Author Takes a Critical Look at Prescription Drugs

DATE August 18, 2004 ACCOUNT NUMBER N/A
TIME 12:00 Noon-1:00 PM AUDIENCE N/A
NETWORK NPR
PROGRAM Fresh Air

Interview: Jerry Avorn discusses his book "Powerful Medicines:
The Benefits, Risks and Costs of Prescription Drugs"
DAVE DAVIES, host:

This is FRESH AIR. I'm Dave Davies, senior writer for the Philadelphia Daily
News, filling in for Terry Gross.

The French philosopher Voltaire once said, `Medicine is something prescribed
by a doctor while waiting for nature to cure the illness.' Our guest Dr.
Jerry Avorn doesn't believe that, but his new book argues that doctors often
prescribe medicines that don't work or cost too much, that drug companies
spend a fortune peddling incomplete or even misleading information, and that
the federal government does too little to find out and tell us which medicines
work and which may cause harm.

Jerry Avorn is an associate professor of medicine at Harvard, and he
supervises drug research at Brigham and Women's Hospital in Boston. He spent
25 years treating patients and studying medication use and outcomes. His new
book is "Powerful Medicines: The Benefits, Risks and Costs of Prescription
Drugs."

Jerry Avorn, welcome to FRESH AIR.

Dr. JERRY AVORN (Harvard University): Thank you. Good to be here.

DAVIES: You open your book with a very clever pharmaceutical riddle. You
tell us a story, that in a former British colony, healers believed in the
wisdom that a distillation of fluids extracted from the urine of horses, if
reduced to a powder and fed to aging women, would ward off all kinds of
diseases and preserve youth. And this became widely used by the healers
throughout the culture. And it was only many years later that modern science
revealed that, in fact, this horse urine extract was useless for most of its
intended purposes and, in fact, caused tumors, blood clots, heart disease and
maybe even brain damage. Solve the riddle. What is the former British colony
and the drug at work here?

Dr. AVORN: Well, the former British colony is the United States of America.
And the drug that I'm talking about there is all the various estrogen
replacement treatments, such as Premarin and Prempro, that were used by so
many millions of Americans for decades. And what I was trying to do in
putting it in that context was--there's sometimes a mystique that develops
about medications in the US, that they are high science and we know everything
about them, and that hardly anything can go wrong because they've been so well
studied, whereas we think of primitive cultures as having these potions that
don't usually do anything and can hurt you. And while that is more true than
not, it's important to realize that sometimes things can go in exactly the
opposite direction. And the estrogen replacement story is a striking example,
although an exceptional example, of how we can have treatments that are really
not based on any good science that actually can hurt people.

DAVIES: It's remarkable that just doctors everywhere were prescribing this
in huge, huge amounts.

Dr. AVORN: Sure. I was, too. I was a big believer because that was the
culture certainly when I was starting out in practice in the '70s and well
into the '80s and into the '90s. That was the gospel. Every smart doctor
knew that when a woman went through the menopause, you put her on hormone
replacement therapy. That was just the right thing. It turns out it wasn't.

DAVIES: Well, and the drug manufacturers told us that there was data to
support, comparative studies which showed in fact that women that were on this
stuff did better in a whole lot of indices of health than when who weren't.
What was wrong with that information?

Dr. AVORN: Well, the problem was that this was all what we call observational
data. That is, many studies very carefully done involving thousands and
thousands of women found that women who were estrogen users turned out to have
less heart disease and less other problems like less Alzheimer's and less
depression and less incontinence than women of the same age and medical
background who were not users of estrogen. And that was pretty compelling.
And as I said, I was convinced along with everybody else.

The one group that wasn't convinced of this, we should say, was the FDA. They
held to their high standard, which they were very correct in doing, that it
had never really been shown in a randomized clinical trial in which women were
arbitrarily assigned to take hormone replacement therapy for years and years,
and other women were arbitrarily assigned to take a dummy pill that looked
just like it but was actually placebo or inactive. And that's the only
grounds on which FDA will approve a product. And, in fact, FDA never approved
estrogen for the use of protecting your heart or preventing Alzheimer's or any
of those other reasons that we now know actually are not true.

DAVIES: So the studies that did compare women who took estrogen to those who
didn't, they were measuring something. What were they telling us?

Dr. AVORN: Right. They were literally correct that the women who chose to
remain on estrogen for many, many years did actually have less heart disease
and less of these other problems than the women who were not estrogen takers.
We now understand, now that there finally was a federally funded randomized
trial where it was done exactly as I said a minute ago, and there was no
difference. In fact, there may even have been worse outcomes in the estrogen
users in some measures.

We now understand that a woman who will seek out estrogen replacement therapy
and then stick with the regimen and take it year in and year out is
fundamentally a different kind of person, clinically, than somebody who
doesn't, whether because the woman who is the estrogen user has more access to
health care or is more careful about her health and maybe she's also taking
blood pressure pills and watching her weight and her diet and getting exercise
and not smoking--all those things which we do know prevent heart disease were
kind of traveling along with estrogen disease when it was studied in this
observational way. And we now understand that it was a phenomenon of
selection bias. That is, the women who chose to be on estrogen were different
from the ones who, in the scheme of things, chose not to be. And when you
randomly allocate people in a trial for the first time, we found out as late
as 2002 that actually it doesn't do what we thought it did.

