Pfizer in court again, this time for Wyeth's menopause treatment Prempro
Filed under: Company News, Healthcare, Pfizer
Pfizer Inc. (PFE) sure is no stranger to finding itself in court. The pharmaceutical giant is constantly defending its practices and drugs, often ending up paying millions if not billions in damages -- even admitting to felony criminal charges. Pfizer has also inherited lawsuits with some of the companies it has purchased. It's recent $68 billion mega acquisition of Wyeth is no different.On Monday, a Philadelphia jury, which had earlier found a link between a woman's breast cancer and the hormone-replacement drug she was taking, also found that Wyeth hid and ignored evidence of the drug's potential cancer risk. The jury awarded Connie Barton an undisclosed amount of punitive-damages.
Barton's case is one of 9,000 Prempro lawsuits across the country. About 1,500 are pending in Philadelphia alone, opening up the door to more potential liabilities for Pfizer, which just recently was ordered to pay a record $2.3 billion fine for illegally marketing painkiller Bextra, which is now off the market.
The drug, Prempro, from Pfizer's unit Wyeth, is a combination of hormones estrogen-progestin (Premarin and Provera) and is taken as a menopause treatment.
Barton took Prempro for five years before she was diagnosed with invasive breast cancer in 2002. Wyeth's lawyer George McDavid had argued that Barton had breast cancer before she began taking Prempro. The jury was not convinced and found that Prempro caused Barton's breast cancer. She was awarded $3.75 million in compensatory damages in September. The punitive award was sealed pending another verdict in a second Prempro case in the same courthouse.
Once again, this case highlights the reasons for the public's longstanding distrust and mistrust of pharmaceutical companies. The AP reports that Esther Berezofsky, one of Barton's lawyers said, "They knew back in the 1970s that these drugs had the potential to cause breast cancer, so they didn't have the studies done." Wyeth, the lawyer added, consistently downplayed bad results.
Only on Monday, Booster Shots reported that a new study by French researchers examined how clinical trials are being reported in medical journals. They found that even though "The reporting of harm is as important as the reporting of efficacy [...] harm is frequently insufficiently reported." Often hard data is not being provided in the publications, and when it is, it is often distorted.
It is interesting that in the editorial to this study, Dr. John Ioannidis of the University of Ioannina School of Medicine in Greece, attributed some of the under-reporting to companies intent on "silencing the evidence." He singled out Merck's (MRK) Vioxx -- the painkiller that doubled the risk of heart attack and stroke, and Pfizer's Neurontin -- an epilepsy drug that the FDA linked to an 80 percent increase in suicidal thoughts and behavior. "In these cases," Dr. Ioannidis wrote, "marketing needs prevail over scientific accuracy and clinical prudence."
During its court case, Wyeth, told jurors that women are now fully informed of the risks and benefits of Prempro. Further, in arguing against the punitive damages, a lawyer, on behalf of Wyeth, said the drug maker changed its practices and policies such as letting its consultants ghostwrite medical journal articles, promoting off-label drug use and giving gifts to doctors. Attempts to reach the company were not immediately answered.
Sales of the drug have plummeted since 2002 when a large federal health study, the Women's Health Initiative, linked the therapy to breast cancer and cardiovascular risks. The study was stopped as a result. Another study this year also showed that lung cancer seems more likely to prove fatal in women who are taking the combination drug.
Berezofsky claims that 200,000 women who got breast cancer could have avoided it had they not taken Prempro. However, Prempro and the combination hormones remain on the market. More than six million women have taken hormone-replacement medicines to treat menopause symptoms such as hot flashes, night sweats, and mood swings.
So far, Wyeth has lost five of eight trials regarding this matter since 2006. All cases are on appeal. In cases in Arkansas and Nevada, some damages were set aside or reduced.
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Reader Comments (Page 1 of 5)
10-27-2009 @ 10:08PM
KIm said...
