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Deadly Medicines and Organised Crime

Page 24

by Peter Gotzsche


  ‘Vanessa was a healthy girl. She didn’t drink or smoke or take drugs – with one exception: over the past year, she had periodically taken cisapride, an acid-reflux drug marketed as Prepulsid. Her doctor, who’d diagnosed her with a minor form of bulimia, prescribed it after she complained of reflux and feeling bloated after meals. Neither their doctor or pharmacist mentioned risks.’ On 19 March 2000, her father watched his 15-year-old daughter collapse on the floor at home. ‘She was rushed to hospital, where she died a day later. The cause: cardiac arrest.’ Five months later, the drug was withdrawn from the market, but it was too late for Vanessa.

  Because of the loss of his daughter, her father became active in politics and got elected to the Canadian Parliament, as he wanted to change drug regulation. He expressed incredulity that prescription drugs aren’t regulated as stringently as other public safety threats: ‘The minister of transportation doesn’t “negotiate” with truckers to keep unsafe vehicles off roads,’ he said. By law, doctors must report unfit drivers and are paid to do so. Fast-tracking drugs to market is like ‘air-traffic controllers being told to land planes more quickly’. Eleven years after his daughter’s inquest, none of his major recommendations for reforms had been implemented.

  We have thousands of drugs at our disposal, and I wonder why no one ever studied whether the availability of so many drugs does more harm than good. I am sure that’s the case. Otherwise, drugs wouldn’t be the third leading cause of death.

  The doctors cannot know about all the dangers, but the patients can. They can read the package insert carefully and stop taking the drug if they think it’s too risky for them. I also hope my book may contribute to making so many citizens angry that they will protest and demonstrate until we force our politicians into introducing some much-needed reforms.

  We know very little about polypharmacy

  Most patients are in treatment with several drugs, particularly elderly patients. A Swedish study of 762 people living in nursing homes found that 67% were prescribed 10 or more drugs.116 One-third were in treatment with three or more psychoactive drugs; around half received antidepressants or tranquillisers; and anticholinergic drugs (e.g. for urinary incontinence) were used in one-fifth. All these drugs may create cognitive impairment, confusion and falls, which carry a considerable mortality among the elderly. The symptoms are often misinterpreted by the patients and their carers as signs of old age or impending disease, e.g. dementia or Parkinson’s, but when doctors stop the medicines, many of the patients apparently become many years younger, drop the wheeled walking frame, which they got because they couldn’t keep the balance, and become active again. A US study found that almost 18% of Medicare patients took drugs that aren’t safe for older people.85

  Just like regulators, doctors see one problem at a time and usually start drug treatment every time. They very often forget about stopping a drug when it’s no longer needed. My most important contribution to internal medicine was to stop drugs in newly admitted patients, only to realise that, quite often, the patients arrived doped with the same drugs by their general practitioner next time they were admitted. It is surely an uphill battle.

  We know very little about what happens when patients take many drugs, but we know enough to act. Every one of them may affect many bodily functions, apart from the intended one, and they may interact in unpredictable ways. We also know that old people are much overtreated, with harmful consequences. A randomised trial showed that drug reduction lowered both mortality and admission to hospital, and a subsequent study in 70 patients where number of drugs was reduced from 7.7 to 4.4 per patient showed that 88% reported global improvement in health and most had improvement in cognitive functions.117 Here is a typical story, apart from the fact that few elderly people are that lucky:118

  When my father was 88, he was hospitalised for dizziness, which occurred after his medication was increased. In the hospital, he was given more medication which made him confused, frightened, and incoherent. Then his doctor transferred him to a nursing home, where he was dirty, crying, begging people to hold his hand, and listed as DNR (Do Not Resuscitate) – and given still more medication.

  I convinced the doctor at the nursing home to discontinue all medication, and I hired a private nurse to give my father an organic diet – rich in fruits, vegetables, grains, beans, nuts, and seeds. In 3 days, my father made such a miraculous recovery that the nurses on the ward didn’t recognise him. When I called to speak to my father, he was back to his old self, and told me that he was bored and looking for a card game. My father was discharged the next day, and died several years later, while relaxing peacefully at home.

  Here is another story, of a woman who was also 88. She gets admitted to hospital after a bout of diarrhoea and dizziness.119 Her family was soon shocked by the quick deterioration in her health and the emergence of some strange new symptoms, including delusions, and they couldn’t wake her. They found out that she was taking several new drugs, including a painkiller and an antidepressant, but she wasn’t depressed, she was rightly grieving for the loss of her former life, because she was now stuck inside a hospital room. At the same time, a psychiatrist diagnosed Alzheimer’s and suggested that she take donepezil (Aricept). Her daughter-in-law refused this and took several of the drugs from her, which had dramatic effects. She became herself again. This experience turned her daughter-in-law into a patients’ advocate: ‘I was looking at all the other people in long term care facilities, where family members were either unaware of the problems or didn’t want to rock the boat, and I thought, “Who the hell is going to speak up for these people?”’

