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?

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.

The patient-doctor relationship - a relationship between unequals

Today's Straits Times carried an interesting report of  contest in a coroner's court between a mother who is a nurse, and a surgeon. The mother, who had lost her daughter in a liver transplant contended the surgeon provided sub-standard care because she had a spat with the surgeon earlier.

She did not convince the coroner. However, the case highlighted the inherently unequal relationship that exists between a patient (and relatives) and the doctor. Here, every patient is in essentially a subordinated position, and generally hesitant to offend the attending physician/surgeon. This is generally the case, unless the relationship is based on a completely elective and unnecessary procedure, when a more commercial/contractual relationship may apply.

This is why I am concerned about how the physician/surgeon goes about taking consent for procedures. Often the consent is taken by the care giver. In this case, the patient is often afraid of offending the doctor. This unequal relationship very clearly does not create the circumstance when a truly voluntary consent can be obtained. This ethical lapse, also applies to the situation when consent is being sought for participation in a experimental procedure or clinical trial when the researcher or care giver is himself/herself the one administering the informed consent.

The more academic hospitals compound the problem further by expecting patients on admission to consent to giving up rights to tissues and genetic material for research purposes. This consent is often taken at most inappropriate times when the patient and his/her relatives are most dependent and submissive.

The hospital ethics committees applying their very utilitarian logic, obviously do not disapprove of these ethical lapses.

Sex and corruption in medicine

 

The recent sex and corruption case at the Central Narcotics Bureau has certainly woken many people up. But there is really nothing new here other than the titillating stories of trysts  and late night sexting between two very gatal (itchy) people. Sex sells. And all through history women have used their wiles to charm their way into position, power and wealth. So was this corruption, or just two very gatal people acting out their fantasies? We won't know for some time, and Gigamole will not speculate.

Nonetheless, Gigamole is reminded that the medical and health industry is not immune to such sex and corruption issues. Just that many do not get flagged out.

The WHO has estimated that the about US$4.1 trillion is spent globally on health services and of this, US$750 billion was on pharmaceuticals. It is a massive industry. The pharma companies aggressively compete for this market, and many (if not all) resort to unsavoury methods to market their wares.

Recently GSK was fined US3 billion for illegal marketing of its products. Part of these charges relate to providing junkets for doctors and various other kickbacks. J&J also had to pay up US78 million to settle charges of bribery and kickbacks it had provided.

Does this happen in Singapore? For sure. But perhaps not so obvious, because of our CPIB. But bribery and kickbacks in some form definitely occurs. Our doctors (especially)  go on junkets all the time. Not to mention kickbacks of various sorts. These are supposed to be regulated and notified to senior management, but nobody really scrutinizes anything, and consultants regard these as the perks of their practices. Medicines Australia reported that the annual spending by Pharma companies in wining and dining doctors and healthcare workers amounted to about A$24 million. How much "hospitality" spending in Singapore? Gigamole doesn't know. In fact the authorities don't really want to know.The public should insist that this be reported and made known publicly.

Any sex involved? Gigamole cannot prove anything. But suffice to point out that the industry is much bigger than selling the odd IT systems. Anybody stopping to point out that the sales reps for pharma companies are invariably attractive young ladies in short skirts?

This is not a problem that affects just pharmaceuticals. Medical devices suffer the same corruptibility. The susceptibility also extends up all levels of the health care chain....all the way from the prescriber, procurer and possibly even the regulator. Can we trust that we have only the best medical information, drugs and devices? Possibly not.

We need to look at this more carefully. The trouble is that the medical industry is seems rather "protected" and few want to stir the pot to root out these problems within the industry.

"You ignore me, how, how, how?"

Sounds like the plaintive cry of a woman scorned. And we all know enough to beware that woman scorned.

Yet, often we Singaporeans are made to feel like the woman scorned. By the gahmen (and their extensions) we love. Gigamole feels that way sometimes. Important issues brought up often meet that deadly wall of silence. The icy stare. The cold shoulder.

