Sign this petition to demand the NIH acknowledge past unethical menopausal research using Premarin and commit to future ethical menopausal research using ovarian hormones.
As an electrical/bio-medical engineer and a menopausal woman, I trusted the National Institutes of Health (NIH) to design ethical clinical trials for menopausal women. My trust was misplaced because the NIH has not designed ethical clinical trials and has betrayed all menopausal women.
What the NIH has done is inexcusable. The NIH deliberately designed clinical trials that would fail. Then, with fabricated data from the failed clinical trials, the NIH published treatment guidelines that said HRT or Hormone Replacement Therapy was unhealthy for menopausal women even though no HRT was used.[i]
The published treatment guidelines came from 3 pivotal clinical trials, HERS, PEPI and WHI (hers, peh-pee, w-h-i)[ii] that were designed by the NIH to unequivocally fail. The NIH ensured the failure of each of these clinical trials by using a drug called Premarin. The NIH intentionally misrepresented Premarin as Hormone Replacement Therapy or HRT for menopausal women.
The NIH was able to fabricate data based on these indisputable facts about Premarin:
- As shown by FDA documents, women who take Premarin and women who don’t take Premarin have the same ovarian hormone levels.
Premarin doesn’t provide any hormone replacement for a menopausal woman and Premarin was fraudulently described as hormone replacement therapy. - The NIH knew that Premarin wouldn’t provide estradiol replacement. Estradiol is the name of the specific estrogen hormone replacement therapy that menopausal women need to improve their health. Since FDA documents couldn’t say that Premarin is estradiol replacement therapy, the NIH instead came up with the meaningless term ‘estrogen replacement’. The word ‘estrogen’ is the name of a category of many different estrogen hormones, and it makes no sense to say a category of hormones can replace one specific hormone. The NIH knows that every estrogen hormone is unique and not interchangeable with another estrogen hormone.
The NIH used a meaningless term instead of being honest that no estradiol replacement would take place. The NIH intentionally misled women with the promise of hormone replacement with no intention of following through on that promise. - The NIH was reckless with the wellbeing of the menopausal women in the HERS, PEPI, and WHI studies that were given Premarin. The NIH knew that Premarin contained over 250 different active hormones, none of which would result in the replacement of any menopausal hormone. The NIH never identified all of these hormones, nor did they release a purpose for all of these hormones. The NIH intentionally avoided monitoring any of the hundreds of hormones in Premarin. The NIH failed to safeguard the women from hormone levels that are too high or too low.
By not doing any hormone testing at all, the NIH was saying that hormone levels were irrelevant and achieving hormone replacement was not a goal. The NIH never informed the women that there would be no hormone replacement nor the purpose of using hundreds of active unidentified hormones that didn’t result in any hormone replacement. The NIH violated the rights of the women to be fully informed before agreeing to participate in the HERS, PEPI and WHI clinical trials. - The NIH knew that Premarin contained powerful estrogens native only to the fetal horse that were many times more powerful than estradiol replacement therapy. The NIH irresponsibly used powerful horse estrogenic hormones without the use of progesterone or testosterone to protect these women from the over stimulation to their cells from the powerful horse estrogen hormones.
The NIH knowingly and unnecessarily put women at risk of severe illness by exposing them to the powerful estrogens native only to a fetal horse without the protection of progesterone and testosterone. The severe illnesses unique to being exposed to powerful horse estrogenic hormones include blood clots, stroke, heart attack, and cancer. - Pfizer, the manufacturer of Premarin, goes to great lengths to manufacture Premarin in the same archaic, expensive, and inhumane way that it has been made since the 1930’s. Instead of modernizing to save money and avoid the inhumane use of horses and their foals, Pfizer sorts through millions of tons of urine produced by 100,000 live maltreated pregnant horses. There is no accounting that would make it more cost effective to board, breed, and slaughter over 100,000 baby horses and their mothers every year than to modernize manufacturing of Premarin without the use of horses. Pfizer knows that to modernize the manufacturing of Premarin would require the FDA to re-approve Premarin under current FDA regulations rather than the 1942 FDA regulations that originally approved Premarin.
Pfizer knows that the FDA would not re-approve Premarin as hormone replacement if it modernized the manufacturing of Premarin.
Menopausal women deserve scientific research based on scientific rigor, not on fraudulent clinical studies. The NIH needs to be held accountable for designing the HERS, PEPI, and WHI trials with the intent of developing treatment guidelines to intentionally mislead and harm menopausal women.
Let the NIH know that you’re not going to tolerate being misled and harmed by clinical trials that were created to fail and harm their participants and by extension, all women. Demand the NIH restore their credibility to menopausal women by designing ethical clinical trials based on scientific principles and transparency with the intent of success.
[i] nihms662892.pdf Data fraud in clinical trials 2015
[ii] HERS – Heart and Estrogen/progestin Replacement Study, PEPI – Postmenopausal Estrogen/Progestin Intervention Trial, WHI- Women’s Health Initiative