We’ve discussed mobile
medicine and hand-held
technology before, but a recent partnership
between drug manufacturer Novartis and internet juggernaut Google takes the
theory to a whole new level. The two companies announced their collaboration to
develop a smart contact lens to monitor blood sugar. Apart from the obvious
implications of a “smart” piece of technology as small as a contact lens, the
impact of results and information available “almost in real-time” could change
the way diabetic patients monitor their blood sugar.
“It’s not going to happen overnight,” said Joe Jimenez, CEO
at Novartis, in the New York Times
article. “This will take a few years, as opposed to a few months.”
As a manufacturer, Novartis would understand the challenges of
the development process better than most. The company had unsuccessfully
attempted to produce glucose-monitoring contacts before. The new smart lens, based
on Google’s prototype, utilizes “miniature sensors and a radio antenna thinner
than a human hair to track glucose levels.” Additionally, Jimenez pointed out that
the partnership with Google gave the project the technological step-ahead it
needed in order to develop a more effective prototype.
“One of the biggest hurdles was miniaturization, and that’s
one of the biggest benefits that Google X brings,” he continued. “This is a set
of engineers that are really doing incredible things with technology.”
While the “smart” contact lenses remain in early stages of
development, they represent a trend in healthcare towards personalized medicine
and interactive testing. According to the NY Times story, as the general
population continues to have a greater understand and, subsequently, take more
control over their health, the healthcare and pharmaceutical industries are
seeing an increased demand for improved medical technology. As of this year,
both Apple and Samsung also offer individual health-monitoring technologies.
In public comments presented to the CMS today, the American Clinical Laboratory Association (ACLA) provided input on various aspects of implementing relevant provisions of the Protecting Access to Medicare Act of 2014 ("PAMA"), which modifies the Medicare reimbursement rate methodology for lab services.
"ACLA supports a measured and thoughtful analysis as well as robust stakeholder engagement in order to guarantee the new fee schedule continues to ensure adequate access to lab services for Medicare beneficiaries," said Alan Mertz, ACLA president.
ACLA's comments primarily focus on the need for CMS to develop or clarify definitions of several key terms, determine when private payor rates must be reported and for what timeframe, build a technology platform capable of accepting millions of discrete pieces of data, and establish coding processes for certain new tests.
A key definition identified by ACLA in its comments was "applicable laboratory" and ensuring that this encompasses the true private market. ACLA pointed out that the text of the statute, as well as Congress' intent, reflects that all major sectors of the laboratory market should be represented in reporting private payor rates, including independent laboratories and hospital outreach laboratories.
The way in which CMS defines the parameters, participants, methods, and timeframes for lab services payment rate and volume reporting, ACLA notes, will have a substantial impact on the rates that the Medicare program pays for clinical laboratory tests. It also has the potential to impact other payors' rates, as many private payors and state Medicaid programs base their reimbursement levels on Medicare rates. ACLA asserts that Medicare rates for lab services are best determined when payment and volume data reflect true market rates for clinical lab testing.
"Modifying the Medicare payment system for clinical laboratory services is a complex undertaking and ACLA is committed to ensuring the end result works for clinical labs, CMS, and Medicare beneficiaries," said Mertz. "Decisions made during this process will have a major impact on the clinical laboratory industry and the patients we serve, and it is important that those decisions work to promote ongoing diagnostic innovations and protect access to critical lab testing for Medicare beneficiaries."
To view ACLA's comments in their entirety, click here.
Researchers from the Icahn School of Medicine at Mount Sinai
and Harvard Medical School recently discovered a connection between a form of
liver cancer and two mutations in the IDH gene. Intrahepatic cholangiocarinoma
(iCCA) is the second most common form of liver cancer. Although there had
previously been evidence of IDH mutations in patients with iCCA, this study
marks the first time the exact genes, IDH1 and IDH2, have been targeted and
identified specifically as a direct link. An story from Newswise
detailed the study and subsequent findings.
“Our findings provide novel insights into the development of
iCCA and offers a possible treatment option for patients suffering from this
fatal disease,” said Josep Maria Llovet, MD, director of the liver cancer
program at Mount Sinai’s Icahn School of Medicine, in the article.