Issues that continue to bounce off the wall of silence::

a] Illegal street racing. All we hear are the Ferrari engines that continue to roar down our city streets in the dead of night.

b] Lab explosions in the NUS. A lab accident after another, yet the Ministry of Manpower, for all their new empowerment through the WSH Act, and the NUS, continue to maintain their walls of silence.
 
c] Research misconduct. The Alirio Melendez story came and went. Yet for all Singapore's vaunted push for research integrity, the Melendez related dirt seems to have been conveniently swept under the carpet.

d] Unregulated wacko medical devices. The HSA sweeps some more dust under the carpet as they maintain their wall of silence of some pretty disturbing information about medical devices let loose in Singapore.

e] Disbarred doctors who can practice in Singapore. The latest question mark that needs to be unmarked by the Singapore Medical Council. Don't hold your breath waiting for an ans They'll intubate you!

You ignore me, how, how, how?

How about a Lemon Law for medical devices?

Gigamole was delighted to read about the Lemon Law for Singapore. Kicks in today! Gigamole wonders why it had taken so long to want to protect consumers, but ne'er mind, better later than never.

Gigamole also wonders how the Lemon Law might protect the patient consumers from faulty medical devices such as heart stents, and other prostheses. It would seem that that the prostheses itself should be covered under the current Lemon Law, since the patient did "purchase" a device. The surgery to implant the device is not covered, as it would be a "service". On the other hand, the surgeon would actually be the retailer of the device, so should be responsible for the replacement of the device if it were faulty within 6 months.

The problem with medical devices is that defects often do not reveal themselves within 6 months. So the patient often has to shoulder the burden of proving that the defect did not live up to expectations of quality.

This raises a further question of who actually provides assurance of quality of the product and who protects the patient consumer from exploitation by manufacturers. One may expect that the HSA, as the government regulator to provide assurances that any device entering the market has an acceptable level of quality and safety. But this is not the case at the moment. The nascent attempts to regulate medical devices ran into bad publicity, and the HSA has since appeared to shrink from doing the right thing.

So now no one knows if the medical devices that are stuck into a patient's body is of acceptable quality and safety. No one knows who is actually protecting the patient consumer. Recently Gigamole has flagged up issues with metal on metal hip implants, transvaginal meshes, cardiac stimulators, heart valves, which have increasingly been cited in various regulatory withdrawals and law suits overseas. But locally, there has only been a deathly silence from the HSA. So no one apparently wants to inform the patient consumer the bad news. No one wants to point the finger at surgeons for retailing faulty devices. Seems to be that the patient's only recourse is through litigation. Even so,  there should be adequate awareness among patient-consumers that there is a problem. Sadly, there is so little local information available for the patient-consumer to use. HSA's silence is certainly not helpful.

Gigamole believes we need a Lemon Law for medical devices. But not just a law,  we need a healthy consumer protection movement for drugs and medical devices.

The cyclist-motorist conflict - It's time the LTA did something

A paralysis of indecision happens when someone cannot decide between two or more courses of action that will independently lead to conflicting outcomes. We have seen how this can affect regulatory agencies such as the HSA, when trying to decide between pleasing the biomedical industry and protecting public interests A proper balance between conflicting outcomes may be difficult to strike. The indecisive will often just sit on their hands, and hope the problem will blow away, or at the very least stay away until the decision maker can escape to another, usually higher appointment.

The problems between cyclists and motorists have been brewing for a very long time. It's not as if the LTA has not been aware of it. Gigamole had posted before on this conflict almost exactly 2 years ago. Yet no action had been taken since then. Recently, this has blown up again because of some tragic and unnecessary accidents between cyclists and motorists. 

An increasing cyclist lobby are rightfully clamouring for more space, more consideration and more safety. On the other hand motorists say cyclists are often irresponsible on the roads, that motorists feel they have more rights to, as they pay road taxes while cyclists do not. Truth be told, both parties do engage in risky, irresponsible behaviour. Who is right?

It is during times like this that the LTA need to step in and openly declare the appropriate boundaries, physical as well as behavioural. It is in this situation that the LTA has been neglectful, and in my mind irresponsibly indecisive. I can appreciate their dilemma. On one hand they do not want to restrict the behaviour and recreational choices of the growing cycling population. Yet the road system is far from adequate to accommodate both cyclist and motorist needs. Motoring traffic is congested enough as it is already. S what does LTA do....? It appears they just want to sit on their hands and hope the problem will be delayed to the next cohort of managers.

