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Sunday, August 5, 2018

NMC Health eyes expansion in Saudi Arabia


Abu Dhabi-based NMC Health is planning to expand in Saudi Arabia due to growing opportunities and strong demand in the health-care sector, its chief executive officer told Gulf News.
The London-listed company has significantly increased its presence in Saudi Arabia in recent times and currently owns five hospitals with a combined bed capacity of 650.
“With a population of 33 million, increasing levels of health insurance and disposable incomes on the rise, the Kingdom of Saudi Arabia is a highly attractive market with strong demographic demand. Hence the reason for our expansion into the kingdom, making us the second largest player in the private sector,” said Prasanth Manghat, CEO and executive director of NMC Health.
A few weeks ago, the health-care firm announced a transformational joint venture with General Organisation for Social Insurance (GOSI) owned by the government of Saudi Arabia to become the second largest health-care player in the kingdom. It also acquired an 80 per cent stake in Riyadh-based Al Salam Medical Group for $37 million(Dh135.89 million) earlier this year.
“In Saudi Arabia, to date, NMC already has invested in developing an increasingly strong geographic footprint. We have seen early success through our verticals-based strategy in the UAE and, in our experience, we believe Saudi Arabia is well suited to replicate this approach.”
The comments come as Saudi Arabia aims to attract foreign direct investment in health care and other sectors to boost its economy as part of the Saudi Vision 2030 that aims to wean away the country from its dependence on oil.
NMC currently manages over 150 health-care facilities including hospitals and clinics in fourteen countries across the GCC (Gulf Cooperation Council), Europe and Latin America.
When asked NMC’s investment outlay on acquisitions and further expansion in the short term, Manghat said the company evaluates every opportunity on merit with various decision-making verticals and then takes a call on allocating the necessary capital.
“Raising or allocating the necessary capital is not an area of concern as much as it is in finding the right business fit. We are keen to grow owing to strong operational and financial performance for many years now.”
On the UAE health-care sector, Manghat said it is poised to grow due to various factors such as the plans of the government to attract inflow of medical tourism as well as the mandatory insurance plan in the Northern Emirates.
“In the UAE, we have been focusing on capabilities enhancement. The group has a strong network and provides for a gamut of health-care services started with multi-specialty and then enhanced through acquisitions by adding long-term care [Provita], fertility [Fakih] and recently Cosmetics [Cosmesurge] expertise.”
“We are also focusing on the Northern Emirates, especially Sharjah where we have a strong presence through Al Zahra Hospital and Sunny Medical centres, and the anticipated rollout of mandatory insurance will further drive growth for the group.”
NMC Health sees further opportunities in the UAE due to the introduction of a 100 per cent foreign ownership law and the 10-year long-term investment visa.
“The advent of additional international investors and providers shall promote transparency and improve quality of health care based on international standards.”
This decision is also going to attract quality medical staff into the country and will also stem the flow of patients to Europe or America on the availability of international care locally, he added.
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Laboratory Corp. of America : Attacked!


Last month, the greed and unscrupulous motives of someone, somewhere, put LabCorp — Alamance County’s biggest employer — in the national news, and not for a good reason.
Malware invaded the company’s information technology system over the weekend of July 14. LabCorp assured its customers that their data was secure; headlines, however, questioned whether data had been breached and whether the millions of confidential health records were at risk.
But money was more important to the attacker than data.
It’s called “ransomware.”
Reports say that LabCorp’s information technology system was attacked by malware called SamSam.
And it wasn’t a random attack, said Megan Squire, a computer science professor at Elon University.
“They specifically go after a target,” she said, adding that other health companies have been infected by SamSam.
Reports say the attack affected 7,000 systems and 1,900 servers company-wide. The perpetrators demanded ransom to remove the malware.
The company didn’t give it to them.
“As part of our in-depth and ongoing investigation into this incident, LabCorp has engaged outside security experts and is working with authorities, including law enforcement,” the company said in a statement. “The investigation has found no evidence of theft or misuse of customer or patient data. We are confident that this ransomware did not and cannot spread to customer networks.”