  Modern medicine doesn’t work well for old people. Every clinician has witnessed the medicalised 80-year-old obsessed with arthritis, Alzheimer’s disease, and serum cholesterol levels. Contrast this patient with someone else in the same physical condition, who admits that her knees are bad and that she has trouble remembering things. Which patient is better off?120

  References

  1 Mundy A. Dispensing with the Truth. New York: St. Martin’s Press; 2001.

  2 Angell M. The Truth about the Drug Companies: how they deceive us and what to do about it. New York: Random House; 2004.

  3 Day M. Don’t blame it all on the bogey. BMJ. 2007; 334: 1250–1.

  4 Bailey RS. FDA corruption charges letter verified. The Los Angeles Post. 2012 April 8.

  5 Tanne JH. Investigators to review conflicts of interest at NIH. BMJ. 2007; 334: 767.

  6 Tanne JH. Former FDA head is fined $90 000 for failing to disclose conflicts of interest. BMJ. 2007; 334: 492.

  7 Andersen NA, Drachmann H. [Psychiatrist gets millions]. Politiken. 2003 Dec 5.

  8 Braithwaite J. Corporate Crime in the Pharmaceutical Industry. London: Routledge & Kegan Paul; 1984.

  9 Blowing the whistle on the FDA: an interview with David Graham. Multinational Monitor 2004; 25(12).

  10 Lenzer J. Crisis deepens at the US Food and Drug Administration. BMJ. 2004; 329: 1308.

  11 Moynihan R, Cassels A. Selling Sickness: how the world’s biggest pharmaceutical companies are turning us all into patients. New York: Nation Books; 2005.

  12 Ross DB. The FDA and the case of Ketek. N Engl J Med. 2007; 356: 1601–4.

  13 Baciu A, Stratton K, Burke SP, eds. The Future of Drug Safety: promoting and protecting the health of the public. Washington, DC: National Academies Press; 2006.

  14 Smith SW. Sidelining safety – the FDA’s inadequate response to the IOM. N Engl J Med. 2007; 357: 960–3.

  15 Willman D. How a new policy led to seven deadly drugs. Los Angeles Times. 2000 Dec 20.

  16 Abraham J. Science, Politics and the Pharmaceutical Industry. London: UCL Press; 1995.

  17 House of Commons Health Committee. The Influence of the Pharmaceutical Industry. Fourth Report of Session 2004–05. Available online at: www.publications.parliament.uk/pa/cm200405/cmselect/cmhealth/42/42.pdf (accessed 26 April 2005).

  18 Graham DJ. COX-2 inhibitors, other NSAIDs, and ca
rdiovascular risk: the seduction of common sense. JAMA. 2006; 296: 1653–6.

  19 Jüni P, Nartey L, Reichenbach S, et al. Risk of cardiovascular events and rofecoxib: cumulative meta-analysis. Lancet. 2004; 364: 2021–9.

  20 Garattini S. Confidentiality. Lancet. 2003; 362: 1078–9.

  21 Union of Concerned Scientists. FDA Scientists Pressured to Exclude, Alter Findings; scientists fear retaliation for voicing safety concerns. 2006 July 20.

  22 Psaty BM, Burke SP. Institute of Medicine on drug safety. N Engl J Med. 2006; 355: 1753–5.

  23 Anonymous. Institute of Medicine urges reforms at FDA. Lancet. 2006; 368: 1211.

  24 Strom BL. How the US drug safety system should be changed. JAMA. 2006; 295: 2072–5.

  25 Abramson J. Overdo$ed America: the broken promise of American medicine. New York: HarperCollins; 2004.

  26 United States General Accounting Office. Food and Drug Administration: effect of user fees on drug approval times, withdrawals, and other agency activities. Sept 2002.

  27 Reuters. Danish drugmaker Lundbeck A/S and Japanese partner Takeda Pharmaceutical Co have submitted a new antidepressant for regulatory approval in the United States. 2012 Oct 2.

  28 Avorn J, Shrank W. Highlights and a hidden hazard – the FDA’s new labeling regulations. N Engl J Med. 2006; 354: 2409–11.

  29 Letter from FDA scientists to President Barrack Obama. 2009 Apr 2. Available online at: http://gaia-health.com/articles201/000201-letter.pdf (accessed 11 Nov 2012).

  30 Lichtblau E, Shane S. Vast FDA effort tracked e-mails of its scientists. New York Times. 2012 July 14.

  31 Rosenberg M. Former FDA reviewer speaks out about intimidation, retaliation and marginalizing of safety. Truthout. 2012 July 29.

