Professionalism/The Durham Fish Oil Trials

Fish Oil Basics

According to the University of Maryland Medical Center, "Omega-3 fatty acids are considered essential" in that they are believe to be integral to human health. What is interesting, however, is that the human body is unable to produce these acids on its own; instead, they are most commonly obtained through food, more specifically in fish, such as "mackerel, tuna, salmon, sturgeon, mullet, bluefish, anchovy, sardines, herring, trout, and menhaden." While it is true that these Omega-3 fatty acids have been around since the dawn of time, recent interest in fish oil supplements have surged in popularity as a remedy to treat "heart disease, high blood pressure, psoriasis, and a number of other ailments." A 2008 survey revealed that 75% of Americans who take some sort of daily multivitamin also take fish oil supplements Additionally, fish oil supplements started to gain national recognition once some people started taking them for use in treating "depression, psychosis, attention deficit hyperactivity disorder (ADHD), Alzheimer's disease, and other thinking disorders." But just what exactly is inside these magic pills?

How Fish Oil is Made and Manufactured

The key ingredient to fish oil supplements is just what it sounds like: oil from certain types of fish that are high in Omega-3 fatty acid oil concentration. The two most notable acids in fish oil that are believed to provide health benefits are eicosapentaenoic acid (EPA) and decosahexaenoic acid (DHA). An understanding of how these acids are harvested from fish and manufactured is important, not only for the sake of being a knowledgeable consumer, but also to ensure again ingestion of harmful or contaminated fish oil tablets which may result from contaminated fish or processing procedures.

Fish oil is manufactured by taking oily fish and cutting it into pieces, which are then steamed and pressed to separate the fat-free solid from liquid. The liquid that is released from the fish consists mainly of fish oil (and all resulting acids from the oil) and water. The solid pieces of fish are set aside and used for other purposes, most often as an ingredient for animal feed; they are not used for human consumption. The collected liquid is then processed to separate the water from the oil. Separation of water and oil is a key step because the water that is separated often times still contains small fishy-solids that can damage or even destroy the intended effect of the Omega-3 acids. Therefore, failure to completely remove all the water from the oil is one way in which defective fish oil tablets may be produced. However, once all water has been removed the oil is processed a second time in an attempt to remove any last-minute impurities that may still be remaining in the liquid. Lastly, anti-oxidants are added to the fish oil to help increase health benefits, as well as for preservation purposes, and the oil is then stored in steel storage containers until it is manufactured into the tiny fish oil tablets that are commercially available in stores.

Quality of fish oil supplements depends mainly on the type of fish being used to gather the oil, in addition to the separation, purity, and enhancement standards listed above used by the plant in the manufacturing process. It is important to note that since fish oil is acquired from fish, it is possible for the fish itself being harvested to be contaminated by pollutants they either ate or were exposed to in the ocean. Therefore, a good test to perform before being committed to taking a bottle of fish oil is to see if a tablet inside tastes "fishy." Lack of a fishy taste often results in toxins or other harmful chemicals in the oil that are destroying its true taste and nature, in which case the entire bottle should be thrown-out and no other tables from the bottle ingested.

Supposed Benefits

According to the NIH, fish oil is most commonly used for conditions related to the "heart and blood system" such as trying to "lower blood pressure or triglyceride levels." Clinical research of fish oil and the human body has yielded the following results:

Effective For

• High Triglycerides: associated with heart disease and untreated diabetes. Doctors believe keeping triglyceride levels below a certain level to maintain a healthy heart.

Likely Effective For

• Heart Disease: Fish Oil may help lower risk of heart disease, though not all research wil agree.

Possibly Effective For

• High Blood Pressure
• Menstrual Pain (dysmenorrhea)
• Rheumatoid Arthritis
• Attention Deficit Hyperactivity Disorder (ADHD)
• Kidney Problems
• Psoriasis

and a myriad of other yet-to-be-proven ailments.

Possible Side Effects

While it is true that taking contaminated Fish Oil can be bad for you, there are currently no proven side affects that could be a deterrent from taking the supplements. The most common known side effects include "a fishy aftertaste, bad breath, heartburn or indigestion, and some other gastrointestinal-related side effects"

The Durham Fish Oil Trials

In Durham, England, the Local Education Authority [LEA] was becoming increasingly concerned about pupils underachieving due problems concentrating and staying on task. As mentioned above, there has been much speculation as to the benefits of fatty acid supplements. Omega-3's are necessary for human health but the body can not make them, thus you have to get them through food. However, the average westerner's diet tends to be low on Omega-3's, and high on man-made trans fats and saturated fats which can increase bad cholesterol among other negative side effects . The LEA clearly had no way of monitoring a complete dietary over-haul for its students, so they decided to use Omega-3 supplements.

