JDRF News

This morning, the Juvenile Diabetes Research Foundation (JDRF) got some less-than-flattering press. No, it wasn't from people on the Islet Foundation Public Message Forum, although JDRF-bashing does seem to be a popular pastime there. This time, the news was that JDRF's internal auditors had discovered hundreds of thousands of dollars missing and apparently, two employees were fired as a result of the incident.

To be sure, any organization has a risk of employee dishonesty, and we should be proud that the organization was able to uncover the scheme on its own and was able to take corrective action. But for me, the real news wasn't about the government investigation into that apparent fraud, rather it was that JDRF's CEO since January 2006, Arnold W. Donald, 53 announced earlier this month that he was taking early retirement, which is effective on Friday (tomorrow) February 29, 2008. He cited urgent "family matters" as the reason for his decision.

Obviously, leaders can and do have family matters which may mean they have to step down, but the bigger question is what the organization's succession plans are? What, if anything, will the change mean as far as the organization's strategy, which under Mr. Donald, has been to push into closing gaps by helping startups commercialize products that can advance treatments and bring products to market that might otherwise never have been commercialized because of industry's risk-averse nature.

Certainly something to think about!

Nonprofit Diabetes Group Is Subject of Investigation
By Anthony Ramirez, The New York Times
February 28, 2008

The Manhattan district attorney is investigating the Juvenile Diabetes Research Foundation International after an internal audit showed that hundreds of thousands of dollars was missing. The audit led to the dismissal of two foundation employees.

Barbara Thompson, the spokeswoman for District Attorney Robert M. Morgenthau, would confirm only that an investigation was under way and provided no details. But Gail Pressberg, the secretary of the foundation's board, said the investigation centered on the misappropriation of funds through fake receipts. She said the receipts were generated on computers and appeared legitimate.

Ms. Pressberg said there was no need for stricter fiscal controls at the foundation because the scheme had been detected by an internal investigation.

"It's a foolish person who tries this," Ms. Pressberg said. "We catch people." She noted, "We had enough evidence to terminate the employees. There's no nonsense in this organization."

Separately, Arnold W. Donald, 53, the foundation's president and chief executive since January 2006, announced earlier this month that he was taking early retirement, effective on Friday. He cited urgent "family matters." On Tuesday night, he directed questions to the foundation's public relations office, which said that Mr. Donald's early retirement was unrelated to the investigation.

The district attorney's investigation was begun at the request of the Manhattan-based foundation, a leading fund-raiser and advocate for diabetes research whose public face is Mary Tyler Moore, the actress and the foundation's international chairwoman. The inquiry follows the circulation of a foundation e-mail message that described the employees who were fired as violating the foundation's expense policy.

Staff members of the foundation describe the violations as involving hundreds of thousands of dollars over five years.

The foundation, at 120 Wall Street, has said that its mission is to find a cure for Type 1 diabetes, which often strikes in childhood and requires patients to have multiple injections of insulin daily or a continuous infusion of insulin through a pump.

Although insulin, a hormone that regulates the metabolism of glucose, is used as a long-term therapy for diabetes, it is not a cure.

The foundation has said that since its start in 1970, it has awarded nearly $1.2 billion to diabetes research, including more than $137 million last year. The foundation said it also funded 700 centers, grants and fellowships in 20 countries last year.

In an e-mail message on Dec. 12 addressed to "J.D.R.F. Chapter, Regional and National Staff," William Ahearn, the vice president for strategic communications and information technology, wrote that the foundation's internal audit department had discovered certain undefined "abuses" in the foundation's publications, editorial, and marketing communications group.

Mr. Ahearn confirmed the authenticity of the e-mail message on Wednesday.

"Full restitution is being sought," the e-mail noted, "and the matter is being reported to the appropriate authorities who may consider criminal prosecution."

Mr. Ahearn identified the employees as Jonathan Stenger, national director, and Jason Brown, national manager. They were dismissed late last year.

Mr. Stenger declined to comment through his lawyer, Andrea Weiss. "We have been fully cooperative with all inquiries from the appropriate parties," Ms. Weiss said on Wednesday.

Mr. Brown did not return repeated telephone calls to his home seeking comment on Tuesday night and Wednesday afternoon.

Ms. Pressberg, the board secretary, said Mr. Stenger and Mr. Brown had "learned how to do a pretty amazing job in reproducing receipts. They looked absolutely real."

"We have very strict controls," she said. "That's why we caught them. If someone can figure out how to reproduce a portfolio so it looks like it comes from a Hilton Hotel or a Sheraton, it's only going to be caught on an internal audit."

Foundation auditors, she said, "called the hotels and found out that X person didn't stay there that night and then they unraveled the whole thing."

Don Aron, a board member and Houston businessman, expressed concern about the effect of negative publicity.

"There are 18 million people that are affected with diabetes," Mr. Aron said, "and outside of the United States government, J.D.R.F. has been the largest funding source for diabetes research.

"It would be a shame," he said, "to think that if two people in our organization did something wrong that that would put a black eye on the organization."

URL for this article:
http://www.nytimes.com/2008/02/28/nyregion/28diabetes.html


Thanks to an e-mail from Allison, I did get a follow-up on my inquiry regarding Mr. Donald's succession. See the following for details:

To: International Board of Directors, International Board of Chancellors, All JDRF Staff, International Affiliates, Chapter Board Presidents
From: James C. Tyree, Chairman of the Board
Date: February 26, 2008

I thought it important to keep everyone up-to-date on some developments resulting from Arnold Donald's decision to retire as President and Chief Executive Officer of JDRF last week.

First, the Board of Directors has formed a committee to begin the search for a new President and CEO. Chaired by Chip Halverson, the committee includes current and former board members Maureen Barunas, Rik Bonness, Dayton Coles, Frank Ingrassia, Rik Kirkland, Leo Mullin, George Nethercutt, Gail Pressberg, and me. The committee will quickly be choosing a search firm, and expediting the process of identifying and interviewing candidates.

Second, with the Executive Committee's approval, JDRF will be managed by the Vice Presidents as a "self managed team" until a new President is brought on board. That group, which has been meeting weekly and working closely together for some time now, will drive the strategic, financial and day-to-day operating activities of the organization. As Chair of the Board, I'll participate in their meetings, but will not be in the role of acting CEO.

We will be certain to continue to communicate information about the management of JDRF, as well as news on the search for a new president and CEO as it progresses.

In the meantime, thank you all for your commitment in continuing to focus on the work at hand – accelerating science leading to a cure for type 1 diabetes and its complications.

Holy Crap! 40 lbs. (18 kg) of Glucose on the Cheap

Last year, my employer promised to implement flexible spending accounts and some other benefits (such as an optional dental plan, paid for with pre-tax dollars, naturally). The deadline for enrollment was this week. To prepare, I spent a fair amount of time analyzing my various co-pays to doctors, pharmacies, as well as expenses paid for glasses/contact lenses and a host of other out-of-pocket expenses related to diabetes so I could accurately estimate how much of my pre-tax income I should allocate.

