Marcial Angell's perspectives on "me too" drugs.  

The former editor in chief of The New England Journal of Medicine, Marcia
Angell is currently a senior lecturer in social medicine at Harvard Medical
School. She disputes the pharmaceutical companies' argument that they need a
high profit margin to fund the research and development of new medicines. In
fact, she says, the industry piggybacks off publicly funded research at the
National Institutes of Health and other academic institutions. She also
argues that most of the companies' profits are not derived from new drugs,
but rather from "me too" drugs, or imitations of drugs already on the
market. This interview was conducted on Nov. 26, 2002.
=After a period where health care costs flattened, they're going up sharply.
Why is the pharmaceutical sector [of health care costs] rising the fastest?

There are a couple of reasons. One [is] price inflation. The price for the
top-selling drugs now averages about $100 for a month's prescription of that
drug. It's well over $1,000 a year. The price per drug is increasing about
three times the rate of inflation. So one is just prices.
 
The other is, through advertising and PR and marketing, consumers are being
switched or preferentially led to take newly patented high-price drugs
rather than generic drugs that might be just as effective. So the kinds of
drugs that are being used are the high-priced drugs.

Third is just the increased volume of use. More people are taking more
drugs. This too is a part of promotion and marketing. For all of life's
discontents, according to the pharmaceutical industry, there is a drug and
you should take it. Then for the side effects of that drug, then there's
another drug, and so on. So we're all taking more drugs, and more expensive
drugs.
 
=Who's most affected by this price inflation and increased drug costs?

The sick and the helpless are those who are most affected by this price
inflation. That is, if you have good insurance that would pay for a
prescription drug benefit -- and fewer and fewer of us do have such
insurance -- but if you do have that insurance, the HMO through which you
have the insurance will bargain for price discounts from the drug companies,
get them somewhat cheaper -- in fact, a lot cheaper. You will have to pay
less in out-of-pocket contributions. 

But for those who are not well insured for prescription drug costs, they're
pretty much left on their own. These are mainly Medicare recipients who have
no supplementary insurance. Medicare, through historical accident, really,
does not pay for outpatient prescription drugs. So Medicare recipients have
to pay out of pocket, unless they have supplemental insurance. 

Not only do they have to pay out of pocket, but they're likely to be taking
more drugs. So if you just look at the price of one of the top selling drugs
-- $1200 per year -- and you look at older patients and seniors, who may be
taking five or six of these drugs, you can see that they're up to many
thousands a year. These are the most vulnerable people. They pay twice as
much for drugs, on average, as will insured younger people who get their
drugs through HMOs.
 
=People who are covered have no idea what drugs actually cost. Seniors are
one of the few groups who actually know the market price.

That's right. They're the ones who are complaining the loudest, and they
should. The rest of us are still, to some extent, cushioned from the
realities of this incredible price gouging that's going on by the
pharmaceutical industry. We're still cushioned to some extent, but that is
going to be less and less. We're going to see our insurers paying just a
defined contribution, and we will have to make up the rest, or dropping
prescription drug benefits altogether. So we too will find out about this
very shortly.

=Some seniors in border states notice that drugs are cheaper in Canada, and
they actually go and get them. What does that tell us about the two systems?

Well, the United States is the only advanced country that permits the
pharmaceutical industry to charge exactly what the market will bear,
whatever it wants. The other advanced countries in Europe and Canada have
some form of price control, either mandatory volume discounts or some way of
limiting price. So on average, Canada spends half of what we spend for the
exact same drugs. Half. 

So if you live on a border state and you can make a bus trip to Canada and
have a prescription, you can -- particularly if you're a senior citizen who
has to pay for drugs out of pocket, and have to take a lot of them -- you
can do very well by taking that bus trip to Canada.
 
=One argument [is that] he Canadians don't invent the drugs. They're
parasitic on our R&D. It's unfair.

In fact, the pharmaceutical industry is what's parasitic on publicly funded
research. The pharmaceutical industry likes to depict itself as a
research-based industry, as the source of innovative drugs. Nothing could be
further from the truth. This is their incredible PR and their nerve. 

