Business booming for plastic giants as change beckons

It’s the worst enemy of environmental campaigners, but people around the world use mountains of plastic every day and business is booming for manufacturers.

Much to the chagrin of activists, an increasingly restrictive regulatory environment appears to have put little dent in the industry’s power so far.

That is changing, however, and plastic giants are starting to adapt.

From 2006 to 2016, global plastic output rose from 245 million to 348 million tonnes, according to the PlasticsEurope trade association. Production rose by 3.9 percent in 2017. In 2016 the growth rate stood at 4.0 percent, and in 2015 at 3.5 percent.

Demand for thermoplastics alone—which includes the most common kinds of plastic, such as PET used in water bottles, polypropylene, polyethylene and PVC—has soared by 4.7 percent yearly from 1990 to 2017.

“Is this going to continue in the coming years? We can assume it will,” said Herve Millet, technical and regulatory affairs manager at PlasticsEurope.

“The reasons why plastic (production is) growing worldwide are not just going to go away all at once,” he added.

The growth of the plastics industry goes hand-in-hand with economic development, Millet said.
The more an economy grows, the more plastic is used in construction, infrastructural development, electrical and electronic industries, and transport.

Single-use plastic packaging—the nemesis of environmental activists—is also in strong demand in developing countries.

China leads the pack

Even in Europe, where anti-plastics campaigning has been especially vigorous, packaging accounts for 40 percent of consumption.

But the world’s leading producer of plastic is China. Today it holds a whopping 29 percent of the market share, up from 15 percent just a decade ago.

European, US and Japanese plastic manufacturers have meanwhile seen their market share shrink.

Where Western producers are doing especially well is in the development of so-called specialty plastics used in the construction, automobile, medical and other industries.

New polymers are also being used in the aviation and space industry, as well as in the creation of specialty athletic footwear.
Pierre Gadrat, who heads the chemicals and materials division of France-based consulting firm Alcimed, said this sector “is just as dynamic, if not more, than before”.

The growth of the plastic industry defies concerted efforts from activists around the world, as well as an increasingly hostile regulatory environment.

Under pressure from campaigners, the European Union, Britain, India and even fast food giants like McDonald’s have all made some headway towards bringing the use of disposable plastic straws to an end.

Plastic bags are also being phased out in countries around the world, while France is set to introduce a ban on plastic plates, cups and cutlery in 2020.

Growing stigma

Emmanuel Guichard of French plastic packaging federation Elipso said the drive to end the use of single-use plastic “does not weigh massively on growth in the sector”.

However, “with all these regulatory measures coming into force, we can’t imagine that they won’t have an impact at some stage”, he added.

As public awareness grows about the terrible harm plastic pollution causes to the world’s oceans and seas, manufacturing giants are starting to worry about their image.
“Plastic as a whole is becoming stigmatised,” Millet of PlasticsEurope said.

In a bid to keep their names clean, plastic industry leaders are recycling more, following the lead of product manufacturers.

“Under regulatory pressure, plastic waste could potentially become… less seen as waste and more as a valuable raw material,” Gadrat said.

Producers of other raw materials such as metals, glass and cardboard have already fully integrated waste into their production cycles.

“This is the future of plastic: a scenario where the industry manages its raw materials and its recycled resources,” said Paris-based waste management company Citeo’s chief scientist Carlos de Los Llanos.

“It will probably take a few years,” he said, adding: “It takes learning how to do it.”

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More nurse practitioners now pursue residency programs

The patient at the clinic was in his 40s and had lost both his legs to Type 1 diabetes. He had mental health and substance abuse problems and was taking large amounts of opioids to manage pain. He was assigned to Nichole Mitchell, who in 2014 was a newly minted nurse practitioner in her first week of a one-year postgraduate residency program at the Community Health Center clinic in Middletown, Connecticut.

In a regular clinical appointment, “I would have been given 20 minutes with him, and would have been without the support or knowledge of how to treat pain or Type 1 diabetes,” she said.

But her residency program gives the nurse practitioners extra time to assess patients, allowing her to come up with a plan for the man’s care, she said, with a doctor at her side to whom she could put all her questions.

A few years later, Mitchell is still at that clinic and now mentors nurse practitioner residents. She has developed a specialty in caring for patients with HIV and hepatitis C, as well as transgender healthcare.

