Malaysia's Clinical Trials Quagmire
Slack enforcement, false registrations, neglect
Multiple breaches of standard practices in clinical pharmaceutical trials are raising doubts about the quality of Malaysia’s medical system and the safety of patients misled into participating in experiments run by doctors accused of gross professional misconduct.
The concerns come as Malaysia’s Director General for Health, Noor Hisham Abdullah assumes a new position with the World Health Organization and as new clinical trials of a controversial anti-Covid-19 treatment, called ivermectin, have begun in public hospitals.
As vaccines prove ineffective against Covid-19 variants, Malaysia’s clinical trials on cheap, widely available therapeutics could be a key contribution to global research efforts but may be fatally compromised by the allegations, which raise doubts about research practices and place patients at risk in local and international clinical research studies.
Multiple clinical trials involving thousands of unsuspecting patients have been registered by medical researchers charged with malpractice who are alleged to have concealed false information from local and international regulators, according to evidence recorded with the Malaysian National Medical Research Register and the ClinicalTrials.org depository run by the US National Institutes of Health (NIH) in the United States.
In one case, neurosurgeon Ramesh Kumar, a researcher at the National University of Malaysia (Universiti Kebangsaan Malaysia) has been conducting trials related to a failed stroke drug produced by a Singapore biopharmaceutical company called Moleac Pte Ltd. Moleac manufactures a drug called NeuroAiD, derived from traditional Chinese medicine, primarily for use in stroke recovery. Clinical trials using NeuroAiD were completed in 2012 and the results, available at the NIH ClinicalTrials depository, showed that it was no better than a placebo in treating stroke patients.
Following the failure, Moleac engaged Kumar for further trials to find alternative uses for the drug. Onel enrolled 30 patients at UKM in Malaysia and runs until 2022. A second has enrolled 2,000 patients at UKM and the National Brain Center Hospital in Indonesia and is to run until January 2022.
Both trials are being conducted by Kumar, who is under investigation for medical malpractice and at the same time under investigation for academic malpractice and breaches of medical ethics regulations at UKM.
According to complaints filed with multiple agencies, the malpractice investigations and misconduct charges have been concealed from the Integrity Unit and Faculty of Medicine at UKM, the United States National Library of Medicine (ClinicalTrials.gov) and the trial participants, who have given their consent to participate without knowing their experimenter-in-chief was charged with malpractice.
Concerns about the trials were raised with regulators in Singapore but were immediately kicked back into the regulatory long grass of Malaysia.
“On the clinical trial that is highlighted, we noted that the trial is conducted in Malaysia and Indonesia,” according to October 2020 emails In from Terence Goh at the National Medical Research Council at the Ministry of Health, Singapore. “Our stand remains in that our regulations govern the provision of healthcare products in Singapore, and do not cover the activities of companies that sponsor healthcare products offered overseas.”
On the investigations into Kumar’s alleged professional misconduct, “we have highlighted this to Moleac, and understand that Moleac is aware of the situation where investigations on the case are ongoing,” Goh wrote. Moleac has so far failed to respond to questions about the trials or Kumar’s involvement.
Malaysian university cover-ups
Meanwhile in Malaysia, in September 2019 the issue of the MMC professional malpractice charges were reported to UKM, where Kumar works in the Faculty of Medicine and where the clinical trials were being held. UKM is directly responsible for the regulation of such trials as a research center appointed by the Malaysian Ministry of Health.
In August 2020, after almost a year, the then Vice Chancellor of UKM, Mohd Hamdi Abd Shukor replied that no action would be taken against Kumar because the university had been informed by him that the MMC investigations had been closed, although a continuation hearing was set at MMC later in the same month.
Further complaints that Kumar has been conducting clinical trials while charged with professional misconduct were filed in August 2020. The clinical trials were registered to be performed on patients at Hospital UKM, the university hospital which is also a center for clinical research.
The case was reopened and passed to the university legal department and then the UKM Integrity Unit. The UKM Ethics Committee for Research scheduled a hearing in October 2020 in which Kumar and co-accused spine surgeon, Mohd Hisam Muhamad Ariffin were called to give evidence.
The inquiry was completed by December 2020 but to date, sources say, the results have been withheld by Fuad Ismail, the chairman of the UKM Ethics Committee for Research, from the UKM Integrity Unit and the Deputy Vice Chancellor for Research, Abdul Wahab bin Mohammad.
Fuad is a direct collaborator with Kumar at the UKM Gamma Knife Center, a multi-million ringgit research center at HUKM. Despite at least nine requests from the Integrity Unit between December 7, 2020 and June 11, 2021 and referrals to the legal department by Zansyuwari Mohd Shahrullail, Special Officer to the Vice Chancellor, Fuad has failed to provide the ethics inquiry report and conclusions of the committee against his collaborator.
At the time of writing the university has still not provided an update on the status of the malpractice investigations completed in December 2020.
False registrations and slack regulation
Another case involves Tikfu Gee, a bariatric surgeon who has been charged by the MMC with three counts of gross professional misconduct. The charges come after an MMC investigation committee found that complaints against him, reported by Asia Sentinel, are probably true and are supported by the evidence provided.
During the period of investigation and following the charges against him, Gee was nonetheless conducting numerous clinical trials at Malaysian public hospitals involving 232 patients, all of them unaware that their experimenter-in-chief was charged with malpractice.
In response to a complaint against Gee for conducting clinical trials while charged with malpractice by MMC the Malaysian regulator, the Medical Research Ethics Committee at the Ministry of Health suspended Gee from ethical clearance.
