[lit-ideas] Re: Fw: Re: Autographs (was Re: US exports)
- From: Andy Amago <aamago@xxxxxxxxxxxxx>
- To: lit-ideas@xxxxxxxxxxxxx, lit-ideas@xxxxxxxxxxxxx
- Date: Tue, 11 Jan 2005 11:04:10 -0500 (GMT-05:00)
-----Original Message-----
From: Eternitytime1@xxxxxxx
Sent: Jan 11, 2005 2:02 AM
To: lit-ideas@xxxxxxxxxxxxx
Subject: [lit-ideas] Re: Fw: Re: Autographs (was Re: US exports)
=20
In a message dated 1/9/2005 6:24:28 PM Central Standard Time, =20
aamago@xxxxxxxxxxxxx writes:
I think my point, which will never be understood, God bless big pharma, is=
=20
that if the FDA was doing its job, people would not need to die before a d=
rug=20
is pulled off the market. If the FDA were doing its job, bad drugs would=
=20
never get on the market.
Hi, Andy,
My point was only that there IS a lot of good that the pharmeucetical =20
industry workers are trying to do. =20
A.A. What is some of the good they're doing?
M.B. Not that they didn't need reform. Sometimes it=20
was seeming that you wanted to get rid of all pharmeucetical =20
companies/medicines that they produce as well as the FDA.
A.A. My statements are that they are producing no new products, just putti=
ng new saddles on old horses, and claiming they're producing new products. =
You conclude that I want to get rid of the industry. Can you connect the =
dots for me?
Regarding the FDA, how is the FDA helping the people it was designed to hel=
p?
=20
M.B. I just wanted to point out that there have been some discoveries made=
(my =20
son's stuff is fairly new, btw) and that not *everyone* in the industry is =
bad =20
and evil--and that there are plenty of people trying very hard to do what t=
hey=20
can to make it better or to provide for alternatives to what currently=20
exists as a 'whole'. =20
A.A. Can you be more specific, or point me in a direction where I can get m=
ore than generalizations about not everyone being bad and evil? =20
=20
M.B. Although I have too many books that I am reading right now to go read =
the =20
one you have suggested (and do wish you would have posted relevant parts --=
even=20
if meant you had to type them in -- instead of simply telling me/us to go=
=20
get the book...), I did look up some reviews of it. Here is one which als=
o =20
discussed the book you have been mentioning--and I thought the comments on =
the =20
FDA were (particularly) relevant as it is not so much (it sounds) as though=
=20
the FDA is *doing its job*, as much as it is that it does not have the fre=
edom=20
to do its job. =20
=20
A.A. Marlena, you work in a library, but I am supposed to type in relevant =
parts. The book is not that long, with big print. Were this an important =
subject to you, you would have read it by now. Which amazes me, that drugs=
and medication are not important enough to know anything about. Our belie=
f systems are good enough.
M.B. Thought also that it was intriguing that the reviewer states that "Nor=
is t
here a lot of sentiment in Washington to take on Big Pharma. In the recent =
=20
election the American people made it clear that they do not want or trust t=
he =20
federal government to regulate much of anything." =20
A.A. And they're getting their way. FDA now regulates very little. The in=
dustry is doing the regulating. Good news perhaps to you.
=20
M.B. I do find it intriguing that the distrust of government is so strong t=
hat we=20
do not understand or recognize the need for oversight...
A.A. People don't care about facts. They just want a benevolent dictator=
, or to believe in a benevolent dictator. If only there were such a thing.=
=20
=20
M.B. Anyway, there are a couple of other books discussed here, too!
A.A. I'd like to know how much money the U of Penn Medical School is taking=
from pharma. How many vacations, uh, seminars they get to attend in Hawai=
i. How much they get paid for being "consultants"? What are the chances t=
hey're going to tell?
=20
Better living with (regulated) chemistry,
A.A. The industry is now regulating the chemistry it produces. Do you like=
that? BTW, how do you feel about Vioxx and other drugs causing deaths, th=
en being pulled? What if you were one of those who had the stroke, or some=
one you know died from taking Vioxx? Just a case of shit happens?
