Note from the Site
While the aim of Kurdistan Food Security
is to raise awareness of the problems faced in endeavouring to achieve a degree
of food security by increasing agricultural input there is also a need to be
constantly aware of food safety problems. We need to be aware that both home
produced and imported food meets the required standards that are
internationally accepted. The recent scandal in Europe, over horse meat being
fraudulently sold as beef, has revealed the need for constant vigilance.
Although consumption of horse meat is not a human health problem the discovery
that horse meat containing phenylbutazone, a veterinary drug that is banned
from use in food animals but given to horses for pain relief, is a cause for
concern as the drug is banned from use in humans.
Illegal drugs entering the human food
supply is a threat to human health but we also face a major threat from the use
of fake medications in hospitals and clinics. Medical services throughout the
world face the threat to patients resulting from fake pharmaceutical products
and while Kurdistan Food Security’s focus is on food production and security we
feel we should also raise awareness of the need for vigilance in the human
health sector.
The following is an article that
illustrates the need for increased awareness of fake pharmaceuticals that pose
a threat both here and in other countries. Much of the information in this
article has been taken from readily available information placed on the
internet by drug manufacturers and health authorities in order to warn doctors
and health authorities of fake products and thereby safeguarding patients.
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Thirty Patients in Erbil Lose their Sight
Following the Injection of a Drug to Treat an Eye Disorder, April 2013
SUMMARY
Avastin (
benvacizumab) is a drug developed by Genentech Roche to reduce the blood supply
to cancer tumours and is used throughout the world on cancer patients. It is
available as single dose vials for cancer treatment but it is also used in many
countries ‘off-label’ as a treatment for eye disorders. When the drug is used
for eye treatments small doses for injection into the eye must be prepared from
the vial the drug is sold in but it is cheaper than the alternative, but
approved drug, Lucentis. There is concern in both Europe and the USA over the
use of Avastin for conditions for which, to date, it has not been approved. In
2012 twenty one people in the USA lost their sight, and one became brain
damaged, following injections with Avastin and investigations into the cases
have found that there was bacterial contamination of the drug as the small
doses for injection into the eye were prepared from the drug vials.
Also in
2012 Roche and Genentech announced that counterfeit Avastin had entered the
pharmaceutical supply chain and it was being sold under the trade name Altuzan.
Investigations revealed that the drug reached the USA from Turkey by way of
Egypt and Europe and that it may have been produced in China. The USA
authorities In April 2013 thirty patients treated for eye disorders at a
hospital in Erbil lost their sight following intraocular injection with
benvacizumab that had been purchased as Altuzan which is the trade name used
for the drug for sale in Turkey. The USA authorities published full descriptions
of the fake product and advised all medical professionals not to purchase the
drug when it was cheap.
In
America a single dose of Avastin prepared for injection into the eye costs
about $50 in the USA while in Britain it costs the National Health Service £60.
The drug used to treat patients in Erbil cost $20 per injection. This indicates
that that the drug used in Erbil was exceptionally cheap and there is the
possibility that it was not genuine. The contents of the vials and their origin
must be investigated while the government needs to review sourcing of drugs. In
addition the production, storage and use of the injections used in the hospital
must also be investigated for the possibility of contamination at some point
while full pathological reports on each patient affected are essential. A full
and comprehensive report of this scandal
THE REPORT ThT
Earlier
this month it was reported that 30 patients in at a hospital in Erbil had lost
their sight following intraocular injection of the drug Avastin for the
treatment of eye disorders such as macular degeneration and retinopathy.
The drug
Avastin (benvacizumab), produced by Genentech, is a drug licensed for use in
cancer treatment. Benvacizumab is an anti-angiongenesis drug that inhibits the
growth of new blood vessels to supply the tumour with the nutrients it
requires. In simple terms the tumour is then ‘starved’ and it shrinks making
the cancer more manageable. The drug has also been used successfully in
treating wet age-related macular degeneration and diabetic retinopathy when it
is used ‘off-label’, meaning in a use it is not licensed for. As in the case of
all drugs there are side effects from the use of the drug in cancer patients
and numerous clinical trials and use of the drug to treat patients Ranibizumab (trademark Lucentis) is a newer,
but more expensive, anti-angiogenesis drug produced by Novartech and can also
be used to treat the eye disorders.
