My Bad Pharma review aims to exploit the dirty deeds of the pharmaceutical industry. Released in 2012 by Ben Goldacre, it’s still valid today and a lot of malpractice still exists. You’re dealing with a $600 billion industry that has the power to bend the rules, find legislative loopholes and cleverly advertise to the masses.
Ben Goldacre is a doctor himself so it adds so much credibility to this book. You know that he’s been misled by the pharmaceutical industry, attended many sponsored conferences and questioned scientific journal articles. He’s been left in the dark just as much as us. I’m going to summarize the key findings in this Bad Pharma review whilst detailing my honest opinion on medical trials.
It stunned me to understand the power pharmaceutical industries have over testing for new drugs. Naturally, drugs have to go through rigorous analysis before entering the market. Only 20% of all drugs that even make it to the trial phase will be approved for mass manufacturing and market consumption.
But when you discover that 90% of all clinical trials are sponsored by the pharmaceutical industry, it’s no wonder results are biased. Think about it, these companies, although filled with hardworking, intelligent people that genuinely want to do good by the public, are in it for profits as well. These drugs ‘should’ aid in sickness but also make money. They’re public-traded companies that need to impress their shareholders.
So they can influence trial results in ways I didn’t think were possible. Without good random spot-checks from journals, communication and reporting, flawed and biased results will continually be reported. And who bears the brunt of this?
Everyone, including doctors. Physicians will decide what to prescribe based on results from journals. How else can they make good judgments? They can also attend conferences (sponsored by pharmaceuticals) and chat with medical sales reps (sponsored by pharmaceuticals). The harrowing part is finding the pharmaceutical industry has a watchful eye over EVERYTHING in the medical field.
In 2012, an investigation looked to replicate the results from 53 separate trials for cancer treatment in the prestigious journal, Nature. 47 of the tests could not be replicated. What use is this? It seems like such a waste to have redundant drugs on the market.
There is so much confusion around medical trials thanks to the distortion from the pharmaceutical industry. Because they want to make tonnes of money, the trial results have to be published in prestigious journals. The likes of Nature, Science & the British Medical Journal. If the results aren’t ‘exciting’ or they’re mediocre, they may be rejected. As such, the drug companies will literally cherry-pick the best trial. Let’s say they ran 10 tests, 9 of which either failed or produced unflattering results. But ONE of them was successful. It would be only this one result that will be mentioned to the peer-reviewed journals. The other 9 trials are forgotten about, forever.
That doesn’t necessarily mean the drug is unsafe, the chances of that are pretty slim. But the possibility of it proving to be highly successful is low. Plus, most tests are conducted on an unrealistic audience. What I mean is that drug companies will select the perfect ‘test subjects’. As my Bad Pharma review shows, anything to paint a great picture of the drug.
This can prove dangerous because the drugs aren’t being tested under realistic settings. An example was a review for an antidepressant trial, where 600 patients were selected. It was found that only ⅓ were eligible for the trial. And during the application process, 186 patients who would have genuinely made excellent test subjects were rejected on the grounds of illegibility.
You’re excluding the people from the trials that need the drugs the most. Ironic, isn’t it? Another instance was in 2007 with 179 asthmatic patients any only 6% were accepted for the trial. That seems crazy. An asthmatic-reliever drug is being tested on a bunch of people that wouldn’t benefit from them. I’m sure the trial data will show lung capacity is excellent in this case! They’re picking the healthiest, most ideal individuals that aren’t representative of the population. Young with little to no health complications is what they want.
Fluke findings are more likely to be published than ‘boring’ ones, even if they prove effective. A study showed in 1998 that 20% of researchers thought their results would be rejected and were hesitant to publish because it wouldn’t intrigue the publishing journal. This could also be why so much data is withheld. To solve this, all research should be published, whether it’s positive or negative.
