2015 US FDA Recommendations For Blood Donations

Summary

In this episode of 'Weekends with Dr. Bernie', the controversial topic of blood donation restrictions for gay men is explored. The discussion begins with the aftermath of the 2016 Orlando mass shooting, highlighting the surge in blood donation requests. It then delves into the FDA's guidelines that previously banned gay men from donating blood but have since been revised to allow donations from those who haven't had sex in the past year and test HIV negative. The video explains the scientific reasoning behind these policies, citing HIV transmission risks and the importance of blood safety. It emphasizes the need for evidence-based regulations to protect the blood supply, while also acknowledging the challenges and ethical considerations involved in balancing public health with inclusivity.

Takeaways

• 🏥 The script discusses the policy on blood donation by gay men in the context of the FDA's restrictions and the historical context of the HIV/AIDS epidemic.
• 🚫 The FDA has revised its guidance to allow gay men to donate blood if they haven't had sex in the past year and test HIV negative.
• 🩸 The ban on blood donation by gay men was initially put in place due to the high risk of HIV transmission, especially in the 1980s when the disease was primarily associated with the gay community.
• 📉 HIV, or Human Immunodeficiency Virus, leads to AIDS, which weakens the immune system and can result in death due to complications from infections that a healthy immune system would normally fight off.
• 📚 A study by Patel et al. in 2014 estimated per-act HIV transmission risks, finding that blood transfusion has the highest risk of HIV infection at 93% per exposure.
• 🌐 The script highlights the disproportionate impact of HIV on certain populations, such as gay black men, and the subsequent effect on other groups like black heterosexual women.
• 🛑 The HIV testing process looks for antibodies, which may not appear for several days or months after exposure, leading to a one-year deferral period for gay men who wish to donate blood.
• 🤔 The script questions the fairness and effectiveness of the current blood donation policies, suggesting that there may be other high-risk groups that are not as strictly regulated.
• 💉 The cost of treating an individual infected with HIV through blood transfusion can be nearly $400,000 over their lifetime, not including additional medical expenses and potential lifestyle changes.
• 🏛️ The FDA's policy is framed as a necessary regulation to protect the blood supply and avoid liability, emphasizing the importance of scientific evidence in policymaking.
• 🔬 The script concludes by encouraging viewers to be skeptical and to examine the scientific data themselves, advocating for legislation based on evidence rather than emotion.

Q & A

What was the context that prompted the discussion on whether gay people should be allowed to donate blood?

The discussion was prompted by the mass shooting in Orlando, Florida, in June 2016, where 49 people were killed at a gay nightclub, and many were injured, leading to a huge influx of people wanting to donate blood.

What is the current policy on blood donation by gay men according to the FDA?

As of the script's recording, gay men who have not had sex in the last year and test HIV negative are allowed to donate blood. Those who do not meet these criteria are not permitted to donate.

What is HIV and how does it relate to the blood donation policy?

HIV stands for Human Immunodeficiency Virus, which inevitably leads to AIDS (Acquired Immunodeficiency Syndrome). It weakens the immune system, making the body unable to fight off infections. The policy on blood donation is related to HIV because the virus can be transmitted through blood, and the FDA aims to prevent the spread of HIV through the blood supply.

Why was there initially a higher association of HIV/AIDS with the gay community in the 1980s?

In the early 1980s, AIDS was known as the 'Gay Man's cancer' because it seemed to only affect gay men, and the mode of transmission was not yet understood, leading to a perception that it was primarily a gay-related disease.

Can you explain the significance of the case of Ryan White in relation to HIV transmission through blood?

Ryan White was a hemophiliac who needed regular blood transfusions. After a bad transfusion in December 1984, he became infected with HIV, which led to AIDS. This case highlighted the risk of HIV transmission through blood transfusions and contributed to the implementation of blood bans for certain groups, including gay men.

What is the estimated risk of HIV transmission through various means according to the 2014 paper by Patel et al.?

The highest risk is through blood transfusion with a 93% chance of infection if transfused with HIV-infected blood. Other risks include vertical transmission from mother to child at about 23%, receptive anal intercourse between men at about 1.4% per exposure, and needle sharing at about 6% per exposure.

Why is there a discrepancy between the infection rates of gay black men and gay white men in the United States?

Gay black men account for more infections as a percentage than gay white men, despite being a smaller population. This discrepancy leads to black heterosexual women being the fourth most infected population when it comes to HIV infections.

How does the HIV testing process for blood donation work, and why is there a waiting period for gay men?

