KUALA LUMPUR, July 18 — In January last year, a healthy young man was reported to have died while several others suffered brain damage during a clinical treatment trial in France.
They had participated as human guinea pigs for a mood disorder drug designed by a Portuguese pharmaceutical company.
Despite the incident having raised serious questions about the safety of privately contracted drug experiments on human patients, often by giant pharmaceutical companies (which are sometimes collectively called “Big Pharma” so as to illustrate just how big and influential they are), the Malaysian government views clinical trials as an opportunity.
Early this morning, Clinical Research Malaysia (CRM), the agency set up by the Ministry of Health to oversee and spearhead the clinical research field that includes running trials for multinational pharmaceutical companies in the country, announced its plan to increase the number of trials to 1,000 by 2020 from the 100 ongoing trials now.
With a market valued at US$25 to US$30 billion a year (RM107 to RM129 billion), it is no surprise why policymakers are taking notice; CRM said the Malaysian government wants it to work towards making the country a “hub” for clinical trials.
“We have all the facilities, demographic and ecosystem to be a hub for clinical trials.. we have an opportunity,” Dr Khairul Faizi Khalid, CRM’s head of business development, said in his presentation this morning.
But it’s not all about money and profits, according to CRM. The agency’s chief executive officer Dr Mohd Akmal Yusof said attracting Big Pharma to conduct trials here also provide opportunities for local doctors to study novel treatment methods by exploring newer drugs.
“Now they can have a better quality of life, enjoy time with family because they have the opportunity to be given treatment otherwise not available [presently],” Dr Mohd Akmal said in his presentation.
Human experiments
To further convince the public on the positives of clinical trials, CRM presented an advertorial to the media — a moving video featuring smiley fictitious patients recovering from serious illness and expressing gratitude for having been allowed to partake in the trials.
The organisation also held a dialogue session with a Stage Three lung cancer patient who is still being “treated” under a trial that has gone on for seven years.
“Thank God. Because I joined the trial, I am okay. I am still around,” the 70-year-old woman said as she wiped away her tears when recalling how the doctor broke the news about the illness to her more than seven years ago.
Despite the feel-good stories and arguments on the importance of clinical research for the medical field and healthcare in general, drug and treatment trials are still in essence experiments, meaning those who participate may be subject to health hazards and potentially, death.
Just last year alone there were several reports of trial-induced deaths in the West, countries supposedly known for their strict regulation and ethical requirements on drug testing.
According to online genetic engineering and biotechnology magazine GEN, there were 13 notable clinical trial failures resulting in nine deaths.
The first on the list, an experiment on “viral gene treatment” on cancer patients, killed two participants in Phase 1 of the trials while the third died from a cause unrelated to the therapy.
Phase 1 of a clinical trial can be considered the most dangerous phase in clinical research; it is when human patients are tested with new drugs or treatment that had previously only been tested in the laboratory and animals, with the main objective being to monitor how human organs react to the new drug or treatment.
CRM said today that it was already conducting Phase 1 trials in an attempt to draw pharmaceutical industry into the country.
“CRM has reached a crucial juncture with the introduction of Phase 1 clinical trials in Malaysia, making the country move higher up the clinical trial value chain,” the organisation said.
Ethical questions
The organisation claimed the move could deliver a Gross National Income of RM578 million and create 1,000 skilled jobs in the industry by 2020.
The kind of money involved in clinical research, powerful multinational pharmaceuticals and biotech companies have raised concern about ethics.
In poor countries like India, clinical research organisations (CROs) have been known to be less forthcoming about information to participants, who are mostly poor and are willing to risk their safety just so they can get paid or be given free treatment.
While participants may be informed about the trials prior to giving consent, just how transparent and truthful is the information?
Will regulators and CROs be transparent about failed experiments or the potentiality of a new drug or treatment to cause serious health damage given the money paid for trials could go up to hundreds of millions ringgit?
According to Dr Khairul and Dr Akhmal, CRM upholds the highest standards of safety and transparency for their trials. They also said CRM has been selective about the type of trials allowed to be held in the country.
“We have very strict regulations and the ethics [committee] is there as check and balance... we have always made sure that only safe trials are held,” Dr Akhmal told Malay Mail Online.
The two bodies that regulate clinical trials here are the Malaysian National Pharmaceutical Regulatory Agency and the National Research Ethics Committee.
CRM also has strict protocols for choosing participants. Unlike in other countries, only selected Malaysians with certain medical preconditions are allowed to partake in the trials.
Apart from travel allowances, they won’t get paid either, which could prevent pharmaceutical companies and CRO exploitation of desperate patients.
Nevertheless, testimonies from participants, either those who posted them on internet forums or the woman who attended CRM’s briefing, have all indicated that clinical trials are not fully hazard-proof.
For example, the 70-year-old patient is one of only two remaining participants in her trial. During an interview with the media, she revealed that some other patients had suffered bad side effects like vomiting blood and skin rashes.
Healthcare experts have advised patients with serious conditions to seek proper counselling before participating in trials.