The residency program “gives you the space to explore things you’re interested in in family practice,” Mitchell said. “There’s no way I could have gotten that training without the residency.”

Mitchell is part of a growing cadre of nurse practitioners—typically, registered nurses who have completed a master’s degree in nursing—who tack on up to a year of clinical and other training, often in primary care.

Residencies may be at federally qualified health centers, Veterans Affairs medical centers or private practices and hospital systems. Patients run the gamut, but many are low-income and have complicated needs.

Proponents say the programs help prepare new nurse practitioners to deal with the growing number of patients with complex health issues. But detractors say that a standard training program already provides adequate preparation to handle patients with serious healthcare needs. Nurse practitioners who choose not to do a residency, as the vast majority of the 23,000 who graduate each year do not, are well qualified to provide good patient care, they say.

As many communities, especially rural ones, struggle to attract medical providers, it’s increasingly likely that patients will see a nurse practitioner rather than a medical doctor when they need care. In 2016, nurse practitioners made up a quarter of primary care providers in rural areas and 23 percent in non-rural areas, up from 17.6 and 15.9 percent, respectively, in 2008, according to a study in the June issue of Health Affairs.

Depending on the state, they may practice independently of physicians or with varying degrees of oversight. Research has shown that nurse practitioners generally provide care that’s comparable to that of doctors in terms of quality, safety and effectiveness.

But their training differs. Unlike the three-year residency programs that doctors must generally complete after medical school in order to practice medicine, nurse practitioner residency programs, sometimes called fellowships, are completely voluntary. Like medical school residents, though, the nurse practitioner residents work for a fraction of what they would make at a regular job, typically about half to three-quarters of a normal salary.

Advocates say it’s worth it.

“It’s a very difficult transition to go from excellent nurse practitioner training to full scope-of-practice provider,” said Margaret Flinter, a nurse practitioner who is senior vice president and clinical director of Community Health Center, a network of community health centers in Connecticut.

“My experience was that too often, too many junior NPs found it a difficult transition, and we lost people, maybe forever, based on the intensity and readiness for seeing people” at our centers.

Flinter started the first nurse practitioner residency program in 2007. There are now more than 50 postgraduate primary care residency programs nationwide, she said. Mentored clinical training is a key part of the programs, but they typically also include formal lectures and clinical rotations in other specialties.

Not everyone is as gung-ho about the need for nurse practitioner residency programs, though.

“There’s a lot of debate within the community,” said Joyce Knestrick, president of the American Association of Nurse Practitioners. Knestrick practices in Wheeling, West Virginia, a rural area about an hour’s drive from Pittsburgh. She said that there could be a benefit if a nurse practitioner wanted to switch from primary care to work in a cardiology practice, for example. But otherwise she’s not sold on the idea.

A position statement from the Nurse Practitioner Roundtable, a group of professional organizations of which AANP is a member, offered this assessment: “Forty years of patient outcomes and clinical research demonstrates that nurse practitioners consistently provide high quality, competent care. Additional post-graduate preparation is not required or necessary for entry into practice.”

“We already have good outcomes to show that our current educational system has been effective,” Knestrick said. “So I’m not really sure what the benefit is for residencies.”

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340B drug discount overhaul at the top of Congress, Azar’s mind

After months of talk, it appears both Congress and the administration are ready to act on reforming a popular drug discount program.

Ahead of a scheduled July 11 hearing (PDF) on the issue, the House Committee on Energy and Commerce posted 15 bills and discussion drafts regarding the 340B program, which mandates that drug manufacturers provide discounts for outpatient Medicaid drugs for low-income hospitals.

Critics, including Republicans and drug manufacturers, claim eligibility for the program is too broad and that the program has strayed from its intended purpose.

Proposed policy overhauls of the program up for consideration include clarifying the intent of the program, establishing a moratorium on the registration of certain new 340B hospitals and associated sites, and limiting the orphan drug exclusion under the program.

Other discussed changes include mandating the administration to conduct more audits of the program and requiring implementation of previous Government Accountability Office recommendations.

Late last month, the nonpartisan GAO made seven recommendations to the Health Resources and Services Administration on how to prevent duplicate discounts and ensure compliance with outside pharmacies.

