NEWS 13
ausdoc. com. au 11 APRIL 2025
NEWS 13
‘ I’ m staying until RFK Jr fires me’
Rachel Fieldhouse“ IT is slash and burn for public health,” says Professor Paul Offit.
Earlier this year, the co-inventor of the rotavirus vaccine had been preparing for the annual influenza vaccine composition meeting when he was told the US Food and Drug Administration( FDA) had axed the meeting from the calendar after 30 years.
The paediatrician, one of the biggest names in immunology, says it reflects a trend since Robert F Kennedy Jr, whose activism as an antivaxxer over the last decade is notorious, became the US Department of Health and Human Services chief in February.
Since Mr Kennedy’ s confirmation, the US Centers for Disease Control and Prevention( CDC) has indefinitely postponed meetings of the Advisory Committee on Immunization Practices.
It paused its flu vaccination promotional campaign for further public consultation, yet the consultation portal was shut when the CDC froze its communications on 22 January.
While a delay to flu vaccinations was unlikely, axing the composition meeting represented the“ discarding of expertise”, Professor Offit told Australian Doctor.
“ Those meetings are lively and sometimes contentious, but it’ s good to have that because … when you have a policy that’ s based on science, you want to make sure that science is held to a high standard,” he said.
CDC, FDA and National Institutes of Health staff were among the mass lay-offs in February in what some dubbed a public service Valentine’ s Day Massacre.
Professor Offit said the US medical community remained“ in shock” yet health institutions were reluctant to speak out because it could put their federal funding at risk.
“ There is a sense the administration will be less transparent and will try to centralise decision-making away from experts,” he said.
This is why Professor Offit is maintaining his role with the FDA’ s vaccine composition team, despite the Department of Government Efficiency— Elon Musk’ s cost-cutting machine— offering to pay public servants until September if they quit immediately.
Staying, Professor Offit says, is the better form of resistance.
“ That’ s what I’ m doing. I’ m going to hang in there until Mr Kennedy fires me.”
Professor Offit said one of the reasons is his fear that CDC staff who do quit will be replaced with Mr Kennedy’ s supporters.
“ I think that’ s already happened, and that is the goal,” he said.
He points to Project 2025, a conservative thinktank’ s blueprint for President Donald Trump’ s administration, which queried how doctors weighed up“ lives saved versus souls saved” when the CDC closed churches in response to COVID-19.
Professor Offit has been openly critical of Mr Kennedy
Professor Paul Offit. and his eight-year leadership of the anti-vaccine group Children’ s Health Defense.
When the appointment of his new boss was confirmed by the Senate, he said:“ I think it’ s a sad day for public health when someone who is a science denialist, conspiracy theorist and virulent anti-vaccine activist is [ leading ] the biggest public health agency in the US.
“ I think every senator who voted for his confirmation should be ashamed of themselves.”
The description he uses during the interview with Australian Doctor is that Mr Kennedy is a“ science nihilist”.
Mr Kennedy’ s arrival coincides with three measles outbreaks across the US.
As of 27 March, there have been a total of 483 confirmed measles cases, with one confirmed death and one under investigation.
More good news on menopause.
Medicine co-pack containing one pack of Estrogel ®( estradiol hemihydrate) plus one pack of Prometrium ®( micronised progesterone) for women with a uterus
is now on the PBS. Greater awareness, more choice and less stigma in menopause 1, 2 and now, three new PBS listings.
PBS information: General Benefit Estrogel Pro, Estrogel & Prometrium are listed on the PBS.
Children’ s Hospital of Philadelphia
“ When a couple of days ago we suffered the first measles death in a child since 2003 … Mr Kennedy’ s response was to simply shrug it off and say glibly,‘ outbreaks occur every year’,” says Professor Offit.
“ That’ s not true. We nearly eliminated measles in this country by 2000. Outbreaks have gotten worse in large part because of him, because of his anti-vaccine advocacy and his scaring people unnecessarily.”
