Ben Goldacre
Saturday March 31, 2007
The Guardian
Direct to consumer drug adverts in America are a proper joy, and especially the TV ones: your life is in disarray, your restless legs/migraine/cholesterol have taken over, all is panic, there is no sense any where. Then, when you take the right pill, suddenly the screen brightens up into a warm yellow, granny’s laughing, the kids are laughing, the dog’s tail is wagging, some nauseating child is playing with the hose on the lawn spraying a rainbow of water into the sunshine and laughing his head off as all your relationships suddenly become successful again. Life is good.
They even have celebrity endorsements for drugs, on chat shows, conveying important treatment information on odds ratios and relative risk – if I can slip into 1990s teen slang for a moment – “not”.
It couldn’t happen here. But now, excitingly, it looks like it might. The pharmaceutical industry has consistently been knocked back in the EU, and was turned away on its last request to “educate” the public in 2004, but the EU “Pharmaceutical Forum” is reconsidering, and reports next month.
Like the rest of the advertising industry, pharmaceutical companies look at their nails innocently when you suggest that adverts might affect behaviour, even though they know – that we know – that they’d only spend money on it if it worked. In fact, specific campaigns have been shown to affect prescribing practice, because modern doctors listen to their patients’ demands, and pharmaceutical consumer advertising is growing twice as fast as advertising direct to doctors, for one simple reason: history has shown that you are stupid and easily led, although your education in bad science may stand you in good stead.
Doctors are trained to spot bullshit, and this is one area where paternalism, I would argue, is acceptable. Pharmaceutical companies produce next-level, postgraduate bullshit. Drug reps brandish literature that is the comedic parallel of the promotional stories you get in the media for supplement pills, but the tricks are far more complicated: they cherry pick the literature – looking only at the positive studies – they use surrogate endpoints – a blood test rather than a stroke – they use inadequate controls – a lower dose of the competitor’s drug. They do all this far more subtly than the homeopaths, or the fish oil gang, because they are addressing a critical audience.
The best the public and journalists can offer in the face of big pharma’s advanced hustling is a rather infantile set of conspiracy theories that all drug company research must be “biased”; but they can’t quite explain why, because it’s boring and largely impenetrable, and so they only focus on the few clear examples of corporate fraud, where safety data has been mischievously withheld.
But the move the drug companies are demanding is far more interesting than the right to produce straight adverts. They want the opportunity to “educate” the public, directly, building awareness of disease, and biological treatments, and re-framing our understanding of our bodies. This is a far more sinister project, and one pursued by all flavours of pill peddler.
The nutritionists and food supplement industry – whom the newspapers continue to picture as a quaint cottage trade, rather than a multibillion-dollar pill industry – run about telling everyone they’ve got food intolerances, or hidden dietary deficiencies, or frightening disease risks, for which they have the solution, in a pill.
The drug companies, meanwhile, overplay the role of medication in the treatment of mild depression, and sell new conditions like “restless legs syndrome”, or “female sexual dysfunction”, for treatment with pills which they, too, already had in the warehouse.
Pills are seductive and easy, especially for problems with a strong psychological or social component; but the tragedy is, in the UK, there is nobody advocating against this disempowering pill mentality: only different groups, some of whom claim to be “alternative”, squabbling over who can sell the most pills.
Please send your bad science to bad.science@guardian.co.uk
You can hassle your European MEP on this issue very easily from this link:
An MEP will be astonished and flattered at your remembering their existence, so this kind of lobbying may well have some impact.
jackpt said,
March 31, 2007 at 12:50 am
I like the one with Abraham Lincoln and the talking beaver:
Rozerem.
No doubt we can look forward to such feats of creativity here in the UK…
goldstein.emmanuel said,
March 31, 2007 at 3:29 am
The first paragraph was enjoyable because I just took a Clonazepam. So it is essentially true. No family, though. Better that way.
censored said,
March 31, 2007 at 8:34 am
I have a confession: my brother is a drug rep. So is his wife. Maybe that’s why I compensate by spending too much time here?
