The corrupt industry

THE CORRUPT INDUSTRY – INSTITUTIONAL CORRUPTION OF PHARMACEUTICALS

The World Health Organization issued a fact sheet about the corruption of pharmaceuticals in 2010, warning about the dangerous and unethical practices and techniques of the industry. Corruption occurs in almost every phase from the development right until the patient has the product in their hands –the usual practices are bribery, falsification of evidence and mismanagement of conflicts of interest. But before going into details, we have to state that the pharmaceutical industry has contributed more for the well-being of mankind than any other; but it’s also undeniable that the avoidable suffering caused by it is also beyond comprehension around the world. The worldwide phenomenon of industrial corruption of pharmaceuticals has reached a new high: the tendency of paying bribes is mind-blowing in the United States alone – a research in 1986 found that 19 of the 20 largest American pharmaceutical companies are the not-so-innocent victims of substantial bribery; we can hardly imagine how these data might have changed in the 28 years since then. In my presentation I would like to highlight the universal patterns and the main dangers of institutional corruption in the industry and also demonstrate it with a painfully current scandal in the field of cancer research.

Paradox of corruption and conscience

In order to understand the origins of the problem we need to take a better look at the motives behind it. The obvious craving for profit is the reason for the so called „paradox of corruption and conscience” as Dr John Braithwaite, an Australian researcher stated in one of his studies; the industry naturally attracts those who are keen on making the world a better place by solving health problems but the mechanism and realities of the market make the temptation for corporate crime also acute. To see this properly, we need to change the way we look at the pharmaceutical industry – instead of picturing it like any other, ordinary business, we should observe it the way we do with aerospace and defence industries. The future of the company often depends on securing the work of a small group of people who can unlock a section of a market with a single product which has already cost a fortune to develop. There is no need for natural competition, pure monopoly is the only way to survive. For such great accomplishment the leaders of the companies are willing to sacrifice everything. From the unethical low of bribing government officials to the point of bribing cabinet ministers to get drugs approved for marketing, companies will do anything humanly possible to improve their chances of being number one.

Let us get away from the playground of the international market and have a closer look at the effect of it all in our day-to-day lives. For us, simple patients, bribery is not the biggest danger but the fraud in the safety testing of drugs. What we often see in movies about lab rats is hardly likely to happen in the real world, the truth is much uglier: rats that die in clinical trials are replaced with live animals, rats that develop tumors are replaced with healthy ones, and, as a mostly American phenomenon, doctors are payed thousands of dollars a patient to test a new drug simply pour the pills down the toilet and tell the companies what they want to hear without the blinking of an eye. But the current hot topic in the media focuses on a less blatant form of fraud against health authorities which has generally caused the greatest loss of life in many other cases before – companies telling half-truths to governments about the severity of side effects or covering up adverse reaction reports from concerned doctors.

The quest for the cure of HPV

The exact scandal that inspired this presentation is the never ending debate about the HPV vaccines. What is HPV to begin with? Human Papilloma Virus is also known as the „wart” virus; there are over 100 strains of it known – they are responsible for the warts that appear on the hands and feet. About 30 of them can be sexually transmitted; however, there are 13 strains of it that have been found to be present in nearly 100% of all cases of cervical cancer. Given this information, it is easily understandable why this area of cancer research was so burningly acute in the last decades. The dawn of the 21st century brought the first results and hopes in the form of two vaccines: the U. S. Food and Drug Administration licensed Gardasil in 2006 and Cervarix in 2009. Both of them are products of a company called Merck. According to the website of FDA, Gardasil is meant for the prevention of vaginal, anal and vulvar cancer, genital warts, and numerous precancerous or dysplastic lesions. It is recommended for girls and women 9 through 26 years of age, but also for men and boys of that age. Both vaccines are usually given as a 3 shot series, and they are officially protective for five years; as for those who question what happens after five years or what can those expect who only get one or two shots – we do not have any data yet. Being the only available vaccines, and also having governmental approval and support, prices are equally spicy. The retail price of either vaccines is about $130 per dose in the United States, so it is a nice sum of $390 for the full series. The prices are a little bit higher in Hungary, even though you might catch a program with government support from time to time; an average citizen has to pay 30 000 forints per dose in order to get the vaccination. All official governmental handouts and prospects state that, according to research, there is no evidence of life threatening danger or severe side effects and that the vaccines are perfectly safe and effective. This is what most people hear about it, or to be honest, that is what the company needs us to know and believe.

