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Dr Aseem Malhotra

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Big Pharma Harms Patients for Profit but Doctors Must Also Share the Blame

Posted: 14/03/2013 23:00

Earlier this week, the government's chief medical officer Professor Dame Sally Davis created headlines by announcing that the threat to our health posed by antibiotic resistance was on a level comparable to global terrorism. She suggested greater government collaboration to financially incentivise Big Pharma to produce newer, more effective antibiotics. But can we trust the pharmaceutical industry to deliver? Unfortunately their recent track record suggests we cannot.

Cardiologists around the world are only recently coming to terms with the fact that an intra-aortic balloon pump, a device that for decades we have been implanting in the sickest patients who have suffered a heart attack has recently been proven to have no objective benefit in reducing the risk of death.

This is following the publication of a randomised controlled trial (the most robust type of study into the benefits of a treatment) in the New England Journal of Medicine. The findings were discussed at an educational conference I attended in late December. A renowned academic presented a slide with a graph showing how the introduction of a new technology is enthusiastically embraced by the profession, often fuelled by the company manufacturing and successfully promoting the benefits of its product. Its implementation increases reaching a peak over a period of time after which enthusiasm wanes once more robust studies, usually independent of industry influence, question its benefits.

The speaker pointed out that as clinical utilisation declines a point is reached where the treatment achieves the "you wouldn't use it on your dog" status. It is then replaced by a newer technology which promises to be an improvement on the previous one and the cycle continues. Unfortunately not a single person in the audience questioned the area under the curve. What about the cost to the thousands of patients? Many would have undoubtedly suffered serious complications such as stroke, kidney failure and even limb amputation. And this doesn't even include the valuable time of the doctors and nurses who for years have been implanting and managing the device for up to several days in the hospital ward under a belief that it was of benefit.

In economic terms the average purchasing cost of the machine that works the pump is approx. £40,000, (a specialist cardiac hospital will have 1-2 of these) and the individual pumps come at around £800 per patient. With approximately 140,000 patients a year worldwide receiving this technology; the overall costs add up to a staggering amount. I would like to believe that such wastage is a rare occurrence in health care but unfortunately this is just the tip of the iceberg.

Last week the British Medical Journal launched a campaign entitled 'Too Much Medicine' in an effort to tackle what now poses one of the greatest threats to human health in the developed world; over diagnosis, and the harms and waste from unnecessary tests and treatments. It's former editor Richard Smith, director of United Health Group's chronic disease initiative recently blogged that only 11% of 3,000 health interventions have good evidence to support them, with 80% of new drugs copies of old ones and 153 million euros a day being lost through corruption in health systems.

In his book Bad Pharma, Ben Goldacre has eloquently drawn attention to how drug companies mislead doctors and harm patients, and is rightly calling for the industry to publish all their trial data. But many of the corporate crimes committed by the pharmaceutical industry wouldn't happen if an influential minority of doctors weren't complicit or wilfully blind to these misdemeanours. Leading clinicians often compromise medical ethics and integrity by lending their name to ghost written articles published in academic journals that may support the approved use of a drug for unlicensed conditions, either for financial gain or greater kudos amongst peers. Peter Gotzsche, director of the Nordic Cochrane centre says " the consequences of these crimes are huge, including the unnecessary deaths of thousands of people and many billions in losses for our national economies every year."

Big Pharma also tries to influence and exaggerate its importance in medical education. Last month the Lancet withdrew its support from a document stating how health care professionals could collaborate with the drug industry. The editor Richard Horton said the action was initiated as a result of information given by University College London medical student Tom Yates, who is active in Conflict Free, a campaign calling for medical education to be freed of industry involvement.

Yates revealed that the document contained false claims including that the industry "plays a valid and important role in the provision of medical education" and that "medical representatives can be a useful resource for healthcare professionals." He told me that he wants universities to dedicate more resources into conducting research so we can be more confident that scientific objectivity is not distorted by vested interests.

