Blogs

http://www.diabetespharmacist.com/uploads/image/prevent%20diabetes%202%281%29.jpg
Earlier this week, the Federal Drug Administration (FDA) announced that they had approved a new drug for type 2 diabetes (see the FDA’s press release here).  Type 2 is the most common kind of diabetes and can develop at any age despite the old misnomer that it was an “adult-onset” disease.  Essentially, your body does not properly release insulin in response to increases in blood sugar (for example, after a meal).  Therefore, sugar is not properly metabolized and builds up in your blood.
Diabetes is a huge concern not only as the seventh leading cause of deaths in America, but also in the high medical costs for  those afflicted.  Statistics show that more than half of diabetes cases are women.  Pregnant women can be affected by gestational diabetes, which typically goes away after the baby is born but can lead to the development of Type 2 diabetes.  This may contribute to the slight sex bias in Type 2 diabetes, where women comprise 58% of all cases (according to a 1995 study by the National Diabetes Data Group).  There is a nice discussion on sex-specific differences in diabetes on Medscape Today, if you are interested in reading more.  The article is accompanied by a long list of references for more detailed information.
I don’t study diabetes and I’m not a doctor, but based on my limited knowledge and reading, it looks like the new drug (which will be sold as Victoza) has a different target in the pancreas than the other drugs already on the market.  (There was a nice overview in this 2001 review article in the journal Nature.)  It’s nice to have more possible treatments since not all drugs work to the same effect in every patient.  There’s evidence out there that some drugs act differently even between men and women!  Of course, with any new drug, time will tell if Victoza causes any long-term effects.  However, it is promising to have a new option for those dealing with diabetes and their loved ones as well.  Has diabetes affected you or someone you know in any way and if so, what has been your (or their) experience with the current drugs out there already?
Useful info on diabetes from the National Diabetes Information Clearinghouse:

• For general information: Your Guide to Diabetes
• For in-depth information: Diabetes in America, a comprehensive book

In a 2009 op ed, New York Times columnist David Brooks noted that America was founded on a puritanical thrift and these original tenets are being undermined by a change in political forces and societal expectations. Brooks theorizes that the major indicator of this shift is the extraordinary loss of homes, ironically, the most visible external indicator that an individual has ‘made it’ in our society; the loss of iconic car brands; and, the health care debate. These same forces are at place in the basic sciences – an original thriftiness in how discoveries, work and training gets done in the academy now challenged by loss of scientific capability (in advanced physics, computing and stem cell biology); loss of laboratories by junior, middle and senior scientists; and an unease with the bust and boom cycles of stimulus money, supplemental funds and the ‘cliff’ scenario. Funding in the basic sciences is inextricably linked to the discovery process.

To meet the challenges in the public sector, government has developed a number of interventional strategies that are still experimental. Superficially, it appears the banks have been saved (although their souls are still in question). The National Institutes of Health (NIH) has similarly fiddled with funding mechanisms, and the data of these experiments are still being collected. Certainly the political realities of funding scientific discoveries may seem like a luxury. But science produces, and the products are valuable. Products include new medicines, new machines, and new ideas.

Learning is the enduring product of the academy. Universities produce the workforce who populate government, pharma, biotech, and the academy. How does this get done - by taxpayer money, of course (and through some tuition dollars). Arguments exist regarding the right way to sustain and expand knowledge and the current funding debates create room for thinking about new mechanisms.

At this point, David Brooks will probably raise one eyebrow and ask, why am I named in this piece?

The NIH Roadmap grants are notable examples of interventional mechanisms that are under scrutiny at the agency. For example, the interdisciplinary research consortium (IRC) grants are an experiment that said interdisciplinary work itself was a goal and that interdisciplinarity could solve intractable problems. What we discover next as a scientific community depends on the recognition that solving intractable biomedical problems (as they arise) is not an oxymoron, but a necessity of society, akin to shelter.

At the end of the day, science relies on a set of political (national and local) realities that shape how and what learning occurs, and society has an expectation that new discoveries will impact their daily lives in the form of new medicine and new knowledge. We don’t have JP Morgan to save scientists at the bench, so, our president and congress should consider the NIH and NSF (National Science Foundation) as important parts of a healthy nation and help ensure that the momentum of discover continues and that assets are available, to ensure the creation of a stable network for discovery. We have new ideas for how to get the biggest bang for every buck and these ideas should be sustained.