Tristan said,
March 31, 2007 at 10:47 am
Ben, good idea trying to throw the alt. brigade off the scent by writing an item critical of Big Pharma but I don’t think it’ll work.
They’ll see through it. You just can’t hide the fact that you’re in the pay of Big Pharma and that you’re part of the new world order. It’s all a conspiracy you see.
stever said,
March 31, 2007 at 11:09 am
On the subject of irresponsible and poorly regulated advertising of drugs…
http://transform-drugs.blogspot.com/2007/03/supercasinos-drugs-and-alcohol.html
case said,
March 31, 2007 at 12:31 pm
Hi Ben – Are GPs required to disclose publicly information about meetings with reps from commercial organisations?
If so, and it is online, it would be interesting to scrape it, collate it and map it out by practice. BadScience would then have a “BadScience in your postcode” system to help us un-re-frame our understanding
– case
Ben Goldacre said,
March 31, 2007 at 1:06 pm
hi case
theyre not, no.
i’ve always been very anti seeing drug reps myself, because i cant see any need when there are systematic reviews and the DTB to read,
http://www.dtb.org.uk/
and because they might plant slightly distorted information in your memory. doctors who see more drug reps do prescribe more, but that might be an association caused by a third factor, rather than causation. eg doctors who are already dodgy/lonely/ill-informed see drug reps v often for pastoral care and as a surrogate for proper continuing education.
evidencebasedeating said,
March 31, 2007 at 1:21 pm
We tend to see them in a ‘controlled environment’, usually dept meetings, where we can play the ‘good dietitian/ bad dietitian’ game and see how soon we can outwit their level of knowledge – not many can discuss issues relative to ARR/RRR or dietary lifestyle confounding variables.
We all HATE drug reps who ‘just happens to be in the vicinity’ at lunchtime – even if they are useful for pens, post-its, notepads, tape measures and even freebie usb’s….. small expenditures expecting big returns…
case said,
March 31, 2007 at 1:35 pm
Hi Ben,
After posting, I thought my suggestion was rather mean spirited: let Doctors meet reps as much as they like – they’re smart enough to make their own minds up and are already over-administered and regulated up to the eyeballs. Why damn they by mere association with pharmaceutical companies?
Anyhow, for information, I had a Google snoot around the topic. There’s a pressure group called No Free Lunch which claims “Most in the profession support a register” of medical professional’s interests, perhaps similar to the MP’s register of interests. Seems this may have had an effect in Scotland(BMJ, 04 “Scottish doctors will have to register financial links to drug companies”) and in the form of The Standards of Business Conduct for NHS staff (based on Department of Health Circular HSG(93)5 ) which sets out some guidelines about how staff should handle conflicts of interest. The Financial Director of a Trust keeps a register of offers made, and gifts, hospitality received which (at least in a couple of the various adaptations of HSG(93)5 I skimmed) should be “made accessible”, although it’s not clear whether this means “accessible to the public”. So, perhaps there is a class of information which if pooled would constitute a register of sorts.
Reckon there’s a good article in this though.
- case
steve said,
March 31, 2007 at 4:48 pm
It’s bad enough dealing with the advertising for OTC products: I have about five people a week asking for chloramphenicol eye drops because ‘it’s been on the telly’. No doubt the same will happen soon with Imigran given that GSK are increasing their TV advertising. If direct to consumer advertising comes in for POMs I think I’ll just emigrate.
Even given all their training doctors and pharmacists are not actually that good at interpreting evidence and seeing through adverts. There has been an almighty kerfufle in the PJ recently over a supplement that strongly pushed Crestor and the JBS 2 optimal cholesterol targets. Surprisingly the supplement was funded by AZ. The GPs in my area have a thing for perindopril at the moment, though there is no evidence that it is any better than any other ACEI.
I was looking at one of the clopidogrel studies last week. The drug that everyone gets put on if they get a slight stomach upset with aspirin. But guess what? The incidence of GI side effects was very similar (and this was with a 325mg dose of aspirin, not 75mg).
