Tag Archives: FDA


Unregulated e-cigarette industry raises health concerns

It’s common now to spot someone in public holding an electronic cigarette and “vaping,” or inhaling and exhaling a cloud of flavored vapor.

Oxford Dictionaries even picked up on the trend, naming  “vape” the 2014 word of the year, signifying the beginning phase of replacing an age-old habit of smoking tobacco. But is vaping a trend that is better or worse than smoking tobacco when it comes to the user’s health?

At Arizona’s first e-cigarette and vapor expo in October, people — some young, some older — walked through the maze of booths looking and testing out handheld devices that are commonly used to replace smoking a tobacco cigarette.

“What now I believe people are being turned on to, why the gums and patches don’t work, is because there’s a whole level that is missing in people’s lives and that’s the social aspect (of smoking),” said Michael Guasch, president of Molecule Labs,  which manufacturers e-liquids. “So when you can sit around and vape with someone and enjoy good conversation in a much more healthy manner, you’re not destroying your clothes and the environment you’re in.”

The two most common styles of electronic cigarettes, or e-cigs, are the traditional disposable cartridge style, which looks more like a tobacco cigarette; and the refillable tank-style“vaping device”, which can look like a pen, is reusable, rechargeable and more commonly used today, according to Guasch.

“An e-cigarette is comprised of a battery, an atomizer, which has a wick with a heating element and then that produces the vapor upon the draw,” said Stephen Beckers, owner of TKO Vapor.

Inside the debate

While the types of liquid flavoring and the catchy names are enticing, it’s what is inside of these e-liquids that counts for consumers.

“E-cigarettes typically contain three main ingredients: nicotine, a flavoring of some kind and propylene glycol — a syrupy synthetic liquid added to food, cosmetics, and certain medicines to absorb water and help them stay moist,” said Frank LoVecchio, D.O., a medical toxicologist at the Banner Good Samaritan Poison and Drug Information Referral Center.

The ingredients inside of the e-liquids are not only responsible for satisfying cravings, but also for creating nationwide debate on just how safe and healthy they are for consumers.

“Various studies suggest the vapors from e-cigarettes contain several cancer-causing substances, as well as incredibly tiny particles of tin, chromium, nickel and other heavy metals, which, in large enough concentrations, can damage the lungs,” LoVecchio said. “These particles likely fleck off the solder joints or metal coil in the devices when heated. Because they are so small, the tiniest bits of metal, known as nanoparticles, can travel deep into the lungs. There, they could exacerbate asthma, bronchitis — an inflammation of the tubes that carry air to and from the lungs — and emphysema — a disease in which the lungs’ many air sacs are destroyed, leaving patients short of breath. So far, there are not enough data to say with certainty whether e-cigs worsen these disorders.”

Since the e-cig industry is still young, the lack of research and studies performed to determine whether e-cigs are a healthier option than using traditional tobacco cigarettes leaves the question unanswered. While tobacco isn’t used in e-liquids, nicotine is and can be addictive.

“Using e-cigarettes avoids the harms of smoke, but the nicotine they contain is addictive and has many known harmful effects,” said Rodney D. Altman, M.D., of Abrazo Health. “It is possible that the aerosol could somehow enhance the delivery of nicotine into the blood or tissues which could outweigh the benefit of avoiding smoke.”

“The primary established danger of nicotine is that the stimulant is highly addictive, although emerging science also links it to an impaired immune system,” LoVecchio said.

The risks for kids

Altman said health concerns with nicotine are not just for vapers themselves, but for children if proper caution isn’t taken when using e-cigs.

“Young children are typically poisoned from traditional cigarettes when they eat them,” Altman said. “Poisoning related to e-cigarettes involves the liquid containing nicotine used in the devices and can occur in three ways: by ingestion, inhalation or absorption through the skin or eyes.  Poisonings for electronic cigarettes are increasing dramatically.  About half of these occur in children under 5 and 6 years of age.”

There is, however, an option for no nicotine in e-liquids, with typical levels ranging from 0-24 mg of nicotine. Selling flavored liquid with no nicotine or lowering a vaper’s nicotine levels throughout a period of time are options provided by some e-cig shops and manufacturers.

