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These stories by Barbara Fox were published in U.S. 1 Newspaper on
March 25, 1998. All rights reserved.
The Quest for Rational Healthcare Decisions
Pharmaceutical and biotech companies develop them,
contract research organizations test them, the federal government
approves them, managed care organizations pay for them, physicians
prescribe them, nurses administer them, and patients take them. But
can anyone really be sure what are the "right" drugs or treatment
procedures from the standpoint of cost compared with successful results?
No. There are no good answers, says Marilyn Dix Smith, a pharmacist
who — after her father died — dedicated her life to finding
those answers, to standardize the data gathering practices of researchers
and hospitals so that physicians and patients can make rational and
appropriate healthcare decisions.
In 1995, along with William F. McGhan (a professor at Philadelphia
College of Pharmacy and Science) and Alan Bakst (of Smith-Kline Beecham)
she co-founded the Association for Pharmoeconomics and Outcomes Research,
now known as the International Society for Pharmacoeconomics and Outcomes
Research (ISPOR). Based at 20 Nassau Street, the organization’s aim
is to translate research into practice to ensure that society allocates
scarce health care resources wisely, fairly, and efficiently.
ISPOR involves the scientific community, the practice community (nurses,
pharmacists, physicians), the managed care organizations, and the
purchasers. "We are plucking out from each type of organization
those people who are interested in looking at economic and clinical
outcomes," says Smith. ISPOR is trying to stimulate its members
to generate the data for comparing drugs or surgical interventions
or new biotech interventions — to compare their costs with clinical
outcomes such as mortality, suffering, and quality of life.
"Just about the time that this idea was born, my father became
extremely ill and died, and I experienced the health care system first
hand," says Smith. "I saw all its inadequacies, even in the
big teaching hospitals. It became my personal goal to look not only
at economics but also the outcomes."
"Quite frankly the world relies on the pharmaceutical companies
for research, but then everything stops. Who is gathering data that
pulls it all together? And is this data collected in a form that will
help everyone make good health care decisions?" asks Smith. She
hopes ISPOR and/or its members will set the guidelines for collecting
the information — what form it should be in, what should be collected,
and how it should be analyzed.
The databases must be standard, so apples can be compared to apples,
says Smith, who has a Ph.D. in pharmaceutical science. "We all
have a standard way of counting the mortgage interest we can deduct
from our income tax. We want to set the same kind of accounting rules
for health care decisions."
John Eichert, of Hastings Healthcare Group on Titus Mill Road,
heralds such technology-based changes. Physicians have typically made
decisions based on anecdotal experience, says Eichert. "We are
moving from a totally disorganized cottage industry full of bright
entrepreneurial physicians to an organized system connected by infrastructure
that won’t be complete for 10 years. Until the infrastructure is there
to share information in real time it will be difficult for physicians
to get the benefit of `best practices.’"
His 100-employee firm is a leader in helping pharmaceutical
clients set up both intranets and databases that are useful for managed
care decisions. For Janssen Pharmaceutica, Hastings helped organize
collective intellectual capital about stroke management into an internal
database, and it has hired one of Janssen’s outcomes research experts,
Patricia Deverka, to expand Hastings’ presence in pharmaco-economics
Hastings has also partnered with the National Conference of State
Legislators and Strategic Health Policy International to assemble
its own database, Medicaid KNet, for the Medicaid portion of managed
care. Just completed, it covers regulatory, legislative, and policy
changes that affect decisions on how to market products in the Medicaid
Hospitals are assembling databases on a larger scale. For instance
David Shulkin, chief medical officer of the University of Pennsylvania
Health System, has pulled together "best clinical practice"
databases for 18 conditions (with the goal of increasing this to 40)
and has disseminated them to several hundred physician groups.
"If Smith can create a community of knowledge and experience,
it will be valuable. But it can be difficult; there is not a culture
of sharing in medicine," says Eichert. For a scientific discovery
or drug to be accepted there must be open discussion and "peer
review." In contrast, "best practices" in disease management
do not have to be shared. If a woman has a particular kind of breast
cancer, she will get whatever combination of radiation, surgery, or
drugs has been deemed best by the doctors at her hospital.