Andy Amago
Marlena in Missouri
=20
=20
Indicting Big Pharma=20
_Arthur L. Caplan_=20
(http://www.americanscientist.org/template/AuthorDetail/authorid/1421;jsess=
ionid=3Dbaaad7_CO-2fo-)=20
=20
=20
The Truth about the Drug Companies: How They Deceive Us and What To Do abo=
ut=20
It. Marcia Angell. xx + 305 pp. Random House, 2004. $24.95.=20
On the Take: How Medicine's Complicity with Big Business Can Endanger Your=
=20
Health. Jerome P. Kassirer. xx + 251 pp. Oxford University Press, 2005. $2=
8.=20
Powerful Medicines: The Benefits, Risks, and Costs of Prescription Drugs.=
=20
Jerry Avorn. viii + 448 pp. Alfred A. Knopf, 2004. $27.50.=20
Is the pharmaceutical industry a dangerous and crooked business that federa=
l =20
and state authorities need to bring to heel? Should those who develop, mark=
et=20
or prescribe drugs hang their heads in shame when faced with the stark=20
reality of what they do to earn a living? Is Big Pharma in fact the moral=
=20
equivalent of the tobacco industry? One could well come away from Marcia A=
ngell's The=20
Truth about the Drug Companies or Jerome Kassirer's On the Take thinking =
=20
so. In both books, the sort of moral opprobrium once directed against Big =
=20
Tobacco is aimed squarely at the pharmaceutical industry, along with its le=
gions =20
of lobbyists, the politicians awash in its campaign contributions and the =
=20
doctors it has bought, free meal by free meal, junket by junket, free sampl=
e by =20
free sample and trinket by trinket.=20
Kassirer and Angell, who are physicians at Tufts and Harvard, respectively,=
=20
and who are both former editors of the New England Journal of Medicine, ar=
e=20
not the only authors currently taking a critical look at industry excesses.=
=20
Harvard physician and pharmacoepidemiologist Jerry Avorn also has a new boo=
k =20
examining some of the problems with the way prescription drugs are brought =
to =20
market, the thoughtful and incisive Powerful Medicines.=20
It's not hard to see why demonization of the pharmaceutical industry has =
=20
become such a popular sport. As Avorn points out, drug companies are now so=
=20
obsessed with profits that they are no longer willing to pay for the innova=
tive =20
research that they claim justifies the high cost of their products. He and =
=20
Angell each demonstrate that the numbers do not support the contention that=
=20
without high prices there would be no money for the next generation of mira=
cle =20
drugs. Avorn notes that data from financial reports submitted to the Securi=
ties =20
and Exchange Commission by nine of the largest U.S.-based pharmaceutical =
=20
companies show the hollowness of this rationale for exorbitant prices. He c=
ites =20
a 2002 report by Families, USA, which indicated that these companies spent =
the=20
greatest proportion of their revenues (27 percent) on marketing, advertisi=
ng=20
and administration. Next came profits at 18 percent=E2=80=94a rate of retu=
rn that=20
almost no other industry expects or can match. Money spent on research and=
=20
development ran a distant third, at 11 percent of revenues. No matter how =
hard=20
drug companies spin these numbers, they reveal priorities that serve neith=
er=20
patients nor the general public.=20
Other data in these three books strengthen the moral case against the =20
industry. In the United States, patented, brand-name drugs sell on average =
for 80=20
percent more than in Canada and 100 percent more than in France and Italy. =
=20
Efforts to redress price inequities by allowing the importation of drugs to=
the =20
United States from Canada have met with fierce resistance from Big Pharma,=
=20
which has waged a bizarre and deceitful campaign to impugn the safety of=
=20
Canadian drugs. The campaign would be laughable had it not been so effecti=
ve in=20
keeping Canadian drugs in Canada.=20
The sins do not end with high prices, huge budgets for marketing and =20
advertising, and efforts to restrain free markets. Drug companies, Angell a=
nd =20
Kassirer remind us, have connived to do everything they can think of to cap=
ture the=20
attention, allegiance and gratitude of physicians. And they have been able =
=20
to think of quite a lot.=20
Dip anywhere at random into The Truth about the Drug Companies or On the=
=20
Take and you will find disturbing passages such as this one (from Angell's=
=20
book):=20
Suppose you are a big pharmaceutical company. You make a drug that is=20
approved for a very limited use. . . . How could you turn it into a blockb=
uster? .=20
. .
