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Designer Drugs Presented by: Frank Clark Beth Nendza Overview Pharmaceuticals History Ethical Code Interesting Cases Ethical Concerns Body response to medicines Drug reactions Human Genome Project Pharmacogenomics Pharmacogenomics SNPs Cancer/other diseases Patient benefits Pharmaceutical and consumer supports Funding Ethical concerns History Oldest known medical book Natives of North and South America Aztecs in Mexico Aspirin Creation of research based pharmaceutical companies -Globalization and Health (Gentry and Webber 1999) Ethical Code American Pharmaceutical Association A pharmacist respects the relationship between the patient and pharmacist A pharmacist promotes the good of every patient in a caring, compassionate, and confidential manner A pharmacist respects the dignity of each patient A pharmacist acts with honesty and 'Integrity’ in professional relationships A pharmacist maintains professional competence A pharmacist respects the values and abilities of colleagues and other health professionals A pharmacist serves 'Individual, community and societal needs’ A pharmacist seeks justice in the distribution of health resources There are many other codes of ethics for those in the pharmaceutical industry Depends on what association they are a part of Theme of these codes of ethics are acting with honesty and integrity, maintaining a personal and confidential relationship with a client and working with professional competence Changing Ethics Recently, many pharmaceutical codes of ethics have passed and added a “conscience” clause This gives pharmacists’ the right to examine their own morals when filling prescriptions Interesting Cases How can this new clause effect you? Utah, a pharmacist refused to fill the “morning after” pill for a patient Pharmacist was fired, but with this clause, pharmacists will now be able to refuse such prescriptions Wal-Mart has announced that their pharmacy will not carry this pill Kmart has announced that if a doctor prescribes any medication, then their pharmacists will be expected to fill it Ethical Concerns Does a pharmacist have the right to pick and choose what medications are allowed to be filled? Is it right for a patient to have to call/stop by a pharmacy until they find one that will fill their prescriptions? How Does The Body Respond To Medications? What are drugs used for? Fight infections Reverse a disease process Relieve symptoms Restore normal functions Aid in diagnosis Inhibit normal body processes Maintain health Medications How is it administered? Orally Intravenously Intramuscular Subcutaneous Rectal How do medicines work in the body? Administration of medications Absorption into blood stream Distribution throughout the body Effected by: Blood supply Organ/compartment size Permeability of tissue membranes Binding of drug to various components of blood and tissues Drug Reactions Journal of American Medical Association Pharmaceutical companies can’t predict drug reactions All medications come with warning labels Drugs and the Human Body (Liska 1997) Heart Drugs Digitalis Digitalis Digitalis Seditives Barbiturates Chloral hydrate Barbiturates Barbiturates Barbiturates Barbiturates Barbiturates Thiazide diuretics Reserpine Barbituates Increased digitalis toxicity Increased digitalis toxicity Enhanced digitalis metabolism Alcohol Alcohol Oral anticoagulants MAO inhibitors Male sex hormones Oral contraceptives Oral antidiabetic drugs Synergism Synergism Diminished anticoagulant effect Increased CNS depression Diminished activity of sex hormones Inhibition of contraceptive action Enhancement of barbiturate activity Minor Tranquilizers Valium, Librium Valium, Librium Major Tranquilizers Phenothiazines Major Tranquilizers Major Tranquilizers Major Tranquilizers Haldol and Innovar Alcohol MAO inhibitors Increased CNS depression Oversedation Alcohol Thiazide diuretics Antihistamines Morphine Lithium Oversedation Shock Additive effect (CNS depression) Enhanced Sedation Increased tranquilizer toxicity Parkinson's Treatments 1-Dopa Artane, Pagitane Oral Contraceptives Antidepressives Prozac, Paxil, Zoloft Bronchodilator Primatene (asthma) Pain Killers Aspirin Aspirin Aspirin Demerol MAO inhibitors Hypertensive crisis Phenothiazines Lowered blood levels of phenothiazines Tegretol, Dilantin, antifungals Diminished contraceptive action MAO Inhibitors Nausea, shivering, confusion, muscle contractions Tagament or antibiotics Potential life-threat Anticoagulants Alcohol Probenecid MAO inhibitors Hemorrage GI Bleeding Inhibition of probenecid Respiratory depression and Increased CNS depression Antibiotics Tetracyclines and penacillin G Antacid or milk Penicillin Tetracycline Tetracyline Oral iron preperations Reduced effectiveness of antibiotic Diminished activity of penicillin Inhibited absorption of iron Why do some people experience drug reactions while others don’t? Dose-related effect Food/drink in stomach Biological variability Age Fat content increases Liver metabolism Kidney excretion Blood protein decreases Increasing sensitivity Circadian rhythm Body temperature varies 2-4C Pulse and blood pressure Not many drugs effected Obesity Drugs that work with a build up of time (Prozac) Genetic factors Genes are very similar Ten fingers, etc Genes do have subtle differences Makes you, you! These differences cause differences in your bodies proteins Medications interact with the body’s proteins Therefore, people will react differently to medications This is why people suffer from nausea and even death from medicine toxicity Research One specific research by Dr. Erin Schuetz of St. Jude Children’s Research Hospital Discovered that CYP3A5 (protein) in some humans was not produced in sufficient levels to metabolize medications Leads to build up and perhaps toxic levels of medication in human system Human Genome Project What is the