Monday, June 29, 2009
Where are we now, and what is the real strategy with regards this infection? Do we take this seriously not not?
The MOH website doesn't contain much more than the latest stats, and an uninformative statement - "Though the number of infected cases has increased, the severity of the disease remains relatively mild. .... Singaporeans should carry on with their usual activities whilst observing good personal hygiene at all times. If unwell, they should see a doctor, stay away from work, school or crowded places, and rest at home."
Ummm...so helpful lor. If it's 'relatively mild' why this concern about staying away etc etc...?
The Straits Times today quotes an unidentified spokesman as saying "We are now preparing to manage the disease in a more targeted and risk-stratified manner".
Ummmm....that's even less helpful I am afraid.
And neither is the ST report from that interview, that Singapore is preparing to switch to the mitigation phase of dealing with the H1N1. Whatever that means. I mean, we are either containing or mitigating... being told that we are preparing to move to mitigation is like saying we want to be there, we should be there and we are going to be there. But where are we exactly?
Clearly the public is confused. And I really don't blame them.
Do we need to still control movement / contact and do voluntary home quarantine? Are all these temperature monitoring really necessary? There is just such a confusing array of containment strategies out in the schools and workplaces, that even more puzzling when you consider we are actually moving (preparing to switch?) to mitigation.
If we are not going to treat all H1N1 cases, and we are not going to swab all flu cases, why do we need, as the spokesman said, to "call 993 for an ambulance" if travelers get flu-like symptoms within a week of return from affected countries?
If the MOH wants the public to be participatory and to be engaged in the management of epidemics/pandemics such as this, information and instructions must be clear and unambiguous. Why do we keep fueling this paranoia if we are really not going to do anything substantive about it?
And we are really not having that clarity of mission at the moment.
No great mystery here. No cat hating vandals at work, I don't think.
Alpha-chloralose is a kind of anaesthetic that has been used for pest control. It is found in rodenticides (includes some moles, unsavoury relatives of mine) and pest baits for bird control.
In all likelihood this is the work of an overenthusiastic pest controller trying to get rid of rats (maybe after the Geylang Serai food court hysteria) or crows, mynahs and starlings in the vicinity.
I suggest the police follow up on the people in the neighbourhood who may have an interest in pest control.
Meanwhile, it will be interesting to find out who actually controls the import and use of pest control chemicals such as chloralose. I imagine it must be the AVA.
Sunday, June 28, 2009
We are really no different from those wretched viruses are we? I mean after all it is the same evolutionary mechanism that drives us. We have to adapt and change to spread our genes across the globe.
In fact, if we think of ourselves as viruses, we are probably the most virulent and lethal organism responsible for the world's worst pandemic ever. And in that regard, we are really not a smart virus at all... so let us not run down H1N1 too soon. No, we are one of the most stupid viruses ever, because we are on the verge of totally destroying our only food source. Mother earth.
So shall we save Gaia?
It is an interesting model. But he is wrong.
This novel H1N1 should not be considered an separate entity from the other H1N1 viruses,or indeed the othe Influenza A viruses. It is more correct to view the entire family of like viruses as an entity - much like the cybernetic borgs in Star Trek. These viruses seek to propagate themselves, find a utilizable biological niche to occupy and as Prof Paul Ananth points, need to stay ahead of host immune systems by a constant changing of their disguise. If they remain genetically static,develop either useless non-infective characteristics, or virulent ones which may overdo their virulence and kill off the host. These are random events. There is a balance that a successful virus strain strikes, but it cannot keep that position indefinitely because the host immune system will eventually hunt it down, and destroy it.
The common cold and Infuenza A have been extremely successful in this constant change and adaptation and engaging us poor humans in this biological cat and mouse game. And they will remain very successful. Influenza A will from time to time produce a virulent and lethal strain. Statistics don't lie. It's only a matter of time. This strain may arise in the most unexpected of places; as this one did. And as we will not have the immunity for it, many will die. But the survivors of the the onslaught will live to fight another day. And they will be stronger. Until the next real pandemic arrives. And so on.
But such is life. Que sera sera?