DAVIES: Well, and you conclude, quoting from your book that "tens of
thousands of extra breast cancers, pulmonary emboli, strokes and other related
side effects didn't need to happen."

Dr. AVORN: That's right. Now that we do have, for a couple of years now,
this well-done federally funded clinical trial, we can actually count up how
many extra heart attacks and breast cancers there were in a very rigorous way
because women were arbitrarily assigned to take estrogen or a placebo. And
we know precisely how many extra cases of cancer and other problems resulted.
And it's staggering. It's one of the larger drug-induced epidemics, if you
will, of modern times.

DAVIES: Let's talk a bit about the role of drug companies in influencing what
doctors prescribe. You write that one of your very first research studies,
maybe even your first, involved a look at why doctors prescribe Darvon and
then also another class of drug which is designed, I guess, to keep arteries
open in the brain--cerebral and peripheral vasodilators, right?

Dr. AVORN: That's right.

DAVIES: Now what did this study tell you? What did you find?

Dr. AVORN: Well, what was striking about those drugs--and we also looked at
an antibiotic that was overused because people were giving it for viral
infections where it had no effect. And I picked those drugs because they had
one property in common: They were horrendously overused. In the purposes for
which they were used, they were either ineffective or no better than other
alternatives you could get over the counter. So, for example, Darvon is
really not much better than aspirin or Tylenol, for that matter. And yet they
were selling like hotcakes. And the question that I was trying to answer was,
why is it that doctors are using these drugs that are either ineffective or no
better than something that you can get without a prescription?

And so we asked doctors what their perceptions of these drugs were, and sure
enough, they told us exactly what the drug ads said to them about efficacy and
about advantage over other products. And we also asked them, where do you get
your information from about drugs in general? And although doctors believed
that they were not being influenced by ads or sales reps or any of the massive
promotional materials that they see, in fact what they believed about the
drugs could only have come from those commercial promotional channels because
there was no article in any medical journal that really ever said that these
drugs did what they believed they did. And so it was a sobering instance of a
lot of us believe or know what we know because of pharmaceutical promotion
rather than because we read it in textbook or a medical journal.

DAVIES: Anybody who's sat in a waiting room knows that doctors are very busy
people. And in addition to looking at patients and looking at lab reports and
writing in files, there's a dizzying array of information that comes through
medical journals and the Web sites about all kinds of things, including
prescription drugs. You describe--I think, in your book, you call it
informational kudzu, this kind of vine that just spreads everywhere and
multiplies.

Dr. AVORN: Right.

DAVIES: How do doctors sort out what to know? And I guess the real
question--I mean, you've pointed at this--is, how do the drug companies seek
to influence them?

Dr. AVORN: Well, one of the major themes in "Powerful Medicines" is that,
unfortunately, there's a lot of very effective communication coming at us as
prescribers that is oriented around product sales. But there is much, much
less information coming at us around just the best available science. And
again, the reasons are that there's an enormous amount of capital behind
trying to get us to use the latest and most flashy, expensive brand-name
product, and coming along and saying, `Well, gee, there's the generic drug
that's been around for 20 years or more that works just as well,' is not a
message that anyone is paid to deliver, for the most part. And so one of the
difficulties is that doctors are inundated with messages about use this latest
and greatest and most fancy new product because that's where the profit
margins are, and yet the older story is not as well-told. And sometimes, as
we saw with another big federal study that came out just two years ago for
blood pressure pills, when you really do the randomized head-to-head
comparison, the older, generic cheap drugs not only are as good as but in fact
work better than some of the new high-price drugs. And yet it's no one's job
to get that information to doctors.

DAVIES: Now apart from the information itself, what techniques do the drug
companies actually use to get doctors' attention?

Dr. AVORN: Well, that's a great question because it was the next logical
question after it became clear in looking at what doctors were prescribing
that it seemed that our pens were being guided more by promotional sources
than they were by pure science. So the question is, how did this happen? And
I began a study of what it is that pharmaceutical companies do to influence
our prescribing. And they're awfully good at it. They're very creative, very
talented and very effective. They will come into our offices with a message
instead of, as we do in academics, expecting someone to turn up in a lecture
hall to listen to us...

DAVIES: Let's be real...

Dr. AVORN: Yeah, go ahead.

DAVIES: Yeah, let me just cut in here. Let's be real concrete. I mean, when
you say they come and talk to you, I mean, does a guy with a coat and a tie
and a suitcase full of drugs show up at a doctor's office, and does the doctor
give him the time?

Dr. AVORN: Sure. We can take as an example the high blood pressure pills
that many listeners may actually be taking. If we are thinking about the
older thiazide diuretics which have been around since the 1950s, they are all
off patent for the most part. They are not advertised that much. There is
not a lot of money to be made off of them because they're all generic and the
profit margins are low. And so there's no one out there trying to convince me
as a practitioner that I should use these drugs.

