Ethical Issues in Health Research in Developing Countries Rio de Janeiro November 19, 2009 Daniel Wikler, Ph.D. Harvard School of Public Health First International.

Ethical Issues in Health Research in Developing Countries

Rio de Janeiro

November 19, 2009

Health Resource Health Resource Allocation: Allocation:

Ethical DilemmasEthical Dilemmas

Daniel Wikler, Ph.D.Harvard School of Public HealthFirst International Conference on

Burden of Disease Studies in Brazil

50 Pills

You are chief of a ward with 100 patients. 50 of these patients need 2 pills to survive.

One pill does not help them. 50 of these patients need 1 pill to survive. You have 50 pills. You can’t get more.

Who should get the pills? On what basis should they be chosen?

Universal Access – Ia: Colon Cancer Screening

In a town of 100,000, the public health department has $100,000 for colon cancer screening. There are two tests: Test A costs $1. If administered to everyone, 100 lives will be saved.Test B costs $2. Administration to half the population, chosen randomly, would save 110 lives

The town must choose between A and B. Which test should the town choose? Why? Source: Peter Ubel, “Cost-effectiveness analysis in a setting of budget constraints: Is It Equitable? ” NEJM

334(18), May 2, 1996

© Daniel Wikler 2008

Universal Access – Ib: Colon Cancer Screening Again

This question is for those who favored choice “A” in the previous question.

Let’s change the context slightly. The proposed screening program is for people who live in the northwest quandrant of the city only. The other quadrants have their own public health departments and the four departments do not coordinate their activities. All other facts remain.

Does this affect your choice? Should it?

Universal Access – IIa:Vaccinating Highlanders

Your job is to vaccinate the people on this island

Question 1: 1000 people live on the island. 800 live on the coastal plain; it will cost $1 to vaccinate each.200 live in the mountains; it will cost $4 to vaccinate each.You have $800 for this work. This would be enough for either

a. Vaccinating everyone living on the coastal plain, but none living in the mountains (=800), orb. Half of those living on the coastal plain and half of those living in the mountains (=500).

Which should you choose?

Universal Access – IIb:Vaccinating Highlanders -- again

Your job is to vaccinate the people on this island

Question 2 (for those who chose (a) for Question 1): Just as you were preparing to leave the island, the Ministry of Health calls and tells you that they have given you another $800 for vaccinations on the island. You can choose either:c. Go back and vaccinate the people living in the mountains (total vaccinations: 1000) or d. Vaccinate the people living on the coastal plain for a second

disease (total vaccinations: 1600 (for 800 people).Which should you choose?

Access and Abandonment

Your clinic offers ARV. 1st -line drugs cost $500. Patients who develop resistance to these require drugs that cost $3000.

Which of these policies should the clinic adopt?

A. Broad Access: All patients in need of treatment will be offered first-line drugs. Expensive drugs will not be offered to patients who develop resistance, who will then die.

B. Non-abandonment: All patients accepted for treatment will be offered all the drugs they need. But only a fraction of those needing treatment will be accepted by the clinic for any kind of treatment. © Daniel Wikler 2008

Hypertension Screening: who should be targeted?

Poor Urban black males

Rich Suburban white males

prevalence high lower

Access to care low high

compliance low high

Life expectancy low high

Lives saved (proj.) 100 140

Who should be dialyzed? 1

A medium-income country recently enacted a national health insurance plan. Though end-stage renal disease is a large and growing problem in this country, the plan did not offer dialysis to those whose kidneys failed. Transplant is available to less than 5% of those in need.

Private insurance covers dialysis. The public demands equity between private and public plans.

Offering dialysis to all who need it would result in a severe distortion of the health budget. The government decides to meet about half the need.

Who should be helped?

Who should be dialyzed? 2Some options

1. A lottery

2. Decisions by local committees

3. Dialyze only those for whom transplant is indicated (age 60 cut-off, no co-morbidities)

4. Age 58 cut-off

5. Distribute years of dialysis:

1. Everyone gets two years

2. Younger patients get more years, if budget permits

6. According to “social worth” (parents, workers)

More Livers Next Year

Dr. Wang, a Chinese transplant surgeon, sometimes has livers suitable for transplant that he cannot use. The reason is not that people in Dr. Wang’s district don’t need them; rather, most of his patients cannot afford them.

Mr. Bigbucks, an American unable to obtain a liver transplant, offers a gift that will enable Dr. Wang to accept patients for the next decade without regard to ability to pay – but only on the condition that the next available liver go to Mr. Bigbucks. Should Mr. Bigbucks get the next liver, denying it to a less wealthy Chinese citizen?

Non-health benefits

Your community faces an epidemic. A vaccine in short supply offers protection. Vaccines will be targeted to the most vulnerable with the exception of health workers and “critical infrastructure” workers, who are assured vaccines.

Most people in your community work for a big company. Executives of the company say that if they die, all their workers will be unemployed. No others can take their place. They propose that the they also be given vaccines. Their workers support this proposal.

The University proposes that 100 of its leading scientists, whose work will greatly benefit the nation and humanity, should also be given vaccines. If they die, no others can complete their research.

Should their proposals be accepted?

Should the numbers count?

Epidemics have broken out on two offshore oil rigs. 100 are in peril on North Rig and 50 are in peril on South Rig. You can save all the afflicted people on either of the rigs, but not both. The people on the South Rig are in your work team, though you all work for the same company. The company has no rules about this.

Are you obligated to save the 100 people on the North Rig? Suppose that you would prefer to save the 50 people on the South Rig (whom you know) – would this be ethically defensible? Why or why not?

© Daniel Wikler 2008

Protecting the vulnerable 1

A life-threatening infectious disease (“ID2”) seems likely to reach pandemic proportions in your city. The single effective drug is in very short supply. A mild variant of the disease (“ID1”) that infected 1/3 of the population four years earlier left its victims more vulnerable to death from ID2. All who are treated survive. Who should be given priority for treatment?

WWPreviously infected by ID1?

Yes No

Risk of infection by ID2

20% 20%

Risk of death if infected by ID2 without treatment

75% 25%

Protecting the vulnerable - 2

Variation: Previous infection by ID1 seems to reduce the effectiveness of the drug. Who should be given priority for treatment?

Previously infected by ID1?

Yes No

Risk of infection by ID2

20% 20%

Risk of death --untreated ID2

75% 25%

Chance of surviving ID2 if treated

50% 100%

Protecting the vulnerable 1: Results

Example with 8 patients of each group, all of whom will survive if treated.

Previously infected by ID1?

ID1s who survive

Non-ID1s who survive

Total survivors

Treat most vulnerable 8 6 14

Treat most likely to survive

2 8 10

Protecting the vulnerable 2a: Results

Variation: Example for 8 patients of each group, where half those who had ID1 and now have ID2 will survive if treated, and all those who did not have ID1 and now have ID2 will survive if treated.

Previously infected by ID1?

ID1s who survive

Non-ID1s who survive

Total survivors

Treat most vulnerable(ID1-pos)

4 6 10

Treat most likely to survive (ID1-neg)

2 8 10

Trolley I

Five people are working on a trolley track as the trolley approaches. If the trolley is diverted to a spur, their lives will be saved; but one person is working on the spur. The driver has a heart attack. You would be able to divert the trolley. Should you?

Illustration: Marc Hauser, Moral Minds

Trolley II

A train will run down and kill five people on the track ahead unless you push a fat man next to you onto the track. Should you?

Illustration: Marc Hauser, Moral Minds