In January this year, Lee Keng Yee, Secretary of MREC, confirmed, “We had withhold (sic) the approval of any study by Mr Tikfu Gee till MMC investigation is cleared.”
At least three trials were registered at Malaysia’s leading public hospital, Hospital Kuala Lumpur (HKL) but in May its director, Dr Heric Corray claimed that Gee was not in full-time practice at HKL and was not involved with research at the hospital. In an email sighted by Asia Sentinel he stated, “Please be informed Dr Tikfu Gee is only doing sessional (work) and is not doing any research in this hospital.”
When presented with the NMRR and ClinicalTrials.org registration of at least three clinical trials at HKL, including one new trial submitted during the period of MREC suspension, Dr Corray replied, “I had discussed with CRC HKL (Hospital Kuala Lumpur). We are aware MREC has suspended Dr Gee from conducting any more clinical trials. From our record, he is not conducting any trials currently.”
Corray failed to clarify whether this was because CRC at HKL had prevented the new trials or whether Gee had conducted earlier trials without the knowledge and approval of HKL.
CRC is the Clinical Research Centre responsible for authorizing clinical trials in a public hospital in Malaysia. According to its own website, the CRC at HKL is also responsible for NMRR registration for any research at HKL and for obtaining MREC ethical clearance for clinical trials at HKL. Clinical trials cannot take place at HKL without the knowledge and approval of HKL CRC.
The same trials were also registered at a second public facility, Hospital Serdang. When contacted about possible malpractice by Gee, Ang KL of the Clinical Research Center (CRC) at Hospital Serdang said, “We certainly understand your concern related to the possibility of the misconduct risk of trials at our hospital, and we appreciate your bringing this issue to our attention. We assure you that the three studies concerned raised by you in the ClinicalTrial.gov list were never registered, initiated, or conducted at the Hospital Serdang.”
Presented with the exact official Malaysian and US clinical trials registrations which confirm the involvement of Hospital Serdang, Ang insisted, “I have mentioned very clearly that none of those studies had ever been conducted or initiated at Hospital Serdang as far as I (am) aware. You have to check with the PI/UPM on why they did what they did in the ClinicalTrials.gov and in the NMRR in the first place. We were absolutely in no part of this.”
In May of this year, Nabeela Mansor from the Public Relations Unit at Hospital Serdang stated in an email seen by Asia Sentinel, “We have done a thorough check with (the) Human Resource Department and Surgery Department Hospital Serdang and concluded that he (Tikfu Gee) has never served or worked in Hospital Serdang.”
Private Sector Safe Havens
Complaints against Gee were filed at Universiti Putra Malaysia (UPM), where Gee worked when registering the trials. In January this year, Zamberi Sekawi, Dean of the Faculty of Medicine and Health Sciences at Universiti Putra Malaysia and a member of the MMC governing council replied that, “We have conducted an internal investigation on this matter. All Dr Gee's clinical trials were conducted at MOH facilities and not UPM Faculty of Medicine and Health Sciences, as he was providing clinical services in Hospital Kuala Lumpur and Hospital Serdang then. (Note: UPM teaching hospital was only operational early last year).”
Sekawi also noted that Gee had failed to comply with the required ethical protocols governed by the JKEUPM (Ethics Committee for Research Involving Human Subjects) at UPM. He said, “Our investigation showed that he had failed to notify JKEUPM on the MREC approvals. Dr Gee is no longer with us and therefore, it is not practical to proceed with an inquiry on the notification issue.”
Gee’s association with UPM ended shortly after the revelations in Asia Sentinel of his involvement in medical malpractice allegations at Prince Court Medical Centre. Gee took an additional appointment in the private sector at Sunway Medical Center. In January 2021 he registered for new clinical trials involving 150 patients at Sunway University which is outside the regulatory scope of the MREC suspension.
Concerns that the trials, which require patient consent, were being conducted by a researcher charged with malpractice and under suspension by the Ministry of Health were filed with Sunway University in April 2021. The President, Sibrandes Pompena, joined Sunway University in 2019 after the collapse of a project in Yantai, China, causing massive financial losses at his previous university in the Netherlands. He has not responded.
The Chairman of the MREC is Noor Hisham Abdullah, the Malaysian Director General for Health. Noor Hisham remains embroiled in numerous scandals most recently involving the Malaysian Royal Family, systemic corruption in the MMC, and long-standing concerns about his handling of the Covid-19 pandemic.
Noor Hisham was recently questioned about an honorary award from the Royal College of Surgeons of Edinburgh in 2017 leading to concerns about the multiple corruption issues being raised with the UK medical institution.
In an email made available to Asia Sentinel, Anthony Oxford, Chief Executive Officer of the Royal College of Surgeons of Edinburgh said, “We are aware of the additional sources of information you refer to and will continue to monitor the situation.”
The concerns about false reporting of the clinical trials on the US database ClinicalTrials.org have been brought to the attention of National Institutes of Health (NIH) in the United States. In January 2021 the Director of the ClinicalTrials.org site, Rebecca Williams, assured that she would personally investigate the matter and said in an email made available to Asia Sentinel, “I am checking on the status of this and will respond further when I have additional information.” At the time of writing, no reply has been received.
As Malaysia tries to raise its profile in medical circles following its representative’s elevation to the WHO Executive Board, concerns about standards in its own local systems will face further scrutiny from international peers, regulators and a growing chorus of concern about the ethics and motives among members of WHO and its advisory committees.
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