Pharmaceutical industry

From Wikipedia, the free encyclopedia

The pharmaceutical industry develops, produces, and markets drugs licensed for use as medications.

[1]
 Pharmaceutical companies are allowed to deal in generic and/or brandmedications and medical devices. They are

subject to a variety of laws and regulations regarding the patenting, testing and ensuring safety and efficacy

and marketing of drugs.
Contents

 [hide]

1 History

2 Research and development

o 2.1 The cost of innovation

o 2.2 "Me-too" drugs

o 2.3 Controversy about drug development and testing

3 Product approval in the US

o 3.1 Orphan drugs

o 3.2 Legal issues

4 Product approval elsewhere

5 Industry revenues

o 5.1 Market leaders in terms of revenue

o 5.2 Market leaders in terms of sales

o 5.3 Patents and generics

o 5.4 Medicare Part D

o 5.5 Mergers, acquisitions, and co-marketing of drugs

o 5.6 Prescriptions

o 5.7 Publications

6 Marketing

o 6.1 To healthcare professionals

o 6.2 To insurance and public health bodies

o 6.3 To retail pharmacies and stores

o 6.4 Direct to consumer advertising

o 6.5 Controversy about drug marketing and lobbying

7 Developing world

o 7.1 Patents
 o 7.2 Nigerian clinical trial

o 7.3 Charitable programmes

8 Pharmaceutical industry in popular culture

9 Industry associations

10 Regulatory authorities

11 See also

12 Notes

13 Further reading

o 13.1 Economics of the industry

o 13.2 Relationship between pharma and the medical

profession

o 13.3 Relationship between pharma and consumers

(general public)

o 13.4 Industry trends

[edit]History

The earliest drugstores date back to the Middle Ages. The first known drugstore was opened by Arabian

pharmacists in Baghdad in 754,[2] and many more soon began operating throughout the medieval Islamic world and

eventually medieval Europe. By the 19th century, many of the drugstores in Europe and North America had

eventually developed into larger pharmaceutical companies.

Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. Key

discoveries of the 1920s and 1930s, such as insulin and penicillin, became mass-manufactured and distributed.

Switzerland, Germany and Italy had particularly strong industries, with the UK, US, Belgium and the Netherlands

following suit.

Legislation was enacted to test and approve drugs and to require appropriate labelling. Prescription and non-

prescription drugs became legally distinguished from one another as the pharmaceutical industry matured. The

industry got underway in earnest from the 1950s, due to the development of systematic scientific approaches,

understanding of human biology (including DNA) and sophisticated manufacturing techniques.

Numerous new drugs were developed during the 1950s and mass-produced and marketed through the 1960s. These

included the first oral contraceptive, "The Pill", Cortisone, blood-pressure drugs and other heart medications. MAO

Inhibitors, chlorpromazine (Thorazine), Haldol (Haloperidol) and the tranquilizers ushered in the age of psychiatric

medication. Valium(diazepam), discovered in 1960, was marketed from 1963 and rapidly became the most

prescribed drug in history, prior to controversy over dependency and habituation.

Attempts were made to increase regulation and to limit financial links between companies and prescribing physicians,

including by the relatively new U.S. Food and Drug Administration(FDA). Such calls increased in the 1960s after

the thalidomide tragedy came to light, in which the use of a new tranquilizer in pregnant women caused severe birth

defects. In 1964, the World Medical Association issued its Declaration of Helsinki, which set standards for clinical

research and demanded that subjects give their informed consent before enrolling in an experiment. Phamaceutical

companies became required to prove efficacy in clinical trials before marketing drugs.

Cancer drugs were a feature of the 1970s. From 1978, India took over as the primary center of pharmaceutical

production without patent protection.[citation needed]

The industry remained relatively small scale until the 1970s when it began to expand at a greater rate.[citation
needed]
 Legislation allowing for strong patents, to cover both the process of manufacture and the specific products,

came in to force in most countries. By the mid-1980s, small biotechnology firms were struggling for survival, which led

to the formation of mutually beneficial partnerships with large pharmaceutical companies and a host of corporate

buyouts of the smaller firms. Pharmaceutical manufacturing became concentrated, with a few large companies

holding a dominant position throughout the world and with a few companies producing medicines within each country.

