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Medicine

Kara Hahn’s prescription medicine take-back proposal aims to enhance Long Island’s drinking water quality

Suffolk Legislator Kara Hahn (D-Setauket) and Suffolk BOE Republican Commissioner Nick LaLota disagreed over the locations of Suffolk’s early voting places. File photo

A two-tiered piece of legislation on the county level is looking to tackle some of Long Island’s most pressing issues, from the medicine counter to the waterways, all in one fell swoop.

A proposal to establish a drug stewardship program throughout the county could potentially build upon existing drug take-back programs, playing off recent legislation enacted in Alameda County, California, and ultimately keep drugs out of our drinking water, lawmakers said. Suffolk County Legislator Kara Hahn (D-Setauket) introduced the piece of legislation earlier this summer with hopes of providing residents with more convenient ways to get rid of their unused medicine before the county’s next general meeting in October.

Suffolk County Legislator Kara Hahn is pushing a bill to make it easier to get rid of leftover medicine. File photo
Suffolk County Legislator Kara Hahn is pushing a bill to make it easier to get rid of leftover medicine. File photo

“This is a duel benefit,” Hahn said. “I’ve wanted to find a way to get pharmacies to be required to take back prescription drugs, and this doesn’t quite require that, but it could be an end result.”

The local law proposal argued that while pharmaceuticals are essential to the treatment of illnesses and long-term conditions, residents at large still do not dispose of them properly, running the risk of certain drugs ending up in public drinking water supplies and causing harm to the environment. And with Suffolk County sitting on top of a sole source aquifer, which provides residents with necessary drinking water, Hahn argued that protecting the aquifer was critical to the health and safety of Long Island as a whole.

“The idea is to begin a discussion on this. Federal regulations have changed to allow pharmacies to take back certain drugs, but the state level has been dragging their feet on the local regulations in order to make this possible here,” Hahn said. “They can’t drag their feet any longer. All kinds of medicines are being found in our water when our health inspectors do their sampling. We have to find a way on both these fronts to control what is happening.”

The legislator said she was playing off the recently passed law in California, which also established a drug product stewardship policy requiring manufacturers to design and fund collection programs for medications. Similar programs have also sprouted up in Canada, France, Spain and Portugal.

A spokesman for Hahn said the bill would essentially establish a manufacturer-administered pharmaceutical take-back program that would provide residents with convenient ways to safely and environmentally responsibly dispose of expired and unneeded medications.

“This program, if adopted, will primarily impact and improve water quality rather than deal with drug abuse,” Seth Squicciarino, the spokesman, said. “However, it is reasonable to assume that if there are less unused, unneeded and forgotten prescription drugs in medicine cabinets, it could reduce drug experimentation especially among first time users.”

Currently, residents’ only course of action when looking to properly dispose of unused medicine is to bring their prescriptions to the 4th Precinct or 6th Precinct of the Suffolk County Police Department, which then dumps the drugs into an incinerator — which Hahn described as the most environmentally friendly way to dispose of drugs right now.

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High cholesterol is a problem that affects a countless number of people in the United States. One of the challenges is that it has no noticeable symptoms but may result in an increased risk of cardiovascular disease, including heart attacks and strokes. So what do we do about it?

Currently, the standard medical treatments for high cholesterol are statins. Statins include rosuvastatin (Crestor), atorvastatin (Lipitor), simvastatin (Zocor) and pravastatin (Pravachol). But now a new drug has been approved by the FDA, and it is the first drug in a new class, proprotein convertase subtilisin/kexin type 9 inhibitors or, more affectionately and easier to say, PCSK9 inhibitors.

The first medication approved in this class was Praluent (alirocumab) on Friday, July 24, 2015 (1). PCSK9 inhibitors are monoclonal antibodies that turn off specific proteins in the liver, reducing the levels of LDL, the “bad” cholesterol (2). Right behind, Repatha (evolocumab), another PCSK9 inhibitor, was just recommended by the FDA advisory board. Usually the FDA follows advisory board recommendations.

Therefore, we will likely have two drugs from this class approved and on the market.

Will PCSK9 inhibitors take the place of statins?
Hardly, at this point. The FDA has taken a conservative and narrow approach when it comes to indications for alirocumab (1). Patients who have either heterozygous familial hypercholesterolemia (FH), a genetic disease that affects about 1 in 500 Americans, or those who have atherosclerotic cardiovascular disease (ASCVD), meaning they have had heart attacks, strokes or chest pain due to plaque buildup in the arteries, are presently candidates for treatment. And then, only if both lifestyle modifications and the highest tolerated dose of statins are not sufficient to produce the desired effects. Then, PCSK9 inhibitors may be added to lower LDL further. Patients who are intolerant of statins and who do not have cardiovascular disease are not currently candidates. This may change, but not at the moment.

Class effectiveness of alirocumab and PCSK9
These drugs have been shown to significantly reduce the LDL levels. In five randomized controlled trials, the gold standard of studies, alirocumab was shown to reduce LDL levels by between 36 and 59 percent over placebo (3).

