Mr. Chairman, I do not think anyone should be censored, but I think having no information can sometimes be better than having bad information. And what the Council of Economic Advisers did was they took lock, stock, and barrel failed…
Mr. Chairman, I do not think anyone should be censored, but I think having no information can sometimes be better than having bad information. And what the Council of Economic Advisers did was they took lock, stock, and barrel failed research. Then it gets repeated and repeated and repeated, this $800 million figure.
According to the pharmaceutical company themselves, that $800 million figure includes $400 million of opportunity costs. That means they could have taken that money and bought Microsoft shares and made more money. That is ridiculous.
Mr. Chairman, just read this report that I will include for the Record by Dr. Donald Light. He is from New Jersey. He teaches at a little school called Princeton. He also teaches at the Princeton medical school. He is the one who went through this. More importantly, in this 2-page report there are almost a page of footnotes. They document what they do.
The problem with the Council of Economic Advisers is they just took this number and they repeated it. They do not document it. They do not ask questions, and so now everyone is running around saying it cost $800 million to develop a new drug. That is not true, and it is worse than having no information at all.
This is one way to send a message to the Council of Economic Advisers, that if they are going to put out information so policymakers at the White House or here on Capitol Hill make decisions based on that information, you better make sure you check the numbers and document them first because bad information is worse than no information at all.
[From the American Journal of Bioethics, Jan. 2004]
Will Lower Drug Prices Jeopardize Drug Research? A Policy Fact Sheet
(By Donald Light and Joel Lexchin)
This documented fact sheet provides evidence that all drug
research by large firms, net of taxpayers' subsidies, is paid
for out of domestic sales in each country, with profits to
spare. Prices can be lower without jeopardizing basic
research for new drugs. More exposure to global price
competition would encourage more innovative research and less
of the derivative me-too research that now dominates.
In the U.S., the FDA Commissioner, Mark McClellan, and the
drug industry are responding to pressures for lower costs by
mounting a large campaign to pressure all other affluent
countries to raise their prices to U.S. levels. They claim
that lower prices do not pay for drug research costs, but we
provide evidence that this is untrue. Ultimately, however,
such nationalistic arguments are based on regarding basic
research and new discoveries, which can happen anywhere, and
the cost of trials, which are carried out in the countries
deemed most commercially advantageous, as part of national
companies and national accounts, when in fact they are part
of a global economy for pharmaceutical products.
fda myths
1. FDA Commissioner, Mark McClellan, holds that other
affluent countries like Canada and the UK set their prices
for patented drugs so low that they do not pay for research
and development (R&D) (McClellan 2003). We can find no
evidence to support that claim.
On the contrary, audited financial reports of major drug
firms in the UK, show that all research costs are paid, with
substantial profits left over, based solely on domestic sales
at British prices (Pharmaceutical Price Regulation Scheme
2002). Likewise, 79 research drug companies in Canada
submitted reports showing their R&D expenditures have risen
more than 50% since 1995, all paid for by domestic sales at
Canadian prices (Patented Medicine Prices Review Board 2002).
Sales to the U.S. and elsewhere are in addition to the
positive, domestic balance sheets.
2. FDA Commissioner McClellan says that European or
Canadian prices are ``slowing the process of drug development
worldwide'' (McClellan 2003). There is no known verifiable
evidence to support this claim. In fact, drug research has
been increasing steadily in Europe as well as in the U.S.,
with some countries having a more rapid increase than the
U.S. (Patented Medicine Prices Review Board 2002).
3. FDA Commissioner McClellan says that ``price controls
discourage the R&D needed
to develop new products'' (McClellan 2003). But there is no
known verifiable evidence to support this claim.
R&D expenditures have been growing rapidly, though it is
becoming more and more difficult to discover breakthrough
drugs on targets not already hit (Harris 2003). The truth
kept from Americans is that first-line treatment for 96% of
all medical problems requires only 320 drugs (Laing et al.
2003). In wealthy countries, more drugs might be appropriate
to treat people who do not respond to first-line agents.
4. FDA Commissioner McClellan charges that efforts to
negotiate lower prices for patented drugs by other countries
(and by major employers, unions and governors in the U.S.)
are ``no different than violating the patent directly'' to
make cheap copies (McClellan 2003). This charge echoes the
drug industry and implies that large buyers seeking better
value should be considered a criminal act.
5. FDA Commissioner McClellan paints a picture of other
wealthy countries driving down their prices to marginal
costs, but the widening gap between prices for patented drugs
in the U.S. and other countries is due to drug companies
raising U.S. prices, not other countries lowering theirs
(Sager and Socolar 2003; Families USA 2003).
6. The ``free-rider'' problem that McClellan emphasizes can
be solved by U.S. prices coming down to European levels,
where they will cover all R&D costs, plus profits that are
higher than those in most industries.