Shulkin has decided not to shelter his databases as proprietary information
because, as an academic institution, Penn aims to advance the field.
Nevertheless, other hospitals may keep their "best practice"
management discoveries to themselves in order to differentiate themselves
from competitors. "Medicine traditionally shares clinical experience
through peer review, but actually implementing clinical care is more
of a business competition," says Eichert.
"You need to connect the knowledge gained through the outcomes
of the research world, the clinical research world, and the real world
of the Main Street doctor practicing medicine," summarizes Eichert.
"It is very important that knowledge in the marketplace be shared,
and the best way to share it is through technology."
But Smith believes that, even though databases may be kept private
to promote a particular hospital group, they must still be held to
high standards of accounting. "Our organization will not force
anyone to share," says Smith, "but someone should at least
be able to standardize how they counted when they make their claim."
"That would be a hot commodity as well as a useful resource,"
says Ron Czajkowski, vice president of the New Jersey Hospital Association
(http://www.njha.com). "The chase for good data is a
hugely competitive field, and everyone has their notion of what good
data is. Some of the chase is being funded by insurance companies,
business, various consumer groups, universities, and by hospitals
themselves. If somebody could come up with a one-stop shopping formula
it would be hugely valuable."
Czajkowski ruefully remembers how a dozen New Jersey hospitals were
upset when the NJHA published unflattering statistics about Caesarean
section rates. These member hospitals pressured the NJHA to keep results
of the next studies secret. Yet the reason why some of them looked
bad in the statistics was not because they were doing anything wrong,
but because their "counting process" differed from their competitor’s.
When they changed "oranges to apples" their "apples to
apples" figures made them look much better.
As for those who looked bad no matter how the count was made —
they learned some valuable lessons and had an opportunity to change
"Even though some of our members disagree, we have a commitment
that sharing data is going to help us improve," says Czajkowski.
ISPOR is on the verge of receiving its first foundation grant, but
it has had ongoing federal support for its professional meetings from
the Agency for Health Care Policy and Research. "It is a new field
and a new professional association as well," says Yen-Ping Chiang,
Smith’s contact at AHCPR. "Standardization of many things certainly
would be the ultimate goal, and at this stage we are still trying
to explore ways how to get there. ISPOR’s work certainly is one of
the important elements."
"People involved in ISPOR discuss what it takes to move the field
forward. Most of ISPOR’s members come from industry and these individuals
will produce the studies," says Chiang.
Chiang also cites, as possible contributors to the standardization
process, the Pharmaceutical Research and Manufacturers of America
(which represents about 100 of the biggest research-based pharmaceutical
and biotechnology companies http://www.pharma.org) plus a
new organization of managed care firms, which he cannot yet name.
Clinical economics will not be subject to federal regulations but
will, he hopes, be governed by a consensus on a common data set. "To
the extent that the marketplace can winnow out useful from non-useful
information, that will be sufficient," says Chiang.
At the hub of all these possibilities is Marilyn Dix
Smith, the great great niece of Dorothea Dix, the visionary social
reformer who founded Trenton Psychiatric Hospital. Smith grew up in
Ohio, where her father was a farmer. With a B.S. and a Ph.D. in pharmaceutical
science from Ohio State, Smith has had a 20 year pharmaceutical career,
including working in retail pharmacies as well as for Abbott Labs,
Lederle Laboratories, and American Hospital Corporation. Formerly
a Dayton resident, she lives in South Jersey with her husband, and
they have four grown children, two in college.
"I said I need to dedicate my new career to making change happen.
It has been an uphill battle — you have to have people believe
in what you do, and I believe in it."
Her strategy: not to make a big splash "but to get people to feel
committed and marching together." The strategy is working. Three
people started from scratch with no funding, and 35 showed up for
the first meeting. Uwe Reinhardt, the noted Princeton health economist,
was the keynote speaker for the second annual meeting, and the third
annual will be in Philadelphia from May 27 to 30. The organization’s
first international meeting is set for Cologne, Germany, in December.
