Thursday, January 22, 2015

Maurice Saatchi's Medical Innovation Bill is more likely to make its proposer money than it is to help anyone who's sick.

Maurice Saatchi, his Medical Innovation Bill, and the booming ‘orphan drugs’ market


Maurice Saatchi has had a great deal of media attention lately. This has focused for the most part on his Medical Innovation Bill (also known as the Saatchi Bill), which he has campaigned for in the wake of his wife's death from cancer back in 2011, and which will have its 3rd Reading in the House of Lords on Friday (23rd January). But Lord Saatchi is also, of course, a very astute and successful businessman.

2013 was a good year for M&C Saatchi Plc, of which Maurice Saatchi is a director and shareholder. CEO David Kershaw attributed the company’s 5.2% rise in revenues in part to “getting back into pharma" with clients such as Reckitt Benckiser and Bristol-Myers Squibb’. Swiss pharmaceuticals giant Novartis is also a Saatchi client, and boasts "one of the industry's largest and most robust oncology pipelines". Medical Marketing & Media predicts that Bristol Myers Squibb will be the world’s biggest orphan drug company by 2020.

The term ‘orphan drug’ refers to a drug developed for the treatment of a rare medical condition. Once the poor relation of the pharmaceutical industry, orphan drugs are now big business. Sales are expected to grow 11% per year and the market is predicted to reach US $176 billion by 2020. The anticipated return on investment is almost twice that of non-orphan drugs.

An article in industry newsletter Fierce Pharma reports that "As many drug makers have figured out, a small patient group can prove extraordinarily lucrative." In 2014, the average orphan drug cost per patient per year was $137,782 compared to an average of $20,875 for a non-orphan drug. 

In the same week that Saatchi’s Medical Innovation Bill reached Committee Stage in the House of Lordsa conference on orphan drugs was held at London's Regent’s Park Holiday Inn, with one of the main attractions an "interactive roundtable discussion" with Dominic Nutt, director of the Saatchi Bill’s PR campaign.

The conference brought together "leading experts and companies such as Novabiotics, Pfizer, AstraZeneca, GMP Orphan SAS, Genethon and M&C Saatchi and many more to discuss the latest developments in the market.” It was billed as "suitable for attendees wanting to enhance development pathways with the growth of the commercial pipeline for orphan drugs and rare diseases, to access tools for consideration to gain early market access and enhance patient recruitment…”

Money Week considers the very prospect of Saatchi’s Medical Innovation Bill a boon to the biotech industry. Of course, the NHS provides a large ‘market’ with a vast number of patients for ‘recruitment’, but what is it about the bill that is so exciting to pharmaceutical companies and the biotech industry in general?

Demonstrating to a reasonable level of certainty that a drug is safe and effective takes time and money. And there is financial risk for investors: the drug may turn out to be not much use or actively dangerous.

The Saatchi Bill is designed to prevent doctors being sued for negligence if they give an experimental treatment (though not for purposes of research: this is expressly forbidden). They gain this protection even if no other doctor would support that treatment, so long as they have ‘obtain[ed] the views of one other doctor’ – who doesn’t have to agree. (What’s more, that one other doctor can be a business partner in a private practice, or a doctor who supplements his income with paid consultancy work for pharmaceutical companies.)

Let’s look at ‘negligence’ in the context of current medical law. Nigel Poole QC, a clinical negligence lawyer with Kings Chambers explains: "A doctor is negligent if he acts in a way which no responsible body of medical opinion would support or which has no rational basis. … A patient can only sue a doctor in negligence if they suffered avoidable harm as a result of his or her treatment. The patient’s family can sue if the negligent treatment caused the patient’s death. … Responsible doctors who are not negligent [as defined above] or who do not harm or kill their patients do not need protecting. … The [Medical Innovation] Bill protects doctors who act in a way which no responsible body of medical opinion would support and as a result harm or kill the patient they have treated." Sir Robert Francis QC, who chaired the Mid-Staffs inquiries, concurs in his damning response to the bill: “It explicitly frees the doctor to offer treatment which has no support from responsible medical opinion.”

