Food-Borne Disease and Food Contamination

FDA, USDA Responsible for Food Safety for Different Categories

According to an insightful and incisive front-page article in the October 21, 2024, edition of The Dallas Morning News, the U.S. Department of Agriculture is responsible for the safety of meat, poultry, catfish and processed egg products, while the Food and Drug Administration is responsible for overseeing mostly everything else, including fruits, vegetables, seafood, diary products, food additives and others. The articles also shines on the growing skepticism of people for our government to keep us safe from food-borne illnesses. The article tells that, among other causal factors, massive misinformation, disinformation and fake information during the COVID era have skewed our views and perception on the government agencies although infection rate may not have jumped up palpably from 2002 to 2022. In 2002, Salmonella infection rate was 16.24 per 100,000 people, according to CDC, compared to Salmonella infection rate of 16.3 per 100,000 people in 2022. Although Former President Barack Obama has signed Food Safety Modernization Act in 2011, its requirement for inspection of high-risk facilities once in three years is still a low bar and many food safety activists want a tighter requirement. 

E-COLI

The deadly E. Coli outbreak in Germany has led to finger-pointing, blame game and lack of decisive steps to find the source of contamination. The strain is different from the more common E. Coli strain: O157:H7 and has been detected in northern Germany on May 2, 2011. Since then, the super-toxic strain has killed 24 people and infected more than 2400 people in Europe, vast majority of them in Germany, with complication afflicting kidney. Initially German authorities blamed Spanish-grown cucumbers as the source of contamination, and then, backtracked after tests have shown strains other than the one found in Germany. The accusation invited swift protest and ridicule from Spaniards. On June 6, 2011, German authorities again pointed out German Sprouts as likely source of contamination, only to backtrack a day later. Meanwhile, a federal food monitoring system, FoodNet, on June 7, 2011 released a report that said of higher rate of appearance in the US of the virulent non-O157 strain found in the deadliest E. Coli outbreak in Germany. According to the FoodNet report, last year (2010) 442 people in the sample area fell ill to O157 strain, 184 out of them hospitalized and two died. According to the same report, 451 were infected by non-O157 strain, 69 out of the infected hospitalized and one died. German investigators might have found the likely source of the deadly E. coli bacteria around June 10. A small organic farm in the German village of Bienenbuettel might have grown the tainted sprouts.

LISTERIA

Cantaloupe Contamination

The Centers for Disease Control and Prevention on September 27, 2011 said that as many as 13 people, including two from the Dallas-Fort Worth area, have died from the possible listeria contamination tied to the cantaloupes from a Colorado farm, Jensen Farms in Holly. State and local officials said that they suspected three more deaths tied to Listeria. Listeria usually affects elderly, pregnant women and others with compromised immune systems. The CDC-reported deaths occurred in Texas (2), Kansas, Missouri, Nebraska, Colorado (2), New Mexico (4), Oklahoma and Maryland. CDC also reported on September 27 an additional 59 illnesses. Listeria is more deadly than well-known pathogens such as Salmonella and E. Coli. Twenty-one people died in an outbreak of listeria poisoning in 1998 traced to contaminated hot dogs and possibly deli meats made by Bill Mar Foods, a subsidiary of Sara Lee Corp. Another large Listeria outbreak linked to Mexican-style soft cheese occurred in 1985 that had killed 52 people. About 800 cases of Listeria contamination happens every year in the USA, according to the CDC, and most of the cases are tied to deli meats and soft cheeses. However, in recent years it was found in produces, in 2009 in Sprouts and 2010 in Celery. The Food and Drug Administration on October 19, 2011 issued a report saying that used, corrosive and dirty equipment bought by the Jensen Farms in July might have led the Listeria contamination of the watermelon that had, as of October 19, led to 123 illnesses, including 25 deaths.

Recall of Deli Meats, Liverwurst Ordered 

After federal officials linked liverwurst samples tested positive to Listeria, U.S. Department of Agriculture on July 26, 2024 ordered recall of Boar Head's liverwurst and other deli meats produced during the same time as liverwurst at a Virginia plant run by the company, Boar Head. Listeria outbreak erupted in May 2024 in several states and caused dozens of illnesses and two deaths. 

