Tuesday, February 18, 2014

Physicians now taking payment by bitcoin: Lower transaction costs, increased privacy protections lead some practices to accept controversial e-currency

Published in Healthcare IT News, Healthcare Finance News, and Medical Practice Insider

Whether looking to draw attention to their practices, experiment with new technology or simply have a bit of fun with their otherwise dreary financial operations, several American medical professionals are now accepting bitcoins, the Web-based virtual currency, in addition to dollars.
Bitcoin, a peer-to-peer, open-source digital currency network that was first launched five years ago, has been getting a lot of media attention lately – sometimes for dark stories such as those spotlighting its role as the currency of choice for Silk Road, an online black market for illegal drugs that was shut down by the FBI this past October.
But it's also getting strong positive attention, especially from Internet thought leaders, because the Bitcoin system, which depends on no centralized authority but rather a loosely affiliated community of techies, offers some key breakthroughs in the areas of information exchange – particularly between parties unknown to each other – and digital cryptography.
The legal status of this so-called cryptocurrency is in flux worldwide, as various policymakers, monetary bodies and tax agencies get up to speed on its true ramifications.
In the meantime, curious people can still educate themselves and explore this new payment alternative without fear and in relative safety.
Doctors who have taken bitcoins have found that doing so is both simple and relatively "unmagical," as San Francisco physician Paul Abramson, MD, put it.
Abramson, founder of My Doctor Medical Group, is a former software programmer and trained electrical engineer with a significant personal interest in privacy.
It was privacy that drew him to learn more about bitcoins. Early assessments of the technology suggested the bitcoin exchange system had significant anonymity protections that could augment existing medical privacy laws and allow patients who sought the ultimate discretion a nearly invisible form of payment.
"It's important for people to be able to maintain their privacy" about all things, but particularly medical issues, Abramson said.
However, as bitcoin use has expanded, further exploration of its privacy protections has shown that, while it does take some effort to uncover a bitcoin user's identity, it is possible.
"As I've learned more about it," said Abramson, "I'm less excited about the anonymous possibility."
In any case, patients in his office seeking medical attention can't very well protect their identity from him – which removes one possible benefit of using bitcoins: the anonymity between buyer and seller.
Despite the media hype and controversy surrounding this new currency, Abramson is almost blasé about the fact that he accepts bitcoins.
"It's actually not that big a deal," he said.
But the benefits do exist. For instance, taking transactions out of the hands of credit card companies can preserve patient privacy, as those organizations can legally access certain protected health information for the purposes of verifying the transactions.
And, as a business practice, accepting bitcoins has real potential to save Abramson money.
He uses a fairly simple setup, where he has a merchant account with a company that handles bitcoins; when he receives bitcoins, that company handles converting them into U.S. dollars. The company charges a 1 percent fee – which is less than the typical 2 or 3 percent transaction processing fee charged by credit card companies.
This method is in fact in common use throughout the bitcoin community: People contemplating a purchase buy bitcoins with dollars, and then, in exchange for goods or services, send them to a vendor, which then immediately converts the bitcoins back into dollars.
But it's only in the conversions where fees arise.
As John Gomez, MD, owner and medical director of RapidMed Urgent Care Center in Lewisville, Texas, points out, to transfer bitcoins from one person to another, there are "zero transaction fees. Zero. It's beautiful."
And there were no startup costs, because his office already had an iPad for other purposes. (One possible problem may arise there, as Apple has recently been removing bitcoin-related programs from its app store.)
Gomez's office manager, Barbie Fiorendino, says no patients have yet used bitcoins to pay for service, but customers are expressing curiosity and interest in the prospect – especially since a local television station did a story about the clinic and bitcoins in January. The clinic distributes printed literature with explanations, and also has a bitcoin section on its website.
Unlike Abramson, Gomez is not planning to convert his payments out of bitcoins. His accountant, who was "very open-minded" about him accepting bitcoins, said he should book his revenue as dollars according to the bitcoin exchange rate at the time of the transaction – and keep records for future years, when he might convert the bitcoins he received back into dollars.
At that time, he would have to calculate capital gains or losses for tax purposes.
His decision to keep his holdings in bitcoins is "a personal belief," he added. "I consider myself a future rich man" because of bitcoins' value prospects, he said.
"There will be ups and downs and there will be potential manipulations," said Gomez, but "in the long run, I think that it's a smart play."
Gomez is more enthusiastic about bitcoins than Abramson – perhaps even qualifying as somewhat of an evangelist.
"I am, generally speaking, an early adopter of technology," Gomez said. Beyond that, "I have certain, I guess you would say politically libertarian leanings," he said.
He is among the many bitcoin enthusiasts who are particularly excited about the existence of a relatively secure currency that is not controlled by a government or other central authority.
Rather, the Bitcoin system is managed by software and mathematical principles, and is made possible by a peer-to-peer network that shares the burden of tracking bitcoins to ensure nobody counterfeits any, or spends the same bitcoin twice.
"It is an abstract concept at first," Gomez admitted – but said that's really no less foreign than the idea that swiping a credit card is a functional stand-in for exchanging dollar bills.
Meanwhile, government regulators are paying close attention, with several countries, the U.S. included, studying how to track – and tax – bitcoin transactions. How those regulations shape up will likely determine the degree to which bitcoins become more widespread, Abramson said.
It's not always easy to use bitcoins, as Wall Street Journal writer Anne Kadet found when visiting various New York City businesses that take them.
"This took some doing," she wrote in January. At one point, using bitcoins was so technologically "cumbersome" that it was "looking like the worst currency ever."
But Gregory Levitin, MD, a Manhattan physician and assistant clinical professor of otolaryngology at the New York Eye and Ear Infirmary, believes bitcoins can help people improve access to medical care.
Levitin, who has patients around the world, was in India and not available for an interview. But in a December press release announcing his acceptance of bitcoins, he said he hoped the move "will open doors to treatment options and follow up care for patients the world over," by allowing them to use "a universal or virtual currency."
One area where Gomez and Abramson agree is the fact that bitcoins are not particularly useful when it comes to their business operations.

