's not enough if people don’t have access to the care that could save their lives."

While its certainly a change in the organization's marketing tactics, from the American Cancer Society's perspective, they see it as a critical element in the fight against cancer. After all, they know that the uninsured are less likely to get recommended cancer screenings, thus are more likely to be diagnosed in more advanced, and often more deadly, stages of the disease. As you might imagine, patients with diabetes are also caught in the dysfunctional U.S. healthcare system, and their prognosis is similarly poor.

According to a 2006 report published by the International Diabetes Federation, the authors used estimates that approximately 45 million people in the U.S. (roughly 17% of the working-age population) are not covered by health care insurance. Using simple, back-of-the-envelope calculations, given that roughly 6% of people in the U.S. have diabetes, of the approximately 45 million people with no healthcare cover, we can conservatively estimate that approximately 3 million people with diabetes in the U.S. lack healthcare insurance. According to a number of different studies, their prognosis isn't good. For example, analysis of a study done in 2002 revealed that when compared to people who had health insurance, people without any form of health insurance who have diabetes received fewer preventive diabetes care interventions and showed generally less-desirable diabetes outcomes. Specifically, a higher percentage of uninsured people had HbA1c levels of 9% or higher; fewer had an annual blood lipid test and/or annual foot exam. It's hard to imagine, but on average, fully one-fourth (25%) of people with diabetes go without a checkup for 2 years if they have been without health insurance for a year or more vs. only 5% of diabetes patients with insurance.

This year, the cancer society formed a collaborative with the heart, diabetes and Alzheimers associations, as well as AARP, to promote awareness of the health access problem. The group adopted as common principles that all Americans deserve quality, affordable health care with transparent costs. While the leaders of the American Diabetes Association, as well as the American Heart Association and the Alzheimers Association applauded the American Cancer Society's campaign, indicating that progress against chronic disease would also be halted until the country fixed its health care system, so far, none of the other organizations have altered their own advertising budgets to seriously promote the issue. But the Times reports that with nearly $1 billion in revenues, the cancer society is the wealthiest of its peers and has spent about $15 million annually on advertising since 1999. By comparison, GEICO, the automobile insurer with the "Caveman" advertisements, spent about $14 million on network advertising in the first quarter of 2007, according to TNS Media Intelligence, a tracking firm.

Healthcare reform is shaping up to be a key issue for the 2008 presidential election, and deservedly so. According to the Washington Post, candidates from both parties are developing plans to address this issue, albiet none of their approaches are terribly radical. But leadership in Washington, including the President and Congress, have largely ignored the issue since 1993, when then President Clinton and his wife attempted to reform the system with what was then derided as "Hillary Care" which died a very painful death. Since then, Congress has done little besides talk about the issue.

In August 2007, the U.S. Census Bureau released data showing that a record 47 million Americans did not have health insurance last year. In spite of these issues, the expense of the U.S. healthcare system has grown (and is expected to explode as the baby boom retires) while the U.S. rankings have slipped behind many countries, including most of Europe, Japan, and even countries including Jordan! Our life expectancy now ranks 42nd, down from 11th two decades earlier, according to international numbers provided by the Census Bureau and domestic numbers from the National Center for Health Statistics.

Some candidates, notably Republican Mitt Romney, who credits himself for the Massachusetts plan (the nation's first), has recently said he would leave the responsibility up to individual states. Using California as an example, that may be easier said than done. The San Diego Union-Tribune is reporting that Governor Schwarzenegger's ambitious plan to overhaul the state's health care system and cover California's estimated 6.5 million uninsured residents is quickly running out of time. The Legislature is scheduled to adjourn Sept. 14, and Assembly Speaker Fabian Núñez recently threatened to bring the proposal for a vote of "no confidence" in the California Assembly, but then backed away. Meanwhile, other states are grappling with the issue in different ways.

Back in April, for example, The Wall Street Journal reported (if you have an online subscription to the WSJ, the article is accessible here) on a universal coverage program engineered by Tennessee Gov. Phil Bredesen, which won national attention as states try to develop plans for universal health care. The only problem is that Tennessee's plan may be more affordable for states that cannot afford plans as extensive as those introduced in more affluent states like Massachusetts or California, but participants in the Tennessee plan get coverage up to a maximum of $25,000 for health expenses annually, and only $15,000 of that can go to hospital bills. If a patient becomes seriously ill or has a major accident, they'll be just as vulnerable as they were before, being forced to either pay the bills themselves or ask the hospital for charity care.

