Myth: women are underrepresented in clinical trials. Reality: men are underrepresented in clinical trials. Source: Report of the NIH Advisory Committee on Research on Women's Health, 2021-2022

sakura_drop · 2024-08-30T21:07:08+00:00

I literally just posted this on the other sub, but it's relevant here too:

'Did Medical Research Routinely Exclude Women? An Examination of the Evidence'

These analyses indicate that before 1990, women routinely participated in clinical trials, and in numbers that are more than proportionate to the number of women in the overall population. Although these analyses of clinical trials appear to be persuasive, they leave unanswered the question of female participation in epidemiologic research.

During this time frame, 13,119 of the published epidemiologic studies included men, and 15,193 studies included women. These numbers represent a 15.8% difference favoring women. ... Overall, the total number of clinical trials favored women by a 26.5% margin, an even greater disparity than that noted for the Medline analysis of epidemiologic studies.

In 1994, the first year in which the tracking system was operational, men were found to represent 44.9% of enrollees in extramural research, women 51.8%, and the sex of the remaining 3.3% was unknown. By 1994, male participation had fallen to 32.2%. 11 Numerically, 1,501,687 fewer males than females were enrolled in NIH extramural research in 1997.

The percentage decline in male enrollments appears to be associated with the growth in female-only protocols. In 1994, the NIH sponsored 95 male-only studies, and 219 female-only studies. 12 By 1997, the disparity had widened to 244 all-male studies vs. 740 all-female studies. 13 Based on data provided by the NIH_Office of External Research, the 1997 single-sex studies enrolled 85,901 males and 1,264,381 females. This difference of 1,178,480 persons accounts for much of the overall NIH shortfall in male enrollment.

A review of sex-specific enrollments in medical research studies, and an examination of the number of epidemiologic studies and clinical trials that included men and women, point to two conclusions: 1) Historically, women were routinely included in medical research, and 2) Women have participated in medical research in numbers at least proportionate to the overall female population.

'The Sex-Bias Myth in Medicine'

What about all the new drug tests that exclude women? Don't they prove the pharmaceutical industry's insensitivity to and disregard for females?

The Food and Drug Administration divides human testing of new medicines into three stages. Phase 1 studies are done on a small number of volunteers over a brief period of time, primarily to test safety. Phase 2 studies typically involve a few hundred patients and are designed to look more closely at safety and effectiveness. Phase 3 tests precede approval for commercial release and generally include several thousand patients.

In 1977 the FDA issued guidelines that specifically excluded women with "childbearing potential" from phase 1 and early phase 2 studies; they were to be included in late phase 2 and phase 3 trials in proportion to their expected use of the medication." But: "FDA surveys conducted in 1983 and 1988 showed that the two sexes had been proportionally represented in clinical trials by the time drugs were approved for release.

The 1977 guidelines codified a policy already informally in effect since the thalidomide tragedy shocked the world in 1962. The births of armless or otherwise deformed babies in that era dramatically highlighted the special risks incurred when fertile women ingest drugs. So the policy of excluding such women from the early phases of drug testing arose out of concern, not out of disregard, for them. The policy was changed last year, as a consequence of political protest and recognition that early studies in both sexes might better direct testing.

To remedy the alleged neglect, an Office of Research on Women's Health was established by the NIH in 1990. In 1991 the NIH launched its largest epidemiological project ever, the Women's Health Initiative. Costing more than $600 million, this fifteen-year program will study the effects of estrogen therapy, diet, dietary supplements, and exercise on heart disease, breast cancer, colon cancer, osteoporosis, and other diseases in 160,000 postmenopausal women. The study is ambitious in scope and may well result in many advances in the care of older women.

What it will not do is close the "medical gender gap," the difference in the quality of care given the two sexes. The reason is that the gap does not favor men. As we have seen, women receive more medical care and benefit more from medical research. The net result is the most important gap of all: seven years, 10 percent of life.

It's like a never ending toppling of a very high, carefully constructed house of cards.

GodlessPerson · 2024-08-30T20:59:49+00:00

Watch as feminists will use past studies (many of which done on prisoners (so obviously mostly male) without their consent) to justify cutting out men completely.

funnystor · 2024-08-30T18:57:39+00:00

Sorry for the double post, the first time I accidentally uploaded a lower resolution version

vtj · 2024-09-01T11:22:32+00:00

The entire NIH report can be found here.

maomaochair · 2024-09-02T13:43:51+00:00

One thing i dont understand about the drug test and trials: When we analyze the race and class of the test subject, they are likely low income and black as they have less other choices so they have more incentive to participate the trails. Or, their human right are neglected, as there were many many clinical to black people with deception or without informed consent in the last century.

So even if women were underrepresented, why it cannot be interpreted as women being priviledged?

Title	Myth: women are underrepresented in clinical trials. Reality: men are underrepresented in clinical trials. Source: Report of the NIH Advisory Committee on Research on Women's Health, 2021-2022
Author	funnystor
Upvotes	170
Comments	8
Date	August 30, 2024 6:56 PM UTC (1 year ago)
Subreddit	Posted in /r/LeftWingMaleAdvocates
Original Link	https://old.reddit.com/r/LeftWingMaleAdvocates/comments/1f533hl/myth_women_are_underrepresented_in_clinical/
Archive Link	https://theredarchive.com/r/LeftWingMaleAdvocates/myth-women-are-underrepresented-in-clinical-trials.1528883 https://theredarchive.com/post/1528883

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