2013Marek Vácha

Deník Metro, 20/11/2012Metro Journal: „Big Discovery. The Scientists can destroy a HIV bacteria.“

A woman comes at 10 week of pregnancy for prenatal care. She has a history of STDs such as gonorrhea.

You offer HIV testing, which the patient refuses, as a routne part of prenatal care.

She returns at 14 and 18 weeks of pregnancy but is still refusing because of anxiety that she may be positive.

You inform tha patient that there are medications that can reduce transmission from mother to child to less than 2 %.

She persist in her refusal. What should you do now?

Although there are medications to prevent transmission of HIV to the fetus during pregnancy, you cannot compel mandatory testing of pregnangt women.

The woman has the right to refuse testing as well as to refuse antiretrovirals.

If the woman is found to be HIV-positive you cannot mandate the use of antiretrovirals even though they are safe and effective in preventing transmission of the virus from mother to child.

The autonomy of the mother legally outweighs the safety of the fetus.

The Case of the Infected Spouse

The following fictionalized case is based on an actual incident. 1982: After moving to Honolulu, Wilma and Andrew

Long visit your office and ask you to be their family physician. They have been your patients ever since.

1988: Six years later the two decide to separate. Wilma leaves for the Mainland, occasionally sending you a postcard. Though you do not see her professionally, you still think of yourself as her doctor

The Case of the Infected Spouse

1990: Andrew comes in and says that he has embarked upon a more sophisticated social life. He has been hearing about some new sexually transmitted deseases and wants to be tested. Testing reveals that he is positive for the AIDS virus, and he receives appropriate counseling.

1991: Visiting your office for a checkup, Andrew tells you Wilma is returning to Hawaii for reconciliation with him. She arrives that afternoon and will be staying at the Moana Hotel. Despite your best efforts to persuade him, Andrew leaves without giving you assurance that he will tell Wilma about his infection or protect her against becoming infected

The Case of the Infected Spouse

Do you take steps to see that Wilma is warned?

Kipnis, K., A Defense of Unqualified Medical Confidentiality. The American Journal of Bioethics 6, no. 2 (2006): 7 - 18

Solution

1. Counseling the patient to notify his partners voluntarily.2. If the patient is unwilling to notify their partners the

nest step is to notify the Department of Health to start theproocess of contact tracing.

3. The health department interviews the patient and attempts to construct a list of partners in order to notify them

1. this is a voluntary process and there is neither a penalty nor criminal threat of prosecution if the patient chooses not to comply.

4. The health department then sends notice to the partner that there is a health-related issue to discuss and the partner is notified in person of their potential exposure to HIV.

1. The name of the source patient is never revealed to the partner and the confidentality of the original partner is maintained.

Solution

If the patient is unwilling to dislclose the maens of his contacts you cannot compel him to do so.

There is no incarceration or criminal penalty for not disclosing these names.

If a patient will not notify his partners and you have certain knowledge of the partner at risk, you have legal immunity to carry out the notification yourself.

There is a legal protection if you do notify the partner, but it is not mandatory for you to do so.

No one has ever been successfully prosecuted for violating a patient´s confidentiality if it is to warn another person who is at risk.

You have a patient in your clinic who is accompanied by her boyfriend

She is clearly having unprotected sex because she is pregnant.

When you ask if her boyfriend knows her HIV status she says, „Of course not – he might leave me if I told him.“

You strongly encourage her to tell him her HIV status

On a subsequent visit, when you ask her if she has notified her partner she says „Not yet.“

You know the boyfriend because he accompanies her to the office visits.

What should you do?

You have legal immunity if you notify the partner.• At this point either you can ask the health department

to notify the partner or you may do it yourself• if the partner were to seroconvert for HIV and you did

not make sure he was notified you would be legally liable because you did not follow your duty to warn.

• this is similar to having a psychiatric patient who told you he was going to harm someone.

Although you have a duty to maintain the confidentiality of the patient, you also have a duty to inform the person at risk.

Dr. I

Dr. I was vaguely disturbed by something about the slim, handsome young man who was in his examining room because of an unstable knee. The knee, however, had unequivocal indications for surgical repair of three ligaments. It could probably be done by arthroscopy but might require an open procedure. The patient agreed to theprocedure and it was scheduled. Dr. I asked him to provide a blood sample for routine nlaboratory tests. He also scheduled a preoperative chest X-ray. After the patient left, Dr. I added an HIV test to the laboratory request.

