The discontinuation of Bexxar is an extreme example of a lifesaving drug being eliminated due to its relatively low profitability. In most cases, when a pharmaceutical company concludes that a niche drug is not making enough money, the product is sold to another, smaller company which continues to make it available. But continued availability is left to the discretion of the company (or companies) that owns the rights to the drug, which is how pharmaceutical companies can withhold potentially lifesaving experimental drugs that have not yet been approved by the FDA -- often, due to concerns that a potential problem resulting from such use could jeopardize the drug's ultimate approval.Luke Timmerman, on Xconomy.com, traces Bexxar's history:
Bexxar, developed in the late ‘90s by South San Francisco-based Coulter Pharmaceutical and acquired in 2000 by Seattle-based Corixa, had a lot going for it. The drug was aimed at a protein marker called CD20, which was already a validated molecular target for cancer, based on the success a couple years earlier of a so-called “naked” antibody from Genentech and Idec Pharmaceuticals, rituximab (Rituxan). Corixa had a well-respected CEO in Steve Gillis who attracted scientific talent, and raised lots of cash. It had a Big Pharma partner in Glaxo to help it manufacture and market the drug to the fullest.
Corixa, unable to turn Bexxar into a profit center, ended up being acquired by GlaxoSmithKline in 2005.
But there was a catch. Oncologists who saw these non-Hodgkin’s lymphoma patients could prescribe rituximab at an infusion center, along with chemotherapy. These doctors made money on every patient that went through their infusion center. Prescribing Bexxar meant they’d have to forgo that revenue stream, and refer the patient to a nuclear medicine pharmacy or radiation oncologist who could handle Bexxar or Zevalin.Are we to believe that the very people who were supposed to be saving patients walked away from a cure over profit? I'm trying hard not to... There were other factors, though:
“There were complicated logistics with having oncologists refer to another part of the healthcare system they normally didn’t interact with,” Rivera says. “We couldn’t get them to change their habits. The doctor would usually say ‘Oh, I’ll give the patient another course of R-CHOP’ (Rituxan plus a specific chemo regimen) instead.”
Younes, the chair of lymphoma at Memorial Sloan-Kettering, has heard the story about oncologists rejecting Bexxar because they didn’t want to refer patients to medical centers that might be seen as competitors. He says that point is “exaggerated” and notes that oncologists refer patients to other specialists all the time. He points to other problems with Bexxar’s commercialization. “It’s almost a comedy of errors,” he says.
There was a muddled clinical trial strategy, Younes said. Multiple trials were opened up to expand Bexxar usage, which may have been well-intended, but the plan ended up confusing physicians about where the drug was most useful, Younes said. A lot of clinical trials were sponsored, making it possible for many patients who might have paid to get the drug to instead get it for free. Then at one point, Glaxo abruptly shut down all the trials, Younes said.So what constitutes bad sales? Reno gives us the numbers:
“They ended up pissing off a lot of people,” he said.
There were headaches in manufacturing an antibody that was linked to radiation. The radioactive piece of the drug came from a supplier in Canada, and the occasional snowstorm would throw the whole supply chain out of whack, causing patients infusions to be delayed, Rivera said. That was a big inconvenience for some patients who sometimes had to drive hours for a scheduled infusion at a big academic medical center, Rivera said.
While Bexxar saved this writer’s life in a clinical trial in 1999 with virtually no side effects and has saved many other lives, sales of the drug did not meet GSK’s expectation. Catalina Loveman, GSK’s director of U.S. external communications, oncology, told IBTimes that total sales of Bexxar in 2012 in the U.S. and Canada were approximately $1 million; for comparison, the blockbuster drug Viagra earned Pfizer a reported $2.05 billion in sales in 2012.Everything is relative. I guess it didn't occur to GSK that those who survive lymphoma might eventually become Viagra customers. Oh, well. I guess a few thousand lives pale in comparison to a few million...well, need I say it?
Like Bexxar, Zevalin has also struggled in the marketplace. In the third quarter 2013, Zevalin’s profits were $8 million. But unlike GSK, Spectrum Pharmaceuticals, makers of Zevalin, is committed to keeping this drug on the market.
“What is happening with Bexxar is virtually unprecedented,” said Spectrum’s chief operating officer, Ken Keller, who came to Spectrum a year and a half ago from California-based Amgen, the world's largest independent biotech company. “I do not know of a single example of a drug company that has walked away from a drug that is this effective. Typically, when a company gives up on a treatment that works this well, they will a find a smaller company to sell it.”
