1. Competency BT10.00 Analyze Biomedical Research. Objective BT10.01 Discuss Biomedical Research 2

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• Competency BT10.00 • Analyze Biomedical Research.

• Objective BT10.01• Discuss Biomedical Research

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What is Science?

• Maybe it is easier to tell you what it is not…• It is NOT like a jigsaw puzzle where once you

get a piece to fit, it stays forever. • Science is ___________ __________. Ideas

are constantly being reshaped, added to, subtracted from, and built upon….more like a lump of silly putty than a puzzle.

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Science is and always has been about……_____________________

• What time will it get dark tonight?• What will happen if I stick my tongue to a

flagpole when the outside temp. is below freezing?

• What will happen when I mix flour, eggs, sugar, and milk in specific combinations and bake the mixture in an oven?

• Science allows us to predict what will happen.

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How to think like a scientist

• You just need to exercise your brain in a few ways. The more clues you have, the better predictions you can make. You need to be to:

• Be curious• Be skeptical• Be flexible• These all add up to “______________

_________________”.

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How to act like a scientist

• Critical thinking is not a guarantee of truth.• Application through the scientific method-

– _________________ is carefully watching.– Hypothesis is an _______________ guess.– Experiment is ________________your hypothesis.– Conclusion is judging on the basis of your

experiment if your _____________ is right or wrong.

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Great Truths and Scientists

• What were the “Great Truths” back then and what are they today????

• Share handout and discuss

• What is a Scientist?• Think, Pair, Share: Generate a list of adjectives and nouns that come to mind when

you think of science and scientists. (Make a class poster listing descriptors)

• Famous Biological Scientists, Their Discoveries and Trends: Homework: Poster and 5 quiz questions for Gallery Walk

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Biomedical Research- the area of science focused on _______________ ______________.

• The study of the processes of life; the prevention and treatment of disease; and the genetic, lifestyle and environmental factors related to disease and health.

• Biomedical (health science) research can be divided into 3 highly interdependent yet broad categories:

_____________, ____________, _____________

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Basic Research• Research conducted to increase

fundamental knowledge. It involves observing, describing, measuring and manipulating natural systems.

• Provides _____________ _______ upon which other types of research are based.

• Not directed toward solving any particular problem.

• If we don’t know how a life process functions _________, we will not be able to recognize and treat it when it functions _____________.

(Heart Throbs activity to gain basic info about heart rates)

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Basic Research Examples• A _______________ assigning

her students to _______ a _______ ___________ ______ on Alzheimer’s disease.

• _______ being deprived of _________ as part of a research study to understand the life process of sleep and/or lack of sleep.

• A new disease in Africa would prompt us to do basic research in America about that disease.

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Applied Research

• Directed toward specific objectives – for example, development of a new drug, treatment, or surgical procedure. Application of basic knowledge to a specific biomedical problem.

• Conducted PRIMARILY with ______________, as opposed to humans all the time.

• Can be non-animal methods (____________ models or tissue cultures.)

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Applied Research Examples

(don’t have to write this, just some examples)

• Synthesis of new anti-cancer drugs• Studies of human growth factors for

diagnostic and therapeutic applications• Production of monoclonal antibodies for

potential use in the diagnosis and treatment of human cancer

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Clinical Research1. Once other forms of research

have taken place clinical research is used to ____________ potential drugs & __________ in __________________.

2. ____________ on what is done in basic & applied stages.

3. Clinical research takes place in a hospital or other clinical setting.

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4. Broad variety of activities & areas of study.A. Human clinical trials-leukemia, cancers, AIDS &

many other diseases. Some people are __________ if willing to participate.

B. Psychosocial & behavioral research- like looking at _________ _________ and test scores of H.S. students

C. Disease control research.

____________ are mainly used when testing _______________ during clinical research.

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Medical Research

• ____________ Research occurs in the _________ stage of ____________ research.

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Biomedical Research MethodsObjective BT10.02

A. Chemical, mechanical, mathematical and ___________________ simulations

B. In vitro (_____ __________) testsC. _________-human ___________ methodsD. ____________ studiesE. _________________________ studies

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A: Chemical, mechanical, mathematical, and computer simulations.

