Ethical Relation Between Doctors and Pharmaceutical Industry !!! Dr. Md. Shahinul Alam Associate Professor of Hepatology Bangabandhu Sheikh Mujib Medical University Dhaka. Bangladesh
Component of presentation History and background Current status in the world What is going on in Bangladesh ? What should be our standard recommendations for Bangladesh ?
Prehistoric Medication (30,000 BC) Ancient man learned from instinct, from observation of birds and beasts. Cool water, a leaf, dirt, or mud was his first soothing application.
Ancient Babylonia (about 2600 B.C.) Practitioners of healing of this era were priest, pharmacist and physician, all in one. Ancient Babylonian methods find counterpart in today's modern pharmaceutical, medical, and spiritual care of the sick.
Medicine in Ancient China (2000 BC) Chinese Pharmacy, according to legend, stems from Shen Nung. He reputed to have tested many of them on himself, and to have written the first Pen T-Sao, or native herbal, recording 365 drugs.
Egyptian Medicine (1500 BC) Though Egyptian medicine dates from about 2900 B.C., best known and most important pharmaceutical record is the "Papyrus Ebers" (1500 B.C.), a collection of 800 prescriptions, mentioning 700 drugs.
Greece Medicine ( About 300 BC) • Most medicines were prepared from plants. • Physicians took care of the pharmaceutical part of treatment and they were responsible for the drug being prepared properly and for the administration of the drug. • Were groups of drug preparers and sellers which some physicians used. Theophrastus the greatest early Greek philosophers and natural scientists, is called the "father of botany
Pharmacy in Greece: Hippocrates • Father of Medicine • Developed the concept of the “ four humors”. • Blood, phlegm, yellow bile and black bile. • Believed that illness was a result of an imbalance of the humors.
Pharmacy in Greece: Dioscorides • Traveled with Roman soldiers and recorded his observations. • Developed the first encyclopedia of drugs, MateriaMedica • A systematic way of describing the drugs, their effects and how they should be stored.
Monastic Pharmacy During the Middle Ages remnants of the Western knowledge of Pharmacy and Medicine were preserved in the monasteries (fifth to twelfth centuries).
The First Apothecary Shops in Baghdad in 754 The Arabs separated the arts of apothecary and physician, establishing in Bagdad late in the eighth century the first privately owned drug stores.
Avicenna – The “Persian Galen” Among the brilliant contributors to the sciences of Pharmacy and Medicine during the Arabian era was one genius who seems to stand for his time - the Persian, Ibn Sina (about 980-1037 A.D.),
Separation of Pharmacy and Medicine (17th Century) In areas where Arabic culture interacted with the West the idea of separation of pharmacy and medicine was passed on.
The First Official Pharmacopeia The idea of a pharmacopoeia with official status, to be followed by all apothecaries, originated in Florence. The Nuovo Receptario, originally written in Italian, was published and became the legal standard for the city-state in 1498.
The Standardization of Pharmaceuticals Development of Chemotherapy
Pharmaceutical Research The Era of Antibiotics
The marketing of medication has a long history An advertisement, c. 1885, promoting the medicinal use of a cocaine based product.
Contribution of Pharmaceutical Industries Approximately 60 percent of biomedical research Clinical trials of more than 70 % Shoulders >50% of the costs of continuing medical education.
Pharma and Doctors Financial entanglement has bred close ties between the industry and physicians Beneficiary of small “educational” gifts such as pens and pads or lunch Many physicians attend dinners to hear expert talk about a product, take educational trips to resorts, or receive funds (explicitly without strings attached) in the form of research grants, trainee support, or lucrative consulting fees
Physician, Pharma and Patient These interactions are defended as a way to provide useful information for physicians as they address difficult problems in treating their patients. But at what point does the influence become corrosive to the good of the patient? Governance of the relationships between physicians and pharmaceutical companies has long relied on professional concern about potential conflicts of interest, rather than legal regulation.
Anti Kickback Law in USA Federal prosecutors applied it in areas in which there was clearly an intent to increase referrals — for example, situations in which one physician kicked back a portion of the Medicare payment for a Holtermonitor to the referring physician. Also for drug prescription
Penalties of Pharma an Example Federal prosecutors charged TAP and Abott with criminal violations of the Prescription Drug Marketing Act,38 were intended to induce prescriptions for Lupron and therefore constituted kickbacks TAP entered into a settlement with the government in which it agreed to pay $290 millionin criminal fines plus $585 million in civil penalties.
Penalties continued On July 14, 2004, Schering-Plough pleaded guilty and paid a fine of $350 million, in part for providing grants to private physicians to conduct educational programs, which prosecutors characterized as kickbacks.
Who should address in Bangladesh? In 2002 and 2003, The American Medical Association American College of Physicians Accreditation Council for Continuing Medical Education Pharmaceutical Research and Manufacturers of America their own codes of conduct
If Not …………. prosecutorial activity that is currently focused on conflicts of interest in the interactions between physicians and pharmaceutical companies
At a Glance • The Global Pharmaceutical market is worth US$300 billion a year • A figure expected to rise to US$400 billion within three year • Companies currently spend their one third of all sales revenue on marketing their product.
Promotional spending on prescription drugs, l996-2002 Source: NIHCM, 2001
Promotional spending on prescription drugs, 2002 Total spending: $21 billion Source: IMS Health
Direct to consumer advertising on prescription drugs,l996-2000 Source: NIHCM, 2001
Direct to consumer advertising spending in the U.S., 2000 Source: NIHCM, 2001
Comparison of median revenue dedicated to R&D, profits, and marketing/administration, Fortune 500 drug companies, 2000 (n=11) Source: Public Citizen, 2001
Main task of drug company employees, 2000 Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar
Drug company jobs in marketing and research, 1995-2000 # Jobs Source: PhRMA Industry Profile 2000; percentages calculated by Sager and Socolar
Profitability of drug industry, l993-2000 2.8% • Source: Public Citizen update of Stephen W. Schondelmeyer calculation, Competition and Pricing Issues in the Pharmaceutical Market, PRIME Institute, University of Minnesota based on data found in Fortune magazine, 1958 to 1999; Fortune magazine, April 2000, Fortune 500 (www.fortune.com).
Fortune 500 drug company profitability compared to all other Fortune 500 companies, 2000 Source: Public Citizen, 2001
Sources of increased drug expenditures, 2000-2001 37% 39% 24% Total increase: $22.5 billion Source: NIHCM, 2002
At a Glance • The 10 largest drugs companies control over one-third of this market • Several with sales of more then US$10 billion a year. And profit margin of 30% • Six are based in USA & other in Europe
Bangladesh • Here, the pharmaceutical industry developed rapidly from the 1980s after the introduction of Drug (Control) Ordinance-1982. • Due to recent development of this sector, the country is exporting medicines to global market including European countries and on the top of it, the industry has been supplying about 95 per cent of the domestic demand for medicines.
Over view of Last 5 Years Pharmacy Market in Bangladesh 2009-13 Pharmacy Market Size is increased 85.38 % Ref. IMS 4th quarter report of 2009-2013
Last year top 10 Company of Bangladesh Ref: IMS 4th quarter of 2013