– A merry heart doeth good like a medicine: but a broken spirit drieth the bones.

There are times people need to take medicine for health. For the most part, Jesus Christ is the answer – not medcine.

The Pharmaceutical Industry discovers, develops, manufactures, and markets medicines, or drug products, to use as medicines that are administered (or self-administered) to patients, aiming to treat, cure, or relieve symptoms. Using very large resources within the industry, the drug companies co-opt the system of medical knowledge to serve their own specific interests, interests which are incompatible with integrity, and with at least some central goals believed to be at the heart of medicine. Pharmaceutical companies substantially augment medical science, conduct their own research, seamlessly plug them into medical science in ways that complement it, and then cultivate them until they become dominant.

 – Drink no longer water, but use a little wine for thy stomach’s sake and thine often infirmities.

In addition to research at NIH, drug manufacturers and biotech companies have significant roles to play in the initial stages of discovering new drugs. Pharmaceutical manufacturers and biotech companies then go through a process of development and approval with FDA to get a drug into the US market. Often, cooperative agreements are formed between research organizations and major pharmaceutical companies to investigate the potential of a new substance for drug use.

Given low success rates, research departments at large pharmaceutical companies will not only be investigating a single drug, but will be looking at many different substances at various points of the development cycle, all at once. The failure of the drug candidates at that point is, obviously, bad news for the drug industry; a very substantial amount of money, time, and effort will have been invested at that point, all to no avail. The pharmaceutical industry is conscious of its responsibilities as producers, and for years, the majority of companies have been voluntary undertaking an assessment of environmental risks for their new products.

Further complicating the relationship between the American drug industry and patients is the fact that American drug manufacturers are allowed to direct-market American-made drugs to patients, a practice which may educate patients about available therapies, but has also been shown to promote excessive prescribing of advertised drugs. Note that research conducted by researchers at the Harvard Business School found that drug manufacturers in the U.S. spent almost double as much money on marketing drugs to U.S. manufacturers than on R&D. Estimates from industry-funded economists have suggested that the development of drugs can cost up to $2,558 billion per drug, but those estimates are based on opaque data and employ assumptions highly favorable to the American drug industry, so the real numbers are likely far lower. In response to particular instances where adverse data in studies sponsored by drug companies were not published, the Pharmaceutical Research and Manufacturers of America has issued new guidelines that encourage companies to report all results and to limit researchers financial participation with pharmaceutical companies.

 – But when Jesus heard that, he said unto them, They that be whole need not a physician, but they that are sick.

In the early years of the drug business, the early adopters focused on innovation and entrepreneurship, but now the regulatory environment of the drug industry has grown more complicated. The Pharmaceutical Industry has been at the forefront of globalization for some time, with drug companies reorganizing their international production footprints often during the nineteenth and twentieth centuries. Pharmaceutical companies first emerged in Germany at the end of the 19th century, but quickly gained prominence in other areas around the world, such as in England and America.

Pharmaceutical firms, first in Germany during the 1880s, and most recently in the United States and in England, established collaborative relationships with academic laboratories. As the popularity and revenues in the pharmaceutical industry increased, drug firms began establishing partnerships with laboratories and research groups in order to accelerate development of new products and improvements of existing ones. With advances in science related to pharmacology, such as molecular biology, large numbers of effective drugs were invented and manufactured. Established chemical companies also entered the emerging market for chemical drugs, as researchers discovered applications of their chemicals in medicine and in science.

 – Who forgiveth all thine iniquities; who healeth all thy diseases;

Other companies, the names for which carry todays recognizable names, started out making organic chemicals (notably dyestuffs) before moving into pharmaceuticals. The first firm to drive development of pharmaceuticals was Merck of Germany, beginning its shift into industrial and scientific concerns in 1827. Merck, for instance, started out in 1668 as a small drugstore in Darmstadt, Germany, and did not start producing drugs on a large scale until the 1840s. While GlaxoSmithKlines origins date to 1715, it was not until the mid-19th century that Beecham became involved in industrial pharmaceutical manufacturing, producing patent medicines starting in 1842, and in 1859, it built the worlds first plant to manufacture drugs exclusively.

The unregulated nature of medicine trading in the 19th century meant there was far less of a rigorous demarcation between pharmaceutical and chemical industries than there is today. The pharmaceutical industry began as neighborhood pharmacies, which expanded from their traditional roles distributing herbal drugs like morphine and quinine into wholesale manufacturing by the mid-1800s, and as discoveries made through applied research. The roots of the pharmaceutical industry lay back in the apothecaries and pharmacies offering traditional remedies from the Middle Ages, offering a range of treatments that were hit-and-miss, based on centuries of folk knowledge. The American pharmaceutical industry emerged in the same milieu in the 19th century that gave birth to the American Medical Association.

 – And the prayer of faith shall save the sick, and the Lord shall raise him up; and if he have committed sins, they shall be forgiven him.

The pioneers who moved the American drug industry from flying by the night to a safer position within society were usually chemists, such as Charles Pfizer and Charles Erhardt, the young German immigrants cousins who arrived in Brooklyn in 1849 with the intention of producing products that were both safe and effective. The enormous size and complexity of the effort to develop penicillin marked a new era for how the drug industry developed drugs. Throughout the history of drug development, drug regulations have been designed to keep drugs on the cutting edge every step of the way, and ensure that drugs are available to consumers in a quality manner. Pharmaceutical regulation is accomplished by a number of regulatory activities during a drugs lifecycle.