Revitalizing Professionalism AMSA’s PharmFree Initiative

1. Revitalizing ProfessionalismAMSA’s PharmFree Initiative

2. Overview • The Pharmaceutical Industry • Marketing to Physicians • AMSA’s PharmFree campaign: What YOU Can do!

3. Part I: The Industry

4. Drug Industry Profitability

5. Drugs are expensive because of R&D right? Source: Data compiled from 2006 annual reports

6. NO! It’s advertising and freebies to doctors Source: From Kaiser Family Foundation Report on Trends and Indicators in the Changing Health Care Marketplace http://www.kff.org/insurance/7031/ti2004-1-20.cfm

7. But it costs $802 million… -Using PHRMA’s own data, and incorporating a period 7 yr R&D period and 7 yr approval period, it was found that the cost of an approved NME was about $150 million (and that’s assuming you take the most recent period) -That number is for a NME, a supposedly innovative drug. It must be significantly less for a me-too drug Source: Rx R&D Myths: The Case Against The Drug Industry’s R&D “Scare Card”, Public Citizen Full Report: http://www.citizen.org/documents/rdmyths.pdf

8. But, we have so many new drugs Inflation adjusted R&D Expenditures New Drug Applications ------ New Molecular Entities -1993-2004, industry reported annual inflation-adjusted research and development expenses steadily increased from nearly $16 billion to nearly $40 billion—a 147 percent increase. -In contrast, the number of New Drug Applications (NDA) submitted annually to FDA increased at a slower rate— 38 percent over this period. -The number of New Molecular Entities (NME) has declined by 40 percent between 1995 and 2004 Source: GAO Nov 2006 Report: New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Dug Development

9. Where is the innovation? Proportion of 1,264 NDA’s submitted by innovation potential, 1993-2004 -60% of the drugs submitted to the FDA from 1993-2004 are strict me-too drugs Source: GAO Nov 2006 Report: New Drug Development: Science, Business, Regulatory, and Intellectual Property Issues Cited as Hampering Dug Development

10. YOU do the research, we get the money • At least 1/3 of big pharma’s drugs are now licensed or otherwise acquired from outside sources – including smaller companies around the world1 • For the 5 top selling drugs in 1995, the NIH found that 16 of the 17 key scientific papers leading to the discovery and development came from outside the industry2 Sources: (1) The Truth About Drug Companies, Angell 57 (2) The Truth About Drug Companies, Angell 65

11. The research smells a little funny • Study examined 4 peer reviewed journals (NEJM and JAMA included) • Many funded by private industry 21.6% • Relevant conflict-of-interest disclosures omitted at least 8% of the time (only first and last authors studied) Source: Goozner M. Unrevealed: Non-Disclosure of Conflicts of Interest In Four Leading Medical and Scientific Journals. CSPI: 2004.

12. Clinical Practice Guidelines: The Standard of Care • 87% of authors surveyed had ties to drug makers • More than half had relationships relevant to specific drugs considered by the guidelines • While only 9% of the authors believe they were influenced, 19% felt others had been influenced • The majority of personal financial conflicts of interest (42 of 44) were not reported in the final publications. Source: JAMA 2002: 287 (5); 612-617.

13. Publication Bias • Research funded by drug companies was more likely to have outcomes that favor the sponsor’s product than research funded by other sources • Positive results were more likely to be published than non-significant or negative results • Results were more likely to appear in non-peer-reviewed symposia Source: BMJ. 2003; 326: 1167-1170

14. One on One • In 2001, the industry's sales force of drug detailers, whose job is to meet individually with physicians and promote company products, numbered nearly 90,000 in the United States — 1 salesperson for every 4.7 office-based physicians1 • In 2001 the major pharmaceutical companies had 623 lobbyists, that is about 1.2 lobbyists per member of congress2 Sources: (1)N Engl J Med 351(18): 1886-1890 (2) Public citizen: The Other Drug War II http://www.citizen.org/documents/Drug_War_II.pdf

15. Part II: Marketing to Physicians & Physicians in Training White coat of the future?

16. Professionalism • Free pens, notepads and office supplies “commercialize” physicians • Gifts, consulting fees and paid vacations create a conflict of interest • Free samples, create a cycle of dependence and poor health delivery

17. Thought Experiments • Who bears the burden of the pens, bottles, post-its, free lunches, paid vacations, etc? • Who subsidizes the cost of the “education” which the industry purports to provide? • Why would each company require billions of dollars of marketing if their products made such a great difference in the lives of patients? Wouldn’t they just sell themselves?

18. Pharmaceutical Branding of Resident Physicians • Survey of 181 primary care residents; 164 (91%) responded. • First asked to complete survey, then asked to empty pockets of white coats. • 98% had eaten drug company-sponsored meal within the past year. • 97% of residents were carrying at least one item with pharmaceutical insignia. Source: JAMA 2001;286:1024

19. Characteristics of GP’s that regularly interact with drug reps • When new drugs became available, these physicians started using the new drugs quicker • Relied less on unbiased, published sources of evidence regarding drug efficacy Source: BMJ. 2003; 326: 1178-1179.

20. Perceived influence of pharmaceutical reps on prescribing practices “You” “Other Physicians” Source: Am J Med 2001;110:551

21. A Physician Survey of the Effect of Drug Sample Availability on Physicians’ Behavior • HTN scenario: • 92% said they would prescribe a diuretic or b-blocker as initial therapy. • When samples were made available, 32 of the 35 physicians who said they would give a drug sample selected a drug that differed from their preferred choice. Source: J Gen Int Med 2000;15:478

22. Effects of using Free Sample Medications on the Prescribing Practices of Family Physicians • When comparing a clinic with samples to others without, doctors at the clinic with samples: • Wrote more scripts for brand name medications • Had a higher average cost per script written • Wrote fewer preferred or formulary brand name drugs • Wrote more scripts for the medicines in the sample closet Source: J Am Board Fam Med. 2006: 19; 443-9.

23. Medical Students’ Exposure to and Attitudes about Drug Company Interactions: A National Survey • 1143 surveys to 3rd years in 8 schools • 93% required to attend at least 1 sponsored lunch. • 69% believed gifts would not influence practice. • 86% had accepted at least one gift. • 86% did not know if school had policy on relationships. Source: JAMA 2005;294:1034-1042

24. Not-so-Modest Meals • Despite industry guidelines published in 2002 requiring the meals provided by the industry be modest, • Meals provided to one Internal Medicine Residency program in Philly over a 6 month period averaged $42.08 per person. • Most of the sponsored restaurants were rated as “extraordinary to perfection” by Zagat Survey. Source: JAMA 2003: 290 (9); 1151-1152

25. The majority of payments were not reported because they had been designated as “trade secrets”. The data was poor in quality and not easily accessed by the public Average Payments in VT were $177 (max $20,000). Average Payments in MN were $1000 (max 922,239). A New Law- Early results from VT and MN Gift Registries Source: JAMA. 2007;297:1216-1223.

26. The Bottom Line… • The Top 5 U.S. pharmaceutical companies would not have spent $41.3 billion dollars in 2006 for marketing and administration purposes if did not work Source: Analysis of 2006 Annual Reports

27. AMSA’s PharmFree campaign: • What YOU Can do!

28. www.amsa.org/prof/pharmfree.cfm • Hold a Pharm Free Week event at your school October 22-27, 2007 • Use unbiased sources of drug information like The Medical Letter • Work for policy at your school to limit contact between drug reps and students • Take the Pharm Free pledge Contact Paige Hatcher at dsp@amsa.org