DESPITE ALL ITS EXCESSES, THIS IS AN important industry that should be saved—mainly from itself. The public is dependent on it, and it should be made
to carry out its original purpose of developing important drugs and selling them at reasonable prices. I have shown how the
industry, corrupted by easy profits and greed, has deceived and exploited the American people. But that is not to say that
everyone who works for big pharma is corrupt or deceitful. In fact, it is my impression that most pharmaceutical employees,
even at the highest levels, accept their own public relations. They honestly believe they are part of an
innovative industry whose prices are an accurate reflection of the value of its products and the costs of making them. That
is a testament to the effects of compartmentalization in big corporations; very few people know the full dimensions of
the business. And it is also a testament to human nature. People want to be proud of their work.
But readers will know by now that the pharmaceutical
industry, despite its many dedicated employees, has moved a very long way from its original mission. In this chapter
I will propose specific reforms that would restore the industry to its purpose and make prescription drugs not only more affordable
but better and safer. My intention is to show what needs to change to make the industry function as it claims to—as
a source of innovative and affordable drugs to help people lead longer, better lives.
In doing so, I will be painting something of an ideal,
in that I will propose reforms even though I know the obstacles to achieving some of them are formidable. In fact, those barriers
would vary greatly. Some reforms, like requiring new drugs to be compared with old ones, could be accomplished virtually overnight
if the political will were there. Others, like changing patent law or achieving uniform pricing have all sorts of global ramifications
and would face almost insurmountable obstacles. But there is value in trying to define the ideal system, so that we can move
toward it in the best way possible—unevenly and incompletely, if necessary—but at least with an understanding
of where we want to go.
My proposals address seven broad problems that have
been discussed in this book. They are listed here with references to the chapters in which they were discussed, in case you
want to refresh your memory. I will not address all the problems discussed in the book or all the reforms one might wish
for, only those I consider most important.
1. Drug
companies produce too many me-too drugs and too few innovative ones. (See Chapters 4 and 5.)
2. The
Food and Drug Administration (FDA) is too much in the thrall of the industry it regulates. (Chapter 11)
3. Drug
companies have too much control over clinical research on their own products. (Chapters 6 and 9)
4. Patents
and other exclusive marketing rights are undesirably long and too elastic. (Chapter 10)
5. Drug
companies have too much influence over medical education about their own products. (Chapter 8)
6. Important
information about research and development, marketing, and pricing is kept secret. (Chapters 1,3, and 7)
7. Prices
are too high and too variable. (Chapters 1 and 12)
I will discuss the key reforms needed to deal with each
of these problems, but it should be understood that the reforms would often have multiple, overlapping effects. For example,
anything that shortens exclusive marketing rights will also affect profits and the ability of the industry to influence government
and the FDA. But the end result is that nearly all of the changes I propose would lead to better drugs at lower prices, and
would loosen the iron lock of big pharma on public policy and the medical profession.
Shift the Emphasis from Me-Too to
Innovative Drugs
A number of steps could be taken to stanch the
flow of me-too drugs. By default, that would force drug companies to put more of their efforts into developing truly innovative
drugs. To start with, U.S. patent law should be enforced in its original form. Courts have progressively weakened the requirement that new discoveries or inventions
be useful, novel, and non-obvious. There is no possible justification, for instance, for a new patent on Prozac to treat premenstrual
tension. Examiners in the U.S. Patent and Trademark Office should not receive bonuses based on how many patent applications
they handle. Since it is easier to grant a patent than to deny it, the current payment practice encourages quick approval,
whatever the merits. Patent reviewers should be salaried for their time, with appropriate managerial supervision to prevent
unreasonable delays.
Food and Drug Administration regulations should
require that new drugs be compared not just with placebos but with old drugs for the same conditions. Approval should depend on whether the new drug adds something useful in terms of
greater effectiveness, greater safety, fewer side effects, or substantially greater convenience. The FDA should be allowed
reasonable flexibility in its judgments, but it should not approve drugs that
on balance offer trivial or no advantages over drugs
already available, and may even be worse. Overnight, that reform alone would force the industry to concentrate on innovative
drugs instead of me-too drugs. If I could choose only one of the reforms I am suggesting, it would be this one. This
change would have multiple beneficial ripple effects. And this is one that could be accomplished easily by congressional legislation.