And if you contrast that with, let's say, the calcium channel blockers, which
are the drugs that really took over market share from these older, more
inexpensive drugs in the 1990s, what we have is an army of very well-dressed,
friendly people called detail men or detail women because they provide the
doctor with the details about the drug. And there are tens of thousands of
these people working all over the country. And a busy doctor will be visited
on a given day by many, many of them. And each one will be hawking the wares
of the company that he or she works for, and will come to my office and give
me free samples, which will get my attention; may give me various kinds of
tchotchkes like a pen or a notepad or perhaps tickets to a Red Sox game or to
a play; or perhaps will invite me to a seminar at the best restaurants in
town, where I've got to listen to the talk and then have a wonderful meal.
And the materials themselves will catch my attention because they've got big
headlines and color graphs and a simple take-home message.

And that really will run circles around the kind of papers that I would write
as an academic, which are likelier to be much more staid and don't have big
headlines or color pictures with them. And what we've learned in our research
and a number of other people have learned is that the listeners may well be on
a calcium channel blocker rather than an older thiazide diuretic because
there's lots of people telling their doctors to use the expensive drugs. And
nobody's out there saying, `Use these other ones; they work just as good.'

DAVIES: My guest is Dr. Jerry Avorn. His new book is called "Powerful
Medicines: The Benefits, Risks and Costs of Prescription Drugs." We'll talk
some more after a break. This is FRESH AIR.

(Soundbite of music)

DAVIES: We're back with Dr. Jerry Avorn. He's a physician who's spent years
researching prescription drugs, and he has a new book. It's called "Powerful
Medicines: The Benefits, Risks and Costs of Prescription Drugs."

You know, doctors, I think we think of as pretty ethical people. I mean, and
I know one family physician, who will remain forever my wife, who, she with
her colleagues, made a no-free-lunch rule finally in their practice because
the drug companies were typically coming in and making a nice pasta spread,
which the support staff really enjoyed. The doctors got together and decided,
you know what, we'll chip in once a week, we'll buy lunch for the staff, but
we're simply not going to take any more free lunches from drug reps. Is there
a movement among physicians to think about this differently?

Dr. AVORN: Yes there is. At my own hospital here in Boston, the Brigham and
Women's, a number of years ago the interns and residents got together and
asked the hospital to please not allow the drug companies to buy the pizza
for pizza rounds on Friday afternoons, and instead asked that my division buy
it because they knew that we would be providing unbiased information in
exchange for the pizza instead of having an obligatory sales rap or set of
brochures staring them in the face as they were trying to have their pizza.

And our hospital's been pretty good at trying to keep drug companies out as
the purveyors of medical education. We figure all of us who are on the
Harvard Medical School faculty, we really should be ashamed of ourselves if we
need to have drug company sales reps coming in to teach our trainees how to
prescribe drugs.

DAVIES: You have a proposal for, in effect, competing with the drug reps,
right? How does it work?

Dr. AVORN: Well, when it became clear to me that we were simply not getting
our point across as academics and as medical school faculty anywhere near as
compellingly as the drug companies were, I reasoned that maybe the reason that
we were doing so poorly at it--and if you just look at prescribing data, the
science was not winning out as well as it ought to--was that we just were not
as good at the game of communication as the drug companies are. And so a
number of years ago, I came up with this concept that came to be known as
academic detailing, which is taking that very, very effective behavior-change
strategy that the drug companies are so good at--sending people to the
doctor's office, giving them engaging materials, doing an interactive
one-on-one conversation--instead of just standing in a darkened room and
giving lectures the way most of my colleagues and I do.

We deployed a team of what we called academic detailers, who were pharmacists
that we sent out to teach doctors how to prescribe better using the same tools
as the drug company uses to get doctors to sell their product for them,
basically. And so these folks would go into doctors' offices and say, `Hi,
I'm from the Harvard Medical School Education Program,' and do the same
strategies as a sales rep would do--be interactive, make sure you're coming to
where the doctor's at cognitively as well as geographically, give them all the
backup they need to change their behavior. And what we found was that by
using that outreach approach, we were able to reduce inappropriate prescribing
very effectively, and that the program actually ended up costing less than it
saved in terms of silly prescribing dollars. And so that approach is now
taking off and has been implemented in a variety of settings, both in the US
and abroad.

DAVIES: So do you see a way for a national army of these independent drug
detailers to get out there and give better information?

Dr. AVORN: Well, when I was first asked that question years ago, I would say
yes, and people would say, `What a quaint idea for a pointy-headed academic to
believe in.' But in the years since we published that first paper in the New
England Journal, exactly that has occurred. There's now a nationwide program
in Australia that is based on this work and the work of other groups that have
been doing this in which the Australian government pays a fleet of pharmacists
to go door to door to doctors and to provide them with unbiased information
about the best available science based on this idea of being user-friendly and
interactive. And the information is not determined by the government. It's
determined by an independent board of physician experts. The government just
pays the bill to send these people out there. And similar programs are on the
ground and functioning now in the United Kingdom and in several provinces in
Canada. And we're about to launch a program of this kind in the state of
Pennsylvania. Another large program of this kind is getting off the ground
this summer in Kentucky. And so what we're seeing is kind of a push back
from, I guess, the world of science and the world of those who are trying to
make sure the drugs are affordable saying we should not leave the education of
doctors about drugs solely or predominantly in the hands of those who are
manufacturing the drugs. And it's taking hold.