Keller acknowledged that neither Bexxar nor Zevalin has been able to break through and become the blockbuster drugs that he says they both should be.
“I’ll be honest: We don’t gain a lot of value from Zevalin,” he said. “We have the data that shows how well it works, but it has still not caught on with many doctors. However, Spectrum will continue to manufacture Zevalin because our CEO [Raj Shrotriya] is on a mission to make RIT the standard of care for lymphoma in the U.S.. If this were only about finances, it could lead to different decision. But this treatment saves lives, and we believe we have an obligation to cancer patients. They deserve to have access to it.”
Dear Accelarad customer,You should have received an email from me on Monday of this week, when I provided our customers an early insight into the announcement that Accelarad is now a part of Nuance Communications. At this time, I wanted to provide you some additional information and invite you to learn more.
You can read the full press release here: (Nuance Unveils PowerShare – April 17,2014)As discussed, this new union brings together our cloud-based medical image sharing technology and Nuance’s PowerScribe radiology reporting and communication platform. The partnership will give you, our valued customer, access to Nuance’s expansive healthcare technology and professional services, while continuing to provide you with the proven software and solid relationships you have come to expect from Accelarad. With this partnership, Accelarad’s SeeMyRadiology solution has been rebranded to align with the Nuance diagnostic brand, and will be part of the Nuance PowerShare Network. To learn more about PowerShare | Image Sharing, sign up to join one of our webinars.
Most importantly, know that the products and people you have come to rely on will not change. Accelarad's leadership team and valued employees will be deeply involved in creating a smooth transition for our customers, and our focus remains on making sure you continue to receive the excellent service you deserve.
Thank you again for your support and confidence in us. We will keep you informed about any incremental changes along the way and are open to your feedback.
Willie Tillery, CEO, Accelarad
Rodney Hawkins, General Manager, Diagnostic Solutions, Nuance
Nuance PowerShare Network Unveiled for Cloud-Based Medical Imaging and Report ExchangeDefinitely an interesting constellation of services! I wonder where this might lead. Ironically, Rodney is also an old friend from the AMICAS days...
Industry’s Largest Medical Imaging Network Helps Providers and Patients Coordinate Care and Share Information Across Distances and Disparate Healthcare Systems
BURLINGTON, Mass., – April 17, 2014 – Nuance Communications, Inc. (NASDAQ: NUAN) announced today the immediate availability of Nuance PowerShare™ Network, the industry’s largest cloud-based network for securely connecting physicians, patients, government agencies, specialty medical societies and others to share essential medical images and reports as simply as people exchange information using social networks. Nuance PowerShare Network promotes informed and connected physicians and patients who can instantly view, share and collaborate while addressing patients’ healthcare needs.
“Organizations are being tasked to communicate efficiently both in and out of their networks to provide clinical insight to physicians beyond one person or office to a much broader team involved in the continuum of care,” said Keith Dreyer, DO, PhD, FACR, vice chairman of radiology at Massachusetts General Hospital and Chair of the American College of Radiology (ACR) IT and Informatics Committee. “Nuance PowerShare Network addresses the information sharing challenge physicians face today with a network that supports things we’ve dreamed of doing for years,” he adds.
Fully Connected Patients & Providers
Nuance PowerShare Network is already used by more than 1,900 provider organizations for sharing images via the cloud using open standards. Made possible through the acquisition of Accelarad, this medical imaging exchange eliminates the costly and insecure process of managing images on CDs and removes silos of information in healthcare that inhibit providers from optimizing the efficiency and quality of care they provide. Anyone can join the network regardless of IT systems in place to instantly view and manage images needed to consult, diagnose or treat patients, enabling clinicians to more seamlessly evaluate and deliver care for patients who transition between facilities or care settings.
Nuance is already used by more than 500,000 clinicians and is a critical component within the radiology workflow and a trusted partner for 1,600+ provider organizations that rely on Nuance PowerScribe for radiology reporting and communications. Healthcare organizations that use Nuance PowerScribe, a group that produces more that 50 percent of all radiology reports in the U.S., can immediately leverage their existing investment and begin sharing radiology reports along with images, such as X-rays, MRIs, CT scans, EKGs, wound care images, dermatology images or any other type of image. This simplifies secure health information exchange between multiple providers, patients and disparate systems without costly and time-consuming interfaces, CD production or the need to install additional third-party systems.