He is also calling for all who provide medical education to openly declare whether they have received funding from or have links to the industry. This would certainly be a step in the right direction but this doesn't necessarily mitigate the potential harm that can still be done to patients and the public. A study revealed that any source who discloses a conflict of interest will feel morally licenced to exaggerate his or her advice more emphatically making the conflicted individual appear more, rather than less credible.

I was very disturbed to read a publication in the New England Journal of Medicine entitled 'Myths, Presumptions and Facts about Obesity'. Some of the key messages of the paper included that there was no evidence that snacking contributed to obesity and that tablets may be the solution to our expanding waist lines. The declarations of conflicts of interests at the end of the paper were more than half a page long, with authors receiving funding from McDonalds, Coca-Cola, Kraft foods and several pharmaceutical companies including Astra Zenica, and Merck.

Marion Nestle, New York University professor of nutrition and food studies said "it raises many questions about what the purpose of this paper is and whether it's aimed at promoting drugs, meal replacement products and bariatric surgery as solutions. The big issues in weight loss is how you change the food environment in order for people to make healthy choices, such as limits on soda sizes and marketing of junk food to children." In my view this not only undermines public health but the authors, many with doctorates also do a disservice to the qualification PhD.

Professor Rory Collins of Oxford deserves to be congratulated in his research in relation to statins, but I do not support his recent calls for everyone to over the age of 50 to take the cholesterol lowering drug. Referring to industry data he states that only 1% who take the pill suffer a serious adverse consequence. But in reality the number suffering from side effects such as muscle pain, or memory problems, that significantly interfere with quality of life is significantly higher. Although there is good evidence in risk reduction for patients with known heart disease, this benefit does not appear translate into an otherwise healthy population. Furthermore, there are serious concerns that statins increase the likelihood of developing type 2 diabetes.

It would be much better for doctors to advocate lifestyle modification. A rigorous study published last month revealed that a Mediterranean diet reduced the risk of heart attack, stroke or death by 30% over a five year period in a high risk population in comparison with a 'low fat' diet. Clinical epidemiologist Professor Simon Capewell told me "this study provides further strong causal scientific evidence that nutrition based primary prevention interventions can be both powerful and rapid."

The medical profession should pay more attention to the risks of poly-pharmacy. Up to a quarter of all hospital admissions in the elderly are due to dangerous medication interactions. But influential academics on guideline boards, often with financial ties to the industry are able to encourage a culture of greater prescribing. It's time to take a breath and reflect on the direction we wish our future health care to be shaped. I believe I speak for the overwhelming majority of doctors in the NHS when I say I went into medicine to practice evidence based, not corporate-influenced medicine. To paraphrase the late Allesandro Liberati founder of the Italian Cochrane centre, "encouraging researchers to concentrate on research that matters to patients, not to their careers or drug companies" would be a good start.

 

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Earlier this week, the government's chief medical officer Professor Dame Sally Davis created headlines by announcing that the threat to our health posed by antibiotic resistance was on a level compara...
Earlier this week, the government's chief medical officer Professor Dame Sally Davis created headlines by announcing that the threat to our health posed by antibiotic resistance was on a level compara...
 
 
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HUFFPOST SUPER USER
Rob Ferris
05:59 PM on 03/16/2013
What a excellent article. I'm not studying medicine (although I hope to after I graduate this year) but even what I've seen from my short time in sports science shows enormous problem with the peer review system. Real, impartial evidence based science often takes a back seat to vested interests and financial incentives.
This is extremely alarming, and casts all of medical science in a very bad light.
12:37 AM on 03/16/2013
Dr Malhotra inadvertently proves his own point - that bad science goes hand in hand with bad pharma. He cites the double-blinded balloon pump device trial - fair enough - but he omits to state that this was a limited trial of just 600 patients. The results are nonetheless exceedingly discouraging, for this particular device, in this particular class of patients. To make sweeping generalisations about the use of this device in other conditions is, however, bad science - but so, so easy to do. I agree that big pharma companies need to release the data from all their trials. I'd then hope that some sort of Darwinian attenuation of the scare mongerers who refuse all medicine would occur. Public domain trial data is all very well but it is not conclusive and nor is it indicative of efficacy and extent of serious and unexpected adverse reactions "in the wild". If pharmaceutical companies and regulators are to engage with the general public on points of drug safety and pharmacovigilance, should that engagement not come with caveats attached and in the expectation that the general public should have some sort of resource to help them interpret the data they see? Other, that is, than common sense which varies so widely from individual to individual.
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HUFFPOST BLOGGER
Dr Aseem Malhotra
06:37 AM on 03/16/2013
Thanks for your comment. I wish there was some stronger evidence for IABP in other conditions but there is no robust data that I am aware of. Guidelines were based upon "expert opinion" and non-randomised data and following this largest RCT specifically in it's most used indication, cardiogenic shock with acute myocardial infarction, it has been down graded both in the United States and Europe. Nevertheless I know that many cardiologists may continue to use the device in the "belief" that it's benefiting the patient. But this is primarily driven by emotional and psychological reasons, not objectivity and it will take a longer time for the "proud" profession to admit, we may have got it wrong.

