When we are sick, we go see a doctor and trust that they will give us the medicine that we need to recover. The doctor knows what medicine to prescribe based on our medical history and the effectiveness and safety of the drug. The details about the efficacy and safety of the drug are supplied by medical trials and pharmaceutical reps. This entire system is based on trust. We trust doctors and doctors trust science. But what if the basis of this trust was all a lie?
Unfortunately, pharmaceutical companies have become increasingly dishonest when it comes to drug trials. Instead of following proper scientific practice, they instead make the drugs look much better than they actually are. Between not providing all the data and purposely imposing flaws in methodology, pharmaceutical companies have become like any other corrupt corporate chasing profits.
In this book summary readers will discover:
- The four major problems associated with drug trials
- Regulatory mechanisms are quite simply, ineffective
- How treatment decisions are influenced
- The possible solution to problematic drug trials
Key lesson one: The four major problems associated with drug trials
Drug trials aim to prove the efficacy of a drug. This will let everyone know that they are working and that there are no adverse effects. Well, this is what we would hope they did. The truth, however, is that there are many problems associated with these trials – problems that inevitably skew results to favour pharmaceutical companies.
Industry-funded trials are biased
Firstly, most of these drug trials are funded by the industry themselves. Studies have shown that when tested by the industry, approximately 85% of drugs yield positive results. In contrast, drugs trials funded by the government yielded positive results in about 50% of their trials. This just goes to show how industry-sponsored trials are biased. To give you an example of how these trials skew data to gain positive results, consider Pfizer’s trials of the proposed pain medication, Pregabalin. The trial was designed so that researchers would measure the pain experienced by participants at regular intervals. As with many other medical trials, a number of participants left the study early because of the negative side effects they experienced when using the drug. So, what did Pfizer do? Do you think they reported how many people left and the side effects they experienced? No, they did not. Instead, Pfizer took the last pain measurement recorded for the participant and used it for the remainder of the trial. This not only disregarded the negative side effects of the drug but also made the drug seem much more effective than it really was. The analysis of the data was eventually re-done following the correct methods and the original results overestimated the efficacy of the drug by approximately 25%.
Publication bias further exacerbates the problem
The second problem with drug trials is linked to the first. Not only are industry-funded drug trials biased, but they also withhold negative trial data and only publish positive results. This is known as publication bias. Once again, Pfizer provides a prime example. It conducted seven drug trials with the antidepressant, Reboxetine. In all seven trials, the effect of reboxetine was compared to the effect of a placebo. Six of these trials resulted in there being no difference between the patients given the drug and those given the placebo. One trial yielded positive results and was thus published. Results of the other six trials were not taken into account nor heard of until the results of an investigation were published in 2010.
Commercial bias also exists
In drug trials, scientific research is not free from commercial bias. This is an implication of business becoming more and more entangled with research and trials being conducted by clinical research organizations. These organizations reduce the cost of trials by outsourcing to poorer countries which brings up some ethical questions. The biggest problem being the clear deviation from the Declaration of Helsinki which stipulates that trial participants should come from a population that could benefit from the results of the trial. So, testing an expensive drug on participants from poorer countries is a clear violation of the declaration. The participants would be unable to purchase the drug if it were successful. But clinical research organizations continue to outsource trials to poorer countries due to the cost savings. Furthermore, the drugs reputability can also be questioned depending where in the world and on whom it was tested. For instance, high blood pressure medication tested in India could differ in efficacy in patients in Europe due to the vast differences in lifestyle, eating habits and access to medicine.
Currently, medical trials have too many ways in which they can be misconstrued
There are many ways in which a medical trial can go wrong. The length of the trial could be wrong, patients could be mispresented, it can even be analyzed wrong. Worst case scenario, results could be fraudulent. This was found to be the case with American anaesthetist, Dr. Scott Reuben. He made up all the data he published regarding clinical trials on pain for over a decade! Another reason trials fail is because they do not consider real patients as participants. Instead, patients used in trials have no complicated medical histories and are not on any other medication which is hardly the case in real life. Therefore the results gained in these trials are never representative. The last issue with drug trials that needs mentioning is that they are tested against ineffective competitors. This makes the drug tested look good in comparison.
Key lesson two: Regulatory mechanisms are quite simply, ineffective
As much as trials are problematic, the regulatory mechanisms that follow are none the better. They are essentially put in place to approve the drugs after trials but before they are sent out to stores. Unfortunately, this never goes according to how it’s supposed to.
Firstly, government regulators are not paid well, however, their insider knowledge is something that is highly valued by pharmaceutical companies. This means that regulators could get paid more if they leave their government post and work in the private sector. As much as this seems like a logical move, regulators who move to the private sector tend to try to prove their worth by getting more drugs approved by using what they know. This is a major conflict of interest but one that continues unhindered, especially since regulatory requirements are so low.
When a new drug is released, the only thing everyone is interested in is if it works better than what is currently available. And, unfortunately for us, most of the time the answer is no. Current regulatory requirements only need the drug to be better than nothing at all. This means that it doesn’t have to be compared to other drugs.
Key lesson three: How treatment decisions are influenced
Did you know that pharmaceutical companies spend approximately twice as much money on marketing as they do on research and development? They see it as the ultimate opportunity to convince doctors of the efficacy of their drugs. Doctors rarely have time to go through new publications regarding new drugs which is why drug reps play such an important role. They are able to approach doctors directly and are known to be hired for their attractiveness and sales abilities. They are also famous for visiting doctors with gifts from the company with promises of a new and exciting drug that will change everything.
Pharmaceutical companies also invest in placing ads in academic journals. While these ads are meant to be objective, studies have shown that this was only true in less than half of these ads in medical journals. Drug companies are prohibited from directly advertising to patients and therefore use some carefully planned tactics to retain their positive image. They fund patient groups and pay celebrities to mention the names of their products. This is a powerful marketing tool for pharmaceutical companies with companies in the US spending as much as $60 billion per year!
Key lesson four: The possible solution to problematic drug trials
So, is there a possible solution to this problem? Randomized trials that are conducted in medical practices could be the answer. If you wanted to compare two drugs that are meant to do the same thing, general practitioners could actively choose to participate in a trial and have the drug randomly assigned to the patient. The doctor would then check up on the patient to check the drug’s effectiveness.
If this type of system were to exist, the data collected would be able to give us an accurate idea of the drug’s efficacy. Also, it would be conducted by doctors themselves and will hopefully eliminate any bias that would occur. But, to summarize, it would solve three problems.
Firstly, it would provide data from real patients and therefore be completely representative. Secondly, it would cost a lot less than current drug trials as they would be conducted during consultations with a doctor that would have to happen in any case. And lastly, the results would be irrefutable as the data collected would be from representative patients and without any bias.
The key takeaway from Bad Pharma is:
Nowadays, drug trials are not as scientifically accurate as they should be. They are heavily influenced by pharmaceutical companies who are sadly, just in it for the money. There are a number of problems associated with drug trials that lead to results looking much better than they actually are. In addition to this, the regulatory mechanisms that exist are not sufficient. If we want to ensure that everyone gets the medicine they require and deserve, the way in which drug trials are conducted need to change. We need pharmaceutical companies to care more about the lives they are affecting and less about the money to be made.
How can I implement the lessons learned in Bad Pharma:
Don’t be afraid to ask questions about the medication your doctor prescribes. Sometimes it’s worth having a conversation about the medication you will be taking and the possible side effects that may occur. It’s also perfectly acceptable for you to do some research on your own. The negative results may not be clear but there will be others who will complain if there are any problems with the drug.
