Hormone Replacement Therapy
Hormone Therapy Linked To Increased Risk for GI Bleeds
Study in postmenopausal women finds link between HRT and bleeds, particularly in lower intestine
Women who take hormone replacements after menopause are about 50% more likely to experience gastrointestinal (GI) bleeding as those not on the treatment, new research shows.
The risk for bleeding appears to be concentrated in the lower GI tract and correlates with increasing duration of hormone replacement therapy (HRT), according to the study of more than 70,000 women. Experts said the findings are not surprising, given previous evidence of the association and the speculation that HRT increases the risk for thromboemboli.
“Increasing exposure to HRT was associated with an increased risk of both GI bleeds overall and lower GI bleeds specifically, and this association persists after controlling for a large number of confounding variables,” reported Prashant Singh, MD, of the Department of Internal Medicine at Massachusetts General Hospital, in Boston, who helped conduct the study.
“We cannot make a causal link on the basis of this study, but there is good evidence that HRT is associated with clotting and this is plausible in that HRT was also found to increase the risk of ischemic colitis,” Dr. Singh said. When the blood supply to the intestines is blocked by ischemic colitis, the mucosa is affected and sloughs off, leading to GI bleeding, said Dr. Singh, who presented his group’s findings at Digestive Disease Week 2015 (abstract 783).
The researchers used data from participants in the Nurses’ Health Study, which has been following a large population of women for more than 25 years. Participants were enrolled between ages 24 and 44 years, and were followed prospectively with surveys every two years.
The incidence of bleeds was adjusted through multivariate analysis for several other risk factors with the potential to promote such bleeding, including aspirin use, use of nonsteroidal anti-inflammatory drugs (NSAIDs), previous use of oral contraceptives, smoking status and body mass index.
The modestly greater hazard ratio (HR) for GI bleeds among women who had ever used HRT compared with those who never had taken the medication did not reach statistical significance (HR, 1.19; P=0.27), but the risk was nearly 50% greater and reached significance for current users compared with never users (HR, 1.46; P=0.02), the researchers reported. The risk for intestinal bleeding increased further when the investigators focused on bleeding in the lower intestinal tract, particularly when comparing current users and never users. For current HRT users, the risk was more than twice as great (HR, 2.12; P<0.01). Importantly as a potential signal of causation, use of HRT was associated with a doubling of the risk for ischemic colitis (HR, 2.30;P=0.04).
Although HRT did not appear to increase the risk for bleeding in the upper GI tract for current users over never users (HR, 097; P=0.91), the risk for bleeds overall, and for lower bleeds in particular, was significantly associated with duration of exposure (P<0.01 for both).
“This study confirms our speculation that hormonal therapy increases the risk of GI bleeding, particularly in the lower GI tract,” Dr. Singh said.
However, the significance of these data in clinical decision making is less clear. Patients take HRT for a broad range of indications, many of which may outweigh the significant relative risk for GI bleeding.
Still, the findings suggest that use of HRT deserves consideration in otherwise unexplained lower GI bleeding among postmenopausal women. For women without a compelling indication for HRT, the risk may warrant avoiding such therapy, particularly for those with a history of lower GI bleeding, Dr. Singh said.
An expert who has written about risk factors for GI bleeding, Angel Lanas, MD, clinical chief of gastroenterology at University Hospital, in Zaragoza, Spain, called the new data “interesting” and said they should be the “basis for further studies” to both confirm the association and understand the clinical implications.
“Lower GI bleeding hospitalizations are rising everywhere, especially in the elderly, and we should understand the risk factors for this complication, which will allow us to implement prevention strategies,” said Dr. Lanas, referring to an article he published several years ago (Am J Gastroenterol 2009;104:1633-1641). “Whether HRT is one of those risk factors needs confirmation in new and more specific studies.”
Source : Gastroenterology an Endoscopy News ( Aug 2015)
Courts Rule that Prempro Causes Cancer, but FDA Still Promotes It
Despite large pay outs to victims, Pfizer keeps selling the hormone replacement drug and the government keeps trying to make sure there’s no competition from the natural alternative!This past week, a court told Pfizer Inc., the multinational pharmaceutical company, to pay $72.6 million in damages to three women. Each had developed breast cancer after taking the company’s hormone replacement drug, Prempro (made from pregnant mares’ urine), for treatment of their menopause symptoms. So why is this drug still being sold?
In 2002, the National Institutes of Health sponsored a Women’s Health Initiative study that showed Prempro is linked to cancer. The research demonstrated that Prempro, which is already known to increase the risk of breast cancer, also makes it more likely that the cancer will advance quickly and prove fatal.
Despite these findings, Pfizer continues to sell the drug—and the FDA has not taken any action to remove drug from the market. In fact, the FDA merely says that “women taking Prempro or other combination estrogen/progestin therapy should consult with their physicians about the relevance of this new information to their treatment,” and that “the FDA is not thinking of taking estrogens or estrogen with progestin drug products off the market at this time.”