Gomez said he wishes more vendors and suppliers took bitcoins. (He has convinced the person who cuts his hair to accept them in payment, however, and he's also ordered items from Tiger Direct, an online retailer that accepts bitcoins.)
Likewise, Abramson says he has nobody with whom he can really do business in bitcoins. His landlord won't take them, and he has asked his employees if they want to be paid in bitcoins, but they have all declined.
There is, however, a cupcake store near his office that accepts them.

Further thoughts on bitcoin


Dos and don'ts
If you're not sure about setting up your practice to accept bitcoins, consider the following suggestions:
"If you don't believe in bitcoin, don't bother," Gomez said. Abramson echoes this, suggesting people not accept bitcoins "unless you understand the potential ramifications," including keeping your bitcoin account information secure (if it's lost, your bitcoins are gone forever, with no way to recover them), as well as exchange-rate fluctuations and government regulatory moves. And it's important to follow new developments in this rapidly changing community.
If you do accept them, Gomez suggested holding them, reflecting his belief that bitcoins will appreciate in value over time. Abramson said just the opposite, calling people who hang onto bitcoins "gamblers" playing a market that has fluctuated wildly, hitting highs of over $1200 per bitcoin in early December to around $600 right now.
That said, "it's easy to take bitcoin," Abramson said. "As a technology I think it's very interesting." He suggests accepting bitcoin "for amusement value," or perhaps as "a marketing move."
Changing behavior
Paul Abramson, MD, of My Doctor Medical Group in San Francisco offers addiction treatment as one of his services, and has found that accepting bitcoins brought him some unexpected business.
"I had some patients who had been buying drugs with bitcoins on Silk Road," an illegal-drug marketplace website that only handled transactions in bitcoins, but was shut down by the FBI in October 2013. "They had been buying heroin with bitcoins."
When they were no longer able to buy high-quality heroin, they decided to seek help from him instead.
As he observed, "you could buy both drugs or drug treatment with bitcoins." But then, "the same is true of hundred-dollar bills, so it's really not that novel."
Bad advice?
CoinMD, a website where users can ask medical questions from a group of anonymous people who claim to be doctors – paying for their advice in bitcoins, has been called "the absolute worst place on Earth to spend your bitcoins," by Wired.
While many of the site's advice givers may be well-intentioned and knowledgeable, and its convenience when it comes to diagnosing minor ailments may seem obvious, Wired points out that "no legitimate licensed physician" would take part in a project like this because they "they would risk losing their license." CoinMD doesn't define how it tracks its contributors or vets their credentials.
So while the idea behind the site might be great in theory, as Iltifat Husain, MD, a practicing emergency physician the editor-in-chief of iMedicalApps, explained to Wired, there's a "tremendous" risk of getting poor advice or a wrong diagnosis. "I would never recommend this site to a patient," he said.

