There’s no shortage of areas to debate when it comes to FDA policies, the need for reform and the argument against the erosion of safety standards.
In fact, there were so many drug and device-related fields to cover, President Trump’s nominee for the top job at the Food and Drug Administration Scott Gottlieb didn’t get a chance to comment on food safety, supplements, and his other potential jurisdictions.
In Tuesday’s nomination hearing, broadcast live, the Senate Health, Education, Labor and Pensions Committee pushed other major areas to the fore.
They included Gottlieb’s “unprecedented” industry ties, drug and device approval speeds, science versus ideology, biosimilars and generics, and Gottlieb’s biggest concern of all: the opioid epidemic.
Handling the boss
Both sides of the aisle seemed concerned about President Trump’s hiring freeze in government departments, including FDA. Committee chair Sen. Lamar Alexander (R-TN) addressed it directly in his opening remarks, asking how Gottlieb would lead a strong agency incapable of hiring new talent.
According to Alexander, former commissioner Robert Califf’s top priority with the passing of the 21st Century Cures Act was to be able to hire and pay the necessary talent to review investigational drugs and devices.
Gottlieb reiterated the importance of FDA possessing a world-class workforce, armed with the resources and tools they need to do their job.
The most direct sentence he could summon, however, was to note that he has been vocal about the need to maintain a strong FDA workforce in the past.
“I will continue to make my opinions known on that issue,” he said.
Others questioned how he could maintain a science-first, objective approach while working beneath an ideological president.
“For those who have worked with me, I haven’t been shy about offering my unvarnished advice,” Gottlieb replied. “We mentioned 866 articles I’ve written where I’ve offered very clear thoughts. I’m going to continue to offer people my very clear thoughts on whatever issues I’m asked to opine on, including my boss’s.”
Unsurprisingly, the political parties returned to their respective corners when Gottlieb’s extensive industry ties were flagged. Democrat senators were concerned about his ability to remain impartial, while Republican’s viewed it as valuable experience in the field.
Sen. Patty Murray (D-WA) began her address by expressing disappointment in the limited amount of time the committee had to review Gottlieb’s application papers, which chronicle his many connections. The full package was received on Friday, Murray said.
“We’ve had just a handful of days to fully understand the extent of Dr. Gottlieb’s unprecedented financial entanglements with the industries he would regulate as FDA commissioner.”
Murray repeated the term “unprecedented” several times, as Senator Alexander reminded the audience that the most recent FDA commissioner, Robert Califf, had extensive industry ties too.
“I’m glad to know that you’ve got a background and experience in the issues before you,” Alexander told Gottlieb.
For his part, the nominee promised to work with ethical experts throughout his tenure. He has already withdrawn from multiple compromising positions and has met the minimum impartiality requirements for the position.
Part of the damage can’t be undone, however, in the eyes of the Democrats. It was pointed out that, if approved, he would likely oversee regulatory filings from some of the many companies that he has consulted for or financially invested in, including Cerecor and CRISPR Therapeutics.
As a prolific writer and speaker, Gottlieb has an established track record indicating he would like to streamline the approval process. Some committee members, particularly Sen. Elizabeth Warren (D-MA) were particularly concerned about this pro-industry approach.
Gottlieb’s biggest message here was that it doesn’t need to be a trade-off.
“We should reject the false dichotomy that it all boils down to a choice between speed and safety,” he said.
The approval process can be improved from many angles, he argued, such as through adapted clinical trials that don’t infringe on the scientific rigor applied.
“We should be reminded always that we save lives by allowing good things to happen,” Gottlieb told the committee. “But we also save lives when we keep bad things from happening.”
Biosimilars and generics
Sen. Mike Enzi (R-WY) floated the issue of biosimilars in question session. Since 2012, four biologics have been approved, he said, but only two made it to the market. By 2021, some 70 more biologics patents will expire, creating a major opportunity for healthcare savings.
Since 2012, four biologics have been approved, he said, but only two made it to the market. By 2021, some 70 more biologic patents will expire, creating a major opportunity for healthcare savings.
“I think many of us have been disappointed by the economic savings we’ve seen from biosimilars so far,” Gottlieb said.
His answer was concise but touched on one of the major issues; FDA giving guidelines to biologics manufacturers in a timely fashion. Uncertainty has clouded the field until now.