There is an ethical issue here, too. It is wrong to
compare a new drug with a placebo if there is an effective drug already on the market, because doing so means some human subjects
are denied treatment during the trial. For that reason, drug trials for serious diseases, like cancer or HIV/AIDS, almost
never have placebo groups. Instead, the new drug is compared with whatever is currently being used. But most new drugs
are not for serious diseases. They are for minor conditions, or for conditions that may be precursors to serious
diseases, like high blood pressure or high cholesterol levels. Here placebo-controlled trials are the order of the day.
I have heard one high-ranking FDA official justify them by implying that he didn't really believe the old drugs were
effective anyway. If we don't know whether Prozac works, he seemed to be saying, why test Zoloft against it? But that is an
argument for higher standards of proof, not for placebo-controlled clinical trials. If there is really doubt about whether
a standard treatment is effective, the FDA should require that clinical trials of new treatments have three comparison
groups—new drug, old drug, and placebo.
Let's look a little more at the benefits of requiring
new drugs to be compared with old ones. First, few me-too drugs would be approved, since it is highly unlikely that each new
one is better than the last at comparable doses. Second, as mentioned, drug companies would be forced to concentrate on innovative
drugs. Third, they could trim their vast marketing budgets, since most of those expenditures are to convince doctors and the
public that one me-too drug is better than another in the absence of evidence. If evidence were required, there would
be far less need for marketing, and we wouldn't have to pay the steep markup in prices it adds. Fourth, there would be far
fewer clinical trials. A great many clinical trials are now designed to get FDA approval for me-too drugs, to find new uses
for them, or (in the case of most Phase IV studies) to jockey for position in a crowded me-too market. In other words, these
trials are really marketing tools. If drugs were approved only when they were clearly superior in some way to drugs already
on the market, the number of clinical trials would plummet, but each one would be far more important. They would serve the
purpose that they are intended to serve and that human subjects are led to believe they serve— to answer a medically
important question: Does this drug add something of value to our ability to treat this condition? Not, "Can I create a big
market for this drug?"
Strengthen the Food and Drug Administration
The FDA needs to be strengthened as an independent
agency. It is now so dependent on the pharmaceutical
industry that it has become big pharma's handmaiden. Industry apologists and antiregulatory conservatives still beat
up on the FDA publicly (check The Wall Street Journal's editorials on the subject), but that is mainly just an
ideological gesture. In fact, the FDA has become extremely accommodating to the industry, as evidenced by the former commissioner's
speech (discussed in Chapter 11) urging other countries to allow drug prices to rise. I once heard another high official in
the agency say publicly that the job of the FDA's Center for Drug Evaluation and Research is to "facilitate" drug development—something
quite different from regulating it. It would seem that the industry, not the public, has become the FDA's client. What
should be done to restore the FDA's proper role?
First, the Prescription Drug User Fee Act should be
repealed—or allowed to expire in 2007. This act, you will remember, authorizes drug companies to pay "user
fees" to the FDA for every drug reviewed. That practice puts the FDA on the industry's payroll, drug by drug. The more drugs
the agency reviews, the more money it gets from industry. It's analogous to the incentive of the U.S. Patent and Trademark
Office to grant patents. This arrangement creates a powerful conflict of interest for the FDA. Moreover, the very notion that
private companies "use" a public regulatory agency is wrong, since the FDA is there to serve the public, not drug companies.
Second, public support should be increased—not
just to make up for the loss of user fees but over and above that amount. The FDA is vital to public health, and it needs
to be adequately
funded. Giving it the resources to do its job properly would pay for itself many times over. Public funding would also restore
balance within the FDA. The Prescription Drug User Fee Act required the agency to put too much of its resources into speeding
up drug approvals, at the expense of other important functions, like monitoring drug safety, inspecting manufacturing
plants, and ensuring truthful advertising. Furthermore, in the rush to approve drugs, the agency is taking shortcuts that
lower the standards for safety and effectiveness. Shortcuts may be justified in certain cases—as at the beginning of
the HIV/ AIDS epidemic—but they should be rare. There is now far too much emphasis on speed at the FDA.
Third, the FDA's advisory committees should not include
experts with financial ties to industry. The notion that they are somehow indispensable is not credible. No one is indispensable.
The truth is that experts are being co-opted by these deals, just as the FDA is co-opted by user fees.
Create an Institute to Oversee Clinical
Testing of Drugs
Drug companies should no longer be permitted to control
the clinical testing of their own drugs. There is too much evidence that this practice biases the research in favor of
the sponsor's drug. It also distorts the type of research done, since companies are more interested in increasing sales
than in obtaining medical knowledge. We really don't need one more study of whether a new drug is better than a placebo
for some slightly different use, but drug companies sponsor them because they help to expand the market.
