Rules and Regulations for Research and Marketing in Food,

Tobacco, and Pharmaceutical Industries

S. van Straten, S.M. Korte, M. A. G. van der Heyden

Introduction
Everyone has seen them and has been confronted by them. The little facts and statements made by
companies during commercials and advertisements, that oppose opinions you might have had or try
to educate you in how you can live healthier and enjoy life more. The main goal of these facts and
statements are however not to educate the public, but to convince you of the beneficial properties of
a certain product. Food, drinks, personal care products, medicinal products and many other types are
sold this way. The claims and statements that are made, are often brought as facts and thus
supported by scientific data. This scientific research is not only essential for the promotion of the
product, but also to ensure safe usage of the product. As obvious as it may seem to research a
products and its contents and give complete and honest information to the consumers, the success
and profit of the product are often the main priorities for a company. This conflict of interest causes
companies to overstate the beneficial effects of the product and keep negatives out of plain view
with the help of small notices on the product or advertisements. However there are practices in
existence that are actually misleading and misguiding, which in turn can cause health hazards for the
consumers involved.
A short introduction to commercial claims and the supporting evidence:
An example for commercial claims is taken from one of the most famous energy drinks Red Bull. Red
Bull is known for their slogan: “Red Bull gives you wings”. And although the company is clear in that
this should not be taken literally, they still list a good variety of reasons why this slogan works in a
figurative way. When you look at Red Bull online1 they have multiple pages listing the benefits of
their product. For this example we look at an official page of Red Bull. The statement ‘Vitalizes body
and mind’ tops the page2 and underneath a handful of ingredients is named with links to different
pages stating the health benefits of each ingredient3. Combine this with a whole list of list of various
activities of when these benefits could help you in your day to day life and it is clear what the
marketing team was going for and how the company wants to present itself and its product. Red Bull
has linked itself to many scientific studies that support their claims. For example the Red Bull website
links their claims of Taurine benefits4 to an article by Belli DC named Taurine and TPN solutions?
published in Nutrition in 1994. Sadly this article is not widely available, but further search helps to
find an article published and although the information is presented in an editorial/review7, the
author is well known on the subject. Belli published earlier articles on the subject and uses data from
scientific research in his reasoning and although an editorial is not considered pure scientific data,
the knowledge is based on the scientific research.8
Further investigations helped to find a small website of a literature review out of 2008 which states
three other articles that Red Bull has quoted in the past to support claims on Taurine.10 Although the
quality of this article is not ensured and reviewed, it might help to show possible extra insights in
behind-the-scenes research for Red Bull products. The focus of this website is on the statements that
Red Bull has advertised the effects of Taurine as a working antioxidant with links to three different
scientific articles: Obrosova et al., 2001, Baum and Weib, 2001, and Li et al., 2006; that support these
claims with their research11,12,13 and the article of Baum and Weib even shows full benefits of
consumption of the Red Bull product.12

Everyone has seen them and has been confronted by them. The little facts and statements made by
companies during commercials, advertisements that oppose opinions you might have had or try to
educate you in how you can live healthier and enjoy life more.
An example for this is one of the most famous energy drinks Red Bull. Red Bull is known for their
slogan: Red Bull gives you wings. And although the company is clear in that this shouldn’t be taken
literally, they still list a good variety of reasons why this slogan works in a figurative way. When you
look at red bull online1 they have multiple pages listing the benefits of their product. For this example
we look at an official page of Red Bull: http://energydrink-us.redbull.com/en/red-bull-energy-
drink#howitworks. The statement ‘Vitalizes body and mind’ tops the page2 and underneath a handful
of ingredients is named with links to different pages stating the health benefits of each ingredient3.
Combine this with a whole list of list of various activities of when these benefits could help you in
your day to day life and it is clear what the marketing team was going for and how the company
wants to present itself and its product.
Claims and their purpose
These claims are often made by marketing teams that try to find and show off all advantages that can
make a difference in the competitive field of selling products within health, medicine and food
markets. These statements are based on research by product development and research teams and
without these claims a product is often doomed for failure. This research is not only vital for product
development and marketing, but also to gain an understanding of the full effects of this product.
Without this knowledge, dangerous and hazardous products could reach the market causing injuries,
diseases, and in severe cases death.
An extremely severe example for this was the Thalidomide or Immunoprin drug. The treatment was
supposed to help with morning sickness and as a sleeping agent. However the drug turned out to
have severe side effect on unborn babies, creating problems in the development, causing
underdeveloped or missing limbs. And Thalidomide was discontinued in 1961 four years after its
release on the market.9
Therefore these research teams are required to upheld themselves to high standards, just like the
research for scientific purposes. This is also true for our example.

Red Bull has linked itself to many scientific studies that support their claims. For example the Red Bull
website links their claims of Taurine benefits4 to an article by Belli DC named Taurine and TPN
solutions? published in Nutrition in 1994. Sadly this article is not widely available, but further search
helps to find an article published and although the information is presented in an editorial/review7,
the author is well known on the subject. Belli published earlier articles on the subject and uses data
from scientific research in his reasoning and although an editorial is not considered pure scientific
data, the knowledge is based on the scientific research.8 However the choice for an editorial as the
source for making health claims on Taurine is not without controversy.

