I thought this trail would lead me to the unicorn’s lair, but sometimes our intuition doesn’t match the reality.

Many people are concerned for the corporate profits from vaccines.  I’ve often encountered the arguments “Vaccine research is conducted by Big Pharma and cannot be trusted” and “Vaccines serve mainly to increase the profits of doctors and medical companies”. These arguments should be taken seriously. How can we try to find out if we have reason for concern? How could we make sure conflicts of interest will not lead to harm?

It is perfectly understandable to be wary of money as a motive that could influence profit-driven organisations in the decisions that affect your health. Certainly there have been cases of individuals behaving in an unethical way in the interest of their own or those of the companies they represent.

To note, vaccine research is not only conducted by pharmaceutical companies. There is a great deal of funding that comes from governments, like those from the Federal funding from John Hopkins Vaccine Initiative, or the 410 million euros invested on vaccine research by the European Union in the last decade. A more recent example is the UK government funding Royal Holloway with 39 million pounds in 2012. The Gates foundation is also a large non-profit supporter of vaccine research, as exemplified with their 55 million dollar commitment here. While medical companies don’t have a monopoly on vaccine research, however, it is true that a majority of the funding still comes from them, and together with doctors, they are the instances that can profit from the sales of vaccines. Does their involvement influence their judgement? What kind of money are we talking about?

How big a business are vaccines?

An article by the National Center of Policy Analysis from 2009 takes a look at the problem of vaccine shortages, and highlight the lack of profit margins as one of the causes – this topic has also been well covered in The Atlantic. Simply put, considered in the context of their profits, vaccines are very expensive to produce. National Center of Policy Analysis:

the vaccine industry itself is at high risk for failure, with shortages becoming more and more frequent.  For example, of the 12 pediatric vaccines recommended for all children, there have been severe shortages of more than half, ranging from a shortage of MMR-vaccine (measles, mumps and rubella) lasting seven months to a shortage of PNU-vaccine (pneumococcal infections like meningitis) lasting nearly two years! […]

What has led to this fragile supply within the vaccine industry?  It is a combination of challenging economic conditions for manufacturers and actions by the federal government which have distorted the market.

To get an idea of the scale of the finances involved, the science blogger Skeptical raptor has taken a look at the details of vaccine profits, and he reports his finds on vaccine revenues:

…estimated 2013 global revenues for vaccines is around US$24 billion. In other words, from the Big Pharma perspective, vaccines make up around 1.82% of their total expected revenues in 2013.

and here are some more of his reflections on the vaccine business as a whole:

..vaccines a small part (about 7%) of the total medical products business. […] For example, and HIV/AIDS vaccine will be a “blockbuster” but the pricing for poorer countries will be so low that it might not even exceed the cost of goods.

In the recent years, the market analysis has a positive outlook on vaccines, thanks to new vaccines (like Prenvnar and Cervarix), and this vaccine ethics site reports on an estimated rise between 2009 and 2016 from 24 to 52 billion dollars. Compared to medications taken daily instead of once or couple of times in a life-time, however, it does not seem that vaccine industry would be the ultimate money-maker. That at least is reassuring in the context of conflicts of interests. Why? It is probably fair to consider most people occupied by medical companies as having average moral standards. Also it is rather straight forward logic to assume that should there be such individuals among the employees who would be ready to compromise their morals in favour personal gain, would be more likely be tempted to do so (and engage on such scheming on a larger scale) if the profits were staggering. That does not erase the possibility of fraud of some kind, but it certainly lessens the likelihood.

Meanwhile, I read an interesting argument from a blogger Married to medicine of how the pure selfish financial incentives of health insurance companies on the other hand, would actually be on the side of the public in this respect:

Vaccinations are paid for largely by private health insurance companies and, for uninsured children, the government.  Hopefully we can all agree that health insurance companies are not an innocent, naive, duped party in this or any other equation.  Not only is the health insurance industry a major political powerhouse, but health insurance companies employ hundreds of physicians whose sole jobs are to find ways to deny coverage for any medical care that is even arguably not “medically necessary.”  If you must have a conspiracy theory, and you really don’t believe vaccines work, maybe you should consider the idea that the “Big Health Insura” put out all the anti-vaxx internet quackery so that fewer people would vaccinate.

