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Thursday, July 5, 2018

Moms can put an end to childhood obesity


Hey, mamas, here’s yet another reason to commit to a healthy lifestyle.
Mothers who model healthy choices — eating a good diet, getting regular exercise, keeping your weight down, drinking sparingly and saying no to nicotine — are 75 percent less likely to have obese kids, according to a new study published in the British Medical Journal on Wednesday.
That number shoots up to 82 percent when a mom encourages her children to do the same.
Although that might sound like common sense, the study’s authors at the Harvard T.H. Chan School of Public Health are the first to prove that a mother’s healthy habits can have a direct, measurable impact on her little ones’ weight.
“An overall healthy lifestyle really outweighs any individual healthy lifestyle factors followed by mothers when it comes to lowering the risk of obesity in their children,” study author Qi Sun says.
While the data show that adhering to all five factors is really best, there’s also good news for those who aren’t quite so high-achieving — moms who eat well but can’t bring themselves to go to the gym, for instance.
Just maintaining a healthy body weight alone makes a woman’s children 56 percent less likely to be obese.

What tech giants really do with your data


Tracking your phone’s gyroscope, scanning your messages and giving your data to third-party companies.
These are just three of the things you agree to when signing up to some tech companies’ apps and sites.
BBC research has found some of the language used in privacy policies and terms requires a university education to be understood.
But dig down beneath the jargon, and there are some surprising realities about how your data is used.

1. Your location is tracked – even if you don’t allow it

Many apps ask permission to track your precise location through your phone’s Global Positioning System (GPS), which users can refuse.
But even if you refuse the app permission, they can still see where you are.
Facebook, for example, collects location-related information aside from your phone’s GPS. It still tracks where you are through IP addresses, “check-ins or events you attend”.
Twitter also “requires” information about your current location, “which we get from signals such as your IP address or device settings”. This is so it can “securely and reliably set up and maintain your account”.

2. Companies pass your data to affiliates…

When you agree to terms and conditions, you often don’t just give your data to that specific app – there’s a lot of intra-group data sharing.
For example, the data that dating app Tinder collects is shared with other members of the Match Group, which includes other dating sites OkCupid, Plenty of Fish, and Match.com.
Tinder says it does so for “maintenance, customer care, marketing and targeted advertising”, and to remove users who violate their terms of use.
Elsewhere, LinkedIn was bought by Microsoft in 2016, and according to its privacy policy, receives data “about you when you use some of the other services provided by us or our affiliates, including Microsoft.”

3. …and you’re also bound by third-party terms

If having to read the tech giant’s terms itself wasn’t enough, you might also have to read those of other companies that deal with your data.
Amazon says they may share your information with third parties: as well as their own terms, users should “carefully review their privacy statements and other conditions of use”.
Or, if you use Apple products, your personal data is shared with companies “who provide services such as information processing, extending credit […] and assessing your interest in our products and services”.
The EU’s General Data Protection Regulation (GDPR), which came into force in May, does not order companies to list these third parties in their terms.
However, Ailidh Callander, legal officer at Privacy International, a charity, says this has worrying implications: “It means that companies like data brokers are able to use your location, your interests, your contacts and much more to profile you.
“Privacy policies can be overwhelming, but it is really important to take the time to look not only at what data is being collected and why, but also who it is being shared with (and for what purposes)”, she adds.
Wikipedia, on the other hand, does not share your personal information with third parties for marketing purposes. Their terms also make a point of saying how they “don’t allow tracking by third-party websites you have not visited”.

4. Tinder collects gyroscope data

Sometimes data collection goes beyond name, age and location.
Tinder says that the app collects data from your phone’s accelerometers (for measuring movement), gyroscopes (which measure the angle you’re holding your phone at), and compasses.
It doesn’t, however, say exactly what that data is used for.

5. Facebook keeps your deleted searches…

Facebook offers the option to delete searches from their history, giving the user the impression that records of their searches are wiped clean.
The problem, however, is that they aren’t.
Their data policy states that while search history can be deleted at any time, “the log of that search is deleted after 6 months”.

6. …and tracks you even if you’re off the app

Facebook even tracks what you do when you’re not signed in to it – or when you don’t have an account.
According to its data policy, it works with “advertisers, app developers and publishers”, who can send them information “about your activities off Facebook”, through something called Facebook Business Tools.
These partners “provide information about your activities off Facebook – including information about your device, websites you visit, purchases you make, [and] the ads you see”.
This happens “whether or not you have a Facebook account or are logged into Facebook”.