To be fair, BlueCross BlueShield of Tennessee says that many people in the state can't afford comprehensive coverage and don't seem interested in high-deductible policies that offer protection against catastrophic expenses for as little as $100 a month. And for those who would otherwise go uninsured, a big advantage of the Tennessee plan is the steep discounts that BlueCross can extract from doctors and hospitals. That will stretch the $25,000 further, says Stan Roberts, health-practice director at Milliman Inc., a Seattle consulting and actuarial firm.

Until Washington approaches this issue seriously and there are Federal standards on healthcare coverage, we're likely to end up with a patchwork of different plans across the 50 states (some deride it as Balkanized coverage, but truthfully, all of the Balkan countries have better healthcare systems than the U.S.). But if the American Cancer Society's advertising campaign works, its possible our politicians will be forced to address the issue in a manner not seen since 1993, regardless of who is in the White House!

Why Glucose Wands May Help Diabetes Educators

Since I have my blog reader search virtually every major newspaper in the U.S. for news stories on diabetes, I can tell you that most stories are from the major newswires (Associated Press, Reuters) and get published in multiple papers. Too often, the coverage is uninformative, uninspiring, underwhelming, and frankly, full of the same one-sided coverage (often omitting key facts) we see in the press all the time. The fact is that diabetes may be making the news, yet relatively few reporters seem to do their homework on the subject, or else their editors cut out important facts, leaving banalities in the articles that actually go to press. Recently, the Pittsburgh Post-Gazette has run a series of articles on "The Out of Control Diabetes Crisis". So far, I have found the coverage to be just more of the same, but this morning's edition was different.

Its no secret that diabetes is a growing health problem, not only in the U.S., but worldwide. Much of the burden for managing this disease falls on the patient, and diabetes education is a vital element in this equation. Yet in spite of the importance of their job, the evidence strongly suggests that the medical profession, including many endocrinologists and diabetes educators, are failing abysmally at their assignment. The rate and incidence of blindness, amputation, heart attacks, and kidney failure caused by diabetes — as reported by the NIH — continues to rise year after year.

Insurance companies and health care providers ponder this failure and, with few exceptions, conclude that "educating people with diabetes" to adhere to an intensive regimen of injections and diets will miraculously solve the problem. Yet education and instruction is often littered with platitudes about future complications for failure to manage the condition as prescribed. Sometimes, education is done in larger facilities (such as at senior centers) so that a whole group of patients can be instructed at the same time. But relatively little has been done to ponder why diabetes education has failed. If you think about typical diabetes education today from the perspective of patients, children are often terrified of instruction on how to pierce themselves with needles and lancet devices, and while adults may be slightly more rational, many adults with diabetes claim they feel fine, so the message often fails to get through.

Several years ago, a diabetes educator from the Pittsburgh area named Mary Jo Dudley, (she now lives in Dover, NH) set out to make diabetes understandable. Mrs. Dudley started a sideline business called Ideabetes in 1989 to create tools to help people understand the disease. A key element in her instruction is the use of various props, including glucose wands, pancreas pillows, insulin spheres and blood sugar bingo cards which are used to demonstrate her points. Her diabetes instruction goes well beyond the boring textbook lessons and actually teaches many diabetes patients a thing or two. Even more importantly, she is able to impart the lesson that diabetes is serious and needs to be managed.

For example, Mrs. Dudley's glucose wands, are clear plastic tubes full of liquid and sequins. But one tube is watery, reflecting normal blood sugar, while the other is syrupy, representing blood with high levels of glucose or sugar. As her wands suggest, when the blood is syrupy with sugar, the heart has more problems pumping it, especially into capillaries in the eyes, legs or kidneys, as proven by the lethargic sequins.

"Glucose attaches to the red blood cells and makes them tacky," Mrs. Dudley said. "Picture in your mind cells swimming in Karo syrup."

Whether they realize it or not, "Most nurses are teachers," Mary Jo Dudley said, realizing early in her career that people need more than cold, hard facts to understand diabetes. So when patients ask why they must keep their blood sugar under control or take aspirin, the answer is simple: it thins the blood and prevents clot formation.

The lesson for today is that teachers are really the key to diabetes education, and that diabetes education and educators are teachers first, nurses second. The job of teaching diabetes control is huge, and once the job is looked at as a teaching role, then there are lots of different ways to approach the issue, the key is to understand patients and develop a way to reach them. Lots of great teachers can indeed change the the world, and many do one student at a time. Perhaps a glucose wand or an insulin sphere might just be the missing element needed to help educators make diabetes education actually work!