So here is Gigamole pleading again with the LTA.... please do something about this. Before more unnecessary deaths occur. Make the rules clear to both the cycling and motoring populations, and be committed to enforce them until such time as behavioural norms can be established.

Regulatory conflicts of interest - lessons for the HSA from SMRT/LTA COI

The recently released findings of the Committee of Inquiry for the SMRT breakdowns has some important lessons for the HSA. Apart from pointing out the lapses in SMRT, it also fingered the failure of the regulator, LTA, in managing the intrinsic conflicts of interest inherent within the workings of the regulator. But the LTA is not alone is this regard. Many, if not all of Singapore's regulatory agencies are stacked full of these conflicts.

The HSA is similarly affected. Gigamole has pointed out these conflicts of interests before. How can a regulator do its job when it has also been tasked with befriending and facilitating growth of the very industry it is supposed to regulate? In some cases, the HSA is itself, also the service provider in the areas where it is supposed to regulate.

 In the recent brouhaha about medical device regulation, the HSA came across looking almost afraid of the industry it is supposed to regulate. Note how very quickly it capitulated to the demands of industrial players. To Gigamole, "regulate with a light touch" really means "I will look the other way while you do your thing. Just don't get into trouble".

In the hurriedly convened "closed" town hall meeting, HSA met up with 370 of the industry players to anxiously reassure them of this "light touch". Conspicuously absent was any representation from any consumer groups. Do patient-consumers not have a voice, and do they not need to be protected? It used to be that we can depend of the Ministry of Health, or its proxy, in the form of a governmental regulatory agency, to have the interests of the public first. But nowadays, this cannot be assumed, because regulators have to be industry friendly, and promote the development of these very industries. And the biomedical industry has become significantly more powerful and insistent of late. The need to "perform" with respect to the Pro-Enterprise Index, speaks volumes.

The LTA had been found wonting because it did not adequately firewall its regulatory functions from the need to also promote. Likewise, Gigamole predicts that it is only a matter of time before the HSA runs into serious problems with major consequences for the patient-consumer if it doesn't make a serious attempt to deconflict these functions.

Smith & Nephew R3 recall - MHRA advisory

Here's a follow up of the Smith & Nephew R3 acetabular system that Gigamole had highlighted a while back. The UK regulators, MHRA (Medicines and Healthcare products Regulatory Agency) has now issued an advisory about the recall. Their advice is pretty similar to the FDA advisory for the DePuy ASR implant recall.

All patients, symptomatic or not, should undergo MRI or ultrasound scanning. They should be followed for the lifetime of the implant in the body. Blood levels should be checked for cobalt and chromium levels. If either scans are abnormal, or metal levels are rising, surgical revision should be considered.

HSA meanwhile is maintaining their wall of silence.

Latest medical device alert about the DePuy ASR hip replacement recall! Please tell your friends and relatives who have had any hip replacements done.

Gigamole had posted on the DePuy ASR hip implant before. Here is an alert issued from the UK Regulators (MHRA - Medicines and Healthcare products Regulatory Agency) just yesterday.

The United Kingdom with Australia are the two regulatory agencies who have tracked this problem, and had been responsible for flagging up the very high rates of surgical revisions for patients who have been implanted  with these prostheses. In 2010, the UK reported revision rates of about 12-13%, compared to usual revision rates of about 1-3%. This prompted DePuy to implement a global recall of the implants. In Singapore, the HSA reported that there were only 319 implants done, with only 1 revision. One must seriously doubt this figure because HSA does not regulate such medical devices and do not have any kind of tracking process in place, so the revision rates they report are only what surgeons and DePuy want to tell them about. One revision in 319 is an amazingly unbelievable success rate by any standards, so clearly the surgeons are not telling anyone about their surgical failures and the need for surgical revisions.

