Sunday, 28 April 2013

Thirty Patients in Erbil Lose their Sight Following the Injection of a Drug to Treat an Eye Disorder, April 2013

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.

Thirty Patients in Erbil Lose their Sight Following the Injection of a Drug to Treat an Eye Disorder, April 2013
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


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.
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:, or
  • Download form4 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.
****For information about this counterfeit medicine, see Roche’s statement:
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.

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