Interesting Article on Roche Mobilisation of Patients for He
Interesting Article on Roche Mobilisation of Patients for He In the Guardian:
guardian.co.uk/g2/story/0,1741697,00.html
I must say that I will never look at CancerBaccup quite the way again after this story.
I only got involved with herceptin because my oncologist, who was on the trial, swore up and down that I needed it, so I figured that it must be a good thing for at least higher risk patients. However, this article has left a bitter taste in my mouth.
Of course, what I think would be best for patients now is for some body to reproduce the Finnish Finher trial on a larger scale. The Finnish trial was (3 * herceptin+taxotere)- 3 * FEC (no herceptin tail) and seemed to produce about the same reduction in recurrence as the Roche-funded trials but with absolutely no additional heart problems (unlike the Roche-funded studies that used a full year of herceptin, usually after an anthracycline). Unfortunately, it had a few hundred patients, whereas the industry-funded ones had thousands. I also think that less time in treatment would be much better for patients. But will this matter be taken up?
charities & drugs companies All charities accept funding from pharmaceutical companies. The only breast cancer group that I’m aware of that doesn’t is Breast Cancer Action in the US. The reason they don’t is on moral grounds because they believe that some of the products produced by companies that own pharmaceuticals are implicated in the causes of breast cancer.
CancerBacup did respond to some of the recent stuff printed in the Guardian.
guardian.co.uk/letters/story/0,1753643,00.html#article_continue
One minute the media is hyping Herceptin and then they get bored with it and start rubbishing it, but this illustrates a fact of life. The only people who can be relied upon to look after the interests of breast cancer patients are breast cancer patients themselves. Politicians, pharmaceuticals, charities, media, the NHS and scientists all have their own agendas which don’t always match ours. I’m not surprised that pharmaceutical companies have realised that “motivated patients can move mountains and boost your drug’s fortunes”. They are in business to primarily make money, not primarily to save lives. Of course they have to show some success in treating diseases successfully otherwise their share price drops.
I notice that on BBC2 Thursday 27th April, there’s a programme at 9pm called Drug Trials - the Dark Side about poor and uneducated people in India being recruited to test new drugs. (The Constant Gardener?)
I agree that a bigger, Finnish type trial seems to be a good next step and I think MPs should be lobbied by breast cancer patients to press for it.
Guardian postition The Guardian editorial team, and notably the Health editor Sarah Boseley, have been taking an anti herceptin stance (some of it quite thoughtful stuff and countering the hype in the taboids.) There was a very critical editorail last week follwoing the Court of Appeal judgment.
On today’s letter page there is a very good response written by Kasia Boddy which I think redresses the balance.
Jane
Advertising has been around us for years (snippets in newspapers and magazines). Cynical about pretty much everything I’m told or I read (20 years in NHS has done that) .
About the only thing the “parties” to this agree is that the data is not yet complete.
I worry too that FinHER will be swept aside. Having just finished a years Herceptin I fully agree that shorter courses would be better for the patient . Pharmaceutical companies need to balance the “discover new drugs and make a positve impact on healthcare” agains the need to make profit for shareholders. but 3 doses vs 18 - no way will they take up this one. (I know maths is a little more involved than this.
The synergistic action of herceptin and taxanes needs ugrent attention - N9831 showed an increased survival (OK cardiac side effects too high to be a “standard” treatment).
How to get such a trial?? Will NICE consider the issue?? - I have concerns about this process if the EU application differs from the US one in the trial date cited. Perhaps one “positive” from all of this is that the regulators (and NICE) will be aware of all the data available.(I can already" hear" the arguements from Roche re “you have to go with licence” if another schedule was suggested).
Such a trial/research project needs national support (Prof Richards??? - individual centres wouldn’t have enough people - ?? what do we want compared ?? 1y HERA vs FinHER - no longer ethical to use a placebo. If it is being paid for already by the NHS it would be surely just a case of organising /collecting data/analysing etc.The cancer charities could have a role in this , lobbying MPs .
Lots of good thoughts on this I must admit that I myself am of two minds on herceptin. On the one hand, I realise that HERA hasn’t yet shown overall survival, but on the other hand increased disease free survival is something, even if it isn’t the main thing and usually disease free survival does lead to disease free survival. My oncologist’s rationale was that drugs for late stage disease consistently work much, much better for early stage disease, so there was little doubt in his mind that HERA is working (and he has lots of patients on the trial).
On the other hand, part of me really feels that this better work because spending so much time at the hospital is doing my head in (not just the treatments, but the MUGA scans, the meetings with the oncologists, etc.). I no longer care whether the 2-year arm of HERA worked or not.
Part of the problem with the herceptin story is that it is highly technical and involves lots of different data from several different trials as well as technicalities (such as whether the one trial that has demonstrated improved overall survival actually achieved it because it was actually two trials of very similar treatments that pooled their data).
Thanks for the tipoff about the BBC2 programme on clinical trials in India, Daphne. I read a really scarey BMJ editorial on that trial at Northwick Park that went pear-shaped and apparently the problem isn’t just that patients overseas suffer on trials overseas, but that unreliable data may be coming into Western drug licencing applications.
The Constant Gardener is a great book. I liked it because it didn’t do a Michael Moore-style hatchet job on the pharmaceutical industry, but raised some very thorny issues.
FinHer is too good an opportunity to miss. I would hope that someone is taking this up. I will have to ask my oncologist next time I see him. For ethical reasons, it would have to be run off against a standard treatment, but might be quite competitive when the heart issues are taken into account.