HGP? Identify all the 30,000 genes in human DNA Determine the sequences of the 3 billion chemical base pairs that make up human DNA How does HGP tie into pharmaceuticals? Pharmacogenomics Imagine 50 years down the road Gene test for what medication is suitable for you Pharmacists being able to look at your genome and help figure out what OTC drugs are best for you What is Pharmacogenomics? Pharmacogenomics is the study of how an individual’s genetic inheritance affects the body’s response to drugs Pharmacogenomics= pharmaceuticals + genomics Holds the promise of individual made drugs Keeping in mind that other factors effect drug reaction Pharmacogenomics is believed to be the key to creating medications that will reduce the harmful side effects of medication Single-Nucleotide Polymorphisms (SNPs) Markers that will indicate connection between drug response and genetic makeup Definition: variation in DNA at a single base that is found in at least 1% of the population Help understand and treat human diseases Help scientists find the position on a chromosome where a particular susceptibility gene is located (reeves) SNP consortium: Non-profit organization, In the process of publishing a high-density SNP map of the human genome Goal: map 300,000 SNPs Orchid bio sciences (Princeton, N.J.) Collaboration with SNP consortium (two projects) Confirms many of the SNPs in the public database Confirmation of SNP: pull together an ethnically diverse panel of DNA, assay for presence or absence of that SNP (rakestraw) Allele frequency determination Allele: alternative form of a gene What is the frequency of occurrence of that SNP within the members of ethnically diverse populations? Formula: # of times SNP appears within each of the populations/total = allele frequency Sequenom (San Diego) Mass spectrometric methods to study SNPs (self validating instrument) Scientists focusing on the changes in the frequency of SNPs as the population ages Cancer and Other Diseases Cancer and pharmacogenomics Pharmacogenomics more crucial to treatment of cancer as opposed to other diseases Current cancer therapies Suffer form low efficacy rates High rates of toxicity Adverse effects Significant consequences of incorrect therapy Variagenics inc Markers Company that wants to use pharmacogenomic pathway approach to develop cancer therapeutics SNPs and Haplotyping Haplotyping: identifies the groups of polymorphism that occur together in each gene Additional genetic markers Efficacy of cancer treatment depends on genetic properties of the tumor Loss of heterozygosity Measure of chromosomal loss Early phases of tumor formation (DNA are lost) Affects gene copy number and function Example: Patient’s cells contain two alleles for drug target 1 highly expressed and 1 with low expression LOH leaves low expression allele Drug target will be present at small amounts in the tumor Less target protein to be inhibited Study (Cairncross et al., J. Natl. Cancer institute, 1998) 100% (24/24) of oligodendrogliomas carrying specific markers for LOH responded well to chemotherapy 25% (3/12) lacking the marker responded mRNA expression analysis Expression levels of specific genes, good predictor of response to chemotherapy Comparison of mRNA expression patterns of responsive and unresponsive Expression profiling: mRNA levels measure to determine which genes are turned on at a given time Methylation analysis Tumors can undergo DNA hypermethylation Occurs at CPG island in the promoter regions of specific genes Poor expression of genes in the region Methylation analysis (cont.) Methylation could affect how tumor respond to drug treatment, if genes are related to drug action Comparison of Normal vs. Methylation patterns in tumor tissue and non responsive and responsive patients Goal: investigate the significance of methylation patterns to drug response Heart disease High salt diet may result in high blood pressure Coronary artery disease and stroke Reduce salt intake Problem: everyone cannot reduce their salt intake by eating a low sodium diet Solution: find genes that link high blood pressure to high sodium University of Minnesota study (American journal of hypertension) Correlating variation in angiotensin-converting enzyme (ACE) gene with sodium sensitivity 24/35 patients with high blood pressure were sodium sensitive Three alleles of ACE correlated with sodium sensitivity Sodium resistant allele: 25% were sodium sensitive 71% with sodium sensitive allele and 83% with both alleles were sodium sensitive Study is useful because it allows scientists to see which individuals are in need of more salt management treatment Physicians help manage their patients health more efficiently Other applications Pain management Environmental medicine Depression HIV/AIDS Patient Benefits 1. More powerful medicines Pharmaceutical companies, create drugs (proteins, enzymes, etc.) Drug discovery Decrease damage to other healthy cells 2. Better, safer drugs Investigate patient’s genetic profile, prescribe best drug therapy Adverse reactions eliminated Speed recovery time 3. Accurate methods of determining appropriate drug dosages No more dosages on the basis of weight and age Solution: basis of person’s genetics Minimize the chance of overdose Benefits Cont. 4. Advanced screening for disease Person can make lifestyle or environmental change at an early age (basis of genetic code) Avoid severity of disease 5. Better vaccines Made of DNA or RNA Activate immune system without causing infections Inexpensive, stable, easy to sore, etc 6. Improvements in drug discovery and approval process Genome targets make it easier for companies to discover new therapies Reduce cost and risk of clinical trials 7. Decrease in cost of health care Decrease in the number of adverse reactions Decrease failed rug trials Decrease time for drug to be approved More drug targets Decrease time period patient is on medication