27 February 2004

---The Case of Medicine and Business

Five years before the prevention trial called the Women's Health Initiative (WHI) involving hormone replacement therapy (HRT) was stopped, a researcher named Professor Klim McPherson, PhD of Oxford University was ignored and ridiculed when he warned that hormone replacement therapy (HRT) increased heart disease risk.

The WHI was US-sponsored, involved 16,000 women, and a 15-year research program to address the most common causes of death, disability and poor quality of life in postmenopausal women -- cardiovascular disease, cancer, and osteoporosis.

It was stopped in July 2002 after finding that the associated health risks outweighed the benefits: women on HRT (long-term use of combined estrogen and progestin as menopausal hormone therapy) had a higher risk of heart disease, stroke, and breast cancer compared to those taking placebo.

In 1997, Professor McPherson and colleagues raised the red flag about HRT and heart disease after analyzing 23 pharmaceutical-industry trials involving some 3,300 women. Instead of finding a 50% reduction in heart disease risk for women taking HRT, as observational studies suggested, the combined data indicated a 40% increase in risk.

The same studies were done by pharmaceutical companies and were used to help them get licences for HRT drugs.

The pharmaceutical companies KNEW (!!!) and still they pushed through marketing and selling HRT drugs.

Professor McPherson published his observations after his study reviews and instead of being heeded, was laughed at.

He had to win a court battle with the drug companies that conducted them to gain access to the findings. Six studies he found showed an even stronger link between HRT use and heart disease risk.

He now says the hormone replacement therapy (HRT) experience could happen again unless drug manufacturers are required to change the way they report clinical trials. He suggests that government regulators require the pharma companies to record all adverse events when they conduct clinical studies and MAKE THEIR RESULTS PUBLIC. This commentary of his is published in the Feb. 28 issue of the British Medical Journal.

What can I say?

Business and medicine simply cannot mix. Business works for profit and profit alone, while medicine works to do no harm.

When will we ever learn? When its too late?

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