The HSA has generally left it to the company DePuy and the surgeons to muddle through by themselves, thereby leaving the patients entirely at the mercy of those responsible for this mess.

In any case, the MHRA has deemed it important enough to issue another alert, this one just coming off the press yesterday. You can look through the alert yourself, and if you don't understand the technical aspects, you can just email me and I will try and explain to you.

All patients who have had hip replacements done should get their surgeons to give them the details of surgery and the type of implant that was used.

To summarize, the MHRA recommends that all patients having these Depuy ASR implants, whether symptomatic or not, to undergo an MRI or ultrasound scan. If the images are abnormal, surgical revision should be considered.

All patients should have their blood analysed for chromium and cobalt levels. If the levels are high and rising, surgical revision should be considered. Patient follow-up should be for as long as the implant is in the body.

Obviously these costs should not be borne by the patient.

It is very unlikely that surgeons are either able or willing to recall all their patients who have had such implants done, so many patients will not be aware of the need for follow up or for implants to be removed.  And HSA isn't really doing very much about this. So please feel free to circulate this information to friends or family members who have had hip replacements done. At the very least, they should get the relevant details from their orthopaedic surgeons.

More tales from the crypt - Don't mess with the mesh!

Lest people think I am somehow targeting my orthopod colleagues in sharing about failed and faulty hips, here is a story from a different part of the body.

Johnson & Johnson's Ethicon subsidiary has very recently been involved in a voluntary recall (called by the company, a "discontinuation") of a series of their products -the Gynecare vaginal meshes. These include -the GYNECARE TVT SECUR™ system, GYNECARE PROSIMA™Pelvic Floor Repair System, GYNECARE PROLIFT™ Pelvic Floor Repair System, and GYNECARE PROLIFT+M™ Pelvic Floor Repair System. These are meshes which are being used in women for the repair of urinary incontinence and droopy pelvic floors. The problem was that these meshes were associated with frequent and severe problems such as - pain, infection, bleeding and painful intercourse.

The story leading up to these recalls is a fascinating study of why medical devices should be better regulated.

• Boston Scientific was the first to introduce the vaginal mesh (essentially a modification of a mesh used for repair of hernias) in 1996. 
• Two years later a few companies, including J&J, got approval under the "similarity" regulatory loophole to market similar meshes. 
• The very next year, Boston Scientific recalled their mesh due to safety reasons. Despite this, the other meshes continued selling into the market. 
• In 2005, J&J sneaked through a number of other meshes without even telling the FDA. The FDA only found out about this in 2007, when J&J tried to get approval for another mesh through the 510(k) loophole. 
• This was regularized in 2008 when the FDA approved all the meshes, but without any clinical data being provided.

Very soon after that, problems began to surface, and the FDA in 2008 issued a warning that adverse events were serious but rare. By 2011, a lot of stuff had already accumulated on the fan. The FDA upgraded meshes to high risk devices, and issued a warning that adverse events were not only serious, they were not rare! In addition they wanted more clinical studies if the meshes were intended to remain in the market.

Two weeks ago, J&J informed that instead of doing more clinical studies, they were 'discontinuing' the meshes from the market. The earlier mesh would remain in the market but with modified warning labels.

In the midst of all this, the situation in Singapore, is as usual, business as usual. These meshes, despite the warnings by FDA have continued to be offered as primary solutions in all our major hospitals - KKH, SGH, NUH. There is no evidence that the 'discontinuation' of the meshes by J&J/Ethicon have been implemented here. HSA has been deathly silent. I am not even sure they have been tracking the problem. A search on their website reveals nothing.

The FDA had made a number of recommendations about the use of these meshes (not just the J&J/Ethicon ones):

For health care providers:
• Recognize that in most cases, Pelvic Organ Prolapse (POP) can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

For patients:
• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

So, some more questions for our HSA, :
Why haven't we done anything about these meshes, since the earliest problems with respect to the Boston Scientific product got recalled; since the first FDA warning in 2008; and the second warning in 2011?

Are these meshes regulated in any way in Singapore?

Is our practice with respect to the use of these meshes consistent with the FDA recommendations above? How do we know?

