Resources and current information regarding novel (“swine”) Influenza, type “A”, (H1N1).

Since the emergence from Mexico this past spring of a novel strain of type A influenza (“H1N1”), there has been justifiable concern over how serious it is compared to usual (fall, winter ) Influenza, its drug responsiveness, and of most current concern, the status of a vaccine. As a general pattern, the older population has proportionately been relatively spared compared with younger and middle aged people. Similar to other strains, pregnancy confers an additional risk. There is some evidence that the older population may have some cross reactivity perhaps conferred by previous vaccinations. This new strain has so far proved susceptible to the drugs TAMIFLU (oral) and the Inhaled drug, RELENZA.
Experience worldwide suggests that this strain is NOT more deadly than customary seasonal influenza.

Useful resources include the following: http://www.cdc.gov/flu , and http://www.nyc.gov/html/doh/html/cd/cd-h1n1flu.shtml. These sites suggest the following: a vaccine, in somewhat smaller doses than desired, is expected to be ready in late October; also that we can expect a rise in Influenza activity this fall and anticipate that this newer and novel, H1N1 strain will be a dominant strain.

Distribution of the particular H1N1 vaccine will be via the NYC Department of Health. The Concorde group has already entered into the registration process with the NYC Department of Health. The CDC website has much useful and practical information about self protection, as well as advice and guidelines for parents and school administrators.

Regular trivalent Influenza vaccine has already begun to be shipped and initial shipments have already arrived at Concorde offices. Please call our office to make an appointment for your customary fall vaccination.

While the priorities of populations most at risk continues to be analyzed, current thinking suggests that toddlers, school age children, school workers, healthcare workers, caretakers of the sick and elderly, and then the older population, will be the primary targets.


Arthur Lebowitz, MD

UPDATE ON SWINE FLU

April 28, 2009
The Health news this week is dominated by reports of recently identified cases of Swine flu, with a cluster of more than 20 in a school in Queens. In addition there have been more than 1800 cases in Mexico with some fatalities occurring in otherwise young and healthy patients. This has echoes of the most heavily affected segment of the population during the Influenza world-wide pandemic of 1918-1919.

Swine flu is a type A influenza that is endemic in swine. It is distinctly unusual for it to enter the human population. (Some of you may remember that there was a swine flu breakout during the Ford administration.) It is not yet clear if our experience will be an illness of low severity as so far has been reported in the United States or of higher severity as seems to be happening in Mexico.

The vaccine that we administered this past fall and winter did NOT contain any component of this swine flu.

In major contrast to the past epidemics, this strain is susceptible to TAMIFLU, a medication that is widely available, as well as the inhaled influenza drug, RELENZA.

We are not at a point where population based prophylaxis with either of these drugs is recommended.

However that may change anytime. I strongly recommend that you consider accessing the CDC’s daily updated website, http://www.cdc.gov/swineflu/ for further detailed information on what symptoms to look for as well as tips on avoiding this illness. These measures focus on such behaviors as crowd avoidance, avoiding social kissing, and frequent hand washing. It is not unreasonable at this point to have a supply of face masks on hand in anticipation of a substantial increase in Flu activity.

New Information About VYTORIN and ZETIA From the FDA

Dear Patients and friends,

As an important follow up to our previous discussion about Vytorin and Zetia, I am pleased to post the FDA’s very recent statement regarding Vytorin.

January 9, 2009 (Rockville, Maryland) — The Food and Drug Administration issued a statement reaffirming its position that lower remains better when it comes to LDL-cholesterol levels and that patients should not stop taking their cholesterol-lowering medications, including Vytorin (ezetimibe/simvastatin, Merck/Schering-Plough)

The statement follows a year-long review of the highly publicized "Effect of Combination Ezetimibe and High-Dose Simvastatin vs Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial".

"The results from ENHANCE do not change the FDA's position that an elevated LDL cholesterol is a risk factor for cardiovascular disease and that lowering LDL cholesterol reduces the risk for cardiovascular disease.Based on current available data, patients should not stop taking Vytorin or other cholesterol-lowering medications and should talk to their doctor if they have any questions about Vytorin, Zetia, or the ENHANCE trial" the FDA concludes.

With the controversy surrounding ezetimibe in the past 18 months, the cardiology and primary care community look forward to the results of IMPROVE-IT, a large clinical-outcomes study chaired by Dr Eugene Braunwald, a noted and widely respected senior cardiologist-researcher. The study will compare simvastatin 40 mg plus ezetimibe 10 mg with simvastatin 40 mg alone in 18 000 patients with a recent acute coronary syndrome. Those results will be available in 2012.

the FDA concludes, "Pending the results from IMPROVE-IT, patients should not stop taking Vytorin or other cholesterol-lowering medications and should talk to their doctor if they have any questions about these medications."

Vitamin B12

Vitamin B12

As promised, the following entry examines the contribution of another key nutritional element to human health – vitamin B12.

