Insulin Vials Topped With Rubber Nipples

What do you all think of this ad?


It's powerful, but don't expect to see it run, as this ad was shelved in favor of a less effective ad that ran for a very short time (see below for that ad).

Apparently this was a concept ad that was proposed to the Department of Health and Human Services in an attempt to raise the nation's historically low rate of breast-feeding. A few years ago, federal health officials commissioned an attention-grabbing ad campaign to try and convince mothers that their babies faced genuine health risks if they did not breast-feed. The campaign featured striking photos of not only insulin vials and syringes, but also asthma inhalers topped with rubber nipples (see BrandWeekNRx.com for all of the pictures).

But this ad, along with several others, were apparently caught up in the scandal involving suppression of information that was at odds with the Bush Administration's line of thinking or did not mesh with an industry that supported President Bush, in this case, the infant formula industry. As the former Surgeon General Richard H. Carmona testifed before Congress this summer, the Bush Administration repeatedly tried to weaken or suppress important public health reports because of political considerations, and this looks like another case of political cronyism beating public health concerns.

The World Health Organization recommends that, if at all possible, women breast-feed their infants exclusively for at least 6 months. The American Academy of Pediatrics says that breast-feeding decreases the incidence and/or severity of a wide range of infectious and autoimmune diseases and may decrease the rate of sudden infant death syndrome in the first year of life. Statistics also show that breast-feeding babies reduces the incidence of type 1 diabetes, lymphoma, leukemia, and Hodgkin disease, and asthma in older children and adults who were breastfed when compared to individuals who were not breastfed.

But despite the known benefits, the U.S. has one of the lowest rates of mother's nursing their infants in the industrialized world. Women tend to do what their mother's did in terms of nursing, and in the U.S., women in the 1950's and 1960's were instructed that formula-feeding was better than breastfeeding.

Not everyone is able to breastfeed their children because public breastfeeding remains illegal in some states, or they work in jobs that do not provide space or time for breastfeeding or pumping, or because their children are adopted. They claim that the proposed ad campaign used hyperbole and scare tactics. But really, that is often the very basis of an effective ad campaign, which is to get consumers to think about something being advertised.

For example, consider the now legendary 1964 "daisy" political ad for Lyndon Johnson. Talk about memorable, that ad aired only once (by the campaign) during a September 7, 1964 movie that aired on NBC, yet remains an advertisement that looms large in the public consciousness decades later.

But as The Washington Post reported, plans to run the ads infuriated the politically powerful infant formula industry, which hired a former chairman of the Republican National Committee and a former top regulatory official to lobby the Health and Human Services Department. Not long afterward, department political appointees toned down the campaign. The result was this lame ad:


Kevin Keane, then HHS assistant secretary for public affairs and now a spokesman for the American Beverage Association, said "We took heat from the formula industry, who didn't want to see a campaign like this. And we took some heat from the advocates who didn't think it was strong enough. At the end of the day, we had a ground-breaking campaign that goes further than any other administration ever went."

But the milder campaign HHS eventually did use had no discernible impact on the nation's breast-feeding rate, which lags behind the rate in many European countries. Statistics cited in The Washington Post article showed the ads actually may have caused a reduction in breast-feeding rates when the ads ran.

I am curious what all the Diabetes OC'ers think about the shelved campaign? Would you have liked to see it run, or did it "scar expectant mothers into breast-feeding" as the lobbyists for the infant formula industry claimed? What are your thoughts regarding the Bush Administration's hostility towards sound science? Should we even be encouraging breast-feeding, or is this up to mothers to make this decision?

Schoolhouse Rock vs. Public Schoolhouse Rock

Today's post is a bit out of character for me (George Simmons of The B.A.D. Blog is better known for his weekly YouTube postings), but perhaps when you have a look, you may see my logic here.

Last night, I was watching the news and there was another story about yet another local school district trying to introduce "healthier" snack options by replacing sodas with (and the logic escapes me here) juice, which often contains as many calories and as much sugar as the so-called unhealthy beverages they are supposed to be replacing.

Bottled water IS healthier, but replacing sodas with juices that are often loaded with high-fructose corn syrup and other crap make the newly chosen beverages no better than the sodas which have been banned by many school districts across the country. I'm sorry, but if you're going to making these moves in the name of health, make sure we aren't just villanizing soda, then replacing it with another form of junk food with a nicer label. In addition, the food included in many public school lunches is equally bad (if not worse), yet entirely sanctioned by the USDA and the FDA. Shame on us! A better bet is to pack our kid's lunches ourselves!

