 |
If the media
is an accurate measure, America has a love/hate relationship with the
pharmaceutical industry today. Open any newspaper, magazine or watch the
evening news and we are likely to see a story about the latest wonder drug
transforming a life. These stories are compelling and heart warming and remind
us that we live in an age of marvelous scientific advances.
However, we are equally likely to see
or read a story about how the pharmaceutical companies spend millions of
dollars promoting their drugs and that these efforts lead to artificial and
undeserved price inflation.
It is not the purpose of this piece to discuss the economics of
the pharmaceutical industry or drug pricing. Rather, I will discuss the
promotional activities of the industry and why, in my opinion, these activities
are important and need to be protected. First, why all of the
fuss?
The Case
Against, and For, Newer Pharmaceuticals
In just the past two decades,
remarkable advances have been made in treating a variety of diseases from
allergies to high blood pressure to cancer. Many of the drugs that started this
transformation are old enough to have gone off patent and are available in
generic form. Many who pay for medical treatment and others with different,
less transparent agendas, would argue that in many cases these drugs are as
good, or good enough, to be used instead of newer, more expensive, still patent
protected therapies.
They often argue that doctors would prescribe these cheaper
medicines if it weren't for the efforts of pharmaceutical promotion and thus
attack those efforts as excessive or worse. They also argue that in many cases
patients are treated for "trivial" disorders that they should be able to
tolerate, such as heartburn, seasonal allergies, toenail fungus and the like.
That these illnesses have an adverse effect on the patient's sense of
well-being and quality of life is not their concern.
So, why do physicians prescribe newer
agents when cheaper generics are available? Generally, their rationale will
fall into one or more of three categories. Foremost will be greater
effectiveness. Some newer drugs work better than the older ones and yield a
better disease treatment for the patient. Interestingly, this may be the least
common driver for many common diseases, where effective treatments have been
available for the last several decades.
A second driver may be safety. Early breakthrough
drugs often carry with them a worrisome toxicity, such as the potential to
cause a serious side effect or the potential to have a harmful interaction with
other medications. When companies see that a new approach works to treat a
disease, they often work on the same mechanism to try to find a way to improve
on the first drug. Sometimes this results in increased effectiveness but often
it results in increased safety or tolerability. Critics deride this kind of
drug research as "me too" research, aimed at "incremental" improvements.
I like to think
of it like this. Drum brakes for cars were a great innovation and worked pretty
well - unless it rained. Fortunately, competitive companies kept working and
came up with disc brakes and then anti-lock brakes. It takes a narrow point of
view to not embrace this "me too" research in automotive brakes for the value
it brings to all of us, even if that value is incremental in nature. I would
argue that such incremental innovation is even more important as it relates to
pharmaceutical products.
The final category relates to patient tolerability and
convenience. This is probably the category that most angers the industry's
opponents. Let's use antihistamines as an example. Classical antihistamines
have been around for many decades. They work pretty well to alleviate allergy
symptoms. Unfortunately, they tend to make us sleepy, interfere with our
ability to work and make it unsafe to drive a car. In fact, the active
ingredient in most non-prescription sleeping pills is an
antihistamine!
The
industry saw the problem and worked for decades to find antihistamines that
didn't cause sleepiness. Ultimately, they were successful. Critics fought hard
against making these drugs widely available to patients, arguing that the
older, generic antihistamines were good enough. Patients and physicians saw
things differently and the newer agents now dominate.
Likewise, patients and physicians
embrace patient convenience. My son's strep throat was recently treated with an
antibiotic that he took once in the morning for five days. Not that long ago,
he would have needed to take a pill four times a day for 14 days. Needless to
say, this strict regimen would have been almost impossible for us to comply
with given the complicated approach. Again, the industry's critics see this
convenience as unimportant while physicians and patients
disagree.
So this
is where the complaints about pharmaceutical promotion fit in. Industry critics
are aware that if physicians and patients don't know about newer agents, and
their advantages, they won't be used. Having repeatedly lost the argument that
generic drugs are "just as good" or "good enough" as newer medications,
industry critics are now aiming at stopping the flow of information altogether,
for example, attacking "direct to consumer" advertising.
This despite the fact that
pharmaceutical promotion is arguably the most regulated form of speech in the
world's free nations. The U.S. Food and Drug Administration, for instance, has
tremendous authority and exercises it freely to control what companies can say
about their drugs. Pharmaceutical companies are often restrained from telling
much of what they know about their drugs, especially if it is
favorable.
How
Doctors Learn About New Therapies
Your internist or pediatrician probably went through four years
of medical school and three years of residency. These are periods of intense
training, including a great deal of reading. If you see a specialist, they will
likely have received an additional three years of training. Surgical
specialists train even longer before they are free to practice independently.
Doctors fresh out
of training are probably at their peak of testable knowledge on the most
current aspects of diagnosis and treatment for the broadest range of diseases.
Further years of clinical practice should add experience and hone their
judgment and in the case of specialists, deepen their knowledge in that field.
However, after just a few years many physicians would not score as highly on
broad examinations. Why?