In response to the report, Reps. Greg Walden, R-Ore., and Michael Burgess, R-Texas, said in a statement, “Oversight has not kept pace with program growth—lacking rigorous oversight, meaningful reporting requirements, and reliable data. Now this new report by the nonpartisan GAO shows that oversight is fundamentally lacking when it comes to important compliance issues for contract pharmacies within the program.”

Walden is chairman of the Committee on Energy and Commerce, which requested the report, and Burgess is chairman of the Health subcommittee.

However, advocacy groups in support of the program caution that major changes to the program could make participation more cumbersome for hospitals.

Overhauls of the program might not be far from the White House’s mind, either.

Alex Azar, secretary of the Department of Health and Human Services, will speak at the 340B Coalition conference in Washington on Monday.

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Gene therapy method developed to target damaged kidney cells

Gene therapy has gained momentum in the past year, following the federal government’s approval of the first such treatments for inherited retinal diseases and hard-to-treat leukemia. Now, research led by Washington University School of Medicine in St. Louis has shown, in mice, that genetic material can be delivered to damaged cells in the kidneys, a key step toward developing gene therapy to treat chronic kidney disease.

The potentially fatal condition affects 30 million Americans, most of whom don’t realize they have chronic kidney disease. No cure exists, and current treatments for end-stage disease mostly are limited to dialysis and kidney transplant. However, the researchers said gene therapy could provide a way to deliver genes that slow or reverse cell damage that leads to chronic kidney disease.

The findings are published July 5 in the Journal of the American Society of Nephrology.

“Chronic kidney disease is an enormous and growing problem,” said senior author Benjamin D. Humphreys, MD, Ph.D., director of the Division of Nephrology at Washington University. “Unfortunately, over the years, we haven’t developed more effective drugs for the condition, and this reality is leading us to explore gene therapy.”

Diabetes, hypertension and other conditions cause chronic kidney disease, which occurs when damaged kidneys cannot effectively filter waste and excess fluids from the body. Because symptoms such as nausea, vomiting, sleep disturbances and swollen limbs are common and nonspecific to the disease, most people don’t realize they have chronic kidney disease until irreparable organ damage occurs. Advanced chronic kidney disease also leads to cardiovascular disease, and patients with kidney failure have much higher rates of death from cardiovascular causes than those with healthy kidneys.

“Part of the reason there have been so few advances in kidney disease treatment is because the kidney is complex, and we don’t fully understand the disease process,” said Humphreys, the Joseph Friedman Professor of Renal Diseases in Medicine. “However, scientists are making progress, and I am optimistic.”

Credit: CC0 Public Domain

To that end, Humphreys and his team—including researchers from Harvard University and Massachusetts Institute of Technology—focused on whether adeno-associated virus (AAV), a relative of the virus that causes the common cold, could deliver genetic material to targeted kidney cells. Until now, no such virus has been capable of delivering genetic material to the kidney, and the new research provides a proof of concept for this approach.

The researchers evaluated six AAV viruses, both natural and synthetic, in mice and in stem-cell-derived human kidney organoids. A synthetic virus, Anc80, created by one of the researchers proved successful in reaching two types of cells that contribute to chronic kidney disease; these cells secrete proteins that gum up the organ and cause irreversible damage. The researchers also showed that the genetic material carried by Anc80 was transferred successfully to the targeted kidney cells. That same virus also was used by the researchers in gene therapy strategies to treat mice with kidney scarring.

“This was a happy surprise,” Humphreys said. “We were not expecting this.”

However, Humphreys cautioned that researchers are still early in the process. In future research, scientists will encounter several challenges, such as the need to identify a gene that can extensively correct damaged kidney cells, he explained. Another issue involves refining the boundaries of gene delivery to prevent delivery of the synthetic virus to other organs.

“The interesting thing about the adeno-associated viruses is that they persist in the body for many months, potentially giving a therapeutic gene a chance to do its work,” Humphreys said. “Chronic kidney disease is a slowly progressive disease so that is an advantage. After many more years of research, we could envision that patients would need injections maybe twice a year as opposed to every week, like with chemo.

“There has been so little innovation in kidney treatment,” he said. “We believe this is a positive step forward.”

