Ona forced faulty remedy as dengue cure – papers

Acting Health Sec. Janette Garin has revoked her predecessor’s inapt use of a faulty remedy for the dreaded dengue.

Garin’s move pacifies drug regulators, researchers, ethicists, and field doctors who, documents show, resist the remedy. It also abides by the World Health Organization and the Dept. of Science and Technology. But it clashes with a faction at the Dept. of Health allied to Sec.-on-leave Enrique Ona.

Stopped was Ona’s prescription of an untested mix of medicines introduced to the Philippines not for dengue but malaria. Both mosquito-borne diseases kill hundreds of Filipinos each year. Garin repealed last week Ona’s Sept. order to use the blend.

Health bureaucrats want Ona ousted for forcing the mixture on them despite inadequate clinical tests and product info. It supposedly was one of two reasons for the sudden resignation in Sept. of Food and Drug Administrator Dr. Kenneth Hartigan-Go. A twin reason was Ona’s alleged refusal to sign the “Mexico City Principles” for biopharmaceutical business ethics. Before that DOH subordinates had criticized, banned, and filed lawsuits against Ona’s dengue drug.

Ona has been put on month-long leave while under investigation for procuring a billion pesos of inefficacious pneumonia vaccines. Garin’s taking of his post has riled fellow undersecretaries and Ona appointees. U-Sec. Teodoro Herbosa nearly sued Garin for attempting to fire him, had not Malacañang intervened to stay put. Garin has reverted to a lower post Asst. Sec. Eric Tayag, also under probe as Ona’s accessory in the questioned vaccine purchase.

The Senate presently is hearing the DOH’s budget for 2015. There, critics assail Garin’s qualifications, saying that as an ex-congresswoman she is a mere political ally of the administration.

Ona’s provocative dengue drug combines anti-malarial artemether and artesunate with the Chinese herb berberine. In Feb. 2012 its US developer asked the DOH to design a clinical trial for malaria. The elite Research Institute for Tropical Medicine declined due to lacking product disclosures. In June-July that year the FDA allowed the importation of the three substances, on condition of further studies.

Trouble sparked in May 2013, when the Palawan provincial health office alerted the FDA of clinical trials being done in two hospitals and two hinterlands. Chief Dr. Louie Ocampo reported that one enrolled child patient had died.

At once then-FDA chief Hartigan-Go dispatched investigators. In far-flung Rizal town the medical team confirmed that the malaria fatality was not part of the trial, but her elder sister was. The team also learned in Bataraza town, the Leoncia Community Hospital, and the Ospital ng Palawan that the malaria trials had been going on since Nov. 2012 without FDA consent. It turned out that Ocampo had warned the four health units against the unauthorized tests in Mar. 2013, and enjoined Ona to stop it as far back as Dec. 2012. Probers heard of more tests being done in Olongapo and Subic, Zambales.

In June 2013 the FDA ordered the US firm, its local partner, and field testers to desist. A lawsuit ensued from alleged ethical and legal breaches. The DOH’s herbal arm Philippine Institute of Traditional and Alternative Health Care countered that the FDA and other units were biased against it.

Last Sept. 24 Ona issued a department order for the PITAHC to use the three anti-malaria drugs in six hospitals, this time for dengue.

As justification he cited stark statistics: 187,031 reported infections, with 921 deaths, in 2012; 204,906 cases, with 660 deaths, in 2013; over 24,900 cases and 100 deaths in 2014.

The five participants were: San Lazaro Hospital, Manila; East Avenue Medical Center and Quirino Memorial Medical Center, Quezon City; Dr. Jose N. Rodriguez Memorial Medical Center, Caloocan City; Amang Rodriguez Medical Center, Marikina City; and Jose B. Lingad Memorial Hospital, San Fernando, Pampanga.

Ona quoted in his order a purported endorsement by the esteemed Dr. Jaime Montoya. The latter heads the DOST’s Philippine Council for Health Research and Development, and affiliate Philippine Health Research Ethics Board.

Montoya told The STAR that he was quoted out of context. He said he in fact had drafted a new protocol for the clinical study because his unit found the old one flawed. He would not say if the misquoting was deliberate.

The WHO nixes the anti-malaria cure for dengue.

Ona has always been controversial. His recycling of anti-malaria mixes as a cure for dengue and the purchase of weak pneumonia shots are but the latest.

When he headed the National Kidney Institute during the past administration, nephrologists flailed his letting rich Arab patients buy organs from penurious Filipino transplant donors. Before Congress confirmed his 2010 appointment as health secretary, Sen. Miriam Santiago first had to make him forbid the organ trading.

Ona also was questioned for overpriced construction and equipping of a new wing at the Kidney Center. Despite this, a presidential sister endorsed him to President Noynoy Aquino.

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