“The challenge of sharing images with interpretive reports is something we’ve heard about consistently from our customers and EHR partners, and we know Nuance PowerShare Network will overcome this major obstacle, helping physicians treat patients more efficiently and effectively,” said Peter Durlach, senior vice president of marketing and strategy, Nuance Communications. “This nationwide network, one that is fully integrated into the EHR workflow and already connected to approximately half of all clinicians producing diagnostic imaging information, is a ground-breaking solution that delivers immediate benefits at an unprecedented scale to our healthcare system.”
“Integrated image and report sharing helps us deliver quality care and drive down costs especially when patients transfer from one facility to another. Whether at their desktop or on their mobile device, our physicians can see the study that was done along with the interpretive report, which provides the information they need to treat the patient and avoid duplicate testing,” says Deborah Gash, vice president and CIO, Saint. Luke’s Health System in Kansas City. “By integrating this with our EHR, PowerShare will enable physicians to manage inbound imaging through one point of access and login. Physicians in our 11 hospitals and 100-mile radius referral network see this cutting-edge technology as a way to deliver the highest level of patient care,” she adds.
To learn more about the PowerShare Network and the new image sharing solution, visit http://www.nuance.com/products/PowerShareNetwork to join one of our webinars. Connect with Nuance on social media through the healthcare blog, What’s next, as well as Twitter and Facebook.
Of the thousand daily frustrations I experience as a radiologist, perhaps the most painful is that of the "portable patient." You see, patients migrate from hospital to hospital, from clinic to clinic, and from office to office. They may be searching for a second opinion, a superspecialist, someone who will give them the particular answer they seek (some want to hear good news, some prefer bad news), convenience, drugs, or some combination of the above.I was pretty smart back then, identifying a problem that many folks far wiser than I have been trying to solve since. And last year, I authored a follow-up article:
As often as not, they acquire a mountain of imaging studies along the way. When asked why they had a particular study at a particular site, the answer is invariably, "My doctor told me to have it there."
Add to that the dependence on our ERs for emergent (or maybe just impatient care, as I like to call it), and the ER's love of imaging studies. Put them together and you've got a collection of the patient's imaging studies spread across a city or even a state.
I've introduced you to a portable patient, and you can see what happened to her because no one knew about the examinations she had already undergone. She was irradiated, magnetized (probably less of a problem), and scared to death (arguably more damaging than radiation) because we have no way to connect the dots of her various studies.Forgive the massive regurgitation of the last post, but you must acquire (or reacquire) the mindset of the necessity of image-sharing.
Well, that isn't quite true. We do have ways -- we just aren't using them... Many years ago, when our old PACS needed replacing, I suggested to the IT types that the three hospital systems in our average town in the South combine efforts to create a single citywide PACS to serve all three hospitals and, particularly, all of their patients. I was told by the illustrious chief information officer that we couldn't even think of working with one of the other hospitals because it was "suing us" (which wasn't quite a lie ... they were challenging a certificate of need application). Millions of dollars and patient welfare down the toilet over C-suite egos.
There were and are other approaches. As an alternative to a central repository, connecting one PACS to another isn't that hard. The best way to do this -- and fulfill all HIPAA requirements in the process -- is to use an image-sharing system such as lifeImage (my personal favorite by a mile).
Don't even bother to suggest that CD-ROMs solve anything. They don't. They get lost, they get broken, they don't always load, the patient forgets to bring the disk, or the original imaging site forgets to send it, and darn, they're closed today...
At one of the clinics we staff, the clinicians come at me at least twice a day, every day, with an outside CD. After three years, I finally was able to convince the powers that be to load the damn things into PACS and merge the data with local exams. But the clinicians don't want to bother with waiting for the disks to load -- they want results now. In my opinion, CDs aren't even worthy of being drink coasters, given that huge hole in the middle. (And their older PACS rejects a significant percentage of the disks anyway.)
Here's where I'm going to anger a lot of people, and this is of course why you like to read my rantings. The following is something that needs to be said, however, and I'm going to say it.
Given that ...
... then it stands to reason that today, in the 21st century, shirking our responsibilities to the patient in this aspect of medical imaging is malpractice. Yes, I used the "M" word. But that's exactly what it is. We are not doing what we should -- and what we must -- for patient care. It is high time to apply technology that has been around for a long time to unify patients' records, imaging and otherwise.