In fact, if you look at where the original research comes from on which new
drugs are based, it tends to be from the NIH [National Institutes of
Health], from the academic medical centers, and from foreign academic
medical centers. Studies of this, looking at the seminal research on which
drug patents are based, have found that about 15 percent of the basic
research papers, reporting the basic research, came from industry. That's
just 15 percent. 

The other 85 percent came from NIH-supported work carried out in American
academic medical centers. In one study, 30 percent came from foreign
academic medical centers. So what we know about the numbers indicates that
the foreign academic medical centers are responsible for more new drug
discoveries than the industry itself.
 
=[What is] the profitability of this industry, compared to other American
industries?


Numero uno. The pharmaceutical industry is stunningly, staggeringly
profitable. The 10 drug companies on the Fortune 500 list last year took in
net profits of 18.5 percent on sales. That's 18.5 percent. That is stunning.
The median for the other industries on the Fortune 500 list was a little
over 3 percent, 3.3 percent of sales. This has been the case for the last 20
years; this is not just a fluke of last year. Year after year after year,
the pharmaceutical industry has led all other industries in profits. ...

The drug companies make the case that their prices are so high, and that
total expenditures are so high, because their R&D costs are very high, as
though they were just eking out, just barely managing to survive. But what
we can see is that their profits are very much higher than their R&D costs,
and therefore they could spend more on R&D if they wanted, and still have
plenty of profits left over. 
 
=They are numero uno in R&D as well, aren't they?

Their R&D costs are very high, in absolute terms. But in relative terms,
they're quite small, that is, relative to their other expenditures and to
their profits. The drug companies spend on average, by their own figures,
last year, 15 percent to 17 percent on R&D. That's a lot of money. There's
no question that that's a lot of money. But their profits are higher. Their
profits are 18.5 percent. That's higher than their R&D. 

What's really interesting is what they spend on marketing and
administration, by their own figures, on average 35 percent. That's over
twice as much as what they spend on R&D. So if they point to their R&D costs
as some sort of justification for the high prices, what on earth can they
say about their marketing costs, which are over twice that much? 
 
=Marketing and administration?

Marketing and administration, yes. One of the problems with talking about
the R&D cost and the marketing cost and the profits, and the way the
pharmaceutical industry does business, is that they're very secretive about
the details. You can't get at exactly what the details are. But you can get
close enough. You can infer from certain things. 

The major drug companies, in general, combine marketing with administrative
costs. So in their annual reports and in their SEC filings, they will give
total expenditures for something they call "marketing administration." The
indications are that the lion's share of that is for marketing. One company,
one of the major companies, does break it down, does separate out marketing
from administration. That company attributes 35 percent to marketing, 6
percent to administration.

If you then also look at how the employees are apportioned, by their own
figures, over a third of their employees are in marketing -- not marketing
administration, but marketing. So I think it's safe to conclude that
somewhere on the order of 30 percent -- over twice the R&D costs -- are
marketing.
 
=Your contention is this slightly skewed picture is partly responsible for
the lack of truly innovative drugs that we've seen lately, and the
proliferation of "me too" drugs?

... The drug companies have found that the best way to make money at low
cost is by turning out drugs that are imitations of other companies'
blockbusters. A blockbuster is commonly accepted to be a drug that sells
more than a billion dollars in a year. So they've found that the best way to
make money is by imitating other companies' blockbusters, or by imitating
their own blockbusters -- making a new version of their own blockbuster,
when the first one is going off patent and they want to have one with a
longer patent life. That's what they have been turning all of their efforts
to now. 

Innovation comes mainly from NIH-supported research in academic medical
centers. The drug companies do almost no innovation now. It's just turning
out one more drug that's similar to a blockbuster. These are called copycat
drugs, or "me too" drugs. That's their major business now.
It's very hard to launch a "me too" or copycat drug, because you have to
convince doctors and the public that they are somehow different and better
from all of the other copycat drugs already on the market. So that's why
their marketing costs have to be so high. ...
 
=To get a "me too" past the FDA doesn't require that they prove it better
than something on the market?