 Explore further: Researchers identify potential new targets for treating kidney disease

More information: “Efficient Gene Transfer to Kidney Mesenchymal Cells Using a Synthetic Adeno-Associated Viral Vector,” Journal of the American Society of Nephrology (2018). DOI: 10.2215/ASN.2018004026

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Malpractice: When Small Oversights Lead to Major Errors

• In large medical groups, where numerous physicians may treat the same patient, extra care must be taken to correctly identify patients and their records.
• Complex systems and processes, which are often necessary for large groups, may also create unintended risks.
• In the following case, there are several points where identity errors could have been caught; physicians need to stay alert and double-check to prevent mistakes that could lead to unnecessary surgery.

The Case

One of the risks in the care given at large medical groups is that many physicians may treat a single patient. Another risk is the complexity of the systems involved and how much trust physicians must place in those systems.

Factor in an error made by an outsider, and the chance of injury increases.

Sara Tompkins (not her real name) was a 43-year-old patient of Dr IM, an internist at a large, multispecialty medical group. On June 23, Dr IM received a telephone message that Ms Tompkins reported getting “food poisoning on June 22 in Las Vegas.” The next day, Ms Tompkins executed an authorization for the Las Vegas hospital to release all medical records, “including x-rays,” to the medical group where Dr IM practiced.

The records from the Las Vegas hospital revealed a sudden onset of nausea, vomiting, and diarrhea. Though records revealed that an x-ray was taken and that gastroenteritis was diagnosed, no copy of the films or of the radiographic report was included in the transmittal. After several further attempts by Dr IM’s medical group to obtain the films, the Las Vegas hospital finally sent copies of the films and of the report to Dr IM in November. Because Dr IM does not read films, she filled out a “radiographic request form” containing Ms Tompkins’ name and age and sent the unopened envelope to the medical group’s radiology department.

Three days later, Dr R, a radiologist at the medical group, reviewed films of Sara Tompkins dated May 29 of the same year. Dr R’s impression was a “contracted, stone-filled gallbladder.” The next week, Dr IM examined Ms Tompkins and advised her that the film from the Las Vegas hospital revealed that she had gallstones. Dr IM referred the patient to the group’s general surgery department for a possible cholecystectomy and noted that the patient “does complain of recurrent epigastric discomfort over time, but is otherwise feeling well.”

Three weeks later, the patient was examined by a general surgeon at the medical group, who recommended surgery for his diagnosis of chronic calculous cholecystitis. The surgeon performed a laparoscopic cholecystectomy. The pathology report revealed cholecystitis but no stones. It was only after surgery that the group discovered that the films sent from the Las Vegas hospital were for another Sara Tompkins, who was 16 years younger than Dr IM’s patient.

The patient sued Dr IM, Dr R, the general surgeon, the assistant surgeon, and the medical group itself for failing to note the difference in the date of birth between the two “Sara Tompkins.” The plaintiff’s theory against Dr IM was that she should have questioned the situation given the incompatibility between the radiologist’s report of a contracted, stone-filled gallbladder and her own clinical findings.

As it turned out, the patient’s attorney dismissed all of the individual physicians and elected to proceed against the medical group alone. The defense of that group was complicated by the group’s loss of several significant medical records. At arbitration, the patient won an award of nearly $600,000 for the unnecessary loss of her gallbladder.

Any physician casually reviewing the facts of the case can easily spot all of the points at which the identify error should have been caught.

The challenge to physicians practicing in large group settings is to stay alert to the kinds of errors that his or her colleagues may have missed.

This case comes from Medicine on Trial, originally published by Cooperative of American Physicians, Inc., to provide risk management lessons from litigated case histories. The original title was “It’s Always Okay to Verify the Patient’s Age.”

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LabCorp Adding Digital Workflows to Pathology Services Via Philips

LabCorp, the Burlington-based diagnostics and drug-development conglomerate, will add digital workflows into its anatomic pathology services under a new collaboration with Royal Philips, a global health technology company.

LabCorp will initially implement the Philips IntelliSite Pathology Solution in four of its laboratories. A company spokesman declined to say which labs would adopt the system but did confirm that one of them would be in North Carolina.

The system is the only digital pathology solution marketed for primary diagnostic use in the United States, the company said in a news release. It helps pathologists review and interpret digital images of surgical pathology slides that are prepared from formalin-fixed, paraffin-embedded tissue. The goals are to provide improved turnaround times and more precise analysis of tissue samples.