  32 Brynner R, Stephens T. Dark Remedy: the impact of thalidomide and its revival as a vital medicine. New York: Perseus Publishing; 2001.

  33 Brody H. Hooked: ethics, the medical profession, and the pharmaceutical industry. Lanham: Rowman & Littlefield; 2008.

  34 Sibbison JB. USA: dirty work in the drug industry. Lancet. 1991; 337: 227.

  35 Wikipedia. Duilio Poggiolini. Available online at: http://en.wikipedia.org/wiki/Duilio_Poggiolini (accessed 10 November 2012).

  36 Abbott A. Italian health sector in disarray following more scandals. Nature. 1993; 364: 663.

  37 Medawar C, Hardon A. Medicines out of control? Antidepressants and the conspiracy of goodwill. Netherlands: Aksant Academic Publishers; 2004.

  38 Day M. Italian police arrest drug officials over alleged falsification of data. BMJ. 2008; 336: 1208–9.

  39 Pfizer memoranda, 24 and 26 April 1989.

  40 Grill M. Kranke Geschäfte: wie die Pharmaindustrie uns manipuliert. Hamburg: Rowohlt Verlag; 2007.

  41 Relman AS, Angell M. America’s other drug problem: how the drug industry distorts medicine and politics. The New Republic. 2002 Dec 16: 27–41.

  42 Ismail M. Drug Lobby Second to None: how the pharmaceutical industry gets its way in Washington. The Center for Public Integrity. 2005 July 7.

  43 Bass A. Side Effects – a prosecutor, a whistleblower, and a bestselling antidepressant on trial. Chapel Hill: Algonquin Books; 2008.

  44 Gøtzsche PC, Jørgensen AW. Opening up data at the European Medicines Agency. BMJ. 2011; 342: d2686.

  45 Anonymous. FDA more transparent than EMEA. Prescrire International. 2002; 11: 98.

  46 Garattini S, Bertele V. How can we regulate medicines better? BMJ. 2007; 335: 803–5.

  47 Kranish M. Drug industry costs doctor top FDA post. Boston Globe. 2002 May 27.

  48 Goozner M. The $800 Million Pill: the truth behind the cost of new drugs. Berkeley: University of California Press; 2005.

  49 McClellan MB. Speech before First International Colloquium on Generic Medicine. Available online at: www.fda.gov/oc/speeches/2003/genericdrug0925.html (accessed 18 February 2008).

  50 Carpenter D, Zucker EJ, Avorn J. Drug-review deadlines and safety problems. N Engl J Med. 2008; 358: 1354–61.

  51 Carpenter D. Drug-review deadlines and safety problems (authors’ reply). N Engl J Med. 2008; 359: 96–8.

  52 Moore TJ, Cohen MR, Furberg CD. Serious adverse drug events reported to the Food and Drug Administration, 1998–2005. Arch Intern Med. 2007; 167: 1752–9.

  53 Lexchin J. New drugs and safety: what happened to new active substances approved in Canada between 1995 and 2010? Arch Intern Med. 2012 Oct 8: 1–2.

  54 Avorn J. Paying for drug approvals – who’s using whom? N Engl J Med. 2007; 356: 1697–700.

  55 Psaty BM, Korn D. Congress responds to the IOM drug safety report – in full. JAMA. 2007; 298: 2185–7.

  56 Harris G, Halbfinger DM. FDA reveals it fell to a push by lawmakers. New York Times. 2009 Sept 25.

  57 Dhruva SS, Bero LA, Redberg RF. Strength of study evidence examined by the FDA in premarket approval of cardiovascular devices. JAMA. 2009; 302: 2679–85.

  58 Van Brabandt H, Neyt M, Hulstaert F. Transcatheter aortic valve implantation (TAVI): risky and costly. BMJ. 2012; 345: e4710.

  59 Collier J. Big pharma and the UK government. Lancet. 2006; 367: 97–8.

  60 Lee K, Bacchetti P, Sim I. Publication of clinical trials supporting successful new drug applications: a literature analysis. PLoS Med. 2008; 5: e191.

  61 European Commission. Strategy to Better Protect Public Health by Strengthening and Rationalising EU Pharmacovigilance. 2007 Dec 5.

  62 HAI Europe. Pharmacovigilance in Europe and Patient Safety: no to deregulation. Press release. 2008 Feb 1.

  63 Larsen H, Nyborg S. [The drug industry asks for control]. Politiken. 2006 Mar 5.

  64 [Committee on Scientific Dishonesty tamed]. Ugeskr Læger. 2005; 167: 3476–7.

