Is there really a need for the "Medical Innovation Bill"? Part III

Is there really a need for the "Medical Innovation Bill"? Part III

I will now deal with the third and fourth objections to the Medical Innovation Bill.

The bill denies patients compensation for negligence

This is categorically not the case. The bill provides assurances for clinicians that innovative treatments will not be considered negligent merely by dint of being innovative, if the process and safeguards in the bill are complied with. There is nothing in the bill that affects the right of the patient for compensation from medical malpractice.
It is important to remember that currently there is no right to compensation for patients injured by experimental treatment. 

The bill will cause confusion

There is no reason why this should be the case. The process required for responsible innovators will be clearly laid out. There may be initial litigation, as there is with any new statute, but the legislation should reduce litigation related to innovation in the medium and long term. 

Is there really a need for the "Medical Innovation Bill"? Part II

Is there really a need for the "Medical Innovation Bill"? Part II

I will deal with the second objection to the Medical Innovation Bill now.

The bill will allow quackery - we should only be practising evidence-based medicine

There are a lot of safeguards for people who participate in clinical research. This is entirely appropriate, as the hallmark of research (as opposed to innovation) is that the primary purpose is gaining knowledge. The patient in a clinical trial typically gets standard care plus a placebo OR the intervention being studied. 

The patient receiving innovative care is not subjected to the placebo lottery. On the other hand, no comparisons can be made between the intervention and no intervention. One of the provisions of the bill will be a data gathering requirement. Currently, there is no systematic collection of evidence from innovative practice. 

Many treatments go through a stage when they are an innovation. Most new surgical treatments are an innovation.There are very few trials comparing surgery with sham surgery, largely because this would be unethical in most cases. Drugs may already be used on a compassionate basis, where the condition is terminal and there are no treatments available.

The bill would not herald a wave of non-evidence based treatments. The proponents of Evidence-Based Medicine must acknowledge two issues: 1) there is little or no evidence for the treatment of some conditions and 2) patient autonomy should not be overridden by a slavish adherence to the principles of evidence-based medicine. The bill clearly would not apply where there are evidence-based treatments. 

Neither would it herald a wave of quackery. There would need to be a process of consultation, fully informed consent, a plausible mechanism, and the best interest of the patient would be paramount. 

The use of innovation is certainly not contrary to the principles of evidence-based medicine. 

Is there really a need for the "Medical Innovation Bill"?

Is there really a need for the "Medical Innovation Bill"?

There is some opposition from both medical and legal professionals to Lord Saatchi's Medical Innovation Bill. The criticisms have four main themes:

1. The bill isn't needed - the law allows safe, responsible innovation
2. The bill will allow quackery - we should only be practising evidence-based medicine
3. The bill denies patients compensation for negligence
4. The bill will cause confusion

I will address each of these in turn. 

The bill isn't needed - the law allows safe, responsible innovation

It is true that under the current legal regime, innovation is permitted. Part of this confusion is related to a misunderstanding to what is meant by innovation in the bill. It does not refer to the conduct of medical research. It refers to the provision of untried treatments to individual patients in the hope of benefiting those individuals, a trial of n=1. 

It is true the law recognizes that medical innovation is essential. It would be negligent NOT to provide new treatments where proven superior to the old treatment (at which stage it could be argued this is the new customary care). No one has suggested that the law intentionally suppresses innovation. There is however an issue of whether the current legal standards have an unintentional effect of discriminating against innovative treatments. So what are the legal standards?

A doctor is not negligent if his treatment corresponds to that generally accepted, or accepted by a responsible body of medical opinion. Further, the basis for this practice can be subject to scrutiny by the courts (although this rarely if ever alters the standard of care). Research is an entirely different matter, because clearly the benefits and harms of the treatment are not known. This is the basis for the current regime of research governance. 

