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Medical device companies fight back against damning results for spinal procedure

Ray Moynihan wrote this Crikey piece about two new trials, published in the latest New England Journal of Medicine, that raise serious questions about the ongoing use of a controversial procedure called vertebroplasty, where bone cement is injected into a person’s vertebrae to try and fix painful spinal fractures.

Writing from Washington, health policy analyst Dr Lesley Russell says the studies are big news there, especially with the Presidential focus on health reform. The devices industry will fight hard to retain a multi-million dollar market, she says:

“It is very interesting to look at the response to the publication of these studies in the US, where one of the arguments raging around the health care reform legislation under consideration in the Congress is government funding of comparative effectiveness research and the use to which the data generated might be put.

President Obama and health and economic policy experts have been calling for just these kinds of studies as a means of controlling health costs and ensuring better health outcomes and the House bill has $1.1 billion to establish a Center for Comparative Effectiveness Research.

Opponents see this as Big Brother, in the form of the government entering the health arena, making decisions that will deprive patients of choice, ration health care and result in ‘socialized medicine’.  The UK National Institute for Health and Clinical Excellence (NICE ) is definitely not seen as nice by these people, who are apparently happy to see decisions about what treatment they get made on the basis of bank balance or the profit motives of their health insurer.

The number of vertebroplasty procedures in the US has doubled in the past six years.  Last year 73,000 people had the treatment which costs $2,500 to $3,000 plus $1,000 – 2,000 for an MRI.  This procedure cost Medicare (the government-funded health care program for people aged 65 and over) $21 million.  The total US market in  vertebroplasty had a value of about $45 million in 2008 and is projected to grow annually at a rate of 13.5 percent.

There is even less data on the effects of kyphoplasty, which involves pumping the vertebra with a balloon to restore its shape before injecting cement, and which has a much larger market, estimated at more than $500 million a year.

But this is now where the US situation is headed, with the industry already out in the media emphasizing how kyphoplasty is different.

There is a comparative study of the two procedures underway, funded by the manufacturers, but results are apparently some way off.  There are some ten US medical device companies who are involved in this field, and the early indications are that they will not cede this profitable arena without a tough fight.

In the meantime, who should make the decisions about continued funding of this treatment and on what basis?

One of the researchers on the US paper has said that people who want vertebroplasty should still be able to get it – but only if they enter a clinical trial that collects data on every case.”

• Lesley Russell is Menzies Foundation Fellow at the Menzies Centre for Health Policy University of Sydney/Australian National University and Research Associate, US Studies Centre, University of Sydney

Comments 3

  1. Patty says:

    Before I read these comments I found a link that says the study results have been misinterpreted and actually show vertebroplasty does reduce back pain.
    http://www.cnbc.com/id/32320616.

    I hope that mainstream media eager to jump on the Obama policy bandwagon are not poisoning public opinion before checking the real facts. If this one story negates 20 years of clinical research than the most vulnerable among us (pain ridden elderly osteo suffers) are going to continue to suffer is silence.

    For those of us not aided by the procedure as evident by the posts here, we should be checking facts before rushing to judgment.

  2. Croakey says:

    Yes, but look who the story is quoting. It’s not surprising they don’t agree with the way the study’s findings have been reported

  3. Bert says:

    It’s naturally interesting to look at the response to the publication in the US as it is about fight or die. As the top US medical device companies are fighting hard to retain the million dollar vertebroplasty market. The vertebroplasty market seems to be much bullish as it is grows annually at a rate of 13.5 percent.

    There is also another way for the device manufacturer companies to make their customer crazy about their products, the Simulation Medical has developed series of products for organizations requiring the ability to use phlebotomy or venous access techniques to demonstrate the benefits of their new products.

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