deal frenzy seek to be first, best or gone
Do a few things, and do them well. Thatâ€™s the strategy the drug industry is
following in a wave of deals where small companies are getting bigger and
the big ones are getting smaller. An industry wide recalibration that has
been building since 2011 reached a peak this week with a flurry of activity
by Pfizer Inc., GlaxoSmithKline Plc and Valeant Pharmaceuticals
The biggest drugmakers are reshuffling units to get rid of ones that donâ€™t
make them leaders in a particular market, while smaller players are buying
competitors to add size, lest they be swallowed up themselves.
Thatâ€™s the reason drugmakers like London-based Glaxo are quitting the cancer
business as Basel, Switzerland-based Novartis AG bulks up. It also may be
why New York-based Pfizer, which has a handful of promising oncology drugs,
tried to buy AstraZeneca Plc, the London-based drugmaker with a
complementary cancer portfolio.
To that end, Novartis agreed to buy Glaxoâ€™s oncology business for as much as
$16 billion, to sell Glaxo its vaccines line for as much as $7.1 billion and
to sell its animal health business to Eli Lilly & Co. for $5.4 billion.
Valeant, meanwhile, announced a bid to buy Allergan Inc. for $45.7 billion,
part of its announced strategy to join the ranks of the worldâ€™s five biggest
The three-company transaction reflects the busiest period of industry deals
since 2009, with $141 billion in pharmaceutical company acquisitions or
divestitures over 12 months, according to data compiled by Bloomberg.
The be-first-or-get-out strategy was the justification for
Indianapolis-based Lillyâ€™s part of the Novartis-Glaxo deal, said Lilly Chief
Executive Officer John Lechleiter. While veterinary medicines werenâ€™t a
priority for Novartis, Lilly sought to make them one.
After the deal closes, Lilly will be the second-biggest animal-health
company behind Zoetis Inc., Mark Purcell, an analyst with Barclays Plc, said
in a note to clients. The same business philosophy is driving dealmaking in
human drugs, according to Lechleiter. â€śYouâ€™re seeing companies strengthening
areas where theyâ€™re already strong and building up critical mass,â€ť he said.
The strategy shift follows a decade of megamergers, including Sanofiâ€™s $74
billion purchase of Aventis SA in 2004, Pfizerâ€™s $64 billion purchase of
Wyeth LLC in 2009, and four other deals since 2002 valued at $40 billion or
more that consolidated the industry into todayâ€™s multinational giants.
Gone are the days when a company with a powerful sales force could go to the
market with the third or fourth drug in a class, then force its way into
blockbuster sales, said John Boris, an analyst with Atlantaâ€™s Suntrust Banks
Inc. Thatâ€™s the reason for Pfizerâ€™s bid for AstraZeneca, he said: Pfizer
needs a deep offering of the best possible cancer drugs.
Pfizer and AstraZeneca are trying to make that transition from a time they
used armies of sales representatives to sell broadly used drugs for basic
health conditions. Years ago, they â€ścould survive on second- and third-tier
assets, based on their marketing muscle,â€ť Boris said in a telephone
Drugmakers canâ€™t do that anymore, and Pfizer may have seen the writing on
the wall. Two potential billion-dollar-plus drugs, Eliquis and Xeljanz, have
fizzled in their starts. And its top experimental drug, the breast cancer
treatment palbociclib, has a potent competitor in Lillyâ€™s bemaciclib.
AstraZenecaâ€™s oncology pipeline has experimental drugs that use the bodyâ€™s
immune system to attack cancers, considered by analysts among the most
promising areas for new treatments. Adding them would make Pfizer a powerful
player in cancer.
Meanwhile, the small are getting bigger. Generic and specialty drugmakers
such as Mylan Inc., Actavis Plc and Valeant have been buying competitors,
expanding geographically and using the deals to cut costs. The result is
consolidation -- the top three generic-drug makers last year had total sales
of copycat drugs that were 23 percent higher than the top three in 2009,
according to data compiled by Bloomberg.
Generic-drug makers are also buying up more profitable injectable and
brand-name drugs in a bid to grow bigger than rivals. Actavisâ€™s $25 billion
deal for Forest Laboratories Inc. will give it a combined market value of
about $60 billion, as of yesterdayâ€™s share prices. That puts it just behind
Visit Bloomberg for the report.
fluid shortage threatens care
Since mid-January, the nurses at the Coastal Cancer Center in Myrtle Beach,
South Carolina, have been spending several hours each week tracking down
suppliers who can provide the intravenous (IV) solutions necessary for
patients scheduled to receive chemotherapy.