The Business of Diabetes: Medco Acquires Liberty

This morning, drug distributor giant Medco Health announced they were buying PolyMedica, whose public face is depicted by its Liberty Healthcare division, featuring everyone's least favorite diabetes spokesman, Wilford Brimley's TV pitches.

You can catch the full press release here. According to Dow Jones, Medco is buying PolyMedica in an all-cash deal, and is paying a hefty 17% premium to PolyMedica's stock price, which is yet another sign of how much money goes into treating diabetes rather than eliminating the disease, and then we wonder why a cure still hasn't been found. Talk about a cash cow -- for diabusiness, that is.

As Medco pointed out to investors this morning, "With spending increasing by 14.5% annually, diabetes treatments by 2009 are expected to overtake cholesterol medicines as the fastest-growing therapeutic category."

Ironic, considering that investments in prevention of type 2 diabetes have been marginal at best, and investments made towards advancing treatment for type 1 have been largely off the radar for most major pharmaceutical companies (that may not be a bad thing). But for what its worth, were you aware that not one new insulin is in the drug pipeline at Lilly (in spite of having lost 35% of its market share over the last 5 years), and even Novo has only 1 major insulin in advanced trials now in the works? Novo's pending contribution: yet another long-acting analog which supposedly doesn't encourage weight gain, and they dare call it an advance over Levemir? Please ...

I for one, find at least some humor in all of this, in spite of the disturbing message it sends about the rich premiums ... in cash ... that big business now places on diabusiness. With that in mind, I am including a few clips that most of us have seen on YouTube, but seem very appropriate here. By the way, its unclear whether Medco is likely to fire Brimley (one could hope, anyway). Medco noted that PolyMedica will "retain its successful patient engagement and service model, Liberty brand, culture and focus," while providing an integrated and complementary set of services and solutions in support of Medco's Therapeutic Resource Center for diabetes care. Truthfully, I suspect Mr. Brimley will have work for a while to come, because in spite of being incredibly annoying, he is also well-recognized, which means a lot in a commodity business like pharmaceutical and medical equipment distributors.

Media Spin on Diabetes Knows No Bounds

This morning's edition of the Los Angeles Times reports that a survey released by the UCLA Center for Health Policy Research found that 7% of California adults were diagnosed with diabetes. The survey also found that in Californians of Asian heritage showed the most surprising increase, swelling from 5% to 6.5%.

Ironically, the California statistics are not dramatically different from the 8% figure that New York City recently reported with much heavy press coverage (see "Diabetes Epidemic Having Devastating Effects In New York City, New Report Shows") in which the New York City Department of Health and Mental Hygiene tried to suggest that the nation's largest city was being disproportionately hit by the so-called diabetes epidemic. Yet as the new California figures suggest, the incidence of diabetes is rising at roughly the same rate nationwide, and that no ethnic groups are being spared.

According to NYC Health Commissioner Dr. Tom Frieden, "The rising cost of treating diabetes is an unsustainable burden on our health system and economy. But even worse, behind these statistics are tragic individual stories that challenge our city and our health system to respond." Cry me a river, Tom. It appears that sunny California is experiencing a comparable rate of growth as New York City.

The UCLA statistics solidify my contention that the New York City Department of Health and Mental Hygiene is doing little more than engaging in media spin to suggest that its undisclosed seizure of patients' labwork is somehow justified, which it is not.

As I reported earlier this week, Federal statisticians have turned to data from the National Health and Nutrition Examination Survey (NHANES), which is a periodic survey of a representative group of Americans that not only asks whether people have been told they have diabetes but that also includes blood tests to find undiagnosed cases. Their surprising conclusion, said Katherine M. Flegal, an author of the paper and an epidemiologist at the National Center for Health Statistics, was that the overall age-adjusted proportion of the population that has diabetes had not really changed from 1988 to 2002, the most recent year for which Federal data are available. Rather, what has changed is that cases of undiagnosed diabetes have dropped sharply.

In the interim, the media spin on diabetes continues to suggest that we have an unprecedented explosion of diabetes cases on our hands, and that public health officials simply cannot respond to the growth. Perhaps its time that reporters start doing their homework instead, and represent the data in an honest, well-thought out manner.

