
Cervical cancer screening at home? US FDA approves kit. Why is this significant?
The Pap smear detects abnormal cells in the cervix (narrow end of the uterus connected to the vagina), which can indicate cervical cancer or precancerous changes. However, many women find this test uncomfortable or painful due to the insertion of a metal speculum and the scraping of cells.. The US device comes with a brush. So no need to put off pelvic examinations.
A US study showed that the at-home cervical cancer screening test is as accurate as a clinical test (96 per cent accuracy) and is preferred by 94 per cent of women.
According to Dr Smita Joshi, a senior scientist at Prayas Health Group, 'Worldwide two out of three women have never been screened in their lifetime and hence improving the screening coverage is important. Self-sampling can help reach the never screened or hard to reach population.' This gap is the reason why women in low-and middle- income countries have the highest cervical cancer burden.
In India, such home collection of samples is still rife with challenges. 'For instance, the logistics of shipping the samplers to the women, ensuring that they understand why this screening is important, correctly following the instructions and collecting the sample are still complex tasks for rural women,' Dr Joshi observed. However, this can also be done with the help of healthcare personnel in remote areas till the women become aware and capable of doing this by themselves, she feels.
Dr Joshi and her team have evaluated if the self-sample collected by the home-grown CERVICHECK kit yields the same test report as that of the clinician-collected cervical sample. The study was conducted in Pune and Baroda with 156 women participants and showed almost similar accuracy results as the clinician's test.
The kit contains an instruction manual, a biohazard bag for keeping the sample and the device itself. It comes as a tube encasing a cytobrush with a piston. Once the tube is inserted in the vagina, one has to rotate the knob clockwise. This pushes the brush deeper inside to collect tissue samples. Once done, the brush is dropped into the collection bag. The women participants rated the self-sampling kit and found its convenience, ease-of-use, comfort and painlessness at 90 per cent and above.
The World Health Organisation's (WHO) envisages cervical cancer screening of 70% of women at least twice in their lifetime, once at 35 and again at 45. 'Although HPV vaccination of adolescent girls will help in reducing cervical cancer incidence in low- and middle-income countries by more than 85 per cent over the next century, adult women, who do not benefit from preventive HPV vaccines, need immediate cervical cancer screening and appropriate management of pre-cancers,' Dr Joshi said.
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News18
11 hours ago
- News18
Ousted FDA vaccine chief Vinay Prasad returning to agency
Washington, Aug 11 (AP) A Food and Drug Administration official is getting his job back as the agency's top vaccine regulator, less than two weeks after he was pressured to step down at the urging of biotech executives, patient groups and conservative allies of President Donald Trump. Dr Vinay Prasad is resuming leadership of the FDA centre that regulates vaccines and biotech therapies, a spokesperson for the Department of Health and Human Services said in a statement Monday. Prasad left the agency late last month after drawing ire of right-wing activists, including Laura Loomer, because of his past statements criticizing Trump. A longtime a critic of FDA's standards for approving medicines, Prasad briefly ordered the maker of a gene therapy for Duchenne's muscular dystrophy to halt shipments after two patient deaths. But that action triggered pushback from the families of boys with the fatal condition and libertarian supporters of increased access to experimental medicines. Prasad's decision to pause the therapy was criticized by The Wall Street Journal editorial board, former Republican Sen Rick Santorum and others. The FDA swiftly reversed its decision suspending the therapy's use. Loomer posted online that Prasad was 'a progressive leftist saboteur," noting his history of praising liberal independent Sen. Bernie Sanders. But Prasad has had the backing of FDA Commissioner Marty Makary and health secretary Robert F Kennedy Jr, who have both called for scrutinizing the use of COVID-19 vaccines. Under Prasad, the FDA restricted the approval of two new COVID-19 shots from vaccine makers Novavax and Moderna and set stricter testing requirements for future approvals. (AP) RD RD view comments First Published: Disclaimer: Comments reflect users' views, not News18's. Please keep discussions respectful and constructive. Abusive, defamatory, or illegal comments will be removed. News18 may disable any comment at its discretion. By posting, you agree to our Terms of Use and Privacy Policy.

