The drug giant, Glaxo Smith Kline, has a lot of explaining to do. This month the company has suffered a public relations storm with charges of bribery, arrests of executives in China, and allegations of falsifying research results, to name a few. Here at home, GSK is also in hot water. CEO Andrew Witty was almost confessional in his public statements regarding a $3 billion settlement with the US Department of Justice for allegations of off-label promotion of Wellbutrin and Paxil, failure to report safety data for Avandia, and pricing irregularities for other drugs. And GSK’s behavior is not an aberration in the world of pharma. They are getting a deluge of scrutiny because they are big, the 7th largest pharma in the world.
The GSK bribery charges open a window into the difficulty of doing business overseas. China is one of many places where bribery is just part of the price of doing business. When pharmaceutical giants set up new entities or companies in China, India, the Middle East, and South Asia, local corruption may penetrate the business units, and then the miasma infecting the business side may spread to the research units.
Audrey Erbes explains in a recent posting that, while it is not clear if the corruption on the business side at GSK directly led to malfeasance on the research side, she points out that:
“Employees in China as well as Chinese ex-patriots recruited to work there have tremendous pressure on them to succeed in this system by their companies and the Chinese government.” Just one example that has surfaced has tainted the scientific credibility of the local research teams at GSK in China.
According to Fierce Biotech:
GlaxoSmithKline ($GSK) has stopped development of an experimental drug for multiple sclerosis after a preclinical study turned out to contain “misrepresentations” in data from its R&D labs in China.
The London-based drugmaker slammed the brakes on a Phase I study of a compound known as GSK 2618960, pending a review of questionable data from a non-drug study of a suspected mechanism in multiple sclerosis. The study involved blood samples of MS patients and the role of a protein known as IL-7 in the disease. Evidence of falsified data in the study has cost two GSK researchers their jobs and prompted the drugmaker to take steps to retract the findings of the study published in 2010 in Nature Medicine.
Read more here.
So how do you, as a working scientist, maintain integrity and morality in the workplace, given the pressures brought to bear. While the business units are in the driver’s seat, so to speak, research and regulatory units of pharma are charged with building the frame, chaise and engines that drive innovation and development. Scientists in industry must attend to quality first to insure that, above all else, we do no harm.
One of the experts often cited in this field is David B. Resnik, J.D., Ph.D. He states that ethics serve to define norms of conduct that distinguish between acceptable and unacceptable behavior. He suggests several components for ethical research, many of which have been incorporated into professional associations, government agencies, and universities specific codes, rules, and policies.
His list of components inherent in ethical research includes:
- Honesty – …in all scientific communications. Honestly report data, results, methods and procedures, and publication status. Do not fabricate, falsify, or misrepresent data. Do not deceive colleagues, granting agencies, or the public.
- Objectivity – Strive to avoid bias in experimental design, data analysis, data interpretation, peer review, personnel decisions, grant writing, expert testimony, and other aspects of research where objectivity is expected or required. Avoid or minimize bias or self-deception. Disclose personal or financial interests that may affect research.
- Integrity – Keep your promises and agreements. Act with sincerity. Strive for consistency of thought and action.
- Carefulness – Avoid careless errors and negligence. Carefully and critically examine your own work and the work of your peers. Keep good records of research activities, such as data collection, research design, and correspondence with agencies or journals.
- Openness – Share data, results, ideas, tools, resources. Be open to criticism and new ideas.
- Respect for Intellectual Property – Honor patents, copyrights, and other forms of intellectual property. Do not use unpublished data, methods, or results without permission. Give credit where credit is due. Give proper acknowledgement or credit for all contributions to research. Never plagiarize.
- Confidentiality- Protect confidential communications, such as papers or grants submitted for publication, personnel records, trade or military secrets, and patient records.
- Responsible Publication – Publish in order to advance research and scholarship, not to advance just your own career. Avoid wasteful and duplicative publication.
- Responsible Mentoring- Help to educate, mentor, and advise students. Promote their welfare and allow them to make their own decisions.
- Respect for colleagues – and treat them fairly.
- Social Responsibility – Strive to promote social good and prevent or mitigate social harms through research, public education, and advocacy.
- Non-Discrimination – Avoid discrimination against colleagues or students on the basis of sex, race, ethnicity, or other factors that are not related to their scientific competence and integrity.
- Competence – Maintain and improve your own professional competence and expertise through lifelong education and learning. Take steps to promote competence in science as a whole.
- Legality – Know and obey relevant laws and institutional and governmental policies.
- Animal Care – Show proper respect and care for animals when using them in research. Do not conduct unnecessary or poorly designed animal experiments.
- Human Subjects Protection – When conducting research on human subjects, minimize harms and risks and maximize benefits. Respect human dignity, privacy, and autonomy. Take special precautions with vulnerable populations and strive to distribute the benefits and burdens of research fairly.
Read more here.
Post this on the wall over your work bench, and may the force be with you!
