This post on the eight hundredth anniversary of the signing of Magna Carta is the second in a Magna Carta series, and the twentieth in the Persecution series.
Faced in 2012 with questions about the $3 Billion fine imposed on GSK – triggered by a sequence of events starting with Study 329, – is it just the cost of doing business? Andrew Witty snapped back:
“Although corporate malfeasance cases end up looking very big, they often have their origin in just… one or two people who didn’t quite do the right thing. It’s not about the big piece. The 100,000 people who work for GSK are just like you, right? I’m sure everybody who reads the BMJ has friends who work for drug companies. They’re normal people… Many of them are doctors.
Accounts of what led to the 2022 Amendments to the Food and Drugs Act vary wildly. Some point to the new President’s first grandson being born with Tetralogy of Fallot linked to the mother’s antidepressant intake. Conspiracy theories invoked Marilyn’s Curse. They noted things like the coincidence of initials between the unknown American Woman whose baby had a Tetralogy of Fallot and Andrew Witty (See American Woman and American Woman 2). Others thought it was triggered by the increasing evidence of cognitive failure in more than one previous President linked by some to the fact both were on Statins.
Whatever the reason, Andrew Witty was recruited from GSK to rewrite the Charter between the people and Pharma. Here is a précis of his option appraisal.
The licensing of drugs is a bureaucratic procedure that has nothing to do with science. As things stand, the way FDA goes about approving drugs has enough of the appearances of science so that most doctors and patients are fooled into thinking there has been a science based decision when there hasn’t.
To an extent the public can’t imagine, the bureaucrats are just interested in getting boxes ticked and to paraphrase Tom Lehrer, “When the drugs go up who cares where they come down, that’s not my department”.
Regulation is completely incompatible with science. Science seeks uncertainty, whereas regulation seeks to abolish uncertainty.
We in GSK thought it must be crystal clear that Pharma does regulation and not science when to support a legal action against the European Medicines’ Agency Data Access policies in 2013 that proposed to let doctors and others see our clinical trial data we argued that this “data” was simply the result of a regulatory exercise and regulators ordinarily maintain the confidentiality of submissions on products they regulate.
This was the winning option in the opinion of the Courts. Some of my colleagues had doubts about our ability to win using this argument while maintaining the illusion that companies do science. The argument was a blow to the self-esteem (amour propre) of FDA and EMA who, while asleep at the wheel, like to claim they base their actions on science.
But medicine predictably noticed nothing. As Thomas More said about the Nobles of England – they’d have slept through the Sermon on the Mount. The only time they woke up was at Runnymede when there was something in it for them – (see Magna Carta).
Regulation needs to be disentangled from science. This cannot easily be done while the 1962 Amendments to the Food and Drugs Act contain an effectiveness criterion. The idea of forcing companies to show their drugs worked was a well-intentioned move but a disaster all round – a simple solution to a complex problem that has made things worse.
In the new regulations to mark the sixtieth anniversary of the 1962 regulations the word effectiveness needs to be replaced by safety.
For those who want companies to say what a drug is for, we can revert to the wording before 1962 by stating a drug should have a clear effect on a structure or function of the body.
Getting rid of the effectiveness criterion would do a lot of things. First it would make it a lot cheaper to develop new drugs. As a result, the cost of drugs would fall, more new drugs would be brought on the market and after marketing a lot of discoveries would be made. We could look forward to a new era of Wonder Drugs to rival the 1950s.
Second it would get rid of off-label marketing at a stroke.
Third it would mean that doctors and patients would have to be personally convinced a drug was actually helping them rather than depend on company claims that it was.
Fourth it there would be much less company clinical trial data and campaigns like BMJ and the Cochrane collaboration to access the data would likely wither on the vine. It would even be safe to appoint Peter Doshi and Tom Jefferson as data access Csars.
Whether a drug works or not is not critical to companies but it is critical to medicine and patients. This is a question that cannot be left to industry. As with a lot of these things women have blazed the way as in trials like the Women’s Health Initiative study of HRT. There were earlier trials run by medicine like this during the 1960s but everyone has forgotten them – it’s so long since medicine ran a serious trial.
This would be real evidence based medicine.
One of the consequences of this is that it would likely mean that a full appreciation of the risks and benefits to be obtained from a treatment would only really be clear several years after the launch of a new compound when the proper clinical trials began reporting. What doctors do while waiting for these results to come in is the key issue. Our hunch is that hope is the most powerful incentive of all for most patients and most doctors. No regulatory system will ever change that.
Quite simply these need to be dismantled. Anyone who doesn’t understand this doesn’t understand marketing – most doctors.
If prescription-only privileges are to be retained in some modified form, only those who do understand the need to abolish them should be involved in any modification.
There are a range of things that could be done such as:
Where alchemists, homeopaths, chiropractors and others, who have slavishly copied medicine, failed to make inroads, we have been able to walk in and leave with the Crown Jewels.
Using clinical trials and ghostwritten articles – the appearances of medicine – we have infected the body of medicine with an AIDs-like virus turning medicine’s defenses against itself. The insertion of these sophisticated adverts into the medical literature has triggered a Clinical Auto-Immune Deficiency (CID) reaction that leads most doctors and scientists to turn as viciously as they would turn on a quack on anyone who questions the results of these ghostwritten articles and trials that have no data and sometimes no patients. It’s been amazing to watch.
Physicians have had decades to find a way to get this cuckoo’s egg out of the nest of science. They could have based clinical practice only on investigations whose data is publicly available. They could have used the Human Rights of their patients as a lever – it is not for instance possible for any doctor to prescribe any branded medicine with informed consent as things stand at present.