Clinical practice is difficult and time consuming. Physicians
today are expected to see more patients, produce more documentation (records)
and must interface constantly with insurance companies and other administrators
to run a successful practice. Many physicians do not have the time or energy to
keep up with the medical literature, especially if they want to have any
meaningful family life or hobbies outside of medicine.
The local hospital, especially academic centers, will
run seminars on a weekly basis but these are usually during the day, not during
nights and weekends when a busy office physician might have a chance to attend.
Physicians are required by law to receive a certain number of hours of
accredited education on an annual basis to maintain their license, but the
effectiveness of those hours is not measured or assured.
This is where pharmaceutical companies
come in. They know that a physician can only prescribe their products if they
know about them and can only prescribe them safely if they know more than the
minimum. Unpromoted drugs do not get used because physicians have either never
heard of them or have simply forgotten about them over
time.
Pharmaceutical companies use a mix of approaches to try to
educate doctors. These include pharmaceutical representatives, sponsoring
accredited and unaccredited seminars at times and places where physicians can
attend, and direct to consumer advertising. Advertising in medical journals and
on commonly used items such as pens, mouse pads, notepads and the like can be
useful reminders. Most important in the mix are sales
representatives.
The Pharmaceutical Representative
Pharmaceutical sales representatives
do not have an easy job. Drug representatives can often be spotted in the
waiting room at the doctor's office or walking around the hospital. They are
usually recognizable in their suits or dresses, carrying large, overstuffed
bags, waiting for long periods for a brief contact with a
physician.
They
are the cornerstones of physician marketing.
The bag carries sales brochures, journal article
reprints and pharmaceutical samples that are provided, in theory, to allow
patients to conveniently start their medication prior to picking up their
prescription at the local drug store. In reality, a large proportion of samples
go to the un- or under-insured. These free drug samples actually amount to
greater than 50% of all promotionally related costs. By law, physicians cannot
charge for these samples, so they must go to patients free of
charge.
Pharmaceutical representatives are expected to master knowledge
about their products and the diseases that they treat. Training is intense,
especially when first hired, and often involves testing to demonstrate mastery
of the information. Mock physician presentations are also held repeatedly to
help the representative learn how to communicate with a busy and often
skeptical physician. A representative that can't answer a physician's questions
will rapidly lose credibility and lose access to that
office.
To conduct
a proper presentation, known in the industry as a detail, takes 10-15 minutes
in a quiet setting. In reality, such extended details are unusual. Today, the
average detail is perhaps two minutes in length with time only to hit the high
points and answer questions, often while standing in a hallway with the
physician performing other tasks. Not so long ago, the average representative
could be expected to conduct 8-10 details a day. That average number is now
thought to be closer to 6-8. Sales representative effectiveness is thought to
be declining and other methods of reaching physicians have and are being
tried.
Educational
Symposia
Not
surprisingly, physicians prefer to learn new information from other physicians,
especially from researchers at the forefront of creating new knowledge. Most
hospitals, especially teaching hospitals, conduct weekly Grand Rounds meetings
of an hour or so in length. These lectures usually count toward a physician's
continuing education hours.
Often these meetings require flying a physician in and paying
some sort of honorarium to compensate them for their time. Today, a
pharmaceutical company often covers such expenses. Not surprisingly, the topics
usually touch on an area of interest to the company, including the role of that
company's drug in therapy.
Companies also will sponsor lunch or dinner presentations,
again often involving an outside speaker. Critics deride these events as bribes
or give-aways to physicians. Since the presentation is occurring during the
physician's lunch or dinnertime, it does not seem inappropriate to feed
them.
Symposia are
also sponsored on other occasions, such as on weekends or at major medical
meetings. Again, most of these provide continuing education credits, cover
state of the art topics and are presented by nationally renowned
speakers.
Direct
to Consumer Advertising
Advertisements in magazines and on television have become a
popular way to reach both physicians and patients. This form of promotion is
drawing a lot of fire from the industry's opponents. They are irritated that
patients learn about the availability of new drugs and then go to physicians
requesting information. Experience has shown that this form of advertising does
increase sales.
Physicians by and large are ambivalent about these ads. On the
plus side, patients are not always effective at communicating what is bothering
them and these ads have been shown to help patients recognize and communicate
about their symptoms better, aiding physicians in making the proper diagnosis.
On the negative side, they put pressure on physicians to be up on the latest
treatments, lest they look behind the times to their
patients.
Critics
argue that patients present with trivial complaints to be treated or that
physicians are bullied into treating them with more expensive advertised drugs
over generics, a variation on the themes explored above. When was the last time
you felt you could "bully" your doctor into prescribing a specific
medication?
What
Does This Mean to You?
If you are a healthcare consumer, you should be very concerned
by any attempts by politicians and special interest groups to attempt to cut
off pharmaceutical promotion. While they may wrap their arguments in complaints
of excessive prices, their motivations often lie elsewhere.
f you are a physician, you are
undoubtedly hearing calls to stop seeing pharmaceutical representatives and to
stop attending company sponsored educational events. I would encourage you, as
physicians, to acknowledge the valuable service being provided in helping to
keep you current on the latest pharmaceutical advances. Just as you need to
consider the source when receiving company sponsored information, I would
encourage you to consider the agendas of those that would have you turn away
from this information source. They may not have your patients' best interests
in mind.
|
|
