Review Category : Health

Biotech Company and Patients Face Off to Gain Access to Their Genetic Tests

iStock/Thinkstock(WASHINGTON) — A Utah-based biotech company that had refused to let four patients access their full genetic information has reversed course, a day before the American Civil Liberties Union filed a complaint with the federal government on behalf of patients in general.

Myriad Genetics provided the patients late Wednesday with genetic information they requested in February. The company described the move as “voluntary” and maintained that it was still within its rights to withhold other patients’ complete results in the future, according to the ACLU.

The ACLU filed a complaint on Thursday with the U.S. Department of Health and Human Services, calling on Myriad to release complete gene information to all patients whenever requested. The ACLU had originally intended to file a complaint on Thursday pertaining specifically to the four patients, but amended its complaint after Myriad’s about-face, ACLU officials said.

“The position Myriad took is akin to a hospital saying that patients can only have a portion of their MRI or a portion of their physical exam records,” said Sandra Park, senior attorney with the ACLU Women’s Rights Project, adding that the company’s prior withholding of the patients’ information “clearly violates the law.”

Richard Marsh, general counsel for Myriad, said in a statement on Thursday that company officials believe the Myriad “has acted appropriately, responsibly and in compliance with the laws and regulations governing patients’ rights to access their genetic data.”

“We believe the complaint lacks merit and should not be accepted,” Myriad added in its statement.

The four patients represented by the ACLU include two women who had been previously diagnosed with breast cancer, a man with metastatic bladder cancer, and his cousin. They all had changes in their DNA, known as gene variants, which were located in the BRCA genes. The BRCA genes, when mutated, are known to be linked to breast, ovarian and prostate cancers, among others.

Myriad classified some of these variants as “benign,” Park said, and as such did not include them in test reports.

In the case of one of the breast cancer patients, Myriad had told AnneMarie Ciccarella in March that the company had already included all unknown variants and those associated with cancer risk in its initial gene report to her, but that they were not required by law to provide the full data. The company, which keeps its data in a private database, also told Ciccarella that it “does not maintain much, if any, of the items” requested beyond what it then provided.

“Their response infuriated me,” Ciccarella said during a news conference Thursday.

However, the email Ciccarella received Wednesday from Myriad showed that there were in fact ten variants on BRCA1 and five on BRCA2 that had been classified as benign and omitted from the original report.

Ciccarella said she plans to share her test results with doctors and researchers to monitor whether the changes in her DNA could be tied to potential health consequences in the future. Making complete genetic information available to patients and researchers, she said, is necessary to advance scientists’ and families’ understanding of what these DNA variants mean.

Myriad, which keeps data in a private database, wrote to Ciccarella in March that it “does not maintain much, if any, of the items” requested beyond what it then provided.

However, the email Ciccarella received Wednesday from Myriad showed that there were in fact ten variants on BRCA1 and five on BRCA2 that had been classified as benign and omitted from the original report.

ACLU officials said they are checking to see if the information she received matches the complete set she is entitled to under the Health Insurance Portability and Accountability Act (HIPAA).

HIPAA ensures that patients have access to their health and genetic information — not only the lab report, but also the “the full gene variant information generated by the test, as well as any other information in the designated record set concerning the test,” according to their guidance on genetic testing.

This is likely the first complaint seeking to enforce a patient’s right to access their own genetic information under HIPAA, Park said.

An HHS spokesperson was unable to confirm this, responding that their “complaint intake system currently does not collect data at this level of granularity.”

The HHS Office of Civil Rights will review the complaint and decide whether to open an investigation, according to Park, who also noted that it is not possible to sue under HIPAA.

HHS records show that it has not previously enforced its guidance against a company denying patients access to their own genetic information.

Myriad was also the focus of a 2013 landmark Supreme Court case, in which the judges unanimously ruled that human genes could not be patented. The company previously held a monopoly on genetic testing for the two BRCA genes. After the ruling, more labs began to offer the genetic tests at much lower prices.

Myriad also announced on Wednesday that it plans to open a web portal to provide patients access to their test results and health information.

