Limits...
Off with the label and on the Avastin bandwagon: why now and how far?

Santhan Gopal KS - Indian J Ophthalmol (2009 Jul-Aug)

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Twenty vitreo-retinal surgeons of India were personally interviewed about the “off label” use of avastin... Any drug that is used in a way other than the label given by the drug control authority of India, would be considered as a new drug which has to be approved by the authority, before usage in general public... Avastin is still legal, though off label and a similar class of drug/s for intraocular use is/are available... Avastin is safe and effective for the time being and presently no change is indicated... At the annual meeting of the American Academy of Ophthalmologists on October 14, 2005, Genentech presented several areas of concern about the drug's potentially adverse effects when used intravitreally for wet ARMD:In view of the fact that avastin contains no preservatives, there could be problems in keeping it sterile during storage and when it is split up by doctors into the small quantities required for retinal treatment there is risk of contamination... No preclinical trial toxicity data exist for use of Avastin in retinal therapy... Phil Rosenfeld (who is leading the study of Avastin for retinal treatment at the Bascom Palmer Eye Institute in Miami), holds the view that the issue of purity is not a problem in his work... All analytical release data has been reviewed by Roche for this manufactured lot and all test parameters were well within limits established for the authorized use of avastin... A review of adverse event reports received in 2008 does not indicate any unusual reporting pattern associated with this lot or any other particular lot of avastin distributed in Canada, when used for the authorized indication... TASS is a sterile postoperative inflammatory reaction caused by a non-infectious substance that enters the anterior segment of the eye and results in toxic damage to intraocular tissues... Roche has neither studied nor sought authorization for the use of avastin in the ophthalmology setting... The patients who cannot afford the higher cost of therapy with lucentis or macugen, may feel that they are being treated with an inferior quality drug... The resultant anxiety needs to be addressed as well... Insurance companies will dictate to the patients and doctors, as to the drug usage... If the results with lucentis are shown to be clearly better than avastin, we will have a major ethical issue.

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Pre injection Diabetic CME (Courtesy: Dr. Nitin Shetty, Bangalore)
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Figure 0001: Pre injection Diabetic CME (Courtesy: Dr. Nitin Shetty, Bangalore)

Mentions: Avastin is used frequently by ophthalmologists. Word search for avastin in the Indian Journal of Ophthalmology website produced 33 articles for the period between 2007 and January 2009, sign of the increased usage of the drug. The reduction of fluid in the retina and improvement in vision after avastin injection is gratifying to all concerned [Figures 1 and 2]. Many with conflicting interests are claimants to this success. There are legal, financial, industrial and ethical implications and the ophthalmologist must be aware of these implications.


Off with the label and on the Avastin bandwagon: why now and how far?

Santhan Gopal KS - Indian J Ophthalmol (2009 Jul-Aug)

Pre injection Diabetic CME (Courtesy: Dr. Nitin Shetty, Bangalore)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2712692&req=5

Figure 0001: Pre injection Diabetic CME (Courtesy: Dr. Nitin Shetty, Bangalore)
Mentions: Avastin is used frequently by ophthalmologists. Word search for avastin in the Indian Journal of Ophthalmology website produced 33 articles for the period between 2007 and January 2009, sign of the increased usage of the drug. The reduction of fluid in the retina and improvement in vision after avastin injection is gratifying to all concerned [Figures 1 and 2]. Many with conflicting interests are claimants to this success. There are legal, financial, industrial and ethical implications and the ophthalmologist must be aware of these implications.

View Article: PubMed Central - PubMed

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

Twenty vitreo-retinal surgeons of India were personally interviewed about the “off label” use of avastin... Any drug that is used in a way other than the label given by the drug control authority of India, would be considered as a new drug which has to be approved by the authority, before usage in general public... Avastin is still legal, though off label and a similar class of drug/s for intraocular use is/are available... Avastin is safe and effective for the time being and presently no change is indicated... At the annual meeting of the American Academy of Ophthalmologists on October 14, 2005, Genentech presented several areas of concern about the drug's potentially adverse effects when used intravitreally for wet ARMD:In view of the fact that avastin contains no preservatives, there could be problems in keeping it sterile during storage and when it is split up by doctors into the small quantities required for retinal treatment there is risk of contamination... No preclinical trial toxicity data exist for use of Avastin in retinal therapy... Phil Rosenfeld (who is leading the study of Avastin for retinal treatment at the Bascom Palmer Eye Institute in Miami), holds the view that the issue of purity is not a problem in his work... All analytical release data has been reviewed by Roche for this manufactured lot and all test parameters were well within limits established for the authorized use of avastin... A review of adverse event reports received in 2008 does not indicate any unusual reporting pattern associated with this lot or any other particular lot of avastin distributed in Canada, when used for the authorized indication... TASS is a sterile postoperative inflammatory reaction caused by a non-infectious substance that enters the anterior segment of the eye and results in toxic damage to intraocular tissues... Roche has neither studied nor sought authorization for the use of avastin in the ophthalmology setting... The patients who cannot afford the higher cost of therapy with lucentis or macugen, may feel that they are being treated with an inferior quality drug... The resultant anxiety needs to be addressed as well... Insurance companies will dictate to the patients and doctors, as to the drug usage... If the results with lucentis are shown to be clearly better than avastin, we will have a major ethical issue.

Show MeSH