Pharmaceutical industry

“ In the past, pharmaceutical houses, ever anxious to market something new, on the slightest provocation have placed on the market, in the form of pills, powder, elixir, ampule, etc., every drug for which some sort of medical recommendation could be found. In marketing these dosage forms, the manufacturer has too often been little concerned about the quality of the drugs used.150 Just at present, for instance, some interest is being shown in iron cacodylate ”

“ The issue, of course, is the safety and efficacy of products which Americans buy. The FDA has been given the responsibility and has executed that responsibility extraordinarily well to make sure when an American citizen buys a pharmaceutical product or a medication, it is what it says it is and it does what the doctor prescribes. ”

“ It is not surprising that proprietary remedies of the latter type flourish so long as physicians unthinkingly accept and prescribe them solely on the manufacturer’s valuation.
“The Council has practically the undivided support of manufacturers of medicinal chemicals; that is, of proprietaries of the first mentioned type. But pharmaceutical firms which have found it profitable to promote proprietaries of the second type—“specialties,” unscientific or ordinary mixtures of pharmaceuticals or biologic products sold under trade names—have not supported the Council. ”

“ Naturally Rule 4 has been bitterly opposed by most proprietary firms. Arguing that many physicians dispense their own drugs, pharmaceutical firms have insisted that every medicinal preparation should bear on its label, not only the dose of the preparation, but also a statement of the diseases in which the article is indicated. ”

“ If they wanted to practise surgery, an extra year in the study of anatomy was required. I published the text of this law, which was issued by the Emperor Frederick II about 1241, in the Journal of the American Medical Association three years ago. It also regulated the practice of pharmacy. Drugs were manufactured under the inspection of the government and there was a heavy penalty for substitution, or for the sale of old inert drugs, or improperly prepared pharmaceutical materials. ”

“ There are big issues at play relative to the future of the health of Americans on the issue of importation, on the issue of negotiation and Medicare, on the issue of biologic generics, and on the issue of making sure that children are adequately tested relative to the application of drugs which are brought to the market. There are big issues relative to safety and big issues relative to whether this country remains on the cutting edge of producing products that help people and give them a better lifestyle with a biological, pharmaceutical, or medical device. ”

“ In certain instances it is absolutely necessary that the article produced shall maintain a definite standard of quality and purity—and, it may be added, shall be sold at a reasonable price. Enterprising pharmaceutical manufacturers have usually been ready to appropriate the results of scientific research by investigators or therapeutic measures suggested by practicing physicians. ”

“ These investigations have included a study of the action of strychnin in cardiac disease, a comparison of the action of absorption and excretion of iodid preparations, a study of the pharmacology of the opium alkaloids, etc. Appreciating that the available knowledge of proprietary drugs is one sided in that it comes from investigations made by interested pharmaceutical concerns or from investigations made at the instigation of these firms, the Council is planning a comprehensive study of many of the synthetic drugs that have gained some vogue during recent years. ”

“ In the light of our knowledge the administration of gland mixtures in the host of conditions enumerated in the advertising circular is irrational and on a par with the use of the shotgun mixtures once in vogue.
Be it a pharmaceutical mixture, a “mixed” vaccine, or a “pluriglandular” product, the combination of two medicinal ingredients in a mixture must be considered contrary to rational therapy unless a good reason exists for such combination. Such mixtures are held in conflict with Rule 10 unless the manufacturer presents acceptable evidence for the value of his combination. ”

“ Article 33
⁠The drug regulatory department under the State Council shall organize experts in pharmaceutical, medical and other fields to evaluate new drugs and re-evaluate the drugs already approved for production.
Article 34
⁠Drug manufacturers, drug distributors and medical institutions shall purchase drugs from pharmaceutical enterprises, which are qualified for production or distribution, with the exception of the Chinese crude drugs where no control by approval number is exercised. ”

“ That physicians have been insufficiently trained in regard to the pharmacy and chemistry of drugs has often been emphasized in pharmaceutical journals where prescriptions containing incompatible drugs are reported and where even plans are brought forward whereby the pharmaceutical profession may aid in remedying this difficulty. ”

“ Now, the demand for this comes from the cost of the drugs. People want to be able to go across the border to Canada, which is obviously a very sophisticated nation, and buy a pharmaceutical product there, which costs significantly less than the same pharmaceutical product may cost in the United States. That is a natural instinct of the market economy and of people. ”

“ Why are almost all the major pharmaceutical breakthroughs and all the biologic breakthroughs coming in the United States? Because we have a market system which allows people to take the risks to develop those products.
We do not fix prices, as they do in Canada or in England, at a rate that is so low that nobody would be willing to invest in developing that product because the return on that investment is too low. We allow people who make the investment, who take the risk, who put the 12 years in, who invest $800 million, to get a reasonable return on their investment and on their effort. ”

“ Pierce's Standard Family Medicines, as well as all the various Tinctures, Fluid Extracts and other pharmaceutical preparations used by the Staff of Physicians and Surgeons of the Invalids' Hotel and Surgical Institute in their practice, is not inappropriately called the World's Dispensary, for within its walls is prepared a series of remedies of such exceeding merit that they have acquired world-wide fame, and are sold in vast quantities in nearly every civilized country. ”

“ The Secretary of Health and Human Services, in consultation with the heads of appropriate agencies, shall submit a report identifying risks in the supply chain for pharmaceuticals and active pharmaceutical ingredients and policy recommendations to address these risks. ”