A Myriad spokesman told ABC News Thursday in an email that “the first phase of the portal will be available by the end of the quarter,” though he did not directly confirm whether patients would be able to access full results through this portal.

“Myriad has a long track record of providing patients with free access to their test reports directly or through their healthcare providers,” the spokesman said in the email.

He did not comment on whether or how Myriad plans to provide complete genetic information in the future.

However, in a letter sent Wednesday to one of the patients represented by the ACLU, Myriad wrote that it had been in talks and “anticipates further discussions” with the HHS Office of Civil Rights.

Ciccarella said she strongly believes her genetic information belongs to her.

“My body, my blood, my data, my choice,” she said.

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

CDC Reports New System for Monitoring Cases of Zika in US Pregnant Women

iStock/Thinkstock(ATLANTA) — The Centers for Disease Control and Prevention (CDC) announced Friday that there have been a few significant changes in the way it will be monitoring the number of women with Zika virus infections in the United States and U.S. territories.

Beginning now, the CDC will report the number of pregnant women with Zika virus infection from two new surveillance systems: the U.S. Zika Pregnancy Registry and the Puerto Rico Zika Active Pregnancy Surveillance System. Already, the case count of pregnant women with Zika virus has increased significantly under these new monitoring systems – but what does it really mean?

Here’s what you need to know:

What are the new numbers?

As of May 12, 2016, two Zika virus infection surveillance systems are monitoring:

• 157 pregnant women in U.S. states with laboratory evidence of possible Zika virus infection • 122 pregnant women in U.S. territories with laboratory evidence of possible Zika virus infection

Why are these so much higher than the numbers we have been seeing?

Until Friday, the totals noted only 48 cases of pregnant women with Zika in U.S. states, and 65 such cases in U.S. territories. These numbers came from CDC reports that used a case definition established in consultation with the Council for State and Territorial Epidemiologists, which included only individuals who had laboratory test results and symptoms or pregnancy complications consistent with Zika.

However, recently published reports indicate that some pregnant women with laboratory evidence of a recent Zika infection without symptoms have delivered infants with microcephaly and other serious brain defects. Therefore, starting Friday, the CDC will report numbers of pregnant women with Zika from the U.S. Zika Pregnancy Registry and the Puerto Rico Zika Active Pregnancy Surveillance System, two systems designed to collect information about pregnancies and birth outcomes among women with any laboratory evidence of possible Zika virus infection, with or without symptoms.

When asked about the big jump in these numbers, the CDC stated: “We have been monitoring pregnant women with asymptomatic and symptomatic Zika infection since February. This is not a change in who we have been monitoring; the change is that we are now publicly reporting the number.”

Are all of these women still pregnant?

They are not, though the CDC notes that the majority of these cases are ongoing pregnancies. The CDC could not provide an exact number, however, on how many of these 279 women were still pregnant and how many were no longer pregnant for any reason.

How many adverse outcomes of pregnancy have been reported?

The CDC says it is not yet reporting the exact number of adverse outcomes (such as microcephaly, other birth defects and miscarriages) “out of concern for the privacy of those families.” The agency did mention that it was “aware of less than a dozen adverse outcomes [related to Zika].”

Is the CDC releasing the specific number of cases of microcephaly and other birth defects associated with Zika?

The agency has not at this point in time but it did not rule out the possibility that it would report these numbers in the future.

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

Police Body Cam Captures Officers Saving Georgia Man’s Life with Automated Defibrillator

Justin Marion (CANTON, Ga.) — In response to dramatic police body cam footage showing the life-saving actions of two Georgia police officers after a man had a heart attack, a city council voted unanimously Thursday to have all of its police patrol cars equipped with the device the officers used to revive the man.

“It was so easy to save a life with an AED,” Canton City Clerk Susan Stanton told ABC News, referring to an automated external defibrillator. “Now, everybody is going to have them in their patrol vehicles.”

Justin Marion was in the middle of a barbell lift at a local Crossfit gym when he slumped over into unconsciousness, gym co-owner Karen Camp told ABC News.

“Everybody was standing there because no one necessarily knew what to do about it,” Camp said. “I think everybody was kind of in shock.”

Camp decided to perform CPR while responding officers were minutes away.