The pharmaceutical industry entered the 1980s pressured by economics and a host of new regulations, both safety

and environmental, but also transformed by new DNA chemistries and new technologies for analysis and

computation.[citation needed] Drugs for heart disease and for AIDS were a feature of the 1980s, involving challenges to

regulatory bodies and a faster approval process.

Managed care and Health maintenance organizations (HMOs) spread during the 1980s as part of an effort to contain

rising medical costs, and the development of preventative and maintenance medications became more important. A

new business atmosphere became institutionalized in the 1990s, characterized by mergers and takeovers, and by a

dramatic increase in the use of contract research organizations for clinical development and even for basic R&D. The

pharmaceutical industry confronted a new business climate and new regulations, born in part from dealing with world

market forces and protests by activists in developing countries. Animal Rights activism was also a challenge.

Marketing changed dramatically in the 1990s, partly because of a new consumerism.[citation needed] The Internet made

possible the direct purchase of medicines by drug consumers and of raw materials by drug producers, transforming

the nature of business. In the US, Direct-to-consumer advertising proliferated on radio and TV because of new FDA

regulations in 1997 that liberalized requirements for the presentation of risks. The new antidepressants, the SSRIs,

notably Fluoxetine (Prozac), rapidly became bestsellers and marketed for additional disorders.

Drug development progressed from a hit-and-miss approach to rational drug discovery in both laboratory design and

natural-product surveys. Demand for nutritional supplements and so-called alternative medicines created new

opportunities and increased competition in the industry. Controversies emerged around adverse effects, notably

regarding Vioxx in the US, and marketing tactics. Pharmaceutical companies became increasingly accused

of disease mongering or over-medicalizing personal or social problems.[3]

[edit]Research and development

Main articles: Drug discovery and Drug development

Drug discovery is the process by which potential drugs are discovered or designed. In the past most drugs have

been discovered either by isolating the active ingredient from traditional remedies or by serendipitous discovery.

Modern biotechnology often focuses on understanding the metabolic pathways related to a disease state

or pathogen, and manipulating these pathways using molecular biology or biochemistry. A great deal of early-stage

drug discovery has traditionally been carried out by universities and research institutions.

Drug development refers to activities undertaken after a compound is identified as a potential drug in order to

establish its suitability as a medication. Objectives of drug development are to determine

appropriate Formulation and Dosing, as well as to establish safety. Research in these areas generally includes a

combination of in vitro studies, in vivo studies, andclinical trials. The amount of capital required for late stage

development has made it a historical strength of the larger pharmaceutical companies. Suggested citation: Tufts

Center for the Study of Drug Development, Annual Impact Report, http://csdd.tufts.edu/[citation needed]

Often, large multinational corporations exhibit vertical integration, participating in a broad range of drug discovery and

development, manufacturing and quality control, marketing, sales, and distribution. Smaller organizations, on the

other hand, often focus on a specific aspect such as discovering drug candidates or developing formulations. Often,

collaborative agreements between research organizations and large pharmaceutical companies are formed to

explore the potential of new drug substances.

[edit]The cost of innovation

Drug companies are like other companies in that they manufacture products that must be sold for a profit in order for

the company to survive and grow. They are different from some companies because the drug business is very risky.

For instance, only one out of every ten thousand discovered compounds actually becomes an approved drug for sale.

