Section 1
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Hatch-Waxman Act of 1984
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Section 1
(50 cards)
Hatch-Waxman Act of 1984
Encouraged the creation of both generic and new medications by streamlining the process for generic drug approval and by extending patent licenses.
Synapse
the junction between the axon tip of the sending neuron and the dendrite or cell body of the receiving neuron
Arsephenamine (Salvarsan)
In 1910, Paul Ehrlich introduced the arsenic-based drug Salvarsan as a remedy for syphilis, a sexually transmitted disease that was exacting a toll on public health similar to that of HIV in recent decades. His methodical search for a specific drug to treat a specific disease marked the beginning of targeted chemotherapy.
Prescription Drug User Fee Act (PDUFA)
Requires manufacturers to pay fees for applications and supplements when the FDA must review clinical studies
What are some of the effects of the antidepressant stimulants?
stimulant-like drugs may be useful for patients with treatment-resistant depression because these drugs may ameliorate symptoms such as anergia, fatigue, hypersomnia, and impaired concentration, which are often initial or residual symptoms of major depression as well as side effects of some antidepressants
3,4-methylenedioxymethamphetamine (MDMA)
Drug similar in structure to amphetamine that stimulates 5-HT release and is neurotoxic at high doses. It is a recreational drug that is often abused.
Why is it important to take all of the antibiotics that have been prescribed for a given illness?
It's important to take all of the medication, even if you are feeling better. If treatment stops too soon, the drug may not kill all the bacteria. You may become sick again, and the remaining bacteria may become resistant to the antibiotic that you've taken. Do not skip doses.
antibiotic resistance
Resistance evolving rapidly in many species of prokaryotes due to overuse of antibiotics, especially in agriculture.
What countries allow DTC advertising?
The United States and New Zealand are the only two countries where direct-to-consumer (DTC) advertising of prescription drugs is legal.
Antibiotics are
also known as antibacterials, are medications that destroy or slow down the growth of bacteria. They include a range of powerful drugs and are used to treat diseases caused by bacteria. Most antibiotics are based on natural products synthesized by bacteria and fungi.
monoamine hypothesis
A deficiency in the availability of monoamines (serotonin, norepinephrine, dopamine) in the synapses contributes to depression
Has the FDA always allowed Direct-to-consumer (DTC) Advertising?
Direct-to-consumer advertising of drugs has been legal in the USA since 1985, but only really took off in 1997 when the Food and Drug Administration (FDA) eased up on a rule obliging companies to offer a detailed list of side-effects in their infomercials
Hepatitis C (HCV)
bloodborne viral disease that affects the liver; transmitted by blood exposure, sharing needles, or from infected mother to infant; rarely transmitted by sexual contact
synthetic lethality
a combination of deficiencies in the expression of two or more genes leads to cell death, whereas a deficiency in only one of these genes does not
pros of opioids
treat moderate to severe pain, though some opioids can be used to treat coughing and diarrhea. Opioids can also make people feel very relaxed and "high" - which is why they are sometimes used for non-medical reasons.
How is Kinase involved in signal transduction?
Protein kinase is a kinase enzyme that modifies other proteins by chemically adding phosphate groups to them. The enzyme is involved in many biochemical signaling pathways within cells (i.e. signal transduction) and effectors in cellular functions, such as cell proliferation and necrosis.
Immune checkpoint inhibitors
A type of drug that blocks certain proteins made by some types of immune system cells, such as T cells, and some cancer cells. These proteins help keep immune responses in check and can keep T cells from killing cancer cells. When these proteins are blocked, the "brakes" on the immune system are released and T cells are able to kill cancer cells better
Many Early cancer therapies
Come from Natural products
What's so good about Solvadi?
It works by reducing the amount of hepatitis C virus in your body, which may help your liver recover. Chronic hepatitis C infection can cause serious liver problems such as scarring (cirrhosis), or liver cancer.
principal monoamine neurotransmitters
neurotransmitters dopamine, noradrenaline and serotonin.
Ways a drug can enhance neurotransmission?
to increase the amount of neurotransmitter released into the synaptic space. Drugs like alcohol, heroin, and nicotine indirectly excite the dopamine-containing neurons in the ventral tegmental area (VTA) so that they produce more action potentials.
How antibiotics work
interfere with some aspect of growth or metabolism in the target bacterium: synthesis of bacterial walls, activity of proteins in the cell surface membrane, enzyme action, DNA synthesis, protein synthesis.