To ensure that clinical trials serve a genuine
medical need and to see that they are properly designed, conducted, and reported, I propose that an Institute for Prescription
Drug Trials be established within the National Institutes of Health (NIH) to administer clinical trials of prescription drugs.
Drug companies would be required to contribute
a percentage of revenues to this institute, but their contributions would not be related to particular drugs (as is the
case with the FDA user fees). The institute would then contract with independent researchers in academic medical centers to
conduct drug trials. The researchers would design the trials, analyze the data, write the papers, and decide about publication.
The data would become the joint property of the NIH and the researchers, not be controlled by the sponsoring company.
The FDA now assigns responsibility for the conduct of clinical trials to sponsors. That practice would end. Responsibility
would lie exactly where it should—with independent researchers and their institutions.
Others have also called for a special NIH institute to evaluate prescription drugs, but
they have generally suggested that it would compare drugs that are already on the market (as was done in the ALLHAT study
discussed in Chapter 6). While that would be helpful, it would address only the effects of the underlying problem, not
the cause. There would be nothing to stop the FDA from continuing to approve large numbers of me-too drugs that were compared
with placebos. My proposal is different. It would have the Institute for Prescription Drug Trials oversee clinical trials
before FDA approval, not afterward. Since drugs would have to be compared with older treatments, many fewer drugs of
dubious benefit would come to market in the first place. Important comparisons of drugs already on the market could be
done within existing NIH institutes, as was true of the ALLHAT study.
How the institute would administer the trials would
have to be worked out carefully. It might prioritize trials on the basis of unbiased expert advice, just as the other institutes
at the NIH have expert panels to decide which research to give priority. But the expectation would be that all trials of scientific
merit would be carried out, and there would have to be some mechanism to appeal decisions not to carry out a proposed trial.
This is not a perfect process, and there may be better alternatives, but the point is that an independent, public agency should
administer all clinical trials to ensure that they are properly conducted— both scientifically and ethically. This is
too important a matter to leave to private contract research organizations, whose only clients are the drug companies.
Because of reductions in the number of me-too drug trials,
there would be many fewer trials altogether, and they could easily be conducted entirely in nonprofit academic settings.
There would be no need for a private research industry, which inherently has a conflict of interest. But if academic
centers perform the trials, it would be essential that they and their faculty researchers be free from their own financial
conflicts. To receive funding, academic institutions should not have equity interest in
the pharmaceutical industry, and researchers should
have no financial ties to companies whose drugs they evaluate. Similarly, expert advisers to the Institute for Prescription
Drug Trials should have no conflicts of interest.
These reforms would eliminate most of the abuses I described
in Chapter 6. Unfavorable research results could no longer be suppressed, and papers could not be manipulated to emphasize
favorable findings. All clinical trials would be publicly registered, and their results available to everyone.
Curb Monopoly Marketing Rights
The period of exclusivity for brand-name drugs is too
long and too easily stretched. That is a major reason for the high costs of prescription drugs and the inordinate profits
of big pharma. There is no legitimate reason for generic competition to be delayed so long.
Paradoxically, the first reform I would suggest to curb monopoly marketing rights
allows drug companies more time to complete their clinical trials. / propose that even if patents are granted before clinical
testing starts, the clock on the patents should not begin ticking until the drugs come to market. In other words, a company
could patent a new drug before launching clinical trials to protect it from competition, but only after the drug is approved
by the FDA and comes to market would the patent's time line begin. Then it might have a duration of, say, six years from the
time the drug came to market, instead of twenty years from the time the patent was filed. That way, clinical testing
would not eat into sales time, so companies would not be in such a rush to complete it and the research could be done more
carefully and thoroughly. (Here I'm assuming there is no National Institute for Prescription Drug Trials.) I am aware that
such a change would be difficult to achieve, given the current move to harmonize patent law internationally. But as I said
earlier, I am sketching an ideal system, and this change would certainly be an improvement.
The law granting drug companies an extra six
months of exclusive marketing rights for testing drugs in children should be repealed. That law is virtual bribery, and it doesn't even accomplish its stated purpose.
Drug companies take advantage of the law to test blockbuster drugs in children whether the drugs are meant for this age-group
or not. For an investment of a few million dollars or less, they can increase their revenues by hundreds of millions.