In the UK the use of
Aventis and Lucentis in the treatment of wet age-related macular degeneration
(wet AMD) is the subject of some debate. Lucentis is a prescription medicine
approved for use on the NHS for patients with the condition. It has been approved by the National Institute for
Health and Clinical Excellence (NICE) and the Medicines and Healthcare products
Regulatory Agency (MHRA) to treat the eye condition. According to research
trials the two drugs had similar results in preventing the loss of sight in
treating the eye condition however there are issues of safety raised around the
use of Avastin which is not licensed for use in treating wet AMD. Avastin is
the cheaper of the two drugs and costs around £60 per injection while Lucentis
costs about £700 per injection. If the cheaper drug was used the NHS could save
more than £84 million a year yet there are concerns regarding the safety of
Avastin, in particular with regards to infection and inflammation of the eye
and the results of longer trials with the drug are required.
The UK’s
Department of Health is under pressure from the Royal National Institute for
Blind People (RNIB) to examine the evidence on the safety of Aventis
emphasising that patient safety should lie at the heart of any decision about
drug treatments. (RNIB June 2012)
Information regarding the
use of Avastin is freely available on the internet. The side effects of Avastin
in the eye are listed as dry or itchy eyes, light sensitivity and detachment of
the retina leading to blindness that can be rectified by surgery. In addition
information is given on the need to store the drug away from light and at
temperatures between 2 – 8C while dilutions of the drug must be used within 8
hours while it is also stated that the drug vials must not be shaken or frozen.
This information suggests that the drug must be handled and used with care by
pharmacists, nursing and medical staff.
In the New York Times,
August 30th 2011, Andrew Pollack reported that 16 people in Florida
and Tennessee had lost their sight following treatment of the eye with Avastin.
As a result there are court cases being brought in both states against the
medical professionals, hospitals and clinics where the treatments were carried
out in addition to state authorities investigating the cases. Pollack states
that Avantis was being used instead of the safer Lucentis as Avantis cost 50$
per shot compared to the $2,000 cost of Lucentis. The indications were that
patients were blinded as a result of bacterial infection of the eye and that
the bacteria, (Streptococcus oralis
and Streptococcus viridis were
isolated from the drug syringes), were a contamination of the drug when
pharmacists divided the contents of vials of Avastin to give the smaller
amounts of drug to be injected into the eyes of patients. This procedure was necessary as the drug was
being used off-label and not supplied in the small doses required for opthalmic
use but as a vial suitable for a single chemotherapy dose for a cancer patient.
In October 2011 Pollark reported another case of sight loss from use of the
drug. In this insance five people in California had also lost their sight
following injection with Avastin and in December 2011 the Canadian Health
authorities warned doctors of the risks associated with the use of the drug for
eye treatments.
In February 2012 Roche and
its US biotech partner Genentech announced that counterfeit Avastin had been
distributed through the USA through legitimate supply chains in Europe and had
been traced to a source in Egypt. The fake Avastin contained starch, salt,
cleaning solvents and other substances. Over the year since then investigations
into the circuitous route by which the fake product entered the USA have
continued and there is evidence that the product initially came from China via
Turkey. However several other incidents have occurred over the last year where
fake Avastin has made its way into hospitals and clinics in the USA and it has
been found in Europe too. The USA authorities have put photographs and detailed
descriptions of the packaging of the fake drugs on the internet to assist
doctors and pharmacists to identify the fake drugs and prevent their use. The
fake products have been packaged as Altuzan which is the trade name of the drug
in Turkey and in some cases the fakes have been traced to Turkey but also to
Syria and Egypt.
The USA’s Food and Drug Administration
warned doctors and hospitals of the fake products and the information in the
appendix has been taken from an FDA information bulletin on the internet.
Photographs of the packaging of the fake drug and the batch numbers on the
packaging give detailed information to enable medical and pharmaceutical staff
to identify fake drugs
The loss of sight recorded in patients at in Erbil
The case must be thoroughly investigated and
there are several points of concern that can be identified and examined.
1. The drug used was from
Turkey so presumably was marketed as Altuzan and was purchased in vials of
16ml. A single vial gave 30 single injections for ophthalmic patients. This
immediately raises the questions ‘Were all the patients who lost sight given
injections produced from a single vial of drug?
2. The preparation of all
injections, storage, dates administered etc must be determined from hospital
and pharmacy records to identify any common factor. Microbiological examination
of vial contents and prepared injections is required.
3. The drug was purchased at a
cost of $600 per 16ml vial. This means each inoculation produced cost $20 and
is considerably cheaper that the $50 per shot price in the USA or the £60 cost
in the UK. Such a low cost raises the question as to the authenticity of the
drug (Refer FDA warning in Appendix)
4. The contents of any vials
remaining from the drug consignment must be chemically determined and the
packaging compared to authentic packaging and that of the fake batches
discovered in the USA and Europe.
5. If the drug proves to be
fake its origins should be investigated with assistance from authorities abroad.