He also stated that the FDA needs to answer specific questions, such as whether or not biosimilars can be used interchangeably.
The discussion moved on, returning later to generic drugs with a question by Sen. Todd Young (R-IN) that played right into one of Gottlieb’s top priorities.
“There are literally billions of dollars worth of drugs each year that are sold as branded drugs at high prices but should be subject to generic competition,” the nominee said in agreement.
A huge part of the problem, Gottlieb said, was the inability of current FDA guidelines to handle new complex drugs. The standard measures for bioequivalence and bioavailability no longer suffice. That confusion prolongs the exclusivity period of the drug, as generics struggle to break into the market.
“This is an area I want to work on,” he said.
The committee and Gottlieb all agreed on the urgency of the opioid epidemic.
“The opioid epidemic in this country is having staggering human consequences,” Gottlieb said in response to a question by Alexander. “I think this is the biggest crisis facing the agency.”
While he said an “all of the above” approach is needed, he singled out opioid alternatives as one of the greatest opportunities to turn the tide on the crisis.
That could include new pain relieving drugs and devices that can administer them in a more localized way. He also mentioned the need for medical options that help patients maintain sobriety.
Photo: VladimirSorokin, Getty Images
Boston Scientific has long expected to be the third wheel to Medtronic and Edwards Lifesciences in the U.S. transcatheter aortic valve replacement (TAVR) marketplace.
It has sung the praises of it Lotus TAVR valve but the product line stands pulled from Europe because of device malfunctions. and has suffered delays in its regulatory pathway in the U.S. And now, while senior management of the company argue that Lotus valve’s introduction in the U.S. is still on track for mid 2018, a transaction announced last week may allow the company to introduce a wholly different TAVR device to the marketplace.
On Thursday, Marlborough, Massachusetts-based Boston Scientific shelled out $435 million in cash to purchase structural heart company Symetis. The Swiss company makes the Accurate and Accurate neo/TF valve systems for patients suffering from severe and symptomatic aortic valve stenosis and those who have a high-risk of undergoing open-heart surgery.
“The steps we are taking reflect our commitment to being a leader in TAVI and structural heart technologies now and over the long-term, as we broaden our portfolio and pipeline to address the needs of our global health care providers and their patients,” said Ian Meredith, M.D., executive vice president and global chief medical officer, Boston Scientific in a news release. “The ACURATE family of valve products is strongly complementary to our cornerstone Lotus valve platform, and this compelling combination of technologies will allow us to provide interventional cardiologists and cardiac surgeons with multiple TAVI offerings for varying patient pathologies and anatomy.” [TAVR is termed transcatheter aortic valve implantation (TAVI) inEurope]
Some analysts did not fully buy the line on Lotus being the cornerstone TAVR product
“… with Lotus being delayed multiple times, taken off the market in Europe, and with BSX yet to launch all five sizes, one has to wonder if this is a backup plan and if Lotus may not be as ready to go as the company hopes,” wrote Sean Lavin, an analyst with BTIG, in a research note on Thursday. “While BSX paid a hefty multiple and this deal may indicate Lotus isn’t quite ready at this point, we see having a backup option as a positive in this multibillion dollar growth market.”
Boston Scientific paid 12 times the 2016 revenue of Symetis, which was $38.2 million last year.
Another analyst — Danielle Antalffy of Leerink Partners —said that the purchase will provide “air cover” for the six-plus months that the Lotus valve is expected to be off of the market. Still, most analysts viewed the deal positively.
The transcatheter aortic valve space is dominated by Medtronic and Edwards Lifesciences in the U.S. though in Europe the two heavyweights have smaller rivals. It is also a place that has seen numerous legal fights over patent infringement.
Edwards Lifesciences prevailed over Medtronic in 2014 in its long battle and the saga ended with the Irish medtech company agreeing to pay royalty payments of at least $750 million to Edwards Lifesciences.
Meanwhile Boston Scientific and Edwards are in the midst of their own legal battle over TAVR. In Nov. 2015, the Massachusetts company slapped a lawsuit against Edwards in Germany related to its European patents pertaining to outer seals of transcatheter heart valves. Edwards countersued, alleging patent infringement by the Lotus valve.