Friday, June 26, 2009
The laboratory confirmed positives are only 27,717, meaning the pick up rate is only 2.7%. I wonder what this means with regards to the alarmist estimates of fatality rates around 0.37% that we have been fed with? With an estimated denominator of ~1 million, the death rates would actually only be ~1/10,000, i.e. 0.01% in the US - far less than the fatality rates of previous pandemics and even seasonal flu.
I think health officials need to be a bit more realistic in their communications, and help us understand this better.
Thursday, June 25, 2009
I wonder how they can tell, since most of the H1N1 will recover even without treatment, and Tamilfu is known to do not much more than shortening the illness by only about 1-2 days? This of course, may be important is shortening the period of infectivity, and possibly also in limiting the extent of the disease, but without a placebo controlled clinical trial no one can be certain that Tamiflu actually does any good despite what lab tests tell us.
I am all for reassuring the public in this time of anxiety, but making unsubstantiated claims like this is really not good reporting. made a somewhat grandiose claim that so far Tamiflu has been effective in all but 2 patients treated.
Tuesday, June 23, 2009
The President of the Singapore Medical Association was prodded out of the kinda slumbering organization to respond to the 'akan datang' move to appoint non-medical people (chiefly their nemesis, lawyers) to Chair the Singapore Medical Council.
I think it is a rather unconvincing response, almost like he doesn't quite believe it himself. Which really underscores the passivity of the profession at the moment. Same for the Singapore Medical Council.
I do however agree with Dr Chong's last point: '...what medical ethics really needs is more moral courage and leadership so that public interest can be better served.' How true. But what has the SMC done that can truly be said to have shown moral courage and leadership? So far it's been hiding behind the law, and only taking to task those who have obviously flouted the 'law'.
If that's all the SMC cares to do, we may as well have a lawyer to Chair, instead of a doctor pretending to be a lawyer.
Disciplinary tribunals are not law courts
I REFER to the letter by Mr M. Lukshumayeh last Saturday, 'SMC post: Don't get emotional, docs'. The writer has failed to understand the objectives of the Singapore Medical Council's (SMC's) disciplinary tribunals (DTs) and has mistaken the DTs for a law court.
The law courts are responsible for interpreting the law and for enforcing punishment when the law is broken. However, whatever is not prohibited by law remains legal and permissible, but may still be unethical. This is where professional tribunals like SMC's DTs come in.
The law cannot spell out everything but sets an absolute minimum for all to observe, while ethics and professionalism demand higher levels of conduct and behaviour than just obeying the law. This is the essence of professionalism and ethics, be it for doctors or other professions.
As such, SMC's objective is to uphold high standards of professional conduct and ethical behaviour among doctors.
Furthermore, the Singapore Medical Association (SMA) does not object to lay people or lawyers in DTs. Lay people bring with them their own valuable expertise and viewpoints. Lawyers ensure that procedural matters pertaining to principles of fairness and natural justice are not overlooked, which is why lawyers are already present now at SMC disciplinary hearings. But having a lawyer or ex-judge chair a DT may bring about long-term consequences that do not serve public or patient interest, even if the move appears superficially rational.
That is because the role of the DT is to ascertain if professional misconduct has occurred in areas which the law is silent on. Legal training, on the other hand, is aimed at understanding if the law has been broken. The two are very different.
The move to allow lawyers to chair DTs will bring about a technical convergence of law and medical ethics, with DT proceedings probably becoming more legalistic, and a slow deterioration in the higher standards of medical ethics, which is against public interest.
Perhaps it is by the same reasoning that lawyers do not sit on the DTs of other professions in Singapore. Higher standards of medical ethics are not achieved by making DT proceedings more legalistic or having more lawyers if DT proceedings are conducted in a fair manner.
Instead, while it may be expedient to get lawyers to chair SMC's DTs now, what medical ethics really needs is more moral courage and leadership so that public interest can be better served.
Dr Chong Yeh Woei
Singapore Medical Association
Monday, June 22, 2009
But are the numbers a good reflection of the real risk of H1N1?
We won't really know because everyone has a different way of computing these numbers depending on whether they want them up or down. The crude estimates would be to take the total reported deaths divided by the total reported cases. If you take the current CDC figures for US it is 87/21449 = 0.4%, not far from Minister Khaw's figures.