Like many kids who grew up in the 1970's, I tend to view Schoolhouse Rock! cartoons with a sense of nostalgia. As Wikipedia notes, these educational cartoon shorts have become cultural icons, so much that they have been parodied on other television shows, including the likes of Saturday Night Live, MadTV and The Simpsons. It is for that reason I thought it might be appropriate to include clips from the original, followed by MadTV's parody, "Public School House Rock" to make my point. Watch them and see if you agree.

First, the original:
Followed by the MadTV version:

Weekend Bits

For those of you who caught my posting yesterday, you may note that I had promised to update the news since Pfizer was not the only drug company to release its earnings yesterday. I must apologize, but I simply forgot to do that yesterday, so I'll address that here, along with a few other miscellaneous items.

Lilly Profits Up, But Few Signs of Improvement Seen in Insulin Business

While Pfizer made the news for its decision to pull the plug on its inhalable insulin product Exubera yesterday, a real powerhouse in the insulin market, Indianapolis-based Eli Lilly and Company also released earnings yesterday. Lilly said its Q3 2007 profit rose 6% on strong sales of drugs such as its Cymbalta depression treatment, and it raised its outlook for the year. Its blockbuster Zyprexa also contributed significantly to the bottom line.

Although Lilly's drug pipeline is somewhat healthier than many of its competitors (Pfizer being a notable example), the company's legendary insulin franchise has, to put this politely, hit the skids in recent years. Furthermore, if you look at the company's clinical trial registry for diabetes, there aren't a lot of new products being investigated (particularly for type 1 diabetes, which account for about 75% of insulin sales according to the CDC), mostly studies are being done to validate insulin therapy. Lilly the only global manufacturer without a complete portfolio of, as rival Novo Nordisk likes to call them, "modern insulins" (a nice way of saying insulin analogs, as they aren't technically insulin), with no basal insulin in its entire portfolio (they took Ultralente off the market in 2005, leaving them with no basal insulin at all). Furthermore, Lilly shares profits with partner Amylin Pharmaceuticals for Byetta and Symlin, so in spite of great performance, Lilly takes about half of what these drugs sell.

In recent quarters, Lilly has underwhelmed investors, in part, because the the top executives in the company are, in the opinions of some investors, dramatically overpaid for basically mediocre performance (see my post here for more). Perhaps more of a concern is the fact that company is so incredibly reliant on "blockbuster" drugs (drugs that sell more than $1 billion per year) for most of its performance. The problem is that once the patents expire, those revenue streams dry up. As Lilly discovered in the mid-1990's when its patent on the blockbuster antidepressant Prozac expired, the company was left with a huge hole in its revenue stream, which resulted in large company layoffs and hard times for a number of years.

To be sure, insulin remains an important part of Lilly's business. Insulin still accounts for just under one-third of the company's revenues. But in September 2005, Lilly ceded its title as the market share leader for U.S. insulin sales to rival Novo Nordisk, the first time since the discovery of insulin. The company has seen its market share plunge from 82% in 2000 to 43% in 2006 according to data from IMS Health. Novo Nordisk and Sanofi Aventis have been the primary beneficiaries, as both companies offer complete portfolios of so-called "modern insulins", while Lilly does not.

As the Indianapolis Star reported, "Lilly's problems in the insulin market grew in part out of a tough choice the company made 7 years ago."

Facing a cash crunch when its blockbuster antidepressant Prozac lost its U.S. patent protection in 2001, Lilly knowingly chose to take money from its insulin marketing budget at a time when insulin sales were poised to take off, and the company dramatically cut back its insulin sales force 5 years ago.

Having said all this, it does raise questions about the major product Lilly is investing in for its insulin business: AIR® Inhaled Insulin, especially given Pfizer's defeat which made the news yesterday. But, Lilly may not make the same mistakes as Pfizer did. If you look at at Lilly's presentation made at the September 25, 2007 UBS 2007 Global Life Sciences Conference, you get a sneak peak at Lilly's product. It does not look like Pfizer's insulin bong, that's for sure! Maybe Lilly's will succeed where Exubera failed.

