May 7th, 2010 by Elizabeth Kissling
In the flood of media commemorating the 50th anniversary of FDA approval of the birth control pill, this story from the Washington Post about its newest iteration may just slide under your radar: FDA approves new birth control pill from Bayer.
Bayer, as you may recall, is the manufacturer of Yaz and Yasmin, which is currently facing more than 1100 U.S. lawsuits and two Canadian class action suits. The new drug, Natazia, contains various dosing of estrogen and progestin throughout the cycle, making it the first four-phase hormonal contraceptive. The new pill uses dienogest, rather than drospirenone, the synthetic progestin in Yaz that is the apparent source of its dangerous side effects. The most common side effects of Natazia in clinical trials included irregular bleeding, headaches, nausea, and vomiting.
Yaz and Yasmin are Bayer’s best-selling prescriptions, by the way - combined sales for 2009 were $1.64 billion.
Tags: Bayer, big pharma, birth control pill, lawsuit, progestins, side effects, yaz
Posted in Birth Control, Pharmaceutical | Comments Off
April 6th, 2010 by Elizabeth Kissling
Guest Post by Barbara A. Brenner Executive Director, Breast Cancer Action
One of the saddest aspects of capitalism is that companies think they can and should own anything they get their hands on. Some time ago, they started obtaining patents on human genes, including two genes implicated in breast cancer: BRCA1 and BRCA2.
The company that obtained the patents on these genes is called Myriad Genetics. With the patents, Myriad controls both the tests given to women to see if they carry mutations on these genes that may predisposed them to breast and ovarian cancer, as well as all the research related to the genes.
How can anyone own our genes? Up until now, no court has been asked that question. But last week, in a ground breaking decision, a federal judge in New York declared that Myriad’s patents on the breast cancer genes are invalid because they patent a part of nature.
That may seem like an obvious thing to most of us, but the research community is up in arms about how their inability to patent genes will inhibit their ability to innovate new treatments. Sounds plausible, but don’t be fooled. These patents are more about making money than they are about taking care of people who are sick. Continue reading...
Tags: breast cancer, genetic research, guest post, Health Care, lawsuit, patent
Posted in Law/Legal, Philosophy | 1 Comment »
December 18th, 2009 by Elizabeth Kissling
You may have heard the news that 23 hormone replacement therapy lawsuits filed by women diagnosed with breast cancer were dismissed by a New York judge this week. Judge Martin Shulman granted Pfizer’s motion to dismiss for two reasons: the plaintiff’s delayed filing exceeded the the three-year statute of limitations in New York, and that “the potential risk of contracting breast cancer from taking HRT medication was well known at all times out there in the stream of public information.” Oddly, Judge Shulman simultaneously asserted “that the debate over HRT health problems has not yet been settled.”
I can’t argue about exceeding the statute of limitations, but it’s difficult for a judge to assert that breast cancer risk of hormone therapy is well known public information. The Lancet reported today that up to half of US adults have trouble interpreting medical information, displaying low levels of health literacy. Health literacy, according to The Lancet, is the ability to comprehend and use medical information that can affect access to and use of the health-care system. Health literacy is more than reading and comprehending news reports of medical issues (which are often of poor quality – see Health News Review for sharp analysis of health news); one must also know how to navigate the complexities of the health care system, including knowing how and when to question one’s physicians and pharmacists. Continue reading...
Tags: advertising, big pharma, breast cancer, drugs, government agencies, Health Care, hormones, lawsuit, Menopause
Posted in Health Care, Law/Legal, Menopause, Pharmaceutical | 1 Comment »
December 16th, 2009 by Elizabeth Kissling
Tags: big pharma, breast cancer, hormones, lawsuit, Menopause, Prempro, viral video
Posted in Internet, Law/Legal, Media, Menopause, Pharmaceutical | Comments Off
December 13th, 2009 by Elizabeth Kissling
There’s a pretty good essay in this weekend’s New York Times (online here Saturday, in print Sunday in the Business section) about how hard Big Pharma has worked to market menopause as an estrogen deficiency disease. In addition to discussion of Wyeth’s advertising campaigns, the article mentions the firm’s contract with DesignWrite, a company drug makers pay to develop manuscripts for publication in medical journals, to prepare at least 60 articles for publication in medical journals on the potential benefits of hormone therapy for cardiovascular disease, Alzheimer’s disease, diabetes, colon cancer, vision loss and other health problems.
The article also includes access to PDFs of some of the thousands of pages of documents from Wyeth that were requested by plaintiffs in the lawsuits against the drug manufacturer. (To date, more than 13,000 people have sued Wyeth claiming that they developed breast cancer and other health problems after taking the company’s menopausal hormone drugs. As we reported three weeks ago, in ten of the twelve verdicts so far, juries have awarded significant sums to plaintiffs. ) The documents available at the New York Times include a publication plan for Wyeth from DesignWrite, a 1995 product launch speech from Wyeth’s marketing director proclaiming the company’s mission of bringing to fruition Dr. Bernadine Healy’s vision of “a world in which the vast majority of women would begin taking HRT, and we know that means Prempro, at menopause and continue on for the rest of their lives.” There’s also this handwritten note from a 1996 meeting about how to respond to a new study raising breast cancer concerns (red markings added by me): Continue reading...