Thursday, February 13, 2014

Downsizing has major benefits

Published in Drug Discovery News

BRISBANE, Australia—After a decades-long search for a so-called “holy grail” of biochemistry, Australian researchers have announced they have found a way to significantly reduce the size of molecules that have similar bioactivity to large proteins, preserving the proteins’ functions while also making the new molecules far more stable in the body.
 
Scientists at the Institute for Molecular Bioscience at the University of Queensland have proved the concept and method of growing small, stable molecules around key amino acids in complement protein C3a, which helps reduce inflammation and fight disease. By focusing tightly on the bioactive area of the protein, they have reduced the size of the molecule from 77 amino acids to just three, making the product much more suitable for inclusion in medications.
 
C3a, like many proteins, is large and expensive to make, as well as quick to degrade once introduced into the body. But this technique not only makes the molecules cheaper and smaller, it also makes them far less susceptible than the full protein to enzyme breakdown or immunogenicity once in the bloodstream.
 
Prof. David Fairlie, who co-led the research group with Dr. Robert Reid, said the method should be generalizable to other proteins with very different functions. “This technique is not specific to C3a. It relies only on knowing the location of a single amino acid of a binding protein within its receptor protein,” he says. “The trick … is of course to first know the location of an amino acid within the biologically active region of that protein, and then to know what amino acids in the target protein that you wish to bind to.”
 
Making that connection possible involves a very complicated multistep process, which is laid out in an appendix to the journal article announcing the discovery, published in Nature Communications in November under the title “Downsizing a human inflammatory protein to a small molecule with equal potency and functionality.” Involving multiple chemicals, heat, stirring and other techniques to build up and rearrange the amino acids so they will fit with the target protein, the process must not only preserve the amino acids themselves, but also build up a molecular scaffold that mimics the shape of the original protein, to ensure proper binding. The method took about 20 years to perfect, including the last 10 years focusing specifically on C3a as an example, Fairlie notes.
 
The breakthrough makes possible new and more effective medications more specifically targeting proteins in the body. Because the method of making smaller molecules is not specific to C3a, “it is potentially applicable to any protein involved in any disease, and most diseases involve proteins interacting with other proteins or macromolecules,” Fairlie says.
 
The lab will continue to work to improve “small-molecule drugs that target the human complement C3a receptor for use in treating inflammatory and metabolic diseases,” Fairlie says. And the researchers will use the now-proven approach to work with other types of proteins, targeting “a wide range of diseases like viral and parasitic infections, inflammatory diseases such as arthritis, metabolic diseases such as obesity, type 2 diabetes and cardiovascular disease and cancers,” according to Fairlie.
 
Beyond protecting the intellectual property with patent applications, the lab is “interested in discussing license agreements with pharmaceutical and biotechnology companies,” says Mark Ashton, manager for innovation and commercial development at Uniquest, the University of Queensland’s main commercialization company.
 
To that end, the lab has established a partnership with Pfizer, including $2.2 million in funding from the Australian Research Council and another $2.1 million from Pfizer itself, to develop specific new medicines with this technique. This may result in some medications that can be delivered orally using smaller drugs, where “currently there are only large peptide drugs available that need to be administered intravenously,” Ashton said.