On March 3, a U.K court ruled that the Lotus valve did infringe on one of Edwards’ patents surrounding its TAVR valves but not the other. It also noted that the Sapien 3 valve from Edwards infringes two of Boston Scientific’s patents for outer seals of transcatheter heart valves. A German patent court issued a similar ruling days later. Edwards has promised to appeal.
In other words, the ” TAVI space is fluid and litigious,” wrote Lavin in the research note and he concluded that “With all the various IP issues, manufacturing issues, doctor preference, and different valves offering different benefits, the reasons for buying Symetis could be multifactorial.”
Photo: Ian Fung Koo / EyeEm, Getty Images
A cure for type 1 diabetes has been “just around the corner” for decades now — or so patients have been told. But the moonshot mission has been rough.
ViaCyte knows this well after years 18 years of R&D. With every step of progress, a new mountain of challenges looms. The company puts its head down and troubleshoots through, with backing from private investors, pharma partners, the California Institute for Regenerative Medicine (CIRM) and the Juvenile Diabetes Research Fund (JDRF).
On Wednesday, the San Diego, California-based company announced a new partner; W. L. Gore & Associates, the multi-billion dollar manufacturer of medical and non-medical fabrics and devices, including the iconic GORE-TEX. If Gore can contribute some materials expertise, one more problem could get solved.
The partnership centers around ViaCyte’s flagship islet replacement therapy.
Type 1 diabetes (aka juvenile diabetes) is an autoimmune disease. It accounts for around 5 percent of all diabetes cases. Some 95 percent are caused by so-called adult-onset diabetes, which is a longer-term metabolic disorder.
While genetic and environmental factors are believed to play a role, the ultimate trigger for type 1 diabetes is not known. At some point, the immune system incorrectly recognizes beta cells in the pancreas as foreign or threatening. It begins systematically destroying them and with that, the ability of the body to produce insulin.
Insulin is the key that allows glucose to enter cells. Without insulin, glucose builds up in the bloodstream while cells are effectively being starved. For decades, patients have replaced the missing insulin with a synthetic version. Yet dosing is problematic. Too little insulin and the blood glucose levels rise; too little and the patient becomes hypoglycemic — a potentially fatal condition if the individual isn’t revived with a readily available source of sugar.
Patients must manage this life or death balancing act for the remainder of their days.
ViaCyte hopes to remove the uncertainty with its PEC-Encap combination product. It comprises PEC-01 pancreatic progenitor (stem cell precursor) cells packaged in an immune-protective device called the Encaptra Cell Delivery System.
Once implanted under the skin, the PEC-01 cells further mature into insulin-producing ‘islets’ — beta cells included. Blood can flow in and out of the device, allowing the cells to register blood glucose in real time and produce an appropriate amount of insulin in response.
To preserve the biological package, ViaCyte has been fine-tuning its transplant device, which CEO Paul Laikind likens to a tea bag.
“In the case of PEC-Encap it’s a semi-permeable membrane that is really the active component of the device,” Laikind said in a phone interview. “That membrane is sized such that oxygen, nutrients, glucose, and even proteins can move freely back and forth across the membrane surface. But it is also sized such that cells cannot. So none of the immune cells of the host are able to penetrate and communicate with the cells inside, so to speak, or directly access the cells in the device. And none of the cells inside the device are able to exit.”
That separation is critical for staving off the two-pronged immune response waiting to neutralize the cells.
Once triggered, the immune system of diabetes patients will forever be geared towards destroying beta cells. That’s the autoimmune component. The second issue is the natural immune rejection that occurs when cells or tissues containing foreign DNA are introduced into a transplant patient. ViaCyte uses stem cells derived from an embryo, which triggers this kind of reaction.
Finding a balance between cell preservation and efficacy is hard. According to Laikind, ViaCyte had progressed into Phase 1/2 trials with the PEC-Encap, but after treating around 20 patients it identified an issue with vascularization.
The membrane doesn’t allow the components of blood vessels to pass through — they’re too big. Yet the cells need nutrients and oxygen to survive.
“When it engrafts, what we need is that vascular network to set down on the outside of the device,” Laikind said.
That’s why Gore’s expertise in medical devices is needed.