The study demonstrated the effect of mutated IDH genes using
mice, showing a decrease in the liver’s ability to health itself and an
increase in “the number of cells to form a tumor. The gene mutations also
resulted in a relationship with the KRAS gene, which is known to be linked to
the development of cancer. The combination of these factors leads to formations
of malignant legions in a liver with weakened defenses and, eventually, iCCA. According
to the story, targeting IDH1 and IDH2 as pathways for iCCA has already resulted
in new clinical trials to determine their impact on iCCA patients.
“iCCA is resistant to standard treatments like chemotherapy
and radiation,” explained Llovet. “Understanding the molecular mechanism of the
disease is the key to finding a treatment that works.”
Although the article pointed out, “there is no first-line,
standard of care and no successful therapies” for patients with iCCA, the study
has provided a necessary first step in the development of a treatment for the
disease. The discovery has opened the door for further investigation into a
relatively mysterious cancer and could potentially lead not only towards a
broader understanding, but also a successful therapy.
The emergence of whole genome sequencing has certainly had an impact on both scientific research and clinical medicine, but there are still a few remaining hurdles preventing widespread use of the technology. While the ability to interpret the raw data provided by genetic testing relies on the computing power of laboratory instruments, few laboratories have the analytical equipment capable of that kind of speed. A recent news briefing from Dark Daily noted on recent study in which researchers at the University of Chicago, using software available to the public, successfully incorporated the “Beagle” Cray XE6 supercomputer in their genetic testing.
“Whole genome analysis requires the alignment and comparison of raw sequence data,” said Elizabeth McNally, MD, PHD, professor of medicine and human genetics and director of the cardiovascular genetics clinic at the University of Chicago’s School of Medicine, in the Dark Daily briefing. “[This] results in a computational bottleneck because of the limited ability to analyze multiple genomes simultaneously.”
According to the release, the research team was able to analyze 240 whole genomes simultaneously. Using the “Beagle,” for their study, titled “Supercomputing for the parallelization of whole genome analysis,” they looked at sequencing information from 61 patients -- which took less than 50 hours and only 25 percent of its total capacity. To put this into perspective, the Dark Daily briefing pointed out that, for a 2.1 GHz CPU, it would take “roughly 47 years to analyze the same data.” Because of this, most current laboratory practices simply analyze the human exome, which is comprised of only about 2 percent of the human genome responsible for protein coding. Although the briefing noted that this is considered to be the basis of 85 percent of “disease-causing mutations,” the ideal method for research would include the whole genome -- an approach that isn’t currently feasible for consistent use.
“By paying close attention to family members with genes that place then[m] at increased risk, but who do not yet show signs of disease, we can investigate early phases of the disorder,” continued McNally. “In this setting, each patient is a big-data problem.”
New screening technologies are continuing to improve the accuracy of testing technologies, but the laboratory’s ability to breakdown and investigate the results of those tests quickly and accurately is every bit as important. By successfully utilizing the “Beagle” supercomputer in the analysis of raw genetic data, the researchers at the University of Chicago have opened the door to improved options for understanding sequenced information. The potential of quicker interpretation capabilities in whole genome sequencing could lead to more standard genetic tests with faster turnaround times and, subsequently, a more cost-effective laboratory model.
A mouse is a mouse is a mouse is a mouse – or so the
research community had thought. As it
turns out, a major component has been missing from the majority of animal testing
for clinical drug production: more female animals. In a recent article
from the New York Times, experts in
the field discussed the importance of incorporating more female subjects into
clinical testing and the subsequent impacts of current, male-dominated models
on women in terms of side-effects after production.
“One of the underlying assumptions has been that females are
simply a variation on a theme, that it isn’t a fundamentally different
mechanism, that if you’ve learned about the male you’ve learned enough to with
both males and females,” said Jill Becker, PhD, a senior research scientist at
the University of Michigan, in the article. “We’ve discovered that’s not always
The use of male animals as the primary subjects in clinical
testing has resulted in some particularly harsh and often serious consequences
for women once a drug has already been in production due to different
physiological responses to a variety of treatments. An example of this is the
FDA’s recent warning for women to cut Ambien pills in half because the female
metabolic process in slower in processing the active ingredient. According to
the NY Times Piece, the NIH has new policies regarding male and female testing
scheduled to be introduced in October, with exceptions most likely to be made
for gender-specific ailments like prostate and ovarian cancers.