Another, more chilling line of analysis comes from the calculation of profits that could be incurred from the treatment of disease. As a layperson interested in vaccines,  Todd W. comments:

Much is often made of the supposed profits made by pharmaceutical companies from vaccines. Of course there is some profit from vaccines.  After all, pharmaceuticals are just like any other industry.  Without profit, the companies would either fold or fail to grow. No profits, no research into how to improve products, to make them more effective or safer.  The pertinent question to ask, then, is whether these vaccines are a sufficient motivation for putting people at risk.  Part of this is another question: what are the profits made by treating the diseases that vaccines prevent?

On his site he has begun an effort of calculating in detail medical sector’s income from the treatment (hospitalizations, acute treatments, treatments of the complications etc) of the epidemics that we are seeing now, resulting from decreased vaccination rates. The science blogger Skeptical Raptor had made independent calculations on the same topic. In the context of the global revenue from all vaccines arriving at 24 billion dollars per year, he makes this comparison:

That would mean one outbreak of one disease in one country would end up giving about 100 billion dollars to Big Pharma. […] if Big Pharma were only interested in making money in the most unethical way possible, they’d be funding the anti-vaccine movement.

It seems that the medical companies have rather modest financial interest in vaccines. This also could explain what I have wondered over ever since I became aware of the vaccine debate: there is a definite lack of commercial advertisements and awareness campaigns on vaccines on the behalf of the medical companies. Every flu season I see countless commercials for cold remedies or cough medicine and other medical or alternative health products. The only ones I’ve seen that are advertising the benefits of vaccines are public health campaigns. The medical companies don’t show much interest for taking part in the vaccine discussion.

What about the pediatricians?

If not the medical companies, could  perhaps doctors have a strong monetary incentive for the compensation they get for administering the vaccines? Looking for data on that I found a scientific paper analysing the situation in pediatric practices in the US, which comes to the contrary conclusion:

We conclude that the vaccination portion of the business model for primary care pediatric practices that serve private-pay patients results in little or no profit from vaccine delivery. When losses from vaccinating publicly insured children are included, most practices lose money.

It seems that you should look elsewhere if you want to make big profits in the pediatric business.

But surely money can influence health business, potentially leading to promotion of unnecessary or unethical products? 

Yes, money surely can. Here is an article on a recently published study on financial conflicts of interest of doctors (gifts, shares, expensive all-included conferences) and how they influence doctors voting behaviour in regulatory contexts and likelihood of prescribing drugs, among other things. The report is also covered in a video from the Health Care Triage. They mention a law, now in effect in the US, which requires registering all forms of payments to doctors from the pharmaceutical industry, making them public information. This kind of scrutiny is important. It’s a tool for avoiding negative effects that financial incentives could inflict on public medical practices.

Control. Scrutiny. Transparency. Conflicts of interest exist. Anything that greatly affects our health should be under rigorous regulation to eliminate possibility of financial bias.

No one could deny that very few if any medical companies would be founded without financial incentives. Because of the potentially powerful effects of the products of pharmaceutical industries (medicines), people and governments do take the role of these companies very seriously. Firstly, all clinical studies must pass the test of peer-review, be published in scientific journals, and be confirmed by further studies. Secondly, every country that I know of has regulatory agencies in place ensuring constant scrutiny of pharmaceutical industry. You get the idea if you browse this International Association of Medical Regulatory Agencies (or IAMRA) member list. The bottom line – there are serious procedures in place to ensure the high quality and ethical application of the products of the pharmaceutical companies.

These procedures provide those very important factors: control, scrutiny, and transparency. They help us minimise conflicts of interest.

There are other areas, however, that allow for a much more lax environment for financial interests to interfere with the apparent motive of health care. Health related products that are sold as natural remedies or supplements, for instance, are virtually un-regulated in the US:

supplements are mainly unregulated, without proof of effectiveness or safety needed to market a supplement, as well as dietary supplements being classified as foods instead of as drugs.

No one draws their herbal supplements from the market when scientific evidence clearly demonstrates that it lacks any effect, or does more harm than good. This incredible interactive graph (only the static image version shown here) compiled by Information is Beautiful gives an idea of the landscape of evidence for supplements. Try it out! It allows you to easily access the research papers on each product. There is a cut-off near the middle that is called the ‘worth it line’.