If they are unsuccessful, Vijay Paudel, MD, an oncologist at the facility,
is faced with the onerous decision of which patients will get their
treatments and who will have to wait.
Normally, securing the weekâ€™s IV fluids takes the cancer centerâ€™s nurses
about half an hour, but a nationwide shortage that began in January has made
the task a day-to-day or week-to-week challenge for oncology practices,
hospitals, and other healthcare facilities across the country. The 2
companies that supply the bulk of the nationâ€™s IV fluids attribute the
shortage to increased demand caused by a difficult influenza season. But
many in the healthcare industry question whether economic and other factors
are the real drivers of the shortage.
Panicked calls from oncology practices having difficulties securing saline
prompted Community Oncology Alliance, an advocacy organization, to conduct
an online survey of its membership in February, according to Ted Okon, MBA,
executive director of the alliance. Of the 66 respondents, most reported
having to take steps to avert shortages, and nearly half reported having to
adjust the way fluids are used.
Okon said oncology practices are trying everything they can to procure
intravenous fluids, including paying excessive amounts for them, using
dextrose instead of saline, and breaking down larger bags. Some suppliers
that have saline are putting pressure on practices to sign a contract to
obtain all of their supplies for a year or to agree to buy other products
from them, according to Paudel.
Hospitals are feeling the squeeze, too. A survey of pharmacy directors by
the American Society of Health-System Pharmacists (ASHP) in early February
found that 76% of US hospitals and other health care facilities were
affected by the saline shortage and that shortages of alternatives were also
More than half reported they were able to meet patient needs by using
various strategies to conserve their supply. But 29% of ASHPâ€™s survey
respondents said they could not meet all patient needs. Almost two-thirds
(64%) of the facilities reported using such alternatives as Lactated Ringer
solution or dextrose/sodium chloride solutions. Nearly half (48%) reported
changing patientsâ€™ doses, nearly a third (29%) reported prioritizing which
patients should get saline, and 3% reported delaying treatment for some
â€śItâ€™s maddeningly frustrating that we donâ€™t have these basics,â€ť said Erin R.
Fox, PharmD, director of the Drug Information Service at the University of
Utah in Salt Lake City, which tracks drug shortages nationwide. Fox said
that although shortages of drugs, particularly sterile injectables, have
become common in recent years, it is unheard-of to have a shortage of such a
Northwestern Memorial Hospital in Evanston, IL, has so far managed to avoid
patient-level effects of the IV fluid shortage, said Gary Noskin, MD, chief
medical officer at the hospital. Other recent shortages have affected
patient care at Northwestern Memorial or required clinicians to switch to
alternatives, Noskin said.
However, a coordinated effort by clinicians, supply chain staff, and the
hospitalâ€™s pharmacy staff has allowed the facility to manage and conserve
the available supply of IV fluids. But the effort, which includes weekly
calls to suppliers and daily inventory audits throughout the hospital, has
come at a cost of staff time. Noskin estimated since the IV fluid shortage
began in January, the cost to the organization by mid-March was about $100â€‰000.
The situation has started clinicians from multiple disciplines talking about
the use of IV fluids. â€śItâ€™s allowed us to systematically evaluate our use of
intravenous therapies and determine what is appropriate and what might not
be,â€ť Noskin said.
The reasons for the shortage arenâ€™t entirely clear, although both the US
Food and Drug Administration (FDA) and the 2 primary US manufacturers of IV
fluids put some of the blame on increased demand for fluids, driven in part
by the 2013-2014 flu season.
Even so, similar shortages have not arisen during previous and more severe
seasons, sparking some skepticism about the current problem. â€śWhy is the
supply chain so fragile that it creates a national crisis?â€ť asked Fox.
Some previous shortages of sterile injectables have been caused by quality
problems, and recent recalls suggest that Baxter and Hospira have not been
immune to these concerns.
â€śThis is all an economic problem,â€ť said Okon. He said changes in the US
Centers for Medicare & Medicaid Servicesâ€™ reimbursement policies for drugs
administered in outpatient settings have exacerbated already tight profit
margins. Still, manufacturers queried by the GAO did not think that these
reimbursement policies were contributing to shortages.
