hormone replacement therapy

Study revisits HRT heart attack risk

Christe Bruderlin-Nelson — Wed, 01 Oct 2008 04:16:51 -0400

A new Danish study involving nearly 700,000 women showed that hormone replacement therapy might not put women at increased risk of heart disease, after all.

In 2002, the Women's Health Initiative study ended because of an increased risk of breast cancer, blood clots, stroke and heart attack in women taking a combination of estrogen and progestin. The study found an increased risk for breast cancer of nearly 25 percent for women taking either Premarin or Prempro.

Because of the announcement, many women discontinued the medications and sales of hormone replacement therapeutics dropped like a rock.

The researchers did not find any increased risk in older women taking the medication, but younger women, aged 51 to 54 years, had a risk of heart attack that was 24 percent higher than women who had never tried the therapy did. And women taking estrogen and progesterone together on a daily basis, as is the case with those taking Prempro, had a 35 percent greater risk.

However, this new study finds that taking the medication differently can lower the risk of heart attack, regardless of the type of estrogen or progesterone. Using a cyclic dosing strategy as well as applying the medication using a skin patch or a vaginal gel both lowered the risk of heart attack with HRT use.

Despite the new study findings, the authors still recommend taking the lowest dose of hormone replacement therapy for the least amount of time.

The study is published in the European Heart Journal.

- find the USA Today story
- read the ABC7.com news

New drug-spending leader: Diabetes

Thu, 15 May 2008 06:59:58 -0400

New data on pharma sales details some big shifts in spending. Diabetes meds have displaced cholesterol drugs as the leading drivers of spending growth, for one thing; generic competition is reining in cholesterol costs even as usage of the meds is increasing. Meanwhile, there's been growth in overall diabetes-drug use, and a shift toward pricier treatments, boosting 2007 spending by 12 percent. Overall drug spending grew by only 2 percent last year as patients used more generics.

Plus, safety concerns affected spending on antidepressants, hormone replacement therapy, and anemia drugs, Medco Health Solutions reports. Safety warnings on Procrit, Epogen, and Aranesp depressed sales by 15 percent, while hormone replacement therapy usage dropped by 9.2 percent. Suicide-risk warnings (and generic competition) hampered growth in the antidepressant market.

A separate report from IMS Health showed that the global market for cancer meds is advancing by leaps and bounds, twice as fast as the growth in all other pharmaceuticals. As emerging countries spend more on healthcare, they're investing more in cancer treatments; they're expected to power up spending on these meds by 12 to 15 percent a year through 2012. The overall global drug market, by contrast, is expected to grow by 6.4 percent.

- find the news at the Wall Street Journal Health Blog
- see the Pharmalot item
- check out the story from the Associated Press
- read the article at CNN Money

ALSO NOTED: Genzyme can't make Myozyme at Boston plant; Ranbaxy, Orchid forge drug-and-API deal;

Tue, 22 Apr 2008 06:59:50 -0400

> FDA won't let Genzyme make its uber-expensive Pompe disease treatment Myozyme at its Boston plant because of a small difference between the batches of Myozyme Genzyme makes now and the new larger batches it was to produce; the regulatory crackdown will leave the drug in short supply in the U.S. and depress Genzyme's 2008 earnings. Report

> Ranbaxy inked a deal with Orchid Chemicals & Pharmaceuticals for multiple finished dosages and active pharmaceutical ingredients. Release

> A Nevada judge ordered Wyeth to post a $58 million bond and pay $1.6 million in attorney's fees for acting in 'bad faith' during settlement talks in the case of three women who sued over the Prempro hormone replacement therapy. Report

> Two drug companies outsourced chunks of their IT systems: Nycomed hired British Telecommunications and Hewlett-Packard to provide it with IT infrastructure, and Janssen Pharmaceuticals tapped Porthus to manage all its electronic customs programming in Belgium. Report

> Celgene got regulatory approval to sell its thalidomide drug in the EU, for use in combination with two other meds for treating multiple myeloma. Report

> Roche's Japanese unit Chugai upped its full-year profit expectations to ¥29 billion from ¥17 billion after government drug-price cuts came in smaller than expected. Report

> Mylan got the FDA nod for its copycat version of AstraZeneca's blood pressure pill Plendil. Report

> Four of San Diego's biggest research institutions are teaming up to form the San Diego Consortium for Regenerative Medicine, a group aimed at advancing stem cell work. And they're planning a $115 million research "collaboratory" that would open in 2010. Report