“Digital pathology offers the opportunity for improved efficiency and enhanced collaboration between our pathologists and our customers,” said Gary M. Huff, chief executive officer of LabCorp Diagnostics. “We are pleased to be the first major commercial laboratory to implement the Philips IntelliSite Pathology Solution, and we look forward to working closely with Philips to identify the best way to integrate a digital pathology solution into our anatomic pathology workflow.”

The product is an automated system for creating, viewing and managing digital pathology images. It consists of a scanner, an image-management system, a display and software tools to manage the scanning, storage, presentation, reviewing and sharing of images.

By supporting the transition to digital workflows, Philips seeks to help pathology laboratories simplify access to histopathology information.

“Digital pathology opens new, innovative ways to help laboratories and hospital systems improve workflows and provide better patient care,” said Marlon Thompson, general manager of Philips Digital Pathology Solutions. “Together with LabCorp, we can accelerate the digital transformation of pathology and intensify collaboration between laboratories and healthcare professionals.”

Dorothy (Dot) Adcock, M.D., chief medical officer for LabCorp Diagnostics, said digital pathology has the potential to improve patient care. “The opportunity to more quickly access tissue images for analysis, to collaborate more readily with specialty pathologists around the globe, and to provide a faster diagnosis can improve patient care in often challenging areas of cancer diagnosis,” she said.

LabCorp has about 60,000 employees worldwide and reported net revenues of over $10.2 billion in 2017.

Philips, which generated 2017 sales of EUR 17.8 billion, has about 74,000 employees in more than 100 countries.

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Biopharma Catalysts on July’s FDA Calendar

Here is a calendar of some of the biggest companies expecting clinical trial and U.S. Food and Drug Administration (FDA) updates in July.

It’s worth mentioning that these dates may be subject to change due to various internal and outside factors. Some of these changes are positive developments and some can be disasters if a company is deeply financed.

As a side note about the Prescription Drug User Fee Act (PDUFA): a Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease.

AbbVie Inc. (NYSE: ABBV) and Neurocrine Biosciences Inc. (NASDAQ: NBIX) are expecting to have a PDUFA date in July for their New Drug Application (NDA) for elagolix in endometriosis-associated pain. If approved, elagolix will be the first new oral medical management treatment option for endometriosis-associated pain in more than a decade.

Durect Corp. (NASDAQ: DRRX) is also expecting a PDUFA date for its NDA of RBP-7000 in late July. The schizophrenia treatment has a target action date of July 28, 2018.

GlaxoSmithKline PLC (NYSE: GSK) has a meeting with the FDA’s Pulmonary-Allergy Drugs Advisory Committee scheduled for July 25. The meeting is in regards to the firm’s supplementary Biologics License Agreement (sBLA) for its chronic obstructive pulmonary disease (COPD) treatment, mepolizumab.

Zynerba Pharmaceuticals Inc. (NASDAQ: ZYNE) is scheduled to present data of ZYN002 at the 16th NFXF (National Fragile X Foundation) International Fragile X Conference in Cincinnati, July 11 to 15. ZYN002 is the first and only pharmaceutically produced cannabidiol, a non-psychoactive cannabinoid, formulated as a patent-protected permeation-enhanced gel for transdermal delivery through the skin and into the circulatory system. ZYN002 is being developed for patients suffering from Fragile X syndrome and certain refractory epilepsies.

Progenics Pharmaceuticals Inc. (NASDAQ: PGNX) has a PDUFA date set for July 30 for its malignant pheochromocytoma and paraganglioma treatment, Azedra.

Catalyst Biosciences Inc. (NASDAQ: CBIO) is scheduled to present interim data from its Phase 2 study of Marzeptacog alfa (MarzAA) on July 18. This data will be pertaining to the subcutaneous efficacy trial in individuals with hemophilia A or B with inhibitors to evaluate the ability of MarzAA to minimize spontaneous bleeding episodes.

Theravance Biopharma Inc. (NASDAQ: TBPH) is expected to report data from its Phase 2a study in patients with symptomatic neurogenic orthostatic hypotension by end of July 2018. Specifically, this data is in regards to its TD-9855 (norepinephrine serotonin reuptake inhibitor).

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