So, no direct to consumer advertising, and doctors need to ask for the absolute risk reduction and the numbers needed to treat.
Gasdoc said,
March 31, 2007 at 7:19 pm
jackpt
We already have feats of creativity from big pharma in the UK.
The creativity that is the scare mongering on environmental tobacco smoke.
In effect these are NHS paid adverts for nicotine replacement.
The admirable goal of conquering tobacco addiction does not excuse bad science in a national TV campaign.
amoebic vodka said,
March 31, 2007 at 8:18 pm
Ben says:
“i’ve always been very anti seeing drug reps myself, because i cant see any need ”
So where do you get your pens, post-its, fluffy toys, mugs and chocolate from then?
bootboy said,
April 1, 2007 at 12:47 am
“So where do you get your pens, post-its, fluffy toys, mugs and chocolate from then?”
Dude, that’s cheap stuff to sell your soul for.
It always strikes me as amazing that doctors, who ought to be well versed in the unreliability of anecdotal evidence and subjective evaluations of efficacy of treatment, think that they’re immune from the subliminal effects of advertising themselves. Even Ben’s going for it:
“and because they might plant slightly distorted information in your memory. doctors who see more drug reps do prescribe more, but that might be an association caused by a third factor, rather than causation.”
What’s this unknown third factor? Flying Spaghetti Monster? Aliens? Shakras?
To me anyway, it’s blindlingly obvious that it’s a causative relationship. Drug reps advertise pills to doctors – more of those pills are prescribed – something that’s been shown to happen in many studies, yet you look for a mysterious third factor. Why?
You can use all of the same arguments you make above (eg. if it didn’t work they wouldn’t spend all that money) for why advertising to doctors is just as bad as advertising to patients. The fact that doctors are a more critical audience (which is a very generous generalisation by the way) isn’t that relevant. Advertising works on many levels and convincing the doctor that pill x is better than the competition isn’t the primary modus operandi of drug reps. Freebies are by no means limited to post-its; pharma companies sponsor many, many holidays (under the guise of conferences, etc) and all sorts of other ‘hospitality’ activities for doctors. This works on the level of implanting subliminal feelings of indebtedness and general good feeling towards the donors. And, as we all know, things that live in your sub-conscious have a habit of expressing themselves in your behaviour.
Still, good article, but I do think that it’s incumbent upon scientific folk to be as critical of themselves as they are of the world around them, otherwise they just make it easy for people to write them off as some sort of apologist. One of the problems with criticising the shoddy science of the pharmaceutical industry is that, as Ben says above, they’re much subtler as they have to be. Their bad science is also written by very smart people who know exactly how to translate any arbitrary result into a spurious reason to buy their product. They’ve got lots of lawyers too.
Ben Goldacre said,
April 1, 2007 at 1:01 am
Ben: doctors who see more drug reps do prescribe more, but that might be an association caused by a third factor, rather than causation.â€
Bootboy: What’s this unknown third factor? Flying Spaghetti Monster? Aliens? Shakras? To me anyway, it’s blindlingly obvious that it’s a causative relationship
i gave some suggestions about the unknown third factor above already. to expand (because it’s an intersting question):
doctors who are already dodgy might be more likely to see drug reps more, whereas whiter than white evidence based medicine advocates might refuse to ever see them. those doctors might have been a bit duff before they even saw the drug rep.
single handed GPs (although there are fewer and fewer of them) are sometimes a bit professionally isolated and lonely, and might see drug reps just for a bit of pastoral care.
overstretched doctors who dont have time to do proper reading might see drug reps as a surrogate for proper continuing education.
there are lots of possible confounding variables, and it would be extremely unwise to dismiss them just because – and i share your prejudice – we don’t like the look of drug reps much.
the real answer to what causes the association will probably be: a bit of everything.
