Pharmaceutical Industry

The pharmaceutical industry is the collective business enterprise employed in discovering, developing, manufacturing, and marketing legal drugs.

• Controversies
• List of pharmaceutical companies

The origins of the pharmaceutical industry can be traced back to the chemical industries (of the late nineteenth century) in the upper Rhine Valley of Switzerland. These industries were producing dye stuffs. When dye stuffs were found to have antiseptic properties, a number of these industries turned into pharmaceutical industries e.g. Hoffman-La Roche, Sandoz, Ciba-Geigy, etc.

Another origin is the drug store. The first known drug store was opened by Arabian pharmacists in Baghdad in 754, and many more soon began operating throughout the Islamic world and Europe. By the 19th century, many of the drug stores in Europe and North America had developed into larger pharmaceutical companies.

Most of today's major pharmaceutical companies were founded in the late 19th and early 20th centuries. https://web.archive.org/web/20100120103354/https://www.scribd.com/doc/21734187/History-of-Pharmaceutical-Industry

The roots of the pharmaceutical industry lie back with the apothecaries and pharmacies that offered traditional remedies as far back as the middle ages, offering a hit-and-miss range of treatments based on centuries of folk knowledge.

But the industry as we understand it today really has its origins in the second half of the 19th century. Whilst the scientific revolution of the 17th century had spread ideas of rationalism and experimentation, and the industrial revolution had transformed the production of goods in the late 18th century, the marrying of the two concepts for the benefit of human health was a comparatively late development.

Merck in Germany was possibly the earliest company to move in this direction. Originating as a pharmacy founded in Darmstadt in 1668, it was in 1827 that Heinrich Emanuel Merck began the transition towards an industrial and scientific concern, by manufacturing and selling alkaloids.

Similarly, whilst GlaxoSmithKline’s origins can be traced back as far as 1715, it was only in the middle of the 19th century that Beecham became involved in the industrial production of medicine, producing patented medicine from 1842, and the world’s first factory for producing only medicines in 1859.

America’s pharmaceutical founding fathers

Meanwhile in the USA, Pfizer was founded in 1849 by two German immigrants, initially as a fine chemicals business. Their business expanded rapidly during the American civil war as demand for painkillers and antiseptics rocketed.

https://web.archive.org/web/20200929225934/https://pharmaphorum.com/r-d/a_history_of_the_pharmaceutical_industry/

The period between 1918 and 1939 was marked by two breakthroughs that presaged the arrival of the pharma industry as we know it today. The first was insulin – Frederick Banting and colleagues managed to isolate insulin that could treat diabetes, up until that point a fatal condition. But it was only in collaboration with the scientists at Eli Lilly that they were able to sufficiently purify the extract and industrially produce and distribute it as an effective medicine.

The second was penicillin, a discovery of an impact possibly unparalleled by any other in medicine. After Alexander Fleming’s initial discovery of the penicillium mould’s antibiotic properties in 1928, and Howard Florey and Ernst Chain’s further experimentation, a government-supported international collaboration including Merck, Pfizer and Squibb worked on mass producing the drug during World War Two, saving thousands of soldiers’ lives. The immense scale and sophistication of the penicillin development effort marked a new era for the way the pharmaceutical industry developed drugs. The war had also encouraged research into everything from new analgesics to drugs against typhus, with a great deal of collaboration between the companies and government.

https://web.archive.org/web/20200929225934/https://pharmaphorum.com/r-d/a_history_of_the_pharmaceutical_industry/

Pharmaceutical Research and Manufacturers of America, also known as PhRMA, is one of the largest and most influential lobbying organizations in Washington. Representing 48 pharmaceutical companies.

PhRMA has 20 registered lobbyists on staff and has contracted with dozens of lobby and PR firms – including Akin, Gump, Strauss, Hauer & Feld, Barbour Griffith & Rogers, DCI Group and The Dutko Group– to promote its members' interests. PhRMA has a record of hiding its lobbying and PR activities, often by paying other organizations, such as United Seniors Association (USA) or the Consumer Alliance, to advocate industry-friendly policies.

