Is the relationship between the industry and prescribers (doctors) in trouble? Richard Smith Editor, BMJ

Answer It could certainly be improved-- made more “professional”

What I want to talk about A story of trouble The context of the relationship How is the world changing? Another story of trouble What are the current relationships between doctors and industry? Conflicts of interest: a case study of entanglement How might the relationships between doctors and industry be improved? Another story of trouble Conclusions

A story of trouble I AstraZeneca’s tactics in promoting rosuvastatin "raise disturbing questions about how drugs enter clinical practice and what measures exist to protect patients from inadequately investigated medicines" The Galaxy series of clinical trials, which investigated the efficacy of rosuvastatin, included "weak data," "adventurous statistics," and "marketing dressed up as research," It has been an "unprincipled campaign" Richard Horton, editor, Lancet Lancet 2003;362: 1341

A story of trouble I Regulators, doctors, and patients as well as AstraZeneca have been poorly served by your flawed and incorrect editorial. I deplore the fact that a respected scientific journal such as The Lancet should make such an outrageous critique of a serious, well studied, and important medicine Tom McKillop, CEO, AstraZeneca

The context Virtually all new drugs in the past 50 years have been discovered or manufactured by the drug industry The industry has consistently been one of the most profitable industries and is truly global It has great political power, particularly in the United States

The context Medicine is also global, but there is no international “health organisation” (WHO, WMA) that has the resources and power of the industry Research-based companies are merging--driven in large part by the costs of discovering new drugs and bringing the to market

The context The power of generic companies (many in India and Brazil) is rising The cost of bringing a drug to market is huge and rising-- which may be no bad thing for large companies as it raises “the barrier to entry”

The context The industry has been largely cut off from the people who take their products The industry has concentrated its enormous marketing resources on doctors--because they have written the prescriptions The “spend” per doctor is enormous Doctors have become addicted to the largesse

The context Companies must produce a good return on investment for shareholders They ideally do this through producing much needed new drugs- -from which everybody benefits But their legitimate commercial values sometimes (even often) conflict with the values of health care workers and systems

The context: examples of value clashes It cannot make commercial sense to produce new drugs for very rare conditions or conditions affecting those who have no money to pay It does make sense to produce a “me too” drug for a profitable market and market it as hard as possible Restrictions on marketing efforts are legitimately strained against

The context: examples of value clashes Drug treatments are favoured over non-drug treatments Companies are understandably reluctant to fund large head to head trials Companies are clever enough to “honestly” get the results from trials they fund Companies favour secrecy for commercial reasons; doctors and patients want transparency

The world is changing Drug companies have a productivity crisis--companies were producing 3 new chemical entities each year on average; now it’s 0.3 (Dresdner Kleinwort Wasserstein) In these circumstances companies may need to market still harder the products they have and “invent” new diseases

The world is changing The current business model of research- based companies is unsustainable-- Dresdner Kleinwort Wasserstein –New discoveries are down –12-15% increase in sales (half of it coming from price increases) is becoming impossible to sustain because of political pressure (4th hurdles, NICE, etc) Answer: more mergers, creating “monopolies” in particular therapeutic areas

The world is changing Direct to consumer advertising has arrived in the US and New Zealand and will probably be unstoppable across the world Companies have to increase their marketing spend dramatically New “relationships” are created with consumers Doctors generally resent companies “going over their heads” and creating expectations that doctors must meet

The world is changing Increasing numbers of bodies— for example, NICE and HMOs— are interested in controlling prescribing A WHO report praises NICE but criticises it for being too close to industry Other prescribers are appearing Doctors may not be the target they once were

The world is changing There is growing understanding of how the industry can get the results it wants—three papers for the Christmas BMJ Governments are increasingly interested in public funding of trials ALLHAT and the Women’s Health Initiative have given that interest a boost

Trouble 2 A journal publishes a paper that combines two trials A and B that show that a drug manufactured by Y, the sponsors of the studies, is better than a drug manufactured by Z A correspondent points out that trial A has already been published—a case of duplicate publication? Trial A and the paper (A and B) had only one common author—an employee of Y

Trouble 2 It also emerges that trial B did not find that Y had better outcomes than Z Then it emerges that on the FDA website the trials A and B both included other outcome measures—possibly ones that matter more to patients—where Z had better outcomes than Y How should the editors/publishers respond?

What are the current relationships between doctor and industry?

16 forms of entanglement between doctors and drug companies Face to face visits from drug company representatives Acceptance of direct gifts of equipment, travel, or accommodation (“Will you advertise my drug on your person for a year if I pay you 20p?”) Acceptance of indirect gifts, through sponsorship of software or travel

16 forms of entanglement between doctors and drug companies Attendance at sponsored dinners and social or recreational events (“If they have to pay the full whack they won’t come?”) Attendance at sponsored educational events, continuing medical education, workshops, or seminars (“Could you hurry up so we can get to the vol au vents?”) Attendance at sponsored scientific conferences (“Bugger Bognor, but the Gritti Palace in Venice sounds good.”)

16 forms of entanglement between doctors and drug companies Ownership of stock or equity holdings Conducting sponsored research (“It’s so hard to get money from the MRC and £800 for registering a patient is not bad.”) Company funding for medical schools, academic chairs, or lecture halls Membership of sponsored professional societies and associations Advising a sponsored disease foundation or patients' group

16 forms of entanglement between doctors and drug companies Involvement with or use of sponsored clinical guidelines Undertaking paid consultancy work for companies (“A return flight on Concorde, five nights at the Ritz Carlton, and 20 grand is not bad for two hours of blah.”) Membership of company advisory boards of "thought leaders" or "speakers' bureaux” (“Flattery and money: I can resist everything except temptation.”)

16 forms of entanglement between doctors and drug companies Authoring "ghostwritten" scientific articles (A critic on Naomi Campbell’s autobiography: “If she can’t be bothered to write it I can’t be bothered to read it.”) Medical journals' reliance on drug company advertising, company purchased reprints, and sponsored supplements (“It’s a million quid and £ profit for reprints of a major trial. Without it I might have to lay off staff. But we’re not influenced in our decision making.”)

Does all this matter? Virtually all new drugs, which have been so important for medicine, have come from drug companies Drug companies must have the right to market their products Prescribing is influenced--often to be unnecessarily expensive

Does all this matter? Information is biased Doctors are too dependent on drug companies for both education and information Companies spend more on marketing than on research Costs are inflated