I just read the review. He's not as pro industry as I expected. I take ex= ception to his statement that their products are not inherently evil. Most= aren't, unnecessary and grotesquely overpriced, but certainly not tobacco.= However, when they cause death and disability, as did Vioxx and the diabe= tes drug, that turns into evil, especially if the companies push these drug= s, then don't remove them for 2-1/2 years after they prove deadly. On top = of which Bush wants to take away the only recourse consumers have left, whi= ch is lawsuits. =20 Also, the reviewer's statement that Washington is not in a hurry to do anyt= hing is because Washington gets a huge chunk of its money from them. Many = (as in many) former senators are now lpharma obbyists. Current representiv= es are heavily funded by them. But Americans don't care. Pharma will step= on their foot, and worse, and they say, aw gosh, thank you sir. And then = I get accused of being an elitist. Doesn't take much to be one, that's for= sure. Andy=20 -----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. Not that they didn't need reform. Som= etimes it=20 was seeming that you wanted to get rid of all pharmeucetical =20 companies/medicines that they produce as well as the FDA. =20 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 =20 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 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 =20 I do find it intriguing that the distrust of government is so strong that = we=20 do not understand or recognize the need for oversight... =20 Anyway, there are a couple of other books discussed here, too! =20 Better living with (regulated) chemistry, 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 ------------------------------------------------------------------ To change your Lit-Ideas settings (subscribe/unsub, vacation on/off, digest on/off), visit www.andreas.com/faq-lit-ideas.html ------------------------------------------------------------------ To change your Lit-Ideas settings (subscribe/unsub, vacation on/off, digest on/off), visit www.andreas.com/faq-lit-ideas.html