HIV testing is done by detecting antibodies that develop in response to the presence of HIV. These antibodies don't always show up immediately, sometimes taking days or months. Therefore, a one-year waiting period without sex and a negative HIV test is required for gay men to donate blood to ensure the safety of the blood supply.

What are the implications of allowing high-risk populations to donate blood without proper screening?

If high-risk individuals donate blood without proper screening, and the blood is HIV-infected, the recipient could incur lifetime medical costs of nearly $400,000 for HIV medications alone, not including doctor's visits and lifestyle changes. This also leads to increased medical costs for third-party payers and potential lawsuits.

What is the speaker's stance on the current blood donation policy for gay men, and why?

The speaker supports the current policy based on the best available scientific data, stating that it is necessary to legislate based on science, not emotions, to ensure the safety of the blood supply. They acknowledge the need for blood but emphasize the importance of being safe rather than sorry.

Outlines

00:00

🏥 Blood Donation Controversy and HIV Risks

In the aftermath of the 2016 Orlando mass shooting, there was a surge in blood donation attempts. However, the FDA has restrictions on blood donations from men who have had sex with men (MSM), which have been revised to allow donations from gay men who haven't had sex in the past year and test HIV negative. The script discusses the historical context of HIV/AIDS, its impact on the gay community, and the scientific data behind HIV transmission risks. It explains why MSM have been historically a high-risk group for HIV, referencing a 2014 paper that estimated per-act HIV transmission risks, showing that blood transfusion has a 93% chance of transmission, and receptive anal intercourse between men has a 1.4% chance per exposure. The video aims to clarify the scientific reasoning behind the FDA's policy on blood donations.

05:01

🤔 The Science and Ethics of HIV Testing in Blood Donations

This paragraph delves into the specifics of HIV testing, explaining that antibodies develop in response to HIV and may not be detectable for days or months after exposure. The one-year abstinence period for MSM before they can donate blood is partly due to the window period for HIV detection. The script challenges the emotional appeals against the FDA's policy, emphasizing the importance of scientific evidence in making public health decisions. It also raises questions about the fairness of the policy, considering that high-risk heterosexual behavior is not similarly restricted in blood donation. The paragraph concludes by discussing the broader implications of HIV infection via blood transfusion, including the financial burden on healthcare systems and the potential for lawsuits.

10:02

🛡️ The Role of Regulation in Public Health and Blood Donation Policy

The final paragraph discusses the role of government regulation in managing infectious diseases and the importance of evidence-based policy-making. It contrasts the need for regulation in infectious diseases with the limited role it should play in chronic diseases resulting from personal actions. The FDA's blood donation policy is framed as a necessary measure to prevent HIV contamination of the blood supply. The speaker encourages viewers to critically evaluate the data and sources presented in the video, advocating for skepticism and verification of scientific claims. The video concludes by acknowledging the need for more blood donations while emphasizing the importance of safety and evidence-based regulation in blood donation policies.

Keywords

💡Blood Donation

Blood donation is the act of giving one's blood for medical use without payment. It is a crucial process for saving lives, especially in emergency situations like mass shootings, which is a central theme in the video. The script discusses the controversy surrounding blood donation policies, particularly for gay men, and the FDA's guidelines that have been revised to allow gay men who haven't had sex in the last year and test HIV negative to donate blood.

💡HIV/AIDS

HIV (Human Immunodeficiency Virus) and AIDS (Acquired Immunodeficiency Syndrome) are infectious diseases that have been central to the debate on blood donation policies. The video explains that HIV leads to AIDS, which weakens the immune system, making the body susceptible to infections. The script also discusses the historical context of HIV/AIDS, noting its initial association with the gay community and the impact on blood screening policies.

💡FDA Blood Ban

The FDA Blood Ban refers to the restrictions set by the U.S. Food and Drug Administration on certain individuals, including gay men, from donating blood. The video script explains that this ban was put in place due to the high risk of HIV transmission within the gay community and the potential for contaminated blood to enter the blood supply. The ban has been revised but still requires a one-year abstinence period for gay men before they can donate blood.

💡Hemophilia

Hemophilia is a medical condition characterized by impaired blood clotting, requiring frequent blood transfusions. The script mentions Ryan White, a hemophiliac who contracted HIV from a blood transfusion, highlighting the risk of bloodborne diseases and the importance of stringent blood screening processes.

💡Antibody Testing

Antibody testing is a method used to detect the presence of antibodies produced by the body in response to a disease, such as HIV. The video explains that HIV does not show up immediately in the blood, so antibody testing is used to determine if a person has been exposed to the virus. This testing method is crucial in determining eligibility for blood donation, as it helps ensure the safety of the blood supply.

