Food and Drugs as Public Health Issues

5/27/15

Vignette 1

• “We are what we eat,” you hear said again and again. “Sure,” you say, “too little is bad, too much is bad, but what other ways can food affect our health?”

Vignette 2• An outbreak of hepatitis A occurs among employees

eating in your cafeteria. To your surprise, the local health department and the CDC quickly investigate the outbreak and trace its source to seafood grown and harvested in an Asian country and to the factory that handled the food in the United States far from your home.

• How is food being traced, you wonder, to allow outbreaks to be so rapidly and efficiently investigated?

Vignette 3• Jessica wondered why she needed a pregnancy test

each month to refill her prescription for acne medication. She was not even currently sexually active. The pharmacist told her that she needed to come in with proof of a recent pregnancy test because serious birth defects are so common with this medication.

• What a pain and what an embarrassment, she thought to herself. Why is all this bureaucracy needed anyway?

Vignette 4John’s cancer was in remission but he was still taking chemotherapy and he often felt very sleepy. His doctor asked whether he wanted to try a new drug that was just approved by the FDA and showed evidence of reducing fatigue. John knew he was taking a chance but he readily agreed. The side effects were worse than expected and John’s doctor told him some of them had never been reported before. “I guess I am part of the experiment,” he told his doctor. “Yes, with new drugs, we are always on the lookout for surprises,” his doctor said. John asked himself if it was worth it to be one of the first to try out a new drug?

Vignette 5

Veronica saw a new dietary supplement that showed promise for reducing blood pressure. The fine print on the bottle said that it was not for the treatment or prevention of any disease. A low dose seemed to have some effect and a higher dose was even better.She started feeling dizzy and went to the emergency room, where they found that she was losing blood. The dietary supplement was thought to be the cause of her bleeding and her reduced blood pressure. Veronica asked, “Do I need to treat dietary supplements as if they are drugs?”

Vignette 6

• Carlos’s doctor told him he wanted to try him on a new treatment for his headaches because the standard treatment was not working. He told Carlos that the drug had been on the market for several years but was not officially recommended for headaches by the FDA. “I have been hearing that it works for headaches and I would like to try it out, if you agree,” the doctor said. Carlos wondered, is that the way medicine is practiced?

What Are Important Milestones in the History of Food and Drugs As Public Health Issues in the United States?

• 1906: The Federal Food and Drugs Act• Creates what is known today as the FDA• Products are required to have accurate labeling

indicating their ingredients• 1938: Federal Food, Drug, and Cosmetic Act• Required safety testing prior to making a new

drug available to the market

What Are Important Milestones in the History of Food and Drugs As Public Health Issues in the United States?

• 1960s: Kefauver-Harris Drug Amendments• Focused on efficacy, not safety, and mandated

efficacy testing before a drug could be approved and marketed

• Due to thalidomide use and resulting birth defects• 1990s: U.S. Supreme Court allows advertising of

prescription drugs

What Ways Can Food Affect Health and Disease?

• The most important are:– Too little food– Too much food–Deficiencies of vitamins and minerals–Contaminants– Individual susceptibilities– Foodborne communicable diseases

How Important is Foodborne Communicable Disease as a Cause of

Morbidity and Mortality?• Due to foodborne diseases, the CDC estimates that

each year:• 1 in 6 Americans get sick• More than 100,000 are hospitalized• Over 3,000 die

• The very young, the very old, and the immunologically compromised as the most vulnerable

What are the Steps in Foodborne Outbreak Investigations?

1. Detecting a possible outbreak2. Defining and finding cases3. Generating hypotheses about likely sources4. Testing the hypothesis5. Finding the point of contamination and the source

of the outbreak6. Controlling the outbreak7. Deciding that an outbreak is over

Steps in a Foodborne Outbreak Investigation

Reproduced from Centers for Disease Control and Prevention. Foodborne Outbreak Investigations. Available at http://www.cdc.gov/outbreaknet/investigations/investigating.html Accessed June 28, 2013.

What is Being Done to Prevent Foodborne Diseases?

• Collaboration between the CDC, FDA, and USDA to create the Foodborne Diseases Active Surveillance Network (FoodNet)– Aims to identify and investigate foodborne disease

from both outbreaks and routine exposure– Estimates the number of foodborne illnesses,

monitors trends in incidence over time, attributes illnesses to specific foods and settings, and disseminates this information

What is Being Done to Prevent Foodborne Diseases?

• In 2010, the Food Safety Modernization Act was passed– Gave the FDA and USDA increased authority– Provided the ability to track foods, including their

origin, date of production, and other data that could be useful in locating the source of the food if a disease outbreak occurred

In the US, What Other Programs Aim to Prevent Food Related Disease and Disability?