But having a closer look at Lilly's "insulin franchise" reveals some interesting findings (this is an excerpt from the company's Q3 2007 Earnings Release, which can be seen here). First, the long-term trend for Humalog sales, while up 12% during Q3, has been less than impressive:

The 12% increase is due, in part, to price increases (which sells for at least 20% more than Humulin insulin), and those are worldwide results, not exclusively U.S. statistics (note that the IMS data depicted in the chart above is U.S.-only). Lilly did note that U.S. sales of Humalog were up 9% during Q3, while international sales were up more than twice that amount -- 20%. But if you move on to slide #14 of the presentation, its revealed that Lilly's Humulin business, which collectively sells almost as much as the insulin analog Humalog in spite of having lost patent protection several years ago, we learn that the old standbys, synthetic human insulin, showed surprising strength, especially since the company salespeople do little, if any marketing of these products. Humulin sales increased a still-healthy 6% to $243 million (although in the U.S., sales fell 6% whereas international sales increased 14%).

The following was excerpted from the Q3 Earnings transcript, specifically, the following statement was from John Lechleiter, President and COO, Eli Lilly and Company:

"Reinvigorating Humalog in the U.S. remains a top priority. The battle for market share is a month-by-month fight, but we remain confident in our strategy and our ability to grow Humalog market share. Let me be clear, we are not where we want to be with Humalog in the U.S. But the story is much better now than a year ago and the gains we've made this year, including continuing positive progress and leading indicators of performance demonstrate our focus and commitment to winning in this highly competitive market.

Providing value to customers starts with innovative therapy options and we are leading the industry with new insulin pens. We launched two reusable pens earlier this year, and we are pleased to announce the FDA approval of our third new pen, a next generation pre-filled device called the KwikPen that we'll launch in the U.S. in early 2008.

Product innovation is only part of the equation. We believe our focus on providing solutions beyond therapy alone, such as superior disease education and a new customer centric approach to form a true partnership with physicians will differentiate LillyDiabetes in the market and contribute to growth for Humalog.

We are encouraged by improvements in several leading indicators, including brand equity scores. For the third consecutive quarter Humalog brand equity score improved relative to competitors. We've seen our biggest gains in two areas, quality and innovation of delivery devices and overall brand preference for Humalog, which has been increasing throughout the year compared to competitive meal-time products.

Beyond the U.S., Humalog is performing well internationally. In the third quarter, Humalog showed volume growth in all of our top nine OUS markets. Italy and Mexico had volume growth in excess of 30%, Japan volume grew more than 20% and the UK, France, Spain and Canada were in the high single low double-digits.

Humulin sales for the quarter were up 6% to $243 million, driven primarily by increased volume outside the U.S. and the favorable impact of foreign exchange rates offered in part by declining process outside the U.S. and lower demand in the U.S."

In the grand scheme of things, the news on Humulin is a good sign. There has been talk of eliminating all forms of human insulin for the market, leaving only patent-protected insulin analogs on the market. Nevermind the large cost differential, or the fact that the safety record on these products has been proven for decades, whereas we have only 10 years follow-up on analogs ... this is about profits. Rival Novo Nordisk's CFO, in effect, admitted to CNBC News in a radio interview last year that Novo intended to eliminate all forms of human insulin from the market because analogs were much better for the company's bottom line. (Hmmm, how exactly does that fit into the company's so-called "triple bottom line" of social responsibility, environmental soundness, and economic viability?). But these numbers suggest that Lilly could foil Novo's desires because of the continued strength of the Humulin business and because the company depends on these products for continued performance in the insulin business, at least until the company can come up with some new products.

Read into this what you like, I just thought these were some interesting take-aways that were worth sharing.

DRI's World of Hope Research Conference Coming November 3rd

Next, my friends at the University of Miami's Diabetes Research Institute (the DRI) would like me to let everyone know about their upcoming "World of Hope Research Conference" being held on Saturday, November 3, 2007 near the DRI's campus in South Florida. It will be held from 8:00AM - 3:00PM, and will feature the DRI's gregarious researchers presenting an update on progress made in the field of cure-related diabetes research. Its open to the public (if you make reservations to attend), and tickets are just $25/person or $60 per family of up to 4 people. Details can be found at the DRI's website.

Sadly, I will not be able to attend this year due to the timing and location (I'd have to fly in), but I have attended the DRI's conferences in New York City in the past, and have to say these events are highly worthwhile. Not only are they informative, and also a well-organized event with a sit-down meal, and better still, participants also have the opportunity to meet and interact with the researchers!

JDRF Celebrity Chef Sam Talbot Wins Title of America's Steamiest Chef

In case you missed this, it looks like JDRF "SpokeChef" Sam Talbot, finalist of season 2's "Top Chef" and restaurateur was the winner of the GLAD SimplyCooking Steamiest Chef Contest, which was an online contest where consumers could vote for who is named America's steamiest chef. Sam will be donating an additional $25,000 to JDRF as a result of this victory.

