Indonesia’s health minister, Terawan Agus Putranto, has alarmed the country’s medical community by recommending that its hospitals start to use a controversial treatment against stroke that he himself has pioneered. Many physicians and scientists say there’s no evidence that the procedure, called intra-arterial heparin flushing (IAHF), works—and it could do harm. Terawan’s longtime, aggressive advocacy for it makes him unfit to lead health policy for the world’s fourth most populous nation, critics say.
“We really need to protect our patients and the whole society,” says Irawan Satriotomo, an Indonesian neurologist working at the University of Florida and a vocal opponent of the treatment’s use.
Details on IAHF are a bit sketchy, but it is a variation on a diagnostic procedure called digital subtraction angiography (DSA), which is used to make blood vessels in the brain visible. In DSA, a catheter is inserted into a patient’s leg and passed up the brain’s blood vessels, and a contrast dye is injected that can be made visible using x-ray imaging. A bit of heparin, an anticoagulant, is injected to prevent blood clots from forming on the catheter.
Terawan, a radiologist by training who became minister of health in October 2019, has turned this diagnostic tool into a treatment, apparently by applying extra heparin to remove any blood clots that may have formed during stroke. He developed the therapy while at the Gatot Soebroto Army Hospital and has reportedly used it on thousands of patients since 2012—not only to treat stokes, but also to prevent them. Among his patients are several prominent businessmen, army leaders, and politicians, including former President Susilo Bambang Yudhoyono. In 2018, Terawan told news website Tirto that he charges $1800 per treatment.
Now, he believes it’s time for a wider rollout. “It can be implemented, why not?” he said at a seminar in Denpasar, Indonesia, in late December 2019, according to local news media. “What we need now is willingness. If we have strong willingness, then we can find the funding.”
But a 2016 review by five Indonesian neurologists concluded there is no evidence that the procedure is effective and said it didn’t comply with internationally accepted stroke treatment standards from the American Heart Association and the American Stroke Association. They pointed out that the procedure carries a small risk of both neurological and nonneurological complications, and a mortality risk of 0.05% to 0.08%.
In a clinical trial in 75 patients published in 2016 in the Bali Medical Journal, Terawan reported that IAHF could “significantly improve muscle strength” in chronic stoke patients. But the results are “statistically unconvincing,” says Rizqy Amelia Zein, an open-science activist and a social psychologist at Airlangga University. Rather than randomizing patients to a treatment or a control group—the standard design in medical research—Terawan measured muscle strength in the same patients before and after his treatment, a far weaker trial design. He used an internationally accepted test to measure muscle strength—the manual muscle test—that uses a scale from one to six, but inexplicably reported mean values of 30.21 and 36.27 in pre- and posttreatment patients, respectively.
Last year, Terawan also published a study of IAHF in 17 children with autism spectrum disorder, whom he claimed suffered from cerebral vein thrombosis. The idea is scientifically baseless, Satriotomo says. “Autism has nothing to do with brain vascularization.”
The Indonesian health ministry did not respond to questions about how Terawan plans to introduce the stroke therapy.
Indonesia’s medical community has tried to stop Terawan before. In 2013, at Satriotomo’s instigation, the Indonesian Neurological Association spoke out strongly against the therapy in an open letter. In 2018, the Ethical Council of the Indonesian Medical Association (IDI) summoned Terawan for a meeting to explain his work. He didn’t show up, and the council found him guilty of four ethical violations: charging large fees for an unproven treatment, falsely promising patients a cure, excessive self-promotion, and not cooperating with the council. IDI revoked Terawan’s membership for 1 year.
But the Indonesian government has not acted. According to an investigation by Indonesian journalists, the previous health minister, Nila Moeloek, in 2018 secretly wrote Mulyono, chief of staff of the Indonesian army, that the army hospital could continue using the treatment even though a working group inside the ministry had advised her to ban it.
In a letter that was leaked to the media, IDI last year asked newly reelected Indonesian President Joko Widodo not to appoint Terawan as health minister—but Widodo ignored the advice. “There are more political reasons than scientific reasoning in this case,” Satriotomo says.
Source: Science Mag