For Herceptin. If the early trials with chemo or tamoxifen - if they had been looked at a similar point, no benefit would have been seen. The problem is (as for any long term survival data - it takes, by the very nature of the data required, years to obtain).
The trials have been assessed - OK not by NICE, but from within the NHS. They are considered well designed and run. Of sufficient statistical size for the results to be reliable. (Reviews that the National Prescribing centre considers “suitable” as sources on which to base prescribing decision in the absence of NICE appraisal - PCTs not funding take note).
A delay to disease progression is usually a marker for overall survival.
The “intruiging possibilities” of the shorter courses of Herceptin as raised by Fin HER has been noted in the offices of the Cancer Czar - I sincerely hope it is acted on.
I
Good points I just wanted to correct my earlier post. I meant that FinHer should be run off against one of the other trial treatments, not a standard treatment, to see whether it really was as good. Since FinHer is probably as good as the treatment the NHS is currently using, such a trial shouldn’t cause ethical trials in this country.
I thought I read that FinHer was being trialed somewhere with larger numbers, but I can’t remember where I read that.
Kasia Boddy’s letter Yes, I agree, a very good letter and it brings out a very important point:
“The Herceptin story is not only important for breast cancer patients. It acts as a test case for many other drugs likely to emerge in the next 20 years.”
The handling of Herceptin in this country shows the amount of work that politicians and health service managers have got to do to develop a proper and fair strategy for providing access to new drugs. Patients will not only be looking at postcode lottery, but also how they fare in comparison to patients in other developed countries.
I noticed in Guardian online today that it is proposed to make a film about “the struggle of Barbara Clark to receive the cancer drug, Herceptin”. hmmm…
The Media Straying off original topic but following Daphnes post - There is more about the proposal to film the "west countrys drug hero Barbara Clarkes amazing story " (papers words not mine) in
If you are interested an the link doesn’t work It was in yesterdays Western Daily Press.- Lists the name of the production company. Feel an email to them is due.
Hmmmmmmmmmmm (sums the whole thing very well)
Daily Mail Had an article in on Tuesday on Herceptin. It followed the same lines, unproven in early stage breast cancer, side effects. There was also an additional article by Lisa Jardine saying that she declined Herceptin because she felt she might be used as an advertisement by Roche and that Roche were pleased with all the publicity that Herceptin was getting since they were not allowed to promote the drug and that this was free advertising.
I would not qualify for Herceptin but, if an Oncologist recommended it as the best course of treatment for me, I would have faith in her/his clinical judgement. It concerns me that it is being turned into some sort of media circus.
(Sorry if this seems woolly, my head cold has exacerbated my Tamoxifen Cotton Wool Brain.)
Anne
Daily Mail - is it bad for your health? Someone once told me that she’d heard/read that the Daily Mail is one of the top ten causes of clinical depression in this country and a colleague recently told me that he’d read that the Daily Mail starts 95% of the food scares in the country.
Scrunched up newspaper’s good for cleaning your windows though - perhaps it’s safer to do that with the Daily Mail than read it.
Regarding oncologists. Surely by recommending an unlicenced drug they are sticking their necks out professionally. Where do they stand legally if one of their patients has heart failure on Herceptin? I think it’s pretty safe to say that if an oncologist recommends Herceptin it’s because he/she believes that it will benefit the patient. It doesn’t mean that they’ve been “bought” by Roche.
Unlicenced drugs Prescribing of drugs that are unlicenced, or prescribing licenced drugs outside of the licence (aka off label). Is a common issue.
The GMC issues guidance as to the issues involved in this for prescribers (general and specific prescribing issues as well as ethical issues around consent)
gmc-uk.org/guidance/library/prescriptions_faqs.asp
Individual trusts may have there own documentation on this subject.
I agree with Dapne - if an Onc recommends Herceptin it will be because for the individual concerned - potential benefits outweigh the risks. Not as as result of Roche pressure/influence.
In terms of what happens if something goes wrong - should it result in litgation. This is where it I guess gets “difficult” - provided Dr had acted along the lines of gmc guidance and in a way similar Drs would and pt aware of risks etc it would seem to me unlikely a claim could be possible. However , having some knowledge of the sorts of things that get to the courts, I accept that this might not be the case.
The Doctor would have professional insurance to cover a claim, as would the employing trust. Guess trust would be the one in court having got the greatest power to pay.
Daily Mail - good for something? It has some of the best gossip!! I tend to flick through it every day - we also take the Telegraph, Guardian and the Sun. The Mail and the Sun are very useful to our media studies students, the Telegraph is good for the economists and the English students and the Guardian is good for science and geography.
I was just rather surprised to see Lisa Jardine writing in it. She’s not a person I would normally associate with the right wing press.
Anne
Daphne I get the impression you’re not keen on the Mail!
Anne
Newspapers I’m not going to single out the Daily Mail - I have a healthy scepticism about the media generally! Reason I mentioned them is that two separate people told me these anecdotes about the Daily Mail.
Oh I can believe it as well. I actually have more patience with the Sun’s Get Yer T*ts Out attitude than the prurience in the DM. At least they’re open about it - even though I can’t stand the bias and the boobs.
What I do find irritating with media is the political bias. Take one story and read it in several different papers and I can guarantee that you’ll get a completely different spin on it, depending on the political affiliation of the proprietor/editor.
Anne