DAVIES: Let's talk a little bit about drug studies and what they tell us,
what they don't tell us and how they're used. A lot of the research about
medications is done by drug companies themselves. Can they fund studies and
then, if they don't like the results, keep them secret? Or can they publish
studies but only publish partial results? What restrictions or regulations
are there which govern the way drug studies are conducted and used?

DAVIES: Well, Dave, I think your first point is a very important one that
most Americans and, frankly, most physicians may not be aware of; that the FDA
does not study drugs hardly at all itself, and that essentially all the
information that it has available in making decisions about drugs is based on
studies that were really done by and run by the manufacturer of that drug.
Now this is often done carefully and rigorously. But we've seen in just the
last couple of months that it can sometimes happen that a company will heavily
promote the findings of studies that it likes and be much more quiet to the
point of almost burying the findings of studies whose results it doesn't like.
And the scandal of the moment on that of a few weeks ago was a company that
makes an anti-depressant. And when it found that its product performed well
in adolescents with depression, that study was all over the airwaves that
doctors were exposed to, but another study that was also a randomized clinical
trial in which it found that the patients given their anti-depressant didn't
do well and in fact may have had a worrisome increase in their suicide rate
was buried. And it just kind of appeared in one Danish textbook that no one
ever read.

And so there is this asymmetry. And while FDA reserves the right to find out
about all those results, it's not allowed to report them because it's seen as
proprietary information. And so we've seen an imbalance of what does get out
to doctors.

DAVIES: So a drug company can literally keep secret results which reveal
harmful effects or ineffectiveness?

Dr. AVORN: Well, they are obliged to tell it to FDA, and FDA is then
responsible for figuring out what to do with it. If there were a really
egregious problem, like the drug was causing immediate fatalities, I would
like to believe that the company and the FDA would do something about it.
But the real issue is the much more common situation where the drug just
doesn't perform so good or it's got a higher rate of adverse events than was
expected, or than its competitor drugs have. And that kind of finding the FDA
is not obliged to release if it does not turn out to be a major new discovery,
but is really just a matter of balance. But of course everything in
prescribing is a matter of balance.

DAVIES: I think that would surprise a lot of people. I think most people
would think that somewhere all of the information that the FDA has about the
safety or efficacy of drugs would be available to physicians. It's not.

Dr. AVORN: What drives prescribing is what is brought to the physician's
attention in an effective way that'll change use. And the fact that there
may or may not be something that lives on a computer disc in FDA is not going
to influence prescribing as much as something that is hammered home with a
variety of lectures and cruises and free dinners and other things. And that
is what drives prescribing. And that's where we need a more neutral voice
out there, trying to give doctors a balanced view, not this free-enterprise
chaos in which we have every company hawking its own wares to the extent that
it will profit, and companies that are not going to profit, who make generic
drugs, are not out there hawking at all.

DAVIES: Dr. Jerry Avorn. His new book is called "Powerful Medicines." He'll
be back in the second half of the show.

I'm Dave Davies, and this is FRESH AIR.

(Soundbite of music)

(Announcements)

DAVIES: Coming up, the FDA's standard for putting a drug on the market. We
continue our conversation with Dr. Jerry Avorn, author of "Powerful
Medicines." Also, filmmaker Ross McElwee. His new documentary "Bright
Leaves" tells the story of how his ancestors just missed making a fortune in
the tobacco business and their descendants became doctors treating patients
with smoking-related illness.

(Soundbite of music)

DAVIES: This is FRESH AIR. I'm Dave Davies filling in for Terry Gross.

Let's get back to my conversation with Dr. Jerry Avorn who's spent 25 years
treating patients and studying prescription drugs. His new book is "Powerful
Medicines: The Benefits, Risks and Costs of Prescription Drugs."

What standard does the FDA hold to allow a drug to get on the market?

Dr. AVORN: This, again, will surprise many listeners, because the belief
that I had before I started looking into this was that there was--that a new
drug needed to have some important medical virtue to it before it was going to
be added to the list of drugs that could be sold in the US. It turns out that
it really doesn't need to be any better than all the other drugs we've got.
It doesn't even need to be compared to any other drug, and it can simply be
compared in many cases to an inert pill like a placebo for as short as perhaps
16 weeks of study. And the outcome of interest that the trial is going to be
based on may be--not did it reduce strokes or did it prevent heart attacks but
did it make your lab values better from a point of view of a cholesterol drug
or did it lower your blood pressure temporarily, or, in the case of diabetes,
did it make your blood sugar lower?