- Not knowing that the patient has had prior studies leads to unnecessary imaging
- Unnecessary imaging may expose the patient to unnecessary radiation, costs, and anxiety
- Unnecessary radiation is bad for you, as is anxiety
- We have ways to share prior studies
We are harming our patients out of ignorance, out of hubris (why would they go to any doctor/hospital/clinic other than me/mine?), and out of greed (I get the revenue if I repeat the study!). This is completely unacceptable...
(A)pproximately 90% of duplicate and potentially unnecessary CT scans were ordered by physicians who have little to no usage of the HIE when combining slices of users with less than 500 queries in 18 months. An opportunity therefore exists to reduce the number of duplicate CT scans if the physician is utilizing HEALTHeLINK to look up information and recent test results on their patients prior to ordering more tests. In addition, this also highlights a need to get more physicians participating and using the HIE in a meaningful way as more than 70% of duplicate CT scans were ordered by physicians who did not query HEALTHeLINK.Another study from the University of Michigan found:
RESULTS:That's a lot of repeat studies. And a lot of excess radiation. We can wait for the study to be delivered from the outside place, or the outside CD to be loaded ("Film at Eleven") or we can redo the study. None of these choices are optimal. We can all see that.
In our sample there were 20,139 repeat CTs (representing 14.7% of those cases with CT in the index visit), 13,060 repeat ultrasounds (20.7% of ultrasound cases), and 29,703 repeat chest x-rays (19.5% of x-ray cases). HIE was associated with reduced probability of repeat ED imaging in all 3 modalities: -8.7 percentage points for CT [95% confidence interval (CI): -14.7, -2.7], -9.1 percentage points for ultrasound (95% CI: -17.2, -1.1), and -13.0 percentage points for chest x-ray (95% CI: -18.3, -7.7), reflecting reductions of 44%-67% relative to sample means.
HIE was associated with reduced repeat imaging in EDs. This study is among the first to find empirical support for this anticipated benefit of HIE.
I spoke with a friend today who is now the sixth person to have heard rumors about Nuance entering the image sharing market. He thinks it will announce the acquisition of a small Atlanta-based company imminently. I know the target company rather well, think highly of the founders, and I’m happy to see them finally reap some benefit from their 15-year-old startup odyssey. They started out as a small PACS company and then carved out a niche by selling data center based teleradiology PACS, which I think delivers the great majority of its $6M or so annual sales.This little company is apparently Accelarad. More on them in a moment. Back to Hamid:
We (lifeIMAGE) started out working with innovators and early adopters who believed in our cause. We believe in eliminating duplication of imaging, avoiding delays in care and excessive radiation, and improving quality of care for patients. To realize our goal, we build software that helps make medical images part of a patient’s record and helps physicians access imaging histories conveniently, from any setting. We’ll soon announce our fifth anniversary as a well funded, privately held company, with many remarkable results that make our team very proud...The cure for the portable patient indeed.
..(I)mage sharing for serving radiology, with 25,000 or so US radiologists, where Nuance has its major presence, has been around for a long time. Innovations in teleradiology are well past their prime, so, we at lifeIMAGE do not see a disruptive opportunity to innovate in that area. We are focused on the far broader need, which exists among large health systems that need to avoid the cost and problems associated with repeat imaging orders. Their ordering physicians, our end-users, are non-radiology image intensive specialists who need access to patients’ imaging histories in order to reduce the rate of repeat exams.
Recently, I’ve been fascinated with what professor Everett Rogers called “the law of diffusion of innovation.” It basically spells out that there is a point at which an innovation reaches critical mass. “The categories of adopters are: innovators, early adopters, early majority, late majority, and laggards.” The early majority buy into a technology when it’s been well vetted by innovators and early adopters first. Every innovative and disruptive company looks for the sign that its technology has started to be adopted by the “early majority.” Nuance’s entrance into the image sharing market is an indication for me that the market is getting ready for broad adoption, validating what we already see in the lifeIMAGE customer statistics. Professor Rogers suggests that once 16% of the market has signed up for a technology, that’s when the early majority starts to adopt. Current lifeIMAGE customers represent nearly 16% of all US physicians...To me, being rather more concrete than some, a "disruptive" technology is one that interrupts my workflow, and nothing could fit that definition better than what Nuance is really known for: Speech Recognition, also incorrectly known as Voice Recognition. Here we have a technology that displaces the human transcriptionist, freeing the hospital from the tyranny of employing said human and paying their salary and benefits. It dumps the work of transcribing and editing onto the radiologist with no increase in pay for the effort. And it barely works. A friend who is totally enamored with SR tried to show me how wonderful it functions in his enterprise. I watched him focus his entire attention onto the report screen, which was three monitors away from the radiographic image he was supposed to be interpreting. Yah, this is great and wonderful stuff. Now it does speed things along. My friend claims to be able to read 300 exams in 8 hours with <1% error-rate because of his beloved SR. I'll simply say that it wouldn't work that well in my hands.