This is truly a grass roots group that nevertheless has high-placed
members. There are 2,000 members, ranging from students to such experts
as Michael Drummond, a British health economist, and Harvard’s Milton
Weinstein. Individual memberships cost just $75, and income from institutional
memberships has been limited to 20 percent of the budget to remove
any taint of bias. It has all been done without major funding, though
a government grant has been obtained, and applications have been made
for foundation grants. A journal will be published soon. In January
APOR changed its name and merged with another organization that had
better funding but lacked leadership.
"These are great times because you have information technology
at your finger tips, means of communicating with the Internet and
the written word, and we are capable of doing so much without a large
support team," says Smith. She has two assistants: Jennifer Olson,
director of meetings and conventions, and Natalie Palyvoda, manager
of member services.
"It’s risky to take on a whole new initiative. There’s not an
umbrella that’s going to catch you," says Smith. "But as more
people get involved, everyone gets excited about what we are doing.
We have students from pharmacy schools calling to ask about starting
What helped fuel her inner fire: the hospital sent a letter addressed
to her father, three months after he died, asking him to come in for
a visit. "My father was a data point who was lost," says Smith.
"Two days after the funeral, my mother and I were faxing out press
releases on the existence of the organizations. It was her therapy.
We honor our mentors and parents by what we do, and I have done some
good things, but I need to do more. There have to be systems using
large databases to find out what are the right treatments and what
are the wrong treatments."
Research, 20 Nassau Street, Princeton 08540-6627. Marilyn Dix Smith,
executive director. 609-452-0209; fax, 609-452-7473. E-mail: firstname.lastname@example.org.
Home page: http://www.ispor.org.
Steven Gross of DevCom makes his living by netting
out what is truly important about a product and showcasing that in
an unusual way. For some conditions (edema and arthritis, for example)
he invented a diagnostic gadget and sold the trademarked invention
to a drug company to be used as a marketing tool.
For the makers of DHA (a little known food additive for infants),
he took an even more innovative approach; he created an unusual concept
— it called for founding an organization named "Pregnant Physicians
for DHA" and arranging for women physicians to appear on television
talk shows. It’s a very persuasive image — a pregnant woman doctor
who says she is taking DHA and plans to feed it to her newborn child.
Gross now positions his firm, not as mere a device-invention company,
but as a full service marketing communications firm that specializes
in the healthcare industry. He started DevCom in Paoli, Pennsylvania,
in 1982, moved it to the Carnegie Center in 1993, and bought a two-building
property at 114 Main Street in Kingston. DevCom moved there last month
and occupies 3,150 square feet.
His move resulted — in "small world" fashion — from
a Friday night encounter at the bar at Lahiere’s, where he met the
building’s owner, psychologist Leonard Blank.
"I love being in Kingston," says Gross. "In our 16 years
in business, this is the first time we have moved into a location
where I personally designed every square inch." Extensive renovations
were accomplished by a Freehold-based firm, Cavanaugh’s. Gross delights
in the high tech conference room complete with motorized 100-inch
projection screen connected to networked and individual PCs. He admits
that until now, his firm has been the one to "come calling"
on clients. "But our plan is to invite them to a `day in the country’
and have a working session in our AV conference room."
Picture an Oprah Winfrey show with five pregnant pediatricians (Gross
hasn’t reached the Winfrey pinnacle yet, but 50 broadcast stations,
including CNN and Fox News, have carried DHA concept on talk shows
or news programs).
DHA stands for docosahexaenoic acid, a fatty acid that Gross terms
"brain food," because 15 percent of the brain consists of
good fatty acid. A New Zealand study has correlated a lower IQ from
babies not breast fed or breast fed babies where the mother was on
a low fat diet.
But in the United States DHA has not been accepted for inclusion in
infant formula. Though it is available "over the counter,"
it is not universally known to pediatricians, so Gross needed a way
to plant DHA in mothers’ minds — to tell them that it is safe
and comes recommended by physicians to improve infant intelligence.
He created the concept for a public relations campaign that involved
sending a mailing to the American Academy of Pediatrics. Within two
weeks, one of the DHA experts, Barbara Levine, director of the Nutrition
Information Center, associate professor at Cornell University Medical
College, was making an appearance on Good Morning America. The organization
has gathered 1,400 members, of which more than 200 are pregnant physicians.