New Progress Being Made in Celiac Diagnosis

As many readers know, celiac disease (a genetic intolerance to gluten, a protein found in wheat, rye and barley, which triggers this destructive reaction to the small intestine, which can lead to malabsorption of nutrients and glycemic instability) is especially common among people with type 1 diabetes because both are believed to be autoimmune diseases. Unfortunately, obtaining a diagnosis of celiac disease is often an exercise in frustration, in part, because there often aren't overt symptoms, and the tools used in diagnosis aren't always 100% accurate. In fact, a diagnosis is often only made by using a process of elimination.

According to the Celiac Disease Center at Columbia University, the current "gold standard" for diagnosis is the small intestinal biopsy, done during a procedure called endoscopy. The diagnosis is based on finding a series of abnormalities in an intestinal biopsy (increased inflammation and villous atrophy) that return toward normal on a gluten-free diet. This means adherence to a gluten-free diet may be required in order to diagnose patients. A follow up biopsy is not always necessary or even performed, but the combination of an abnormal biopsy and improvement of symptoms after gluten is eliminated from the diet is usually enough to establish a diagnosis. Blood tests that indicate higher-than-normal levels of specific antibodies may also be used to support the diagnosis, but positive antibodies are not required to make the diagnosis, and many doctors fail to order these tests.

For this reason, an article published in Reuters late yesterday (one of those you might miss otherwise) may bring some good news. Apparently, scientists in Italy have pioneered a method that improves the accuracy and speed of diagnosis significantly using what is sometimes called a "pill camera", officially known as video capsule enteroscopy or VCE. Read the Reuters article here:

Video capsule may soon diagnose celiac disease

NEW YORK (Reuters Health) - A new device -- video capsule enteroscopy (VCE) -- accurately detects intestinal atrophy in patients suspected to have celiac disease, according to a report in the American Journal of Gastroenterology.

The diagnosis of celiac disease currently requires upper GI endoscopy with multiple biopsies to identify the characteristic irregularities in the mucus tissue of the small bowel, the authors explain. GI endoscopy is a procedure in which a tube is inserted into the digestive tract. The tube is equipped with a small camera to visualize abnormal tissues, which can be biopsied or removed.

Celiac disease is a genetic disorder in which the body's immune system damages the small intestine in responses to foods containing gluten, a protein in wheat, rye and barley. Celiac disease may cause a variety of symptoms. Diarrhea, abdominal pain, irritability and depression are common, but some people may have no symptoms. Treatment for the condition is a gluten-free diet.

Dr. Roberto de Franchis from the University of Milan, Italy and associates tested the performance of VCE in 43 patients with signs or symptoms suggestive of celiac disease and compared the results to those obtained by conventional upper GI endoscopy with biopsies.

Of 32 patients found to have abnormal tissue, 28 were diagnosed with celiac disease by capsule endoscopy, yielding a sensitivity of 87.5%.

VCE had 90.9% specificity, 96.5% positive predictive value, 71.4% negative predictive value for diagnosing celiac disease.

"The recently introduced VCE may be a valid alternative to...biopsy in this patient population, since it provides high-quality images of the small bowel mucosa," the investigators conclude. "Furthermore, it is minimally invasive, which may improve patient acceptance, and it allows exploration of the whole small intestine, which may lead to the identification of (abnormal tissue) beyond the segments reached by upper GI endoscopy."

They add that the findings "await confirmation in a larger study."

SOURCE: Reuters Health, August 20, 2007 and the American Journal of Gastroenterology, August 2007.

Photo: The Given® video endoscopy capsule, courtesy of the New South Wales (Australia) Government Health Service.

Diabetes: "epidemic" may be too strong a word

This morning's edition of The New York Times featured an article entitled "An Increase in Diagnoses May Not Mean a Higher Rate of the Disease, a Survey Shows," no doubt written to address the oversimplified media response to recent reports that the diagnosis of diabetes is at its highest levels in history.

To get a better idea of whether the disease is striking more people or whether more people who have the disease are receiving diagnoses, the article notes that statisticians have turned to another set of federal data. It is from the National Health and Nutrition Examination Survey (NHANES), which is a periodic survey of a representative group of Americans that not only asks whether people have been told they have diabetes but that also includes blood tests to find undiagnosed cases. (I would just personally add that NHANES does not capture what type of diabetes a person has, thus the counts do little to track the growth in type of diabetes, which is a major flaw that has yet to be corrected. More recent data, notably from the SEARCH for Diabetes in Youth, suggests that incidence both types of diabetes are growing, and that previous estimates of type 1 diabetes may have been under-counted).

Still, the article reports that in a paper published last year in Diabetes Care, federal scientists used those data to ask what was the total proportion of the population with diabetes — diagnosed and undiagnosed.

