Lawyer and scholar Dr. Marc Rodwin identifies five key areas in which doctors, governments, and the public rely and improperly depend on the pharmaceutical industry. Here are the five areas of improper dependency:
1. Governments and the public improperly depend on drug companies to set priorities on drug research and development (R&D), despite the misaligned interests between public health policy and corporate profit goals.
2. Governments, doctors, and the public improperly depend on drug companies to conduct clinical trials on their own medications. These clinical trials are supposed to test for and establish the safety and efficacy of their new drug products; however, pharmaceutical firms’ corporate interests bias their evaluations of their own medicine products.
3. Governments, doctors, and the public depend on drug companies to decide what clinical trial data to disclose to doctors and the public. Drug companies selectively report safety and adverse events data, so the knowledge that we and our doctors have on medications is corrupted and incomplete. Furthermore, drug companies are free to selectively report and distort clinical trials, providing doctors with incorrect and inaccurate safety and prescribing information. Drug companies are also not required to publish any study results for the public and doctors to access. Drug companies typically report only favourable study results, while hiding and burying unfavourable results. Even with clinical trial registries, such as ClinicalTrials.gov in the United States, companies can still delay reporting of data. Drug companies also do not filed their trials on the registry on time and violate other requirements. Additionally, no authority regulates or enforces that the data posted on these registries actually and accurately reflects the data from the registered clinical trial. Furthermore, clinical trial registries do not make available the most useful study information, which is found in the clinical study report, which summarizes the analyzed results that companies submit tot he government for approval.
4. The public, doctors, and governments largely depend on drug companies to analyze and disseminate information on the risks of drugs once they are approved and on the market; however, it is well-known that we cannot rely on manufacturers to effectively warn the public and doctors about the risks of their own medications.
5. The public and doctors rely on drug companies to provide product information. Governments and physicians also rely on drug companies to finance continuing medical education (CME) and other professional activities that inform doctors of medication information.
Rodwin provides the following solutions to each of the aforementioned improper dependencies:
- Public money needs to be redirected to target pharmaceutical research that the public most needs, rather than on research that will benefit the bottom line
- In addition to conducting trials on their own medications, drug companies conduct clinical trials specifically on off-label uses and disseminate these results to physicians so that doctors prescribe their medications for non-approved uses. Rodwin proposes that prescriptions for these off-label indications should be documented by physicians, directly on the script. This is necessary to track the benefits and risks associated with these off-label prescriptions. To improve patient safety and adverse events reporting, physicians could be required to note on each script the patient's diagnosis and the purpose for the off-label prescription. Using this information, we could evaluate the benefits and risks of off-label prescribing for specific drugs. This way, we could identify the harmful drugs sooner than if these declarations were not made. Furthermore, independent third parties could be commissioned to evaluate off-label drug prescription declarations when they exceed a designated threshold.
- Governments and regulatory agencies should require that drug firms disclose clinical study reports for all clinical trials and that the regulatory agencies disclose all clinical study reports provided to them by drug companies seeking approval for new drugs.
- A new system is needed to fund CME. Rodwin argues that commercial interests should not be permitted to directly or indirectly donate funds to CME accreditation activities and sessions. These funds should, instead, be allocated by the federal government. Rodwin proposes that this money could be obtained by imposing a tax on drug firms to finance independent CME. (Japan does something similar, where there are pools of funding to which many drug companies contribute, so that when the money from these pools is allocated to research and other uses, physicians and researcher recipients remain unaware of the original corporate source of funding, therefore, decreasing the potential negative effects of financial conflicts of interests and feelings of reciprocity toward drug company sponsors.)
These widespread and systemic practices promote institutional corruption by improper dependency. The interests and goals of the health care system, patients, and doctors by means of public policy diverge from interests of corporate profit gain, further undermining aims of accountability, scientific objectivity, and integrity. These reforms would promote equitable access to affordable necessary medications, unbiased assessments (which are used to determine the success of a drug in the approval process) of medications during clinical trials, and honest and non-manipulated reporting of drug trial results so that drug approval committees and physicians can make informed decisions regarding safety and prescribing.
Find and download Five Un-Easy Pieces of Pharmaceutical Policy Reform for free at: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=2295002
See also Marc Rodwin's books: Conflicts of Interest and the Future of Medicine and Medicine, Money, and Morals: Physicians' Conflicts of Interests