We need simpler trials
Simplicity is the ultimate form of sophistication. Research seems to mainly be conducted for commercial gain, which adds more confusion to the mix. We need bigger, simpler trials. Because of the distortion of data, people die because we don’t know which drug is best. There was a case in Nigeria in 1996 where 11 children died no thanks to the pharmaceutical company Pfizer. They had a new trial drug for meningitis called trovafloxacin that was continually being given to the children, EVEN though there was a proven successful treatment: ceftriaxone. The patients were not given this drug and sadly passed away. Shockingly, the case was only settled in 2009 where they were prosecuted by the Nigerian government.
Can you see how complicated the process is? 13 years later those families that mourned the loss of their children were given justice.
One way to make more money is to spend less, and the pharmaceutical industry is great at it.
As discussed selecting very healthy individuals is advantageous, and that’s also because they make the drug cheaper. You don’t need to implement as many safeguards. The risk assessments don’t need to be as thorough, and to make it worse, EMA (European Medicines Agency) state that a risk management document must be drafted. Yet, the drugs company can produce their own. It seems crazy to not have an external provider carry out this analysis as nobody truly knows what hazards have been considered. One thing for certain, it saves the drug companies money.
Is it only the pharmaceutical industry to blame?
It looks like the whole system is to blame. An investigation showed EMA didn’t give out a lot of the trial reports in 2007 and protected the intellectual property of drug companies. How can this be classified as safe or good practice? When potentially life-threatening information is withheld. EMA act as regulators in the medical industry and permit the release of drugs onto the market. Doctors need access to this data, yet EMA withheld it. I suppose they figured the drug companies were more important.
Regulators see all the data and make the final decision on the drug’s outcome – it’s their decision alone. Doctors have no say in it, neither do any other external entities. That’s risky because the data isn’t being analyzed by an adequate number of people. Wouldn’t you rather have more eyes scrutinizing the data? All human beings are fallible; regulators are no exception. I think there should be at least another professional body that can analyze the results so that it’s more representative of the entire population.
Moreover, if EMA decides not to permit drugs publishing, the trial data should still be published. Why withhold this knowledge when we can learn from the mistakes? And even trial data for a permitted drug goes ‘missing’. Drug companies, EMA and any ethics committee should be obliged to publish ALL data, regardless of good or bad results. Trial data that is unflattering is twice as likely to go missing. And there are ethics committees out there with a track record of having unpublished data, yet are permitted to continue their job.
There should be some sort of global register where trial data is published, and you can filter on the year, specific date, drug company, journal, ethics committee or whatever. Either way, it should all be made available. Because right now regulators don’t have this in place, they can publish poor summaries of the drugs (because not enough people, including doctors, can see the data), and even they might not see all the results. Drug companies fund the trials so in the contract they have the final say. If the result doesn’t reflect well on them, chances are we won’t hear of it.
Rather than just taking the regulators word for it, we need free access to the CSR (clinical studies report) to see exactly what happened during trials. That way, when the likes of NICE receive the data (National Institute for Health and Care Excellence), they can provide strong advice on clinical practice, health promotion and such like.
Brian Tracy would be proud. Although a lot of doctors won’t admit it, they’re influenced by medical advertisements and pharmaceutical-sponsored conferences. It does influence their prescribing behaviour, and therefore affects patients. And who knows what degree of truthfulness these ads contain. A study showed only 67% of them had some sort of review. To compound the problem, they’re frequently visited by sales reps.
Don’t get me wrong, they have to put food on their families tables, so I can’t rant about getting rid of sales reps. But the truth of the matter is they have influenced doctors to prescribe a drug that may not be best for the patient, simply because the sales reps are told to sell it. It’s not their fault, they’re just following orders most of the time. But there could be better drugs out there and the doctor has neglected them in favour of this wonderfully pitched drug.
This can easily happen. Drugs sales reps are very well trained and could be the doctor’s prime source of information. There are very few doctors that continue formal education after completion of their medical degree or gain professional qualifications. It’s very hard for them to do so because they’re super busy and with information overload in abundance. Many won’t have time to read countless journals, so why not listen to the sales rep bearing chocolates and flowers?