Their surprising conclusion, said Katherine M. Flegal, an author of the paper and an epidemiologist at the National Center for Health Statistics, was that the overall age-adjusted proportion of the population that has diabetes had not really changed from 1988 to 2002, the most recent year for which federal data are available.

No doubt, the incidence of both types of diabetes is rising, particularly among certain groups that had previously had lower levels of diagnoses, such as Blacks and Hispanics, and that probably reflects the fact that we have become better at diagnosing people. But some question whether the term "epidemic" is really appropriate in the case of diabetes. Regardless, talk is cheap, what we really need is to address the cause behind the increase in both type 2 AND type 1. So far, little has been done in that regard except a lot of finger-pointing.

Bones May Be A Factor Contributing To Type 2 Diabetes (in Mice, Anyway)

I generally do not report much on issues pertaining to type 2 diabetes, in part, because of the the fact that so much of that news is what I would consider to garbage. Because I am not personally impacted by type 2 diabetes, many of these developments have little personal relevance to me. However, there are occasional exceptions that impact all people with diabetes. Sometimes discoveries have implications for a much wider audience, including society as a whole as well as a factor contributing to beta cell proliferation. I should forewarn and caution my readers that discoveries on mice may be irrelevant to humans.

Researchers at Columbia University Medical Center have recently identified a surprising yet critically important novel function of the skeleton. They've shown for the first time that in addition to being calcified, inert structures, the skeleton is also an endocrine organ that helps control blood glucose metabolism and weight and may therefore be a contributor to the development of type 2 diabetes.

Perhaps we shouldn't be too surprised. After all, we know that bone marrow found within large bones is responsible for producing new blood cells, and we also know that disorders in this function is responsible for leukemia. However, the Columbia researchers found that a protein made only by bone-forming cells (osteoblasts) called osteocalcin was not merely a structural protein as widely thought. Osteocalcin is also a hormone with totally unanticipated yet crucial functions. The research, which was published in the August 10, 2007 issue of the scientific journal Cell, demonstrates that bone cells release a hormone called osteocalcin, which controls the regulation of blood glucose and fat deposition through synergistic mechanisms that were previously not recognized.

As it turns out, osteocalcin directs the pancreas' beta cells, which produce the body's supply of insulin, to produce more insulin. At the same time, osteocalcin directs fat cells to release another hormone called adiponectin, which thereby improves insulin sensitivity. It has previously been shown that people with type 2 diabetes have have low osteocalcin levels, suggesting that altering the activity of this molecule could potentially be an effective therapy. That hypothesis is supported by the Columbia research, which showed that mice with high levels of osteocalcin activity were prevented from gaining weight or becoming insulin-resistant even when they ate a high fat diet. Analysis of mice lacking the osteocalcin protein showed that they developed type 2 diabetes, increased fat mass, a decrease in insulin and adiponectin expression, and decreased beta-cell proliferation.

The authors showed, in mice at least, that an increase in osteocalcin activity prevents the development of type 2 diabetes and obesity, potentially opening the door for novel therapeutic avenues (e.g. drugs) for the prevention and treatment of type 2 diabetes.

"The discovery that our bones are responsible for regulating blood sugar in ways that were not known before completely changes our understanding of the function of the skeleton and uncovers a crucial aspect of energy metabolism," said Gerard Karsenty, M.D., Ph.D., chair of the department of Genetics and Development at Columbia University Medical Center, Paul Marks Professor in the Basic Sciences, and senior author of the paper. "These results uncover an important aspect of endocrinology that was unappreciated until now."

Karsenty and his colleagues had previously shown that leptin, a hormone released by fat cells, acts upon and ultimately controls bone mass. They reasoned that bones must in turn communicate with fat, so they searched bone-forming cells for molecules that could potentially send signals back to fat cells.

This discovery showed for the first time that one hormone has a synergistic function in regulating insulin secretion and insulin sensitivity, and that this coordinating signal comes from the skeleton. Additionally, osteocalcin enhances the production of insulin-producing beta cells, which is considered one of the best, but presently unattainable, strategies to treat diabetes.

This research was supported by the National Institutes of Health, the American Diabetes Association, the Japan Society for the Promotion of Science, and the Pennsylvania Department of Health.

Note: This story has been adapted from a news release issued by Columbia University Medical Center. Photo: Agricultural Research Service (ARS)/U.S. Department of Agriculture.

The Debate Over Generic Biopharmaceuticals: Which Concerns Are Genuine, and Which Are Fear-Mongering?

