Seems the potential conflicts-of-interests between private healthcare companies and government regulators are not limited to the US. The near-universal policy to follow-the-money seems to also hold true in the UK as well.
From the BJM Report:
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Big promises have been made for the Galleri blood test, which its maker, the Californian biotechnology company Grail, says is capable of detecting more than 50 types of cancer. Harpal Kumar, president of Grail Europe, has hailed the test as a “groundbreaking and potentially life-saving advance that could have a tremendous human and economic benefit.”
The NHS is currently running a £150m trial of the test, involving more than 100 000 participants in England. Depending on the results, the plan is to roll out a further pilot involving up to one million tests.12 If effective, the test would help the NHS meet its target to diagnose 75% of cancers at an early stage by 2028. Trial success would also hand Grail a lucrative deal; although contract details remain confidential, a single test in the US currently retails for $950 (£750; €880).
Multicancer early detection tests such as Galleri are touted as a game changer. Instead of screening for one disease at a time, as the NHS does for breast, bowel, and cervical cancer, for example, technology now exists that has the potential to test for dozens of cancers from a single blood sample.
But experts believe that Galleri has been overhyped and that the current trial is unethical. Concern is mounting over why this particular new screening test has been selected, how it is being evaluated, and whether the bar to success has been set too low.
New evidence
Documents leaked to The BMJ indicate that the criteria being used, unpublished until now, are unsuitable to justify a new national screening programme aimed at saving lives.
They show that even Mike Richards, the chair of the independent UK National Screening Committee, has privately voiced “serious concerns” to Amanda Pritchard, NHS England’s chief executive, about the trial and its ability to provide sufficient evidence “on whether the benefits of testing outweigh any potential harms and at reasonable cost.”
Other documents obtained by The BMJ detail the deal between the NHS and Grail, raising questions about whether it is too industry friendly. As well as agreeing to buy one million tests after satisfactory completion of the first stage of the trial,1 the NHS has committed itself to buying five million more tests by 2030 if the test fulfils certain criteria, show documents seen by The BMJ. In return, Grail would build a “new state-of-the-art test processing and sequencing facility in the UK once the NHS commits to purchasing minimum annual volumes, keeping the UK at the global forefront of clinical application of genomics.”3
Richard Sullivan, director of the Institute of Cancer Policy at King’s College London, says that the Grail deal is a “clear cut case of public risk and private profit.” He says, “It is following a pattern established in this country over the past decade where the regulatory or evidential bar is being set lower and lower in favour of the private sector, with the public sector (that is, our taxes) taking all the risk.”
Added to these concerns, it emerged in June that Grail is facing a class action lawsuit in the US.4 Embittered investors, faced with steep losses, claim that the company exaggerated Galleri’s effectiveness to increase its share price. The plaintiffs claim it was “false and misleading” that the rollout would “save tens of thousands of lives.” A Grail spokesperson told The BMJ that they “don’t comment on ongoing litigation.”
(emphasis added)
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Here is link to the full BJM Report:
Galleri promises to detect multiple cancers—but new evidence casts doubt on this much hyped blood test, the BJM, Feature, BJM Investigation, BJM 2024, (Published 07 August 2024).
this is nothing like the outright fraud at Theranostics. it is cutting edge research towards developing a cell free blood test for many cancers ,especially aggressive cancers using DNA Methylation patterns as the focus of the test (Grail)
It may not be ready for prime time but the kinks will only be worked out as it is further deployed. There was a Peter Attia MD podcast on the Drive with Alex Arabia MD the scientific developer of the test. It is well worth a listen. #290 on Feb 29, The role of Liquid biopsies for early cancer detection, the role of epigenetics in aging and the future of epigenetics research. At peterattiamd.com/The Drive. It is promising IMO Paul/ MB
Paul - Agree 100% re: Theranos comment. It was done somewhat tongue-in-cheek and, in respect of your comment, I will edit it out of the post. Poor taste on my part is not really a very good excuse for adding it. 🙊
As for the BJM paper, it raises genuine concerns over the nature of the relationships between the medical "industry" and government agencies/regulators charged with protecting the public interest in allocating our tax dollars to reflect the best health outcomes - both in the short and long-terms. In particular, impartiality is near non-existent on the part of many regulatory agencies in the US - due to the unrestrained revolving doors that exist between the public and private sectors that impact all aspects of our health and welfare. (The bailout of the bad actors in the financial sector in 2008 being maybe the worst recent example.) Preventing the employment of regulators in any industry they regulate (for say a minimum of five years) would change that dynamic overnight.
I also look at the current rush to GLP drugs, as the magic (and costly) solution to the overweight/obesity epidemic, as another potential misallocation of limited resources for healthcare. In spite of the well-founded arguments that point to the cost-effectiveness of these drugs for solving multiple metabolic problems, the issue is that we are once again treating the symptoms rather the cause. The special interests that benefit from the obese and overweight populations are powerful agents that prevent the sorts of fundamental changes that would (could) solve the problems at their root cause; i.e., bad diets made up of poor quality ultra-processed food in unhealthy formulations and quantities, coupled with inactive lifestyles. Peter Attia refers frequently to his notion that what we need is Medicine 3.0 with a focus on prevention vs. treatment. Unfortunately we are locked into a system that has zero incentives on the prevention end and seemingly endless ones on the treatment end.
Some years back, I remember reading a MedPage Today post by Vinay Prasad that, upon hearing of his death, honored one of his professional mentors, Dr. Eli Estey, MD,. In the post (and in the internally linked interview with Dr. Estey), he describes how drug development and treatment protocolsoriginated not from the private special interest sectors, but rather from the doctors and researchers in the clinic. This passage from his tribute highlights how much things have changed (A link to the full post is below):
"Cancer medicine was different then. The majority of cancer research was funded by public sources and philanthropy, and the role of the biopharmaceutical industry was virtually absent. Research moved fast and chaotically. A clinical observation could rapidly transform into an investigational protocol, and paperwork and bureaucracy had not yet metastasized and sapped the strength of clinical researchers."
Now the drug/medical industry design the clinical trials and pay doctors directly to run them. (see ProPublica's Dollars for Docs and the newer, updated Open Payments for how much they pay them!) They even seem to more and more even write the research papers for clinical trials, with the docs relegated to little more than the role of proof-reading signatories.
Links:
What Happens When All the Great Doctors Are Gone? — In commemoration of the late Elihu (Eli) Estey, MD, by Vinay Prasad, MD, MPH, MedPage Today, Perspectives, October 13, 2021
Dollars For Docs - How Industry Dollars Reached Your Doctors, ProPublica (Note: with the advent of the Open Payments US Gov. website the ProPublica data was last Updated October 17, 2019.)
P/MB - In closing out this reply, Thanks for the commentary & I hope those steps have turned into walks, with the ultimate goal being runs. Stay strong, safe, and well. Ciao - Capt'n cujoe
I was told by a tour organizer that their best clients are the pharmaceutical companies sponsoring medical congresses. Their mandate is simple: "Pay anything docs and their spouses request. We cover for anything". I was naive enough to ask: " Do they pay for the wives also?". The answer was much illuminating: "Of course, but it doesn't amount much. Only the additional air ticket and the cost of organising a parallel program for accompanying persons. The room is already paid, single or double occupancy doesn't make any difference. In fact, the cost to the pharma company is less if the doc is with his wife". "How come this", I asked. "Do you know how much you have to pay for calling a hooker in a 5 star hotel?". I remained speechless!!!
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New prostate cancer diagnosis @ 52
