Monday 15 December 2014

Saatchi Bill and Medical Anecdotes

Opponents of the Medical Innovation Bill (aka as the Saatchi Bill), such as Sarah Wollaston MP, have been very vocal in attacking the Bill by making a number of false claims about what the Bill will do. One such argument is that the Bill will undermine medical progress by doing away with clinical trials, and that instead we will just have to rely on individual anecdotes that arise from doctors using innovative off-label treatments on patients. In fact Sarah Wollaston even referred to the Bill as the ‘Medical Anecdotes Bill’ in her recent speech in the House of Commons.

There are a number of points that to raise in response to this false assertion.

First, there is no intention to replace clinical trials. The Bill is about treating patients with no place left to turn – these are people who have exhausted standard therapies and for whom there are few options left to explore. If a clinical trial is open and the patient is eligible then that is the place to go if it is in the patient’s best interest. There may be cases where it is the right thing to do, just as there are cases when it will not benefit the patient who is offered the additional choice of an non-standard treatment (for example an off-label drug with evidence of clinical activity in the patient’s illness). This will be decided on a case by case basis, what it will not do is force doctors to ignore clinical trials or undermine the trials process.

We also have to keep in mind that for many rarer cancers, genetic conditions and chronic illnesses there are few clinical trials available. Just as important, even when there are clinical trials open, many patients may not be eligible because of prior treatments, confounding conditions, age or physical status restrictions and so on. What are patients supposed to do when they cannot gain access to clinical trials? Many of the opponents of the Bill act as if there are no unmet patient needs, as if every patient has access to trials and that there is no need to consider alternatives.

Secondly, rather than leaving us with a collection of anecdotes, the Bill offers the prospect of making a huge step forward in medicine through the creation of a central database to record patient data. This database will be hosted at Oxford University, and work is progressing with the Department of Health to work out the details. A central database which will record each patient’s details, the treatment they receive and their outcomes is actually a hugely advance in medicine. With all of the patient data recorded we do not have a collection of anecdotes but a database that we can mine and explore and use to design clinical trials based on the signals we can glean from real patient data. It also means that non-standard treatments that work can be identified more quickly, and just as importantly those that do not work can also be identified and discouraged. This isn’t a replacement for the clinical trial, it’s an advance on the system we now have.

The central database is really the essential piece that makes the Bill so compelling. It offers doctors looking for innovative treatments a chance to explore and learn from the experience of their colleagues. Many of the opponents of the Bill suggest that it is not needed – they claim that doctors are already free to innovate and explore non-standard therapies. But what is not in place now is a standard process for this to occur, nor a method by which doctors can learn from each other and help to evolve the breakthroughs we so badly need.
And, finally, a central database means that patient safety will be increased. As all data has to be recorded, those unscrupulous individuals prescribing crank treatments will have to reveal their data, they will no longer be able to keep their results away from scrutiny as they now can.


36 comments:

  1. You said:

    "One such argument is that the Bill will undermine medical progress by doing away with clinical trials"

    Can you point out where this has been claimed?

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    1. It's the gist of what has been claimed by many people opposed to the Bill. For example, in her adjournment speech Sarah Wollaston made the statement:

      Far from promoting medical innovation, the Bill could undermine recruitment to genuine clinical trials. ... If the Bill is passed and undermines enrolment in clinical trials, we will be doing a grave disservice to medical innovation, and it will be to our great shame to have done so.

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    2. So, you've taken "undermine recruitment to genuine clinical trials" and turned it into "doing away with clinical trials" to create a straw man.

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    3. This is certainly implied by opponents of the Bill. And it is less of a strawman than Sarah Wollaston using a fake cancer cure like GcMAF (available now over the internet) and suggesting that the Bill will give carte blanche to scammers exploiting cancer patients.

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    4. You said it was the gist of what had been said, citing Dr Wollaston as an example when it clearly isn't. Also, I don't recall ever having seen any opponent of the MIB say this and it seems you can't provide any evidence for your straw man either, undermining the premise of your article.

      "And it is less of a strawman than Sarah Wollaston using a fake cancer cure like GcMAF (available now over the internet) and suggesting that the Bill will give carte blanche to scammers exploiting cancer patients."

      A straw man is a straw man. However, your new claim is that that Dr Wollaston suggests the Bill will give carte blanche to scammers with fake cures.