LabCorp said that it blocked the ransomware and enhanced its security measures, and was confident that the ransomware could not reappear on its network.
“LabCorp takes data privacy and security very seriously and has robust security systems, protocols, and redundancies in place,” the company said. “We responded quickly and decisively to protect our patient and customer data and to resume operations.”
The incident revealed that even a company with resources as vast as LabCorp is vulnerable to attack.
There was a time when the average computer user just had to worry about hackers infecting their computers with viruses that would shut their systems down.
A nuisance, to be sure, but now, with new sophisticated malware, the stakes are much higher.
And if that is so, how can small business and other computer users protect themselves?
Local computer security experts say that they see cases of ransomware in Alamance County and that with proper precautions, while the risk of attacked is always there, it can be reduced.
Elliot Lynch, owner of ValuSystems Computers on South Church Street in Burlington, recalled a recent case of an elderly woman whose husband had recently died.
His poetry that he had written was stored on her computer, along with photos.
Her computer was infected and the perpetrators demanded $500. She did not pay it.
“A lot of people are heartbroken because who has five hundred or a thousand bucks to retrieve their information?” Lynch said.
Ransomware operators demand that their victims pay the ransom with cyber currency, like BitCoin, so it can’t be traced.
Elliot and other computer experts say that the most important thing is to back up and patch up.
“If you have a good backup, your hand is not forced to pay anything,” said Robert Marsh, owner of Pinnacle Computer Systems, also on South Church Street in Burlington.
Back up computer data, photos, documents and other information on a USB drive. Keep it in a safe place.
“If you are business, you may want to consider multiple backup strategies,” said Lynch, such as cloud services.
A business should consider keeping their data backed up on two drives — one for the office, another that can be kept at a separate, secure location in case of fire or floods.
Patch up means making sure that your computer is protected with the latest software updates.
And Lynch recommends that people get their computers scanned professionally at least twice a year. He also advises that people change their passwords periodically.
Other safety precautions include not giving your credit card number to unknown sources and being wary of phone calls and emails from people claiming to be banks. And be wary of clicking on links in an email.
If you are the victim of a ransomware attack, immediately shut down your computer and contact an IT professional.
Antivirus software company Symantech offers these tips:
* Don’t pay the ransom. Even if the ransom is paid, there is no guarantee that you will be able to regain access to your files.
* Restore any impacted files from a known good backup. Restoration of your files from a backup is the fastest way to regain access to your data.–
* Don’t give out personal information when answering an email, unsolicited phone call, text message or instant message. Phishers will try to trick employees into installing malware, or gain intelligence for attacks by claiming to be from IT. Be sure to contact your IT department if you or your coworkers receive suspicious calls
* Use reputable antivirus software and a firewall. Maintaining a strong firewall and keeping your security software up to date are critical. It’s important to use antivirus software from a reputable company because of fake anti-virus software.
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Sun Pharma recalls over 5.2k units of testosterone cypionate injections from US


The US arm of the domestic drug major Sun Pharmaceutical Industries is recalling over 5.2 thousand units of testosterone cypionate injections from the American market, the latest enforcement report of the US health regulator has said.
Sun Pharmaceutical Industries Inc is recalling 5,215 units of 10 mL vials testosterone cypionate injections in the strength of 200 mg/mL, on account of “presence of particulate matter: organic and inorganic compounds detected in vials of product,” the report said.
The injections were manufactured by Sun Pharmaceutical Industries at its Halol facility, it added.
As per the report by the United States Food and Drug Administration (USFDA), the ongoing voluntary nationwide recall is a class II recall.
According to the US health regulator, a class II recall is initiated in a situation “in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The injections are indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.
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J&J Bets on Chinese Startup That Uses Llama DNA to Fight Cancer

At a cancer conference in Chicago in June last year, a little-known Chinese startup stunned researchers with early results showing its experimental gene therapy was abating an aggressive form of blood cancer in patients back home.