• 1. Strengths of computer models Computer simulations ______________

____________ & _________ of existing data. It provides a method of ________ _________ animals.____________ # of animals

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Scientists Use Weather Satellites to Curb Epidemics

Scientists at NASA's Goddard Space Flight Center and the Walter Reed Army Institute of Research announced that some diseases can be predicted from weather patterns. As a result of this prediction, resources can be allocated and distributed to treat the disease and to reduce or eliminate the source of the outbreak….computer models used as a research method.

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2. Limitations of computer models

Can _________ replace laboratory testing.Do not ____________ data but only process

what is entered by ________. Prohibitively (__________) expensive.

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B: _____ _______ tests “In glass” – takes place in an artificial environment. (________________________)

Ex: -Ames test for __________________.-Pregnancy tests (“the rabbit

died”)

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1. Strengths of in vitro studies

Critical to the study of microorganisms, like __________ because they can only ____________ in ____________ cells.

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2. Limitations of in vitro studies

In vitro cultures can’t tell us how a substance affects a __________ animal system. The ___________ of different cells, tissues, organs can’t be represented with the use of in vitro.

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C: Non-human animal models Strengths: 1.) ____________ provide the best known ___________ for

______________ in the lab. 2.) Similarities between animals and humans outweigh

differences. ___________ the __________ structures (__________,

_____________, __________) as humans.

Limitations:Animals are ________ humans. Animals ___________ to house

and feed. Don’t worry about their well being because the use of animals

is ________________ by federal regulations.

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D: Human Studies-Clinical Trials

• Most often used in developing _________________ drugs

• Scientists need actual human data from controlled studies

• Is the drug biologically active in humans?• Is it ________ in humans?

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Phase I Trials The first stage of human testing, typically

enrolls a small number of _____________ volunteers and takes approximately 1 year.

These studies are primarily concerned with assessing risks and side effects associated with a drug.

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Phase II trials• Enroll between ______ - _______ volunteers with the

condition the drug is designed to treat. These studies provide further information about safety and focus on determining the best dose of a drug. Scientists also watch for signs of effectiveness, but Phase II trials are generally too small to provide clear evidence about benefit. Takes about 2 years.

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Phase III trials• Enroll several _______

to ____________ of volunteers, often at multiple study sites nationwide. They provide the chief evidence for safety and effectiveness that the FDA will consider in deciding whether to approve a drug. This phase takes approx. ______ yrs.

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Phase IV trials

• Also called post-marketing studies, are often required by FDA after a drug is approved. The trial sponsor must monitor the health of individuals taking the drug to gain further insight into its long-term safety and effectiveness and the best way to use it. It takes about ______ years to complete.

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A long and expensive process

• It takes approximately ________ years from initiation of animal and other lab studies through all phases and submission of data to the FDA for approval.

• For each new medication approved the cost is hundreds of ____________ of dollars.

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E: Epidemiological Studies The field of medicine concerned with the study

of Epidemics, an outbreak of disease that affects a much _________ number of people than is _______ for the locality or that spreads to regions where it is ordinarily not __________.

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Experimental Epidemiology• In the practice of medicine, the truth can be hard to find. • Should menopausal women take estrogen?• Is angioplasty or medication better for mild heart attacks? • Does a beer a day keep coronaries away?• The pendulum swings back and forth, and the truth is revealed in

bits and pieces. • Limited by ethical and legal considerations.• Studies are conducted on cells, animals, and people.• Papers are published, and investigators stake their claims in the

popular press.• Physicians weigh in with opinion and anecdote. • Yet the truth remains elusive, fluid, ever-changing.

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Descriptive Epidemiology: analyzes data

Demonstrates the tremendous differences in incidence across countries, with more than a 50-fold increase in risk for the Finnish population compared to the Mexican population.

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Observational Epidemiology

Observing methodologiesto investigate thepathogenesis of any disease process like asthma, COPD, and etc. to the understanding and treatment of a variety of Diseases.