. . . You could simply market the drug for unapproved ("off-label") uses=
=E2=80=94
despite the fact that doing so is illegal. You do that by carrying out=20
"research" that falls way below the standard required for FDA approval, th=
en=20
"educating" doctors about any favorable results. That way, you could circu=
mvent the=20
law. You could say you were not marketing for unapproved uses; you were me=
rely=20
disseminating the results of research to doctors=E2=80=94who can legally p=
rescribe a=20
drug for any use. But it would be bogus education about bogus research. It=
=20
would really be marketing.=20
Angell goes on to show that this is exactly what many pharmaceutical =20
companies have done. In the name of "research," they have subtly encouraged=
doctors=20
to use drugs for unapproved purposes, or for groups of patients (children,=
=20
for example) in whom the agent's effectiveness has never been studied. The=
=20
industry has also encouraged "innovative" prescription practices on the pa=
rt of=20
doctors who are not equipped to safely monitor and to learn from what they=
are=20
doing. Outrage about this sort of conduct infuses every page of her powerf=
ul=20
book.=20
Kassirer, like Angell, is no slouch at condemning ethical shenanigans:=20
Big business and physicians alike are involved in a massive charade.=20
Representatives of the drug companies claim repeatedly that marketing serv=
es an=20
essential function in the health-care delivery system by helping to educat=
e=20
doctors so they can prescribe drugs more appropriately. At the same time, =
they=20
press their drug salesmen to push the newest (and usually the most expensi=
ve)=20
products, and their surrogate intermediaries, the medical education compan=
ies,=20
are advertising their services as "persuasive" education.=20
Kassirer does not write with the same overt anger as Angell, but his quiet =
=20
fury is palpable as he watches his beloved medical profession being corrupt=
ed=20
by businesses willing to do whatever it takes to get their drugs prescribe=
d.=20
It turns out to be relatively easy to make the case against bloated profits=
, =20
the herd mentality of companies looking for blockbusters, dishonesty in =20
marketing and crass schemes to pay off doctors, politicians and the media. =
No one=20
can read these books and not believe that something needs to be done to =20
reform the way drugs are discovered, patented, sold and used in the United =
States=20
and around the world. But these books are far less satisfying when it come=
s=20
to providing solutions.=20
Despite all the corruption documented by Angell, Kassirer and Avorn, the =
=20
pharmaceutical industry is not the tobacco industry. Its products may somet=
imes =20
be sold at bloated prices and marketed using techniques more commonly=20
associated with used car dealers and Internet mortgage brokers. And some o=
f those=20
products may even turn out to be dangerous or ineffective. But Big Pharma,=
=20
unlike Big Tobacco, is not selling inherently evil products. Many American=
s have=20
benefited from pharmaceuticals, and more do so every year, which is as muc=
h a=20
cause of higher total expenditures for the nation as are increases in the=
=20
prices of individual drugs. So medicine has no real choice but to deal wit=
h Big=20
Pharma; nobody wants it just to go away. But clearly the drug industry mus=
t=20
be better regulated.=20
Angell and Kassirer take a fairly straightforward route in their =20
prescriptions for reform: Get the pharmaceutical industry away from the med=
ical =20
profession. Prohibit the drug companies from underwriting continuing medica=
l =20
education, get their sales representatives ("detail" people) out of hospita=
ls and=20
doctors' offices, and shut off the junket pipeline. And stop the industry =
from=20
flooding the airwaves with ridiculously deceptive direct-to-consumer =20
advertising.=20
Easy enough to say, but these are deeply ingrained practices that will prov=
e =20
next to impossible to eradicate. If you take the detail men and women out o=
f =20
doctors' offices, they will quickly reappear in the homes, country clubs,=
=20
civic organizations and vacation spots of physicians. Companies are willin=
g to=20
invest heavily in these activities, which means that control (rather than=
=20