Hindustan Times
12 hours ago
- Hindustan Times
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Illustration: Vartika Sharma Chart 1 Political drama followed. Laura Loomer, a conspiracy theorist with access to President Donald Trump, accused Vinay Prasad—Dr Marks' successor and a long-standing critic of loosening evidentiary standards for drug approvals—of being a 'leftist saboteur' bent on derailing 'Trump's deregulatory mission'. Her attack was widely seen as criticism of his decision to pause Sarepta's therapy. On July 28th the FDA reauthorised the treatment's use for some younger patients. By the next day Dr Prasad had resigned to 'spend more time with his family'. George Tidmarsh, a physician-scientist newly in charge of the agency's other key drug-evaluation division, became acting head of this one, too. But on August 9th Dr Prasad was re-hired, apparently after being persuaded that the FDA's commissioner, Martin Makary, supported him. Ms Loomer responded by threatening exposés of FDA officials. It is hardly a picture of stable decision-making at an agency responsible for regulating products that account for some 14% of America's GDP. Drugs that target rare diseases, known as orphan drugs, constitute a distinctive segment of the pharmaceutical industry, one that is replete with extraordinary financial promise, scientific risk and knotty ethical considerations. The FDA polices this frontier. It is a treacherous mandate even without interventions by the likes of Ms Loomer. And while the challenges for rare-disease drugs are especially acute, they mirror those facing the entire sector in a regulatory landscape for drugs and new treatments that is growing ever more politicised and unstable. Though 200m-500m people worldwide suffer from rare diseases—and nearly half of these illnesses affect children—drugmakers had long neglected the development of treatments. To spur such work Congress passed the Orphan Drug Act in 1983. It offers companies seven years of market exclusivity. Between the legislation's strong incentives and advances in cell and gene therapies, orphan drugs have become an important sector for biotech firms. Today these therapies account for roughly half of the new drugs the FDA approves. They are lucrative, too. Some companies, such as Sarepta, rely almost entirely on orphan drugs for their revenue. Even Johnson & Johnson, a pharmaceutical giant, earned roughly a third of its revenue from these treatments in 2024, according to Evaluate, a pharmaceutical-analytics firm (see chart 2). Mr Makary, the new commissioner of the FDA, has joined a long line of agency chiefs in calling for faster drug reviews, which can take ten months. In June the FDA launched a pilot scheme to cut that to just a month or two for treatments deemed to support 'national interests'. Because robust randomised trials are often unfeasible for rare diseases given the tiny patient pool, Mr Makary has also talked about developing quicker alternative approval pathways for orphan drugs. But these moves towards innovation have been undermined by the administration's inclination to shoot first and aim later. Speaking on the Megyn Kelly Show, a podcast, Mr Makary announced a plan to speed up drug approvals for ultra-rare diseases by relying on 'a plausible mechanism', meaning a scientific explanation showing that treatments could theoretically lead to improved outcomes. Such a standard would be 'about as low as it goes', argues Daniel Kracov, a lawyer who advises pharmaceutical firms on regulation. However, parents of patients with diseases so rare that they can be impossible to run trials for are pushing for new ways to win approval for novel drugs. Officials at the FDA worry that the push to accelerate approvals without hiring more staff will backfire. One reviewer who works on rare diseases notes that during evaluations of proposed treatments for them, the science can be less familiar, the clinical trials smaller, and approval may hinge on less conventional intermediate evidence. This uncertainty can breed scepticism initially. What often persuades reviewers of a treatment's safety and efficacy is statistical stress-testing and other scrutiny of the evidence that can take months. Speeding this up risks causing reviewers to err on the side of caution, which could lead to fewer approvals, not more. Side effects may include Congress is another source of uncertainty. Lawmakers have so far failed to reauthorise a voucher programme that encouraged drugmakers to pursue treatments for rare pediatric diseases. In exchange, companies received a voucher granting expedited FDA review for another drug. The vouchers are transferable and can be sold for tens of millions of dollars on a secondary market (see chart 3). Amid instability, 'vouchers are selling for more, because there is some possibility that Congress will not get this done by the end of 2026', says David Ridley, a health economist at Duke University. Drug development typically takes a decade or longer, which is why investors prize policy certainty. 'The biggest thing is, you want the FDA to be consistent,' explains Matt Phipps, a biotech analyst at William Blair, an investment bank. 'You want them to tell you something and then stick with it and not change their minds at the last minute.' Smaller biotech firms that fuel early innovation across the industry will struggle most to ride out the volatility. Funding cuts at the National Institutes of Health, the wellspring of biomedical research, and threats of pharmaceutical tariffs have given a hypersensitive industry additional reasons to retreat. More uncertainty at the FDA is likely to make it harder to approve drugs in general, and possibly orphan drugs especially. Rollercoasters are no fun when you have no choice but to ride them. America-s-drug-regulator-is-in-turmoil


Hindustan Times
13 hours ago
- Hindustan Times
What is kava? Major warnings issued on TikTok about ‘Feel Free' drinks amid kratom products ban in Louisiana
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