What is vitamin B12?

Vitamin B12, also known as cobalamin, is a necessary co-factor in a variety of metabolic processes. It supports the synthesis of red and white blood cells, as well as the production and maintenance of healthy nerve cell membranes.

Cobalamin cannot be synthesized by the human organism; it must be ingested. Fortunately, this vitamin is ubiquitous in foods derived from animals.

Unlike other B vitamins, for which the body generally has only a few weeks to months of inventory, humans are capable of storing substantial quantities of vitamin B12, primarily in the liver. Younger adults have anywhere from a 2 to 3 year supply in reserve. .

B12 is the only vitamin that has a heavy metal ion – cobalt – in its structure. A more detailed discussion of vitamin B12 and its common dietary sources can be found at the NIH's office of dietary suplements, http://ods.od.nih.gov/index.aspx . Then type in "vitamin B12" in the search box.

What diseases and symptoms are related to a deficiency of vitamin B12?

This essential vitamin was first identified in the early part of the 20th century as the result of an intensive investigation of the pernicious anemia and its causes. As tests became available to measure this compound, additional disorders were found to be associated with a deficit of B12, including constipation, fatigue and depression. A persistent deficiency can cause a variety of subtle neurologic symptoms, including tingling sensations, balance issues and even a decrease in cognitive capacity.

How is vitamin B12 absorbed by the body?

Several steps are necessary before the body can make use of vitamin B12 once it is ingested in a meal. In a healthy person, stomach acid releases B12 from the proteins to which it is bound. It then combines with a substance produced by the stomach called “intrinsic factor” , and is absorbed in the final section of the small intestine, called the ileum. It is noteworthy that only 6 micrograms of vitamin B12 is required on a daily basis.

Who is at risk of becoming deficient?

As might be inferred from the description of the absorption process, patients with a diseased or absent distal portion of the small intestine (for example, in the case of Crohn’s disease) are particularly susceptible to vitamin B12 deficiency. Also at higher risk are strict vegetarians, as well as persons with a form of chronic gastritis, which causes inflammation and atrophy of the stomach glands. Others who may be at higher risk are those people who have had stomach surgeries, including the growing number of patients who have undergone gastric banding for the management of morbid obesity.

How are deficiencies treated?

In the past, patients with pernicious anemia in particular were treated with monthly injections. Now, with the availability of high dose oral B12, most patients can be managed with a daily supplement, ranging from 500 to 1000 micrograms. Dosages of this magnitude are required because the body can only absorb about 1% of this form of the vitamin.


At MPHA, we routinely check vitamin B12 levels as part of your annual physical, and more often if you have already had supplements prescribed. As always, if you are concerned that you may have a deficiency, please do not hesitate to consult with your physician.

Call When Sick

Right before Christmas, I heard from a patient who had fainted the night before, while sick with a stomach flu. She wasn’t going to “bother me” with a call until she was finally urged to do so by a family member. I can only wonder what she believed was the threshold of illness required before picking up the phone!

Thus, I would like to take this opportunity to emphasize a core purpose of the MPHA health care model. It is to create a limited membership, which ensures that I have the time to fully attend to each individual patient. Moreover, your call provides me with much needed information about illnesses that are occurring throughout the community.

While I am hoping that I don’t receive an avalanche of calls about hang-nails, simple colds, and headaches, I do want to encourage all members to contact me when you are ill, so that I can advise you and stay abreast of your health.

NEW VITAMIN RESEARCH HIGHLIGHTS STRONG LINK BETWEEN VITAMINS AND HEALTH

Importance of Vitamin D

For the majority of today’s Americans, the major health threats of just a few decades ago are outside of our experience. Words that struck fear into people the world over – polio, smallpox, tuberculosis, mastoid and bone infections – have largely passed from the lexicon of the average American. Likewise, childhood illnesses caused by nutritional deficiencies, such as rickets, pellagra, and scurvy, have been eliminated in the U.S. with prevalence of vitamin and mineral “fortified” foods, particularly milk. Despite this progress, the danger of vitamin deficiencies remains for adult men and women.

New research has linked vitamin D deficiencies with illnesses ranging from Parkinson’s to inflammatory bowel disease. Vitamin D has long been recognized as essential to bone health and the prevention of osteoporosis due to its crucial role in promoting the absorption of calcium from the intestines. But more recently, studies have clarified its function as an immune system optimizer and proven its ability to reduce the growth and spread of certain cancers. This work has demonstrated that an inverse relationship exists between cancer risk and vitamin D levels, with a lower incidence of colon, prostate, lymphoma, and breast cancers when vitamin D levels are highest. Moreover, the incidence of metastases for patients with these diagnoses was lower when vitamin D levels were raised.