PhRMA was a member of ALEC's “Private Enterprise” Board of Directors as of 2016, with lobbyist Jeff Bond representing it on the board.[11] PhRMA was also a 2011 recipient of ALEC's Private Sector Member of the Year Award, a “Chairman” level sponsor of 2011 ALEC Annual Conference, which equated to $50,000 in 2010, a sponsor of Louisiana Governor Bobby Jindal's plenary luncheon speech at the 2011 ALEC Annual Conference, and a “Vice Chair”-level sponsor of the 2016 ALEC Annual Conference. A list of ALEC corporations can be found here.¹⁾

ALEC is a corporate bill mill. It is not just a lobby or a front group; it is much more powerful than that. Through ALEC, corporations hand state legislators their wishlists to benefit their bottom line. Corporations fund almost all of ALEC's operations. They pay for a seat on ALEC task forces where corporate lobbyists and special interest reps vote with elected officials to approve “model” bills. Learn more at the Center for Media and Democracy's ALECexposed.org, and check out breaking news on our ExposedbyCMD.org site.

Soon after Wisconsin Governor Scott Walker came into office, Walker and GOP state legislators pushed for the adoption of Wisconsin Act 2, an ALEC-influenced bill that benefitted the bottom line of PhRMA members. The bill seeks to implement “tort reform” by “limiting the ability to hold corporations accountable for causing injury or death” and “make it easier for corporations like drugmakers to escape liability for manufacturing dangerous products or products with insufficient warnings about hazards.” The legislation drew heavily from ALEC Model bills on tort reform, including the “Constitutional Guidelines for Punitive Damages Act” and the “Product Liability Act.”²⁾

(Ezekiel) Zeke Emanuel M.D. is a senior fellow at American Progress and the vice provost for global initiatives. He was the founding chair of the department of bioethics at the National Institutes of Health (NIH) and served on former President Bill Clinton’s Health Care Task Force,³⁾

Scott Gottlieb M.D. Gottlieb Was The Commissioner Of The Food And Drug Administration (FDA) Under The Trump Administration. As Of November 15, 2021. According to their Pfizer board member page, Dr. Scott Gottlieb is a member of Pfizer’s board of directors.

• Mar 1, 2019 Public citizen: Companies Are Reaping Benefits from Social Influencers, and Big Pharma Wants In

Different governing bodies regulate the pharmaceutical industry according to their own legal and governance structures.

(select highlights not full list)

1905 - The American Medical Association, through its Council on Pharmacy and Chemistry, initiates a voluntary program of drug approval that would last until 1955. To earn the right to advertise in AMA and related journals,companies submitted evidence, for review by the Council and outside experts, to support their therapeutic claims for drugs.

1914 - The Harrison Narcotic Act requires prescriptions for products exceeding the allowable limit of narcotics and mandates increased record-keeping for physicians and pharmacists who dispense narcotics.

1930 - The name of the Food, Drug, and Insecticide Administration is shortened to Food and Drug Administration (FDA) under an agricultural appropriations act.

1938 - The Federal Food, Drug, and Cosmetic (FDC) Act of 1938 is passed by Congress, containing new provisions- Extending control to cosmetics and therapeutic devices.- Requiring new drugs to be shown safe before marketing, starting a new system of drug regulation.

1951 - Durham-Humphrey Amendment defines the kinds of drugs that cannot be used safely without medical supervision and restricts their sale to prescription by a licensed practitioner.

1966 - FDA contracts with the National Academy of Sciences/National Research Council to evaluate the effectiveness of 4,000 drugs approved on the basis of safety alone between 1938 and 1962.

1970 - In Upjohn v. Finch the Court of Appeals upholds enforcement of the 1962 drug effectiveness amendments by ruling that commercial success alone does not constitute substantial evidence of drug safety and efficacy. FDA requires the first patient package insert- oral contraceptives must contain information for the patient about specific risks and benefits.

1977 - Introduction of the Bioresearch Monitoring Program as an agency-wide initiative ensures the quality and integrity of data submitted to FDA and provides for the protection of human subjects in clinical trials by focusing on preclinical studies on animals, clinical investigations, and the work of institutional review boards.

