Feb. 22, 2023 — Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the FDA warns.
The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.
The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.
The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination.
On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.
Forbes sits with Alexis Ohanian at his Florida home to discuss the future of crypto following the fallout of FTX. The Reddit cofounder makes the argument for hard-to-seize assets before discussing his latest venture, Seven Seven Six, and more.
U.S. chicken producers want to do their part to bring down current soaring egg prices by selling their 400 million surplus eggs to food producers.
But first they have to convince the FDA to change the rule that prevents eggs laid by chickens in the meat industry to be used for human consumption.
Egg prices have surged over the past year thanks to the ongoing bird flu outbreak and the highest inflation in decades, prompting calls for a price-gouging investigation. The national average retail price of a dozen eggs hit $4.25 in December, up from $1.79 a year earlier, according to the latest government data.
The National Chicken Council trade group submitted a formal petition to the Food and Drug Administration Thursday asking officials to drop a rule passed in 2009 that keeps chicken producers from selling their excess eggs because they aren’t refrigerated right away.
“Already faced with record egg prices, consumers might be hit even harder in their wallets as we head into the Easter season unless FDA provides us with a pathway to put these eggs to good use,” said Ashley Peterson, the trade group’s senior vice president of scientific and regulatory affairs.
The bird flu outbreak has had an outsized impact on egg prices because more than 43 million of the 58 million birds that have been slaughtered to help control the spread of the virus have been egg-laying hens. But egg farmers have also been grappling with high feed, fuel and labor costs that have contributed to the rising prices.
It’s not clear exactly how big of an impact the eggs chicken producers want to sell might have on prices because there are roughly 100 billion eggs a year produced in the U.S., so adding 400 million more to the market may not have a huge effect.
The FDA said it would review the Chicken Council’s petition and respond directly to that group. But concerns about food safety are what drove them to adopt the rule that prohibited the sale of the eggs in the first place.
When a broiler hatchery produces eggs, they are kept at 65 degrees until they are ready to be placed in incubators to be hatched. The FDA said in its rule that eggs that are going to be used for food need to be stored at temperatures below 45 degrees within 36 hours.
The Chicken Council said it believes the eggs would be safe because they would be pasteurized before they were used by food producers. The eggs that chicken producers don’t need to produce more chickens for meat production wouldn’t be sold to consumers in grocery stores. Instead they would go to makers of food products and processed eggs that are sold to bakers and other food companies.
The Chicken Council estimates that this FDA rule prohibiting the sale of these eggs costs chicken farmers about $27 million a year because currently the eggs are either thrown away, rendered or used for animal food.
But the United Egg Producers trade group said it would be a bad idea to relax food safety rules to allow these eggs laid by chicken producers to be sold.
“The safety of eggs is always the priority for America’s egg farmers, as is firm compliance with all regulatory requirements related to food safety,” said Oscar Garrison, the egg trade group’s vice president of food safety regulatory affairs. “United Egg Producers opposes the petition by the National Chicken Council because it does not comply with the egg safety rule.”
For decades now, gay men have been barred from giving blood. In 2015, what had been a lifetime ban was loosened, such that gay men could be donors if they’d abstained from sex for at least a year. This was later shortened to three months. Last week, the FDA put out a new and more inclusive plan: Sexually active gay and bisexual people would be permitted to donate so long as they have not recently engaged in anal sex with new or multiple partners. Assistant Secretary for Health Rachel Levine, the first Senate-confirmed transgender official in the U.S., issued a statement commending the proposal for “advancing equity.” It “treats everyone the same,” she said, “regardless of gender and sexual orientation.”
As a member of the small but honorable league of gay pathologists, I’m affected by these proposed policy changes more than most Americans. I’m subject to restrictions on giving blood, and I’ve also been responsible for monitoring the complications that can arise from transfusions of infected blood. I am quite concerned about HIV, given that men who have sex with men are at much greater risk of contracting the virus than members of other groups. But it’s not the blood-borne illness that I, as a doctor, fear most. Common bacteria lead to far more transfusion-transmitted infections in the U.S. than any virus does, and most of those produce severe or fatal illness. The risk from viruses is extraordinarily low—there hasn’t been a single reported case of transfusion-associated HIV in the U.S. since 2008—because laboratories now use highly accurate tests to screen all donors and ensure the safety of our blood supply. This testing is so accurate that preventing anyone from donating based on their sexual behavior is no longer logical. Meanwhile, new dictates about anal sex, like older ones explicitly targeting men who have sex with men, still discriminate against the queer community—the FDA is simply struggling to find the most socially acceptable way to pursue a policy that it should have abandoned long ago.
