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A gluten-free diet can significantly improve symptoms in patients with irritable bowel syndrome.
Gluten control may help with IBS

By David Dunaief, M.D.

Dr. David Dunaief

Gluten has been gaining in notoriety over the last several years. When we hear someone mention a gluten-free diet, several things tend to come to mind. One may be that this is a healthy diet. Along the same lines, we may think gluten is bad for us. However, gluten-free is not necessarily synonymous with healthy. There are many beneficial products containing gluten.

We might think that gluten-free diets are a fad, like low-fat or low-carb diets. Still, we keep hearing how more people feel better without gluten. Could this be a placebo effect? What is myth and what is reality in terms of gluten? In this article I will try to distill what we know about gluten and gluten-free diets, who may benefit and who may not.

But first, what is gluten? Most people I ask don’t know the answer, which is okay; it is part of the reason I am writing the article. Gluten is a plant protein found mainly in wheat, rye and barley.

Now to answer the question of whether going gluten-free is a fad. The answer is a resounding “no” since we know that patients who suffer from celiac disease, an autoimmune disease, benefit tremendously when gluten is removed (1). In fact, it is the main treatment.

But what about people who don’t have celiac disease? There seems to be a spectrum of physiological reaction to gluten, from intolerance to gluten (sensitivity) to gluten tolerance (insensitivity). Obviously, celiac disease is the extreme of intolerance, but even these patients may be asymptomatic. Then, there is nonceliac gluten sensitivity (NCGS), referring to those in the middle portion of the spectrum (2). The prevalence of NCGS is half that of celiac disease, according to the NHANES data from 2009-2010 (3). However, many disagree with this assessment, indicating that it is much more prevalent and that its incidence is likely to rise (4). The term was not even coined until 2011.

What is the difference between full-blown celiac disease and gluten sensitivity? They both may present with intestinal symptoms, such as bloating, gas, cramping and diarrhea, as well as extraintestinal (outside the gut) symptoms, including gait ataxia (gait disturbance), malaise, fatigue and attention deficit disorder (5). Surprisingly, they both may have the same results with serological (blood) tests, which may be positive or negative. The first line of testing includes anti-gliadin antibodies and tissue transglutaminase. These measure a reaction to gluten; however, they don’t have to be positive for there to be a reaction to gluten. HLA–DQ phenotype testing is the second line of testing and tends to be more specific for celiac disease.

What is unique to celiac disease is a histological change in the small intestine, with atrophy of the villi (small fingerlike projections) contributing to gut permeability, what might be called “leaky gut.” Biopsy of the small intestine is the most definitive way to diagnose celiac disease. Though the research has mainly focused on celiac disease, there is some evidence that shows NCGS has potential validity, especially in irritable bowel syndrome.

Before we look at the studies, what does it mean when a food says it’s “gluten-free”? Well, the FDA has weighed in by passing regulation that requires all gluten-free foods to have no more than 20 parts per million of gluten (6).

Irritable bowel syndrome

Irritable bowel syndrome (IBS) is a nebulous disease diagnosed through exclusion, and the treatments are not obvious. That is why the results from a randomized controlled trial, the gold standard of studies, showing that a gluten-free diet significantly improved symptoms in IBS patients, is so important (7). Patients were given a muffin and bread on a daily basis.

Of course, one group was given gluten-free products and the other given products with gluten, though the texture and taste were identical. In six weeks, many of those who were gluten-free saw the pain associated with bloating and gas mostly resolve; significant improvement in stool composition, such that they were not suffering from diarrhea; and their fatigue diminished. In fact, in one week, those in the gluten group were in substantially more discomfort than those in the gluten-free group. There were 34 patients involved in this study.

As part of a well-written March 4, 2013 editorial in Medscape by David Johnson, M.D., a professor of gastroenterology at Eastern Virginia Medical School, he questions whether this beneficial effect from the IBS trial was due to gluten withdrawal or to withdrawal of fermentable sugars because of the elimination of some grains, themselves (8). In other words, gluten may be just one part of the picture. He believes that nonceliac gluten sensitivity is a valid concern.

Autism

Autism is a very difficult disease to quantify, diagnose and treat. Some have suggested gluten may play a role. Unfortunately, in a study with children who had autism spectrum disorder and who were undergoing intensive behavioral therapy, removing both gluten and casein, a protein found in dairy, had no positive impact on activity or sleep patterns (9). These results were disappointing. However, this was a very small study involving 22 preschool children. Removing gluten may not be a panacea for all ailments.

Antibiotics

The microbiome in the gut may play a pivotal role as to whether a person develops celiac disease. In an observational study using data from the Swedish Prescribed Drug Register, results indicate that those who were given antibiotics within the last year had a 40 percent greater chance of developing celiac disease and a 90 percent greater risk of developing inflammation in the gut (10). The researchers believe that this has to do with dysbiosis, a misbalance in the microbiota, or flora, of the gastrointestinal tract. It is interesting that celiac disease may be propagated by change in bacteria in the gut from the use of antibiotics.

Not everyone will benefit from a gluten-free diet. In fact, most of us will not. Ultimately, people who may benefit from this type of diet are those patients who have celiac disease and those who have symptomatic gluten sensitivity. Also, patients who have positive serological tests, including tissue transglutaminase or anti-gliadin antibodies are good candidates for gluten-free diets.

There is a downside to a gluten-free diet: potential development of macronutrient and micronutrient deficiencies. Therefore, it would be wise to ask your doctor before starting gluten withdrawal. The research in patients with gluten sensitivity is relatively recent, and most gluten research has to do with celiac disease. Hopefully, we will see intriguing studies in the near future, since the U.S. market for gluten-free packaged products has grown to over $1.5 billion.

References: (1) Am J Gastroenterol. 2013;108:656-676. (2) Gut 2013;62:43–52. (3) Scand J Gastroenterol. (4) Neurogastroenterol Motil. 2013 Nov;25(11):864-871. (5) medscape.com. (6) fda.gov. (7) Am J Gastroenterol. 2011; 106(3):508-514. (8) medscape.com. (9) 9th annual AIM for Autism Research 2010; abstract 140.007. (10) BMC Gastroenterol. 2013:13(109).