“I came over, checked for a pulse. He was not breathing,” Camp said. “He turned blue. I rolled him over and did CPR.”

Canton Police Officers Patrick Duncan and Jimmy Butler arrived at the gym, and their patrol car happened to be one of the few vehicles equipped with an AED. Their body cams show the frightening and intense situation unfold as they, along with Camp, coax Marion to hang in there as they attach the AED to the unresponsive man. Laying shirtless on the floor, Marion jerks from the shock of the AED. CPR is again performed by one of the officers. Marion starts to breathe.

“I don’t have any recollection of that day,” Marion told ABC News. “I spent the last three years focusing on my health, losing weight and getting in shape. This is the last thing I expected to happen to me. I thought I was doing everything right.”

Marion said doctors confirmed he suffered a heart attack and had significant heart blockage. The aircraft maintenance technician considers himself very fortunate after he said doctors told him only 10 percent of people who suffer such a heart attack survive.

“It was a miracle,” Marion said. “They [doctors] said they don’t usually get to have this type of conversation with patients.”

After the incident, the Canton City Council approved funding for the purchase of 17 more AEDs so that all 33 police patrol vehicles will be equipped with one.

Canton Police Chief Mark Mitchell said he is proud of officers Duncan and Butler.

“They are extremely professional officers,” Mitchell said. “They are hardworking. They don’t see themselves as heroes. They’ll tell you that’s what they do. They feel like that’s just part of their job.”

The officers, along with Camp, will be honored on June 2.

“I’m just very grateful that it turned out the way it did,” Camp said.

“I was incredibly fortunate that those Canton police officers were just a few minutes away and that particular unit was equipped with an AED,” Marion added. “If another unit responded that didn’t have an AED, I don’t know if the outcome would have been the same.”

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

FDA Announces First Nutrition Label Change in 20 Years

FDA(WASHINGTON) — Labels on packaged foods are getting a nutritional makeover after the White House and Food and Drug Administration (FDA) announced a major overhaul of the labeling process — the first such update in 20 years.

The new labels will make the calorie count more obvious and include a new line for added sugar like high-fructose corn syrup or other sweeteners. FDA officials said specifying how much added sugar is in products with both grams and percent daily value will help Americans make healthier choices.

Another new rule updates serving sizes that are more in line with amounts that people actually consume. For example, a serving size for 12-oz and 20-oz bottles of soda will now be listed as one bottle. FDA officials stressed the change is a more accurate representation of how much people consume in one sitting (and they are not encouraging individuals to drink more soda).

Labels will gradually change over the next two years before the deadline in 2018.

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

Dramatic Increase in Number of Pregnant Women with Zika Monitored in US

iStock/Thinkstock(ATLANTA) — Federal health officials are now reporting a dramatic increase in the number of pregnant women being monitored for possible complications related to the Zika virus based on recent evidence about the virus’ impact on pregnant patients who do not outwardly show symptoms of the infection.

The number of pregnant women being monitored after having a suspected Zika infection has more than doubled, from 112 to 279, in the U.S. and U.S. territories after changes made in reporting by officials from the Centers for Disease Control and Prevention.

CDC officials clarified Friday they were being more transparent after recent findings showed that even pregnant women who were infected with Zika virus but did not show symptoms had still given birth to children with birth defects.

Previously, only pregnant women with a laboratory-confirmed diagnosis and symptoms were being reported to the public, according to the CDC.

“We’ve learned a lot in the past four months and now we know of reports of asymptomatic Zika infection linked to microcephaly, miscarriage,” said Dr. Margaret Honein, chief of Birth Defects Branch at the National Center for Birth Defects and Developmental Disabilities.

Microcephaly is a birth defect in which the infant is born with an abnormally small head and brain, leading to significant developmental issues.

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

Your Body: Added Sugar in Frozen Yogurt

Creatas/ThinkstockBy DR. JENNIFER ASHTON, ABC News Senior Medical Contributor

Many can agree that fro-yo is delicious. But being that it’s yogurt, it’s also healthy for you, right?

I hate to disappoint you, but even the plain flavor at your local frozen yogurt shop is absolutely different than the plain yogurt in the grocery store.