Strict precautions made more sense 30 years ago, when screening didn’t work nearly as well as it does today. Patients with hemophilia, many of whom rely on blood products to live, were prominent, early victims of our inability to keep HIV out of the blood supply. One patient who’d acquired the virus through a transfusion lamented to The New York Times in 1993 that he had already watched an uncle and a cousin die of AIDS. Those days of “shock and denial,” as the Times described it, are thankfully behind us. But for older patients, memories of the crisis in the ’80s and early ’90s linger, and cause significant anxiety. Even people unaware of this historical context may consider the receipt of someone else’s blood disturbing, threatening, or sinful.
As a doctor, I’ve found that patients tend to be more hesitant about getting a blood transfusion than they are about taking a pill. I’ve had them ask for a detailed medical history of the donor, or say they’re willing to take blood only from a close relative. (Typically, neither of these requests can be fulfilled for reasons of privacy and practicality.) Yet the same patients may accept—without question—drugs that carry a risk of serious complication that is thousands of times higher than the risk of receiving infected blood. Even when it comes to blood-borne infections, patients seem to worry less about the greatest danger—bacterial contamination—than they do about the transfer of viruses such as HIV and hepatitis C. I can’t fault anyone for being sick and scared, but the risk of contracting HIV from a blood transfusion is not just low—it’s essentially nonexistent.
Donors’ feelings matter, too, and the FDA’s policies toward gay and bisexual men who wish to give blood have been unfair for many years. While officials speak in the supposedly objective language of risk and safety, their selective deployment of concern suggests a deeper homophobia. As one scholar put it in The American Journal of Bioethics more than a decade ago, “Discrimination resides not in the risk itself but in the FDA response to the risk.” Many demographic groups are at elevated risk of contracting HIV, yet the agency isn’t continually refining its exclusion criteria for young people or urban dwellers or Black and Hispanic people. Federal policy did prohibit Haitians from donating blood from 1983 to 1991, but activists successfully lobbied for the reversal of this ban with the powerful slogan “The H in HIV stands for human, not Haitian.” Nearly everyone today would find the idea of rejecting blood from one racial group to be morally repugnant. Under its new proposal, which purports to target anal sex instead of homosexuality itself, the FDA effectively persists in rejecting blood from sexual minorities.
The planned update would certainly be an improvement. It comes out of years of advocacy by LGBTQ-rights organizations, and its details are apparently supported by newly conducted government research. Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, cited an unpublished study showing that “a significant fraction” of men who have sex with men would now be able to donate. But the plan is still likely to exclude a large portion of them—even those who wear condoms or regularly test for sexually transmitted infections. An FDA spokesperson told me via email that “additional data are needed to determine what proportion of [men who have sex with men] would be able to donate under the proposed change.”
Research done in France, Canada, and the U.K., where similar policies have since been adopted over the past two years, demonstrates the risk. A French blood-donation study, for instance, estimated that 70 percent of men who have sex with men had more than one recent partner; and when Canadian researchers surveyed queer communities in Montreal, Toronto, and Vancouver, they found that up to 63 percent would not be eligible to donate because they’d recently had anal sex with new or multiple partners. Just 1 percent of previously eligible donors would have been rejected by similar criteria. The U.K. assumed in its calculations that 35 to 50 percent of men who have sex with men would be ineligible under a policy much like the FDA’s, while only 1.4 percent of previous donors would be newly deferred. If the new rule’s net effect is that gay and bisexual men are turned away from blood centers at many times the rate of heterosexual individuals, what else can you call it but discrimination? The U.S. guidance is supposed to ban a lifestyle choice rather than an identity, but the implication is that too many queer men have chosen wrong. The FDA spokesperson told me, “Anal sex with more than one sexual partner has a significantly greater risk of HIV infection when compared to other sexual exposures, including oral sex or penile-vaginal sex.”
If the FDA wants to pry into my sex life, it should have a good reason for doing so. The increasing granularity and intimacy of these policies—specifying numbers of partners, kinds of sex—gives the impression that the stakes are very high: If we don’t keep out the most dangerous donors, the blood supply could be ruined. But donor-screening questions are a crude tool for picking needles from a haystack. The only HIV infections that are likely to get missed by modern testing are those contracted within the previous week or two. This suggests that, at most, a couple thousand individuals—gay and straight—across the entire country are at risk of slipping past our testing defenses at any given time. Of course, very few of them will happen to donate blood right then. No voluntary questionnaire can ever totally exclude this possibility, but patients and doctors already accept other life-threatening transfusion risks that occur at much greater rates than HIV transmission ever could. When I would be on call for monitoring transfusion reactions at a single hospital, the phone would ring a few times every night. Yet blood has been given out tens of millions of times across the country since the last known instance of a transfusion resulting in a case of HIV.