Visit JAMA for the report.
Communication for Epidural Corticosteroid Injection
FDA is warning that injection of corticosteroids into the epidural space of
the spine may result in rare but serious adverse events, including loss of
vision, stroke, paralysis, and death. The injections are given to treat neck
and back pain, and radiating pain in the arms and legs. The effectiveness
and safety of epidural administration of corticosteroids have not been
established, and FDA has not approved corticosteroids for this use.
FDA is requiring the addition of a Warning to the drug labels of injectable
corticosteroids to describe these risks. To raise awareness of the risks of
epidural corticosteroid injections in the medical community, FDAâ€™s Safe Use
Initiative convened a panel of experts, including pain management experts to
help define the techniques for such injections which would reduce
The expert panelâ€™s recommendations will be released when they are finalized.
FDA will convene an Advisory Committee meeting of external experts in late
2014 to discuss the benefits and risks of epidural corticosteroid injections
and to determine if further FDA actions are needed.
Read the MedWatch safety alert.
New data signal
smaller jump in healthcare costs
Statisticians working with insurers to project next year's insurance premium
rates say they expect to see an average increase of about 7%, well below the
feared double-digit increases making recent headlines.
"The double-rate increases we've been hearing are probably exaggerated,"
says Dave Axene, a fellow with the Society of Actuaries, adding that there
would be wide variation across the country. "That's not what we're seeing
from the actuarial organizations â€” I guess we're being a little bit more
Axene says that as insurers dig through the new health exchange enrollees to
figure out their ages and health conditions to determine next year's
premiums, he expects an overall increase of 6% to 8.5%. He bases that on
work he and others within the society have done with insurance clients.
Before the Affordable Care Act, premiums rose an average of 7-10% a year.
Axene warns there could be wide variations in actual costs."In some states,
there's a very wide spread between the high rate and the low rate â€” in
Manhattan, it was 2-to-1 â€” but these are averages," he says.
He's also been able to get an early read on some of the people who have been
enrolling, though the March and early-April exchange enrollees' data aren't
yet available. The early enrollees tended to be people with "higher
morbidity," he says â€” about 6-8% had higher-than-average healthcare needs.
But that had been expected, and probably won't play a large part in next
However, insurance costs are likely to rise more in coming years as
reinsurance and risk corridors disappear in 2017. Part of the reduced growth
rate could be due to improvements in the healthcare system that will
continue to rein in costs over time.
Several new reports also hint at a bend in the health cost curve â€” even as
health spending picks up with the improving economy.
The change after years of large increases in how much healthcare costs seems
to be coming for several reasons, the reports find: Americans are using
their prescribed medications more often, which may be keeping them out of
the hospital; payment systems have begun to reward quality over quantity,
which has encouraged a team-based, data-driven approach; and record numbers
of medications have been developed to address chronic disease, while older
medications have come off their expensive patents.
The findings include a report from the IMS Institute for Healthcare
Informatics that found that even as health care spending has rebounded with
the economy, the growth rate remains lower than usual. In addition, the
Congressional Budget Office (CBO) projected lower health insurance premiums
than originally expected.
"Growth in medicine spending remains at historically low levels despite a
significant uptick last year, and continues to contribute to the bending of
the health care cost curve," says Murray Aitken, executive director of IMS,
which provides reports to health companies and creates market forecasts. "We
think (the uptick in spending is) a reflection of a stronger economy, more
patients with insurance and some relief of pent-up demand for services
because of the economic downturn."
IMS found that Americans spent $329.2 billion on healthcare last year â€” up
3.2% from 2012 and a rebound after spending went down 1% in 2012. The report
listed several reasons for the change, including expired medication patents,
price increases, higher prices on new medicines and more consumers using the
health care system.
The study found that even before the rollout of the Affordable Care Act,
consumers shifted to high-deductible plans and paid higher out-of-pocket
Aitkin says people spent more on drugs and less on follow-up visits and
hospitalizations, which could be key to keeping the growth rate low. Health
experts have long held that if people can afford â€” and take â€” prescribed
medications, it may keep them safe from heart attacks or low blood sugar
levels, and ultimately keep their overall health costs lower.
Aitkin says 23% of prescription drugs had no co-pays in 2013, mostly because
of provisions within the Affordable Care Act, including the one for coverage
of contraceptives as preventive medications. Women saved $483 million in
out-of-pocket costs in 2013 for contraceptives alone.