Ironically, though it lowers the LDL considerably, 10-year risk assessment calculator for cardiovascular disease based on the Framingham Heart Study does not include LDL as a consideration (4).

Caveats for this new drug class
There are two significant limitations. One is the outcomes data, and one is the cost. Oh yeah, and I forgot to mention that you need to inject the drug every two weeks.

While this class has shown impressive results in reducing LDL levels, especially compared to statins, it is still in trials to determine whether the reduction in bad cholesterol actually translates into a reduction in cardiovascular events. Trials are not expected to be finished until 2018 (5). This may be one reason for the FDA’s limited treatment population.

Already, drug costs seem to be soaring. Just when we thought they were getting better for statins, since most of them now are generic, here comes a new class of cholesterol-lowering drugs with an even higher price tag. The annual cost for treatment is expected to be around $14,600 (3). This does not help. According to Sanofi and Regeneron Pharmaceuticals, the companies involved, this is a low price for the type of drug, monoclonal antibodies, and the savings from preventing cardiovascular events will be worth the price.

Ironically, the drugs have yet to demonstrate this outcome.

The side effect profile
Unfortunately, with just about every medication there is the dreaded side effect profile. Presently, it seems that alirocumab has a mild side effect profile. These include itchiness, bruising, swelling and pain in the site of injection, flu symptoms and nasopharyngitis (inflammation of the mucous membranes of the nasal passages and pharynx) (3). There were also some allergic reactions that involved hospitalization. As a class, monoclonal antibodies are known to potentially precipitate significant infection. We will have to wait and see whether or not this is the case with PCSK9 inhibitors. Remember, it took a number of years before we knew some of statins’ adverse reactions and the extent of their side effects.

The role of statins
With the recent ACC/AHA guidelines for statin use, published in 2013, these drugs continue to be prescribed for a broader audience of patients. They recommend that those who have LDL levels between 70 and 189 mg/dL and at least a 7.5 percent risk of a cardiovascular event over 10 years are candidates for statins for primary prevention, and this is cost-effective (6). That does not mean these patients necessarily need to have elevated total cholesterol nor elevated bad cholesterol.

In an even broader recommendation, a recent study suggested that people between the ages of 75 and 94 could be on a generic statin for primary prevention of a heart attack or death as a result of coronary heart disease (7). These results were based on using two studies and then forecasting from those results. The authors suggested that this may be both clinically and financially effective. However, they did acknowledge that this would exclude those with adverse reactions to statins.

Have we gone too far with this recommendation? According to an editorial in the same journal, harm from modest side effects would most likely limit the use of these drugs in this population (8).

Impending triglycerides
In two trials, results show that patients who have acute coronary syndrome (ACS) and who are treated with statins have a 50 to 61 percent increased risk of a cardiovascular event in the short term and long term if their triglyceride levels are mildly elevated, either greater than 175 or 195 mg/dL depending on which of the two studies is considered (9). ACS is defined as reduced blood flow to the heart resulting in unstable angina (chest pain), heart attack or cardiac arrest. In one of the two trials, the long-term effects of high triglycerides >175 mg/dL were compared to triglycerides <80 mg/dL. Almost all of the patients were on statins and had LDL levels that were near optimal (<70 mg/dL) with a mean of 73 mg/dL. By the way, “normal” triglycerides, according to most labs, are <150 mg/dL.

Move over bones — vitamin D for healthy cholesterol
In a non-drug-related study, it turns out that high vitamin D levels in children are associated with lower total cholesterol levels, non-HDL “bad” cholesterol levels and triglyceride levels overall (10). The authors note that higher non-HDL levels in children may result in a greater risk of cardiovascular disease in later life.

Though it is exciting to have more options in the arsenal for medical treatment, the moral of the story is that those who do not fit the FDA’s criteria for usage should most likely watch and wait to see how longer term side effects and outcomes play out. Statins are beneficial, as we know, but we may be overreaching in terms of the patient population for treatment. In my clinical experience, lifestyle changes including diet and exercise are important for reducing triglycerides to normal levels. And finally, it is never too early to start mild prevention for cardiovascular disease, such as by managing vitamin D levels.

References:
(1) FDA.gov. (2) health.harvard.edu. (3) medpagetoday.com. (4) cvdrisk.nhlbi.nih.gov. (5) J Am Coll Cardiol. 2015:23;65(24):2638-2651. (6) JAMA 2015; 314:134-141. (7) Ann Intern Med 2015; 162:533-541. (8) Ann Intern Med 2015; 162:590-591. (9) J Am Coll Cardiol 2015; 65:2267-2275. (10) PLoS One. 2015 Jul 15;10(7):e0131938.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com or consult your personal physician.

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File photo

Stony Brook Medicine announced on Friday that the Eastern Long Island Hospital board of directors has voted unanimously to approve an affiliation with Stony Brook University Hospital, subject to the successful completion of the definitive agreement and all regulatory and other approvals.

