Letter from Mumbai 201
THE GLYCEROL TRAGEDY REVISITED
Administration of contaminated glycerol
had led to the death of 14 patients at the J.J. Hospital in
Mumbai between 21 January and 7 February1986. The state
government appointed Justice Bhaktawar Lentin under the
Commissions of Inquiry Act, 1952 to probe into the tragedy.
(For a review of Justice Lentin’s report on these deaths
see Natl Med J India 1988;1:144–8.) Ten
years later, on 1 December 1997, The Indian Express
carried a news item entitled ‘Lentin report on J.J. deaths
lies in cold storage’:
‘The commission had
passed strictures and recommended immediate departmental
action against the then Dean R. S. Chandrikapure, S. V.
Shaligram (Professor and Head of the Department of
Pharmacology), V. G. Deshmukh (Medical Superintendent), A.
K. Jamadagni (pharmacist), S. B. Satalkar, N. D. Dharap, P.
K. Torvi, S. M. Dolas, P. K. Kochar and B. K. Bijamwar (all
from the department of industries). In addition, the
commission had recommended that the Anti-Corruption Bureau (ACB)
should be directed to hold a high-level probe against the
officials of the industries department.
‘… However, the state
government has cold-shouldered … the recommendations.
‘… The then health
minister Bhai Sawant, former health minister Baliram Hiray,
officials from the Food and Drug Administration (FDA), R. D.
Kulkarni, V. C. Sane, S. D. Bhirud, V. D. Deshmukh and N. D.
Kulkarni were liable to be proceeded against for charges of
corruption after appropriate inquiries were made by the ACB
or any other competent investigating authority on its
behalf.
‘As per official
records, though the FDA officials were suspended for some
period, most of them were reinstated with back wages after
they were acquitted on the basis of departmental inquiry.
Shaligram had failed to withdraw the contaminated drug
though it was brought to his notice. The commission held him
grossly negligent in not providing proper circulars
to the department. However, the departmental inquiry found
no substance in the charges levelled against him. In most of
the cases, the departmental inquiry officer had given almost
similar findings. "Such findings by the departmental
inquiries make a mockery of the commission’s
recommendations," remarked a senior official of the law
and judiciary department.’
Mr Justice Lentin passed
away on 22 April 2000 without seeing any disciplinary action
against those indicted by him.
My thoughts were directed
to this double tragedy (to lives and to justice) by a report
in The New York Times on 6 May 2007. I quote from
this report:
‘The kidneys fail
first. Then the central nervous system begins to misfire.
Paralysis spreads, making breathing difficult, then often
impossible without assistance. In the end, most victims die.
‘Many of them are
children, poisoned at the hands of their unsuspecting
parents.
‘The syrupy poison,
diethylene glycol, is an indispensable part of the modern
world, an industrial solvent and prime ingredient in some
antifreeze.
‘It is also a killer.
And the deaths, if not intentional, are often no accident.
‘Over the years, the
poison has been loaded into all varieties of medicine—cough
syrup, fever medication, injectable drugs—a result of
counterfeiters who profit by substituting the sweet-tasting
solvent for a safe, more expensive syrup, usually glycerin,
commonly used in drugs, food, toothpaste and other products.
‘Toxic syrup has
figured in at least eight mass poisonings around the world
in the past two decades. Researchers estimate that thousands
have died. In many cases, the precise origin of the poison
has never been determined. But records and interviews show
that in three of the last four cases it was made in China, a
major source of counterfeit drugs.
‘Panama is the most
recent victim. Last year, government officials there
unwittingly mixed diethylene glycol into 260,000 bottles of
cold medicine—with devastating results. Families have
reported 365 deaths from the poison, 100 of which have been
confirmed so far. With the onset of the rainy season,
investigators are racing to exhume as many potential victims
as possible before bodies decompose even more.
‘Panama’s death toll
leads directly to Chinese companies that made and exported
the poison as 99.5 per cent pure glycerin.