Are these figures believable? Well they are pretty much what we have at the moment. It is probably quite an overestimate I believe. Why do I say this? Well.... reported case numbers do tend to be an underestimate, because many who develop flu symptoms may not be tested for H1N1 at all. On the other hand the deaths numbers are probably an overestimate because many H1N1 cases who die have many other concurrent problems and their deaths though associated with H1N1 may not be directly attributed to H1N1. So in all likelihood the numerator is an overestimate while the denominator is an underestimate, making it very likely the actual risk of dying is much less than the ~0.37% quoted by Minister Khaw.
Also the numbers have been inflated because the early death rates in Mexico and even the US were very high.... This has come down substantially. If you look at data from UK, Australia and Canada,...those with health care standards on par with the US and were involved later, the death rates are much lower - UK (1/2773 = 0.036%), Australia (1/2733 = 0.036%) and Canada (16/6457 = 0.25%).
Peter Doshi published a paper in the American Journal of Public Health last year criticizing the ways that scientists have traditionally computed fatality risks of pandemics. He is of the opinion the the risks have generally been inflated, for various reasons.
I quote from his paper:
"The notion that pandemic influenza’s fundamental property is excess mortality is difficult to reconcile with the recorded influenza death data over the past century. There are many possible explanations, one of which may be the tendency to generalize the exception—the 1918—1919 pandemic. In 1918, doctors lacked intensive care units, respirators,respirators, antiviral agents, and antibiotics, an important fact in light of historical evidence of interactions between influenza and secondary bacterial respiratory pathogens (e.g., Haemophilus influenzae) as a significant cause of death during the pandemic.
It is also important to recognize that commercial interests may be inflating the perceived impact of influenza and other infectious “pandemics.” There is a clear need for more evidence-based accounts of influenza in the context of historical epidemiology and current social and medical advances."
He concludes (2008):
"Whatever the reasons for the misconceptions, should the trends observed over the 20th century continue to hold in the 21st, the next influenza pandemic may be far from a catastrophic event."
Sunday, June 21, 2009
A mouse who became a lion. How true. Someone we could have easily dismissed as an academic failure, proved himself through his compassion for the marginalized and the down-trodden, to become the Father of Counselling in Singapore, has set an almost impossible example for us to follow.
It does not matter if we do not always agree with him. But we must recognize his greatness during the time he walked with us on this earth.
Mr Yeo, in pace requiscat.
It is an important discussion, because it will help us come to terms with what the institution of marriage really is. This does have repercussions for the future, because the earning power of men and women will become less (although I think not for a long time more), and also when the same sex marriage people start pushing their agenda. Actually I am not to sure how much Dr Soin's push for 'gender equality' comes from her close association with AWARE and her ideas of a genderless marriage. This is certainly not advancing the cause of women, but reducing the approriate consideration of the gender based disadvantage that women have in the marriage relationship.
Marriage to my mind is, and will remain an equal partnership where the partners bring different assets and resources into the relationship and are intrinsically unequal. This cannot be denied. On one hand, women tend to marry up (yes, yes, there are exceptions, I know), they bring their womb and eggs and commit to being a mother (and yes, of course there are exceptions!) and by and large, they tend to step down their ambitions and career advancements to look after the home. To this end they become more of a dependent than a provider. This is a reality, and in her push to advance the idea that women are as masculine as men, Dr Soin should not forget this.
But having come into the partnership as non-equals, marriage is an equalizer, and the partnership becomes an equal partnersip, where both have equal responsibilities for the family and child rearing (should there be children). Best of all, family wealth become equally shared.
Within the institution of marriage, there are three recognizable elements should a marriage dissolve:
a] sharing of conjugal property
b] mainenance of the wife as a dependent (in recognition of her dependent status during marriage)
c] continued shouldering of the parental roles, fiscally and functionally.
These are not gender equal, and it is right that the Women's Charter continue to protect the rights of women with respect to these issues. It is true that in some isolated situations, the roles may somehow be reversed, in part of in whole, and the courts should have some leeway in determining how to vary the outcomes accordingly. But these would be by far, the exception than the rule.
Dr Soin, in her attempt to be progressive should not quickly barter these away. Marriage is an equal partnership, but needs to recognize that the individual partners are not true equals.
