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Deceit of Big Pharma? Lošinjski dani bioetike Darko Polšek [email protected] Literature: • • • • • • • • • • • Marcia Angell. 2004. The Truth About the Drug Companies. How They Deceive Us and What to do About It. Marcia Angell. 2004. The Truth About the Drug Companies, New York Review, July 15. Marcia Angell. 2006. Your Dangerous Drugstore, New York Review, June 8 Marcia Angell. 2005. The Body Hunters, New York Review, October 6. Jerome Kassirer. 2005. On the Take. How Medicine’s Complicity With Big Business Can Endanger Your Health Generic Drug Entry Prior To Patent Expiration. 2002. Federal Trade Commission Study http://www.ftc.gov/os/2002/07/genericdrugstudy.pdf David Willman. 2000. How a New Policy Led to Seven Deadly Drugs, LA Times, Dec. 20. Ben Kage. 2005. The truth about medical journals, and how drug companies exert heavy influence over published scientific articles, http://www.NewsTarget.com/010315.html Dani Veracity. 2005. The great direct-to-consumer prescription drug advertising con: how patients and doctors alike are easily influenced to demand dangerous drugs Alexis Black. 2006. Silencing public health advocates: Outspoken Vioxx critic loses job after testimony against Merck in federal trial Alexis Black. 2006. Fraud in medical research: A frightening, all-too-common trend on the rise How Big Pharma was made • • • • Bayh-Dole Act (enabled universities and small businesses to patent discoveries made by research sponsored by National Institutes of Health) 1980. Until then, taxpayer-financed discoveries were in the public domain, available to anyone. That means that drug companies no longer have to rely on their own research for new drugs, and only few do. Researchers become part owners of patents and small companies, or receive stock options in companies – conflicts of interest This act transformed the ethos of medical schools and hospitals. (“Technology transfer”) How Big Pharma was made • 1984. Hatch-Waxman Act. In a series of laws, monopoly rights for brand-name drugs was extended from 8 years (in 1980) to about 14 years (in 2000)– billions of dollars surplus in drug sales. • Two forms of monopoly rights: – USPTO (Patent and Trademark Office) – FDA (Food and Drug Administration) • Shortening of testing period, shortening of aproval period – more money cashed • Medicaid is not allowed to negotiate drug prices Buying researchers their conflict of interests (Kassirer) • • • • • • Researchers and physicians are “on the take” Researchers become part owners of patents and small companies, or receive stock options in companies – conflicts of interest Researchers and physicians do not disclose financial ties to big companies Since 1980’s companies sponsor meetings of physicians in resorts, foreign countries, cruise ships. Sometimes it is an excuse to go playing golf, see sights etc. Sponsorship entitles them to influence the content of the program Scientific meetings as a marketing opportunity In 1999. revenues for sponsoring scientific meetings by big pharma was 600 million dollars (Public Citizen) Buying researchers and physicians • • • • • “More than 40% of life science researchers at 50 universities had accepted gifts, discretionary funds, trips to meetings…” (Kassirer, 18) At SAGES (Gastrointestal surgeons society) surgeons volontarily disclosed: 60% of senior surgeons and 40% of junior surgeons had at least one conflict of interest. The average number of conflicts per surgeon was approximately two, and two individuals had ties to five companies. (Kassirer 19) (# of conflict = # of ties to Pharma companies). “Consulting fees” to researchers, physicians, members of NIH and FDA Appointment to the speaker’s bureau (of Big Pharma company) is used as a “payback” for participation in clinical drug trials. Doctors are used as marketing promotors Buying physicians II • • • • • • • • • • For helping Big Pharma finding appropriate subjects for drug experimentation For prescribing experimental drugs For prescribing drugs for off-label purposes For ghostwriting (for instance in editorials – blaming competing drugs etc.) By giving “free samples” of drugs which may be refunded in cash by the patient or Medicaid For helping companies avoid lawsuits By profiting from a class-action lawsuits For influencing NIH and FDA decisions For “shadowing” (marketing representative influencing patient’s decisions in doctor’s offices) For tainting information to patients Buying authors and reviewers in scientific journals (Kassirer, 22) • Journal of American Medical Association and New England Journal of Medicine in 1990’s abandoned peer-review policy which required an author and a reviewer to disclose financial conflict of interests. Rationale given: “It is extremely difficult to find authors who were