The decision was ruled an important first step toward advancing Stony Brook’s collaboration to ensure North Fork residents have greater access to high-quality care, according to Kenneth Kaushansky, senior vice president for Health Sciences and dean of the Stony Brook University School of Medicine.

“We are grateful to SUNY’s visionary leadership in its support of our continued work to establish agreements with community hospitals in Suffolk County for the care of Long Island residents,” said Reuven Pasternak, chief executive officer for Stony Brook University Hospital and vice president for health systems at Stony Brook Medicine.

Thomas E. Murray Jr., chairman of the Eastern Long Island Hospital board of trustees said his group had been deliberating over the past several months on finding a strategic partner. He said Stony Brook best fulfilled the board’s mission to best address what he called the evolving health needs of his eastern community.

State Sen. Ken LaValle (R-Port Jefferson) said he could not be more pleased with the news, given his experience working to move the hospital forward.

“Throughout my tenure, I have worked hard to make certain that quality, affordable medical services are accessible to residents throughout my district,” he said. “This unanimous decision ensures that people on the North Fork and Shelter Island will continue to receive expert medical care close to home.”

Stony Brook and Eastern Long Island will immediately initiate a collaborative planning effort to develop a long-term strategic plan to ensure current and future health care needs are addressed.

“While the delivery of health care and especially hospital care is rapidly changing, becoming a part of Stony Brook University Hospital will allow Eastern Long Island Hospital to make this complex transition while continuing to carry out our long-time promise to the community. The hospital has been here for 110 years and this affiliation will ensure that the health care needs of the community are met for years to come,” said Paul J. Connor, III, president and CEO of Eastern Long Island Hospital.

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Focusing on clinical and population improvements for our communities

By Joseph Lamantia

Whether or not you’ve already heard of the Delivery System Reform Incentive Payment Program, one thing is for certain: it’s about to change health care in our state.

In April 2014, New York State Governor Andrew M. Cuomo announced that New York had finalized terms with the federal government for a groundbreaking waiver enabling the state to reinvest $6.2 billion in federal savings generated by Medicaid Redesign Team reforms. Known as DSRIP, the program promotes community-level collaborations, with a focus on improving health care for patients covered by Medicaid and those who are uninsured.

The main goal of the program is to reduce avoidable emergency room visits and avoidable hospital admissions among Medicaid and uninsured populations by 25 percent over a five-year period. The plan is to accomplish this through enhanced collaboration among providers, improved electronic and direct communications, and ready access to primary care and behavioral health services.

For example, offering after-hours appointments can help patients who work full-time; translation services can assist those for whom English is a second language; and transportation to appointments can help patients who don’t have access to a vehicle or public transportation.

The DSRIP initiative for Suffolk County and its network of providers is called the Suffolk Care Collaborative.

The Office of Population Health at Stony Brook Medicine is administering the SCC and is responsible for coordinating more than 500 countywide organizations, including hospitals, skilled nursing facilities, long-term home health care providers, behavioral health professionals, community-based organizations, certified home health agencies, physician practices and many other integral health care delivery system partners.

Some of the 11 focus areas of the SCC are diabetes care, pediatric asthma home-based self-management, cardiovascular care, behavioral health access and substance abuse prevention programs. Central to all programs is a coordination-of-care effort using care mangers embedded in the community to support health care providers and patients to achieve individual health goals. Connecting with patients at the point of care, identifying needs and providing appropriate support in the community will help prevent unnecessary emergency room visits and hospitalizations, and support a healthier population.

Suffolk County has approximately 150,000 uninsured residents and 240,000 Medicaid enrollees who can benefit from the program’s initiatives. And, because improvements made will affect the overall health care delivery system, they have the potential to benefit everyone — enhancing the patient experience and outcomes. When providers collaborate on patient care, information can be shared, test duplication can be avoided and preventive measures can be put in place to help all patients stay healthier.

Visit www.suffolkcare.org to learn more about the Suffolk Care Collaborative.

Joseph Lamantia is the chief of operations for population health at Stony Brook Medicine.

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It is very interesting that the amount of coverage by the lay press concerning thyroid nodules does not reflect the number of people who actually have them. In other words, more than 50 percent of people have thyroid nodules detectable by high resolution ultrasound (1); however, when I searched the New York Times website, the last time it wrote about them was in 2010.

Regardless, you can understand how coverage should be more in the forefront. Fortunately, most nodules are benign. A small percent, 4 to 6.5 percent, are malignant, and the number varies depending on the study (2). Thyroid nodules are being diagnosed more often incidentally on radiologic exams, such as CT scans of the chest, MRI scans, PET scans and ultrasounds of the carotid arteries in the neck (3).

There is a conundrum of what to do with a thyroid nodule, especially when it is found incidentally. It depends on the size. If it is over one centimeter, usually it is biopsied by fine needle aspiration (FNA) (4). This is the cutoff point for asymptomatic nodules found with a radiologic exam. Most are asymptomatic. However, if there are symptoms, these might include difficulty swallowing, difficulty breathing, hoarseness, pain in the lower portion of the neck and a goiter (5).