Further investigations helped to find a small website of a literature review out of 2008 which states
three other articles that Red Bull has quoted in the past to support claims on Taurine.10 Although the
quality of this article is not ensured and reviewed, it might help to show possible extra insights in
behind-the-scenes research for Red Bull products. The focus is on the statements that Red Bull has
advertised the effects of Taurine as a working antioxidant with links to three different scientific
articles: Obrosova et al., 2001, Baum and Weib, 2001, and Li et al., 2006; that support these claims
with their research11,12,13 and the article of Baum and Weib even shows full benefits of consumption
of the Red Bull product.12
Research like this is essential for safe and good use of products and can really support marketing in
showing off the advantages of a product. However this extensive research also clashes with the
business side of the story in multiple ways. The research is expensive which could comprise
budgets/costs and competitive prices. Also researchers investigating the properties of certain
products are usually sponsored by the company that owns that certain product, which can cause a
conflict of interests.64 Like non-sponsored research the teams are required to publish research in
high-impact journals, but the pressure for sponsored researchers to find positive results can be even
higher than for their non-sponsored counterparts. As they are reliant on financing by the company
that owns the products that they are developing/researching, and these companies have more
benefit from positive results.
Sources and nuanced perspective
And although the Red Bull page does not complete all their claims with sources and research data,
they provide a few sources to the public of whom not all sponsored. And these sources do all support
positive outcomes for the product. Showing the positive outcomes helps to benefit the view on the
product, but the ingredients mentioned are not always fully undisputed. A short expedition for
scientific papers on caffeine, Taurine, and the vitamins mentioned on the ingredients page of Red
Bull,3 will show an incredible wide array of outcomes on the substances and even the energy drink
itself. For instance Taurine, an amino acid which is present in high quantities in a normal human
body, and heightened dosage is often associated with problem with digestion, dehydration,
abnormal heart rates and hypotension.14,15 While Taurine also has been described as useful agent in
diabetes mellitus and hypertension.14,15,16 The problem herein is that although there are beneficial
effects of the substances and the drink in certain quantities, organisms, tissues, and situations, there
will be cases where they will have negative effects. This nuanced view is logical as this balance of
substances defines life, and it will help to put positive outcomes into perspective. The specific
outcome of the sources that were used by Red Bull is an obvious choice for a company, but the
amount of reliable sources is vital. And although for example more and more research is helping to
support that caffeine also has beneficial effects on health,17,18 there is still an amount of papers that
will state the opposite in different types of experiments.19,20 The marketing team has in this case
made the choice,5 for limiting the sources to a few research papers with positive outcomes and a less
cluttered outlook, instead of creating a fully complete page with a larger amount of sources covering
the subject. This limited view is normal and the most effective choice for our society, wherein people
often are not interested in the details and only want to know what applies to them. A limited view in
our products, for example food/drinks/drugs, can cause health hazards for people who are unknown
to the nuance and specific details in specific situations, and are only informed with these limited
health claims.
Another example of research that is used for the benefit claims of commercials are smaller opinion
based researches like polls and comparative experiments. These polls can be used to create extra
insight in popularity, customer satisfaction and customer usage. These do not give results that give
information over actual functioning and safety of the product in specific situations. And unless they
are done in a scientific manner in combination with medical examinations, create a form of pseudo-
science were the results are better not to be used for claims about the product. This is mainly
because these investigations are incredibly reliant on who is asked and what questions were asked,
which could open up possibilities for data manipulation. The same is true for comparative research
where the comparisons to other different products does not always give a clear and neutral view of a
product and its effects. By comparing products to specific competitors or similar products a more
positive view can be created. Which can sometimes be misleading to customers.
Red bull also uses these comparative experiments to support their product. For example the sugar
contained in their standard energy drink is compared to apple and orange juice at least twice on their
website with links to two different sources: The book Food Chemistry by H.-D. Belitz, W. Grosch, P.
Schieberle, third edition (2004), and a German research on products Springer-Verlag by Stiftung
Warentest (7/2012).6,21,22 As these products are often considered as more healthy products. The
energy drink is put in this context, and the amount of sugar seems considerably less. And although
this is completely true, the view is comparative to other products and the properties of these
products also play a role. Popular orange and apple juice are nowadays often produced by soda
companies and these are known to put larger quantities of sugar in their product to enhance flavor
combined with the natural sugar content of the fruit, having comparable sugar quantities as their
respective soda drinks.23 And therefore some of these products are more unhealthy than perceived.
Using this comparison helps to put the product of Red Bull in perspective, but will not always help to
create a nuanced and conclusive view on the product.
Scientific misconduct and mishaps
A third option for research to gain knowledge on a specific product is through lots and lots of data,
which can be used to find significant differences between people who use product X versus people
who don’t. These statistical researches are made possible by our ever increasing collection of data of
everything; from medical data from the hospital to purchases we make over the internet. Although
these investigations can discover many new connections between lifestyles, consumption, age of
death and many more, they are also vulnerable to malpractice. P-fishing -also known as p-fishing, p-
hacking or data dredging- is a relatively new scientific misconduct made easier by all these statistical
developments. P-fishing is the practice, in which enormous amounts of data are used just to find
statistical significant relationships. The sheer amount of data causes random combinations of data
points that show as a significant result, but are in most cases not correlated if researched properly,
and should be considered as a random outcome as result of the sheer size of the experiment.24,25
Therefore there should also be a nuanced view on claims based on these type of researches.
Although we usually perceive forms of scientific misconduct as purposefully changing data and
experiments to achieve certain results, a lot of problems are likely caused by the creation of a
message to the public out of the scientific results.26 As the research and the marketing is often done
by two different teams/departments, communications and the different skill sets of the teams could
often have been the reason for miscommunication and errors that create wrong messages and
claims.27
Not only companies and research teams make mistakes in their communication to the public. Media
also plays a huge part. Misinterpreted research statements often reach the headlines in popular
online news sites, as the writers for these sites are often not educated enough to fully understand
the true meaning of papers and are misguided by catchy titles. Another new addition to this problem
on news sites/papers is native advertising. The concept of native advertising is creating a form of
advertising that disguises and presents itself as a news article, complete with ‘facts’ and ‘claims’.
Only to differentiate itself by admitting sponsorship to specific companies.28,29 This situation is similar
to sponsored research as there is an immediate conflict of interest, however rules are more limited
and the writers are not prosecuted for deliberately false advertising. So where sponsored research
had some flaws and risks, native advertising is just plainly misleading. And in the best cases done by
companies that actually have a good product that does what it promises to do. Other media outlets
are also used TV-commercials and even TV-programs can contain many statements, but without
proper scientific research as support. An odd example are the stories told by TV-doctors, like for
example Dr Oz who has been using his own show and title to advertise several medical products and
supplements.30 His statements have actually been researched and only slightly half of them have
been confirmed or supported by scientific research.31 Which is extremely dangerous in combination
with his popularity and the effects his title has on his credibility. For this practice he has been sued
and his trial is still ongoing, but this does not change the fact that millions of products with limited
scientific evidence on their functionality have been sold and might even harm the users.