💡Per Act HIV Transmission Risk

The term 'Per Act HIV Transmission Risk' refers to the probability of contracting HIV through a specific act or exposure. The video script cites a study that estimates these risks for various activities, such as blood transfusions and sexual practices, to inform viewers about the relative dangers associated with different modes of HIV transmission.

💡Receptive Anal Intercourse

Receptive anal intercourse is a specific sexual practice where one partner receives the penis or other objects into their anus. The video script discusses the risk of HIV transmission associated with this practice, particularly in the context of men having sex with men, and how it contributes to the high rates of HIV infection within the gay community.

💡Needle Sharing

Needle sharing refers to the practice of using needles that have been used by others for drug injection, which is a high-risk behavior for HIV transmission. The video script mentions needle sharing as a significant risk factor for HIV infection and the reason for clean needle programs in certain countries.

💡Healthcare Costs

Healthcare costs are the expenses associated with providing medical services, including treatments for chronic diseases like HIV. The video script highlights the financial burden of treating HIV-infected individuals, which can reach hundreds of thousands of dollars over a lifetime, emphasizing the importance of preventing HIV transmission through blood donations.

💡Ethical Issues

Ethical issues in the context of the video relate to the moral dilemmas and principles surrounding blood donation policies, particularly the restrictions on gay men. The script suggests that while the FDA's policies may seem discriminatory, they are based on scientific evidence and the need to protect public health, raising questions about the balance between individual rights and societal responsibilities.

Highlights

The FDA has revised its guidance on blood donation for gay men, allowing those who haven't had sex in the last year and test HIV negative to donate.

HIV is the most significant infectious disease epidemic since 1950, leading to AIDS which weakens the immune system.

AIDS was initially known as the 'Gay Man's cancer' in the early 1980s due to its prevalence in the gay community.

Ryan White, a hemophiliac, contracted HIV through a blood transfusion, highlighting the risk of blood supply contamination.

In 2010, 70% of new HIV infections were among men who had sex with men.

A 2014 study by Patel et al. estimated per-act HIV transmission risks, finding a 93% chance of infection through blood transfusion.

Receptive anal intercourse between men has a 1.4% chance of HIV transmission per exposure.

Needle sharing among injection drug users has a 6% chance of HIV transmission per exposure.

HIV testing relies on detecting antibodies, which may not appear for several days or months after exposure.

Gay black men have a higher percentage of HIV infections relative to their population compared to gay white men.

Black heterosexual women are the fourth most infected population when it comes to HIV infections.

The current FDA policy on blood donation is based on scientific evidence and aims to prevent HIV contamination in the blood supply.

The cost of treating an individual infected with HIV through blood transfusion can reach nearly $400,000 over their lifetime.

The FDA's blood ban is a regulatory measure to prevent liability in cases of HIV contamination.

The speaker encourages skepticism and verification of scientific data, including the information presented in the video.

The video concludes that blood donation policies must be based on scientific evidence rather than emotions, for safety reasons.

