Transcript Working With Drug Companies - HIV Research Catalyst Forum

Working With
Drug Companies
Lynda Dee
AIDS ACTION BALTIMORE
David Evans
AIDSMEDS.COM
HIV Research Catalyst Forum
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?
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
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).
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.
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
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.
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
What we ask them for…
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Develop treatments
Assess safety
Design studies that give clear answers
Fully disclose results of studies
Reasonable prices
Charitable contributions
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
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.
Activists and Industry
Past
Present
Future
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
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???
Pricing Outrage
Current Relationship with Industry:
From Actions To Negotiations
• Today all drug companies meet with
community
• Community review protocols to ensure realworld, patient-friendly designs and inclusion
• Promote industry collaborations
• Promote appropriate advertising and
promotional strategies and “reasonable”
pricing
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
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
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