Hormone Therapy
Teamed Up Seeking Justice Against the Pharmaceutical Industry
Bubalo, Hiestand & Rotman, PLC, the Becker Law Office and other law firms have joined forces to seek justice for women who have been injured by taking oral hormone replacement therapy drugs, such as Prempro, Premphase, Premarin, Provera, and other estrogens and progestins. Together, these law firms combine dozens of lawyers who are devoted solely to protecting your rights. Bubalo, Hiestand & Rotman, PSC and The Becker Law Office, with other firms, are members of the Plaintiffs' Personal Injury Discovery Committee (PPIDC), a committee appointed by the federal district court in Arkansas to prosecute these actions against the responsible drug companies that manufactured and marketed these drugs. We are devoted to representing one woman at a time, and addressing her individual injuries.
Bubalo, Hiestand & Rotman and its other team members have filed a major lawsuit in St. Louis against the pharmaceutical companies who are the market leaders in producing these dangerous products.
Injuries Caused By Hormone Therapy:
- Breast Cancer
- Heart Attacks
- Strokes
- Venous Blood Clots
- Auto-Imune Disease
- Ovarian Cancer
- Galbladder Cancer
Hormone Therapy Industry
Primary Drug Companies Involved
Hormones and a History of Harm: DES and Uterine Cancer
Combined Therapy Causes Disease
Hormone Therapy Industry
For decades, the pharmaceutical industry has marketed and sold estrogens (both opposed and/or unopposed by progesterone or progestin), under the brand names Prempro, PremPhase, Premarin, Provera and others to women and their doctors to replace the female hormones lost during menopause. During this time, the drug companies convinced the medical community and the general public that menopause was a disease that needed to be treated with hormone replacement therapy drugs. The drug companies claimed that their hormone replacement therapy drugs could not only cure typical menopausal symptoms such as hot flashes, night sweats and irritable mood swings - they claimed that the drugs also could prevent heart disease and other long term illnesses.
The drug companies made these claims despite the absence of clinical trials to test the safety and efficacy of these drugs on a long term basis. All that changed on July 9, 2002 after the National Heart Blood and Lung Institute (NHLBI), a division of the National Institute of Health, announced that it had stopped a major clinical trial of the risks and benefits of combined hormone replacement therapy.
The NHLBI study was a 15-year clinical study conducted by the Women's Health Initiative (WHI), which was to have continued until 2005. However, the NHLBI terminated the WHI study after data revealed that, instead of preventing heart disease, there was a marked increase in heart disease, stroke, blood clots, and hip fractures in women taking combination hormone replacement therapy after an average follow up of 5.2 years, compared with women who took placebo. Most alarming was the conclusion of the WHI study that taking combination hormone replacement therapy increased a woman's risk of breast cancer by 26%.
The WHI study revealed the following alarming risks (which clearly outweigh the listed benefits) for women who took long-term combination therapy:
- Breast cancer - up 26%
- Strokes - up 41%
- Blood Clots in the veins - up 107%
- Blood clots in the lungs - up 113%
- Heart disease - up 29%
- Hip fractures - down 34%
- Spinal fractures - down 34%
- Colorectal Cancer - down 37%
The WHI Study also found that the combination hormone regimen should not be initiated or continued for primary prevention of coronary heart disease.
Studies subsequent to the WHI study show that the long term effects of combination hormone replacement therapy are even more severe than the WHI study revealed. The studies and findings stemming from the WHI have shown, literally, an epidemic of breast cancer likely caused by the use of combination hormone therapy. Scientific proof has shown that hormone replacement therapy is now recognized as a catalyst to increase the risk of hormone positive breast cancer, heart attacks, strokes, deep vein thrombosis, pulmonary emboli, ovarian cancer, and lupus, to list a few.
On January 6, 2003, Wyeth, the manufacturer of Premarin and Prempro, abandoned its long-standing marketing strategy of promoting the long-term use of Premarin and Prempro, and announced that it was adopting new labeling for its hormone therapy drugs in light of the WHI findings. The warnings now emphasize that Prempro and other forms of combination hormone therapy are not approved for the prevention of heart disease.