“It’s right to have a wide variety of different levels,” Gusich said. “Let the customer pick whatever works best for them. We don’t want them to be at a higher dose of nicotine than what they were normally smoking in regular cigarettes. This is their chance to be able to choose what they want and make it easier for them to adjust to this lifestyle.”

However, even if there is no nicotine present in the e-liquid cartridge someone is inhaling, there is still a potential for health risks with propylene glycol.

“Propylene glycol, for example, is usually eaten (in cupcakes, soft drinks and salad dressings) or slathered onto the body (in soaps, shampoos and antiperspirants) — not breathed into the lungs,”  LoVecchio said, “so this needs to be studied. For example flour—can damage the lungs when inhaled.”

Terminology confusion, inaccurate labeling and just who exactly is making the e-liquids also present areas for health concerns.

Since the e-cigs industry is still relatively new and lacks standardizations and regulations by the FDA, potential risks arise with inexperienced manufacturers — or even consumers — handle the nicotine.

“I think the risks from e-cigs come from lack of standardization and not knowing what some companies are putting in their liquids,” Beckers said

Booming business

E-cigs have become so popular in the short eight years they’ve been available, the industry surpassed $1 billion in sales in the United States in 2013.

“There’s so many different companies trying to get into it, it’s almost like a gold rush,” said Geoff Habicht , chief operating officer of Smoking Vapor. “You have these vape shops opening up on every corner and there’s several thousand in Arizona. The market this year will be about $4 billion and is expected to be $7 billion or $8 billion next year.”.

The e-cig industry may seem like a great place for entrepreneurs to get rich fast, but it won’t be for long. With the impending FDA regulations on the selling and manufacturing of e-liquids, a lot of the small shops could disappear because of the inability to meet strict guidelines.

“Like any business, there are a lot of businesses that fail,” Habicht said. “We’re going to reach a point of saturation where you can’t have a vape shop on every single corner.”

When it’s all said and done, there will be more than two sides to this story. The e-cig industry advertises itself as healthier alternatives to smoking tobacco cigarettes. Some lawmakers and medical professionals are pointing out that there is no scientific evidence to back up these claims. Consumers, especially Millennials, are more focused on the social aspect. Regardless of who is right or wrong, consumers need to be educated on what they’re putting in their bodies.

“This is a product that should not be advertised at all to kids,” Guasch said. “They should never be a product that makes you look cool.”


FDA calls out Kind bars for misbranding

Granola bars are often a quick snack throughout the day to provide a boost of energy and satisfy hunger in between meals, but some of the most common bars may not be as a healthy as they claim.

The Food and Drug Administration served Kind LLC, the company behind Kind Bars, with a warning letter to clean up their act March 17. The company was found in violation of multiple infractions containing their labels.

In August 2014, the FDA looked into the labeling four of Kind Bar’s products. The FDA revealed that the Kind Bar flavors Almond and Apricot, Almond and Coconut, Peanut Butter and Dark Chocolate +Protein, as well as Dark Chocolate Cherry Cashew + Antioxidants were all misbranded.

According to the report, the biggest violation points to the labels bearing statements that imply the product is good for keeping a good health regime. Phrases such as “good source of fiber,” “low sodium,” “no trans fat,” and “+ protein,” appear on some or all of the products in question.

Aside from pointing out blunt errors, the FDA moves on to pick out exact violations of the bars and why they are not in accordance with mandates. One example pertains to the claim that the bars are “antioxidant-rich.”

The FDA mandates that “antioxidant-rich” food are classified as such when they account for 20 percent or more of more of a Reference Daily Intake nutrients that have been recognized as antioxidants, such as Vitamin C, Vitamin E or beta carotene.

In the case of Kind, the Nutrition Facts label stipulate that the products contain 15% of the daily value for Vitamin E, zero percent of Vitamin C and A.

Another phrase favored by Kind Bars is “healthy,” but the FDA reports that Kind cannot use healthy because it does not meet the requirements. In order to be classified as healthy, a product cannot exceed 15% of calories from saturated fat or exceed 1 gram of saturated fat per 40 grams Reference Amount Customarily Consumed (RACC).

In addition to misbranding, the bars do not contain proper allergen information. The products contain soy; however, the allergen notice does not make note that. They also use the phrase “tree nuts” in place of the specific nuts used in the bars and “dairy” in place of milk.