Up until this point, my "system" for tracking expenses was pretty much to save any receipts and put them into an old shoebox, which after a year of collecting receipts was surprisingly full. The good news is that I have a very good idea of what I need to set aside, and my savings during 2008 should be quite substantial!

One item I was a bit troubled by was the amount of money I spent on glucose (dextrose) tablets for treating hypos. At $5.95 for a bottle of 50 tablets ($4.95 for a bottle if and when I happen to be near a Wal-Mart -- and since there isn't a single Wal-Mart in any of New York City's 5 boroughs I am aware of, its usually when I venture into the suburbs), but the cost adds up surprisingly fast.

Truth be told, I probably waste a fair amount of these things, as I've removed more than a pocketful of yuck after I've washed pants with a roll of tablets in it, but still, the markup is unbelievable. As I noted in my previous post on glucose tablets back in 2006, "lets face it, making dextrose tablets is not complex drug engineering", so the prices are akin to highway robbery. When I considered what I had spent on those things during 2007, it occurred to me that there had to be a better way.

Last Halloween, I happened to "discover" Smarties in my local store and I bought a few bags meant for trick-or-treaters. Not only were their ingredients pure dextrose (plus the obligatory artificial coloring, citric acid, etc.) and they were surprisingly easy to measure. The basics are as follows: each roll is 6 grams, therefore 2 1/2 rolls = 15 grams of sugar (or, more specifically, 0.4 grams per tablet), plus no one looks at me strangely when I open them or consume them. But the biggest benefit was that the cost was a fraction of the cost that our diabusinesses friends catering to the needs of a largely dependent population sell their competing products for. So, in my planning stage, I decided to seek out a bulk supply for the coming year. As it turns out, the smarties.com website has an online store, and enables customers to buy "cases of bulk" Smarties en masse. I ordered a case of Smarties 15 Tablet Rolls, which the website says contains approx. 2,400 rolls per case. The cost was $50, plus shipping. That equates to about what I would spend for about 8 or 9 bottles of glucose tabs in my local pharmacy.

Yesterday, they delivered my order. I must admit, I was expecting a box close in size of my usual mail-order shipment of test strips from Medco Health. I was therefore a bit surprised by how big a bulk order of these things actually is!

I received a good sized box (about 3 times the size of my test strip orders) which weighed 40 lbs. (18 kg)! Now, on a per-gram basis, we're talking about pennies vs. dollars here, so it was indeed a very good bargain. But it looks like I'm covered for hypo treatments for a quite a while. Perhaps the only place I'll still keep the regular tablets will be the glove compartment of my car, as the last place I want to be unwrapping rolls of Smarties is while I'm behind the wheel, but all things considered, I will be switching to these smaller-sized tablets which retail (and bulk) are far cheaper. If anyone is looking to slash their miscellaneous diabetes expenses for the coming year, consider ordering a case of Smarties -- now I know why they call these things Smarties, but I cannot help but wonder if that means when I bought glucose tabs if I was a dummy?

Lilly Introduces KwikPen for Humalog and Humalog Mixtures

In case anyone missed it, today Lilly announced a new pen called KwikPen(TM) for Humalog and Humalog mixtures. Matt Beebe, Humalog Brand Leader at Lilly USA is quoted as saying "KwikPen, prefilled with Humalog and Humalog Mixtures, provides people with diabetes an exciting new option for accurate insulin dosing with the convenience of an easy-to-use prefilled pen", although its unclear just how the new product is different from Lilly's original Humalog and Humalog Mixtures prefilled pens. I cannot help but wonder if Lilly makes these, or if Hospira does (see my previous post for details)! Still, I thought I'd pass it along ...


Eli Lilly and Company (LLY) Launches KwikPen(TM) for Humalog(R) and Humalog Mixtures
2/21/2008

INDIANAPOLIS, Feb. 21 /PRNewswire/ -- Completing an unprecedented year of innovation in insulin delivery devices, Eli Lilly and Company (LLY) today announced the launch of KwikPen(TM), a new insulin pen prefilled with the Humalog(R) (insulin lispro injection [rDNA origin]) brand of insulins. KwikPen is the third new insulin pen Lilly has launched in the last 12 months to help improve the daily management of diabetes, following the successful launches in 2007 of HumaPen(R) MEMOIR(TM) -- the world's first digital insulin pen with memory -- and HumaPen(R) LUXURA(TM) HD, a reusable pen for people who need insulin dosing in smaller increments.

(Photo: http://www.newscom.com/cgi-bin/prnh/20080221/NYTH010)

KwikPen is a prefilled insulin pen designed to be convenient, easy to use and discreet. KwikPen's design can help fit a mealtime insulin, such as Humalog, into the daily lives and routines of people with diabetes.

KwikPen is now available by prescription in pharmacies prefilled with the Humalog brand of insulins, including Humalog, Humalog(R) Mix75/25(TM) (75% insulin lispro protamine suspension, 25% insulin lispro injection [rDNA origin]) and Humalog(R) Mix50/50(TM) (50% insulin lispro protamine suspension, 50% insulin lispro injection [rDNA origin]). The Humalog brand of insulins are indicated for use in patients with diabetes to control high blood sugar.

Lilly's original Humalog and Humalog Mixtures prefilled pens are also available. Patients using the original Humalog and Humalog Mixtures prefilled pen do not need to convert at this time unless they choose to do so in consultation with a health care professional.

"KwikPen, prefilled with Humalog and Humalog Mixtures, provides people with diabetes an exciting new option for accurate insulin dosing with the convenience of an easy-to-use prefilled pen," said Matt Beebe, Humalog Brand Leader, Lilly USA. "We know living with diabetes presents challenges day-by- day, meal-by-meal. At Lilly, our goal is to provide innovative therapies that help patients accurately and discreetly manage their use of mealtime insulin, as well as practical solutions beyond therapy that help patients live successfully with diabetes."

Last year, Lilly launched two innovative reusable pens -- HumaPen MEMOIR and HumaPen LUXURA HD - to help address those diabetes management needs.

HumaPen MEMOIR, available by prescription nationwide for use with Humalog, presents sophisticated technology and features in a consumer-friendly "push- to-know" digital display that allows patients to record and review their last 16 insulin doses, including the priming doses. Many insulin users need multiple injections per day, so the ability to record doses and the time of the dose may help simplify the daily management of diabetes. This is especially important for both patients and physicians when developing a diabetes treatment plan that utilizes accurate recording of mealtime doses.

HumaPen LUXURA HD is a reusable pen that can deliver Humalog in half-unit increments from 1-to-30 units. Also available by prescription, this type of pen may be attractive to people with diabetes that do not need large amounts of insulin, or parents of some children with diabetes.

To learn more about insulin delivery devices for use with the Humalog brand of insulins, visit http://www.humalog.com.

