"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:
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).
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.
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 with powerful lobbying efforts that leave the FDA with their hands tied behind their backs. Light, et al. comment that, "Quicker reviews and less evidence of clinical benefit have rewarded the hidden business model of developing still more drugs with minor benefits." The name of the game is to develop as many molecularly unique drugs for patenting and profits, rather than medical benefit or safety.
Further risk taking for the sake of profits can be seen in the increasing rise of 'off-label' recommendations from manufacturers and drug reps to doctors. Light et al. found that, "While trying drugs for new uses is clinically important, especially for certain populations such as children and cancer patients, 75 percent of off-label prescribing is neither supported by sound evidence nor accompanied by an organized means for gathering such evidence. Companies retain leading experts to expand use, broaden clinical guidelines, and conduct small, short sham trials that companies get published and hand out to their physician-customers as 'evidence.' " This distortion and aggressive pushing of untested drugs into clinical settings and marketing brings serious questions about what is really happening in hospital and clinical settings in the United States.
What should be done?
Light et al. offer a few ideas for how to shift the healthcare out of the grips of the pharmaceutical lobby. They make the simple suggestion of separating manufacturers from those who do the testing. Truly evidence-based medicine must aim to reduce bias and having profit motives and financial ties to a drug or product clearly creates a conflict of interest. Another recommendation is to remove all outside funding being funneled into the FDA and to restrict its resources to public funds, to limit influence and regulatory capture. More recent efforts by groups like Physicians for a National Health Program aim to not only acknowledge these problems and the obstacles of an entrenched broken system but seek to organize a movement that will force changes and reform. Gaffney and Lexchin acknowledge that for the US to really be able to implement the much needed reforms, "full implementation would require a universal single payer system" (Gaffney et al. 2018).
Other strategies look at changing reporting and transparency requirments on prescribing doctors. Some research has been down to show the positive effects of enforcing more transparency with regards to gifts and incentives from drug companies to medical providers. King and Bearman found that, "The pharmaceutical industry spends roughly 15 billion dollars annually on detailing – providing gifts, information, samples, trips, honoraria and other inducements – to physicians in order to encourage them to prescribe their drugs." By forcing doctors to report the details of where they receive financial gifts and funding appears to dramatically reduce drug administering, simply by bring awareness to their financial ties. There is some resistance to this, of course, as is spoken about by Dr. Leanna Wen in her 2014 TED talk, but with public interest and political push-back, there can be positive change that benefits patients and costs in the long run.
Much of the European Union has adopted policies that the US could follow and adjust to improve the US drug testing and approval process. Changes in testing requirements that ensure transparency are also suggested. The most obvious being a mandatory reporting of all adverse reactions and drop-out rates. Light et al. recommend that the US Congress would do well to restoring trust in the FDA by "creating a National Drug Safety Board with adequate powers, funds, and mandates to independently investigate and report on drug safety issues."
Obviously, the deeper problem of the private influence big money has over the election process underlies all of these issues and Light et al. note that no real change will occur until, "until third-party payers, politicians, and the people decide they want to stop paying so much for so many drugs of little value and then for treating the millions harmed by those drugs. Nor is it likely until the campaign to restore institutional integrity to Congress through funding elections by the 99 percent, rather than by the one percent, is successful."
In the meantime, there are growing options with the integration of medicine that aims to reduce risk and improve outcomes.
Obviously, acupuncturists are not influenced by pharmaceutical lobbying which grants them a greater capacity and interest in developing safe, appropriate, and cost-effective treatments. Acupuncture, and the larger system of traditional East Asian medicine aims to correct the health of the body through it's own mechanisms. It is a system that has proven itself and continues to prove itself as medicine further unravels the complexity of the human body, functional biology, and holistic models that all medicine is shifting towards.
Mind and body were never separate in East Asian medicine. Gut health and mental health were always connected. Immunity and digestion were always connected and their interrelationship understood. Motor function and brain health/cognitive function were always recognized and understood. Chinese herbal medicine has recognized and treated unresolved viral infections or the effects of poorly treated bacterial and fungal infections over time. All of these 'discoveries' in recent years are fundamental concepts to traditional East Asian medicine. There is a respect for the complexity and unique story of a person's physiology that requires careful listening, observing, and thoughtful treatment that understands all treatment has potentially positive and negative effects.
This thoughtfulness and holistic view that underlies East Asian medicine is being welcomed into the medical institutions as patients seeks better care and better results, especially in the face of a failing and corrupt pharmaceutical marketplace where true 'health care' is hard to find or out of financial reach. East Asian medical practitioners learn Western medical science and are trained to understand allopathic medicine. They can hold two views, but remain rooted in practicing medicine for the individual patient in front of them, always advocating for their health and healing, rather than relying on questionable influence and an unmanageable world of ever-new drugs.
Light, D. W., Lexchin, J., & Darrow, J. J. (2013). Institutional corruption of pharmaceuticals and the myth of safe and effective drugs.
King, M., & Bearman, P. S. (2017). Gifts and influence: Conflict of interest policies and prescribing of psychotropic medications in the United States. Social Science & Medicine, 172, 153-162.
Gaffney, A., Lexchin, J., & Canadian Pharmaceutical Policy Reform Working Group. (2018). Healing an ailing pharmaceutical system: prescription for reform for United States and Canada. BMJ, 361, k1039.