more_vert
FILMS such as Side effects and Love and other Drugs satirise the pharmaceutical industry, presenting it as corrupt, aggressively profit-seeking and devoid of sympathy for patients.
Lighthearted though these films may be, they do seem to capture prevailing views held by many in the medical profession. A recent debate in the BMJ went so far as to liken pharma to the tobacco industry and questioned whether journals should publish research funded by the drug industry, given the controversy over its integrity.
As a doctor who has worked in the pharma and medical device industries in Australia in recent years, my experience suggests we should reassess these views.
Cases of fraudulent activity by pharma have been widely publicised. But does the whole industry deserve to be tarnished?
In Australia, the promotion of prescription medicines is highly regulated. The industry operates under a self-governing code, the Medicines Australia Code of Conduct, which is authorised by the Australian Competition and Consumer Commission (ACCC). Member companies face significant fines (and, possibly, reputational disrepute) if found to be in breach of the Code’s standards for the ethical promotion of medicines.
The Code is revised periodically, becoming stricter at each iteration. For example, the next amendment is likely to require member companies to improve disclosure of payments made to doctors — an onus which was previously left on recipients to declare when deemed required.
Punitive measures for regulatory breaches seem an effective deterrent — regardless of motive, no employee wants responsibility for bringing such action upon the organisation. Company practices are frequently audited — by both internal and external parties — to ensure compliance with the myriad applicable regulations. Such is the extent of this control that companies often have entire departments dedicated to ensuring compliance.
In my experience working in medical and marketing departments in the pharma industry, promotional materials and campaigns were subject to rigorous internal scrutiny to ensure they were supported by the best available data. Off-label promotion was prohibited, regardless of the available evidence.
The evidence itself? Yes, much of it is funded by pharma but regulators, including the US Food and Drug Administration, the European Medicines Agency and the Therapeutic Goods Administration, demand certain studies are undertaken before they will approve a new product.
If pharma didn’t fund these trials, who would? What would happen to innovation?
It has been observed that research funded by pharma is more likely to report a positive outcome than unfunded research. This is not surprising, since less promising compounds are unlikely to attract the interest of the industry and progress through the development cycle.
Investigator bias is certainly possible but is not confined just to pharma. In fact, a recent study suggested that retractions due to misconduct were actually less likely to be funded by pharma than those that did not declare such support.
Regardless of the funding source, clinicians should always scrutinise research outcomes.
An unfortunate consequence of the strict regulation of the pharma industry is the implied notion that without these constraints, the devious motives of the industry would flourish. But just as not all doctors enter the profession “to help people”, not all pharma employees are driven by the acquisition of money and success at any cost. I’ve met many people in the pharma industry who are actually motivated by positive patient outcomes.
Perhaps at the root of this misperception is that pharma is an isolated commercial player in an environment where the majority of stakeholders (doctors, regulators, patients) are all publicly funded. Inherently, each does not understand the other.
However, if the right medicines are used in the right patients with positive outcomes, isn’t this mutually beneficial for all parties?
I’m not suggesting we blindly trust pharma. It is important for doctors to maintain some degree of scepticism and ensure they make their own informed decisions — as they would for any other purchase.
The representative sitting in your waiting room is not necessarily a wolf in sheep’s clothing. They might just have the same aspirations as you.
Dr Christine Gee is a deputy medical editor of the MJA, who has worked in the pharmaceutical industry.
Loading ...
Dr Gee does not mention the book Bad Pharma by Ben Goldacre
She should acknowledge
FDA and TGA are funded by the industry they regulate
They are reluctant to release data to independent investigators under the mantra of commercial in confidence
There is plenty of data showing witholding of studies with negative results
Peer reviewed journals are supported financially by the drug industry
The whole profession bears responsibility for not acting to modify the behaviour of the industry
In the end money talks
Thanks for the article. Certainly there are profit motives in pharmaceutical manufacturing – otherwise it would be unsustainable. Poor business practices do exist, and they should be minimised. Clinicians should get their pharmaceutical education from unbiased sources. None of this, however, means that pharmaceuticals are all ”bad”, nor that manufacturers of unnecessary supplements, herbal or homeopathic ”remedies” are any more ethical. IN fact, the opposite is generally true – generating profit without efficacy.