But, they can opt not to test less profitable drugs in children even though they are more likely to be used in this
age-group. The FDA now has the authority to require pediatric testing as a condition of approval. But it rarely
uses it. It should. Imagine the uproar if the FDA let drug companies get away with testing drugs just in men, even though
they would probably be used in women as well.
The loopholes in the Hatch-Waxman Act should
be closed so that exclusivity cannot be stretched out for years. You will remember from Chapter 10 that drug companies may file for many additional patents on an already
patented and approved drug. By suing generic companies for infringement of these secondary patents, they can trigger successive thirty-month
stays on generic competition. This should not be possible. The way to stop it is clear. First, Hatch-Waxman restrictions should
be enforced. Only patents listed in the FDA Orange Book can be the basis for such lawsuits, and these are supposed to
be restricted to patents that pertain to the original drug and its approved use. The FDA completely ignores that restriction
and permits drug companies to list whatever secondary patents they wish—no matter how frivolous or far removed from
the original drug. That should be stopped, as the Federal Trade Commission urged. It should be the FDA's responsibility to
make sure patents are eligible for listing in the Orange Book. Of course, if patent law were strictly enforced, so that patents
were granted only for discoveries or inventions that are truly useful, novel, and non-obvious, there wouldn't be so many secondary
patents.
There is no reason for a thirty-month stay on generic companies entering the market
just because brand-name companies sue them. Even if a brand-name company genuinely believes that a relevant patent would be
violated, it could sue the generic company without an automatic extension of exclusive marketing rights. Generic companies
would be very wary of violating a valid patent, since they would be liable for the brand-name company's loss of sales. Hatch-Waxman
should also be reformed to make it impossible for brand-name companies to make sweetheart deals with generic manufacturers
to delay entry into the market. The first generic company to win approval after a lawsuit is given six months' exclusive marketing
rights. That exclusivity should be contingent on the generic company bringing a drug to market as quickly as possible. The
2003 Medicare prescription drug benefit law contained some provisions for modifying Hatch-Waxman, but how they will work is
still unclear.
Get Big Pharma Out of Medical Education
We need to end the fiction that big pharma provides
medical education. Drug companies are in business to sell drugs. Period. They are exactly the wrong people to evaluate the
products they sell. I am not saying that all of the information drug companies provide to doctors is false. Some of it is
useful and valid. But information from companies comes mixed with hyperbole, bias, and misinformation, and there is often
no way to tell which is which. Good education about prescription drugs, like all education, needs to be as objective
and critical as possible.
Yet drug companies pour money into medical schools and
teaching hospitals, they support most continuing medical education, and they subsidize professional meetings. Wherever
clinicians are educated, big pharma is there to help. There is no question that it influences educational content. The
result is that doctors not only receive biased information but learn a very drug-intensive style of medicine. They come to
believe that there is a drug for everything and that new drugs (of which they have many free samples) are always better than
old ones. Once and
for all, we should clarify a simple
fact: Drug companies are not providers of education, and they cannot be. No laws, regulations, or guidelines should be
based on the idea that they are.
The medical profession needs to take full responsibility
for educating its members. There are a few simple steps to make this happen. First, medical schools should teach students
about drugs, not leave such education to industry-sponsored programs and teaching materials. Many of our best schools
have virtually eliminated the pharmacology courses that used to teach the basic principles of drug actions and uses. Second,
teaching hospitals should regard drug company representatives just as they do other salespeople, who are not allowed to
traipse around at will, promoting their wares and offering gifts and meals to medical students and doctors in training. Third,
the profession needs to take responsibility for continuing medical education. Just as there should be no private clinical
research industry, there should be no private medical education industry hired by the drug companies. This would mean that
continuing medical education would be less well financed, but it can be made much less expensive without any loss of quality.
Finally, professional associations should be self-supporting. If breaking their dependence on drug companies means
increased membership dues, so be it. Meetings would benefit by being more modest, serious, and purposeful. But if
doctors want to go to a resort in Hawaii for a meeting,
let them pay for it.
Many doctors would agree that drug companies should have no input into the content of medical
education but argue that it is acceptable for them to support it at arm's length. I disagree. The industry's immense marketing
expenditures are tacked on to the prices of prescription drugs. Much of that increased sales income goes toward "education"—remember
the missing $35 billion (see Chapter 8)? I believe the public, if asked, would not want to provide such handsome subsidies
to doctors. Of course, if educational grants from industry really had to be completely at arm's length, such grants
would soon largely disappear. These companies are not charities. They expect a return on investment, and they get it—precisely
because what they call education is designed to increase sales. As concern grows about marketing masquerading as education,
some companies may create separate education budgets. But no matter what you call it, the overall purpose is the
same—to sell drugs.