Indication

Humalog, Humalog Mix75/25 and Humalog Mix50/50 are for use in patients with diabetes to control high blood sugar. Humalog should be used with a longer-acting insulin, except when used in combination with sulfonylureas in patients with type 2 diabetes.

Important safety information

Humalog insulins should not be used during episodes of hypoglycemia and in patients sensitive to Humalog or one of its excipients. The safety and effectiveness of Humalog in patients less than 3 years of age have not been established. Safety and effectiveness of Humalog Mix50/50 and Humalog Mix75/25 in patients less than 18 years of age have not been established. There are no clinical studies of the use of Humalog insulins in pregnancy or nursing mothers.

A potential side effect associated with the use of all insulins is low blood sugar. Low blood sugar can happen suddenly and symptoms may be different for each person and may change from time to time. Know your symptoms of low blood sugar. Severe low blood sugar can cause seizures and be life- threatening. Follow your health care provider's instruction for treating low blood sugar and regularly checking blood sugar levels. Other side effects may include: weight gain, low blood potassium, changes in fat tissue at the site of injection, and allergic reactions, both at the injection site and over the whole body. Whole body allergic reactions are less common, but may be life-threatening.

Starting or changing insulin therapy should be done cautiously and only under medical supervision.

Humalog and Humalog mixtures start lowering blood sugar more quickly than regular human insulin, allowing for convenient dosing immediately before a meal (within 15 minutes). Humalog can even be taken immediately after your meal. Because Humalog is a mealtime insulin, you may also need a longer-acting insulin to get the best blood sugar control (except when using an insulin pump).

About Diabetes

According to the Centers for Disease Control and Prevention, diabetes affects nearly 21 million Americans; of that, nearly one-third, or approximately six million people, do not know they have the disease. Diabetes is the sixth leading cause of death in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.

About Lilly Diabetes

Through a long-standing commitment to diabetes care, Lilly provides patients with breakthrough treatments that enable them to live longer, healthier and fuller lives. Since 1923, Lilly has been the industry leader in pioneering therapies to help health care professionals improve the lives of people with diabetes, and research continues on innovative medicines to address the unmet needs of patients. For more information about Lilly's diabetes products, visit www.lillydiabetes.com.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers -- through medicines and information -- for some of the world's most urgent medical needs. Information about Lilly is available at http://www.lilly.com.

Humalog(R) is a registered trademark of Eli Lilly and Company. Humalog(R) Mix75/25(TM) and Humalog(R) Mix50/50(TM) are trademarks of Eli Lilly and Company. Humalog(R) KwikPen(TM), HumaPen(R) MEMOIR(TM) and HumaPen(R) LUXURA(TM) HD are trademarks of Eli Lilly and Company.

CONTACT: J. Scott MacGregor, +1-317-651-1494, cell: +1-317-440-4699

Web site: http://www.lilly.com/
http://www.lillydiabetes.com/
http://www.humalog.com/

Tell the FDA "No" to Off-Label Marketing

Last Friday, the U.S. Food and Drug Administration (FDA) gave draft guidance that people concerned about patient safety should be outraged about: broadening the marketing of drugs beyond what the drug has already approved by the FDA. The FDA will accept comments from the public on the proposal and take it up for final consideration in 60 days.

The press covered the story, but considering that it was published over the weekend, the story may have slipped by many readers. The New York Times gave perhaps the most comprehensive overview. But The Wall Street Journal also gave a slightly more business-oriented review.

Today, doctors are already free (as they always have been) to prescribe drugs for a purpose other than what the label specifies. But what we're talking about here is enabling drug companies to sell and market drugs for purposes which have not undergone clinical trials.

The FDA's move already is raising objections from a wide cross-section of interesting allies. California Representative Henry Waxman wrote to the FDA urging it to hold off on issuing these guidelines, which he argued would create a "large loophole" in the laws against off-label promotion. "It's a conflict of interest for the company to be promoting sales when they haven't been able to establish that a drug is safe and effective through the rigorous FDA process," Mr. Waxman said.

The blogosphere has cried foul, and you should too. Consider the following perspectives:

BrandWeekNRx's Dr. Peter Rost, and author of the book "The Killer Drug" wrote:

"Once this is allowed, the door is completely open for drug companies to promote their drugs for anything their heart desire. ... Clearly they [the FDA] are interested in helping someone, and that doesn't appear to be the public."

Merrill Goozner, and author of the book "The $800 Million Pill" elaborated further:

"Note what isn't in the policy: It doesn't say that the studies of unapproved uses must be from randomized controlled clinical trials, which is the gold standard of medical research. All the proposed guidance says is that the studies should be 'adequate and well-controlled clinical investigations that are considered scientifically sound by experts with scientific training.'"

Considering the already sad state of affairs involving the FDA, with everything from not inspecting foreign chemical manufacturers involved in drugs which have killed Americans, to hastily approving drugs which have later been proven unsafe, the latest guidance couldn't be more ill-timed, but the FDA moved ahead on this nevertheless. The Federal Register has more details, but the basics are as follows:

Submit written comments on the draft guidance to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/oc/op/goodreprint.html.

Tell the FDA that this guidance is ill-timed and should NOT be implemented at this time. The benefits seem questionable at best, except for the drug industry. Considering the potential problems, this guidance seems rushed and should not be implemented at this time.

ACCORD Study Halted? Welcome to the Program!

For the most part, I have remained pretty silent about the recent results from the failed ACCORD (Action to Control Cardiovascular Risk in Diabetes) study, in part, because the results do not impact people with type 1 diabetes at all. However, to read the NIH's spin on the trial, see here.

Incidentally, I happen to agree with my friend Colleen who suggests that the naming of these studies to have an acronym that suggests something about the study has really gotten out of hand -- it's no longer cute anymore. She says that one of these days, she is going to pursue a diabetes study called FART, although she hasn't figured out what exactly that would study at this time, but her point is well-taken.

Anyway, today's New York Times features a story entitled "Diabetes Health Involves More Than Just Blood Sugar Levels, Doctors Say", which is pretty self-explanatory. The only question I have is why do they consider this news?

Before I get to my diatribe, let me just say that for those of us who live in New York City, we are routinely barraged with a commercial from the local cable provider, Time Warner Cable, but the entire debate brings to mind Time Warner's commercial, so I'll share the 30 second spot with you all here:



To everyone who was shocked by the results to the ACCORD trial, and most certainly, the U.S. Food and Drug Administration, and many clinicians out there, I say "get with the program".

The fact is that the medical profession has remained almost fixated exclusively on metabolic control since the conclusion of the Diabetes Complications and Control Trial (DCCT), as if nothing else mattered to the patient's or their health. In recent years, this issue has become so bad, that in the September 29, 2007 edition of The Lancet entitled "Patient-important outcomes in diabetes—time for consensus", the authors (largely from the Mayo Clinic) reported that a majority of diabetes clinical trials in the U.S. ignore virtually everything except glycemic control.