jjbp said,
April 1, 2007 at 7:50 am
I have a friend who used to work for one of the car manufacturing multinationals, and she says that they work on the principle that their TV advertizing is as much to do with convincing those people who already own that brand of car that they made the right decision, as convincing new people. Maybe it is the same with pills…
Deano said,
April 1, 2007 at 10:38 am
Good explanation of the ‘Third Party technique’ here:
http://www.prwatch.org/node/5899
- another term I think is relevant is the creation of ‘astroturf’ coalitions or ‘astroturf marketing’. That is the creation of ‘fake grassroots’ organisations (geddit) and media campaigns to promote a product or point of view:
http://www.prwatch.org/prwissues/2003Q1/astroturf.html
kim said,
April 1, 2007 at 11:54 am
Sometimes you don’t need adverts to do your job for you: you’ve got the media. Look at how newspapers, radio and tv programmes have all pushed Herceptin as a wonder drug for breast cancer when in fact its uses are limited to a few types of breast cancer and the results there aren’t quite as wonderful as we’re led to believe. I bet there are breast cancer sufferers all over the country demanding Herceptin from their oncologists. (Though one would expect oncologists to be less susceptible to this than GPs.)
And then you’ve got Merck, who created a “pressure group” to promote the cervical cancer vaccine.
Evil Monster said,
April 1, 2007 at 12:44 pm
I work in the pharmaceutical industry.
I followed the link from “postgraduate bullshit” in the original post. It leads to something called AdWatch that criticises a GSK ad.
The AdWatch article contains a statement that there was “a statistically significantly higher risk of cardiac failure” in the active treatment group. Supposing the sample size to be 2180 per group, I get a p-value of approximately 0.01. That’s hardly strong evidence for such a sample size. Moreover, we are not told how many tests were performed in order to find a p-value
kingshiner said,
April 1, 2007 at 1:38 pm
A GP mate of mine got shot of a particularly intrusive Bayer rep by asking him if the company still had any Zyklon B pens left
Twm said,
April 1, 2007 at 5:34 pm
>>jackpt
Wow, that looks like kingdom hospital does drug adverts. I particularly like Abe saying “if you have had trouble sleeping for four scores and seven years then give rozerem a try”.
i was shocked when I went to the states for the first time on business and spent some time in my hotel room flicking channels. With the help of the TV I could easily mistake my jet lag for several other serious conditions.
At least the Rozerem web site has quite good coverage of achieving healthy sleep through routine and avoiding stimulants at night. The sleep assessment tool reported my sleeping habits as normal and made no suggestion of using the product based on the results.
It is unfortunate when the doctor is seen simply as the key master to the medicine cabinet.
What I find particularly distressing about drug adverts is that they list symptoms. I would be far happier if they stated “if your doctor has diagnosed you with X, then product A is the best treatment because…”.
There is not enough information about the normal thresholds of human emotion and physiology. “tense nervous headaches? That’ll be the JDs and cokes last night”. Or “Feeling depressed? Try getting up early and going for a run for a month. Then we can talk about the key to the medicine cabinet”.
Or “it’s good to grieve”
Kim – New scientist (31st march) has an Editorial on the rising demand for untested cancer drugs. It points out the correlation between demand and media exposure under the umbrella of “cancer” rather than trail results for specific cancers.
j said,
April 1, 2007 at 9:56 pm
Coincidentally, just seen a call for papers for this – http://gs.strath.ac.uk/content/view/240/130/ A conference on spin, w/ a panel on “Disease mongering, science and health”. Might be interesting if someone wants to talk about Big Pharma and/or CAM pill-pushing?
baraitalo said,
April 1, 2007 at 10:05 pm
I’m a practice nurse, and drug reps are not allowed over the doorstep. They still manage to send advertising materials, though, unsolicited. These are not used on the premises. I recently visited a practice which had sticky notes all over the place still advertising vioxx….