Above all marriage is not genderless.
Saturday, June 20, 2009
Doctors have come out to defend the need for patient confidentiality. And they are right. It is wrong to name patients publicly because they are entitled to a certain level of confidentiality about their condition. I say a certain level, because this entitlement is not absolute.
The American Medical Association in their Code of Medical Ethics say:
"that the information disclosed to a physician during the course of the patient-physician relationship is confidential to the utmost degree. As explained by the AMA's Council on Ethical and Judicial Affairs, the purpose of a physician's ethical duty to maintain patient confidentiality is to allow the patient to feel free to make a full and frank disclosure of information to the physician with the knowledge that the physician will protect the confidential nature of the information disclosed. Full disclosure enables the physician to diagnose conditions properly and to treat the patient appropriately. In return for the patient's honesty, the physician generally should not reveal confidential communications or information without the patient's express consent unless required to disclose the information by law. There are exceptions to the rule, such as where a patient threatens bodily harm to himself or herself or to another person"
The Singapore Medical Council Ethical Code and Ethical Guidelines states:
" A doctor shall respect the principle of medical confidentiality and not disclose without a patient’s consent, information obtained in confidence or in the course of attending to the patient. However, confidentiality is not absolute. It may be over-ridden by legislation, court orders or when the public interest demands disclosure of such information. An example is national disease registries which operate under a strict framework which safeguards medical confidentiality.
There may be other circumstances in which a doctor decides to disclose confidential information without a patient’s consent. When he does this, he must be prepared to explain and justify his decision if asked to do so."
So there are exceptions to the code.
The question here is whether the conditions here qualify to be exempted. In this case, the condition is not really life threatening, and although it was rather socially stupid and irresponsible to expose others to the risk if you think you are infected, this doesn't really go beyond being stupid and socially irresponsible. Naming is little more than a vindictive,punitive act.
On the other hand, it this were a really serious epidemic and a real risk of fatal consequences, then it might qualify for naming - not as a punitive act but for epidemic control.
For example, under current conditions, there is a real gap between exposure and effective contact tracing and quarantine/treatment. This gap can be in terms of days before the contact team can track down named contacts. This delay can be shortened if case contacts can self identify and come forward for advice/quarantine/treatment. But self identification requires that people know who the cases are and if they have had exposure to the case. In the case of the German researcher, I can only know if I have been exposed if I knew who he was and where he worked.
In the case of NUS' Prof Lee (reported in TODAY yesterday), he was only able to self identify because he could identify Case 73 by flight and seat details, and because of this, he was able to inform MOH and self impose home quarantine. If he had waited for MOH contact tracing team and track him down and serve the quarantine orders, there could well have been up to 2-3 days delay and otherwise preventable exposure to colleagues and family members.
We need to be mindful of the negative consequences of naming. Above all we should never do it out of vindictiveness. But we need to keep in mind the possibility that at some point in time (with some other epidemic) appropriate naming may actually save lives.
Friday, June 19, 2009
Just as a distraction from the media obsession about H1N1, here is an interesting report from TIME about the origins of homosexuality.
The article is called "Why Some People Are Gay: Notes (and Clues) from the Animal Kingdom". Only some excerpts are reproduced here. You can read more from the original article.
"We have known for at least a decade that hundreds of animal species — including birds, reptiles, mollusks and, of course, humans — engage in same-gender sexual acts. But no one is quite sure why. After all, same-sex couplings don't usually result in offspring. (I say usually because when male marine snails pair with other males, one partner conveniently changes sex, allowing for reproduction.) Evolutionarily speaking, homosexuality should have disappeared long ago.
A yearlong study just completed at the University of California at Riverside offers several fascinating competing theories about why same-gender sexual behavior has endured. And although it's gay-pride month — and the 40th anniversary of the Stonewall riots that sparked the gay-rights movement — not all the theories will give same-gender-loving humans a reason to celebrate.
What all these theories have in common is that same-sex sexual activity is either an accident or a quirky genetic method of helping males impregnate females. Which raises the evolutionary question of why men and women who are exclusive gay and lesbian exist. One answer is that exclusive gays and lesbians are a relatively new creation: the concept of exclusive homosexuality barely existed before modernity; even a century ago, most same-sex-attracted men and women got married and had kids."