This is a HUGE problem, especially for the FDA who ignores everything but a medicine's impact on blood glucose levels (the FDA's stance has effectively been: Gastrointestinal side effects? Who cares ... Hypoglycemia? Who cares -- the only thing that seems to matter to our drug regulators is whether the drug lowers blood sugar levels). This applies to not only type 2 medicines (although there is far more research into these than there are for improvements on insulin) but also type 1 treatments and protocols. When I first called attention to this issue, I added that The Lancet article's authors wrote:

"Unfortunately, HbA1c loses its validity as a surrogate marker when patients have a constellation of metabolic abnormalities, when the most common complications are macrovascular, and when the treatments have multiple poorly understood effects."

These words were never more true today.

To that, I would say that the results from the ACCORD trial should bring far more attention to this matter. The fact is that the fixation on glycemic control above all else has been detrimental to patient health. Although many doctors consider the bigger picture, I have been calling for more attention to this issue for years. Now, apparently, I have a growing chorus of Johnny-Come-Latelies who are now claiming that there's more to diabetes treatment than glycemic control. Let me just add, that in my 2007 Year-End Review, I called attention to this very need. Now we need drug makers, doctors and the Food and Drug Administration to get with the program, too.

My hope is that the "shocking" findings in the ACCORD study have finally given some widespread, and badly-needed attention to this important patient need.

Big Pharma Deception

On Monday, I posted that some brand-name insulin manufacturers have been deceiving patients by slapping their brand-names on insulin made by third-party manufacturers. Since 2003 at least, Lilly has had FDA approval to sell Humulin® R (and apparently, Humalog®, too) made by Hospira, Inc.'s "One 2 One Contract Manufacturing Services" (known previously as Abbott Laboratories' One2One Global Pharmaceutical Services which was spun-off as an independent company in 2004).

Do you know this company? Well, if you use Eli Lilly and Company's Humulin R or Humalog, perhaps you should. The fact is that Lilly has been contracting the manufacture of vials of Humulin R and Humalog to Hospira, Inc. (which is headquartered in Lake Forest, IL), but has an FDA-approved manufacturing plant for protein in McPherson, KS. If you don't believe me, try reading what's printed on the insert in your next package of insulin. Below, I have included a relevant excerpt from the current FDA-mandated package insert for Humalog, taken directly from Lilly's website which highlights the third-party manufacturing relationship:



Perhaps the packages should also be updated (I took some Photoshop liberty on a package for Humulin R here):



Of course, this does explain how Lilly was able to shelve plans last year for a new insulin manufacturing plant in Manassas, Virginia. Apparently, it's far cheaper and easier to let someone else make it, and simply slap their label on the product. But a commenter suggested that brand-name manufacturers had higher standards than generics companies.

Gimme a break.

When it comes to recombinant DNA manufacturing, the FDA has outlined standards that all companies must follow, generic or brand-name alike. But thanks to lobbying from the brand-name insulin manufacturers, quality controls are strictly voluntary, not mandated by the FDA, according to a 1998 change in policy entitled "Removal of Regulations Regarding Certification of Drugs Composed Wholly or Partly of Insulin" (also found here) which effectively exempts synthetic insulin manufacturers from batch testing -- the sort which vaccine manufacturers are obliged by FDA policy (and U.S. law) to conduct at regular, periodic intervals. Insulin manufacturers may indeed do this testing voluntarily, but why isn't this mandated policy, or more specifically, if it's so important to patient safety for vaccines and other biopharmaceuticals, why was the rule discontinued for insulin?

I responded to the comment by noting that although Lilly is presently approved to sell Hospira insulin made in Kansas, there is no reason why the company cannot contract with another manufacturer. According to FDA documents, India's Biocon, Ltd. has had the FDA seal of approval since January 27, 2004 to manufacture human insulin in bulk at the company's facility in Bangalore. In addition, since February 5, 2001, another company based in the Netherlands known as Organon BioSciences NV, which as of November 19, 2007, is now part of the American pharmaceutical company Schering-Plough. Schering-Plough also owns Diosynth, another large bulk insulin supplier also based in the Netherlands. Schering-Plough was recently implicated for holding back information about the pivotal, failed clinical trial called Enhance which compared Vytorin (a combination of Zetia and Zocor) with Zocor alone and showed no difference. The company's president, Carrie Cox, is now being investigated for insider trading of stock options by selling her stock before the study results were released to investors. Once again, big pharma and ethics displayed at its finest!

A fair number of people I've met on various diabetes social networks and message boards feel adamantly that drugs coming from India are inherently lower quality. Initially, I shared these concerns, but today, I'm no longer so sure. With the outright deception and greed that has been going on in big pharma, and the clearly unethical management such as at Schering-Plough and others, it makes me honestly wonder if outsourcing to an Indian company is really any worse? I'm starting to think otherwise! After all, Indian companies already have a significantly lower-cost of scientists, manufacturing and intellectual capital, so they have nothing to gain by delivering a low-quality product. In fact, they are trying to establish themselves as viable, global players, so they may be more likely than the big guys to adhere to the letter of the regulations, while big pharma routinely tries to weasel their way out of them with lobbyists and other shady maneuvers. Think about that!

Meet Mike Coleman

This morning, the blog Pharmalot had a posting entitled "Meet Mike, Your Generic Biologics Lobbyist", and I thought it would be appropriate to reiterate the need for Congress to move forward on this very issue. It was indeed a surprise to many (including me), but as I posted last week, even President Bush's 2008 budget calls for Congress to pass legislation to enable generic biopharmaceuticals.

Last week, Insmed had one of its scientists, Mike Coleman, offer a "researcher's view" of the value of generic biopharmaceuticals. Coleman makes for an unusual lobbyist. But apparently Insmed, which has projects under way to develop several different generic biopharmaceuticals, is banking on a new 'educational campaign,' another way of saying public relations (PR), to influence Washington and the public on this subject.



Although insulin is not considered by law to be a biopharmaceutical (it is grandfathered under the Federal Food, Drug & Cosmetic Act, not the Public Health Services Act which governs vaccines and most other biopharmaceuticals) but it has nevertheless been caught up by the FDA's refusal to outline procedures for generics manufacturers to obtain approvals. (More details can be seen in my previous postings on this topic, which can be found here.)

Last year, a bill introduced by California Rep. Henry Waxman, and New York Senators Charles Schumer and Hillary Clinton was never voted on. In essence, the bill, called the "Access to Life-Saving Medicine Act" would mandate the FDA to outline procedures for generics manufacturers to obtain approvals. It does not mandate additional clinical trials, rather it leaves that up to the FDA to decide on a case-by-case basis when additional trials are necessary to secure an approval.

This is no small issue, but the U.S. is now several years behind the European Union when it comes to moving forward on generic biopharmaceuticals. The main reason seems to be lobbyists for the drug and biotech industry who have managed to delay what is likely to be the inevitable, while screwing the American taxpayer (largely via the cost of Medicare Drug coverage) as well as our healthcare providers out of as much money as they can for as long as possible before the other shoe drops.