7. Drug company profits, after all R&D costs, have long
been more than double the profits of Fortune 500
corporations. In recent years they have jumped to triple and
even quadruple the profits of other major companies (National
Institute for Health Care Management 2000). The global firms
spend two and a half to three times more for marketing and
administration than for research (Families USA 2001).
8. Americans pay for more R&D than any other country
because the United States accounts for more sales than any
other country. But while the U.S. accounts for 51% of world
sales, it took 58% of global R&D expenditures invested in the
US to discover only 43% of the more important new drugs
(NCEs) (European Federation of Pharmaceutical Industries and
Associations 2003). This means that other countries are
helping to pay for the large, inefficient U.S. R&D
enterprise, the opposite of what the editors of Business Week
claimed (Business Week editors 2003). William Safire's claim
of a ``foreign rip-off'' as Americans pay for the world's R&D
is contradicted by the facts above (Safire 2003).
research is misdirected by the industry, against patients' interests
9. Most drug innovation provides little or no therapeutic
advantage over existing * * *
Independent review panels plus a major industry review
conclude that only 10-15% of ``new'' drugs provide a
significant therapeutic breakthrough over existing drugs and
involve a new chemical or molecule (Barral 1996; Prescrire
International 2003; National Institute for Health Care
Management Research and Education Foundation 2002). Other
industry-sponsored figures are much higher but not reliable.
10. The FDA approves drugs that are better than nothing
(placebo) but does not test them against the best existing
drugs for the same problem. Most research is for ``new''
drugs to treat problems already treated by other drugs.
11. About 18% ofthe drug industry's research budget goes to
basic research for breakthrough drugs. About 82% goes to
derivative innovations on existing drugs and to testing.
The long-standing survey of basic research by the National
Science Foundation estimates that basic research has
increased to 18% of the total research and development (R&D)
budget for the pharmaceutical industry. It used to be less
(National Science Foundation 2003). Industry-sponsored
figures based on secret unverifiable data are much higher but
not reliable (DiMasi, Hansen, and Grabowski 2003). The 85-90%
of ``new'' drugs that have little therapeutic gain reflects
equal protection from competition for much less investment
and risk.
12. Congress has repeatedly extended patent protection for
drugs beyond what other industries enjoy, despite much higher
profits year in and year out. Government protection from
normal competition is now more than 50% greater for the drug
industry than a decade ago (National Institute for Health
Care Management 2000). These incentives reward research into
derivative large markets, rather than to finding effective
treatments for diseases that have none.
13. These facts constitute the Blockbuster Syndrome: the
lure of monopoly pricing and windfall profits for years spurs
the relentless pursuit for drugs that might sell more than $1
billion a year, regardless of therapeutic need or benefit.
Research projects for the disorders of affluent nations
proliferate, as do clinical trials. Doctors are paid like
bounty hunters to recruit patients for thousands of dollars
each. Most patients get the misimpression that the
experimental drug will be better than existing ones (Wolpe
2003). The corruption of professional judgment, ethics and
even medical science follow (Williams 2003; Wazana 2000;
Barnett 2003; Lexchin, Bero, Djulbegovic et al. 2003;
Bekelman, Mphil, and Gross 2003; Villanueva, Peiro,
Librero et al. 2003; Fletcher 2003).
Drug research costs much less than claimed
14. Drug companies claim to spend 17% of domestic sales on
R&D, but more objective data reports they spend only 10%
(National Science Foundation 2003). Thus, only 1.8% of sales
goes to research for breakthrough new drugs (18% x 10%) (Love
2003).
15. Taxpayers pay for most research costs, and many
clinical trials as well.
In 2000, for example, industry spent 18% of its $13 billion
for R&D on basic research, or $2.3 billion in gross costs
(National Science Foundation 2003). All of that money was
subsidized by taxpayers through deductions and tax credits.
Taxpayers also paid for all $18 billion in NIH funds, as well
as for R&D funds in the Department of Defense and other
public budgets. Most of that money went for basic research to
discover breakthrough drugs, and public money also supports
more than 5000 clinical trials (Bassand, Martin, Ryden et al.
2002). Taxpayer contributions are similar in more recent
years, only larger.
16. The average amount of research funds the drug industry
needs to recover appears to be much less than the industry's
figure of $800 million per new drug approved (NDA).
The $800 million figure is based on the small
unrepresentative subsample of all new drugs. It excludes the
majority of ``new'' drugs that are extensions or new
administrations of existing drugs, as well as all drugs
developed by NIH, universities, foundations, foreign teams,
or others that have been licensed in or bought. Variations on
existing drugs probably cost much less because so much of the
work has already been done and trials are simpler.
