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Questioning the institutional corruption that drives pharmaceutical medicine.


"A systematic review of the 39 methodologically strongest studies performed in the U.S. between 1964 and 1995 examined patients who were hospitalized due to a serious adverse drug reaction (ADR) or who experienced an ADR while in the hospital. The review found that 4.7 percent of hospital admissions were due to serious reactions from prescription drugs that had been appropriately prescribed and used. In addition, 2.1 percent of in-hospital patients who received correctly prescribed medications experienced a serious ADR, for a total of 6.8 percent of hospital patients having serious ADRs. Applying this 6.8 percent hospital ADR rate to the 40 million annual admissions in U.S. acute care hospitals indicates that up to 2.7 million hospitalized Americans each year have experienced a serious adverse reaction. Of all hospitalized patients, 0.32 percent died due to ADRs, which means that an estimated 128,000 hospitalized patients died annually, matching stroke as the 4th leading cause of death. Deaths and serious reactions outside of hospitals would significantly increase the totals." (Light, D. W., Lexchin, J., & Darrow, J. J. (2013). Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.)

An editorial published in 2013 by Donald W. Light, Joel Lexchin, and Jonathan J. Darrow, titled "Institutional corruption of pharmaceuticals and the myth of safe and effective drugs" sparked a powerful debate and discussion that was picked up by U.S. News in 2016. The paper's premise is that there is a fundamental corruption of the primary American medical institutions driven by regulatory capture, eroded consumer protections, and a failure of medical institutions to uphold their mandate to do no harm in the face of profits and convenience. The authors of the editorial break down the systemic failures into three mechanisms of corruption:

  1. through large-scale lobbying and political contributions, the pharmaceutical industry has influenced Congress to pass legislation that has compromised the mission of the Food and Drug Administration (FDA).

  2. largely as a result of industry pressure, Congress has under funded FDA enforcement capacities since 1906, and turning to industry-paid 'user fees' since 1992 has biased funding to limit the FDA’s ability to protect the public from serious adverse reactions to drugs that have few offsetting advantages.

  3. the pharmaceutical industry has commercialized the role of physicians and undermined their position as independent, trusted advisers to patients.

Peering under the hood, so to speak, Light, Lexchin, and Darrow show the various mechanisms that are used through political means, within research methodology, through advertising, and by influencing clinical practice, to ensure not greater medical outcomes, but greater profits. Over time, the FDA has reduced the amount of resources and time spend reviewing new drugs. Much of the safety standards are relegated to the manufacturers, leading the FDA themselves to note in their follow-up studies, that, "These detailed studies corroborate what FDA staff told the Office of the Inspector General, namely, that concerns arising near the end of the review period are not adequately addressed, that needed meetings with advisory committees are not held, and that label warnings and contraindications are hastily written. As a result, there are 'tens of thousands of additional hospitalizations, adverse drug reactions, and deaths.' " (Light, et al. 2013) All of this is also apparently at the cost of actual advances despite industry costs. As Gaffney and Lexchin note, "despite achieving some important advances, the drug industry’s record on innovation is derisory relative to its vast revenues and profits. Most new drugs offer little new besides higher cost, while firms often extend market exclusivity through trivial modifications and secondary patenting" (Gaffney, A., Lexchin, J., 2018). Attempts to remedy this always seem to be met wit