“Every cell has a sex,” explained Janine A. Clayton, MD,
director of the NIH office of research on women’s health, in the story. “Each
cell is either male or female, and that genetic difference results in different
biochemical processes within those cells.”
The article also predicted some resistance among scientists
in the research community due to additional strains the new regulations might
place on experiments as the inclusion of animals of both sexes could
potentially double the number of subjects needed to deliver the necessary
results. Additionally, the article noted scientists' concerns regarding the need
for more extensive calculations made to factor in changes in hormones and the
reproductive cycle. On the other hand, the long-term decrease in serious, potentially
harmful side effects of drugs incorrectly calibrated for women stands to
drastically improve the effectiveness of clinical medications.
Imagine adding letters to the alphabet. Suddenly after
centuries of working with 26 letters, there are just whole new possibilities
for different words and phrases that had never been explored before. How would
we use the new letters? As it turns out, research scientists at the Scripps
Research institute in La Jolla, CA have been asking themselves the same
question, but with a very different alphabet. According a recent article
from NPR, Floyd Romesberg, PhD, along with the rest of the researchers in the
department of chemistry, managed to introduce two new letters to the genetic
“This is the first time that people have integrated a truly
synthetic, manmade thing into the machinery -- in this case the most
fundamental aspect of the machinery, the DNA -- and used it do something that
system does, in this case store information,” said Romesberg in the NPR story. “And
obviously we can now store more information than we could before
Romesberg and the research team created two synthetic
letters in addition to A, C, T and G (adenine, cytosine, thymine, and guanine).
Not only were the new codes successfully introduced into the DNA of a strain of
E. coli, but they were duplicated as the cells multiplied, implying that the
codes could be passed down. Of course, the findings remain in the preliminary
stages of testing, but the prospect of new genetic combinations is especially
exciting in terms of its impact down the road.
“Maybe you get three consonants and one vowel. Maybe there
are some words you can write and you can string them together to make, sort of,
primitive stories,” continued Romesberg. “But if you could have a couple extra
letters, there’s more that you could write. Having the ability to store
increased information would allow you to write more interesting words, bigger
words, more complicated words, more nuanced words, better stories.”
While the team’s goal was simply to create fully integrated
coding for the storage of genetic information, the new letters were
intentionally left unreadable to the cells. According to the article, the next
step for researchers will be to use the manmade letters to “use it to do something
that a cell wouldn’t normally do -- like make a new kind of protein.” Along
with the potential for a more advanced ability to engineer functions at the
genetics level, the research could also provide additional insight on biology
and even “how life got started in the first place.”
It’s pretty widely agreed that stress can be unhealthy.
Whether it comes down to high blood pressure, muscle tension or simply having
trouble sleeping, the physical implications of stress can have physical
implications on an otherwise healthy lifestyle. In a recent press
release from Stem Cells Translational Magazine, researchers from both the
UC-Davis Institute for Regenerative Cures and California State University
examined the impact of stress in the healing process for chronic injuries and
afflictions in a study led by Roslyn Isseroff, MD, and Mohan R. Dasu, PhD.
“The precise process that prevents their healing is unclear
except for two constants: a prolonged inflammatory response and the bacterial
colonization of the wound bed,” said Isseroff. “These two interrelated factors
are thought to contribute to the wound’s chronic state.”
According to the release, the presence of a protein called
epinephrine (adrenaline) functions to start the process of healing by
increasing activity to TLR2. This allows inflation to occur and, as a result,
promotes healing. The presence of bacteria, however, can cause “crosstalk,”
disrupting the signals to epinephrine. In their study, the research team examined
how increased epinephrine and TLR2 as a result of elevated stress levels could
impact the stem cells and keratinocytes altered to help heal the wound, and
found that the crosstalk produced by the increase led to the impaired healing
of the injury.