Could it be that MOH is testing the limits of it's capabilities to cope in a 'real' serious pandemic? If so, well, let me inform the MOH that we have already exceeded our capacity to cope. Alarming isn't it? We can't even cope with 103 cases.
- Quarantine facilities are bursting at the seems. Only for foreigners, I am told. I think Aloha Loyang will soon resemble a refugee camp.
- Local contacts serve the quarantine at home, - I suppose so that they can continue to infect their family members.
- Meanwhile their family members continue to move freely and therefore are free to infect the world at large.
- Even when quarantined at home, the Home Quarantine Orders are served so late as to be meaningless.
- CDC sends home infected patients, only to readmit them again. Read about Filipino worker, unlinked case.
- Contact tracings are delayed.
- and six hundred 993 calls per day??
Containment or mitigation, MOH? Maybe it's time to go to mitigation. Unless of course, the real reason for delaying is that we are still trying to get our mitigation resources up to scratch.
Thursday, June 18, 2009
Aloha Loyang is bursting at the seams now and can barely contain non-locals. Locals serve out their quarantine at home. Paranoia continues to seep through the work place, and social activities are disrupted.
So quo vadis, MOH? Containment or mitigation?
Wednesday, June 17, 2009
Because the incubation period for malaria can be quite long, usually 9-40 days, the cases surfacing at the moment may have all been infected a few weeks ago.
Tuesday, June 16, 2009
One problem that was brought to my attention was that of surgical revisions, as a consequence of implants and prostheses etc. Unbeknownst to the public, this can be particularly problematic. You see, unlike drugs, which undergo extensive preclinical and clinical testing, medical devices are onlty minimally tested. There are few procedures to regulate the entry of these untested prosthesies and implants into the market, and we have no idea how many of the numerous implant/prosthesis fail, or how many patients need to undergo surgical revisions for these implants.
These figures are obviously important for the patient, but no one tracks these numbers and the surgeons are obviously not going to tell the patient how bad their figures are.
Maybe it's time for HSA to relook this blindspot in the regulation of medical devices so that patients can be better protected. At least they should be aware of the quality of the implants and prostheses being put into their bodies.
Here is some data I manage to pull out from a Swedish study on hip implants.
Makela et al. J Bone Joint Surg Br. 2008 Dec;90(12):1562-9.
Not so bad. At least numbers not increasing. But obviously the infection risk in the environment, i.e. the anopheles mosquito hasn't been eradicated yet.
Since the last press release that we had 40 cases, the tally has gone up by 9 (including a Biopolis worker possibly having infected colleagues there) to a grand total of 49, but the media has been deafeningly silent about the jump in infections.
Methinks there is a policy now to mute the public announcements. This is not necessarily a bad thing, because the previous hysteria was quite inappropriate.
So let's now get into dealing with this quietly and sensibly.
I am not sure if it's just editorial interest in the subject or if it's part of a process pushing towards the acceptance of gestational surrogacy in Singapore. Coming so soon after the controversies about the human organ trade, I am understandably suspicious that it is the latter.
It is a issue that is fraught with ethical and legal problems.... certain a lot more complex than the organ trade stuff. Heng BC, previously of NUH had reviewed the topic in 2007. I reproduce the abstract here (if you want the pdf of the review, just drop me a note), :
Gestational surrogacy is currently banned in Singapore but is much debated. Some ethical guidelines and legislation for permitting gestational surrogacy in Singapore are proposed and discussed including: (i) review and approval of gestational surrogacy by the Ministry of Health on a case-by-case basis; (ii) stringent guidelines for gonadotrophin stimulation, IVF and ICSI procedures in 'traditional' surrogacy; (iii) restriction of gestational surrogates to parous married women with stable family relationships; (iv) exclusion of foreign women from acting as gestational surrogates, except for close relatives of the recipient couple; (v) reimbursement and/or compensation of gestational surrogates based on the direct expenses model; (vi) exclusion of medical professionals from surrogate recruitment and reimbursement; (vii) the surrogacy contract must make it legally binding for the prospective recipient couple to accept the child, even if it is born with congenital deformities; (viii) stringent guidelines for combining surrogacy with egg donation from a third woman, who is neither the social nor gestational mother. Policymakers in Singapore should conduct a public referendum on the legalization of gestational surrogacy and actively consult the views of healthcare professionals, religious and community leaders, as well as the general public, before reaching any decision.