Gardasil is available since 2006, and in 2009 the very first nationwide HPV post licensure study has been published by CDC (Centers for Desease Control and Prevention) including clinical review of medical records associated with reports to VAERS. VAERS is the Vaccine Adverse Event Report System which is a voluntary system that collects reports from individuals who feel that they had an adverse event, a bad health outcome after receiving the vaccine. This study in the Journal of the American Medical Association included these main findings: between 2006 and 2008 23 million doses were nationally administered and there were a total of 12 424 reports to VAERS of adverse events. 94% of them were not serious; an adverse event is considered serious if it is life threatening or results in death, permanent disability, abnormal conditions at birth, hospitalization or prolonged hospitalisation. The most common events reported were fainting, pain and redness, dizziness, nausea and headache, which do not really seem to be severe consequences, but we cannot walk past by those 772 adverse events – 6% of all reports – that described serious conditions. 32 women died, others have been diagnosed with unusual neurological illnesses such as the Lou Gehrig’s Disease (it is a neurodegenerative illness that can be characterised by muscle spasticity, rapidly progressive weakness due to muscle wasting; this results in difficulty in speaking, swallowing and breathing), but the remaining reports about blood clots in the lungs and heart are just as terrifying and dangerous. The Package Insert and the Patient Information about Gardasil is available at the website of FDA; and surprisingly they only list the following possible side effects: headache, nausea, bruising, dizziness and fever – not a word about the slightest chance of something severe happening.

In the same year something unexpected happened: Dr. Diane Harper, one of the researchers of Gardasil who helped design and carry out the Phase II and Phase III safety effectiveness to get it approved, and also authered many of the published papers about it, spoke out about the contradictions in connection with the vaccine. It is quite unusual that a researcher who had been the paid speaker and consultant for Merck publicly criticizes a vaccine she helped get approved. In her statement she highlights her biggest worries; first of them is that there are no results proving that it remains effective beyond five years, and this raises questions about the CDC’s recommendation that the shots can be given to girls as young as 11-years old. “If we vaccinate 11 year olds and the protection doesn’t last… we’ve put them at harm from side effects, small but real, for no benefit. The benefit to public health is nothing, there is no reduction in cervical cancers, they are just postponed, unless the protection lasts for at least 15 years, and over 70% of all sexually active females of all ages are vaccinated.” She also says that the side effects that were reported could be proven riskier than the cervical cancer that Gardasil is supposed to prevent – and that cancer of the cervix is usually entirely curable if detected at an early stage through normal Pap screenings. Dr. Harper agrees that Gardasil is safe for most girls and women but the side effects reported so far call for more complete disclosure for patients; people should be told that „protection from the vaccination might not last long enough to provide a cancer protection benefit, and that its risks – “small but real” – could occur more often than the cervical cancer itself would.” Last but not least, she also spoke about Merck’s aggressive marketing of the vaccine and that it may have given women a false sense of security.

This last statement indicates further thoughts about the company’s influence. How far can one company push so that even governmental decisions are made in favour of the product and its selling? Well, the aggressive marketing campaign with commercials filled with smiling faces of women who could not be happier might not have been the only reason for governmental support. One thing is for sure: in more and more states is HPV vaccine mandated for school attendance in the United States. It means that parents do not actually have the choice whether they want to have their children vaccinated or not, unless they are fine with them not being able to go to school, and of course we may not know how well-informed they are about the possible side effects and adverse events related to Gardasil. The situation in Hungary is less intense, but parents in elementary schools are almost attacked with papers about HPV vaccines and are given advice about how and when they should get it for their children. Views about Gardasil move on a wide range from vaccine-haters to absolute supporters but the debate is not going to end in the near future; not if it depends on Merck and its financial interests.

The cure for corruption – what would be the price?

Is there a way to stop corruption, falsification and spreading of misleading information in order to gain amenities and profit in the market? Well, the answer may sound pessimistic but also realistic. As long as money is involved, the process is unstoppable. Let me reach back to the WHO fact sheet to illustrate it: in Third World countries, as much as 89 percent of health care spending is lost to corruption, while unethical practices cost First World countries an estimated $12 billion to $23 billion a year. Worldwide, this amounts to a loss of 10 to 25 percent of all drug procurement spending, or nearly $190 billion. Money is the ruler of this world, and I do not think that any of us could name a stronger weapon than that. Regulation by law however can be helpful in some cases because, according to the WHO, countries without appropriate legislation or regulation of medicines, enforcement mechanisms for laws, regulations and administrative procedures are most likely to be plagued with corruption. In order to see the complexity of proper legal regulation we need to examine how the companies get away with all of this, or as we would often ask ourselves: how do honest and good-hearted people sleep at night in an industry where such unethical and downright criminal conduct occurs? Silly as it sounds: by simply not knowing about it. The complexity of global organisations makes it easily possible for the left hand to not know what the right hand does; but other solutions are even more straightforward: some companies have vice-presidents responsible for going to jail who receive a nice amount of money in order to save their bosses’ positions when needed.

To summarize it, I would like to express that institutional crime in the pharmaceutical industry is a worldwide problem which endangers the life of millions, and lays down every effort to gain money and monopoly over the market. As individuals, we may not see all of it or the solution to it but by properly studying the subject we shall have a chance of lowering its influence on our lives.

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