Ladies, get bio identical hormone replacement. It saved my life and it won't EVER cause cancer. Pharma cannot patent anything natural so they painted the bioidenticals with the same paint brush. They not only lose money on the hormones but also on the other related drugs such as sleep aides, diet aides, bone drugs and I can go on and on. Read the Suzanne Somers books. She is no ditz. I have been taking them for years and I look and feel great. Research this very important subject.
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10-27-2009 @ 10:46PM
LJC said...
What Kim said!! Bioidentical hormones gave me back my life after premature menopause. www.thewileyprotocal.com
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10-28-2009 @ 12:32AM
Dorothy Sooter said...
I was on premarin and one other menapause drug for 16 years. I started out on low dosage and they increased it through the years. In 1998 I went to the Doctor for a constant discharge. They discovered I had two cysts on my ovaries. I was 64 and did not have insurance so the Doctor had me take blood test and I waited until I was 65 and had insurance. I was sent to another Doctor who did not examine me and said I had to have a hysterectomy.
I just wanted him to remove the cysts but he scared my husband and I had the hysterectomy. I was still on the hormone replacement and in 2002 a lump in my breast was invasive cancer. I requested that they remove both breast because it had come on so fast. The Doctor agreed. The television was then telling all women the possibility of the hormones and breast cancer. I stopped the hormones and my discharge stopped but I already had the cancer. The Doctor that did my hysterectomy said the discharge would stop but it never did until I stopped the hormones. I was fortunate after the surgery that my lymph nodes were not affected and I did not
have to have chemo, radiation or take the pill Tomaxafin (think that was the name). I had an HMO and developed lympadema in both arms. It took the HMO 14 months to get me therapy and by then it was too late. I was fortunate in having a good Doctor for the removal of my breast and am quick to tell the younger population not to take any of the hormone replacements.
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10-28-2009 @ 10:59PM
J. said...
I am so sorry you had to go through all that you did. I hope you are healthy and strong now, and feeling great. May God bless you.
10-29-2009 @ 1:50AM
ChickaDee said...
Hello Dorothy,
I too am a breast cancer survivor for 9 1/2 years. I was dx with invasive stage 2. Had a mastectomy with free flap reconstruction and all of my lymph nodes were removed. Had chemo for 6 months. Didn't need tamoxifin because my tumor was estrogen negitive. That's prob why you didn't need it either.
Only patients with estrogen positive tumors get tamoxifin. ...which means that the tumor was brought on by estrogen.
I'm sorry about your lymphedema. There are specialty therapists that only treat lymphedema. You should check with your Dr. or local Amer Cancer Society for information.
I hope you are cancer free. Best of luck and stay healthy.
10-28-2009 @ 12:36AM
jj said...
I don't take anything from chemestry. I wasn't born with pills on my mouth. Don't believe much on chimicals. Today's meds are only good to utinice people.
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10-28-2009 @ 1:58PM
Tibbott said...
Good God. Learn to spell.
10-28-2009 @ 12:42AM
Sunni said...
The ladies above are right. I was so miserable and this went on for 7 years. I simply couldn't take it anymore! I did read Suzanne Somers book and I found a physician in a wellness clinic where I live that prescribes only bioidentical harmones. They do work. I was astonished and wondered why I didn't do it sooner. I have several girlfriends on them too and they are very pleased.
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10-28-2009 @ 12:55AM
Sunni said...
Of course I feel very bad for Dorothy but I would never take anything like premarin or prempro. I would just suffer all the symptoms. I hadn't heard about the bio identical harmones until a girlfriend got on them. After that is when I got Suzanne's book and went to see the doctor she went to. Of course my husband was against the whole idea but our personal life was also suffering due to menopause symptoms. So not only could I not sleep but I was grouchy, had no sex drive, had sweat pouring off me all the time, and extreme dryness. There was simply no way to enjoy getting close so I decided then and there I would try it and that if worse did come to worse a few quality years was better than lots of miserable ones. I've not been sorry so far but I have no intention of staying on them for 16 years or for even 5 years. That would probably be my max unless it becomes unaffordable before then since I have no insurance.
