1. Working With Drug Companies Lynda Dee AIDS ACTION BALTIMORE David Evans AIDSMEDS.COM HIV Research Catalyst Forum

2. OVERVIEW 1)How do drug companies work? 2)How has the community advocated for better drugs, better access and cheaper drug prices with pharma? 3)How is the community working with companies today?

3. How do Companies Work? Primary purpose, as with any company, is to find or create a market, sell drugs and make a profit for shareholders Secondary purpose (more important to some than others) is to help alleviate suffering from diseases

4. Profit Potential Pharma profits tripled between the 70s and 80s. Pharma was one of the most profitable industries through the 1980s and 1990s. The most profitable drugs made more than 20% profit. Comparison: some industries are thrilled to much greater than the rate of inflation (roughly 2 to 4 percent).

5. The FDA Label For what indication(s) can they market their products? How does their product compare to a placebo or a comparator drug? What are the serious and common side effects? (Potential Black Box Warning) What are the less serious and rarer side effects? If they even say the brand name of the drug they are officially selling it.

6. When do they start marketing their products? Identify or create market Identify/build molecules Animal studies FDA Approval Human studies Sales to doctors and patients

7. Marketing Techniques They can “detail” study results to prescribers They can mention efficacy (sort of) and side effects (definitely) to patients Communication with non-prescribing professionals is a bit murky in practice.

8. How do companies see the community? HIV is unique, largely due to strong activism. Companies approach us to: Consult on trial design, marketing and charitable giving Enhance the image of the company among you, your constituents and providers Soft sell - can they get you to ask a client or doctor about a product? Sometimes see organizations and advocates/activists as gatekeepers

9. What we ask them for… Develop treatments Assess safety Design studies that give clear answers Fully disclose results of studies Reasonable prices Charitable contributions

10. Reasons they give for denying our requests Pressure from shareholders for high profit. Pressure to expand or create market. Pressure to increase marketing budgets at the expense of the research pipeline. Pressure to avoid any additional cost and risk of drug development. Cost of research is so high - good research demands high prices

11. Things to Remember Individual employees can be nice people, but most are hired and paid to be nice to you. Many companies have had to be dragged to the negotiation table during the course of the epidemic Companies generally act in their own self interest Charity is entirely contingent on profit You don’t get if you don’t ask There are occasional exceptions to these rules, but they are the norm.

12. Past Present Future Activists and Industry Past Present Future

13. Activists and Industry Initial confrontations involved drug prices Burroughs Wellcome (BW): AZT’s $10,000 annual price, ultimately reduced by 20% Meetings were haphazard Companies called meetings, set dates, location and agendas Meetings were often marketing dog and pony shows

14. Abbott Labs Drug Development on the cheap 400% Price increase on Norvir Enron of Big Pharma Activist and physician outrage destroyed their relationships Learning from mistakes???

15. Pricing Outrage

16. Current Relationship with Industry: From Actions To Negotiations Today all drug companies meet with community Community review protocols to ensure real- world, patient-friendly designs and inclusion Promote industry collaborations Promote appropriate advertising and promotional strategies and “reasonable” pricing

17. ATAC DDC Research Principles Significant numbers of women, people of color, IDUs, and co-infected in Phase II and III Minimize risk to treatment naive patients in Phase II Active agents in control arms, multiple experimental agents in new drug arms and in EAPs Key drug interaction studies early in development Pre-approval kidney & liver impairment trials Pediatric formulations

18. Drugs for Multi-Class Resistance Double and Triple Combination EAPs: Working with the FDA, Forum and Industry to design double, triple experimental combination EAPs for multi-drug resistant patients Based on FDA’s new EAP regulations, permitting earlier access to intermediate sized groups Major challenge: Availability of appropriate drug combinations in same drug development phase

19. Fair Pricing Coalition (FPC) Founded by Martin Delaney and Linda Grinberg in 1999 2002 two-year US price freeze Guidance to ADAP Directors, resulting in $50 million to ADAPs Prevent unreasonable drug price increases Initiate Co-Pay Assistance Programs