What is the legal recourse for patients who have been 'misguided' by J&J/Ethicon?

Another medical device bites the dust - the Smith & Nephew R3 acetabular system

Here we go again. Now it's the Smith & Nephew Acetabular System, being voluntarily recalled by the manufacturer, Smith & Nephew Surgical Pty Ltd. Here is an announcement carried through the Australian Therapeutic Goods Administration (TGA). In 2010, the company had actually been issued a warning letter by the FDA about non-compliance with Good Manufacturing Practice. Doesn't this sound similar to the recent mess about the DePuy hip implant recall?

Well, now they finally have to issue a voluntary recall of the hip implant prosthesis, after unusually high failures recorded in Australia and UK. Launched in 2007, apparently about 7700 of these metal liners have been used globally. There is no record of how many of these metal upon metal implants have been used in Singapore itself. To date, it is uncertain how this recall is being implemented in Singapore. One of the recognized problems with metal on metal implants is the potential for erosion and resultant cobalt and chromium poisoning. The recommendation now is for patients who have had such implants to be subjected to life-long screening for toxicity.

So more questions for the HSA:

a] Do we know how many of these implants have been used in Singapore?
b] Do we have a record of patients who have received these implants, and are there processes in place to recall these patients for observation and toxicological screening?
c] How is this being tracked? How are patients expected to know?
d] Why is there no public dissemination of this information? Is this recall being implemented at all in Singapore?

More loopy unregulated medical devices horror stories - the Myxo annuloplasty ring

Gigamole had posted previously on the Edwards SAPIEN heart valve operation recently carried out at the National Heart Centre. It seems that the Edwards Lifesciences company has been getting into all kinds of problems recently also with respect to their Myxo annuloplasty ring. (Online references at the end of this post)

Essentially, the problem was triggered by the complaints from one patient at the Northwestern University research hospital, who claimed that the valve that was inserted into her heart in 2006 was not a FDA approved device, and she was not made aware that it was an experimental option. Furthermore, the surgeon who operated on her was an inventor of the valve and also received royalties from the marketing of the device. The fallout from her complaints have been significant and protracted. Although the university has denied any wrong doing, the patient's position has been supported by another of her doctors at Northwestern.

The background information, very simply outlined here, about this saga, are as follows:
a] In 2001, the FDA apparently rubber-stamped the industry's petition to reclassify heart valve annuloplasty rings to a lower risk category so that it can qualify for the 510(k) regulatory loophole. This meant that the industry can avoid doing clinical trials of an innovation if it can be shown to be insignificantly different from an earlier invention. Edwards Lifesciences used this loophole to launch their Myxo annuloplasty rings, even though they had filed for patents documenting significant differences from older versions.
b] Consequently, at the time the patient received the implant, the FDA did not even know of its existence. The FDA says it therefore never gave any approval. If it is an unapproved device, it should be regarded as an experimental device. The company and the university says it is not experimental, and that it did not require FDA approval under the 510(k) loophole. Meanwhile the surgeon has published the data as part of a clinical study.

The controversy continues to brew and has provoked cries for the FDA to review its approval procedures for medical devices.

Further readings here:
http://www.theheart.org/article/1230079.dohttp://www.theheart.org/article/960385.do http://articles.chicagotribune.com/2011-05-22/health/ct-met-medical-devices-20110521_1_annuloplasty-rings-faulty-heart-valve-diana-zuckerman
http://online.wsj.com/article/SB126151643854401921.html http://www.medicaldevicestoday.com/2009/07/medical-device-fda-510k-policy-modifications-faces-mounting-scrutiny-.html

What have all these got to do with us here in small, faraway Singapore?

For starters, we should not be too over-reliant on decisions made by FDA, and should develop our own opinions on the matter. This is not to say we have to duplicate all the evaluations, but merely we need to scrutinize all innovative medical devices to form our own opinion as to how much pre-marketing data is required. The FDA is wrong to say "... companies, not the agency, are best qualified to determine whether modifications affect a device's safety or effectiveness." Companies are motivated by self interest. Mostly of the commercial sort. Interestingly the HSA has a pdf file on this Myxo ring, but the file is mysteriously not accessible.