That's plausible, but we don't know, since these are drugs that people are
going to take for a lifetime whether a new drug that is approved on that basis
is really going to be worth having around for the next 10 years if it's a
life-long drug based on a 16-week study compared against placebo. And,
unfortunately, you pass that test and that's enough to get your drug approved
and then it's nobody's job to take the next step and say, `Well, OK, this
diabetes drug is better than a sugar pill or an inert pill in making your
blood sugar lower, but does that mean that I, as a doctor, ought to switch to
it?' I don't have the data when I'm writing a prescription to be able to know
that because the FDA only requires that it be tested for a couple of months
against an inert substance.

DAVIES: Well, by that standard, I mean, couldn't the drug Premarin, the
estrogen replacement, which was taken off the market because of its potential
harmful effects, I mean, it did have some beneficial effects on some health
indices. I mean, by that statement, could Premarin be marketed today?

Dr. AVORN: Yes, in fact it is still used for the temporary management of
menopausal symptoms and it does work well for that, for the hot flashes and
the immediate problems when a woman is going through the menopause. What it
was never tested for was the lifelong use that accounted for virtually the
lion's share of its use.

DAVIES: Does the FDA have a mandate to prosecute or take action against drug
companies that make unfounded claims about their products?

Dr. AVORN: The FDA is very careful in making sure that companies don't make
unfounded claims. They are less careful than they used to be. In fact, in
the Bush administration one of the early acts of the new general counsel at
FDA was to announce that they would no longer as aggressively pursue
problematic claims made by drug companies in their ads and in fact the number
of enforcement actions has gone down over earlier years because of this `let's
not overregulate industry' kind of orientation that we now have. But if you
read the ads very carefully, again, to come back to the estrogen example, the
ads never exactly said `this drug will prevent heart disease,' or `this drug
will make it more likely that you'll get Alzheimer's disease.'

The ads really stuck more or less to the letter of the law saying this is good
for the treatment of menopausal symptoms. And all the heavy lifting for all
those other messages happened in various continuing education courses or
speakers' bureaus that the manufacturer would sponsor where doctors who had
friendly messages to the drug would be paid to go around the country and give
talks in hospitals and medical schools. And the company itself was careful
trying not to cross the line as best it could into making false claims because
they let other people do that for them.

DAVIES: You write that Americans spend a lot more on prescription drugs than
other industrialized countries. Give us a sense of what the difference is and
what the health impact is.

Dr. AVORN: Americans pay anywhere between 40 percent and 100 percent more
for the same drugs made by the same companies as do people in other parts of
the world and I'm thinking here of Canada and Western Europe. And ironically
these are the same plants, making the same products and purveyed by the same
companies. It's just that most other industrialized countries manage to keep
a lid on what is charged for drugs and the US is really the last
industrialized country that allows this to be totally what the traffic will
bear and if a patient is told by their doctor `you need a certain drug,' and
it costs them $1,000 a year, they're going to have a hard time saying no
because, after all, `my doctor said I should take it.' And that's why the US
is--pays so much more for drugs than any other country per capita.

DAVIES: One of the things the drug companies say, of course, is, you know,
yes, we have huge revenues but if you want research and development to cure
new diseases and treat all kinds of problems that we can't treat today, that's
going to cost a lot of money. Do they have a good point?

Dr. AVORN: Well, in the book I call that the research ultimatum. That is,
if we cannot make lavish profits, we're just going to stop discovering new
drugs and you're all going to die, and I think that's an overstated claim by
the industry for a couple of reasons. One is that the industry is one of the
most profitable. For most of the last 20 years it has been `the' single-most
profitable industry of any industry group in the country. And in fact far
more dollars get plowed back into promotional activities and marketing or into
just profits for shareholders than get plowed back into research and
development. There are more folks working in the big drug companies doing
marketing and sales than there are doing research at present. And, in fact,
an awful lot of the most important findings that lead to new drugs are done in
university settings and they're funded by the National Institutes of Health or
other federal-supported programs or private philanthropies, and so the idea
that somehow the drug companies are the only source of important biomedical
research that leads to new drugs is simply not true.

DAVIES: To be concrete, I mean, how big of a cut of the cost of drugs goes to
the sales and marketing effort?

Dr. AVORN: Well, this was looked at by the Department of Health and Human
Services, which is not exactly a rabidly anti-industry group these days and
they found in looking at the filings of the nine or 10 biggest drug companies
in the US that about 30 percent of their total revenues is devoted to
marketing, promotion and administration so that's about nearly a third. About
20 percent is devoted to profit, that is, goes back to the shareholders, and
only about 13 percent is for research and development, and so that's a rather
disproportionate amount that's not going to R&D for the drug dollars that we
are spending. And it's probably a very inefficient way for us to discover new
drugs compared to other alternatives.

DAVIES: What's your attitude toward people going to Canada to get drugs and
getting them from Canadian Internet sites?

Dr. AVORN: The FDA has done a lot of scare tactics about this but, in fact,
Canada's a very civilized country and it is not difficult for FDA to certify
Canadian pharmacies or Canadian vendors just as it certifies vendors for drugs
in America. One of the ironies, these are not weird drugs made in a bathtub
in Bangladesh. These are usually the same drugs made by the same companies in
the same factories as Americans buy, they just aren't marked up as much. And
it would be quite easy for FDA to be able to certify FDA-approved Canadian
pharmacies or British pharmacies or French pharmacies that would get us the
medication we need. And they're not doing it, not because of medical reasons,
but because of political reasons.