By law, a drug company cannot market drugs unless those drugs are approved
by the FDA. The FDA approves the drugs if the manufacturers have shown,
through clinical trials, that they're reasonably safe and effective. But
here's the catch: To show that drugs are effective, the manufacturers only
have to compare them, usually, with a placebo -- that is, with a sugar pill.
So all they're required to do is show that this new drug is better than
nothing. They are not required to show that it's better than other drugs
already on the market for the same condition. 
That's why there are so many "me too" drugs on the market. There's no
comparison with older drugs. There's no comparison with generic drugs. The
last thing the companies want to do is have a head-to-head comparison with
similar drugs already on the market.

[My note: but for cancer drugs, the FDA does require data proving a benefit
over existing drugs by comparisons against standard treatments in controlled
clinical trials.]

 
=If theirs was better, they would want one, wouldn't they?

How will they know that it's better until they test it? Then they take the
real risk that it will turn out to be worse. So what we have now is a
blizzard of "me too" drugs, copycat drugs, that may be worse than the drugs
already on the market, that may actually be worse than generics. There's no
reason to think that they're better, and they could be worse. They could
have more side effects. There is no way to know that, because the FDA does
not require that a new copycat drug be compared with the older drug already
on the market.
 
=So they use this marketing budget to try and--

That's right. If the drug company produced a cure for AIDS or a cure for
cancer, you wouldn't need a big marketing budget. The world would beat a
path to its door. You have to have a huge marketing budget to convince the
public that Nexium is better than Prilosec. That takes a great marketing
budget. So that's where these marketing expenditures are going.

Now, the FDA itself categorizes the drugs that it reviews as either likely
to be an improvement over drugs already on the market -- and they get what's
called a priority review -- or as unlikely to be an improvement over
whatever is already on the market -- that is, it's likely to be no better
than what's already out there. 

The number that are categorized as "likely to be an improvement" by the FDA
has been going down and down and down. Last year, 2001, only 66 drugs were
newly approved. Only 66 out of this whole gigantic industry, and that too
has been going down. And of those 66, only 10 were classified as likely to
be an improvement over whatever was already on the market. The other 56 were
all "me too" drugs. That's pathetic, really, 10 out of 66 likely to be an
improvement.
 
=Until recently, marketing was done ... directly to physicians, which still
is the largest part of the marketing budget. But in 1997, the FDA permitted
direct-to-consumer advertising. Talk about the significance of that.

Direct-to-consumer advertising was always allowed, but only under certain
conditions. Those conditions were that the company advertising the drug had
to say what the side effects were; had to, in some detail, spell out what
the risks of the drug were as well as the benefits. 

In 1997, that was changed. Now drug companies don't have to spell out the
risks. All they have to do is refer the viewer or the listener or the reader
to where they might go if they want to [to find about] out about risks. "Go
to your doctor. Tell your doctor you have kidney disease or liver disease,"
[which is] something you would hope that your doctor would already know. But
that's what they say at the end of ads. Or "Here's an 800 number." So they
don't have to, when they're advertising drugs, say, "And, oh, incidentally,
this may cause bone marrow suppression, or a rash, or it may ruin your
liver." They don't have to say that anymore. 

So that created a huge opening for direct-to-consumer advertising, which
coincides with the age of the consumer. The consumer, for various reasons,
is now more of an active participant in his or her health care. So suddenly
you had all of these ads that don't go through the side effects in any
detail, or the risks in any detail -- that now account for about $3 billion
of pharmaceutical expenditures.
 
=But they still refer the patient to go see the doctor. So why should this
distort [the market]?

Well, because it is the age of consumerism. It convinces consumers that they
need drugs that they might not need, that they need some drugs at all. ... 

There is this kind of marketing that is designed to convince people that
they need pills. It's designed to convince them that they need particular
pills that happen to be more expensive, or just going on patent rather than
coming off. Then, armed with this feeling, the consumer goes to the
physician, who often just prescribes the pills. It's a buyer's market here.
Doctors don't want to lose patients. They don't want to say no to patients.
They're, in some sense, too busy to say no to patients. They are forced to
see more and more patients more and more rapidly. It's faster to write out a
prescription than it is to try to talk with patient and convince the patient
that he or she may have been manipulated by these ads. 

