Investigations into Johnson & Johnson's marketing practice - the ongoing saga of unregulated medical devices

One thing has led to another as the US Department of Justice launched an investigation into the marketing practices of the large medical device manufacturer Johnson & Johnson. At the heart of it is the number of recalled hip replacement products since 2010. Gigamole has blogged about this before.

Do not for one moment believe this will put a dent into J&J's marketing strategies. The company is no stranger to these financial penalties. It, like many other companies, have considerable sums of money set aside to cater for these penalties. After all these, Gigamole is sure the company will still be in the black. Two years ago, J&J was forced to pay off US$78 million for having paid bribes and kickbacks. Apparently bribing orthopaedic surgeons is a common practice among device manufacturers. In a report in the Archives of Medicine in 2011, the authors reported on 5 device manufacturers (Zimmer, DePuy Orthopaedics, Biomet, Smith & Nephew and Stryker) who had paid out, in 2007 alone, US$198 million to 939 orthopaedic surgeons.

Which is why medical devices need to be regulated. HSA is being very unwise in leaving medical devices unregulated, because in so doing, they are leaving the patient-consumer at the mercy of the device manufacturers. It is foolish and naive to believe that industry have anything else on their agenda than to generate profit for their shareholders.

To date however, the problems of the recalled De Puy hip replacement devices in Singapore remain unresolved. The HSA appears unwilling to take a strong public position about this. And patient-consumers remain unprotected.

Gigamole wonders when HSA is going to do the right thing?

Hearing but not listening. Beyond the population white paper.

We all know the expression 'to hear but not listen'. How many times have we screamed' in exasperation at our kids, and for that matter - our kids screamed at us..   " .....but you are not listening!! *sigh*

Our present gahment seems a bit like that, isn't it. Minister Ng Eng Hen, said in no uncertain terms "We heard  Singaporeans clearly". PM Lee in his post election speech said it too..." We hear all your voices.". Hear, hear. The question is...have they listened?

In Medicine, hearing is a function of the auditory organ, the ear and all its connections. If you can't hear, it is a malfunction of the organ. Something is damaged, or there's just a big cockroach stuffed into your ear. But if you can't understand despite hearing.... something is wrong higher up. Some people call this an auditory Perception Difficulty, and link it with the more recognizable group of dyslexic conditions.

But it is not necessary that the gahment has something so crippling. More likely, they are just locked into an ideological frame of mind, that they cannot see anything worth considering beyond the ideology. Talk about needing to think out of the box. Here is a bunch of smart (very smart, I believe), high salaried technocrats, who believe that all they have is in that box, and cannot conceive of any possibilities outside of that box.

So when they hear, they actually cannot understand. So when they say they hear, what they mean is that they  have heard the noise and clamour, and believe that their failing is merely that they have not worked hard enough to make us come round to their way of thinking. So they will try harder, to make us understand.

Sadly, with potentially tragic outcomes.

恭喜发财！万事如意！

Happy Lunar New Year all! Here's wishing the black water snake will bring us better news than the white paper did!

Our hospitals' creative definitions of charity.....

Leong Sze Hian's expose on the NUH (Patient Care Charity Fund) and TTSH  Community and Charity Funds' use of collected money provided another jaw dropping moment for Gigamole.

What's going on here?

How can you use funds collected under the guise of charity to pay for education and training of staff, and the building of hospital infrastructure? For the NUH Fund, only 52% of expenditure apparently went to needy patients, while 48% went to medical education, training and research. For the TTSH Fund, apparently only 47% went to real charity-worthy needs. The rest of the expenditure apparently went to finance the building of infrastructure in the form of a new Emergency Diagnosis and Therapy Centre.

If these revelations are true, Gigamole is extremely offended. Clearly these are abusing donor's and patient's trust, not to mention demeaning to the idea of charity.

The Commissioner of Charities should have something to say about these.