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, visit www.medicalcompassmd.com or consult your personal physician.

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Studies have shown that eating grapefruit reduces your risk of developing diabetes.
Be wary of ‘no sugar added’ labels

By David Dunaief, M.D.

Dr. David Dunaif

We should all reduce the amount of added sugar we consume because of its negative effects on our health. It is recommended that we get no more than 10 percent of our diet from added sugars (1). However, we are consuming at least 30 percent more added sugar than is recommended (2).

Is all sugar bad for us? The answer is not straightforward. It really depends on the source, and when I mention “source,” my meaning may surprise you.

We know that white, processed sugar is bad. But, I am constantly asked which sugar source is better: honey, agave, raw sugar, brown sugar or maple syrup. None are really good for us; they all raise the level of glucose (a type of sugar) in our blood.

Two-thirds of our sugar intake comes from processed food, while one-third comes from sweetened beverages, according to the most recent report from the Centers for Disease Control and Prevention. (2) Sweetened beverages are defined as sodas, sports drinks, energy drinks and fruit juices. That’s right: Even 100 percent fruit juice can raise glucose levels. Don’t be deceived by “no added sugar” labels.

These sugars increase the risk of, and may exacerbate, chronic diseases, such as diabetes, heart disease, high blood pressure, cancer and obesity. This is such a significant problem that several legislative initiatives have been introduced that would require a warning label on sweetened drinks (3).

However, I did say that sugar’s source impacts its effect. Most fruits have beneficial effects in preventing disease, including diabetes, and do not raise sugar levels, even in patients with diabetes. It is a myth that whole fruit raises your sugar levels. However, dried fruits, fruit juice and fruit juice concentrate do raise your sugar levels. Note that sugar extracted from fruit has an effect similar to that of sugar added to foods and sweetened beverages. Let’s look at the evidence.

Heart disease

When we think of sugar’s effects, heart disease is not usually the first disease that comes to mind. However, results from a 20-year study of 31,000 U.S. adults showed that, when comparing those who consumed the least amount of added sugar (less than 10 percent of calories daily) with those who consumed 10 to 25 percent and those who consumed more than 25 percent of daily calories from sugar, there were significant increases in risk of death from heart disease (4). The added sugar was from foods and sweetened beverages, not from fruit and fruit juices. This was not just an increased risk of heart disease, but an increased risk of cardiovascular death. This is a wake-up call to rein in our sugar consumption.

Obesity and weight gain

Does soda increase obesity risk? An assessment published in PLoS One, a highly respected, peer-reviewed journal, showed that it depends on whether studies were funded by the beverage industry or had no ties to any lobbying groups (5). Study results were mirror images of each other: Studies not affiliated with the industry show that soda may increase obesity risk, while studies funded by the beverage industry show there may not be any association.

In studies without beverage industry funding, greater than 80 percent (10 of 12) showed associations between sugary drinks and increased weight or obesity, whereas with the beverage industry-funded studies, greater than 80 percent of them did not show this result (5 of 6). The moral of the story is that patients must be diligent in understanding how studies are funded; and if the results sound odd, they probably are. If this is the case, make sure to ask your doctor about the studies’ findings. Not all studies are equally well designed.

Diabetes and the benefits of fruit

Diabetes requires the patient to limit or avoid fruit altogether. Correct? This may not be true. Several studies may help change the long-standing, commonly held paradigm that fruit should be restricted in patients with diabetes and to prevent development of diabetes.

One study found that whole fruit may reduce the risk of diabetes by reducing inflammation and reducing insulin resistance (6). Specifically, results demonstrated a reduction in the inflammatory biomarker hsCRP. Ultimately, this may result in better glucose control. A potential reason for these impressive results may be the high levels of flavonoids, specifically anthocyanins and flavones.

Flavonoids, as a class, are phytochemicals (plant nutrients) that provide pigment to fruits and vegetables and may have substantial antioxidant activities. Substances that are high in these two flavonoids include red grapes, berries, tea and wine.

Another study, a meta-analysis that looked at three large studies, including the Nurses’ Health Study, NHS II, and the Health Professionals Follow-up Study, showed that those who consumed the highest amount of anthocyanins were likely to experience a 15 percent reduction in the development of type 2 diabetes (7). Researchers compared those in the highest quintile of anthocyanin consumption with those in the lowest quintile.

Specifically, at least two servings of blueberries per week were shown to reduce the risk of diabetes by 23 percent, and at least five servings of apples and pears per week were also shown to reduce the risk by 23 percent. These were compared to those who consumed less than one serving per month. This is a small amount of fruit for a significant reduction.

From the same three studies, it was also shown that grapes, bananas and grapefruit reduce the risk of diabetes, while fruit juice and cantaloupe may increase risk (8).

In still another diabetes study, involving those who were newly diagnosed with type 2 diabetes, the risk of increasing glucose levels was no greater in those who consumed more than two servings of fruit per day, when compared to those who consumed fewer than two servings per day (9).

The properties of flavonoids, which are found in whole fruit, may also result in anticancer and anticardiovascular disease properties, the opposite effect of added sugars (10).

Chronic disease incidence and complications from these diseases have skyrocketed in the last several decades. Therefore, any modifiable risk factor should be utilized to decrease our risk. By keeping added sugar to a minimum in our diets, we could make great strides in the fight to maintain our quality of life as we age.

We don’t have to avoid sugar completely; we still can satiate a sweet tooth by eating ripe fruits. Our access to fruit, even off-season, has expanded considerably. The most amazing thing is that fruit may actually reduce the risk of diabetes, something we thought for years might exacerbate it.