Wednesday, February 12, 2014

Jazz Pharmaceuticals is jamming

Published in Drug Discovery News

DUBLIN—Rapidly expanding its orphan-drug portfolio and planning for $1 billion in revenue in 2014, Irish company Jazz Pharmaceuticals is in the process of acquiring Italian drug firmGentium, and has acquired anti-narcolepsy drug ADX-N05 from Aerial BioPharma, based in North Carolina.
The Gentium acquisition, announced in mid-December, is worth roughly $1 billion, with Jazz making a tender offer of $57 per share to Gentium holders (a 26-percent premium on the volume-weighted average share price over the previous 60 days). Jazz will pay for the deal with a combination of cash on hand, a $500 million incremental term loan from Barclays and the remainder under its existing senior secured credit agreement with Barclays. The company estimates its borrowing costs at 3 to 3.5 percent interest.
The deal will bring into Jazz’s stable a promising drug, Defitelio (defibrotide), which treats severe hepatic veno-occlusive disease (VOD) in children and adults receiving hematopoietic stem cell transplants. In October, Defitelio was approved by European regulators for sale in the European Union, and is protected under orphan-drug exclusivity laws there through 2023.
Hematopoietic stem cell transplantation (HSCT) is more common in Europe than the United States, with 35,200 EU patients in 2013, compared with 19,500 U.S. patients, and 7,600 in the rest of the world. About 10 percent of HSCT patients develop severe VOD, which can involve multiple organ failure; untreated, it has an 80-percent mortality rate within 100 days.
Defitelio is also designated as an orphan drug by the U.S. Food and Drug Administration (FDA); it is not approved yet, but is in Phase 3 clinical trials and has fast-track status for FDA approval pending the results of those trials. There are no other drugs approved in the United States for VOD, according to Jazz disclosure materials.
In addition, Defitelio is being studied to treat graft vs. host disease, which could boost its sales potential significantly, the company anticipates.
Defitelio joins a handful of other orphan drugs in Jazz’s portfolio, addressing hematology and oncology, pain, psychiatric needs and sleep disorders. The company’s major earner in that last category was Xyrem (sodium oxybate), which brought in $154 million of the $230 million the company grossed in the third quarter of 2013. While the results of previous acquisitions and expansions mean Xyrem’s share of overall company revenue is dropping, the drug’s earning power remains on the rise. The Q3 total was 15 percent higher than the previous quarter, and 150 percent higher than the same quarter a year earlier.
In the wake of the deal, Bloomberg News reported that Jazz could be a very attractive acquisition target, with high growth and expanding potential. An advisory from Leerink Swann Research analyst Jason Gerberry said the opportunity “appears reasonably attractive, and potentially durable,” with an initial market size of up to $100 million.
A mid-January acquisition, ADX-N05, will expand Jazz’s presence in the sleep sector. Carrying worldwide development rights (except certain parts of Asia) and patent protection through 2027, the deal cost $125 million in cash, plus up to $272 million in future milestone payments, as well as ongoing royalties to both drug creator Aerial BioPharma and New Jersey-based SK Biopharmaceuticals, which holds the remaining Asian development rights.
The drug treats narcolepsy, which has in the United States about 25,000 patients with inadequate control of their condition; a major growth opportunity will come if ADX-N05 is also approved to treat obstructive sleep apnea, which offers a potential U.S. market of between 150,000 and 275,000. 
At a Jan. 13 presentation at the JP Morgan Healthcare Conference in San Francisco, Jazz chairman and CEO Bruce Cozadd presented slides saying the company expects between $867 million and $877 million in total revenue for 2013, but projects surpassing $1 billion in 2014.

Labor Relations: Blacklisting companies that ship work overseas

Published in the Portland Phoenix

Seeking to protect nearly 20,000 Maine jobs from being sent overseas, labor and union activists lobbied the state legislature last Thursday, with solid support and some modest, but expected, opposition. The bill they supported, LD 1710, would pressure companies that have customer-service call centers in Maine to keep their work in the United States.
Sponsored by Troy Jackson, a Democratic senator from Allagash who is running to replace Congressman Mike Michaud (who is himself running to replace Republican Governor Paul LePage), the bill would require call-center companies to notify the state before relocating call centers from Maine to foreign countries. (It does not require notification if a company moves elsewhere in the US.) And it would require all state-agency call centers to be in Maine.
Notification would have negative effects beyond bad publicity. The bill declares all companies that send Maine call-center jobs overseas ineligible for any “direct or indirect state grant, state guaranteed loan or tax benefit” for a period of five years after
the relocation.
Companies that, at the time of relocation, were receiving state benefits would have to repay to state coffers the unused amounts.
A recent union-conducted tally found 19,470 call-center jobs in Maine, with an average annual wage of $31,500, according to Jenn Nappi, assistant business manager of the International Brotherhood of Electrical Workers Local 2327, which represents most FairPoint employees in Maine.
FairPoint, which has about 900 unionized call-center workers in Bangor, Portland, and South China, is not the largest such company in Maine. That firm is LL Bean, which has about 2000 call-center staffers in Portland, Bangor, and Lewiston. Other major call-center players, according to the union research, are Bank of America with nearly 1000 people between Belfast and Brunswick, T-Mobile with 520 people in Oakland, and TD Bank with 500 in Auburn.
Companies often move call centers in search of low-cost labor: In 2009, the Baldacci administration’s economic commissioner John Richardson said Maine’s low wage levels should be considered by call-center firms (see “Maine — the India of the United States?” by Jeff Inglis, at thePhoenix.com/AboutTown).
In 2011, Carbonite, a Boston-based data-storage company, brought 150 call-center jobs from India to Lewiston. But other companies have gone the opposite direction: In February 2012, Bank of America closed a call center in Orono, laying off 200 people. Nappi and the IBEW say those jobs likely went to other Bank of America call centers in the Philippines.
And in September 2013, Sykes Enterprises, a Florida-based helpdesk company, closed a Wilton call center, laying off 150 people. The company has nearly 60 call centers in 25 countries, the IBEW says.
Some of these companies, including T-Mobile, have received tax incentives and other state support in exchange for promises of increased hiring.
“We’re constantly allowing all these companies to have all these great breaks, but we don’t require anything of them,” Nappi says.
There is, however, a possible loophole in the draft law, which allows state aid to go to a company that offshores work if not doing so “would result in substantial job loss in the State or harm the environment.”

