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Most scientists fantasize about that so-called eureka moment when, after years of hard work, academic challenges and mental anguish, it all makes sense. While I have experienced these moments from time to time during my career as a scientist, it has happened less frequently as a lay person. This morning, while reading a Science Times article on Thomas R. Friedan , former New York City health commissioner and current head of the Centers for Disease Control in Atlanta, GA, I had one of those moments.

After reading the passage:

campaigns to ban trans fats, post calorie counts in chain restaurants, reduce salt in processed food and tax high-calorie sodas. He had a supportive boss in Mayor Michael R. Bloomberg and a receptive populace in New York, but if he were to try anything similar at the C.D.C., tough Congressional hearings could be in his future because conservative lawmakers on Capitol Hill often oppose such measures

it finally dawned on me that conservatives, in general, don’t give a damn or care about human health. Or perhaps, the underlying message may be: “don’t tell me how to eat or take care of myself; it’s my life and I know what is best for my health and me.” Unfortunately, since over half of the American population is obese or overweight and the incidences of diabetes and hypertension among younger and older adults has reached unprecedented epidemic proportion it is becoming increasingly evident that most Americans, regardless of their political affiliations, don’t know how to adequately manage their health.  And, to make matters worse, the inability or unwillingness of these individuals to maintain their health increases the cost and may block access of otherwise healthy Americans to adequate healthcare.

As an American, I strongly believe in individuals’ rights and freedom of expression. However, I also believe that summarily opposing unobtrusive measures to improve human health—based almost exclusively on political philosophy or personal financial gain—is morally bankrupt and overtly un-American!

Until next time…

Good Luck and Good Eating!!!!

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Johnson & Johnson today announced it received a Complete Response letter from the U.S. Food and Drug Administration (FDA) for ceftobiprole. The agency requested additional information and recommended additional clinical studies be conducted in order to consider a future approval of ceftobiprole in this indication. J&J’s New Drug Application (NDA) for ceftobiprole was originally submitted to the FDA in May 2007 for the treatment of complicated skin and skin structure infections (cSSSI), including diabetic foot infections.  The company received an approvable letter in March 2008 and submitted what it thought to be the necessary information necessary to garner approval of the new antibiotic

Ceftobiprole is a novel, broad-spectrum, anti-MRSA cephalosporin with activity against methicillin-resistant Staphylococcus aureus (MRSA), penicillin-resistant Streptococcus pneumonia and many clinically important Gram-negative bacteria, including Pseudomonas. The antibiotic was licensed from Swiss-based Basilea Pharmaceutica Ltd. in February 2005. 

The regulatory review process is ongoing in Europe and other countries for the use of ceftobiprole in adults for the treatment of complicated skin and skin structure infections. Ceftobiprole is approved in Canada, Switzerland, Russia, Azerbaijan, Ukraine and Hong Kong.

J&J intends to discuss the best path forward with the FDA as soon as possible. New antibiotics are necessary to combat the growing trend of multiple drug resistant strains of bacteria that are responsible for an increasing amount of bacterial infections.

Until next time...

Good Luck and Good Job Hunting!!!!

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e-Patients Connections 2009 (#epatcon) was held this past Monday and Tuesday at the Park Hyatt hotel in Philadelphia, PA. BioCrowd was one of several co-sponsors of the event. The theme of the conference, organized by Kevin Kruse a veteran medical communication and training expert, who now runs Kru Research, was to “reach, engage and educate empowered digital health consumers.” And, boy, did it deliver! While this was Kru Research’s first official conference, it was well organized, extremely interactive and the quality of the speakers was second to none! Topics that were featured included social media and the life sciences industry, technological advances in e-based healthcare delivery, the relationship between the news media and healthcare information and the continuing evolution of online and e-based healthcare communities.

Conference attendees included representatives from the life sciences industry, medical communications experts, advertising and marketing professionals and a multitude of social media enthusiasts and consultants who kept the Twitter screen humming throughout the meeting (a big shout out to the “troublemaking table”). And, surprisingly, there was a representative from the Division of Drug Marketing and Advertising and Communications (DDMAC) at the US Food and Drug Administration, who I believe, was one of the most sought after individuals at the meeting. CNN reporter Elizabeth Cohen who writes the Empowered Patient and racecar driver Charles Kimball, a type I diabetic and company spokesperson for Novo Nordisk also gave talks.

