Healthy Skepticism Library item: 20088

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Brook S
Bones of contention
The Weekend Australia 2002 Feb 224

Abstract:

Science is producing new wonder drugs faster than we can work out how to pay for them, reports Stephen Brook.

Full text:

For Jillian Sheffield, Enbrel is more important than her house. “I need this drug no matter what,” she says.

Last year, she told her husband, Hilton Solyom, to be prepared to sell their Adelaide home so she could continue taking it, at a cost of $1400 a month.

Five years ago, an ache in her knee and fierce swelling signalled rheumatoid arthritis had entered her life.

“It progressed from there like a creeping thing that went from place to place and ruins one thing and then moves on”, she says.

Walking is difficult because her bones push close to the skin of her deformed feet, but silicon pads and a cane help her get round. She has taken Enbrel for two years and can now cope with getting out of bed.

The couple are not selling up yet. But Solyom’s civil engineering contract runs out in three months and the future is uncertain.

Many rheumatoid arthritis sufferers in Australia are desperate to use Enbrel, a bio-tech drug so advanced a factory of living cells creates it. But it is a drug the country cannot afford.

Enbrel costs Australian patients $18,000 for an annual course, a price determined by Wyeth, the giant US pharmaceutical company that makes it.

Since mid-2000, when Enbrel was approved for use in Australia, Wyeth has lobbied the Pharmaceutical Benefits Advisory Committee – an independent government agency – to place it on the Pharmaceutical Benefits Scheme. Such a move would drop the cost for patients to just $3.60 per script for pensioners, or $21.40 for those on a full income, unlikely for patients with intractable rheumatoid arthritis.

Wyeth says putting Enbrel on the PBS would cost $11 million in the first year, with the cost rising before plateauing at $63 million by the fifth year. But it joins other biotech drugs – for Crohn’s disease, intractable type 2 diabetes, asthma and chronic hepatitis B and C – in being rejected by the PBAC for not being cost effective.

The Enbrel case illustrates a big problem in science and public health policy. While technology such as the Human Genome Project offers the prospect of a whole new range of miracle drugs, society’s ability to sort out how to pay for them is not keeping pace.

Politics enters heavily into whether one drug is affordable against another. The PBAC recently caused a storm by recommending the PBS subsidise the impotence drug Viagra for a very limited group of patients. John Howard threw out the recommendation.

But the fact that the PBAC had even suggested a cost subsidy for impotent men to get erections was more deserving then Enbrel has angered arthritis sufferers.

When Margaret Teece felt a twinge in her shoulder 18 years ago, she dismissed it as a strain caused by moving the television. Now, rheumatoid arthritis has deformed her right hand and her knees, and forced a complete shoulder reconstruction. Unlike Sheffield, Teece cannot afford a course of Enbrel. After using some other drugs, she had lost 6kg and – at one point – half her hair.

Teece, 55, of Waniassa, Canberra, strongly disagreed with the PBAC recommendation on Viagra, which, she says, is a recreational drug, not a life-saver.

“I was very disappointed but not surprised because I thought it was a political judgement, not medical”.

The issue, of course, is complex. Viagra costs $70 a month; Enbrel, 20 times as much.

But Wyeth says Enbrel’s much higher expense is a product of the way it is created. Rheumatoid arthritis – not to be confused with the much more common osteoarthritis – is caused by the immune system chemical, Tumor Necrosis Factor, going haywire and attacking the joints. Enbrel takes excess TNF away from the cells and neutralises it.

At a giant $US1 billion ($2 billion) plant in Seattle, Enbrel-producing cells live in a massive two-storey high container where, the way Wyeth tells it, they are fussed and pampered like babes.

“The cells producing Enbrel require lots of special care, including nourishment, space and virtually round-the-clock monitoring”, says the company website.

Biotech drugs are not new. Insulin has been produced in a similar way for more than two decades. What is new is the incredible complexity of many of the drugs. When compared to insulin, the molecular structure of etanercept (Enbrel’s generic name) looks like a cruise liner moored against a tugboat.

A genre discovered by Wyeth subsidiary Immunex which produces the TNF inhibitor is transferred into Chinese Hamster call lines. Combined with a special growth factor manufactured by Adelaide company Gropep, it is turned into a miniature Enbrel factory.

Les Cleland, medical adviser to Arthritis Foundation of Australia and professor of rheumatology at Royal Adelaide Hospital, supports subsidising Enbrel.

“For people for whom all else has failed we would have to say ‘yes’, considering the impact the disease can have on people”.

Wyeth has campaigned hard to get Enbrel on the PBS, making submissions to the PBAC and hiring a Canberra lobbying firm to brief journalists about the drug’s benefit.

Geno Germano, managing director of Wyeth Australia, rejects PBAC’s argument Enbrel is not cost effective: “While the cost is significantly higher for Enbrel, nothing ever produced [has its] effectiveness”.

Worldwide sales of Enbrel now approach $US750 million, but the drug has not broken even on its research costs, he says.

A March 7 Sydney meeting will see pharmaceutical companies and economic, professional and consumer groups attempt to formulate how PBAC can fund higher cost drugs and not further blow out its budget, which was $3.8 billion last year.

To keep up public pressure, AFA has organised a meeting on March 13 at Sydney’s Parramatta Riverside Theatre complex. It will be webcast live.

Cleland argues Enbrel should be very carefully targeted. Wyeth, rheumatologists and the AFA submitted a proposal to PBAC to control the spending on Enbrel which would see patients tested by independent third parties to assess their suitability for the drug. The subsidy would be restricited to those patients for whom it other treatments have failed. PBAC rejected the proposal.

Gold Coast rheumatologist and president of the Australian Rheumatology Association Julien De Jager doubts such a scheme would work long-term.

“The way Wyeth is advertising for people in the [US], they are putting up the drug for people who have not had any other treatment. There’s no way on God’s earth that the Government is going to agree to that.”