References: (1) health.gov: Dietary Guidelines for Americans 2015-2020, eighth edition. (2) cdc.gov. (3) reuters.com. (4) JAMA Intern Med. online Feb 3, 2014. (5) PLoS Med. 2013 Dec;10(12):e1001578. (6) J Nutr. 2014 Feb;144(2):202-208. (7) Am J Clin Nutr. 2012 Apr;95(4):925-933. (8) BMJ. online Aug 29, 2013. (9) Nutr J. published online March 5, 2013. (10) Plant Foods Hum Nutr. 2004 Summer;59(3):113-122.

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, visit www.medicalcompassmd.com or consult your personal physician.

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Raising the new Stony Brook Southampton Hospital flag at the celebration to introduce Stony Brook Southampton Hospital, from left, Cary F. Staller, Esq., SUNY Board of Trustees and Stony Brook Foundation Board of Trustees; Ambassador Carl Spielvogel, SUNY Board of Trustees; L. Reuven Pasternak, MD, Chief Executive Officer, Stony Brook University Hospital, and Vice President for Health Systems, Stony Brook Medicine; Kenneth Kaushansky, MD, Senior Vice President, Health Sciences, and Dean, Stony Brook University School of Medicine; Robert S. Chaloner, Chief Administrative Officer, Stony Brook Southampton Hospital; Samuel L. Stanley Jr., MD, President, Stony Brook University; Kenneth P. LaValle (R-Port Jefferson), New York State Senator; Kenneth B. Wright, Chair, Southampton Hospital Association Board; Kathy Hochul, New York State Lieutenant Governor; Fred W. Thiele Jr. (I-Southampton), New York State Assemblyman; Fred Weinbaum, MD, Chief Medical Officer and Chief Operating Officer, Stony Brook Southampton Hospital; and Marc Cohen, SUNY Board of Trustees. Photo from SBU

By L. Reuven Pasternak, M.D.

When hospitals in the same region are able to work together, they can deliver health care to residents in ways that are complementary, efficient and effective.

Dr. L. Reuven Pasternak

We are celebrating a major milestone in the development of the Stony Brook Medicine health system to transform health care on the East End of Long Island. On Aug. 1, Stony Brook finalized an agreement with the 125-bed Southampton Hospital — now called Stony Brook Southampton Hospital — to join as a member of Stony Brook Medicine.

Although Stony Brook and Southampton have been providing health care services to the East End for nearly 10 years, this formal agreement will enable us to improve health care quality and access, coordinate care and improve efficiency for patients through shared resources and managing the flow of patients between the two facilities.

Patients will benefit from this relationship because it helps our hospitals match the level of care provided to the level of care needed in the facility ideally suited to a patient’s needs. It provides patients from eastern Long Island with greater access to Stony Brook Medicine’s specialists, clinical trials and advanced technology, combined with the convenience and personalized care of a community-based hospital.

In the time that it has taken to finalize our agreement, we have successfully collaborated on bringing new services to the East End, the most critical of which is the new cardiac catheterization laboratory, part of the Audrey and Martin Gruss Heart & Stroke Center, which will be the first on Long Island to open east of Route 112, and where clinical operations are scheduled to begin on Sept. 5.

An aerial view of Stony Brook Southhampton Hospital. Photo from SBU

And coming in late 2018 is the new Phillips Family Cancer Center, a facility that will be staffed by both Stony Brook-based physicians and physicians from Southampton and promises to make top-level cancer care more easily accessible to East End residents.

Stony Brook and Southampton have been working collaboratively in our hybrid operating room, which is also part of the Audrey and Martin Gruss Heart & Stroke Center. This specialty operating room, equipped with sophisticated imaging, enables Stony Brook board-certified vascular surgeons to perform minimally invasive interventions to treat abdominal aortic aneurysms, complex peripheral arterial disease, carotid disease and the entire spectrum of vascular conditions.

Additional cardiology services have been established in the East End area. Stony Brook cardiologists Travis Bench, M.D., and Dhaval Patel, M.D., have opened practices at 676 County Road 39A, Southampton, and 600 Main Street, Center Moriches, so that patients with specific types of focused cardiac issues can get care closer to home.

Another important benefit of our agreement is that we now have additional clinical training sites to support the growing class sizes of Stony Brook’s undergraduate and graduate medicine training programs, as well as health technology programs. Graduate medical education programs, including internal medicine, family medicine internship and residency programs, plus osteopathic medicine programs in surgery and transitional year resident programs are currently being offered at Stony Brook Southampton Hospital with additional rotations planned for emergency medicine medical students and residents.

Together we are taking a bold step forward for the advancement of health care as we build on our successful collaborations to better serve the needs of Long Islanders.

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

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Christina Loeffler, the co-owner of Rely RX Pharmacy & Medical Supplies in St. James, works at one of the few non-major pharmacies in the county participating in the program to give low to no cost Narcan to those with prescription health insurance coverage. Photo by Kyle Barr

By Kyle Barr

The opioid crisis on Long Island has left devastation in its wake, and as opioid-related deaths rise every year, New York State has created an additional, more affordable way to combat it. To deal with the rash of overdoses as a result of addiction, New York State made it easier for people with prescription insurance to afford Naloxone, a common overdose reversal medication.

On Aug. 7, New York Gov. Andrew Cuomo (D) announced starting Aug. 9 that people with prescription health insurance coverage would be able to receive Naloxone, which is commonly referred to as Narcan, for a copay of up to $40. New York is the first state to offer the drug for such a low cost in pharmacies.

Narcan kit are now available for low to no cost at many New York pharmacies. File photo by Rohma Abbas

“The vast majority of folks who have health insurance with prescription coverage will be able to receive Naloxone through this program for free,” said Ben Rosen, a spokesperson for the New York State Department of Health.

Before the change, the average shelf cost of Narcan, which is administered nasally, was $125 without prescription with an average national copay of $10. People on Medicaid and Medicare paid between $1 and $3, Rosen said.