Drug companies sometimes contend that direct-to-consumer
advertising is also educational, but it is even less educational than company-sponsored meetings for doctors in Hawaii. There is no way consumers can evaluate clinical claims in a thirty-second TV advertisement.
The purpose and the effect of these commercials is to increase pressure on doctors to prescribe the latest, most expensive
me-too drugs. Direct-to-consumer advertising should be prohibited in the United States just as it is in other advanced countries. At the very least, it should be regulated more stringently. Big pharma and the
advertising agencies, which have a huge financial stake in the ads, would strongly resist, so any such action would probably
require a congressional mandate. For reasons of public health and safety, however, the FDA is acknowledged to have authority over pharmaceutical advertising,
so there is no question of an unfettered "right to commercial free speech" in this case. The issue is how, and how much, it
should be regulated.
Open the Black Box
Big pharma badly needs some transparency. It gets away
with exploiting the public in part because of its extraordinary secrecy. Drug companies reveal very little about the most
crucial aspects of their business. Yet, unlike other businesses, they are dependent on the public for a host of special favors—including
rights to NIH-funded research, long periods of market monopoly, and multiple tax breaks that almost guarantee a profit.
Because of these special favors and the importance of its products to public health, as well as the fact that government
is a major purchaser of its products, the pharmaceutical industry should be regarded much as a public utility. Its books should
be open.
We ought to know exactly what drug companies spend on R & D and how it is broken down,
not only by function but by individual drugs once they are patented and enter clinical trials. We should know the relative
amounts spent on preclinical, clinical, and market research. Expenditures on clinical trials for each drug should be
separated into their various phases, including Phase IV studies. And we should know how much drug companies spend on
marketing research, and where that money is budgeted.
The enormous black box known as "marketing and administration" also needs to be opened.
Where do those tens of billions of dollars really go? How much for top executive compensation? How much for lawyers?
How much for "educating" doctors and the public? All of these categories should be broken down into their components. These
expenditures produce a huge markup on drugs, and the public is entitled to know the details about them.
Price reform is discussed in the next section, but prices
are also a big part of the industry's secrets. It is extremely difficult to find out what various purchasers actually pay
for their prescription drugs. Drug companies publish their average wholesale prices, supposedly the prices they
recommend wholesalers charge pharmacies. But in practice, the average wholesale price means little. In fact, AWP is sometimes
said to stand for "Ain't What's Paid." Different customers are charged very different prices, and exactly what any given
customer pays is often obscured by discounts and rebates. Those who pay something close to the average wholesale price are
mainly people with no insurance, although prices may still vary from pharmacy to pharmacy. Most prosecutions of drug
companies have had to do with defrauding Medicaid or Medicare by inflating prices, sometimes in conjunction with offering
kickbacks to doctors or pharmacy benefit managers. It is only by virtue of the secrecy, complexity, and great variability
of pricing arrangements that drug companies can get away with bilking their biggest customer—the government—and
exploiting individuals without bargaining power.
Establish Reasonable and Uniform Pricing
Drug prices should be not only transparent
but reasonable and as uniform as possible for all purchasers. The great disparities that now exist, with the most vulnerable people paying the highest prices, are unfair. Prices
need to be regulated in some way to make them generally affordable. Pharmaceutical profits could still be very high, even
with significantly lower prices, especially if marketing expenditures were greatly reduced. Since the biggest single
purchaser of prescription drugs is the government, it could negotiate or regulate prices on behalf of everyone, much
as the governments of other advanced countries do. For people who are too poor to afford needed drugs, there could be subsidies,
but prices should not vary, only the payer. Uniform prices would prevent the current chaos that serves as a cover for fraud,
kickbacks, and price gouging. It would also be desirable if prices were roughly the same in all developed countries, as well
as within the United States, since big pharma is a global industry and great disparities create problems across borders
(as we are now seeing with Canada).
That does not mean other developed countries should
allow prices to climb to match U.S. prices,
which former FDA Commissioner Mark McClellan seemed to recommend, apparently with the backing of the Bush administration. Instead, based on
full knowledge of the industry's profits and expenditures, we should try to converge toward a reasonable price. The industry
and its apologists claim that the higher prices Americans pay are to cover R & D costs, but that ignores the fact that
the big drug companies are profitable all over the world and their total profits actually exceed their total R &
D expenditures. They are not just squeaking by, as industry apologists imply, but in recent years are making three to six
times the profits earned by other Fortune 500 companies. One might just as well argue that Americans should pay higher prices
to cover marketing costs, or to ensure that the top ten U.S. drug companies continue to make their extraordinary profits—more
total profits than all the other Fortune 500 companies put together in 2002.