Much expense is incurred in the early phases of development of compounds that will not become approved drugs.
[4]
 In addition, it takes about 7 to 10 years and only 3 out of every 20 approved drugsbring in sufficient revenue to

cover their developmental costs, and only 1 out of every 3 approved drugs generates enough money to cover the

development costs of previous failures. This means that for a drug company to survive, it needs to discover a

blockbuster (billion-dollar drug) every few years.[4]

Drug discovery and development is very expensive; of all compounds investigated for use in humans only a small

fraction are eventually approved in most nations by government appointed medical institutions or boards, who have to

approve new drugs before they can be marketed in those countries. In 2010 18 NMEs (New Molecular Entities)were

approved and three biologics by the FDA, or 21 in total, which is down from 26 in 2009 and 24 in 2008. On the other

hand, there were only 18 approvals in total in 2007 and 22 back in 2006. Since 2001, the Center for Drug Evaluation

and Research has averaged 22.9 approvals a year.[5] This approval comes only after heavy investment in pre-clinical
development and clinical trials, as well as a commitment to ongoing safety monitoring. Drugs which fail part-way

through this process often incur large costs, while generating no revenue in return. If the cost of these failed drugs is

taken into account, the cost of developing a successful new drug (New chemical entity or NCE), has been estimated

at about 1.3 billion USD[6](not including marketing expenses).

Industry-wide research and investment reached a record $65.3 billion in 2009.[7]

A study by the consulting firm Bain & Company reported that the cost for discovering, developing and launching

(which factored in marketing and other business expenses) a new drug (along with the prospective drugs that fail)

rose over a five year period to nearly $1.7 billion in 2003.[7]

These estimates also take into account the opportunity cost of investing capital many years before revenues are

realized (see Time-value of money). Because of the very long time needed for discovery, development, and approval

of pharmaceuticals, these costs can accumulate to nearly half the total expense. Some approved drugs, such as

those based on re-formulation of an existing active ingredient (also referred to as Line-extensions) are much less

expensive to develop.

Calculations and claims in this area are controversial because of the implications for regulation and subsidization of

the industry through tax credits and federally funded research grants.[8]

[edit]"Me-too" drugs

Competition between pharmaceutical companies has resulted in “me-too” drugs, which are defined as chemically-

similar compounds or compounds with the same mechanism of action as an existing, approved chemical entity.
[9]
 According to an FDA report in 2004, there were 941 new drug and biologics license application approvals between

1995 and 2004, of which only 311 were “new” biologics or New Molecular Entities, defined by the FDA as “containing

an active substance that has never before been approved for marketing in any form in the United States”.[10]

Critics of the pharma industry point out that “me-too” drugs are only brought to market because their development is

cheaper and less risky.[11] However proponents point to the cost benefits of market competition between similar drugs.

It may take 10 or more years for a drug to go from discovery to FDA Approval, and if a new clinical pathway is

discovered, multiple companies often will research a compound to treat within this pathway leading to several similar

or "me-too" drugs to arrive in what seems to be nearly at the same time.[12] This is why some suggest that much of the

“me-too” drug phenomenon is a result of parallel research at rival companies.[13][14]

[edit]Controversy about drug development and testing

Due to accusations and findings that some clinical trials conducted or funded by pharmaceutical companies may

report only positive results for the preferred medication, the industry has been looked at much more closely by

independent groups and government agencies.[15]

In response to specific cases in which unfavorable data from pharmaceutical company-sponsored research was not

published, the Pharmaceutical Research and Manufacturers of America have published new guidelines urging

companies to report all findings and limit the financial involvement in drug companies of researchers.[16] US congress

signed into law a bill which requires phase II and phase III clinical trials to be registered by the sponsor on the clinical

trials.gov website run by the NIH.[17]

Drug researchers not directly employed by pharmaceutical companies often look to companies for grants, and

companies often look to researchers for studies that will make their products look favorable. Sponsored researchers

are rewarded by drug companies, for example with support for their conference/symposium costs. Lecture scripts and

even journal articles presented by academic researchers may actually be 'ghost-written' by pharmaceutical

companies.[18] Some researchers who have tried to reveal ethical issues with clinical trials or who tried to publish

papers that show harmful effects of new drugs or cheaper alternatives have been threatened by drug companies with

lawsuits.[19][20]

[edit]Product approval in the US

Main article: Food and Drug Administration #Regulation of drugs

In the United States, new pharmaceutical products must be approved by the Food and Drug Administration (FDA) as

being both safe and effective. This process generally involves submission of an Investigational new drug filing with

sufficient pre-clinical data to support proceeding with human trials. Following IND approval, three phases of

progressively larger human clinical trials may be conducted. Phase I generally studies toxicity using healthy

volunteers. Phase II can include Pharmacokinetics and Dosing in patients, and Phase III is a very large study of

efficacy in the intended patient population.