Early data suggest that the overall risk-benefit calculus of receiving blood isn’t likely to change. When eligibility criteria were first relaxed in the U.S. a few years ago, the already tiny rate of HIV-positive donations remained minuscule. Real-world results from other countries that have recently adopted sexual-orientation-neutral policies will become available in the coming years. But modeling studies already support removing any screening question that explicitly or implicitly targets queer men. A 2022 Canadian analysis suggested that removing all questions about men who have sex with men would not result in a significantly higher risk to patients. “Extra behavioral risk questions may not be necessary,” the researchers concluded. If there must be a restriction in place, then one narrowly tailored to the slim risk window of seven to 10 days before donation should be good enough. (The FDA says that its proposed policy “would be expected to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period.”)
As a gay man, I realize that, brief periods of crisis during the coronavirus pandemic aside, no one needs my blood. Only 6.8 percent of men in the U.S. identify as gay or bisexual, so our potential benefit to the overall supply is inherently modest. If we went back to being banned completely, patients would not be harmed. But reversing that ban, both in letter and in spirit, would send a vital message: Our government and health-care system view sexual minorities as more than a disease vector. A policy that uses anal sex as a stand-in for men who have sex with men only further stigmatizes this population by impugning one of its main sources of sexual pleasure. There is no question that nonmonogamous queer men have a greater chance of contracting HIV. But a policy that truly treats everyone the same would accept a tiny amount of risk as the price of working with human beings.
The Centers for Disease Control and Prevention on Friday urged people with weak immune systems to take extra precautions to avoid Covid after the dominant omicron subvariants knocked out a key antibody treatment.
These precautions include wearing a high quality mask and social distancing when it’s not possible to avoid crowded indoor spaces, according to the CDC.
The guidance comes after the Food and Drug Administration on Thursday pulled its authorization of Evusheld, a combination antibody injection that people with weak immune systems took as an additional layer of protection to prevent Covid infection.
The FDA pulled Evusheld because it is not effective against 95% of the omicron subvariants circulating in the U.S. This includes the XBB subvariants which are now causing 64% of new cases, as well as the BQ family that is responsible for 31% of reported infections.
Although most Americans have largely returned to normal life as the Covid pandemic has ebbed, people with weak immune systems remain at higher risk of severe disease because they do not mount as strong of an immune response to the vaccines.
Still, it is important for people with weak immune systems to stay up to date on their Covid vaccines by receiving the omicron booster because the shots can slash the risk of severe disease, according to the CDC.
If you have a weak immune system and develop Covid symptoms, you should get tested as soon as possible and receive treatment with an antiviral within five to seven days, according to CDC.
Available antivirals include Paxlovid, remdesivir or molnupiravir, but patients should talk to their doctor to find out which treatment is best. Some people cannot take Paxlovid due to how it interacts with other drugs they are taking.
People with weak immune systems include cancer patients who are on chemotherapy, organ transplant patients who are taking medication for their transplant, people with advanced HIV infection, and those born with immune deficiencies.
Some 7 million adults in the U.S. have a condition, like cancer, that compromises their immune system, according to the CDC.
Peter Hotez, MD, PhD, dean, National School of Tropical Medicine, Baylor College of Medicine; co-director, Center for Vaccine Development, Texas Children’s Hospital, Houston.
Paul Offit, MD, director, Vaccine Education Center and professor of pediatrics, Children’s Hospital of Philadelphia.
Michael T. Osterholm, PhD, director, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Minneapolis.
Ground Truths. Eric Topol, MD: “The bivalent vaccine booster outperforms.”
CDC: “COVID Data Tracker: Weekly Review,” “Rates of Laboratory-Confirmed COVID-19 Hospitalizations by Vaccination Status,” “Trend in the Number of COVID-19 Vaccinations in the U.S.”
FDA: “Vaccine and Related Biological Products Advisory Committee January 26 Meeting Announcement.”
The New England Journal of Medicine: “Immunogenicity of BA.5 Bivalent mRNA Vaccine Boosters,” “Antibody Response to Omicron BA.4-BA.5 Bivalent Booster,” “Neutralization against BA.2.75.2, BQ.1.1, and XBB from mRNA Bivalent Booster,” “Bivalent Covid-19 Vaccines – A Cautionary Tale.”