FNA biopsy is becoming more common. In a recent study evaluating several databases, there was a greater than 100 percent increase in thyroid FNAs performed over a five-year period from 2006 to 2011 (6). This resulted in a 31 percent increase in thyroidectomies, surgeries to remove the thyroid partially or completely.

However, the number of thyroid cancers diagnosed with the surgery did not rise in this same period. To make matters even more confusing, from 2001 to 2013, the number of thyroid cancers increased by 200 percent.

The study authors call for a need for more detailed guidelines, which are lacking for thyroid nodules.

Though the number of cancers diagnosed has increased, the mortality rate has remained relatively stable over several decades at about 1,500 patients per year (7). Thyroid nodules in this study were least likely to be cancerous when the initial diagnosis was by incidental radiologic exam.

DIFFERENTIATING WHEN FINE NEEDLE ASPIRATION RESULTS ARE INDETERMINATE
As much as 25 percent of FNA biopsies are indeterminate. We are going to look at two modalities to differentiate between benign and malignant thyroid nodules when FNA results are equivocal: a PET scan and a molecular genetics test. A meta-analysis (a group of six studies) of PET scan results showed that it was least effective in resolving an unclear FNA biopsy. The PET scan was able to rule out patients who did not have malignancies significantly but did not do a good job of identifying those who did have cancer (8).

On the other hand, a recent molecular-based test was able to potentially determine whether an indeterminate thyroid nodule by FNA was malignant or benign (9). This test was a combination of microRNA gene expression classifier with the genetic mutation panel. I know the test combination sounds confusing, but the important takeaway is that it was more effective than previous molecular tests in clarifying whether a patient had a benign or cancerous nodule.

Unlike in the PET scan study above, the researchers were able to not only rule out the majority of malignancies but also to rule them in. It was not perfect, but the percent of negative predictive value (ruled out) was 94 percent, and the positive predictive value (ruled in) was 74 percent. The combination test improved the predictive results of previous molecular tests by 65 to 69 percent. This is important to help decide whether or not the patient needs surgery to remove at least part of the thyroid. The trial used hospital-based patients, but follow-up studies need to include community-based practices.

IS A NEGATIVE FINE NEEDLE ASPIRATION DEFINITIVE?
We know that FNA is the gold standard for determining whether patients have malignant or benign thyroid nodules. However, a negative result on FNA is not always definitive for a benign thyroid nodule. When this occurs, it is referred to as a false negative result. In a recent retrospective (looking back at events) study, from the Longitudinal Health Insurance Database in Taiwan, 62 percent of thyroid nodules that were cancerous were diagnosed with one biopsy and 82 percent were found within the year after that biopsy (10). However, about 17 percent of patients needed more than two FNA biopsies, and 19 percent were diagnosed after one year with cancerous thyroid nodules.

THE POTENTIAL SIGNIFICANCE OF CALCIFICATION ON ULTRASOUND
Microcalcifications in the nodule can be detected on ultrasound. The significance of this may be that patients with microcalcifications are more likely to have malignant thyroid nodules than those without them, according to a small prospective study involving 170 patients (11). This does not mean necessarily that a patient has malignancy with calcifications, but there is a higher risk. The results demonstrated that more than half of the malignant thyroid nodules, 61 percent, had microcalcifications.

THE GOOD NEWS
As I mentioned above, most thyroid nodules are benign. The results of a recent study go even further, showing that most asymptomatic benign nodules do not progress in size significantly after five years (12).

This was a prospective (forward-looking) study involving 992 patients with between one and four benign thyroid nodules diagnosed cytologically (by looking at the cells) or by ultrasound. The factors that did contribute to growth of about 11 percent of the nodules were age (<45 years old had more growth than >60 years old), multiple nodules, greater nodule volume at baseline and being male.

The authors’ suggestion is that the current paradigm might be altered and that after the follow-up scan, the next ultrasound scan might be five years later instead of three years. However, they did discover thyroid cancer in 0.3 percent after five years.

In considering risk factors, it’s important to note that those who had a normal thyroid stimulating hormone (TSH) were less likely to have a malignant thyroid nodule than those who had a high TSH, implying hypothyroidism. There was an almost 30 percent prevalence of cancer in the nodule if the TSH was greater than >5.5 mU/L (13).

The bottom line is that there is an urgent need for new guidelines regarding thyroid nodules. Fortunately, most nodules are benign and asymptomatic, but the number of cancerous nodules found is growing. We are getting better at diagnosing nodules. Why the death rate remains the same year over year for decades may have to do with the slow rate at which most thyroid cancers progress, especially two of the most common forms, follicular and papillary.