  65 Greene JA, Choudhry NK, Kesselheim AS, et al. Changes in direct-to-consumer pharmaceutical advertising following shifts from prescription-only to over-the-counter status. JAMA. 2012; 308: 973–5.

  66 Welch HG. Should I be Tested for Cancer? Maybe not and here’s why. Berkeley: University of California Press; 2004.

  67 Welch HG, Schwartz L, Woloshin S. Overdiagnosed: making people sick in the pursuit of health. Boston, MA: Beacon Press; 2011.

  68 Andersen NV. [Drug giant uses American pressure in Danish drug case]. Politiken. 2004 Aug 31.

  69 Amendment to the Federal Food, Drug and Cosmetic Act. Washington, DC: 4 Jan, 2007. Available online at: www.fda.gov/oc/initiatives/HR3580.pdf (accessed 8 July 2008).

  70 Moore TJ, Furberg CD. The safety risks of innovation: the FDA’s Expedited Drug Development Pathway. JAMA. 2012; 308: 869–70.

  71 Jefferson T, Jones MA, Doshi P, et al. Neuraminidase inhibitors for preventing and treating influenza in healthy adults and children. Cochrane Database Syst Rev. 2012; 1: CD008965.

  72 Meier B. Contracts keep drug research out of reach. New York Times. 2004 Nov 29.

  73 Lurie P, Wolfe SM. Misleading data analyses in salmeterol (SMART) study. Lancet. 2005; 366: 1261–2.

  74 Rickard KA. Misleading data analyses in salmeterol (SMART) study – GlaxoSmithKline’s reply. Lancet. 2005; 366: 1262.

  75 Castle W, Fuller R, Hall J, et al. Serevent nationwide surveillance study: comparison of salmeterol with salbutamol in asthmatic patients who require regular bronchodilator treatment. BMJ. 1993; 306: 1034–7.

  76 Salpeter SR, Buckley NS, Ormiston TM, et al. Meta-analysis: effect of long-acting beta-agonists on severe asthma exacerbations and asthma-related deaths. Ann Intern Med. 2006; 144: 904–12.

  77 FDA Drug Safety Communication: new safety requirements for long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs). 2010 Feb 18. Available online at: www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm200776.htm (accessed 8 October 2012).

  78 Nelson HS, Weiss ST, Bleecker ER, et al. The Salmeterol Multicenter Asthma Research Trial: a comparison of usual pharmacotherapy for asthma or usual pharmacotherapy plus salmeterol. Chest. 2006; 129: 15–26.

  79 Curfman GD, Morrissey S,
Drazen JM. Products at risk. N Engl J Med. 2010; 363: 1763.

  80 Harris G. Pfizer says internal studies show no Celebrex risks. New York Times. 2005 Feb 5.

  81 Caldwell B, Aldington S, Weatherall M, et al. Risk of cardiovascular events and celecoxib: a systematic review and meta-analysis. J R Soc Med. 2006; 99: 132–40.

  82 Sherman M, Marchione M. Pfizer: Celebrex raises heart attack risk. ABC News. 2004 Dec 17.

  83 Avorn J. Powerful Medicines: the benefits, risks, and costs of prescription drugs. New York: Vintage Books; 2005.

  84 Avorn J. Dangerous deception – hiding the evidence of adverse drug effects. N Engl J Med. 2006; 355: 2169–71.

  85 Petersen M. Our Daily Meds. New York: Sarah Crichton Books; 2008.

  86 Whitaker R. Anatomy of an Epidemic. New York: Broadway Paperbacks; 2010.

  87 Smith SM, Schroeder K, Fahey T. Over-the-counter (OTC) medications for acute cough in children and adults in ambulatory settings. Cochrane Database Syst Rev. 2012; 8: CD001831.

  88 Tomerak AAT, Vyas HHV, Lakhanpaul M, et al. Inhaled beta2-agonists for non-specific chronic cough in children. Cochrane Database Syst Rev. 2005; 3: CD005373.

  89 Glintborg D. [Cough medicines for acute respiratory infections, what is the evidence?] Rationel Farmakoterapi. 2003 Jan 4.

  90 Sharfstein JM, North M, Serwint JR. Over the counter but no longer under the radar – pediatric cough and cold medications. N Engl J Med. 2007; 357: 2321–4.

  91 Public Health Advisory: FDA Recommends that Over-the-Counter (OTC) Cough and Cold Products not be used for Infants and Children under 2 Years of Age. 2011 Feb 23.

  92 Parvez L, Vaidya M, Sakhardande A, et al. Evaluation of antitussive agents in man. Pulm Pharmacol. 1996; 9: 299–308.

  93 Goodyear MD, Lemmens T, Sprumont D, et al. Does the FDA have the authority to trump the Declaration of Helsinki? BMJ. 2009; 338: b1559.

 

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