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.

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.

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.

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?

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?