Lord Saatchi has been campaigning for a new law since his wife, novelist Josephine Hart, died from a form of ovarian cancer in 2011.
He introduced to the House of Lords a proposed new law, the Medical Innovation Bill, (or the ‘Saatchi Bill’ as it has become known) primarily to allow the responsible use of innovative new treatments for diseases by dispensing with negligence law in relation to decisions to provide treatment.
The premise of the Bill is to give doctors legal protection to use experimental drugs on patients, when other options have been exhausted and as long as it is in the best interests of the patient. It could bypass some of the lengthy regulatory testing processes required for safety and effectiveness.
Saatchi’s Bill progressed quickly through the House of Lords, with the full weight of the Saatchi PR team behind it and, significantly, Government backing, despite opposition from most medical and patient organisations.
It was then sent off to the Commons but this week was suddenly, and controversially, in effect, killed off by the Lib Dems, who have now withdrawn all support for it.
While there is sympathy for Saatchi who wants to find something positive and meaningful from his personal tragedy, the overwhelming response of the main medical bodies and patient safety community has always been to oppose this Bill.
So should the Bill have been ‘killed off’?
Efforts to fulfil desperate hopes of extending life are understandable, even if the chances are small, particularly if the patient takes full responsibility for the consequences and no one else is harmed. However using experimental treatment outside of clinical trials may not be the right solution.
A recent CMF Triple Helix article provides more detail about the background, dilemmas and competing interests, but here are my top ten concerns:
1. Drugs in early phase of development may not only lack efficacy but may be less safe than preliminary data shows. For example, it is estimated that only 5% of cancer drugs undergoing human testing are eventually approved for human use as a result of safety problems, lack of efficacy or being economically unviable.
2. There is often overestimate of benefit from early (phase 1) trials and it is easy to forget that these are still experimental, tests, not therapies. Media reports at this stage can incite premature expectations of benefit from investigational drugs and raise false hopes, unsupported by research.
3. Clinical trials may take longer if patients who could participate are also given the option to have an untested or partially tested drug outside of a study context. Every experimental drug is tested in clinical trialsagainst a placebo or an established treatment, but a common misconception is that experimental drugs are better than existing treatments. Why then would anyone volunteer to take part in a double-blind, placebo-controlled trial when one might be given the placebo and not the new treatment under study?
4. Unbiased and meaningful data outside of clinical trials can be difficult to gather, particularly information on efficacy. Allowing access to a drug that has not passed the usual rigorous regulatory controls and trials could make it harder and longer to collect clinical data on safety and efficacy, possibly even delaying approval of that drug as a properly tested treatment.
5. Pressure may be put on doctors by patients to provide a new treatment against their better judgment, even if they have concerns about safety and efficacy after early trials. Doctors may feel they cannot refuse to offer investigational treatments as they could be seen to be removing hope from the patient and lacking in compassion.
6. Informed consent – difficult enough when a body of evidence has accumulated following clinical trials – is much more difficult when there is little evidence to support the effectiveness, safety and risk-benefit profile of an innovation.
7. Patients, especially the seriously or terminally ill, are particularly vulnerable and can be open to manipulation and exploitation. Relaxation of current governance controls risks exposing patients to false hope, futile and potentially harmful (and expensive) treatments.
8. The Bill could leave patients who have been harmed by negligent treatment without any redress and ‘encourage unsafe and unaccountable practice by doctors’ claimed longstanding advocate of patients’ rights, Baroness Masham during the Second Reading.
9. Would the authority of regulators be progressively weakened by pressure to approve drugs prematurely? Drug regulation has developed because of the premature introduction of some drugs that had not been sufficiently tested, leading to some disasters. Regulatory requirements are in place to protect patients from unknown risks.
10. The Bill is, arguably, unnecessary as current law already allows doctors to try new treatments. The recent outbreak of Ebola lead to the experimental treatment, ZMapp, being fast-tracked into treatment and it appears – so far – to have been relatively successful in the few cases where it has been used.
There are no easy answers to achieving a balance between encouraging innovation and drug development while protecting patients. Currently, using innovative treatments is a bureaucratic process and we probably do need a cultural shift towards more openness and flexibility with innovative treatments.
While the rapid use of ZMapp does show that current legislation already allows the development and use of innovative treatments, it nevertheless remains a rare example.
In many ways, the Bill is well-intentioned, however it was flawed and should not have progressed so far in the face of so much opposition and well-placed concerns. It has been left to the LibDem Health Minister, Norman Lamb, to close it down.
Which leaves me with another big concern that has implications far beyond this single Bill: did the House of Lords fail to scrutinise this legislation properly? And if so, can they then be trusted to apply rigorous, informed and unbiased scrutiny to other medical bills in the future?
Posted by Philippa Taylor
CMF Head of Public Policy