IN the early 1960s, across Europe, doctors were confronted with a strange and distressing phenomenon. Hundreds of reports started pouring in about babies being born without arms and legs. They had flippers or fingers emerging from their shoulders. Many were born with eye and ear deformities, and severe internal damage such as malformed kidneys and anal atresia (a condition where there is no external opening to the bowel). Some were born with deformed genitals, or no genitals at all.
The deformed babies had one thing in common: their mothers had taken a drug called thalidomide, that was marketed during the 1950s and early 1960s as a sedative. By the time the drug could be withdrawn, over 8,000 thalidomide babies were born worldwide.
FIFTY YEARS AFTER THE THALIDOMIDE TRAGEDY
The Thalidomide tragedy brought out into the open a practice that the pharmaceutical industry indulges in on a regular basis even today. The Thalidomide tragedy occurred because the German drug company, Chemie Grunenthal, and a number of other companies worldwide, produced and marketed thalidomide, without paying attention to existing evidence that the drug could be extremely toxic. They were following what was standard industry practice – keep denying reports of toxicity and influence doctors to prescribe a toxic medicine even if it jeopardises the health of thousands.
Before the drug was marketed, Grunenthal’s own studies showed that the drug was toxic, but the company continued to recommend that the drug was absolutely safe. The company even started selling the drug as a sedative for children as well. Grunenthal’s campaign to “prove” the drug’s safety included 50 advertisements in major medical journals, 200,000 letters to doctors around the world, and 50,000 circulars to pharmacists. In Britain, Grunenthal’s distributor — Distillers Company Biochemicals Ltd. (DCBL) — sent pamphlets to doctors claiming that: “Distaval (the brand name for thalidomide in Britain) can be given with complete safety to pregnant women and nursing mothers without adverse affect on mother or child.”
By the winter of 1961, neither Grunenthal nor DCBL could ignore the information detailing thalidomide’s devastating effects. In November, Grunenthal pulled the drug off the market and in December, DCBL followed suit. But this came too late for thousands of women who were to deliver deformed babies – finally over 8,000 thalidomide babies were born in 46 countries, and some estimates put the number of stillbirths (babies born dead) at twice that number.
PROMOTION OF MEDICINES – PROFITS BEFORE PEOPLE
The Thalidomide saga ended with the companies involved finally having to pay millions as compensation to the families of victims. But, sadly, little changed as regards how drug companies market medicines. Fifty years have passed since the thalidomide tragedy, but companies continue to put profits before the lives of people across the world. It is estimated that one-third of the cost of a medicine is made up of by money that the manufacturing company spends in promoting the drug.
Among all industry sectors, the pharmaceutical industry is by far the most profitable in the world. The industry, in order to maintain this extremely high level of profitability, uses different methods to influence how medicines are used and prescribed. They need to do this because most new medicines that they introduce are not real advances over existing medicines. In fact many of them are inferior to existing medicines and may also have unacceptable side-effects. Studies show that, in the last decades, less than 3 per cent of medicines that were introduced, actually could be termed as major advances over known treatments. The challenge, then, before the industry is to promote medicines that have little additional benefit to offer, and in addition may have serious adverse effects. To circumvent this problem the industry has built a vast network, whose sole aim is to influence doctors, chemists and consumers into prescribing, selling or consuming medicines that they may not need or which may have serious side effects.
This network, aimed at promoting medicines, uses all kinds of means – fair or foul – to solicit higher sales for medicinal products. Inappropriate promotion of medicines is the norm rather than the exceptions. The World Health Organisation (WHO) has for long taken note of this phenomenon. It defines drug promotion as: “all informational and persuasive activities by manufacturers and distributors, the effect of which is to influence the prescription, supply, purchase or use of medicinal drugs”. There have been several attempts to curb unethical, and often criminal, methods employed by companies to promote medicines. The WHO has attempted to promote a “model code of conduct” on promotion of medicines, which has consistently been obstructed by the pharmaceutical industry. Many countries, especially developed countries, now try to monitor the promotion of medicines. There is also a growing attempt by associations of medical professionals in many parts of the world to curb the complicity of doctors in promoting medicines. However, most such efforts have been only partially successful, and the bane of unethical promotion continues to afflict the health sector like a festering sore, that distorts rational and scientific practice of medical science.
THE INDIAN STORY – TRAIL OF CORRUPTION
India is typical of what happens as regards drug promotion in many countries in the world today. Indians spend, approximately, Rs 50,000 crore every year in buying medicines, i.e. Rs.2,000 for every family in the country. It has been estimated that at least 50 per cent of this expenditure is incurred on irrational or unnecessary drugs. This adds up to a colossal waste of Rs 20,000 – 25,000 crore every year.