One of the Pregnant Physicians for DHA doctor-members,
Jane Oski, was the daughter of the late Frank A. Oski, the chief of
pediatrics at Johns Hopkins, who spent the last two years of his life
trying to educate the FDA and the pediatric community on the importance
of DHA and another fatty acid, ARA, on infant neural development.
DHA Neuromin dietary supplements (as compared to vitamins) are marketed
by such manufacturers as Solgar, Solaray, Source Naturals, and Nature’s
Way. All are sourced from Devcom’s Maryland-based client, Martek Biosciences,
which cultures algae to produce a DHA that Gross says is the "purest
in the world." Firms who take their DHA from fish are taking it
from the secondary source, says Gross, and they do not use the term
Neuromin on the bottle. He also notes that infants are not supposed
to eat fish until they are two years old.
"But if you extract the DHA from cultured algae you don’t have
anything bad, and you can replenish the levels that women should be
taking while they are pregnant," says Gross.
Generally recognized as a safe substance, DHA is supposed to improve
night vision, has been found to lower triglycerides, has not been
found to affect HDLs, and is being studied for its effect on Alzheimer’s
Disease. "When I was on the regimen, my night vision was radically
enhanced," says Gross. He believes there is a correlation between
children with ADD (attention deficit disorder) and low DHA levels,
and that American women, with their low-fat diets, have the lowest
DHA levels in the world.
More traditional to Devcom’s business is a just-trademarked device,
the "edemeter," which takes the guesswork out of measuring
fluid retention, usually determined by pressing your thumb into a
swollen ankle and counting how long it takes for the indentation ("pit")
to resolve. The inexpensive hand-held edemeter has a timer that measures
the recovery. The fancy version comes with a built-in pressure gauge.
"When it hits a certain predetermined level of pressure it automatically
clicks on the timer, independent of the person doing the test,"
"We would sell this as a trademarked invention to a drug company
with an anti-hypertensive product that doesn’t cause edema," says
Gross. When a sales person goes to a doctor’s office, he or she demonstrates
the edemeter, perhaps using it on the physician’s own ankle, then
pivots to a conversation about the product. "It penetrates communication
barriers in a much more sophisticated way than a presentation, and
it lets the product rise or fall on its own merits."
Gross grew up with a medical legacy; his father was an award-winning
biochemist who died at age 44 during his heart transplant operation.
He majored in biology and chemistry at St. Peters College, Class of
1968, worked at Merck, Sharp & Dohme in sales and advertising for
10 years, then went to the food and pharmaceutical division at FMC
Corporation. "Over the years I had created several inventions
that we call medically relevant brand reminder items that have some
functionality for physicians," says Gross, adding with pride that
many are listed in the FDA’s 510K register (U.S. 1, November 24, 1993).
Gross brings his avocation to his work; with his brother Dave, a casino
music director, he can create his own synthesized musical scores.
He plays seven instruments. As a serious violinist, he is vice president
of the Princeton Music Club (he’s hosting the June meeting), and has
done a deluxe annual report, pro bono, for the New Jersey Symphony.
He’ll use that report plus the annual report of the New Jersey American
Heart Association as a showcase.
"The way we sell our product is by showing `before and afters.’
You don’t have to be a rocket scientist or a specialist to see that
they are very dramatic," says Gross.
— Barbara Fox
Gross, CEO. 609-924-4666; fax, 609-924-3999. E-mail: DevCom@adv.com.
Selling to Managed Care
It’s a new world out there, in managed care, and a
new division of a familiar marketing firm aims to help pharmaceutical
firms stake out their claims. MediMedia Managed Care does health care
marketing and communications services and is particularly focused
on helping pharmaceutical companies sell to managed care organizations.
It moved onto Phillips Boulevard last fall and is expanding now to
Bradley Kozar, the president and COO of the division, was one of the
earliest to devote his efforts to marketing a drug company’s products
to managed care organizations. "I had a more bullish attitude
about it than most," says Kozar. "Though the traditional routes
to success were in sales, product management, or market research,
I saw managed care as an opportunity rather than as a threat to success."
