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I suspect that many of you (after reading the title of this post) might be expecting another rant about the need for new antibiotics to treat infections caused by multiple drug resistant strains of bacteria. Sorry to disappoint you because that isn’t what this post is about. After reading and listening to several seemingly disparate radio and newspaper stories this morning, I decided to combine three different stories into a single post that touches on several common themes.

First, I heard a story on NPR this morning (while driving my daughter to middle school) about FDA’s initiative to require that oysters harvested from the Gulf of Mexico be pretreated before they can be served in restaurants and eaten raw. The reason for this initiative is that a majority of live oysters harvested from the Gulf of Mexico are usually contaminated with the opportunistic bacterial pathogen Vibrio vulnificus and other Vibrio species. Approximately, 15 or more immunocompromised patents die each year and many more get ill after ingesting raw Louisiana oysters infected with V. vulnificus. FDA, (which for those of you who don’t know also regulates the food and cosmetic industries in addition to the drug and devices industries), spent the past few years crafting regulatory guidelines that called for mandatory  treatment (irradiation or pasteurization) of oysters from the Gulf of Mexico before they are served “raw” at restaurants and other commercial food operations. The regulations were to be implemented sometime in 2011. While many of the larger commercial Louisiana-based raw oyster producers already pre-treat their oysters before they are sold to restaurants, the pretreatment requirement would be economically onerous and challenging to “mom and pop” oyster business throughout Louisiana. Not surprisingly, given the economic devastation caused by hurricane Katrina several years ago, FDA was assaulted by oyster manufacturing trade groups and Louisiana politicians and lobbyists asking the agency to delay implementation of the new rules. Unfortunately, FDA officials caved and yielded to the onslaught and agreed to conduct a pilot study designed to assess the effectiveness of the program before forcing the new rules on the Gulf Coast oyster industry.  For the record, I love eating raw oysters and the thought of eating a so-called “raw oysters” that have previously been pasteurized or irradiated seems unseemly and unappealing to me. However, FDA’s mission is to provide Americans with a safe food supply and to minimize the incidence of any public health risks associated with or caused by it. The fact that FDA was cajoled and yielded to calls that that the agency placed economic concerns ahead of known public health risks is lamentable and truly regrettable. Rather than spending excessive amounts of money on lobbying efforts to delay appropriate public health initiatives, the Gulf Coast oyster industry and its trade groups and lobbyist ought to consider investing in efforts to combat global warming and Gulf of Mexico water pollution, which in turn, would reduce the bacterial load of live oysters harvested from the Gulf of Mexico and serve to raw oyster enthusiasts. 

On a more upbeat note about infectious diseases (sort of), there was an article in today’s Science Times which reported the results of a study that linked exposure to five so-called common pathogens, Chalmydia pneumoniae, Helicobacter pylori, cytomegalovirus and Herpes simplex types 1 and 2 to increased risk of stroke. According to the article, each of these pathogens may persist after acute infections and contribute to an ongoing chronic low level infection. These low level infections coupled with chronic inflammation of blood vessels induced by the infections may contribute to the increased likelihood of stroke. While intriguing, authors of the study warn that their results don’t establish a cause-and-effect relationship between these infections and stroke. More research will be required to determine whether or not there is a definitive link between these infections and the incidence of stroke..

Speaking of stroke and heart attacks, I want to turn my attention to the clinical trial results reported yesterday by Merck & Co about its cholesterol-lowering drugs Zetia and Vytorin. As you may recall, a brouhaha erupted about a year ago about whether or not the cholesterol-lowering effects of  Merck’s  blockbuster drugs Zetia and Vytorin (which is a combination of Zetia and the statin Zocor) actually protected patients from increased risk of heart attack and stroke. The results of the long awaited study which were presented at an American Heart Association meeting on Monday support previous findings of two earlier clinical studies which showed that despite lowering LDL cholesterol levels, Zetia and Vytorin don’t reduce the risk of heart attack or stroke in at-risk patients. 

In the study patients who were at risk for cardiovascular disease were treated with statins in combination with either Zetia or Niaspan (a prescription, controlled-release formulation of over-the-counter niacin supplements that exhibits cholesterol-lowering properties). Patients who received statins plus Niaspan had decreased thickening of the walls (caused by atherosclerosis) of the carotid artery whereas those treated with Zetia failed to inhibit arterial plaque buildup. In other words, Zetia (and Vytorin) which are expensive prescription drugs don’t provide any health benefits beyond those offered by statins, many of which (including Merck’s Zocor) are available as low-cost generics.

