Pharma and Bioethics
Gift giving to doctors: The International Federation of Pharmaceutical Manufacturers & Association declared that pharmaceutical companies can no longer lavish gifts on doctors to sway prescribing practices.
The revised code of ethics, updated January 1, 2007 for the first time in a decade, applies to the group’s 26 member companies, including Pfizer Inc., and bars pharma companies from giving doctors money or gifts that might manipulate drug choices.
The industry group’s director general, Harvey E. Bale, highlighted the “need to make sure the product is the best product for the patient and it’s not influenced by gifts and it’s not influenced by hospitality or vacations.”
Large pharmaceutical companies spend about one-third of their revenue on sales and marketing, much of it aimed at doctors. Studies cited in the British Medical Journal have found that the relationships influence doctors’ prescribing behavior.
Disclosure issues:
- Report: Zyprexa maker minimized possible risks
- FDA Proposes Labeling Changes to Over the Counter Pain Relievers
Experimental drugs: The Food and Drug Administration (FDA) today December 11, 2006, proposed significant regulatory changes to make experimental drugs more widely and easily available to seriously ill patients with no other treatment options and to clarify the circumstances and the costs for which a manufacturer can charge for an experimental drug.
The proposed rule changes are aimed to enable more patients who lack satisfactory alternatives to have access to unapproved medicines, while balancing the need for safeguarding the individual patient and to ensure the continued integrity of the scientific process that brings safe and effective drugs to the market.
Clinical trials: An independent Expert Scientific Group (ESG) convened by the Secretary of State for Health to examine trials involving new types of drugs, following adverse reactions experienced by participants in the clinical trial of the drug known as TGN1412 earlier this year.
The ESG made twenty-two recommendations and concluded that there is a need to develop new medicines for conditions where current treatment is inadequate but, in clinical trials, the well-being of volunteers must always come first and that this must be safeguarded in the future.
Key areas:
- the need for scientific advice from independent experts before trials of high risk substances are approved
- the application process, conduct and environment of clinical trials
- the skills and future specialist training needs of those conducting clinical trials
- the location of trial units and the provision of adequate medical back up in case of problems arising.
IRBs: More than a third of doctors who sit on the review boards that oversee the integrity of clinical trials have financial ties with companies whose drugs are being tested in those trials.
- Study Monitors May Often Have Financial Conflicts
- Many Study Review Board Docs Have Ties to Drug Industry
NIH Survey shows that 80% of patients don’t care whether their doctors or hospitals have financial ties to companies whose drugs are being tested.
FDA: Does FDA’s mission to regulate drugs for the public safety and health supersede patient access to drugs? Should terminally ill patients have access to any experimental drug? Should children with life-threatening illnesses or mentally ill adults also have access to experimental drugs? Will providing access to unapproved drugs hinder the drug development process? Will manufacturers have increased liability as the result of the Abigail Alliance decision? How will this decision affect clinical trials? In the end, are patients better or worse off as a result of this decision?
An expert panel will meet on February 27, 2006 in Washington, DC to discuss the above issues.