This presentation may be a useful resource, published prior to the aforementioned RCT
http://www.powershow.com/view/841cd-NTY1N/A_Systematic_Review_and_Metaanalysis_of_the_Value_of_Intraaortic_Balloon_Pump_Therapy_in_Patients_wi_powerpoint_ppt_presentation
09:19 AM on 03/16/2013
But there is a bigger problem here. 50 years after thalidomide was withdrawn, medical schools are still not teaching pharmacovigilance and medical professionals are still not practising pharmacovigilance. I hope you don't mind me asking but how many yellow forms have you submitted, Dr. Malhotra? I'm not having a go - but it's a valid question since you bring up the subject of safety - the single most powerful tool in the quest for safety is spontaneous reporting of adverse events and nobody does it, it's a scandal. The public at large have no grasp of the concepts of relative risk and relative benefit - it's not taught at schools, it's not something we talk about - it's always Daily Mail-style absolute risk. The numbers, the stats, the epidemiology, the pharmacoepidemiology - it's beyond most doctors let alone most lay people. And THEN we have big pharma. And they can get away with it because even though regulators now have teeth, they don't use them. It's always the threat of withdrawal of licence, not the fact of withdrawal. The situation would be comical if it wasn't so tragic, vested interests at every turn, at the intersection of incompetence, ignorance, greed, laziness and bureaucracy.
05:01 PM on 03/15/2013
Statins used for cholesterol control are a demonstration of how drug firms have misled us all. No one has looked at the fact that the increased use of statins has also coincided with more depression, liver compliants, muscle weakness etc. The chemicals used in statins are used in many drugs with the manufacturers knowing doctors will prescribe another drug they produce to combat the side effects.
GOVs tell us we drink too much as liver compliants have increased or have the complaints increased at a similar rate to the increased use of statins, the same can be said of the increase in cases of depression. The statins lower cholesterol but make muscles weaker so encourages the taker to burn less calories making matters worse.
Doctors should not be able to issue drugs like statins unless they also show the persons has seen an independant dietician etc beforehand and has been on a more natural program before drugs can be prescribed.
lastpost
see biography
03:56 PM on 03/15/2013
“Big Pharma Harms Patients for Profit”
Ideologies converting themselves into religions to concentrate on their own continuation, rather than that of the entity they once served, isn’t novel. ‘Though is often bound in a tome.

“the threat to our health posed by antibiotic resistance was on a level comparable to global terrorism”
And no respect-er of gated community, nor boardroom door either.

“the area under the curve”
is no place for ‘pessimists‘. As optimists call realists.

“I would like to believe that such wastage is rare”
But the cost of paying someone to look into it, against potential savings if confirmed, has got to be worth a punt.

“waste from unnecessary tests”
If investment was made into automated devices able to routinely undertake such tasks. Wouldn’t it be possible to improve accuracy, and make savings available for the better use of clinicians?

“drug companies mislead doctors and harm patients”
and are only bound by the oath of hypocrisy?

“ghost written articles”
should perhaps be viewed with a certain scepticism. If the spirit of full disclosure, hasn’t been entered into.

“a campaign calling for medical education to be freed of industry involvement”
highlights the dangers of pernicious academia?