This action on part of the state comes at a critical time. Over 300 people from Suffolk County died from opioid-related deaths in 2016, according to county medical examiner records. On Aug. 10, President Donald Trump (R) declared the opioid issue a national emergency, meaning that there is now more pressure on Congress to pass legislation to deal with the crisis, as well as a push to supply more funds to states, police departments and health services to help deal with the problem.

The drug is available in over 3,000 pharmacies across New York and well over 100 pharmacies in Suffolk County. This includes all major pharmacies like CVS Health, Walgreens and Rite Aid, but also includes a few local pharmacies that already participate in the state Aids Drug Assistance Program and Elderly Pharmaceutical Insurance Coverage and Medicaid, according to Kathy Febraio, the executive director of the Pharmacists Society of the State of New York, a not-for-profit pharmacists advocacy group.

The program is only available for people who either have Medicare, Medicaid or health insurance with prescription coverage. Otherwise, officials said that those who lack insurance who need access can get it through a number of free Narcan training courses.

“We think that anything that can have an affect on this crisis is a good thing,” Febraio said. “This will certainly help. We need anything that will get Naloxone into the hands of those who need it.”

While Suffolk County Legislator and Presiding Officer DuWayne Gregory (D-Amityville) likes the idea of additional access to Narcan, he is skeptical about whether those who get it know how to properly administer it.

Narcan kits are now available for low to no cost at many New York pharmacies, like at Rely RX Pharmacy & Medical Supplies in St. James. Photo by Kyle Barr

“You don’t need a PHD to know how to use it, but there is some training that would help people be more comfortable, such as how to properly use it in an emergency situation and how to store it so that it is accessible while making sure children can’t get their hands on it,” he said. “Unfortunately the epidemic is so wide spread. Everyone knows someone who is affected.”

Christina Loeffler, the co-owner of Rely RX Pharmacy & Medical Supplies in St. James, one of the few non-major pharmacies in the county participating in the program, said though the business has not yet received many calls for Narcan, the state requires pharmacists to demonstrate how to use it.

“You have to counsel the patient and show them how to use it,” she said. “We were showed videos, we were given kits to practice on before we were certified to do it. I feel like it’s a good thing that they’re doing it.”

The county currently provides numerous Narcan training courses for locals, where they receive training and free supplies of the life-saving drug. Suffolk County Legislator Sarah Anker (D-Mount Sinai) said that she will be co-hosting a free Narcan training course Oct. 5 at Rocky Point High School with support from the North Shore Youth Council.

“They absolutely need to be trained,” she said. “Narcan is almost a miracle drug — it brings people back from death. However, people need to know what they’re doing so that it is administered correctly.”

Check on the New York State Department of Health website’s opioid overdose directories section for a full list of participating pharmacies.

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The use of Narcan is demonstrated on a dummy during a training class. File photo by Elana Glowatz

By Jill Webb

For five years the Suffolk County Department of Health’s Opioid Overdose Prevention Project has been doing their part to help community members save lives. To commemorate the project’s fifth anniversary an Opioid Overdose Prevention class was held July 31 at the William J. Lindsay County Complex in Hauppauge.

The class trained participants in the essential steps to handling an opioid overdose: recognizing the overdose, administering intranasal Narcan, and what to do while the Emergency Medical Service teams are en-route. These training procedures meet the New York State Department of Health requirements, and at completion of the course, students received a certificate along with an emergency resuscitation kit, which contains the Narcan Nasal Spray.

Narcan, also known as Naloxone, is administered to reverse an opioid overdose, and has saved many lives. Before the project was put into place, only advanced Emergency Medical Services providers could administer Narcan to overdose victims.

“The No. 1 incentive is to receive a free Narcan kit,” Dr. Gregson Pigott, EMS medical director and clinical director of the Opioid Overdose Prevention Program, said. “That’s really the draw.”

He said the class appeals to many people in the field, such as nurses or treatment professionals.

AnnMarie Csorny, director of the department of health’s community mental hygiene services, said another motivation to take the class is “to be better informed, and to have a kit available on you that you would be able to use should you see someone. It doesn’t always have to be your loved one, it could be someone in the community.”

Starting in 2012, the department of health services’ division of emergency medical services has held more than 278 classes. Within this time, approximately 9,000 participants have learned how to recognize an opioid overdose and administer Narcan. Since its start, Narcan has saved the lives of over 3,000 individuals.

Those who have been trained in administering Narcan include EMTs, school district staff and opioid users themselves. The program has developed from how to handle an overdose into adding a discussion of opioid addiction.

“Initially it was just about recognizing signs and symptoms of overdose, how Naloxone is packaged, what it does, what it doesn’t do, what to expect when you administer it, and how to get a refill,” Pigott said.
Now, the program integrates treatment aspects along with prevention techniques.

“I don’t wanna say we just give them Narcan and say, ‘OK here’s how to give it out.’ Pigott said. “I’d like to give them a little bit more background on the epidemic and how we got to where we are, and resources. You have a lot of parents in there who are anxious that they have a son or daughter who is hooked on this stuff. They don’t just want Narcan, they want help for their son or daughter.”

Taking it a step further, in 2016 the county health department started to work with local hospitals to get Narcan kits to those who are at risk of an opioid overdose. They also help educate them along with their families on the risk factors, signs, and symptoms of an opioid overdose.

Suffolk County also operates, with the help of the Long Island Council on Alcoholism and Drug Dependence, a 24/7 substance abuse hotline at 631-979-1700. The line was established in April 2016 for crises, and has received 1,217 calls as of May 31.

On the Opioid Overdose Prevention Program’s impact, Csorny believes it’s a start to tackling a huge issue.

“I think it’s certainly opened the discussion of lines of communication,” Csorny said. “It has, I believe, empowered people to get the support they need and to talk about the things that are not there.”

While the program has educated hundreds of people, and saves many lives, Pigott knows more needs to be done in handling the opioid epidemic.

