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ETHICS Dr Peter Wilmshurst.


‘Ideally, assessment ofany treatment should be sufficiently rapid to ensure that good treatments get to patients quickly. However, there should also be sufficient checks in place to ensure that less effective or unsafe treatments do not make it to market.’


they will want someone to show them how to use it. Often, the device manufacturer will bring in a surgeon from another unit who has previously used the device. This person will be paid for their time by the device manufacturer. The surgeon may think that they are acting as a clinician but in fact they have become part of the marketing arm of the manufacturer. “Consultancy payments to clinicians


are quite common. I was offered consultancy fees exceeding £50,000 for my role in helping to design a major trial, sitting on the steering committee and being the principal cardiologist. I refused to take the money, opting instead to do it for free to avoid a conflict of interest.” Another issue highlighted by Dr


Wilmshurst is that of reporting adverse events. He said: “If I see an adverse event with a drug, I have no problem with reporting to the MHRA using the Yellow Card Scheme. However, if you report an adverse event relating to a device that you have implanted, there is a concern that the problem may be shifted back to you, the surgeon. No one wants to gain a reputation as being someone who cannot make devices work, particularly if they undertake private work.” Dr Wilmshurst has some personal


experience of libel actions being brought by device companies. “I was sued by a medical device company, which has since gone bankrupt and I have subsequently been vindicated – I refused to put my name on a paper relating to the trial because the contents were false, in my opinion, and omitted relevant adverse facts about the product. “I am also aware that concern about


litigation has prevented other cardiologists from reporting adverse events. There is a device, used relatively infrequently in the UK, that has caused cardiac tamponade by perforation of the heart requiring emergency surgery in several patients. It has also required additional devices to be put into other patients to help seal leaks that occur. However, some of these complications have not been


26 THE CLINICAL SERVICES JOURNAL


reported to the MHRA, possibly because the manufacturer concerned has a record of litigation.” In conclusion, Dr Wilmshurst said it


was important to ask why standards of evidence for drugs and implantable devices are different? How do we deal with conflicts of interest around medical devices and clinical trial used as evidence for licensing? And how do we get operators/implanters to report adverse events with medical devices?


A new route to market At the same seminar, Andy Goldberg, consultant orthopaedic surgeon and founder of the Medical Futures organisation, suggested an alternative route to market for medical devices. “Just because an innovation is new does not necessarily mean that it is any better than existing products,” began Mr Goldberg. Some innovations come about as a


result of the introduction of a disruptive technology – one that offers a change in the paradigm of how things are done. However, the majority of innovations are in reality incremental improvements to an existing norm. Mr Goldberg offered a healthcare example to demonstrate this point. “Charnley pioneered the metal on polyethylene hip replacement in the 1960s – a good example of a disruptive innovation. Since that time there has been a wealth of similar innovations and these have all been incremental innovations, offering variations of the same. Indeed, the National Joint Registry today now lists more than 600 combinations of different brands of hip and knee replacements. It is a daunting task for a clinician to make a decision about which device to use when there is so much choice.” Mr Goldberg then showed the


audience a chart produced by the National Joint Registry, which identified


the top five cementless hip stem brands dating from 2003 to 2010. The chart showed that the number of protheses being used has increased rapidly, from 4,000 in 2003 to over 32,000 in 2010. “The outcome data for the top two brands – Corail and Furlong HAC – are similar,” said Goldberg. “So what led to one of the products being, by far, the market leader today?” He believes that product success is often more down to the marketing capabilities of the device manufacturer and that this has a huge impact on healthcare practice today.


Route to adoption “Of course,” he said, “adoption of any innovation first requires potential adopters to be made aware of the innovation. In healthcare there needs to be a good evidence base to justify the use of a new technique or product. In the healthcare environment, the evidence base and research relating to an innovation is critical and is pivotal in the decision making process.” The steps required for the introduction


of innovation into the healthcare sector include preclinical testing, first-in-man studies, clinical trials, and post-marketing surveillance. “However, there is a discrepancy between the evidence the regulatory authorities require and those that clinicians and subsequently commissioners require. Hence many drugs and devices are marketed in the absence of meaningful clinical or cost- effectiveness data,” said Goldberg, who was worried by this and went on to question why, as in some cases, it can take 10 years or more for the National Institute for Health and Clinical Excellence (NICE) to produce guidance on a product, and why NIHR funded trials tend to be commissioned well after technologies have apparently been adopted by the profession.


A new way forward Mr Goldberg went on to propose an interesting potential new way forward which could benefit all the stakeholders involved in the process of bringing a new product to market – the FDA/MHRA, clinical groups, NICE, insurers/ commissioners and industry and charities. He proposed that, at the very beginning of a new product development, a technology panel, comprising all the stakeholders involved in the process of product introduction, should review the idea to clearly identify early in the process


‘The decision about whether to grant a CE mark is made by one of around 76 Notified Bodies, many of whom are private companies.’


MARCH 2012


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