Innovation as defined above is somewhere between the two. Although adherence to standard practice protects a doctor from claims of negligence, the law certainly does not consider that deviation from standard practice is negligent BUT there is greater onus on the practitioner to justify his individual practice. Thus it is incorrect to say that the law does not permit innovation, but neither is it correct to say that there are no legal barriers to innovation. As Dame Butler-Sloss commented in Simm v Simm

"Is there a responsible body of medical opinion which would support the PPS treatment within the United Kingdom?” the answer in one sense is unclear. This is untried treatment and there is so far no validation of the experimental work done in Japan. The Bolam test ought not to be allowed to inhibit medical progress."

So it is clear that the Bolam test does potentially inhibit medical progress. As for whether the current law really is a barrier to innovation, I'm not sure if the empirical data are available to show this. Certainly when the first bio-engineered trachea was implanted, it was not in the UK. Numerous other innovations come out of countries with less investment in medical research but a more permissive medico-legal environment. The argument isn't that innovation isn't permitted by the law, but that the current regime inhibits innovation. Not by particular decisions, but by the uncertainty that responsible innovation will be supported. The opponents will argue that this points to a need for greater education. The supporters of the bill might argue that it is necessary to get out of the risk-averse culture in the UK by a new statute that provides assurances that innovation in certain strictly defined situations will not be considered negligent by comparison to an inappropriate legal standard. As Lord Wolff put it

"I do know about ... cases where doctors are sued for negligence because they have innovated in the treatment they offer, rather than following generally-accepted medical standards."

adding

"It is important to understand here that we are talking about a new law that will make a limited, but significant contribution in a small number of difficult cases. Maurice Saatchi, with the support of Health Secretary, Jeremy Hunt, and of the government, is seeking to introduce legislation that will only apply to: (1) patients who are not responding to conventional treatments; (2) patients who give their consent to such innovation; (3) new treatments that are still at a experimental stage; (4) new treatments that hold out a real prospect of being able to help, both the patient and others in similar circumstances who come after them."

from http://www.telegraph.co.uk/news/features/10785352/Saatchi-Bill-your-last-chance-to-help.html

Lord Saatchi's Medical Innovation Bill: a response to some criticisms

Lord Saatchi's Medical Innovation Bill: a response to some criticisms

I support Lord Saatchi's Medical Innovation bill. Why?

On my first reading of the first draft, I was unsure, but after further analysis and hearing the arguments made by Lord Saatchi on the recent google hangout -https://plus.google.com/u/0/events/c80kqapi0048lilguoc1idq0934 
- I am persuaded that this will be a useful measure (although there needs to be some re-drafting, which the bill team recognize and is part and parcel of the consultation process). The bill team are genuinely engaging with criticisms and concerns, but some of the criticism and comments are unfair and I would like to address these.

#1: It's a Tory bill.

No, this bill has been proposed by Lord Saatchi on the basis of his convictions rather than party politics. He wishes to see medical innovation facilitated following the sad passing of his wife Josephine from ovarian cancer, a condition for which current treatment is found wanting. 

#2: It's a quack's charter.

There is a need to tighten up certain parts of the draft, but the emphasis of the bill is on appropriate innovation. It is not a free pass for reckless experimentation. It will require the innovator to be a registered medical practitioner, consult with the multi-disciplinary team, act in the patient's best interest and for the treatment to be plausibly effective.

#3: There's no need for the bill as current medical negligence law permits innovation.

The proposal of the bill is in response to clinicians' perception of the legal risks of innovation. These partly relate to the current standards for medical negligence. The Bolam-Bolitho test for clinical negligence will remain unchanged however - this bill simply provides an exception in strictly defined circumstances.

#4: There's no need for the bill as doctors are not commonly sued for providing innovative treatment (as stated by the MDU). 

The lack of law suits does not prove that the threat of litigation does not impede innovation. Part of the bill's aim is to give doctors the confidence to innovate by providing a clear legal framework.

#5: Patients need protection. 

The bill does not reduce the protection for patients; it simply empowers patients and their doctors to explore innovative treatment where there are no options otherwise. It permits patients to exercise their autonomy in a paternalistic research governance regime.

#6. The bill's badly written.

The bill is at the draft stage, so improvements can and will be made.

The bill will probably go through several drafts. The bill team welcome the input of professionals and the public to ensure that the bill achieves its aims and wins the support of the stakeholders. The consultation page is here: 

https://www.gov.uk/government/consultations/medical-innovation-proposals-to-make-clinical-negligence-law-clearer

"This is servants' work!"

"This is servants' work!"

In Harry Potter: The Philosopher's Stone, when Draco Malfoy is taken into the Forbidden Forest as a punishment, he remarks "This is servants' work!" His remark is not prompted by disdain, but fear. We have no sympathy for his petulant protests, because he simply wants his social inferiors to take the risks. He will acknowledge neither his own cowardice nor the bravery of the servants whom he would want to deal with such situations.

This reminds me of the attitude of some people towards nurses. Nursing requires various personal qualities of compassion and empathy. This is why we should value and respect good nurses. Instead, the ethos of the current UK government seems to be that this is a given, and just like Draco Malfoy these qualities should be simply expected of the servants. Jeremy Hunt seems to believe that different training is required to ensure compassion rather than adequate staffing levels or pay rises. This attitude reflects the comments of Julie Bailey. 

Of course compassion is at the heart of nursing. But the ruling classes think you can pay somebody for compassion.Their belief is that compassion is something that is paid for, nurses are the professionally compassionate. Compassion as a professional service. Her self-published diatribe contains this message again and again. 

Nursing is servants' work. And Jeremy Hunt is Draco Malfoy. 

Medical Innovation Bill and Tort Law

Medical Innovation Bill and Tort Law

Lord Saatchi is trying to steer a bill to facilitate responsible medical innovation through Parliament. His personal mission is motivated by the death of his wife from ovarian cancer, a disease which as well as being difficult to diagnose is difficult to treat. There are many rare and less common cancers which collectively amount to a majority of cancer deaths: 

Current data shows that 46% of cancers diagnosed are rare and less common cancers, yet they account for 54% of cancer deaths

from http://www.cancer52.org.uk/about-cancer52/

The draft of the Medical Innovation Bill states:

1        Responsible innovation

   

   (1)   The purpose of this Act is to encourage responsible innovation in medical treatment and to deter reckless departure from standard practice.

   (2)   It is not negligent for a doctor to depart from the pre-existing range of accepted treatments for a condition (standard practice) if the decision to innovate is taken responsibly.

   (3)   A responsible decision to innovate will, in particular, be based on consideration of—

 (a)    the reasons why the available research or other evidence is insufficient or unclear including, in particular, whether it is referable to the nature of the condition (as in, for example, a cancer that affects relatively few patients),

 (b)   the relative risks that are, or can reasonably be expected to be, associated with the treatment the doctor proposes to apply and other treatments,

 (c)    the relative likely success rates of the treatment the doctor proposes to apply and other treatments, in the doctor’s reasonable judgment,

 (d)   the relative likely consequences of applying, or failing to apply, the treatment the doctor proposes to apply, and other treatments;

 (e)    opinions or requests expressed by or in relation to the patient, and

 (f)    any other matter that appears to the doctor to be reasonably necessary to be considered in order to reach a clinical judgment.

(  (4)   A responsible decision to innovate must be made in accordance with a process which is accountable, transparent and allows full consideration of all relevant matters; the process may include, in particular—

 (a)    decision-making within a multi-disciplinary team;

 (b)   notification in advance to the doctor’s responsible officer (within the meaning of Part 5A of the Medical Act 1983);

 (c)    explanation to the patient of the doctor’s reasons for proposing to depart from standard practice, including discussion of any contrary opinions expressed by the doctor’s colleagues.

   (5)   Nothing in this section permits a doctor—

 (a)    to provide treatment without consent that is otherwise required by law, or

 (b)   to administer treatment for the purposes of research or for any purpose other than the best interests of the patient.

The aim of the bill is to ensure that doctors have the confidence to responsibly innovate. It is not blanket immunity for the quacks to exploit. It is attempting to make the legal situation sufficiently clear that innovation is not deterred. 

