Health|F.D.A. Considers new approach to blood donation by gay and bisexual men
The agency may introduce a personalized risk assessment to replace the current ban on men who have had sex with men in the past three months.
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The Food and Drug Administration is considering a more individualized strategy for screening gay and bisexual men for blood donation amid an ongoing national blood shortage, according to an official briefed on the proposal.
The FDA has long discouraged men who have sex with men from donating blood. A complete ban was introduced in the 1980s, for fear of HIV. transfer. In 2015, the agency allowed gay and bisexual men to donate if they had not had sexual contact with other men in the previous year.
The period was reduced to three months after severe blood shortages during the Covid-19 pandemic.
The new plan requires men who have sex with men to complete a questionnaire about condom use and recent sexual activity, among other risk factors. The idea, which is still up for debate, would be to allow those who haven’t found new partners in the past three months to donate.
The strategy was first reported by The Wall Street Journal. In a statement on Wednesday, the F.D.A. said new data “is likely to support a policy transition to individual risk-based donor screening questions for HIV risk reduction. transfer.”
The outline of the plan is controversial among L.G.B.T.Q. advocates, who say blood donation policies have been discriminatory in the past and that unequal treatment remains a concern.
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“I think it’s a small step in the right direction,” said Sarah Kate Ellis, the president and chief executive of GLAAD, an L.G.B.T.Q. interest group that has been calling for an end to the ban for years.
“However, it is not where it should be. Our community and leading medical experts have been saying for years now that these decisions made by the F.D.A. makes on blood forbidden to the L.G.B.T.Q. community are based on stigma, not science. And we see that pattern continuing here.
The new approach is designed to strike a balance between activists who don’t want restrictions on those single gay and bisexual men and blood banks who want to eliminate the risk of a recipient contracting HIV, the FDA said. official, who requested anonymity to describe the internal discussions.
Several major blood centers are completing an FDA-funded study designed to assess the safety of replacing the current three-month waiting period with a more individualized assessment.
The researchers, who enrolled about 1,600 gay and bisexual men in eight metropolitan areas, hope to identify a set of screening questions that could distinguish men who are more likely to have recently contracted HIV. of those less likely to contract the virus.
Participants in the project, known as the ADVANCE study, answered a variety of questions about their recent risk-related behaviors, such as whether they had new sexual partners or were taking pre-exposure prophylactic drugs known as PrEP, which may increase the risk of HIV infection, said Brian Custer, director of Vitalant Research Institute and principal investigator on the study.
The blood of the participants was also tested for H.I.V. and the antiretrovirals used in PrEP.
The researchers have already shared an interim analysis with the F.D.A. and should have final results ready before the end of the year, said Dr. Custer. He declined to provide more information about the preliminary findings, citing a confidentiality agreement with the FDA, but said he expected the results to be informative for the agency.
“I am really convinced that we have important information for the F.D.A. to be able to consider what an individual risk-based approach to donor selection might look like,” he said.
Susan Stramer, vice president of scientific affairs for the American Red Cross, said in a statement that the study was designed “to make blood donation a more inclusive process while preserving the safety of the blood supply.”
“While we have not been notified by the F.D.A. In terms of policy changes at this time, the Red Cross looks forward to a future where eligibility for donation is not based on sexual orientation, and more healthy individuals can donate blood to help patients in need,” she said.
The current blood shortage is tracked daily by America’s Blood Centers, the industry association for 59 community facilities. On Wednesday, about a quarter of the centres, or 16, had less than a day’s supply in stock.
“In this post-pandemic environment, blood donations organized by companies – in particular – have not returned to pre-pandemic levels as the way people work has changed,” said Nick Gehrig, the senior director for communications at Vitalant , in an email.
Why would a blood donor be rejected?
Low blood pressure (13.6%), cupping (11.6%) and fewer hours of sleep the night before donation (5.8%) were the main causes of rejection in this study.
. You have Hepatitis B, Hepatitis C, HIV/AIDS, or may have been exposed to these diseases through sexual contact. Hepatitis B and C and HIV/AIDS are diseases that can be transmitted through blood transfusion, and therefore persons suffering from these diseases are not eligible to donate blood.
Do you pass DNA when donating blood?
No, receiving a donation does not change the patient’s DNA. Interestingly, however, in most people it is possible to detect a very small amount of DNA from the donor in the recipient’s blood for a few days after the transfusion.
Can Blood Transfusion Affect the DNA Test? Studies have shown that donor DNA in blood transfusion recipients persists for several days, sometimes longer, but the presence of genetic testing is unlikely to change significantly.
How long after blood transfusion can you genetically test?
Transfused patients: Wait at least 2 weeks after a packaged cell/platelet transfusion and at least 4 weeks after a whole blood transfusion before drawing blood for testing. Chemotherapy patients: DNA quality may be affected if the patient has received chemotherapy within the last 120 days.
How long after a blood transfusion can you develop antibodies?
Patients who have not previously been sensitized may develop antibodies to platelets approximately 3-4 weeks after transfusion. However, patients previously immunized by transfusion, pregnancy or organ transplantation may develop antibodies to platelets as early as 4 days after transfusion.
How long does blood from a blood transfusion stay in your body?
Erythrocyte survival and longevity measures obtained with transfused erythrocytes agree well with those obtained using metabolic labeling studies, indicating an overall good survival with a maximum of 135 days post-transfusion (Mollison et al., 1987; Luten et al., 2004 ).
How long after transfusion can you check iron studies?
In conclusion, the results of this study suggest that biochemical tests performed 48 to 72 hours after a red blood cell transfusion are reliable for the etiological diagnosis of anemia, including iron deficiency anemia, when the results are interpreted in light of the whole blood before transfusion. count results, in …
Can you do a DNA test after a blood transfusion?