“These findings have implications for understanding the
mechanism controlling the differing susceptibility to infections and immune/inflammatory-related
conditions in wounds,” commented Anthony Atala, MD, director of the Wake forest
Institute for Regenerative Medicine and editor of Stem Cells Translational
Medicine, in the release.
It’s important to remember to take a deep breath and relax
sometimes, otherwise those annoying injuries that just won’t seem to go away
might end up sticking around even longer. Not only is stress a mental strain,
but the physiological impact can be detrimental to the healing process. The “crosstalk”
seen in cell signals from increased stress can throw a wrench into the body’s
natural ability to heal itself.
Not only does Medical Laboratory Professional’s Week (MLPW)
celebrate the services provided by laboratorians throughout the year, but now
it provides a platform from which to educate the public about the roles of
these professionals and the potential for employment within the industry.
Originally part of the “COLA Cares” initiative, “Give Back Days” began during
MLPW 2011. In a recent interview with James Liggins, Chief Marketing Officer at
COLA, he described the intended purpose of the “Give Back Days,” as well as the
effect they have had on the industry overall.
“The reality is that, while job growth in this sector is
faster than average, clinical laboratories across the nation have reported
difficulties in recruiting new staff,” said Liggins. “This program is COLA’s
way of helping to alleviate that worker shortage in the future.”
After the initial success of the MLPW 2011 Give Back Day in
Baltimore, Md., COLA has continued the program annually, expanding to include
local high schools, community colleges, universities and other venues. As the
program has expanded, COLA staff members give presentations describing a day in
the life of the typical medical laboratory professional, demonstrate simple
laboratory tests and conduct fun experiments with participants.
“Our program now includes additional career presentations at
schools, science expos and other venues; mentoring opportunities for interested
students; and expanded scholarship support aid for students interested in
medical laboratory careers,” explained Liggins.
COLA’s Give Back Days feature a number of campaigns to
increase awareness of the laboratory’s role in the healthcare industry and
promote it as a viable career option. In addition to the outreach and
continuing education programs offered during Give Back Day, COLA also offers
scholarships to aspiring laboratorians and endowments to education programs
catering towards future medical laboratory technologists.
“We are also
launching a course for allied health professionals, emphasizing the components
of good clinical laboratory practices,” continued Liggins. “Designed for nurses
and other healthcare personnel who work in hospitals, clinics and physician’s
offices, the course will provide non-laboratorians with a basic knowledge of
quality laboratory testing procedures in healthcare settings.”
The course, “Fundamentals of Clinical Laboratory Testing,”
will be offered through Howard Community College’s continuing education
program. COLA hopes to expand the
program elsewhere throughout the U.S. in the future.
MLPW is a time to celebrate the work of laboratories across
the country, but why not use the spotlight to promote the profession among the
rest of the industry and potential co-workers? In addition to their Give Back
Days, COLA is also in the process of implementing “COLA Giving Back 365 Days a
Year,” which will expand on areas already covered and include a new disaster
relief program. AS Part of MLPW, COLA encourages laboratories everywhere to
take part in COLA’s Give Back program with a free kit offered on their website
Type 2 diabetes has been a growing concern in the United
States for several years. While the established research has pointed to two
specific hormones, glucagon and insulin, as the primary factors leading to the
development of the disorder in patients, researchers have discovered a third
key player in a recent news
release from Johns Hopkins. The Johns Hopkins scientists discovered that
Kisspeptin 1 (K1), a hormone typically associated with puberty and fertility,
directly influences and interferes with the production of insulin in the
“Glucagon and insulin alone never really made complete
sense,” said Mehboob Hussain, MD, lead investigator, endocrinologist and
metabolism expert at the Johns Hopkins Children’s Center. “There was always
something missing and, we feel, kisspeptin 1 is a very good candidate to be
that missing part. All of our findings point in this direction.”
According to the release, the general opinion prior to the
discovered impact of K1 was that the slow build-up of blood sugar due to
elevated levels of glucagon eventually tired out the pancreatic beta cells
responsible for insulin secretion. Instead, it seems that, rather than the
cells slowly wearing out, high glucagon triggers the production of K1, which
targets the cells and suppresses the secretion of insulin, leading to the high
blood sugar and low insulin levels associated with the disorder. In experiments
with human blood and liver cells and eventually mice, once the Johns Hopkins
researchers rendered their livers incapable of producing K1, the levels of
insulin and blood sugar returned to normal.
