Over the counter medicines

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Finding ethical over the counter medicine

Pharmaceutical companies are paradoxical. On the one hand, they are involved in ameliorating suffering and saving lives, which should be the most ethical activity on earth. On the other hand, it is hard not to be horrified by many stories of their behaviour.

This paradoxical nature stems from the system that has been set up.

The basic problem is that the profit incentive, and the patent system which is used to pay for drug innovation, clashes quite badly with the provision of basic needs.

As will be talked about below, the system that we have has resulted in more than half of pharmaceutical company spending going on things that are pretty worthless, or even actively harmful: researching copycat drugs that do little for health, engaging in marketing that sways doctors away from prescribing on the basis of the evidence, and fighting legal battles.

Which companies make what medicines

This score table above shows each company’s best-known brands. The table below shows all their brands.

Table highlights

Tax avoidance

The tax situation with these companies appears to be almost uniformly dire. The only companies to not get marked down for receiving our worst rating for likely use of tax avoidance were Boehringer, which got a middle rating, and Lane’s Health and Diomed Developments, which got a best.

Independent indexes

We marked companies down if they did very badly in the Access to Medicine Index or the All Trials Index.

Those companies that were marked down were Boehringer Ingelheim and Bayer in the case of the former, and in the case of the latter: Bayer, Johnson & Johnson, Sanofi and ViiV Healthcare (majority owned by GlaxoSmithKline).

Spending priorities and prices in pharmaceuticals

When you see how pharmaceutical companies spend their money, it is pretty shocking.

The industry spends twice as much on marketing as it does on research and development.

However, it doesn’t stop there. About 75% of the research and development spending itself goes on ‘me too’ or copycat drugs, which are almost identical to an existing drug, but have some marginal benefit – maybe they have an easier dosing regimen or avoid some of the other drug’s minor side effects. They allow the new company to swoop in and take the money but don’t really help anyone else much.

Meanwhile, only 4% of the products that were approved between 2000 and 2011 were for neglected diseases found in low- and middle-income countries, like sleeping sickness or Chagas disease.

The ‘Access to Medicine’ initiative, which is run by the Bill & Melinda Gates Foundation and the UK Government, rates companies on how much they are investing in researching poor-world drugs.

The companies on the table were ranked as follows:

Access to medicine rating

GlaxoSmithKline’s top position is due partly to its comparatively large number of relevant research projects. In 2014, it applied for regulatory approval for the first partially successful malaria vaccine.

The company is also doing something on pricing and, in 2016, it said that it would not file any patents for its drugs in the least developed countries.

At the other end of the scale, Bayer has a “low proportion of equitable pricing strategies” and has a comparatively small amount of relevant research projects.

While GSK’s better practice is obviously commendable, it still has to be seen in the context of the fact that overall, across the industry, investment is low.
 

The need for governmental intervention in the medicine industry

The patenting system gives companies exclusive rights to a new drug for 20 years.

Although the poor are suffering from a lack of investment, the patent system has created a situation in which they aren’t the only ones being neglected.

Many important potential medical research avenues are not being explored simply because they are nonpatentable, like generic drugs that might work for a different disease from the one for which they were designed. If the drug is out of patent, nobody has any financial interest in researching whether they work more widely, so they don’t.

And even worse: despite the impending global disaster of antibiotic resistance, there is scant investment going on into researching new antibacterial drugs, due to the lack of financial incentives.

The campaigning organisation Global Justice Now has been pushing for governments to adopt a more mission-oriented approach to health research, which is already used in other industries such as weapons, where governments set the agenda for what innovation needs to take place. Research and development for specific projects could be paid for upfront through grants or prizes.

There is some chance that this could gain momentum because there is a sense in which this issue transcends rich and poor – if you get sick and the research hasn’t been done into your condition, no amount of money will help you.

Sharp price rises in medicine

With the monopoly established by a patent, the drug company can then charge whatever people will pay. And obviously, in the case of a lifesaving drug, the limit on what people will pay is pretty much whatever they have.

This system is justified on the basis that private companies need to be paid for the investment they put into research, and it is true that bringing a drug to market isn’t cheap. But at the same time, they are also riding on the back of others.

A third of new medicines actually originate in publicly funded institutions like universities, and two-thirds of all drug research and development globally is paid for out of public funds.

Global Justice Now, in its 2017 report ‘Pills and Profits’, gives many examples of what appears to be gross profiteering by the pharmaceutical companies in the table, on the back of public discoveries:

• Sanofi acquired the rights to Alemtuzumab, despite it having been developed at Cambridge University. It was originally developed to treat Leukaemia, but Sanofi relaunched it as a drug to treat MS and raised the price from £2,500 per MS treatment course in 2012, to £56,000 per treatment course.
• In 2012, Pfizer raised the price of a 100 mg packet of Phenytoin sodium, an anti-epilepsy drug, from £2.83 to £67.50.
• Johnson and Johnson has the rights to Abiraterone, an effective drug for advanced prostate cancer. It was discovered and developed at the Institute of Cancer Research, which is largely publicly funded. Yet its NHS use been restricted for years due to its enormous price.