Secondly, doctors do not have the inalienable right to stick all kinds of experimental devices into patients with firstly getting ethics approval, and regulatory approval. It is unclear how many similar annuloplasty rings have been used on our patients without notification and approval of the HSA, or even ethics committees. It remains unclear whether the previously blogged about SAPIENS tricuspid valve prosthesis was approved by the ethics committee as an experimental procedure, since it was not an approved medical device.

Thirdly, proper informed consent by the patient is required. Gigamole notes the favorable developments recently to develop better informed consent procedures. This has been long overdue. Gigamole hopes that the consent process will make the distinction between routine accepted practice and experimental procedures using methods that have not been approved by the HSA. Patients are not all willing to be guinea pigs.

Just a parting trivia...... The company Edwards Lifesciences makes exciting new valves here in small faraway Singapore. Their factory in Changi North Crescent, opened in 2008.

Shooting from the hip: Another unregulated medical devices horror story

Gigamole had posted earlier about the possibility that a recent heart valve replacement surgery may not have been approved. Now for those who still insist on the "I-see-nothing" approach towards the issue of medical device regulation, here is a story to think about before you go to bed. Especially if you were one of those who had received a metal-on-metal hip replacement.

There is a kind of total hip prosthesis manuctured by a company called DePuy Orthopedics, a subsidiary of Johnson & Johnson. These hip replacements called the ASR Resurfacing System and the ASR XL Acetabular System, have metal cups as well as metal heads fitting into the cups. That's why they are referred to as metal-on-metal prostheses.

The prostheses first appeared at about 2003 and 2005 respectively, and were allowed into the US market without the need to do any clinical trials, through an FDA regulatory loop-hole called the 510(k) clearance. All seemed well and rosy until 2007 when Australia, one of the first to have a National Joint Replacement Registry detected that the prostheses had a relatively high rate of failure and surgical revision. Although the company knew about this, it continued to market the prostheses world-wide while phasing it out in the US. In 2010, the UK found similar failure rates and also issued 3 safety alerts. It wasn't just the hip prostheses failing. The metal surfaces grating on each other tended to flake of and expose patients to high levels of chromium and cobalt; some as much as 600 times higher than physiological levels.

In August 2010, the company finally issued a global recall.

In Singapore, these prostheses had been available since 2006. These entered the market and have been in use in patients for 4 years without any kind of regulatory approval. Because we do not have a joint replacement registry like Australia and do not track the post-surgical performance of these prostheses, we have been completely blinded when it came to device failures, and potential toxicities. Without a registry it has been almost impossible to enure that all patients implanted with these artificial joints can come forward to have their replacements replaced. We do not even check on whether these patients had or continue to have cobalt or chromium toxicity.

So patients in Singapore have a very serious problem. How many of our patients even know if they have had a DePuy hip replacement done? (Patients should ask their surgeon and call DePuy) Of these, how many have come forward and have been appropriately advised to get the corrective surgery done, at the cost of the company? Does the HSA know the extent of the problem? How are they looking after our patient's well being? Is anyone tracking cobalt and chromium levels in our patients?

The ASR problem hasn't quite gone away yet despite the global recall in 2010. The manufacturers have set aside billions of dollares to deal with potential lawsuits. Do our patients know they can sue the company?

Recently the BBC and the BMJ jointly reported on this regulatory failure. The manufacturer's apparently continued to market the device despite being aware of the problems.

The Lancet also carried a recent report, after analyzing the Joint Registry data from England and Wales, about how bad these metal-on-metal implants were.

Meanwhile, in Singapore, we don't even have a compulsory registry to know what is going on. The industry, media (and sadly the medical professionals as well) continue to whip up the hysteria suggesting that we should all leave well enough alone and not regulate medical devices at all. Gigamole is all for the HSA taking a stronger proactive position in protecting the interests of our patient-consumer. Methinks they have looked the other way long enough.

Where is Salma Khalik when you really need her?

Was the valve used in National Heart Centre operation approved as a medical device?