Effects and what to do

These misguiding messages and claims have their effect on society. Customers that are misled, do
not only buy products that might not deliver what the customers thinks it delivers. However it might
also affect the lifestyle and health unbeknownst to the consumer. A product that is perceived
wrongly could affect dietary programs, over/under intake of substances in cases of food, drinks.
Causing for example overconsumption of salt, fats, and sugar, which all have their own health risks.
However this is not the main problem. Awareness on our diets is ever increasing and more and more
people are investing more time in choosing their food properly. Bigger risks are attached to
supplements, medical products, and medicines. In the best case scenarios the benefits of the
products are less than promised, but in the worst cases withheld information causes the product to
prescribed/used wrongly and the individual may harmed or even die from the adverse effects. A
good example from the past herein is smoking. Smoking has been marketed as non-harmful product
in 20 century, and often associated with improved lifestyles and in extreme cases even with
th

beneficial effects for human health.32 Although this is one of the extreme cases from a period with
less rules and regulations, smoking and its marketing and research should be considered as one of
the reasons why society should keep a close eye on what is going on in this scientific research and
marketing structure. A situation unsupervised like this could cause harm to millions with little to
none ways to protect and help the affected.
All these possible approaches for making claims and creating a positive product perception are
clearly powerful and people are often persuaded in their choice of products by these methods.
However we need to protect ourselves from the malpractices and the misleading to prevent damage
to individuals, to consumer confidence in products, and to trustworthiness of scientific research. This
research paper focuses on three important parts of this process: The first is understanding the past
to see what happens if the system fails and people do not care enough, so that we do not repeat
mistakes. The second is getting a full grasp of the current situation, what we have improved and
where the system is still vulnerable. And the final third part focuses on what needs to happen next to
prevent the situation from getting worse and how we can improve the process, so that we can better
protect ourselves from shortcoming and dangerous products.

Questions
We now have strict rules and regulations and multiple organizations and agencies that try to
combat the misleading of consumers and the spread of false information and fraudulent research.
However how do rules and regulations come to be and what do these rules and regulations
combat?
As mentioned before there have been many earlier problems with the spreading of false facts by
marketing teams. Not only the smoking has played a huge role in this. There are many industries and
companies that used a variety of methods to mislead the public and create a (bigger) market for their
product. We are going to look into a range of these methods of malpractice that were used with the
help of a number of examples for different companies within the food, beverages, and health
industries and even other products that affected the health of their consumers/users. First off it has
to be said that these examples are dated from multiple decennials ago and have already been
addressed by the proper authorities.
Tobacco industry and their efforts to hide evidence of the harmful effects of smoking.
As mentioned before, the smoking industry are one of the biggest examples of misleading consumers
to improve it sales. Smoking rose to popularity at the end of the 19th century due to mechanization
and marketing. Important factors in the limited resistance to smoking in that time was the limited
knowledge on the diseases that are affected by smoking. Lung cancer was only discovered in the 18th
century and the amount of studied cases in 1900 was just reaching 140. Even though this was the
case medical scientist were already suspecting the effects of smoking on lung cancer as early as 1898
as medical student proposed that the appearance of lung cancer in tobacco workers might be caused
by the tobacco. In 1912 Isaac Adler also summarized his findings on the ever increasing numbers of
primary lung tumors on autopsied bodies. And mentioned alcohol and tobacco as possible causes.32,33
The numbers of studies that showed the possible effects continued to increase during the 20th
century and the evidence became stronger due to population studies, animal experimentation,
cellular pathology and the identification of cancer-causing chemicals in cigarette smoke. For example
a study from C. S. Muir and R. Kirk showed the effects of chewing tobacco in mice in 1960 with the
help of extensive tissue research. Biopsies were taken from the mice and ulcerations and lesions
were carefully investigated.34 Showing the impact of the tobacco on the mice.
Another study H. F. Dorn from 1959 was done based on the data retrieved from surveys, which is like
most of the data from that time period. He investigated the mortality of smokers and non-smokers
and compared them to the expected mortality ratios. Showing evidence for the malignant effects of
smoking. Combined with autopsy reports, he also linked the tobacco consumption to a wide variety
of types of cancer.35