In addition, the doctors themselves are manipulated by the same ads, and
also by what amounts to bribery from the drug companies. The drug companies
turn up. They have $8 billion worth of free samples that they give to
doctors. The doctors hand out the free samples to patients. It makes the
doctor look good. The patient has free samples. But both the doctor and the
patient, from that point on, are hooked on that particular drug. And believe
me, it's not going to be a generic, and it's not going to be a drug that's
just going off patent. It is going to be a new, newly patented, high-price
drug. So in a sense, both the doctors and the consumers are sucked into a
sort of "bait and switch," because sooner or later they will have to pay
for[that drug.]
 
Doctors are supposed to be the informed actors in this picture. Isn't it a
flaw that they're so easy to manipulate?
It certainly is. If I sound easy on the doctors, I don't mean to be easy on
the doctors, because in the last analysis, it's the doctor who writes the
prescription. That's why the drug companies spend so much time and so much
of their marketing expenditures on the doctors. That's where the action is.
Yes, [the companies] spend a lot of money on consumer ads. They spend an
awful lot of money on Congress, on lobbying, on political campaigns. But the
lion's share of their attempts to manipulate the situation goes to the
doctors, because they are the ones who write the prescriptions. 

They do this in part by perpetrating a gigantic fiction, and that fiction is
that somehow they are not only in the business of selling drugs, but they
are also in the medical education business and the medical research
business. Now, that's nonsense. Their investors expect them to make as high
profits as they possibly can. They are investor-owned businesses and their
fiduciary responsibility is to their investors, which means selling drugs. 
But they have managed to make a lot of people believe that they are also
somehow educating them about drugs. That can't be. It's as though you look
to beer companies to educate you about alcoholism. There is a conflict of
interest there. Drug companies might educate you about drugs as long as
they're talking about the benefits, but are they doing to talk about the
down side? Are they going to say to a bunch of doctors, or patients, "Our
drug isn't really very good; the other company makes a better drug?" No. It
simply doesn't happen. It can't happen. But doctors pretend to believe that
they're in the education business, because they both benefit from this. ...
 
Why doesn't the medical leadership do something about this? Why doesn't the
AMA have their own objective data on drugs? Why are doctors so easy to
corrupt?
Well, I wouldn't say they're any easier [than] anybody else. But they're no
less easy, either. ...
The other thing I want to say is, the academic medical centers are
abdicating their responsibility to teach pharmacology. There is very little
teaching that goes on in medical schools now about drugs, about their down
sides as well as their benefits, about classes of drugs, about
cost-effective prescribing of drugs. To a large extent, the academic medical
centers, the medical schools, have abdicated this and left that to the drug
companies to do. They permit drug company representatives, salespeople,
pretty much unfettered access to medical students, to interns and residents
in hospitals. The salespeople are wandering the halls of almost every major
hospital in this country, handing out freebies to the young doctors, telling
them all about their new drugs, which, the evidence shows, the young doctors
pretty quickly respond to and prescribe. And the medical centers stand back
and let that happen.
 
=Counter arguments. Drug companies argue that a big reason more money is
spent on drugs than in the past is increased utilization.

There's no question that the increasing use of drugs is one reason for the
increase in expenditures. There's no question about that. Pricing is only
part of it. It's also the increased use, and some of these drugs are indeed
great advances that probably do keep people out of the hospital or spare
them surgery. But most of those were the result of NIH-funded research. 

The "me too" drugs, I'm not at all convinced that they are a success story.
There is no question that they are heavily promoted by the drug industry.
The drug industry does not say, "You probably don't need these drugs." The
drug industry says, "Yes, go out and ask your doctor about this drug." So I
find that an odd sort of argument for them to make, that they're really
trying to discourage the use of drugs.
 

=They say R&D is enormously lengthy and expensive because the attrition rate
is incredibly high.

Yes, it is. It is true that only a handful of the drugs that start out in
testing make it through to FDA approval. That's one reason that the drug
companies are turning their efforts to "me too" drugs, where you just have
to twiddle a molecule a little bit to make essentially the same drug, or
make the same drug for a slightly different use. ... 
 
=Isn't it unfair to single out the pharmaceutical companies? Surely there's
a lot of waste and inefficiency in the rest of medicine.