With plain yogurt, you’re going to get protein, no added sugar and probiotics, making it a good and healthy choice.

At ABC’s Good Morning America, we looked at the nutritional information for the plain frozen yogurt from five national chains. They averaged 18 grams of added sugar per serving, with some as high as 28 grams of added sugar — that’s equivalent to seven sugar cubes.

So what should you do?

Look for shops that serve a 4-ounce size. A 4-ounce serving of frozen yogurt is slightly less than the size of your fist.

And lastly, consider it an occasional treat, not a daily practice.

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

3-Year-Old Battling Cancer to Be Sworn into FDNY

iStock/Thinkstock(NEW YORK) — A 3-year-old boy from Hawaii is to be honored by the Fire Department City of New York at the end of this month — being sworn in as a junior firefighter.

Trucker Dukes was diagnosed with stage 4 neuroblastoma at a year old, mom Shauna Dukes told ABC News. And although he’s fighting a serious illness, Trucker, whose dad is a firefighter, hasn’t forgotten the thing he loves most: the fire department.

“I’m pretty sure he was just born a firefighter, so his love of fire trucks comes very naturally,” Shauna wrote to ABC News Thursday. “He loves his daddy and has grown up in his daddy’s station, which I’m sure also contributed.”

The Dukes family live on the island of Maui, but Trucker and his mom fly back and forth to New York for his cancer treatments. Trucker’s 3rd birthday party in April was hosted by firefighters from FDNY Engine 22, Ladder 13, Battalion 10.

“After we hung out at our dear friend Capt. Jim Grismer’s firehouse for St. Patrick’s Day, some of the photos blew up on Facebook and the fire commissioner contacted Capt. Jim saying they wanted to do that for him,” Shauna said.

On May 31, Trucker will be sworn in as an FDNY “Junior Firefighter.” The FDNY often honors young children like Trucker, who are bravely battling an illness, the department told ABC News.

“Trucker is always excited to see ‘his boys,'” Shauna said. “I’m not sure if he actually realizes what a big deal this is.. What has been ‘Trucker boy’s’ normal is so not normal. This has been one of our biggest, tragic blessings.”

She added: “We are so happy and so honored to have been adopted by the FDNY and to have them celebrate Trucker. It’s really something special.”

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

CDC: Public Pools, Hot Tubs Rife with Health and Safety Violations

iStock/Thinkstock(ATLANTA) — As the weather warms and Memorial Day looms, children and adults alike will soon be flocking to swimming pools. But just when you thought it was safe to go back in the water, a new report from the U.S. Centers for Disease Control and Prevention is warning water-lovers to be careful before jumping into the deep end.

The CDC looked at inspection data from the five states with the most public pools and hot tubs, which included 48,632 public aquatic venues, that were inspected in 2013.

The report revealed that 80 percent of public aquatic venues had at least one violation and one in eight were closed after the inspection due to serious health and safety violations. The most common violations involved improper pH (15 percent), which is a measure of the water’s acidity; safety equipment (13 percent); and disinfectant concentration (12 percent).

“No one should get sick or hurt when visiting a public pool, hot tub, or water playground,” Dr. Beth Bell, director of the CDC’s National Center for Emerging and Zoonotic Infectious Diseases, said in a statement Thursday. “That’s why public health and aquatics professionals work together to improve the operation and maintenance of these public places so people will be healthy and safe when they swim.”

Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York City, told ABC News the findings emphasize how people need to be alert and aware of their surroundings when they go to a public pool.

“You take for granted that you’re safe when you go to these facilities,” said Glatter, who was not involved in the new CDC report. He said these lapses in safety can result in infections and increases in communicable diseases.

There are basic steps people can take when visiting the pool to diminish the risk of getting sick. While the CDC advises using test strips, Glatter said people can also ask a lifeguard or manager about maintenance.

“I think [you should] look around the cleanliness of the pool,” Glatter said. “If can you see the bottom when you [get to] the deep end,” it’s a sign that it’s clean.

The CDC released the Model Aquatic Health Code this year to give guidance to local and state authorities that oversee public aquatic spaces.

