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WHEN the COX–2 inhibitor rofecoxib (Vioxx) was withdrawn from the market in 2004, the focus of doctors and the media was — understandably — on the cardiovascular risk for patients who took the drug.
As a journalist covering the story at the time, I never considered that allegations that the manufacturer had downplayed the drug’s potential dangers to patients also raised questions about the potential misuse of public money.
Hypothetically, if doctors prescribe a drug listed on the Pharmaceutical Benefits Schedule (PBS) based on false claims about its safety or efficacy, this not only puts patients at risk but could also be seen as defrauding the public purse.
Yet, while patients who suffer harm are often eager to sue pharmaceutical companies for damages, large-scale prosecutions for fraud are a rare occurrence in our health system.
While doctors accused of overservicing under Medicare rules may face action over the relatively small sums involved, corporate giants who transgress tend to remain unscathed.
Legal experts writing in this week’s MJA are calling for the introduction of American-style anti-fraud laws to bolster actions against companies that act fraudulently by, for example, illegally marketing off-label uses of a drug or making false claims about safety and efficacy.
In the US, such laws have proved very cost-effective for government, allowing it to claim treble damages — three times what the court would normally award — from offenders, with actions against some companies totalling in the hundreds of millions of dollars.
Crucially, the laws also provide protection and financial reward to industry insiders who blow the whistle on fraudulent behaviour.
Whistleblowing is a rare phenomenon in Australian health care where, the MJA authors say, “it is not encouraged, rewarded or adequately protected”.
In the US, where whistleblowers may be entitled to receive a 15–30% share of any funds recovered by the government, prosecutions often rely on the insider information they provide.
If you’re wondering whether the Australian taxpayer would stand to benefit from an equally tough regime here, it’s worth noting that the American arms of seven out of the eight market-leading pharmaceutical companies (and PBS suppliers) in Australia have faced actions under the US laws.
Our PBS is a precious and, by world standards, generous mechanism for ensuring people have access to the medications they need at an affordable price.
It’s also extremely expensive.
If we want it to remain sustainable, we need to have a legal framework that allows us to take effective action against any organisation or person who would seek to manipulate it for their own ends.
Jane McCredie is a Sydney-based science and medicine writer.
Posted 2 May 2011
IMHO – Big Pharma run what look like pristine trials; But are they – The Null hypothysis is ignored and experiments appear designed to give the “right” answer.
The other abomination is to examine the results before the completion date, finding a miniscule benefit for (guess what), the company’s drug. Academics love this, it allows them to attend international conferences to hear how kosher and real this difference is, and why it would be unethical to continue with a trial half way through.
Multidisciplinary meetings (another abomination if misused, and used as a star chamber) derive their material from such studies and dissenters are regarded as pariahs.
By the way, I discovered that one senior clinician/academic did not know what the null hypothesis is!!!!!
My complaints about modern medicine are legion; be grateful to be spared. At least we are spared the abomination of desolation, aka the UK NHS>
The first step, in my opinion, is to require the findings of all clinical studies to be publicly accessible, regardless of whether they are favourable or unfavourable to the sponsoring entity or its predisposed bias.
The true purpose of independent evaluation of data should be to determine the objectivity involved and non-biased support, or challenge, of the conclusions reached by the author(s). It should, also, be to determine the appropriateness of the manipulation of the data involved, to support such conclusions.
It would be extremely helpful to reach some consensus on the criteria to reliably define such terms as “treatment failure”, “cured”, “disease free” , “incontinence” and “impotence”, etc. Such agreement would more accurately provide reliability of comparative content or acknowledge that we are trying to compare apples and oranges. To say that 2 or more “outcomes” are essentially equivalent, when 2 decidedly different criteria for success or failure are used is, in my opinion, deceptive and ingenuous. It would be more valid to acknowledge that reliable comparisons simply cannot be drawn, due to such obvious discrepancies. – JEH
Jane, I totally agree, but a far bigger and associated problem exists with the big pharmaceuticals in these days of evidence-based medicine and it is closely aligned with the recent MJA Insight story (http://www.mjainsight.com.au/view?post=call-for-registry-on-conflicts-of…) on conflicts of interest for doctors authoring articles and writing guidelines in medicine.
If only the companies that own the drugs can afford to do the studies that create the “evidence” and they design the studies, do the statistics and interpret the results (that are kept secret because they are “commercial in confidence”), then our need for independent authors and editorial writers and writers of guidelines has never been greater. These authors and reviewers have also never been more difficult to find.
Do we have to accept industry takeover of “evidence-based medicine”, with all the vast cost and other implications for future generations?
I sincerely hope we will continue to push for full disclosure and transparency of all industry data and of all financial relationships with doctors who do the analysis and interpretation of the data on behalf of journals, governments and the public who rely on us.
The authors didn’t consider the question of whether such laws would apply to all the health fraud that goes on in the complementary and alternative medicine industry, eg, “making false claims about safety and efficacy”, and the promotion of a wide range of pseudo-scientific testing methods for making ‘diagnoses’ which have no sound biological basis. As far as I know, the law hasn’t made the slightest dent on these problems in the USA. I know we have to make sure our own house is in order, and agree that seriously bad behaviour by Big Pharma should be severely punished, but in terms of day-to-day health fraud the CAM industry is a FAR bigger problem.
The big question is: Do our legislators have the political will to consider outlawing health fraud across the board? I suspect that would make debates about euthanasia, gay marriage, climate change, etc, seem like storms in a teacup!