Month: November 2022

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 embraced by the American Red Cross 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

If the first goal of a drug advertisement is to grab your attention, this ad for Entyvio (vedolizumab) works.

You see a young woman getting into her car, sitting in her work cubicle, sitting in a restaurant, and finally in the waiting room of her doctor’s office. But she’s not sitting on the seat of the car or on a chair; in every scene, she’s sitting on the lid of a toilet.

Strange, right?

Why all the toilets?

The voiceover provides a clue: “When you live with moderate or severe Crohn’s disease or ulcerative colitis, your day can be full of reminders of your condition. Never knowing, always wondering.” And there’s another hint: the woman keeps grimacing and clutching her belly.

But these clues may not be enough. What’s never explained in this ad is that abdominal pain and sudden diarrhea are among the most common symptoms of Crohn’s disease and ulcerative colitis, conditions known collectively as inflammatory bowel disease (IBD). The “never knowing, always wondering” refers to the way people with these conditions often have unpredictable bouts of diarrhea and an urgent need to get to a restroom. And that’s why there are toilets everywhere.

What does this ad get right?

The ad provides useful information about:

• How this treatment works. Crohn’s disease and ulcerative colitis are two forms of IBD that cause inflammation of the intestinal tract. Given as an infusion every two months, vedolizumab works by blocking cells involved in that inflammation. The ad uses visually appealing animations and graphics to get these points across.
• Side effects. The FDA requires every drug ad to describe common and potentially serious side effects. For vedolizumab, possible side effects include infusion reactions, allergic reactions, liver problems, and an increased susceptibility to infection. The ad highlights an infection called PML, noting that it’s “a rare, serious, potentially fatal brain infection.”
• Benefits. The voiceover states that “in clinical trials, Entyvio helped many people achieve long-term relief and remission.”

What else do you need to know?

As with most drug ads, this ad doesn’t provide all the information that’s important to know about this medication, especially if you’re a person with IBD for whom this drug might be helpful.

For starters, the ad never explains that diarrhea and abdominal pain are among the most common symptoms of Crohn’s disease and ulcerative colitis. And while the ad focuses on frequent diarrhea, it never mentions more serious complications, such as

• bleeding, fistulas (abnormal connections between the intestines and other parts of the body), perforation of the bowel, and bowel blockage 
• an increased risk of colorectal cancer
• inflammation in other parts of the body, including joints and eyes.

The ad also omits:

• Explaining how moderate to severe Crohn’s and ulcerative colitis is defined. Generally, it would include people with either condition who have large areas of intestinal inflammation, deep ulcers in the walls of the intestines, or who have had surgery; and those who haven’t responded to other standard treatments.
• Other ways to treat Crohn’s disease or ulcerative colitis. Steroids, azathioprine, infliximab, ustekinumab, risankizumab, and other drugs are also options to treat these disorders. 
• The high cost of this drug (up to $52,000/year). For some, health insurance may cover much of this cost, and a discount program is mentioned at the end of the ad (though eligibility details are not provided). Still, for many people with IBD, the cost of expensive drugs like Entyvio is a major barrier to receiving optimal care.

Also troubling is the way the ad skims over two important points:

• Little information is provided about PML. The ad doesn’t even say what the letters stand for: progressive multifocal leukoencephalopathy. PML is a virus that can infect the brain, often causing death or severe neurologic disease.
• What benefits does the drug deliver? Only one sentence speaks confidently about benefits, and no details are provided. How often people do taking this drug have at least some relief from their symptoms? How often do they experience remission of symptoms? And how long do these improvements last?

The bottom line

The ad ends with the young woman driving home after her doctor’s visit. She’s sitting on a regular seat for the first time. She glances at the rearview mirror and smiles at the toilet that’s been relegated to the back of the car. The message is clear: she’s better now and doesn’t have to worry about having to rush to the toilet since her doctor prescribed vedolizumab.

Of course, it doesn’t always work out this way in real life. Then again, drug ads aren’t intended to show real life. They’re intended to promote a product. That’s a good reason to maintain a healthy dose of skepticism about drug ads, and to rely instead on your doctor and other unbiased sources for your health information, such as the National Institutes of Health websites.

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