DAVIES: What do you like or not like about the prescription drug plan that
the administration has passed and Congress has approved?

Dr. AVORN: OK. The difficulty we're gonna see, and we've already started to
see, with the new Medicare drug benefit, is that the policy was pretty much
written by the pharmaceutical industry and the insurance industry and it works
very well for them. I don't think it's going to work very well for the
nation's elderly because it doesn't contain in it any way in which we can try
and get doctors to make sure that we're prescribing the most cost-effective
drug for the elderly patients that we see. And for that reason the costs are
just going to balloon out of control and it's going to be a fiscal disaster
before it's six months old, I predict.

DAVIES: One of the points you make in your book is that of all the drug
studies that are done out there, that nobody seems to have an interest in
doing a clinical trial which asks the question: Is the new fancier, more
expensive drug really more effective than the established cheaper one? But
sort of nobody has an interest in doing that kind of study. And it occurs
that one people that might have an interest in that kind of information would
be an HMO or a big insurance company that pays the costs and could save a lot
of money if they could prescribe cheaper drugs. Why don't they fund these
kinds of studies?

Dr. AVORN: That is a great question that I've been perplexed by for the last
20 years or so. There's a number of groups out there with very deep pockets
that are spending enormous sums that they really are having trouble affording
on drugs. It's not just the HMOs, it's also the Veterans Administration, it's
also the state Medicaid programs. And soon it will be the Medicare program
itself. And I've wondered for decades why is it that with all the billions of
dollars that these payors are spending paying for drugs that they're not
mounting these studies. And I think it comes down to the sense that they fear
the FDA's minding the store and that somehow this work will get that done by
somebody else.

And the big problem is that it isn't getting done and we probably will be
seeing, as this gets more and more out of control, a new stream of research
coming online in which there will be these very clinically irrelevant studies
that do get done. Who will fund them is not yet clear. But we've got to have
somebody out there and it's not going to be the companies. When a new drug
that comes out that's supposed to be better than the old stuff, actually
testing that in a clinical trial, because we can't go on just always adding
the new drugs to the prescription pad without ever asking, as any prudent
payor would, `Is the incremental cost that I'm going to have to shell out for
this getting me in any kind of incremental benefit?' So we've got a big gap in
our science policy in this area.

DAVIES: Well, Jerry Avorn, thanks so much for speaking with us.

Dr. AVORN: Thanks for having me.

DAVIES: Dr. Jerry Avorn. His new book is "Powerful Medicines: The
Benefits, Risks and Costs of Prescription Drugs."

Coming up, tobacco wars in the Old South. We meet documentary filmmaker Ross
McElwee.

This is FRESH AIR.

* * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * * *

Interview: Ross McElwee discusses making documentaries
DAVE DAVIES, host:

Documentary filmmaker Ross McElwee lives in Boston and teaches filmmaking at
Harvard but he grew up in North Carolina and many of his films involve
journeys back to his native South. In "Sherman's March," McElwee pursued
seven Southern women looking for love. In his new film, "Bright Leaves,"
McElwee tells the story of his ancestors' involvement with the tobacco
industry. The film is in part a reflection on tobacco and tobacco addiction
in the modern South.

McElwee begins with a fascinating piece of family lore. His
great-grandfather, John Harvey McElwee, was a 19th century tobacco grower and
was the first to come up with the popular Bull Durham blend, but the family
story has it that the McElwees lost their patent and potential fortune to the
famous Duke family of North Carolina. In this scene from "Bright Leaves,"
McElwee introduces us to his second cousin, a small-town lawyer and vintage
film buff named John McElwee. He's discovered an old Hollywood movie called
"Bright Leaf," a melodrama about a rivalry among post-Civil War tobacco
growers.

(Soundbite of "Bright Leaves")

Mr. JOHN McELWEE: The author of the novel on which the movie was based was
also from North Carolina, did the research based on stories involving North
Carolina tobacco growers. And it just seems very likely that our
great-grandfather's story had to have been incorporated into this. And I
think, really, it's the basic theme of this movie. It's the same--what
happened to our great-grandfather is pretty much what happens to Gary Cooper
in this film.

Mr. ROSS McELWEE: Who were the co-stars with Gary Cooper in this?

Mr. J. McELWEE: Lauren Bacall and Patricia Neal, Donald Crisp, Jack Carson.

Mr. R. McELWEE: So this was a major production.

Mr. J. McELWEE: Oh, yeah. Yeah, this was an A picture directed by Michael
Curtiz. He had done "Casablanca," "Yankee Doodle Dandy," "Adventures of Robin
Hood." He was Warner's top director at the time.

Mr. R. McELWEE: With our great-grandfather being featured as...

Mr. J. McELWEE: Exactly.

Mr. R. McELWEE: ...Gary Cooper. Incredible.

Mr. J. McELWEE: That's right.