All of this is straining health budgets around the world. NHS spending on medicines has risen by 29% in the past five years.

It is normal for companies to charge wildly different prices for patented drugs in different countries. Indeed, this is one of the reasons that the US spends twice per capita what we do on healthcare - without the NHS to bargain and push prices down, medicine prices are many times higher in the US.

A current issue in the US is the soaring price of insulin, which is made by three companies, one of which is Sanofi. 

At least six uninsured US diabetics have died in the last few years because they were rationing their insulin due to not being able to afford enough, and there have been street protests against the companies involved.

For more information see Global Justice Now.

Pharmaceutical companies and their distorting influence

Over the past few years, the doctor, journalist and evidence freak Ben Goldacre has been crusading to tackle drug company distortion of medical evidence, the extent of which, according to Ben’s writing, has been truly staggering.

Multiple studies have shown that if you look at published drug trials, those that were funded by a drug company will have positive findings a lot more often than those that are government-funded.

It might be tempting to look for some subtle manipulation of the data to explain this, but there is a much simpler explanation for most of it, which is that drug companies have just shoved results they don’t like in a drawer.

Not only have half of the trials that have been conducted never been published, but positive trials are twice as likely to have been published as negative ones.

The amazing thing is that this has been allowed to go on to such an extent. While there are token rules on publishing trial data, they are not enforced, and flaunting them is endemic.

Goldacre thus started a campaign in 2013 called ‘All Trials’ which calls for all past and present clinical trials to be registered and their results reported. It has been having some success, although its recent research shows there is still a long way to go: in 2018 it found that 46% of EU trials have not reported results according to the EU’s rules. 

Companies have not responded equally to these demands for transparency.

GlaxoSmithKline quickly agreed to share clinical study reports for all trials back to 2000 and set up a unit within the company to process them.

AbbVie and InterMune instead sued the European Medicines Agency to try to prevent equivalent documents being released. ‘All Trials’ therefore does a ‘transparency index’ of all pharmaceutical companies, rating them on their commitment to trials transparency. 

Those companies that are on the table have the following rankings:

Trials transparency rating

Marketing medicines

Warping the medical literature is not the only place that Goldacre describes pharmaceutical companies introducing huge biases into a system that really needs to be cold, clinical and objective. Over half of the industry’s – huge – marketing budget goes on ‘drug reps’.

There is now one drug rep for about every three to six doctors. In theory, drug reps just inform doctors about medicines. But of course, it helps things along if they are nice and charming, and give doctors little gifts, and keep notes on their personal lives so as to be able to bond with them better. 

Rather ridiculously, the doctors who engage with this mostly deny that it influences them while agreeing that it probably does influence other doctors. It has been shown that doctors who spend more time with reps are less likely to prescribe rationally, instead being more likely to prescribe the products from the reps’ companies.

Drug companies also pay for tutorials, teaching and conferences, staffed with experts who like their drugs. And obviously, they don’t do this out of the kindness of their hearts.

One leaked calculation, done by Merck, of its ‘return on investment’ from running discussion groups for doctors, was that a dollar spent on teaching brought in two dollars in revenue from an increased prescription of its drugs.

None of this is inevitable. In Norway, the industry is banned from funding any continuing medical education for doctors. In the UK, they are allowed to fund all of it.

As Ben Goldacre says in his book:

“The Department of Health spends a few million pounds a year providing independent medicines information to doctors. The industry spends tens of billions on providing biased information.

This presents a bizarre situation: doctors’ continuing education is paid for, almost exclusively, by the industry whose products they buy with public money, and by the industry that has been shown routinely to mislead them.”

This is a symptom of the culture that has led academics to be repeatedly encouraged by neoliberal UK governments to engage more with industry, with little
concern for the conflicts of interest generated. Obviously, all of this has effects on health. But it also has effects on money.

A 2010 study calculated that at least £1 billion is wasted every year from doctors using branded drugs when there is an identical generic drug available.6

Patient support groups 

Another area where pharmaceutical companies exert covert influence is through patient support groups, who often receive substantial funding from them – hundreds of thousands of pounds per group – without properly declaring it.

From 2012 to 2016, the drug industry donated over £57 million to UK patient organisations.

The amount is rising fast, and the annual amount more than doubled over the period. Pfizer was the biggest donator and, in 2016, it gave over £5 million to Cancer Research UK and Breast Cancer Now. Pfizer has just launched a very expensive new breast cancer drug called Palbociclib.