      It is perfectly clear that the MIB would at least protect patients from unqualified scammers (but it certainly does nothing to stop people falling prey to scammers on the Internet). Dr Wollaston did refer to those who might want to provide unevidenced treatments, but she made it perfectly clear (Column 842) that there are doctors who might like to provide treatments such as GcMAF. Of course, a doctor could provide GcMAF at present if he/she so wished: the MIB is not needed for that. What currently does act as a deterrent is the uncertainty of whether the doctor would be able to pass the Bolam and Bolitho tests in a court - tests that GcMAF would, IMHO, fail and deterrents that the MIB removes.

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    5. I specifically said: "One such argument is that the Bill will undermine medical progress by doing away with clinical trials, and that instead we will just have to rely on individual anecdotes that arise from doctors using innovative off-label treatments on patients." If you look at what various opponents of the Bill have been saying, it is that the Bill will 'undermine' or 'put patients off' from joining clinical trials. Effectively the charge is that the Bill will weaken the trials system. Futhermore, opponents have repeatedly claimed that the Bill will leave us with collections of anecdotes instead. Sarah Wollaston specifically used the phrase the 'medical anecdotes bill'. This is not a straw man of my invention but a very clear implication.

      Furthermore, Sarah Wollaston has twice now used a specific case of a constituent who has been sold a fake cure (GcMAF) as a convenient mechanism to attack the Bill, when clearly the case has occured under existing legislation. This is hardly a fair tactic - it's an emotive attempt to scare people.

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    6. 'Putting patients off clinical trials' isn't the same as 'doing away with clinical trials', is it?

      But I'm really not sure you want to raise the issue of the use of emotive language and scaring people.

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  2. You do realise that the 'central database' has not been included in the Bill? There does not appear to be any desire from the SaatchiBill team to make this a comuplsory element. Without this 'essential' element, isn't the last shred of justification for the Bill blown away?

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    1. Yes, I do realise that it's not part of the Bill. As I understand this it will be in the guidance notes that will be issued with the Bill. Currently the Saatchi team, the Department of Health and a team at Oxford University are working on this.

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    2. Why is something that is apparently so crucial never even been mentioned in the (very) many different versions of this Bill?

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    3. As stated, it will be in the guidance notes issued by the Department of Health.

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    4. It looks to me like this 'guidance notes' database is nthing but a fig leaf to hide the central embarassment of the Bill that all it does is transfer the risks of these unproven treatments from the Pharma Companies and the doctors who are prepared to use them firmly onto the shoulders of the sick and dying.

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    5. Are you seriously suggesting that the Department of Health, the Saatchi team and the people at Oxford University are undertaking some sort of charade? Is this a conspiracy then to protect the drug companies?

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    6. I do not know if it is intentional or not, but it is without question that risk is being transfered from the Pharma companies and doctors onto patients. The Bill is explicitly trying to remove the right of patients to ask courts to look at the decisions made by doctors. As such, the risk of the treatment falls firmly on the patient.

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  3. You say "The Bill is about treating patients with no place left to turn [who] have exhausted standard therapies and for whom there are few options left to explore."
    Nowhere in the Bill is there any requirement that standard treatments have been exhausted, or even tried, before the doctor uses the process in the Bill to prescribe a treatment unsupported by any responsible body of medical opinion.

    Also "What are patients supposed to do when they cannot gain access to clinical trials? Many of the opponents of the Bill act as if there are no unmet patient needs"
    That is a difficult position for a patient to be in and of course there are unmet patient needs, but the Bill cannot change this as it gives exactly no new rights whatsoever to any patient.

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  4. Thank you for your blog post Pan. As you rightly mention we are currently working with Oxford University on the database which is, as Lord Saatchi and others stated in the House of Lords on Friday, absolutely vital.

    Clinical trials remain the gold standard and the Bill in no way stops people from being entered on them. But as you rightly state, and as Prof Walker has written both for us and the Telegraph, there simply are not enough trials for everybody - in particular for rare cancers and diseases like Duchenne.

    Liz Scarff - Medical Innovation Bill team.

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  5. Dear Pan, as a member of the Bill team I can confirm that:

    1/ Sarah Wollaston has stated publicly, and incorrectly, that the Bill will undermine clinical trials. The reality is that under the bill if an appropriate trial is open, from which data relevant to the patient will be available, then the doctor will not be able to rely on the bill, under the 'best interests' clause.

