Monday, November 24, 2014

The Saatchi Bill, or, How England Could Become Quack Paradise

"Hi. I'm Lord Maurice Saatchi, and I'm trying to help quacks."
The other day, I wrote an open letter to members of the various state legislatures in the United States about so-called "right to try" laws. These laws purport to make it easier for terminally ill patients to seek out and obtain treatment with experimental drugs. The reality is that the laws leave patients in the lurch. State right to try laws simply create false hopes for patients and leave them to take on incredible risks while giving up some of their rights to legal redress. So far, five states have passed right to try laws without any serious critique by legislators. To some degree, I don't blame them. Who wants to deny a patient the right to try anything to prolong their life? Yet those legislators who pass these laws are being far more cruel than any who vote these laws down.

But if you think state right to try laws in the United States are bad, take a look at the United Kingdom's Medical Innovation Bill (HL Bill 48 [full text]), also known as the Saatchi Bill, after its sponsor, Lord Maurice Saatchi. As with right to try laws, the intent of the Saatchi Bill is well-meaning, but the end result is likely to be far more harmful for patients than imagined by the bill's supporters.

The impetus for the Medical Innovation Bill appears to be the death of Lord Saatchi's wife. He has campaigned to change current U.K. medical negligence law. Enter this bill. The aim, according to Lord Saatchi, is to make it easier for physicians to be innovative in the treatment they prescribe for patients.

Under current law, if a patient dies or suffers serious injury while under a doctor's care, the doctor will likely not be found guilty of negligence if they were adhering to accepted medical practice. Generally, in negligence cases, courts use a "reasonable person" standard. In essence, what would a reasonable person do under similar circumstances. When it comes to highly specialized professions, like medical doctors, the standards are elevated somewhat. U.K. case law gives us the Bolam test. Established by the case Bolam v Friern Hospital Management Committee, the Bolam test states that as long as a health professional acts in accordance with practices that are accepted by a responsible body of medicine, they are not negligent. However, those who depart from such accepted practices can be found guilty of negligence. The standard tends to favor the physician in a negligence suit.

But the case law is a bit more complicated then that, because there is also the Bolitho test. In Bolitho v City and Hackney Health Authority, the court decided that adherence to medical standard is not, in and of itself, a valid defense against negligence. The medical standard has to be logically defensible. A physician must consider all of the risks and benefits of both the course of treatment pursued, as well as competing options, and to avoid a claim of negligence, their decision must have a logical basis. The Bolitho test makes the situation somewhat more equitable for patients seeking redress. If a medical standard makes no logical sense, then adherence to that standard is not appropriate.

Enter the Medical Innovation Bill. Under this legislation, a doctor who departs from standard medical care will not be considered negligent as long as their decision is made responsibly. Here is how the bill defines making a responsible decision:
(3) For the purposes of taking a responsible decision to depart from the existing range of accepted medical treatments for a condition, the doctor must in particular—
(a) obtain the views of one or more appropriately qualified doctors in relation to the proposed treatment,
(b) take full account of the views obtained under paragraph (a) (and do so in a way in which any responsible doctor would be expected to take account of such views),
(c) obtain any consents required by law to the carrying out of the proposed treatment,
(d) consider—
(i) any opinions or requests expressed by or in relation to the patient,
(ii) the risks and benefits that are, or can reasonably be expected to be, associated with the proposed treatment, the treatments that fall within the existing range of accepted medical treatments for the condition, and not carrying out any of those treatments, and
(iii) any other matter that it is necessary for the doctor to consider in order to reach a clinical judgement, and
(e) take such other steps as are necessary to secure that the decision is made in a way which is accountable and transparent.
A "qualified doctor" is a doctor having "appropriate expertise and experience in dealing with patients with the condition in question". What constitutes "appropriate expertise and experience" is left undefined.

Proponents of this bill argue that the fear of litigation prevents doctors from prescribing experimental, unapproved treatments. One advocate that I encountered on Twitter linked to a Daily Mail article about a young father diagnosed with motor neuron disease. The article discusses how drug companies are reluctant to provide an experimental drug to patients for fear of being sued in the event of an adverse reaction or death. The story goes on to note that while doctors are also hesitant for similar reasons, this father was able to find a doctor to prescribe an unapproved drug, but only after he signed a disclaimer waiving his rights to sue. After some time, he was no longer able to obtain the drug that appeared to be helping him, but not because the doctor wouldn't give it to him anymore out of fear of litigation, but because he could no longer afford the £180 per day cost of the drug. The Saatchi Bill would not have helped him in any way.

In fact, the Saatchi Bill is unlikely to really help any patients. On its surface, it may appear to make things easier for patients by removing doctors' fear of being sued. So what's wrong with it? As already illustrated, current law in the U.K. allows patients to get access to experimental treatments through channels similar to compassionate use regulations in the U.S. The Medical Innovation Bill would not change that. Patients who opt to pursue an experimental treatment are responsible for any costs incurred. This bill does not change that, either. Any financial difficulties would still be there. What the bill does do is remove patients' right to sue if a doctor is negligent.

And while the goal of the bill may be a noble one, it will, in reality, likely lead to far more harm to patients by protecting quacks. While the Medical Innovation Bill requires that a doctor seek the views of at least one other "qualified" doctor, what constitutes "qualified" is not well defined; the consulting doctor does not need to be independent; nor is there any requirement that the treating physician actually follow the views of the consulting doctor(s). Nothing in the law would prevent a team of quacks from teaming up to fleece desperate patients who, under the bill, would not only lose their money for no gain, but would now have no legal recourse to recover any damages.

Although the bill's supporters focus on patients with terminal, incurable conditions, all conditions are open. Whether the condition is minor or severe, quack treatments would be permitted. Again, should a patient suffer serious harm, they could not sue the quack.

Despite all these flaws, supporters may argue that the bill promotes innovation and research. However, as The Guardian points out, the Saatchi bill actually does not permit research:
(5) Nothing in this section permits a doctor to carry out treatment for the purposes of research or for any purpose other than the best interests of the patient.
The end result of this is that not only can doctors not gather information on an experimental drug's efficacy, they cannot collect data on whether the drug is harmful.

And remember that story about the father with motor neuron disease? Well, it turns out that the Motor Neurone Disease Association, which supports patients with motor neuron disease, strongly opposes the Saatchi Bill. Indeed, the medical community who, according to proponents of the bill, so fear litigation and would thus benefit from the legislation overwhelmingly oppose it as it currently stands.

Lord Saatchi's Medical Innovation Bill, although purporting to help patients, will, in the end, only benefit quacks. Patients are already able to access experimental drugs through a compassionate use pathway outside of a clinical trial. The bill does not help patients cover the costs associated with the drug. It strips legal rights away from patients in the event that they are harmed by the non-standard care. Nothing in the bill protects the most vulnerable patients from exploitation by predatory doctors who would stand to benefit the most from this bill. In the end, the Saatchi Bill would make England and Wales the Happy Hunting Ground of quacks.

2 comments:

  1. An excellent account of the absurdity of the Medical Innovation Bill which may become law in England & Wales. As the UK charity for patient safety & justice we strongly oppose it. Peter Walsh, ceo, Action against Medical Accidents (AvMA) www.avma.org.uk @PeterWalshAvMA

    ReplyDelete
  2. Just when I thought that science was making great advances, some jerk comes around and breaks my hope for humanity.

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