An estimated 80,000 brands of various drugs available in the Indian market, while the WHO lists a little over 300 drugs which can take care of an overwhelming majority (over 95 per cent) of the health problems of a country. A majority of the estimated 80,000 products in the market are either hazardous, or irrational or useless. The pharmaceutical companies and the government regulatory bodies are both to blame for allowing such a situation to develop in this country. But all this would not be possible without the active involvement of the medical profession, who contribute by prescribing such irrational and useless drugs. One reason for this is the fact that there is almost no source of regular unbiased, authentic information on drugs available in the country. Given the rapid changes in treatment procedures and introduction of a large array of new drugs (many unnecessary as we have discussed earlier), medical practitioners need to update their knowledge regularly. Such a system of continuing medical education is largely absent in this country, and most doctors do not find the need to take time out from their busy practice to update their knowledge by reading the most recent books and journals. Thus we have the sad practice of a bulk of medical practitioners depending on promotional material supplied by Pharmaceutical companies. Obviously such promotional material only provides biased information to doctors, with a view to maximising the sale of the products being promoted.
The drug industry in India spends 20 per cent of its annual sale – approaching Rs 10,000 crore – in promoting medicines. This works out to about Rs 100,000 per doctor per annum and each doctor prescribes drugs worth Rs 50,000 per annum. The practices adopted by the industry to promote medicines has been documented by various studies, including one that was published in the Indian Journal of Medical Ethics (April – June 2007). As we have discussed earlier, the most prevalent method of “pushing” medicine sales is through distribution of drug information that conceals more than it reveals. But this is just the tip of the iceberg.
Representatives of drug companies are taught to give small gifts to doctors, to keep their brand in the doctor’s memory. These “brand reminders” vary from desktop items to minor medical equipment, including prescription pads and rubber stamps (with the names of drugs manufactured by the company). Such apparently innocuous “gifts” constituted the bulk of “gifts” from drug companies to doctors even a few decades back. But today the situation has started changing rapidly and brand reminders are increasingly being replaced by gifts of greater value. These range from jewellery to electronic items such as air conditioners, washing machines, microwaves, cameras, televisions, and even automobiles! Pharmaceutical companies offer larger “incentives” to consultants and specialists who are considered “good” prescribers, as verified by neighbourhood chemists. Doctors in public teaching hospitals are also considered a prize catch as they are in a position to influence new entrants into the field (medical students and junior doctors).
To ensure that the “incentives” actually work in generating more prescriptions for a particular brand of a medicine, such incentives are now linked with the number of prescriptions generated. Printed handouts are distributed by companies giving targets for doctors, with incentives like a cell phone handset for prescribing 1,000 tablets, an air cooler for prescribing 5,000 tablets and a motorcycle after 10,000 tablets were prescribed!
The story becomes murkier still. Select doctors are sponsored for foreign conferences organised by drug companies under the garb of “scientific” conferences — registration fees, air tickets and stay for doctors and their spouses are paid for by the company. Not just individual doctors, associations of medical professionals are prime targets as well. Over the past decades, conferences of medical associations have moved out of academic institutions to five-star hotels which serve lavish cocktail dinners – entirely paid for by drug companies.
In perhaps the most blatant display of corrupt practice yet, companies have even abandoned the fig leaf of “scientific conferences” to justify all-expenses paid trips for doctors to exotic locales, and have been known to announce such trips to locales ranging from the Sunderbans to Bali.
TIME TO BREAK THE UNHOLY NEXUS NOW!
Clearly, such practices make a mockery of the Hippocratic oath and jeopardize the health of millions of unknowing patients – many of whom receive medicines only because his physician has been unduly influenced into prescribing it. As we have noted earlier, a part of the solution to this state of affairs lies in instituting mandatory continuing medical education (CME) programmes for all doctors and by regularly producing unbiased drug information (on the lines of the British National Formulary, for example).
In recent months two initiatives instituted by the Department of Pharmaceuticals (DoP) and the Medical Council of India, need to be taken note of. The DoP has been engaged in persuading industry associations to adopt an Uniform Code of Pharmaceutical Marketing Practices (UCMP). Several meetings have been held and while the department claims that such a code has been finalised, other sources indicate that the associations representing big companies are attempting to dilute the model code to make it unworkable. Concerns have been raised about the fact that this is a “voluntary” code, and no punitive measures are indicated against those who violate the code.
In parallel, the Medical Council of India moved an amendment last year in the Indian Medical Council Act and inserted an additional Section 6.8, titled: “Code of conduct for doctor and professional association of doctors in their relationship with pharmaceutical and allied health sector industry”. The amendment is designed to bar doctors from receiving gifts, sponsorships, etc. from the industry and from promoting specific medicines in any other manner. Recently, the chairperson of the MCI has indicated that the MCI is going to recommend to the government quantum of punishment for those who violate the new amendment to the MCI’s regulations. In themselves, these are welcome measures. Concerns however remain regarding how these measures will be implemented. The MCI and the state Medical Councils, till now, have earned the reputation of being toothless bodies and very few actions have been initiated against erring doctors by them. Amendments to the Act need to be followed up with granting of statutory powers to the MCI that allows it to take suo moto note of violations of the Act (at present the MCI acts only if there is a complaint). Further, the amendments moved by the MCI cover individual doctors but do not address the nexus between the industry and professional associations.
The nexus that exists between the drug industry and a section of doctors in the country is extremely deep and well organised. Powerful vested interests have a stake in making infructuous any attempts to break, or even dent, this nexus. The government needs to play a much more proactive role in breaking this chain of corruption and malpraxis that hits at the very root of rational practice of medicine.