Sam said, "Even in its simplest form cooking can be very sensual. When I create a meal for a guest in my home kitchen I want the experience to solicit a meaningful, even steamy response. I'm proud to be in the running for Steamiest Chef because my involvement will help the JDRF International fund research and support children with diabetes."

By the way, for those of you New Yorkers who wish to visit Sam's restaurant which opened in June, known as Spitzer's, you can catch some more background info. from The New York Times here. However, it appears he may have parted ways with his partners, so he may have left that venture already. I'm sure he's working someplace, but the question is where?

The Business of Diabetes: Pfizer Pulls the Plug on Exubera

Well, third-quarter earnings are being released en masse this week and next, and among the major drug companies, Pfizer and Lilly are releasing their earnings results today (October 18, 2007).

Pfizer was the first one to release its results, and the company released a bombshell of sorts: they are pulling the plug on Exubera, the inhalable insulin that was released with much fanfare back in 2006! But the company made numerous mistakes in entering a business segment (diabetes) that they knew nothing about, and approached the market with a sense of arrogance that doomed the product.

Pfizer Inc posted third-quarter 2007 revenues of $12.0 billion, a 2% decline from the same period last year. The company's reported net income was $761 million in the third quarter of 2007, a decrease of 77% from the same period last year, primarily reflecting pre-tax charges of $2.8 billion related to the decision to exit Exubera, its inhaled insulin product to treat diabetes.

"We are encouraged by our operating results in the third quarter, and we remain on track to achieve our full-year 2007 revenues and adjusted diluted EPS goals. Meanwhile, we made an important decision regarding Exubera, a product for which we initially had high expectations," said Jeff Kindler, Chairman and CEO. "Despite our best efforts, Exubera has failed to gain the acceptance of patients and physicians. We have therefore concluded that further investment in this product is unwarranted."

"We will work with physicians to transition Exubera patients to other treatment options in the next 3 months. We remain committed to investing significant resources in the development of new and innovative medicines to manage diabetes, including monitoring inhalation technologies and other innovative delivery systems for insulin and other medicines."

Frank D'Amelio, Chief Financial Officer, added, "The Exubera pre-tax charges of $2.8 billion related primarily to the write-off of assets associated with this product, as well as the accrual of other exit costs. More specifically, these charges are comprised of approximately $1.1 billion of intangible assets, $661 million of inventory, $454 million of fixed assets and $584 million of other exit costs."

I was among those who predicted Exubera would fail, and I said it from the beginning (see here for my original post), so this is a vindication of sorts. Back in July, I reported that the manufacturer of the Exubera inhaler was cutting jobs because demand for the so-called insulin bong were far below company forecasts. Prior to that, in May, I reported that Pfizer planned a huge direct-to-consumer advertising campaign that was designed to convince patients, primarily those with type 2 diabetes, that they needed Exubera. But as I noted even then, some Wall Street analysts had started to question whether Pfizer would even recoup the $1.3 billion it spent to acquire the exclusive rights to Exubera, which they acquired from rival Sanofi Aventis. I reported that it was unclear whether marketing alone will be sufficient to overcome the medical, economic, practical and legal concerns that have hurt Exubera.

Specifically, I cited a quote from Merrill Lynch analyst David Risinger, who said "We are not aware of any pharmaceutical product that has ever become a blockbuster that was not endorsed by specialists."

I also noted that our own David Kliff, publisher of Diabetic Investor, a specialist investment data company said "I think Pfizer is on drugs" if it believes it will get $2 billion a year from Exubera. If Pfizer does reach its goal, "I'm going to run down Madison Avenue naked," he said. Kliff believed Pfizer would be lucky if Exubera ultimately did half the business that Pfizer was predicting. Well, it looks like we were right and David will not have to run naked down Madison Avenue! Sorry to disappoint anyone who was hoping to catch him streaking through the streets of Manhattan!

Commenting on Pfizer's performance was Michael Obuchowski, a principal at Altanes Investments LLC in New York who doesn't own Pfizer shares: "This is not a good quarter," he said. "The company is in crisis, and the company is not behaving like they are in crisis. They are not replacing the revenue they are losing."

Pfizer's net income was the smallest since a profit of $301 million in the first quarter of 2005. Excluding costs of the Exubera write-off and other items, Pfizer earned 58 cents a share, beating the 52-cent average estimate of 16 analysts surveyed by Bloomberg.

I will update this posting a bit later today after Eli Lilly releases their results (they release them at 9:00), so please be sure to come back!