A fourth phase of post-approval surveillance is also often required due to the fact that even the largest clinical trials

cannot effectively predict the prevalence of rare side-effects. Post-marketing surveillance ensures that after marketing
the safety of a drug is monitored closely. In certain instances, its indication may need to be limited to particular patient

groups, and in others the substance is withdrawn from the market completely. Questions continue to be raised

regarding the standard of both the initial approval process, and subsequent changes to product labeling (it may take

many months for a change identified in post-approval surveillance to be reflected in product labeling) and this is an

area where congress is active.[21]

The FDA provides information about approved drugs at the Orange Book site.[22]

[edit]Orphan drugs

Main article: Orphan drug

There are special rules for certain rare diseases ("orphan diseases") involving fewer than 200,000 patients in the

United States, or larger populations in certain circumstances. [23]Because medical research and development of drugs
to treat such diseases is financially disadvantageous, companies that do so are rewarded with tax reductions, fee

waivers, andmarket exclusivity on that drug for a limited time (seven years), regardless of whether the drug is

protected by patents.

[edit]Legal issues

Where pharmaceutics have been shown to cause side-effects, civil action has occurred, especially in countries

where tort payouts are likely to be large. Due to high-profile cases leading to large compensations, most

pharmaceutical companies endorse tort reform. Recent controversies have involved Vioxx and SSRI antidepressants.

[edit]Product approval elsewhere

In many non-US western countries a 'fourth hurdle' of cost effectiveness analysis has developed before new

technologies can be provided. This focuses on the efficiency (in terms of the cost per QALY) of the technologies in

question rather than their efficacy. In England NICE approval requires technologies be made available by the NHS,

whilst similar arrangements exist with the Scottish Medical Consortium in Scotland and the Pharmaceutical Benefits

Advisory Committee in Australia. A product must pass the threshold for cost-effectiveness if it is to be approved.

Treatments must represent 'value for money' and a net benefit to society. There is much speculation[24] that a NICE

style framework may be implemented in the USA to ensure Medicare and Medicaid spending is focused to maximize

benefit to patients and not excessive profits for the pharmaceutical industry.

In the UK, the British National Formulary is the core guide for pharmacists and clinicians.

[edit]Industry revenues

For the first time ever, in 2006, global spending on prescription drugs topped $643 billion, even as growth slowed

somewhat in Europe and North America. The United States accounts for almost half of the global pharmaceutical

market, with $289 billion in annual sales followed by the EU and Japan.(pdf) Emerging markets such as China,
Russia, South Korea and Mexico outpaced that market, growing a huge 81 percent.[25]

US profit growth was maintained even whilst other top industries saw little or no growth.[26] Despite this, "..the

pharmaceutical industry is — and has been for years — the most profitable of all businesses in the U.S. In the annual

Fortune 500 survey, the pharmaceutical industry topped the list of the most profitable industries, with a return of 17%

on revenue."[27]

Pfizer's cholesterol pill Lipitor remains a best-selling drug world wide. Its annual sales were $12.9 billion, more than

twice as much as its closest competitors: Plavix, the blood thinner from Bristol-Myers Squibb and Sanofi-

Aventis; Nexium, the heartburn pill from AstraZeneca; and Advair, the asthma inhaler from GlaxoSmithKline.[25]

IMS Health publishes an analysis of trends expected in the pharmaceutical industry in 2007, including increasing

profits in most sectors despite loss of some patents, and new 'blockbuster' drugs on the horizon.[28]
Teradata Magazine predicted that by 2007, $40 billion in U.S. sales could be lost at the top 10 pharmaceutical

companies as a result of slowdown in R&D innovation and the expiry of patents on major products, with 19

blockbuster drugs losing patent.[29]

[edit]Market leaders in terms of revenue

Main article: List of pharmaceutical companies

The following is a list of the 20 largest pharmaceutical and biotech companies ranked by healthcare revenue. Some

companies (e.g., Bayer, Johnson and Johnson and Procter & Gamble) have additional revenue not included here.