Boar Expands Its Recall

The U.S. Department of Agriculture announced on July 30, 2024 that Boar's Head was expanding its recall to an additional 7 million pounds of products from 71 categories under Boar's Head and Old Country produced at the firm's Jarratt, Virginia plant between May 10, 2024 and July 29, 2024. The recalled products include, among others, liverwurst, beef salami, ham and bologna.

Inspectors Wave Red Flags on Boar's Head Plant Two Years Ago

The Dallas Morning News reported on September 12, 2024 that it was a mystery why authorities didn't take any meaningful measures after the USDA food inspectors had found several non-compliances at the Jarratt, Virginia plant during inspection between September 27, 2022 and October 4, 2022.

USDA IG to Investigate Department Handling 

Sen. Richard Blumenthal, D-CONN, asked USDA Inspector-General Phyllis Fong in a September 5, 2024, letter to launch a departmental investigation into how the USDA inspectors and Virginia state inspectors had handled various internal inspection reports that had earlier revealed very unsafe and unhygienic conditions prevailing at the now-shuttered Boar Head's plant in Jarratt, Virginia. On October 15, 2024, Sen. Blumenthal told that Fong had agreed to conduct an internal probe into USDA and Virginia inspectors' handling of those alarming reports. According to the CDC, at least 10 people had died and more than 50 were hospitalized in 19 states since the Listeria outbreak related to Boar's Head products in May 2024. Under a program, the state inspectors of Virginia undertake many of the food inspection procedures on behalf of the USDA. Now, that program is under scrutiny. 

SALMONELLA

Egg Recall

Two Iowa farms--Hillandale Farms and Wright County Egg--recalled recently almost half-a-billion eggs tied to Salmonella contamination that had sickened more than thousand people. The 80-billion count egg industry now faces tremendous challenge to win the heart and soul of American consumers.

Onion Recall

Centers for Disease Control and Prevention on October 21, 2021 announced the recall of onions imported from Chihuahua. The CDC recommendation to toss out the onions imported from that area of Mexico and distributed by ProSource Inc. of Hailey, Idaho among the nation's grocery stores and restaurants came after more than 600 people were sickened in more than 37 states, including 158 Salmonella cases in Texas. 

ORGAN TRANSPLANT, UNOS, HEPATITIS C

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Promising Drugs for Hepatitis C

The Food and Drug Administration on April 25, 2011 published its review of a promising drug for Hepatitis C two days prior to scrutiny by an outside expert panel. The drug, BOCEPREVIR, by Merck & Co. and another drug, TELAPREVIR, by Vertex Pharmaceuticals Inc., to be brought to FDA on April 28 are to act by blocking the enzyme Protease, which allows the hepatitis virus to reproduce. These drugs are different than the existing drugs such as RIBAVIRIN pills and INTERFERON-ALPHA injection which work by boosting immune system.

Source: The Associated Press; The Dallas Morning News

Information Based on May 14, 2011, Edition of The Dallas Morning News
Food and Drug Administration on May 13, 2011 approved Merck's bumper Hepatitis C drug BOCEPREVIR (VICTRELIS). About 3.2 million in the U.S. have Hepatitis C and 12,000 people die from it.

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Organ Transplant Operation at Crossroads

America's organ transplant endeavor and the complex operation of shipping organs to 63 transplant centers face uncertain future, according to a front-page report carried by The Dallas Morning News on July 4, 2023. The uncertainty arose from a difference between the nation's transplant oversight body, United Network for Organ Sharing, or UNOS, and one of the nation's premier organ-screening companies, Buckeye Transplant Services, over the use of transplant data. UNOS accused Buckeye of using an automated tool that scoured UNOS' internal data, and subsequently prohibited the organ-screening company from accessing a nationwide system of the donated organs, DonorNet. As a result, Buckeye will be forced to stop the organ screening as early as this week, leaving the job of organ screening up to transplant center medical professionals. The net outcome is delayed and postponed organ transplantation, resulting in hundreds of avoidable deaths.

Research: Segregation Found to Hinder Access to Live Kidney Transplantation 

The Washington Post reported on April 7, 2024 that a recent study, published in the JAMA Internal Medicine, found that the access rate to live kidney transplantation in a segregated area is less than that of in a less segregated area. The hurdle to live kidney access is universal irrespective of race. The researchers included 162,587 first live-donor kidney transplant candidates from January 1995 to December 2021, and tracked the candidates on an average of 1.9 years. 