7. LinkedIn scans your private messages

If you thought private messages were private, think again.
LinkedIn uses “automatic scanning technology on messages”, according to its privacy policy.
Twitter, meanwhile, stores and processes your messages.
It uses data about “whom you have communicated with and when (but not the content of those communications) to better understand the use of our services, to protect the safety and integrity of our platform.”

8. And if you’re under 18, your parents should have read this with you

Apple’s terms say that “children under the age of majority should review this Agreement with their parent or guardian to ensure that the child and parent or legal guardian understand it.”
Yet as BBC research found, to sit through and read their privacy policy and terms would take the average adult more than 40 minutes – let alone the average 13-year-old.
And if reading the privacy policy once wasn’t enough, Amazon invites you back to check again: “Our business changes constantly and our Privacy Notice will change also. You should check our website frequently to see recent changes.”

9. Don’t use your iPhone to make nuclear weapons

Finally, Apple has a line in its UK terms of use telling customers not to use their products “for any purposes prohibited by United States law”.
According to their definition, that includes “without limitation, the development, design, manufacture or production of nuclear, missile or chemical or biological weapons”.

ASCO Updates Clinical Guidelines for HER2+ Breast Cancer


The American Society of Clinical Oncology (ASCO) has updated its clinical practice guidelines on systemic therapy for patients with human epidermal growth factor receptor 2 (HER2)–positive advanced breast cancer.
In 2014, ASCO published evidence-based clinical practice guidelines (J Clin Oncol2014;32:2078-2099) on the optimal management of this population of patients with breast cancer. The goal of this update is to provide oncologists and other clinicians with current recommendations regarding treatment of these patients.
However, after an expert panel identified and reviewed 622 publications, they concluded that no results would change the 2014 guideline recommendations.
The updated guidelines are therefore almost unchanged and were published online June 25 in the Journal of Clinical Oncology.

Key Recommendations

The current recommendations for optimal medical therapy for patients with advanced HER2-positive breast cancer include the following:
  • HER2-targeted therapy–based combinations for first-line treatment should be recommended except for highly selected patients with estrogen receptor–positive or progesterone receptor–positive and HER2-positive disease. In those cases, endocrine therapy may be used alone (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after first-line HER2-targeted therapy, second-line HER2-targeted therapy–based treatment is recommended (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after second-line or greater HER2-targeted treatment, third-line or greater HER2-targeted therapy–based treatment is recommended (type: evidence based; evidence quality: intermediate; strength of recommendation: moderate).
  • Combination treatment with trastuzumab, pertuzumab, and a taxane is recommended for first-line treatment, unless taxanes are contraindicated (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after first-line HER2-targeted therapy, trastuzumab emtansine (T-DM1) is recommended as second-line treatment (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • If disease progresses during or after second-line or greater HER2-targeted therapy but the patient has not received T-DM1, clinicians should offer T-DM1 (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • For those already receiving HER2-targeted therapy and chemotherapy combinations, chemotherapy should continue for approximately 4 to 6 months (or longer) and/or to the time of maximal response, depending on toxicity and in the absence of progression. HER2-targeted therapy should continue after chemotherapy is stopped, and no further change in the regimen is needed until progression or unacceptable toxicities (type: evidence based; evidence quality: intermediate; strength of recommendation: moderate).
  • If a patient finished trastuzumab-based adjuvant treatment 12 months or less before recurrence, the second-line HER2-targeted therapy–based treatment recommendations should be followed (type: evidence based; evidence quality: intermediate; strength of recommendation: moderate).
  • If trastuzumab-based adjuvant treatment is completed more than 12 months before recurrence, first-line HER2-targeted therapy–based treatment recommendations should be followed (type: evidence based; evidence quality: high; strength of recommendation: strong).
  • For hormone receptor–positive and HER2-positive disease, the following may be recommended:
    • HER2-targeted therapy plus chemotherapy (type: evidence based; evidence quality: high; strength of recommendation: strong).
    • Endocrine therapy plus trastuzumab or lapatinib (in selected cases; type: evidence based; evidence quality: high; strength of recommendation: moderate).
    • Endocrine therapy alone (in selected cases; type: evidence based; evidence quality: intermediate; strength of recommendation: weak).
ASCO has also added a qualifying statement: Although clinicians may discuss using endocrine therapy with or without HER2-targeted therapy, most patients will still receive chemotherapy plus HER2-targeted therapy.