“Anonymous”. All information about a drug is available in the form of the Product information. The PI is a legal document and must be approved by the TGA. As I said, hospitality, travel is now severely restricted to stop outlandish request from repeat offender for s/ships. Uncle Tom I was up late last night because I am on annual leave at the moment, so what time I am up is really none of your business, and how it adds to your argument I really have no idea. 1. Here is a copy of the “Human Research Ethics Committees and the Therapeutic Goods Legislation”. 2. Q’s on C/trials?,a clinical trials nurse would be a good start, ask about data collection, scrutiny and reporting. 3. The media do what they want. 4. Re GPs, reps are not allowed in many practices unless they provide a coffee, tea or lunch. The request comes from the Dr’s! The Reps tell me if they never did another lunch they would be over the moon, it is a waste of time and money in most cases. If you are concerned about how Pharma operate, why not put your hand up for the “transparency working party” that Medicines Australia initiated, or about pharmacovigilance post marketing of medicines – http://www.tga.gov.au/safety/australian-pharmacovigilance-sponsors.htm I expect you will read none of this. Your choice. I just get sick of uneducated and biased people such as yourself.
We will put the “uneducated cheap shot” down to a careless slander at 1.16am.
if that much has been invested in a medical device or pharmaceutical, then the necessity to recoup expenditure means that:
1. trials will be designed to show a benefit
2. data will be mined to tease out positive differences
3. If that fails, a media release will showcase this ‘new breakthrough’ so that patients ask for it
4. Reps will persuade doctors that this is new and great and it really is best practice now, and you should catch up with what all your colleagues are doing and is that focaccia to your liking I can bring something different next time
When push comes to shove, shareholder returns is priority one; designing useful medicines or devices is the means to that end, but that’s as far as altruism goes.
My advice to students is: get your pharmacologic advice from independent sources, not drug reps; ask yourself when tempted to eat drink or travel courtesy of pharma-“what would my patients think of this”; research needs pharma, patients need clinicians- the 2 can work well together as long as there is a middle man.
Interesting comment ” Pharma research is rarely innovative” poster.
You use the ICU as an example of where there is little contribution from Pharma in life saving medicines, that is most remarkable.
The Meningoccal B vaccine has been recently TGA approved. This vaccine took 20 years to develop with a huge investment fom Novartis. If you work in the ICU you will appreciate, as with other vaccines that serious and life threatening invasive infections can be a thing of the past, greatly reducing the patient load in ICU, not to mention the dreadful suffering of patients.
This is just one example. There are better chemotherapy agents, transplant drugs, and powerful antibiotics and antiviral medications used in ICU that pharmaceutical companies have spent years in developing. Along the way there are many failures that don’t get past phase 2 of trials, the money invested is lost too.
As for Medical Device, if it is shown to have no benefit, the Hospital committees that make decisions on purchasing capital equipment simply won’t buy it without good evidence.
As I said in my above post, those who complain about the Pharma industry, do not see Reps, and never take the time to understand how Pharma really operates. The old ‘ they are only in it for the money” is an uneducated cheap shot.
The bulk of innovative research is government funded. There’s no money in it. Useful clinical research on established drugs, particularly for ICU use, is government funded in Australia and also France. Vital data on adrenaline, noradrenaline, dopamine, albumin and other out of patent but widely used drugs usefully guides patient care. Big pharma research is often trivial, as is well documented. Most sponsor stands at a recent critical care conference were for ultrasound machines and devices. Sadly, one of those devices had been shown just that week to provide no patient benefit, in the recently published ProCESS trial (also government funded). Big Pharma takes over when there is money to be made, not for innovation.
Thanks Christine for your article.
Working in the Pharma industry for the past 25 years, I have seen great changes in transparency and a very effective, enforced Medicines Australia Code of conduct.
I for one, as are many of my colleagues, extremely pleased the industry has tightened up on the way medicines are promoted, the ceasing of “brand reminders” and the tightening to almost nonexistence of sponsorships to health professionals.
Prior to these changes in recent years many of us were seen as a walking “show bag” or in some cases the same doctors year in year out asking for money for a conference they “needed to go to”. The industry had their hands tied to some degree in asking for some type of return for sponsorships as the industry cannot simply cannot ask that, and this type of Dr’s were aware of that , and sourced funding from every company possible.
Today thankfully, any sponsorship must adhere to very strict enforceable regulations; any promotional activity has to be reported to the ACCC within 10 days of an event, including any costing’s of food and drink which is capped and not extreme.
Those who still complain about the value of education and information on medicines the Pharmaceutical industry make available for them, so they can treat their patients with new and effective treatments, are usually ones who do not see Reps anyway.
And that is fine by me.
Dr Gee is quite right to point out how much we owe the pharmaceutical industry for the tremendous advances in therapeutics in the last two centuries. She is also right to warn us of the importance of maintaining our own independent scrutiny of published research outcomes. This should be the main function of institutional Journal Clubs.