The researchers found that

* 7.1% Black transplant candidates in the more racially segregated neighborhood did receive a live kidney over a three-year period vs. 9.0% accessibility for Black recipients in less segregated areas

* 19.7% White transplant candidates in the more racially segregated neighborhood did receive a live kidney over a three-year period vs. 20.1% accessibility for White recipients in less segregated areas

HEART TRANSPLANT

First Transplant of Pig Heart in Human

In the first ever, hopefully successful, animal-to-human transplant, also known as Xenotransplantation, the heart from a genetically modified pig was implanted in a dying man, 57-year-old David Bennett. The transplant was performed by Dr. Bartley Griffith, a distinguished professor at the University of Maryland Medical Center. The medical team took more than seven hours to perform the transplant on January 7, 2022. On January 10, 2022, a statement was issued on behalf of the medical center, saying that Mr. Bennett was doing well. If Mr. David Bennett continues to improve, it will herald a new era of organ transplant. Previously, xenotransplantation was tried, but human bodies had rejected those organs. Most notably, in 1984,  Baby Fae, a dying infant, survived 21 days with a baboon heart. But this time, it is different as the pig used for heart transplant has to go through the gene-editing process to remove a sugar in its cells that's responsible for hyper-fast organ rejection. The organ came from Revivicor, a division of United Therapeutics. 

Bennett Dies 

David Bennett, who made news after receiving a curated pig's heart in January 2022 and apparently was doing well in the aftermath of the transplant, died on March 8, 2022. The surgeon who led the transplant surgery, Dr. Bartley Griffith, issued a statement on March 9, 2022, calling Bennett "a brave and noble patient who fought all the way to the end". 

Second Patient to Receive Pig Heart Transplant Reported Doing Well after a Month

Lawrence Faucette became the second patient to receive a highly genetically modified heart from a pig. The surgeons at the University of Maryland Medical Center on September 20, 2023 performed the highly experimental procedure to implant a pig heart in Faucette. The first patient to receive xenotransplantation died after two months. Although the exact cause for the death of David Bennett was not known, there were traces of virus found in his transplanted heart. That gave some lessons in terms of better full-proofing the process with more precise virus testing and other improved protocols in the second xenotransplantation. 

On October 20, 2023, a month after the transplantation, a video of a relatively healthy Lawrence Faucette was released by the medical center. The head of the transplantation team, Dr. Muhammad Mohiuddin, said that Faucette's "heart is doing everything on its own". 

Faucette Dies Six Weeks After Pig Heart Transplant

Lawrence Faucette passed away six weeks after a successful transplant of pig heart into his body, according to a statement issued on October 31, 2023 by the University of Maryland Medical Center. 

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Successful Pig Kidney Transplant in Human

Massachusetts General Hospital doctors on March 16, 2024 made a historical leap in advancing the pig-to-human organ transplantation as they performed a four-hour medical procedure to transplant a genetically edited pig kidney into Richard Slayman. Richard Slayman lived for 52 days after a pig kidney transplantation. 

Second Pig Kidney Transplantation, First Woman to Receive Xenotransplantation 

The NYU Langone Transplant Institute announced on April 24, 2024 that the U.S. had its second human transplantation of the genetically modified pig kidney in recent days. The patient, Lisa Pisano, 54, is now recovering well, according to Langone Transplant Institute. Lisa Pisano is the first woman to receive a pig organ. What made Lisa Pisano's case more novel compared to Richard Slayman's kidney Xenotransplantation is that Pisano's heart has failed too, thus disqualifying her from traditional transplant procedure. First, doctors had to stabilize her failing heart by implanting a pump, Left Ventricular Assist Device, or LVAD, on April 4, 2024. Her kidney transplantation happened on April 12, 2024. 

Lisa Pisano died after 86 days although her kidney had to be removed after 47 days.

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First Xenotransplant Outlives a Crucial Threshold

Towana Looney is the first person with pig-to-human transplant that has lived more than 60 days, a milestone and achievement, The Dallas Morning News has reported in its January 26, 2025, print edition. There were only four other people in the U.S. who had received a pig organ, two each in kidney and heart. None of them lived beyond two months. 

