Vioxx and Merck and the FDA, oh my!

jmstuart's picture

 Julia Stuart

Biology 103
Web Paper #1
The Vioxx Controversy
 
In the scientific world, absolute truth can only be found by repeating an experiment an infinite number of times. With this fact in mind, scientists as a community must accept that their current theories can never be completely true, but just another step in the process of explaining the world. However, how does this view of the scientific process impact the search for vaccines and medications for disease prevention? When is a medication or vaccine “safe enough” to be used? In the United States, the population depends on a combination of pharmaceutical companies, the Food and Drug Administration, and health care professionals. The Food and Drug Administration (FDA) has the final say in which drugs-both prescription and over the counter-can be sold in the United States. In order to decide what is allowed to be put onto the market, the FDA looks at clinical trials, animal testing, side effects, and the manufacturing process of the drugs, as well as continuing to monitor the medication after its initial approval. (1) The two aims of the FDA are sometimes conflicting, because they are responsible for both ensuring the safety of new treatments as well as making sure cures are accessible to people in need as soon as possible. For example, Vioxx, an arthritis medication, was withdrawn from the market after six years and after more than 20 million Americans had taken the drug. (2) In the end, how much responsibility lies with the regulators such as the FDA and pharmaceuticals as opposed to doctors and consumers?
Looking specifically at the controversy caused by Vioxx provides an inside view into the way America’s drug testing system functions. Vioxx was meant to be a drug used to combat arthritis pain, as well as other common symptoms such as cramps and fever, but without the gastrointestinal side effects sometimes found with other pain relievers. Because this drug was so widely marketed, the  discovery of dangerous side effects became a very high profile indictment of the drug approval system in the United States. The case study that proved the link between Vioxx and cardiovascular problems such as heart attacks and strokes attributed around 27,000 heart attacks or cardiac arrest to the usage of this drug. (3) In 2004, Merck, the company that produced Vioxx, voluntarily recalled their product. (4) However, the debate that this situation spawned included whether FDA was too passive in their approach to a clear case of risks to public health associated with this medication, or whether Merck itself launched advertisements minimizing the potentially deadly side effects known to be associated with the drug. 
Pharmaceutical companies can have an essential conflict of interests when marketing potentially dangerous drugs. The profits at stake must also be taken into account in order for the corporation to survive and compete. This is essentially the reason for the FDA’s existence: to provide a government service working solely to ensure the safety of the American people. This is only the ideal, however. The actually efficacy of FDA guidelines depends on many factors, including unbiased medical studies and the amount of regulatory power they are given over the drugs available to consumers. After the Vioxx incident and many other smaller cases like it, Congress passed measures that allow the FDA to require further clinical testing and forcing companies to include certain information on the label. (5) Some even want the power of the FDA to extend even further, giving the agency power to recall medications. Is this one governing body enough to ensure the safety of patients though?
As with any medication or treatment, the potential benefits must be weight against the observed negative effects. Even though many guidelines exist in the medical community, at some point the arbitrary nature of drawing the line between “safe” and “unsafe” becomes difficult to determine. The essential conflict in the pharmaceutical business is that the science and the financial goals may not always align. Further strengthening of the FDA is mainly needed to enforce safety regulations as determined by the best information available, but also to make sure that research is open to the people most directly affected by the drugs. Ultimately, and especially with the power of the drug lobbies in Washington, it’s impossible to regulate ethicality, meaning that consumers will always be at some risk. Health is uniquely precarious in the scientific world because the failure of a medication can have such devastating and calculable human costs. The challenge of deciding when science is “right enough” to aid the public is augmented by the political and financial struggles of science as a business. Situations such as Vioxx’s failure, while unfortunate, can potentially lead to greater awareness and hopefully a better future solution.
Sources:
 
(1) http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/default.htm
 HYPERLINK "http://www.npr.org/templates/story/story.php?storyId=5470430" http://www.npr.org/templates/story/story.php?storyId=5470430
 HYPERLINK "http://www.ahrp.org/infomail/04/10/12.php" http://www.ahrp.org/infomail/04/10/12.php
(4) http://www.merck.com/newsroom/vioxx/
(5) "Expansion of FDA oversight power sought.(FROM THE HILL)(United States Food and Drug Administration)." Issues in Science and Technology 24.2 (Wntr 2008): 17(2). Academic OneFile. Gale. Library of Michigan. 28 Sept. 2009 
< HYPERLINK "http://0-find.galegroup.com.elibrary.mel.org/gtx/start.do?prodId=AONE" http://0-find.galegroup.com.elibrary.mel.org/gtx/start.do?prodId=AONE>.
 
Other Sources:
 HYPERLINK "http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106290.htm" http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm106290.htm
 
 HYPERLINK "http://www.medilexicon.com/drugs/vioxx.php" http://www.medilexicon.com/drugs/vioxx.php
 
http://seattletimes.nwsource.com/html/localnews/2004350606_webvioxx16m.html

Comments

Paul Grobstein's picture

drug development: what can/can't be expected from it

"The challenge of deciding when science is “right enough” to aid the public is augmented by the political and financial struggles of science as a business."

Maybe there are two separate issues here?  One is the issue of both drug development and "science as a business."  And the other is making consumers (and drug companies and regulators) aware that "absolute truth can only be found by repeating an experiment an infinite number of times," ie that it shouldn't be expected to exist?  

You've clearly touched on matters of concern to lots of people, as per below.  Yes, of course, drug companies are inclined to err on the side of profits.  Maybe though its the first issue that's more generally important?   For more on the role scientists might/perhaps should play in all this see Science and Public Responsibility

Anonymous's picture

Merck recently lost its

Merck recently lost its appeal on a jury award of more than $4M: http://www.newsinferno.com/archives/13175#more-13175

Anonymous's picture

Vioxx was responsible for the

Vioxx was responsible for the deaths of more than 3,000 people, according to claims on the $4.35 billion pool for those injured by Merck's drug: http://www.newsinferno.com/archives/13126#more-13126

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