Tuesday, 16 February 2016

Why is Big Pharma bad for your health?


This is the text of the introduction to last week's talk at our branch meeting - many thanks to the comrade who gave this. 

If you like what you read here, why not come and join the discussion at our weekly meetings? We meet on Thursdays at 7 pm at the West End Community Centre on Mackworth Road in Derby, next to Britannia Mill. See you there!


 
Why Big Pharma Is Bad For Your Health

Introduction

Every year a handful of the biggest pharmaceutical corporations are well-represented amongst the most powerful Fortune 500 companies of the world. Big Pharma’s top eleven corporations generated net profits in just one decade from 2003 to 2012 of nearly three quarters of a trillion dollars. Pharma company Johnson and Johnson made the most profits of any US company in 2014, making $74.3 billion.
Both Big Pharma’s highly profitable revenues and absolute economic and political power in the United States and world are unprecedented.

The profit motive distorts the type of science that gets carried out and the type of science that gets prioritized.

For the last decade, major pharmaceutical companies have relied heavily on blockbuster drugs to generate sales. Blockbuster drugs are defined as medicines generating global sales of at least $1 billion annually. But the industry is in crisis as many of the patents on these drugs are about to expire, which will mean the market is then flooded by generic versions of these drugs.

To get around this company’s create a “me-2” drug, where they take an existing drug and slightly alter the chemical formula of it and then market it as a completely new drug. 75% of drugs approved by the American regulator, the FDA, in 2004 were “me-2” drugs. The FDA will approve a drug that’s better than placebo.

Drug companies spend around twice as much on advertising and marketing as they do on research and development. In America drug companies spend $4 billion a year advertising directly to consumers and $24 billion marketing to doctors.

Doctors can’t be expected to keep on every new development, so they rely on the big pharma companies for their information on new drugs. These companies typically promote their new drugs to doctors through drug reps. There’s approximately one drug rep for every six GPs in the UK. Drug reps are usually young and attractive, and are well known for buying doctors free lunches, taking them for out for expensive meals and giving them free gifts, all paid for by the big pharma companies. Drug reps take notes on newly qualified doctors to keep track of them and maintain relationships with them. They also reportedly sometimes attempt to gain access to areas of hospitals intended for medical staff only.

When doctors start to refuse to see drug reps, the pharma companies instead approach doctors directly and flatter them by telling them they want them to be a “thought leader”. They’re then paid a lot of money and given a script written by the drug company, which they then deliver to an audience who may not realize who has written the talk.

All of this leads to a massive conflict of interest if a doctor is prescribing a drug they’ve been paid to promote, it breaks the trust people have in their GPs to recommend the right medicine for them.
People in regulatory bodies usually have very close working relationships with people in the pharma companies, meaning people quickly moving from one side of the industry to another.

There is a deep conflict of interest in pharmaceutical companies sponsoring trials on their own drugs. The pharma industry sponsors 90% of published clinical trials. A worrying statistic given that, a Ben Goldacre shows, in the 192 trials they looked at, industry-funded trials were 20 times more likely to produce results that favoured the drug.

If the trial seemed to be producing negative data it is stopped prematurely and the results were not published, or if it is producing positive data it may be stopped early so that longer-term effects are not examined. Many of the trials that fail to show the results a company had hoped were typically buried.

As Goldacre argues – this publication bias, where negative results remain unpublished, is endemic within medicine and academia. As a consequence, he argues, doctors may have no idea what the effects are of the drugs they prescribe”

This desire to create profits no matter what leads to cutting corners and fraudulent methods, which can be lethal for us, the patients. Fortunately for us medical trial data now must be fully published, after a change in the law last year, but this means all the medicine created before then is based on flawed and incomplete data.

There are many examples of companies selling drugs they know don’t work, but don’t want to lose their profits. In 2004, Glaxxo-Smith-Kline, continued marketing a drug, Paroxetine, to children, which was revealed could cause them to have suicidal thoughts. The company knew this, yet kept the drug on the market to keep making profits, until it was caught. All of the big pharma companies over the years have had to pay out billions for malpractice and unethical behavior.

Their behavior leads to conspiracy theories – such as big pharma companies are withholding treatments to major diseases like cancer. And the rise of anti-vaccination movement in America, where people are convinced vaccinations cause autism and in the last two years there’s been an outbreak of measles (an easily preventable disease) in over 17 states, due to parents not vaccinating their children.