Ben Goldacre said,
April 1, 2007 at 10:12 pm
thats interesting baraitalo , out of interest, who made that decision, the practise manager, the doctors, or the team collectively?
one thing i find that is quite corrosive is when drug reps turn parts of teams against each other. a fairly common situation is where the doctors don’t want anything to do with drug reps, and neither does anyone really, but the drug reps were paying for the whole team to go out for dinner together fairly regularly (low nhs wages for all staff remember) and the whole situation causes resentment.
Nickynockynoonoo said,
April 1, 2007 at 10:52 pm
In the USA, prescriptions are usually covered by medical insurance. The doc may prescribe but the final decision is with the insurance co.
I imagine it would be extremely complicated here with NHS budgets. The GP’s will easily become the bad guys.
The American TV adverts are groanworthy but obviously work.
GRRRRR Educate the public! Well meaning friends and relatives will understand even less about chronic conditions and put pressure on the patient to try the fix-all wonder drug.
IMO this move is an insult to the medical profession.
pv said,
April 1, 2007 at 11:25 pm
In Italy the drug reps are allowed wait for their turn along with everyone else in the waiting room. If you are ill and in pain and the pharmaceutical folks are in front of you then you’ll have to wait your turn. Bastards!
Filias Cupio said,
April 1, 2007 at 11:47 pm
One possible “third factor” in the prescription/drug-reps correlation is the age of the doctor’s patients. A doctor who sees many elderly patients would be expected to prescribe more. Then all we need for the correlation is for these doctors to also see more drug reps for some reason. (Because they prescribe lots, they think they need to be “better informed”, and are deluded into thinking drug reps will do this for them?)
But I agree, over-prescribing is a more natural explaination.
On doctors investing in drug companies: it shouldn’t matter too much under normal circumstances. A doctor who invests heavily ($100,000) in a billion-dollar company (i.e. small for a drug company) owns a ten-thousandth of them. If they send $100,000 in extra business to that company through over-prescribing, their share of that is just $10 (which is further reduced by the cost of producing the drugs.) (The argument changes if it is a million-dollar company instead.) Kick-backs in the guise of drug-rep gifts would be a much more efficient method of corrupting doctors.
Ben Goldacre said,
April 2, 2007 at 12:03 am
mm, to be honest i reckon any theory that relies on doctors being explicitly corrupt and prescribing the wrong drugs to the patients in exchange for money is going to be very peripheral at best. the presentation of misleading data is obviously significant, and a much more important and unfortunately complex issue.
CaptainKirkham said,
April 2, 2007 at 9:59 am
The commenters here may wish to take in this post by a UK GP:
http://nhsblogdoc.blogspot.com/2006/10/feeding-at-trough.html
on the subject of advertisements aimed at doctors. He has plenty of things to say about the practise of ads to doctors. They may be better educated than the general public of course, but the fact is that, just like advertising to the general public, the pharmaceutical companies would not spend money on ads to doctors if it did not change behaviour.
censored said,
April 2, 2007 at 2:10 pm
I hate my brother and all he stands for
Though he did once give out some lovely felt tips with a strawberry smell. And the latest pens for some statin or other are very good too. I also particularly liked a magnetic paper clip holder with a synthetic anus in the top. One side felt healthy, the other side was what a possibly cancerous prostate felt like. Marvellous.
His take on what he does? Well, doctors can’t possibly be expected to read up on every drug out there. They’re simply there to offer them the information they need for intelligent prescribing.
Dr Aust said,
April 2, 2007 at 8:28 pm
Re. oncologists prescribing herceptin – on the whole doctors feel their key responsibilty is to the patrients, and quite right too. But sometimes this has, and will, lead them to support patients in demanding drugs whose benefits are rather marginal. Don’t think herceptin is the best example of this, as it seems to be clearly indicated for SOME kinds of breast cancer – the issue with herceptin was more the insane cost of the drug.
The example that always strikes me as a key one for this issue is the various drugs (mostly enhancers of acetylcholine neurotransmission) touted by the Pharmas for Alzheimer’s. NICE ruled (as I remember it) that there was no convincing evidence that the drugs worked. Much of the “pro” evidence the Pharmas cited related to various surrogate outcomes (see above) , and pretty much no benefit could be shown in standard morbidity and mortality measures. These slight hints, NICE said, weren’t enough to justify the NHS spending money on the drugs.