Nature Medicine: “Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1 and XBB.1 by parental mRNA vaccine or a BA.5 bivalent booster.”
BioRxiv: “Bivalent mRNA vaccine improves antibody-mediated neutralization of many SARS-CoV-2 Omicron lineage variants,” “Improved Neutralization of Omicron BA.4/5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent BA.4/5 Vaccine.”
Kaiser Family Foundation: “ How Much Could COVID-19 Vaccines Cost the U.S. After Commercialization?”
Leading Vapor Trade Group Urges FDA to Adopt Reforms to Protect Sanctity of Scientific Process
Press Release –
Dec 20, 2022
WASHINGTON, December 20, 2022 (Newswire.com)
– Following the Reagan Udall Foundation release of their final report reviewing the operations of FDA’s tobacco program, Vapor Technology Association Executive Director Tony Abboud released the following statement:
“The Reagan-Udall Foundation’s independent review of FDA’s tobacco program has uncovered systemic problems inside the Center for Tobacco Products that allowed political decisions to override the science-based recommendations of FDA professional staff concerning the authorization of vaping products that would provide safer alternatives for adult smokers looking to quit combustible cigarettes.
“The Reagan-Udall review was requested by FDA Commissioner Califf to address problems with the Center for Tobacco Products (CTP) programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. Their observations included the following:
CTP has no strategic plan and must create one that identifies the Center’s strategic objectives and plots an operational roadmap to achieve them.
CTP must resolve how to weigh the public health benefits of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms to youth who use ENDS.
CTP has not clearly articulated what is required to meet the appropriateness for the protection of public health standard.
CTP struggles to function as a regulator due to some of its own policy choices.
CTP faces significant challenges in clearing policies through the career and political infrastructure.
CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction.
CTP has not been transparent regarding its failure to clear the market of illegal products.
CTP’s current goals and priorities are unclear in communication and practice.
“The Vapor Technology Association has raised concerns for years about the opaque and questionable operations of the CTP. Reagan-Udall’s review highlights a shifting and arbitrary decision-making process, untethered from science due to political or external pressures, that has damaged the marketplace for safer vaping products, impaired the FDA’s credibility, undermined the FDA’s mission of harm reduction by denying millions of American smokers truthful information and authorized products. We are pleased to see many of the recommendations VTA provided to the Reagan-Udall Foundation reflected in the Foundation’s report.
“The fact that CTP has continued to issue major decisions despite deficiencies highlighted by Reagan-Udall is highly questionable. VTA agrees that ‘CTP must invest the time, now’…to create and implement a Strategic Plan’ and that ‘the path to resolving many of the Center’s current challenges starts with establishing the scientific and policy framework to make clear and timely product decisions.’ For that reason, the FDA Commissioner should instruct CTP to stand down on issuing any further denials of less harmful nicotine alternative product applications until CTP has been able to review and implement the safeguards and recommendations made by the Reagan-Udall Foundation, and VTA stands ready to assist FDA and CTP by providing the necessary stakeholder input that the Foundation also said was necessary,” said Tony Abboud.
ABOUT VTA The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.
Opinions expressed by Entrepreneur contributors are their own.
California startup Upside Foods just cleared a major hurdle in bringing its lab-cultured chicken to a sandwich near you. The U.S. Food and Drug Administration (FDA) said in a press release published Wednesday that the agency had completed its “first pre-market consultation of a human food made from cultured animal cells.”
The FDA cleared Upside to continue creating meat products with its animal cell culture technology. Though the company still needs approval to sell its lab-grown chicken (or seafood or meat), the FDA has concluded by analyzing how Upside produces its meat that it is safe for consumption. The agency does not question its safety.
This is a significant step forward for producers of meat grown from cultured cells. Upside Foods founder Uma Valeti said in a statement that the company has “made history … as the first company to receive a ‘No Questions’ letter from the FDA for cultivated meat.”
“This milestone marks a major step towards a new era in meat production,” Valeti said, “and I’m thrilled that U.S. consumers will soon have the chance to eat delicious meat that’s grown directly from animal cells.”
Upside Foods still has another major milestone to go, however, to receive permission to sell its product. In addition to FDA approval, the company also needs approval from the Food Safety and Inspection Service, which is under the U.S. Department of Agriculture (USDA).