“mitigate the potential harm that”
is concomitant with mis-absorption of finite resources during economic downturns.

“The declarations of conflicts of interests at the end of the paper”
should perhaps by law, be assigned to the opening page.

“lifestyle modification”
Because a lifetime guarantee isn‘t extendible.
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Reith
what's a micro-bio?
03:37 PM on 03/15/2013
One of the perpetuators of patient ignorance is the arrogant doctor who allows no discussion. Dare a patient suggest a remedy even if they already know its efficacy from, say, previous treatment. And doctors who refuse to believe a patient is having a bad reaction to a drug. Fine with allergies and their immediate effect but not so in other cases. You simply can't ask them questions like "What alternatives are there?" or "What risks are attached to this?"

Sometimes their mannerisms provoke a smile - You tell the doctor you have a pain and she/he asks “What sort of pain?” With a malign doctor one can't help a retort. “Well, a red one with a yellowish fringe and sort of oval-shaped.”

For sure, arrogant medics do not help educate the service user in what’s what. Or in my case and probably many others, restore trust in what seems little better than trial and error.
02:45 PM on 03/15/2013
The government and media are to blame.

The politicians all have shares and often eats on the board of large Pharmaceutical companies as do many media barons.

This is why socialism does into work as Politician's are corrupt, so giving them more power would make everything worse not better.
HUFFPOST SUPER USER
OH72
02:40 PM on 03/15/2013
It was this overfocus on pharma-bashing that allowed Andrew Wakefield to get as far as he did with his forgeries, to the point where they cost actual lives in the UK. It was all too easy to believe in a conspiracy of vaccine manufacturers against the oh so innocent doctor who knew better.

The pharmaceutical industry needs to be called out when it produces bad science. But so does anyone else. And believing you are tackling the problem when you are railing against pharma is merely demonstrating you're part of the problem, not the solution, as you are not really fighting bad science but merely an enemy that much like Wakefield allows you to produce yourself as the hero fighting against monsters - the road of vanity that has produced plenty of damage already.
HUFFPOST SUPER USER
OH72
02:40 PM on 03/15/2013
If one actually understands what good science looks like and takes a broad sample of the medical literature, the focus on big pharma can only be called as being a well-meant but disastrous attempt to overfocus on one aspect of a problem at the expense of tackling the problem itself.

The problem itself is bad science, not bad pharma. Any stroll across the poster session of a medical conference, any skim of a second or third rank medical journal (and individual articles in even the top ranks) reveal the staggering ignorance on even basic statistical concepts that is widespread among MDs. A lot of pharmaceutical companies not only arrange for statistics courses for their customers, but employ biostatisticians for their own studies.

A review of the big scandals in life science over the last decades will reveal that it didn't need big pharma to cause even highly respected researchers to engage in wholesale fraud and deliberately forge data. Vanity and getting carried away with the desire to find something to help patients were sufficient to the point where what must not be could not be and the data was fitted to the ideas that simply "had to be right".
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HUFFPOST SUPER USER
Richie2012
Your micro bio is empty.
01:51 PM on 03/15/2013
Levothyroxine - synthetic thyroxin - used to treat under active thyroid conditions. Underactive thyroid leave you feeling awful with no energy - often leading to job loss and fivorce.

Now, before LEvo was used to treat thyrodi dissorders we used natural dessicated thyroid (NDT) from a pig. It was not only adequate it was more effective (than Levo is today) in many cases. Then big pharma came along and peddled all sorts of rubbish to say that Levo was much better than NDT. Now GPs won't prescribe NDT. Meanwhile, gene testing shows a variation (a 2009 study) in some patients (a statistically significant group) showing that the homronal ingredients of NDT are better absorbed by some patients who cannot properly absorb Levo. Therefore some patients given Levo are not properly treated and lead a life of misery. Go look on stopthethyroidmadness.com
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Reith
what's a micro-bio?
01:50 PM on 03/15/2013
Brilliant article. We need this put before the public more often. It’s always been a disgrace to me that patients are held in ignorance of the validity of medical advice they receive. If they attempt to research they’re usually up against a stone wall as the results of all clinical trials of a drug are simply not available, an issue Goldacre takes up, pharma outfits knowingly publish just results that promote their product - even then, not to the public.