Innovation is distinct from medical research. The motivation for innovation is to benefit the individual patient. An example of innovation would be compassionate use of an unproven drug. By contrast, the main motivation of medical research is to gain knowledge about the efficacy and safety of a treatment for future patients. This will usually entail providing some patients with the treatment, and others with regular treatment and/or a placebo.

It is always necessary to explain to patients the nature of the treatment they are receiving, and in the case on innovative treatment the patient must understand that the treatment is untried, and may have unexpected side-effects. The law is well aware of the need for medical innovation, yet certain legal doctrines militate against innovative treatments. 

There are various solutions that have been suggested. One is the principle of offsetting risks, so that where a treatment creates new risks but also reduces known risks, this should be taken into account in clinical negligence cases (this is discussed in 'Misalignments in Tort Law' by Ariel Porat, Yale Law Journal (2011) 121:82). 
Another is the application of strict liability to injuries as a result of innovative treatments. This is unattractive to me, as the patient receiving innovative treatment knows the risks and intends to benefit from the innovative treatment. This suggestion is based on the assumption that doctors are most concerned about reputational damage, and so strict liability removes the aspect of blame. This ignores the issue of publicity and prospect of disciplinary hearings.
 A third option I propose is the establishment of a statutory scheme similar to the vaccine damage scheme which offers some payment for injuries caused by innovative treatments, but not tortious damages. The clinician would be required to register his innovation on a national register which enable data to be collected on innovations, and to use a statutory consent form which emphasizes the unknown adverse effects of innovative treatments.

The problems of the "not guilty" verdict

The problems of the "not guilty" verdict

The criminal justice system has at its heart the principle that the accused is presumed innocent until proven guilty. Further, it requires that the bench or the jury be certain before they pronounce someone guilty. There are good reasons for these positions, but they do however cause certain problems. 

The person who is acquitted (or found "not guilty") is in an uncertain position. Because of all the well-founded reasons for requiring a high standard of proof, the "not guilty" verdict does not equate to a finding of factual innocence. More and more the simple fact of being charged and tried is taken into account in various civil procedures. Thus the person who is acquitted on the basis of the jury's belief in his innocence may be no better off than the person who the jury considered was probably guilty. 

The other aspect is the plight of the complainant. The verdict of "not guilty" is not a statement of disbelief of the complainant as such. There may be good evidence that the complainant was a victim of harm. However, emphasizing that the "not guilty" verdict is not an exoneration of the accused brings us back to displacing the presumption of innocence, and so impugning all acquitted defendants. There is no easy answer. 

Gender Identity Disorder vs Body Integrity Identity Disorder

Gender Identity Disorder vs Body Integrity Identity Disorder

It has become an accepted treatment for gender identity disorder to offer to suitable patients sex reassignment surgery (SRS). The classic description by someone with gender dysphoria of themselves is 

I'm a man trapped in a woman's body (or vice versa).

Thus the rationale for amputating healthy genital and other tissue is to "restore" the person to their "correct" body. 

There is a condition called body integrity identity disorder, also sometimes called apotemnophilia (although this term also applies to people with a fetish for amputees). People with this affliction have a deep-seated desire to become amputees. They will inflict lesions on the limb in order to procure a surgical amputation, risking death through septicaemia. Mo Costandi mentions a death in his article in the Guardian:
http://www.theguardian.com/science/neurophilosophy/2012/may/30/1
They may even attempt DIY amputations. There is evidence of specific brain lesions that will produce this disorder. In response to the persistent attempts by some patients to force amputations, one surgeon in a Scottish hospital began offering elective amputations for such patients (see link). However, this practice was stopped by the hospital management. 

The parallel with sex reassignment surgery is striking. It could be argued that BIID is different in that the goal is not a whole normal body. SRS is justified by medical consensus, and exempted from the prohibitions on clitoral excision under the Prohibitions of Female Circumcision Act 1985. WHO does not classify clitoral excision as part of SRS under female genital mutilation. On the grounds of consistency, it is difficult to understand why elective amputation is not seen as ethical.