There are also examples of companies marketing drugs for things they’re not tested or created for. Because the drugs are expensive to create, the companies want to try to push them in as many directions as they can, sometimes with damaging consequences. The psychotropic drugs, in particular second generation anti-psychotic (SGA) medications, have been spread far and wide in this way and further away from their original indication for schizophrenia-like psychosis.

Finding a new market for a drug, can mean finding a new problem or a new disease. Innovation is no longer necessarily driven by a health need; rather a commercial one.
Some suggest that big pharma’s strategy has been to invent ‘need disorders’ like the controversial female sexual dysfunction disorder (treated with SSRIs). Critics suggest that clinicians are encouraged by the pharmaceutical industry to develop new diagnostic categories in which to test efficacy of their compounds and develop a new market need. 

There’s a great need a new class of antibiotics to cope with new evolving types of bacteria, which becomes resistant to what we already have. There’s been no new class of antibiotics since the late 80s.

Like other drugs, a new antibiotic costs millions to develop. But, unlike other drugs, it has to ‘sit on the pharmaceutical company shelf’ until antibiotic resistance deems other compounds no longer effective. This means its value cannot be immediately realised.

Furthermore, within a couple of years, and the organism for which it was developed is now resistant or the epidemic has reached such proportions in countries with restricted resources, that the company, for ethical, (we can safely assume not for conventional business) reasons, is being impelled to give away its product for free.
Antibiotics, anti-viral agents and possibly even vaccines, may simply not represent good business for pharma.

Direct government intervention is needed to fund research into new antibiotics; it can’t be left for the market to decide. Antibiotics need to be using sparingly, to avoid bacteria resistance.

Possible defenses of the industry

The introduction of the new law requiring all clinical trial data be published shows the pharma industry can very occasionally fixes its own problems.

In America a clause was added to the Affordable Healthcare Act, which meant that lists are now published online showing all the perks a doctor has received from any pharmaceutical company. But these are minor tweaks, which still keep the existing system in place, rather than radically overhauling it.

Conclusion

Given that the entire industry revolves around profit as the motive to create new drugs and treatments, how do we replace this? What other incentives could motivate people, other than the desire for wealth and status, to want to cure diseases and make the world safer?























How Big Pharma Stops Us Making Progress by Camilla Royle: https://www.youtube.com/watch?v=Ut_4a4wIJXY&index=233&list=WL

The average UK person takes 14,000 pills over their lifetime.

Creating something affordable, which helps people isn’t a good business model for big pharma.


Western pharma companies tried to get Indian companies to pay for using generic versions of their products






Big Pharmaceuticals could be nationalized and become part of the NHS

Big pharma research is skewered against neglected tropical diseases, the Ebola virus was discovered in the 1970s, but work on a vaccine only started recently after the outbreak

Solutions to diseases such as TB can’t be solved simply through medicine and also need greater social interventions, such as better housing

Stop producing so many Me-2 drugs, stop spending so much on advertising and make all the data from medical trials available publically, the current industry prioritizes its profits over everyone’s health


Yellow card scheme -





Notes on Bad Pharma by Ben Goldacre:


it’s hard to make a judgment about the effectiveness of a medicine, if only the positive results are published. Negative results of clinical trials are frequently not published, and thus people’s understanding is limited and distorted.

He writes that

For example, in a 2007 journal article published in PLOS Medicine researchers studied every published trial on statins — drugs prescribed toreduce cholesterol levels.

He writes that these positive results are achieved in a number of ways. Sometimes the industry-sponsored studies are flawed by design (for example by comparing the new drug to an existing drug at an inadequate dose), and sometimes patients are selected in a way that will make a positive result more likely. In addition, the data is analysed as the trial progresses.

Producing positive results in clearly not left down to chance. Some trials are manipulated by comparing a new drug to inadequate doses of another drug. In others trial patients are selected in the knowledge that they will most likely react well to the experimental medication.

Reboxetine, an anti-depressant drug, was approved for use by the UK’s Medicines and Healthcare products Regulatory Agency (the MHRA- if you’ve not heard of it before don’t worry, a 2006 Ipsos MORI survey found 55% of hospital doctors hadn’t either.)

All the evidence suggested Reboxetine was a safe and effective treatment. That is, all the evidence that was actually published.