Treatment for Brain Metastases

At the same time, ASCO has also updated its 2014 consensus-based guideline recommendations (J Clin Oncol. 2014;32:2100-2108) for the management of brain metastases in patients with HER-2 positive advanced breast cancer.
Once again, after a review of 622 articles, the expert panel found no additional evidence that would warrant a change to the previous recommendations.
The key recommendations include the following:
  • Options for patients with a favorable prognosis and a single brain metastasis include surgery with postoperative radiation, stereotactic radiosurgery (SRS), whole-brain radiotherapy (WBRT with or without SRS), fractionated stereotactic radiotherapy (FSRT), and SRS (with or without WBRT); serial imaging every 2 to 4 months may be used to continue to monitor for local and distant brain failure.
  • Options for patients with a favorable prognosis for survival and limited (two to four) metastases include resection for large symptomatic lesion(s) plus postoperative radiotherapy, SRS for additional smaller lesions, WBRT (with or without  SRS), SRS (with or without  WBRT), and FSRT for metastases greater than 3 to 4 cm. For metastases less than 3 to 4 cm, options include resection with postoperative radiotherapy.
  • WBRT may be offered for patients with diffuse disease/extensive metastases and a more favorable prognosis or symptomatic leptomeningeal metastasis in the brain.
  • Options for patients with a poor prognosis include WBRT, best supportive care, and/or palliative care.
  • For patients with progressive intracranial metastases despite initial radiation therapy, options include SRS, surgery, WBRT, a trial of systemic therapy, or enrollment in a clinical trial.
  • For patients whose systemic disease is progressive at the time of brain metastasis diagnosis, HER2-targeted therapy is recommended.
  • Patients without a known history or symptoms of brain metastases should not undergo routine surveillance with brain MRI.
Several of the authors for both guidelines have disclosed relationships with industry.

HCA to open 24/7 ER in east Houston as Harvey-shut hospital preps for demo


HCA Healthcare’s Gulf Coast Division will open a freestanding emergency services site on July 17, according to a press release.
HCA Houston ER 24/7 will be at 6191 E. Sam Houston Parkway North in the New Forest Crossing shopping center off Beltway 8 near Highway 90. It will occupy a 5,625-square-foot space that used to house a CHI St. Luke’s Health-Baylor St. Luke’s Emergency Center location, HCA Gulf Coast spokeswoman Debra Burbridge confirmed.
A ribbon cutting ceremony will be held July 16 from noon to 2 p.m. In addition to emergency physicians, the new center will offer access to on-call specialists, on-site testing and imaging, and direct admission to a hospital if necessary, per the release.
HCA is opening the new ER to help fill a gap left when East Houston Regional Medical Center closed.
“The Gulf Coast Division is committed to providing emergency services in the east Houston area and has been for more than 40 years,” Gulf Coast Division President Troy Villarreal said in the release. “Unfortunately, Hurricane Harvey destroyed East Houston Regional Medical Center, leaving many people in the area without a nearby, easily accessible place to seek medical attention in case of an emergency.”
The hospital, at 13111 East Freeway on the Bayshore Medical Center campus, was evacuated on Aug. 25 in preparation for Harvey and was flooded with nearly 6 feet of water during the storm, according to a letter to the Texas Workforce Commission and a press release. The hospital never reopened, and HCA announced in November that it would close for good. Floodwaters from Tropical Storm Allison in 2001 and Hurricane Ike in 2008 also had significantly damaged the hospital, which factored into the decision to close.
Now, demolition of the facility is scheduled to begin in late July, Burbridge told the Houston Business Journal. An exact timeline for the entire process has not been determined. Houston-based Cherry Cos. is working on the demolition.
Pre-demolition work currently is underway and includes removing usable equipment and materials from the hospital, Burbridge said.
HCA Healthcare’s Gulf Coast Division owns the East Houston Regional Medical Center building and its land, but the company is still considering several options for the property’s future, Burbridge said.
According to Harris County Appraisal District records, the hospital’s 6.7-acre property includes 212,117 square feet of buildings, most of which were remodeled in 2016. In 2017, the property was appraised at nearly $27.68 million, but the 2018 appraisal dropped to less than $9.26 million, per HCAD.
HCAD records show two smaller tracts of land also listed at 13111 East Freeway, at least one of which is also owned by HCA. That 1.25-acre tract doesn’t have any buildings listed on it and was appraised at $334,316 for 2018. The third tract has a 31,054-square-foot building on nearly 0.27 acres, and its appraised value dropped from $1.4 million in 2017 to $307,509 in 2018.
HCA Healthcare Inc. (NYSE: HCA) is based in Nashville, Tennessee. A little over a year ago, HCA announced it would buy three Houston hospitals from Dallas-based Tenet Healthcare Corp. and one from Franklin, Tennessee-based Community Health Systems Inc. Those deals made HCA Gulf Coast the largestHouston-area health care system, based on its 4,110 local licensed beds as of September 2017.
HCA Healthcare Inc. reported $43.6 billion in revenue for 2017, up about 5 percent from 2016, according to a filing with the U.S. Securities and Exchange Commission. As of Dec. 31, the company had about 253,000 employees nationwide.

