The commercial world of pharmaceuticals contains many bright and highly motivated scientists who genuinely want to develop or extend human knowledge to assist with the management or eradication of disease. As with all sectors of society there are those who are more diligent about their work than others, and there are those who seek to make a financial return regardless of the risks involved. A recent article in PLOS exposes the dramatic use of ghost writers and nefarious activities of Wyeth in their promotion of the menopausal hormone therapy Prempro (conjugated equine oestrogens [CEEs] and medroxyprogesterone acetate [MPA]).[1]
Key Points
- Some 1500 documents revealed in litigation provide unprecedented insights into how pharmaceutical companies promote drugs, including the use of vendors to produce ghostwritten manuscripts and place them into medical journals.
- Dozens of ghostwritten reviews and commentaries published in medical journals and supplements were used to promote unproven benefits and downplay harms of menopausal hormone therapy (HT), and to cast raloxifene and other competing therapies in a negative light.
- Specifically, the pharmaceutical company Wyeth used ghostwritten articles to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular “benefits” of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson’s disease, vision problems, and wrinkles.
- Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.
I remember seeing a Terry Wogan evening show where a well known, but older (read menopausal) actress was celebrating the invention of HRT and the rejuvenation of her energy and ..shhhhh her love life! This unpaid non peer reviewed endorsement of a new category of lifestyle drugs was instrumental in pushing patients to ask their Dr’s for this medicine.
HRT, has had a rocky history. Initially heavily promoted by more august bodies than Terry’s show as a panacea to all ills, by 1998 the HERS trial showed it didn’t prevent cardiovascular events after all,[2] and by 2002 the Women’s Health Initiative trial showed it also increased the risk of breast cancer and stroke.[3] We now know it increases the risk of dementia and incontinence.
Today, despite definitive scientific data to the contrary, many gynaecologists still believe that the benefits of HT outweigh the risks in asymptomatic women.[4] This non-evidence–based perception may be the result of decades of carefully orchestrated corporate influence on medical literature.
Comment
It remains a challenge to read papers and see that they have been guided by commercial events into a collective opinion for which the recovery is financially rewarding but the cost to humans disproportionately high.
Without doubt these sorts of ghost written papers have been rife, and despite well meaning attempts to control this they still go on.
For all the lack of suitable RCT trials on natural medicines, especially food supplements we can be confident in saying that the risk of adverse – or fatal reaction to a collectively touted intervention/nutrient will never amass the level of damage this single drug therapy has – let alone all the other casualties of medication.
We all want safe effective treatments and in an integrated view most us do not care which family of agents we use if they work – but where there is a better risk to benefit ratio, humans naturally gravitate to the lower risk option – hence the continued consumption of alternative medicines.
References
[1] Fugh-Berman AJ. The Haunting of Medical Journals: How Ghostwriting Sold “HRT”. PLoS Med. 2010 Sep 7;7(9). pii: e1000335 View Full Paper
[2] Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. Heart and Estrogen/progestin Replacement Study (HERS) Research Group. JAMA. 1998 Aug 19;280(7):605-13.View Full Paper
[3] Rossouw JE, Anderson GL, Prentice RL, LaCroix AZ, Kooperberg C, Stefanick ML, Jackson RD, Beresford SA, Howard BV, Johnson KC, Kotchen JM, Ockene J; Writing Group for the Women’s Health Initiative Investigators.
Risks and benefits of estrogen plus progestin in healthy postmenopausal women: principal results From the Women’s Health Initiative randomized controlled trial. JAMA. 2002 Jul 17;288(3):321-33. View Full Paper
[4] Fugh-Berman A, Scialli AR (2006) Gynecologists and estrogen: an affair of the heart. Perspect Biol Med 49: 115–130. View Abstract