Pfizer has now lost ten of the eighteen Prempro cases decided by juries since trials began in 2006. The drug-maker got some of those verdicts thrown out after the trial or had the awards reduced, offered settlements on others, and appealed the rest. Pfizer has also had cases thrown out before trial. The drug giant announced in May that it had settled a third of the pending Prempro cases and had set aside $772 million to help resolve the claims.
As we reported last week, drug companies can take these settlements in their stride because they know the government will never prosecute them. Besides, Pfizer had already made $2 billion before the 2002 study was released, so the money they pay in settlements is simply chalked up to the cost of doing business.
The collusion between Big Pharma and the government has ensured that the safer alternative—compounded bioidentical estriol—is still banned by the FDA. Not a single adverse event has ever been reported for bioidentical estriol.
You may recall from our earlier reporting on estriol that FDA essentially created new policy when the agency issued warning letters to compounding pharmacists prohibiting them from compounding estriol. Why would the FDA do such a thing? Because our government follows the dictates of the drug industry. In this case, it was in response to the Citizen Petition which Wyeth (now part of Pfizer) sent to FDA, asking them to pursue enforcement. Wyeth/Pfizer didn’t want competition for Prempro, and the FDA obeyed. The deadly, cancer-causing drug is still freely sold and marketed. Can you imagine the outcry if a supplement caused cancer but was still available for sale?
Due to an outpouring of protest from grassroots activists like you, behind-the-scenes lobbying by ANH-USA and other concerned organizations, and conflicting federal court decisions, at the moment there is a something of a stand-off on the issue—no new crackdowns have taken place. But FDA still has not revoked their ban on this natural, safe, inexpensive, and effective alternative to Prempro.
Source : Alliance for Natural Health
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Pfizer Will Pay $330M To Settle Prempro Cases
Pfizer has agreed to pay about $330 million to settle more than 2,200 lawsuits charging its Prempro hormone replacement therapy caused women to develop breast cancer, embracing a strategy used by several other drugmakers to cap the cost of growing product-liability litigation that can worry investors. The cases settled for an average of about $150,000, according to Bloomberg News, which first reported the settlement, although a Pfizer spokesman disputed the figures. The move came after a Pennsylvania appeals court reinstated $1.7 million in compensatory damages and $8.6 million in punitive damages against Pfizer in a lawsuit filed by an Arkansas woman, who alleged its Wyeth unit failed to warn that Prempro could cause her to develop breast cancer.
The settlement comes just weeks after Ian Read took over as Pfizer ceo, suggesting a desire to put aside an eight-year-long battle over Prempro. In recent months, GlaxoSmithKline has agreed to pay large sums to resolve lawsuits alleging harm from its Avandia diabetes pill and Paxil antidepressant (see here and here). Similarly, AstraZeneca has settled lawsuits over its Seroquel antipsychotic (read this).
The Superior Court of Pennsylvania issued the ruling Monday, reversing a 2007 trial court decision to grant Wyeth a new trial and throw out the compensatory damage award. The appellate panel concluded no “fraud on the court took place here and a new trial should not have been granted,” according to the Superior Court of Pennsylvania (here is the ruling).
The ruling means Pfizer must also pay anotherl $2.4 million in interest, Esther Berezofsky, the attorney for the plaintiff, Mary Daniels and her family, tells Bloomberg News. Pfizer is considering its options.
For those keeping score, Pfizer has now lost eight of 15 Prempro cases that were decided by juries since trials began five years ago. However, Pfizer has succeeded in having some verdicts tossed after a trial or had awards reduced. Some verdicts, meanwhile, were settled and some are on appeal. Pfizer also won dismissals of more than 3,000 cases before these went to trial.
Source : One Click Group via Pharmalot
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Pfizer Must Pay $1.6 Million Drug Damages, Judges Say
Pfizer Inc., the world’s largest drugmaker, must pay $1.68 million plus undisclosed punitive damages to a woman who blamed her breast cancer on the Prempro menopause drug, after an appeals court reinstated a verdict. In 2007, a trial jury in Philadelphia Court of Common Pleas awarded Mary Daniel and her family $1,681,650 from Pfizer’s Wyeth unit, plus punitive damages that the court kept secret. A judge later overturned the verdict. Daniel filed an appeal with the Superior Court of Pennsylvania.
The three-judge panel ruled yesterday that “contrary to Wyeth’s contentions,” no “fraud on the court took place here and a new trial should not have been granted” by the lower court.
“The company disputes the fairness of the previous trial and the appropriateness of the jury’s verdict. We are considering all our legal options,” Christopher Loder, a spokesman for New York-based Pfizer, said today in an e-mailed statement.
Annual sales of Wyeth’s hormone-replacement drugs once topped $2 billion before the Women’s Health Initiative study, sponsored by the U.S. National Institutes of Health, suggested that women on the therapy had a 24 percent higher risk of breast cancer.
Pfizer rose 4 cents to $19.08 at 2:07 p.m. in New York Stock Exchange composite trading.
The case is Daniel v. Wyeth, 040602368, Court of Common Pleas (Philadelphia).
Source : Bloomberg Business
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