eradication) is probably the most realistic goal.=20
Nor is there a lot of sentiment in Washington to take on Big Pharma. In the=
=20
recent election the American people made it clear that they do not want or=
=20
trust the federal government to regulate much of anything.=20
What Angell and Kassirer, for all the power of their books, fail to convey =
is=20
that the activities they rightly condemn are all symptoms of deeper, more =
=20
serious problems in the pharmaceutical industry. As Avorn correctly notes, =
it=20
is a lack of science as much as venality that is responsible for the confl=
icts=20
of interest and inefficiencies that are rife in medicine's relationships=
=20
with the drug business.=20
Americans think that the U. S. Food and Drug Administration provides tight =
=20
oversight ensuring the safety and efficacy of drugs. But the FDA lacks the =
=20
authority and resources to do this job well. The FDA and its European =20
counterparts can demand that pharmaceutical companies provide them with dat=
a to show=20
that drugs are efficacious. But they have no mandate to show that drugs are=
=20
effective=E2=80=94that they will work not only in closely monitored clinica=
l trials but =20
also in the real world under a variety of conditions. Nor is there any =20
systematic, independent source of evidence about the comparative value of d=
rugs and=20
medical technologies. Head-to-head trials comparing a drug with a rival =20
company's similar product or generic version are almost nonexistent. There =
are no=20
databases that report the results of all trials in a standardized way, =20
describing adverse events and efficacy in various subpopulations. "The init=
ial FDA=20
approval of a drug should be seen as the beginning of an intensive period o=
f =20
assessment, not the end," Avorn says. But that's not the case. And into thi=
s =20
data vacuum rush the detail men and women bearing gifts.=20
Doctors, patients, policy makers and regulators are all blind as bats when =
it=20
comes to having the data needed to rein in the huge excesses of the =20
pharmaceutical industry. If no one can really say which drugs are the most =
effective=20
for whom and which will get the job done most cheaply, then marketing base=
d=20
on trinkets, junkets and hype will continue to flourish. If no one challen=
ges=20
the industry to live up to its stated ethical goal of using science to=20
benefit patients, then simply telling the industry's detail men and women t=
o keep=20
out of the lecture halls at medical schools will do little to weaken their =
=20
influence.=20
Not only is there insufficient science guiding the pharmaceutical business,=
=20
the financial incentives it has are pointing in the wrong direction. Big=20
Pharma still looks to make its breakthroughs and find its blockbusters by =
creating=20
pills that lots of us can take every day for most of our lives. This means=
=20
that the supply of birth control pills, remedies for toenail fungus,=20
cholesterol blockers and antidepressants is ample, whereas vaccines are sc=
arce. Big=20
Pharma and its university partners pay little attention to public health a=
nd=20
the ailments of the poor because there is little money to be made from the=
m.=20
To have drugs, we must have a pharmaceutical industry. The key to reforming=
=20
it in the short run is, as these books show, going after its worst excesses=
=20
and tamping them down. In the long run, more serious measures are needed. =
With=20
its self-proclaimed ethical mission in mind, the industry must be=20
restructured. It needs to be firmly grounded in science and properly motiv=
ated to=20
provide us with the drugs that will do us all the most good. Accomplishing=
that is=20
a matter of dialogue and redirection, not demonization.
Reviewer Information
=20
=20
Arthur L. Caplan is Emmanuel and Robert Hart Professor and chair of the =20
Department of Medical Ethics at the University of Pennsylvania School of M=
edicine=20
in Philadelphia. He is the author or editor of many books; recent volumes =
he=20
has coedited include The Human Cloning Debate (Berkeley Hills Books, 2004)=
,=20
Health, Disease and Illness: Concepts in Medicine (Georgetown University=
=20
Press, 2004) and Who Owns Life? (Prometheus Books, 2002).=20
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