And hospitalizations from emergency room visits decreased 14.6%, possibly
because consumers were encouraged to try other options first. Prescribing
pain medications, probably in response to narcotic addiction, has also gone
This week, the CBO downgraded its original premium projections by about 15%
lower than projected in the fall of 2009, in part due to "lower projected
health care costs for the federal government and the private health sector."
Visit USA Today for the article.
under scrutiny after two nurses wounded in stabbings
Two nurses wounded in two separate attacks at two different Los Angeles
County medical centers continued to recover Monday, but their injuries
further illustrate the need to improve hospital workplace safety, an
â€śWe can not stand by while nurses, other hospital staff, patients, families,
and visitors are put in harmâ€™s way in hospitals that fail to provide the
measures that will protect their staff and the community,â€ť said Malinda
Markowitz, co-president of the California Nurses Association. â€śIt is time
for the Legislature to act.â€ť
The association is backing a bill introduced by Sen. Alex Padilla,
D-Pacoima, that would require the stateâ€™s Occupational Safety and Health
Standards Board to adopt workplace violence prevention plans to protect
health care workers from aggressive and violent behavior. The Senate Labor
Committee is expected to hold a hearing on the bill on Thursday.
But the California Hospital Association opposes the bill, saying it is
unnecessary because current law already requires hospitals to adopt and
implement a comprehensive workplace violence prevention plan.
Meanwhile, a spokeswoman for the Los Angeles County Sheriffâ€™s Department
said security tapes at one of the entrances at Olive View-UCLA Medical
Center in Sylmar would be reviewed and an investigation was ongoing, but no
details were released on how 26-year-old Ramiro Carnalla was able to bypass
a weapons screening area with a knife early Sunday morning.
Carnalla was arrested on suspicion of stabbing a nurse repeatedly inside the
Sylmar hospital. His bail was set at $55,000. Deputies and officers found
him after they heard a woman scream and went to the source of the outcry,
spokeswoman Lt. Denise Stephenson said in a statement.
Weapon detectors were installed at all Los Angeles County hospitals after a
gunman walked into the walk-in clinic at County/USC Medical Center in 1993
and shot up the facility. He wounded three doctors and held two other staff
members hostage for four hours.
In a separate incident on Sunday, a second nurse was wounded about seven
hours later at Harbor-UCLA Medical Center. Thomas Robert Fredette, 38, of
Santee was arrested on suspicion of stabbing a nurse in the ear with a
Visit Los Angeles Daily News for the story.
bans e-cigarettes after patient on oxygen catches fire while using one
Syracuse, NY - A Syracuse hospital is warning patients not to use electronic
cigarettes after a patient on oxygen caught fire while puffing on one of the
devices. Joe Galloway, a Syracuse Fire Department investigator, said the
cause of the March 22 fire at St. Joseph's Hospital Health Center has not
been determined yet, but he confirmed the patient had an electronic
Dr. Sandra Sulik, the hospital's vice president of medical affairs, is
convinced an e-cigarette sparked the fire. "There's no doubt about it," she
Electronic cigarettes, or e-cigarettes, deliver nicotine or other substances
to a user in the form of vapor. The fire investigation at St. Joe's comes at
a time when there is growing concern nationally about the safety of
e-cigarettes which are not regulated by the government and have been linked
to poisonings and fires.
The patient, whose identity was not released by the hospital, was burned
across her face from ear to ear, said St. Joe's spokeswoman Kerri Howell.
The patient had an e-cigarette in her mouth and was using oxygen when the
fire started, Howell said. The patient is now at home doing well, Howell
The woman suffered first- and second-degree burns and was transported to the
burn unit at Upstate University Hospital, according to Galloway.
Brandon Leonard, a St. Joe's patient safety representative, was in the
patient's first-floor room helping her roommate when he heard a loud pop and
saw flames through a privacy curtain separating the patients' beds. Leonard,
who is also an emergency medical technician, ran to the other side of the
room where he saw flames around the patient's nose and fire shooting out of
the end of a hose connected to an oxygen outlet in the wall.
E-cigarettes typically contain a rechargeable, battery-operated heating
element, a replaceable cartridge filled with liquid nicotine or other
chemicals and an atomizer that when heated converts the contents of the
cartridge into a vapor. Manufacturers of the smokeless, odorless devices say
they can be used almost any place.
