Pharmaceutical industry in the 2000s
The pharmaceutical industry in the 2000s experienced significant growth, driven by an aging population, advancements in technology, and global competition. This decade saw a strong emphasis on research and development, leading to a wide array of new medications for various health conditions, reducing the reliance on invasive procedures. However, the industry faced numerous legal challenges regarding the safety of some drugs, with high-profile cases emerging over medications like Vioxx and the Ortho Evra birth-control patch, leading to substantial lawsuits against major pharmaceutical companies.
Developing a new drug is a lengthy and costly process, often exceeding $1.3 billion and taking an average of twelve years, with only a small fraction making it to market. Drug companies must navigate several stages of testing, including preclinical research and multiple phases of clinical trials, before seeking regulatory approval from the FDA. Despite the industry's contributions to healthcare, it has also been criticized for inadequate testing and aggressive marketing practices that may promote unnecessary medications. Overall, while the pharmaceutical industry has made significant strides in improving health outcomes, concerns about drug safety and ethical practices have prompted ongoing scrutiny and debate.
Pharmaceutical industry in the 2000s
The industry that researches, develops, manufactures, and markets prescription and over-the-counter drugs earned enormous profits and drew criticism throughout the 2000s
The United States has the largest pharmaceutical industry in the world. Fueled by the aging population, technological advances, and global competition, the industry expanded tremendously in the 2000s. Research and development continued to grow during the decade. The pharmaceutical industry was affected during the 2000s, however, by numerous lawsuits regarding the safety of medications.
The pharmaceutical industry has created an abundance of different drugs to treat an array of ailments. Because of this, many health-care providers began to rely less on invasive surgeries and other procedures and more on treating ailments with prescription medications. The pharmaceutical industry came into the forefront during the 1980s and 1990s as it focused on developing more drugs, including those to treat cancer, heart disease, and AIDS. During the next two decades, pharmaceutical companies relied heavily on research and development of new drugs and various ways to market and distribute them.
Billions of dollars go into the research and development of new drugs each year. The high cost is due to the high risk involved and the many steps pharmaceutical companies must take to develop and test new drugs. Creating and developing a new drug cost more than $1.3 billion in 2005, according to the US pharmaceutical industry’s advocacy group Pharmaceutical Research and Manufacturers of America. In addition to the high cost, time is a factor when developing drugs. It takes an average of twelve years to develop a new drug, and while patents exist for medications, they typically only last twenty years. Other drug companies can release generic versions of name-brand drugs once a patent expires. Also, research is expensive because only a tiny percentage of newly developed drugs make it to clinical trials, and even fewer reach the human testing phase. Only about 10 percent of all new drugs make it to human testing, and only 2 percent will be approved for use. Many scientists—including biochemists, chemists, molecular biologists, pharmacologists, physiologists, statisticians, and toxicologists—are involved in the research of new drugs. They are needed to study every aspect of a drug from its makeup to how it works.
New Drug Development
Drug companies must go through several stages to develop a drug. During preclinical research, scientists research diseases and ailments and develop experimental drugs to combat these diseases and ailments. These experimental drugs are then tested in laboratories and animal studies. After this step is complete, the drug company must file an investigational new drug application (IND) with the US Food and Drug Administration (FDA), which monitors and regulates the pharmaceutical industry. If the IND is approved, the drug company can move to clinical trials.
During phase I of the clinical trials, drugs are administered to a small number of patients, and the safety and tolerability of the drugs is studied. If successful, the drug moves to phase II, which tests the effectiveness of a drug. During this phase, researchers determine many factors about the medication, including its safety and risks as well as its dosage. If the drug is deemed effective and safe, it will move to phase III. During this phase, the drug is administered to a larger number of people to confirm its safety and effectiveness. After these steps are complete, the pharmaceutical company must file a new drug application (NDA), which contains all of the information regarding the new drug. If the FDA approves the drug, it can be made and distributed. It must also undergo phase IV of the process, in which drug companies continue studying a drug to determine if any long-term side effects exist.
Drug Safety and Lawsuits
Throughout the 2000s, many lawsuits were filed against pharmaceutical companies regarding the safety of certain drugs. Sometimes through continued research, drug companies find that their drugs have harmful side effects that were not apparent during the initial testing. This was the case with pharmaceutical giant Merck and its painkiller Vioxx. The company found that those taking Vioxx showed an increased risk of heart attack and stroke, so it pulled the drug off the market in 2004. In 2007 the company settled thousands of lawsuits concerning Vioxx. The following year, Johnson & Johnson settled hundreds of lawsuits filed by patients using the Ortho Evra birth-control patch. The lawsuits claimed that the patch caused blood clots, heart attacks, strokes, and death in some cases. Other lawsuits during this time questioned the safety of drugs such as Wyeth’s Prempro and Premarin hormone-replacement drugs, AstraZeneca’s antipsychotic drug Seroquel, and Pfizer’s antiseizure medication Neurontin.
Impact
The pharmaceutical industry has had many positive as well as negative impacts on American consumers and physicians. It has developed many drugs that have greatly improved the quality of life for those suffering from diseases and ailments. It continues to research and develop drugs that in the future could impact those suffering from incurable diseases, such as AIDS. The industry has been blamed, however, for not fully testing drugs that have been found to have harmful side effects, including death. It also is often criticized for pushing unneeded drugs on Americans through aggressive marketing and advertising campaigns.
Bibliography
California Biomedical Research Association. “Fact Sheet: New Drug Development Process.” California Biomedical Research Association. California Biomedical Research Association. Web. 30 Nov. 2012. PDF file. A fact sheet explaining the new drug development phases.
Gavura, Scott. “What Does a New Drug Cost?” Science-Based Medicine. Science-Based Medicine, 14 Apr. 2011. Web. 30 Nov. 2012. An article exploring the costs of developing new drugs.
Helfer, Adam. “Drugging America: The Drug Industry Exposed.” Washington Times. Washington Times LLC, 27 Mar. 2011. Web. 3 Dec. 2012. An interview with a former pharmaceutical representative who speaks critically of the industry’s aggressive marketing tactics.
Schmit, Julie. “More Drugs Get Slapped with Lawsuits.” USA Today. USA Today, 23 Aug. 2006. Web. 1 Dec. 2012. Describes recent legal challenges to a number of pharmaceutical companies.
Wadman, Meredith. “Merck Settles Vioxx Lawsuits for $4.85 Billion.” Nature. Nature Publishing Group, 13 Nov. 2007. Web. 30 Nov. 2012. This article describes the legal challenges to Merck regarding the side effects linked to Vioxx.