NICE’s decision was followed by loud protests from patient groups, carer groups, Alzheimer’s charities, and from a fair number of neurologists and geriatricians who argued this was taking off them the only vaguely hopeful drug they could offer the patients and their families.
This sort of scenario is where the murky relationship between the Pharma people and some doctors is at its most contentious. If many leading clinicians had run studies on the drugs for the Pharmas and had other close ties – including financial – to the companies, then there would always be the feeling they might be rather more disposed to be sympathetic to the company line. Of course, distentangling this from their stated genuine belief that they had seen the drugs help their patients was rather tricky. Symbiosis?
This sort of thing of course, is exactly why NICE and the Drugs and Therapeutics Bulletin are so important, the idea being that they deliver analysis of drug effectiveness and value for money while being wholly independent of the drug companies’ embrace.
Wonko said,
April 3, 2007 at 2:51 pm
Herceptin is a better example of the tactics that the pharmas will employ in a state that bans direct marketing. Instead, patients were funded to bring court cases against PCTs to try to secure the drug before NICE had the opportunity to authorise it.
In such circumstances, it is essential to have a Secretary of State for Health who is prepared to stand up to this kind of pressure so that the NICE system of approval is not undermined. What a good job we have Patr… er… oops!
Ben Goldacre said,
April 3, 2007 at 3:09 pm
i’ve got the best herceptin story mankind has ever seen coming soon.
evidencebasedeating said,
April 3, 2007 at 5:11 pm
Promises, promises….
is this where Basant Puri pops up again??
Deano said,
April 3, 2007 at 11:19 pm
“Instead, patients were funded to bring court cases against PCTs to try to secure the drug before NICE had the opportunity to authorise it.”
- classic ‘Astroturf marketing’
Jalestra said,
April 4, 2007 at 3:56 am
Quite frankly the drug commercials in America have made Americans pill happy hypochondriacs (sp?). If we were qualified to write our own prescriptions we’d be doctors! It also makes doctors more apt to just prescribe a pill, making it harder for those of us who would like the doctor to look at all of us and talk to us. Here if you’re a fat, bored housewife who’s husband isn’t paying enough attention to, you’re doctor will be more than happy to stick you on 5 or 6 pills to make you forget all that and even give you a made up “disease” to cover your prescription dope habit.
I go out of my way to find doctors that do not allow drug reps in their office. (nofreelunch.org) If a drug rep does come in and especially if he’s seen before any patients still in the waiting room, then I’ll leave.
Evil Monster said,
April 5, 2007 at 3:09 pm
I’ve already criticized the AdWatch article linked from the original post. Out of curiosity, I read the source paper for the GSK ad and found that the AdWatch article is seriously deceptive.
AdWatch claim that there was a statistically significant difference between treatments in coronary failure. The source paper gives the p-value as being 0.05. That’s only statistically significant at the 5% level if the 0.05 was rounded up, rather than down (which just goes to make clear that hypothesis testing is non-scientific). Many people would argue that the test should be adjusted for multiple comparisons, anyway. But in any event, that kind of p-value does not represent strong evidence of a difference by any stretch of the imagination.
It gets worse, though. The source paper makes clear that an independent cardiologist was employed to go through all the data relating to serious adverse events, including CHF, and his/her expert opinion differed in some cases from what was reported by the sites (most of which will have expert cardiologists). The p-value relating to the independent cardiologists classification was 0.26.
The AdWatch people have clearly misrepresented what was reported in the source paper. This isn’t the only place in which they’ve done it either. They criticized the ad for reporting the glucose results rather than glycated hemoglobin. But the clinical trial titrated patients to achieve the then current guideline targets which were for glucose. The authors of the source paper make clear in more than one place. So the glycated hemoglobin data represent what happens to gh if you titrate glucose to target and is not indicative of what would happen if the patients had been titrated to gh targets. Again, the AdWatch people are deliberately misrepresenting the source paper.
