Prices of a large number of drugs were surreptitiously but ‘meticulously’ increased by 40-55 per cent over the past 16 months as part of the ground work preparations for the so-called ‘Bibile policy’ introduction of drug price reductions implemented by the authorities in collaboration with the Pharma Mafia. The transnational pharmaceutical industry, or ‘Big Pharma’ [a name coined by the Western medical journalists] which controls the entire health services of the third-world nations during the late 20th century, feared three giants—the World Health Organisation[WHO] affiliated to UN; the Food and Drug Authority [FDA] of United States and of course our legendary Pharmacology Professor, Senaka Bibile and his drug policy which received the support of WHO.
The Mafia conspired astutely, spending Billions of Dollars through their agents to get around the high ranking men attached to the former two organizations bringing them under their domain successfully, but failed miserably in handling the Professor, who was on a great mission, but they had other ideas; earlier, it was generally observed that the ‘threat’ to the influential Trans-nationals posed by him may have had some bearing on his untimely and mysterious death in 1977 while on a mission to Guyana to introduce his policies in that country under a UN project. However, later it became a well known ‘secret’ that Dr Bibile was murdered by inducing cardiac arrest by means of a drug that has been there, since 1940s. They say, one of his colleagues was involved in the assassination to ensure that he would not make progress from the ‘heart failure’ by not taking prompt action or taking a delayed course of action to recover him. Known as the pharmaceutical Mafia was involved in Prof Bibile’s assassination, the truth will emerge one day.
Transnational mafia, CCC and the patients
The Ceylon Chamber of Commerce (CCC), Sri Lanka’s leading trade chamber issuing a statement, had criticized the health ministry’s price control on 47 medicinal drugs, under the pretext of looking after the interests of the consumer and economy. It says the customer choice is limited and that it distorts the market place. They also accuse of ‘hastily introduced price controls’ and ‘such ad-hoc moves, distorting the market, could have a lot of negative unintended consequences to the consumer, market place as well as to the overall country’s economy.’ Statement emphasizes, “It severely impacts private sector decision making, harms Sri Lanka’s international standing as an open economy, restricts consumers/patients ability to make free choices based on their individual affordability, and creates overall distortionary effects.” Their concerns are understandable; it is obvious that they have to safeguard the interests of the corporate sector.
The reduction of prices of a few products at high-end, constituting only 2 to 3 per cent by volume, using an unrealistic median based calculation, circuitously invited the Mafia to increase the low priced products up to the maximum retail price as per gazette. To illustrate the point, take the case of Losartan, a drug used to treat high blood pressure (hypertension). The price of a tablet varies from 2/- to 28/-: irrespective of the negligible sales volume for its most expensive brands, mathematically the median lies close to 28/- , accordingly they fixed the maximum retail price at 10/- Either they were clueless about Bibile formula or succumbed to mafia’s ‘pressure’ and deliberately ignored this vital error of not using the weighted average method. The ‘high-end’ category or the elite using 2 to 3% of the exceptionally costly products, the prices will slide down to go with the MRP (maximum retail price) fixed by them. The rest, 97-98% who belong to the middle-class and the poor would remain immediately unaffected. But the Transnational mafia is now appeased and authorized by a gazette notification to increase the bottom end products to match the MRP which is far above the current price levels, and could become severely disadvantageous to the user.
There had been numerous instances in the past where the mafia succeeded in preventing a resurrection of Senaka Bibile policies. The National Medicines Regulatory Authority [NMRA] has paved the way for big pharma to gradually introduce price hikes on the bottom end products to match the gazette limits. The hoax has worked again—Bibile’s name has been used to camouflage, cheat and deceive the general public and the President, someone who took a keen interest from the day he took over the ministry of health in 2010.
The medicinal drugs cannot be scientifically and methodically examined in detail for ascertaining the constitution or structure to verify their real quality, in our ill-equipped out-dated laboratories that the health ministry can boasts of. The testing done at this end is just another deceptive act. We are totally depending on the manufacturer’s authenticity, and if he is not truthful, as in most instances, we may get an inferior drug with lesser strength or effectiveness.
Professor Bibile’s principle and UNCTAD
Professor Bibile’s principle of developing a rational pharmaceutical policy intended to ensure that people would get reasonable drugs at an affordable price, was based on ensuring that doctors prescribe the minimum required drugs to treat the patient’s illness.
This policy was used with enormous benefit to Third World countries as a model for expansion of policies based on rational pharmaceutical use in other countries as well by the WHO, the United Nations Conference on Trade and Development (UNCTAD) and the Non-Aligned Movement [NAM]. Due to the far reaching effects of his proposals and policies, he has been called the ‘greatest medical benefactor of humanity that Sri Lanka has hitherto produced’.
UNCTAD, in fact scrutinized the Sri Lankan practice, concluding that an examination of the Sri Lankan model could give other third-world countries an insight into ways of devising, developing and executing integrated national medicinal drugs policies. With Prof Bibile’s backing, they published “Case Studies in the Transfer of Technology: Pharmaceutical Policies in Sri Lanka”. This document has proved to be a priceless guideline for developing countries which was recognized widely at the World Health Assembly in Geneva in May 1982. It intended to commence pharmaceutical reorganizations. His policy may be found translated into many languages with health authorities of almost every Third World country, barring in Sri Lanka which has welcomed the mafia since 1977 to date under every government. There had been only two Health Ministers since late 1970s, [P Dayaratne and Maithripala S] who did not submit to the dictates of the Mafia, but they were too feeble in acting against them, who by now had bonded their relations with the bureaucracy and the top echelons of the political hierarchy.