Celgene, Accord Healthcare Resolve Revlimid Patent Dispute


Celgene Corp. (CELG) and Accord Healthcare Ltd. have resolved patent claims over Celgene’s leading product, blood-cancer drug Revlimid.
Under the terms of the settlement, Accord has agreed to vacate challenges to Celgene’s patents, Celgene said Thursday in a securities filing. Also, Celgene granted Accord the ability to market a generic version of Revlimid, the drug lenalidomide, for certain conditions as soon as early 2022, before Celgene’s patents and other restrictions in the U.K. and other European countries expire.
Other terms of the settlement weren’t disclosed.
The deal effectively protects Celgene’s Revlimid sales through early 2022. In its annual report filed with the Securities and Exchange Commission in February, Celgene had guided for European protection “through at least 2022.”
Revlimid, the company’s flagship cancer treatment, accounted for more than half of its $13 billion revenue in the most recent year.
This year, Celgene expects Revlimid net sales to reach $9.5 billion, up from $8.19 billion in 2017.
In 2015, Celgene reached a similar settlement with Natco Pharma Ltd., allowing the Indian drug maker to sell a limited amount of the generic version of Revlimid in March 2022.
Accord, one of the fastest-growing generic pharmaceutical companies in the U.K. and Ireland, sued Celgene in the U.K. last year. The matter was slated to go to trial this year.

Wainwright Unfazed By Zynerba Ending Trial: Drug ‘Wasn’t In Our Numbers’


Zynerba Pharmaceuticals Inc ZYNE 4.58% stock plummeted 17.8 percent at Thursday’s open after the company ended a Phase 1 study for ZYN001, a tetrahydrocannabinol patch. While there were no adverse effects, the drug failed to meet the targeted top-line results.
Shares regained ground steadily over the day, and were down 3.28 percent at the time of publication late in Thursday’s session.
H.C. Wainwright maintained its bullish view of the company and said ZYN001 had never factored into their estimates.

The Rating

H.C. Wainwright analyst Oren Livnat reiterated a Buy rating on Zynerba with a $23 price target.

The Thesis

The drug “wasn’t in our numbers,” Livnat in a Thursday note. “In fact, we view this early-stage ZYN001 termination as a sign of responsible drug development.” (See the analyst’s track record here.)
The analyst’s valuation is entirely based on ZYN002, an orphan-designated transdermal cannabidiol gel for Fragile X syndrome.
The company said it will be focusing its efforts and resources on developing ZYN002.
Zynerba is set to present new short-term and long-term data from its successful open-label “FAB-C” Phase 2 in FXS at the National Fragile X Foundation International Conference on July 12. ZYN002 is expected to enter Phase 3 trials shortly after, with top-line data projected to be available in the second half of 2019.
Livnat’s valuation assumes a 35-percent probability of success in FXS, product launch by 2021 and 30-percent penetration into the FXS population. All this translates to a peak U.S. sales estimate of $700 million.

Ironwood preparation for activist-driven R&D split puts 40 staffers out of work


Ironwood may have avoided sparring with activists by introducing an R&D split-off, but its employees paid the price.
The Massachusetts drugmaker last week pink-slipped 40 workers, or about 6% of its total staff, according to an SEC filing. The layoffs came “in connection with Ironwood’s intent to separate” its R&D unit from its marketed meds and GI business, the company said.
Ironwood didn’t give details about which departments were hit, other than saying it spared its field-based sales force. Approximately 630 full-time employees will remain on the roster after the reduction, which will likely cost between $5 million and $5.5 million to execute and wrap up by year’s end, the company added.

“We’re making strong progress on executing this separation, including the recent identification of employee roles and responsibilities within the two new companies,” a company spokeswoman toldthe Boston Business Journal in a statement.
The drugmaker, which markets GI product Linzess alongside Allergan, unveiled plans for the R&D divorce in May after fielding demands from activist Sarissa Capital. Under the blueprint, Ironwood will keep Linzess and its treatments for gout and abdominal pain, as well as a prospect for gastroesophageal reflux disease. The new company’s pipeline, meanwhile, includes therapies for orphan diseases and products targeting the nitric oxide signaling pathway for blood flow.

And the strategy worked: Shortly thereafter, Sarissa said it would back Ironwood’s board in its current form instead of trying to win a seat for its leader, Carl Icahn protégé Alex Denner. The spin “is a good first step toward creating shareholder value at Ironwood while preserving strategic optionality,” Sarissa said in a statement at the time.