Pig Kidney Removed after Recipient's Body Begins Rejecting

After 130 days, the Xenotransplant seems to be not working as the immune system of Towana Looney begins to reject the transplanted pig kidney. On April 4, 2025, Towana Looney's transplanted pig kidney was removed and she was back on dialysis. Her doctors made a public announcement on April 11, 2025. 

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FDA Approves Clinical Trial for Pig Kidney Transplantation 

The Food and Drug Administration gave two biopharma firms to run clinical trial for Xenotransplantation from pigs to humans after the gene-editing process, United Therapeutics Corp. and eGenesis both announced on February 4, 2025. Before formal approval for the clinical trial, FDA granted compassionate-care approval for such Xenotransplantation. 

New Hampshire Man Receives Pig Kidney Transplant

A New Hampshire man, Tim Andrews, 66, received Xenotransplantation of a genetically modified kidney on January 25, 2025, the hospital that had carried out the procedure, Massachusetts General Hospital, announced on February 7, 2025.

A Second N.H. Man Successfully Receives Xenotransplant

The Dallas Morning News reported in its September 9, 2025, edition that a second New Hampshire man, Bill Stewart, was faring well after receiving a genetically modified pig kidney transplant at Massachusetts General Hospital in Boston on June 14, 2025. Another New Hampshire man, Tim Andrews, received a transplant in January 2025. Meanwhile, Food and Drug Administration approved a rigorous study on xenotransplant that would be led by Dr. Leonardo Riella of Mass General. 

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AIDS-Infected Now Allowed to Donate Organ for Transplant

In a leap forward towards destigmatizing AIDS and the people afflicted by it, U.S. okayed kidney or liver transplant from a donor with AIDS to a receiver with AIDS. The new policy of organ donation went into effect on November 27, 2024. 

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UNOS Extends Deadline for Cutting off Access to Its Database

The body that manages the nation's complex organ transplant system is extending a deadline for a vendor to cut off access to a key UNOS database to July 19, 2023. Buckeye Transplant Services filed a lawsuit on July 2, 2023 contesting the UNOS' decision to cut off its access to the database, DonorNet, beginning this week. UNOS alleged that Buckeye was using an automated tool to collect proprietary transplant data. The clash between UNOS and Buckeye is so convoluted that the government agency, Health Resources and Services Administration, that regulates the nation's transplant system has distanced itself from both the entities. The Washington Post reported on July 4, 2023 about the database access cutoff extension. 

Estrogen-only Therapy Helps Cutting Cancer Risks

The recent findings that Estrogen-only therapy helps cut breast cancer by 23% has been published in The Journal of the American Medical Association on April 5, 2011. The findings are based on the tracking the participants in the so-called Women's Health Initiative that had included 10,739 women who had previously had a hysterectomy, the surgical removal of uterus. This study has been stopped in 2004 after stroke risks were seen in the group. Although the women had stopped taking the therapy in 2004, they had been monitored as is the normal practice in any large clinical study. The drop of 23% in cancer rate compared to placebo group is significant. For another group in the WHI study that was taking Estrogen-Progestin combination, the therapy was halted in 2002 as the elevated risks for breast cancer and heart attacks were detected. Usually Estrogen is recommended for relieving hot flashes and other symptoms related to menopause, Progestin is recommended to minimze the effect on uterus. The combination therapy was given to women who didn't have a previous hysterectomy. The findings from the Estrogen-only group, however, didn't show any improvement/deterioration related to blood clots, stroke, hip fracture, colon cancer or overall death rates compared to Placebo group.

Source: The Dallas Morning News (April 6, 2011)

High-Fiber Diets Helpful

According to a study published on February 14, 2011 in the Archives of Internal Medicine, high-fiber diets help in enhancing the longevity. The U.S. government study, involving more than 388,000 adults ages 50 to 71 and conducted by the National Institutes of Health and AARP, shows lower risks of death associated with high-fiber diets from: (1) Heart Disease, (2) Infectious Disease, and (3) Respiratory Illnesses. The study also estabilshes a negative correlation between the high-fiber diet and cancer deaths in men, but not women (as a Statistician, I am wondering what causes the discrepancy). The study also found strong evidence of health benefit from diets high in fiber from grains.