A last example is from E. L. Wynder and G. Wright who specifically investigated the carcinogens and
carcinogenesis of tobacco in 1957. Investigating the various ingredients and their properties with
chemical fractionation, molecular distillation and ion-exchange experiments, reinforcing the already
growing knowledge of the carcinogenic properties of tobacco and tar.36
While the scientific evidence on the negative effects grew, the tobacco industry kept marketing to as
many individuals they could reach. This was so much the case that there was even a cartoon figure
Joe Camel who helped market cigarettes to children and teenagers. Although the industry will
probably not admit it, individual comments made by employees and executives support that this was
indeed a positive effect of their campaign.
A Philip Morris Executive even wrote that “hitting the youth can be more efficient even though the
cost to reach them is higher, because they are willing to experiment, they have more influence over
others in their age group than they will later in life, and they are far more loyal to their starting
brand.” (1957)37
Not only did the industry market to as many people that could reach, they were also aware of the
possible risks of smoking and even more aware of the ignorance of the public towards these risks. In
1954 a poll was done and only 41 percent of the interviewed stated they believed smoking is one of
the causes for lung cancer. And this research also revealed that 48% of the doctors still smoked. This
ignorance was easily manipulated by the tobacco industry.32 Not only have there been an abundance
of recorded statements from within the company where the companies refer to their efforts to stop
the awareness of the health hazards caused by smoking. For example they denied found evidence of
smoking hazards or admitted to trying to find evidence that would protect their case.
Imperial Tobacco: “I state that in our considered opinion there is no proof at all that smoking causes
lung cancer and much to suggest that it cannot be the cause.” (Imperial Tobacco, 1956)37
Helmut Wakeham, Head of Research and Development of Philip Morris, wrote: “Let's face it. We are
interested in evidence which we believe denies the allegations that cigarette smoking causes
disease.” (Philip Morris, 1970)37
However their efforts did not only limit themselves to the internal structure of these companies.
Many statements from the companies were also targeted at the public to reinforce the ignorance of
the consumers. For example there was the advocacy advertisement A Frank Statement to Cigarette
Smokers, which was a joint undertaking of multiple manufacturers in 1954. Which promised three
important points:
Promise 1: “We believe the products we make are not injurious to health”
Promise 2: “We are pledging aid and assistance to the research effort into all phases of tobacco use
and health”
Promise 3: “We always have and always will cooperate closely with those whose task it is to
safeguard the public health”33
As we now know these promises were all short lived if they were ever true at all. A 1972 propaganda
film went even beyond that. ‘Smoking and Health: The Need to Know’, was shown throughout the
USA, and even to teenagers. The movie was a huge success for the industry as the creator Anne
Duffin at the Tobacco Institute was able to report that the film had reduced by 17.8% the number of
people agreeing that ‘Cigarette smoking causes lung cancer’ (from 74.9% to 57.1%).32
So the constant denial of scientific evidence by the industry was extremely effective on the
appearance that smoking had in the past, but how is it that the scientific research and government
did not expose these practices? For the beginning of the 20th century the lack of evidence was
mainly the reason, but in the midst of the 20th century the science seemed indisputable. This is
where rules and regulations came into play or rather the lack of or a lack of legal power. Seeing that
this combined with the ignorance of the public and the legal power of the companies kept this
structure in place for a longer period. However most of this was addressed and rectified during the
second half of the 20th century. For example the FDA helped to enact a number laws to stop the
spread of misinformation by smoking and to decrease the marketing done by these companies. After
identifying smoking as a cause of increased mortality in 1964 based on a First Report of the Surgeon
General’s Advisory Committee on Smoking and Health, they created in 1965 the Federal Cigarette
Labeling and Advertising Act, which required a health warning on cigarette packages, required
Federal Trade Commission to submit annual report to Congress on tobacco industry advertising and
labeling practices, and required the Department of Health, Education, and Welfare to submit annual
report to Congress on health consequences of smoking. Other important laws that were created,
were for example:38,40
The public health cigarette smoking act, enacted in 1970 that required a health warning on cigarette
packages and prohibited cigarette advertising via television or radio.38,40
The comprehensive smoking education act from 1984 which created the four separate warning labels
for cigarette cartons and tobacco advertisements.38,40
The comprehensive smokeless tobacco health education act from 1986 which also created the three
separate warning labels for smokeless tobacco cartons and its advertisements. It also prohibited the
use of smokeless tobacco advertising via television and radio, required a report on smokeless from
the Department of Health and Human Services every other year. And required reports on the annual
sales, marketing and advertising from the Federal Trade Commission on smokeless tobacco, and a
confidential list of all additives and nicotine content in smokeless tobacco product from their
producers.38,40
Measures like these are still active nowadays and are an important factor in nowadays decreasing
number of smokers in western countries. Just like the new laws created for tobacco, other
substances also were regulated by individual laws based on their properties.
A more complete act covering a wider protection against misleading claims and harmful products
would come from the False Claims Act, which originated from 1863 but suffered from the conditions
of the world wars and lost most of its power. It was amended in 1986, 2009 and 2010 to update its
contents and it has been one of the most effective counters versus misleading information, giving
individuals the opportunity to sue companies when they were provided with shortcoming products.39

As we saw in the past few examples there have been many regulations and rules enacted to
combat the spread of misinformation and unethical marketing, but…
Which organizations and agencies are responsible for the rules and regulations and how does this
system work?
Each government can set his own rules and regulations and often has their own agency in place. For
example in the USA this is the FDA. The FDA was founded in 1906 and is tasked with safekeeping the
health of the public by ensuring the safety of food, drug, cosmetics, veterinary medicines, biological
products, medical devices, tobacco and radiation-emitting products.40
And FDA states that: FDA is responsible for advancing the public health by helping to speed
innovations that make medical products more effective, safer, and more affordable and by helping
the public get the accurate, science-based information they need to use medical products and foods
to maintain and improve their health.40
And as we saw in the tobacco industry the FDA indeed does try to address problems with insuring
that the public gets the accurate, science-based information they need. However this agency is not
only agency responsible within USA. Whereas the FDA has more focus on the scientific part of the
malpractice in marketing discussed in this paper, there is also an agency that focuses more on the
marketing end. The FTC, this organization created in 1914 with its main focus on protecting
consumers and promoting competition.40
In its own words on the protection of consumers: The FTC protects consumers by stopping unfair,
deceptive or fraudulent practices in the marketplace. We conduct investigations, sue companies and
people that violate the law, develop rules to ensure a vibrant marketplace, and educate consumers
and businesses about their rights and responsibilities.40
A last example of an import organization is PhRMA founded in 1958, which focusses mainly on the
rules and regulations surrounding the use of pharmaceuticals in the US. Their mission as stated by
themselves is: Our mission is to conduct effective advocacy for public policies that encourage the
discovery of important, new medicines for patients by biopharmaceutical research companies. To
accomplish this mission, we are dedicated to achieving these goals in Washington, D.C. and across
the country.40
The combination of these agencies tries to fight misinformation from marketing and is quite effective
at doing so. When malpractices are identified these instances can take the violators to court with the
help of the laws they helped to enact. Like for example the FDA and quoted by the FDA themselves:
the Federal Food, Drug, and Cosmetic Act of 1938 was passed after a legally marketed toxic elixir
killed 107 people, including many children. The FD&C Act completely overhauled the public health
system. Among other provisions, the law authorized the FDA to demand evidence of safety for new
drugs, issue standards for food, and conduct factory inspections.40 The legal power of these
organizations is most important in these feats. And in most cases this is sufficient and the
malpractices can be stopped.
For the identification of malpractices these organizations rely on input by the consumers and specific
teams like for example the regulatory research and monitoring teams of the FDA.40
When the agencies fail in combatting the problem, they usually rely on governments themselves to
create new laws, which in turn depends on the representatives chosen by the population.
Another layers to this system are added by the EU which controls a part of the regulations and rules
within the participating countries in Europe and larger international organizations like the WHO. For
example the structure for the rules and regulations controlling international pharmaceutical
companies is divided in three layers with an additional International and European layer (figure 1).51
Figure 1, Summary of different code and regulatory mechanisms applying to international pharmaceutical companies.
Taken from Ethical pharmaceutical promotion and communications worldwide: codes and regulations. J Francer51

The last piece in the puzzle are journals and their efforts to prevent flawed researches from entering
the public domain. Their reviewers are essential in rejecting false information which in turn could be
used by companies to market their products. These rejections are extremely important as published
articles are sometimes enough to create enough contradictory statements, which could impair the
legal side of banning misleading advertisements. Like mentioned in the tobacco industry, companies
could hold onto their misleading information for a longer period of time by denying the evidence of
the health hazards of smoking. As legal processes of these sizes often take a lot of time and can be
affected by the legal power of both sides. And preventing the use of false scientific articles can play a
vital role in preventing longer lawsuits and lower the chances of losing these cases.