There certainly is. The pharmaceutical industry isn't the only place where
there's waste and inefficiency and profiteering. That happens in much of the
rest of the health care industry. I think that drugs are perhaps on the
front burner when we think about the exorbitant costs of our health care
system, because it's here that the costs are rising faster than ever. It's
here that there's so much distortion about what's actually going on. It's
here that people are feeling it more, because Medicare recipients don't have
any benefits for outpatient drug costs.
 
=Companies argue it's important to keep this a largely private market to
protect innovation, and that's why drug companies in other countries are
less innovative. Over half of all drugs are produced here.

This is like Holy Roman Empire: It's not holy, it's not Roman, it's not an
empire. This question has many of the same problems. Almost every element of
what you just said is wrong. Let's look at the big drug companies first. Of
the 10 top drug companies, five are European and five are American. Their
innovation is much the same. Their turnout of new drugs is much the same.
Their marketing budgets are much the same. Their profits are much the same.
This, in fact, is a global industry. 

All of them have the lion's share of their sales here, because prices are so
much higher in the United States than they are in Europe and Canada. So it's
sort of good public relations to portray themselves as quintessentially
American businesses. They're not. Even in countries where there are price
controls, these companies are doing extremely well. So that's the first
thing that's wrong with your question.

The second is the implication that these are innovative businesses. They are
not innovative businesses. They are giant marketing and PR machines that
turn out predominantly "me too" drugs, and whose truly innovative drugs are
based mainly on taxpayer-funded work. So they are not innovative. ... 

What is going on here, when the pharmaceutical industry insists that they
should be essentially left alone, is a threat. It's a threat to the American
public. They are saying, "Don't mess with us. Do nothing about our obscene
profits. Do nothing about these unsustainable increases in prices, or else
we will not give you your miracle cures." Well, guess what? They're not
getting them the miracle cures in the first place. But that is their very
successful PR pitch. "We are the source of all miracles. Don't mess with
us." ...

One thing that is insufficiently appreciated, because it's disguised by the
drug industry's public relations, is the degree to which they are dependent
on the government. They like to portray themselves as a sort of model of
American free enterprise and ingenuity. Nothing could be further from the
truth. They are an exemplar of free enterprise, only in the sense that they
are free to charge whatever the market will bear in this country, and that
they are free to decide what drugs they want to turn out. They would rather
turn out another baldness drug than a drug that affects the Third World, or
even a vaccine for Americans. So they are free, in that sense. They are free
to charge what they want. They're free to decide what they're going to turn
out. 

But they are not an exemplar of free enterprise, when you look at the fact
that they are utterly dependent on congressional favors and
government-granted monopolies in the form of patents and FDA exclusive
marketing rights. Patents are usually given for 20 years from the time you
file that patent. During that time, it's illegal for any other company to
sell the same drug. The FDA also has another form of exclusive marketing
rights, and may approve a new use. They will give the drug a certain length
of time that it can be sold without fear of any competition. 

It used to be, about 20 years ago, that the time that a drug company had a
monopoly was limited to the time of the patent minus the time it took for
clinical testing, because that's usually done after the patent is issued and
the time it took for the FDA to approve the drug. So in practice, the time
that a company had to market a brand name drug free of any competition
amounted to about eight years. Seventeen years in those days was the length
of the patent, minus the time it took for clinical trials and FDA approval.
That time is now about doubled. The patent life is now about 20 years. The
time for clinical testing and for FDA approval is shorter. There are a
number of maneuvers, thanks to an industry-friendly Congress, that allow
them to stretch the patent life longer. 

So now drug companies probably have on the order of 13-14 years to sell
their brand-name drugs without fear of competition. After the exclusive
marketing rights expire, then what's called generic drugs can enter the
market. These are simply copies made by other companies. They have to be
identical in terms of their effectiveness. The FDA does see they're
identical. But they don't have to go through all the research costs. So
after the patent has expired or the other exclusive marketing rights have
expired, then generics can get into the market. As soon as generics get into
the market, the prices drop steeply, on average to about 20 percent,
one-fifth of what they were before. 

