Trapped by Medicines: Can anyone walk out?

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Dr.  Richard  S. Rajapaksa

Unnecessary drugs for simple illnesses. Prescriptions of expensive brands of pharmaceuticals. Pointless laboratory tests. Unwarranted imaging such as CT and MRI. Needless medical procedures. “Diseases” that do not exist, but are “treated”. This is a world-wide phenomenon. All of which end up as profits of the pharmaceutical and medical devices industry.

It is big business. The estimated turnover of the twelve largest pharmaceutical companies in the world was around US$ 450 billion in 2010. The profit of these companies alone came to almost US$ 100 billion. They are rich. They are powerful. Are they ethical? Well …..

The New York Times and BBC reported on July 02, 2012 that one of the biggest companies on that rich-list pleaded guilty to criminal charges and agreed to pay a US$3 billion (yes, 3 billion!) for settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company.
The company pleaded guilty to the charges of illegal promotion of prescription of drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed.

A US attorney, quoted by BBC stated that the sales force of this company bribed physicians to prescribe its products “using every imaginable form of high-priced entertainment, from Hawaiian vacations [and] paying doctors millions of dollars to go on speaking tours, to tickets to Madonna concerts”
Do you think that such things happen only in the United States of America? A popular Sinhala song comes to mind.

According to the US Department of Justice, the previous highest settlement was US$ 2.3 billion paid by an even larger pharmaceutical multinational in 2009. It pleaded guilty to charges of illegal promotion of several of its pharmaceutical products and paying kickbacks to healthcare providers to induce them to prescribe these products.
Last year, another giant multinational on the same rich-list pleaded guilty to criminal and civil charges, and paid US$ 1.5 billion. This company, among other things, had maintained a specialised sales force to market a drug using false claims, induced health care providers to use this drug and downplayed risks of the drug.
There are many other such examples. The enormity of the settlement amounts reflects the enormity of the crimes. Crimes for which the imposed fines were in billions of dollars. Can this not happen elsewhere? After all, all three companies operate in many other countries, including our own.

In Sri Lanka, currently, the pharmaceutical market is estimated to be worth around Rs. 50 billion annually. Assuming that the profit margins are the same as elsewhere, this year, the profit of this industry will be around Rs 10 billion.  Yes, Rs. 10,000,000,000.  Internationally, it is estimated that at around 20% of revenue is spent on marketing by the pharmaceutical industry. Some argue that this could be much higher.

However, if we take the 20% estimate, at least Rs. 10,000,000,000 is doing its rounds, “marketing” pharmaceuticals in Sri Lanka. In this context, “marketing” means things that an entity does to increase its sales and profits. As the examples from the US show, in this game, anything goes. That includes even Madonna concerts, in some instances.  If so, will we, the general public stand a chance?

The agency responsible for regulation of pharmaceuticals in Sri Lanka is the Cosmetics, Devices and Drugs Regulatory Authority, which is under the Ministry of Health. Assuming its website in up to date, currently Sri Lanka can boast of over 8,800 registered pharmaceutical formulations.

This includes over 150 varieties of the anti-cholesterol drug Atorvastatin and the antibiotic Amoxicillin, almost 100 varieties of Metformin the anti-diabetic drug, over 100 varieties of Esomeprazole and around 80 varieties of Omeprazole, both medications for Gastritis, and over 70 varieties of Paracetamol and so on.  Describing this as excessive will be an understatement.

Can the regulatory agency and the National Drug Quality Assurance Laboratory of the Ministry of Health be reasonably expected to assure quality of all the registered pharmaceutical drugs? It is likely that these two agencies are overwhelmed by the avalanche of products that it has to monitor.

Even under such trying circumstances, according to the regulatory agency website, no less than 66 drug formulations have been found to be of poor quality and have been removed from the market in Sri Lanka this year. There are many injectable drugs in this list, which we all know are given to severely ill patients. There were also eye drops, drugs for diabetes, hypertension, epilepsy, asthma heart disease, mental illnesses as well as antibiotics among them.

Many questions arise. Were you, your child, husband, wife, father, mother, brother or sister given these drugs before their dubious “quality” was discovered? Were there losses of life? How many suffered adverse reactions? How many had their illness and sufferings prolonged? How many other such “medicines” are out there right now? We will never know.

However, the answers to the following questions are certain. Will those who suffered be compensated? No chance. Will those responsible for releasing at least some of these on us ever be punished? No way.

So, we the public,  are not only paying more for drugs, submitting ourselves to needless tests, being treated for non-existent conditions etc. etc., but also gobbling up and getting injected with dubious substances which we think are medicines.