6. Storage and handling of the
drug by suppliers, pharmacists and hospitals. Where were the injections for use
in the patients prepared? This can be a source of infection as identified in
the cases in the USA.
7. What were the clinical and pathological
findings with regard to those who lost their sight? Was there evidence of
infection introduced into the eye? Did detachment of the retina occur?
A full and thorough
investigation is absolutely essential and a review of the government’s drug
purchasing system must be made. The purchasing of cheap, medical products puts
patients lives at high risk as it is well known that the international pharmaceutical
market is a target for fraudsters who make easy money from the supply of
illegal drugs. In view of the concerns raised in both Europe and the USA on the
safety of using benvacizumab off label for the treatment of eye disease the KRG
should consider the purchase of ranibizumab which, although more expensive, is
approved for ophthalmic procedures.
Appendix
Statement issued by Food and
Drug Administration(FDA) of U.S.A 14th
February 2013.
Counterfeit Version of Avastin in U.S.
Distribution
Statement Update Issued: July 10. 2012
FDA has issued letters to medical
practices in the United States that purchased unapproved medications that may
include the counterfeit versions of Avastin or Altuzan. The medical
practices purchased unapproved medications from foreign distributors such as
Clinical Care, Quality Specialty Products (QSP), Montana Health Care Solutions,
and Bridgewater Medical.
·
Statement Issued: Feb. 14, 2012
FDA sends letters to 19 medical practices
about counterfeit product and other unapproved cancer medicines
The U.S. Food and Drug Administration
(FDA) is warning health care professionals and patients about a counterfeit
version of Avastin 400mg/16mL, which may have been purchased and used by some
medical practices in the United States. Avastin is an injectable medicine
used to treat cancer and is administered to patients in clinics, hospitals, and
doctors’ offices. The counterfeit version of Avastin does not contain the
medicine’s active ingredient, bevacizumab, which may have resulted in patients
not receiving needed therapy.
In a related action, FDA has issued
letters to 19 medical practices in the United States that purchased unapproved
cancer medicines that may include the counterfeit Avastin. The counterfeit version is labeled as Avastin, manufactured
by Roche. Roche is the company that manufactures Avastin approved for
marketing outside of the United States.
Roche conducted laboratory
tests that confirmed the counterfeit version of Avastin. Packages or vials may be
counterfeit if they:
- are labeled
with Roche as the manufacturer
- display batch
numbers that start with B6010, B6011 or B86017
The only FDA-approved version of Avastin for use in the
United States is marketed by Genentech (a member company of Roche). The
FDA-approved version does not include the Roche logo on the packaging or
vials. In addition, Genentech’s FDA-approved version of Avastin vials and
packaging have a 6-digit numeric batch number and expiration
dates in a 3-letter month and 4-digit year format (e.g., JAN 2014).
Genentech’s Avastin products are safe and effective for their intended
uses.
The 19 medical practices in the United
States purchased unapproved cancer medicines and, potentially, the counterfeit
Avastin, from Quality Specialty Products (QSP), a foreign supplier that may
also be known as Montana Health Care Solutions. Volunteer Distribution in
Gainesboro, Tennessee is a distributor of QSP’s products. FDA has requested
that the medical practices stop using any remaining products from these
suppliers. FDA cannot ensure the safety or efficacy of any of these
unapproved products.
Based on information to date, FDA has
determined that none of the unapproved cancer medicines received by these
medical practices from Volunteer Distribution are in shortage in the United
States. FDA-approved versions of these medicines are available in
adequate supply to meet current demand.
Medical practices that have obtained
unapproved products from foreign sources, in particular from Volunteer Distribution
and/or QSP, should stop using them and contact the FDA. These products
should be retained and securely stored.
To report suspect counterfeit products
and other suspect unapproved products obtained from Volunteer Distribution or
QSP/Montana Health Care Solutions or other sources:
Health care professionals and consumers
are asked to report adverse events related to the use of suspect injectable
cancer medicines to the FDA’s MedWatch Safety Information and Adverse Event
Reporting Program either online, by regular mail, by fax, or by phone. Health
care profssionals and consumers can either:
- Complete and
submit the report online: www.fda.gov/MedWatch/report.htm, or
- Download
form or call 1-800-332-1088 to request a
reporting form, then complete and return to the address on the
pre-addressed form, or submit by fax to 1-800-FDA-0178.
FDA
continues to evaluate this counterfeitمزيف medicine situation and we will provide updates.
FDA has
issued letters to medical practices in the United States that purchased
unapproved medications that may include the counterfeit versions of Avastin or
Altuzan. The medical practices purchased unapproved medications from
foreign distributors such as Clinical Care, Quality Specialty Products (QSP),
Montana Health Care Solutions, and Bridgewater Medical.