lifeIMAGE is the most utilized image sharing network, designed for use by physicians across a wide range of clinical disciplines—neurology, orthopedics, cardiology, oncology, surgery, etc. Our position is unique in that our engine of innovation is fueled by this population of doctors, who encounter patients with outside imaging histories on daily basis. We also help providers with patient engagement strategies and lead the way in providing access to patients who can in turn share their imaging records with providers of their choice. So, indeed new market forces may very well validate the market and expedite adoption of our disruptive and expansive technology, innovation for which is guided by multi-disciplinary specialists, including radiologists....
When I was CEO of AMICAS, our team spent some time studying the concepts around disruptive technology. Its definition in Wikipedia is, “A disruptive innovation is an innovation that helps create a new market and value network, and eventually disrupts an existing market and value network (over a few years or decades), displacing an earlier technology.” That is what our web-based PACS was back in 1999.
Our medical imaging solution combines the ease of social networking with the clinical precision and security that medicine demands, making medical image sharing with patients, colleagues and other organizations easier than ever. Accelarad allows you to quickly and securely upload, access, manage and share medical images from any Internet-connected computer, mobile device or via our app. So you have images and reports from any originating institution, physician or system at your fingertips from a single portal, allowing you to focus on what you do best–delivering patient care.
I pushed hard for an "outside study" solution. We were regular victims of Philips PACS non-DICOM CD's every night from a particular hospital. We looked at both lifeIMAGE and Accelarad, and went with the latter and it works well for us. However, the Nuance purchase suggests to me that they want to be a complete 3rd party reading group, and replace groups like Optimal. Once they can share images well, dictate reports and disseminate results, they become a radiology department for anyone. I'll bet they start advertising over-reads/consults by big institution names before it's all over.Hey, just because you're paranoid doesn't mean they aren't out to get you...
It just looks to me like they are assembling the pieces of the puzzle to become "Uber Radiology". The video mentions/shows a graphic for telemedicine; that screams 3rd party. Any site can be set up to just put their system as a destination on each modality. Boom, you send them your images, they can be read. It's not even a "PACS to PACS transfer" but a replacement PACS. No onsite storage is needed, just the Nuance cloud.. oops until the internet is down and you don't have your images anywhere...
BURLINGTON, Mass., – April 7, 2014 – Nuance Communications, Inc., (NASDAQ: NUAN) today announced that it has named Trace Devanny as president of Nuance’s Healthcare business. Mr. Devanny will oversee Nuance’s largest division and lead its efforts to deliver a more seamless approach for healthcare professionals to document, share and use clinical information. He will report to Paul Ricci, Nuance chairman and CEO.
“Our healthcare business presents a significant opportunity for innovation, leadership and growth in today’s dynamic healthcare environment,” said Paul Ricci, chairman and CEO of Nuance. “As a healthcare technology industry veteran, Trace brings a powerful skillset that combines operational excellence, team development, customer engagement and a strategic vision. I look forward to working with him to lead Nuance and our healthcare business through its next phase of growth.”
Mr. Devanny has more than 30 years of executive leadership experience in the healthcare IT industry, having held executive leadership roles in multi-billion dollar, international healthcare organizations. He joins Nuance from TriZetto Corporation, where he served as chairman and CEO. At TriZetto, he drove revenue and bookings growth in excess of 20 percent and led the organization through a business and sales model transition. Previously, he held several executive roles at Cerner Corporation, most recently as president, over an eleven year period where he was instrumental in growing the company and revenues from a $340 million business in 1999 to a $1.8 billion healthcare IT leader. Earlier in his career, Devanny was president and COO of ADAC Healthcare Information Systems and held a series of executive positions with IBM and its healthcare business. He holds a BA degree from the University of the South.
“Improving quality of care while driving down healthcare costs is one of the most significant challenges that providers face today. Nuance is advancing these initiatives through innovative solutions that make it easier for providers to deliver patient care,” said Trace Devanny. “I look forward to working with this talented and ambitious organization to build on our momentum and make an even greater impact on the healthcare system at this important point in its history.”