Dr. I

Dr. I was anxious about blood-borne infections and was glad he had gotten his hepatitis B shots. The day before a planned surgery, the patient´s laboratory and radiology reports came back. His blood cell count showed reduced lymophocytes. The HIV test was positive. To make matters even more perplexing, the radiologists reported a lung infiltrate that suggests tuberculosis.

Dr. I wondered about what to tell his patient and what to do about the surgery.

Solution

Dr. I erred when he obtained a potentially lifechanging tests and did not inform his patient and obtain consent.

He probably realized this when the result returned.

At that point, the ethical imperatives for Dr. I are to ascertain whether the patient knows his HIV status to explain why the patient was tested for HIV to disclose the results of zhat test and the chest radiograph to defer the scheduled operation until it is safe and

desirable for thepatient to proceed to determine whether the patient has another doctor who

can capably address his infectious diseases

Over 90 % of HIV infected people live in the poor countries of the Southern Hemisphere.Two-third of these in sub-Saharan Africa alone.

AIDS prevalence rate1986 – 2001among adults age 15 - 45

Estimate Range

People living with HIV/AIDS in 2010 34 million 31.6-35.2 million

Proportion of adults living with HIV/AIDS in 2010 who were women (%)

50 47-53

Children living with HIV/AIDS in 2010 3.4 million 3.0-3.8 million

People newly infected with HIV in 2010 2.7 million 2.4-2.9 million

Children newly infected with HIV in 2010

390,000 340,000-450,000

AIDS deaths in 2010 1.8 million 1.6-1.9 million

http://www.avert.org/worldstats.htm

http://www.avert.org/worldstats.htm

The number of people living with HIV rose from around 8 million in 1990 to 34 million by the end of 2010. The overall growth of the epidemic has stabilised in recent years. The annual number of new HIV infections has steadily declined and due to the significant increase in people receiving antiretroviral therapy, the number of AIDS-related deaths has also declined.Since the beginning of the epidemic, nearly 30 million people have died from AIDS-related causes

AIDSAIDS

till 2002 42 millions of deaths on the whole till 2002 42 millions of deaths on the whole

AIDS2004 HIV has so far infected more than 60 milion people

20 million have already died Joint United Nations Programme on HIV/AIDS

estimates that by 2020 the AIDS epidemic will have claimed a totaly of nearly 90 million lives

According to WHO, AIDS is now responsible for about 5 % of all deaths worldwide cancer 12 %, heart attacks 12 % , strokes 9%, lower

respiratory tract infections 7 % tuberculosis 3 %, malaria 2 %, car accidents 2 %, homicides

1 % roughly 8000 people die of the disease every day

AIDS 2004: USA

As of December 2004, an estimated 944,306 persons had received a diagnosis of AIDS, and of these, 529,113 (56%) had died

Sub-Saharan Africa2004 average prevalence among adults there is

9 % Botswana 39 % Zimbabwe 34 % Swaziland 33 % Lesotho 31 %

the AIDS epidemic has cut the average life expectancy from 62 to 47.

In 2010, about 68% of all people living with HIV resided in sub-Saharan Africa, a region with only 12% of the global population

The number of AIDS-related deaths declined by nearly one-third in sub-Saharan Africa between 2005 and 2011. The Caribbean experienced declines in AIDS-

related deaths of 48% between 2005 and 2011 and Oceania 41%.

However two regions experienced significant increases in AIDS-related deaths; Eastern Europe and Central Asia (21%) and the Middle East and North Africa (17%).

Cost of AIDS

when one considers personal medical costs, direct costs of research, and indirect costs such as education, screening, and potential productivity losses,

the disease carries a yearly price tag of over $ 8 billion

2012

the population affected by the disease has extended to all groups from „high-risk groups“ to „high-risk

behaviours“

AIDS

1981: On June 5, the Centers for Disese Control (CDC) Mortality and Morbidity Report listed an unusual outbreak of opportunistic infections such as Pneumocystis carinii pneumonia among gay men "gay cancer"

T-lymocyte infected by HIV (blue)

History

GRID - gay-related immune disorder

july 1981 108 cases reported, 43 individuas had died

1982: Acquired Immunodeficiency Syndrome becomes the term used by the CDC to describe thr unusual outbreak of opportunistic infection

1984: Virus HIV is identified by a team of French scientists

1987: FDA approves AZT (azidothymidine), the first antiviral agent to treat AIDS

AIDS began as a mutant virus that was iked up from a species of African monkey and transferred to humans by way of bites