> Cambridge, MA-based Stromedix has landed $25 million in a Series B round of venture capital. Report

> The bill on sequencing a genome has fallen from a few billion dollars to about $60,000 in just five years. And now two companies want to use nanotech to knock that price down to just $100. Report

> University of Cincinnati researcher Melissa DelBello is getting some added scrutiny for failing to disclose large sums of money she received from AstraZeneca a year after completing a study of Seroquel for bipolar disease. Report

And Finally... "Chemo brain" symptoms may not be byproducts of fatigue and depression associated with cancer treatment, but side effects of a common chemo drug, 5-fluorouracil, a new study found. Report

ALSO NOTED: Appeals court votes for FDA approval shield; Suicides rose as depression treatment fell;

Wed, 09 Apr 2008 06:59:50 -0400

> A federal appeals court backed the drug industry's arguments that it should be insulated from lawsuits over FDA-approved products, ruling 2-1 that antidepressant makers GlaxoSmithKline and Pfizer could not be held liable for the suicides of two patients using SSRIs. Report

> A new study shows rising suicide rates among children and teens in Canada, two years after drug regulators there warned of the safety risks of antidepressant use in children; the climbing suicide rate coincided with a 10 percent drop in the rate of doctor visits for depression treatment among children. Report

> Galderma Pharma has wrapped up its $420 million tender offer for fellow dermatology drug company CollaGenex Pharmaceuticals. Report

> Louisiana's new attorney general withdrew a multimillion-dollar antitrust lawsuit filed against Amgen by his predecessor. Report

> The healthcare and IT company McKesson has agreed to pay $190 million for McQueary Brothers Drug Co., a pharma and beauty products distributor based in Springfield, Mo. Report

> Novartis' plans to erect three wind turbines on its Grimsby, England, campus have drawn fire from environmentalists worried that the huge windmills might disturb birds. Report

> India's Dabur Pharma has agreed to supply Thailand with a copycat form of Sanofi-Aventis' Taxotere, which the Thai government is importing under a patent-busting compulsory license. Report

> Estrogen-only hormone replacement therapy has been linked to a benign breast-lump disease that's often a precursor to cancer. Report

> There's a shakeup under way at Inotek. The Beverly, MA-based developer says it is closing several international sites and a pilot manufacturing facility in Israel as it focuses all of its efforts on its two main programs and two preclinical programs. Report

> Endo Pharmaceuticals says a close reading of a non-approvable letter from the FDA for Frova prompted officials to pull their request to gain approval for the short-term relief of menstrual migraine. Report

> Scientists at Memorial Sloan-Kettering Cancer Center in New York City have identified the molecular process by which breast cancer cells spread to other tissue during metastasis. Report

And Finally... Russia has improbably emerged as a world leader in new cancer vaccines. The country's regulatory body approved the use of Antigenics' new kidney cancer vaccine, Oncophage--a world first. Report

Cancer risk lingers when hormones stop

Wed, 05 Mar 2008 06:59:54 -0500

Remember all the brouhaha over the Women's Health Initiative study, which showed that women using hormone therapy were more likely to develop breast cancer and also had increased risk of cardiovascular problems? Well, one of the big questions then was whether those risks dissipated once therapy stopped.

The answer, apparently, is yes and no. After a little over two years of follow-up, University of North Carolina researchers found that women in the study who'd been given hormones had about the same number of heart attacks, strokes, and blood clots as those given placebo. So the heart risks seem to have eased after the women stopped taking the hormone pills.

But the patients on hormones still had a slightly higher risk of cancer: the disease arose at a rate of 1.56 percent per year among those women compared with 1.26 percent among women in the placebo group. The difference isn't enough to dial 911 about, but, as one of the researchers said, "it's something to be aware of."

Nevertheless, treatment guidance remains the same; women should use hormone therapy at the lowest effective dose and for the shortest time possible. Apparently women have been following this advice, too; sales of Wyeth's Prempro and Premarin fell from about $2 billion in 2002 to about $1 billion. That's a figure Wyeth would like to see maintained, at least. Of the new study, Wyeth said, "Hormone therapy remains and good and viable choice."

- read the study abstract in the Journal of the American Medical Association
- check out the article in the Wall Street Journal
- see the New York Times coverage

Related Articles:
FDA cries halt to 'bio-identical' hormones. Report
HRT doesn't protect women from heart disease. Report
Wyeth wants end to customized HRT treatments. Report