Last March, Novo Nordisk A/S sent one of its exectutives, Inger Mollerup, to Congress to testify (and scare) legislators about the risks of making it too easy for generics makers. As a business, the company's motives were clear: make it as costly and time-consuming as possible for generics makers, which will help fatten Novo's bottom line. But there were some noteworthy disclosures made in that testimony. I will give you some excerpts here:

Novo Nordisk's Vice President for Regulatory Affairs admitted to Congress that biologic medicines are created without tools and models that predict safety; clinical laboratory tests are insufficient to determine immunogenecity/other issues; and the FDA has also admitted no general safety threshold even as low as 0.1% is sufficient because protein impurities are highly reactive to the human body at low exposure. In essence, Novo claims that other than through human experimentation (patient guinea pigs) we have no technology to prove the fact that synthetic insulin works. But insulin, unlike most biopharmaceuticals, is already fully characterized.

Different, Higher Standards for Generics?

Mr. Mollerup also stated that generics makers should be required to undergo batch testing and Adverse Events (AE) reporting (to paraphrase his message) in order for patient safety to be traceable. Gee, that sounds like a good requirement, doesn't it? However, Mr. Mollerup failed to disclose is that since 1998, his company and the other insulin manufacturers have been exempt from doing batch testing. Isn't that slick? Tell Congress that they must require generics makers to do something that they aren't required to do. The bigger question is why the FDA has enabled this in the first place if it's to ensure patient safety?

There is plenty of evidence what the company is trying to do. In January 2006, Novo Nordisk's Chief Financial Officer, Jesper Brandgaard, in an interview with CNBC/Dow Jones, actually admitted that his company intended to eliminate human insulin and replace it with more expensive, patent-protected insulin analogs:

"We are about to convert the market from human insulin onto insulin analogue. If we look at it globally, we have more than 40% of the market now converting to analogue. So we are actually in a different situation from most other companies. We are taking our portfolio from being generic product, human insulin, onto a patent-protected insulin analogue. So we are actually getting our portfolio on-patent, not off-patent."

I have already noted in my coverage of Q3 2007 earnings, archrival Eli Lilly and Company seems to be holding Novo up from fulfilling its ambition to put everyone on a patent-protected insulin analog, as Lilly's Humulin franchise remains a highly-profitable business, and Lilly cannot afford to eliminate medicines that collectively sell over $1 billion annually at this time. But it's obvious that the business plan is to convert everyone to more expensive, patent-protected insulin analogs, even though there is NO validated scientific proof that they improve glycemic control. Its all about money, but if that's the case, who is going to make regular human insulin? Perhaps only generics makers.

The Meaning of Brand-Names

One other point: your insulin may carry the brand-name company's name on its label, but its relatively easy for the drug company to outsource the manufacturing to third-parties who may not have the same quality-controls. For example, Eli Lilly and Company does not make all of its Humulin® in their Indianapolis factory (or factories owned by Lilly abroad). In fact, a document on file with the U.S. FDA enables Lilly to outsource manufacturing of Humulin R to Abbott Laboratories (which was spun off in 2004 to become Hospira One 2 One Contract Manufacturing Services), in McPherson, Kansas as an additional, FDA-approved manufacturing site. Its possible that others have been filed with other manufacturers, both domestically and internationally.

It's about time to finally clean up the whole act at the FDA. No more different standards for brand-name drug companies like Eli Lilly and Company, Novo Nordisk or Sanofi-Aventis while requiring a different, more-stringent standard for generics makers! Batch testing should be mandated as a requirement for all manufacturers, and let the proposed legislation enable the FDA decide when additional clinical trials are required to secure the Agency's approval.

Competition in Patents for "SmartInsulin"?

As my readers know, I think one of the most promising developments in terms of treating patients with type 1 diabetes is the concept of "SmartInsulin". The concept is simple enough (relatively speaking, of course): the SmartInsulin would be injected into a depot under the skin, just as all insulin is injected presently. But instead of the insulin all working at the same time, it would be released into the bloodstream only when glucose levels increase above a certain threshold. The benefits are multiple: it would drastically reduce hypoglycemia, it would also reduce the amount of testing required, and ideally, it would also improve glycemic control. That would be superior to an artificial pancreas any day!

Recently, a poster on the Islet Foundation Public Message Forum inquired about U.S. Patent 7317000 which was issued to Novo Nordisk A/S. A follow-up to that message suggested that it appears to be just a "concept", not something with a working model. That person noted that it appeared that the company was attempting to patent every possible way that insulin could be made reactive to blood glucose. But the moderator noted that if it was attempting to patent glucose-responsive "smart" insulin as a concept (and not as a particular chemical innovation), then it might not be worth much of anything. It is known that Novo has no "Smart Insulin" undergoing clinical trials (any phase) at this time, as that information is disclosed on the company's website under the heading "R&D Pipeline".

The filing date of Novo's patent precedes U.S. Patent Application 0040202719, which was filed by Todd Zion and a few others at the Massachusetts Institute of Technology (MIT). That particular concept has subsequently been licensed to SmartCells, Inc. by MIT, which headed by Mr. Zion as the CEO. I am not a patent attorney (nor do I play one on television) but I'm curious if Novo's pre-emptive patent (if it is pre-emptive) would require SmartCells, Inc. to get additional license or pay fees to Novo Nordisk if and when they are ready for commercialization? Any lawyers or others have any thoughts on that, please comment!

As you may recall, when I interviewed SmartCells, Inc.'s CEO Todd Zion last June, he was very explicit when he assured me that SmartCells' discoveries were not necessarily in Novo Nordisk's pocket as a result of its relationship with Jens Brange. He also noted that his venture capitalists would not allow that to happen even if he wanted it to because they all expect a return on their investments! He then confided that his suspicion was that assuming clinical trials work as anticipated, then ultimately, the product would be licensed to the highest bidder, which although not necessarily in the best interests of patients or their healthcare providers, it would ensure that the venture capitalists who are funding the company get their due return on investments. He was confident that his patents had undergone a thorough review and were not in danger due to a pre-emptive concept idea from another company, either Novo Nordisk or the Japanese researchers cited in Novo's patent.

Last year I reported that researchers at The University of Texas School of Health Information Sciences at Houston had announced pre-clinical test results in the September issue of the International Journal of Nanomedicine demonstrating the feasibility of a "smart particle" insulin release system that effectively "detects" spikes in glucose or blood sugar levels and releases insulin to counteract them. Of course, the UT Houston results were on a pulmonary (inhaled) delivery system, but the concept had been proven nevertheless.

A few observations here. First, I'd like nothing more than competition for this concept. I don't think there's nearly enough competition in insulin development. It is notable that Eli Lilly and Company is absent from this discussion, as their insulin business is in dire straights. Maybe that's because the company hired Dr. Robert J. Heine to run that business -- a move I questioned when others were claiming what a brilliant addition he made for the company. The reason: Dr. Heine specializes in the treatment of type 2 diabetes, not type 1, and once again, treatments for type 1 have fallen to a lower position at the company. No, Dr. Heine cannot reverse decisions made years ago as far as not investing in research, but is continuing support for inhaled insulin, which doesn't look like it will be sufficient to turn that sagging business around. But competition between SmartCells and Novo could be an interesting development!