“I’m realizing that Narcan isn’t the answer,” Pigott said. “It’s a nice thing to say, ‘Hey I got a save, this person was turning blue, not breathing, and then I squirted the stuff up the nose and we got them back.’ But then on the backside of that, the person wakes up and they’re like, ‘Ugh, what just happened to me?’ and then all of a sudden withdrawal kicks in.”

Pigott said after the withdrawal kicks in the users will decide to get treatment or not to, and if they chose the latter they will most likely start using again — administrating Narcan isn’t going to change that.
“That’s the biggest problem we have: it’s a quick fix, and you’re really not fixing anything,” Pigott said. “It’s much more complicated than just giving out Narcan.”

The next step in handling the opioid epidemic, according to Pigott, is getting better treatment options. He said most of the county’s treatment programs are abstinence-based; detox programs in learning how to be drug-free.

“It might be effective at the time but once you’re out of the program it’s easy to get tempted, easy to relapse,” Pigott said. “I think treatment needs to be addressed more and I think there needs to be more options for people.”

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Above, the Cusumano family of St. James stands in front of their newly donated 84-panel solar system that will be used to offset the costs of raising a son with autism. Photo by Sara-Megan Walsh

By Sara-Megan Walsh

A St. James family is looking ahead to brighter days raising their son with autism after receiving a generous donation.

The Cusumano family received an extensive 84-panel solar system donated by SUNation Solar Systems and its not-for-profit SUNation Cares, which will supply free electricity for life. The funds saved will be used to help their 14-year-old son Dylan attend weekly equine therapy sessions at Pal-O-Mine Equestrian in Islandia.

“When we can all come together as a team it makes a tremendous difference in people’s lives, especially people like the Cusumanos who are most deserving to reap the benefits and tremendous rewards that were generously donated,” said Lisa Gatti, founder and executive director of Pal-O-Mine.

The solar panels donated to the family were the end result of positive community building by several local companies. Gatti said she was introduced to Scott Maskin, CEO and co-founder of SUNation, a Ronkonkoma-based solar panel company, through Empire National Bank, where they are both customers. Maskin said as he learned firsthand about the nonprofit work done by Pal-O-Mine to benefit children with disabilities, he asked Gatti if there was a family he could step in to help. That’s when the Cusumanos were nominated.

“We are overwhelmed by the generosity and I think we were stunned because we feel there are so many needy families on Long Island,” said Amy Cusumano, Dylan’s mother. “The gift of solar panels lessens our load or burden so the money we are using to pay an electric bill, we now get to decide if we can increase his horse time or do something else for the boys.”

Dylan, the oldest of the Cusumano’s five sons, started horseback riding at Pal-O-Mine at age 5 due to the therapeutic benefits. Equine therapy provides children with disabilities with positive vestibular, or inner ear, input, can improve speech and language skills, help with walking and can increase fine and gross motor skills, according to Gatti.

“[Dylan] didn’t speak when he came to Pal-O-Mine,” she said. “One of his first words was ‘walk.’ I remember Ms. Cusumano being shocked he began to speak while he was riding.”

Despite seeing improvement, Amy Cusumano said she was forced to discontinue her son’s horseback riding lessons for a few years when financial hardship struck. She said it was heartbreaking.

“When he’s on the horse, he’s so at peace, he’s so totally Dylan,” his mother said. “So when we can give him that half an hour a week where he can just enjoy himself and have some fun, it’s money well spent.”

Cusumano said Dylan’s medical care costs run $35,000 to $40,000 a year on average between co-payments, therapy and those services not covered by insurance. The estimated $3,000 a year the solar panels will save the Cusumano family will be used to help pay for his adaptive riding, which typically costs $260 for four 30-minute sessions.

Dylan’s individually tailored plan through Pal-O-Mine has him riding Ella, a 12-year-old palomino haflinger, once a week. His mother said Dylan frequently requests to go see his horse and cares for her. Horseback riding is motivating to him, and gives Dylan a sense of empowerment and independence, according to Cusumano.

“Autism is not the primary thing we are thinking about,” she said. “Maybe we’re thinking about how amazing he is or that he can ride a horse.”

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Coffee may decrease levothyroxine absorption

By David Dunaief, M.D.

Dr. David Dunaief

It seems like everyone has heard of hypothyroidism. But do we really know what it is and why it is important? The thyroid is a butterfly-shaped organ responsible for maintaining our metabolism. It sits at the base of the neck, just below the laryngeal prominence, or Adam’s apple. The prefix “hypo,” derived from Greek, means “under” (1). Therefore, hypothyroidism indicates an underactive thyroid and results in slowing of the metabolism.

Many people get hypo- and hyperthyroidism confused, but they are really complete opposites. Blood tests determine if a person has hypothyroidism. Items that are tested include thyroid stimulating hormone (TSH), which is usually increased, thyroxine (free T4) and triiodothyronine (free T3 or T3 uptake). Both of these last two may be suppressed (2).

The thyroid sits at the base of the neck, just below the Adam’s apple and is responsible for maintaining metabolism.

There are two types of primary hypothyroidism: subclinical and overt. In the overt (more obvious) type, classic symptoms include weight gain, fatigue, thinning hair, cold intolerance, dry skin and depression, as well as the changes in all three thyroid hormones on blood tests mentioned above. In the subclinical, there may be less obvious or vague symptoms and only changes in the TSH. The subclinical can progress to the overt stage rapidly in some cases (3). Subclinical is substantially more common than overt; its prevalence may be as high as 10 percent of the U.S. population (4).

What are potential causes or risk factors for hypothyroidism? There are numerous factors, such as medications, including lithium; autoimmune diseases, whether personal or in the family history; pregnancy, though it tends to be transient; and treatments for hyperthyroidism (overactive thyroid), including surgery and radiation.

The most common type of hypothyroidism is Hashimoto’s thyroiditis (5). This is where antibodies attack thyroid gland tissues. Several blood tests are useful to determine if a patient has Hashimoto’s: thyroid peroxidase (TPO) antibodies and antithyroglobulin antibodies.