The phrase Big Pharma is often used to refer to companies with revenue in excess of $3 billion,

and/or R&D expenditure in excess of $500 million. (Note the chart below uses millions as its base, hence a figure of

53,324 translates as 53,324,000,000 or 53 billion.)

Total Healthcare R&D Net income/ (loss)

Revenue 2006(USD millions) 2006(USD millions)
Company Country Revenues(USD millions Employees 2006
Rank 2008
)
1 Pfizer USA 67,809 7,599 19,337 122,200
2 Novartis Switzerland 53,324 7,125 11,053 138,000
3 Merck & Co. USA 45,987 4,783 4,434 74,372
4 Bayer Germany 44,200 1,791 6,450 106,200
United
5 GlaxoSmithKline 42,813 6,373 10,135 106,000
Kingdom
6 Johnson and Johnson USA 37,020 5,349 7,202 102,695
7 Sanofi-Aventis France 35,645 5,565 5,033 100,735
8 Hoffmann–La Roche Switzerland 33,547 5,258 7,318 100,289
United
9 AstraZeneca 26,475 3,902 6,063 50,000+
Kingdom
10 Abbott Laboratories USA 22,476 2,255 1,717 66,800
Bristol-Myers
11 USA 17,914 3,067 1,585 60,000
Squibb
Eli Lilly and
12 USA 15,691 3,129 2,663 50,060
Company
13 Amgen USA 14,268 3,366 2,950 48,000
Boehringer
14 Germany 13,284 1,977 2,163 43,000
Ingelheim
15 Schering-Plough USA 10,594 2,188 1,057 41,500
16 Baxter International USA 10,378 614 1,397 38,428
Takeda
17 Japan 10,284 1,620 2,870 15,000
Pharmaceutical Co.
18 Genentech USA 9,284 1,773 2,113 33,500
19 Procter & Gamble USA 8,964 n/a 10,340 29,258
SUM 497,519 70,843 110,077 1,342,700
AVERAGE 24876 3542 5504 67135

Source: Top 50 Pharmaceutical Companies Charts & Lists, Med Ad News, September 2007[30]

[edit]Market leaders in terms of sales

The top 15 pharmaceutical companies by 2008 sales are:[7]

[31]

Rank Company Sales ($M) Based/Headquartered in

1 Pfizer 43,363 US
2 GlaxoSmithKline 36,506 United Kingdom
3 Novartis 36,506 Switzerland
4 Sanofi-Aventis 35,642 France
5 AstraZeneca 32,516 United Kingdom
6 Hoffmann–La Roche 30,336 Switzerland
7 Johnson & Johnson 29,425 US
8 Merck & Co. 26,191 US
9 Abbott 19,466 US
10 Eli Lilly and Company 19,140 US
11 Amgen 15,794 US
12 Wyeth 15,682 US
13 Teva 15,274 Israel
14 Bayer 15,660 Germany
15 Takeda 13,819 Japan

[edit]Patents and generics

Depending on a number of considerations, a company may apply for and be granted a patent for the drug, or the

process of producing the drug, granting exclusivity rights typically for about 20 years.[32] However, only after rigorous

study and testing, which takes 10 to 15 years on average, will governmental authorities grant permission for the

company to market and sell the drug.[33] Patent protection enables the owner of the patent to recover the costs of

research and development through high profit margins for the branded drug. When the patent protection for the drug

expires, a generic drug is usually developed and sold by a competing company. The development and approval of

generics is less expensive, allowing them to be sold at a lower price. Often the owner of the branded drug will

introduce a generic version before the patent expires in order to get a head start in the generic market.
[34]
 Restructuring has therefore become routine, driven by the patent expiration of products launched during the

industry's 'golden era' in the 1990s and companies' failure to develop sufficient new blockbuster products to replace

lost revenues.[35]