I think David Brooks may still be confused about his relationship to this blog post, but perhaps can be persuaded that as long as the academy is the home to discovery research, and as long as the public is funding its work, there is a requirement for public funds to flow in a way that makes every dollar convert to new ideas and impact human health as quickly and efficiently as possible.

The Food and Drug Administration (FDA) is warning the public about a counterfeit version of the weight-loss drug Alli 60 mg capsules (120 count refill pack) being sold over the Internet, particularly at online auction sites.
The counterfeit product is illegal and unsafe. FDA advises people who believe that they have a counterfeit product not to use the drug and to dispose of it immediately. There is no evidence at this time that the counterfeit Alli product has been sold in retail stores.
Photo of authentic Alli
According to the FDA, the counterfeit Alli looks similar to the authentic product, with a few notable differences. Counterfeit Alli has:
* a missing LOT code on the outer cardboard packaging
* an expiration date that includes a month, day and year (real Alli only has month and year)
* plain foil for the inner safety seal without words on it (real Alli has the words “SEALED FOR YOUR PROTECTION” printed on it)
* large capsules with white powder, as opposed to small white pellets found in real Alli
* a slightly taller plastic bottle with a wider cap and coarser ribbing on cap than is seen in real Alli.
Alli is an FDA-approved, over-the-counter weight-loss drug that contains orlistat as its active ingredient. The counterfeit version does not contain orlistat, instead it is made with varying amounts of sibutramine, a stimulant drug. Although sibutramine is the active ingredient in another FDA-approved prescription weight-loss drug, it is only to be used in specific doses and under the supervision of a physician. Preliminary lab tests revealed the counterfeit version contained sibutramine and not orlistat. Since then, FDA lab tests on the counterfeit product show that people may be taking three times the usual daily does (twice the recommended maximum dose ) of sibutramine if they are following the dosing directions for Alli. Side effects from excessive sibutramine include elevated blood pressure, stroke and heart attack if you have a history of heart disease; and anxiety, nausea, heart palpitations, racing heart, insomnia and small increases in blood pressure if you are healthy.
If you have been taking the counterfeit product, stop taking the drug and throw it away; contact your health provider if you are experiencing more than mild symptoms, especially if you have a history of cardiovascular disease; and call FDA’s Office of Criminal Investigations at 800-551-3989 or by visiting the OCI Web site

Melina Kibbe honored at White House
Melina Kibbe, M.D., associate professor at Northwestern’s Feinberg School of Medicine, vascular surgeon at Northwestern Memorial Hospital and co-chief of the vascular surgery service and director of the Vascular Laboratory at the Jesse Brown VA Medical Center recently received the Presidential Early Career Award for Scientists and Engineers (PECASE) at the White House.   This is the highest honor given by the U.S. government to outstanding scientists and engineers who are in the early stages of their research careers.
Her current research portfolio was primed, in part, by two Pioneer Awards the Institute for Women’s Health Research (IWHR) awarded Dr. Kibbe and her postdoctoral fellow in 2008 and 2009, respectively.  Her research focuses on preventing vascular injury and scarring in blood vessels following stent surgery.   It wasn’t until Dr. Kibbe  ran into Dr. Teresa Woodruff,  IWHR Director, a few years ago, who asked Kibbe if she was including female animals in her research, that she gave it much consideration. After that meeting, Kibbe searched publications in her field that included sex as a variable and she found there was very little.   With her Pioneer Awards, she proposed to include male and female animal models to study the benefits of nitric oxide (NO)-based therapies following stent surgery and found that the effect was totally different between the sexes!
The Pioneer Awards were developed by the IWHR to encourage researchers to include sex and gender analyses in their studies, and the work done in the Kibbe lab demonstrates how a small amount of funding targeted to sex-based research can produce startling results and change a whole field of study.   The immeasurable aspect of the PECASE award that Dr. Kibbe received is the invaluable  publicity it will give her research.  This may help focus on the importance of including sex variables in future vascular research and open doors to new collaborations and larger funding.