Tags: advertising, big pharma, breast cancer, drugs, economics, hormones, lawsuit, Menopause
Posted in Advertising, Law/Legal, Media, Menopause | 2 Comments »
December 11th, 2009 by Elizabeth Kissling
Tags: big pharma, boys/men, breast cancer, drugs, economics, Girls, Health Care, lawsuit
Posted in Girls, Health Care, Law/Legal, New Research, Pharmaceutical | 2 Comments »
November 23rd, 2009 by Elizabeth Kissling
There are more than 10,000 lawsuits against Wyeth/Pfizer regarding the link between PremPro and breast cancer. There have been 12 verdicts so far, and juries have awarded money to the plaintiffs in ten of those cases. The latest was announced today, in Donna Kendall v. Wyeth (Phila. CCP, June Term, 2004, No. 0965). The jury awarded Ms. Kendall $6.3 million in compensatory damages, and $28 million in punitive damages.
So far, thirteen women have settled their claims with Wyeth/Pfizer, but if awards like these continue, can we expect Pfizer soon to be offering to settle the rest?
The film clip at left is a video press release prepared by Littlepage Booth, the Houston law firm that represented both Connie Barton and Donna Kendall in their claims against Wyeth/Pfizer.
Tags: big pharma, breast cancer, lawsuit, Menopause, Prempro
Posted in Law/Legal, Menopause, Pharmaceutical | 2 Comments »
October 27th, 2009 by Elizabeth Kissling
Connie Barton, an Illinois woman who developed breast cancer after taking Prempro for menopausal symptoms, was awarded punitive damages by a jury in Philadelphia yesterday. The jury has already awarded her $3.7 million in compensatory damages, back in September, but we will not learn the amount of punitive damages until another Philadelphia jury reaches their verdict in similar case against the Pfizer, the drug’s manufacturer. (Technically, the case was filed against Wyeth, but the two companies just completed a merger deal last week, and Wyeth is now a subsidiary of Pfizer.)
Wyeth’s attorneys successfully argued that public revelation of the amount of damages might influence the jurors in Kendall v. Wyeth. However, the jury’s finding that Wyeth ignored evidence that the drug could cause cancer is now public information. Would I sound bitter if I said I hope that news influences potential jurors?
According to the news story about Barton’s case at philly.com, Pfizer has now lost five of eight trials over its hormone-replacement drugs since cases began reaching juries in 2006. 1500 more trials against Wyeth are pending at the Philadelphia Court of Common Pleas. But a longer story in Philadelphia Magazine reports 23 out of 31 cases set for trial have been resolved favorably for Wyeth; the company has settled five, and several are on appeal. Continue reading...
Tags: big pharma, breast cancer, lawsuit, Menopause, Prempro
Posted in Law/Legal, Menopause, Pharmaceutical | Comments Off
September 26th, 2009 by Elizabeth Kissling
The popular birth control pill, Yaz is in the news again. Readers may remember that last autumn, Bayer (the maker of Yaz) was sanctioned by the FDA for their television commercials, “because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits and minimize the risks associated with Yaz.” The FDA actually required Bayer not only to end the advertising campaign immediately but to make amends by publicizing corrective information — an unusually bold move from the FDA. That led to the ad shown at right.
Bayer was cited by the FDA again earlier this year, for failure to follow proper quality control in the plant that manufactures the synthetic hormones used in Yaz.
Bayer is now defending itself against 74 lawsuits filed by users who developed health problems, such as blood clots or heart attacks. Bayer is taking the FDA citations seriously and plans to “defend itself vigorously against the suits.” Dr. David A. Grimes, a clinical professor of obstetrics and gynecology at the University of North Carolina medical school and paid consultant to Bayer says the risk of injury from Yaz is tiny. “My dictum is that a multiple of a rare event is still a rare event,” says Grimes. And the New York Times seems far more concerned with how the FDA citations and the lawsuits will affect Yaz’ image and sales than they are with women’s health.
Didn’t these people learn anything from the saga of the Dalkon Shield?
October 2, 2009
Edited to Add: The New York Times report neglected to mention that Swissmedic is investigating the death of a young woman from the effects of pulmonary embolism that may be linked to her use of Yaz.
Tags: birth control pill, commercials, contraceptives, FDA, lawsuit
Posted in Law/Legal, Newspapers, Pharmaceutical | Comments Off
Readers should note that statements published in re: Cycling are those of individual authors and do not necessarily reflect the positions of the Society as a whole.
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