However as we saw in our examples there are limitations to what these organizations and agencies
can do and there are factors and problems that can severely slow down this process. So…
What are the shortcomings in the current system and in which areas are the agencies and
organizations too limited in power and measures?
A big issue is often that each case of misleading cases that comes to court is not a guaranteed victory
for agencies like FTC and FDA. This is for a couple of reasons, larger companies with a lot of legal
power and high budgets for legal departments are often successful in elongating legal procedures. As
they are able to afford better lawyers for a longer period of time than some agencies are able to do.
This creates opportunities for companies to dodge certain laws as they can stall out some
government agencies. Or they are able to reduce measures they have to live by. An example of this is
the same tobacco companies as in earlier examples. The tobacco industry is still a booming business
even though the percentage of smokers in most western countries is decreasing. This is mainly due
to increased export to third world countries. Rules and regulations in countries like these are often
more limited and creation of new laws is often opposed by the legal power of big companies that
sometimes have bigger incomes than the GDP of these countries. This creates a lot of pressure on
any agency that tries to oppose the marketing of harmful products like cigarettes. Togo is country
that suffers from these problems and although the tobacco industry was required to label cigarette
cartons with warning messages, the high illiteracy of the populace renders this mostly useless. The
warning images that we know of in western countries would be a more effective measure. However
the companies are unwilling to cooperate with these proposed laws. And often state they are not
willing to help a government with any health fad if this would mean creating negative publicity for
themselves.41,42
Another means for companies to evade certain rules and regulations is changing the labeling of the
product without changing the composition or ingredients. However changing the products labels can
help to pass by certain rules and regulations that specific products need to abide by. Changing a
certain drug that would combat diabetes from a medical drug to a supplement or a homeopathic
products can significantly reduce requirements for safety or testing, while still enabling the product
to enter the market. This change can be ever so slight and products can appear as a genuine
medication, but the lower scientific testing and sometimes disputable ingredients would set the
product apart from actually being a proper treatment to certain diseases. These products reaching
the market enables off-label marketing.44 All though off-label seems unethical and dangerous, there
have been numerous cases of off-label use working as a remedy. This does not however set the
subject free from controversy as the testing is essential for safe use. And for these reasons there are
both FDA approved and unapproved off-label drug uses,43 based on experiences with specific drugs in
specific situations. The marketing of off-label products is likely more apparent in countries like the
USA, where marketing straight to the public is possible. Although most of the times the public is not
able to get these medicines on their own, the commercials usually end with the sentence “ask your
doctor about this product”. And doctors play an important role in further educating the patients in
why sometimes these products would do more harm than good; which would be the end of a
problem, although not perfect, but doctors can also be a target of these marketing programs. And
these marketing programs have often been described as forms of bribery to get doctors to subscribe
specific medicines more. A big underlying issue within this is that drug companies can often get their
hands on the data that shows the prescribing drugs of individual doctors. With this information,
companies can actually control if doctors prescribe enough of their product and not their
competition. Which could harm those that would benefit more from competitors products.
A problem with advertisements that is also often misleading is how these are set-up. Although this is
not illegal and often just considered marketing, providing benefits of a certain product first by a
seemly credible person (like a doctor or celebrity) and then quickly strolling through side effects, can
also be considered as a form of spreading misleading information. This is a smaller issue, but
widespread nonetheless. An example from USA is for example a diabetes type 2 product that would
help as a last possibility to improve the health of a patient. The product is explained by a former
basketball player and all its benefits are listed in around one minute. Then the camera pans out and
the celebrity stops speaking and goes on to entertain, and a different voice takes over and explains
all risks associated with the drug.45 Although the drug is effective at what it does46 and lists all
benefits and risks, the weight of importance is shifted to the benefits by the structure of the
commercial. An example from the Netherlands is Lactacyd. Although also an effective products with
enough supporting scientific evidence, a commercial started with a statement that just washing with
water would not protect the vaginal hygiene.47 A statement like that carries some impact as this
opposes what most women are taught. However the statement is also false, in healthy situations this
is enough to safe keep vaginal hygiene. However when the normal PH gets messed up like during
problems with vaginal hygiene, a product like Lactacyd could help to restore a healthy situation.48,49
Even though the commercial already has undergone some changes to prevent further
misinformation, it does show that simply making poorly worded statements can already cause
misleading product advertisements.
Lastly we discuss a problem closer to scientific end of the spectrum and that is open access journals.
Although the idea behind these journals is great and these journals could help to spread more
research to wider group of people. However this system is also sensitive for fraud. There are open
access journals that have too few control mechanisms in place or worse allow almost any article to
get accepted to the journals. Which in turn would help false research to be published and used as
scientific evidence for companies to use. To show how easy it can be to publish an article in some
magazines a comedian named Adam Connover created with some help a fake article on The Possible
Irritating Effects of Nutritional Facts,50 which got published in Aperito an open access journal with the
focus on advances in nutrition and food. To summarize the article quickly, only the abstract show
some forms of being a genuine article, while the rest of the article contains no useful information
whatsoever and instead describes parts of Connover’s own TV show mixed with completely random
figures on non-relevant information. Although this is one instance of this system messing up, it shows
that this system does have some sensitive areas. And this is not meant as remark to voluntary
reviewers that do help to uphold the quality of scientific papers, but more as awareness-creating as
the work of reviewers to uphold quality might not protect the scientific world from false and
fraudulent papers getting published.

How to improve this current situation?