A More Cautious FDA Warns of Risk for Pancreatitis with Amylin's Drug

In a sign that the FDA does not want to see a repeat of the events that occurred regarding the type 2 diabetes drug Avandia requiring more label warnings due to risk of cardiovascular events associated with that drug, the U.S. Food and Drug Administration has called attention to something which appears to be a tiny risk associated with another type 2 diabetes drug, Byetta. The Avandia incident received widespread media attention and brought Congress to re-examine the FDA's review procedures.

Yesterday, the FDA reported that the popular injectable medicine to treat type 2 diabetes, Byetta (known generically as exenatide), may be linked to cases of acute pancreatitis in some patients. Pancreatitis is an inflammation of the pancreas. Acute pancreatitis (the kind that was linked by the FDA to Byetta) occurs suddenly and lasts for a short period of time but usually resolves itself. Chronic pancreatitis, on the other hand, does not resolve itself and results in a slow destruction of the pancreas. However, either form can cause serious complications, which may include bleeding, tissue damage, and infection.

Amylin has agreed to add information about acute pancreatitis to the precautions section of Byetta's label, the FDA said.

Alice Bahner Izzo, an Amylin spokeswoman, said that information about pancreatitis is already on Byetta's label, but that it's being updated to give clear advice on what signs and symptoms doctors should look for.

Based on IMS Health data, there were 56,969 prescriptions written in the last week of September alone for Byetta, yet the FDA reports that they have reviewed a mere 30 cases of acute pancreatitis, which is comparatively tiny. According to Amylin, the total number of scripts written for Byetta is significantly larger.

"It's a rare but serious event," Ms. Izzo said of pancreatitis. Byetta has been used by 700,000 patients in the U.S. since the drug was introduced.

Of particular note is that the FDA said that, of the 30 cases of pancreatitis that were reported, 27 patients had at least one other risk factor for developing the pancreatitis, such as gallstones or alcohol use. In 6 cases symptoms of pancreatitis began or worsened soon after the dose of Byetta was increased from 5 micrograms twice daily to 10 micrograms twice daily, the FDA said. In 22 of the 30 cases, reports indicated patients improved after discontinuing Byetta.

Is this a legitimate concern for patients? Possibly (especially if you are one of the patients impacted), and the FDA is recommending that patients who are taking Byetta should seek prompt medical care if they develop unexplained, persistent severe abdominal pain, which may or may not be accompanied by vomiting. But in the grand scheme of things, the risk appears to be quite low.



Amylin drug suspected in pancreatitis cases: FDA
By Reuters Health
Tue Oct 16, 2007 3:04pm EDT

WASHINGTON (Reuters) - Amylin Pharmaceuticals Inc's and Eli Lilly and Co's diabetes drug Byetta may be linked to cases of acute pancreatitis in some patients, U.S. health officials said in an alert issued on Tuesday.

The U.S. Food and Drug Administration said it has reviewed 30 reports of pancreatitis in patients taking Byetta, known generically as exenatide.

"An association between Byetta and acute pancreatitis is suspected in some of these cases," an FDA alert said.

Amylin has agreed to add information about acute pancreatitis to the precautions section of Byetta's label, the FDA said.

Shares of Eli Lilly and Amylin were off 1.3 percent and 4.5 percent, respectively, in afternoon trading after the FDA alert. Shares of Alkermes Inc, the drug-delivery technology of which is being used to develop a long-acting version of Byetta, were down about 5 percent.

Officials at Amylin were not immediately available for comment. A Lilly spokeswoman had no immediate comment.

The FDA said doctors should tell patients taking Byetta to seek prompt medical care if they develop unexplained, persistent severe abdominal pain, which may or may not be accompanied by vomiting.

Byetta should be discontinued should pancreatitis be suspected, the FDA said. Should pancreatitis be confirmed, Byetta should not be restarted unless an alternative cause is identified, the agency advised.

(Additional reporting by Lewis Krauskopf and Ransdell Pierson in New York and Toni Clarke in Boston)

Unsolicited Healthcare Advice for Chronic Illnesses Offered by One-Third of All People

It turns out that unsolicited advice about chronic illness like diabetes is seen as a taboo topic by many people, akin to politics and religion according to a new survey of more than 1,000 American adults. But the number and percentage who feel it is taboo is not as many (or as high) as one might expect. The survey was released by Evercare, a provider of health plans for people who have chronic illnesses, are older, or have disabilities which is owned by healthcare giant United Healthcare.