    Indeed, the Bill supports trials - by providing initial evidence for a putative new treatment, which can then inspire a full and proper trial. This is one reason why Dame Sally Davies supports the Bill.

    2/ Lord Saatchi has many times and publicly stated he will put a mandatory obligation to register innovations under the aegis of the bill on a sharable database. He said this again on Dec 12 in the Lords. We are negotiating with the Dept of Health on how this should be done - not if it will be done.

    3/ You are right to raise the issue of trials and to pose the question as to what happens to patients, with rare diseases, for whom the evidence base is thin and for whom standard treatment means only death. In their case, when there are no trials, objectors to the Bill have no clear nor convincing answer.

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    1. "Lord Saatchi has many times and publicly stated he will put a mandatory obligation to register innovations under the aegis of the bill on a sharable database. He said this again on Dec 12 in the Lords."
      In which case, why is a requirement to record treatments in a shareable database not been included in any version of the Bill, including the most recent post-Report one?

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    2. 'Undermining clinical trials' isn't the same as 'doing away with' them, is it?

      I also echo Rob's comment: why has the recording of treatments not been part of the Bill up till now? Pan said he understood it would simply be 'guidance notes that will be issued with the Bill', but you contradict this, saying it is the avowed intention that the recording of treatments in a database will be included in an amended Bill. Can you say at what stage this amendment might be published?

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    3. Dominic,

      you said: "You are right to raise the issue of trials and to pose the question as to what happens to patients, with rare diseases, for whom the evidence base is thin and for whom standard treatment means only death. In their case, when there are no trials, objectors to the Bill have no clear nor convincing answer."

      I am an objector to the Bill, and I have an answer: they will use unlicensed drugs because as you will know they can already currently do that.

      The Bill does not allow doctors access to any drugs that they cannot currently access, funding to buy/use them that is not currently already in existence and it does not allow them to provide ANY procedure that they cannot currently provide.

      Am I wrong?

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    4. @Anonymous - There is a problem of institutional culture at work here as well. I know from direct personal experience with my own family, and with families that I have since supported that very often doctors do not prescribe the non-standard treatments that they can prescribe. The reasons are complex but are not to do with lack of evidence - they are to do with stepping out of the institutional comfort zone and taking a different route. The Bill sends a clear signal that this is legally OK to do and so encourages doctors to take the steps that they can do now but chose not to.

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    5. Pan said:

      "There is a problem of institutional culture at work here as well...The reasons are complex but are not to do with lack of evidence - they are to do with stepping out of the institutional comfort zone and taking a different route."

      So, to do with culture rather than fear of litigation?

      "The Bill sends a clear signal that this is legally OK to do and so encourages doctors to take the steps that they can do now but chose not to."

      It is legally OK to do that now and there are safeguards in place to protect patients. However, if doctors are not aware of the current legal landscape surrounding the provision of unlicensed and/or untested treatments, why do you believe it is necessary to introduce a new law to educate or encourage them rather than, say, providing information and guidance?

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    6. Because very often legislation can help drive institutional change. That is not to say that there aren't other avenues to be explored in helping this process along.

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    7. What's the evidence that legislation is the best way to drive institutional change or even that it will be effective in doing so?

      And what other avenues have been explored before pushing a Bill through Parliament that will drastically change the law, encourage irresponsible experimentation and remove tried and tested patient protections?

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  6. Hi Pan

    Thanks for replying. The problem is that none of the research bodies (Wellcome, MRC, Cancer Reserch UK), medical protection societies (MDU, MPS) or either the GMC or BMA managed to find evidence of what you are saying. Nor have I read anything from anyone connected with the Bill that proves that this institutional culture issue is inhibiting doctors from providing what they want to provide.

    Even if there was, the fact is that the law does not actually inhibit them. If a patient had a form of cancer for which the standard procedure provided no hope, and after discussion with her the doctor provided something 'innovative', that's not negligence. The patient, should they sue in such circumstances, has a zero chance of success. Remember, nobody has been able to provide a single example of a doctor being sued for innovating.

    Given this, the BMA's suggestion that educating doctors to change the culture is better than legislation is sensible, wouldn't you agree?

    In particular since this Bill has a number of unintended consequences and vague language that would mean (as some of the bodies I listed above argue) more rather than less litigation.

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    1. I work with three different charities that support patients with late stage cancers. The problem crops up in patients from all three organisations - the fact that it doesn't show up in official sources is puzzling and is perhaps symptomatic of the institutional cultures I mentioned.