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10-28-2009 @ 4:28AM
JLS said...
When you suffer horribly from hot flashes it becomes a quality of life issue. I do not wish to live decades miserable. This drug is a gift. It gave me back my life. Breast cancer is no. 7 in a long line up of what is killing women. SEVEN-get it? All of these women who march and get loud every year are making everybody think it's happening MUCH MORE THAN it is! Somebody better wake up and look at heart disease and lung cancer. It's a much greater threat. Before you think I am either stupid, or haven't tried all these other crazy things and natural remedies, I have. They did nothing. I want a good quality of life while I am living. I can accept fate when it comes. I read the study and most of those women who got breast cancer from the HRT were in their sixties, already had things like Lupus, etc. They were sick to begin with. My OB/GYN told me he noticed that as well when he read it. Some of us will get breast cancer anyway Again, it's No. 7, not anywhere near the top illnesses killing us women. I am a 58 year old litigation atty. and can weigh evidence having done it for decades.
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10-29-2009 @ 12:19AM
ChickaDee said...
JLS, I don't know where you got your information, but
BREAST CANCER IS THE NUMBER 2 KILLER IN WOMEN.
Heart disease is number one.
Get your facts straight!
10-29-2009 @ 12:34AM
ChickaDee said...
JLS, I added a link for you to read.
Here are the top 10 diseases that women get.
CANCER (including breast) IS NUMBER 2!!..... NOT NUMBER 7 !!
Type 2 Diabetes is number 7
You are giving out the wrong information to women.
Here's the link.
http://www.mayoclinic.com/health/womens-health/WO00014
10-28-2009 @ 5:34AM
Ginny F. said...
Most women don't realize, that the discomfort they feel at menopause is a big wake up call to CHANGE their DIET and habits. (such as smoking, meat, sugar and salt intake) Once they do, they will find uncomfortable symptoms are greatly reduced!!
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10-28-2009 @ 8:31AM
sheilph2 said...
I am in the no risk category of breast cancer-- none in the fam. etc. Five years to the day after taking Prem-Pro they said to stop taking it and I developed DCIS and had a lumpectomy, which is not all that attractive. The radiation, which seemed to trigger diabetes, high BP and cholestrol, is also not without side effects.
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10-28-2009 @ 9:18AM
Amy Rosenberg said...
We need to remember that we existed for years as young girls w/o the large amounts of hormones we need in our middle years to reproduce. I find it a comfort to be w/o these large amounts of hormones as I age. I eat soy products as well as yams and take calcium and other vitamins. So far, no problems and I am well into my 70s. I had very heavy periods and do not miss that bother either. I have two healthy sons and 7 grandchildren. I am also very healthy.
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10-29-2009 @ 9:22AM
Brandy said...
We also didn't have to have sex with our husbands for a happy marriage when we were young girls. I had to have a hysterectomy at a very young age and I am taking the bioidenticals.
10-28-2009 @ 9:34AM
Debbie said...
I too took Prepro for years as I had early menopause at 38. I developed a lump and immediately stopped taking prepro. 2 weeks later it had disappated. I was a lucky one. Dr's think it was hormone generated which could lead to cancer. Thank god I found it in time.
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10-28-2009 @ 10:05AM
Barbara said...
I was on a HRT known as Activella. I stopped taking it when the breast cancer research was released. Then the lining of my uterus became so thin that I had the choice of using an estrogen cream vaginally or taking Activella again. Neither choice sounded good, but I opted for the HRT. Any advice would be welcome.
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10-28-2009 @ 11:29AM
rann948 said...
Foolish, vain women who seek to delay the inevitable should not make money off their mistakes.
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10-28-2009 @ 7:59PM
rpm said...
Rann, no women where told that they would probably get breast cancer by taking prempro to make their lives slightly better in some cases, and greatly in other cases. When they told their doctors about their discomfort, well, Weyth, told the doctors, hey, anyone having those problems, we have the answer.
Don't blame the victims. Blame the company who knew the score, and just wanted profits.