While the HSA was conducting their briefing about how they were going to tweak the regulatory processes for low risk devices, we have this bit of exciting news about the groundbreaking operation done at the National Heart Centre.

Exciting because it was the first such operation done in Asia. Essentially, the operation was a minimally invasive insertion of a bioprosthetic (cow tissue in steel) valve to correct for a mitral valve failure. The valve-in-valve design was developed in 2007 when it first underwent clinical studies. In November last year the Edwards SAPIEN valve received a much heralded approval from the FDA. But here is where there is a bit of problem. The FDA approval was only for the use of the valve for aortic valve stenosis, not for correction of the mitral valve. And only in patients who are too ill for open heart surgery. In fact the US FDA had made a note in its approval that the valvular operation, even for aortic stenosis was not without problem - patients had 3 times more chance of developing a stroke.  But there had been no similar FDA approval for a modified valve for mitral valvular disease. Gigamole is not sure if any major regulatory agencies have approved the mitral version of the valve, let alone the HSA.

So here are Gigamole's questions:

a] Did the FDA approve the mitral valve-in-valve as a medical device?
b] Did any regulatory agency world wide approve the mitral valve-in-valve medical device?
c] Did the HSA approve the mitral valve-in-valve medical device?  And if so, on what grounds? If not, what was the approval process for surgeons at the National Heart Centre to go ahead and operate using an FDA and HSA unapproved medical device?

Please do not mistake my questions as being anti-innovation and anti-progress. Devices such as this valve-in-valve device needs to be properly evaluated in terms of risk benefits before use. The aortic version was studied since 2007 before it was approved by the FDA. Although the valve had been modified for mitral valve use also in 2007, this never received the same warm response, and as far as Gigamole is aware, the FDA in its wisdom never gave approval for the mitral valve version. Treating the mitral valve is not as straightforward on terms of risk-benefit assessments as for aortic stenosis. To those who advocate that we blindly follow the FDA's approval must also accept that we should also take guidance from the FDA's tardiness in approving this procedure.

HSA and the regulation of medical devices - an exercise in agenda setting?

The theories of agenda setting are well known, I believe, to all mass comms graduates as well as journalists. Although the formal theories were only formulated about 40 years ago, ideas that the media can influence public opinion have been recognized since the early part of the 20th century.

The recent brouhaha about the regulation of medical devices by the HSA can perhaps be seen in the context of agenda setting. That the media plays an important role in agenda setting is beyond doubt. How the agenda is set however depends on who plays the media. To the media savvy, the media becomes a collaborator in the shaping of public opinion. A media-savvy politician therefore gets a pretty smooth road.

Where HSA failed has been in not recognizing how important the management of public expectations was in the implementation of complex and public-sentiment sensitive policies such as the regulation of medical devices. By defaulting on this, it has willy-nilly allowed the media to set the agenda in a direction contrary to public policy. So, not only has the media been allowed to tell us what issues are important, but it is being allowed to tell us what opinion we should form  about the issue. Note the teaser on the front page of the Straits Times today - "Patients should worry about vanishing medical devices". Really? Vanishing medical devices?

Poor HSA CEO John Lim is in the hot seat now. It seems like it is the fashion nowadays to run down the CEOs! I am waiting for the day when someone flashes an old D&D picture of him on a sedan chair carried by half maked women! But it should be recognized that the move towards regulating medical devices had not been developed overnight, but has been on the stove for about a decade. During this decade, the policy has been deliberated and refined under the guidance of 2 Ministers of Health and 2 Board Chairmen. I guess the second team has been quite unlucky to be on watch when this policy was finally ready to be implemented. But seeing how the SMRT issue developed, it seems highly unlikely even this team will get any credit for the mess. So, sadly, it looks like CEO John Lim will be the one catching the ball.

Regulation of medical devices - a follow up

Even as discussions continue in Singapore between the HSA and medical practitioners, this problem has been brewing in the US of A as well.

Recently, St Jude's Medical, Inc in St Paul, Minneapolis, USA has been involved in a spat with authors of a report entitled "Deaths Caused by the Failure of Riata and Riata ST Implantable Cardioverter-Defibrillator Leads" in the Heart Rhythm Journal. St Jude's Medical, Inc are the manufacturers of the Riata electrodes. Concurrently, they have stopped selling two of the electrodes. Electrodes which had been 'approved' by the FDA, ..... apparently.