Many of the issues overlap with those of organ trading, but there is one specific issue which is unique to this situation that we should be aware of:
How to transfer the baby to the recipient parents? By adoption? How to legally compel the recipient parents to accept? Can the recipient parents change their minds? What will happen to the baby if they change their mind?
Monday, June 15, 2009
I must say I haven't really thought much about this issue before, but was rather horrified at how frequent mistakes were. The ST report cited a Telegraph report alluding to as much as a staggering 40 mistakes per 10,000 cycles in 2006-07 (up from 15/10,000 in 2003-04). The Daily Mail refers to a report due soon showing 200 such 'serious mistakes' and 'near misses' this year. (The British Fertility Society however without citing figures, reassures that these errors are 'extremely rare'.
I am horrified.
An MOH report 2004/5 on IVF can be found here. In 2002 there were 1569 IVF treatments. Todate we must have done way beyond 10,000 treatments, but I can't find any data on IVF errors in Singapore. Are we that error free? Or have the errors been swept under the carpet somehow?
MOH should enlighten us on how IVF errors are being monitored, or is it that no one wants to know or tell?
Saturday, June 13, 2009
Any impact on the global economy? So far no apparent negative impact. It's travel as per normal. Shopping as per normal.
One good thing about the pandemic is the super boost for the vaccine industry, and all related industries with regards to pandemic preparedness.
Market Research Media estimates that the size of the global pandemic preparedness market is in the region of a staggering US$52 billion in 201o-2015. The orders for vaccines alone is sizeable. The supply of influenza vaccines to the European market itself will net GSK US$1 billion.
The safety of existing and new vaccines has been the subject of a raging debate. Much of the controversy centres around the inclusion of mercury (thimerasol) and aluminium in the preparations of the various vaccines. Thimerasol is used largely as a preservative, but has been incriminated in CNS and renal toxicity. There have also been suggested associations with autism in children. Aluminium on the other hand is use mainly as an adjuvant to increase the immunological response to the antigen. It has also been suggested to be involved in brain damage and behavioural problems in children.
Most of these claims are pretty alarmist and poorly substantiated but there have been a lot of pressures to remove these from vaccine preparations.
One other problem with vaccines relates to the fear of the unknown. Vaccines are usually produced throgh fairly complex biological means, many of which are proprietary and unique to companies. Many of these processes are fairly recent innovations, the safety of which have not been extensively validated. We really don't know too much about the long term consequences of being exposed to products and contaminants from these commercial bio-industrial processes. On surface they appear to be safe. We can only hope that the longer term effects will be just as innocuous.
Gor more information about vaccine safety:
US Centers for Disease Control and Prevention, Immunization Safety Office
Vaccines are still one of the most effective means to control infections, and good access to vaccines is of critical importance in managing epidemics and pandemics such as those caused by the current novel H1N1. The issue of vaccine safety is difficult to resolve because many of the suggested toxic effects are much delayed effects whose postulated causal relationship with the vaccines are extremely difficult to prove. Nevertheless it is vitally important for health authorities to address these issues openly and provide a high degree of public reassurance. In this pandemic, there will be pressures to embark on vaccination programmes early, and perhaps prematurely, before full clinical trialing has been completed. Full public disclosure of data relating to the vaccine safety will be even more important.
Friday, June 12, 2009
Vaccines are made by producing either live 'bugs' which have been attenuated so that they don't produce disease, or by engineering a protein that carries all the required antigens and that will be able to 'teach' the human body to immunologically recognize the bug and therefore to produce an immunological defense against it. These are usually industrially complex processes many of which are proprietarily protected and unique to each manufacturer. This generally makes it difficult for the regulators like the FDA and our own Health Science Authority (HSA) to figure out which processes are safe and acceptable etc. The final vaccine is analyzed principally as a chemical product to ensure it does not contain known pathogens, and biological contaminants and toxins.