‘…The counterfeit
glycerin passed through three trading companies on three
continents, yet not one of them tested the syrup to confirm
what was on the label. Along the way, a certificate falsely
attesting to the purity of the shipment was repeatedly
altered, eliminating the name of the manufacturer and
previous owner. As a result, traders bought the syrup
without knowing where it came from, or who made it. With
this information, the traders might have discovered—as The
Times did—that the manufacturer was not certified to
make pharmaceutical ingredients.
‘An examination of the
… poisoning cases last year—in Panama and earlier in
China—shows how China’s safety regulations have lagged
behind its growing role as low-cost supplier to the world.
It also demonstrates how a poorly policed chain of traders
in country after country allows counterfeit medicine to
contaminate the global market.
‘…Beyond Panama and
China, toxic syrup has caused mass poisonings in Haiti,
Bangladesh, Argentina, Nigeria and twice in India.’
(emphasis mine)
The New York Times
report added: ‘In Bangladesh, investigators found poison
in seven brands of fever medication in 1992, but only after
countless children died. A Massachusetts laboratory detected
the contamination after Dr Michael L. Bennish, a
paediatrician who works in developing countries, smuggled
samples of the tainted syrup out of the country in a
suitcase. Dr Bennish, who investigated the Bangladesh
epidemic and helped write a 1995 article about it for BMJ,
formerly known as the British Medical Journal, said
that given the amount of medication distributed, deaths
"must be in the thousands or tens of thousands. It’s
vastly underreported,"
Dr Bennish said of diethylene glycol poisoning.
‘Doctors might not
suspect toxic medicine, particularly in poor countries with
limited resources and a generally unhealthy population, he
said, adding that most people who die don’t come to a
medical facility.’
There is little hope that
the contamination can be stopped at its source. The New
York Times report frankly stated: ‘ "Chinese
officials we contacted on this matter were all reluctant to
become involved," the American Embassy in Beijing wrote
in a confidential cable. "We cannot be optimistic about
our chances for success in tracking down the other possible
glycerine shipments." ’
Under these circumstances
it is imperative that we pay special attention to the
recommendations made by the US Department of Health and
Human Services (Food and Drug Administration) Center for
Drug Evaluation and Research this May.1
These
were made to alert pharmaceutical manufacturers, pharmacy
compounders, repackers and suppliers to the potential public
health hazard of glycerine contaminated with diethylene
glycol in the hope that the detection of such contamination
could help avert future tragedies. The guidelines were based
on their analyses of earlier catastrophic use of
contaminated gylcerine.
‘These cases reveal the
following similarities:
‘The pharmaceutical
manufacturers of the syrups that contained contaminated
glycerin did not perform full identity testing on the
glycerin raw material, including tests to quantify the
amount of DEG present and to verify the purity of the
glycerin received.
‘The pharmaceutical
manufacturers of the syrups containing contaminated glycerin
relied on the certificate of analysis (COA) provided by the
supplier.
‘The origin of the
glycerin was not easily apparent from the COA. The COA
obtained by the pharmaceutical manufacturers of the syrups
was often a copy of a COA on the letterhead of the
distributor and not the COA provided by the manufacturer of
the glycerin. The chain of custody or distribution history
of the glycerin was also not readily known because the
glycerin may have been sold several times between its
manufacture and its use in medicinal syrup or other drug
product.
‘As a result of these
practices, DEG-contaminated glycerin entered the
pharmaceutical raw material supply chain.’
The US Department of
Health and Human Services (Food and Drug Administration)
Center for Drug Evaluation and Research recommends the use
of analytical testing procedures on all lots of glycerin
such as the two-part test, (i) using ‘infrared absorption’
and (ii) using gas chromatography listed in the United
States Pharmacopeia monograph for glycerin. One
alternative procedure is a thin-layer chromatography (TLC)
method published in the Journal of AOAC International.
Our ignoring these
recommendations will certainly result in further deaths—especially
of the poor.
