If the PIP Breast Implant Scandal had happened 40 years ago, we would not have reduced cardiac mortality

The juxtaposition of two recent stories caught my attention recently: the clamouring for greater regulation following the PIP breast implant issues, and coverage of the academic paper reporting halving of heart attack deaths.

The reason it caught my attention was that the call for greater regulation was based on the premise that the current regulatory regime was too lax.  Yet the lower cardiac mortality was partly due to yesteryear's relatively permissive regulatory regime.

Regulation has two aspects to it.  The first aspect of regulation is to qualify and understand devices so that they are authorised for the appropriate therapeutic areas.  The second aspect - which is the aspect that this blog majors on - is to perform a test.  Are devices "good" - i.e. promote patient health without commensurate risks, or "bad" - damage patient health or not promote it sufficiently when the risks are taken into account.  And the "test" aspect of regulation is an imperfect science that tries to call true bads, bad and true goods, good.  As with all tests, regulation is not perfect, and it may come up with false positives (i.e., truly bad devices being allowed) or false negatives (i.e., truly good tests being denied).

The call for greater regulation that we have heard is effectively a call to make it more difficult to get false positives.  But regulation is a human process, and the only way you will get more false positives is by having fewer positives (and therefore more false negatives).  Therefore you will have really good tests not coming through the regulatory regime.

Both errors impose costs.  The question is which system imposes lower overall costs.

My argument is that it is not clear that the current method imposes too high a cost, and needs to be tightened.  I would well argue for more permissivenesss.  You may well ask why I say that.  I point to two key facts:

• PIP implants (product of what detractors have called this lax regulatory regime) have not really had a great cost directly on human morbidity or mortality.   As Dame Sally Davies writes in her letter, "there is no clear evidence at present that patients with a PIP implant are at greater risk of harm than those with other implants."

Dame Sally Davies has reassured the medical community that the evidence for a panic is not there

• Yet, we are already at a point where extremely valuable innovations may not have ever reached the market under today's regulatory regime.  John Adler, the man behind the CyberKnife, describes the difficulties he  had in bringing his innovation to the market.  Given the difficulty he faced, despite being based in Silicon Valley, and despite the fact that it was a few years ago when regulations were not as tight, I am quite certain that in today's world or in any other location, he may have been thwarted before CyberKnife had an impact on so many lives.

The Accuray story is not unique: Lonnie Smith has mentioned the difficulties Intuitive Surgical faced with the da Vinci.  The reality is that in today's world, the pace maker, the stent, laparoscopic surgery and so on would face a very difficult battle.  Had something like the PIP scandal blown up 40 years ago, and been followed by over-tight regulations, we would not be reading today of much reduced cardiac mortality.