A colleague asked me to post this entry under the nom de plume J. E. Cochran -- a thought provoking post, I thought:
Informed consent, in a clinical trial, requires that a clinical trial subject be fully informed of all the risks and the benefits of taking part in the trial before participation. The goal of informed consent is that the subjects should have all relevant information, and be able to make their own decisions as to whether they should participate in the clinical trial. This approach is complicated not only because of the complicated information that must be presented to the subject,
which can rarely be fully understood, but also the fact that the information must be kept a secret for business reasons.
The requirement of informed consent, was proposed by physicians, ethicists, and even the US Food and Drug Agency (FDA) and the International Committee on Harmonization (ICH). However, while informed consent does invoke a warm fuzzy feeling and is great PR for
the pharmaceutical industry, the practical procedures and implicationsare far from having been completely worked out.
Pharmaceutical companies spend hundreds of thousands of dollars a year protecting their intellectual property by using patents, trade secrets, copyrights, etc. Accordingly, the investigators, subjects, institutions and all other related personnel who would have access to
the drug or its data are subject to strict confidentiality provisions. Practically speaking, however, it is commonly known that researchers talk amongst themselves and patients routinely discuss their treatment protocols with each other. Drug companies hope to curtails this
practice but realize that they have little choice but to "play along." The research industry chooses from only 3-5% of the entire practicing physician population. This population not only does the required research to approve a drug, but consists of key opinion leaders and a
significant portion of the initial prescribing population. In light of the clout of this researcher population, the industry prefers not to antagonize this population by the stringent enforcement of the confidentiality provisions. The practice of stringent enforcement of confidentiality provisions becomes even murkier when we talk about allowing patients to see the Investigator's Brochure (IB).
The IB is a grouping of the significant scientific data, in the original scientific language, which is made available to the investigator so that the investigator knows all the relevant risks
and benefits when enrolling patients. Conversely, the informed consent form is a significantly simplified document that hopes to inform patients, in a language that they can understand, of only the most important risks and benefits. The trade-off, caused by the use of this simplified language, is that a lot of the risks are not completely addressed in the standard informed consent form.
The question therefore arises: Considering the private and proprietary nature of new chemicals entities (NCEs), and the possible lack of complete information in the typical informed consent form, can a potential subject, request to have access to not only the informed consent form (which the subject is usually required to sign or acknowledge), but also the investigator's brochure?
Pro Business and intellectual property (IP) advocates, as advised by their lawyers, err on the side of protection of the data. They believe that the data generated from the drug can save lives, if only given a chance, and provided a profit can be made on the drug. They believe that this profit can only be made if their drug remains unique and the data generated from their studies is not mis characterized. They hence assert that the patient should only have access to the data that is meant for them and provided since that information has been customized for them such that it is easy for them to understand and difficult to mis-characterize. On the other hand, the drug companies believe that the data provided in an IB is difficult for the lay person to understand, and easy to mis characterize. Furthermore, if that data is provided to competitors, it can serve as a source of erosion of profits since the competitors will either mis-characterize
the data or develop me-too products. To avoid all these complications, pro business and intellectual property advocates err on the side of protection of the data.
On the other hand, patient rights advocates believe that despite the confidentiality provisions, the subject must have access to all data. These advocates believe that the understandability of the data is a significant goal, but should not be a barrier to access to this data. They point out that informed consent cannot occur in the absence of complete information. They also assert that the fact that subjects may not understand the data is an inadequate explanation since the
information should be phrased such that it can be easily understood. (IP advocates point to the inherent risks in over warning and the lack of focus present in 40 page informed consent forms.)
Both sides have valid concerns, each of which must be addressed. However, these concerns must not only be addressed in the vacuum of academia but in the bustling streets of commerce with true capitalism testing what the market supports.
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