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Somebody once said “Jews know two things—suffering and where to find good Chinese food”. Since I am Jewish, it is not surprising that I have experienced a fair amount of suffering throughout my life and, wherever I go, I seem to know where to find “good” Chinese food.  That said, my interest was piqued when I found a post in Yahoo Science News entitled “Study finds Chinese food good for your heart”. Given my lifelong fondness and penchant for Chinese cuisine, I thought that all of that eating that I had done had finally paid off. Unfortunately, after reading the subtitle of the article; “Chinese red yeast rice reduces repeat heart attacks/mortality rates” I realized that my joy and optimism were somewhat premature.

According to the report, researchers at Jefferson Medical College found that a partially purified extract of Chinese red yeast rice, Xuezhikang (XZK), reduced the risk of repeat heart attacks by 45%, revascularization (bypass surgery/angioplasty), cardiovascular mortality and total mortality by one-third and cancer mortality by two-thirds. The multicenter, randomized, double-blind clinical study was conducted on about 5,000 heart attack patients, ranging in age from 18-70 during a five-year period at over 60 hospitals in the People's Republic of China. Study participants were given 300-milligram XZK capsules or a placebo and tracked over a five-year period. The XZK extract used in the study contained a combination of lovastatin, lovastatin hydroxyl acid, ergosterol and several uncharacterized components.

Based on study results, the study’s authors believe that XZK may offer therapeutic benefits to people at risk of heart attack and cardiovascular disease. However, they cautioned that the active pharmacologic ingredient (API) of the red yeast rice is unknown and it isn’t clear how XZK works to fight cardiovascular disease.

Chinese medicine practitioners have long touted the benefits of red yeast rice for heart patients. Nevertheless, this is the first controlled clinical study of red yeast rice that tends to substantiate these claims. According to the study authors it is important to note that “the commercially available over-the-counter supplement found in your average health food store is not what was studied here. Those over-the-counter supplements are not regulated (by the US Food and Drug Administration), so exact amounts of active ingredient are unknown and their efficacy has not been studied yet.”

It is unfortunate that I didn’t know about the benefits of red yeast rice during my recent trip to China. I certainly would have gone out of my way to try some. That said, given the plethora of exotic foods that I tasted in China, maybe I ate some XZK without knowing it!

Until next time

Good Luck and Good Eating (Chinese of course)……

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I apparently made a few errors in the post about the recent Salmonella food poisoning outbreak at PU (pun intended). I want to thank the anonymous member of the Princeton Graduating Class of ’09 for pointing out the inconsistencies and errors in the post.  First, the so-called “dining clubs” are actually called eating clubs. Second, fraternities and sororities are allowed at PU and I hear that they are alive and well. Finally, I inadvertently noted that the University has severed contracts with several of its produce suppliers which may have been the putative source(s) of the outbreak. In fact, the University didn’t cancel contracts but only temporarily closed a few of the eating stations at the Frist Campus Center. My local newspaper reported that contracts where severed–I guess you truly can’t believe everything that you read!

I was duly chastised for not adequately verifying my information before I hastily crafted the post. I stand corrected and will attempt to be more vigilant in the future. That said, I think that my lack of understanding of the practices and customs at Princeton University is directly related to the fact that I attended Cornell as an undergraduate. Mea Culpa!

Until next time…

Good Luck and Good Job Hunting!!!!!

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Yes, even the Ivy League isn’t immune to food poisoning outbreaks from time-to-time. There are currently 10 confirmed cases of Salmonella food poisoning at Princeton U. Another 50 people or so have also fallen ill with gastrointestinal symptoms consistent with Salmonella food poisoning.  As a precaution, university officials have temporarily discontinued doing business with their produce suppliers. For those of you who don’t know, Princeton is famous (infamous?) for its so-called dining clubs. These clubs take the place of sororities and fraternities which are not allowed at this august institution of higher education. Obviously, there is more than eating that goes on at these “dining clubs.”

The reason I am blogging about the outbreak is two-fold. First, I live about seven miles from Princeton and it has been all over the local news. Second, I did my PhD work on the pathogenesis of Salmonella gastroenteritis. So, Salmonella food poisoning is dear to my heart (thankfully, not my gastrointestinal tract). Many infectious disease experts tend to dismiss the seriousness of Salmonella gastroenteritis. This is likely because it is usually not as devastating as shigellosis or infections caused by enteroinvasive strains of Escherichia coli (which is actually Shigella masquerading as E. coli). As my major professor once put it “You know when you have Salmonella gastroenteritis—if you can’t decide than it is not salmonellosis.”