DAVIES: I asked Ross McElwee how his great-grandfather lost the Bull Durham
tobacco patent.

Mr. R. McELWEE: Well, we don't know exactly what happened, but somehow, he
lost control of that trademark. I think, by simply reversing Bull Durham to
Durham Bull--his original phrase of Durham Bull, and that somehow became
switched to Bull Durham. They just flip-flopped the phrase, and that became
the name of a very popular brand of tobacco. At one point, during the height
of the popularity of this kind of tobacco, they had an image of the Durham
Bull draped over one of the great pyramids of Egypt. So this thing was a
worldwide phenomenon. `Bullpen,' the phrase in baseball, where the pitchers
warm up, is named that, named bullpen, because pitchers used chewing tobacco,
and one of the tobaccos they favored was Bull Durham. And so that, the fact
that it was so popular and had earned so much money for the Dukes, is
something that my family has always had to kind of wrestle with.

DAVIES: Well, I wonder what your lawyers thought about a film which appeared
to depict the notion that this prominent and successful family had, in effect,
cheated your family out of its rightful due. I mean, is that, in fact, what
happened?

Mr. R. McELWEE: Well, I don't think so. I mean, I don't think it's ever
been that simple, and it's never been proven. It went through legal
procedures, the whole case did, and many, many different trials, I think,
occurred in which this issue was debated by, you know, a judge and a jury and
so forth. And the legal outcome of all of those cases was that my
great-grandfather did not have the right to the trademark. And I think the
family long ago accepted that, and I think what was interesting to me was that
hypothetically, if we did still control this tobacco fortune, how would that
affect us? How would that affect me? And I think it was just a kind of way
in which I could begin to explore part of the ethical paradox of having that
kind of a family fortune.

DAVIES: And one of the interesting things, of course, is that your family
gets out of the tobacco business and produces a string of doctors who treat
North Carolinians damaged by tobacco.

Mr. R. McELWEE: Yes, that's correct. And I think I allude to that in the
film as a kind of agricultural pathological trust fund that was left for my
family given that there was no family fortune inherited, but there was this
awful other legacy. But I do want to say that I don't think the film has a
tone of condemnation for the tobacco industry, nor for the people who grow
tobacco. I'm really trying to do something much more complex than that. It's
such a delicate issue for North Carolina. It's not simply a matter of saying
that all tobacco should cease to be grown now. I think that that would put a
lot of people out of work. And North Carolina is trying to deal with the
problem, but that there is not simple solution. This crop is rooted into the
economic and psychological history of the state of North Carolina and to the
people who live there. And so my film explores the complexity of that.

DAVIES: Bull Durham. Tell us, where did that name come from? Was it a
particular blend of tobacco, and did it have anything to do with a bull?

Mr. R. McELWEE: Actually, the story is that my great-grandfather and an
associate of his, a guy named Green, ran a barn trying to think of what to
call this concoction. And they heard a bull bellowing off on the horizon
somewhere in this farmland of North Carolina, and my great-grandfather said,
`Ah, that's what we'll call it, Bull.' And they liked Durham, because there
was a kind of mustard that was imported from England at the time that was
called Durham. And for no particular reason, they just put those two words
together and, in fact, it became quite successful as a trademark.

DAVIES: And lives on in a famous movie about minor league baseball.

Mr. R. McELWEE: Absolutely.

DAVIES: You mentioned that tobacco and its role in North Carolina society and
culture is something which is evolving. And one interesting piece of that,
late in the film, you visit a small town which has, I guess, a tobacco
festival in which there are beauty queens. And it's the last one, right?

Mr. R. McELWEE: It is the last official tobacco festival in that particular
town. They are in the process of changing it over to something called
Farmers' Day, in which it won't just be a celebration of tobacco, but of all
crops grown in the area. But in a way, it's a little bit sad. This festival
has existed for 50 years, has always been called the Tobacco Day Festival and
was changing its name at this point. So I think it's very much a mark of
changing times in North Carolina that I happened to have been in that town and
have filmed what essentially was the last parade in a 50-year history of
parades celebrating tobacco.

DAVIES: You discover what used to be a tobacco warehouse of your
great-grandfather, I gather, which is now...

Mr. R. McELWEE: Mm-hmm.

DAVIES: ...a beauty shop or a beauty college, something like that, right?

Mr. R. McELWEE: Yes, it's a hair academy, as they say down in North
Carolina. Yes, and in this warehouse where, you know, my great-grandfather's
tobacco had been piled high at one point, there are now people learning
to--how to tease hair, I guess, or dye hair. And I liked very much the
paradox of that, that it had gone from being a kind of warehouse where tobacco
was gathered together and sent out, and now it had become a beauty parlor.
And I ended up filming some of the beauticians on their cigarette break and
had sort of an amusing exchange with them about when they were going to quit
smoking and they told me various things.

DAVIES: What did you hear in their answers that eliminated that question you
had about why people take up smoking and sort of dance with the risks that it
brings?