This morning, The Wall Street Journal Health Blogger David Armstrong had an interesting post that pertains to generic biopharmaceuticals. Specifically, he writes about Genzyme's (a Boston-area biopharmaceutical company) struggle to produce enough of a promising drug to treat a rare genetic disorder which he believes adds more fuel to the raging debate about generic biotech drugs. Specifically, he notes that Genzyme is having trouble persuading the FDA to sign off on its medicine known as Myozyme made in big batches because the FDA wants to be sure the drug produced in large tanks is the same as the stuff Genzyme made successfully on a smaller scale. Thats a legitimate concern, but its really up to the FDA to inform the drug maker how they are to address those concerns to ensure patient safety.

As I have chronicled on this topic as developments occur, there is now legislation pending in Congress (S. 623/H.R. 1038, the "Access to Life-Saving Medicine Act of 2007") which would not only legalize generic biopharmaceuticals (the FDA prefers the term "follow-on" proteins), but would also outline procedures for the FDA. The key, however, is that the agency would be given considerable leeway to make decisions on a case-by-case basis, which puts more pressure on the people reviewing the medicines and less on the agency itself. For the past 6 years, the FDA has danced around this issue, effectively extending the patents on biopharmaceuticals such as insulin (notably Humulin and Novolin R and N), whose patents expired years ago.

Perhaps I should provide some quick but relevant background. For those of you unfamiliar with the term, unlike regular drugs which are simple, chemical compounds, biologic medicines (or biopharmaceuticals) usually depend on living organisms such as bacteria or yeast to grow and requires maintenance of precise conditions in order to grow. They are not chemical drugs, but more complex proteins and/or peptides. Insulin is one of the first-generation biopharmaceuticals (along with human growth hormone), and has been commercially available for over 2 decades.

As I first wrote in my groundbreaking article on generic insulin back in January 2007, the introduction of generic insulin has been stymied by a variety of political and competitive factors. But whether we like it or not, passing legislation which outlines specific procedures for generics manufacturers to obtain approval from the FDA is critical to the emergence of generic insulin in the U.S. market.

The Genzyme story noted in David Armstrong's posting is a legitimate concern for many of the newer biopharmaceuticals. Think about it this way: just imagine if one bottle of insulin was dramatically different in strength from another, and the same dosage could not be relied upon to have the same blood glucose-lowering effect. One day, it works fine, the next day you plunge into hypoglycemia. To some extent, we have already seen some example of that with synthetic, rDNA-origin insulins, as many patients complain that their dosages do, in fact, not always yield predictable results, but their complaints are routinely written-off by doctors and many diabetes educators as patient error (in carb counting, fat content of meal, etc.). However, its important to note that the FDA relies on the manufacturers to have their own quality-control procedures in place, they do not require them.

This is because insulin is considered by the FDA to be nothing more than a small-molecule chemical drug, which is governed by the Federal Food, Drug & Cosmetic Act. The pending legislation on biogenerics would do nothing to guarantee our insulin strength does not vary from one batch to the next nor does it require batch testing to ensure that. But that isn't stopping fear-mongerers like the Biotechnology Industry Organization (BIO) from implying that only brand-name manufacturers will produce reliable medicines. The only problem with that claim is that they are up against some of the drug industry's biggest and best-prepared companies, such as Israel-based Teva Pharmaceutical Industries Ltd., an $8 billion/year giant in the world of generics, Swiss drugmaker Novartis and its Sandoz unit, and U.S.-based companies such as Barr Pharmaceuticals. None of them are fly-by-night companies, and most have established themselves as leaders because of their price and quality. But unlike smaller startups, these giants are very familiar with the legal tactics employed by brand-name rivals and are very well-prepared to respond in an appropriate manner.

Even more importantly, unlike newer biopharmaceuticals, the genetic structure of insulin (and human growth hormone) is very well-characterized, meaning its genetic structure can easily be verified with fairly simple tests. Another key difference is that few patients take insulin without blood testing to estimate their dosage, and because of that, the concerns differ in some of the more complex medicines like anemia treatments which can mean life-or-death. The system is far from perfect, but we should not allow BIO to use fear-mongering to delay this critical legislation any further!

Smart Cells, Inc. Secures Additional NIH Funding

Back in June, I published an interview I did with the President and CEO of SmartCells, Inc., Todd Zion.