I am happy to report that I never came down with gastroenteritis while working for over three years with enteroinvasive Salmonella strains (even though I was routinely mouth pipetting and eating lunch in the lab; practices which aren’t acceptable by today’s standards). I like to think that “the bugs” were afraid of me. Alternatively I had either a great immune system or extremely good aseptic techniques. Whatever the reason, it is always embarrassing when card-carrying microbiologists come down with the disease(s) that they are studying. Luckily, I never came down with the disease caused by the bacterium that I was studying during my first postdoctoral fellowship—Neisseria gonorrhoeae. That would have been extremely difficult to explain!

Until next time…

Good Luck and Good Job Hunting (remember to wash your hands)!!!!!!!!

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I spent the entire morning reading various articles, blog posts and comments about what is wrong with the US Food and Drug Administration (FDA). Not surprisingly, phrases like “drug lag”, the large size and costs of clinical trials, political and corporate influence, reduced numbers of NME approvals etc appeared ad nauseum. These are the same old, tired complaints with the agency that have been bandied about for the past 10 years or so. 

In my opinion, the bottom line is this: the agency is egregiously under staffed and under funded despite the fact that companies pay steep user fees for regulatory reviews. I can understand why corporate America is dissatisfied with the service that it receives from FDA. It is natural to expect good customer service after paying large sums of money to a service provider.  However, it is important to note, that the words “customer service” don’t appear any where in the Food, Drug and Cosmetic Act of 1938 (although it can possibly be implied fromPDUFA in 1992 and FDAMA in 1997).  Nevertheless, what is mentioned in the FD&C is SAFE and EFFICACIOUS pharmaceuticals, biologics and medical devices. Put simply, safe and efficacious products, not customer service, is REAL the mission of FDA.  With this in mind, the agency is legally required to do everything in its power to provide Americans with carefully scrutinized and safe medical devices, pharmaceutical and biotechnology products.

If we Americans want FDA to accomplish its REAL mission, then the agency must be sufficiently funded, adequately staffed and have strong, non-partisan leadership. Unless this occurs, FDA will continue to struggle and remain dysfunctional well into the 21^st century.

Until next time…

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The US Food and Drug Administration announced late last week that it intends to post inspectors in embassies and consulates throughout the developing world to improve the quality of the food and medicines that flow into the US. FDA Commissioner Andrew C. von Eschenbach (Bush’s latest appointee to head the agency), said that he wants to have “boots-on-the-ground in developing nations like India and China and regions like Central and South America and the Middle East.” At present, less than 1% of the food imported into the US is inspected each year

As many of you know, FDA inspectors are required to visit both domestic and foreign manufacturing facilities that produce food, cosmetics and medicines that are sold in the US. By law, these inspections must take place every 3 years. Unfortunately, due to budget shortfalls and inspector shortages, routine inspections at domestic facilities are now taking place every 4 to 5 years– it is unclear how frequently inspections occur at foreign manufacturing facilities.  Based on von Eschenbach’s call for more foreign-based inspectors, the answer is likely “not frequently enough.”

The obvious solution to this problem is to increase the agency’s budget to hire and train new inspectors. However, despite repeated attempts by lawmakers, the Bush administration has steadfastly refused to endorse or consider budget increases for the agency. Instead, White House officials have urged the agency to uses any means possible to “bolster the aggressiveness and effectiveness of foreign health regulators” to prevent unsafe or tainted products from reaching the US market. I do not want to sound overly cynical but good will can go only so far with financial inducements or incentives.

Despite the obvious need for more inspectors, von Eschenbach admitted that his plan to post inspectors in foreign countries is “only in its infancy”. Also, he hasn’t decided whether he will ask Congress for additional funding for the agency or find money in the current budget for the foreign inspectors. I suspect that “finding money” in the current budget would translate into curbing other regulatory activities at FDA –something that would not bode well for the already-embattled agency. The inability of von Eschenbach to secure funding to train and deploy new inspectors is another reason why I believe that the FDA Commissioner ought not to be a political appointee!

Until next time…

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

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