DTC Pharmaceuticals Cons
- Hurts the doctor-patient relationship - Information quality is limited - Adversely affects the elderly and those in poor health - Raises drug prices
First FDA approved genetically engineered product
Flavr Savr tomato in 1994. Developed by Calgene, it was engineered to have a longer shelf life by inserting an antisense gene that delayed ripening.
cocaine risks
-Overdose -HIV infection -Hepatitis B infection -Hepatitis C infection -Mood disorders -Cardiovascular disease -Respiratory illness -Gastrointestinal disease
combination therapy in HIV
Combination antiretroviral therapy drug regimen classes Prevent the virus from replicating and reduce viral load. Help restore CD4 counts and immune function. Reduce complications fromHIVand improve survival. Reduce transmission ofHIVto others
Taxol
A chemical in Pacific yew tree bark that has cancer-fighting properties
Viral Life Cycle
viruses infect cells by attaching to specific receptors, and then either fusing with the plasma membrane, being brought in by endocytosis, or injecting their genome into the cell. The virus reproduces by replicating and translating genetic material using the host cell's ribosomes, tRNA, amino acids, and enzymes. Viral progeny are released through cell death, lysis or extrusion.
What information does the FDA require today in DTC ads?
The ads typically contained the product name, the disease or condition it treats, the potential benefits, and a link to a product's Web site. The FDA stated that because the links mentioned the product name and its use (and sometimes even other product claims), risk information also had to be provided.
Where is the limbic system located?
superior to the brainstem, and encased by the cerebrum
What chemical warfare agents led to the first forms of chemotherapy?
By World War II, at least two dozen medical researchers transformed mustard agents into cancer chemotherapy. In the 1940s, sulfur mustard, commonly called mustard gas, and nitrogen mustard, a derivative of mustard gas, became a new formof cancer treatment.
Risks of MDMA
Hyperthermia - high ambient temperature (crowded room) + excitability
Classes of Antidepressants
Selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs)
What limited the use of Salvarsan?
It was the world's first blockbuster drug and remained the most effective drug for syphilis until penicillin became available in the 1940s.
Alexander Fleming (1928)
discovered the first antibiotic, penicillin
How is Taxol made?
produced from a resource that is rapidly being depleted. It is extracted from the bark of the Pacific yew tree, a slow growing tree native of the pacific north west. It takes an average of six, one hundred year old trees to treat each patient.
cocaine medical use
limited medical use, but it is still used as a local anesthetic in surgical procedures.
What neurotransmitter is thought to be responsible for the addictive properties of antidepresants stimulants?
These chemicals include serotonin, dopamine, and norepinephrine.
Schedule I Substances
have a high potential for abuse, have no currently accepted medical use in treatment in the United States, and in their use under medical supervision do not meet accepted safety standards examples include: marijuana, LSD, GHB, Heroin, MDMA
Where does morphine come from?
Seedpod of the opium poppy plant
Kinase
an enzyme that catalyzes the transfer of a phosphate group from ATP to a specified molecule.
the steps in the viral life cycle that antivirals inhibit
-Viral RNA or DNA synthesis -Viral enzymes -Viral binding to cells -Production of the protein coats (capsids) of new viruses
Cost of developing and marketing a drug?
Developing a new prescription medicine that gains marketing approval is estimated to cost drugmakers $2.6 billion according to a recent study by Tufts Center for the Study of Drug Development and published in the Journal of Health Economics
Cancer Treatment side effects
1. Damage to ovaries or testes causing sterility 2. Hair Loss 3. Nausea 4. A weak immune system
What happens at a synapse?
When a nerve impulse reaches the synapse at the end of a neuron, it cannot pass directly to the next one. Instead, it triggers the neuron to release a chemical neurotransmitter. The neurotransmitter drifts across the gap between the two neurons.
DTC Pharmaceuticals Pros
DTC adverts also help to destigmatise and raise awareness of certain disorders, prompting patients to seek medical attention when they might not have otherwise. In short, patients become more motivated to take control of their healthcare and become more active partners in the patient-doctor relationship.
signal transduction
the transmission of molecular signals from a cell's exterior to its interior
Penicillin
Antibiotic drug that combats bacteria by interfering with bacterial cell-wall synthesis
Name some things that helped the discovery of drugs post World War II
- increased federal funding, improved clinical trial formats, impact of biotechnology
Where is the neocortex located?
surface of the cerebrum
Section 2
(31 cards)