Pharma Lecture

Pharma Lecture Would it be ok for me to take $500 from Shering-Plough to begin lecture with plug for Clarinex? Are Ray etc – the crack dealers in Bourgois’ In Search of Respect any worse than Pharmaceutical industry? All pushers & interesting overlap in techniques (cheap introductory offers to get hooked) Marcia Angell wrote polemic, and I’m sure we’d find nice people work for Pfizer etc… But… Angell (former editor, New England Journal of Medicine) shows… 1) Clinical Trials a) Rigged through all sorts of tricks: (i) compare new drugs with placebos, not real rivals (ii) compare v rigged dose of rival (iii) use partial data – cf Celebrex 6 months instead of full year of data they had VIOXX the same (iv) Use young subjects with few side effects new drugs may actually be worse than old cheaper ones – as with diuretics for hypertension b) Clinical trials not really run by doctors anymore Doctors often paid bounty on subjects they recruit – so incentive to cut corners CROs (Contract Research Organizations) subcontract to doctors & control study design, analysis etc See Le Carre’s The Constant Gardener on CROs Often written up by drug Companies & doctors paid to sign, edit Adriana Petryna studies CROs Looking at techniques for manipulation Many find subjects in Ukraine & E. Europe – drug trials have become kind of surrogate health care Go there for lax regulations What owed to these subjects once trials over? “professional Guinea pigs” c) Contract clauses to prevent publication Betty Dong (UCSF) & synthroid (hyperthyroidism) Boots invoked confidentiality clause to prevent her from phblishing her finding that synthroid no more effective than cheaper generic Nancy Olivieri, L1 & Apotex – similar situation See Rachel Schuchman, The Drug Trial Scientific authority invoked in drug studies, but actual practice of science being hollowed out d) Only convenient trials declared medical journals now asking for trials to be registered at outset, so can’t be hidden 2) FDA a) Underfunded to look at drug ads, safety issues b) Reliance on user fees from drug companies to review clinical trial data. (New since mid-90s). Is Angell right that “he who pays the piper…”? c) Many on FDA panels also consult for Drug Companies Similar issue for NIH employees, amny of whom consult for pharmaceutical companies NIH used to be public service. Now danger its mainly route to stock options, consulting fees – real source of wealth Cf. Congressional staffers who endure long hours and low wages so they can get to work for lobbying firms Hijacking of meaning of public service: regulatory job now avenue to private wealth 3) Medical Journals a) Have had weak conflict of interest policies until recently, didn’t know interests of authors Sheldon Krimsky found often still undeclared b) Don’t ask who really wrote articles c) Hard to find unbiased referees & editorialists because everyone funded by some corner of the pharmaceutical industry Krimsky (Science in the Private Interest) found clear effects of sponsorship on judgment DSM: 56% authors have financial ties to Pharmaceutical industry, 80% for psychiatric disorders like PMDD, anxiety disorders etci d) Ad revenue from Pharmaceutical companies vital to medical journals 4) Marketing a) According to Angell, 30% costs – added to sticker price b) US one of only 2 countries with Direct To Consumer ads really about disease construction, not informing public 1997 provision about advertising side effects watered down – now just direct public to a website. (Note much of the evisceration of regulations done by Clinton – this isn’t a Republican v Democratic issue) Direct to Consumer ads increased by three times 1997-2001 c) corruption of Doctors detailers (salespeople)– often former cheerleaders free mugs, lunches, vacations, conferences etc for doctors pharmaceutical companies give free seminars for doctors’ required continuing education Marcel Mauss & gift theory: “no gift is given but in the expectation of a return.” free samples for doctors & patients til hooked prescription tracking to test doctor compliance recent direct mail episode re antidepressants (patients getting direct mail solicitation to change anti-depressant brand). Privacy issues Kaiser Permanente has forbidden much of this to drsii 5) Patents & Generics a) Techniques to fend off generics test on kids – worth extra 6 months challenge generic in court – worth 30-month delay repeat above over & over for multiple patents pay off generic manufacturer not to produce 1999 Abbott offered Zenith $2 million/month not to make hytrin – blood pressure drugiii repatent as new drug: clarinex v Claritin Prozac v Serafem repatent for new illness: PMDD, social anxiety disorder Trent Lott has bill to reform system & speed generic approvals Supported by many states, generic Companie & big Companies like GM (worried about health care costs of workers) Opposed by Pharmaceutical companies 6) Overall dysfunctional situation You’d think market system would unleash entrepreneurship & be best at meeting public health needs Instead, we have these bizarre dysfunctions, many because we don’t really have free market system but system where large Companies have used lobbying power to enter into alliance with state & use public resources against interests of consumers: Incidentally, over 34,000 registered lobbyists in DC – doubled since 2000 65 for each Congressman starting salaries can be $300,000iv a) Companies pick up public research on cheap, don’t do enough R&D of own taxpayer pays twice: through NIH, NCI, NSF through medicare, Medicaid Not getting many innovative new drugs, just “me-toos” for large chronic markets for statins, anti-arthritis drugs b) 30% on marketing v 15% on R&D paying to be made to want drugs that may not work & may not need c) Wildly different prices for same drugs You’re in trouble if no HMO to bargain for you Those too poor to afford health insurance lack bargaining power: “poor pay more” d) Shortage of drugs we really need: few new antibiotics because they cure you quickly, so little profit to be made kids’ vaccines, flu vaccine (lasts one year) malaria drugs (because malaria largely afflicts Third World where people can’t afford drugs) Bill Gates is the workaround solution: his foundation now funding research on malaria e) Can’t even get cheaper drugs from Canada recent warning notes in parcels lobbyists have blocked free trade with spurious safety arguments These dysfunctions concealed by propagandistic rhetoric about amazing new drugs 7) Public (or at least media) beginning to perceive problems re drugs & health care: a) Outcome problems U.S. ranks about 23 in life expectancyv “Among 33 industrialized nations, the United States is tied with Hungary, Malta, Poland and Slovakia with a death rate of nearly 5 per 1,000 babies, according to a new report. Latvia's rate is 6 per 1,000.”vi “In 2002 the United States spent $5,267 per person on health care. Canada spent $2,931; Germany spent $2,817; Britain spent only $2,160. Yet the United States has lower life expectancy and higher infant mortality than any of these countries.”vii Yet pays 50-100% more per capita than other industrial countries for health care 40 million uninsured bizarre insurance rules: will pay for diabetes amputations but not preventive care to forestall them! b) Industrial competitiveness issues $2,000 of your GM car for health insurance not an issue in Japan, Germany etc, where there is universal health care Paul Krugman arguing lack of single-payer health care dragging US industry down Then, there are free riders: Walmart externalizes health care costs to taxpayer to maintain economic competitiveness c) Medicare drug benefit largely written by pharma lobbyists Congress told it would cost $400 million, then news leaked that Admin deliberately concealed real price & many seniors will be no better off because of “donut” unpopular with seniors & deficit hawks Possible Reforms Clinical trials that compare new with established drugs Stricter rules for granting patents Repeal Prescription Drug User Fee & strengthen FDA No more industry shills on FDA committees Independent clinical trials run by universities through NIH Ban Direct To Consumer ads Ban drug reps in operating rooms etc Ban drug Company subventions of continuing education of doctors Charge everyone the same for same drug – with subsidies for poor Limit Companiess to 1 30-month stay for patent litigation Forbid generic Company collusion with big pharmaceutical companies – bribes not to produce. i Dan Vergano, “Study: medical manual’s authors often tied to drug makers” USA Today 4/20/06. ii Gardiner Harris, “In Article, Doctors back ban on drug companies’ gifts” NYT 1/25/06:A11) Sheryl Gay Stolberg & Jeff Gerth, “how companies stall generics and keep themselves healthy” NYT 7/23/00:A1). iii iv v Restoring the Public Trust By Bill Moyers TomPaine.com Friday 24 February 2006 Christopher Shea, “Primary Paths.” BG 1/1/06 C4 vi US Newborn Survival Rate Ranks Low By Lindsey Tanner The Associated Press Tuesday 09 May 2006 vii Pride, Prejudice, Insurance By Paul Krugman The New York Times Monday 07 November 2005