This is important in the UK, as representatives of patient groups often sit on NICE advisory panels which feed into the decisions about which drugs the NHS should use.

There is plenty of evidence that the money has an effect. One study looked at patient groups lobbying the European Commission. Those that were funded by pharmaceutical companies were substantially more likely to support “an expanded role of the pharmaceutical industry as an information provider” on drugs.

For more information see All Trials or Ben Goldacre’s book, Bad Pharma.

The opioid crisis in the US

The US opioid crisis has now received significant coverage in the media. Over two million people are estimated to be addicted, and tens of thousands are dying every year from overdoses. In 2017, the US government announced a nationwide public health emergency.

The most widely publicised drug has been Oxycontin, made by Purdue Pharma.

In May 2007, Purdue Pharma pleaded guilty to misleading the public about its addictiveness and agreed to pay US $600million in damages. 

In the subsequent years, the lawsuits against Purdue have become an avalanche, and it is now facing over 2000. Many of these are from public authorities – 45 out of the 50 US states are suing the company.

The cases are being compared to the lawsuits against the tobacco industry, which resulted in a $246 billion settlement in 1998.

Purdue Pharma does not sell over-the-counter medicine in the UK. However, the scandal has recently widened to also include other companies who do, including Johnson & Johnson and Teva.

The state of Oklahoma is suing both companies, accusing them of engaging in deceptive marketing of opioids, even to children.

Given that the accusations have been about what the companies told the public, most articles on the topic seem bizarrely silent on the subject of restricting companies from engaging in direct-to-consumer advertising, which is banned nearly everywhere other than the US.

Although opioid prescriptions have also risen somewhat in other countries, including the UK, what happened in the US was on a different order of magnitude.

Bayer outside of pharmaceuticals

Bayer and pesticides

Pharmaceuticals are only one part of Bayer’s portfolio. It is also a huge producer of pesticides.

Neonicotinoids are a class of pesticides that are chemically similar to nicotine, developed by the company in the 1990s.

Since 2018, the three main types of neonicotinoids have been banned in the EU for all outdoor uses, due to their effect on bees. It took an excessively long time to get this ban due to a protracted scientific fight, with Bayer and Syngenta funding their own studies which found there to be no problem.

However, in February 2018, the European Union’s Food-Safety Agency conducted a major review of the science to date and concluded that there was no longer room for doubt – neonicotinoids do pose a high risk to bees. The ban was enacted later that year. 

Trump has rolled back the Obama-era neonicotinoid legislation in the US. Some individual states have restricted their use in various ways, but many have not.

Bayer is still fighting the bans and claiming that “when used CAREFULLY and in accordance with the label, neonicotinoids should not have any effect on bees.”

Bayer and Monsanto

Bayer bought Monsanto in 2018 and discontinued the Monsanto brand: its products are now marketed under the Bayer name.

It may now be regretting buying Monsanto. Shortly after the purchase, a US court ruled that Monsanto’s weedkillers contributed “substantially” to a San Franciscan’s terminal cancer and that the company had acted with “malice” in failing to warn of the danger.

In the last month, two more California court rulings went the same way, and Bayer was ordered to pay a mammoth US$2 billion in damages. That leaves more than 13,000 similar cases making their way through the US courts.

All of these cases concern glyphosate, which Monsanto brought to market in 1974 under the name Roundup. It is the world’s most widely used weed killer and, since its patent expired in 2000, it has been sold by various manufacturers.

There is no clear scientific consensus on the link with cancer.

The World Health Organisation’s International Agency for Research on Cancer (IARC) classified it, in 2015, as “probably carcinogenic in humans”. However, two years later, the European Food Safety Authority ruled that “the substance is unlikely … to pose a carcinogenic threat to humans”.

Sri Lanka banned use of glyphosate in 2015 but, throughout most of the world, it is still being used.

Bayer has recently admitted that Monsanto had, from 2016, compiled a list of 200 influential European politicians, activists and journalists who were critical of pesticides and collected information about them. This practice may have been illegal.

Generics

Medicines have two different names, the brand name, and the ‘generic’ name – the name of the active ingredient. For example, sildenafil is the generic name for Viagra.

You may not be able to pronounce the generic name, but if you write it down and look for it, you can often find the same thing being sold without the brand name. It will probably be significantly cheaper, and it may mean that you don’t have to support a company that you don’t like.

Some examples of brand-named over-the-counter medicines for which generics are available are:

• Canesten (Clotrimazole pessary and cream)
• Nurofen (Ibuprofen)
• Anthisan (Antihistamine cream)
• Pepto Bismol (Bismuth subsalicylate solution)
• Nytol (Diphenhydramine tablets)
• Calpol (Paracetamol oral suspension)