It was then transmitted among the African population via direct mucous to mucous contact, through semen and perhaps blood exchange

From Africa, the disease spread to Haiti, and was later carried to the United States, probably by homosexual males

(Edge, R.S., Groves, J.R., (2007) Ethics of Health Care. A Guide for Clinical Practice, 3rd ed. Thomson Delmar Learning, NY,USA, p.284)

2008 Luc Montagnier received a

Nobel prize

Harald zur HausenBorn 1936German Cancer Research Center,Heidelberg, Germany

Françoise Barré-SinoussiBorn 1947Institut Pasteur,Paris, France

Luc MontagnierBorn 1932World Foundation for AIDS Research and Prevention,Paris, France

AIDS

HIVHIV

Immune Response - Overview

Life cycle

Δ 32 CCR5

Δ 32 CCR5

9 % Europeans have CCR5-Δ 32 deletion 32 bp in coreceptor CCR5 coding

gene HIV can not „land“ on this cell and a patient is

therefore immune

0 % Africans has this deletion CCR5-Δ 32 allele is common in northern

Europe and declines dramatically in frequency to both south and east

Evoluce viru HIV

Resistance proti léku 3TC začíná téměř ihned po aplikaci a za několik týdnů dosahuje původní úrovně

AIDS and Cancer

In AIDS, the human immunodeficiency virus (HIV) promotes development of an otherwise rare cancer called Kaposi´s sarcoma by destroying the immune system, thereby permitting a secondary infection with a human herpes virus (HHV-8) that has a direct carcinogenic action.

Origin of HIV

the last common ancestor of the group M HIV – 1 viruses lived in 1930s this common ancestor could, in principle, have

lived in either a chimpanzee or a human

because the sequence of the RNA genome of HIV is known, RT-PCR can be used to amplify, and thus detect, HIV RNA in blood or tissue sample

uses the enzyme reverse transcriptase (RT) in combination with PCR and gel electrophoresis

in this example, samples containing mRNAs from six embryonic stages of hummingbird 1. cDNA synthesis is carried out by incubating the

mRNAs with reverse transcriptase and other necessary components

2. PCR amplification of the sample is performed using primers specific to the hummingbird β-globin gene

3. Gel electrophoresis will reveal amplified DNA products only in samples that contained mRNA transcribed from the β-globin gene

Result: the mRNA for this gene is first expressed at the stage 2 and continues to be expressed through stage 6

2013

Ethical Problems

Do health care practitioners have a duty to treat? What is an acceptable risk for health care

professionals? Should the patient be warned if the health care

practitioner is HIV positive? Should the practitioner be warned of the patient

is HIV positive? Should infected practitioners be allowed to

continue practice? What is the meaning of confidentiality when it

comes to AIDS, and who should be told?

It is ethically unacceptable to refuse to treat HIV or take care of HIV-positive patients simply because they are HIV-positive.

2006: changehttp://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

CDC changed its recommendation about HIV screening for patients in health care settings

the recommendations moved away from specific, explicit informed consent, usually in written form, to general, implicit consent as part of the acceptance of medical care. previous policies required specific disclosure of

information and a decision to accept or refuse testing.

specific, explicit consent would still be expected in nonclinical settings

2006: changehttp://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

For patients in all health-care settings HIV screening is recommended for patients in all

health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening).

Persons at high risk for HIV infection should be screened for HIV at least annually.

Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.

Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings.

2006: changehttp://www.cdc.gov/mmwr/preview/mmwrhtml/rr5514a1.htm

For pregnant women HIV screening should be included in the routine

panel of prenatal screening tests for all pregnant women.

HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening).

Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing.

Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

Transmission

heterosexual sexhomosexual sexoral sexneedle sharingtransfusion with contaminated boold

productchildbirthbreast feeding

Spreading

sexual intercourse (both homo and heterosexual) (in ČR 84% cases)

blood-to-blood contact – blood transfusion, needle sharing among drog abusers etc.

from pregnant woman to a fetus (cca 20 – 30% pregnancies)BTW we see how useful organ a placenta is!)much higher number is via breast-feeding

(HIV+ women must not feed their babies)

Succes in preventing programme in Thailand

and Ivory Coast

New infections among men who have sex with men in Amsterdam1991 – 2000It appears that the introduction of effective long-term drug therepies, which for some individuals have at least temporalily transformed HIV into a manageable chronic illness, may also have prompted an increase in risky sexual behavior.