Six months the later, the startup, Nanjing Legend Biotechnology Co., received $350 million from Johnson & Johnson for the global rights to co-develop and market the experimental treatment. In May, the U.S. Food and Drug Administration approved its testing on Americans, making it the first Chinese-developed gene therapy to receive such a signoff. The companies plan to kick off a U.S. trial later this month.
The collaboration between J&J and Legend shows how aggressively China is seeking to transform itself from a maker of cheap, copycat medicines into a producer of complex drugs — aided by looser regulations and government policies to fast-track innovation.
Peter Lebowitz, who heads cancer research at J&J’s drug arm, Janssen Pharmaceuticals, said he was skeptical when he heard of Legend’s Chicago presentation. “It might not be real,” he recalled thinking.
A senior Janssen scientist who attended the presentation persuaded Frank Fan, Legend’s chief scientific officer, to showcase results to Mr. Lebowitz. Dr. Fan visited J&J’s Spring House, Pa., facility days later.
Janssen executives flew to Nanjing the following month. The 20-member-plus team outnumbered Legend’s 19 employees at the time, Dr. Fan said. They spent two days poring over Legend’s science and results, interviewing participating doctors and patients.
“Overall, it all checked out,” Mr. Lebowitz said. We “became pretty convinced that this data was remarkable.”
For J&J, the deal is a way into a lucrative field of gene therapy known as CAR-T, for chimeric antigen receptor T-cells.
CAR-T therapy involves extracting patients’ disease-fighting white blood cells, genetically modifying them in lab to more vigorously attack the disease, then re-injecting them into their bodies.
U.S. scientists paved the way for the first such treatments — by Novartis AG and Gilead Sciences Inc. — to be approved last year. Those therapies treat aggressive forms of lymphoma and leukemia.
But it is in China that the most tests on patients are happening, according to a U.S. National Library of Medicine database. Chinese scientists have forged ahead in part because Beijing has made scientific innovation a national priority and singled out genetics-based therapies like CAR-T.
The field is so new that China didn’t have rules for such experiments until a few months ago.
Legend needed permission only from local hospitals to start testing its experimental therapy on patients in 2015. In the U.S., FDA permission is needed before any experimental treatment can be tested on humans. While China’s FDA recently introduced similar rules, companies continue to run experiments through hospitals, which have the authority to sign off on doctors’ research on patients, alarming Western scientists who fear a botched test may set back the field.
“Clearly it gives them a competitive advance,” said Carl June, a University of Pennsylvania immunologist whose research led to the development of Novartis’s CAR-T treatment, Kymriah. He noted, however, that “early stage testing can be done with very little oversight.”
Novartis is sponsoring a CAR-T trial at Penn that, like Legend, targets multiple myeloma patients on whom traditional therapies have failed.
Cambridge, Mass.-based BlueBird Bio Inc. and partner Celgene Corp. are also testing a multiple myeloma CAR-T candidate. The companies are ahead in testing their candidate in the U.S., meaning they could apply for regulatory approval there before Legend.
Legend’s scientific breakthrough came in an unusual place: the DNA of an American llama. Dr. Fan knew from previous research that disease-fighting proteins, or antibodies, produced by the woolly mammal could be manipulated more easily than those produced by mice or humans.
He engineered them to latch onto two sites on a malignant protein found in multiple myeloma patients, increasing the odds that it would be destroyed. Then, he genetically modified patients’ white blood cells so that they produce the re-engineered llama-based antibody. Once the cells are injected back into patients’ bodies, the antibodies latch onto the malignant proteins and help diffuse them.
At a hospital in the city of Xi’an, where Dr. Fan once worked, many patients improved after signing up for Legend’s research in late 2015. Among them is 55-year-old farmer Zhan Fengying, whose cancer had made her so weak that death seemed imminent before she enrolled in Legend’s research in mid-2016. “My entire village was sure I was going to die. So was I,” she said.
