Drug Testing, Design, Marketing

1. Drug Testing, Design, Marketing Drug Discovery

2. Ancient Sources • Many drugs still in use today were originally derived from a plant, animal or mineral source from hundreds or even thousands of years ago.

3. Discovery and Creation DISCOVERY CREATION • A totally new chemical can be discovered in the environment from plants, from animals, from the ocean, or from the soil. • A totally new chemical can be derived from molecular manipulation of a drug that is already in use.

4. Recombinant DNA Technology AKA gene splicing or genetic engineering- • This process involves using enzymes in a test tube (in vitro) to cut apart a segment of a DNA molecule from a human cell. • In 1982, human insulin Humulin, became the first recombinant DNA technology drug approved by the FDA Gentic manipulation

5. Stem Cell Therapy Stem cells are immature cells that are capable of differentiating into ANY type of body tissue. Stem Cell therapy involves the use of stem cells to repair or replace damaged cells in the body

6. Gene Therapy • In patients who are missing a specific gene or have an abnormal gene that is the cause of a disease, gene therapy can be used. • The WORLD’S first gene therapy occurred in 2007. • A normal version of a gene was used to correct an inherited disorder of the retina of the eye in a 23 year old patient in England.

7. What’s in Name? • CHEMICAL NAME • From the moment of its’ discovery or design every drug has a chemical name that is assigned by the International Union of Pure and Applied Chemistry. This name describes a drugs’ molecular structure, distinguishing it from all other drugs. • Although this name is used by the drug companies, this name is long and complicated, so the drug is given a name that is easier to use for the general public. This new name is the . . . • GENERIC Name

8. TESTING of Drugs In Vitro Testing In Vivo Testing • Chemical Testing of a drug done in a laboratory in test tubes is known as In Vitro testing. • In Vitro is Latin for glass • Testing carried out on animals or humans is known as in vivo testing. • In Vivo is Latin for living

9. Clinical Trials • There are three phases of human testing which are known as Clinical Trials. • Drug Phase I- a group of healthy volunteers (10-100) are used to study a safe dosage range, evaluate side effects, and establish a final correct dose.

10. PHASE II AND III • In Phase II, the drug is given on an experimental basis to about 50 to 500 patients who actually have the disease that the drug is intended to treat. • During Phase III, the drug is administered to several hundred or thousand sick patients exactly the way in which it would be prescribed once on the market. • The performance of the drug is compared to other drugs currently being used to treat the same disease in order to evaluate its’ effectiveness.

11. Double Blind Studies are completed, using a plecebo . In this type of study, neither the patient nor the researcher knows which patients are receiving the drug and which are receiving a placebo. PLACEBO: a substance that has NO pharmacologic effect. They are “sugar pills” or for injectibles; normal saline.

12. The data collected for just one patient in just one clinical drug trial can amount to hundreds of pages of documentation. • The ulcer drug Cimetidine or Tagamet, is a case in point. After 4 years of testing, the drug company Smithkline had accumulated a stack of documents 17 feet high that had to be taken to the FDA in a truck.

13. Drug Marketing Advertising for OTC drugs is regulated by the Federal Trade Commission. The advertising for Rx drugs is regulated by the FDA

14. How Marketing Has Changed: • For many years, drug companies promoted their prescription drugs by advertising to physicians in the form of visits from a pharmaceutical representative, free samples, promotional literature, and advertising in medical journals. • Now the “direct to consumer” approach has become the commonly used form of advertising a drug.

15. Consumers are watching Ads for prescription drugs and are encouraged to,”Ask your doctor if this drug is right for You!” This has created a Consumer-driven shift encouraging patients to ask for the drug of their choice, rather than the choice of their physician’s. Consumer driven shift

16. 1981was the first direct-to-consumer print advertisement;it was an analgesic. • 2004was the year Cialis was first introduced to television during a Super Bowl commercial. Direct to Consumer Advertising

17. Patents • Generic Name –Original name assigned • Trade Name: a name assigned for marketing by the Pharmaceutical Companies. • The trade name of a drug is registered with the U.S. Patent Office as a registered trademark. While the drug remains under patent, only the original drug company has the right to advertise and market the drug under that name.

18. Drug Warnings and Recalls • WARNINGS- • If a drug is associated with adverse side effects, the FDA may elect to have the drug company expand the warning label to include new information. • RECALLS- • If the FDA deems that a drug on the market is no longer safe for consumers, they may decide to recall the drug entirely.

19. Safe Drugs It is the responsibility of the FDA to monitor drugs on the market to ensure their safety for the public.