In what is undoubtedly a vote of confidence in their basic concept, last week, SmartCells announced that the company had been awarded $283,515 grant for Phase I funding as part of the NIH/NIDDK's "Fast-Track" Small Business Innovation Research (SBIR) program. SBIR is a unique funding source (separate from the NIH's intra and extramural research programs) awarded to companies in the private sector whose work the National Institutes of Health deems very promising with a good chance of being commercialized. SmartCells' grant was awarded to support stability testing of the company's glucose-regulated insulin formulations. After successful completion of the Phase I work, $2,445,628 in Phase II funding will be available for continued manufacturing development.

This is a positive sign for SmartCells, which up until now has had little difficulty in securing government and venture capital for its continued research. However, private venture capital is not as free-flowing as it was a few years ago, in part because credit markets are tighter. As The New York Times reported today, "The liquidity in the credit markets was abysmal," said William H. Gross, chief investment officer of the bond management firm Pacific Investment Management Company, known as Pimco. "On Friday, afternoon, the brokers were unwilling to make markets in almost anything that didn't have a Treasury or agency sticker attached to it. That's pretty bad."

What the SBIR grant does is ensures that SmartCells will have a source of funding even if venture capitalists prove more difficult to lure in the immediate future. As I noted previously, SmartCells represents the rational future of insulin replacement therapy, one that is not burdened with endless calculations, hypoglycemia, and one that eliminates the kind of testing many now require to obtain reasonable "control". SmartCells' basic concept is to encapsulate human insulin nanoparticles in a polymer that would theoretically "detect" a diabetic's glucose levels automatically, and therefore release only the appropriate amounts of insulin at precisely the right time to keep blood sugar levels steady. The big deal is that it would completely eliminate hypoglycemia, and also significantly reduce the burden of blood testing.

So far, preclinical testing has passed several major hurdles, and human trials are likely to be pursued in the future. When I spoke with Todd Zion, he suggest that human trials could be ready as soon 2009 or 2010. With another source of funding secured, it looks like SmartInsulin is one step closer to becoming reality.

Should My Blog Feature Advertising?

Yesterday, the Peter Rost of the blog BrandWeek NRx reported that U.S. House of Representatives Judiciary Committee had approved a bill designed to shield both bloggers and journalists from federal prosecution for protecting confidential sources. But, and its a big but, the bill excludes casual bloggers by stipulating that the protections apply only to those who derive "financial gain or livelihood" from the journalistic activity. However, he notes that based on the wording, it is expected that bloggers who receive "even minimal revenue from advertising" would be covered by this bill. Rost believes this is a major milestone in the blog world, and further blurs the line between bloggers and journalists.

The key, however, is that ad revenues are an important distinction, if for no other reason than the legal protections that the legislation would provide. While most casual bloggers are unlikely to run into legal issues anyway, with unwarranted telephone taps in the name of the war on terrorism, its not inconceivable. While its not law yet, the development did make me consider whether I should consider taking advantage of Google's AdSense tool on my blog. I'm already registered so I can share in any revenues generated from my article published on DiabetesThought.com, so it would not be a major undertaking to include something on my blog, and I might just derive some revenue, too. You know the type of advertising I'm referring to: outrageous and downright deceptive (and untrue) claims of miracle, natural cures for diabetes, including the autoimmune variety known as type 1. However, Google is pretty ethical about it, with prominent designation indicating "Ads by Google" so readers can judge for themselves.

What does anyone else think or do? What about the legal protections it might soon afford? How many of you already feature this, or some other type of online advertising? Would you consider the blog any less credible?

Show Me The Money!

August 1 marked the start of JDRF's "Promise to Remember Me" campaign. A major objective of the campaign this year is to convince the Federal Government to renew the Special Statutory Funding Program for Type 1 Diabetes Research, which is set to expire in 2008. President George W. Bush signed the last extension of that program (in 2000 or 2001, I can't recall), so its possible he will also approve it this year if the legislation is sent to the White House for approval. What's at stake is more than one-third (35% to be exact) of all Federal funding allocated to type 1 diabetes research which comes from that "special" program. (The remainder comes from the annually appropriated funds to the NIH to support type 1 diabetes, and a tiny, highly targeted funding program also exists within the Department of Defense to fund the development of remote sensing technology, which is seen as having application not only for diabetes management, but also for the U.S. military.)