Despite the lack of any clear medical or health benefits, sales of Zetia and Vytorin generated about $4.8 billion in sales last year. You would think that Merck and its stakeholders would be devastated by the results of the new study. However, they were actually happy about the news—they were fearful (based on data from the earlier studies) that Zetia may actually increase the risk of heart attack and stroke! What is particularly revealing (and disturbing) about the whole Zetia/Vytorin story is that Merck is relieved that an expensive drug that it heavily promoted as being beneficial and safe is in reality not beneficial. When did it become acceptable that the only requirement for FDA approval of prescription drugs is safety? Doesn’t a drug have to also show a positive therapeutic and clinical effect (over previously approved drugs for the same indication) before it wins regulatory approval? The fact that physicians continue to prescribe ineffective, multi-billion dollar drugs like Zetia instead of cheaper and effective generic versions of cholesterol-lowering drugs another troubling sign of  our current economic situation and the need for healthcare reform in the US.

Finally, for you patent aficionados, there was an illuminating and incisive op-ed piece in today’s NY Times that shed light on the problems with the current US patent approval process. While I have substantial experience in this area, I learned more from reading this article than I did from the many years that I worked closely with patent and intellectual property attorneys. This article is a must read for those persons considering careers in intellectual property and patent law and entrepreneurial individuals who are interested in starting up life sciences companies.

Until next time...

Good Luck and Live and Learn!!!!

 

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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 am old enough to remember when the artificial heart was invented and used to extend the life of Barney Clark, a dentist in Seattle, WA. It was a phenomenal accomplishment back in the day. So, it seemed appropriate to me that Robert Jarvik, the guy who invented the artificial heart, appeared in Pfizer’s Lipitor ads as a spokesperson to promote heart health. However, a Congressional committee examining consumer drug advertising has questioned whether the Lipitor ads may have misrepresented Dr. Jarvik and his credentials to promote the drug.

Although Dr. Jarvik has a medical degree, he is not a cardiologist nor is he licensed to practice medicine! Further, one television ads depicts Dr. Jarvik as an accomplished rower but the ad used a body double for him and, as it turns out, he does not even row! To make matters worse, a former colleague of Jarvik contends that he is not the actual inventor of the artificial heart. He suggested that the distinction belongs to Jarvik’s mentor Willem J. Kolff and his associate Tetsuzo Akutsu at the University of Utah. Go figure! Despite the firestorm, Pfizer continues to air the television ad ( I saw it just a few days ago).

Pfizer has spent more than $258 million advertising Lipitor (a cholesterol-lowering statin) since January 2006, most of it on the Jarvik campaign in an attempt to protect Lipitor from generic competition. Lipitor is the world’s best selling drug and generated $12.7 billion in revenues in 2007. While Lipitor has patent protection until 2010, some patients have already switched to a generic version of a competing cholesterol drug Zocor. According to published reports Pfizer agreed to pay Jarvik about $1.35 million under a two-year contract that expires next month. I think it is safe to assume that Jarvik will not appear in any future Lipitor ads.

As many of you may know, drug companies FDA is not required to review direct-to-consumer ads before they are aired to the American public. While some companies request FDA review of their promotional materials before they are used in advertising campaigns, the vast majority of companies do not. Unfortunately, because of this regulatory loophole, direct-to-consumer advertising has turned into something of a cat and mouse game–there are only consequences and penalties if you get caught misrepresenting or not fully disclosing information about your products.

In my opinion, Pfizer’s misrepresentation of Jarvik’s credentials (and Jarvik’s complicity) is unethical and unconscionable. More importantly, it demonstrates how easily and willing companies are to “bend the truth” to preserve blockbuster drug franchises that generate billions of dollars in annual revenues. I think that what Pfizer did was wrong and shameful. The company should be fined and sanctioned for the Lipitor campaign. That said, it is likely that the size of the fine levied by FDA will pale in comparison to Lipitor revenues generated by the Jarvik campaign. I believe that it is time for Congress and FDA close the loopholes in current direct-to-consumer advertising regulations–the safety and health of the American public depends on it!

Until next time….