free of conflicts”. • “Conflicts were so extensive that medical journals were unwilling to use valuable space in the paper pages of the journal to print them. On Web pages authors’ financial conflicts encompassed three single-spaced typewritten pages” Buying political influence http://www.citizen.org/congress/campaign/special_interest/articles.cfm?ID=6537 • • • • • • • The drug industry spent $262 million on political influence in the 1999-2000 election cycle: $177 million on lobbying, $65 million on issue ads and $20 million on campaign contributions. The industry hired 625 different lobbyists last year to buttonhole lawmakers – or more than one lobbyist for every member of Congress. Unlike data on contributions and campaign ads, this comprehensive information on lobbying has recently become available (most lobbying details for the second half of 2000 didn’t become available from Congress until May 2001 and no organization has analyzed the data as thoroughly as Public Citizen). The bill for this team of lobbyists in 2000 alone: $92.3 million – a $7.2 million increase over what the industry spent for lobbying in 1999. Brand name drug companies spent $90.0 million, generic drug companies spent $2.3 million. Drug companies took advantage of the revolving door between Congress and other branches of the federal government and the industry. Of the 625 lobbyists employed in 2000, more than half were either former members of Congress (21) or others who previously worked in Congress or in other federal government positions (295). The drug industry spent more (based on available data) on lobbying and other political persuasion than any other industry in 1999-2000. The drug industry lobbyists were well-connected: 33 served as Chief of Staff to members of Congress; 11 others worked for the powerful House Ways and Means Committee, which has jurisdiction over a Medicare drug bill; eight others worked for the key Senate Judiciary Committee, where drug patent law is crafted. In addition, six worked for the Bush I administration; five worked for former House Speaker Newt Gingrich (R-Ga.); four worked for former Senate Judiciary Chairman Orrin Hatch (R-Utah); five worked for current Senate Health, Education, Labor and Pensions Committee Chairman Edward Kennedy (D-Mass.); four worked for former Senate Majority Leader Trent Lott (R-Miss.); and three worked for current Senate Finance Committee Chairman Max Baucus (D-Mont.). Buying approval (at NIH, FDA and White House) • David Willman (LA Times) disclosed major conflicts of interest among the most prestigious scientists at the NIH. Since 1995 scientists in NIH may have financial relations with Pharma industry. • Conflicts of interest at drug advisory committee meetings for the U.S. Food and Drug Administration (FDA) are common and often of considerable monetary value, finds a study (JAMA. 2006;295:1921-1928) conducted by Public Citizen and published in The Journal of the American Medical Association. The study details financial conflicts of interest between drug advisory committee members and the companies producing the drugs they evaluated; it also examines conflicts with competing companies. The study exposes statistically significant relationship between certain conflicts and votes in favor of the drug under consideration. • In 2006. President G. Bush tried to enact a law stripping the legal liability of Big Pharma for injuries by the drugs approved by the FDA (so far not successfully) Marcia Angell: The Truth about the Drug Companies • In 2001, about 2,3 million Americans served as human subjects in experiments and drug tests. (29) • Contract research organizations routinely offer doctors large bounties (averaging about $7000 per patient in 2001). In one trial physicians were paid $12000 per patient, plus $30000 for the enrollment of the sixth patient. Risk: it induces doctors to enroll patients who are not really eligible. (31) Marcia Angell: The Truth about the Drug Companies • In 2001. FDA had only 30 people to review 34000 patent claims. Now it has 9.000 people to oversee industry = 95.000 businesses (food, drugs, vaccines, blood products, medical devices) worth more than a trillion dollars. • Total time from testing to marketing drugs ranged from 610 years. In 2002. it was 16 months and is getting shorter. Marcia Angell: The Truth about the Drug Companies • Big Pharma claims it spends $800 million dollars on each new drug (some claim $1,7 billion). That is false: By calculating industry’s own R&D costs divided by # of drugs – it comes to $175 million after taxes. • However, R&D costs are tax deductable and R&D costs include all sorts of marketing gimmics. So, a realistic figure is $100 million. • All sorts of promotional activities (including soft-money) are filed as R&D costs (as to be tax