In 2010, researchers discovered that seven trials had been conducted testing the drug against a placebo. Nothing unusual there. But only one trial, the one with positive results, had been published. That trial dealt with just 254 patients. The other six trials, which tested on over 2,000 people, all showed that the drug was no better than a placebo. The negative results never saw the light of day: the trials were not published.
This isn’t breaking any rules. Goldacre tells us this is a perfectly common occurrence.

"Medicine is broken ... We like to imagine that medicine is based on evidence, and the results of fair tests. In reality, those tests are often profoundly flawed. We like to imagine that doctors are familiar with the research literature, when in reality much of it is hidden from them by drug companies. We like to imagine that doctors are well-educated, when in reality much of their education is funded by industry. We like to imagine that regulators only let effective drugs onto the market, when in reality they approve hopeless drugs, with data on side effects casually withheld from doctors and patients....” – Ben Goldacre



Doctor’s training funded by the industry

No quality control – drugs don’t always work properly, have a huge number of side effects, and yet still get approved











Critique of Bad Pharma –







LaMattina describes his experience on an American talk show, The Dr Oz Show, during which the host catalogued, to great audience acclaim, the existence of Four Secrets That Drug Companies Don’t Want You To Know:
  1. Drug companies underestimate dangerous side-effects 
    2. Drug companies control much of the information your doctor gets
     
    3. You’re often prescribed drugs that you don’t need
     
    4. Drugs target the symptoms, not the cause”





The overall purpose of clinical trials, from a manufacturer’s perspective, is to collect information to support a drug’s regulatory approval. If you’re a frequent reader of this blog you’ll know that there is no shortage of criticism of regulators for the work they do in evaluating new drugs. One of the biggest is the challenge of obtaining expert opinion on new drugs from individuals who may have significant conflicts of interest. This is a common problem, where those with the most experience using a drug, are often in direct conflicts of interest, most frequently because of compensation for participation in clinical trials. The conflicts that can exist between regulators and the industry it regulates are real, and probably managed less transparently than we would like.

Goldacre spends time describing how regulators worldwide do a generally poor job of both collecting safety information, but also sharing it with health professionals and the public. Some of the recommendations he has to improve regulation includes:
requiring companies to compare new drugs against the current “standard of care” rather than placebo
raising the evidence bar to demand trials that answer more relevant questions useful for patients and physicians
dramatically increasing the transparency of drug evaluation process, so that the evidence supporting decisions can be evaluated
improving the way we share information on the risks and benefits of drugs

















The most prescribed drugs of all are painkillers that typically are highly addictive. Big Pharma with the help of their global army of doctors have purposely and calculatingly turned a large percentage of us especially in the United States into hardcore drug addicts, both physically and psychologically addicted to artificial synthetic substances that are detrimental to our health and well-being. More than three quarters of US citizens over 50 are currently taking prescribed medication. One in four women in their 40’s and 50’s is taking antidepressants. Though the US contains just 5% of the world population, it consumes over half of all prescribed medication and a phenomenal 80% of the world’s supply of painkillers. Those who admit to taking prescription drugs on average take four different prescription drugs daily.







And the third reason our relationship with the pharmaceutical Industry and how runs it itself matters is that large pharma conglomerates can control product supply, product price and product demand. We have recent evidence of ways in which price-fixing and market share have been manipulated/divvied between the major players.  Larger companies also means less likelihood of smaller companies either being competitive or perhaps taking risks with novel compounds. One business strategy of larger companies is to focus on the money-spinners.


Contrary to popular belief, the pharmaceutical industry is not shy of prevention. In fact, the NHS spends a small fortune on preventive prescribing: cholesterol-lowing medications, heart slowing drugs and the like. We do not expect people to lower their own cholesterol or exercise their heart into a better shape. In my view, pharma has actively encouraged modern man to take a pill rather than take responsibility.















The 2015 Harris corporate reputation poll is out and the news for Big Pharma isn’t good, to say the least.  In the poll—which measures the “reputation quotient” of the most visible American companies among the general public—Big Pharma ranked ninth out of 14 industries and was right in line with insurance companies and airlines when it comes to respect”

Jacky Law – “Outlining the history of the pharmaceutical industry, Law identifies what she says is the failure of a regulatory framework that assumes pharmaceutical companies always produce worthwhile products that society will want.

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