The United Front Government of Sirimavo Bandaranaike in 1970 appointed Dr. S. A. Wickremasinghe, leader of the Communist Party and Professor Senaka Bibile to lead a commission of inquiry to investigate this issue and they suggested the institution of a national policy and of a state body to regularise the trade.
Bibile’s contribution to development in the area of drugs was acknowledged publicly during the 35th World Health Assembly, in Geneva in May 1982. A careful selection of drugs was an essential component of the policies he advocated. The Billion Dollar question here is why our health authorities could not work out a formula based on Bibile’s basic principles in an effort for far-reaching reforms? Bibile strongly advocated the necessity of making it compulsory that the doctors did prescribe drugs strictly under its Generic name only! The legislation introduced in 2015 made a mockery of prescription habits, when they deliberately worded it, “use the Generic name, but a brand name could be mentioned.” Lack of awareness on the part of general public is the cause for the swindlers to prosper. They are ignorant of the extremely injurious properties of superfluous ‘medicines’ they use and the billions lost in foreign exchange. The media has a role in educating them on incomparable gains that the nation could achieve under Bibile reforms.
Ceylon Chamber of Commerce
CCC statement further says, “most ‘originator’ brands are faced with an unviable ceiling price, that is neither reflective of cost nor of quality.” The CCC pointed out, ‘international firms would not want to subject their products to the possibility of unofficial arbitrage trade in the region, originating from Sri Lanka’.
The Chamber warned that it could prevent ‘higher quality drugs’ developed with innovation in the originator countries coming into Sri Lanka. This affects not only individual choice of consumers, but also affects the country’s ability to continually access the newest medication.’
More on ‘international firms’ and ‘higher quality drugs’
We wish to remind the general public, as we have done on many occasions on these columns, the corrupt practices of the so-called ‘international firms’; ‘higher quality drugs developed with innovation in the originator countries’ and ‘the newest medication’ and that we are going to ‘lose access to’ as referred by the CCC.
Ms Margret Hamburg - Commissioner, FDA -US, stated in her address to the Annual Conference sponsored by WHO, “It is sad that we live in a world in which some ‘criminals’ are willing to maximize profits by placing poison in infant formula, and medically necessary drugs. It is a reality we must face. And more importantly it is a reality that we must become more proactive in dealing with.” - ‘Partnership for Safe Medicine’
Corrupt Practices by the Trans-national Mafia
An exclusive feature of pharmaceutical marketing is that the final user or the ‘customer’ for a product is the medical practitioner and not the patient who pays for it. The misguided or ill-advised practitioner tricked by the marketer fall into this category, while there are ‘mischievous’ professionals who are lured into it by the corrupt importer, who doles out rewarding ‘santhosams’, ranging from five-star weekends for his or her family, sponsorships of children’s medical studies abroad, lucrative monthly remuneration and many more in exchange for ‘prescriptions’ as dictated by them. The poor ignorant patients are compelled to pay a lofty price for an inferior superfluous drug risking their physical organs to a bundle of chemicals with many side-effects.
The multinational industry is capable of counteracting every institution that stands in its way by using its wealth and power. The mafia invades, grab and bring under their dominion, top men managing institutions that deal with manufacturing, importing, teaching, registering, quality guaranteeing, prescribing of drugs in both the state and the corporate sectors. They cover even the administrative, legal, academic, bureaucratic, and political authority in the field. Finally they all fall into their payroll. The ‘Big Pharma’, are facing serious consequences in selling substandard products at high-priced in their own regions, especially the West, have preferred safe sanctuaries in third world nations, where it is easy to ‘compete’ with ineffective rules and regulations administered by men who are vulnerable to corruption.
Kickbacks are rewards such as jewellery, free vacations, cash, sponsored retreats, or other gifts used to attract medical professionals into using specific drugs. Lavish doctor/patient retreat that is funded by a pharmaceutical company to entice the prescription and use of a particular drug.
People engaging in this type of fraud are also subject to the federal Anti-Kickback statute.
Examples of fraud cases by the so-called big ‘Foreign Firms’- GlaxoSmithKline [GSK] was involved in the largest health-care fraud case in the U.S.:the company pleading guilty to criminal charges agreed to a $3 billion settlement on July 2, 2012; the largest payment by a pharma industry. It is in relation to the company’s unlawful promotion of prescription drugs, its failure to account for safety data, bribing medical specialists, and promoting drugs for uses without licence. The drugs involved were Paxil, Advair, Wellbutrin, Zofran and Lamictal. The state investigation of GlaxoSmithKline was commenced largely on the sources of information provided by whistleblowers who filed two lawsuits against the multi-national. GSK settled the amount, the largest civil False Claims Act settlement in history.
Pfizer $2.3 billion: Pfizer taken to courts for criminal allegations settled, $2.3 billion for drugs, Bextra (an anti-inflammatory drug), Lipitor (a cholesterol drug), Geodon (an anti-psychotic drug), Norvasc (anti-hypertensive drug), Zithromax (antibiotic), Viagra (erectile dysfunction), Zyrtec (antihistamine), Zyvox (an antibiotic), ), Relpax (anti-migraine drug), Lyrica (an anti-epileptic drug Celebrex (anti-inflammatory drug), and Depo-provera (birth control).