Unfortunately, with the passage of the Medicare
reform bill in 2003, public policy has moved in exactly the opposite direction from any reasonable brake on pharmaceutical
prices. The prescription drug benefit expressly forbids Medicare to use its purchasing power to bargain for lower prices.
That provision was tantamount to writing a multibillion-dollar check—signed by taxpayers—to big pharma. (Not for
nothing does this industry have the largest lobby in Washington.) Expenditures on drugs will quickly rise to exceed the value of the benefit. Worse, the money diverted to drug companies,
pharmacy benefit management companies, and private insurers will have to be squeezed out of taxpayers, and the most likely
way that will be done is by cutting other Medicare services or raising premiums and charging higher deductibles and co-payments. This bill should
be repealed, and replaced by a simple measure that guarantees all Medicare beneficiaries appropriate coverage of their drug
costs, with government-negotiated payments to industry and a medically based formulary.
The Medicare bill also stipulated that prescription
drugs cannot be imported from Canada without
the approval of the Department of Health and Human Services, something that has so far not been forthcoming, although
there are some signs that that position may be softening. Yet there is no reason to believe that drugs imported from Canada are any less safe than other drugs, and some reason to suppose they are safer than
those bought in the United
States, since the
high-profile counterfeiting cases have occurred here. But importation is best seen as a temporary measure, pending other
reforms that would lead to more uniform pricing across borders. It treats the symptoms, not the disease.
Some Final Thoughts
Prescription drugs are an essential part of modern medical care. Americans need good new
drugs at reasonable prices. Yet the pharmaceutical industry is failing to meet that need. There is a widening gap between
its rhetoric and its practices. Driven by its lust for profits, it seems almost bent on eventual self-destruction. Its current
way of doing business is not sustainable. Both the federal government and the medical profession have been co-opted by big
pharma's wealth and power, but sooner or later that will have to change. The Medicare prescription drug benefit will give
the industry a huge boost, but it cannot last. Those who pay for drugs—government, insurers, and individuals—simply
do not have the money to continue to support the industry in its present form. And the public is angry.
In thinking about reform, it is useful to consider
the industry in terms of its functions. Which does it do well, which badly, and which shouldn't it be performing at all?
The industry supposedly discovers, develops, tests, manufactures, distributes, and promotes drugs. We have seen that
it contributes much less to discovery and early development than it claims but instead feeds off the NIH, and universities
and smaller companies in the United States
and abroad. Maybe we should simply accept that fact. But then it makes no sense to continue to reward big pharma as though
it were the major source of innovation. Clinical testing could continue to be the industry's responsibility, but it should
be conducted at arm's length, preferably through an Institute for Prescription Drug Trials. The industry should play no role
whatsoever in medical education. What remains is what this industry could do very well, if it redirected its efforts—the
development of promising drug candidates, manufacturing, distribution, and a reasonable amount of marketing. This would
bring the industry into line with reality, which is very different from its pretensions.
We need to remember that much of what we think
we know about the pharmaceutical industry is mythology spun by the industry's immense public relations apparatus. In
this book, I have
set out to expose the most important of those myths—the claims that big pharma's prices reflect its R & D costs,
that it is innovative, and that it is a shining example of American free enterprise. As we have seen, this industry actually
spends far more on marketing and administration than on R & D. It is not innovative. And it lives on government favors
and shrinks from competition. If you know that, you should be immune to the kind of threat the pharmaceutical industry specializes
in: "Give us everything we want, or we might have to stop producing miracle drugs."
Finally, in this chapter, I suggested how the industry could be reformed. Those suggestions
were not meant to be comprehensive but to deal with what I believe are the most important problems. As I said at the
outset, nearly all would lead to better drugs at lower prices. Most of the changes could be achieved with simple congressional
legislation. That is where you come in. Your representatives in Congress will not deviate much from the industry script unless
you force them to. We saw a sad demonstration of that fact with the 2003 Medicare reform bill, which was made to order by
and for big pharma. Your representatives will stand up to the industry only if you demand that they do. I have tried to arm
you with the facts. Yes, the pharmaceutical industry has enormous clout, but what finally matters most is concerted
public pressure.