1981 - FDA and the Department of Health and Human Services revise regulations for human subject protections, based on the 1979 Belmont Report, which had been issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The revised rules provide for wider representation on institutional review boards and they detail elements ofwhat constitutes informed consent, among other provisions.

1987 Investigational drug regulations revised to expand access to experimental drugs for patients with serious diseases with no alternative therapies.

1988 - Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services with a Commissioner of Food and Drugs appointed by the President with the advice and consent of the Senate, and broadly spells out the responsibilities of the Secretary and the Commissioner for research, enforcement, education, and information.

The Prescription Drug Marketing Act bans the diversion of prescription drugs from legitimate commercial channels. Congress finds that the resale of such drugs leads to the distribution of mislabeled, adulterated, subpotent, and counterfeit drugs to the public. The new law requires drug wholesalers to be licensed by the states; restricts reimportation from other countries; and bans sale, trade or purchase of drug samples, and traffic or counterfeiting of redeemable drug coupons.

1991 -The policy for protection of human subjects in research, promulgated in 1981 by FDA and the Department of Health and Human Services, is adopted by more than a dozen federal entities involved in human subject research and becomes known as the Common Rule. This rule issues requirements for researchers who obtain and document informed consent, secures special protection for children, women, and prisoners, elaborates on required procedures for institutional review boards, and ensures that research institutions comply with the regulations.

2004 - Project BioShield Act of 2004 authorizes FDA to expedite its review procedures to enable rapid distribution of treatments as countermeasures to chemical, biological, and nuclear agents that may be used in a terrorist attack against the U. S., among other provisions.

2005 - Formation of the Drug Safety Board is announced, consisting of FDA staff and representatives from the National Institutes of Health and the Veterans Administration. The Board will advise the Director, Center for Drug Evaluation and Research, FDA, on drug safety issues and work with the agency in communicating safety information to health professionals and patients. Three final guidances were published to fulfill FDA's commitment to the risk management performance goals that are part of the 2002 reauthorization of PDUFA. * Premarketing Risk Assessment * Development and Use of Risk Minimization Action Plans * Good Pharmacovigilance Practices and Pharmacoepidemiologic Assessment

https://web.archive.org/web/20210306155449/https://www.fda.gov/media/74571/download

The Thalidomide scandal of 1961 prompted an increase in the regulation and testing of drugs before licensing, with a new amendment to US Food and Drug Administration (FDA) rules demanding proof of efficacy and accurate disclosure of side-effects for new medications (the Kefauver-Harris Amendment) being implemented in 1962. Likewise, the 1964 Declaration of Helsinki put greater ethical structures on clinical research, clearly cementing the difference between production of scientific prescription medicines and other chemicals. https://web.archive.org/web/20200929225934/https://pharmaphorum.com/r-d/a_history_of_the_pharmaceutical_industry/

Part One - THE ROCKETING COST OF HEALTH CARE

Drug companies employ many means in bribing doctors and medical institutions. Dr Levin writes;

“Young physicians are offered research grants by drug companies. Medical schools are given large sums of money for clinical trials and basic pharmaceutical research. Drug companies regularly host lavish dinner and cocktail parties for groups of physicians. They provide funding for the establishment of hospital buildings, medical school buildings, and 'independent' research institutes.

“The pharmaceutical industry has purposefully moved to develop an enormous amount of influence within medical teaching institutions. This move was greatly facilitated by several factors. The first was the economic recession, which caused a marked constriction in federal funding for research programs. Academic scientists lacked funding for pet research projects.

The second was the tremendous interest that academic scientists held in biotechnology, the stock market, and the possibility of becoming millionaires overnight. The third is the fact that academic physicians tend to lack real clinical experience. In the university, the physician is an expert in esoteric disease, end-stage disease, and animal models of human disease.

He or she has little or no experience with the day-to-day needs of the chronically ill patient or the patient with very early symptoms of serious illness. As the academic physician does not depend upon the good will of the patient for his or her livelihood, the patient's well-being becomes of minor consideration to him or her. All these factors make the academic physician a very poor judge of treatment efficacy and a willing pawn of health industrialists.