Clinical research sponsored by pharmaceutical developers is usually conducted to the highest possible standards. Every piece of paper generated in the research must be available for scrutiny by regulators in the USA, European Community and Australia. Every variance from good research practice provides another reason to reject or modify the approval requested – at huge expense to the drug’s sponsor. The material published in the peer-reviewed literature is only a small sub-set of this vast amount of data. The International drug trials registers provide us extra assurance of honest reporting.
No, the Pharma rep is not a wolf in sheep’s clothing, but rather a fellow professional. But the Corporation they represent has a legal duty to its shareholders to trade profitably. In the case of innovative new medications, the corporation has the patent life of the drug in which to re-coup its multi-billion dollar investment in the research, development and regulatory approvals process behind the drug. It is human nature to go as hard as possible for the goal.
I have seen some egregious examples of pharmaceutical companies ‘buying’ the support and influence of my colleagues. Every time I saw it I was filled with shame. It is still happening, and not just in pharmaceutical companies. Some of the worst perpetrators are the device manufacturers.
Naive apologists for the abuses perpetrated by the pharmaceutical industry should also read a new book entitled “Deadly Medicines and Organised Crime: How big pharma has corrupted health care” by Dr Peter Gotzsche published in 2013 by Radcliffe Publishing. The author too has worked within the industry!! MJA Insight should be embarrassed for having provided space for its own internal apologist.
Thank you for citing our evidence on misconduct retractions and funding source. This ended up being one of the top 5 articles downloaded that year from Current Medical Research & Opinion. It struck a chord. Readers of Retraction Watch will be aware of how the findings from our study are being subsquently and consistently replicated in real life – MOST retractions due to misconduct occur in academia. The Manichean view of research (industry bad, academia good) is neither accurate nor helpful. Any study is subject to risks of bias – financial or non-financial -and we should judge the integrity of the study based on the study itself, not the funding source.
Having worked in academia and industry (in North America and the Asia-Pacific region), I have seen exemplary and questionable behaviours in each sector. Given the ease of focusing on financial COI, however, it is not surprising that industry has been in the spotlight. As the past editor of JAMA, Catherine DeAngelis said to me in Chicago (and please read this out loud with a strong NY accent), “Industry got itself into this mess and industry’s gotta get itself out of it”. True.
One way industry is doing that is through more frequent and more comprehensive AUDITS of its publication practices. Some may say (and I agree with them) that such audits are long overdue, but are they occurring with any regularity in academia? I don’ think so and this means real-life learning opportunities are being missed. Industry needs to do better, but, so too, does academia. Everyone needs to know how to plan, conduct, and publish research ethically.
Best read Bad Pharma by Ben Goldacre for some proper insight. It is not a hysterical rant by some high-minded zealot, but a very clear-headed exposition about how we are all massaged.
2 take-home messages:
1. that drug rep in your waiting room is NEVER necessary
2. show us the trials that the companies choose NOT to publish: they are also part of evidence-based medicine
of course Christine is right — up to a point. We need them, and they need us, agreed. Pharma personnel are, for the most part, members of the same species as us, many gifted with altruistic intentions, etc. They are also prone to the same self-serving deceptions and blind spots as us. I think the problems (selective publication, repeated fraud, off label marketing etc.) arise mainly because of the profit-driven system they work in. The practice standards and penalties Christine mentions have been notably ineffective in reigning in bad behaviour over recent years. A pattern of ‘recidivist’ offending has prompted calls for steeper penalties and/or jail terms for execs. Harsh perhaps, but some would say necessary. To manage this situation a new ‘engagement’ is needed. I suggest a complete ‘firewall’ between them and us regarding medical education. Colleagial contact regarding research is desirable, but must be transparent, as should the data be. The YODA project suggests this may be possible, but continued (healthy) skepticism is warranted.
Well said, Christine.
The industry has been demonised by a few high-minded individuals who seem to think that Pharma is evil.
I agree wholeheartedly with your comment about funding research – certainly Universities or Clinical Departments do not have the funds to do so. If not Pharma, then who?
It is doubly hypocritical when certain specialist societies have policies not to accept pharma funding but have no inhibitions when it comes to industry helping to sponsor/fund their annual conferences.
As you say, some pharma activities have been grossly unethical and perhaps even corrupt, but just as there are rotten apples in all walks of life and in all professions, it does not mean the whole industry needs to bear the insulting remarks coming from certain academics railing against them.
They are not an altruistic body, and there is no doubt that the profit motive is strong. Yet virtually all recent research is funded by pharma and the availability of valuable new drugs would not occur without them.