" In Sri Lanka, currently, the pharmaceutical market is estimated to be worth around Rs. 50 billion annually. Assuming that the profit margins are the same as elsewhere, this year, the profit of this industry will be around Rs 10 billion.  Yes, Rs. 10,000,000,000.  Internationally, it is estimated that at around 20% of revenue is spent on marketing by the pharmaceutical industry. Some argue that this could be much higher. "

This should not happen in Sri Lanka, which, in past has shown the world how the pharmaceutical market can be regulated, for the benefit of the people. The World Health Organization is taking this concept, developed in Sri Lanka, worldwide, and people of many countries have benefited.  Paradoxically, the same principles are eroded to almost unrecognisable levels here.

Are doctors victims too? Yes, if victimhood is defined as being manipulated into harming those you are supposed to protect, for others to profit. In the Sri Lankan context, this can even be described as being manipulated into harming those who paid for your education since you were 5 years old, until you passed out as a doctor, or in some cases until you specialised.

Even doctors who are honest and ethical face a dilemma in situations where there is no confidence can be placed on the drug regulatory system. Should he prescribe the least expensive drug? Or the more expensive brand? How can he be sure of the quality of the drug which he has prescribed? Will he not be more inclined to prescribe an expensive brand? The pharmaceutical industry marketers are skillful at playing on these fears.

How do the doctors who knowingly toe the line of the pharmaceutical industry justify their behaviour? Probably as any other individual would justify a behaviour that the person knows is unbecoming himself. The pharmaceutical industry has mastered this art of “helping” such doctors to maintain this behaviour. Once the tried tested methods of manipulation kicks in, professionalism, ethics or perceived rationality offer no protection.

They become puppets. Puppets whose chains originate in corporate offices.  Chains that are pulled by those unseen by the puppets. Puppets, who in turn manipulate the poor and the helpless.  Puppeteers rake in the riches. Puppets get the crumbs. The manipulated gets none.

The process of psychological manipulation of doctors has been detailed lucidly in a recent publication by academics of the Georgetown University and the Ethics Centre of Harvard University of the USA, entitled “Physicians under the Influence: Social Psychology and Industry Marketing Strategies”.
There, its authors state: “Pharmaceutical and medical device companies apply social psychology to influence physicians’ prescribing behaviour and decision making. Physicians fail to recognise their vulnerability to commercial influences due to self-serving bias, rationalisation, and cognitive dissonance. Professionalism offers little protection; even the most conscious and genuine commitment to ethical behaviour cannot eliminate unintentional, subconscious bias.”

The marketing strategy, according to the authors, relies on creating the “illusion that the industry is a generous avuncular partner to physicians.”
What is the solution they offer? “A culture in which accepting industry gifts engenders shame rather than gratitude will reduce conflicts of interest”. Yes, calling a spade a spade. Bribes as bribes. Recognising shameless behaviour as shameless behaviour.

Is there any hope? There is. Doctors are supposed to be intelligent beings. They should abhor being manipulated, especially being manipulated to act against the interests of patients whom they are bound professionally, morally and ethically to protect.

They should be the bulwark between the puppet masters and us. The authors of the study state it more elegantly.  “In order to resist industry influence, physicians must accept that they are vulnerable to subconscious bias, and have both the motivation and means to resist industry influence”.

Where does all this leave the rest of us? However rich, influential, or educated we are, all of us are victims of this charade. To make things worse, the marketing arms of the pharmaceutical industry play almost the same tricks with us, as with doctors.

For example many of us would consider the most expensive brand of a drug as more effective than a less expensive brand of the same drug. Whether this is true or not, cannot be stated with certainty, where regulatory systems are weak or overwhelmed. Especially in an age when counterfeiting of pharmaceuticals is rife. Even the prescriber or the pharmacist is none the wiser.

For individuals there is little choice. The least we can do is discussing this issue with our doctors or pharmacists, if there is any chance. The more empowered, insightful and influential amongst us should look at the ways of changing this culture of manipulation for individual and corporate profit. We should attempt to change this milieu that promotes accumulating riches by robbing the ill and the frightened.

As always, the vector of the problem should be addressed. Remember, mosquito breeding is controlled to control dengue. The same principal should apply. The pharmaceutical industry, the puppet master, should be controlled through all available means. Talk is cheap. It is the action that counts.  
Reigning in this rampant industry and making it work for the benefit of the people is possible. Many countries are moving in the right direction. Sri Lanka once led the world in this issue. We should take the lead once again.

The writer can be reached at [email protected]