REFERENCES:
(1) AACE 2013 Abstract 1048. (2) Thyroid. 2005;15(7):708. (3) uptodate.com. (4) AACE 2013 Abstract 1048. (5) thyroid.org. (6) AAES 2013 Annual Meeting. Abstract 36. (7) AACE 2013 Abstract 1048. (8) Cancer. 2011;117(20):4582-4594. (9) J Clin Endocrinol Metab. Online May 12, 2015. (10) PLoS One. 2015;10(5):e0127354. (11) Head Neck. 2008 Sep;30(9):1206-1210. (12) JAMA. 2015;313(9):926-935. (13) J Clin Endocrinol Metab. 2006;91(11):4295.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

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An exterior view of the Stony Brook University Cancer Center. Photo from SBU

By L. Reuven Pasternak, MD

Thanks to major advances in cancer prevention, early detection and treatment, many patients are enjoying longer lives and maintaining their quality of life, as the number of cancer survivors grows.

Anyone living with a history of cancer — from the moment of diagnosis through the remainder of life — is a cancer survivor, according to the National Cancer Survivors Day Foundation. In the United States alone, there are more than 14 million cancer survivors. That’s cause for celebration, and for the past 10 years, that’s exactly what we’ve been doing at Stony Brook University Cancer Center at our annual National Cancer Survivors Day event.

Stony Brook’s 11th annual celebration will take place on Sunday, June 14, from 11 a.m. to 3 p.m., at the Cancer Center, and will feature a talk about the Cancer Survivorship Movement by inspirational speaker Doug Ulman. A three-time cancer survivor and a globally recognized cancer advocate, Ulman, with his family, founded the Ulman Cancer Fund for Young Adults. The nonprofit organization is dedicated to supporting, educating and connecting young adults who are affected by cancer. Ulman is also known for his work at LIVESTRONG and now as president and CEO of Pelotonia.

All cancer survivors are invited, whether they were treated at Stony Brook or not. In addition to Ulman’s talk, attendees can enjoy a variety of outdoor activities, musical entertainment and light refreshments. They can also participate in the very moving Parade of Survivors. To register, visit www.cancer.stonybrookmedicine.edu/registration or call 631-444-4000.

Cancer Center staff members actively partake in the day’s events and look forward to reconnecting with patients. It’s gratifying for them to see the strides these survivors have made throughout the years to lead normal and productive lives after a cancer diagnosis.

National Cancer Survivors Day is just one of a number of ways Stony Brook reaches out to the community. The Cancer Center has created many initiatives and programs to help make life a little easier for patients with cancer, including support groups, cancer prevention screenings and the School Intervention and Re-Entry Program for pediatric patients.

As a leading provider of cancer services in Suffolk County, Stony Brook is constructing a state-of-the-art Medical and Research Translation (MART) building that will focus on cancer research and advanced imaging and serve as the home of our new Cancer Center. Located on the Stony Brook Medicine campus, this 245,000-square-foot facility will allow scientists and physicians to work side by side to research and discover new cancer treatments and technology.

The MART will double Stony Brook’s capacity for outpatient cancer services and enhance all cancer care for Long Island and beyond. And once it is completed in 2016, we’ll have one more reason to celebrate life after a cancer diagnosis.

L. Reuven Pasternak, MD, is the CEO of Stony Brook University Hospital and vice president for health systems, Stony Brook Medicine.

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By Susan Risoli

Acupuncture might be a health care system that works for you. It’s relaxing. It can give you more energy. Acupuncture treatments promote wellness and healing.

The World Health Organization has published a long list of conditions that acupuncture treats effectively. (“Acupuncture: Review and Analysis of Reports on Controlled Clinical Trials.”) The list includes various types of pain, including headache and back pain,  depression, stress and side effects of chemotherapy.

Because Chinese medicine embraces several components, your acupuncturist will offer more than just acupuncture. He or she may be a practitioner of herbal medicine. It’s likely that they will talk to you about healthy exercise, such as tai chi or qigong — and these are activities they probably have done themselves. He or she might give you nutritional guidance. He or she may also be trained in massage or Asian bodywork — Tui na and Amma are examples. For thousands of years, these ways of healing have helped people, so you may want to ask your acupuncturist how you can learn more about these modalities.

How do you find a licensed acupuncturist? Like you would any other professional: ask around among your friends. Chances are you already know someone who’s been treated with Chinese medicine. Your medical doctor, chiropractor or massage therapist also may know a good acupuncturist. Or you can check the practitioner listings on the websites of the Acupuncture Society of New York, www.asny.org), or the National Certification Commission for Acupuncture and Oriental Medicine, www.NCCAOM.org. Be aware that in New York state, licensed acupuncturists are independent practitioners, and you will not need a doctor’s referral to start acupuncture treatment. The websites mentioned give information about the training and credentials necessary to practice acupuncture. Your health insurance might or might not cover acupuncture treatments; you’ll need to discuss it with your practitioner.

Acupuncture itself involves insertion of very thin, flexible needles, at specific places on the body. The guiding principle of acupuncture is that the places where the needles are inserted — acupuncture points — help the body direct and adjust the energy that is flowing through your organ systems. This energy is called qi (pronounced “chee.”) Acupuncture supports your body and helps it work better so that underlying diseases and their symptoms can be treated effectively.