The LEA partnered with the Dyslexia Research Trust and Dr. Alex Richardson, whose specialty is on how fatty acids can help with learning conditions. They chose to do a double-blind, six-month long trial throughout the 2002 school year, with a one-way cross over at the mid-point. This meant that neither the children nor those administering the capsules would know whether the child was receiving the placebo or the supplement, and that all participates would be on the supplement for the second half of the study. In order to ensure compliance, the capsules were administered by school staff before classes started, at lunch-time, and before the students went home every day for a total of 1000mg per day, and parents were to administer the capsules on the weekend. All of the participants were selected on the basis that they were not fulfilling their potential at school, though their general ability was normal . The study assessed: reading, spelling, handwriting, drawing, visual and auditory memory, and perceptual skills as well as excitability/hyperactivity, manual dexterity, ball skills, static and dynamic balance and organisational skills.

The children in the active group saw significant improvements in reading, spelling, and behavior compared to the placebo group, and during the second half of the study the placebo group crossed over to fatty acid supplements and saw considerable improvements in the same areas. The study found that "compared to those in the placecbo group, children taking active supplementation made significant decreases in 11 out of 13 behavioral ratings, including features of inattention, hyperactivity, and impulsivity." Though there was no noticeable effect on treatment of motor skills observed, it was concluded that fatty acid suplementation may offer a safe efficacious treatment option for educational and behavioral problems .

Ethical Questions

In September of 2008, Ben Goldacre, a well-known science writer and psychiatrist published an article in The Guardian newspaper decrying the Durham Fish Oil Trials. Dr. Goldacre called the Durham study “possibly the greatest example of scientific incompetence ever documented from a local authority.” While the news coverage of the Durham experiment called what happened a "trial," they later told Dr. Goldacre that they had never outwardly used that terminology. Dr. Goldacre also claims that the researchers in the fish oil trials refused to give him information he had requested under the Freedom of Information Act.

Dr. Goldacre has made a career out of commenting on science to a general audience. In his book, Bad Science, Goldacre looks at scientific studies that he considers flawed, and does a case study analysis in hopes of improving the way in which experiments are designed and executed. He also has a column in The Guardian under the same name as his book, which continues on the theme of pointing out and commenting on what he considers inaccuracies in popular science. A large part of his livelihood, and most of his notoriety, comes from criticizing studies. Therefore, it is not be unreasonable to conclude that he at the forefront of the attack being led against the Durham fish oil trials, if for any reason, to simply to further his career.

While It is intuitive that students who can follow a strict regimen (such as taking a pill every day) are more likely to have success in school due to better discipline and focus. However, the researcher in this particular experiment removed children from the study that did not meet their 80% standard for compliance. This is to say that of the 3,000 children initially in the study, only 629 were used for the analysis. Hence, by switching everyone over to fish oil, the researchers were able to justify narrowing their sample group, possibly for the purpose of removing unfavorable data points who would pose as outliers in experiment data. The results of the study are inevitably inconclusive because they could simply be a correlation with consistency of doing a task (taking daily fish oil tablets) and having good study habits.

Conflicts of Interest

If this study accurately showed that fish oil could help students perform better in school, then naturally, it follows that many concerned parents would begin to put their children on fish oil supplements. This would lead to an increase in the demand for fish oil, and therefore, would drastically increase industry’s profits. Additionally, it is important to note that only one supplier of fish oil was used in conducting this study. Therefore, if this company’s fish oil brand was acknowledged by the study as being a successful tool in improving student effectiveness, parents would be more most likely be more prone to buying the brand mentioned in the study. This would ultimately give the company a competitive advantage and allow for success in achieving a greater market share.

One big criticism regarding this particular trial is that whether or not the Dyslexia Research Trust put pressure on the scientists to find favorable results. Since the Dyslexia Research Trust gets a significant portion of its funds for researching methods to treat dyslexia, the publicity of finding a positive effect of fish oil on dyslexia would increase interest in their organization and therefore, would likely increase their number of donations. The Dyslexia Research Trust was not the only party who would benefit from favorable results, however. In Durham, the local schools' test scores were low, and the city council was under pressure to fix it--fast. If they could improve performance of their students with something as simple as a magic pill, or in this case, fish oil tablets, then there would be hope of regaining trust of its citizens and staying favorable with their voters. In addition to the pressure to find a quick fix for this problem, if the experiment failed then the parents of the students that participated would feel as though their time had been wasted, and the voters would consider their money to have been robbed of them in performing the fish oil trials.

Who Is To Blame: The Scientists Or Society?

In many parts of Western society there exists a culture that believes that every problem can be solved with a pill. Overhauling the students' diet was not an option; neither was providing more special programs for students with learning needs or reducing class sizes. The easiest and cheapest possible solution, therefore, was some sort of pill or vitamin--especially something inexpensive and easily obtained like fish oil. Therefore, the trials may have actually been the by-product of this "pill culture" mentality, reinforcing the notion that the most convenient way to change a student's performance is through digestion of some sort of vitamin. After all, this would be a quicker and easier way of solving the problem than physically changing the student's study habits or work environment.