Another product being forwarded by the ViaCyte is a straight transplant of insulin-producing cells. The patient would need to take immune-suppressing medications indefinitely to protect the introduced cells. According to Laikind, the side effect profile of this approach is better suited to patients who struggle to maintain stable blood glucose levels or for the 10-40 percent of patients who have hypoglycemia unawareness. In the latter cases, the individuals are unaware their blood sugar is dropping and thus, can’t halt their descent into hypoglycemia.
Beyond ViaCyte, other companies are attempting to break into the field.
Novo Nordisk, the world’s largest manufacturer of diabetes drugs, has signaled its intent to move into stem cell therapies. Another company, Semma Therapeutics, is eying up clinical trials, having developed a method for efficiently producing beta cells en masse.
Both are several steps behind ViaCyte, which is a blessing and a curse for the San Diego team. The company has raised millions as the flag bearer for a lasting therapy for type 1 diabetes. But it is also the first to encounter unforeseen challenges in the field. It’s those challenges that continue to stall any chance of a cure. For now, at least.
Photo: Hero Images, Getty Images
Sleep: the one thing we all need, but many of us don’t get enough of.
Adults between the ages of 18 and 64 need seven to nine hours of sleep each night, per the National Sleep Foundation‘s recommendation. Adults aged 65 and up need between seven and eight hours of sleep each night. The significance of sleep has even spread to the mainstream media, with Arianna Huffington writing a whole book (called The Sleep Revolution) about sleep.
For many, sleep disorders serve as a blockade to getting the necessary amount of sleep. In fact, approximately 70 million people across the United States suffer from sleep disorders. The World Health Organization notes that sleep disorders impact almost one billion people globally. And the prevalence of sleep disorders is increasing at a rate of 9 percent per year.
To solve this issue, Redwood City, California-based Somnology is collaborating with the National Institutes of Health’s National Institute of Diabetes & Digestive & Kidney Diseases.
Somnology and the NIDDK will utilize the Somnology Plex Sleep Scanner to research how diet and environment can impact people’s sleep metrics. Additionally, the organizations will create models of the human sleep cycle, which will be implemented in Somnology’s software.
When compared with a traditional visit to a sleep center, the Plex offers consumers numerous benefits. In a phone interview with MedCity, Somnology CEO and cofounder Patrick Yam outlined a few. It often takes consumers several months to get in for a visit at a sleep center. The visit, which can cost anywhere between $2,000 and $7,000, only offers a snapshot of one’s sleep patterns. “You’re sleeping in a foreign bed and you’ve discounted the fact that sleep is dynamic,” Yam said. After the visit, it takes around one month for a consumer to receive information and results.
The Plex, on the other hand, provides consumers with actionable data at a much faster rate. Users can wear the Plex while they sleep, and it monitors their breathing patterns, pulse and oxygen levels. Because it integrates with the MobileSleepDoc Pro app, users can easily see their results from their mobile device.
If left ignored, sleep disorders can have negative consequences on consumers’ overall health and well-being. With sleep disorders come accentuated comorbidities like obesity, diabetes and Alzheimer’s. “We need to get ahead of it,” said Yam.
Despite the increasing problem of sleep disorders, individuals like Huffington and Yam continue to advocate for the cause. “Sleep can no longer remain a secondary benign concern,” Yam said. “The adversarial health detriments are far too great.”
Photo: Ray Kachatorian, Getty Images
The Centers for Medicare and Medicaid Services has released guidelines on Medicare coverage for continuous glucose monitors, and one medtech company stands to make a whole lot of money from the change.
San Diego-based DexCom is the only manufacturer of a continuous glucose monitor (CGM) defined as therapeutic, meaning patients can make treatment decisions using the device. The DexCom G5 Mobile System provides the glucose level, the direction and rate of change, and uses built-in customizable alarms to alert wearers when their glucose is too low or too high. Low glucose levels can induce seizures, loss of consciousness, coma and death.
DexCom, diabetes professional societies, endocrinologists, the American Diabetes Association and the Juvenile Diabetes Research Foundation (JDRF) have been working on this with CMS for years, according to DexCom CEO Kevin Sayer.
“It does expand our patient base to a group of people who really need this technology,” Sayer said in a phone interview. “It’s more than a nice business opportunity. It’s going to be a life-changing experience for these people. It will be something that will be fun to be part of.”
