Hip Hip Hurray? Nah, Hip Hip Boo!


Everything you probably didn’t want to know about the medical device industry, all mixed up in a single, ripping yarn. The story includes, but is not limited to, some or all of the following: megalomaniac tycoons, ruthless surgeons, sixty foot tsunamis, flash photography, gay inventors, leather-clad lesbians on Harley Davidsons, flesh-eating bacteria, victims, vampires and vegetarians…
Hip Hip Boo is my current writing project, and third novel. I’m intending to finish it some day soon. The plot for story has come to me gradually, and it’s still evolving. For a long time I’ve wanted to write a thriller set inside the healthcare industry, where I worked for more than twenty five years. It doesn’t take great insight to see that the business of producing medical devices, like any other, is competitive and capitalistic. The demands of competition mean that if there is a corner to a financial destination, it will probably be cut. Anyone in the business for long will have seen stuff that would astonish outsiders. Just as in banking, there are big incentives to concentrate on short term profit at the expense of a long term job well done.

The Plot of Hip Hip Boo
All of the stuff below is woven into the plot of Hip Hip Boo. Added to the mixture:
  • echoes of the thalidomide tragedy of the 1960s, where a wonder drug that was used to treat morning sickness in pregnancy was, far too late, discovered to cause disastrous birth defects.
thalidomidechildren
‘Thalidomide children’
  • Manipulation and suppression of clinical trial data, exposed by Ben Goldacre in his book, Bad Pharma (if the results don’t suit you, no need to make them public, just don’t publish them and no one will know)
  • Weakness in medical device regulation, exemplified by the PIP breast implant scandal
  • the labyrinthine world of intellectual property, a cash cow for patent lawyers; hundreds of millions of dollars can be won and lost on a court’s decision
  • inevitably, GREED is a big theme in the plot of Hip Hip Boo

greed
Greed makes me indignant!

Finally the story includes, but is not limited to, some or all of the following: megalomaniac tycoons, ruthless surgeons, sixty foot tsunamis, flash photography, gay inventors, leather-clad lesbians on Harley Davidsons, victims, vampires and vegetarians, glamorous executives, heartless managers, soulless bosses, lounge lizards, mad cows, man eating tigers, flesh eating bacteria, blood sucking aphids, Scientologists, Sikhs and Seventh Day Adventists, paedophile boffins, dying patients (of course), kerb and other crawlers, arse lickers and cockroaches in the same foetid phrase, daylight robbery, graveyard zombies, gas gangrene, bent politicians, honey-skinned maidens, Chechen bad guys, operating theatre scenes with pints of red, O Rh+ve blood, high nursing-home jinks, page three models, dashes of humour... and transatlantic humor, bondage and badinage, passionate scenes of an adult nature. And forensic insight into the shades of grey that lurk between the good and the bad in medical devices.

A true story
To give one example of a blatant lack of concern for patients in medical device development, in 1985 I was involved in the clinical trial of a potentially wonderful new artificial heart valve. Trials in those days were far less regulated than they are now, and the numbers enrolled were not based on rational, statistical calculations; (it is fundamental, and ethical, in clinical research to involve just enough patients to give a statistically significant result, but not to expose more than necessary to the unproved drug or device being trialled). In those days, investigational centres actually paid for the products they were testing. I can still hear a money-minded Marketing VP, a high up company honcho, in the context of the $1,500 the company was earning for each clinical trial valve used, and uninfluenced in the slightest by any scientific consideration, exhorting the clinical research team with these exact words, “WE NEED B-I-G V-O-L-U-M-E CENTRES.”

Sales, and no doubt the VP’s bonus? YUP!!! Consideration for the patients? NOPE!!! In 1985 there was hardly a person in the company who would not have chosen the wonder valve if they’d needed to have one put in. Oh dear! Within five years, typically after just six to eighteen months in individual patients, almost all of the valves had to be explanted. They’d all failed. In ‘BIG VOLUMES’, Mr Marketing Cheese.

The slippery slope
The field of medical devices is dynamic. Amazing new products such as coronary artery stents emerge quickly. Just as quickly, under fierce competitive pressure, these wonder inventions, and I’m not being sarcastic, are improved upon by rivals. Profit - shareholder value - provides the commercial pressure. To be competitive, rapid development and testing are essential. But the boundary between saving time, a good thing, and cutting corners, emphatically a bad thing, is not a clear one. In the excitement of new treatments, corners cut only become apparent with hindsight.

So, actual lives may be lost unnecessarily. With a drug, a typical adverse event may be diarrhoea or a headache or a rash. With a Class III, i.e. significant risk, medical device, malfunction may lead directly to death. Do not pass GO. Do not collect £200. Just die!

You can look up the examples - these events happened!
Other heart valves, too, have proved catastrophically flawed, but only after finding their way onto the market. The Björk-Shiley heart valve is an example.

björk-shileyvalve
Björk-Shiley heart valve - those shiny metal struts fractured, often fatally, because of poor manufacturing practice


Medtronic pacemaker leads are another well known example of devices that have killed - some versions of these leads had a tendency to break, with dire consequences for the hearts they were supposed to pace.

Failing products are eventually found out by the system and withdrawn, but never soon enough. It can be difficult to detect problems quickly. Regulators have been painfully slow in insisting on proper so called ‘postmarket surveillance’ and industry has dragged its feet. There’s no money in postmarket surveillance, only cost. Poor regulation is a regular theme with medical devices. Read the book - you’ll be inspired to lead a healthy life!