Preclinical or animal testing for safety and effecacy is kinda useless although it is often done as part of the vaccine development process. Vaccine efficacy and toxicity is highly species specific because it engages the immune system, and in this case animal indicators of efficacy and toxicity are almost totally unrepresentative of whatever may happen in humans. At best, it picks up only very gross and obvious effects.
There is a mandatory period of clinical testing. But again, this is often very artificial because at best it only demonstrates the ability of the vaccine to induce an immunological response. This antibody response does not mean there is immunity against the bug in a real infection since this clinical testing is in normal uninfected individuals, and the anitbody produced tested against a test tube bug. So real efficacy against the bug can only be presumed. One can really only know the true efficacy when the vaccine is trialed in the context of the prevention of a real infection/epidemic. This is difficult to do and takes a lot of time because the occurence of an epidemic is unpredictable.
So most vaccines are licensed into the market, based on very indirect evidence of efficacy and safety. To makes matters even more uncertain, many postulated toxicity effects of vaccines appear very late after the vaccination. For a new vaccine, such delayed toxicity may never ever be discovered until many many years down the road. Many toxic effects will in fact never ever be detected or proven.
All this makes the licensing of vaccines very difficult. Even for large regulators such as the FDA. You can read more about this here. (FDA’s Role in the Regulation of Vaccines ). Our HSA doesn't even tell us how this is done. Vaccination programmes unlike most other drug treatments are given prophylactically to normal healthy people, on only the anticipation of a possible infection. In this context, our expectation of safety should be even more critical. But in fact, for vaccines, our knowledge of the efficacy/toxicity balance is even more clouded.
So how does our HSA do it? Even more clouded.
When an emergency situation arises, such as the occurence of a pandemic, there can be a suspension of regulatory restrictions. In the US, :
"An additional tool available to speed product availability is the ability for FDA to allow the use of unapproved products and unapproved uses (so-called “off-label” uses) of approved products, in a declared emergency, under the Emergency Use Authorization (EUA) provision of the Food, Drug, and Cosmetic Act. This authority was expanded under the Project BioShield Act. To authorize such emergency use, FDA would need to find that the agent can cause a serious or life-threatening disease or condition; that based on the available information it is reasonable to believe that the product may be effective against the disease or condition; that the known and potential benefits of the product’s use outweigh the known and potential risks; and that there is no adequate, approved and available alternative. "
We don't know if such an 'emergency use authorization' exists in the Singapore context, and under what conditions it make be activated. For the current H1N1, there seems no justification since for it (yet) since there does not seem to be any evidence that it can be considered to 'cause a serious or life threatening disease/condition'.
So HSA/MOH, can provide us some assurance that should we try and move into mass vaccination programmes for H1N1, that the vaccines being rushed into production (especially by our A*star/EDB boutique biotech companies), are safe and effective?
Thursday, June 11, 2009
Wednesday, June 10, 2009
Note the 2 front runners, Mexico and US. So it should be American flu, should it not?
Incidentally the graphs are on a semi-log plot which means that a straight line would represent an exponential rate of growth. What we can see is that all the plots are biphasic, meaning they have at least two slopes - and initial rapid exponential growth which then flattens out to a slower growth. I guess this means that either the virus loses steam, or that more extreme control measures in the community begin to take effect.
What should be noted also is the divergence of the infection and the death plots. A month ago, total deaths were approximately (hard to read off a semi-log plot) 1.2% of total infections, but now it is less than 1% (closer to about 0.55%).
This graph on a linear plot shows the divergence clearer.
Malaria in Singapore tends to be of two main types - those caused by Plasmodium falciparum or those by Plasmodium vivax. Malaria infections begin in the liver, but quickly moves to the red blood cells. It is the repeated waves of red cell to red cell infections that give rise to the cycles of fever.
Infection due to falciparum tends to be severe and carries high risk of brain involvement (cerebral malaria) and renal failure due to severe haemolysis. Vivax infection of the other hand tends to me mild, but is notoriously difficult to eradicate and 'cure' as it carries a dormant form in the liver cells which reactivates from time to time. This reactivation gives the wrong impression that it is a new infection.