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Epidemiology

Information gathering occurs _______ the fact. They do not demonstrate a direct cause &

effect, but instead show a statistically significant association between exposure & disease.

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Strengths of epidemiological studies

• Offers scientists an opportunity to study the effects in humans exposed to chemicals and disease-causing organisms.

• Identifying _______________ in diseases.• These patterns can then be traced to

causative factors.

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.• Often in emergencies, the ability to gather data is severely restricted due to exposure.

• This may be due to insecurity preventing survey workers from carrying out data collection or lack of resources preventing health workers from submitting surveillance data.

• Lack of access may also be due to difficulties in communication and transport to remote areas.

• Epidemiology is also constrained by the rapid changes in the health and nutritional status of many emergency-affected populations.

• By the time appropriate data and collected and analyzed, the conclusions and recommendations derived from these analyses may be out of date.

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Limitations of Epidemiological

Benefits of Biomedical ResearchBT10.03

• A: Contributions to human health 1.) Treatment for heart disease—heart-lung machine 2.) Treatment for cancer 3.) Treatment for diabetes 4.) Bone marrow transplants 5.) Early vaccines 6.) Polio vaccine 7.) Chicken pox (Varicella) 8.) Hepatitis 9.) Fluoride-many countries add to water to decrease tooth

decay. 10.) Penicillin & other antibiotics

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Treatment for heart diseasethe _________-_________ machine

• _____________ cardiac surgery 40 years ago.

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Smallpox

• In _______, the World Health Organization launched a global campaign to ___________ Smallpox.

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Heart Disease• The reduction of

____________ _________ has decreased HEART disease by _____%.

• An experimental drug for heart disease is currently in Phase I clinical trials. How long before it will be approved for public use?

• 2,4,8, or 11 years

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CANCER

• __________ is the ____________ studied in biomedical research efforts.

• Gene therapy

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________________ is inflammation of

the liver.• The liver is

characterized by the presence of inflammatory cells in the tissue of the organ.

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Hepatitis A• Hepatitis A: The virus is found in the stool of an infected

person. It is spread when a person eats food or drinks water that has come in contact with infected stool.

• Sometimes a group of people who eat at the same restaurant can get hepatitis A. This can happen when an employee with hepatitis A doesn't wash his or her hands well after using the bathroom and then prepares food.

• The disease can also spread in day care centers. Workers can spread the virus if they don't wash their hands well after changing a diaper.

• Some things can raise your risk of getting hepatitis A, such as eating raw oysters or undercooked clams. If you're traveling in a country where hepatitis A is common, you can lower your chances of getting the disease by avoiding uncooked foods and untreated tap water.

Hepatitis B

• Hepatitis B: Hepatitis B is a virus that infects the liver. Most adults who get hepatitis B have it for a short time and then get better. This is called acute hepatitis B.

• You can have hepatitis B and not know it. You may not have symptoms. If you do, they can make you feel like you have the flu. But as long as you have the virus, you can spread it to others. It is spread through contact with the blood and body fluids of an infected person.

• Blood products, sexual intercourse, IV needles

Hepatitis C• Hepatitis C is a disease caused by a virus that infects the liver.

In time, it can lead to permanent liver damage as well as cirrhosis, liver cancer, and liver failure.

• Many people do not know that they have hepatitis C until they already have some liver damage. This can take many years. Some people who get hepatitis C have it for a short time and then get better. This is called acute hepatitis C. But most people who are infected with the virus go on to develop long-term, or chronic, hepatitis C.

• Although hepatitis C can be very serious, most people can manage the disease and lead active, full lives.

Symptoms of Hepatitis• Symptoms include:• Feeling very tired. • Mild fever. • Headache. • Not wanting to eat. • Feeling sick to your stomach or vomiting. • Belly pain. • Diarrhea or constipation. • Muscle aches and joint pain. • Skin rash. • Yellowish eyes and skin (jaundice). Jaundice usually appears only after

other symptoms have started to go away.

Insulin

• 1ST ____________ from a _________ pancreas & used to treat a 14 year old boy in ______. Today we can genetically engineer it. ____________ are made to produce human insulin.

