Month: February 2023

While the FDA rules for blood donation were revised twice in the last decade, one group — men who have sex with men (MSM) — continued to be turned away from donating. Now new, evidence-based FDA rules will focus on individual risk rather than groupwide restrictions.

Medical experts consider the new rules safe based on extensive evidence. Let’s review the changes here.

The new blood donation rules: One set of questions

The May 2023 FDA guidelines recommend asking every potential blood donor the same screening questions. These questions ask about behavior that raises risk for HIV, which can be spread through a transfusion.

Blood donation is then allowed, or not, based on personal risk factors for HIV and other blood-borne diseases.

Questions for potential blood donors

Screening questions focus on the risk of recent HIV infection, which is more likely to be missed by routine testing than a longstanding infection.

The screening questions ask everyone — regardless of gender, sex, or sexual orientation — whether in the past three months they have

• had a new sexual partner and engaged in anal sex
• had more than one sexual partner and engaged in anal sex
• taken medicines to prevent HIV infection (such as pre-exposure prophylaxis, or PrEP)
• exchanged sex for pay or drugs, or used nonprescription injection drugs
• had sex with someone who has previously tested positive for HIV infection
• had sex with someone who exchanged sex for pay or drugs
• had sex with someone who used nonprescription injection drugs.

When is a waiting period recommended before giving blood?

• Answering no to all of these screening questions suggests a person has a low risk of having a recently acquired HIV infection. No waiting period is necessary.
• Answering yes to any of these screening questions raises concern that a potential donor might have an HIV infection. A three-month delay before giving blood is advised.

Does a waiting period before giving blood apply in other situations?

Yes:

• A three-month delay before giving blood is recommended after a blood transfusion; treatment for gonorrhea or syphilis; or after most body piercings or tattoos not done with single-use equipment. These are not new rules.
• A waiting period before giving blood is recommended for people who take medicines to prevent HIV infection, called PrEP (pre-exposure prophylaxis). PrEP might cause a test for HIV to be negative even if infection is present. The new guidelines recommend delaying blood donation until three months after the last use of PrEP pills, or a two-year delay after a person receives long-acting, injected PrEP.

Who cannot donate blood?

Anyone who has had a confirmed positive test for HIV infection or has taken medicines to treat HIV infection is permanently banned from donating blood. This rule is not new.

Why were previous rules more restrictive?

In 1983, soon after the HIV epidemic began in the US, researchers recognized that blood transfusions could spread the infection from blood donor to recipient. US guidelines banned men who had sex with men from giving blood. A lifetime prohibition was intended to limit the spread of HIV.

At that time, HIV and AIDS were more common in certain groups, not only among MSM, but also among people from Haiti and sub-Saharan Africa, and people with hemophilia. This led to blood donation bans for some of these people, as well.

A lot has changed in the world of HIV in the last several decades, especially the development of highly accurate testing and highly effective prevention and treatment. Still, the rules regarding blood donation were slow to change.

The ban from the 1980s for MSM remained in place until 2015. At that time, rules were changed to allow MSM to donate only if they attested to having had no sex with a man for 12 months. In 2020, the period of sexual abstinence was reduced, this time to three months.

Why are the blood donation guideline changes important?

• Removing unnecessary restrictions that apply only to certain groups is a step forward in reducing discrimination and stigma for people who wish to donate blood but were turned away in the past.
• The critical shortage in our blood supply has worsened since the start of the COVID-19 pandemic. These revised rules are expected to significantly boost the number of blood donors.

The bottom line

Science and hard evidence should drive policy regarding blood donation as much as possible. Guidelines should not unnecessarily burden any particular group. These new guidelines represent progress in that regard.

Of course, these changes will be closely monitored to make sure the blood supply remains safe. My guess is that they’ll endure. And it wouldn’t surprise me if there is additional lifting of restrictions in the future.

About the Author

Robert H. Shmerling, MD, Senior Faculty Editor, Harvard Health Publishing; Editorial Advisory Board Member, Harvard Health Publishing

Dr. Robert H. Shmerling is the former clinical chief of the division of rheumatology at Beth Israel Deaconess Medical Center (BIDMC), and is a current member of the corresponding faculty in medicine at Harvard Medical School. … See Full Bio View all posts by Robert H. Shmerling, MD

Prostate cancer progresses slowly, but for how long is it possible to put off treatment? Most newly diagnosed men have low-risk or favorable types of intermediate-risk prostate cancer that doctors can watch and treat only if the disease is found to be at higher risk of progression. This approach, called active surveillance, allows men to delay — or in some cases, outlive — the need for aggressive treatment, which has challenging side effects.