Legend’s results haven’t been peer reviewed. Data reviewed by The Wall Street Journal, show that 39 out of 57 multiple myeloma patients treated through September had no detectable trace of cancer in their bone marrow a median 7.6 months after receiving the therapy. At a follow-up measurement in February, it had taken a median 15 months before some patients’ cancers progressed in that group, although most patients stayed in remission, the company said. Six other patients died because of what the company said were their diseases progressing.
Legend is a unit of GenScript Biotech Corp., a firm that designs artificial genes for drug companies. GenScript co-founder Frank Zhang created Legend in 2014 in an effort to advance cancer care after losing his father to the disease.
Mr. Zhang appointed Dr. Fan to pursue CAR-T research with a team of three scientists.
The team shared a lab and even a fridge with GenScript colleagues. “They would laugh at us saying we were wasting our time and burning their cash, ” Dr. Fan said.
Since the Chicago conference, GenScript’s stock has risen more than sevenfold. Legend plans to approach China’s FDA as early as next year for permission to market what would be the nation’s first CAR-T treatment.
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Rite Aid to host special shareholder meeting


Special Shareholder Meeting to vote on the proposed merger with Albertsons will be held in New York on August 9 at 8:30 am.
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Diet Heavy in Meat Boosts Liver Disease Risk


Higher consumption of animal protein was independently associated with an up to 40% increase in the risk of nonalcoholic fatty liver disease (NAFLD) in overweight, predominantly elderly Caucasians, researchers reported.
While the associated risk was higher than that of classic NAFLD risk factors, surprisingly there was no increased risk with fructose consumption, reported Louise J.M. Alferink, MD, of Erasmus MC University Medical Center in Rotterdam, and colleagues.
“Contrary to previous literature, our results do not support a harmful association of monosaccharides and disaccharides with NAFLD,” the authors wrote in Gut, but noted that most previous research has been done on fructose consumed in sugary soft drinks, while in this study population the main source was fruit.
The new research supports current evidence on the importance of dietary composition in NAFLD independent of caloric intake and may lead to more specific dietary recommendations for the prevention and management of NAFLD, the investigators said. “In particular, it shifts focus from the carbohydrate and fat debate towards the third, previously underexplored macronutrient, protein.”
In the analysis from the population-based Rotterdam Study, 3,882 participants were assessed for the following parameters: average intake of protein, carbohydrate, fat, and fiber via a 389-item Food Frequency Questionnaire and the presence of NAFLD via ultrasonography in the absence of excessive alcohol use, steatogenic drugs, and viral hepatitis.
The mean age of participants was 69.7; a total of 58.3% were female, 97.6% were Caucasian, and 337 (34.4%) were found to have NAFLD. The overall median body-mass index (BMI) was 26.9, compared with 29.3 in those with NAFLD; 90.1% in this group were overweight versus 59.1% in those without NAFLD.
The average overall daily caloric intake was 2,031 kcal and slightly lower in the NAFLD group, at 1,996 kcal. Metabolic syndrome was present in 73% of participants with NAFLD versus 40.8% in those without, and 23.7% versus 7.5% had diabetes mellitus.
Among participants, 132 were lean and 1,205 were overweight. Total protein was associated with NAFLD in overweight individuals after adjustment for sociodemographic and lifestyle covariates, for an odds ratio (OR) of 1.40 in the highest quartile (Q4) of intake quartile 4 versus the lowest (Q1) quartile (95% CI 1.11-1.77).
This association was driven by animal protein (OR Q4 versus Q1 1.54, 95% CI 1.20-1.98). After the researchers adjusted for metabolic covariates, only animal protein remained associated with overweight-related NAFLD (OR Q4 versus Q1 1.36, 95% CI 1.05-1.77). No risk increase was observed with vegetable protein.
The researchers said that interestingly, monosaccharides and disaccharides were actually associated with a trend to lower overall NAFLD prevalence (OR Q4 versus Q1 0.66, 95% CI 0.52- 0.83), but this effect diminished after adjustment for metabolic covariates and BMI. No consistent associations were observed for fiber or any fat subtypes, including monounsaturated fatty acids.