Postscript: On 9 July 2007, Chinese media announced that
Zheng Xiaoyu, former director of China’s State FDA (SFDA)
was executed for corruption. Zheng was convicted of taking
bribes worth 6.5 million yuan ($850 000) from 8 firms. This
is the first time since 2000 that China has imposed death
sentence on an official of his rank.
Zheng, head of the SFDA
from 1998 to 2005, was sentenced on 29 May 2007 and his
appeal was heard in June 2007.
Investigators found that
Zheng and his subordinates abused new rules in renewing drug
production licences to squeeze kickbacks from companies,
spurring the spread of fake drugs in a system plagued by
corruption.
Last week, a court handed
down a suspended death sentence on one of Zheng’s
subordinates on the same charges. Another senior SFDA
official was jailed for 15 years in November 2006 for taking
bribes and possession of an illegal gun.
‘The nest of corruption
in the SFDA has done incalculable harm to the state and
people’, the Procuratorial Daily said.
The contrast between this
action and the inaction of the Government of Maharashtra is
noteworthy.
THE MAHARASHTRA MEDICAL COUNCIL: RENEWAL
OF REGISTRATIONS
For the first time since 1965, I received a letter from this
august body on a matter unconnected with elections to it.
Thus far, it has ignored all doctors registered with it,
deeming it unnecessary to involve us in any dialogue on
matters pertaining to health, the care of the ill or
education of the public on matters medical. Nor have we been
favoured with its own views on topics such as the
sterilization of the mentally handicapped, female foeticide,
forceful feeding of prisoners, corrupt doctors, medical
consultants facilitating hospitalization of politically
powerful and the rich sentenced to prison and the lack of
medical ethics as a subject in the curriculum of medical
colleges.
The letter we received
recently asked us to renew our registration with it. Towards
this end we were to fill in a form which required, among
other details, attested copies of the registration
certificates (MB,BS and specialization) earlier issued by
itself and two passport-sized photographs with name and
registration numbers on them. Why they needed attested
copies of their own registration certificates remains a
mystery unless, of course, as is not uncommon in such august
organizations, ‘the files are missing’.
Oh, yes, they also needed
a demand draft for Rs 500 for re-registering us. Cynics in
the medical profession were quick to ask why the simple task
of re-registration cost Rs 500 as they could think of no
other expense incurred by the Council on any of us.
My application form for
re-registration and demand draft for Rs 500 and those of 3
colleagues were received by the Council in February 2007.
Since patience went
unrewarded over the next two months, my colleagues and I
ventured to enquire with the Council as to the fate of our
applications.
The conversation in the
office of the Council went somewhat as follows:
We: ‘Could you please
let us know the fate of our applications? Here are the
copies.’
Clerk: ‘I will have to
look up.’ (The computer on the table was then activated.)
‘Hmm. Please give me the old registration numbers of each
of you.’
These were duly supplied
separately although they were printed on the copies we had
proffered.
Clerk: ‘The
registration numbers on two forms are wrong. Please supply
the correct numbers.’
We: ‘This is not
possible as we have given you the attested photocopies of
your own registration certificates.’
Clerk: ‘Well my
computer is not accepting these numbers.’
To cut a long story
short, we were eventually promised our new registration
documents in a few days. The application for re-registration
sent on 14 February 2007 eventually elicited a response in
print on 26 May 2007, stating that we have been
re-registered for a period of 5 years from 1 March 2007.
This letter includes an ominous paragraph: ‘It is stated
that Medical Practitioners/Graduates registered with this
Council will be required to approach this Council two months
in advance before expiry of the above period of five years
for next renewal of registrations as per section 23(C) of
the Maharashtra Medical Council (Amendment) Act, 2003.’
I have already made a
note in my diary and hope to be prepared for the next ordeal
in January 2012, if I’m still around then!
REFERENCE
-
US Department of Health and Human
Services (Food and Drug Administration) Center for
Drug Evaluation and Research: Guidance for Industry.
Testing of glycerin for diethylene glycol. www.fda.gov/cder/guidance/index.htm (accessed
on 1 June 2007).
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