My favorite talks were those presented by online patient community organizers including Tricia Geoghegan of Ortho-McNeil-Janssen Pharmaceuticals who created the Facebook ADHD Allies community, Lisa Tate of WomenHeart and Robert Schumm of Bayer Consumer Care who created Facebook Strong@ Heart and Rachel Lewinson of the Juvenile Diabetes Research Organization and Susan Harrow Rago of Novo Nordisk who created Juvenation.org a website dedicated to those with Type I diabetes. These communities are outstanding examples of how partnerships between pharmaceutical companies and advocacy groups can help to better educate the public and heighten awareness about potentially life-altering diseases. Another example of a great online community and healthcare portal is Insomnia 123.com. This website was conceived and constructed by Christine Macadams and her partners’ one of whom is a practicing physician. Unlike the other online communities, which are sponsored and mainly supported by consumer healthcare division of large pharmaceutical companies, Insomnia 123.com was exclusively created by a group of concerned individuals who wanted to better educate and improve the lives of people with insomnia—a largely unreported and self-medicated condition.

On the technical side, the talks presented by Lee Segal of Klick, Kevin Durr of Avantera , Ian Kelly of Red Nucleus and Scott Ballenger of ListenLogic were illuminating and extremely informative. Some of the innovations taking place in digital media are exciting and almost overwhelming at times (even for a social media enthusiast like me). I think the company to watch is ListenLogic which uses semantic search engines to collect real time data and “chatter” on the web. This technology may provide a cost-effective solution to assuage the concerns of many life sciences companies that claim that collecting and analyzing overwhelming amounts of data is one of the main reasons why they are reluctant to entry the social media space.

Marc Monseau of Johnson and Johnson gave an illuminating talk on his experiences as a corporate blogger and Twitter user and described some of the challenges that had to be overcome before his company was able to break the “social media barrier.” Janice McCallum, an economist by training and a healthcare communications and media expert gave an informative talk about the growing role and impact of patient-generated healthcare content on patient awareness and education.

Finally, the novel and innovative Pecha Kucha sessions were outstanding and extremely well done! While all were expertly crafted, Dr. Val’s and Jonathan Richman’s Pecha Kucha were memorable. Dr. Val’s, which was extremely powerful and moving, was performed entirely in verse and Jonathan’s was—well, one of Jonathan’s always entertaining and informative presentations.

In summary, the “e-Patient Connections 2009” was a resounding success and in my opinion reached its goal to “reach engage and educate empowered digital health consumers.” That said, I can’t wait for “e-Patient Connections 2010” meeting!!!

Hat tip to @ellenhoenig and @eileenobrien for inviting me to my first tweetup (great fun) and finally meeting @janice McCallum, @christianeTrue, @stevewoodruff and Silja aka @whydotpharma! 

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Over the past few years, I have heard rumors that artificial sweeteners like saccharine, aspartame and sucralose actually cause people to gain rather than lose weight. I summarily dismissed these stories because they did not make sense to me nor did I think that they had any scientific merit–until today!

Purdue University psychologists Drs. Susan Swithers and Terry Davidson fed rats yoghurt sweetened with glucose (15 calories per teaspoon) or yoghurt containing the artificial sweetener saccharin (0 calories per teaspoon). Rats that were fed the saccharin-sweeten yoghurt subsequently consumed more calories, gained more weight, put on more body fat and were unable to regulate dietary intake of calories as compared with rats that were fed glucose-sweetened yoghurt. The authors surmised that breaking the connection between a sweet sensation and high-calorie food, changes the body’s ability to regulate caloric intake. This could partly explain why obesity has risen with the increasing use of artificial sweeteners in drinks. The study’s findings are consistent with emerging evidence that people who drink more diet drinks are at higher risk for obesity and development of the metabolic syndrome that increases the risk for heart disease and diabetes.

So, how do the authors explain their seemingly paradoxical findings? Swithers and Davidson postulate that ingestion of sugar-rich (sweet) foods provides a ‘salient orosensory stimulus” that signals that the body is about ingest a lot of calories. This, in turn, induces the body to physiologically-prepare itself for ingestion of a high calorie meal. However, when the false sense of sweetness (provided by the artificial sweetener) is not followed by consumption of large amounts of calories, the system gets “confused”– causing people to eat more or expend less energy to account for the calorie imbalance. Nevertheless, the good news is that people who use artificial sweeteners can still count calories to regulate caloric intake and body weight. Unfortunately, as the authors suggest, counting calories requires a more conscious effort and a lot more work than routinely consuming low-calorie foods.

Although this study was conducted in rats, its findings are consistent with the observations that increased use of artificial sweeteners can contribute to human weight gain. Despite the study’s findings, similar experiments must be conducted in people to substantiate or refute the authors’ hypothesis.

Until next time…

Good Luck and Good Job Hunting (lay off the aspartame and splenda)!!!!!!

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