Yet patients are the users of the product. They have a right to know. But they have been trained to take what they’re told on trust, the medical profession having lorded it with their role distancing, their talking down, their deification by the BMA sitting as it does on a golden throne up in the clouds somewhere, out of reach of mere mortals.

Few people have sussed that the profession has insidiously stolen their freedom to be responsible for their own health. Grudgingly it still allows people the right to decline treatment but that is discouraged as is self-medication. It is now an enforced dependence, arguably right in some instances (absolutely with crisis medicine).

The disgrace, though, is that many doctors may be none the wiser than their patients. Were things otherwise, this whole issue of antibiotics would never have arisen.
01:08 PM on 03/15/2013
dont smoke ,however they do shove some unpleasent ingredients in the bakky and cigs regardless .how that effects the effects is a bit of a clue possibly /its a plant after all and humans have indulged for centuries so that beggs the question how many ancient groups of people around the globe who used the plants with no harsh consequenses could but now days the stuff is potentially responsible for alot of lung cancers ect not tomention the impact on the atmosphere be it enclosed or outdoors ??? are we targeting the wrong cause of where the actual harm has originated from ?think plenty of people know the answer to that don't you? just on the off chance someone is listening its worth a comment i think
12:53 PM on 03/15/2013
to that question about how these cost reducing reforms that meant to encourage bla bla bla effecting food we buy as asked above sounds wonderful and simple dosn;t it .oh if only real world life was that straight foward how fluffy and nice it must be for some .people are struggling majority through no fault of their own and the cost of basic essential living needs is forever getting either taxed or just not enough of it to go round for various reasons or the prices go up why is there people with zilch zero experience or relevent knowledge to make such health related rules up in first place able to do just that? dont make any reasonable sense in my humble opinion .from out here its the ones getting bad press who trying to do what they can to help us lot out here .if people dont know better that is a little worrying dont you think.so many issues to tackle and until we get our own house in some sort of order all these little bits will not go away any time soon because the resourses are not there anymore and potentialy due to get worse grimm truth of it
12:09 PM on 03/15/2013
there will always be cases where some people do become too large for life as it were far nicer way of putting it and yes of course they need some help but also we need to look first for possible reasons too its just too complex an issue to shove under one sole heading that in reality is making the problems far worse ,think about that ? also some people will have an underlying medical condition or exposure to something causing weight gain is that their fault ???? society and attitudes all play a role .there are larger people who are very active and well and decent .some people have a genetic gene ,in fact i pretty sure its not many who are large that are "lazy slobs ".you got to ask WHY SUDDENLY in a short span of time do we have this "obese" thing .????? all this so called healthy living advice dosn't appear to be working out to well does it ,but hhhhmmmm if only there some explanation .........i dont know enough about the surgical option but a quick fix can often do far more harm and i not prepared to comment on that till have more insight if it was avaliable of course?
11:22 AM on 03/15/2013
This time last week this was in the realms of c.onspiracy th.eory.
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11:10 AM on 03/15/2013
The big pharma scandals like Flu shots. Do you have the Flu Shot? then had the Flu. Vaccines are also given to people that should not Pregnant women and young children. Always look at the insert to see what is in the shot and the side effects. Also refuse to take any shot with Mercury (Hg) or Alumin (Al), usualy named as Thimerosal. MMR side effects from the CDC site Mild Problems
Fever (up to 1 person out of 6), Mild rash (about 1 person out of 20) Swelling of glands in the cheeks or neck (about 1 person out of 75). Moderate Problems Seizure (jerking or staring) caused by fever (about 1 out of 3,000 doses) Temporary pain and stiffness in the joints, mostly in teenage or adult women (up to 1 out of 4) Temporary low platelet count, which can cause a bleeding disorder (about 1 out of 30,000 doses) Severe Problems Serious allergic reaction (less than 1 out of a million doses)Several other severe problems have been reported after a child gets MMR vaccine, including:
Deafness, Long-term seizures, coma, or lowered consciousness, Permanent brain damage.