Too often, statin advocates will communicate a drug’s relative risk reduction (impressive number), without quoting the absolute risk reduction (trivial number), a practise we consider unethical (see graph)
The FOURIER trial was cited as evidence of benefit but it did not show a mortality benefit. In fact, there were more cardiovascular deaths and total deaths in the group taking the PCSK9 inhibitors compared to placebo, albeit not statistically significant.
Researchers recently “reanalysed” the data in the FOURIER trial, and found some deaths may have been misclassified. These authors concluded that the potential harm from the treatment is higher than initially reported @BMJ_Openbmjopen.bmj.com/content/12/12/…
A systematic review & meta-analyses of 54 trials using PCSK9 inhibitors, published in @Heart_BMJ, reported no reduction in total mortality or cardiac deaths despite dramatic reductions in LDL-C heart.bmj.com/content/105/15…
The problem with assuming that the benefits of #statins continue to accumulate over decades, is that it ignores the fact that statin harms also accumulate -- especially if the harms take years to manifest e.g. cognitive decline and diabetes mellitus.
Our own findings were confirmed by a 2023 metaanalysis of 60 RCTs of statins, PCSK9 inhibitors & ezetimibe (cholesterol-lowering therapies), which found no association between the degree of LDL-C reduction & cardiovascular or total mortality journals.lww.com/cardiovascular…@LDLSkeptic
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.@CMO_England says excess deaths from heart attacks since pandemic is coz people aren't getting statins & blood pressure pills BUT @carlheneghan shows no “evidence that lipid regulating & antihypertensive drugs were prescribed less in the last 3 years based on the NHS’s data.”
NICE says “high cholesterol is a significant risk factor” for heart disease, but ignores all evidence to the contrary.
Trial data shows new FDA-approved Alzheimer's drug #lecanemab can lead to 'brain shrinkage'.
Advocacy groups celebrate its approval but critics question if the benefits outweigh harms & object to FDA decision without input from advisory committee. maryannedemasi.substack.com/p/alzheimers-d…@RxRegA
No FDA advisory panel?
"The FDA once again has shown a lack of concern for the public, patients, and healthcare providers. Convening its advisory panel would have helped reassure everyone that the FDA’s decision was scientifically sound and transparent,” said @woodymatters
FDA 'accelerated' approval of #lecanumab accepted lower burden of proof for benefit e.g. showing lower amyloid protein in brain (surrogate marker) instead of showing a clinically meaningful benefit for person with Alzheimer's disease on a day-to-day basis.
Dubbed the "warfarin alternative," rivaroxaban has been prescribed more than 80 million times in the US alone. In 2020, it was rated 10th in the global sales rankings and generated almost US$7 billion that year.
The FDA identified numerous & serious data integrity deficiencies at 8 of the study’s 16 clinical trial sites. But when the trial was published in the Lancet in 2009 the investigators made no mention of the data integrity issues.
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Leaked email by former FDA criminal investigator says FDA "turned a blind eye" to Pfizer's "knowing submission of fraudulent data" involving the pivotal #mRNA trial.
Allegations were made by a former federal agent in the FDA’s Office of Criminal Investigations (OCI).
This job of this law enforcement agent was to investigate healthcare fraud.
OCI consists of ~200 agents, hired from US Secret Service, FBI, IRS Criminal investigations unit etc
OCI was established by former FDA Commissioner David Kessler, off the back of the generic drug scandal in the late 80s. Kessler was determined to crack down on fraud after FDA employees were found guilty of accepting bribes from generic drug makers.
“There was no humility or admission of fallibility, no reflection that the lockdowns may have done more harm than good, especially to children’s schooling, or that vaccine mandates were pointlessly divisive” nypost.com/2022/11/30/as-…
Fauci exhibited stress when he was asked why he dismissed the “Wuhan lab leak” theory of the origins of COVID in favor of the less plausible “natural” hypothesis, and denied knowing about the proxy funding of dangerous gain-of-function research on viruses by the NIH.
Fauci was prickly when asked why he dismissed the advice of eminent medicos from the most prestigious universities in the US and the UK, who penned the Great Barrington Declaration in October 2020, urging a less extreme, more scientifically orthodox way of dealing with the virus.
A former staffer in the FDA’s Office of Criminal Investigations was also concerned about the agency’s failure to fully tackle @IamBrookJackson complaint about falsified data in Pfizer’s mRNA vaccine trial.
The FDA only has 89 inspectors to oversee hundreds of thousands of clinical trial sites.
“I don’t think that it is a sufficient number of staff to do that kind of level of oversight...The FDA must have enough of a presence to dissuade investigative sites from committing fraud”