Ethical practices – pharma’s obligation
pharmafile | March 8, 2011 | Feature | Research and Development, Sales and Marketing | ethics, industry relations, industry reputation
Pharmaceutical companies are not charities, and neither is any other business, by definition. Capitalism as a recognised system has been around for hundreds of years, but earlier civilisations used production and trading to generate wealth for themselves.
The idea of multiple ownership in the form of shares took hold in London’s coffee shops of the eighteenth century, and has made shareholders a powerful force.
Today, the largest public corporations are beholden to block voting by members who are corporations themselves – pension funds, life insurance companies, and other financial groups.
Is this a good or a bad thing? The answer is that it can be either. The private equity boom which preceded the recent crash was driven by a need to cut loose from the constraints of big investors, by using bank loans to buy them out.
Thus released from the fetters of timid shareholders, the new owners are able to make ruthless changes to improve efficiency.
Laden with debt from the bank loan, the company pays little tax, yet the owners pay themselves big bonuses.
Typically, they avoid tax on those as well, by pretending to live abroad. The company then goes back to the stock market, to be bought by (you guessed it) the corporate investors who sold it in the first place – but the price is much higher now. Should we wonder why our pension schemes are doing so badly?
Ethical business practices
I don’t know if such a trick has been pulled with a pharma company, but the point of the story is to ask you whether such business practices are ethical.
Pharma companies continue to be criticised for various abuses, and some have received swingeing sanctions. Big fines have been levied for sales and marketing violations, and it almost seems accepted that sailing close to the legal wind is normal.
I should not point a finger at any particular sector, but I can give some examples. I once did some consulting in the generics area, and was a bit surprised at how the development and launch time plan was compressed. Basically, the launch date was set up to a year before the branded drug came off patent. The generics company knew it would be sued, but it could fund its defence out of sales, and the patent would expire before the case came to court.
Unethical, or just sharp practice? Perhaps a bit of both. I suspect they hoped for an easy ride through the courts, on the underdog versus big pharma basis.
Clinical trials and sponsors
But I should focus on more familiar territory, that of innovative drug development – how is it that major biases persist?
Studies are regularly appearing which show that clinical trials favour the sponsor’s drug versus the comparator. Can it be that the books are being cooked? From what I know of the grinding effort that goes into conducting trials these days, I think that is unlikely.
Much more likely is the possibility that the study design was ‘adjusted’ in the first place.
Indeed I know this happens, but I could not reliably estimate how often. What if the pharmacokinetic profiles of the study drug and the active comparator differed? They are very unlikely to be the same. So the time points for assessments could be selected to show the sponsor’s drug in a better light.
Publication bias is frequently cited, but there is a very big difference between failing to get a completed study published, and deliberately withholding data.
I just saw a paper which claims that systematic reviews are not to be believed. This is, it is said, because for some studies the request for raw data was refused. Now this question is going to be beset with arguments about which studies should be included, and I don’t have space to consider all those. But rather than simply to refuse, would it not be more ethical to release anyway and let the reviewer decide whether the quality is high enough for inclusion?
There is the view that, for most of the time the onerous regulation of our industry does work, and that abuses are rare. We should perhaps tolerate these, as a fair price to pay for effective medicines that have dramatically improved health and lengthened our lives.
Inevitably there will be a trade-off, and no industry will be 100% free of carelessness, and people who think that the end justifies the means. However, I have a feeling that in the long run, honesty might just be a more viable policy.
Vendor auditing
Some years ago a business associate said to me: “The trouble with you Les, is that you are too honest.” He, and others of my acquaintance at the time considered that grossly inflating a company’s capabilities was the way to win business.
Their game plan relied on the usual delay between award of contract and project start – time spent on building up the capacity to do the work. Apart from the big risk that it would not all come together in time, there was the matter of vendor auditing.
If suppliers could be absolutely trusted to tell the truth about what they can do, and to deliver on their promises, pharma companies could save the cost of pre-award audits.
True, the regulators demand such audits, but surely this emanates from a history of broken promises?
Good clinical practice is no longer a guideline, it is the law, and ignorance of the law is never an excuse.
Everyone should know what they have to do – so if they could all be trusted, no audits and inspections would be necessary. But I seem to be saying that non-compliance is always because of dishonesty, and we all know that isn’t the case.
Almost all the time, it is a matter of simple error, from which nobody is immune, not even me! Yet on the very few occasions that I have found myself dealing with possible fraud, there has always been a mixture of error and apparent dishonesty.
Let me paint some hypothetical pictures, which may or may not reflect real situations.
A clinical trial sponsor might be suspicious about the way data had been altered by an investigator. Further checking reveals that the patient’s medical records had been amended to match the trial data. Now the data in question concerns selection criteria, so it appears that the patient was entered in error and then the data changed to make them eligible.
When challenged, the investigator immediately offers to withdraw the patient, and gladly to forego payment. They seem relieved to have got off so lightly.
Investigation example
In another scenario, an academic researcher might be challenged as to the validity of a published study, by someone with inside knowledge. The ethics committee chairman is not interested, and the researcher’s employer appoints one of his most sympathetic colleagues to conduct an investigation – which is as expected to be a whitewash.
There is no suggestion that the study was deliberately fraudulent, but certain shortcomings are very clear, and have been consistently denied. Is such a denial ethical?
Finally, buried in some study files is evidence of GCP non-compliance which needs to be reported to the regulator.
The problem was found by an auditor, but the company is embarrassed to take action as the files had sat on the shelf for months, and the time limit for reporting is long gone.
So instead of explaining the circumstances to the regulator, the company falsifies the date it found the problem.
The message from all of these is how easy it is to dig holes deeper and deeper, until it’s impossible to get out.
Maybe the impact of such hypothetical cases is small, and you could argue that we should worry more about data on blockbuster drugs being distorted or withheld.
But I wonder whether compromising integrity over small things inevitably escalates.
Ethical focus
I would love to be able to give you evidence from controlled studies that companies which are more ethical – are more profitable, but I don’t know of any.
I do know that ethical investment portfolios do very well, some of them much better than average, which is certainly encouraging.
Conversely, I haven’t really observed that the most ethical people rise to the top.
Take the example of Alan Sugar’s TV franchise ‘The Apprentice’, which contrives to concentrate on some of the most obnoxious young people imaginable in one place – his boardroom.
I have more in mind a principle less mechanistically demonstrable, but with which I hope most would agree. I am arguing for something that goes against some of my gut instincts, in that it has no clear business case.
Very simply, integrity should prevail because it is intrinsically right.
Les Rose is a freelance clinical scientist and medical writer.
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