Primary Drug Companies and Drugs Involved
The primary drugs responsible for the damaging effects of hormone replacement therapy and the drug companies that manufacture them are:
- Premarin (Wyeth), alone or when used in combination with Provera (Pharmacia/Upjohn/Pfizer), Cycrin (Wyeth), or MPA (Barr Laboratories or Greenstone Limited, a subsidiary of Pharmacia/Upjohn/Pfizer
- Prempro (Wyeth)
- Premphase (Wyeth)
Hormones and a History of Harm: DES and Uterine Cancer
The history of hormone therapy in women contains numerous red flags that should have cautioned drug companies against the widespread use of these therapies, without adequate testing. Unnecessary injury associated with the use of these therapies is the rule, not the exception. Two examples are the use of DES and uterine cancer.
Birth Defects
A stampede of pharmaceutical companies sought to market Synthetic Estrogen or "DES". In their haste for profits, none of the pharmaceutical giants paused to question the safety or benefit of this drug. By 1947, the FDA approved DES for the treatment of miscarriages even though no testing had been performed. This form of synthetic estrogen stayed on the market for this purpose until 1971 and was given to millions of pregnant women. Tragically, mothers who took DES had a 40% to 50% increased chance of breast cancer. It also caused multiple birth defects and other injuries, as explained below:
- DES sons may have lowered sperm counts; sterility; increased risk of testicular cancer; missing, small, or undescended testicles; cysts; and abnormally small penises, as well as a higher than average risk of depression.
- DES daughters are the best-known victims of the drug. Among them, their mothers' DES use has been linked to immune system disorders, bone loss, and breast cancer. In addition, DES daughters have been shown to have suffered from cervical dysplasia, a potentially pre-cancerous condition; adenosis, a "pre-cancerous cell change"; a cancer known as clear cell adenocarcinoma (found in approximately one of every one thousand DES daughters); a T-shaped uterus; a small, hooded, or incompetent cervix; and an increased risk of miscarriages and ectopic pregnancies. These reproductive system malformations often result in difficulties conceiving and carrying children to term and contribute to the injuries in their children...1
Unfortunately, the reckless attitude of the drug industry toward hormones did not end with DES. The use of "unopposed" estrogen (Wyeth's best seller being Premarin®) also resulted in an epidemic of endometrial cancer.
The following Figure 12 shows the annual number of estrogen prescriptions to women ages 50-74 in a sample area when compared to the number of new cases of endometrial cancer. As the prescription rate for estrogen fell, so did the incidence of cancer.
Figure One
By the 1980's, the increased risk of endometrial cancer from "exogenous estrogen," (like Wyeth's best seller, Premarin®) had become obvious. Studies consistently found that the long term use of estrogen increased the chances of cancer at least three times or perhaps more.3
1 See generally "DES Third-Generation Liability: A Proximate Cause," 18 Cardozo L. Rev. 1217, 1220-21 (1996)1221. (Authority and footnotes deleted.)
2 Donald F. Austin, M.D., MPH and Kathleen M. Roe, MPH, The Decreasing Incidence of Endometrial Cancer: Public Health Implications, 72 American Journal of Public Health, No. 1 (January, 1982).
3 See, e.g., Hulka, B.S., et al., Estrogen and Endometrial Cancer: Cases and Two Control Groups from North Carolina, 137 Am. J. Obstet. Gyneocol. 92 (May, 1980) (relative risks were as high as 4.1 for estrogen taken more than 3 ½ years); See also Jelovek, F.R., et al, Risk of Exogeenous Estrogen Therapy and Endometrial Cancer, 137 Am. J. Obstet. Gynecol. 85 (May, 1980).
Combined Therapy Causes Disease
The solution of the drug industry to endometrial cancer of the uterus was "combined therapy." Combined therapy involved coupling estrogen with progesterone. Before the 1980's, women were prescribed primarily estrogen only. This caused a lack of hormonal balance because estrogen alone over stimulated the lining of the uterus causing uncontrolled growth. This hyper stimulation, in turn, resulted in a condition known as "hyperplasia." To avoid this risk, progestins were given, to induce menses. Bleeding allowed the endometrial lining of the uterus to shed and brought the otherwise uncontrolled growth somewhat under control, due to a balance of the progestins "opposing" the estrogen.