Transcripts

SU My name is bernard and Welcome to

weekends with Dr bernie should Gay

people Be allowed to Donate Blood we'll

answer that question Today in june 2016

in Orlando Florida one of the biggest

Mass shootings occurred Here in the

United States 49 people at a Gay

nightclub were killed and more than

people were injured this prompted a Huge

Huge influx of people wanting to Don

Blood Because in a Mass Shooting you

Lose Blood if you've been Shot If you

don't have enough Blood your organs In

Your Body Won't Be able to get enough

Oxygen most importantly The Brain and if

it doesn't Get enough Oxygen then you

Die there's also a multitude of Other

problems that happen When It Comes to

Massive Blood loss so this prompted A

lot of people to want to Give Blood

however The United States Food and drug

administration has banned Gay people Gay

Men Who have had Sex with Men from Don

Blood Now i should say this guidance has

been revised if you are a Gay Man and

you haven't had Sex in the last year and

you Test hiv negative You are able to

Donate Blood but If you don't Fit Any

one of those Two criteria You are not

able to Donate Now Let's go into Why

You're not able to Donate hiv is the

biggest infectious disease epidemic

That's occurred Since 1950 it stands for

Human immunodeficiency Virus and

inevitably leads to something Called

aids Which is a ed immunodeficiency

syndrome It's Not The hiv or The aids

that Kills you It's The result that

comes from those that do What aids does

is that it eventually weakens your

immune System to the Point Where your

body's Not able to Fight off things that

normally occur and that people with

Healthy functioning immune Systems are

able to Fight off meaning that you can

get extremely Strange and rare fungal

pneumonias you get fevers all the time

and Pretty much Your Body bec comes

Infected repeatedly until you Die the

first cases of these infections were

found in 1981 Five Men in Los Angeles

had a very rare fungal pneumonia and

They All died from it and throughout the

early 80s aids was known as The Gay

Man's cancer Because it seemed that Only

affect Gay Men and nobody knew exactly

How It was transmitted until the mid 80s

in the US there Was a Kid named Ryan

White Who is a hemophiliac meaning that

he had Blood issues and needed New Blood

transfused into him very often Now After

a bad transfusion occurred in December

1984 he then got Infected with hiv which

ultimately LED to aids you really

wouldn't expect To A middle schooler of

that age to be involved in the Gay

Community at the time but he was Still

expelled from his Middle School Because

at that Time people didn't know How hiv

was transmitted but Because this

happened Now there's an Even bigger

Scare Because not Only Gay Men were

getting it but Now The Blood supply is

potentially tainted and it Looks Like

You can transmit hiv through Blood so

Now This is Where The Blood Band has

really Taken Form on Gay people Because

in 2010 70% of new hiv infections

accounted for were with Men Who had Sex

with Men and from Every Single Year that

we've been tracking this We find that in

between about 60 to 70% of all New

infections are Coming From Men Who have

Sex with Men so Now Let's get into the

Real Science behind hiv Transmission

there Was a Pap written in 2014 that was

by patel at all the Link is in the

description below It's titled estimating

Per Act hiv Transmission risk a

systematic review and in Here They Look

at 8,000 papers filtered down to 15

which looked at How people got Infected

with hiv so In this Paper which wasn't

Just in the United States They looked at

all these different studies and

calculated particular risk rates that

could happen Per 10,000 exposures and in

here through a Large Large sample size

They were able to find that The highest

risk For getting hiv Infected would be

through a Blood transfusion in fact It

looks Here that you have about a 93%

Chance of getting Infected if you are

transfused with Blood that is Infected

with hiv Now interestingly enough In

this Paper They also found that vertical

Transmission from mother to Child which

would be breastfeeding or Even Maybe

Just having Birth To A Child while You

are hiv positive results in about 23%

Chance of getting Infected The Third

highest One is going to be receptive

Anal intercourse Now When I looked

through All Of The sources that listed

on Here this was receptive Anal

intercourse between Men not necessarily

between Man and a woman and mainly

That's Just Because This is the at risk

population although typically in

heterosexual Sex it will be the woman

that is on the receptive end although

these Days I don't know anymore and it

appears with this Men to Men receptive

Anal intercourse you have about a

1.4% Chance of getting Infected that

would be Per exposure Now I know people

don't normally have Sex Just Once

anyways so this Chance is actually

getting Pretty High with repeated

exposures to receptive Anal intercourse

Now The fourth highest One is going to

be not that Big of a Surprise It's going

to be needle sharing with injection drug

use That's Why They have Clean needle

programs in certain countries but that

actually Just comes Out to to 6% Chance

of getting Infected and of course

Because these are habitual users that6%

compounds with Every Single exposure

meaning that If you do it 100 times

There is a Pretty Big Chance that It

Will have compounded and that you would

have gotten Infected at some Point Now

of particular Note That's interesting on

Here insertive Anal intercourse gives

you a1% Chance of getting Infected this

would be the person inserting is not

Infected but The person receiving is

Infected and of course heterosexual Sex

that would be receptive penal vaginal

intercourse is UH

08% Chance of a risk of infection and

insertive penile vaginal intercourse has

a

04% Chance of getting infection Per

exposure meaning that if you are a Man

having Sex with a woman Who is Infected

and you do it vaginally you have a04%

Chance of getting Infected Now it's very

interesting to see because from this

Chart Here Gay Black Men as a percentage