“Pharmaceutical companies, by enlisting the aid of influential academic physicians, have gained control of the practice of medicine in the United States. They now set the standards of practice by hiring investigators to perform studies which establish the efficacy of their products or impugn that of their competitors….

Dr Alan Levin is an Adjunct Associate Professor of Immunology and Dermatology at the University of California. He is a Fellow of the American College of Emergency Physicians, the College of American Pathologists, and the American Society of Clinical Pathologists. Dr Levin is also a recipient of fellowships and awards from Harvard Medical School and other medical institutions, and was Director of various research laboratories. ⁴⁾

How the pharmaceutical industry took control of the hospitals, universities, research and other institutions in the early part of this century is amply demonstrated by world-famous medical historian and author, Hans Ruesch, in his devastating expose: Naked Empress or The Great Medical Fraud (55) (1992). The book is an absolute must to read. Naked Empress exposes massive corruption and fraud in medicine, science, industries, governments, media, and various organisations. The importance of this book cannot be overstated.

In Naked Empress, Ruesch cited another important expose titled The Drug Story (1949), by American investigative reporter, Morris A. Bealle. According to Bealle; “America's largest and most ruthless industrial combine, the Rockefeller Empire” which was built on Standard Oil Company in the early part of this century became interested in the drug trade after making breath-taking profits from palming off bottled petroleum called Nujol as a supposed cure for cancer and later constipation.

In 1939 the Drug Trust was formed by an alliance of the world's two greatest cartels in world history - the Rockefeller Empire and the German chemical company, I.G. Farbenindustrie I.G. Farben. Drug profits from that time onwards curved upwards into gigantic proportions and by 1948 it became a 10 billion dollar a year industry.

I.G. Farben's unsavoury past is highlighted by the fact that during the Second World War it built and operated a massive chemical plant at Auschwitz using slave labour. Approximately 300,000 concentration-camp workers passed through I.G. Farben's facilities at Auschwitz and at least 25,000 of them were worked to death. (58) Also, others were brutally killed in I.G. Farben's drug testing programs. (59) Twelve of I.G. Farben's top executives were sentenced to terms of imprisonment for slavery and mistreatment offences at the Nuremberg war crime trials. (60)

Hoechst and Bayer, the largest and third largest companies in world pharmaceutical sales respectively, are descended from I.G. Farben. In September 1955, Hoechst appointed Friedrich Jaehne, a convicted war criminal from the Nuremberg trials, as Chairman of its supervisory board. Also, a year later, Bayer appointed Fitz ter Meer, another convicted war criminal, as Chairman of its board. (61)

On the Rockefellers' moves towards “influencing” medical colleges and public agencies in the United States, Bealle writes;”The last annual report of the Rockefeller Foundation itemizes the gifts it has made to colleges and public agencies in the past 44 years [from 1948], and they total somewhat over half a billion dollars.

These colleges, of course, teach their students all the drug lore the Rockefeller pharmaceutical houses want taught. Otherwise there would be no more gifts, just as there are no gifts to any of the 30 odd drugless colleges in the United States.”

The Rockefellers did not restrict their “educational” activities to the US alone. In 1927 they formed the International Education Board which “donated” millions of dollars to foreign universities and politicos, with all the usual strings attached.

As these huge amounts of money were being “donated” to drug-propagandising colleges, the Rockefeller interests were expanding world-wide. It was large enough 40 years ago for Bealle to state:

“It has long been demonstrated that the Rockefeller interests have created, built up and developed the most far reaching industrial empire ever conceived in the mind of man. Standard Oil is of course the foundation industry upon which all of the other industries have been built….

“The keystone of this mammoth industrial empire is the Chase National Bank with 27 branches in New York City and 21 in foreign countries [now renamed the Chase Manhattan Bank with over 200 branches in the US and abroad]. Not the least of its holdings are in the drug business. The Rockefellers own the largest drug manufacturing combine in the world, and use all of their other interests to bring pressure to increase the sale of drugs.”