“ That there is a healthy tendency to use single drugs for their definite action and to discard combinations (be they shotgun proprietaries or “mixed” vaccines) is perhaps best illustrated by the fact that at the last revision of the U. S. Pharmacopeia a considerable number of complex antiquities were omitted from that book.
Feeling confident that this meets with the endorsement of the profession, the Council is examining more critically the evidence for the value of pharmaceutical mixtures.— (From The Journal A. M. A., May 10, 1919.) ”

“ In no one direction has the Council made greater effort than in its endeavor to secure the fullest cooperation of the various pharmaceutical houses. The difficulty has been, and always must be, the fundamental antagonism between objectives that are largely commercial on the one hand and purely scientific on the other. Nevertheless, the Council has always believed—and has acted on the belief—that there is a possible middle ground wherein the interests of therapeutics would not be injured but would go hand in hand with a commercial development based on enlightened self-interest. ”

“ In the chemical factories every drug required by the Medical Pharmacopoeia and every chemical required in the arts and manufactures was made, but no drugs were sold except on a medical prescription, or chemicals except to responsible parties. ”

“ Progress toward a rational and scientific drug therapy must continue, and, therefore, it is important that the Council on Pharmacy and Chemistry should continue to make the investigation of proprietary medicines its chief work. ”

“ But it is not to pure chemistry alone that we are indebted for the elegant dosing of the present day; progressive pharmacy, with its tablets, its coated pills, and its capsules, has put to shame the old-time purveyor of galenicals. ”

“ Through laboratory research work, modern medical science has progressed to such an extent that in some diseases the form of medication has changed entirely, while in others medication is reduced to a minimum. Chemical combinations, synthetics, biological products, vaccines, etc., have all in a natural sequence deprived the pharmacist of many prescriptions. ”

“ Every pharmacist has observed the greatly increased development of the commercial side of the drug business as compared with its scientific side, which rather seems to be accorded a secondary place in the conduct of its affairs, regardless of the fact that this feature is the one that gives it character, and the only one that distinguishes it from ordinary merchandising. ”

“ The immediate and positive beneficial results of the law may be seen in the fact that now very few, if indeed any, spurious or sophisticated chemical preparations, for phar­ma­ceu­ti­cal purposes, are even offered at our ports, or by any possibility find their way into our markets. ”

“ Everything is left to the spirit of trade, and to the laws of supply and demand. The advances that have been made in pharmacy have come from within itself, unaided by any assistance from the state governments, and looked upon often with coldness or distrust by the public. In this way, in some of the large cities, with the influence of the sister profession of medicine, something has been done; but, even there, how much remains to be accomplished before pharmacy can assume the rank it holds in France and Germany! ”

“ There are few things which the public are less able to judge of than the quality of drugs; and when these are compounded into medicines it is scarcely possible, even for medical men, to decide whether pure or adulterated ingredients have been employed. This circumstance, concurring with the present injudicious mode of paying for medical assistance, has produced a curious effect on the price of medicines. ”

“ Prescription economy does not mean to buy medicines where you can get them the cheapest—unless you can be sure of absolute purity, freshness and medicinal activity. Bring your prescriptions to us and we know that you will get the best and not pay too much for it, either. This is prescription economy.—Curtin and Perkins, St. Joseph, Mo.
We may not be the nearest drug store to you, but we will come the nearest to pleasing you, both in service and quality.—Miller’s Pharmacy, Chattanooga, Tenn. ”

“ The drug also has a definite market value and the pure substance in the form of powder, tablets or pills could not be sold at a price greatly in excess of the market value. Thus manufacturers, from business policy, add to it other drugs. There are now on the market numerous more or less secret and “fancy” preparations of phenolphthalein for which a price is charged out of all proportion to the value of the preparation. ”

“ In order to insure purity of product and protection against exploitation, it has been deemed necessary in certain instances to protect the discoveries by patents. It is the purpose of the institute to permit any drugs which may prove of practical therapeutic value to be manufactured under license by suitable chemical firms and under conditions of production which will insure the biological qualities of the drugs and their marketing at reasonable prices. ”

“ Perhaps it is, by right of conquest, for the medical profession seems to be thoroughly subjugated. The distributor of drug samples is always working in the business interests of his firm and himself. How would it do to insist on payment for our time from the agents of some of our irresponsible, mushroom fake medicine factories?
There is another side to the picture. Drug manufacturers—even some of those engaged in the manufacture of quasi-proprietary medicines—have done much for pharmaceutic elegance and convenience. Many of our manufacturers are conscientiously proceeding along ethical lines. ”

“ Concocted, not to benefit humanity, but to enrich their manufacturers, advertised as positive cures of diseases which the utmost skill of the medical profession cannot control, sometimes inert, sometimes dangerous from the poisons which they contain, pressed upon the attention of the people with impudent persistence and colossal mendacity, the infamous compounds, called patent medicines, are purchased by the credulous public in almost incredible amounts. ”

“ With this attitude on the part of the men supposed to be serving the public and the medical profession by the practice of pharmacy, is it any wonder that it is difficult to induce the medical profession to prescribe official preparations or combinations of official drugs in place of ready-made commercial substitutes largely drawn from among the proprietaries or specialties? ”

“ The invention of distillation, sublimation, and other chemical processes necessitated laboratories, furnaces, and costly apparatus; so that it was thought proper that those who devoted themselves to pharmacy should be indemnified by an exclusive trade; and monopolists could be kept under closer inspection so that the danger of their selling improper drugs or poisons was lessened or entirely removed. ”