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Pharmaceutical Company Control of the Information Environment

Pharmaceutical Company Control of the Information Environment. Adriane Fugh-Berman MD Georgetown University Institute for Teaching and Research on Women, Towson University March 9, 2007. Drugs. Can save lives and improve health …when used appropriately

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Pharmaceutical Company Control of the Information Environment

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  1. Pharmaceutical Company Control of the Information Environment Adriane Fugh-Berman MD Georgetown University Institute for Teaching and Research on Women, Towson University March 9, 2007

  2. Drugs • Can save lives and improve health …when used appropriately • FDA approves drugs for specific indications • Risks are balanced against benefits • All drugs have risks

  3. New drugs are more risky • Over 25 years, 1 in 5 new drugs was withdrawn or acquired a black box warning • Half of these changes occurred within two years of approval Lasser et al. JAMA 2002;287(17):2215

  4. Use of drugs by elders • More than 90% of persons ≥65 years old used a least one medication per week • More than 40% used at least 5 medications per week • 12% used at least 10 medications per week Kaufman DW. JAMA 2002;287:337

  5. Pharmaceutical company promotion • Encourages demand for the newest, most expensive drugs • Most new drugs are me-too drugs, or combinations of old drugs • New drugs are not necessarily better • In general, generic drugs are safer than branded drugs simply because we know more about them

  6. Pharma and Education • Pharmaceutical companies fund many “educational” efforts • Disease awareness campaigns are meant to expand populations eligible for treatment • Promotion ensures that the newest, most expensive drugs are the best-known therapies

  7. Drug Costs • In 2002, average expenses for Rx drugs $1,100 per person (75% higher than 1997) • average out-of-pocket expenses for prescription drugs were about 50% higher than in 1997 (CDC) • In 2004, $188.5 billion was spent on Rx drugs • Drug costs constitute 10.7% of health care expenditures (GAO)

  8. ADR Frequency by Drug Use Frequency (%) 0-5 6-10 11-15 16-20 Number of Medications May FE. Clin Pharmacol Ther 1977;22:322-8. Slide courtesy of Kaim Calis, NIH

  9. The costs of promotion • In 2000, total promotion cost for Rx drugs was almost $16 billion • About $5 billion spent on detailing • For comparison, the 2007 NIH budget is $29 billion

  10. What drug reps cost • Between 1995 and 2005, the number of drug reps in the US increased from 38,000 to 100,000 • Pharmaceutical companies spend $150,000 annually per primary care rep and $330,000 per specialty rep* • Average annual income for a drug rep is $81,700 ($62,400 plus $19,300 bonuses)** *Med Ad News 2004;23(3):1; ** Pharm Exec 2005 (January)

  11. Promoting the profitable • There are more than 10,000 drugs in the US pharmaceutical market • More than half of promotional expenditures are concentrated on the top-selling 50 drugs Ma J et al. Clin Ther 2003;25(5):1503-17

  12. Docs vs. Reality • Studies consistently show that promotion increases prescribing * • Studies consistently show that physicians do not believe that promotion affects prescribing** *Chren MM et al. JAMA 1994 Mar 2;271(9):684-9; Lurie N et al. J Gen Int Med 1990;5:240-243; Wazana A. JAMA 2000 Jan 19;283(3):373-80. **Sigworth SK et al. JAMA. 2001;286(9):1024-5.McKinney WP et al. JAMA 1990;264(13):1693-7.

  13. Meetings:Pharma controls CME • In 2004, more than half of the $2 billion dollars spent on CME came from pharmaceutical manufacturers • Medical Education and Communication Companies (MECs) launder money for pharma • 75% of their income is from firms that manufacture FDA-regulated products • Medical schools are just as bad • Pharma provides almost two thirds (63.8%) of CME income to medical schools (ACCME)

  14. Advertising in medical journals • 5 of 6 physician organizations raised at least10% of annual revenue from advertising in affiliated medical journals • More than 95% of ads in JAMA are for Rx drugs • Pharma companies also purchase “sponsored” subscriptions • And are the largest purchaser of reprints Fugh-Berman A, Alladin K, Chow J. PLoS Medicine 2006;3(6):e130

  15. What about R&D costs? • Between 1970 and 2005, research and development accounted for between 8.5% and 17. 3% of sales(PhRMA Annual Membership survey 2006) • Pharma spends 3 times as much on marketing as it does on research

  16. DTCA • In the first half of 2006, $2.47 billion was spent on DTCA in the U.S.* • Advertising leads to more requests for advertised medicines** • DTCA does not benefit healthcare quality † *Thomaselli R. Advertising Age, 77(43):8. **Mintzes et al. CMAJ 2003; 169(5): 405. †Gilbody et al. Qual Saf Health Care 2005;14:246-250.