"Managed care has created bigger winners and bigger losers, and
I am comfortable with that scenario," says Kozar. "If you
understand the marketplace and develop the right relationships based
on trust, credibility, and getting close to the customers, and you
have the right programs and services, there is a tremendous opportunity
for those who do it right. You become the winners."
"A company like mine tries to assist the pharmaceutical firm to
develop the most appropriate managed care, clinical, pharmacoeconomic,
and quality of life message — that differentiates the product
and sells the HMO on the merits of the product," says Kozar, who
usually represents the more expensive brand names that compete with
the cheaper generics.
"Brad has been active in managed care for many many years and
is considered an expert in managed care marketing," says John
Eichert, president and CEO of the 100-employee Hastings Healthcare
Group on Titus Mill Road. "He is a very smart guy, and he has
lots of good contacts in the managed care world."
Indeed, says Kozar, those relationships help facilitate
all the marketing moves. To position a product he might convene a
customer advisory board of 10 to 12 medical directors. Then he has
to help get it listed on an HMO’s "formulary" so it can be
prescribed. Then he needs to encourage "pull through," i.e.
give sales representatives the tools they need to encourage the physicians
to use the product.
"Having held some of the positions that my clients have, having
been responsible for creating contracts for a drug company, and having
created a managed care division, I have credibility very few people
have," says Kozar.
Kozar grew up in a family of six kids in Bedford, a suburb of Cleveland,
where his father was a middle manager. He majored in interpersonal
communications at the University of Toledo, Class of 1980, and interned
as a staff assistant to Howard Metzenbaum, the senator from Ohio.
Kozar spent eight years at Marion Laboratories, leaving in 1988 as
marketing manager of managed care markets. He has also directed institutional
and managed healthcare for Ortho Biotech (a Johnson & Johnson division.
He helped create Johnson & Johnson Healthcare Systems. He also managed
marketing activities for Emron Inc., a full-service managed healthcare
education, research, marketing, and communications firm. Most recently
he was the managing director of Medicom Excel, publishers of managed
care trade publications.
He is married to a physician who had to sell one practice and extricate
herself from another in order to accommodate the moves required by
his career. "She had faith that through hard work and by making
some moves I could be a fairly substantial contributor," says
Kozar. They live in Flemington and have two children.
MediMedia is most familiar to clinical physicians as a provider of
Triple i prescription pads, customized with the doctor’s name and
number, and sponsored by a drug appropriate to the physician’s specialty.
It also provides CliniForms, patient record charts appropriate to
a specialty. In California it offers prescription and formulary guides
(a book for HMO physicians with the approved and recommended drugs)
and plans to release them in other states soon.
Veterinary Learning Systems, a sister organization, has been at this
address on Phillips Boulevard since the early 1990s. The animal healthcare
division of MediMedia International Group, VLS is a publisher, video
producer, and seminar developer that employs 44 people. The parent
company is now based on Park Avenue in Manhattan but will move to
Teterboro this spring. A sister company, MediMedia Infoscan, publishes
formulary guides and is located in Horsham, Pennsylvania. Kozar can
tap Infoscan’s database of nearly 800 managed care formularies. He
claims Infoscan’s is the largest and most up-to-date database of managed
care formularies in the nation.
Optimism and interpersonal skills, says Kozar, are among the keys
to success in the managed care world. "Coming from a family of
five boys you had to learn to talk your way out of some things,"
Kozar admits. "My parents clearly always preached that hard work
was key. That you should be a positive person, and that everyone has
their own problems, so don’t be a complainer."
"My father used to say the A students are the doctors and attorneys
of the world, and the lawyers are your B students. But it’s the B-minus
students and C students with a broad focus — who have more than
just book knowledge — who run the world."
"Coming from a big family, I believe that if we are positive,
enthusiastic, and solution oriented, we are going to win more than
we lose," says Kozar. "I don’t want people to bring just complaints
to me. Managed care doesn’t have to be doom and gloom if you know
how to differentiate your product."
— Barbara Fox
Suite 100, Trenton 08618. Bradley Kozar, president, COO. 888-724-2302;
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