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

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Unraveling the Cholesterol Conundrum

By now, I am sure that everyone is sick of hearing about Zetia, Vytorin, cholesterol levels and heart disease. Whether you like it or not, results from the now infamous Enhance study have certainly caused many scientists and physicians to rethink the relationship between cholesterol levels and heart disease and stroke. Conventional wisdom (and current medical dogma) holds that low LDL cholesterol levels reduce the risk and incidence of heart disease and stroke. This belief is now so widespread and entrenched in that the medical community that FDA now approves drugs to prevent heart disease, as it did with Zetia and Vytorin, solely on the evidence that they lower LDL cholesterol levels. Unfortunately, Enhance study results indicate that lowering LDL cholesterol levels alone are not sufficient to reduce the incidence of heart disease or stroke. 

Zetia, one of the active ingredients of Vytorin, lowers blood LDL cholesterol levels by reducing absorption of cholesterol in the gut (from foods that we eat). In contrast, the other ingredient in Vytorin, Zocor, is a statin that acts to lower LDL cholesterol by interfering with its production in the body. The results of the Enhance study, which showed that Vytorin doesn’t reduce the risk of heart disease or stroke any better than Zocor itself, suggest that the only way to prevent heart disease and stroke (by lowering LDL cholesterol) is through statin use. This assertion is supported by results from clinical trials involving Lipitor and Zocor (both statins), which showed that lowering LDL cholesterol also resulted in a lower incidence of heart disease and stroke. This suggests that statins may act to reduce heart disease and stroke by mechanisms other than their LDL cholesterol-lowering properties. Indeed, statins have also been found to reduce inflammation, keep artery walls flexible and healthy and help to maintain LDL and HDL cholesterol balance in the blood.

There were hints along the way which suggested that the relationship between LDL cholesterol and heart disease and stroke were not as straightforward as it seemed. For example, torcetrapib, a Pfizer drug that lowers LDL and raises HDL cholesterol, was being evaluated in clinical studies that were subsequently halted because it increased the risks of heart attack and stroke rather than prevent them. Another example is estrogen replacement therapy which is known to lower LDL cholesterol levels but failed to reduce the incidence of heart attack and stroke in clinical studies. Nevertheless, it did not take much to convince FDA that lowering LDL cholesterol levels alone was sufficient to prevent or reduce the incidence heart disease a stroke. This notion was strongly substantiated by results from clinical studies with Lipitor and Zocor which showed a strong relationship between lowering LDL cholesterol and reducing the risk and incidence of heart disease and stroke. Unfortunately, it now appears likely that the ability of statin drugs to reduce the incidence of heart disease and stroke is related to other mechanisms besides lowering LDL cholesterol. For an excellent historical review and recap of the cholesterol story, I suggest reading an article is this Sunday’s NY Times by Gary Taubes.

So what are the lessons learned from this story? First, I think that it is unwise to make assumptions about cause and effect relationships until all of the data is carefully analyzed and vetted. Second, it is our obligation as scientists, whether we are company employees or not, to point out inconsistencies or problems with prevailing theories regardless of personal or professional consequences. Finally, and perhaps most importantly, FDA must not allow drug companies to influence or affect the type or amount of data that it requires to approve new drugs.

Until next time…

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

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Merck and Schering Plough have taken out two-page ads in several major newspapers defending their cholesterol drugs Zetia and Vytorin whose efficacy has been seriously questioned following release of data from a clinical study called ENHANCE late last week. The new ad campaign takes direct aim at the fallout from ENHANCE which showed that neither Zetia nor Vytorin (Zetia plus Zocor) is more effective in preventing heart attack or stroke than a cheaper generic version of Zocor alone.

The ad offsets the most important line in boldface: "All of us at Merck and Schering-Plough proudly stand behind the established efficacy and safety profiles of ZETIA and VYTORIN." And then it's "signed" by Robert J. Spiegel MD, Chief Medical Officer of Schering and Merck’s VP of External Medical and Scientific Affairs, Richard Murray MD. However, this advertising blitz may be too little, too late. Consumer and physician confidence in Merck and Schering Plough have fallen precipitously after the ENHANCE data were released last week.

According to various sources, the companies reportedly spent more than $100 million on a highly visible, slick marketing campaign to promote Vytorin and Zetia last year. Who doesn’t recognize the ubiquitous commercials with the folksy violin music and the "colorful" relatives dressed to look like food to accentuate the point that cholesterol levels are related to family history (genetics) and the foods that one consume. They have taken a new tact with today’s ads which showcase a matter-of-fact advertising approach. We'll see if it the new, less flamboyant advertising campaign can staunch the hemorrhaging that it taking place today at both companies.

Until next time…

Good Luck and Good Job Hunting!!!!!

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