Latest & Greatest
AMA Seeks to Ban Direct-toConsumer Advertising
Concerned that a growing number
of prescription drug and medical
device ads may be driving demand
for expensive treatments despite the
ability of as-effective and less-costly
alternatives, the American Medical
Association (AMA) recently voted in
favor of banning direct-to-consumer
advertising.
Even though the U.S. Food and
Drug Administration (FDA) and
Congress are the only entities that
have the power to enact such a ban,
the AMA views this new policy as
a step toward making prescription
drugs more affordable, arguing that,
as more people seek drugs they may
not need, drug prices and money
spent on selling them are on the rise.
Spending on direct-to-consumer
advertising has increased 30 percent
in the past two years, amounting to
$4.5 billion. At the same time, prescription drug prices have increased
nearly 5 percent this year, the AMA
explained.
“[This vote] reflects concerns
among physicians about the negative
impact of commercially driven promotions, and the role that marketing costs play in fueling escalating
drug prices,” said Patrice A. Harris,
MD, MA, the board chair-elect at
18
ASH Clinical News
the AMA, in a press release from
the agency. “Direct-to-consumer
advertising also inflates demand
for new and more expensive drugs,
even when these drugs may not be
appropriate.”
The AMA’s new policy calls for
convening a physician task force and
launching an advocacy campaign to
promote more affordable prescription drugs, by demanding choice and
competition in the pharmaceutical
industry and greater transparency in
prescription drug prices and costs.
The AMA also plans to monitor
pharmaceutical company mergers
and acquisitions to determine how
they will affect drug prices.
As part of the new policy, the
AMA will encourage actions by
federal regulators to limit anticompetitive behavior by pharmaceutical companies against generic
manufacturers through manipulation
of patent protections and abuse of
regulatory exclusivity incentives.
The agency argues that a greater
understanding of factors that contribute
to prescription drug pricing, including
research, development, and manufacturing, is necessary for all health-care
stakeholders, including physicians,
patients, manufacturers, and payers.
Members of the pharmaceutical
industry, however, took issue with
the AMA’s decision. Tina Stow, of
the Pharmaceutical Research and
Manufacturers of America, argued
that direct-to-consumer advertising
offers “scientifically accurate information to patients so that they are
better informed about their healthcare and treatment options [and it
leads to] important doctor−patient
conversations about health that
might otherwise not take place.”
Sources: American Medical Association, “AMA calls for ban on
direct to consumer advertising of prescription drugs and medical
devices,” November 17, 2015; The Washington Post, “American
Medical Association urges ban on TV drug ads,” November 19, 2015.
Researchers
Develop Novel
Assay to Predict
Heparin-Induced
Thrombocytopenia
A novel PF4-dependent p-selectin
expression assay (PEA) has proven effective in detecting platelet-activating
heparin-induced thrombocytopenia
and thrombosis (HIT) antibodies,
according to research presented at the
57th ASH Annual Meeting.
These antibodies preferentially recognize heparin/platelet factor 4 (H/PF4)
bound to platelet glycosaminoglycans in
the absence of heparin, the researchers,
led by Anand Padmanabhan, MBBS,
MA, PhD, of the Medical Sciences Institute at the BloodCenter of Wisconsin,
explained.
Dr. Padmanabhan and colleagues
compared the diagnostic performance
of PEA versus the serotonin release assay (SRA), which is considered the gold
standard for HIT testing. Ninety-one
serum samples from patients referred
for HIT testing (with clinical scores
ranging from 0 to 8) were tested using
both assays. Samples were considered
HIT-positive if patients had intermediate or high 4T scores and PF4
ELISA optical density (OD) values >1;
samples were considered HIT-negative
if patients had intermediate to high 4T
score with PF4 ELISA OD <1.
Overall, PEA had greater accuracy
for identification of samples from HITpositive patients compared with SRA
(0.93 vs. 0.82; p=0.01). “PEA has many
attractive features, including its technical simplicity and its ability to allow
physicians to identify patients suspected of having a high likelihood of HIT,
suggesting that its use may facilitate
early diagnosis and improve management of this diagnostically challenging
disorder,” the authors concluded.
Source: Padmanabhan A, Jones C, Curtis BR, et al. A novel
PF4-dependent platelet activation assay identifies patients
likely to have heparin-induced thrombocytopenia/thrombosis
(HIT). Abstract #764. Presented at the 2015 ASH Annual
Meeting, December 7, 2015; Orlando, Florida.
FDA Grants Accelerated Approval to
Daratumumab for
Multiple Myeloma
The U.S. FDA granted accelerated
approval to daratumumab injection
for patients with multiple myeloma
(MM) who have failed at least three
prior lines of therapy, including a
proteasome inhibitor and an immunomodulatory agent. Daratumumab
is the first monoclonal antibody approved for the treatment of MM.
The recommended dose of daratumumab is 16 mg/kg administered
once every week for eight weeks,
then once every two weeks for 16
weeks, followed by once every four
weeks until disease progression.
The approval was based on a multicenter, open-label study evaluating
response rates in 106 patients with
relapsed or refractory MM treated
January 2016