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The Great Subutex U-Turn - Injecting The Macabre Facts
Fri, Sep 01, 2006 |
The tale is awfully familiar.
Subutex (buprenorphine hydrochloride) was introduced by the Singapore government in 2002 as a sort of wonder drug to rid heroin addiction. But it turned into a hot potato when the news finally broke in 2005 that existing addicts undergoing treatment and new entrants without previous drug addiction problem were concocting a lethal new drug mixture.
This is done by dissolving Subutex in water and mixing it with the sleeping pills Erimin-5 or Dormicum, both of which are crushed into a fine powder. The entire assortment is then injected into the body to create a high. The frequent injections cause the veins to harden, resulting in a gangrene which can ultimately take the life of the abuser.
Between 2002 to August 2006, there were no existing legal clauses to stop this act.
Retracting an ill policy after 4 years elicits contrasting opinions from different segments of the country.
For the 47-years old enigmatic government of Singapore, it was another monumental moment to vaunt their self-conceived efficiency in 'fixing' problems of their own creation.
To the rest of the country enduring the ramification of the silly policy, 4 years is a terribly long wait for attention, especially from an elected government constantly boasting of having the land's brightest brains within their swelling ranks whilst big-mouthing no end their legendary ability to look 3 generations beyond any policy.
Seeking to rein in the runaway political embarrassment, Subutex addicts were ordered to sign up for a Subutex Voluntary Rehabilitation Programme (SVRP) within a tight 2-week window. Those who sign up will be allowed to continue to take the drug under medical supervision until they start on the programme.
After the 2-weeks dateline, anyone caught with Subutex will be forced to undergo rehabilitation the first two times they are caught, and jailed and caned subsequently.
Subutex was also rapidly promoted to the category of a Class A Controlled Drug, which subjects traffickers and illegal dealers to 20 years in jail and 15 strokes of the cane.
What followed was a series of sensational arrests of Subutex traffickers and illegal dealers by the Central Narcotics Bureau (CNB). Doctors were also investigated, castigated for profiteering from the trade of Subutex, and blamed for aggravating the situation.
The decisive impetus would have been a classical fairytale achievement for the government. But the indelible facts reveal something more macabre.
(1) Wisdom On Hindsight, Vision In Backside
In late July this year, Minister of Health Khaw Booon Wan was reported to state that he had concluded that Subutex abuse was a problem in Singapore after studying the situation over the last few months.
His party comrade Senior Minister of State for Law and Home Affairs Associate Professor Ho Peng Kee had earlier in March acknowledged in Parliament that the CNB had identified the problem of Subutex abuse since "late 2003", and that the drug agency had been "working with MOH" on the problem.
Khaw was Acting Minister for Health in 2003 (he was appointed Minister of Health in 2004). Conclusively therefore, the Health Minister took nothing less than 31 "few months" (2 years and 7 months) to study a festering problem.
A distinctive pattern soon emerged in his public comments over the month of August to suggest that the 'well-meaning' government was somehow blindsided
"The introduction of Subutex is a classic example of a good intention that has led to an UNINTENDED DETRIMENTAL OUTCOME."
"The good intention has unfortunately yielded opposite and UNEXPECTED RESULTS."
"The problem continues to grow, despite various restrictive measures put in by the Government last year (2005)....Let us tackle this problem fundamentally and nip it BEFORE IT BECOMES UNMANAGEABLE."
"The way it was introduced, suddenly overnight a few thousand doctors were potentially able to prescribe it freely. I think freely is the correct word - almost freely. That, I think, is to me is NOT VERY WISE."
"IF WE HAD KNOWN all these then I suppose we wouldn't have introduced it."
Khaw reckoned that it was a "learning experience". It was a poor joke. He might not realise that the Singapore government had had more time than he would like to admit.
In 2002, the same year Singapore adopted Subutex, the United States (US) Food and Drug Administration (FDA) Center for Drug Evaluation and Research introduced a risk-management plan for the use of Subutex which included education, supervised dose induction, limiting the use of Subutex to supervised administration, and the monitoring of local drug markets and drug-using network areas, to state a few.