Many of the problems mentioned here, have been around for a long time and have been studied and
published in scientific articles to create increased awareness on the subject. And not only that, but
articles like these help to create an oversight of the biggest problems we are facing. For example the
article by J. Francer on Ethical pharmaceutical promotion and communications worldwide: codes and
regulations.51 Which is a complete article on the promotion of pharmaceuticals, the problems faced,
an analysis, the rules and regulations worldwide and what to do when rules are broken by
individuals. Articles like these should reach and inform as many as possible in the pharmaceutical
industry to promote ethical behavior. And the increase of awareness is vital to improving the
situation. Another example of a successful article on the matter is the article of C.E. Kearns Sugar
Industry and Coronary Heart Disease Research: A Historical Analysis of Internal Industry Documents
from September 2016,52 which contained a similar message as the articles on smoking mentioned in
this paper.
Extreme examples from the past and current problems are incredibly relevant for improving the
process and the advice given by the writers that studied the subject can help to improve the system,
but only if there is enough support of the public for it to change.
Changes that are proposed to system are for example: The improvement of Open Access Journals
and an increased awareness in the models limitations, which was for example mentioned in the
articles:
Some Thoughts on the Future of Libraries, Journals, Impact Factors, and Replicability;53
ResearchGate is no longer reliable: leniency towards ghost journals may decrease its impact on the
scientific community;54
Academic nightmares: Predatory publishing; How to Recognize and Avoid Potential, Possible, or
Probable Predatory Open-Access Publishers, Standalone, and Hijacked Journals.55
Problems with advertisements for pharmaceuticals, which often advised doctors to be cautious on
the data presented by pharmaceutical advertisements and to be better informed on the adverse
effects caused by the problem.56,58
And for example the limitations of rules and regulations like the false claims act on off-label
advertising.57 Which rightfully stated that the organizations reinforcing these rules should be more
powerful and gain more resources to combat problems like these.
Based on the recommendations by most of these articles, there is a need for more rules and
regulations and more regulatory power by the respective authorities to combat the problems
mentioned before. And already enacted rules and regulations have to be updated often to stay
relevant in this fast changing environment.

Conclusion/summary

Marketing sometimes clashes with research. Where research is mainly focused on finding the truth
and discovering more knowledge, marketing tends to favor its own beneficial truths. This is a
controversial statement and it is certainly not true for a lot of companies. However we know that this
is true for a least a number of cases, which is harmful enough. So it is highly important for the public
health that we have a number of safety rules and regulations in place for products and marketing.
In the past less rules were in place, governmental agencies were less developed and scientific
research was not far enough to combat abnormal of false claims. In these periods malpractices in
marketing were abundant and often not perceived as so by the public, because of the limited
countermeasures and ignorance towards these problems.
The progress made by governmental agencies and the development of scientific research and
scientific journals absolutely changed this for the better and the current situation is much improved
from the past.
So now we see that there is a tendency for companies to market products by making as many
beneficial claims as possible to standout from other competitors. These messages are made in
specific ways to cause a need for their product, so usually these claims contain messages on a better
state of living and improving ourselves. These claims can be made based upon research done by the
company or already published data. These publications are checked thoroughly by reviewers before
they were published by scientific journals. The claims and product are also obligated to follow rules
and regulations of specific product types, which are based on acts and court decisions made in the
past. When the companies do not follow these rules or harm individuals, large agencies are able to
step up and sue these companies to protect the public health. And in court the rules can then be
enforced and adapted based on specific cases. Companies sued can then be forced to change their
marketing claims, product, or the product can even be taken away by the agencies.
Although the current system limited and this is mainly caused by the enormous power and influence
some companies have, which is sometimes too much for agencies to combat. In the same category
are also problems like the slowness of the legal process and its sensitivity towards specific situations
and details that could prolong the case and or change the outcome. In the scientific area there are
also limitations in the battle against fraudulent and false research. This is mainly caused by new
research possibilities like P-fishing and the creation of money-centered open access journals. Lastly
communication channels are also a problem, but unlike the others, this is something we will probably
not be able to tackle as miscommunication and shortcomings in fact checking are just mistakes and
no offenses of the law.
Our focus on improving this problem should be on the agencies and organizations that have the
power and responsibility to protect consumers and patients. By supporting these organizations and
giving them enough means, we can have a better control over the misuse of shortcoming scientific
data and false claims.
Discussion
The problems described in this paper are not new and the concern and interest in the subject of me
and people like me is because of this ongoing evolution of scientific misuse and the spread of false
statements. Any individual I know, does know examples of this misuse and forms of false information
spreading across media. Multiple articles on specific issues have already been written on the
combination of marketing, healthcare, and scientific research. And especially the marketing of
pharmaceuticals. With subjects regarding disease mongering, marketing to doctors, sponsored
research, misleading advertisements, off-label drug use, and many more.60,61,63,64,65,66,67,68

A variety of other often described problems in the same context, are mentioned below:
Disease mongering is connected to the marketing to doctors, which was addressed earlier. The
problem is related as doctors diagnose diseases more often and prescribe more meds, which is
usually caused by incentives and pressure from pharmaceutical companies.63 The diagnoses and
prescriptions are made even though individuals might not be sick or suffer from treatable
harms.58,59,60

An interesting case of disease mongering by companies is Listerine which has popped up in scientific
articles and popular media alike. The mouthwash that started off as a cleaning based on the same
antiseptic properties, created the term halitosis.61,62 The term that means bad breath was first
announced as a disease that would impair living a normal social life. The marketing of the new
mouthwash was successful because of the introduction of the term. And the fear for the disease
created by the term and the marketing campaign was the main reason for the success of the Listerine
mouthwash, which is even admitted –though in different wordings- by Listerine itself.61,62

Off label drug use is also often discussed and investigated, and explained as the usage of drugs for a
function that they are not tested or meant for. The usage can be beneficial if all others measures fail
and the drug has been known to improve specific conditions. However most of the times this usage
can be dangerous as the drug was not approved for this specific disease by organizations like the FDA
as research showed shortcoming, absent or negative effects. It often combines with the malpractice
of changed product tags as drugs that were not approved by the FDA, can still be used against the
same disease as an off-label homeopathic drug.43,44

Cases like these, should make everyone realize that there are flaws in the current system, even
though it is miles better than what is was before. Although most people with adequate experience
and knowledge are able to recognize false information when this is provided to them, it is vital that
we create a better system that will also protect the ones that do not have these capabilities.
Important is that we try to improve this situation as best we can and there are a number of ways to
make improvements to the current system.

Realizing that not everyone is aware of the problem is mentioned before and therefore increasing
the information flow to these people could be an interesting start. Educating people from early on
that commercials and advertisements can lie and where to look for when trying to find reliable
information, would be an important improvement of their skillset and would help them keep
themselves safe from harmful products.