So far it appears that the current 'spike' of malaria is of the vivax variety. If so, this 'spike' may just be due to reactivation of old infections. But I don't think so. No reason for reactivations to ocur in clusters. In anycase, vivax infections are nothing to be to worried about.
Tuesday, June 9, 2009
The MOH unfortunately does not tell us if these were P. falciparum or P. vivax. A 2000 report attributed about 2/3 of all reported cases to vivax, while 1/3 was due to the more dangerous falciparum parasite. Severe falciparum infections can have a mortality of about 15%, so it's nothing to be sneezed at. (Compare H1N1 mortality of <0.1%)
I don't usually have a high regard for Malaysia's politicians and bureaucrats, but here, I must take my hat off to Dr Ismail Merican for making a clear stand about this.
Malaysia opposes organ trafficking, transplant tourism & commercialism Director-General of Health Tan Sri Dr Ismail Merican said yesterday: “We are against organ trafficking, transplant tourism and transplant commercialism.”
By : Annie Freeda Cruez
He fears that what is happening in some other countries, where human trafficking to source for organs, may occur here. He does not want the vulnerable and poor to be made to sell their organs.
He warned that commercialisation of organ, tissue and cell transplantation, and any act that might indirectly promote or lead to commercial transactions of organs, was prohibited.
“Although it has not been reported in Malaysia, we are aware that it is happening in this region. We are against it,” he told reporters at the inaugural three-day World Health Organisation regional meeting on Guiding Principles on Human Organ Transplantation at a hotel here jointly organised by the WHO and the Malaysian Society of Transplantation. It is supported by the Health Ministry.
The ministry, he said, was against inducing vulnerable individuals or groups such as illiterate and impoverished people, illegal immigrants, prisoners and political or economic refugees being made living donors.
“We know that countries are struggling to attain self-sufficiency in the availability of organs for transplantation. It is in this unfortunate situation that unethical market practices such as transplant tourism and human trafficking are rearing their ugly heads,” he said.
There was a need to “decapitate these ugly heads” and restore order and accountability to the practice of organ transplant and that was the reason why WHO had prepared the revised guiding principles on human organ transplantation, he said.
Worldwide, he said, there were attempts to regulate the unbridled commercialisation with various strategies, proposals and mechanisms to “introduce morals into the market”.
However, the ingenuity of regulated “organ entrepreneurs” knew no bounds, said Dr Ismail.
Truth of the matter is that with everyday that passes....with even more information that we get about this "pandemic" (that didn't quite become a pandemic), it is becoming more and more common to encounter health care givers who would roll their eyes when the spectre of H1N1 is raised. It is increasingly difficult to maintain this very artificial level of 'alertness' when it is obvious that so few are dying even as the number of infections go up. Healthcare givers are not taking the infection seriously (but should they?). MOH itself doesn't seem to take it too seriously (but should they?). WHO sometimes appears to be almost wishing that more people would die, so that the pandemic can be justified.
It's all very bizarre.
I think the reality of the situation is that the healthcare givers themslelves are less and less convinced of the seriousness of this 'pandemic'. This disconnect between the public proclamations and the sentiments and reality on the ground is something the MOH should be very careful about. You have to worry when you believe you are in a war, but your troops do not actually believe in your cause.
Wednesday, June 3, 2009
There is more than a bit of this in the H1N1 story isn't it? Is it serious or not? Is it cause for worry or not? Is it a pandemic or not? Is the sky falling? Are the headlamps approaching? Friend or foe?
Leaders cannot be paralyzed by indecision. One cannot go to war dithering about whether it is a skirmish, battle or war, undecided about the enemy's advance.
The more this drags out, the more it sadly reflects the lack of leadership at the WHO, at a time when leadership is sorely required.
Meanwhile Singapore's tally has gone up to 11 cases, all of whom are well.
While our attention has been distracted by H1N1, aka American flu, aka swine flu... some may be assured to know that all's well with respect to the other potentially problematic infections in Singapore. Dengue has been behaving itself. Chikugunya has been predictably making its home in Singapore at a very low level of endemicity. Hand foot and mouth disease is down way low, maybe because of the increased level of hygiene because of the H1N1 paranoia.
But unbeknownst to many, we are having a small spike of malaria.