“Our findings suggest that glucagon issues the command, but
K1 carries out the orders,” explained Hussain. “And, in [doing so,] it appears
to be the very cause of the declining insulin secretion seen in type 2
Additionally, Hussain and his colleagues speculated that the
evolution of K1 arose from the need to prevent dramatic decreases in blood
sugar during fight-or-flight situations. This research, while still in its
preliminary stages, has offered a third key component in the assessment of type
2 diabetes and the possibility of a new method of treatment for the disorder. Rather
than treating as needed with the injection of insulin, the disorder could
potentially be cured by limiting and even eliminating the production of K1.
Regenerative medicine is a field that seems like something
right out of the pages of science fiction. In a recent study from the
University of Pittsburgh Medical Center (UPMC), researchers studied the effect
-- and subsequent success -- of stem cells derived from human muscle tissue in
repairing nerve damage in mice. A UPMC press
release detailed the study and speculated on the potential impacts to the
healthcare industry given the results of the experiment.
“This study indicates that placing adult, human
muscle-derived stem cells at the site of peripheral nerve injury can help heal
the lesion,” said Johnny Huard, PHD, senior author and professor of orthopedic
surgery, UPMC School of Medicine. “The stem cells were able to make
non-neuronal support cells to promote regeneration of damaged nerve fiber.”
According to the release, the study involved creating a
quarter-inch defect in the sciatic nerve of test mice and then treating with
“cultured human muscle-derived stem/progenitor cells” injected into the damaged
nerve. It noted that treatments for peripheral nerve damage have had limited
success so far, so the introduction of a successful treatment utilizing
regenerative medicine techniques is a promising start -- even if it was only in
the preliminary stages of testing. Not only did the treated mice experience
full regeneration in the nerve, but the study also found that the mice
eventually experienced a restored gait.
“Even 12 weeks after the injury, the regenerated sciatic
nerve looked and behaved like a normal nerve,” commented Mitra Lavasani, PHD,
assistant professor of orthopedic surgery at the UPMC School of Medicine and
author of the study. “This approach has great potential for not only acute
nerve injury, but also conditions of chronic damage, such as diabetic
neuropathy and multiple sclerosis.”
The ability to heal living organisms simply by using their
own biological materials puts modern science in view of fictional pipedreams. The
early success of tests incorporating regenerative medicine could potentially
make room for uses in healthcare for humans. The press release specified injury
repair and the developments of “delivery systems, such as gels,” and a
prospective next step in healing larger areas.
For as developed and state-of-the-art as modern medicine has
become, the standard practice for organ transportation has a lot of catching up
to do. Typically moved from facility to facility in an ice-filled cooler via
helicopter or some other form of emergency vehicle, the tissues in organs start
to breakdown and the organ becomes unusable after a certain period of time. A
from NPR covered a potential breakthrough for the storage and transportation of
lung (and possibly heart) transplants.
“For the first time, the donor lungs can be maintained in a
breathing, warm, nourished state during transport,” said Abbass Ardehali,MD ,
transplant surgeon at the UCLA School of Medicine in the NPR story.
According to the story, the “lung in a box” or Organ Care
System “circulates blood through the lungs and pumps oxygen through the lobes.”
Essentially, this allows the lungs to continue to function for an extended
period of time before being utilized for a transplant. The company behind the “lung in a box,”
TransMedics, is also working on similar technology to keep hearts beating
outside the body -- the NPR story even noted that it “keeps a heart warm, pumps
blood through it and feeds it nutrients.”
Additionally, the portable nature of the machine allows it to be
transported with the organ to ensure better preservation during longer
“On an annual basis, more than 30 or 40 hearts in Hawaii go
unused,” continued Ardehali in the NPR piece. “Because of the distance, these
hearts cannot be transported to the mainland.”