Tuesday, February 11, 2014

Saving lives with testing

Published in Drug Discovery News

MUNICH, Germany—Seeking to commercialize a genetic diagnostic test that can reduce the incidence of suicide in patients taking antidepressants, Boulder, Colo.-based Sundance Diagnostics has licensed technology from Germany’s Max Planck Institute of Psychiatry.
The financials are not being disclosed by the privately held Sundance, said company CEO Kim Bechthold, though she did say Sundance is taking over patent costs and will pay a sales-based royalty to the Planck Institute. The test will be ready within the next month or two, she said, adding that licensing agreements with commercial lab companies around the country are in the works.
Based on research published in Neuropsychopharmacology in 2011, the test looks at a patient’s full genome for 79 markers of risk of emergent suicidal ideation. Initial research identified those markers, but then the Planck researchers, led by Andreas Menke and Elisabeth Binder, sought insight into the predictive power of those markers.
“When they tested their markers against 500 new patients, they could actually predict about 90 percent correct,” Bechthold says. “For a laboratory test, it’s out of this world.”
There are some limitations on the results, including that the test was only applied to Caucasians and people over the age of 18, though Bechthold admitted “every age of child is being prescribed antidepressants.” She also noted that teens are among the least likely to seek additional help for their depression and are also at risk of not telling their parents what their true thoughts and feelings are.
But the promise is so strong, Bechthold said, that Sundance will work to extend the test results to greater numbers and more diverse populations (including people of Asian and African descent), as well as potentially people under 18. The company will also seek approval from the U.S. Food and Drug Administration, which will allow the company to make claims about the test’s predictive power. Bechthold expects that approval within 18 months.
In the Planck Institute research, people at low risk of emergent suicidal ideation were identified correctly 93 percent of the time, Bechthold said. Those at high risk were identified less successfully, but she said even that division could be very useful, allowing physicians to focus their attention on those patients who are likely to be more at risk.
The market is massive: According to the U.S. Centers for Disease Control and Prevention, 11 percent of Americans age 12 and up are already taking antidepressants, and 9 million new prescriptions are written each year in the United States (as of 2006, so current numbers are likely higher). A further 9 million new prescriptions are written worldwide each year. At $200 to $300 per test, Bechthold said, “the potential profit is $1.8 billion.”
And the test is attractive, because no studies have been able to identify clinical indicators for doctors to detect emergent suicidal ideation induced by antidepressant drugs, leaving them operating in the dark even as they write more and more prescriptions. Rather than putting millions at risk every year—it is estimated that between 6 percent and 13 percent of the population is susceptible to antidepressant-induced emergent suicidal ideation—they can screen patients with a rapid cheek-swab test administered in the office. Results come back from the lab within two days, an important factor since 97 percent of patients who develop this adverse reaction do so within the first 29 days.
“This is a window into something [the doctor] simply can’t guess and has no way of knowing,” Bechthold said.
Adding to the demand for the test may be an additional result of the Planck research. Since 2005, all antidepressant prescriptions in the U.S. have carried a suicide warning, and there is an additional warning targeting patients 25 and under, who have been deemed by the FDA to be at elevated risk as compared to older patients.
National Institute of Mental Health research has shown, however, that there is no age at which risk is higher or lower; the Planck research confirmed that finding in its population, which ranged in age from 18 to 75.
Bechthold said Sundance, which focuses on adverse drug response and genetics, knows that genetic tests are commonplace in treatments for cancers and infectious diseases and is looking forward to bringing the first genetic test into neuropsychiatry. The company will work with Planck on further research in this and other areas.