[edit]Medicare Part D

In 2003 the United States enacted the Medicare Prescription Drug, Improvement, and Modernization Act (MMA), a

program to provide prescription drug benefits to the elderly anddisabled. This program is a component of Medicare

(United States) and is known as Medicare Part D. This program, set to begin in January 2006, will significantly alter

the revenue models for pharmaceutical companies. Revenues from the program are expected to be $724 billion

between 2006 and 2015.[36]

Pharmaceuticals developed by biotechnological processes often must be injected in a physician's office rather than

be delivered in the form of a capsule taken orally. Medicare payments for these drugs are usually made through

Medicare Part B (physician office) rather than Part D (prescription drug plan).

[edit]Mergers, acquisitions, and co-marketing of drugs

A merger, acquisition, or co-marketing deal between pharmaceutical companies may occur as a result of

complementary capabilities between them. A small biotechnology company might have a new drug but no sales or

marketing capability. Conversely, a large pharmaceutical company might have unused capacity in a large sales force

due to a gap in the company pipeline of new products. It may be in both companies' interest to enter into a deal to

capitalize on the synergy between the companies.

[edit]Prescriptions

In the U.S., prescriptions have increased over the past decade to 3.4 billion annually, a 61 percent increase. Retail

sales of prescription drugs jumped 250 percent from $72 billion to $250 billion, while the average price of

prescriptions has more than doubled from $30 to $68.

Retail prescription drug sales 1995 to 2006 PDF from www.census.gov

[edit]Publications

The drug company Merck & Co. publishes the Merck Manual of Diagnosis and Therapy, the world's best-selling

medical textbook, and the Merck Index, a collection of information about chemical compounds.

[edit]Marketing

A promotional item given to a psychiatrist

Main article: Pharmaceutical marketing

Pharmaceutical companies commonly spend a large amount on advertising, marketing and lobbying. In the US, drug

companies spend $19 billion a year on promotions.[16] Advertising is common in healthcare journals as well as

through more mainstream media routes. In some countries, notably the US, they are allowed to advertise direct to the

general public. Pharmaceutical companies generally employ sales people (often called 'drug reps' or, an older term,

'detail men') to market directly and personally to physicians and other healthcare providers. In some countries,
notably the US, pharmaceutical companies also employ lobbyists to influence politicians. Marketing of prescription

drugs in the US is regulated by the federal Prescription Drug Marketing Act of 1987.

[edit]To healthcare professionals

Currently, there are approximately 81,000 pharmaceutical sales reps in the United States[37] pursuing some 830,000

pharmaceutical prescribers. A pharmaceutical representative will often try to see a given physician every few weeks.

Representatives often have a call list of about 200-300 physicians with 120-180 targets that should be visited in 1-2

or 3 week cycle. The number of pharmaceutical sales reps has been shrinking between 2008 and 2010, an estimated

30% industry wide reduction has occurred and current estimates are there may only be 60,000 pharmaceutical sales

reps in the United States.[37]

[edit]To insurance and public health bodies

Private insurance or public health bodies (e.g. the NHS in the UK) decide which drugs to pay for, and restrict the

drugs that can be prescribed through the use of formularies. Public and private insurers restrict the brands, types and

number of drugs that they will cover. Not only can the insurer affect drug sales by including or excluding a particular

drug from a formulary, they can affect sales by tiering or placing bureaucratic hurdles to prescribing certain drugs as

well. In January 2006, the U.S. instituted a new public prescription drug plan through its Medicare program known

as Medicare Part D. This program engages private insurers to negotiate with pharmaceutical companies for the

placement of drugs on tiered formularies.