A final issue the FDA had with Kind LLC was that they do not have a permanent address listed. The address listed on the product labels is in fact a PO box, and the FDA’s attempts to track down their physical address through a 411 search pulled up multiple locations in New York for the company.

Kind LLC announced on their website, kindsnacks.com, Tuesday that they are currently in the process of working on the new labels.

The company also chose to defend why their bars are healthy. A key ingredient in the bars is nuts; however, nuts contain fats that exceed the FDA approved amount.


FDA approves return of nausea treatment

The only drug specifically designed for the treatment of morning sickness in pregnant women will be back on the market in June of this year. The treatment was pulled from shelves thirty years ago but a thorough investigation finds the drug safe and the FDA gave its approval yesterday.

“This is fabulous news,” says Dr. Stephanie Freeman of MomDoc Women For Women, with 15 offices throughout the Valley. “Obstetricians have been using Unisom as an off label medication for pregnancy related nausea for years, and the ingredients are similar.  To have Bendectin back as an option will provide relief of pregnancy related nausea for many women without as much of the sedation side effects of many medications we use now.”

FDA approval means a new version of the drug formerly known as Bendectin will return to United States pharmacies under a different name, Diclegis. The drug is considered safe and effective in treating nausea. In the thirty years since it was removed, the treatment has undergone more scrutiny for safety than any other drug used during pregnancy.

The original scare came from lawsuits claiming the drug caused birth defects. What the research found is that there are any given numbers of pregnancies which result in children with birth defects. Government estimates are 1 in 33 babies are born with birth defects regardless of medication used during the pregnancy. Studies concluded that Bendectin did not increase that risk.

More than half of all women experience at least some nausea and vomiting during pregnancy caused by hormonal swings. Only about one percent of women experience severe vomiting called hyperemesis gravidarum, the condition which hospitalized Britain’s Duchess of Cambridge Kate last year.

The treatment’s ingredients are not magical. Vitamin B6 and over-the-counter antihistamine doxylamine found in some sleep aids are the main ingredients. The difference with this prescription only drug is that the ingredients are released in a delayed-reaction coating designed for daily dosage before nausea is a problem.

Doctors do advise trying alternatives first including eating protein snacks before bed and nibbling crackers or sipping ginger ale before getting out of bed. Frequent, small meals seem to help some women as well.


FDA approved thyroid cancer drug tested by TGen

The FDA has approved a thyroid cancer drug successfully tested at Virginia G. Piper Cancer Center Clinical Trials, a partnership of Scottsdale Healthcare and the Translational Genomics Research Institute (TGen).

The U.S. Food and Drug Administration approved cabozantinib for the treatment of progressive, metastatic medullary thyroid cancer (MTC), a rare endocrine gland cancer affecting the thyroid. Previously, MTC patients had limited treatment options.

“This was a really exciting trial. We have a drug that blocks the gene that causes a rare type of cancer,” said Dr. Michael Demeure, the Site Principal Investigator on the Phase III clinical trial and endocrine surgeon at Scottsdale Healthcare. “We’re trying to do more tests like this to try to bring innovative and exciting new cancer drugs for our patients.”

More than 56,000 Americans will be diagnosed with thyroid cancer this year, and 1,780 will die from the disease. About 4 percent of thyroid cancers are medullary, a form of carcinoma that originates from the parafollicular, or C, cells, which produce the hormone calcitonin. Physicians are able to confirm a diagnosis of MTC by detecting elevated levels of calcitonin in the blood.

MTC often is not detected until its late stages. And unlike 90 percent of differentiated thyroid cancers, MTC does not respond to the most common treatments, making it difficult to manage.

The RET gene, which is part of the family of tyrosine kinase proteins, plays a role in the development of MTC. Cabozantinib is an inhibitor of multiple receptor tyrosine kinases, including RET, MET and VEGFR2.

“Cabozantinib targets tyrosine kinases that are important in medullary thyroid cancer, including RET, MET and VEGFR2. When such tyrosine kinases — which are known to play a role in tumor growth and metastasis — are also the drug target, that gives you hope that you can impact favorably on the disease,” said Dr. Demeure, contrasting MTC with other cancers, such as pancreatic cancer, where the precise genetic source of the cancer remains unconfirmed or unknown.