Good News in the Last Bush Budget?

You might be surprised to hear me write that. To be sure, I cannot stand the Food and Drug Administration's user-fee system, and some have complained that the Bush budgets have consistently short-changes the FDA. But all things considered, I suspect we won't see any progress on either issue during 2008. But I did find what I believe to be good news in the Bush budget.

As my readers know, I chronicled the story about impediments to new competition in the insulin market (see here for the original article, and provided that Google's Blogger cooperates, some fairly extensive follow-up coverage might also be accessible). Unfortunately, last year -- thanks largely to lobbyists for the pharmaceutical industry -- the U.S. Congress delayed passing legislation which would have removed the final impediments for generic insulin, not to mention other, in the words of the FDA, "follow-on protein products". The bill was known as S.623/H.R. 1038, known as the "Access to Life-Saving Medicine Act of 2007". For those of you who don't have time to read all of the links, note that there are NO legal impediments to generic insulin today because it is considered a small-molecule drug not unlike aspirin, but the FDA's failure to outline procedures for generic manufacturers to attain approvals has prevented them from emerging.

Anyway, as I predicted in my 2007 Year-End Review, I said that the legislation would almost certainly re-emerge this year, and I was right! On Monday, Reuters reported that the budget for the Food and Drug Administration (FDA) would include mandates for the Agency to move ahead with that. The President surprised many by calling on for legislation enabling the FDA to approve generic biologics, which are made from proteins from living cells.

Of course, Lehman Brothers analyst Tony Clapsis did say the Bush Administration's support for generic biologics was a boost to the cause, but he felt that competing plans in the U.S. House of Representatives might prevent any changes this year.

"My view is they missed their opportunity last year," Clapsis said.

I suspect that is most unlikely. The fact is that a budget agreement, whether or not you agree with President Bush or Congress, will have to move forward at some point this year, or the Government will shut down. A complete budget shutdown hasn't occurred since the 1970's if I am not mistaken. With support from both Mr. Bush and Congress, it looks likely that some agreement will come, and not a moment too soon, as far as I am concerned.

Let me just say that I personally am not very likely to use generic insulin myself. But the cost savings to the U.S. healthcare (or is that "sickcare"?) system would be enormous. A 2007 study undertaken by pharmacy benefits manager Express Scripts Inc. found that generic insulin could save the U.S. $797 million in the first year, and totaling in excess of $16 billion over 10 years. And the libertarian in me cannot stand impediments to free markets -- as we have today's insulin market. I think we're very likely to see some progress this year. The reason I support generics is I feel that the only solution to the lack of innovation we're seeing in the insulin market is competition. I don't like being treated like a cash cow by the drug industry!

Book Review: "Invisible Frontiers: The Race to Synthesize A Human Gene"

A True Story of Oversized Egos, Incredible Greed ... and Insulin!

Its been a while since I last did a book review, in part, because of the holidays and the time it took me to finally sit down and read a book. My review is on the 1987 book "Invisible Frontiers: The Race to Synthesize a Human Gene" by Stephen S. Hall.

Although it took me a while to get around to reading it, this now out-of-publication book is one I highly recommend checking out at your local library if you're so inclined, or you can find it used at online bookstores, too. Just what is Invisible Frontiers all about? Not really a topic I expected to find terribly interesting reading, but the story turned out to be one of the most interesting stories which just happened to chronicle the development of synthetic "human" insulin back in the late 1970's to the early 1980's. In retrospect, it seems only fitting that this true story occurred at the very beginning of the Reagan Era, as the prevailing attitudes of the time produced the hit television show Dynasty, gave birth to Madonna as "the Material Girl" and, of course, characters from the movie Wall Street like the villainous Gordon Gekko who proclaimed "Greed is good" seemed to define that era. But what is most interesting is that those attitudes evidently infected the normally conservative and upstanding world of science, too.

My reason for reviewing this book now, aside from the fact that I just finished it, is because the end of the month (on January 28) will mark the 21st anniversary of the day Genentech was incorporated as a Delaware corporation. It was indeed interesting to examine that company's role was in diabetes care and treatment, and let's just say, the genuine facts are far more interesting than what I've read in the press or from PR departments!

First, some background. A few weeks ago (January 18, 2008, to be exact), I bookmarked an interesting post from Dr. Bill Quick's SharePosts at MyDiabetesCentral.com. Some of you may be familiar with another diabetes authority, David Mendosa, who also posts regularly at the same website. Dr. Quick's post was entitled "Where did beef and pork go?" and Dr. Quick mentioned that he had received an e-mail inquiring about the insulin which served millions of patients quite well for over 75 years.

Dr. Quick appropriately referred the patient to the U.K.'s Insulin Dependent Diabetes Trust for more information on the subject, which was indeed an excellent recommendation. But Dr. Quick also pointed out "The writer has some good questions, but sadly, has some misinformation mixed in." Dr. Quick noted that some heart medications had been discontinued, but I feel compelled to respond because Dr. Quick also has some misinformation in his own response to the patient's question, perhaps because he has bought into the pitch from the proponents of biotechnology hook, line and sinker? I cannot comment on that.

But Dr. Quick wrote "To get back to insulin: why did pork and beef insulin disappear? Two reasons that I'm aware of: purity, and production cost." He later adds "And it's my understanding that the production costs for extracting animal-sourced insulin were rising, as the production costs for making semisynthetic human insulin have fallen, so economically, it's cheaper to make insulin by semisynthetic methods." I should also note that insulin made by recombinant DNA is not semisynthetic, it is purely, 100% synthetic. The insulin you buy from your local pharmacy in the U.S. has never seen a pancreatic beta cell before. And while it may have been just like someone's human body once produced, it is not necessarily just like my or your human body once made, as the manufacturers do not use my personal DNA (or yours) in its production.

Anyway, while these reasons certainly sound logical, indeed after 26 years or so, that's what the manufacturers and their sales reps have been drilling into the heads of doctors about their genetically-engineered synthetic insulin for decades now. The only problem is one I have noted before: it is very selective disclosure of the truth, in effect misrepresenting that data to present the truth in a way that benefits one party more than the other. They aren't exactly lying about the purity, but they are making it sound like the old stuff was completely full of garbage, which wasn't the case at all.

Dr. Quick is right when he notes that the source for beef and pork insulin products were extracted from pancreases from cows and pigs used in meat production, but to state that the insulin that was made in that manner was somehow "impure" is categorically false, at least by the time synthetic insulin was introduced. A friend of mine has noted that the introduction of chromatographic gels and high-pressure liquid chromatography (HPLC) equipment saw "pure" insulin undergo even more purification, so that by the late 1970's insulin marketers could display "highly purified" on their products without invoking any claims of false labeling. As a matter of fact, purified animal insulins ultimately achieved a purity rate of 99%. Ironically, even with the use of today’s HPLC techniques, synthetic "human" insulin can only advertise a purity measure of 97%!