FDA-, DEA, CDC- AND NIH-RELATED NEWS

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CDC Lowers the Safe Lead Threshold for Children

In an action that has been overdue for quite some time, Centers for Disease Control and Prevention on October 28, 2021 has tightened the definition of lead poisoning, increasing the number of children with high lead levels from 200,000 to 500,000. Many experts believe that there is no safe lead level, and the action has been long time coming as the last revision of lead standard has been done in 2012. Although the CDC's internal scientists think that the standard should be revisited every four to five years, the issue has taken the back seat under Trump administration, according to the head of CDC's Center for Environmental Health, Patrick Breysse. 

In 1970s, the average lead concentration in the blood of children ages 1 to 5 years was 15 micrograms per deciliter. Thanks to phasing out of lead-based paints, removing the ingredient from our water system and other preventative measures, the average lead concentration in the blood has come down to 0.83 micrograms per deciliter during 2011-2016. The acceptable threshold for lead concentration in blood for children ages 1 to 5 years was set 10 MGDL in 1991. The threshold was lowered in 2012 to 5 MGDL. On October 28, 2021, it was lowered to 3.5MGDL. 

CDC to Revamp Focus

CDC Director Dr. Rochelle Walensky told the agency's staff on August 17, 2022 that the country's prime disease-fighting agency would change its focus and pivot more on operational efficiency, collaboration and execution strategy and less on publication. 

Dr. Walensky to Step down on June 30, 2023

CDC Director Dr. Rochelle Walensky on May 5, 2023 told the agency staff that she would step down on June 30, 2023. President Joe Biden later in the day issued a public statement, lauding the role of Dr. Walensky for her leadership to fight against "once-in-a-generation pandemic with honesty and integrity". 

Former North Carolina Health Official Named as CDC Chief

White House on June 16, 2023 named Former North Carolina Health and Human Services Secretary Dr. Mandy Cohen as the next director of Centers for Disease Control and Prevention. President Joe Biden lauded her experience of leading large government organizations, including the North Carolina state health agency from 2017 to 2021. 

One-in-Five Mothers Mistreated during Pregnancy

A mind-blowing finding made public by the Centers for Disease Control and Prevention points at  staggeringly high rate of maternal mistreatment. The Dallas Morning News reported on August 23, 2023 that almost 20% women did face mistreatment, including screaming, denial of services and other adverse situations. Many of them complained about lack of their physical privacy. The research, Vital Sign, makes the U.S. the worst among its high-income peers as far as the maternal treatment is concerned. Maternal discrimination, a broader category that includes racial and other discrimination, affects 28.9% of the pregnant women:

* Black: 40.1%

* Hispanic: 36.6%

* Indigenous: 31.4%

* White: 26%

* Asian: 22.6%

Also, the maternal mortality rate has risen in the U.S. during pandemic. In 2020, it was 23.8 deaths per 100,000 live births, but it shot up to 32.9 in 2021. In Texas, the situation is far worse, with maternal mortality rate exceeding 40 per 100,000 live births. 

Syphilis Cases Hit Record since 1950

After falling to a record low in 1998, Syphilis began to rise again. According to the STI Surveillance Report issued by the CDC on January 30, 2024, total cases of Syphilis reached 207,225, a 17% increase and highest since 1950. Infectious cases rose 9% to circa 59,000. Total cases include infectious cases, latent cases and congenital cases where pregnant mother passes the disease to her child. 

Kennedy Fires All 17 Members of ACIP

Health Secretary Robert F. Kennedy Jr. on June 9, 2025 took one of most radical steps to overhaul the vaccine advisory cadence. He fired all 17 members of the Advisory Committee on Immunization Practices, or ACIP. He pointed out conflict of interest as the key reason to replace all ACIP members. Kennedy said that he would soon name members to the ACIP. 

American Medical Association President Dr. Bruce Scott said that "today's action to remove the 17 sitting members of ACIP undermines the trust and upends the transparent process". 

Kennedy Names Eight New Members of Revamped ACIP

Two days after firing all 17 members of a key advisory panel, Health Secretary Robert F. Kennedy on June 11, 2025 named eight new members to the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices. By the founding charter, ACIP should have at least eight members. Many of the new members are vaccine skeptic or vaccine benefit naysayers. 