So with the Saatchi Bill, the need to demonstrate safety and effectiveness is greatly reduced. Doctors can try experimental treatments that have no evidence to support them, the pharmaceutical companies can supply the drugs, and the risk is borne entirely by the patient. “Alarmingly non-specific in its wording, the Bill opens up several potential means of causing harm to patients without recourse to protective legislation," according to an editorial in The Lancet Oncology.

The Medical Innovation Bill’s stated aim is "to encourage responsible innovation in medical treatment." Does it address a lack of funding for research? A lack of resources within the NHS for new treatments? The bureaucracy surrounding regulation of new treatments, or the professional regulation of doctors? No. None of these. Not in any way, shape, or form. Maurice Saatchi has decided that a fear of litigation is the problem.

The Medical Defence Union and the Medical Protection Society have stated clearly that they do not believe doctors are prevented from innovating by a fear of litigation. The British Medical Association and the Royal Medical Colleges don’t think so either. They do not support the bill; neither does the NHS Litigation Authority or the Medical Research Council. No one has been able to find a single case where a doctor has been sued for innovating. Even Harry Woolf, a supporter of the Bill and a former Lord Chief Justice, cannot cite a single such case.

And yet, as its sole contribution to medical innovation, the Saatchi Bill blandly states: "It is not negligent for a doctor to depart from the existing range of accepted medical treatments for a condition if the decision to do so is taken responsibly." In current law, negligence means falling below a minimum standard of competence. It has nothing to do with a decision to depart from accepted practice, however that might be defined – there is no central register of accepted treatments, as Nigel Poole QC has pointed out. But under the Saatchi Bill, provided the doctor follows a few ill-defined procedures prior to giving the treatment, s/he cannot later be sued no matter how devastating the harm suffered by the patient as a consequence of that treatment.

Most patients condemned to death by a dreadful disease – and those who make decisions on their behalf – are willing to try anything, anything at all to prolong their lives. Under existing law doctors already can and do provide innovative treatments, including orphan drugs both trialled and un-trialled, when it is reasonable to think the treatment is in the best interests of the patient; existing law protects both doctors and their patients. The Ebola patients recently and currently being treated on the NHS are a good example of this.

The Lancet Oncology editorial cited above states "doctors are already able to innovate outside the context of trials." Particularly in oncology and paediatrics, drugs are often used ‘off-label’ (i.e. for a patient group or condition for which the drug has not been trialled). And in fact, proper monitoring, reporting, and appraisal of off-label use can provide valuable insights for future use. He states further that ‘there are many ways in which doctors can access drugs that are in early-stage clinical trials but not yet widely available.” (ibid)

All the Saatchi Bill does is to remove existing protection from patients when the doctor gives a treatment no colleague would support. According to Dr Marika Davies, a medico-legal adviser at the Medical Protection Society said, it “will put patients who are desperate to try anything at risk of harm from unsuccessful, ineffective and possibly harmful treatments.” The Editorial in the Lancet Oncology cited above offers an example, “the provision of [unlicensed drugs] on a desperate whim, in an unmonitored environment, could lead to patient harm. … Even if the drug had advanced to later testing, but is not yet licensed, pharmaceutical companies would be required to disclose data about toxicities to national licensing agencies only. This information may not stop pharmaceutical companies from promoting their treatment to medical professionals. Doctors could end up prescribing drugs that hurt their patients, only to find later that the toxicities were known, but undisclosed. Clearly this would cause preventable harm to patients; it could also cause ‘immeasurable psychological pain for doctors who believed they were providing the best care for their patients’ ibid Pharmaceutical companies have been known to fall short of ethical practice in promoting their drugs to doctors. Novartis, for example, was involved in two scandals in Japan alone last year, one of them for failing to disclose known side effects of leukemia drugs.