Also, in respect of their influence on insulin pharmacokinetics, moderate concentrations of certain insulin antibodies may, in fact, be of positive advantage to all diabetics without endogenous insulin secretion (e.g. people with type 1 diabetes) because insulin binding antibodies effectively increase the insulin's clearance rate and distribution space and therefore help to prolong its pharmacological and biological half lives. [Gray RS, Cowan P, et al., Influence of insulin antibodies on pharmacokinetics and bioavailability of recombinant human and highly purified beef insulins in insulin dependent diabetics. Br Med J (Clin Res Ed). 1985 Jun 8;290(6483):1687-91. See also here] Dr. Quick is right that the level of purity increased steadily over the years, but putting things in perspective, it should be noted that by the late 1970's, pork insulin being sold was 99% pure, and therefore was no less "pure" than today's synthetic insulin.

Consider an excerpt from Invisible Frontiers:

Dennis Kleid [one of Genentech's founder's] vividly recalls the moment when some long-cherished conceits about the uniqueness of genetically engineered insulin began to crumble in his own mind. It came during a trip to Indianapolis in December 1979, when the seasoned hands at Eli Lilly and Company showed the visiting upstart cloners through the insulin plant and explained to them how insulin was prepared the old-fashioned way.

"We were under the impression that it was impure and there was crap in it and stuff like that," Kleid remembers. "But that stuff was crystallized two times in the process. It was incredibly pure stuff. And there were only a few parts per million of contaminants. That was a real eye-opener. They were not making crap. Maybe they used to. But they certainly, in the last few years were not making it. And they impressed upon us very, very clearly that this [human insulin] was going to be no advantage at all." The newer way of making porcine insulin did not prompt allergic reactions, the biologists were told, and Lilly had enough glands to last for a long time.

As the tour of the facilities continued, the complicated economics of insulin production became clear as well. The Genentech scientists viewed a vault filled with vials of insulin. They were shown a freight car full of frozen pancreases, fresh from the stockyards, 25 cents per gland, shipped by the ton. They were shown where the glands were ground up prior to the extraction and purification of insulin. The recombinant DNA alternative was elegant and less messy, but not necessarily simpler and, more important, not necessarily cheaper, despite all the persistent suggestions, dating back to the ferocious public debates on recombinant DNA, that it might be.

Hmmmm, so there we have an admission from one of Genentech's founders that he himself was sorely mistaken about the quality of animal insulin sold by the early 1980's, and on top of that, he also notes that the process they had developed was not necessarily any cheaper. More on the cost issue in a minute.

It's worth acknowledging that some people did have allergies to animal insulin. Some have estimated that may have been as much as 10%, largely with beef insulin, which differs from human by just 3 amino acids (not dramatically different in that it has a comparable number of "different" amino acids that Lantus, Novolog/Novorapid, Levemir or Apidra have from human insulin). And before you reach the conclusion about how much better the new stuff is, you should also know that it is seldom disclosed that some 4% of people with type 1 diabetes also experience severe allergic reactions to synthetic "human" insulin, a severe form of lipodystrophy even though they do not have physical manifestations of the metabolic syndrome or lipodystrophy. Others have routinely complained about problems related to hypoglycemia unawareness with the synthetic insulin, which was actually scientifically validated in the early trials undertaken by Lilly in Germany, but somehow never managed to warrant further investigation by regulators.

The book also interviewed Dr. Rachmiel Levine -- a key player in the development of biosynthetic insulin from his work at City of Hope Medical Center near Los Angeles. In 1985, Dr. Levine was asked to respond to some of his major predictions made 7 years earlier about genetically-engineered insulin and how his predictions had panned out:

Is human insulin cheaper?

"No," replied Levine, "that hasn't turned out to be the case yet." At that point, perhaps the only major difference between human insulin by recombinant DNA and purified pork preparations was price: the porcine insulin cost less than Humulin. Recently [circa 1987], the price differential has vanished, according to diabetologist Dr. Jay Skyler, "and purified pork is essentially dead as a product."

Finally, has human insulin alleviated the problem of supply?

"Well," Levine answered, "we haven't reached the stage where it needs alleviation. But one can never tell."

The book continues to look back on the development:

The jury is still out, however, on any advantages of human insulin over purified pork preparations. Dr. Mayer Davidson, director of the Diabetes Center at Cedars-Sinai Medical Center in Los Angeles, reflects a general sentiment among clinicians when he says, "So far, I don't think it's been a big breakthrough." Dr. Andrew Drexler, of New York University Medical Center agrees, saying, "As a general phenomenon, we all see it as a minor, incremental improvement."

Some observers doubt that the price will ever drop significantly. Why? "It's called an oligopoly," says analyst Scott R. King [formerly] of Montgomery Securities [which was acquired by NationsBank in 1997, now known as Bank of America Corp.] in San Francisco. [Incidentally, Scott R. King is not the same guy as the editor of Diabetes Health magazine]

Although not mentioned by Dr. Quick in his post, another element that is frequently mentioned about that time was that the rush to create insulin via recombinant DNA technology was driven by a looming shortage of animal pancreases. Supposedly, people weren't eating as much meat, which meant fewer pancreases, therefore the supply was going to run out.

Indeed, Dr. Irving S. Johnson, who was the Vice President of Research at Lilly Research Laboratories back in the mid-1970's and was one of the people at the company who decided to hold the now-(in)famous seminar on the topic of making insulin by genetic engineering (its 16th symposium) back in May 1976, one which the scientists from Genentech happened to attend. Several years later, Dr. Johnson wrote an article entitled "Human Insulin from Recombinant DNA Technology" which was published in the journal Science on February 11, 1983. There is a noteworthy excerpt from that publication, too:

In the early 1970's we began to be concerned about a possible shortage of insulin. Until now, the world's insulin needs have been derived almost exclusively from pork and beef pancreas glands, which were collected as by-products from the meat industry. This supply changes with the demand for meat and is not responsive to the needs of the world's diabetics. Indeed, from 1970 to 1975, the supply of pancreas glands in the United States declined sharply (1) and remained on a plateau at that lower level in succeeding years. There is no accurate way to predict availability of future supplies of glands, although we predicted that the demand for insulin would continue to increase. Our concern was whether or not there would be a time when the supply of bovine and porcine pancreas glands might not be sufficient to meet the needs of insulin-dependent diabetics.

(1) U.S. Department of Agriculture estimates, Livestock and Slaughter Reports (Bulletin of Statistics 522, Economic, Statistic and Cooperative Services, Washington, D.C., 1980).