So you can see that for a drug company that has a blockbuster -- that is, a
drug that makes a billion a year -- everything depends on extending their
right to market that exclusively, without generic competition. ... There are
many, many ways to do that now. This is where, in my opinion, the industry's
true innovative genius, lies -- in the multiple ways in which their legions
of lawyers can extend the period of exclusive marketing and keep generics
off the market.
 
=If they've been successful with the federal government, they now face the
states. If a state brought in price control -- this is now in the Supreme
Court -- would the sky fall for drug innovation?

No, because they don't do much now. Drug innovation would come from the same
place it comes from now. You know, this is a drug company choice, to
concentrate on "me too" drugs and to rely on getting its innovative drugs
from the academic medical centers. This is the choice that they make.
 
=Might you be less willing to look at a more risky prospect if you had
smaller profits, if we had Canadian-style prices?

I would hope, if there's some price control, and that price control includes
some limitation on the use of "me too" drugs -- that is, a formulary -- that
this would redirect the R&D efforts of the drug companies toward trying to
discover and develop important new drugs, and not "me too" drugs. I think
that that could be one result. It's not going to hurt the drug companies in
terms of their profitability. Because the profits are so large, there's a
lot of room there. If they stopped with the "me too" drugs, their marketing
costs could be much less, and that's an even bigger source of savings. 

The problem -- and this is an interesting thing -- the problem is not how
profitable is the industry, in a sense. It's how much are the profits are
increasing, because that's what investors want. The investment market is an
odd thing. It doesn't look at what the profits are making. It looks at, "Are
they more than they were yesterday? Can I sell my stock for more than I just
bought it for?" So in a sense, investors say to the drug companies, "What
have you done for me today? Never mind that you pulled in last year 18.5
percent of your sales in net profits. Never mind that. What's it going to be
this year?" 

Of course, no industry can keep climbing like that. They can't, and they
haven't, in the last couple of years. They can't keep going up in these
astonishing, stunning profits. It can't be done. But it shows how responding
to their investors can, in a sense, put them between a rock and a hard
place, and distort what they call innovation, so that it's the very
opposite. It's less risky to make an empty "me too" drug than it is an
innovative drug.
 
=The states, [such as] Oregon, are talking about a functional marketplace.
When we buy cars, we can go to Consumer Reports. Why can't we rely on drug
companies for objective information? Why is it left to state and federal
governments to fill in this gap?

You have a lot of stuff mixed up in that question. You have the research,
and you have the states versus the federals. I'm going to have to break
these down.

The state governments, as you say, are faced with a swelling Medicaid
budget, and they have to balance their budget. Much of the swelling Medicaid
cost represents the increase in drug expenditures. So they're well nigh
desperate to get some handle on drug costs, and they're going at it in two
different ways. 

One, they're looking at the pricing. They're essentially pulling together
the Medicaid patients and the uninsured, and in some cases, I believe, the
Medicare population, who have no supplementary drug insurance, because
ultimately the states are going to have to pay for this. So they're pulling
them together in one population, and making the argument that they should be
able to bargain with the drug companies for volume discounts, in much the
same way that the Veterans' Affairs system does, or that the large HMOs do.
They bargain for discounts. So the states are saying, "We ought to be able
to do that, too." So that's one thing. They're looking at prices.

But they're also looking at "me too" drugs. They're saying, "Why should we
pay for newly patented, brand name, 'me too' drugs, when there's no evidence
that they're any better than generic drugs or older brand name drugs that
are going to go off patent soon? Why should we do that?" So they're looking
at what's called formularies, lists of drugs for various conditions, that
are the most cost-effective drugs. They're saying, "We'll pay for these
drugs. But we won't pay for the more expensive drugs, brand-name drugs, for
which there's no evidence of increased effectiveness." They are the two ways
in which the states are moving. ...

But in terms of the formularies to limit drugs to those that have been found
safe and effective compared to things already on the market, it seems to me
that the fundamental place to do that is in the FDA. The FDA should change
its policy -- and this would probably take some enabling legislation from
Congress. Instead of allowing drugs to be approved on the basis that they
are better than sugar pills, they should be required to make the companies
show how they compare with drugs already on the market. And until that
happens, I don't think we'll truly get a handle on "me too" drugs.
 
=So even before they're released there should be a higher standard of
efficacy?

