Pharmaceutical Drug
Pharmaceutical drugs are substances specifically designed to diagnose, treat, cure, or prevent diseases in individuals, distinct from other types of drugs that might produce psychoactive effects. In the U.S., the Food and Drug Administration (FDA) is responsible for evaluating and approving these drugs to ensure their safety and efficacy. The pharmaceutical industry, which encompasses companies that research, develop, manufacture, and sell these drugs, has evolved significantly since its inception in the late 19th and early 20th centuries. Pioneering figures like Paul Ehrlich laid the groundwork for developing synthetic medicines, leading to breakthroughs in treating diseases such as pneumonia and tuberculosis.
Despite their life-saving potential, pharmaceutical drugs have been the subject of considerable public scrutiny due to high costs, allegations of concealed health risks, and conflicts of interest between pharmaceutical companies and healthcare professionals. The rising expense of developing new drugs, which can exceed $2.3 billion, has prompted discussions about the sustainability of the industry, while the opioid crisis has highlighted issues of over-prescription and addiction linked to certain pain medications. Major pharmaceutical corporations like Pfizer and Merck dominate the market, generating billions annually, which raises ongoing ethical questions about the intersection of healthcare, profit, and patient welfare.
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Subject Terms
Pharmaceutical Drug
A drug is any item, other than food, that produces a psychoactive or physical change in an individual’s body when consumed. A pharmaceutical drug is a specific type of drug whose purpose is to diagnose, treat, cure, or prevent diseases; in the United States, the federal Food and Drug Administration (FDA) evaluates which drugs are approved as pharmaceutical drugs. Dietary supplements and herbal remedies exist in addition to pharmaceutical drugs. However, such supplements have not been approved by the Food and Drug Administration and their packaging labels must contain the disclaimer, "This product is not intended to diagnose, treat, cure, or prevent any disease." The corporations that conduct research and development of pharmaceutical drugs, and who manufacture and sell these drugs, are collectively known as the pharmaceutical industry (sometimes referred to simply as "PharMA" or "Big PharMA").
Brief History
Efforts to treat diseases, injuries, and ailments date back thousands of years, but until the past century, such medications, elixirs, and ointments were limited to ingredients that could be extracted from plants or animals. The emergence of the pharmaceutical industry began amid efforts to develop synthetic (human-made, as opposed to natural plant- or animal-based) medicines in Europe and the United States in the late nineteenth and early twentieth centuries. In 1906, German doctor Paul Ehrlich theorized that research laboratories could employ chemists to identify the specific microbes that caused diseases. In addition, Ehrlich advocated that laboratories use chemists to develop specific treatments (which he called "magic bullets") to kill disease-causing microbes. Ehrlich is often credited as a pioneering figure in the emergence of the pharmaceutical industry.
By the mid-twentieth century, several pharmaceutical companies had been established in North America and Europe. They conducted clinical and scientific research on the factors that cause particular diseases, as well as searched for drugs and medications that could fight diseases. Some of the earliest successes of the pharmaceutical industry were in combating pneumonia, tuberculosis, and diarrhea. In 1900, these three conditions caused one-third of all deaths in the United States; by 1940, the death rate among Americans of this trio of diseases had declined to less than 10 percent as a result of medical innovations.
However, by the late twentieth century, public criticism of the pharmaceutical industry and its for-profit motives had increased substantially. One major criticism questioned the rates at which doctors, perceived as working hand-in-hand with pharmaceutical companies, prescribed medications to patients. Perhaps more than any other type of pharmaceutical drug, the alleged growing over-prescription of painkiller medications (such as OxyContin, Percoset, and Vicodin) since the 1980s generated sharp criticism. This trend occurred during a time in which the pharmaceutical industry considerably expanded its promotion and advertising of painkiller drugs, even funding pain clinics where such medications were routinely prescribed. Between 1999 and 2022, overdose deaths involving opioids increased substantially in the US, according to the Centers for Disease Control and Prevention (CDC) in 2024. Other criticisms of opioids are that they can be highly addictive and can easily serve as a "gateway" drug through which addicts move on to "harder" drugs, particularly heroin.
The pharmaceutical industry has sparked controversies on several grounds, both in the United States and internationally. These controversies pertain to the expensive and rising costs of pharmaceutical drugs, efforts to conceal health risks associated with certain drugs, and conflicts of interest regarding the relationship between pharmaceutical manufacturers and physicians.
Pharmaceutical companies have established close partnerships with many health care professionals in the United States, leading some observers to raise concerns over alleged conflicts of interest that arise with such relationships. Such conflicts of interest can affect drug trial results, influence medical practice, and undermine patient trust in medical practitioners and treatments. For example, The New York Times reported that 84 percent of doctors nationwide admitted to having a "financial relationship" with either a drug or medical device manufacturer in 2009. In 2013, Pfizer spent $12.6 million on paid speaking engagements for doctors, while Forest Labs spent more than $32 million. One of the most serious allegations of conflicts of interest arose in 2012, when it was revealed that a clinical trial on Avandia (a diabetes drug produced by GlaxoSmithKline) concealed results that indicated the drug greatly increased the risk of heart attacks in consumers. The eleven authors of the trial had each received financial payments from GlaxoSmithKline, and four were company employees and stockholders. The fallout over this incident raised further questions over the New England Journal of Medicine, arguably the nation’s most prestigious medical journal, which regularly publishes articles on the development of new drugs. Of the seventy-three articles on clinical drug trials published in the journal between 2011–2012, sixty trials had been funded by the respective pharmaceutical company and fifty had company employees as authors. This raised alarm over the objectivity and reliability of clinical drug trials, particularly since the objective of pharmaceutical companies is to promote and sell their products.
To increase transparency of financial relationships between pharmaceutical drug manufacturers and medical practitioners, in 2013, the federal government established the Open Payments database as part of the Affordable Care Act. Administered by the Centers for Medicare and Medicaid Services, the Open Payments program requires that pharmaceutical companies and other organizations report payments they have made to practitioners. The data is collected and published annually in a publicly accessible database.
The rising costs of pharmaceutical drugs also came under criticism in the 2000s and 2010s. The Tufts Center for the Study of Drug Development at Tufts University estimated that the cost of researching, developing, and marketing a new drug in 2013 had increased to $2.3 billion. This price tag was triple the cost for 2003. Historically, medical research had been funded by the federal government or research-based colleges and universities, but pharmaceutical companies contend that in a context of declining public funding for their research, companies must pay the costs of their own research, thus driving up the prices of drugs.
Pharmaceutical Drugs Today
The global pharmaceutical industry continued to grow in the 2020s, generating more than US$1.6 billion in 2023. Major pharmaceutical companies in terms of pharmaceutical drug revenue include Pfizer, Johnson & Johnson, AbbVie, Merck, Roche, Sanofi, AstraZeneca, Novartis, GlaxoSmithKline, Merck, Bristol-Myers Squibb, and GlaxoSmithKline (GSK). Pfizer, a manufacturer of COVID-19 vaccine Comirnaty and COVID antiviral medication Paxlovid, saw its sales revenue decrease as demand for both drugs fell.
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