Statue of Liberty and New York City Skyline with Manhattan Financial District, Battery Park, Water … [+] of New York Harbor, World Trade Center, Tourboat and Blue Sky.
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Third quarter GDP growth came in at 2.6%, reversing GDP declines in the first and second quarters, but there are still signs of economic weakness. Sales to U.S. consumers continue to slow, inflation remains high, and over the next decade the Congressional Budget Office predicts real GDP growth to average less than 2% per year. A struggling economy is not inevitable, however, and a new report from the Center for Growth and Opportunity (CGO) at Utah State University explains the policy reforms needed to achieve abundance rather than stagnation.
In their new report, authors Taylor Barkley, Jennifer Morales, and Josh Smith explain that achieving abundance means faster economic growth, better living standards, a cleaner environment, and cheaper prices. They acknowledge that America faces headwinds—labor shortages, housing shortages, and various supply chain problems. But America is also the home of the world’s most innovative and successful companies, first-class universities, and remains the number one destination for immigrants.
America has long been the world’s hub of innovation, and by leaning into our willingness to take risks we can continue to pace the world and ensure economic opportunities for everyone.
The first piece of the abundance agenda is maintaining competitive markets. America’s strong system of property rights and efficient capital markets make it relatively easy (though not easy enough) to start and grow a business. Policies that change this, such as stifling so-called “Big Tech” with new antitrust rules or more government oversight and regulation, would reduce economic dynamism and make it harder for upstarts to compete and overtake entrenched incumbents.
Studies show that more regulation increases prices, increases poverty, exacerbates income inequality, reduces employment, and decreases business investment. An abundance agenda streamlines regulation so duplicative and overly burdensome regulations do not impede entrepreneurs.
A stark example from the report is the FDA approval process. The process is taking longer and longer, which prevents important medicines and medical devices from getting into the hands of consumers. The FDA should shorten approval times by allowing post-launch monitoring of drugs. This would enable consumers to use new drugs while the FDA continues to collect data on safety. The FDA should also shift its focus to safety monitoring rather than efficacy testing, as this would also make drugs available sooner.
The authors also recommend removing barriers to transportation innovation. The Federal Aviation Administration should have a deadline for integrating drones into aviation rules. Drones are already providing immense benefits to consumers around the world, but America is falling behind due to regulatory uncertainty.
Congress should also instruct the FAA to allow some supersonic flights to help create a market for faster air travel. There have been advances in supersonic flight, but until the rules change routine supersonic flights that dramatically speed up travel times—San Francisco to Tokyo in six hours instead of ten—will remain a dream.
The report also discusses reforms to the National Environmental Policy Act, or NEPA. NEPA causes significant litigation and delays on projects from dams to solar panels, but a few changes could alleviate much of the problem.
First, NEPA should be amended so that federal agencies can issue a Finding of No Significant Impact (FONSI) for projects without first conducting a longer, more complicated Environmental Assessment (EA). Currently, even if an agency believes a FONSI is appropriate, it still must conduct an EA. The proposed change does not preclude agencies from conducting an EA if they think it is necessary, it just does not require one.
NEPA could also add geothermal projects to its list of categorical exclusions. Certain oil and gas projects are already excluded, and since geothermal projects are conducted in much the same way the exclusion makes sense. Geothermal is a relatively clean source of energy and new projects provide jobs for oil and gas workers looking to transition to a new industry since they require many of the same skills.
In another study, Mario Loyola of the Competitive Enterprise Institute (CEI) makes additional recommendations to reform NEPA. He notes that the uncertainty of the NEPA process causes significant social losses and that the “uncertainty has many sources, most important of which is litigation risk, which maximizes the amount of time and resources that agencies devote to processing permit applications out of all proportion to the environmental costs and benefits at stake.”
Loyola makes several recommendations to speed up the NEPA process and reduce litigation risk. First, Congress should allow project developers to prepare the materials needed for agency permit certification. If agencies take too long to issue or deny a permit based on these materials, developers should be given provisional permits to start construction subject to monitoring.
Second, Congress should create a unified federal permitting process so project developers do not need to go through a half-dozen different agency processes to get the necessary approvals.
Next, agencies should be held to a substantial-compliance standard so that provided reports and materials that are mostly right enable a project to move forward. Congress should also tighten the rules on standing to prevent parties that are clearly not affected by a project from holding it up with a lawsuit.
Finally, Congress should establish programmatic and general permits for major categories of infrastructure projects that have similar environmental impacts. This would expedite the permitting process.