U.S. Fertility Rate Dropping, CDC Says

The Associated Press reported on July 24, 2025 that the U.S. had experienced another year of contraction in fertility rate last year (2024), based on the data provided by the Centers for Disease Control and Prevention. The fertility rate last year stood 1.599 kids per woman, a slight drop from the 2023 figure of 1.621. The total births, though, in 2024 increased by 1%, or circa 33,000, compared to 2023, totaling 3.6 million births.

In 1960s, the U.S. fertility rate was around 3.5, but plummeted to 1.7 by 1976 after the so-called Baby Boom Era ended. It gradually rose to 2.1 in 2007, before trending down again amidst a spike in 2014.

Deadly Bacteria Rising, CDC Warns

The Centers for Disease Control and Prevention on September 23, 2025 issued an unusual warning, saying that the deadly NDM-CRE bacteria was rising and this family of bacteria was resistant to anti-biotics. NDM-CRE is part of Carbapenem-Resistant Enterobacterales, or CRE, family responsible for about 1,000 U.S. deaths annually, according to a read by a 2022 CDC report. NDM refers to an enzyme that makes the antibiotics impotent. During early days of COVID-19 spread, doctors abundantly prescribed antibiotics, assuming that it's a bacterial--not viral--infections, leading to proliferation of the spread of NDM-CRE. 

Major Rollback of Infant Vaccination Regime

In a major setback to the public healthcare system, a reconfigured--and now stashed in by vaccine deniers--advisory panel on December 5, 2025 voted to stop recommending Hepatitis B vaccination for all newborns. The December 5, 2025, vote by the Advisory Committee on Immunization Practices, or ACIP, is a slap and huge blow to the progress that has has been made over the years. 

CDC Drops Four Childhood Vaccines off Immunization Schedule 

It's a dark and tragic day for the American public healthcare system. On January 5, 2026, Centers for Disease Control and Prevention led by Director Jim O'Neil dealt a severe blow to the public healthcare system in the U.S. as it dropped recommendation for four childhood vaccines--Rotavirus, Influenza, Meningococcal disease and Hepatitis A--from the immunization schedule. 

The January 5, 2026, guidance came after HHS Secretary Robert Kennedy dropped recommendation for COVID-19 and Hepatitis B vaccines for children, citing debunked autism theory. 

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Marijuana to be Reclassified a Lower-grade Controlled Substance

As part of his campaign promise, President Joe Biden pardoned many people who had been imprisoned for possession of pot. His administration on May 16, 2024 took the boldest step ever as the DOJ approved a plan to reschedule Marijuana from the Schedule I substance to Schedule III substance. The Drug Enforcement Administration will publish the reclassification rule. 

Daily Marijuana Use Surpasses Daily Drinking

In the first time since Marijuana has been made legal for medicinal or recreational purpose, the daily, or near-daily, users of the Marijuana have surpassed the daily, or near daily, drinkers, according to a research published in the journal Addiction on May 22, 2024. 

According to the research, 17.7 million people used daily, or near-daily, Marijuana compared to 14.7 million daily, or near-daily, drinkers in 2022. The revelation came a week after the Biden administration planned to reclassify Marijuana. 

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French Company Files for Permission of OTC Sales of Birth Control Pills

Adding to political and healthcare fight of the nation, a French pharma company, HRA Pharma, on July 11, 2022 filed for OTC (over-the-counter) sales of its birth control pill, Opill. HRA Pharma has acquired the drug from Pfizer in 2014, but has not marketed in the U.S. Birth control pills are widely available in the U.S. since 1960s, but normally require a doctor's prescription. Most of the birth control pills contain Progestin, which blocks sperms from entering the cervix, plus Estrogen that contributes to rare blood clots. According to the available research data, 3 to 9 women per 10,000 suffer blood clots while taking birth control pills compared to that of 1 to 5 cases per 10,000 without birth control pill. FDA will decide in the coming days whether sales of birth control pills without a prescription are safe and efficacious. In 2006, FDA has encountered similar dilemma for OTC authorization of the contraceptive Plan B. 