The Virginia G. Piper Cancer Center at Scottsdale Healthcare enrolled two patients with MTC as part of an international randomized clinical trial of more than 300 patients.

FDA’s approval on Nov. 29 was based on demonstrating improved progression-free survival (PFS). The estimated median PFS was 11.2 months for patients taking cabozantinib, compared to 4 months for patients taking placebo. The drug is sold as COMETRIQ and marketed by South San Francisco-based Exelixis, Inc.

One patient who continues to benefit from clinical trial treatments at Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials is Gordon Hunt, 68, a retired life-insurance salesman from Phoenix.

Hunt said he started noticing discomfort in his neck several years ago. After seeing a series of specialists, a calcitonin test finally confirmed that he had an advanced case of MTC.

Hunt endured several surgeries that included the removal of his thyroid and lymph nodes in his neck and chest. Following his most recent surgeries more than two years ago, performed by Dr. Demeure, Hunt’s calcitonin levels dropped from a one-time high of 3,300 picograms per milliliter, when he was first diagnosed, to about 500 pg/ml.

After receiving cabozantinib since February 2011, Hunt’s calcitonin levels are down to about 250 pg/ml, indicating that the cancer might still be in his system, but he has had no detectable tumors.

“I feel like he saved my life,” Hunt said of Dr. Demeure, who suggested he take part in the cabozantinib clinical trial.

“I’m just thankful for it, because I’m sure I’d be probably ready for another surgery of some sort if I hadn’t been on the medication,” said Hunt, who also expressed gratitude to the entire staff of the Virginia G. Piper Cancer Center at Scottsdale Healthcare. “They’ve been responsive to my every need.”

Hunt said he at first suffered side effects, including vomiting, diarrhea, stomach pains, weight loss and constipation. But by lowering his dosage, the side effects eventually diminished, he said. Dose reduction was required in 79 percent of clinical trial patients, according to the FDA.

Hunt receives monthly doses of the drug along with tests for calcitonin, as well as quarterly scans for tumors.

Between doses, he and his wife Nancy, a retired schoolteacher, travel extensively, including trips in the past year to California, Texas, Missouri and Australia.

“We’re still active, so that’s a good thing,” said Hunt, noting that the couple, who have lived 47 years in Phoenix, still go regularly to the gym and are active in their church.

“I’m excited. I played a part in making it (FDA approval) happen,” Hunt said. “I thank God that I was chosen to take part in obtaining the approval of the medication. If it works for me, it’s going to work for other people, and that’s good.”

In addition to treating MTC, cabozantinib is being explored as a therapy for numerous tumor types, including prostate, ovarian, brain, melanoma, breast, and non-small cell lung cancers.

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Combination of Diet and Radiation Therapy Shows Promise

A team of brain cancer researchers at Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center has effectively treated brain tumor cells using a unique combination of diet and radiation therapy. The study, “The Ketogenic Diet Is an Effective Adjuvant to Radiation Therapy for the Treatment of Malignant Glioma,” was published in PLOS ONE.

Led by Adrienne C. Scheck, PhD, Principal Investigator in Neuro-Oncology and Neurosurgery Research at Barrow, the groundbreaking research studied the effects of the ketogenic diet in conjunction with radiation therapy for the treatment of malignant gliomas, an aggressive and deadly type of brain tumor. The ketogenic diet is a high-fat, low-carbohydrate diet that alters metabolism and is used in the treatment of pediatric epilepsy that does not respond to conventional therapies. The diet’s affects on brain homeostasis have potential for the treatment of other neurological diseases, as well.

In the study, mice with high-level malignant gliomas were maintained on either a standard or a ketogenic diet. Both groups received radiation therapy. Dr. Scheck’s team discovered that animals fed a ketogenic diet had an increased median survival of approximately five days relative to animals maintained on a standard diet. Of the mice that were fed a ketogenic diet and received radiation, nine of 11 survived with no signs of tumor recurrence, even after being switched back to standard food, for over 200 days. None on the standard diet survived more than 33 days.