Purpose: Molecular testing is often indicated for recently transfused patients. However, there are no guidelines regarding the potential interference of donor DNA or whether it is necessary to wait a certain amount of time after transfusion before performing genetic testing.
Can a person on testosterone donate blood?
The U.S. Food and Drug Administration has ruled that blood drawn from people receiving testosterone replacement therapy is safe and appropriate to administer to patients in need of red blood cells.
Can I donate blood after a testosterone injection? In some cases, testosterone can cause your hemoglobin (a protein in your blood that carries oxygen) to rise above the acceptable range for donation. Don’t worry, we test your hemoglobin level before each donation and if it falls within the acceptable range on the day, you can donate.
What medications disqualify a person from donating blood?
The following drugs prevent you from donating blood:
- Accutane.
- Antibiotics *Donors taking antibiotics are eligible to donate 24 hours after their last dose.
- Antiplatelet medications.
- Avodart.
- Blood thinners (such as Coumadin, Heparin, Lovenox, Warfarin)
- Bovine insulin.
- Hepatitis B Immunoglobulin.
How often can I donate blood on testosterone?
Hereditary hemochromatosis donors and donors using testosterone are allowed to donate blood more frequently than every eight weeks, and their blood is used for transfusion when necessary. All donations from these individuals are eligible to earn reward points.
Can you donate blood if you are on steroids?
Some people are at high risk for blood-borne infections, making them ineligible to donate blood. These high-risk groups include: Anyone who has used injected drugs, steroids, or any other substance not prescribed by a doctor in the past three months.
Can you give blood if you’ve had steroids?
You should not donate blood if you have used illegal intravenous drugs or taken anabolic steroids intravenously in the past 3 months (unless prescribed by a doctor).
How long after taking steroids can you donate blood?
Must not donate if: c) Less than seven days after completion of a course of oral or injected steroids for asthma, other conditions related to allergies or a musculoskeletal disorder. d) A donor has required long-term treatment (six months or more) in the past 12 months.
Should you donate blood on steroids?
Due to the risk of blood-borne infections, not everyone can donate blood. Groups not eligible for blood donation are: Anyone who has used injected drugs, steroids, or any other substance not prescribed by a health care provider in the past three months.
Can I donate blood if I’m obese?
Obesity is common among blood donors in the US, although somewhat less common than in the general population, and is associated with recognized demographic factors. Blood donors with a higher BMI are recruited specifically for certain blood collection procedures.
What weight should you not donate blood? Have good general health and feel good. Be at least 17 years old in most states (16 years old with parental consent in some states). Weigh at least 110 lbs.
How much blood does an obese person have?
Obese gravids had a similar estimated total blood volume as normal weight women (8103 ± 2452 vs. 6944 ± 2830 ml, p = 0.1), but a lower blood volume per kilogram of weight (73 ± 22 vs. 95 ± 30 ml/ kg, p = 0.007).
How much blood does a 200 pound person have?
For a 200-pound, 6-foot man, the blood volume is estimated to be 7.2 quarts, or about seven and a half quarts. For a 100-pound, five-foot-tall woman, the estimate is three and a half gallons, or 3.7 quarts. The normal range for an adult human is usually estimated at five to six litres.
Do obese people need more blood?
Obese individuals need more blood to supply their bodies with oxygen and nutrients, which causes an increase in blood pressure. Your body will also need more pressure to move this blood.
What is the blood volume of an average sized adult?
The amount of blood circulating in a person depends on their size and weight, but the average adult human has nearly 5 liters of circulating blood.
Does being overweight affect your blood?
Carrying weight around your waist can make it harder for your body to use a hormone called insulin, which controls your blood glucose (sugar) levels. This can lead to type 2 diabetes. High levels of glucose in your bloodstream damage your blood vessels and increase your risk of cardiovascular disease.
Can I donate plasma if I weigh 300 pounds?
Plasma donors must be at least 18 years old. Plasma donors must weigh at least 110 pounds or 50 kilograms. Must pass a medical examination. Complete a comprehensive medical history screening.
How heavy is too heavy for plasma?
To donate plasma you must: Be at least 18 years old. Maintain good overall health. Weigh 110 pounds or more (50 kilograms)
How much plasma can I donate for my weight?
Donation volume limits, set out in the FDA memorandum, depend on weight. The collection volume (SP and anticoagulant) for a 110-149 lbs donor is 690 mL; 150-174 lbs, 825 ml; and 175 lb., 880 ml. Donor distributions are presented. Knowledge of Source Plasma (SP) donor demographics sheds light on the SP collection industry.
Can you donate plasma if your obese?
Can I donate? Yes, you can donate plasma if you are between the ages of 18 and 70, weigh at least 50 kg and are in good health.
Can I donate plasma if I weigh 350 pounds?
To donate your plasma, you must first meet a number of criteria: Be at least 18 years old. Weigh 110 pounds or more. Generally in good health.
Do they check weight before donating blood?
Just like a visit to the doctor, your weight and blood pressure will also be recorded at the time of your donation. In addition, your blood will be tested by the center after your donation and you will be informed if it is not eligible for any reason.
What do they measure before donating blood?
Before donating, the Red Cross checks your hemoglobin level, a measure of the protein in your blood that carries oxygen to help nourish tissues throughout your body. Iron is part of hemoglobin. Hemoglobin does not measure whether your body’s iron stores are healthy.
Does weight matter donating blood?
Weight: You must weigh at least 110 pounds to be eligible to donate blood for your own safety. Blood volume is in proportion to body weight. Donors who weigh less than 110 pounds may not tolerate the removal of the required volume of blood, as can those who weigh more than 110 pounds.