Progestin was added to protect against UTERINE CANCER. However, the role of progestin and estrogen concerning BREAST CANCER were untested and unclear. As early as 1980, independent studies suggested a causal connection between HT and breast cancer.4 Unfortunately for the women taking these drugs, the warning signs went largely unheeded by the drug companies.
The form of progestin used in most combined therapies, starting in the 1980's after the disaster of endometrial cancer, was Medroxyprogesterone acetate (MPA). MPA is contained in many of the drugs sold by the drug companies as the "opposition" to estrogen supposedly needed to avoid uterine cancer. Provera® (manufacturered by Pharmacia / Upjohn / Pfizer), Cycrin® (Wyeth), and Prempro® (Wyeth) contain MPA.
Other drug companies made a generic form of MPA in order to capture a share of the HT market. Although MPA was combined with estrogen to supposedly protect against uterine cancer, it has been used for years to induce breast cancer in laboratory animals for the purpose of studying breast cancer and its treatments. Moreover, progesterone has just been recognized by the World Health Organization ("WHO"), International Agency for Research on Cancer ("IARC"), as a known human carcinogen. The IARC's recognition was made on the basis of studies of laboratory animals that have been known for decades.5
Importantly, this HT combination of known carcinogens, after sales of "monotherapy" or "unopposed" estrogen alone were destroyed by the risk of uterine cancer, began without any safety studies or "clinical trials." Clinical trial is explained by Reference Manual on Scientific Evidence, 2nd at 338:
- To determine whether an agent is related to the risk of developing a certain disease or an
adverse health outcome, we might ideally want to conduct an experimental study in which the
subjects would be randomly assigned to one of experimental study in which the subjects would
be randomly assigned to one of two groups: one group exposed to the agent of interest and the
other not exposed. After a period of time, the study participants in both groups would be
evaluated for development of the disease. This type of study, called a randomized trial,
clinical trial, or true experiment, is considered the gold standard for determining the
relationship of an agent to a disease or health outcome. Such a determining study design
is often used to evaluate new drugs or medical treatments and is the best way to ensure
that any observed difference between the two groups in outcome is likely to be the result
of exposure to the drug or medical treatment.
(Emphasis Added.)
Until July, 2002, combination HT had never been subjected to the "gold standard" required of almost all modern medications. In other words, no one had tested these drugs in clinical trials for safety and efficacy prior to giving them to millions of women. As of July, 2002, 38% of American women used HT.6 Forty-six (46) million prescriptions were written for Premarin® in the year 2000 with more than $1 Billion in sales to its manufacturer.7 In addition, "... 22.3 million prescriptions were written for Prempro® (conjugated estrogens plus medroxyprogesterone acteate)."8 "Since the mid-1980's, combined estrogen/progestin use [had] steadily increased." 9
As stated in the accompanying editorial that appeared in JAMA on the date the initial findings of the WHI were published: ".the whole purpose of healthy women taking long-term estrogen/progestin therapy is to preserve health and prevent disease. The results of this study [WHI] provide strong evidence that the opposite is happening for important aspects of women's health.." 10
4 Ross, R.R., et al., A Case-Control Study of Menopausal Estrogen Therapy and Breast Cancer. 243 J.A.M.A. 1635 (April 1980).
5 IARC's Fourth Annual Report on Carcinogens, emphasizes that there has been no adequate human study of the effect of progesterone. However: "Progesterone is reasonably anticipated to be a human carcinogen based on sufficient evidence of carcinogenicity in experimental animals (IARC 1982)."
Go to: http://ehp.niehs.nih.gov/roc/toc10.html for a complete copy on line.
6 Fletcher, Suzanne W., et al., Failure of Estrogen Plus Progestin Therapy for Prevention, 288 J.A.M.A. 366 (July, 2002).
7 Id.
8 Id.
9 Id.
10 Fletcher, Suzanne W., et al., supra. at 367.
Call Bubalo, Hiestand & Rotman for a Free Evaluation of your Hormone Therapy case at Toll Free 1-866-870-2489.