The FDA and the Drug Enforcement Administration (DEA) decided in the same year that
The potential for abuse led to the necessity of increasing the penalties for illegally obtaining, possessing, or abusing Subutex.
Physicians prescribing the drug must become certified by attending a special training course. Physicians also must agree to refer patients for drug addiction counselling.
A special identification number from DEA must appear on all Subutex prescriptions to aid law enforcement and anti-diversion officials in tracking any diversion of the drugs.
Physicians prescribing Subutex must maintain a log of all patients using the drug and record the medication that has been prescribed to them.
It will take Singapore another 3 wasted years and an escalating Subutex abuse statistics before the government dictated in late 2005 that
All Subutex prescriptions have to be recorded electronically and patients can only be treated by one doctor.
Doctors who prescribe Subutex will be given access to the central addiction registry for drugs so they can check that patients are not seeing other doctors as well.
All doctors who want to prescribe the drug must attend eight hours of training at the Institute of Mental Health to update themselves on how to treat addicts trying to give up hard drugs.
However, the biggest missing puzzle was the accompanying drug called Suboxone (see section below) which the government had bypassed.
The apparent mistake in the Singapore approach was that the stringent procedure which the US strictly adheres to was completely missing for years from the Singapore protocol.
Khaw reportedly said that his priority was to help the addicts rather than embark on a witch-hunt. Given the nature of the government's obvious culpability resulting from prolonged hand-sitting, his decision is understandable.
The Health Minister has nevertheless reaffirmed the need for an elected government to put good vision where it would not be sat on.
(2) The Suboxone Mystery
Subutex was conceived in the US to treat drug addiction in conjunction with another drug called Suboxone (buprenorphine hydrochloride and naloxone hydrochloride). Both were the product of a US Cooperative Research and Development Agreement between Reckitt Benckiser and the US National Institutes of Health’s National Institute on Drug Abuse. The effort spanned more than 10 years before the drugs were approved for use in the US in 2002.
Subutex contains only buprenorphine hydrochloride. This formulation was developed as the initial product. Suboxone contains an additional ingredient called naloxone to guard against misuse.
Suboxone was designed specifically to meet the US FDA requirements for a more diversion-proof drug for use in opiate addiction therapy. The naloxone contained in Suboxone guards against abuse - If an abuser crushes and injects or snorts the Suboxone tablet, the naloxone in it precipitates withdrawal symptoms instead of the typical high.
Subutex is only given during the initial first few days of treatment, while Suboxone is used during the long maintenance phase of treatment.
The US National Drug Intelligence Center (NDIC), a component of the U.S. Department of Justice, reiterated the precautionary measures for Subutex in 2004 with a publication
On October 8, 2002, FDA approved buprenorphine in two formulations, Subutex and Suboxone, for use in opiate addiction therapy. Subutex (buprenorphine hydrochloride) is used in the initial stages of therapy while Suboxone (buprenorphine hydrochloride and naloxone hydrochloride) is used in the maintenance stage.
The Singapore government has engaged only half the recommended therapy, and ignored all warnings and advices from the US agencies. This mistake was to be their undoing as Subutex abuse became a needless nightmare.
Suboxone came close to being introduced in May 2005 when a news report indicated that MOH had been in discussions with Schering Plough, the distributor of Suboxone (and Subutex), over the potential implementation of the drug. The news further affirmed that the US was the only country using Suboxone then.
The trail went cold and fell out of public consciousness. MOH was apparently not prepared to answer the tough questions of why Suboxone was not used in conjunction with Subutex as the US FDA had recommended from the onset in 2002.
The MOH cannot however avoid the ignominious destiny of another entry in Singapore's black book of government blunders.