Estrogel ® Pro, as well as Estrogel ® and Prometrium ®, are now available on the PBS for your post-menopausal patients, giving greater access to a hormone therapy that treats her range of menopause symptoms. 3, 4
Please review the Product Information before prescribing, accessible at besins-healthcare. com. au / PI or 1800 BESINS( 237 467), or by scanning the QR code:
Minimum Product Information Estrogel( estradiol hemihydrate) gel. Indications: Hormone replacement therapy( HRT) for estrogen deficiency symptoms in postmenopausal women. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The lowest effective dose should be used for the shortest duration. Contraindications: Known, past or suspected breast cancer; Known or suspected estrogen-dependent malignant tumours( e. g. endometrial cancer); Undiagnosed genital bleeding; Untreated endometrial hyperplasia; Previous or current venous thromboembolism( e. g. deep venous thrombosis, pulmonary embolism); Known thrombophilic disorders( e. g. protein C, protein S, or antithrombin deficiency); Active or recent arterial thromboembolic disease( e. g. angina, myocardial infarction); Acute liver disease, or a history of liver disease as long as liver function tests have failed to return to normal; Known or suspected pregnancy; Lactation; Known hypersensitivity to the active substances or to any of the excipients; Porphyria. Precautions: Appraisal of the risks and benefits should be undertaken at least annually. Refer to full Product information( PI) for conditions which require supervision during treatment with Estrogel. Treatment should be withdrawn if the following occur, jaundice or deterioration in liver function; significant increase in blood pressure; new onset of migraine type headache; pregnancy. Caution: endometrial hyperplasia and carcinoma, breast cancer, ovarian cancer, venous thromboembolism, coronary artery disease( CAD), ischaemic stroke, thyroid function, elderly, ALT elevations, paediatric use( see full PI). Interactions: use of concomitant skin medications, surface active agents or strong skin cleansers and detergents should be avoided at site of application, metabolism of estrogens may be increased by concomitant use of inducers of hepatic enzymes such as anticonvulsants( phenobarbital, phenytoin, carbamezapine) and anti-infectives( rifampicin, rifabutin, nevirapine, efavirenz, ritonavir and nelfinavir) and some herbal preparations( St John’ s wort) reducing the effectiveness of estrogen. Estrogel as a transdermal administration might be less affected than other oral hormones by enzyme inducers. Concomitant use of estrogens with lamotrigine may decrease lamotrigine plasma concentrations. Caution is warranted for co-administration with hepatitis C virus( HCV) combination regimens ombitasvir / paritaprevir / ritonavir with or without dasabuvir and the regimen glecaprevir / pibrentasvir may cause greater than usual ALT elevations. Pregnancy Category B3; not for use in lactation. Adverse Effects: headache, nausea, abdominal pain, breast swelling / pain, breast enlargement, dysmenorrhea, menorrhagia, metrorraghia, leucorrhoea, endometrial hyperplasia, weight gain( increase or decrease), water retention with peripheral edema( see full PI). Dosage and Administration: Estrogel should be used daily on a continuous basis. Estrogel as an estrogen only product is indicated only for women without a uterus. In women with an intact uterus it is recommended to add a progestogen for at least 12 days of each month. Although some women will respond to 1.25 g daily( 1 pump), the usual starting dose is 2.5 g per day( 2 pumps). If after one month of treatment, effective relief of menopausal symptoms is not obtained the dosage may be increased to a maximum of 5 g( 4 pumps)( see full PI). The lowest effective dose should be used for maintenance therapy. The optimal daily maintenance dose needs to be reevaluated regularly( e. g. annually). Estrogel should only be continued for as long as the benefit outweighs the risk. The correct dose of gel should be dispensed and applied to clean, dry, intact areas of skin e. g. on the arms and shoulders, and / or inner thighs. The area of application should be as large as possible. Refer to Full Product Information before prescribing. Minimum Product Information Prometrium( oral, micronised progesterone) Indications: menstrual irregularities; adjunctive use with an estrogen in postmenopausal women with an intact uterus. Contraindications: known allergy / hypersensitivity to progesterone or excipients; severe hepatic dysfunction; undiagnosed vaginal bleeding; known missed abortion / ectopic pregnancy; mammary / genital tract carcinoma; thromboembolic disorders; thrombophlebitis; cerebral haemorrhage; porphyria. Clinically Significant Precautions: not a treatment for premature labour; not a contraceptive; discontinue if unexplained visual loss / changes, proptosis, diplopia, papilloedema, retina vascular lesions or migraine; use caution in conditions affected by fluid retention and history of depression, diabetes, hepatic dysfunction, migraine, photosensitivity and during lactation; increased risk of breast cancer and venous thromboembolism with estrogen concomitant therapy( refer estrogen PI); may cause drowsiness; may affect laboratory test results. Clinically Significant Interactions: caution with P450 enzyme inducers and inhibitors; may increase antidiabetic medication; bioavailability may be reduced by smoking and increased by alcohol abuse. Very Common and Common Adverse Effects: menstrual disturbances; headache. d1 – d25. Secondary amenorrhoea: 400mg / d for 10d. Ovulation disorders / anovulation: 200 – 300mg for 10d( d17 – d26, inclusive).
References: 1. Hailes J. Menopause has gone mainstream: What does this mean for women today? [ Internet ]. [ accessed 2025 Feb 17 ]. Available from: https:// www. jeanhailes. org. au / news / menopause-has-gone-mainstream-what-does-this-mean-for-women-today 2. Parliament of Australia. Menopause [ Internet ]. Senate Community Affairs Committee. [ accessed 2025 Feb 17 ] Available from: https:// www. aph. gov. au / Parliamentary _ Business / Committees / Senate / Community _ Affairs / Menopause 3. Estrogel ®( estradiol hemihydrate) Product Information, updated 18 December 2023. 4. Prometrium ®( micronised progesterone) Product Information, updated 1 Feb 2022. MHT: Menopausal Hormone Therapy Estrogel ® and Prometrium ® are registered trademarks of Besins Healthcare. Besins Healthcare Australia Pty Ltd ABN 68 164 882 062. Suite 5.02, 12 Help Street, Chatswood NSW 2067. Office phone( 02) 9904 7473. For medical information call 1800 BESINS( 237 467). www. besins-healthcare. com. au EPR-EST-PRM-2338 March 2025