One theory behind the success of the treatment is that the ketogenic diet may reduce growth factor stimulation, inhibiting tumor growth. Barrow scientists also believe that it may reduce inflammation and edema surrounding the tumors. This is believed to be the first study of its kind to look at the effects of the ketogenic diet with radiation.

Dr. Scheck believes that the study has promising implications in the treatment of human malignant gliomas. “We found that the ketogenic diet significantly enhances the anti-tumor effect of radiation, which suggests that it may be useful as an adjuvant to the current standard of care for the treatment of human malignant gliomas,” she says.

Dr. Scheck adds that the ketogenic diet could quickly and easily be added into current brain tumor treatment plans as an adjuvant therapy without the need for FDA approval. She is currently exploring options for clinical trials.


FDA picks Riester for anti-smoking campaign

Adweek has reported that the FDA has picked six agencies — including Phoenix-based Riester, which has previously been involved in youth tobacco prevention advertising — to work on a new anti-smoking initiative, which together have a spend ceiling of $390 million over the next five years. Ending a bidding process that began in September 2011, Grey, Mullen, Draftfcb, Campbell-Ewald, American Legacy Foundation and Riester were chosen for the task.

The group of agencies will now be given assignments or will submit proposals in a competitive scenario.

The focus of the program will target teens with the aim of preventing smoking or getting them to stop while they’re still young. Unlike other more mass-market anti-smoking campaigns, the FDA, which has regulatory oversight of the tobacco industry, doesn’t want to demonize tobacco, sources said. Rather, the marketing will present a more positive image of life without tobacco.

Dr. Quiet with a breast cancer patient - AZ Business Magazine March/April 2012

Never Quiet On Cancer Care: Center To Focus Breast Cancer

Valley doctor creates first center to focus exclusively on women fighting breast cancer

Dr. Coral Quiet is anything but … quiet, that is. This busy mother of two has been one of the loudest voices in Arizona’s war against breast cancer for more than two decades.

“When I moved to Arizona in the early-1990s, I was horrified to learn that not only were there ZERO breast cancer-only specialists, but that nearly 80 percent of breast cancer patients in Arizona were being treated with mastectomies, a number exponentially higher than the national average,” said Quiet.

A mastectomy, which is the complete surgical removal of the breast and necessary in aggressive cases, is disfiguring to a woman.

Determined to make a difference, Quiet began focusing her care here in the Valley solely on breast cancer treatment, research and education. While touching the lives of women one-at-a- time was making a difference, by the late 1990s she wanted to do more.

So, in 1998, she co-founded the Arizona Institute for Breast Health with Dr. Belinda Barclay-White, which offers women who have been diagnosed with breast cancer a second opinion, free of charge.

Quiet tirelessly works to bring a volunteer team of physicians and medical professionals whose specialties include breast radiology, breast surgery, medical oncology, radiation oncology, reconstructive surgery, and breast pathology into one room each week to evaluate the best medical and surgical options for the preservation of a woman’s life, body and emotional well-being.

But she didn’t stop there.

In 1999, Quiet attended an international breast cancer conference and had the chance to meet Dr. Robert Kuske, who was presenting early results of his new treatment for breast cancer called Brachytherapy, an accelerated five-day treatment for selected patients with early stage breast cancer that treats a much smaller volume of breast and other tissues and avoids treating the breast skin with radiation.

Never one to bother with “Quiet” time, she not only introduced brachytherapy in Arizona in the early 2000s, but she eventually convinced Kuske to come and practice in Arizona as well.

Over the next several years, she helped to pioneer the Mammosite catheter for FDA studies and pioneered a new device, SAVI, which is able to treat many more women with early stage breast cancer while avoiding high doses of radiation to skin and ribs. She also took time out to act as a spokesperson for the American Cancer Society, lecturing and volunteering for the organization where she could.

As the number of women getting mastectomies declined, and those choosing body and breast-conserving treatments like brachytherapy and SAVI skyrocketed, Dr. Quiet decided to make even more noise.

Determined to provide the same level of customized care to non-breast cancer patients, Quiet and Kuske also developed a secondary practice, Arizona Radiation Oncology Specialists, with the goal of partnering cancer experts statewide with cutting-edge cancer technologies to maximize patient care. With the help of new partners, they have opened three Arizona Radiation Oncology Specialists centers in the past three years, while investing in technologies new to the Southwest.

