HK Drug Safety Consortium calls for a halt; HA issues swift denial

The Hong Kong Drug Safety Consortium (DSC) Tuesday urged the Hospital Authority (HA) to halt the "on-going unauthorized" clinical trials of Avastin (bevacizumabin) on patients suffering from wet Age-Related Macular Degeneration (AMD) in public hospitals.

The DSC alleged that the trials are being conducted in violation of the city's Pharmacy and Poison Ordinance, for no prior approvals were obtained from the Department of Health (DH). This, the DSC said, has exposed the patients to risks of several side-effects, including blindness.

An HA spokeswoman, however, promptly issued a denial.

An email sent by the HA to the DSC revealed that the alleged trials "are initiated and conducted by the Li Ka Shing Faculty of Medicine of the University of Hong Kong instead of the HA".

Meanwhile, according to the HKU Clinical Trial website, clinical trials by the HKU have been going on since Jan 31, 2008, in areas of eye and adnexa, to evaluate the use of intravitreal Avastin in the treatment of exudative AMD.

An HKU spokesman confirmed Tuesday that clinical trials on Avastins as treatment for wet AMD and Diabetic Macular Edema are going on in local hospitals with permission from the Institutional Review Board (IRB).

"It is unacceptable for HA hospitals to conduct clinical trial on humans without ensuring patients' safety," said Practicing Pharmacists Association of Hong Kong (PPAHK) President Iris Chang. She said a DH approval is essential to guarantee the quality of the medicine and safety of patients.

The IRB, she added, is mainly composed of professors from the HKU and doctors from the HA.

The DSC that comprises three local medical organizations - the Hong Kong Doctors Union (HKDU), the Practicing Pharmacists Association of Hong Kong (PPAHK) and the Alliance of Patients Mutual Help Organization (APMHO), claimed that clinical trials involving the off-label use of Avastin are going on at Queen Mary Hospital, United Christian Hospital and Tuen Mun Hospital. All of these come under HA administration. And it was estimated that dozens of patients had received the "unauthorized trials" at these hospitals, according to PPAHK president Tsang Kin-ping.

A DH spokesman said Avastin is a registered pharmaceutical product prescribed for treating cancer and is routinely given to colorectal cancer patients. However, it's not prescribed for eye afflictions.

The DH spokesman also told China Daily that "a medical practitioner may apply his judgement and prescribe medication."

"After all it's patients' safety and health that count most. Any unauthorized treatment should be stopped immediately," said Tsang, who also called for strict supervision.

China Daily

(HK Edition 11/03/2010 page1)