So what is a typical acupuncture treatment like? During the first appointment, you’ll fill out some paperwork, as you would at any medical visit. Your practitioner will perform a thorough intake and health history. He or she may ask questions you’ve never been asked, or even thought about before. That’s because, in Chinese medicine, many aspects of the body and its functions give clues about the patient’s overall health. The acupuncturist will look closely at your tongue, and feel your pulse at several places on each wrist. The appearance of your tongue, the quality and speed of your pulses, and the questions you answer all give clinical information that will help the acupuncturist plan your course of treatment. If you have questions about Chinese medicine, or your specific treatment, your acupuncturist is there to listen. He or she will be happy to discuss it with you.

Susan Risoli is an acupuncturist, a practitioner of herbal medicine and has been trained in Amma, a type of Asian bodywork.

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Triglycerides is a term that most of us recognize. This substance is part of the lipid (cholesterol) profile. However, this may be the extent of our understanding. Compared to the other substances, HDL (“good” cholesterol) and LDL (“bad” cholesterol), triglycerides are not covered much in the lay press and medical research tends to be less robust than for the other components. If I were to use a baseball analogy, triglycerides are the Mets, who get far less attention than their crosstown rivals, the Yankees.

But are triglycerides any less important? It is unclear whether a high triglyceride level is a biomarker for cardiovascular disease – heart disease and stroke – or an independent risk in its own right (1) (2). This debate has been going on for over 30 years. However, this does not mean it is any less important.

What are triglycerides? The most rudimentary explanation is that they are a kind of fat in the blood. Alcohol, sugars and excess calorie consumption may be converted into triglycerides.

Risk factors for high triglycerides include obesity, smoking, a high carbohydrate diet, uncontrolled diabetes, hypothyroidism (underactive thyroid), cirrhosis (liver disease), excessive alcohol consumption and some medications (3).

What levels are normal and what are considered elevated? According to the American Heart Association, optimal levels are <100 mg/dL; however, less than 150 mg/dL is considered within normal range. Borderline triglycerides are 150-199 mg/dL, high levels are 200-499 mg/dL and very high are >500 mg/dL (3).

While medicines that focus on triglycerides, fibrates and niacin, have the ability to lower them significantly, it is questionable whether this reduction results in clinical benefits, like reducing the risk of cardiovascular events. The ACCORD Study, a randomized controlled trial, questioned the effectiveness of medication; when these therapies were added to statins in type 2 diabetes patients, they did not further reduce the risk of cardiovascular disease and events (4). Instead, it seems that lifestyle modifications may be the best way to control triglyceride levels.

Let’s look at the evidence.

EXERCISE – TIMING AND INTENSITY
If you need a reason to exercise, here is really good one. I frequently see questions pertaining to optimal exercise timing and intensity. Most of the answers are vague, and the research is not specific. However, hold on to your hats, because a recent study may give the timing and intensity answer, at least in terms of triglycerides.

Study results showed that walking a modest distance with alacrity and light weight training approximately an hour after eating (postprandial) reduced triglyceride levels by 72 percent (5). However, if patients did the same workout prior to eating, then postprandial triglycerides were reduced by 25 percent. This is still good, but not as impressive. Participants walked a modest distance of just over one mile (2 kilometers). This was a small pilot study of 10 young healthy adults for a very short duration. The results are intriguing nonetheless, since there are few data that give specifics on optimal amount and timing of exercise.

EXERCISE TRUMPS CALORIE RESTRICTION
There is good news for those who want to lower their triglycerides: calorie restriction may not the best answer. In other words, you don’t have to torture yourself by cutting calories down to some ridiculously low level to get an effect. We probably should be looking at exercise and carbohydrate intake instead.

In a well-controlled trial, results showed that those who walked and maintained 60 percent of their maximum heart rate, which is a modest level, showed an almost one-third reduction in triglycerides compared to the control group (maintain caloric intake and no exercise expenditure) (6). Those who restricted their calorie intake saw no difference compared to the control. This was a small study of 11 young adult women.Thus, calorie restriction was trumped by exercise as a way to potentially reduce triglyceride levels.

CARBOHYDRATE REDUCTION, NOT CALORIE RESTRICTION
In addition, when calorie restriction was compared to carbohydrate reduction, results showed that carbohydrate reduction was more effective at lowering triglycerides (7). In this small but well-designed study, patients with nonalcoholic fatty liver disease were randomized to either a lower calorie (1200-1500 kcal/day) or lower carbohydrate (20 g/day) diet. Both groups significantly reduced triglycerides, but the lower carbohydrate group reduced triglycerides by 55 percent versus 28 percent for the lower calorie group. The reason for this difference may have to do with oxidation in the liver and the body as a whole. Both groups lost similar amounts of weight, so weight could not be considered a confounding or complicating factor. However, the weakness of this study was its duration of only two weeks.

FASTING VERSUS NONFASTING BLOOD TESTS
The paradigm has been that, when cholesterol levels are drawn, fasting levels provide a more accurate reading. Except this may not be true.

