Beginning in the 1980s during the Reagan administration, the approval and regulation processes for therapeutics have been deregulated and evolved into an increasingly complex and poorly working system with rampant fraud. Irrespective of the many other failures of the system, the use of surrogate measures has been encouraged and found to be of questionable value (Darrow et al, 2020). The use of surrogate measures means that a drug is not being tested for efficacy in treating the disease, rather the drug is being tested to modulate some measure that is associated with disease. For example, if a patient has gout, a disease with symptoms of inflammation, severe pain, redness, and swelling in joints, then a surrogate endpoint of serum uric acid (associated with the disease) can be used to determine efficacy of a drug instead of the disease itself. Remember, patients with gout don’t go to see their physician complaining of high serum uric acid levels. The FDA has increasingly accepted less data and more surrogate measures, and has shortened the review times for drug approvals. In our pro-business, deregulated environment, the process has become so corrupt that one drug was approved, despite the scientist at FDA who evaluated the drug disapproving the drug (Lowe, 2016), because the physician, Janet Woodcock, M.D., in charge of the review process, didn’t want the company to go out of business because the company’s drug wasn’t approved (Harper, 2016). I’ll repeat that: a drug was approved by a physician at the FDA for reasons of profit, even though the scientists evaluating the drug said the drug shouldn’t be approved. While increasing numbers of drug candidates are failing (DiMasi et al, 2016), and those approved and on the market are increasingly causing adverse events and deaths (Chen, 2018), the regulatory deregulation and short-cuts have not led to an increase in new drug approvals or to reduced total development times (Darrow et al, 2020). More than half of our drugs don’t work (Smith, 2003). For example, the FDA’s approval of bevacizumab for progressive glioblastoma, an aggressive brain cancer, “the confirmatory trial, with more than 400 patients, reported no improvement in terms of overall survival, quality-of-life end points, or neurocognitive functioning.” Furthermore, almost two-thirds of the patients on bevacizumab had severe to life-threatening side effects (DiMagno et al, 2019). Unfortunately, the only thing working in the drug development process is that the rich are becoming richer – Physicians are highly paid by pharma companies to put their names on ghostwritten medical journal publications (Wilson and Singer, 2009) or just steal the work of their Ph.D. colleagues and add their name (McCook, 2018), and billions are made by the drug companies (Herman, 2019), of which ownership is mostly by the wealthy (Cohen, 2018). When it comes to taking prescription drugs, do as Nancy Reagan told us about those other kinds of drugs: “just say no.” All of this is explained in greater detail, along with alternatives to prescription drugs in my upcoming book, “Thinking and Eating For Two: The Science of Using Systems 1 and 2 Thinking to Nourish Self and Symbionts”(Maguire, 2020).
References
Chen C (2018) FDA Repays Industry by Rushing Risky Drugs to Market. ProPublica, June 26, 2018.
Cohen P (2018) We All Have a Stake in the Stock Market, Right? Guess Again. NY Times, Feb. 8, 2018.
Darrow JD et al (2020) FDA Approval and Regulation of Pharmaceuticals, 1983-2018.
DiMagno S et al (2019) Accelerated Approval of Cancer Drugs—Righting the Ship of the US Food and Drug Administration. JAMA Intern Med. 179(7):922-923.
DiMasi JA et al (2016) Innovation in the pharmaceutical industry: New estimates of R&D costs. J. Health Econ., 47:20-33.
Harper M (2016) Approving A Muscular Dystrophy Drug Ignites A Civil War At The FDA. Forbes, Sept. 20, 2016.
Herman B (2019) Axios analysis: Drugmakers getting richer. May 13, 2019.
Lowe D (2016) Sarepta Gets An Approval – Unfortunately. Science Translational Medicine, Sept. 20, 2016.
Maguire G (2020) Thinking and Eating For Two: The Science of Using Systems 1 and 2 Thinking to Nourish Self and Symbionts. Smashwords, Los Gatos, CA.
McCook A (2018) Prominent health policy researcher plagiarized colleagues’ work, Dartmouth investigation finds. STAT, August 20, 2018.
Smith R (2003) The drugs don’t work. BMJ. 327(7428): 0.
Wilson D, Singer N. (2009) Ghostwriting is called rife in medical journals. New York Times. 2009 September 11; B5.
Stem Cells, Health, Technology 