Article from: The Australian
THE ethics committee of an Australian university gave the green light to a study involving a trial of a new ADHD drug after being wrongly told by a researcher that the US Food and Drug Administration had dropped a “black box” warning that the drug brought an increased risk of suicidal thoughts.
It has also emerged that Curtin University failed to disclose to the parents of the children in the study the full extent of involvement in the study by Eli Lilly Australia, the multinational company that markets the drug, Strattera.
Concerns surrounding the conduct of the trial have emerged following a 15-month battle with the West Australian university and Eli Lilly to have details of the study released under Freedom of Information laws.
The documents, the release of which Curtin fought hard to prevent, reveal that its ethics committee, which approved the research, was given incorrect information regarding the potential suicide risks associated with Strattera.
Curtin was ordered to hand over the documents to West Australian Labor MLA Martin Whitely, a vocal ADHD medication critic, by the state’s Acting Information Commissioner John Lightowlers.
“It’s taken 15 months to get information that shows the university’s ethics committee were given completely wrong information about the suicide warnings attached to this drug,” Mr Whitely told The Weekend Australian.
According to the documents, Associate Professor Heather Jenkins, the university researcher who led the trial, told Curtin’s ethics committee in June 2006 that the US Food and Drug Administration had revoked a black-box warning about the increased risk of suicidal thoughts associated with the drug, citing an article to back up her claim which had appeared in the US medical journal Pediatric News.
“Since the study has been approved, there has been some publications related to the rare occurrence of suicidal ideation in some patients who were taking Strattera,” Professor Jenkins told the ethics committee. “This initially led to a black-box warning from the FDA, which was subsequently revoked following further investigations.”
This was wrong. The FDA black-box warning – the strongest it issues – had been in place for eight months at the time Professor Jenkins advised the committee it had been lifted and the Pediatric News article she cited said so.
Further, Associate Professor Jenkins appears to have cited the incorrect publication she used to support her incorrect claim to the ethics committee that the FDA had revoked the Strattera warning. According to a summary document provided by Curtin University that details Professor Jenkins’s argument, she said it had appeared in the Harvard Mental Health Letter in April 2006. No such article appeared in that issue but an article by the same name and by the same author does appear in the April 2006 edition of Pediatric News.
Australia’s drug regulator, the Therapeutic Goods Administration, had also placed its strongest possible warning on Strattera regarding the suicide risk two months before Curtin considered Professor Jenkins’s application.
A separate document provided by the university to parents of children being considered for the study lists serious adverse events associated with the drug, including liver damage, cardiovascular disorders and gastrointestinal problems. However, no mention is made of the increased suicide risk associated with the drug.
In 2006, Curtin was deliberating on whether to renew Professor Jenkins’s drug trial application. The project had stalled because its research partner, Sydney’s Children’s Hospital Education Research Institute (CHERI) at Westmead, had withdrawn from the project.
According to the documents, the head of CHERI advised Professor Jenkins that the Children’s Hospital at Westmead’s ethics committee had “too many objections to put in writing”. The hospital refused to answer questions from The Weekend Australian about the nature of those objections.
Professor Jenkins did not respond to questions from The Weekend Australian but Curtin University has vigorously defended the conduct of the drug trial. In a statement, its acting vice-chancellor, Linda Kristjanson, said Curtin’s human research ethics committee was “fully informed and was not misled on any aspect of the study”.
“Before approving the study, the university’s human research ethics committee conducted a rigorous independent review that complied scrupulously with the National Statement on Ethical Conduct in Research Involving Humans – as prescribed by the National Health and Medical Research Council,” Professor Kristjanson said. She said information was given to parents by the pediatrician who diagnosed their children and prescribed the medication.
The extent of Eli Lilly’s involvement in the trial of its own drug is also revealed despite Professor Jenkins’s claim in a statement to parents of children in the study that: “Eli Lilly has signed an agreement with Curtin University of Technology that confirms that the university investigators are completely independent of their company. This means that Eli Lilly Australia has not influenced the design of the study.”
The documents show that a drug company employee was paid to work on the study as an investigator who would “contribute to the overall conduct of the study through advice on design and implementation”. In an email from Eli Lilly’s director of corporate affairs and health economics to Professor Jenkins in 2002 during the set-up phase of the project, he wrote: “We (Eli Lilly) would like the opportunity for our clinical research physician to look at the proposed protocol in more depth. We have some initial thoughts regarding a couple of additional instruments that may be worth including.”
Eli Lilly contributed $145,000 in cash and in-kind support to the trial. The trial also received a $500,000 grant from the Australian Research Council.
Parents of children who participated were told that Eli Lilly had supplied the medication free, that the company had made a financial contribution and that its medical staff would be available to the researchers and doctors for information purposes.
Eli Lilly Australia, which also fought the release of the documents, said: “Lilly Australia feels that these documents, relating to the study, contained confidential information and their release is not necessarily in the public interest.”
Its spokeswoman said the company had early in the study provided “technical advice” on outcome measures on an “as needed basis” but was dissociated from the study as a “partner investigator” in September 2004 and continued as an “industry partner organisation” after that time.
This is yet another classic case of the main principles governing the pharmaceutical “business with disease.” It is not in the financial interests of the pharmaceutical industry to prevent common diseases – the maintenance and expansion of diseases is a precondition for the financial growth of this industry.
Creating and funding their own trials and studies, and designing these in a way that they produce favourable and profitable results, using the name(s) of reputable universities is one of the strategies of “Big Pharma” to get new drugs approved and subsidised by governments. In real terms, it is not the government who provides these subsidies, it is your tax dollar which contributes to the enormous profits of “Big Pharma”.
Any studies and trials cited should always be analysed very carefully by the reader.
- Who designed the study?
- How was the study designed?
- Who conducted the study?
- Who financed the study?
- Have financial interests been adequately disclosed?