[edit]To retail pharmacies and stores

Commercial stores and pharmacies are a major target of non-prescription sales and marketing for pharmaceutical

companies.

[edit]Direct to consumer advertising

Main article: Direct-to-consumer advertising

Since the 1980s new methods of marketing for prescription drugs to consumers have become important. Direct-to-

consumer media advertising was legalised in the FDA Guidance for Industry on Consumer-Directed Broadcast

Advertisements.

Internationally, many pharmaceutical companies market directly to the consumer rather than going through a

conventional retail sales channel. For example, Japan-based Kenricomarkets largely though its company website.

[edit]Controversy about drug marketing and lobbying

There has been increasing controversy surrounding pharmaceutical marketing and influence. There have been

accusations and findings of influence on doctors and other health professionals through drug reps, including the

constant provision of marketing 'gifts' and biased information to health professionals;[38][39] highly prevalent advertising

in journals and conferences; funding independent healthcare organizations and health promotion campaigns;
lobbying physicians and politicians (more than any other industry in the US[40]); sponsorship of medical schools or

nurse training; sponsorship of continuing educational events, with influence on the curriculum;[41] and hiring

physicians as paid consultants on medical advisory boards.

To help ensure the status quo on U.S. drug regulation and pricing, the pharmaceutical industry has thousands of

lobbyists in Washington, DC that lobby Congress and protect their interests. The pharmaceutical industry spent $855

million, more than any other industry, on lobbying activities from 1998 to 2006, according to the non-partisan Center

for Public Integrity.[42]

Some advocacy groups, such as No Free Lunch, have criticized the effect of drug marketing to physicians because

they say it biases physicians to prescribe the marketed drugs even when others might be cheaper or better for the

patient.[43]

There have been related accusations of disease mongering[3] (over-medicalising) to expand the market for

medications. An inaugural conference on that subject took place in Australia in 2006.[44] In 2009, the Government-

funded National Prescribing Service launched the "Finding Evidence - Recognising Hype" program, aimed at

educating GPs on methods for independent drug analysis.

A 2005 review by a special committee of the UK government came to all the above conclusions in a European Union

context[45] whilst also highlighting the contributions and needs of the industry.

There is also huge concern about the influence of the pharmaceutical industry on the scientific process. Meta-

analyses have shown that studies sponsored by pharmaceutical companies are several times more likely to report

positive results, and if a drug company employee is involved (as is often the case, often multiple employees as co-

authors and helped by contracted marketing companies) the effect is even larger.[46][47][48] Influence has also extended

to the training of doctors and nurses in medical schools, which is being fought.[49]

It has been argued that the design of the Diagnostic and Statistical Manual of Mental Disorders and the expansion of

the criteria represents an increasing medicalization of human nature, or "disease mongering", driven by drug

company influence on psychiatry.[50] The potential for direct conflict of interest has been raised, partly because

roughly half the authors who selected and defined the DSM-IV psychiatric disorders had or previously had financial

relationships with the pharmaceutical industry.[51] The president of the organization that designs and publishes the

DSM, the American Psychiatric Association, recently acknowledged that in general American psychiatry has "allowed

the biopsychosocial model to become the bio-bio-bio model" and routinely accepted "kickbacks and bribes" from

pharmaceutical companies.[52]

[edit]Developing world

The role of pharmaceutical companies in the developing world is a matter of some debate, ranging from those

highlighting the aid provided to the developing world, to those critical of the use of the poorest in human clinical trials,

often without adequate protections, particularly in states lacking a strong rule of law. Other criticisms include an
alleged reluctance of the industry to invest in treatments of diseases in less economically advanced countries, such

as malaria; Criticism for the price of patented AIDS medication, which could limit therapeutic options for patients in

the Third World, where most of the AIDS infected people are living.

In September 2008 the Open Source Drug Discovery Network was launched in India to combat infectious diseases

common to developing countries.