Truth is the FDA's way of regulating of medical devices is not exactly exemplary. A report from the Institute of Medicine has pointed out major deficiencies in the way the FDA deals with medical devices and have recommended a major overhaul of the regulatory process for medical devices. This will come as no comfort to those in Singapore who advocate blind acceptance of what the FDA pronounces as acceptable.

Globally, the experience in regulating medical devices has lagged far behind the regulation of pharmaceuticals. Is it necessary? Absolutely. But the question of how needs a lot more discussions and harmonizing. This is a rapidly growing problem that badly requires some regulatory solutions. To do nothing will be irresponsible. We need the HSA to be vigilant, and to keep their eyes on  developments not only in the US but in other countries such as Britain, Australia, Canada, Japan as well as the European Community.

So to those who are  targeting the HSA as villains in this regulatory necessity, think again. They would do better to redirect their angst towards those who are making money out of peddling inferior and/or unsafe devices.

Regulation of medical devices? What shocking news?

Woke up this morning to the shocking news of HSA's intention to regulate medical devices. More correctly,  the shocking news of the doctors' responses to the impending regulations. What crap!

Regulation of medical devices have lagged far behind that for pharmaceuticals, and regulations have been long overdue. While pharmaceuticals require extensive testing for safety and efficacy, medical devices have escaped such scrutiny. As a result many poor quality products have been inflicted on unsuspecting patients. These range from breast implants, stents, artificial joints and various other prostheses. (Consumer Reports reviews this problem with reference to a report from the Institute of Medicine. 4 types of devices were singled out - surgical meshes, lap-bands, hip implants and cardiac devices.)

Recently, the French Company making the Poly Implant Prosthese (PIP) gel breast implants were hit by a major scandal when it was discovered that they had been using industrial grade silicone instead of medical grade ones, leading to the company going into liquidation. Of greater concern than the financial woes of the company was the exposure of unsuspecting women to the increased risk of ruptures of the poor quality implants.

Will the new regulations slow down the utilization of medical devices? Without doubt. But this slow down is necessary until manufacturers and doctors get used to dealing with public expectations of quality. Currently device failure rates are not even being monitored so no one has any idea of of how many faulty devices breakdown or fail.

HSA's regulations are both timely and essential for the protection of consumer safety, and we should welcome them. On the other hand, our doctors' hysterical lamentations that these regulations will only increase their practice inefficiencies and reduce the quality of medical care are misplaced, and sound totally self-serving.

LTA and regulatory capture? HSA are you listening?

A week ago in the Sunday Times Senior Correspondent  Christopher Tan write a nice article about the recent SMRT wayang and the LTA, raising the issue of a regulatory capture occurring between the transport regulator LTA and the transport industry.

The concept of regulatory capture is very much assocated with Economics Nobel Laureate George Stigler. It refers to the type of government failure when a public sector regulator has a cosy cosy relationship with the regulated service provider, to the extent that the regulator becomes a promoter of the regulated rather than a protector of the public needs.

Is the LTA a victim.... or are we, the public, victims of the regulatory capture between LTA and the transport industry.

This is actually not an isolated problem affecting the LTA, but can be seen to exist in many of Singapore's regulators.

The HSA (Health Sciences Authority) for example may be in such a predicament. Formed in the past from all the disparate MOH subunits in the Ministry of Health that the MOH wanted to decant from the Ministry, the functions of the various parts of the HSA range all the way from service provision, regulatory and promotional. Regulatory capture?...certainly many opportunities for this to develop in the HSA. Successive Board Chairmen and CEs have not made any attempt to deconflict all these functions, choosing instead to keep the easy and cosy relationships which made their work easier. However, unless this regulatory captures are dismantled, one has to question to what extent public needs are sacrificed to meed the needs of the industry.

By the way, George Stigler was also well known in medical circles for his attempt to optimize the daily recommended diet. Like all economic solutions, the result was totally unpalatable.