"Breaking the Chain"

clean needle exchange provision of free condoms fro high school

students screening prospective blood donor testing of blood supplies abstinence in high-risk situation

Reagan Administration: „conservative“ approach

no sex before marriage faithfullness in marriage no drugs

Clinton Administration: „pragmatic“ approach

HIV is not transmissed by sexual intercourse, byt by unprotected sexual intercourse

condom throwaway needles

Bushova administrativa 2004 - 2008 ABC program

abstinence be faithful condoms

HIV+ Health-care worker

There is no duty on the part of an HIV positive health-care worker to inform his patients of his HIV status.

An HIV-positive physician who practices high-risk surgical and obstetric procedures is expected to maintain precautions to protect the patietns from transmission.

Dr. Acer Case

Dr. David J. Acer, a Florida dentist, infected six of his patients with the AIDS virus.

Fifty-seven other health-care professionals have told the authorities that they are H.I.V.-positive; 19,000 of their patients have been tested. Not one has caught the virus from medical treatment.

Dr. Acer Case

But no one expected the example to be such an anomaly - one dentist with six cases versus 57 professionals with no cases.

Before he died of AIDS in 1990, Dr. Acer wrote an open letter to his patients saying:

"I am a gentle man, and I would never intentionally expose anyone to this disease. I have cared for people all my life, and to infect anyone with this disease would be contrary to everything I have stood for."

it is far more likely that the practitioner will be infected by the patient than the other way around.

100 health care providers had contracted the disease from patients (2007).

Edge, R.S., Groves, J.R., (2007) Ethics of Health Care. A Guide for Clinical Practice, 3rd ed. Thomson Delmar Learning, NY,USA,p. 288

A 32-year-old pregnant woman comes to your prenatal clinic. She has a history of syphilis and gonorrhea in the past but her VDRL/RPR is negative now. An HIV test is offered as a routine part of her prenatal evaluation as well as because of the history of previous STDs. You explain to her the importance of the test for her baby´s well-being. She refuses the test when offered.

What should you do?

1. No test+. she has the right to refuse2. PCR RNA viral load testing as an

alternative3. Consent for HIV testing is not needed in

pregnancy because it is to protect the health of the baby.

4. Add the test to the other toutine tests that are to be drawn

5. Administer empiric antiretroviral therapy to prevent perinatal transmission

6. HIV testing is now part of routine prenatal care and no specific consent is needed.

You have a patient who is an HIV-positive physician. He has recently found out that he is HIV-positive. He is very concerned about confidentiality and you are the only one who knows he is HIV-positive. He asks you who you are legally obligated to inform.

What should you tell him?

1. His insurance company2. State government3. His patients4. His patients, only if he performs a

procedure such as surgery where transmission canoccur

5. No one without his direct written consent6. His employer7. The hospital human resources

department

1. His insurance company2. State government3. His patients4. His patients, only if he performs a

procedure such as surgery where transmission canoccur

5. No one without his direct written consent6. His employer7. The hospital human resources

department

patients with HIV have a right to privacy as long as they are not putting others at risk

you have no mandatory obligation to inform the state, his insurance, his employer

you and the patient do not have a mandatory obligation to inform his patients of his HIV status even if he is a surgeon

If the automatic right to know the HIV statsu of the patient does not exists, the the patient does not automatically have the right to know the HIV status of the physician.

It works both ways.

You have an HIV-positive patient in the office. You aks her if she has informed her partner that she is HIV-positiev. She has repeatedly resisted your attempts to have her inform the partner. She is pregnant with his child. The partner is in the waiting eoom and you ave met him many times.

What should you do?

1. Inform the partner now.2. Respect her confidentiality3. Refer your patient to another

physician who is comfortable with her wishes.

4. Tell the partner to practice safe sex from now on but don´t tell him her HIV status

1. Inform the partner now.2. Respect her confidentiality3. Refer your patient to another

physician who is comfortable with her wishes.

4. Tell the partner to practice safe sex from now on but don´t tell him her HIV status

You have full legal protection if you inform the partner.

The safety of an innocent person is always more important that privacy.

You are not legally mandated to inform the partner directly but you are protected if you do so.

You definitely are liable if the patient´s partner seroconverts and you did not tell him he was at risk even though you knew

This is a version of the Tarasoff case in psychiatry

if you know that harm may occur, but you do nothing, then you are liable.

If partner notification is going to occur, you must inform the patient that you will inform the partner.