Myths versus realities

I would like to separate the myths from the realities with hypothyroidism. Does treating hypothyroidism help with weight loss? Not necessarily. Is soy potentially bad for the thyroid? Yes. Does coffee affect thyroid medication? Maybe. And finally, do vegetables, specifically cruciferous vegetables, negatively impact the thyroid? Probably not. Let’s look at the evidence.

Treatments: medications and supplements

When it comes to hypothyroidism, there are two main medications: levothyroxine and Armour Thyroid. The difference is that Armour Thyroid converts T4 into T3, while levothyroxine does not. Therefore, one medication may be more appropriate than the other, depending on the circumstance. However, T3 can be given with levothyroxine, which is similar to using Armour Thyroid.

What about supplements?

A recent study tested 10 different thyroid support supplements; the results were downright disappointing, if not a bit scary (6). Of the supplements tested, 90 percent contained actual medication, some to levels higher than what are found in prescription medications. This means that the supplements could cause toxic effects on the thyroid, called thyrotoxicosis. Supplements are not FDA-regulated, therefore, they are not held to the same standards as medications. There is a narrow therapeutic window when it comes to the appropriate medication dosage for treating hypothyroidism, and it is sensitive. Therefore, if you are going to consider using supplements, check with your doctor and tread very lightly.

Soy impact

What role does soy play with the thyroid? In a randomized controlled trial, the gold standard of studies, the treatment group that received higher amounts of soy supplementation had a threefold greater risk of conversion from subclinical hypothyroidism to overt hypothyroidism than those who received considerably less supplementation (7). Thus, it seems that in this small, yet well-designed, study, soy has a negative impact on the thyroid. Therefore, those with hypothyroidism may want to minimize or avoid soy. Interestingly, those who received more soy supplementation did see improvements in blood pressure and inflammation and a reduction in insulin resistance, but, ultimately, a negative impact on the thyroid.

The reason that soy may have this negative impact was illustrated in a study involving rat thyrocytes (thyroid cells) (8). Researchers found that soy isoflavones, especially genistein, which are usually beneficial, may contribute to autoimmune thyroid disease, such as Hashimoto’s thyroiditis. They also found that soy may inhibit the absorption of iodide in the thyroid.

Weight loss

Since being overweight and obese is a growing epidemic, wouldn’t it be nice if the silver lining of hypothyroidism is that, with medication to treat the disease, we were guaranteed to lose weight? In a recent retrospective (looking in the past) study, results showed that only about half of those treated with medication for hypothyroidism lost weight (9). This has to be disappointing to patients. However, this was a small study, and we need a large randomized controlled trial to test it further.

WARNING: The FDA has a black box warning on thyroid medications — they should never be used as weight loss drugs (10). They could put a patient in a hyperthyroid state or worse, having potentially catastrophic results.

Coffee

I am not allowed to take away my wife’s coffee; she draws the line here with lifestyle modifications. So I don’t even attempt to with my patients, since coffee may have some beneficial effects. But when it comes to hypothyroidism, taking levothyroxine and coffee together may decrease the absorption of levothyroxine significantly, according to one study (11). It did not seem to matter whether they were taken together or an hour apart. This was a very small study involving only eight patients. Still, I recommend avoiding coffee for several hours after taking the medication. This should be okay, since the medication must be taken on an empty stomach.

Vegetables

There is a theory that vegetables, specifically cruciferous ones such as cauliflower, cabbage and broccoli, may exacerbate hypothyroidism. In one animal study, results suggested that very high intake of these vegetables reduces thyroid functioning (12). This study was done over 30 years ago, and it has not been replicated.

Importantly, this may not be the case in humans. In the recently published Adventist Health Study-2, results showed that those who had a vegan-based diet were less likely to develop hypothyroidism than those who ate an omnivore diet (13). And those who added lactose and eggs to the vegan diet also had a small increased risk of developing hypothyroidism. However, this trial did not focus on raw cruciferous vegetables, where additional study is much needed.

There are two take-home points, if you have hypothyroid issues: Try to avoid soy products, and don’t think supplements that claim to be thyroid support and good for you are harmless because they are over the counter and “natural.” In my clinical experience, an anti-inflammatory, vegetable-rich diet helps improve quality of life issues, especially fatigue and weight gain, for those with Hashimoto’s thyroiditis.

References: (1) dictionary.com. (2) nlm.nih.gov. (3) Endocr Pract. 2005;11:115-119. (4) Arch Intern Med. 2000;160:526-534. (5) mayoclinic.org. (6) Thyroid. 2013;23:1233-1237. (7) J Clin Endocrinol Metab. 2011 May;96:1442-1449. (8) Exp Biol Med (Maywood). 2013;238:623-630. (9) American Thyroid Association. 2013;Abstract 185. (10) FDA.gov. (11) Thyroid. 2008;18:293-301. (12) Crit Rev Food Sci Nutr. 1983;18:123-201. (13) Nutrients. 2013 Nov. 20;5:4642-4652.

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, visit www.medicalcompassmd.com or consult your personal physician.

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Adding cruciferous vegetables to your diet significantly decreases the risk of developing multiple cancers. Stock photo
Small studies show diet may affect gene expression

By David Dunaief, M.D.

Dr. David Dunaief

Cancer, a word that for decades was whispered as taboo, has become front and center in the medical community. Cancer is the number one killer of Americans, at least those less than 85 years old, even ahead of cardiovascular disease (1). We have thought that diet may be an important component in preventing cancer. Is diet a plausible approach?

An April 24, 2014, article published in the New York Times, entitled “An Apple a Day and Other Myths,” questioned the validity of diet in the prevention of cancer. This article covered cancer in general, which is a huge and daunting topic.

The article’s author referenced a comment by Walter Willet, M.D., a professor at the Harvard School of Public Health’s Epidemiology and Nutrition Department, as indicating that the research is inconsistent when it comes to fruits and vegetables. The article went on to state that even fiber and fats may not play significant roles in cancer.