Although the technology for the “lung in a box” has not yet
been approved by the FDA, the NPR story mentioned trials and studies either
underway or in preparation to test the equipment’s effectiveness. Ardehali commented
on Hawaii, noting the sometimes extended amounts of time it takes to transport
vital donor organs – especially from more extreme distances. Due to these
concerns, the benefits of the technology behind the Organ Care System could be
substantial for those waiting on transplant lists across the country.
In a recent post,
I covered some unique opportunities presented by crowdfunding for technological
advances in areas like molecular diagnostics. While the crowdsourcing mentality
can work well in gathering funds for equipment producers, crowdsourcing medical
information through sites like Wikipedia can carry more limitations and even
dangers. A recent article
from NPR opened up discussion on the subject.
“I think that’s the double-edged sword of Wikipedia,” said
Amin Azzam, MD, MA, professor of psychiatry at the University of California, in
the NPR piece. “Because anyone can edit, we don’t necessarily know the
expertise of the people doing the editing. [On] the other hand, the reason it’s
so popular is because everyone can contribute.”
The story noted that, according to a January IMS Health
Institute study, Wikipedia is “the ‘single leading source’ of healthcare
information for both patient and healthcare professionals.” Due to the website
being open to the open to public editing, this is not always a benefit and can
lead to the circulation of incorrect medical information. According to the article, Azzam teaches a course in which he
works with fourth-year medical student to clean up the material available on
Wikipedia, editing pages and improving the quality of information.
“It’s not just adding references and not just improving the
gaps,” continued Azzam in the NPR piece, “but thinking about how to make it
more readable and more digestible for the people that are reading Wikipedia.”
An intriguing side effect of having student edit the pages,
as noted both by Azzam, is that they were forced to present the information in
a way readers could comprehend. One
commenter on the NPR page even took it a step further and wrote, “Med
School students editing Wikipedia articles does something else which no one
here has commented upon--it just might help the future doctors learn to talk to
Patients in a way that the patients can understand,” suggesting that the
practice could also potentially improve patient communication.
We’re all familiar with the popularity of crowdfunding
websites like Kickstarter for both the largely successful and also the somewhat
misguided attempts to gather funding for movies and music videos, but lately a much more serious group has
turned to crowdfunding: clinical researchers. In an effort to gain additional
funding for its handheld POC DNA test for malaria and drug resistance,
tentatively called “Q-POC,” a biotech company based in Newcastle, UK, QuantuMDx
Group, decided to turn to internet-based public funding on Indiegogo as of
February 12, 2014. A recent video
explains the technology as well as the concept of the project.
“Our Crowdfunding campaign is unique,” explained Elaine
Warburton, OBE, CEO of QuantuMDx, in a press release. “Not only are we looking
for contributors to support this phenomenally worthy cause to help save many
hundreds if not thousands of children’s lives, but we’re also offering everyone
the chance to leave a lasting legacy in the fight against malaria by
contributing their winning ideas to the look and feel of our device and to take
part in re-naming it from the current research name of Q-POC.”
According to the press release, the world loses one child
per minute due to malaria. The impact of a handheld DNA testing assay without
the need for clean water or a stable electricity source could make all the
difference in developing nations and countries in need. The funds rasied via
Indiegogo will go towards further development and the effort to expand clinical
trials for the new technology.
“We have spent years developing our tech and we now have a
prototype device that has completed a sample-to-result malaria DNA test in
under 15 minutes,” said Jonathan O’Holleran, CSO of QuantuMDx and inventor of
their signature handheld assay, in the press release. “Contributions will help
take our life-saving device from the lab to the field and directly save lives.
We have health workers around the world crying out for our technology and are
now receiving the support of major MGOs, we just need help to finalize our
development and drive the technology through clinical trials.”
I’ve discussed handheld
options and extreme
POCT before. In a domestic capacity, similar handheld devices to the “Q-POC,”
could potentially change how we care for home-bound patients, while the foreign
applications are virtually limitless -- especially in regards to developing nations.
For modern clinical laboratories, the addition of a fully mobile, handheld
molecular testing device could change the concept of laboratories and expand
the reach of modern medicine.