About half of the $800 million figure consists of
``opportunity costs'', the money that would have been made if
the R&D funds had been invested in equities, in effect a
presumed profit built in and compounded every year and then
called a ``cost.'' Drug companies then expect to make a
profit on this compounded profit, as well as on their actual
costs. Minus the built-in profits, R&D costs would average
about $108 million 93% of the time and $400 million 7% of the
time.
The $800 million estimate also does not include taxpayers'
subsidies via deductions and credits and untaxed profits
(DiMasi, Hansen, and Grabowski 2003; DiMasi, Hansen,
Grabowski et al. 1991). Net R&D costs are then still lower.
Contrary to some press reports from the industry, screening
for new compounds is becoming faster and more efficient and
the time from initial testing to approval has shortened
substantially (Kaitin and Healy 2000). The large size of
trials seems more due to signing up specialists to lock in
substantial market share. Advertising firms are now running
clinical trials (Bassand, Martin, Ryden et al. 2002; Peterson
2002; Moyers 2002).
17. Because clinical trials have become a high-profit sub-
industry, trial ``costs'' appear to be much more than is
necessary.
An international team of experts estimates that clinical
trials could be done for about $500 per patient rather than
$10,000 per patient, a 95% reduction (Bassand, Martin, Ryden
et al. 2002). The most detailed empirical study of trial
costs also concludes that costs can be much less than
reported (The Global Alliance for TB Drug Development 2001).
U.S. drug prices very high
18. Americans seem unaware how much more they are paying
for drugs than other countries, in the name of the ``free
market'' where prices are controlled by corporations. So-
called ``price controls'' abroad are negotiated wholesale
prices. Corporate price controls in the U.S. are un-
negotiated monopoly prices, which then large buyers negotiate
down.
According to a detailed analysis, American employers and
health plans pay at wholesale 2.5-3.5 times the prices in
Australia and other countries with comparable prices for
patented drugs (Productivity Commission of Australia 2001).
There is no evidence that these prices do not cover research
costs. U.S. generic prices shadow patent drug prices and are
also 2.5-3.5 times more.
19. High American prices are essentially monopoly rents
charged to employers in every other industry. They shift
profits from other industries to the drug industry.
20. If American prices were cut in half, research budgets
would not have to suffer unless executives decided to cut
them in favor of marketing, luxurious managerial allowances
or high profits. They probably would not, because R&D gets
such favorable tax treatment compared to other expenses.
Lower prices would save other Fortune 500 companies billions
in drug benefit costs, and drug company profits could come
into line with the profits of the companies who pay for their
drugs.
Realign incentives to reward true innovation
21. Current incentives strongly reward derivative
innovation. We get what we reward.
22. Because the U.S. is by far the biggest spender, it has
by far the most R&D and new drugs. Four other industrialized
countries, however, devote more of their GDP to R&D for new
drugs than the U.S. (Patented Medicine Prices Review Board
2002).
23. Officials of drug companies commonly claim that nearly
all new drugs are discovered in the U.S. However, the
industry's own studies (and others) show that over the past
quarter century, the U.S. has accounted for less than or
about the same as its proportionate share of international
new drugs, not more and certainly not nearly all (Barral
1996; European Federation of Pharmaceutical Industries and
Associations 2000). Until 2002, even the U.S. pharmaceutical
industry was investing an increasing percent of its R&D
budget in highly productive research teams abroad
(Pharmaceutical Research and Manufacturers of America 2002).
24. Americans are getting less innovation and paying a lot
more. Competing countries profit from these American self-
delusions by covering their R&D and keeping their own drug
prices reasonable, while leaving drug companies to make
bonanza profits from the monopoly American market.
25. Price competition has been the greatest spur to
innovation for over 200 years. Price protections reward
derivative and me-too innovation as well as excessive costs
and a focus on blockbuster marketing. If we want lower prices
and more breakthrough innovations, we need to change the
incentives to reward those goals (Baker and Chatani 2002).
Mr. Chairman, will the gentleman yield?
Mr. Chairman, I just want to come back to one point because I think a lot of people may not have been paying attention. This study that we are talking about where we got the $800 million figure originally started with a study that was funded by pharmaceutical companies. That number then gets repeated by the President's Council of Economic Advisers, and we all believe that it is true. We have an independent research that was not financed by PhRMA. That was done by a professor who was at Princeton from New Jersey. More importantly, he was an adviser to this President on health policy. Let me add one other thing: He is a Republican.
Now, this is, I think, far more credible than that number that keeps getting bantered around and bantered around. Bad numbers are worse than no numbers at all. This is the one way to say to the Council of Economic Advisers to the President of the United States they ought to be ashamed.
Whether or not this amendment passes, the point, I think, is made: that if they are going to put information out to the President, out to the public, out to policymakers about important issues like this, they had better make sure that the facts are correct.