Underscores Complexity of NAFLD
Asked for his perspective, Zobair M. Younossi, MD, MPH, of Inova Fairfax Hospital in Falls Church, Va., who was not involved with the research, said: “The findings underscore that NAFLD is a very complex disease, and that diet is only one component. The most important message is that we have to think about maintaining healthy dietary habits, eating all kinds of foods, and not overdoing any one nutritional component.”
Younossi pointed out, however, that since NAFLD is a common but not a progressive liver disease, it would be more important to focus on the impact of diet in those patients who progress to nonalcoholic hepatosteatosis, which would require biopsy.
Alferink and co-authors explained that the protein-related mechanisms of action remain unclear, but one hypothesis proposes that nitrate, nitrite, heme iron, and their byproducts in both unprocessed and processed meats could act as mediators between intake and cardiovascular and metabolic homeostasis. Heme iron has been associated with increased oxidative stress and insulin resistance, while nitrate and nitrite have been linked to endothelial dysfunction and insulin resistance. One large prospective cohort study found that nitrate, nitrite, and heme iron from red meat as well as saturated fat correlated with a higher risk of developing chronic liver disease.
Another possible mechanism is low-grade metabolic acidosis induced by animal-protein acid load. High acid load might suppress growth hormone secretion and subsequent insulin-like growth factor-1 response, both associated with NAFLD. In addition, some experimental studies have shown that high dietary acid load reduces extracellular pH and insulin sensitivity and decreases beta cell response. This could lead to NAFLD, since insulin resistance is the key dysfunction in this disease, the researchers said.
Younossi added that the preservatives used in prepared meats and the antibiotics and hormones used in raising animals may also predispose to steatogenesis.
Citing the need for more research on the relevant cause-and-effect pathways, Alferink and colleagues wrote: “Ultimately, we need to understand more about the dietary components that put individuals at risk for NAFLD before we can make any firm dietary recommendations for the prevention and treatment of NAFLD.”
The team noted several limitations to the study, including the cross-sectional design, which means causality could not be addressed, as well as the potential for residual confounding. In addition, “reverse causality” may have been at play, the researchers said, since diabetic participants (13.1% of the total) might have altered their eating habits. Also, as with any self-administered questionnaire, the responses are subject to potential reporter and recall bias, including the probable underreporting of caloric intake by overweight participants. Finally, in terms of generalizability, the results may not be applicable to the macronutrient/NAFLD profiles of younger, non-Caucasian cohorts.
The Rotterdam Study is supported by the Erasmus MC University Medical Centre and Erasmus University Rotterdam; the Netherlands Organization for Scientific Research; the Netherlands Organization for Health Research and Development; the Research Institute for Diseases in the Elderly; the Ministry of Education, Culture and Science; the Ministry of Health, Welfare and Sports; the European Commission and the Municipality of Rotterdam.
The authors reported having no relevant conflicts of interest, and Younossi reported having no competing interests in relation to his comments.
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Safety of Fentanyl Risk Evaluations Questioned at FDA Advisors Meeting


There was no clear-cut decision at an FDA advisory committee meeting Friday about whether the Risk Evaluation and Mitigation Strategy (REMS) for transmucosal immediate-release fentanyl (TIRF) is working.
But a number of concerns were raised about whether patients who need the powerful painkillers can get them, and whether they are being prescribed to patients for whom they’re not intended. Research on the TIRF REMS has also called into question whether the FDA is properly reacting to warning signs.
“I know the FDA thinks the REMS is working, and I guess that depends on your definition of working,” said Lewis Nelson, MD, of Rutgers University in Newark, New Jersey, and the FDA Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC).
“I still think it’s yet to be proven that it’s working. And I’m not convinced we don’t have to actually raise the barrier a little bit,” he noted.