are smaller population here in the

United States than Gay White Men but yet

They account for more infections as a

percentage than Gay White Men and

unfortunately this leads to Black

heterosexual Women being the fourth most

Infected population When It Comes to hiv

infections Pretty Strange Given The

results Here In this Paper that there's

a 1.4% Chance of Men getting Infected

through receptive an intercourse but yet

Black heterosexual Women have this High

of an infection Rate relative to their

population now When It Comes to the Data

and Part of the reason Why if you are a

Gay Man trying to Give Blood that you

can have had Sex for more than a Year

before you can Donate Blood Part of that

reason is Because to test for hiv Inside

your Blood hiv doesn't Show Up right

away so the way that They Test For it is

something Called an antibody which

develops In Your Blood in response to

the exposure and presence of hiv a lot

of times those antibodies Don't Show Up

for several Days Sometimes months

meaning that If you Test hiv negative

After a Year and haven't had Sex in that

Time that you are most likely Okay to

Donate that Blood so Now When we go and

Look at A lot of these News articles

They actually Go and neglect this

scientific Evidence that appears It's

actually publicly available on a Center

for disease Control website but yet in

Here The They appeal to Em Motion by

saying that Gay Blood is the same as

Anybody else's Blood and to that Point I

will definitely agree honestly Blood is

Sexual orientation neutral Now The

problem is is that when you have a High

risk population that is known to have

the highest infection rates then This is

Part of the reason Why we have the Ban

but Now interestingly enough we know

that Maybe Only about 60% of the

population Who are Infected with hiv are

Gay meaning that there's 40 Per of Other

people Who aren't and What's stopping

Somebody from having a bunch of

promiscuous straight Sex and then able

to Donate Blood When a Gay Man Who Maybe

has had Sex Once In The last year is not

able to Donate Blood Now Here in lies

the problem We have this highrisk

population That's known for extremely

high infection rates compared to

heterosexual people and Given The fact

that The Gay population is much smaller

than The heterosexual population When We

have News articles like this That call

the fda policy homophobic You are

strictly strictly negating the Evidence

This is scientific Evidence This is the

best Evidence that We have Today Now the

question then lies should We not allow

Gay people to Donate Blood and

unfortunately the answer right now Given

our regulatory Framework is Yes Because

should Somebody Get Infected Via Blood

transfusion Because Of hiv Infected

Blood that wasn't screened right and

that The person May have had Anal Sex

Just Four Days ago Within the time

Window that hiv would not Be able to be

detected that particular person is going

to incur a Cost of Close to $00,000 over

their lifetime to Just have to Pay For

The hiv medications that doesn't include

The doctor's visits that doesn't include

the side effects that that person has to

endure or The lifestyle Changes that

need to happen Because They Now have to

take medicines to treat the hiv this

then leads To A Huge Huge problem of

thirdparty payers having to deal with

these issues and having to pay for all

of these Drugs That's going to increase

the Medical Cost for Everybody Else and

then not to mention the lawsuits that

are going to occur When Somebody donated

Blood and unknowingly had hiv which that

is also a really Big Part of the

population too Now This is an

interesting exercise in allowing

government to regulate our lives in the

of infectious disease When these things

Go unmitigated you get things like The

Black Death and quite honestly

government does have a Role When It

Comes to infectious disease now When It

Comes to chronic diseases like Type two

diabetes I don't think that They should

really have anything to do with your own

actions or lung cancer with Smoking but

then there's also Another Element of

disease Such as alzheimers which We

Don't Even know How it occurs but with

the position that The fda has and our

current regulatory environment The fda

is acting in their Own own interests in

making this Blood Ban happen Because

They Can't Be liable When hiv tainted

Blood enters Into the Blood supply in

Mass and unfortunately throwing tantrums

on the Internet saying that these are

homophobic policies is not going to Help

Any Cause Because This is the best Data

that We have Today Now could this Data

Be Wrong absolutely When It Comes to

Science you have to always be skeptical

in fact You should Be skeptical of

Everything that i say you should Try to

Pull this article Up you should Try to

read through All Of The Source that They

cite and see whether or not They align

with the Proper Data that comes Out Of

Here can you reproduce This those are

the kinds of questions that you need to

Ask I Really would like for more Blood

to be in the supply Because quite

honestly whenever I work at a Hospital I

see that This is a problem We don't have

enough Blood and that more people being

able to Give Blood would be ultimately a

Better thing unfortunately We have to be

careful about it you have to be Better

Safe than Sorry and That's the

conclusion that We have to come to Today

they've lifted The Ban from lifetime to

now One Year I would like to see that

Time Be shortened but as of right now

This is the best Data that We have and

This is the Science behind it and We

Must legislate based on the Science not

on our emotions anyways Leave a like If

you enjoyed this Video I hope you did or

leave me a comment I'm sure I will Get

much hate from this but trust me as of

this time in this recording The Science

has been Set and quite honestly It's Not

Just The Science but there's a whole

bunch of Other ethical issues that Come

Up but Subscribe If you like to see more

I'm Plan on doing at least One Medical

Video Every week I hope you guys like

this kind of stuff Thanks so much for

hanging Out with me this Weekend and

I'll See You in the Next One Adios

amigos