I don’t necessarily disagree with this assessment. However, I would like to emphasize that Willet also commented that there are no large, well-controlled diet studies. This leaves the door open for the possibility that diet does have an impact on cancer prevention. I would like to respond.

As Willet hinted, the problem with answering this question may lie with the studies themselves. The problem with diet studies in cancer, in particular, is that they rely mainly on either retrospective (backward-looking) or prospective (forward-looking) observational studies.

Observational studies have many weaknesses. Among them is recall bias, or the ability of subjects to remember what they did. Durability is also a problem; the studies are not long enough, especially with cancer, which may take decades to develop. Confounding factors and patient adherence are other challenges, as are the designs and end points of the studies (2). Plus, randomized controlled trials are very difficult and expensive to do since it’s difficult and much less effective to reduce the thousands of compounds in food into a focus on one nutrient. Let’s look at the evidence.

The EPIC trial

Considered the largest of the nutrition studies is the European Prospective Investigation into Cancer and Nutrition (EPIC). It is part of what the author was using to demonstrate his point that fruits and vegetables may not be effective, at least in breast cancer. This portion of the study involved almost 300,000 women from eight different European nations (3). Results showed that there was no significant difference in breast cancer occurrence between the highest quintile of fruit and vegetable consumption group compared to the lowest. The median duration was 5.4 years.

Does this study place doubt in the dietary approach to cancer? Possibly, but read on. The most significant strength was its size. However, there were also many weaknesses. The researchers were trying to minimize confounding factors, but there were eight countries involved, with many different cultures, making it almost impossible to control. It is not clear if participants were asked what they were eating more often than at the study’s start. Risk stratification was also not clear; which women, for example, might have had a family history of the disease?

Beneficial studies with fruits and vegetables

Also, using the same EPIC study, results showed that fruit may have a statistically significant impact on lung cancer (4). Results showed that there was a 40 percent decrease in the risk of developing lung cancer in those that were in the highest quintile of fruit consumption, compared to those in the lowest quintile. However, vegetables did not have an impact. The results were most pronounced in the northern European region. I did say the answer was complex.

Ironically, it seems that some other studies, mostly smaller studies, show potentially beneficial effects from fruits and vegetables. This may be because it is very difficult to run an intensive, well-controlled, large study.

Prostate cancer

Dean Ornish, M.D., a professor of medicine at UC San Francisco Medical School, has done several well-designed pilot studies with prostate cancer. His research has a focus on how lifestyle affects genes. In one of the studies, results of lifestyle modifications showed a significant increase in telomere length over a five-year period (5).

Telomeres are found on the end of our chromosomes; they help prevent the cell from aging, becoming unstable and dying. Shorter telomeres may have an association with diseases, such as cancer and aging and morbidity (sickness). Interestingly, the better patients adhered to the lifestyle modifications, the more telomere growth they experienced. However, in the control group, telomeres decreased in size over time. There were 10 patients in the lifestyle (treatment) group and 25 patients in the control group — those who followed an active surveillance-only approach.

In an earlier study with 30 patients, there were over 500 changes in gene expression in the treatment group. Of these, 453 genes were down-regulated, or turned off, and 48 genes were up-regulated, or turned on (6). The most interesting part is that these changes occurred over just a three-month period with lifestyle modifications.

In both studies, the patients had prostate cancer that was deemed at low risk of progressing into advanced or malignant prostate cancer. These patients had refused immediate conventional therapy including hormones, radiation and surgery. In both studies, the results were determined by prostate biopsy. These studies involved intensive lifestyle modifications that included a low-fat, plant-based, vegetable-rich diet. But as the researchers pointed out, there is a need for larger randomized controlled trials to confirm these results.

Cruciferous vegetables

A meta-analysis involving a group of 24 case-control studies and 11 observational studies, both types of observational trials, showed a significant reduction in colorectal cancer (7). This meta-analysis looked at the effects of cruciferous vegetables, also sometimes referred to as dark-green, leafy vegetables.

In another study that involved a case-control observational design, cruciferous vegetables were shown to significantly decrease the risk of developing multiple cancers, including esophageal, oral cavity/pharynx, breast, kidney and colorectal cancers (8). There was also a trend that did not reach statistical significance for preventing endometrial, prostate, liver, ovarian and pancreatic cancers. The most interesting part is that the comparison was modest, contrasting consumption of at least one cruciferous vegetable a week with none or less than one a month. However, we need large, randomized trials using cruciferous vegetables to confirm these results.

In conclusion, it would appear that the data are mixed in terms of the effectiveness of fruits and vegetables in preventing cancer or its progression. The large studies have flaws, and pilot studies require larger studies to validate them. However, imperfect as they are, there are results that indicate that diet modification may be effective in preventing cancer. I don’t think we should throw out the baby with the bath water. There is no reason not to consume significant amounts of fruits and vegetables in the hopes that it will have positive effects on preventing cancer and its progression. There is no downside, especially if the small studies are correct.

References: (1) CA Cancer J Clin. 2011;61(4):212. (2) Nat Rev Cancer. 2008;8(9):694. (3) JAMA. 2005;293(2):183-193. (4) Int J Cancer. 2004 Jan 10;108(2):269-276. (5) Lancet Oncol. 2013 Oct;14(11):1112-1120. (6) Proc Natl Acad Sci U S A. 2008 Jun 17;105(24):8369-8374. (7) Ann Oncol. 2013 Apr;24(4):1079-1087. (8) Ann Oncol. 2012 Aug;23(8):2198-2203.

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, visit www.medicalcompassmd.com.

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‘Why’ is as important as ‘how’

By David Dunaief, M.D.

Dr. David Dunaief

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 or need to lose weight can.

The factors that contribute to weight loss may depend on stress levels. 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 to weight gain.

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).

Focus on improving your health by making lifestyle modifications like walking your dog.