“I’ll get my quiet time when I’m dead,” said Dr. Quiet. “Today, the fight continues in the war against cancer – a war we will win.”

Arizona Business Magazine March/April 2012

2010 Health Care Leadership Awards

2010 HCLA – Researcher

Honoree: Nabil Dib, Medical Director

Nabil Dib, MD, M.SC., FACC
Director, Cardiovascular Research
Mercy Gilbert Medical Center

A highly respected interventional cardiologist, Dr. Nabil Dib, director of cardiovascular research for Chandler Regional and Mercy Gilbert Medical centers, serves as principal investigator for a variety of cardiovascular clinical trials, including cardiac regeneration involving cell and gene transplant, new pharmaceuticals and genomics.

Nabil Dib, MD, M.SC., FACC Director, Cardiovascular Research Mercy Gilbert Medical Center, 2010 Health Care Leadership Awards

With a support team of 10, Dib treats patients with advanced cardiac disease and provides expert consultation to referring physicians from all specialties. His clinical services include assessment and diagnosis of cardiac diseases, angina, heart failure, arrhythmias, and vascular disorders, as well as pre-operative cardiac surgical evaluations.

In addition, Dib performs more than 330 non-surgical procedures annually, such as cardiac catheterization, balloon angioplasty, coronary artery stenting, intravascular ultrasound, percutaneous left ventricular assist devices, and peripheral vascular interventions.

A tireless scientist, Dib is committed to improving the lives of people suffering from heart disease by developing innovative treatment methods. One of his current areas of focus involves cardiac adult stem cell transplantation to determine if heart tissue damaged by a heart attack can, in fact, be regenerated. His research is also exploring the regeneration of blood vessels through gene therapy. To date, he has completed two leading-edge research projects in translational adult stem cell research, which led to FDA clearance for both projects to begin Phase I clinical trials.

Dib is the founding member and president of the International Society for Cardiovascular Translational Research, a nonprofit organization whose purpose is to bring innovations tested and proven through research into mainstream medical practice for the benefit of patients.

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Finalist: Mitchell Shub, MD

Mitchell Shub, MD
Medical Director/Research
Phoenix Children’s Hospital

Dr. Mitchell Shub, medical director of research at Phoenix Children’s Medical Group, has been in a leadership position at the hospital for 25 years. While he still sees patients on a daily basis, most of his time is spent overseeing research operations on campus. Mitchell Shub, Medical Director at Phoenix Children's Hospital, 2010 Health Care Leadership Awards

Additionally, he is co-chair of the Institutional Review Board, and chair of the Scientific Review Committee that reviews all investigator-initiated research studies and fosters collaborations with the University of Arizona Medical School, Arizona State University, T-Gen and Mayo Clinic.

Shub is involved in three research projects of his own and is developing two others, funded by grants from the National Institute of Health, UA and pharmaceutical companies.

In the health care industry for 28 years, Shub serves as professor of clinical pediatrics/associate head of the department of pediatrics at the UA. In this capacity, he oversees all pediatric training for medical students, and with the dean makes decisions on appointments, academic promotions and academic program development.

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David Winston, MD, FACP, AGAF
Director, Gastroenterology & Hepatology
Cigna Medical Group

Dr. David Winston has a long-standing commitment to medical research, and throughout his 35 years in medicine he has worked to develop a deeper understanding of the treatment and prevention of colon cancer and Hepatitis C.
Winston has been director of gastroenterology and hepatology at Cigna Medial Group in Sun City for nearly 20 years, and is a clinical investigator for the University of Arizona College of Medicine.

David Winston, MD, FACP, AGAF Director, Gastroenterology & Hepatology Cigna Medical Group, 2010 Health Care Leadership Awards

He has participated in 33 research studies, 18 of which he served as principal investigator. He has published 33 papers and lectured in 25 cities and five countries around the world about new advancements in GI treatment and research.

As a practicing physician, Winston treats patients daily for a wide variety of gastro and digestive needs, such as stomach pain, frequent indigestion, and chronic GI problems, and encourages patients to participate in clinical trials so science can progress in the areas of early cancer detection.

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