Additional reforms mentioned in the CGO report include immigration reform, ideas for expanding broadband access, policy changes to protect the environment, and suggestions for increasing the resiliency of America’s electricity grids. Some state and local reforms not mentioned that would also improve economic growth include zoning and land-use reforms, occupational licensing reforms, and pro-growth tax reforms.
So far, President Biden’s economic agenda has been the most anti-growth of the last 40 years. His administration’s barrage of regulations and profligate spending helped create the highest inflation rate in two generations. The Fed has been forced to raise interest rates in response, bringing us closer to a recession.
It does not have to be this way. America’s workers and entrepreneurs are still capable of great things, but they cannot achieve them while held back by the weight of our current anti-growth policies. With the right policy reforms, we can remove the barriers people face and achieve abundance.
Unilever has said that dry shampoo brands including Dove are contaminated with a cancerous chemical called benzene, a Bloomberg report stated. The list of brands recalled by the consumer goods company also included names like Nexxus, Suave, Tresemmé and Rockaholic and Bed Head dry shampoo maker Tigi, an official notice posted on the Food and Drug Administration’s website Friday read. According to media reports, the recall pertains to products made before October 2021.
The problem with aerosols has largely appeared to be from the propellants that are used to spray the products from the cans. As per Unilever, this was the case with its dry shampoo recall. The company has not released the amount of benzene content that was found in the products, and has said that it recalled them out of caution.
According to the report, this isn’t the first time that dry shampoos have been pointed out as a problem. P&G had recalled its Pantene and Herbal Essences dry shampoos in December last year, citing benzene contamination.
Valisure Chief Executive Officer David Light said that it unfortunately makes sense that other consumer-product categories, like aerosol dry shampoos, could be heavily affected by benzene contamination. The officer added that they are actively investigating this area.
The Food and Drug Administration has said that daily exposure to benzene in the recalled products is expected to cause adverse health consequences. “Exposure to benzene can result in leukemia and other blood cancers”, Bloomberg quoted the agency.
In less than two weeks, you could walk out of a pharmacy with a next-generation COVID booster in your arm. Just a few days ago, the Biden administration indicated that the first updated COVID-19 vaccines would be available shortly after Labor Day to Americans 12 and older who have already had their primary series. Unlike the shots the U.S. has now, the new doses from Pfizer and Moderna will be bivalent, which means they’ll contain genetic material based both on the ancestral strain of the coronavirus and on two newer Omicron subvariants that are circulating in the U.S.
These shots’ new formulation promises some level of protection that simply hasn’t been possible with the original vaccines. “A bivalent vaccine will have some benefit for almost everybody who gets it,” Rishi Goel, an immunologist at the University of Pennsylvania, told me. “How much benefit that is, we’re still not exactly sure.” People who aren’t at high risk could end up only marginally more protected against severe outcomes, and no one thinks the shots will banish COVID infections for good. There is, however, a simple rule of thumb that nearly everyone can follow to maximize the uncertain gains from a shot: Wait three to six months from your last COVID infection or vaccination.
Put that rule into action, and it plays out a little differently, depending on your circumstances.
If you haven’t had an Omicron infection:
If you haven’t had COVID since about November 2021, the advantage of a bivalent booster over the original formula is obvious, and as long as you haven’t gotten boosted recently, there’s every reason to get the new one right away. (If you have been boosted in the past few months, your antibody levels are probably still too high for a new shot to do much for you.) Marion Pepper, an immunologist at the University of Washington, told me that Americans who have already gotten three or more doses “have probably maxed out the protective capacity” of the original shots. By contrast, the bivalent vaccines offer something new to those who have so far escaped Omicron: a lesson on the spike proteins of the BA.4 and BA.5 subvariants, which will help the immune system fight the real thing should it get into your body. “I’m just super excited to get the bivalent vaccine,” says Jenna Guthmiller, an immunologist at the University of Colorado who has not yet had COVID. “I think it’ll be really nice and ease my mind a little bit.”
Veterans of Omicron infections might still have something to gain from seeing the BA.4 and BA.5 spike proteins—especially if your goal is to avoid getting sick with COVID at all. Past a certain number of shots, boosters’ impact on your long-term protection against severe disease is unclear, Goel told me. Paul Offit, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told me he doesn’t plan on getting a booster at all this fall because, after three vaccine doses and an infection, “I think I’m protected against serious illness.” But if you want to stave off infection, Goel said, “the bivalent vaccines, or really any variant-containing vaccines, have real value.” That’s because formulas based on a given variant have been shown to temporarily increase your stock of antibodies that target that variant.