  17. Beware of websites and webpads… • Your doc’s website may be a present from Pharma • Information is collected • Pharmaceutical company websites can use information you submit to market products to you • Filling out forms on a webpad sends info back to sponsoring company

  18. Pharma knows you • About three fourths of pharmacies sell prescribing data • Insurers sell data as well • The data is combined to reconstruct your medical history • Your name isn’t on this material • Why is this useful?

  19. Menopausal hormone therapy • Hormones have long been promoted for health promotion, disease prevention, and aging reversal • Hormones first used as anti-aging therapy in men in the late 19th century

  20. “While not all women are affected by menopause to this extreme degree, no woman can be sure of escaping the horror of this living decay.” • “The mental depression typical of so many menopausal women can be avoided by early treatment and often alleviated even in obstinate cases. Difficult family situations can often be wholly remedied by estrogen therapy for the woman involved.” Feminine Forever Robert A Wilson MD, M Evans 1966/1968

  21. “Menopausal symptoms, such as weakening of the bones, dowager's hump, gastro-intestinal disorders, heart trouble, hardening of the arteries, atrophy of the breasts and sexual organs, disturbed vision, wrinkling of the skin, pains in the joints, etc, can be avoided by premenopausal therapy and often cured by post-menopausal therapy.” Feminine Forever,p 159

  22. JAMA July 1, 1968; 205(1):8

  23. In the last 20 years HT has been promoted for: • Youthfulness • Osteoporosis prevention and treatment • Cardiovascular disease prevention • Prevention of dementia • Prevention and treatment of incontinence • Mood disorders

  24. In RCTs… • HT has not benefited • Mood • Incontinence • CVD • Dementia • HT does benefit • Hot flashes • Vaginal dryness • Fracture risk

  25. Bidil: Race-based medicine • Two older drugs: hydralazine and isosorbide nitrate • 1986 Vasodilator Heart Failure Trial (VHeFT1) showed H/IN to be slightly better than placebo • 1991 VHeFt2 showed that an ACE inhibitor was superior

  26. Sifting old data • Reanalysis of VHefT2 showed a benefit of H/IN for some African Americans • 2004: African American Heart Failure Trial (AHEFT) showed that adding H/IN to standard therapy for CHF improved outcomes

  27. Is Bidil better? • No study designed to look at outcomes in African-American patients has compared Bidil directly with standard therapy for CHF • AHRQ metaanalysis of 3 RCT found no difference in mortality between African Americans and Caucasians using ACE inhibitors

  28. Bidil sets a bad precedent • Promotion of Bidil as African-American drug may cause docs to prescribe it alone… • And avoid it in others who might benefit • There is more variability within a racial/ethnic population than between populations • Data-dredging of failed studies may now be expected

  29. Disease-mongering • Diseases have been invented or their incidence or importance exaggerated • Risk factors have been turned into diseases • There are more well people than there are sick people

  30. Recommended Books Abramson, John. Overdo$ed America Angell, Marcia. The truth about the drug companies Avorn, Jerry. Powerful medicines David, Healy. Let them eat Prozac David, Healy. The antidepressant era Elliott, Carl. Better than well Goozner, Merrill. The $800 million pill Kassirer, Jerome P. On the take Moynihan, Ray. Selling Sickness Mundy, Alicia. Dispensing with the truth Reidy, Jamie. Hard Sell Washburn, Jennifer. University, Inc

  31. Organizations • No Free Lunch nofreelunch.org • Healthy Skepticism healthyskepticism.org • Health Care Renewal hcrenewal.blogspot.com • National Women’s Health Network women’shealthnetwork.org • Our Bodies Ourselves ourbodiesourselves.org • GoozNews gooznews.com • PharmaWatch pharmawatch.blogspot.com • Center for Science in the Public Interest Integrity in Science Project Integrityinscience.org • American Medical Student Association amsa.org • Health Action International haiweb.org

  32. PharmedOut.org • Funded by the Attorney General Prescriber and Consumer Education Grant Program • News, resources, film clips, slideshows, pharma-free CME, and eventually modules on pharmaceutical promotion

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