Apart from the lack of efficacy on many of the products marketed to us under the banner of boosting health, even more alarming was the discovery from the New York State attorney general’s office, when they decided to investigate the contents of a score of widely used herbal products: the herbs were missing. The pills were made of something else. Here:

Among the popular products examined were ginkgo biloba, St. John’s wort and ginseng pills. Four out of five of the products tested did not include any of the herbs listed on their labels. Even worse, hidden ingredients and contaminants could be dangerous to people with allergies to those substances.

So what about financial interest in this context? It turns out that nutritional supplements are already a much bigger business than vaccines. In 2012 they generated 32 billion dollars in revenue (compared to 24 billion dollars from vaccines), and estimates have them almost doubling to 60 billion dollars a year by the year 2021. This could be partly thanks to the increased marketing of alternative health products through social media, as reported by the Forbes.

If you are not regulated for what you sell, and in fact, what you sell has such little effect, that you don’t even have to include the marketed ingredient in your product – because no one will notice – you have a unique opportunity. Perhaps it is not such a surprise that this kind of opportunity has proven impossible to resist. When there are no restrictions on what your pills are made of, you can manufacture supplements with very low cost indeed, and so doing greatly widen the margins of profit. What you are in fact selling is the idea of natural healthfulness, and the capsules or pills are but a vector for the idea.

Do vaccine critics have conflicts of interest?

The most famous vaccine critic, Andrew Wakefield, fabricated evidence about the MMR vaccine. Later on it was found that he was being funded through the solicitors seeking evidence to use against the manufacturers. This is an example of the gravest kind of result from a conflict of interest – pure fraud combined with infliction of harm. The British Medical Journal reports that the entire current campaign of mistrust against vaccines was fabricated in order to make profit.

Unfortunately, there are many influential vaccine critics that also fall into the supplement camp – they are salesmen of unregulated herbal supplements and homeopathic remedies. But natural medicine surely is under more regulation than supplements? One could hope so. Recent investigation by CBC included submitting an application to register a fake natural remedy in Canada. They included photocopied pages from a 1902 homeopathy book as a reference, and bam, new children’s fever remedy was registered.

Homeopaths promote the use of their own products in place of vaccines. The conflict of interest for smearing vaccines doesn’t get more direct than that. And the money in it? The WHO analysed data from 9 countries (as diverse as Sweden and Sudan) and found a 42% increase in sales of herbal medicine between years 1999 and 2001, in just two years. In 2012, sales from homeopathic products reached 6.4 billion USD in the US alone. What about their global market? A homeopathy site reports on a market analysis that put homeopathic sales at 60 billion dollars in 2013, and estimated they would reach a whooping 115 billion by this year, 2015. Let me underscore this: these profits are for homeopathic products which have no evidence for being effective. This conclusion was shared by the recent national health review committees both in the UK and Australia: homeopathic remedies are ineffective and unethical. Sadly that probably doesn’t stop those more than 100 billion dollars in homeopathy industry profits a year.

Then market analysis sources for this graph are listed in the end of the post

The osteopath Joseph Mercola, as an example, has made a big business warning against the government conspiracy of vaccines while also selling alternative remedies. He has even received warnings for the illegal health claims he has made for his products. Mercola’s profits, warnings and more have also been covered by Quackwatch. One medical researcher, in an open letter to her father, laments:

Jenny McCarthy has made millions selling books about how she “cured” her son Evan of his autism. Joseph Mercola makes millions selling dietary supplements (untested and largely unregulated, by the way), and lives in a two million dollar mansion. I know you’ve criticized creationists; well, these people are the creationists of the medical field. They distort, they cherry-pick their evidence, and they cause the public to lose confidence in credentialed scientists because of their writings. Credentialed scientists like myself, who carry out the vast majority of this research but certainly don’t live in million-dollar homes.

But if financial conflicts of interest can be anywhere, how can we make sure not be fooled by people on either side of the vaccine camp?

The answer is: science. Why science? Because science *is* the way of not to fooling ourselves. Science doesn’t accept an answer until it has been proven multiple times by independent groups of researchers. If new convincing evidence comes to light, science corrects itself. Science keeps doubting. It applies the most rigorous methods of uncovering and getting rid of errors, frauds, and misinformation. And science is the one undertaking of its kind.

