Dr. Richard Mabry: This Little Pill Went to Market

Monday through Wednesday this week we're celebrating Dr. Mabry whose fourth novel is coming out this week. Leave a comment on any of his posts and you'll be eligible to win Diagnosis Death and a signed copy of Lethal Remedy! Must live in the US. Winner will be drawn Friday, October 7th, 2011 at midnight and announced Saturday, October 8th!

                Welcome back, Richard!

                Ever wonder how that pill or capsule you just took came into being? It’s a complex process, and one that the average consumer never considers. As I often said when I was still practicing medicine, most patients don’t care how it’s done. They just want to be well, and they’d prefer it occur retroactively.

Sometimes accidents lead to great discoveries. The prototypical event was the discovery of penicillin by Sir Alexander Fleming. He was a great researcher but a poor housekeeper, and returned to his laboratory on September 8, 1928, after a month’s holiday to discover in the midst of a pile of Petri dishes that one of his bacterial cultures was contaminated by a fungus, and that the bacteria hadn’t grown in the area of the fungal colonies. After calling the substance “mould juice” for a while, he eventually named it after the fungus, which was Penicillium notatum. However, it wasn’t until 1941 and the outbreak of World War II that the work of Florey and Chain allowed penicillin to be mass-produced in order to treat war wounds.

  Things are different now. Every major pharmaceutical company has huge sections and large budgets devoted to R&D—research and development. Exact figures aren’t readily available, but it’s generally accepted that most new compounds never progress beyond the Phase I stage. By the time some of them do eventually make it through all the necessary steps, there’s been a massive amount of time and money invested in them. That’s why pharmaceutical companies are anxious to recoup their investment and make a profit before their patent on the preparation expires and the generic manufacturers—often derogatorily referred to as the “me too” companies—take advantage of the opportunity to produce the same medication without all the R&D costs. Patents are generally filed early in the development process, because although they typically run for twenty years, the drug may not reach the market until a lot of that time has expired.

 Bear in mind that before reaching the stages of human testing, drugs have been tested in the laboratory using a variety of animals. Only if they pass these tests do they enter into the phases of human trials necessary to seek eventual approval for marketing. (http://www.nlm.nih.gov/services/ctphases.html) 

In a Phase I trial, researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify adverse effects. Most drugs never make it beyond this phase, generally because of side effects. This is when the company must consider a decision to scrap further research on that compound, even though time and money have been invested in its development.

If a drug makes it to the Phase II trial, it’s given to a larger group of people to determine its effectiveness and observe for adverse consequences. There’s still not been a comparison with other known effective drugs. The emphasis is on safety and effectiveness, although some dose-ranging tests may occur, determining the lowest effective dose without side effects.

Phase III is the true test of the drug, because at this point carefully designed studies compare it with a known and already approved compound for effectiveness, still watching for adverse effects and frequently using different dosages to determine the optimum one. Following successful Phase III testing, an extremely detailed application is filed with the Food and Drug Administration. (http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/NewDrugApplicationNDA/default.htm)

            After the drug comes to market, testing isn’t finished. Pharmaceutical companies continue to gather reports from physicians about the drug’s effectiveness and—most important—any adverse reactions. This Phase IV testing is the reason patients are urged to report problems with their medications to their doctors. Minor side effects such as nausea are common. But severe side effects send up a red flag. This occurred when a popular antibiotic class turned out to be the cause of tendon ruptures in a significant proportion of patients treated with it. Phase IV reports can result in anything from a “black box warning” on the information that accompanies the prescription to withdrawal or modification of the offending compound (as happened with an antihistamine that posed a heart rhythm problem to certain patients).

            So the next time you take a pill or capsule, know that a lot of effort has gone into its development. And, if you wonder whether everyone involved in the process played fair and reported all their results accurately…well, they undoubtedly did, but what if they didn’t? That’s the premise of my next novel, Lethal Remedy. Hope you read it and enjoy it. (http://www.amazon.com/Lethal-Prescription-Trouble-Richard-L-Mabry/dp/1426735448/ref=sr_1_1?ie=UTF8&s=books&qid=1305904911&sr=8-1)

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Dr. Richard Mabry built a worldwide reputation as a clinician, researcher, and teacher before retiring from medicine. His published series, Prescription for Trouble, under Abingdon Press includes Code Blue and Medical Error. Diagnosis Death released today! Dr. Mabry is also current Vice President of the American Christian Fiction Writers group. You can learn more about him at his website and follow him on his blog.