How long that extra-protective state lasts, or whether it’s sufficient to prevent any infection whatsoever, is still a scientific puzzle. The original boosters were shown to increase antibody levels to a peak about two weeks after the shot, then decay steadily over the following three months. We don’t know yet whether a bivalent formula will change that timeline, Goel said.
But you can still use it to estimate approximately when your protection will be at its highest. You might, for example, choose to err on the early side of that three-to-six-month timeline if you have a particularly high-risk event coming up in the next few weeks. “If all we had was the original booster and I was going to an indoor wedding or something, I think it would be reasonable to get that booster,” Pepper said.
“You’re still riding the wave of antibodies that you generated as a result of that infection,” Guthmiller told me, so a shot won’t do much for you yet. That’s true regardless of which Omicron subvariant you might have been infected with, she said, because BA.2 infections have been shown to protect fairly well against today’s dominant strains, BA.4 and BA.5. (BA.2 became dominant in the United States back in March.) The severity of your illness doesn’t really matter either, Goel said. A higher fever and more intense cough might indicate that your immune system got extra revved up, he said, but they could just as easily mean that your body needs more help responding to the coronavirus. In either case, once a little more time has passed, getting the bivalent vaccine could help extend your body’s memory of its last COVID encounter, and keep infection at bay.
If you’re at high risk:
Certain groups of people should get any booster as soon as it’s available to them, the experts I spoke with emphasized to me: immunocompromised people, people over the age of 50 or so, and people with medical conditions that put them at high risk of severe disease. If you fall in one of these categories and haven’t received all the boosters you’re eligible for, “I wouldn’t wait for the bivalent,” Offit said. For people in these high-risk categories who have already gotten the recommended number of boosters, you should get the new one as soon as it’s available to you. (The FDA and CDC have not yet indicated whether they will recommend a waiting period between your most recent shot and the bivalent booster.) Goel recommended waiting at least a month after your most recent infection or shot, but if you’re very worried about your risk, you don’t need to stretch the delay to three months. Your body might still have extra antibodies floating around, but with no practical way to check at scale, “I’m honestly in favor of recommending boosting as a way to maximize individual benefit,” he said.
Waiting is always an option if you want to know more about how the bivalent vaccines perform. The FDA and CDC are set to green-light the shots based on human data from the existing boosters and other experimental bivalent boosters that didn’t make it to market in the U.S.—plus trials on the new formula in mice. Pfizer and Moderna simply haven’t progressed very far in their human trials. While there’s no reason to suspect that the new shots won’t be safe, Offit recommended opting for the original boosters until more safety and efficacy data are available, which could be as soon as a couple of months after the rollout—as long as the vaccine makers or the government collects that information and makes it public. But Guthmiller and Goel said they weren’t concerned about the lack of human data, and the bivalent shot is almost certainly the better bet.
There is one significant reason to avoid waiting too long for the bivalent shot: It offers the greatest protection against infection from the subvariants it’s actually designed around. BA.4 and BA.5 might be with us through the fall and winter—or they might give way to a different branch of Omicron, or even a variant that’s entirely unlike Omicron. You’d certainly be better off against this new variant with a bivalent booster than no booster at all. But if you want to maximize your anti-infection shield while you have it, consider putting it up against the enemy you know.
COLUMBIA, Md., September 23, 2019 (Newswire.com)
– On each day in 2017, 91 deaths were attributed to opioid overdose; in fact, the number of overdose deaths involving opioids has increased six-fold since 1999. The numbers are clear: clinicians are failing to alleviate the nation’s growing opioid crisis. Through an adaptive-learning continuing medical education (CME) program, a collaboration of several organizations (Rockpointe, University of North Texas, CogBooks, and O’Donnell Learn) and available through the American Board of Medical Specialties (ABMS) CE Certification Directory, is offering a new approach to help clinicians turn the tide against an epidemic that has had catastrophic consequences.
To help address the opioid crisis, the FDA developed a risk evaluation and mitigation strategy (REMS) for the use of outpatient opioid analgesics and, in 2012, issued an educational blueprint to provide guidance on prescribing opioid analgesics for pain management. In September 2018, the FDA updated the blueprint to include additional information on pain management, such as components of an effective treatment plan, non-pharmacologic treatments for pain, pharmacologic treatments for pain (non-opioid and opioid analgesics), and a primer on addiction medicine. It also widened the scope of the blueprint to apply not only to prescribers, but to all healthcare providers involved in the management of patients with pain.