Increased focus on the prevalence of vitamin D deficiency reveals that a substantial proportion of the adult population has suboptimal levels of this crucial dietary element. Because the health effects of vitamin D are only obtained after it is converted to its active form as a result of sunlight exposure, certain segments of our population are even more prone to deficiencies. These include people who get very little sun, often the elderly, and especially darkly pigmented individuals, since melanin blocks sunlight absorption.

How much sun exposure is necessary depends on a variety of factors, including geographic location, amount of skin pigmentation, use of sunblock and age. Conversion of vitamin D to its active form requires about 25% of the amount of sun exposure that would otherwise cause a burn. However, a safer and more reliable way to achieve optimal levels is to first measure the amount of one’s active form of vitamin D with a blood test. If levels are low, we typically recommend supplementation in one of several ways. Available over the counter are Calcium citrate or carbonate, combined with 400 units of vitamin D3 (the active form) once or twice a day, taken with food. Another option is pure vitamin D3, now available in several strengths. I recommend the 1000 unit dosage as safest, taken ONCE a day. Lastly, I may issue a prescription for higher dose vitamin D, depending on other coexistent conditions.

If, after reading all this, you are now concerned about your risk of vitamin D deficiency, please be reassured: As an MPHA member your vitamin D levels are analyzed at least yearly as part of your comprehensive health evaluation, and addressed as necessary. Should you have any reason to believe that your level has changed since your last physical, please do not hesitate to contact the office.

Future topic: Vitamin B12.

Zetia - Getting Past the Hype and Alarmism

With the past several months of media buzz – both positive and negative - regarding Zetia (the trade name for the drug ezetimibe), I think it is time to lay out the facts about this medication and the recent studies that led to this increased attention, as well as our current options for treating high cholesterol.

As background, Zetia works by interfering with cholesterol’s absorption through the wall of the small intestine. When taken alone or in addition to a statin, it reliably further lowers LDL cholesterol (commonly referred to as “bad” cholesterol) by about 20%.

The Question of Efficacy
Beginning with a front page article in the New York Times in January 2008, questions began surfacing about the efficacy of Zetia. The study that raised these questions, called “ENHANCE”, was eventually published in May of this year. ENHANCE was conducted in Europe and focused on a small group of patients with a rare type of very elevated cholesterol (total cholesterol more than 400 and LDL cholesterol averaging 300). One subset of patients was treated with a high dose of Zocor (simvastatin-80mg), while the others received the same dosage of Zocor combined with Zetia (as the drug Vytorin). After 18 months, all of the study participants had the lining membrane in their carotid arteries re-measured – and no difference was seen. While the New York Times and a prominent cardiologist immediately questioned whether this medication should ever be prescribed, cooler and more thoughtful experts pointed out the many weaknesses in this rush to judgment.

These experts noted several deficiencies in the ENHANCE study. A foremost objection was the absence of information regarding the treatments that study participants had previously received. With their very elevated cholesterol levels, it is reasonable to expect that the patients had previously been receiving treatment with a variety of medications – and that treatment may have influenced the results of the study. Moreover, the LDL cholesterol levels achieved by the end of the study, averaging 180 in the Zocor group and 150 in the Vytorin group, are insufficient to halt the progression of arterial atherosclerosis, as documented in other generally accepted studies conducted over the last three years.

It is important to clarify that the U.S. Food and Drug Administration only requires pharmaceutical companies to show that a medication is safe and works as claimed – in this case, that the drug lowers cholesterol. Proof is not required that such reduction actually saves lives over the long term. This is because more than 20 previous studies consistently demonstrated that lowering cholesterol, by whatever means, translates into a 40%- 80% reduction in heart attacks and new angina over the research period - usually three - five years.

Studies with large numbers of patients are now ongoing which seek to demonstrate whether additional lives are saved due to Zetia’s capacity to further lower cholesterol.

Zetia and Cancer
Articles appeared in the New York Times of September 2nd and in the prestigious New England Journal of Medicine of September 4th about a small study called“SEAS” that assesses whether Vytorin could slow the progression of aortic valve narrowing. No differences were demonstrated between the treated and control group regarding progression of aortic valve narrowing. It is also important to note that this study did not in any way seek to address atherosclerotic artery disease progression or Vytorin’s efficacy in that regard. Unexpectedly, in the short 18 month period of the SEAS study, there were a higher number of new cancers diagnosed in the treatment group than in the placebo group. The investigators noted that this could be due to chance. Because of the potential seriousness of this issue, attention has turned to the two ongoing and much larger studies of Vytorin and Zetia that are currently in progress. It is important to note that no excess incidence of cancer was found in either of these two studies.

What is a patient’s best option? The most prudent approach at this time is to try to achieve widely accepted LDL targets without using Zetia. However, as often is the case with patients judged to have atherosclerotic disease or increased cardiovascular risk, using Zetia as an add-on to a statin class drug is the only way to achieve those goals. Currently, the questions raised about cancer risk are too inconclusive and the purported numbers far too small to consider stopping Zetia and placing oneself at known higher risk for a cardiovascular event.