Mr. R. McELWEE: Well, I think that it connects to a very essential part of
human nature, which is that of denial that these young women--they were
probably 18 or 19 years old--were saying that they would quit smoking when
they had children or one of them says, `I'll quit smoking when I, you know,
have lung cancer.' I mean they're making jokes about that, but in a way, the
humor of that I think for me underscores something much more profound, which
is the degree to which people are capable of denial. And we're all capable of
denial. We have to be in order to keep living because we all die. And I
think the cigarette smoking, again, kind of focuses this in a wonderfully
metaphorical way. You know, how we deal with the fact that
existentially--with the fact that our lives come to an end. And smoking, in a
way, I think, pushes that to the forefront. It makes you deal with it or
makes you deny it.

DAVIES: Filmmaker Ross McElwee. His latest documentary is called "Bright
Leaves." We'll hear more after a break.

This is FRESH AIR.

(Soundbite of music)

DAVIES: We're back with documentary filmmaker Ross McElwee. His new film,
"Bright Leaves," deals with his family's history in the North Carolina tobacco
industry.

You also spoke to tobacco farmers who, you know, seemed like very decent
people who, in an information age, know an awful lot about the hazards and
misery that smoking has brought. It was an interesting contrast to see these
nice folks talking about something with, you know, death-dealing qualities.

Mr. R. McELWEE: Yes, well, I think the thing that I ended up--the qualities
that I ended up respecting in these people were their sincerity and also the
fact that they were at least acknowledging, most of them, that there was a
paradox here, and that they did have to eventually come to deal with it. And
I think that just the fact that they can acknowledge the fact that there's a
paradox here, that there are things about smoking that are threatening and
dangerous to people means that they're beginning to face the issue in some
way, or at least the farmers that I spoke to were beginning to face the issue.
And I think also what interested me about them was the degree to which they
were so religious and somehow there was no contradiction, no paradox in their
religiosity with the fact that they were growing something that was
potentially dangerous to people. But the other thing the film explores is--I
mean part of what makes smoking such a complex issue is that I also filmed
people who had been smoking since--there's one man I filmed who had been
smoking since he was four years old and he was in, you know, pretty good
health and he had had a grandmother who'd lived to be 109 and she had smoked
all of her life. And so what makes it complicated is that, of course,
genetically, smoking is not necessarily something that's going to bring your
life to an early end. It probably will, it may, but it's not definite. And I
think that little window of chance that you'll escape what most people succumb
to if you smoke is another factor that keeps--that makes denial possible.

DAVIES: As you explore the contrast between your own ancestors who were in
the tobacco business and the Duke family, which became billionaires at it, you
discovered that while there is a Duke University and a Duke Medical School,
there is a McElwee Park somewhere, right?

Mr. R. McELWEE: Yes, there's a McElwee Park that I'd not heard of until I
visited with a historian in Statesville, North Carolina, a local historian,
who revealed its presence to me. And it was this tiny, little back lot
connected to the manufacturing--the factory that my great-grandfather had
built in Statesville, North Carolina. And someone, some historical society
had designated the land next to the factory as McElwee Park. And it's a
rather--hurts me to say so--but a rather shabby affair. It has a little sign
saying McElwee Park, and then a single bench between two stunted trees. And
this somehow qualifies as a park. And, you know, for me it's a humorous or
kind of comic emblem of what happened to the family fortune. And I return to
it periodically to muse on the complexities of tobacco and fate during the
course of the film.

DAVIES: Is there a moment maybe when you were making "Bright Leaves" when you
say, `Yes, this is it, this is why documentary filmmaking is my love.'?

Mr. R. McELWEE: Those moments are what keep you going making these films.
These films are not easy to make, but it's those little moments of discovery.
And I think for me, the moment, the scene, the day that most fulfilled exactly
that quality that you're talking about was the tobacco parade that occurs at
the end of the film in which when I saw the sign indicating that it was the
50th tobacco parade in this little town in eastern North Carolina, I thought,
`Well, this might be worth checking out.' And the minute I started filming I
realized I was so happy that I began filming this because it was just moment
after moment of surprise in terms of the beauty queens who kept coming by, and
there were so many of them and the preparations of the crowd before the
parade. And then there was this moment where these riding lawn mowers were
kind of performing precision movement of some kind in the parade itself, and
there were all of these things that you could not have dreamt up if you'd been
writing a script of what a parade would have been like in this kind of
situation. And those are those moments when you just are so delighted to be a
documentary filmmaker because, in fact, you're not directing, you're just
receiving what the world is handing to you. And I think that was certainly
the scene that embodied that quality for me as a filmmaker.

DAVIES: Well, Ross McElwee, thanks so much for speaking with us.

Mr. R. McELWEE: Thank you. It's been my pleasure, Dave.

DAVIES: Documentary filmmaker Ross McElwee. His latest film, "Bright
Leaves," opens next week at Film Forum in New York City.

(Credits)

DAVIES: For Terry Gross, I'm Dave Davies.
Transcripts are created on a rush deadline, and accuracy and availability may vary. This text may not be in its final form and may be updated or revised in the future. Please be aware that the authoritative record of Fresh Air interviews and reviews are the audio recordings of each segment.