CMS announced its decision to cover the monitors for Medicare patients in January, and this week said that patients who have either Type 1 or Type 2 diabetes and who must intensively manage their insulin will be able to obtain reimbursement for the devices.
To get the coverage, beneficiaries must meet four criteria, according to CMS:
- Have a diagnosis of Type 1 or Type 2 diabetes;
- Have used a home blood glucose monitor and performing four or more blood sugar tests per day;
- Take multiple daily injections of insulin or use a continuous subcutaneous insulin infusion pump;
- Have a treatment regimen that requires them to make frequent adjustments based on their blood sugar test results.
“These definitions would apply to almost everyone with Type 1 diabetes,” JDRF senior vice president for advocacy and policy Cynthia Rice said in a phone interview. “It might not apply to everyone with Type 2 diabetes.”
JDRF raises money for research and awareness of Type 1 diabetes, which is usually diagnosed in children and young adults. People aged 65 and older who have Type 1 diabetes have usually been suffering from it for decades, and are more susceptible to low blood sugar because their bodies are less able to detect it, Rice explained.
“Lows can happen at night or during the day,” Rice said. “But at night, one of the advantages of the alarm is that other family members can hear it.”
DexCom began ramping up its production following CMS’ January decision. The company plans to open a second factory, in Arizona, in 2018, Sayer said. About 75 percent of the 200,000 patients who use the G5 are based in the United States and most are covered by commercial insurance, he added. Sales have grown from $66 million in 2011 to $571 million in 2016.
Medicare will reimburse for CGMs at a rate of $250 to $275 per month or about $3,000 per year, which covers rental of a durable component and purchase of disposable accessories, Sayer noted. The other major manufacturer of CGMs, Medtronic, does not have the proper FDA labeling for to obtain Medicare coverage. The company did not respond to requests for comment.
Private insurers began covering CGMs in 2008 and 2009, according to Rice.
“It took a long time to get CMS here, but it’s wonderful that they have taken this step,” Rice said. “We’re really pleased with their decision in January, and what happened yesterday really makes it real, makes it ready to implement. So many people will benefit from having access to this important technology.”
Photo: Jirsak, Getty Images
Physical therapy is a big part of orthopedic care, and as the era of bundled payments take hold, albeit with a pause here and there, virtual rehab is poised to take off.
Traditional widget makers are sensing an opportunity in this trend. Take Breg, the sports medicine manufacturer and distributor based in Carlsbad, California.
At the recently-concluded annual meeting of the American Academy of Orthpaedic Surgeons (AAOS), Breg executives were showing off a new sensor-device connected to a mobile app that can guide patients through their daily exercise routine following orthopedic surgery.
This is the first time the company has forayed into the digital health, Internet of Things space, confirmed Brad Lee, president and CEO, in a booth interview last week where demos of the Breg Flex system were being presented. Lee said the impetus for the product dates back seven years ago when the company underwent a strategic shift.
“Rather than focusing on the widgets we provide to an orthopedic caregiver, [we wanted to] focus on managing the pain points in their world in the orthopedic episode,” Lee said.
As providers are moving to a value-based system in healthcare, accelerated by alternative payment models especially in joint replacement, hospitals have scrambled to understand where you can take costs out. Everyone has landed squarely on post-acute care — once the joint replacement procedure is complete. One item on the cost chopping block is physical therapy.
“We are actively moving toward online physical therapy programs and our goal is to eliminate physical therapy for hips, only use in knees when we need it …,” said Richard Iorio, a hip and knee surgeon at NYU Langone Medical Center, at a panel discussion on orthopedic bundled payments last week at AAOS.
And that’s exactly where Breg’s Flex system fits in.
“This product Flex was developed for the post-surgical rehabilitation segment of the episode.”
Here’s what the product incorporates: A chargeable Bluetooth wireless sensor, worn by patients to track progress with prescribed PT exercises with a companion mobile app.
The sensor and app work in concert to record range-of-motion that is key to better clinical outcomes. The data is also shared in real time with providers such that clinicians can tweak exercise protocols. The interactive patient app has a virtual avatar that guides patients through exercises. The system can also collect patient-reported outcomes that are key to getting reimbursed for certain orthopedic procedures such as joint replacement under bundled care programs.
Lee explained that Breg Flex also works with the electronic medical record of a practice or a hospital.