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, autoimmune diseases and a host of others. 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 vs. low-fat diets

Is a low-carbohydrate, high-fat diet a fad? It may depend on diet composition. In the publication 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 lb), 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 an 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 end points. 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, when compared to a low-fat diet, showed a significant reduction in cardiovascular events — clinical end points 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) was followed, there was a similar amount of weight loss compared to no intervention at all (6). Both diet types resulted in about 8 kg (17.6 lb) 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 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, whatever our endeavors. Weight loss goals are no exception. Let me elaborate.

A 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):10990-10995.

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, visit www.medicalcompassmd.com.

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Organizers of the 3rd annual Genome Engineering: The CRISPR-Cas Revolution event, from left, Maria Jasin, Jonathan Weissman, Jennifer Doudna and Stanley Qi. Photo courtesy of CSHL

By Daniel Dunaief

One day, the tool 375 people from 29 countries came to discuss in late July at Cold Spring Harbor Laboratory may help eradicate malaria, develop treatments for cancer and help understand the role various proteins play in turning on and off genes.

Eager to interact with colleagues about the technical advances and challenges, medical applications and model organisms, the participants in Cold Spring Harbor Laboratory’s third meeting on the CRISPR-Cas9 gene editing system filled the seats at Grace Auditorium.

Jason Sheltzer. Photo from CSHL

“It’s amazing all the ways that people are pushing the envelope with CRISPR-Cas9 technology,” said Jason Sheltzer, an independent fellow from Cold Spring Harbor Laboratory who presented his research on a breast cancer treatment.

The technology comes from a close study of the battle between bacteria and viruses. Constantly under assault from viruses bent on commandeering their genetic machinery, bacteria figured out a way of developing a memory of viruses, sending out enzymes that recognize and destroy familiar invaders.

By tapping into this evolutionary machinery, scientists have found that this system not only recognizes genes but can also be used to slice out and replace an errant code.

“This is a rapidly evolving field and we continue to see new research such as how Cas1 and Cas2 recognize their target, which opens the door for modification of the proteins themselves, and the recent discovery of anti-CRISPR proteins that decrease off-target effects by as much as a factor of four,” explained Jennifer Doudna, professor of chemistry and molecular and cell biology at the University of California at Berkeley and a meeting organizer for the last three years, in an email.

Austin Burt, a professor of evolutionary genetics at the Imperial College in London, has been working on ways to alter the genes of malaria-carrying mosquitoes, which cause over 430,000 deaths each year, primarily in Africa.

“To wipe out malaria would be a huge deal,” Bruce Conklin, a professor and senior investigator at the Gladstone Institute of Cardiovascular Disease at the University of California in San Francisco and a presenter at the conference, said in an interview. “It’s killed millions of people.”

Carolyn Brokowski. Photo by Eugene Brokowski

This approach is a part of an international effort called Target Malaria, which received support from the Bill and Melinda Gates Foundation.

To be sure, this effort needs considerable testing before scientists bring it to the field. “It is a promising approach but we must be mindful of the unintended consequences of altering species and impacting ecosystems,” Doudna cautioned.

In an email, Burt suggested that deploying CRISPR in mosquitoes across a country was “at least 10 years” away.

CSHL’s Sheltzer, meanwhile, used CRISPR to show that a drug treatment for breast cancer isn’t working as scientists had thought. Researchers believed a drug that inhibited the function of a protein called maternal embryonic leucine zipper kinase, or MELK, was halting the spread of cancer. When Sheltzer knocked out the gene for MELK, however, he discovered that breast cancer continued to grow or divide. While this doesn’t invalidate a drug that may be effective in halting cancer, it suggests that the mechanism researchers believed was involved was inaccurate.

Researchers recognize an array of unanswered questions. “It’s premature to tell just how predictable genome modification might be at certain levels in development and in certain kinds of diseases,” said Carolyn Brokowski, a bioethicist who will begin a position as research associate in the Emergency Medicine Department at the Yale School of Medicine next week. “In many cases, there is considerable uncertainty about the causal relationship between gene expression and modification.”

Brokowski suggested that policy makers need to appreciate the “serious reasons to consider limitations on nontherapeutic uses for CRISPR.”

Like so many other technologies, CRISPR presents opportunities to benefit mankind and to cause destruction. “We can’t be blind to the conditions in which we live,” said Brokowski.

Indeed, Doudna recently was one of seven recipients of a $65 million Defense Advanced Research Projects Agency award to improve the safety and accuracy of gene editing.

The funding, which is for $65 million over four years, supports a greater understanding of how gene editing technologies work and monitors health and security concerns for their intentional or accidental misuse. Doudna, who is credited with co-creating the CRISPR-Cas9 system with Emmanuelle Charpentier a scientific member and director of the Max Planck Institute for Infection Biology in Berlin, will explore safe gene editing tools to use in animal models and will specifically target Zika and Ebola viruses.

“Like most misunderstood disruptive technologies, CRISPR outpaced the necessary policy and regulatory discussions,” Doudna explained. The scientific community, however, “continued to advance the technology in a transparent manner, helping to build public awareness, trust and dialogue. As a result, CRISPR is becoming a mainstream topic and the public understanding that it can be a beneficial tool to help solve some of our most important challenges continues to grow.”

Visitors enjoyed a wine and cheese party on the Airslie lawn during the event. Photo from CSHL

Cold Spring Harbor Laboratory plans to host its fourth CRISPR meeting next August, when many of the same scientists hope to return. “It’s great that you can see how the field and scientific community as a whole is evolving,” Sheltzer said.

Doudna appreciates the history of Cold Spring Harbor Laboratory, including her own experiences. As a graduate student in 1987, Doudna came across an unassuming woman walking the campus in a tee-shirt: Nobel Prize winner Barbara McClintock. “I thought, ‘Oh my gosh, this is someone I revere,” Doudna recalled. “That’s what life is like” at the lab.

Brokowski also plans to attend the conference next year. “I’m very interested in learning about all the promises CRISPR will offer,” she said. She is curious to see “whether there might be more discussion about ethical and regulatory aspects of this technology.”

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