2.5 million new scientific papers are published each year, and not all of them are medicine, but a fair chunk will be. And doctors can’t go through every trial, so they get the synthesized version from the sales rep. Essentially, the pharmaceutical industry will do anything they can to generate sales through doctors. They’ll pay for advertising space in journals, which is by FAR the biggest source of income for these journals. Subscriptions from their readers (doctors, you and I) amount to much less.
Furthermore, the aim is to build long term relationships with doctors through sales reps and sponsored conferences. They could be taken out for lunch and attend seminars that paint a flattering picture of the drug, sometimes with little quantitative analysis. 29 studies looked at the impact sales reps have on doctors decisions and 17 of them showed they are more likely to prescribe the promoted drug. It’s not showing signs of getting better as drug reps numbers have doubled in the last 2 decades. Hopefully, the Bad Pharma review shows the power of the drug rep.
They’ll even go as far as celebrity endorsements. A notable example is with Rob Lowe, who was removed from NBC for promoting a chemotherapy treatment. I think that whether this treatment is dear to his heart or not, it shouldn’t be happening. He was no doubt paid a handsome fee for his endeavours. Sales of the treatment would start to pour in just because he’s associated with the drug. And branding plays a big role. When you private label something, it instantly become more attractive. How else does Lacoste get away with charging £100 for a sweater, or Nike for £120 trainers? If you affix an aesthetic brand label to a drug, then doctors are influenced by it. They’ll pick this over the generic white bottle that could be a far better treatment.
Besides, if an article is beautifully written, a doctor is more likely to be impressed by the drug. There could be some flaws in the trial data and questionable results, but a doctor may gloss over this if it’s skillfully written. This is called ghostwriting, where professional writers are paid to write medical articles. What’s worse is a professor or doctor’s name will be affixed to the paper and chances are they had very little to do with it! But if it adds credibility to the article they’ll do it. Around ⅓ of all articles are published by commercial medical writers. I suppose it’s just another subtle way to advertise your drugs as part of the $60 BILLION spent on ads every year in the USA alone.
I mean, that’s plagiarism, right? Ben Goldacre made the point that if a university student took credit for work that isn’t theirs (blatantly copied), then they could be severely disciplined. Even kicked off the course. Plagiarism is detected via a system called Turnitin, which universities have used for years to check for honest in students work. Why can’t the pharmaceutical industry use this? Basic checks for honesty and merit should be paramount.
Can we have it cheaper?
We’ve touched on how drug companies can save money already, but there’s another startling way they do so. Increasingly, trials are being conducted overseas. Why? Because it’s cheaper. However, it’s rather dangerous to do so because a drug may be tested in a country that it won’t even be marketed in. For example, GSK has moved half of all trials to low-cost countries, such as Southeast Asia. And if the drug is only available in the Western World, it doesn’t stack up because these countries have TOTALLY different gene pools, hygiene levels and health & safety standards. It obscures the results.
You see, people are different across the world. Is depression the same for someone in China compared to a UK-native? We metabolize drugs differently. Thus, drugs are being produced with an intended audience in a different continent, and notable differences on how our bodies process the drug.
More than half of all clinical trials for the U.S. are conducted elsewhere and is falling at a rate of 6% every year, and 10% in the UK. In 2008, CROs (contract research organization – the team that will research clinical test) carried out 9,000 trials in 115 different countries and on 2,000,000 people. If it costs the U.S. $30,000/patient in their home country and $3,000/patient in Romania, which do you think they’re opting for?
Bad Pharma Review Conclusion
All of the statements in this book are comments made by Ben Goldacre himself. I’ve just repackaged them in my own words. I found the book fascinating and wanted to write a summary of it. I hope you this Bad Pharma review informative. Purchase it from Waterstones if you like.
Also, check out my other review posts here.
Goldacre, B. (2012). Bad pharma. [Old Saybrook, CT]: Tantor Media, Inc.