Improving or adding control mechanisms for open access that are lacking would also be an excellent
process. Or the creation of a acts that would prevent companies from using articles from extremely
low impact journals to support essential claims. Which is controversial as low impact would not mean
bad or false information. However the addition of the reviewing process to essential statements in
advertising on the internet, television, radio and other media outlets can be a vital improvement.
Both could help to reduce the possibilities for companies to create and use false data for the
marketing of their products.
However even more essential would be to support the agencies that protect the public from harmful
products or misinformation. Improving the legal strength of these agencies and the funding would
help these organizations immensely with their capabilities and mainly their effectiveness in courts.
Essential for improving the scientific and marketing community is that governmental agencies are
large and strong enough to check as many cases as possible and act on them as quickly and
efficiently as possible. Possibly even giving them the possibility of recreating scientific experiments to
reduce more forms of fraud. Or giving the ability to have specialized teams of paid reviewers to check
important and possibly false/fraudulent articles. Keeping these organizations free from corruption is
vital. And the added power could help them closes mazes in the legal net that protect millions of
people from possibly harmful products. We can do this by supporting parties that promise to help
governmental agencies like FTC and FDA and by communicating to organizations like these when
disputable cases are found to notify them of possible threats. Of course most of this might be
unreachable even with improved budgets, but limiting the harm done to the population can maybe
even reduce costs of insurances and hospitals in the future and even more important, limit the harm
done to consumers and patients.
Sources

Official Red Bull webpage and subsites:

1. http://www.redbull.com/us/en
2. http://energydrink-us.redbull.com/en/red-bull-energy-drink#howitworks
3. http://energydrink-us.redbull.com/en/ingredients-red-bull
4. http://energydrink-us.redbull.com/en/taurine-red-bull
5. http://energydrink-us.redbull.com/en/caffeine-red-bull
6. http://energydrink-us.redbull.com/en/sugars

7. Belli DC; Taurine and TPN solutions? Nutrition. 1994 Jan-Feb;10(1):82-4.

8. Belli DC; Chapter: Use of taurine in total parenteral nutrition.
Book: Amino acids in critical care and cancer. R. Latifi ed. - Austin : R.G. Landes, 1994. - pp.
53-74.
9. Sherman M; odide: A twenty-five year perspective. Food Drug Cosmetic Law J. 1986; 41: 458-
466.

10. Literarture review of Z.J. Ramsey for Psychology department of Vanderbilt University:
Does Red Bull really give you wiiings?: Studying the benefits/risks of energy drinks.
http://healthpsych.psy.vanderbilt.edu/2008/redbull.htm

11. Obrosova IG; Taurine Counteracts Oxidative Stress and Nerve Growth Factor Deficit in Early
Experimental Diabetic Neuropathy. Experimental Neurology. 2001 Nov;172(1):211–219.
12. Baum M & Weiß M; The influence of a taurine containing drink on cardiac parameters before
and after exercise measured by echocardiography. Amino Acids. 2001 Feb;20(1):75–82.
13. Fei Li; Taurine reverses neurological and neurovascular deficits in Zucker diabetic fatty rats.
Neurobiology of Disease. 2006 June; 22(3):669–676.
14. Roysommuti S; Perinatal taurine exposure affects adult arterial pressure control. Amino
Acids. 2014 Jan;46(1):57-72.
15. Takashi Ito; The potential usefulness of taurine on diabetes mellitus and its complications.
Amino Acids. 2012 May; 42(5): 1529–1539.
16. Visram S; Consumption of energy drinks by children and young people: a rapid review
examining evidence of physical effects and consumer attitudes. BMJ Open. 2016 Oct 8;6(10).
17. Talanian JL; Low and moderate doses of caffeine late in exercise improve performance in
trained cyclists. Appl Physiol Nutr Metab. 2016 Aug;41(8):850-5.
18. Costill DL, Dalsky GP, Fink WJ; Effects of caffeine ingestion on metabolism and exercise
performance. Medicine and Science in Sports. 1978, 10(3):155-158
19. Atik A; Caffeine for apnea of prematurity: Effects on the developing brain. Neurotoxicology.
2016 Nov 27;58:94-102.
20. Cabrera OH; Caffeine combined with sedative/anesthetic drugs triggers widespread
neuroapoptosis in a mouse model of prematurity. J Matern Fetal Neonatal Med. 2016 Dec
7:1-8.
21. H.-D. Belitz, W. Grosch, P. Schieberle; Food Chemistry. third edition (2004).

22. Springer-Verlag, Stiftung Warentest (7/2012).

23. Official webpages for Pepsi and Coca Cola companies and their products:
http://origin-www.pepsicobeveragefacts.com/
http://www.coca-cola.co.uk/drinks
24. Selvin HC & Stuart A; Data-Dredging Procedures in Survey Analysis. The American Statistician.
1966; 20(3): 20-23.
25. Forstmeier W; Detecting and avoiding likely false-positive findings - a practical guide. Biol Rev
Camb Philos Soc. 2016 Nov 23.

26. Webpage of statistics Canada on the misinterpretation of data:

http://www.statcan.gc.ca
http://www.statcan.gc.ca/edu/power-pouvoir/ch6/misinterpretation-
mauvaiseinterpretation/5214805-eng.htm

27. Arndt S; Effects of errors in a multicenter medical study: preventing misinterpreted data. J
Psychiatr Res. 1994 Sep-Oct;28(5):447-59.
28. Matteo S, Dal Zotto C; Native Advertising, or How to Stretch Editorial to Sponsored Content
Within a Transmedia Branding Erap. 169-185.
29. Howe P, Teufel B; Native advertising and digital natives: The effects of age and
advertisement format on news website credibility judgments. ISOJ Journal, 2014; 4(1).