If you want to know how best to know if something is true, listen to the scientific consensus. For vaccines, that means starting here: Main sources of vaccine information.

I would like to borrow the eloquent words of the passionate Facebook page, whose alternative name, to avoid obscenities, is I flipping strongly dislike dogma. They write beautifully about the scientific consensus and whether it can be bought:

Every group that denies scientific consensus supports their denial with the accusation that consensus can be bought and paid for. Big pharma has purchased the right to direct scientists to say vaccines are safe. Monsanto has greased the wheels of GMO testing to show GE crops to not be harmful. How then do we explain why big oil, which controls far more wealth than big pharma and Monsanto combined, has failed to dictate the scientific consensus on global warming?

What is being ignored is all the times scientific consensus has been bad for big business and the denialist campaigns that pop up when it is. For example, big tobacco threw a mountain of money at the scientific findings which said smoking contributes to lung cancer. Although they have had success in influencing laws and politics, the best they could do with science was to muddy the waters for a few years. Eventually, evidence won out and today there is little doubt in the public mind that smoking is linked to cancer. A very similar story unfolded when science suggested leaded gasoline was bad for human health. (http://bit.ly/TUV4OB) How do we explain these failures of big money to buy consensus without admitting that the currency of consensus is evidence?

What successfully countered the efforts of those companies was the standards of scientific consensus. Those same standards report that vaccines are safe, GMO’s are not inherently harmful, and climate change is real.

Money can indeed sow the seeds of doubt, and an ill-informed, non-critical thinking public can provide soil for them them to take root. But, without science to nurture them, they eventually falter and die. Money cannot sustain denialism forever. It is impossible to contradict nature, and scientific consensus is the best proxy we have available for nature’s voice.

Science is the most difficult instance to bribe, because the only currency it accepts is evidence. Be wary of people, they may always suffer from bias and have conflicts of interest. But whereas following the money may lead to dubious places, where people are concerned, following the money into science only leads to more research. No money in the world can stop people from wanting to understand how the world really works. That curiosity is what I put my trust in.

Additional evidence of the unknowns in the supplement industry – omega-3 supplements that do not in fact contain omega-3

“More than half of the n-3 fatty acid supplements on the South African market do not contain the claimed EPA and/or DHA contents as stated on product labels, and they contained CD levels higher than that in unused vegetable oils obtained from opened containers used for domestic cooking purposes.”
http://www.ncbi.nlm.nih.gov/pubmed/22159321

“Almost all fish oil supplements available in the New Zealand market contain much lower concentrations of long chain n-3 PUFAs than claimed by the product label. Importantly, the majority of fish oils exceeded the recommended indices of oxidative markers.”
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4300506/

The market research

I’ve learned that global market research is a business, and to check the results first hand, I’d have to purchase a pile of marked reports. What I have used in this piece are reports on the paywalled market analyses by relevant organisations. Data for the graph can be found in these sources:

Vaccines:

• Center for vaccine ethics and policy
  http://centerforvaccineethicsandpolicy.net/2009/04/20/world-vaccines-market-2008-2013forecast/
• http://centerforvaccineethicsandpolicy.net/2011/03/27/world-vaccines-market-and-future-forecast/
• http://centerforvaccineethicsandpolicy.net/2010/01/17/global-vaccines-revenues-projected-to-more-than-double-by-2016/
• http://www.marketsandmarkets.com/Market-Reports/vaccine-technologies-market-1155.html
• The WHO global vaccine market trends http://who.int/influenza_vaccines_plan/resources/session_10_kaddar.pdf

Supplements:

• Statista http://www.statista.com/statistics/308579/global-prediction-nutritional-supplement-revenue/
• http://www.forbes.com/sites/davidlariviere/2013/04/18/nutritional-supplements-flexing-their-muscles-as-growth-industry/
• http://www.nutraingredients.com/Suppliers2/A-global-look-at-supplements-on-the-rise

Homeopathy:

• Global Industry Analyst as reported by http://www.homeopathyheals.me.uk/site/front-page/111-frontpage/3263-sales-of-homeopathic-medicines-to-reach-116-billion-by-2015
• http://www.homeopathytoday.org/tag/market-for-homeopathic-medicine/