In a new analysis, fasting may not be necessary when it comes to cholesterol levels. NHANES III data suggests that nonfasting and fasting levels yield similar results related to all-cause mortality and cardiovascular mortality risk. The LDL levels were similarly predictive regardless of whether a patient had fasted or not. The researchers used 4,299 pairs of fasting and nonfasting cholesterol levels. The duration of follow-up was strong, with a mean of 14 years (8).

Why is this relevant? Triglycerides are an intricate part of a cholesterol profile. With regards to stroke risk assessment, nonfasting triglycerides possibly may be more valuable than fasting. In a study involving 13,596 participants, results showed that, as nonfasting triglycerides rose, the risk of stroke also rose significantly (9).

Compared to those who had levels below 89 mg/dL (the control), those with 89-176 mg/dL had a 1.3-fold increased risk of cardiovascular events, whereas those within the range of 177-265 mg/dL had a twofold increase, and women in the highest group (>443 mg/dL) had an almost fourfold increase. The results were similar for men, but not quite as robust at the higher end with a threefold increase.

The benefit of nonfasting is that it is more realistic and, according to the authors, also involves remnants of VLDL and chylomicrons, other components of the cholesterol profile that interact with triglycerides and may affect the inner part (endothelium) of the arteries.

What have we learned? Triglycerides need to be discussed, just as we review HDL and LDL levels regularly. Elevated triglycerides may result in heart disease or stroke. The higher the levels, the more likely there will be increased risk of mortality – both all-cause and cardiovascular. Therefore, we ideally should reduce levels to less than 100 mg/dL.

Lifestyle modifications using carbohydrate restriction and modest levels of exercise after a meal may be the way to go to the best results, though the studies are small and need more research. Nonfasting levels may be as important as fasting levels when it comes to triglycerides and the cholesterol profile as a whole; they potentially give a more realistic view of cardiovascular risk, since we don’t live in a vacuum and fast all day.

REFERENCES:
(1) Circulation. 2011;123:2292-2333. (2) N Engl J Med. 1980;302:1383–1389. (3) nlm.nih.gov. (4) N Engl J Med. 2010;362:1563-1574. (5) Med Sci Sports Exerc. 2013;45(2):245-252. (6) Med Sci Sports Exerc. 2013;45(3):455-461. (7) Am J Clin Nutr. 2011;93(5):1048-1052. (8) Circulation Online. 2014 July 11. (9) JAMA 2008;300:2142-2152.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

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Weight loss should be a rather simple concept.  It should be solely dependent on energy balance: the energy (kilocalories) we take in minus the energy (kilocalories) we burn should result in weight loss if we burn more calories than we consume. However, it is much more complicated. Frankly, there are numerous factors that contribute to whether people who want to or need to lose weight can.

The factors that contribute to weight loss may depend on stress levels, as I noted in my previous article, “Ways to counter chronic stress.” High stress levels can contribute to metabolic risk factors such as central obesity with the release of cortisol, the stress hormone. (1)  Therefore, hormones contribute.

Another factor in losing weight may have to do with our motivators.  We will investigate this further. And we need successful weight management, especially when approximately 70 percent of the American population is overweight or obese and more than one-third is obese. (2)

Recently, obesity in and of itself was proclaimed a disease by the American Medical Association. Even if you don’t agree with this statement, excess weight has consequences, including chronic diseases such as cardiovascular disease, diabetes, osteoarthritis and a host of others, including autoimmune diseases.  Weight has an impact on all-cause mortality and longevity.

It is hotly debated as to which approach is best for weight loss.  Is it lifestyle change with diet and exercise, medical management with weight loss drugs, surgical procedures, or even supplements? The data show that, while medication and surgery may have their places, they are not replacements for lifestyle modifications; these modifications are needed no matter what route is followed.

But, the debate continues as to which diet is best. We would hope patients would not only achieve weight loss, but also overall health.

Let’s look at the evidence.

