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November 14, 2015

Pro-pharma bias in the NICE menopause guidelines

Last week’s headlines about NICE’s (National Institute of Clinical Excellence) new menopause guidelines (click here) will have pleased the hormone therapy (HT*) manufacturers.

“One million women could benefit from HT, says NHS menopause guidance” The Guardian

“Women SHOULD be given HT to fight menopause, says health watchdog because the benefits far outweigh the risks” Daily Mail.

This is a big change from the long-standing Medicines and Healthcare Devices Regulation Authority (MHRA) advice:

“to use HT only for symptoms and in the lowest dose and for the shortest time possible.”

That cautious advice had been based on two Cochrane reviews, the latest versions of which had concluded:

“combined HT significantly increased the risk of a coronary event (after one year’s use: Attributable risk 4 per 1000, 95% CI 3 to 7), venous thrombo-embolism (after one year’s use: AR 7 per 1000, 95% CI 4 to 11), stroke (after three years’ use: AR 18 per 1000, 95% CI 14 to 23), breast cancer (after 5.6 years’ use: AR 23 per 1000, 95% CI 19 to 29), gallbladder disease (after 5.6 years’ use: AR 27 per 1000, 95% CI 21 to 34) and death from lung cancer (after 5.6 years’ use plus 2.4 years’ additional follow-up: AR 9 per 1000, 95% CI 6 to 13).” Click here for the full review.

“there is strong evidence that treatment with hormone therapy in post-menopausal women overall, for either primary or secondary prevention of cardiovascular disease events has little if any benefit and causes an increase in the risk of stroke and venous thromboembolic events.” Click here for full review.

There hasn’t been any significant new research since either review was written, and NICE couldn’t avoid concluding that combined HT increased venous thromboembolism and stroke. But by conducting a new review and restricting their main analysis to women under 60, which ruled out most Women’s Health Initiative (WHI) trial participants, NICE managed to conclude that there was no increased risk of cardiovascular disease or breast cancer. The point estimate remained that for every 1000 women taking combined HT there would be an additional five heart attacks and five breast cancers, but with fewer trial events, NICE was able to claim that the differences could have occurred by chance. Casting doubt on the evidence that HT increases cardiovascular disease and breast cancer made it easy to spin the conclusion that it was under-prescribed.

But surely NICE would not have commissioned doctors who were biased in favour of HT? The conflicts of interest are listed in appendix C (click here).  Here are the pecuniary ones.

Terry Aspray consultant physician, member of advisory board for Lilly Pharmaceuticals.
Deborah Holloway nurse, chair RCN women’s health conference sponsored by Bayer.
Sally Hope general practitioner, lecture fee from Consilient Health.
Nick Panay gynaecologist, advisory board and sponsored conference fees from Pfizer, sessions sponsored by Bayer and Novo-Nordisk and advisory board meeting coordinated by Shinogi pharmaceuticals.
Anthony Parsons gynaecologist, International Menopause Society meeting attendance fee paid by Novo Nordisk, and advisory board fee from Novo Nordisk.

None withdrew from discussion of the HT advice section.

Dr Panay also forgot to mention his consultancies with Bayer and Abbott (click here) or his other fees from Baxter, Schering, Eli Lilly, Galen, Janssen Cilag, Merck, Novo Nordisk, Novogen, Organon, Orion, Procter & Gamble, Se-cure, Servier, Shire, Solvay, Storz, and Wyeth (click here).

The report’s chair Professor Mary Anne Lumsden and the expert advisor Professor Peter Collins declared no pecuniary interests, but were also forgetful.

I’m happy to forgive Professor Lumsden forgetting her 2004 HT research supported by grants from NovoNordisk and Solvay pharmaceuticals (click here); after all it was along time ago.

But it’s disappointing that Peter Collins so conveniently forgot his more recent service as paid consultant to Eli Lilly, Berlex, Merck, Pantarhei, and Pfizer, and his lecture fees from Berlex, Merck, Pfizer, Novo Nordisk, and Organon (click here). Was he really the best person to interpret HT’s cardiac risks?

I don’t think I’m being overly cynical in seeing bias here? In 2000, and 2004 Elena Hemminki and Klim McPherson wrote two important papers in which they extracted data from a large number of HT trials in younger women, and showed, long before the WHI trials, that evidence of cardiovascular harm was being withheld by pharma. Neither paper was in an obscure or difficult to access journal.

Hemminki E, McPherson K. Value of drug-licensing documents in studying the effect of postmenopausal hormone therapy on cardiovascular disease. Lancet. 2000 Feb 12;355(9203):566-9. (Click here)

McPherson K, Hemminki E. Synthesising licensing data to assess drug safety. BMJ. 2004 Feb 28;328(7438):518-20. (Click here)

Failing to cite these two papers is a pretty good test of a biased HT review. The 253 page NICE guidelines with their five huge appendices had plenty of space to do so, but failed the test.

NICE should be ashamed of itself. Pharma must be pleased with their investment.

Jim Thornton

*Hormone replacement therapy (HRT) changed to hormone therapy (HT) Jan 2016

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