Instrumental in Rockefellers' moves towards making the world drug-dependent is their enormous influence on the media. Commenting on this, Ruesch explains;

“So the stage was set for the 'education' of the American public, with a view to turning them into a population of drug dependents, with the early help of the schools, then with direct advertising and, last but not least, the influence the advertising revenues had on the media.

“A compilation of the magazine Advertising Age showed that as far back as 1948 the larger companies spent for newspapers, radio and magazine advertising the sum total of $1,104,224,374, when the dollar was still worth a dollar. Of this staggering sum the interlocking Rockefeller-Morgan interests (gone over entirely to Rockefeller after Morgan's death) controlled about 80 percent, and utilized it to manipulate public information on health and drug matters - then as now.

“Anybody who tries to get into the mass media independent news, contrary to the interests of the Drug Trust, will sooner or later run into an unbreakable wall….

“For big advertisers it is easy not only to plant into the media any news they wish to disseminate, but also to keep out the news they don't want to get around. A survey in 1978 by the Columbia Journalism Review failed to find a single comprehensive article about the dangers of smoking in the previous seven years in any major magazine accepting cigarette advertising….

“Even the most independent newspapers are dependent on their press associations for their national news. And there is no reason for a news editor to suspect that a story coming over the wires of the Associated Press, the United Press or the International News Services is censored when it concerns health matters.

Among the many publications owned by the Rockefeller Drug Trust, there are: Fortune, Life, Time, Readers Digest and Newsweek magazines, and the Encyclopedia Britannica. These publications are constantly pushing drugs.

Leaving no stone unturned, Ruesch shows how the Drug Trust, in securing their drug interests, planted stooges into senior positions of colleges, universities, and government bodies. About the Food and Drug Administration, Ruesch charges:

“When a good law was enacted many years ago for protecting the American public from spoiled food and poisonous drugs, the Drug Trust lost little time to get its hooks into the government bureau that was charged with enforcing the law.”

“Apparently, the FDA doesn't only wink at the violations of the Drug Trust whose servant it is (such as the mass deaths in the ginger jake and sulfathiozole cases), but it is particularly assiduous in putting out of business all competitors of the Drug Trust, like the vendors of natural therapeutic devices that improve the health of the public and thus decrease the profits of the Drug Trust….

“And the situation is practically identical in all the other industrialized countries, notably Great Britain, France and West Germany.”

The Civil Abolitionist carried an article rightly titled “FDA: The American Gestapo Prosecutor or Persecutor?”, which reported that on May 6, 1992, the clinic of Jonathan Wright MD, a highly regarded nutrition specialist, was assailed by 22 armed men because the doctor had been treating his patients with safe natural substances that didn't meet the FDA's approval. During the SWAT type attack the front door was kicked open, guns were pointed directly at staff and the shocked patients were herded into a room. Also patient records, equipment, business records and vitaminsupplies were confiscated. At the time of the article, the FDA had not as yet filed charges against Dr Wright.

In Australia, a repeal of Schedule 1, Exemptions of the Therapeutic Goods Act, scheduled for January 1994, would minimize access to natural therapy remedies by natural therapists and would threaten the existence of the natural therapy profession and manufacturers of natural therapy remedies.

Morris H. Rubin, Editor and Publisher of The Progressive, writes in an article in January 1977;

“Corporate power has become the dominant force in our society… All attempts to check the mounting power of the corporate giants have failed. Consider the two most important instruments forged by the progressive forces of the country in their crusade to curb the march of monopoly; the regulatory system and the antitrust program…

“The regulatory system lies in shambles, and the corporations which were intended to be regulated in the public interest now dominate these regulatory agencies. The betrayal of the public trust is virtually complete… The antitrust laws are virtually dead letters. It is clear from recent disclosures that the Antitrust Division of the Justice Department is almost immobilized because of deals made over its head and behind its back in the White House and other corridors of power…”

“The oil lobby, perhaps the most powerful lobby on earth, is almost matched by hospital owners and doctors.” - President Carter, 1979. Copyright 1993, 1995 by the Campaign Against Fraudulent Medical Research, P.O. Box 234, Lawson NSW 2783, Australia. ⁵⁾