[edit]Patents

See also: Criticism of patents

Under World Trade Organization rules, a developing country has options for obtaining needed medications

under compulsory licensing or importation of cheaper versions of the drugs, even before patent expiration (WTO

Press Release). Pharmaceutical companies often offer much needed medication at no or reduced cost to the
developing countries. In March 2001,South Africa was sued by 41 pharmaceutical companies for their Medicines Act,

which allowed the import and generic production of cheap AIDS drugs. The case was later dropped after protest

around the world.

[edit]Nigerian clinical trial

See also: Kano trovafloxacin trial litigation

In 1996, a pediatric clinical trial conducted on behalf of Pfizer tested the antibiotic Trovan allegedly without first

obtaining the informed consent of participants or their parents.[53][54][55][56]

[edit]Charitable programmes

Charitable programs and drug discovery & development efforts are routinely undertaken by pharmaceutical

companies. Some examples include:

 "Merck's Gift," wherein billions of River Blindness drugs were donated in Africa [57]

 Pfizer's gift of free/discounted fluconazole and other drugs for AIDS in South Africa [58]

 GSK's commitment to give free albendazole tablets to the WHO for, and until, the elimination of lymphatic

filariasis worldwide.

 In 2006, Novartis committed USD 755 million in corporate citizenship initiatives around the world, particularly

focusing on improved access to medicines in the developing world through its Access to Medicine projects,

including donations of medicines to patients affected by leprosy, tuberculosis, and malaria; Glivec patient

assistance programmes; and relief to support major humanitarian organisations with emergency medical needs.
[59]

However, some NGOs such as Médecins Sans Frontières do not routinely accept corporate donations of medicines.

More precisely, they do not become reliant on such supplies of medicines because the supply is dependent upon the

fluid, profit-driven charities of said pharmaceutical companies, and thus may dry up during a critical or otherwise
important time. The book An Imperfect Offering: Humanitarian Action for the 21st Century by ex-MSF

president James Orbinski describes this in detail.

[edit]Pharmaceutical industry in popular culture

As for many other major industries since the middle of the twentieth century, the pharmaceutical industry has been

portrayed as a global shadowy force in numerous western fiction works. Notorious films such as The Fugitive (1993)

and novels/films such as The Constant Gardener characterize this trend.

[edit]Industry associations

 European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

 Drug Information Association (DIA)

 European Federation of Pharmaceutical Industries and Associations (EFPIA)

 European Pharmaceutical Market Research Association (EphMRA)

 International Federation of Pharmaceutical Manufacturers and Associations (IFPMA)

 Japan Pharmaceutical Manufacturers Association (JPMA)

 New York Health Products Council (NYHPC)

 Pharmaceutical Research and Manufacturers of America (PhRMA)

 Irish Pharmaceutical Healthcare Association (IPHA)

[edit]Regulatory authorities

Main article: Regulation of therapeutic goods

 International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals

for Human Use (ICH)

 European Medicines Agency (EMEA)

 Therapeutic Goods Administration (Australia) (TGA)

 U.S. Food and Drug Administration (FDA)

 Ministry of Health, Labour and Welfare (Japan)

 Medicines and Healthcare products Regulatory Agency (MHRA)

 Central Drugs Standards Control Organisation (India) (CDSCO)

 Ukrainian Drug Registration Agency[2]

[edit]See also

 100,000,000 Guinea Pigs: Dangers in Everyday Foods, Drugs, and Cosmetics  (book)  History of pharmacy

 Biotechnology  List of top selling drugs

 Cautionary and advisory label  List of pharmaceutical companies

 Clinical trial  List of pharmacies

 Contamination control  National pharmaceuticals policy

 Cost effectiveness analysis  NICE

 Drug development  Orphan drug

 Drug design  Pharmaceutical marketing

 Drug discovery  Pharmaceutical lobby

 Generic drug  Prescription drug prices in the United States

 Health care system  Use of biotechnology in pharmaceutical manuf

[edit]