But they haven’t done anything like this. The branches of medicine linked to the prescribing of branded products are finished as a profession. They have no brand value.
The market has now developed so that nurses, pharmacists, clinical psychologists and others can take over the role of prescribing drugs and are far less expensive than doctors.
If medicine has any value and we believe in market forces, abolishing it might lead to a solution. If people and governments come to think they need a set of experts who have brand value when it comes to good quality information on drugs, a new profession will be called into being.
Other physicians practicing in areas of medicine where branded products have little penetration could be allowed to continue.
One issue for others to consider is whether areas of medicine that are heavy users of medical devices are as badly affected as mainstream medicine.
A further option might be a promotion of patient co-operatives. Groups like ACOR.org are making a significant difference to healthcare. They might find it far easier to work with nurse and pharmacist prescribers than with doctors.
One of the few things that might have influenced my behavior as CEO of GSK would have been a boycott. Record fines and even jail time are not deterrents. Almost everyone views these as a cost of doing business already. A jailed CEO might even boost share value.
We in GSK know that boycotts can hurt. In the crisis over making ARVs available to South Africa for AIDs the threat of a boycott was the only time our Board substantially altered its position.
The boycott would be aimed at getting companies to hand over Adverse Event data. Groups like AllTrials – which we did a lot to nurture – are campaigning for efficacy data. It’s been interesting to watch them punch themselves out on this issue which is tied to disease indications that don’t exist, and center on meaningless surrogate markers, and are produced for bureaucratic purposes only. These data are frankly close to worthless and are not what we have been trying to hide anyway.
What we have been hiding has always been the adverse event data.
In 1962, in the frantic panic triggered by thalidomide all the wrong options were picked – the effectiveness criterion, prescription-only arrangements, and controlled trials. They all looked good at the time but companies are a bit like the dinosaurs in Jurassic Park, we are always going to find a way around the controls.
There was only one proposed change we really didn’t like and made sure we killed off – this was a proposed revision to the patent arrangements. Having US style product patents has been the key to the Pharma companies becoming Magna Pharma – the most profitable corporations on earth.
Companies need to be rewarded but the current product patents reward us beyond the dreams of avarice for delivering treatments that increasingly shorten life and increase disability.
There are other ways to cut this cake such as process patents, that would make blockbusters less valuable. Process patents would put a premium on diversifying the portfolio of compounds we hold rather than have us dependent on a small number of blockbusters.
At a stroke this would begin to turn us away from making everyone chronically diseased for life in order to make huge amounts of money out of them and away from just looking for drugs that millions will consume even though they don’t need them and turn us toward drugs that everyone will recognize are worth paying a lot of money for.
The last decade has seen a huge fuss about access to Clinical Trial Data since we in GSK kicked open this door by posting the results of our trials on depressed children on the company website. We have been able to keep the lid on this and have fall back options such as the AllTrials proposals that if adopted will probably leave academics worse off vis-à-vis transparency than they are now.
We have taken some risks to win the argument so far by claiming that patients’ data is confidential – when pretty well everyone who volunteers for a company trial expects that independent experts will get to view the data at some point and would be horrified to find this is not the case. So far this has been a winning argument.
But the startling thing that everyone has missed so far and shows no signs of spotting is that there are thousands or hundreds of thousands of drug trials that remain completely unregistered, where there are no issues of clinical confidentiality. These are studies undertaken in healthy volunteers – normals. There is a compelling cases for ensuring these data are made fully available.
These contain the data we really want to hide – the adverse event data.
Companies will likely need an amnesty for some of the abuses of people that will come to light if the new regulations make these studies available to view.
This is a key step.
We have taken astonishing steps to prevent decent reporting, or to denigrate reporting when it happens, and to manage the perception of risk rather than risks themselves. If the Nazis had access to our bag of tricks, there would be real and widespread doubt that the Holocaust ever happened.
For instance companies supported the development of an FDA MedWatcher App in 2013. This was widely applauded as we knew it would be. But it was in fact a way for companies to reduce the expense of maintaining a pharmacovigilance department, reduce their legal liabilities, and transform adverse events into anecdotes all in one go. Companies you see have a duty to follow up and decide if their drug caused the problem – FDA don’t have this duty.
But what was astonishing about all this was that pretty well everyone completely bought the idea that when it comes to working out whether a drug has caused a problem, a bureaucrat in FDA who is there because they don’t like meeting patients, has never treated the condition you have and never used the drug you are on, would be better placed than a good team of doctor, pharmacist and informed patient perhaps in touch with other good teams, to work out what’s going on.
If we’re good enough to get people to buy this, perhaps next April 1 we should see if we can persuade people the earth is flat.
Unless an independent patient organization gets involved in assembling real-time data and both doctors and patients combine to put risk mitigation programs in place, the other changes are less likely to work.
The bottom line is the average drug has at least 100 effects. Using clinical trials we have been hugely successful in hypnotizing doctors and patients to focus on one effect and to miss the other 99. This blind spot is the major driver of Pharmageddon (See Marilyn’s Curse).
If the climate change encroaching on healthcare is to be rolled back, we need someone to spit on some clay on the ground, make a paste, and rub it into the eyes of doctors or anyone who ends up prescribing.
Following the Supreme Court decision in the Matrixx case (note to self – check I am not confusing this with the movie), which said that while doctors and patients have no rights to access company adverse event data, shareholders have, one option is through Government to give everyone a shareholder stake or stakeholding in companies.
There was a doctor on my panel who had a different point of view. Dr Crusoe. She produced a minority report which I will forward under separate cover.Share this: