Saturday, June 30, 2012

The Sunday Times greatest mess up of all time - ROTFL!!!

I was literally ROTFL as I read this morning's Sunday Times report on Euro 2012. Even as a non soccer fan, I was able to pick up a gazillion hilarious typos. Someone had a bit much ethanol last night and didn't do the proof before print! To be fair, the article was attributed to the Times, London. But still.....  :)

See if you can pick out more errors than me...

Hero 2012
Andrews Anisette
Zealander Del Pierre
Diego Marauding
Lineal Mess
ghostly pale modified player
Serge Roams
Cyst Fibreglass, Spain attacking modified

I didn't even try to decipher the nicknames - Little Ghost, Pale knight and Liver Atom.

Tuesday, June 26, 2012

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.

Wednesday, June 20, 2012

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?

Selling off our heritage - the plight of Kampong Glam

Most would have missed the plaintive appeal (tucked way down on Page 42, Sunday Times 17 June), of Ms Hidayah Amin about how Kampong Glam may be losing  its story to the glitz of Omani wealth. Kampong Glam was a Malay enclave, originally designated for the occupation of Sultan Hussein Shah (himself of Bugis heritage) and his family. The area was primarily populated by immigrants from Java, Sulawesi and Bawean. There were Indian and Middle Easterners as well, but they mostly assimilated into the Malay culture. Ms Amin would know as, being the great grand-daughter of Haji Yusoff the belt merchant, she lived in the big yellow house, smack in the middle of Kampong Glam. At least until the government forcibly acquired the property.

She is so right, and her appeals should not go unheeded. The Malay culture needs to be protected, and it is fundamentally wrong to continue to assume that propagating a pseudo Middle Eastern Islamic facade is  equivalent to preserving the Malay heritage. The richness of Malay, Javanese, Sulawesian and Boyanese cultures need to be specifically protected as well. Unfortunately though, there are few who are wealthy and powerful enough on their side to fight for them.

Their voice desperately needs to be heard. We have lost too much of our true Singaporean heritage already.

Tuesday, June 19, 2012

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?

Monday, June 18, 2012

What sort of role model do we want our kids to have? Woffles or Vincent?

Over the last week 2 characters have emerged from mundane Singapore life that exemplify very contrasting personal values and characters. To me, they are lessons for us as to what our noble values should be. In today's world our kids are in great danger of being lured into the fast road to wealth, fame and self-centredness.... at all costs. We need to take a pause in our mad rush to wealth to think about what values we should want our kids to have.

On one hand we have a uber-wealthy and influential cosmetic surgeon and socialite, Woffles Wu, hiding behind an old employee just to get out of 2 speeding summons. Whether he pulled strings to get off with a mere slap on the wrist is not the issue here.

On the other side of the coin, we have a working class tour guide, Vincent Toh, leading a group through the deserts of Sinai. When the tour group was unexpectedly attacked by Bedouins, Vincent selflessly offered to be the hostage so that his tour charges could go free. To everyone's relief, Vincent was released after 8 hours of captivity. Two contrasting characters with very different personal value systems. Who do we want our kids to emulate?

Is Justice blind in Singapore?

Recent happenings have prompted many to ask if justice is indeed blind in Singapore. Intriguing question, since I wasn't at all sure how the idea that justice should be blind actually came about.

The only Greek goddess that regularly had a blindfold was actually the goddess of fortune/fate (Fortuna, Tyche/Dike). It really wasn't until about the 15th century that a number of goddess imageries were conflated to give the idea that justice is scaled, sworded and also blind. Even so, the goddess of justice (Justitia) is not always portrayed outside our courthouses as being blind. For example, outside the Old Bailey in London, Justitia is clearly sighted. Outside the Legislative Council Building in Hong Kong, on the other hand, Justitia is presented as wearing a blindfold.

Interestingly, On top of our old Supreme Court Building, the tympanum carries a scene conceptualized by artist Rodolfo Nolli, where Justitia is represented. The scene apparently depicts: "......the central figure represents Justice; to the left is a person begging for mercy (or protection), and next to him are the legislators with books in hand, representing the Law. On the other side of Justice is a figure showing gratitude, then a man and a bull, and two children holding a sheaf of wheat, all representing Wealth, Prosperity and Abundance where Law and Justice prevails."

But the scene looks too intriguing to just refer to official interpretations. In the spirit of the book Da Vinci's Code, I tried my hand at explaining the scene as I saw it. Firstly it should be noted that the Singapore version of Justitia is similarly scaled, sworded but fully sighted. On the right of Justitia are two very sorry looking figures. At the extreme end, the one with the snake is probably Adam wallowing in his sin, unforgiven. Just next to Justitia is another unforgiven figure begging for mercy. Between them, a pair of very conspiratorial looking figures, plotting to throw the book at the guilty ones. On Justitia's left however, by the hand that holds the sword, is a very grateful forgiven woman. One can only guess at why she has been forgiven. Following her however, is an entourage bearing icons of power and prosperity - cattle and grain.

Was the artist trying to make a statement about how justice operates? Here clearly justice is not blind. Does wealth and prosperity feature in the dispensing of justice? I leave it to your interpretation of this very interesting and oft overlooked piece of public art. After all art, like beauty, lies in the eye of the beholder.

Oscar Wilde did write that "Life imitates Art far more than Art imitates Life".

Friday, June 8, 2012

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:

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.