LOW-CARBOHYDRATE DIETS VS. LOW-FAT DIETS
Is a low-carbohydrate, high-fat diet a fad?  It may depend on diet composition.  In a newly published study of a randomized controlled trial (RCT), the gold standard of studies, results showed that a low-carbohydrate diet was significantly better at reducing weight than low-fat diet, by a mean difference of 3.5 kg lost (7.7 lbs.), even though calories were similar and exercise did not change. (3)
The authors also note that the low-carbohydrate diet reduced cardiovascular disease risk factors in the lipid (cholesterol) profile, such as decreasing triglycerides (mean difference 14.1 mg/dl) and increasing HDL (good cholesterol). Patients lost 1.5 percent more body fat on the low-carbohydrate diet, and there was a significant reduction in inflammation biomarker, C-reactive protein (CRP). There was also a reduction in the 10-year Framingham risk score. However, there was no change in LDL (bad cholesterol) levels or in truncal obesity in either group. This study was 12 months in duration with 148 participants, predominantly women, with a mean age of 47, none of whom had cardiovascular disease or diabetes, but all of whom were obese or morbidly obese (BMI 30-45 kg/m2).
Although there were changes in biomarkers, there was a dearth of cardiovascular disease clinical endpoints.  This begs the question; does a low-carbohydrate diet really reduce the risk of developing cardiovascular disease (CVD) or its subsequent complications?  The authors indicated this was a weakness since it was not investigated.
Digging deeper into the diets used, it’s interesting to note that the low-fat diet was remarkably similar to the standard American diet; it allowed 30 percent fat, only 5 percent less than the 35 percent baseline for the same group.  In addition, it replaced the fat with mostly refined carbohydrates, including only 15 to 16 g/day of fiber.
The low-carbohydrate diet participants took in an average of 100 fewer calories per day than participants on the low-fat diet, so it’s no surprise that they lost a few more pounds over a year’s time.
Patients in both groups were encouraged to eat mostly unsaturated fats, such as fish, nuts, avocado and olive oil.
As David Katz, M.D., founding director of Yale University’s Prevention Research Center noted, this study was more of a comparison of low-carbohydrate diet to a high-carbohydrate diet than a comparison of a low-carbohydrate diet to a low-fat diet. (4)
Another study actually showed that a Mediterranean diet, higher in fats with nuts or olive oil, compared to a low-fat diet showed a significant reduction in cardiovascular events- clinical endpoints not just biomarkers. (5)  However, both of these studies suffer from the same deficiency: comparing a low-carbohydrate diet to a low-fat diet that’s not really low-fat.

DIET COMPARISONS
Interestingly, in a meta-analysis (a group of 48 RCTs), the results showed that whether a low-carbohydrate diet (including the Atkins diet) or a low-fat diet (including the Ornish plant-based diet), the results showed similar amount of weight loss compared to no intervention at all. (6)  Both diet types resulted in about 8 kgs. (17.6 lbs.) of weight loss at six months versus no change in diet.  However, this meta-analysis did not make it clear whether results included body composition changes or weight loss alone.
In an accompanying editorial discussing the above meta-analysis, the author points out that it is unclear whether a low-carbohydrate/high animal protein diet might result in adverse effects on the kidneys, loss of calcium from the bones, or other potential deleterious health risks.  The author goes on to say that for overall health and longevity and not just weight loss, micronutrients may be the most important factor, which are in nutrient-dense foods.
A recent Seventh-day Adventist trial would attest to this emphasis on a micronutrient-rich, plant-based diet with limited animal protein.  It resulted in significantly greater longevity compared to a macronutrient-rich animal protein diet. (7)

PSYCHE
Finally, the type of motivator is important in whatever our endeavors.  Weight loss goals are no exception.  Let me elaborate.  A recently published study followed West Point cadets from school to many years after graduation and noted who reached their goals. (8)  The researchers found that internal motivators and instrumental (external) motivators were very important.  The soldiers who had an internal motivator, such as wanting to be a good soldier, were more successful than those who focused on instrumental motivators, such as wanting to become a general.   Those who had both internal and instrumental motivators were not as successful as those with internal motivators alone.  In other words, having internal motivators led to an instrumental consequence of advancing their careers.
When it comes to health, an instrumental motivator, such weight loss, may be far less effective than focusing on an internal motivator, such as increasing energy or decreasing pain, which ultimately could lead to an instrumental consequence of weight loss.
There is no question that dietary changes are most important to achieving sustained weight loss. However, we need to get our psyches in line for change. Hopefully, when we choose to improve our health, we don’t just focus on weight as a measure of success.  Weight loss goals by themselves tend to lead us astray and to disappoint, for they are external motivators.  Focus on improving your health by making lifestyle modifications.  This tends to result in a successful instrumental consequence.

REFERENCES
(1) Psychoneuroendocrinol. online 2014 April 12.  (2) JAMA 2012;307:491–497.  (3) Ann Intern Med. 2014;161(5):309-318.  (4) Huffington Post. Sept 2, 2014.  (5) N Engl J Med. 2014 Feb 27;370(9):886.  (6) JAMA. 2014;312(9):923-933.  (7) JAMA Intern Med. 2013;173:1230-1238.  (8) Proc Natl Acad Sci U S A. 2014;111(30):10990-5.

Dr. Dunaief is a speaker, author and local lifestyle medicine physician focusing on the integration of medicine, nutrition, fitness and stress management. For further information, go to the website www.medicalcompassmd.com and/or consult your personal physician.

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Jacob Mathew mugshot from SCPD

Police charged a Port Jefferson neurologist with forcible touching on Wednesday, a couple of months after authorities say he had inappropriate contact with a patient.

According to the Suffolk County Police Department, Dr. Jacob Mathew inappropriately touched a female patient when she visited his Oakland Avenue office for treatment in February.

The SCPD did not identify the patient and said her name would be kept confidential.

The doctor, 58, was arrested at his office on Wednesday, police said, shortly before 4 p.m.

Attorney information for Mathew was not immediately available. He will be arraigned at a later date.

Anyone with information related to the police investigation is asked to call the 6th Squad at 631-854-8652.