deductable) Marcia Angell: The Truth about the Drug Companies (innovation) • Is the industry really inovative? Between 1998 and 2002, 415 drugs were approved, 83 per year. Of those 133 were new molecular entities. Of those 133, only 58 were priority review drugs, i.e. 12 innovative drugs per year. • In 2001 and 2002, only 7 innovative drugs were approved per year. “And that’s it – the five-year grand total of innovative drugs from this mighty industry” (55) • But the real scandal is the fact that the few innovative drugs that do come to market nearly always stem from publicly supported research. (56) At least a third of Big Pharma drugs are acquired from outside sources, small countries. • Big drug companies are competing not so much to find new drugs but for the limited number of drugs to licence. Marcia Angell: The Truth about the Drug Companies (generics) • 77% of registered drugs are me-too drugs or generic ones. To get approved, they just have to show they are more effective than placebo. On the basis of placebo-controlled trials, drugs can be approved that are actually worse than drugs already on the market. (74) • People with uncommon diseases are not of much interest to drug companies because the market is small. • Once upon a time, drug companies promoted drugs to treat diseases. Now, they promote diseases to fit their drugs. (86) Especially interesting is psychiatry. Marcia Angell: The Truth about the Drug Companies • New drugs are patented and FDA approved solely by – changing their terms of use – changing their diagnostic span – changing their quantities – changing their coating (???) Marcia Angell: The Truth about the Drug Companies (drug effectiveness) • ALLHAT trial of the treatment of high blood pressure tested: 1. calcium channel blocker Norvasc (Pfizer) 2. alpha-adrenergic blocker – Cardura (Pfizer), 3. ACE inhibitor - Zestril (AstraZeneca) and Prinivil (Merck) 4. generic diuretic (water pill). Diuretic turned out to as good for lowering blood pressure, and better for preventing devastating complications like heart disease.!!! ALLHAT study shows that diuretics are the best choice to treat hypertension, medically and economically!!! (96) • Researchers do not control clinical trials anymore; sponsors do. (100) Marcia Angell: The Truth about the Drug Companies (bias and deceit) • One survey of seventy articles about their safety found that 96% of authors who were supportive of the drugs had financial ties to the companies that made them, and only 37% of authors who were critical had such ties. (107) • Authors of industry-funded studies were more than five times as likely to recommend the company drug as authors of studies funded by nonprofit organizations – regardless of actual results. • Handbook for trials of Big Pharma drugs: – Enroll only young subjects in trials even if the drugs tested are for use of elderly people. – Compare the new drug with an old drug given a too low a dose. – Administer the old drug incorrectly. – Design trials that are too brief to be meaningful. – Present only part of the dana (ignore unfavourable results) – Suppress negative results • In antidepressant drug testing, on average placebos were 80% as effective as the drug tested!!! Marcia Angell: The Truth about the Drug Companies (masking bribes by “education”) • “It is crucial for big pharma to maintain the fiction that these expenditures ($19 billion promotion + $35 billion “education”) are for education, not promotion, because by doing so it can evade legal constraints on its marketing activitis. And it is also good public relations. (136) If drug companies can convince doctors to prescribe drugs for off-label uses, sales go up. That is where “education” comes in. If drug companies pretend they are merely informing doctors about other potential uses, they can circumvent the law. And that is what they do. Consequences: • No new drugs in pipeline – Of 78 drugs approved by FDA in 2002, only 17 contain new ingredients, and only 7 are classified by FDA as improvements over older drugs. • • No fundamental research from the Big Pharma People are buying drugs from Canada (and elsewhere – Internet) “Constant gardener business” Comment on “Constant Gardener” by Marcia Angell (NYRev October 6, 2005) “The story is based on the premise that a pharmaceutical company would be so threatened by disclosures of its activities that it would have someone killed. That is what is fantasy. In fact, many of the practices that so horrified le Carré's heroine are fairly standard and generally well known and accepted. They seldom provoke outrage, let alone murder. A company like KDH would not kill someone like Tessa even if it were willing to do so; it wouldn't have to. Her concerns would have seemed isolated and futile, and the companies would hardly have taken notice of them.”