by Julia Medew

THREE Melbourne oncologists say cancer treatment research published in one of the world’s most prestigious medical journals may have been compromised by a drug company that funded the study.

Publication of the research in The Lancet may have boosted the drug’s perceived value to doctors and patients around the world, helping its manufacturer, Roche, make billions of dollars from the product, they said.

In a letter sent to The Lancet last year, Associate Professor Ian Haines from Cabrini Hospital and two colleagues said they were concerned that 27 out of 32 authors of the research published last October had potential conflicts of interest, given they had declared various financial links to drug companies, including Roche.

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One of these 27 authors was a paid employee of the company.

The research examined the efficacy of Roche’s drug MabThera (also known as rituximab), for patients with chronic lymphocytic leukaemia (CLL) – the most common type of leukaemia diagnosed each year in Australia.

It concluded the drug improved survival rates for patients with the disease, causing the drug to be widely funded and adopted by doctors around the world.

The letter, signed by Professor Haines, Dr Patrick Elliott, of Cabrini, and Dr Robert Stanley, of Monash Medical Centre, also questioned a comment piece on the study, written by Professor Peter Hillmen from St James’s University Hospital in Leeds, given he had declared speaking fees and honorariums from Roche.

”We were surprised by the hyperbole in your editorial appraisal of the recent publication of the CLL8 study which did not, in our opinion, provide a balanced and considered review of the strengths and weaknesses of the study,” Drs Haines, Elliott and Stanley wrote in their letter to The Lancet.

”The editorial writer shared the same potential financial conflicts of interest as 27 of the 32 study authors and appeared too enthusiastic in his embrace of the study with terms like ‘gold standard’, ‘heralds fundamental changes in management of CLL’ and ‘landmark’.”

The Lancet rejected the allegations, and authors of the research said they stood by its integrity and the benefits of the drug.

But Professor Haines said Professor Hillmen’s and the 27 authors’ declared potential conflicts may have influenced the research in a conscious or unconscious fashion, resulting in a more favourable outcome.

”The CLL8 study has been funded by one of the world’s largest drug companies [Roche] which stands to make billions of dollars in extra profits if it is positive.”

A spokesman for The Lancet, Tony Kirby, said the journal’s publication of the pieces was appropriate and adhered to its publication guidelines, which ask authors to declare financial and personal relationships with other people or organisations that could inappropriately influence their actions.

A separate letter written by the three Melbourne doctors was published in The Lancet last week, outlining some of their concerns about the research, but Professor Haines said the word limit for submissions meant they made their points about conflicts of interest in a cover letter to the journal’s editors.

Professor Hillmen rejected the allegations about his comment article and said any such article could be criticised in this way, since ”virtually all” authors reporting on many trials have links to drug companies.

”It is convention to disclose one’s potential conflicts, which I and the authors of the CLL8 manuscript have done and it is for others to decide how much, if any, this undermines the conclusions drawn,” he said.

Professor Hillmen said he had not overstated the findings of the research, which at the time, was the only trial to ever show convincing improvement in survival for CLL patients.

”The addition of rituximab (MabThera) to FC [fludarabine cyclophosphamide] chemotherapy has been widely adopted and funded throughout the world on the basis of this trial (and other well-designed trials that support its conclusions),” he said.

”As an individual who has been involved in developing treatments for CLL for over 15 years with the aim of improving outcomes for patients it is indeed gratifying that at last we are making some progress in a disease that in most patients leads to a premature death.”

Two of the 27 authors who contributed to the original study are Melbourne-based oncologists, Dr John Catalano of Frankston Hospital and Professor John Seymour of Melbourne’s Peter MacCallum Cancer Centre.

Both doctors declared ”consultancy or board membership for Roche”, and payments for educational presentations for the company.

Professor Seymour said that although he had declared potential conflicts of interest, it did not undermine the integrity of the research.

Professor Seymour said the large cost of clinical trials meant it was extremely difficult to find non-drug-company funding and that he hoped the issues raised by Professor Haines and his colleagues would not result in patients missing out on MabThera, a ”proven life-extending therapy”.

”I strongly support the conclusions and validity of the study as published, and whole-heartedly endorse the comments made by Professor Hillmen in the accompanying editorial,” he said.

A spokesman for Frankston Hospital said Dr Catalano was unavailable for comment as he was on leave.

Roche Australia did not return calls made by The Age.

Article link: http://www.theage.com.au/victoria/drug-company-links-may-have-compromised-cancer-study-20110120-19xz6.html

We Lost the War on Cancer – Review of Alternative Cancer Therapies

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We have lost the war on cancer. At the beginning of the last century, one person in twenty would get cancer. In the 1940s it was one out of every sixteen people. In the 1970s it was one person out of ten. Today one person out of three gets cancer in the course of their life.

The cancer industry is probably the most prosperous business in the United States. In 2014, there will be an estimated 1,665,540 new cancer cases diagnosed and 585,720 cancer deaths in the US. $6 billion of tax-payer funds are cycled through various federal agencies for cancer research, such as the National Cancer Institute (NCI). The NCI states that the medical costs of cancer care are $125 billion, with a projected 39 percent increase to $173 billion by 2020.

The simple fact is that the cancer industry employs too many people and produces too much income to allow a cure to be found. All of the current research on cancer drugs is based on the premise that the cancer market will grow, not shrink.

John Thomas explains to us why the current cancer industry prospers while treating cancer, but cannot afford to cure it in Part I. In Part II, he surveys the various alternative cancer therapies that have been proven effective, but that are not approved by the FDA.