(3) Cometh The Angel In White
At the height of the Subutex issue in August this year, Senior Minister of State for Law and Home Affairs Associate Professor Ho Peng Kee rendered his angelic morals by proclaiming that
"Addicts should not be treated with drug replacement therapy as that will only prolong their addiction from one drug to another."
He further emphasised the government's consistent "zero tolerance towards drug abuse", adding that the "use of Subutex as a substitute drug runs contrary to that stance."
"It was introduced by MOH (in 2002) with good intentions but unfortunately yielded opposite and unexpected results. The therapy did not work in Singapore."
He went on to uphold his belief that an effective policy of curbing Subutex abuse requires "a shift away from advocating the use of the drug as a substitute for opiate dependency'."
Second-guessing the effects of a policy is a justifiable pastime for one who does not have the benefits associated with public office appointment - Copious human and financial resources.
Ho does not qualify for that hobby.
Ho Peng Kee was the Parliamentary Secretary to the Minister for Law and Minister for Home Affairs from 1993 to 1997 whereupon he was appointed the Minister of State for Law and Home Affairs. 4 years later in 2001, he was upgraded to his present rank.
When the Subutex policy was injected into public veins in 2002, he was in a good position to stand his ground and debate the values he now holds so dearly. He did not whimper.
His more senior colleague Wong Kan Seng, Minister of Home Affairs since 1994, was equally closemouthed on the government's tolerance towards compromising the principal of "zero tolerance".
And in a Parliament overwhelmingly dominated by members from his political party, discussion of the Subutex issue was exceedingly scarce.
The sole record came in March 2006 from a MP of the Sembawang constituency Dr Mohamad Maliki Bin Osman. The latter said that
"Recently, press news of the emergence of subutex as an alternative to heroin is rather worrying......One of the issues raised is the perception that subutex is what is called a legal drug......What was also reported was the emergence of a black market for subutex...."
He then proceeded to ask
"Is MHA or MOH tracking the number of subutex abusers? Does CNB see the abuse of subutex as a worrying phenomenon? What is CNB's position and strategy with regard to handling the subutex abusers? How does CNB intend to address this problem of the black market, if it is true that it exists?"
His party comrade Ho replied that
"Since the abuse of Subutex first came to CNB's attention in late 2003, CNB has been working with MOH to explore possible measures to tackle the problem......Given that MOH's control measures were implemented recently in November last year, I think we should allow some time for the measures to take effect and then we can assess.......CNB remains vigilant and we will not hesitate to make Subutex a controlled drug, if the need arises."
Ho was yet again presented with an opportunity to exercise the principal of "zero tolerance". Once again, inexplicably, he passed off the chance.
Four short months after that fateful reply, "the need" to make Subutex a controlled drug suddenly arose.
The Health Minister remarked in August this year that Subutex abusers habitually congregated openly at his constituency of Sembawang where one of the most prolific Subutex-dispensing general practitioner clinics was located.
Khaw had been redeployed in Sembawang on the eve of the election in May which he subsequently won. However, Dr Maliki, who has been the MP for Sembawang since 2001, came to take up the issue only in 2006, 2 months before polling day. And he was informed only via the news.
(4) Conclusion
The number of Subutex pills (both in 2mg and 8mg) sold in Singapore offered a startling warning since 2002
2002 - 78,764
2003 - 335,580
2004 - 619,472
2005 (up to September) - 609,854
2005 November to July 2006 - 600,000 (approximately)
Despite the exponential increase, the government was apparently unworried.
It is ironical that the ease with which CNB effectuated a slew of arrests in the days following the implementation of the austere measures merely serves to reinforce the observation that the problem created by the wrong policies for Subutex had gone on for noticeably much too long.
The Health Minister remarked in August this year that
"The rest of the world believes in chemical substitution. In our case, it reaffirmed that it is the wrong approach. It's a wrong approach. It's a very soft approach, but it causes more problems."
It is most intriguing to note that in view of the common belief of both Khaw and Ho that the drug-against-drug approach was wrong, it begs asking how the government's initial plan to use Subutex even passed the drawing board stage.
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