• USDA administers food security programs• Requires that all people at all times have

access to sufficient, safe, nutritious food to maintain a healthy and active lifestyle

• Covers approximately 15% of the U.S. population

• USDA food security programs:• Supplemental Nutrition Assistance Program

(SNAP)• Formerly called “food stamps”• Makes relatively expensive items, such as

fresh fruits and vegetables, accessible to those with low incomes

In the US, What Other Programs Aim to Prevent Food Related Disease and Disability?

• USDA food security programs:• Special Supplemental Nutrition Program for Women,

Infants, and Children (WIC)• Federal grants to states for supplemental foods,

healthcare referrals, and nutrition education• For low income pregnant women, postpartum

women, and infants and children up to age 5 at nutritional risk

In the US, What Other Programs Aim to Prevent Food Related Disease and Disability?

Why Is Drug Safety Considered an Important 21st Century Public Health Issue?

• The Institute of Medicine (IOM) estimates that nearly 100,000 Americans die each year as a result of adverse effects of drugs

• High profile issue in recent years• Vioxx and its contribution to heart disease

What Do We Mean by Preclinical Research on Drugs?

• Drug testing begins before any human beings have received the drug– The FDA requires animal safety studies before a

drug can be studied in humans– However, animal models may either fail to detect

subsequent effects in humans or demonstrate high-dose effects that are difficult to interpret• Not a perfect method

What Do We Mean by Preclinical Research on Drugs?

• Animal testing is administered to two different species at levels well above the equivalent dose expected to be used in humans– Researchers look to detect cancer, teratogenicity

(fetal malformations), and effects on fertility– Investigate toxic effects on drug sensitive organs• Liver, kidneys, bone marrow

What is Phase 1?• The initial administration of a drug to human beings• Focuses on the pharmacology of the drug:– Absorption– Metabolism– Excretion

• Aims to establish the dosage range and route of administration to be used in subsequent studies

• Examines safety issues• Capable of identifying common and serious side effects

What is Phase 1?• Duration of exposure to drugs may be quite short– Days to weeks

• Small number of participants• Focuses on:– Effects on organs that are known to be especially

sensitive to drugs• Liver, kidney, bone marrow, testicles

– Effects that may be expected based on the known actions of a particular class of drugs

What Are Phase 2 and Phase 3?• Designed to establish efficacy of a drug for a

particular use or indication– Need to establish that on average, the drug

improves outcomes under research conditions• Phase 2 trials- small, sometimes uncontrolled, trials

designed to determine whether there is a suggestion of efficacy– Used to justify expensive, potentially harmful, and

time consuming Phase 3

What Are Phase 2 and Phase 3?• Phase 3 trials- large randomized control trials– Gold standard for establishing efficacy for one

particular indication– However, there are limitations for establishing

safety:• Too small• Too short• Too simple

What Are the Implications of FDA Approval of a Drug?

• FDA approval implies:– The drug may be advertised and marketed for a

particular indication, the one for which it was studied and approved

– It may be prescribed by clinicians for any patient• Off-label prescribing- the prescribing clinician has

the authority to use the treatment for indications or at dosages not specifically approved by the FDA

How Are Adverse Effects of a Drug Monitored in Phase 4 After FDA Approved?

• Spontaneous reporting system– Those who prescribe the drug and patients are

encouraged to report side effects to the FDA• However, it is not required

• Patients who receive a new treatment over the first few months to few years after the initial marketing approval need to be regarded as part of the experiment

What Else Can be Done?• The Food and Drug Administration Amendment Act

of 2007 provided new authority to the FDA to:– Require that more representative patients be

included in randomized control trials– Require follow-up studies of drugs to monitor

their performance in clinical practice– Develop large database systems to link pharmacy

records with electronic medical records to assess side effects on an on-going basis

What Else Can be Done?• The Food and Drug Administration Amendment Act

of 2007 provided new authority to the FDA to (cont.):– Place increased restrictions on who can prescribe

a particular drug and what conditions need to be fulfilled before it can be prescribed

– Approve and monitor drug advertising to clinicians and patients

– Withdraw drugs from the market when serious issues of safety are raised

Do All FDA Regulated Products Receive the Same Effectiveness and Safety Assessment as

Prescription & Non-Prescription Drugs?• Vaccines undergo many of the same phases of testing

and monitoring• Dietary supplements fall under different regulations

than “conventional” drug products• Cannot be promoted as treatment for or prevention

of a disease• Manufacturer is responsible for determining safety,

not the FDA

What Other Products Does the FDA Regulate?

• The FDA also regulates:– Cosmetics– Medical devices– Biological products, such as the blood supply– Tobacco products