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

Yellow Fever Outbreak Called ‘Serious’ As Deaths Near 300

iStock/Thinkstock(NEW YORK) — Experts from the World Health Organization (WHO) emergency committee convened Thursday to discuss the growing yellow fever outbreak and determine whether to designate it a global health concern. Though it labeled the outbreak a “serious” concern, the committee stopped short of declaring it a global public health emergency.

The WHO committee said it is a “serious public health event which warrants intensified national action and enhanced international support” but was not yet a public health emergency of international concern.

An estimated 2,267 people in Angola have contracted the yellow fever virus in this outbreak, and approximately 300 have died, according to WHO officials.

Three countries — the Democratic Republic of Congo, Kenya and China — have reported the infection in travelers who had recently returned from Angola. The disease has been mainly spread by the mosquito Aedes aegypti, which also spreads Zika and other diseases.

Professor Oyewale Tomori, chairman of the WHO yellow fever emergency committee, said more resources were needed to deal with the outbreak.

“With 300 people dead, it reinforces the potentially explosive nature of the disease and risk internationally,” he said in a call with reporters Thursday.

There is a vaccine that prevents yellow fever but no cure for those infected. The WHO said it is working with manufacturers to stockpile more vaccine doses. It recommends that anyone visiting Angola get a yellow fever vaccination.

In most cases, the illness lasts three to six days and can have a range of symptoms, from virtually none to fever, chills, severe headache, back pain, general body aches, nausea, vomiting, fatigue and weakness, according to the U.S. Centers for Disease Control and Prevention.

In 15 percent of cases, a brief remission can be followed by a more severe case characterized by high fever, jaundice, bleeding and eventually shock and failure of multiple organs.

Copyright © 2016, ABC Radio. All rights reserved.

Read More →

San Francisco May See Health Warnings on Some Soda Ads This Summer

iStock/Thinkstock(SAN FRANCISCO) — San Francisco residents may see warning signs on certain soda advertisements about the beverage’s possible health hazards starting this summer.

But the battle over the warnings will continue even though a federal court denied a move by the American Beverage Association and other state associations to block the warnings.

The groups had tried to block the message from the beverage ads in the city that states: “WARNING: Drinking beverages with added sugar(s) contributes to obesity, diabetes, and tooth decay. This is a message from the City and County of San Francisco.”

According to court documents, the warning will be required on paper, poster and billboard ads in areas like stadiums or bus shelters. It will not be required in newspaper, TV or radio ads, or on the internet. It will also not be required on menus or the actual containers. When featured, the warning must take up “20 [percent] of the area of each” ad, the court docs state.

After the court’s ruling earlier this week, the ABA said it “look[s] forward” to continuing its fight in court.

San Francisco would be the first city to have warnings on publicly displayed soda ads. The city may also have a ballot initiative on the November ballot for a tax on soda consumption. Other cities like Philadelphia and Boulder, Colorado, are also considering measures to institute some kind of soda tax.

Soda consumption is at its lowest level in 30 years, according to Beverage Digest, a trade publication, as consumers turn to healthier beverage options.

Last July, the ABA, the California Retailers Association and the California State Outdoor Advertising Association sued the city of San Francisco to overturn the ad law that was enacted last year, saying it suppresses First Amendment private speech and penalizes private speakers for their views on sugar-sweetened beverages, according to the complaint.

The plaintiffs had hoped for an injunction to prevent the city from enforcing the law. But on Wednesday, the court denied their motion for a preliminary injunction. Judge Edward Chen wrote in his decision that the plaintiffs “are not likely to succeed on the merits of their First Amendment claim, and it is unlikely that they would suffer irreparable harm if the ordinance were to go into effect.”

The ABA said in a statement following the court’s decision, “We are disappointed in the Court’s ruling on our motion for a preliminary injunction as we believe that the City of San Francisco’s mandate violates the constitutional rights of a select group by unfairly discriminating against one particular category of products, based on one ingredient found in many other products.

“We are reviewing the decision and look forward to making our case on the merits of this ordinance in court.”

Copyright © 2016, ABC Radio. All rights reserved.

Read More →