“The entire recording of the rehabilitation episode is now documented in the patient’s history seamlessly,” he added.
Breg Flex is FDA-exempt because it simply monitors and tracks and does not offer clinical decision support.
In that context, the device is different from other virtual rehab programs on the market such as Reflexion Health’s Vera virtual rehab program. The San Diego-based company uses the Microsoft Kinect gaming console and the Vera avatar to guide patients through their at-home exercise regimen. The system received FDA clearance in 2015.
But like Breg, other companies also seem to feel that FDA clearance to use a digital product for remote physical therapy is not needed. Zimmer-Biomet, the Indiana company that holds the largest market share in hip and knee replacements acquired the RespondWell virtual rehab program that is also not FDA-cleared.
Aside from regulatory clearance that distinguishes companies in the field, another characteristic serves as a point of distinction. Companies like Jintronics and Reflexion Health use the Kinect platform thereby tying joint replacement patients to a console or a TV to do their daily rehab. All Breg Flex needs is a cell phone, or tablet and a sensor-device.
“We are measuring range of motion in the rehab process with a high degree of accuracy in a remote location that doesn’t require to be tethered to any other technology except the sensors on your knee and a phone, which is not a huge burden,” Lee said.
In other words, patients can be out and about, and still get their rehab done.
While that may be a distinguishing factor, the virtual rehab space is getting crowded with several companies vying to win. But Breg’s CEO shrugged it off.
“There is a huge market and there will be a lot of good players in the space,” he said.
Photo: Breg Inc.
If you walked through the sprawling exhibit floor of the San Diego Convention Center last week, you would have noticed products galore. Mannequins being pretend treated on hospital beds, and all kinds of medical devices being touted for surgeons and other buyers.
And yet the annual meeting of the American Academy of Orthopaedic Surgeons was less about rods and screws and the latest techniques in surgery, and more about bundled care and the shift from volume to value. And this despite the fact that the Trump administration appointees are putting a temporary pause on programs that expand or implement bundled care.
This is an important shift given that device vendors in the past would dazzle surgeons with the latest technologies as physician preference and large egos would rule hospital purchasing decisions. All of it without a thought placed on how much those shiny objects cost.
And now the pendulum has swung to where device manufacturers are casting themselves as partners to help solve hospital’s problems.
Take Johnson & Johnson’s DePuy Synthes for instance.
“We have more than 25 people in supply chain that goes to the hospital and help hospital management looking at end-to-end supply chain to look for opportunities for efficiencies and in inventory management,” declared Juan-Jose Gonzalez, president of DePuy Synthes, in an interview at AAOS in an enclosed area of its exhibit. “And outside you will see the Johnson & Johnson Care Advantage that are looking at supporting patients before a procedure, during a procedure, and in the recovery phase.
Care Advantage is J&J’s services business and this year at AAOS, all the major orthopedics players were eager to flex their services muscle.
In fact, even when Stryker launched its total knee on the reportedly million-dollar Mako surgical robot — that a Zimmer-Biomet executive dismissed as a “showbot” without directly naming it — the Kalamazoo, Michigan company was stressing the economic evidence and value to surgeons rather than a feat of engineering.
Here’s Stuart Simpson, vice president and general manager, Stryker, explaining how doing a partial knee replacement using the Mako robot has proved value, in a phone interview last week.
“We have seen the 30-day complication rate reduced by 36 percent with Mako versus nonMako. And we have seen the cost of complications and readmissions for Mako cases 66% lower than nonMako cases in the 90-day period,” he said. “And that’s even accounting for the additional cost of using Mako.”
The hope is the economic value will extend to the robotic use of total knee replacements as well.
Plus, just as J&J DePuy Synthes has its Care Advantage services platform and its own strategy to gain market share, Stryker has its Performance Solutions business aimed at improving hospital and OR efficiency, among other things.
Not to be outdone, the biggest hip and knee company by market share — Warsaw, Indiana-based Zimmer-Biomet — has also tweaked its consulting business to highlight its services chops. It’s called Signature Solutions. At AAOS, the company’s exhibit contained an impressive circular zone that showed off how the company is leveraging both new technology and partnerships to stay with the patient and the hospital from before a joint replacement or orthopedic procedure all the way to recovery at home.