      Changing such cultures is hard - perhaps the BMA suggeston would be better, but the fact is that they are only discussing it because of the Bill. Furthermore, a legal change can help push that cultural change along.

      Finally, I would suggest the central patient database is a hugely important spin-off that promises a major advance in medicine.

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    2. I agree about the database, although I will reserve judgment until I see that reporting cases to it is compulsory. As those above have noted, that is not currently the case.

      But I guess that we'll have to agree to disagree about the culture. The 100 eminent oncologists who wrote to The Times also felt that there was no issue there. But where we agree is that the culture SHOULD be one where doctors are unafraid to provide such help to patients.

      But the elephant in the room is the Bill's unintended consequences. It is poorly constructed, could lead to more litigation and is not the answer even if we accept that the problem that it identifies is there.

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    3. I'm glad that we agree that we want a culture where doctors are not afraid to provide such help to patients. By the same token, if the Bill is poorly constructed then the thing to do is help further amend and improve it. Killing the Bill would send out a very negative message to the medical community and would risk further entrenching the status quo.

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    4. Pan said:

      "Killing the Bill would send out a very negative message to the medical community and would risk further entrenching the status quo."

      You - or at least the Bill's PR team - have first to show that the status quo can be improved (it can, but not by this Bill, of course) and that this Bill will do that and do less harm than good. This has not (yet) been demonstrated.

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  7. Wow, this post is yet another example of the misinformation being peddled by the Saatchi team and their misinformed supporters.You are putting vulnerable patients at risk. Unforgivable.

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    1. How exactly is this post putting patients at risk? What is unforgivable is denying patients a chance to try non-standard treatments in a controlled and scientific manner. It's this denial that drives vulnerable patients into the hands of quacks selling miracle cures over the internet. Far from putting patients at risk, the Bill will improve safety by giving us the data to identify what works and what doesn't - ultimately leading to the prospective clinical trials which we need.

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    2. What 'controlled and scientific manner' does the Bill require?

      The Bill - as it currently stands - will not improve safety or knowledge. There is, as yet, no requirement to record details of any treatment. But even if it is mandated in some new version of the Bill somewhere down the line (and, given the apparent reluctance of the Bill's PR team to take on board previous criticisms, we need to wait to see what any such amendment actually says), recording of individual stories about individual patients will tell us virtually nothing about a treatment and will not drive innovation.

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  8. Allowing untested treatments to be used on desperate patients is inviting quacks to take advantage. That's why quacks love this Bill so much. Doctors are already, and DO, use non standard treatments with no fear of litigation. All this Bill does is remove vital patient safety mechanisms. It gives NO data at all. I can only presume you don't actually know what "data" is, if you think a voluntary Excel sheet of random unstandardised uncontrolled experiments is it. To suggest that ANYONE has said it will mean the end of clinical trials is utterly dishonest. It will however, as Dr Wollaston ACTUALLY said, undermine recruitment to trials. That will make the amazing progress we have already made in treating cancer far more difficult in future.

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    1. "I can only presume you don't actually know what "data" is, if you think a voluntary Excel sheet of random unstandardised uncontrolled experiments is it."

      Thank you for that unwarranted insult. I guess hiding as an Anonymous poster has certain advantages...

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  9. "I work with three different charities that support patients with late stage cancers. The problem crops up in patients from all three organisations - the fact that it doesn't show up in official sources is puzzling and is perhaps symptomatic of the institutional cultures I mentioned."

    This chasm between the way Drs behave and the way they are reported as behaving is the subject of my article about the Saatchi Bill, URL attached.

    If you downgrade everything not said by a Dr to the level of "anecdote", evidence of all such embarrassing fears can easily be made to disappear.

    Then, if you point that out, it's "oh it's just education".

    So it's a lack of education that makes Drs THINK there are legal dangers for them in prescribing off-label?

    Such an unhelpful situation as Drs feeling unable to prescribe off-label treatments to people with no other option just because they are clueless about the law is then just glossed over.

    The lack of visibility of the problem isn't that puzzling when you realise that it IS the problem.

    Sadly, the "debate" is more like a mis-matched game of pool in which you can pick any ball as long as it's the red one.

    Another symptom of the same problem.

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  10. Sorry, the URL for the article "When Doctors Throw their Hands in the Air" mentioned above didn't show up so here it is:
    Http://is.gd/Saatchi

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