According to the survey, which was released yesterday, 82% of respondents said they knew someone with a chronic illness, but were more likely to discourage friends or loved ones from buying the wrong house (65%), loan them a large amount of money (56%), advise them against taking a job they didn't think was right for the person (48%), or tell them their spouse was unfaithful (41%). Just over one-third (34%) were likely to suggest ways for this person to better manage their care, which is comparable to the number who said they'd debate politics (37%) or religion (33%) with a loved one or friend.

But while Health Day News suggested that was a low number, I would dare say that the percentage people who feel entitled to offer unsolicited advice was surprisingly high. After all, why is it that one-third of people feel comfortable to offer advice on a subject they are usually unqualified to talk about? I don't usually offer my advice on child-rearing, nor would parents feel a person without children is entitled to offer them advice on that subject. Why, then, do so many people who do not even know there are two forms of diabetes feel entitled to offer advice on the subject?

I am hardly alone in my assessment that far too many people who do not know what they're talking about feel entitled to offer unsolicited advice to people with diabetes. Manny Hernandez' social networking site for diabetes "TuDiabetes" featured a thread related to this topic, and its a continued source of frustration for those of us with diabetes. Ignorance about diabetes seems to be widespread among advice-givers, which was validated by Medtronic Minimed's research published earlier this year. Its therefore no wonder most respondents to the Evercare survey actually said they would prefer to receive advice about managing a chronic illness from a health care professional (67%), followed by a spouse (10%) or parent (7%). Interestingly, men were twice as likely as women (14% vs. 7%) to have their spouse give them such advice, and women seem to have an easier time offering health advice to their children (24%) than men (16%) such as their husbands do.

The moral to all of these findings is as follows: First, if you're going to offer unsolicited advice to people with diabetes, make sure you know what the heck you're talking about. Comments like "Should you be eating that?" are likely to be ignored for any number of different reasons, and are usually considered bad manners if nothing else. Also talk to the person, and remember, you having a label "the food police" is not a term of endearment!

George Clooney & Patient Privacy Rights

This week, patient medical records and patient privacy received some unusual media attention because one of Hollywood's own, George Clooney, allegedly had his medical records violated by more than two dozen employees at the Palisades Medical Center in New Jersey who supposedly handed his medical records over to the media. Clooney visited the medical center when he and girlfriend, Sarah Larson, were treated for injuries sustained in a motorcycle accident recently. Those employees, incidentally, have been suspended without pay for a month. They were suspended because Clooney is a celebrity, but if the same thing happened to an average person, I suspect they wouldn't have even been reprimanded.

Unfortunately, medical privacy is a huge issue that has yet to receive the kind of public attention it deserves because most of your medical records remain on paper files that reside in your doctors' offices. That makes theft (of the sort that have become known only since a groundbreaking California law made public disclosure of data violations mandatory, see here for a listing) highly unlikely. But with legislators pushing electronic records as a way to streamline the billing process (in spite of having no evidence to show that cost savings will result), and companies like Microsoft pushing this issue, your medical records someday be floating around cyberspace and you'll have no right to stop it as you do with your credit bureau because there are no laws on the books protecting you.

Today, I received notice that at 3:00 EST (October 10, 2007), the Founder of the organization Patient Privacy Rights, Dr. Deborah Peel, M.D. will be on Star Jones Court TV to make 4 clear points:

1. HIPAA is a joke. It's not a "Privacy" Rule, it's a "Disclosure & Exposure" Rule

2. The violation made the news because the victim was George Clooney, but every day the average American's personal health information is being seen, sold and stolen by millions of individuals and businesses without your consent and over your objections.

3. Congress must pass legislation that ensures individual Americans, not insurers, employers, hospitals, banks or creditors , control all access to their own health records.

4. However, you can take the Patient Privacy Rights form to every doctor, hospital, lab or pharmacy to let them know that they cannot release your health information without your consent. But its impossible to impact Congress without massive public support for patient health privacy.

If you have the chance, try to catch the Star Jones show this afternoon. Even if you can't, do visit Patient Privacy Rights for more information on this important topic!

The Business of Diabetes: Q3 Business News

Dow Jones is reporting that shares of French pharmaceutical giant Sanofi-Aventis rose 2.8% in Paris amid market speculation that Pfizer is eyeing the purchase of a stake in Sanofi-Aventis from oil giant Total and cosmetics firm L'Oreal (which once owned a majority stake in Sanofi prior to its merger with Aventis), and supposedly Pfizer may also be mulling a full takeover. Sanofi Aventis is the manufacturer of the world's best-selling insulin analog: Lantus, as well as the rapid-acting insulin analog Apidra, and Amaryl, a sulfonylurea to treat type 2 diabetes. Traditionally, the French government encouraged companies own large shares of other French companies in spite of having no strategic interest via tax incentives. But these days, many French companies now trade in London as well, where investors look down on these cross-ownership holdings because it makes analysis of the true net worth difficult and therefore limits share potential. Also, as truly multinational companies, the French tax benefits are no longer as compelling as they were 20 or 30 years ago. As a result, many major French multinatinals are divesting their cross-holdings in an unprecedented fashion.

Regarding a Pfizer acquisition of L'Oreal and Total's Sanofi Aventis shares, "The question (of whether Pfizer can take over Sanofi-Aventis), iconoclastic not long ago, is now being openly asked," said analysts at Natixis in a note. The analysts noted that Pfizer is facing sales erosion and has very few products in final development. "Hence we think that it will have to either undertake regular adaptation of its costs or envisage a merger ... Sanofi-Aventis is the most plausible target for Pfizer."

It seems highly likely that L'Oreal and Total will divest their holdings in Sanofi Aventis, but whether Pfizer shareholders will see such an acquisition of those holdings as a wise investment remains an unresolved question. As of right now, it is only speculation, but the saying "where there's smoke, there is fire" certainly lends some credibility to this speculation. To be sure, Sanofi Aventis' has been much more forthcoming with investors in recent quarters, and while the company's new drug pipeline is undoubtedly more attractive than Pfizer's, its not smooth sailing for either company. The bigger question is whether Pfizer buying a stake or an outright acquisition would resolve fundamental problems for either company, or whether it would merely be another distraction?

In other diabetes business news, this Thursday (October 11, 2007), Biodel Inc.'s (Nasdaq: BIOD) Chairman and CEO, Solomon Steiner, will present a corporate update at the BIO InvestorForum 2007 in San Francisco at 11:00 AM PST (2:00 PM EST), which is a national investor forum to explore investment trends and opportunities in life sciences, with a focus on public and venture-stage growth companies as well as those poised to join the growth "watch list" in 2008. The news release for that can be found here. The company notes that interested parties may access a link to a live audio webcast of that presentation in the investor relations section of Biodel's website at http://investor.biodel.com/, but I've provided a direct link above. In any event, a replay of this presentation will be available for 14 days, (or until October 25, 2007).

The company will also present at the Insulin Congress on November 24, 2007, which if you can imagine, is an educational congress solely devoted to insulin therapy, and there may be useful take-aways from this event. This is not the first Insulin Congress, but I would imagine that more info. will be available on their website after the 2007 Insulin Congress is complete.

Meanwhile, the Pharmaceutical Executive's Marketing & Sales Summit will take place a few weeks earlier (November 4-6, 2007) in Philadelphia. Normally, this type of event would be just another sales conference, but its worth noting that this year will feature keynote addresses from Deirdre P. Connelly, who is the President of Lilly USA; Martin Soeters, now President of Novo Nordisk (formerly Senior Vice President of Novo Nordisk North America and President of Novo Nordisk Inc., the company's U.S. affiliate). As I reported a few weeks ago, Martin Soeters is being moved to take up the position as Senior Vice President of the Europe region at Novo Nordisk's world headquarters in Denmark, which will occur officially on January 1, 2008, so this will likely be Martin Soeters' last presentation in his current capacity. Mr. Jerzy Gruhn will assume the U.S. roles currently held by Mr. Soeters. Finally, Christopher A. Singer, EVP and COO, PhRMA, the pharmaceutical industry's trade and lobbying group will also give a presentation. Mr. Singer will speak on how industry executives can deal with the current environment, in which drug pipelines have little in the way of likely blockbusters, as well as increased government and public scrutiny. I usually disagree with PhRMA on most of their positions, but it will be interesting to hear what strategic directions they are suggesting for their members!

There are likely to be some interesting take-aways from all of these presentations and meetings, so you may want to visit the links I have provided here.

Finally, in recent months, we have been hearing a lot of praise for gastric bypass surgery in treating obesity and type 2 diabetes. However, today, Jacob Goldstein of The Wall Street Journal's Health Blog writes that a study being presented today at the annual scientific meeting of the American College of Emergency Physicians in Seattle suggests that patients should proceed with caution, and that there is always a dark underside to this surgical procedure. Specifically, the number of people showing up at emergency rooms with complications months or even years after the surgery is increasing dramatically. The problem that's sending many patients for emergency care: internal hernias. I have said this all along: there is no easy way out. Anyway, although this story has absolutely nothing to do with type 1 diabetes (or The Business of Diabetes, for that matter), but it was in today's Wall Street Journal Health Blog, and as a patient advocate/reporter, I do like to call attention to those issues that are sometimes overlooked, thus I'm including a link to the story here. That's all for today!

2008 ADA Scientific Sessions to be Held in San Francisco

The American Diabetes Association has announced that next year's "Scientific Sessions" will be held in my former hometown, San Francisco, at the Moscone Center from June 6-10, 2008. In fact, one of my previous offices was located right next door, at 201 Third Street (right next to the San Francisco Museum of Modern Art), so I know the area very well. These sessions are aimed at the medical community, but the reality is that journalists, which is a term used quite loosely, can be extended to include bloggers, too. The benefits of attending are tremendous. Not only will you have access to new research, but the vendor exhibitions blow away anything you might find at the lame "Diabetes Expos" the ADA has introduced. The key, if you're interested in attending, is to make your reservations in advance, and to plan accordingly.

I'm not sure I'll be able to attend, but I recommend going if you're able! For details, see the link above!

Branded Identity

Well, it had to happen sooner or later. I've finally decided to bite the bullet and brand my online identity (sort of). My blog URL will be moving in the not-too-distant future, but since I'm not changing carriers, hosts or anything, the process should be almost seemless. Still, you might want to add the following address to your blog readers so its already there when I officially move:

http://blog.sstrumello.com/

so its already in there when I make the switch, which will probably happen over the next two months.

I haven't moved anything yet (I'm still shopping around for some template design changes), but I wanted to give everyone a heads up that its coming. If you visit http://www.sstrumello.com/, you'll pretty much get a page announcing the eventual move. Note that the "blog" prefix will designate my blog address, which is actually hosted in a different location. But you can just add my new blog address "http://blog.sstrumello.com/" to your reader now ... go ahead ... it won't hurt, I promise!

At Last, FDA Approval of SYMLIN Pen-Injector Devices

Well, it has been promised for nearly 3 years now, but today, the company revealed that they were in receipt of an approval from the U.S. Food and Drug Administration (FDA) for the SymlinPen 60 and the SymlinPen 120 pen-injector devices for administering SYMLIN (or pramlintide acetate) injection. According to the news release, the pens are expected to be available to patients by December 2007.

Patients have long complained that SYMLIN is cumbersome to use, in part, because there are no pen injection devices for the use with SYMLIN, therefore its not portable. As a result, dosing SYMLIN on the run is more cumbersome and less convenient, and may have slowed doctor and patient uptake of this insulin-adjunctive treatment approved for all forms of diabetes. The Amylin/Lilly partnership have promised a pen for several years, but bringing one (or in this case, two) to market received a lower priority as the company struggled to market a pen for the type 2 medicine Byetta instead amid production problems and surging product demand for Byetta.

However, Amylin also stated that FDA had issued a "Not Approvable" letter for SYMLIN use with basal insulin in patients with type 2 diabetes who have not achieved desired glucose control. SYMLIN is currently only approved in the U.S. for patients with either type 1 or type 2 diabetes who use mealtime insulin and need improved glucose control. In other words, SYMLIN cannot be used by type 2 patients who are using only long-acting insulins like Lantus or Levemir. It's no secret that the Amylin/Lilly partnership had hoped to promote the use of SYMLIN as a kind of weight-loss drug for the type 2 market, but this FDA action will limit this to patients who are using a full basal/bolus combination and may therefore exclude many type 2 patients who use only basal insulin. Not that this is the final word on this.

For example, Daniel M. Bradbury, President and CEO of Amylin
Pharmaceuticals did say "We will initiate discussions with the FDA to clarify their response for its use with basal insulin alone." Of course, "not approvable" does not necessarily mean it is not approvable, only that the FDA needs more information before they will approve it for that use. I suspect the reason for this application was to make SYMLIN marketable to the large number of type 2s who use only basal insulin. But basal insulin-only is not necessarily the optimal insulin therapy for most type 2 patients, so this may therefore limit the ability to market SYMLIN in the fashion the partnership had hoped. Regulators will no doubt seek to limit "off-label" marketing of this medicine, especially given Lilly's recent problems in off-label marketing of its schizophrenia/bipolar disorder medicine Zyprexa which received public notice following an exposé published in The New York Times last year, and more recently, the FDA notice that Lilly failed to disclose adverse effects of Cymbalta, which is being marketed as a treatment for diabetic neuropathy in addition to depression.

It is worth noting that the FDA approved two different sized SYMLIN pens, the SymlinPen 60 is targeted at the type 1 market, while the SymlinPen 120 is targeted at the type 2 market, reflecting the different dosage requirements applicable to both groups.