The implementation of the Affordable Care Act, or ObamaCare,
has already seen several new laws and regulatory measures introduced since its
implementation, with many more soon to be on the horizon. One of these is the Sunshine
Act, a law requiring public disclosure of any financial agreements between
healthcare vendors and providers. Recent articles from both the New England
Journal of Medicine (NEJM) and Dark
Daily discussed the specifics of the new law and the potential impact to
those affected in the healthcare industry.
In terms of the specifics, the Sunshine Act became effective
on August 21, 2013 and the NEJM story identified all drug or device
manufacturers in the US, as well as doctors of medicine, osteopathy, dentistry,
podiatry, optometry, chiropractic medicine, physicians and teaching hospitals.
In order for an amount to require disclosure, it must be a transaction of at
least $10 or more than $100 annually. The law also requires that certain items
also be reported, including “cash or a cash equivalent, in-kind items or
services, stock, consulting fees, compensation for services other than
consulting, honoraria, gifts, entertainment, food, travel (including the
destination), education, research, charitable contributions, royalties or
licenses, current or perspective ownership or investment interest, speaker
compensation for CME events and grants.”
Additionally, the Dark Daily piece discussed some concerns
about the financial disclosure, specifically regarding the strain placed on the
relationship between patients and providers. While the impact of financial
records being made available online could be substantial for “computer-savvy
patients,” there is also concern that availability of this information could
jeopardize the trust between patients and physicians, leading patient to
ultimately question a doctor’s decisions. The information is set to be
published as of September 2014.
“Whether transparency will lead to fewer relationships is
really the million dollar question,” commented Daniel Carla, MD, director of
the Pew Charitable Trusts Prescription Project, in the Dark Daily piece. “The
kinds of relationships that may drop off may well be the most inappropriate
The story went on to note that Carla also mentioned the
possibly of pharmaceutical companies or medical equipment manufacturers finding
new ways to maintain relationships with physicians and clinicians. The NEJM
article, on the other hand, examined the purpose of the program: “to provide
objective information on the type of financial relationships that exist between
manufacturers or GPOs and physicians or hospitals.” Regardless of the predicted
changes, the Sunshine Acts stands leave its mark across the healthcare
Apart from its impact on industry vendors, providers and
patients, the Dark Daily briefing also noted another area that stands to be
affected: the laboratory. According to the Dark Daily article, the impact could
be seen by pathologists and laboratory professionals, especially in the case of
in vitro diagnostics, manufacturers of which fall under the vendor category of
the new law. In the coming future, new policies -- not only federal, but within
the companies themselves -- should be taken into account for laboratory
The influence of genetic sequencing has left its mark across
the healthcare industry. In a recent partnership with Pennsylvania’s Geisinger
Health System, Regeneron Pharmiceuticals, who recently came out with Eylea for
age-related macular degeneration, is looking to take some of the the first
substantial steps in making that vision a reality. A recent story
from the New York Times detailed the
extent of the project.
According to the article, the price of whole genome
sequencing has already dropped significantly since it was first announced and
continues to do so as more and more advancements are made in the field, it
hasn’t quite reached the “$1000 genome” mark yet. As such, the collaboration
between Regeneron Pharmiceuticals and Geisinger Health will mainly be focused
on patient exomes rather than the entire genome at first. The study, which
reflects smaller projects across the country and around the world, will be
mutually beneficial to both parties.
medically, it’s pretty exciting,” said Leslie G. Biesecker, MD, chief of the
genetic disease research branch at the National Human Genome Research
Institute, in the New York Times
piece. “As far as I’m aware, it’s the largest clinical sequencing undertaking
in this country so far by a long shot.”
All patient information used by Regeneron will remain
confidential and used for research, while Geisinger will be able to keep the
patient data for their own records. The New
York Times article continued, noting similar public studies in Britain,
Saudi Arabia, and varying health systems across the United States. Additionally,
the department of veterans affairs is also planning a large-scale DNA
collection as the price of sequencing continues to drop.
Since it was announced over a decade ago, the industry has
been expecting a surge of new drugs targeting our genome. The potential Impact
of prescriptions that function and work directly with a patient’s DNA stands as
a landmark in treatments. As genetic medicine is a field that has been poised
to expand rapidly for years, the industry can finally expect to see more
genetic-based treatments and medications along with increased testing for
patients with the shrinking cost of sequencing options.