30. Dr Oz official webpage:

http://www.doctoroz.com/

31. Korownyk C; Televised medical talk shows—what they recommend and the evidence to
support their recommendations: a prospective observational study. BMJ 2014
32. Proctor RN; The shameful past. The history of the discovery of the cigarette–lung cancer link:
evidentiary traditions, corporate denial, global toll. Tob Control 2012;21:87-91.
33. Cummings KM; Failed promises of the cigarette industry and its effect on consumer
misperceptions about the health risks of smoking. Tob Control 2002;11:i110-i117.
34. Muir CS and Kirk R; Betel, Tobacco, and Cancer of the Mouth. Br J Cancer. 1960 Dec; 14(4):
597–608.
35. Dorn HF; Tobacco consumption and mortality from cancer and other diseases. Public Health
Rep. 1959 Jul; 74(7): 581–594.
36. Wynder EL and Wright G; A study of tobacco carcinogenesis. I. The primary fractions. TOC.
1957 march/april; 10(2): 255–271

37. A paper for the WHO and ASH organizations on the tobacco industry:
Bates C, Rowell A; Tobacco explained. The truth about the tobacco industry...in its own
words. ASH London, 1998.

38. Webpage timeline enacted laws FDA versus smoking:

https://betobaccofree.hhs.gov/laws/

39. False Claims Act information. Webpages from https://www.justice.gov and

http://www.phillipsandcohen.com:
https://www.justice.gov/sites/default/files/civil/legacy/2011/04/22/C-
FRAUDS_FCA_Primer.pdf
http://www.phillipsandcohen.com/False-Claims-Act-History/

40. Official webpages for FDA, FTC and PhRMA:

http://www.fda.gov/
https://www.ftc.gov/
http://www.phrma.org/
41. Tavernise S; Tobacco Firms’ Strategy Limits Poorer Nations’ Smoking Laws. NY Times 2013
Dec 13.
42. Agbavon P; The Tobacco Industry and Tobacco Control Movement in Togo. Association
Togolaise des Jeunes pour le Developpement (ATJD) 2001 Nov.

43. Webpage of FDA on off-label drug use:

http://www.fda.gov/ForPatients/Other/OffLabel/default.htm
http://www.fda.gov/RegulatoryInformation/Guidances/ucm126486.htm

44. Discussions on off-label drug use on Science Based Medicine:

https://sciencebasedmedicine.org/
Novella S; The Debate About Off-Label Prescriptions. November 12, 2008
Novella S; Off-Label Use of Prescription Drugs. August 26, 2009

45. Victoza commercial:

https://www.ispot.tv/ad/AK2g/victoza-moment-of-truth-featuring-dominique-wilkins

46. Jackson SH; Liraglutide (Victoza). The First Once-Daily Incretin Mimetic Injection For Type-2
Diabetes. P T. 2010 Sep; 35(9): 498-502, 529.

47. Webpage of Stichting Reclame Code on the controversial remarks in the original commercial:
https://www.reclamecode.nl/webuitspraak.asp?ID=142859&acCode

48. Eusaph AZ; Lactacyd FH as an adjuvant therapy for vulvovaginal infections in Pakistani
women: FRESH study, a satisfaction survey. J Pak Med Assoc. 2016 May;66(5):521-7.
49. Decena DC; Metronidazole with Lactacyd vaginal gel in bacterial vaginosis. J Obstet Gynaecol
Res. 2006 Apr;32(2):243-51.
50. Conover A; "The Possible Irritating Effects of Nutritional Facts" Advances In Nutrition And
Food Technology. Aperito. 29 Sep, 2015.
51. Francer J; Ethical pharmaceutical promotion and communications worldwide: codes and
regulations. Philosophy, Ethics, and Humanities in Medicine 2014
52. C.E. Kearns; Sugar Industry and Coronary Heart Disease Research: A Historical Analysis of
Internal Industry Documents. JAMA Intern Med. 2016;176(11):1680-1685.
53. Elwood TW; Some Thoughts on the Future of Libraries, Journals, Impact Factors, and
Replicability. J Allied Health. 2016 Winter;45(4):235.
54. Memon AR; ResearchGate is no longer reliable: leniency towards ghost journals may
decrease its impact on the scientific community. J Pak Med Assoc. 2016 Dec;66(12):1643-
1647.
55. Danevska L; How to Recognize and Avoid Potential, Possible, or Probable Predatory Open-
Access Publishers, Standalone, and Hijacked Journals. Pril (Makedon Akad Nauk Umet Odd
Med Nauki). 2016 Nov 1;37(2-3):5-13.
56. Villanueva P; Accuracy of pharmaceutical advertisements in medical journals. Lancet. 2003
Jan 4;361(9351):27-32.
57. Kesselheim AS; False Claims Act prosecution did not deter off-label drug use in the case of
neurontin. Health Aff (Millwood). 2011 Dec;30(12):2318-27.
58. Mintzes B; Pharmaceutical sales representatives and patient safety: a comparative
prospective study of information quality in Canada, France and the United States. J Gen
Intern Med. 2013 Oct;28(10):1368-75.
59. Tiner R; The pharmaceutical industry and disease mongering. The industry works to develop
drugs, not diseases. BMJ. 2002 Jul 27; 325(7357): 216.
60. Moynihan R; Selling sickness: the pharmaceutical industry and disease mongering. BMJ. 2002
Apr 13; 324(7342): 886–891.
61. Dossey L; Listerine’s Long Shadow: Disease Mongering and the Selling of Sickness. Explore
2006 sep; 2(5): 379–385

62. Listerine official webpage:

https://www.listerine.co.uk
https://www.listerine.co.uk/about

63. Grande D; Limiting the influence of pharmaceutical industry gifts on physicians: self-
regulation or government intervention? J Gen Intern Med. 2010 Jan;25(1):79-83.
64. Lundh A; Industry sponsorship and research outcome. Cochrane Database Syst Rev. 2012 Dec
12;12:MR000033.
65. Melander H; Evidence b(i)ased medicine--selective reporting from studies sponsored by
pharmaceutical industry: review of studies in new drug applications. BMJ. 2003 May
31;326(7400):1171-3.
66. Villanueva P; Accuracy of pharmaceutical advertisements in medical journals. Lancet. 2003
Jan 4;361(9351):27-32.
67. Othman N; Quality of claims, references and the presentation of risk results in medical journal
advertising: a comparative study in Australia, Malaysia and the United States. BMC Public
Health. 2010 May 29;10:294.
68. Zetterqvist AV; Misleading advertising for antidepressants in Sweden: a failure of
pharmaceutical industry self-regulation. PLoS One. 2013 May 1;8(5):e62609.