In 1999, British researchers launched a clinical trial comparing outcomes among 1,643 men who were either treated immediately for their cancer or followed on active surveillance (then called active monitoring). The men’s average age at enrollment was 62, and they all had low- to intermediate risk tumors with prostate-specific antigen (PSA) levels ranging from 3.0 to 18.9 nanograms per milliliter.

Long-term results from the study, which were published in March, show that prostate cancer death rates were low regardless of the therapeutic strategy. “This hugely important study shows quite clearly that there is no urgency to treat men with low- and even favorable intermediate-risk prostate cancer,” says Dr. Anthony Zietman, the Jenot W. and William U. Shipley Professor of Radiation Oncology at Harvard Medical School, anda radiation oncologist at Massachusetts General Hospital who was involved in the research and is a member of the Harvard Medical School Annual Report on Prostate Diseases editorial board. “They give up nothing in terms of 15-year survival.”

What the results showed

During the study, called the Prostate Testing for Cancer and Treatment (ProtecT) trial, researchers randomized 545 men to active monitoring, 533 men to surgical removal of the prostate, and 545 men to radiation.

After a median follow-up of 15 years, 356 men had died from any cause, including 45 men who died from prostate cancer specifically: 17 from the active monitoring group, 12 from the surgery group, and 16 from the radiation group. Men in the active surveillance group did have higher rates of cancer progression than the treated men did. More of them were eventually treated with drugs that suppress testosterone, a hormone that fuels prostate cancer growth.

In all, 51 men from the active surveillance group developed metastatic prostate cancer, which is roughly twice the number of those treated with surgery or radiation. But 133 men in the active surveillance group also avoided any treatment and were still alive when the follow-up concluded.

Experts weigh in

In a press release, the study’s lead author, Dr. Freddie Hamdy of the University of Oxford, claims that while cancer progression and the need for hormonal therapy were more limited in the treatment groups, “those reductions did not translate into differences in mortality.” The findings suggest that for some men, aggressive therapy “results in more harm than good,” Dr. Hamdy says.

Dr. Zietman agrees, adding that active surveillance protocols today are even safer than those used when ProtecT was initiated. Unlike in the past, for instance, active surveillance protocols now make more use of magnetic resonance imaging (MRI) scans that detect cancer progression in the prostate with high resolution.

Dr. Boris Gershman, a surgeon who specializes in urology at Harvard-affiliated Beth Israel Deaconess Medical Center, and is also an Annual Report on Prostate Diseases editorial board member, cautions that the twofold higher risk of developing metastasis among men on active surveillance may eventually translate into a mortality difference at 20-plus years.

“It’s important to not extend the data beyond their meaning,” says Dr. Gershman, who was not involved in the study. “These results should not be used to infer that all prostate cancer should not be treated, or that there is no benefit to treatment for men with more aggressive disease.” Still, ProtecT is a landmark study in urology, Dr. Gershman says, that “serves to reinforce active surveillance as the preferred management strategy for men with low-risk prostate cancer and some men with intermediate-risk prostate cancer.”

Dr. Marc B. Garnick, the Gorman Brothers Professor of Medicine at Harvard Medical School and Beth Israel Deaconess Medical Center, and editor in chief of the Annual Report, points out that nearly all the enrolled subjects provided follow-up data for the study’s duration, which is highly unusual for large clinical trials with long follow-up. The authors had initially predicted that patients from the active monitoring group who developed metastases at 10 years would have shortened survival at 15 years, “but this was not the case,” Dr. Garnick says. “As with many earlier PSA screening studies, the impact of local therapy on long-term survival for this class of prostate cancer — whether it be radiation or surgery — was again brought into question,” he says.

About the Author

Charlie Schmidt, Editor, Harvard Medical School Annual Report on Prostate Diseases

Charlie Schmidt is an award-winning freelance science writer based in Portland, Maine. In addition to writing for Harvard Health Publishing, Charlie has written for Science magazine, the Journal of the National Cancer Institute, Environmental Health Perspectives, … See Full Bio View all posts by Charlie Schmidt

About the Reviewer

Marc B. Garnick, MD, Editor in Chief, Harvard Medical School Annual Report on Prostate Diseases; Editorial Advisory Board Member, Harvard Health Publishing

Dr. Marc B. Garnick is an internationally renowned expert in medical oncology and urologic cancer. A clinical professor of medicine at Harvard Medical School, he also maintains an active clinical practice at Beth Israel Deaconess Medical … See Full Bio View all posts by Marc B. Garnick, MD