Innovation is a word with very positive connotations, but “the history of medicine is littered with good intentions and innovations that seemed like a good idea but turned out to have disastrous side effects” - as Conservative MP Dr Sarah Wollaston, a former GP, pointed out in an Adjournment Debate on the bill in the House of Commons last month. She also pointed out that the extraordinary developments in medicine over the last 40 years have been thanks to clinical trials establishing efficacy and risks.

The Medical Research Council, the Academy of Medical Sciences, the Association of Medical Research Charities, the Motor Neurone Disease Association, Parkinsons UK, the British Heart Foundation, Leukemia and Lymphoma Research and the Wellcome Trust, among others, have pointed out that the Bill may inhibit genuine medical innovation as it could discourage patients and their clinicians from participating in clinical trials by encouraging the provision of novel treatments on an ad hoc basis, thereby producing unlinked anecdotal evidence that is virtually useless. Dr Sarah Wollaston describes as a "fundamental flaw" the fact that the Bill "specifically precludes the treatments being linked in any way, so we will learn nothing from these treatments. Lord Saatchi’s premise is that his Bill will advance medical knowledge, but there is no evidence that it will advance medical knowledge an inch because we will not be able to answer that fundamental question about whether there are unintended harms from the treatments or any long-term benefits." She goes on to say, ‘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.’ (ibid)

If the Medical Innovation Bill is enshrined in law, the incentive for pharmaceutical companies to develop their products beyond the experimental stage all but vanishes. With the Saatchi Bill, they can make a return on investment without the need to progress to clinical trials or market authorisation. And without clinical trials, the opportunity to advance the development of effective treatments is lost.

Current law is flexible and innovative practice by individual doctors is expressly permitted where reasonable. Current law does not undermine clinical trials, within which doctors work collectively to produce innovations of great value to patients. Current law protects both patients and doctors and promotes responsible, ethical medical practice.

A vast number of medical professionals and eminent lawyers, along with respected charities and patient advocacy groups oppose Lord Saatchi’s Medical Innovation Bill on the grounds that it is both dangerous and unnecessary. A handful of quotes below indicates the strength of the opposition the Bill’s supporters ignore:

 “If there is misunderstanding [regarding the protection offered by current law] then it should be corrected by guidance, not by legislation which exposes vulnerable patients to unjustified risk and deprives them of remedies when mistreated by those who have no acceptable justification for what they have done.” 

Sir Robert Francis QC

 ‘We are dismayed that the bill is being promoted as offering hope to patients and their families when it will not make any meaningful difference to progress in treating cancer. … We are concerned that rather than promoting responsible scientific innovation in the treatment of cancer, the Medical Innovation Bill will actually encourage irresponsible experimentation producing nothing more than anecdotal ‘evidence’, at the potential expense of causing serious harm and suffering to patients, their families and carers.’ 

Letter from 100 oncologists to The Times 13th November 2014

 ‘[The Medical Innovation Bill] is fundamentally flawed in its premise, it is unnecessary, it removes essential protections for patients, and it increases the risks of their exposure to maverick doctors. I believe it will undermine not only patients’ safety but medical innovation…’

Dr Sarah Wollaston MP ibid 

“I conclude with the words of Michael Baum, one of the leading innovative surgeons in cancer in this country, whose contribution to breast cancer is second to none. He has said to me that in his view, “Their Lordships are walking over a precipice if they pass this Bill”. We have to listen to that very carefully.”

Lord Robert Winston

The Lancet Oncology’s opinion is this Bill should never be enshrined in law.” 

If neither patients nor doctors nor medical science nor British law are well served by this bill, what purpose does it serve? Who benefits from it? M&C Saatchi Plc had another very good year in 2014 and the noble Lord and his team are "looking forward to the Third Reading of the Medical Innovation Bill this Friday in the House of Lords."

I have looked through Hansard and other relevant documents to see if Maurice Saatchi has declared a financial interest in his Medical Innovation Bill. I’ve found no evidence that he has done so.

The British public are entitled to full, clear, and accurate information about this bill, not the smoke and mirrors of a PR campaign.‘orphan-drugs’-mark?

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