Absolutely. There's no standard now. It just has to be better than nothing.
It has to be shown to be safer or more effective or substantially more
convenient, or in some way an improvement over similar drugs already on the
market, or generic drugs already on the market.
 
=Who's going to do this job? Why isn't the medical leadership more involved
in this? Why should it be left to state legislatures? 

The problem is this: In the academic medical centers, the medical schools,
the teaching hospitals, almost all of the NIH-funded research is basic
research, the fundamental mechanisms of disease, early stage research. The
research that looks at drugs, that evaluates drugs, clinical trials in human
subjects, is funded mostly by the pharmaceutical industry, and they attach
strings to that funding. 

One string -- it isn't explicitly stated as such, but it is in fact a string
-- is "Don't look at our new drug compared with other older drugs in the
same family. Look at it either compared with placebos, or sugar pills, or
look at it compared with a drug for maybe the same condition but of a
different class, a completely different class. Or we're not going to give
you the money for these studies." 

That in fact is what happens. You see study after study that is really set
up, designed by the company, to show what they want to find. The studies
that do compare drugs head to head, a new drug with older drugs of the same
class, are often funded by the NIH. The NIH does fund some clinical trials.
 
It's essential that it comes from an independently funded source, to be
credible?

Well, it doesn't have to be from an independently funded source. It has to
be designed; the data have to be collected; it has to be interpreted; the
publication has to be independent. The funding can come from the company. I
think it should. It always did -- but without the strings attached. 

Now the companies design the studies in such a way that it's tilted toward
their new product. They often keep the data, assert ownership of the data.
They often write the papers. Maybe the author then signs off on the paper.
They interpret the data. They analyze the data. So there are a lot of
strings attached now, such that the drug company is intimately involved with
the evaluation of its own products. There's an astonishing conflict of
interest there, but it goes on. The medical centers, they want the funding,
and so they sit still for this.
 
=If we did have effective head-to-head studies for drugs, could we save a
lot of money?

We could save an awful lot of money. The FDA itself indicates that 56 of the
66 newly approved drugs last year were "me too" drugs. If each of these
drugs had to be compared with the best of its class already on the market, I
would imagine that most of them would never reach the market. Nor would you
see this constant marketing of drugs that are just like other drugs. ...
 
=Do we as consumers have to play a role in evaluating treatments? We've so
far been protected, with insurance, from the costs of procedures.

Well, I have mixed feelings about that. I'm very wary of any kind of scheme
in the health care system that requires individuals to feel the pain of
paying for the illness as well as the pain of enduring the illness. That
seems to be a double burden. It seems to me that any decent society takes
care of sick people, and that we should do the same thing. So I would hate
to see consumers be forced to calculate, particularly sick and poor people,
whether they can afford a drug they need. The issue is: Do they need it? 

I think there, if you had formularies -- and these were done independently,
and drugs were not added to that formulary unless there was clear scientific
evidence that they were better than something already on the formulary -- if
that were done, then I would not object to consumers having to pay extra for
those drugs that didn't make it to the formulary. I think that would be
fine. But they shouldn't have to pay for anything on the formulary.
 
=Why shouldn't the drug companies be able to charge whatever the market will
bear? Every other industry does. Why a different standard?

Well, there are a couple of reasons. One, drugs can be vital to people's
health and even to their lives. If people are forced to forego those drugs,
or, as many Medicare recipients do, play those drugs out by taking them in
half doses, or sharing them with their spouse, or taking the drugs instead
of paying for food or heat, then that is simply not right -- for people to
be denied a vital thing so that drug companies can make higher profits.

Second, other companies are not living off of government-granted monopolies.
General Motors does not have a government-granted monopoly on its cars.
Toothpaste, there's not a government-granted monopoly. So the pharmaceutical
industry enjoys great public support, not only in terms of patents and
exclusive marketing rights, but also in terms of huge tax breaks -- this
industry pays less than other industries in taxes -- and also in the R&D
subsidization through NIH-funded research. So, in two ways, it's not like
other industries.

june 19, 2003

http://www.pbs.org/wgbh/pages/frontline/shows/other/interviews/angell.html

[Non-text portions of this message have been removed]



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