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Glucometer

• A device used to measure a persons blood sugar levels. Today there has been developed a machine that uses _________ ___________ blood.

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Bone marrow transplants

• Transplantation of blood stem cells derived from the __________ ______________.

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Availability of Vaccines

• Why are children under 2 still not vaccinated with the recommended vaccines?

• _________________________- to be unaware, not very concerned

• Lack of ______________

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____________ are not familiar with infectious diseases & so have become _____________ about vaccinations.

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Polio vaccine• The first was developed by

________ ________, first tested in 1952, and announced to the world by Salk on April 12, ________.

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Dr. Albert Sabin• Worked on a polio vaccine

that could be administered ____________.

• It was made from an ____________________ virus. (meaning weakened ________ organisms)

• It was administered on a ________ cube. (Yum Yum)

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Chicken pox (Varicella)• Is a highly ______________

illness caused by primary infection with varicella zoster virus characteristic spots appearing in two or three waves, mainly on the body and head rather than the hands and becoming itchy raw pockmarks, small open sores which heal mostly without scarring.

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Shingles

• Also called herpes zoster, is a painful rash caused by the same virus that causes chickenpox. Once a person has had chickenpox, the virus can live, but remain inactive, in certain nerve roots within the body. If it becomes active again, usually ______________ in life, it can cause ___________________.

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Biomedical Research

• Has had a profound impact on childhood cancer (_______________) that, in the 1950’s, killed ____________child diagnosed with it within ________ months. Survival rate is 75 % now!

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Biomedical Research

• ____________ diseases • Research on tooth decay lead to what element being added to the drinking H2O? ___________________

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Alexander ____________

Discovered the antibiotic _____________.

• Penicillin is one of the earliest discovered and widely used antibiotic agents, derived from the Penicillium mold.

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• B: AIDS research continues (Acquired Immunodeficiency Syndrome)

1.) Began in early ___________s 2.) Caused by a ___________ 3.) HIV infection progresses to AIDS when

immune system is impaired & individual becomes susceptible to opportunistic infections.

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Approximately 4 out of 10 U.S. AIDS deaths are related to ________ abuse.

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T CELLS

• T cells belong to a group of white blood cells known as lymphocytes, and play a central role in cell-mediated immunity. They can be distinguished from other lymphocyte types, such as B cells and natural killer cells by the presence of a special receptor on their cell surface called T cells receptors.

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4. Animals are an important part of AIDS research.

5. Anti – HIV drugs available

6. A number of possible vaccines have been developed and are being tested in humans.

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• Bodily fluids• Infected blood • Breast milk

– ___________________ __________ ___________ – Being aware if one’s partner is infected – Using condoms.– Sterilized needles or sharing needles – Health workers should wash hands and use protective

barriers, such as, gloves and goggles when handling infected blood.

• Mothers infected with HIV should not breastfeed their child.

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Common sense preventive measures best way to prevent AIDS.

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c. Multiple benefits to animal

From mice to dogs, pigs to electric eels, a variety of animal species contribute each year to medical breakthroughs that save millions of human lives each year.

Through research on these animals, scientists have discovered _______and______________

for a number of human and animal ailments.

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Benefits for Animals

• Artificial joints for dogs• Cancer treatments• Chemotherapy• Heart disease treatment• Nutrition research for pet food• Vaccines for pet diseases• Anesthesia

Health Problems shared by Animals and Man

• Allergies, Arthritis, Anemia• Bronchitis• Cancer, Cataracts• Deafness, Diabetes• Emphysema, Epilepsy• Heart disease, Hypertension• Infertility, Influenza• Kidney disease, Leukemia• Rabies, Tetanus, Tuberculosis• Vitamin Deficiencies…..to name a few

More benefits for Animals

• Advancing their health: their contributions are being repaid, we owe them for their help.

• Keeping them healthy: better nutrition, medications and vaccines.

• Helping sick animals: artificial hips, pacemakers, cataracts, hearing aids, cancer treatment

• In vitro fertilization for endangered species.

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