FDA to Ease Blood Donation Rules for Bisexual and Gay

On January 27, 2023, Food and Drug Administration announced that it would do away with a 3-month abstinence requirement for gay and bisexual men. The draft guidelines are another feather to the cap of relaxing the blood donation requirement and lowering or eliminating discrimination based on sexual orientation. U.S. had imposed lifetime ban on blood donation by gay and bisexual men in early 80s. In 2015, U.S. lifted lifetime ban, and instead, allowed one-year abstinence to qualify for blood donation. In 2020, as blood donation and blood stockpile have fallen, authorities further relaxed the requirement by dropping year-old abstinence condition and replace it by 3-month abstinence.  requirement. 

FDA Grants Emergency-use Authorization for Dual Flu-COVID At-home Test

Food and Drug Administration on February 24, 2023 granted emergency-use authorization for the first at-home test for the duo of jambalaya of flu and COVID-19. Lucira COVID-19 and Flu Test is designed to be administered in the form of a nasal swab with the results to be obtained in 30 minutes. 

FDA Approves OTC Birth Control Pill

Almost six decades after entering the market that had transformed millions of women's and girls' lives and proving their efficacy and safety, Food and Drug Administration on July 13, 2023 granted over-the-counter (OTC) sales of Opill, also called norgestrel, that had taken added significance after last summer's Supreme Court verdict to overturn Roe vs. Wade. Dublin-based pharmaceutical giant Perrigo will begin selling Opill over the counter, most likely, beginning January or February 2024. The other birth control pills, though, are to remain prescription-only for now. 

FDA Approves a Pair of Sickle Cell Therapies

Food and Drug Administration on December 8, 2023 approved two gene therapy treatments for sickle-cell disease. They have been developed by Vertex Pharmaceuticals and CRISPR Therapeutics as well as a second one by Bluebird Bio. The therapy developed by Vertex works differently than Bluebird. 

The Vertex therapy, called the Casgevy, aims to push back the body cells to fetal cell phase. It's the adult cells that have changed from the fetal format into ones with characteristics of sickle-cell disease. It's the CRISPR technique that extricates the gene from the adult cells so that the hemoglobin is produced again in the same quality and genetic format as in the birth. 

The Bluebird therapy, also called the Lyfgenia, adds copies of a modified gene to reverse the sickling process of the blood cell. The Bluebird therapy is, thus, also known as anti-sickling hemoglobin producing therapy. 

Experts Ask FDA to Retract Approval of Opioid Risk Identifier Test

The Food and Drug Administration in December 2023 has granted an accelerated approval of the AvertD test developed by SOLVD Health that identifies an elevated risk for an opioid addiction based on the patient's genetic test. The FDA and pro-approval experts argue that the test will empower a doctor with additional insight while prescribing an opioid to a patient. 

On April 4, 2024, 31 experts from genetics, addictions, ethics and psychiatry wrote separate letters to the FDA and CMS, respectively, pleading for retracting the approval for AvertD as it might lead to a false sense of security to patients who tested false negative and lead doctors to "refrain from prescribing opioids" even under a compelling scenario, especially adversely affecting the health of patients who tested false positive. 

FDA Approves a Nasal Spray for Food Allergy  

EpiPen is the tool of choice for millions of people in the U.S. to counter and mitigate Anaphylaxis, a severe food allergy. Food and Drug Administration on August 9, 2024 granted authorization for a needle-free alternative, a nasal spray, Neffy, designed and developed by ARS Pharmaceuticals Inc. 

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Fauchi to Retire in December 2022

Dr. Anthony Fauchi, a household name during the time of the pandemic and the face of the fight against COVID-19 as well as the vicious target of political attack by Conservatives, announced on August 22, 2022 that he would retire in December 2022 as the head of National Institute of Allergy and Infectious Diseases. He advised seven U.S. presidents on infectious diseases and public health policy during his stint in various roles in the federal government. Under President George W. Bush, Dr. Fauchi designed the PEPFAR to bring lifesaving HIV treatments to Africa. In 2008, President Bush awarded him the Presidential Medal of Freedom. 

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IPREX Study on AIDS Prevention

According to this study, an anti-retroviral pill--Truvada, a combination of two drugs, tenofovir and emtricitabine--helps prevent AIDS. The study, nicknamed iPrEx, included nearly 2,500 men in six countries and was co-ordinated by the Gladstone Institutes of the University of California, San Francisco. The results are better than the results made public in the summer of 2010 that a vaginal microbicide had protected 39% of all the women testing it and 54% of those who had used it faithfully.

Source: The Dallas Morning News (November 24, 2010)