Some have estimated that JDRF funds as much as 25%-30% of all research conducted for type 1 diabetes (excluding pharmaceutical research, which has been minimal for type 1). Unlike type 2 diabetes which receives almost all of its research funding from the Federal Government (again, excluding pharmaceutical research, which is substantial), type 1 diabetes is unique in that such a large portion of the research done is actually financed by the people who live with the disease itself. That speaks volumes about the determination of the individuals and families who live with this condition and to bring their disease to an end, and it also enables them to have a much larger say in what the research priorities should be for their disease since they are raising the funds to pay for it. But the other side of that equation is that to some extent, it has also enabled the National Institutes of Health to shift focus more towards the more common form of diabetes (type 2), which is why type 1 diabetes is the only major disease to obtain Federal funding in this unique manner.

As I reviewed the e-mails I've received from JDRF over the past week or so, I began thinking about the organization's research priorities. Former CEO Peter Van Etten really pushed stem cell research, and his reasoning was that if scientists could culture an unending supply of beta cells in laboratories, more patients could receive transplants and be cured. He also reasoned that they could develop better ways of transplanting islets which would enable them to be done without immunosuppression. Some did not agree with his views, but no one could say he did not work to set priorities and strategies for JDRF.

However, I have struggled to put my finger on JDRF's new(er) CEO Arnold W. Donald and what exactly his contribution has been. I was initially unimpressed, and quite frankly, the guy rubbed me the wrong way. But after a more thorough examination, I do see some signs of progress. Notably, since he has taken the reigns, one of his primary objectives has been for JDRF's role to be helping to fill gaps in the drug and therapeutic development process, and in that regard, he has indeed shown significant progress and should be congratulated. The most visible example is the "artificial pancreas" concept, and while thats a visible manifestation, the article published in a February 2007 edition of The Wall Street Journal (see here for details, and here for the article itself) suggests that JDRF has pushed into less visible areas as well. This is an important new direction for the organization, and I think a good one.

For example, in the area of autoimmunity, JDRF has partnered with TolerRX in Massachussetts, and MacroGenics, a Maryland-based company to fund the first Phase III trial JDRF has ever sponsored. Phase III trials are the last stage before applying to the FDA for approval to market a product, and the idea is that by helping at this stage, some of these efforts may be commercialized which would otherwise never have made it that far due to a lack of funding. The trial is testing an anti-CD3 antibody in patients who have recently been diagnosed with type 1 diabetes. The research these Phase III trials are building on showed that this antibody could preserve beta cell function in newly diagnosed patients for up to 18 months after diagnosis. His reasoning is that if JDRF can prevent diabetes from spreading in the newly diagnosed, then JDRF could also gain insight, and perhaps the ability to reverse it. These are important steps, but frankly, don't do much for the million or so people who live with this condition and work to fill JDRF's coffers each year.

But JDRF has not forgotten that. They did report progress in filling the gaps in getting treatments for complications farther along the product development pipeline. For example, several drugs aimed at alleviating diabetic eye disease are now in clinical trials. JDRF is also collaborating with Genentech to test a drug called Lucentis in a Phase II trial for diabetic macular edema, and JDRF is also planning a Phase II trial testing this drug against diabetic retinopathy. Lucentis has already been approved by the FDA for age-related macular edema, so the journey to the market for diabetic complications could be accelerated.

But gaps in treatment for type 1 diabetes remain, and continue to widen when compared to type 2 diabetes. There have been only a handful of improvements in treatment since insulin was discovered. And not everyone is enthusiastic about a so-called artifical pancreas. I'd like to see Mr. Donald move JDRF to step in to fill a number of important therapeutic gaps. One notable example, a development stage biopharmaceutical company based in Sweden called Creative Peptides who is engaged in the discovery and development of biopharmaceutical drugs to treat long-term complications of type 1 diabetes, and their lead drug (synthetic C-Peptide made from rDNA origin) development project is currently in phase II clinical trials. The company has secured U.S. and European patents for their work (see here for the U.S. Patent information). Started by a number of researchers from the esteemed Karolinska Institute in Stockholm, like all startups, the cost of trials is an impediment to faster progress. Ultimately, Creative Peptides may well succeed, but commercialization of their products will require a partnership with a large pharmaceutical company for manufacturing and product marketing expertise. That usually guarantees the larger partner marketing exclusivity for some period. But patients would likely benefit by having JDRF working to fill a gap and ensure that all manufacturers offer it.

My initial reaction to Arnold W. Donald was not positive (see my posting on that here), but after 18 months on the job, I must admit that I have indeed warmed to his big push for JDRF to "fill in the gaps". But in order for him to make JDRF a more donor-centric organization, I want to see more quantifiable progress and details reported on this regularly. To borrow a famous line from the movie Jerry McGuire, "Show me the money!"