That certainly sounds like a legitimate concern, right? Indeed, before I edited the Wikipedia entry for "recombinant DNA", here is what the entry originally stated:

In the 1920s, there was no known way to produce insulin. The problem was solved, temporarily at least, when it was found that insulin from the pancreas of a pig could be used in humans. This method was the primary solution for diabetes until about six years ago. The problem with insulin production was raised again: There were not enough pigs to keep the supply of insulin intact. Scientists needed to devise another way. This is where one of the biggest breakthroughs in recombinant DNA technology happened.

However, Invisible Frontiers also discloses the truth: that the people at Lilly had screwed up their forecasts by confusing kilograms with pounds! Here is that excerpt:

To hear some tell it, there was never a supply problem with pig pancreases in the first place. "The whole thing was rubbish," insists Paul Haycook, research director at Squibb-Novo. "There was never a shortage of pig pancreases, and there never will be." Haycook blames the scare on a miscalculation by an official who had prepared projections for the Food and Drug Administration - a mistake based, ironically, on a mistake in an Eli Lilly training brochure which confused kilograms with pounds. Instead of projecting an insulin shortage by 1982, a revised FDA report predicted adequate insulin supplies through the year 2006. In any event, there is never likely to be a shortage caused by a scarcity of pancreases.

You can't make stuff like this up! In fact, by 1987, Genentech was earning $5 million in licensing fees from Lilly. And by then, Lilly had already spent $40 million to build a new plant in Indianapolis to make the stuff. There was no turning back.

Again, Invisible Frontiers addresses the response, which was not exactly one where patients were beating their doctors' doors down to get the synthetic "human" insulin:

A sampling of initial reaction shows that Humulin was greeted more as a technological than a medical breakthrough, and that this sentiment was building even before the drug reached pharmacies. As early as 1980, the British magazine New Scientist reported, "Other big chemical manufacturers predict that Eli Lilly's massive $40 million investment in two plants to make insulin - may be a classic example of backing a loser."

And the Economist [concluded]: "The first bug-built drug for human use may turn out to be a commercial flop. But the way has now been cleared-and remarkably quickly, too-for biotechnologists with interesting new products to clear the regulatory hurdles and run away with the prizes."

So, there you have it. The real story, told in gory details in the book "Invisible Frontiers: The Race to Synthesize A Human Gene". It was all about a few scientists from UCSF who were competing with a handful of other scientists from Harvard and University of Chicago who were in a race to grab the gold and glory before others got to it. They didn't care about people with diabetes, rather, the diabetes population was just a tool used to secure their wealthy retirement. And the product of their labor did not improve the lives of people with diabetes, either.

Some point to insulin analogs as an example of how genetic engineering has helped patients with diabetes, but as I noted in my 2007 Year-End Review, those don't deliver superior glycemic control yet they cost a lot more than regular insulin. I'll let you judge for yourselves, but lets just say this book was A True Story of Oversized Egos, Incredible Greed ... and Insulin!

Health 2.0? Don't Get Me Started ...

A few weeks ago, Christopher Berry e-mailed me that he was launching a new site called DiabeticLive. I have been far too slow in updating my links section, but have since added it. Chris also runs diabeticdiscussion, which has an active message board and community.

The launch came just prior to the introduction of another social networking site, this time diabetesfriends.net, which Kerri eloquently addressed the other day. The site has a very inviting feel and the members are quite hospitable. But as Kerri noted, "Another feather in the Health 2.0 cap or a real trailblazing network? We'll be the judges on that." and she's right. The real issue for me is that much as the nonprofit world has evolved with charities focused on every conceivable niche one could possibly imagine, to some extent, I think the same thing is happening with all of these social networking sites. I'm not big on this Health 2.0 stuff; to me, there are already so many out there and I cannot help but wonder if there's enough room for all of them to flourish. I think there IS, provided a few rules are followed.

I am the first to argue that competition is a good thing (in fact, I have written an entire article about the benefits of competition, which seems to be lacking in the insulin market right now thanks to lawmakers' inaction and penchant for endless conversation driven largely by drug company lobbyists), but I have personally reached a point where I no longer have time to be active on every site, and that's one reason I am concerned about the proliferation of all of these sites out there. I have started to confuse my login names, passwords and even site names!

To be sure, the founder of diabetesfriends.net, Jens Christensen, seems like a really nice guy and I hope his site will flourish, in much the same way that Manny's TuDiabetes site has. This is only my personal opinion, but I would strongly recommend that Jens consider focusing on a particular niche which is not presently being served by the many sites out there. Perhaps his unique focus should be on the type 2 universe?! That's really up to him, but its certainly a strategy worth considering.

A while back, Gina and I had a conversation about the then-future of her (and Jon Schlaman's) site, DiabetesTalkFest (DTF). She mentioned that activity on the message boards had slowed down and she was thinking about doing something radical to help things along. My recommendation to her was to focus on the one area where her site really had differentiated itself: hosting online chats in the site's chatroom with people of interest to the diabetes community. I believe others told her the same thing. DTF was unique because it was created by people with diabetes, and therefore has a more objective perspective than some other sites. Also, DTF has, over the past few years, had a terrific ensemble of what I would describe as "diabetes luminaries" ranging from Nicole Johnson-Baker (of Miss America and dLife fame) to Linda Gonder-Frederick, from University of Virginia Health Systems, and one of the developers of Blood Glucose Awareness Training (BGAT) for people with hypoglycemia unawareness. In between, DTF has had guests from all aspects of life with diabetes, and the site's chatroom functionality and guest roster has enabled it to maintain a vital place in the diabetes community. It may not have the same number of members as TuDiabetes, but there is no question that the site has found its calling, and I think Gina and Jon have managed the site well to reflect changes in the world around us.

Interestingly enough, I also recently spoke with Kelly Close about possible changes they may be exploring for their diaTribe site. I told her basically the same thing I said to Gina. My suggestions to Jens (or anyone else who is competing in this arena) are as follows:

1) Find your niche, one which you and only you can address, and go with it.

2) Do not try to compete or overtake organic communities. Consider that a few years ago, another network called the Diabetes Blog Network, which aimed to become a "community is designed to help diabetes patients and their caregivers by creating a centralized destination for helpful, personal diabetes information" but it was no secret that commercial interests saw the rival Diabetes OC as their target. I remember Allison blogged about that, saying something like "I am hoping they will just disappear" or something to that effect (that was before she switched her blog from Google's Blogger to Wordpress, so I couldn't find the posting ... maybe Allison can refer me to it!). Regardless, that has largely happened because the Diabetes OC was the first, the original and the community had already been established. The lesson: don't enter battles you cannot hope to win!

3) Third, the whole point of these online communities is sometimes lost by people sponsoring these seminars. Its all about the community, not who can develop a fancier website or has the niftiest features. That is not to discount that features can and do count, but to push commercial interests over the interests of the community is one reason many such communities have tried and failed. I think working together is certainly the new mantra.

4) Finally, take advantage of these networks to promote your site, and what is different and unique about yours. Again, it incorporates all of these communities and work with, rather than against them, to promote what your niche is all about.

So, those are my words of advice. But Health 2.0? Please, I think that may be just a forum for discussing these self-evident truths!