"Drug Makers' Data on Side Effects Is Called Lacking in a Report"

Andrew Babyak                                                                                   February 5, 2015

Chem C Odd                                                                                       Mr. Ippolito

Thomas, Katie. "Drug Makers' Data on Side Effects Is Called Lacking in a Report." The New York Times. The New York Times, 02 Feb. 2015. Web. 05 Feb. 2015. <http://www.nytimes.com/2015/02/03/business/drug-makers-data-on-side-effects-is-called-lacking-in-a-report.html?ref=science&_r=0>.

            This article states that the records of prescription drugs and the harmful side effects that they cause do not meet the standards that they are required to meet.  This error is a result of the lack of information sent to the FDA (Food and Drug Administration). In several cases, manufacturers do not include the gender or age of the patient, or the time the event took place. And, despite the importance of data in determining the side effects of a prescription drug, the information collected on adverse effects from doctors and patients is voluntary.  The FDA and the manufacturers both provide their own reports so that the data can be compared and contrasted.  However, when the manufacturers submit poor data to the FDA, there is relatively nothing to reflect on.  The manufacturers should have a more in-depth analysis of each side effect that has occurred for the drug that they produced.  This is because “drug manufacturers’ reports account for about 97 percent of all adverse events that are recorded” (Katie Thomas).  The study of the hepatitis C treatment Sovaldi is an important example of how the lack of records can significantly affect consumers.  The hepatitis C treatment, approved at the end of 2013 was an effective drug for patients as well as profitable for manufacturers.  It has cured many patients.  However, even though this seems like such an important drug, Sovaldi’s manufacturer only “included basic information in about 39 percent of the adverse event reports submitted to the FDA” (Thomas).  Recently, Vertex created a similar drug that was contrasted with Sovaldi’s manufacturer.  Vertex’s reports include “reasonably complete information” 71 percent of the time when reporting adverse events.  When the two treatments were contrasted, Sovaldi’s records were not properly detailed, which did not allow the two treatments to be properly contrasted.  One issue that is making reporting even less reliable is the fact that drug companies are often required to report an adverse effect before obtaining the necessary data to determine whether or not the drug used could be to blame.

            The lack of diligence in the reports of the side effects for prescription drugs must be fixed as soon as possible.  If not, the general public and the consumers of these drugs will be significantly affected.  As a competitive swimmer, I am prone to sinus and ear infections.  As a consumer of prescription medications, I need to be made aware of possible side effects in order to make an informed choice for the drug, which is best for me.  If the records are not properly kept on the prescription drugs that I will take to cure my illness, I might be put at a very high risk for an adverse event.

I thought that this article by Katie Thompson overall was a well-written article.  It was very informative as well as interesting. I would never expect drug manufactures not to keep detailed records of the side effects of the drugs they create.  I had to question whether or not drug companies might be under reporting in their own best interest! The article does a great job of establishing both the drug manufacturers' perspective as well as the FDA’s.  Also, Thomas does a good job of presenting the case that manufacturers must keep more detailed records of the side affects that their drugs can cause.  One area that made the article difficult to read was the vocabulary.  I believe that some of the words such as adverse, gleaned and assailed make it difficult for the reader who is in high school to understand the article.  The article should be more directed to the general public, so it is more easily communicated and is not directed to only the mature and adult readers.