The Alirio Melendez research misconduct issue finds resolution.... well, at least some kind of resolution ...!

After one and a half years of dingdonging, the Melendez research misconduct investigations  finally get an NUS report. Twenty one papers were associated with plagiarism, fabrication and falsification. Strangely, the NUS refuses to say which papers. But the NUS apparently exonerated all the co-authors. Whoohoo......! Nobody else were responsible!

Incredible news, I must say. The lead authors of the papers not responsible? I am sure Melendez was not the lead author for all 21 papers. How can this be?

In the NUS, I am told, there is a scheme of apportioning glory and credit for scientific publications. This is for the purpose of chalking up points for promotions and other 'rewards'. The lead and the corresponding authors get 50% of the credit each. All the other co-authors stuck in between get 10% each. On this model, one published paper with a mass grave of 10 co-authors can chalk up a total of 180% credit.

Contrast this with research misconduct, where suddenly everyone in the mass grave is invisible and not involved, and only one person takes the blame for everything.

You go figure the logic!

Depuy hits the headlines in Singapore - finally!

Straits Times Health Correspondent Salma Khalik finally decided the Depuy hip implant problem was important enough to highlight. A half-page spread today.... whoohoo....! Gigamole had been beating this gong for the last 6 months and wondering if anyone was listening. So....thank you Ms Khalik!

Truth is HSA has floundering somewhat with respect to medical devices regulation. With all good intention, it started to do something about it but mismanaged the implementation. After an hysterical outcry from suppliers and practitioners, it pulled back from doing the right thing. Kinda like 3 steps forward and 2.9 steps back.

The Depuy hip implant failure is now subject of a national class action lawsuit in the USA. Just a few days ago, Johnson & Johnson agreed to settle in Australia for A$30,000 per patient. In Singapore however, the situation is far from clear.

There are many problems.
a] Lack of patient awareness. A dear doctor letter was sent out, but there has been no follow up by any responsible party.
b] No one has any idea who received the implant. There is no registry of such implant use.

c] HSA has no idea who is affected, and what to do about it. Gigamole thinks they have just been hoping the problem will fade away in time.
d] There is no service laboratory in Singapore that will measure chromium and cobalt for toxicity.

There is no equivalent of a lemon law for medical devices in Singapore, and no patient consumer movement to look into the interests of the patient-consumer. Like it or not, the only authority who can do this is the HSA, but they seem clueless and toothless.

Silence is golden, NUS? I am disappointed.

Sometimes I wonder if the National University of Singapore (NUS) values good press above doing the right thing. I understand that managing the corporate profile is important, and that for a school such as the NUS that relentlessly chases the rankings, avoiding bad press is important. But there are other ways of managing your reputation than just avoiding difficult issues.

Here the imposed silence on student blogger Alvin Tan's punishment says a lot about NUS character and maturity. I am not interested in the sordid details about what the blogger did, but the consequences of what he did especially while he was a scholarship holder. Whatever NUS's disciplinary decision was, there are important lessons for everyone. Transparency in dealing with such a difficult issue will show to the world the heart and soul of the university. We need to know what value systems, the NUS stands for. If the disciplinary action was fair and honest, why is there a reluctance to make it known? There are lessons for everyone.  As a world class university aspirant, the NUS should not fear engaging in public discussions and debate, even about its own corporate decisions.

But I am disappointed. Because it seems clear that the NUS has opted to hide behind zipped lips and walls of silence rather than bravely engaging the public. This has been how the NUS has chosen to manage previous incidents - from research malpractices to spectacular lab accidents. To date, the public remains in the dark about what mistakes were made and what actions taken. Valuable opportunities to learn from these incidences have been lost. This over-reliance on the strategy of retreating behind walls of silence is very damning, and I believe in the longer term, will stunt the intellectual growth of the university. Perhaps some timely advice from the managing editor of the SPH who sits on the NUS Board of Trustees is appropriate here.

It's time the NUS grew up.