Thomas Kiklas, cofounder of the Tobacco Vapor Electronic Cigarette
Association, said he's not heard of any cases of e-cigarettes igniting
oxygen. Kiklas said there have been a few reports of e-cigarettes exploding.
He said those cases involved e-cigarettes that were overcharged or users who
put the wrong batteries in them.
Since the fire, St. Joe's has been telling patients e-cigarette use is not
allowed. The hospital has a policy that prohibits tobacco use inside its
buildings or outdoors on its campus. The policy also prohibits e-cigarette
Sulik said some e-cigarette users who have quit smoking regular cigarettes
do not consider themselves smokers and assume anti-smoking rules do not
apply to them. Sulik said the patient who was burned had quit smoking three
years ago, but had not told hospital staff about her e-cigarette use before
the fire. The hospital also is making new signs to alert patients, visitors
and staff that e-cigarette use is prohibited.
Visit Syracuse for the story.
A top hospital
opens up to Chinese herbs as medicines
The Cleveland Clinic, one of the country's top hospitals, is a surprising
venue for the dispensing of herbs, a practice that is well established in
China and other Eastern countries but has yet to make inroads in the U.S.
because of a lack of evidence proving their effectiveness.
The herbal clinic, which opened in January, has one herbalist who sees
patients on Thursdays. Patients must be referred by a doctor and will be
monitored to ensure that there are no drug-herbal interactions or other
complications. The herbal clinic is part of the hospital's Center for
Integrative Medicine, whose offerings also include acupuncture, holistic
psychotherapy and massage therapy.
"Western medicine does acute care phenomenally.â€¦ But we're still struggling
a bit with our chronic-care patients and this fills in that gap and can be
used concurrently," says Melissa Young, an integrative medicine physician at
While acupuncture programs have sprouted across the U.S., there are only a
handful of herbal clinics. Osher Center for Integrative Medicine at
Northwestern University and NorthShore University HealthSystem, affiliated
with the University of Chicago, both include herbal medicine among their
Jamie Starkey, lead acupuncturist at the Cleveland Clinic who got the herbal
clinic started, says there is little scientific research outside Asia on
using herbs as medicine. Ms. Starkey says she had to translate studies to
convince the Integrative Medicine's former medical director that an herbal
clinic could be effective.
"The evidence base for these approaches using modern rigorous methods of
randomized trials is quite thin," says Josephine Briggs, director of the
National Center for Complementary and Alternative Medicine, part of the
National Institutes of Health. NCCAM is funding research looking at
fundamental biological mechanisms of some herbal products. But they are not
currently funding any efficacy studies involving humans. Some research is
looking at how herbs may affect drug metabolism.
There are thousands of herbsâ€”primarily plant parts but also some animal and
mineral productsâ€”that are used in traditional Chinese medicine. Herbs are
usually used in combinations and can be taken as capsules, tinctures,
powders or tea. Herbs can be toxic if taken in the wrong dose.
At the Cleveland Clinic's herbal center, new patients are given a one-hour
consultation that may include a battery of questions (How's your sleep? Body
temperature? Ringing in your ears? Headaches?), a physical examination of
the tongue, and the traditional Chinese method for pulse-taking (three
fingers on each wrist to check different pulses corresponding to various
organ systems). They are asked to sign a waiver acknowledging that "herbal
supplements are not a substitute for a medical diagnosis."
Consultations are $100 and are not covered by insurance. Follow-ups are $60
and a one-month supply of herbal formulas costs on average about $100. On
one day at the clinic last month patients had needs ranging from chronic
pain to anxiety, digestive issues and multiple sclerosis.
Visit the Wall Street Journal for the article.
propose new regulations for e-cigarettes
The Food and Drug Administration will propose sweeping new rules on Thursday
that for the first time would extend its regulatory authority from
cigarettes to electronic cigarettes, popular nicotine delivery devices that
have grown into a multibillion-dollar business with virtually no federal
oversight or protections for American consumers.
The regulatory blueprint, with broad implications for public health, the
tobacco industry and the nationâ€™s 42 million smokers, would also cover pipe
tobacco and cigars, tobacco products that have long slid under the
regulatory radar and whose use has risen sharply in recent years.
The new regulations would ban the sale of e-cigarettes, cigars and pipe
tobacco to Americans under 18, and would require that people buying them
show photo identification to prove their age, measures already mandated in a
number of states.
Visit the New York Times for the article.