There are yet more flaws in the AdWatch criticism of the GSK ad, but if you had any interest in spotting bullshit, you would have spotted them already. Criticising the pharma industry for bad science, and using extremely misleading and deceptive non-science to do so doesn’t seem very consistent.
Ben Goldacre said,
April 5, 2007 at 3:31 pm
hi monster, i’m not sure why youre criticisng adwatch for preferring glycated haemoglobin, as it is a far more appropriate measure of control and correlates better with long term outcomes. not nec disagreeing but can you expand?
i agree that gleaning evidence of risks like ccf from a study like the one adwatch refer to is always difficult, because you may not have a hypothesis about what side effects will be caused before starting to collect data, so you do run into multiple comparison problems, so adverse outcome stuff may well be more hypothesis generating/worry-forming than confirming. i’m not sure the criticism of that one point trashes the entirety of the adwatch project (which is also well received in academic quarters etc) but i do agree it is something to think about.
Evil Monster said,
April 6, 2007 at 9:54 am
The trial titrated to glucose guidelines which were current at the time the trial was initiated. So the trialists were following good practice. If they had titrated to gh, which became the recommendation at some point during the conduct of the study, the results would have been different and there may very well have been a bigger difference between treatments. Think about a single patient who is titrated to meet his glucose target. Having met it, he might not have met his gh target, but titration is stopped. If it hadn’t been, drug would have been titrated again. The study can’t tell us what the results would have been if patients had been titrated to gh and to focus on that rather than glucose is misleading. The fact that the guidelines changed must really piss of the sponsor. They have to focus on glucose, knowing that people aren’t that interested any more.
I have other issues with the AdWatch article (though the p-value crap is what bugs me the most). The criticism of the graph is misplaced because the normal range of glucose is way away from the origin. So far as I know, values close to the origin may be incompatible with life. So the origin is of no more interest that 20 or 40 or any other value. I’m sure the authors of the AdWatch article have been told that it is misleading to plot data without including the origin, but unfortunately, there’s no substitute for reading the y-axis. Think about plots of share prices or atmospheric pressure. They don’t include the origin because it is of no interest. I have still other issues, but can’t be bother typing them out. The industry is heavily regulated and FDA at least gets very pissed if sponsors promote on unrepresentative evidence (as happened with Zyvox).
As mentioned in my original post, I work in the pharmaceutical industry. The people I work with are proud of their scientific integrity and are extremely concerned with ethics. The picture of the industry as a monster that will do anything to get more money doesn’t match my experience. There are, of course, many criticisms that can be reasonably levelled at the pharma industry, but they are complex.
Surrogate endpoints are used because once there is an effective treatment, it is unethical not to use it. In a diabetic population, for example, patients would have to be treated to control their blood pressure, their cholesterol and triglycerides, and their glucose. The rate of cv events in the comparator group becomes so low that the size and duration of a trial needed to find, say, a 20% reduction in hazard becomes prohibitive. Because regulators want more treatment options for patients, they accept commonly agreed surrogates because the only other option is for companies to kill effective drugs in development because by the time the survival studies have finished, there’s not enough patent life left to make any money. So either a class of drug is abandoned after the first 2 (or so) in class are on the market, or compromises are made. Late in class drugs are often cleaner and more effective, so what do you do?
I happen to think that companies should be required to provide survival data before going to market, but that has to mean that patent extensions are granted, that reimbursement goes up, or something else. So far as I can see, there’s no attractive way out.
diudiu said,
December 21, 2009 at 6:12 am
links of london links of london
links london links london
links of london jewellery links of london jewellery
links of london sale links of london sale
links london sale links london sale
links of london bracelet links of london bracelet
links of london charms links of london charms
links of london necklace links of london necklace
links of london bangle links of london bangle
links of london earrings links of london earrings
links of london ring links of london ring