Rockpointe’s new adaptive-learning CME activity, “Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS) and the New FDA Blueprint,” presents participating clinicians with a thorough review of the FDA’s updated educational blueprint to facilitate the evidence-based management of pain in their patients on a daily basis. The education provides tools to help clinicians mitigate issues associated with opioid therapies, such as misuse and addiction. The program aims to educate 10,000 clinicians using adaptive-learning technologies, with the results to be submitted for publication in a peer-reviewed journal.
Physicians across many specialties manage acute and chronic pain in their patients on a daily basis. With 58 opioid prescriptions written for every 100 people in the United States in 2017, it is imperative that clinicians integrate non-pharmacologic and non-opioid analgesics into pain treatment plans in an evidence-based manner, appropriately identify patients who are candidates for opioid therapy, and recognize how to effectively monitor these patients during treatment periods. This activity is intended for those involved in direct patient care, including clinicians registered with the DEA who are eligible to prescribe all opioid analgesics. In addition, because of the broader scope of the revised FDA educational blueprint, the intended audience may include members of the healthcare team who are not authorized to prescribe.
After completing the activity, participants should be able to:
· Define the components of an effective treatment plan, such as treatment goals, patient engagement, and collaboration within the healthcare team;
· Assess the risks and benefits of non-pharmacologic therapies prior to initiating long-term pharmacologic therapy;
· Identify patients who are candidates for treatment with non-opioid pharmacologic analgesics;
· Evaluate criteria for initiating opioid analgesics; and
· Identify risk factors for addiction to opioid analgesics.
Adaptive Learning
The program’s adaptive-learning instructional design allows for a tailored educational experience that addresses the unique needs of each learner. The activity incorporates text, interactive questions, and audio recordings of faculty experts synced with a slide presentation. Depending on each participant’s response to the questions in the activity, an algorithm creates a unique educational pathway. Those with a good grasp of a concept move closer to completion, while others with less knowledge are provided additional content/questions to assist in gaining an adequate understanding of a topic. Post-activity content-based questions are used to assess learning, along with measures of clinicians’ perceptions of the content and their confidence in managing patients with pain.
This CME program is available online at www.CElink.Rockpointe.com. Clinicians will be able to claim CME credit upon successful completion of the program.
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of the University of North Texas Health Science Center (UNTHSC) and Rockpointe. UNTHSC is accredited by the ACCME to provide continuing medical education for physicians. UNTHSC designates this enduring material for a maximum of 3.0 AMA PRA Category 1 Credits™.
Through the American Board of Medical Specialties (“ABMS”) ongoing commitment to increase access to practice relevant Continuing Certification Activities through the ABMS Continuing Certification Directory, “Opioid Analgesics: Risk Evaluation and Mitigation Strategy (REMS) and the New FDA Blueprint” has met the requirements as a MOC Part II Self-Assessment or MOC Part II CME Activity (apply toward general CME requirement) for the following ABMS Member Boards:
MOC Part II Self-Assessment Activity Physical Medicine and Rehabilitation
MOC Part II CME Activity Allergy and Immunology Anesthesiology Family Medicine Internal Medicine Medical Genetics and Genomics Nuclear Medicine Pediatrics Physical Medicine and Rehabilitation Preventive Medicine Psychiatry and Neurology Radiology Thoracic Surgery Urology
This CME webcourse is available through Aug. 30, 2020, and the on-demand format allows participants to view the presentation at their own convenience from the comfort of their home or office.
This activity is supported by an independent educational grant from the Opioid Analgesic REMS Program Companies. For a list of REMS Program Companies, see: https://ce.opioidanalgesicrems.com/RpcCEUI/ rems/pdf/resources/List_of_RPC_Companies.pdf.
Through effective continuing medical education, Rockpointe strives to improve and advance the quality of patient care. Its educational programs have been at the forefrontof new issues in healthcare, including implementing MIPS, combating the nation’s opioid crisis, and utilizing technical advances that improve care. As part of its commitment to quality, Rockpointe works to inform the continuing-education community of significant quality-improvement issues through news and analysis on Policy and Medicine. In addition, its popular Medical Education Exchange (MEDX) CME regional meetings include sessions on the basics of quality improvement and alternative payment models, as well as relevant and scientifically accurate sessions on numerous disease states. All sessions include links back to associated National Quality Priorities to reinforce the bigger picture and the triple aim of: 1) improving health and 2) lowering cost to 3) better the patient experience. At Rockpointe, education equals quality.