Patient engagement is part of the new focus at Zimmer-Biomet’s services business. The company has partnered with a firm called HealthLoop for better supporting patients who have to deal with information overload as they get ready for a joint replacement
“What HealthLoop does is really two key components – no. 1, it helps to break down that information so the patient gets messages before the stay and then also afterwards. So their care plan is sent to their phone, tablet or computer,” explained Joe Tomaro who leads the go-to-market strategy of the Signature Solutions business, in a booth interview at AAOS. “The other part that Health Loop does is that it collects patient-related outcomes information as well as information post-surgery as to the number of physical therapy visits, home care visits, when did home care start – all of which is real important to estimate how much [the procedure] costs and all of that information you don’t get from the payer until six months later.”
The latter becomes exceedingly important in the Comprehensive Care for Joint Replacement Program which reimburses hospitals for collecting patient-reported outcomes. Zimmer-Biomet has also acquired a virtual rehab company called RespondWell to help joint replacement patients perform their daily physical therapy at home, thus reducing the need to go to a physical therapist.
Meanwhile, all this focus on services and value-based care by all the major players have not gone unnoticed by surgeons at AAOS.
“If you go out to the floor right now in Technical Exhibits, the big booths within all the large total joint companies — Zimmer, DePuy, Smith & Nephew — are all taken up with their programs to manage the bundles because they have now seen that managing the bundle is really important,” declared Thomas Barber, an orthopedic surgeon with Kaiser Permanente and chair of AAOS’ Council on Advocacy
And that’s a sea from just being focused on titanium and steel implants and products.
Photo: Gregory Kramer, Getty Images
In 2017, the drug naloxone is almost a household name. It’s a frontline therapy for reviving individuals that have overdosed on opioids such as heroin, oxycontin, and fentanyl — an increasingly common occurrence in U.S. towns ravaged by an epidemic of opioid abuse.
Opiant Pharmaceuticals has been part of that crusade with the FDA approval and widespread use of its proprietary nasal naloxone spray. Now, the Santa Monica, California company is turning its attention to other addictive disorders — including bulimia nervosa.
On Monday, the publicly-traded company announced the initiation of an up to 80-patient Phase 2 trial of an opioid antagonist (receptor blocking) nasal spray in the widespread and potentially life-threatening disorder.
According to the National Eating Disorders Association (NEDA) bulimia is characterized by “a cycle of bingeing and compensatory behaviors such as self-induced vomiting designed to undo or compensate for the effects of binge eating.” Patients typically have low self-esteem and feel out of control when around food.
Many neural pathways, including dopamine, acetylcholine, and serotonin, have been implicated in the disorder. The latter served as the basis for the approval of Prozac, a selective serotonin reuptake inhibitor (SSRI), as a treatment for bulimia. Studies suggest such antidepressants “may be modestly effective in BN over the long term.”
A significant unmet need remains, which is why Opiant is targeting the addictive properties of dopamine.
A 2012 review of the brain pathways involved in the disorder points to a dysregulation of the dopamine and opioid systems. The authors note a number of studies that have shown opioid blockers such as naloxone and naltrexone can help limit excessive eating in animal models of the disease.
In an email forwarded by a company representative, CEO Roger Crystal explained the addictive cycle.
“The reward from binging on foods arises from the ingestion of food high in sugar, fat or salt, that activates the opioid system in the brain through the release of the body’s own endorphins when these foods are eaten,” Crystal said. “The activation of the opioid system in the brain is thought to cause the release of dopamine, that causes the reward sensation.”
With its fast-acting mechanism, Opiant’s nasal spray could be used when the individual feels susceptible to a binging episode. By blocking opioid receptors in the brain, the reward pathway could be shut down, suppressing the urge to overeat and thus, the self-perceived need for subsequent purging.
Crystal noted that the company has early Phase 2 data from binge eating disorder, which also involves extreme overeating. That’s important because translating the physiology into humans presents a challenge. Animal models can’t capture the complex underlying emotions that fuel the disorder.
It would seem many societal pressures are at play, with far more women than men affected. An estimated 1.5 percent of American women will develop the condition at some point in their lives.
Opiant expects to report topline data from this study in the first half of 2018, gauging safety and tolerability, as well as its impact on clinical outcomes, including changes in eating behavior.
Photo: Des Green, Getty Images
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