Two FDA advisory committees — the Drug Safety and Risk Management Advisory Committee (DSARM) and AADPAC — met to discuss the fentanyl oversight program.
In written testimony that was not presented orally at the meeting, G. Caleb Alexander, MD, and Joshua Sharfstein, MD, of Johns Hopkins University in Baltimore, submitted documents obtained through the Freedom of Information Act indicating the agency had early clues TIRF drugs were going to patients who did not have cancer or were not opioid-tolerant.
“Our preliminary findings indicate that the TIRF REMS program has generated red flags for years,” the Hopkins researchers wrote. “There have been multiple warnings that many providers have been engaged in inappropriate prescribing, placing patients at risk.”
TIRF drugs are used to manage breakthrough pain in adult patients with cancer. Because fentanyl’s potency can cause life-threatening respiratory depression in patients who are not already taking opioids, TIRF medicines are supposed to be limited to opioid-tolerant patients.
Under the TIRF REMS, which was approved in December 2011, TIRF medicine application holders must ensure that outpatient prescribers and dispensing pharmacies are specially certified, that distributors supply TIRF drugs only to certified pharmacies, and that patients are enrolled in the REMS. Patients must sign a patient-prescriber agreement stating they know about the risks and that they reviewed a product-specific medication guide. Prescribers also must attest that they understand the risks TIRF medicines pose.
But according to Alexander and Sharfstein’s findings, the FDA in 2013 supported relaxing the original language in these agreements — now prescribers no longer have to affirm that their patients have been using opioids “around the clock” for at least a week and are “opioid tolerant.”
A pharmacy claims study presented at the meeting indicated that only 58% of patients who started a TIRF medicine were opioid-tolerant, with tolerance defined by the average daily dose of opioids a patient received in the 7 days before a TIRF prescription.
And data from several sources suggested rates of abuse and adverse events had risen from the pre- to post-REMS period. But in many reports presented Friday, findings had small sample sizes or lacked details.
Of 549 deaths reported from August 2016 to August 2017, for example, 355 cases lacked sufficient evidence to determine whether they could have been caused by a TIRF. A selected analysis of 308 of those cases showed TIRF drugs were used for cancer pain in 43% of patients and for noncancer pain in 5%; the reason for TIRF prescription was not reported 52% of the time. In 81% of those selected cases, neither opioid tolerance or concomitant opioid medications were reported.
The initial TIRF REMS included Abstral, Actiq, Fentora, Lazanda, Onsolis, and generic equivalents; Subsys, a sublingual fentanyl spray from Insys Therapeutics, joined in January 2012 when it was approved by the FDA. In May 2018, the U.S. Department of Justicealleged Insys had paid kickbacks and encouraged physicians to prescribe Subsys for patients who didn’t have cancer. The federal government also has pursued criminal cases against Insys employees and Subsys prescribers.
Outpatient TIRF use has dropped significantly since the REMS started: in 2017, fewer than 5,000 people received TIRF prescriptions, a small fraction of people with cancer pain, several physicians speculated. But of those 5,000 patients with TIRF prescriptions, 42% received Subsys.
“Are the numbers of events rising because of some defect in the REMS program? Or is it because we now have a different mix of TIRF products being used?” asked DSARM member Steven Meisel, PharmD, of Fairview Health System in Minneapolis. “This could all be an artifact on the basis of the fact that now we’ve got Subsys. There’s no data one way or another on that, but it’s certainly a possibility.”
But Alexander told MedPage Today that agency oversight of TIRF drugs fell short in many ways.
“There are a number of steps that the FDA could have taken — and still can — to improve the safe use of TIRFs, including strengthening provider and patient education, improving the written patient-provider agreement form, and disenrolling prescribers who consistently put patients at risk by prescribing TIRFs for individuals lacking opioid tolerance,” he said.
Alexander, who said he hopes his research will increase transparency in REMS programs in general, noted, “there is little publicly available information about the TIRF REMS or other REMS programs, meaning that patients, prescribers and policymakers are left guessing how well these programs are working, and how they can be improved.”
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