The first follow-up of a landmark study of hormone use after menopause shows heart problems linked with the pills seem to fade after women stop taking them, while surprising new cancer risks appear, according to an analysis published in the Journal of the American Medical Association. And the new risks for other cancers, particularly lung tumors, in women who’d taken estrogen-progestin pills for about five years puzzled the researchers and outside experts, the Associated Press writes.

Those risks “were completely unanticipated,” says Gerardo Heiss of the University of North Carolina in Chapel Hill, lead author of the follow-up analysis to the Women’s Health Initiative, the government-funded study that was halted six years ago. The analysis focused on participants in the first two to three years after the study ended. During that time, women who took hormones but stopped were 24 percent more likely to develop any kind of cancer than women who’d taken dummy pills during the study.

“There’s still a lot of uncertainty about the cause of the increased cancer risk,” co-author JoAnn Manson, chief of preventive medicine at Harvard’s Brigham and Women’s Hospital, tells the AP. The cancers included breast tumors, which also occurred more frequently in hormone users during the study. The increased risks for all cancers amounted to only three extra cases per year for every 1,000 women on hormone pills, compared with nonusers. Still, Heiss says the results suggest that former hormone users need to be vigilant about getting cancer screening including mammograms. “Vigilance is justified,” he says. “No alarm, but vigilance.”

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Drug makers increased their prices last year by an average of 7.4 percent for brand-name meds most commonly prescribed to the elderly, and the increase was about 2.5 times the overall inflation rate, according to AARP, which released the report and has been tracking prices charged to wholesalers since 2002.

In discussing the findings, AARP notes the price increases have been slightly greater since the Medicare drug benefit began Jan. 1, 2006, the Associated Press reports. In the four years before the benefit, wholesale prices rose between 5.3 percent and 6.6 percent annually, according to AARP. This is the study.

AARP officials say the outcry over high drug prices has diminished since the Part D benefit was created. “Unfortunately, many manufacturers have taken the absence of an outcry as a green light to go ahead and raise prices even more,” John Rother, AARP’s policy director, tells the AP.

All but four of the 220 brand-name prescriptions in the study had price increases during 2007, and nearly all exceeded the rate of general inflation. Among the top 25 drug products, Sanofi-Aventis’ Ambien sleeping pill had the largest price increase at 27.7 percent. By comparison, Bristol-Myers Squibb’s Plavix blood thinner had a price increase of 0.5 percent. Please click on ‘Read More’ below, to see the chart for the increases on the 25 most widely prescribed meds.

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A federal judge dismissed a lawsuit seeking to halt sales of the only “morning-after” contraceptive pill available in the US without a prescription, Reuters reports. The suit was filed by the Association of American Physicians and Surgeons and anti-abortion groups against the FDA over its decision to allow non-prescription sales of the Plan B pill sold by Barr Pharmaceuticals. The pill, you may recall, can reduce the risk of pregnancy when taken within three days of intercourse.

The US District Court for the District of Columbia granted a motion filed by the FDA and Barr motion to dismiss the suit, saying the plaintiffs had failed “to identify a single individual who has been harmed by Plan B’s OTC (over-the-counter) availability,” according to the ruling. The lawsuit claimed the drug was not proven safe without a prescription and sought to reverse the FDA decision and require a prescription for all Plan B sales. The AAPS hasn’t yet decided whether to appeal.

Backers of reproductive rights applauded the decision. “They still don’t have any evidence in terms of why they think it is harmful,” Janet Crepps, deputy director for domestic programs at the Center for Reproductive Rights, tells Reuters. “This is the right decision for women.” FDA spokeswoman Rita Chapelle says the agency was pleased with the dismissal of the suit. Barr spokeswoman Carol Cox called the lawsuit “meritless.”

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The government’s watchdog agency is investigating whether the FDA’s review process cleared two blockbuster meds - Avandia and Vytorin - without sufficient proof of their safety or effectiveness, the Associated Press reports. Specifically, the GAO has agreed to study whether the FDA should approve drugs based on biological measures, like cholesterol and blood sugar, without evidence they improve more meaningful measures like survival.

“There’s enough of a pattern of problematic drugs to ask for an independent review of how the FDA follows up on the effects of medicines that it’s approved,” says Chuck Grassley, the Iowa Republican on the Senate Finance Committee who requested the investigation, in a statement.

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To be precise, 53 percent say the advertising is mostly a good thing, and 67 percent agree that these ads educate people about treatments and encourage them to get help for conditions they might not have been aware of, according to a survey conducted by USA Today and public opinion researchers at the Kaiser Family Foundation and the Harvard School of Public Health. They polled 1,695 adults ages 18 and older this past January. (Look here).

On the negative side, the biggest complaint has to do with cost - more than three-quarters say the cost of the ads makes meds too expensive, and four in ten say this bothers them “a lot.” While 68 percent say there are too many prescription drug ads on television and 66 percent believe ads encourage people to take meds they don’t need, fewer say they are bothered “a lot” by either of these issues - 27 percent and 34 percent, respectively. By the way, 46 percent think many ads are too sexually explicit, but only 20 percent say they are bothered a lot.

Not surprisingly 91 percent of Americans have seen or heard prescription drug ads, and 32 percent have talked to a doc about a prescription drug they saw advertised. Among those who have talked to a doc about a drug they saw advertised, 44 percent say their doctor gave them a prescription for the drug they asked about, and 54 percent say their doc recommended another med, resulting in 82 percent who got a scrip either for the drug they mentioned or another drug.

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A controversial New Jersey bill to require informed consent from a minor’s parent before a doc can write a prescription for any psychotropic that already carries a Black Box warning is picking up steam. An assembly committee yesterday passed the bill - which you can read here - unanimously and now a state senator is poised to introduce a companion version. A spokeswoman for Shirley Turner says the senator plans to ‘drop the bill’ this week.

This a turnabout from just three months ago, when the bill appeared to be dead after a year-long fight by a pair of New Jersey moms and their allies, who argue that informed consent is the only way to make sure info is passed from docs to patients. In particular, they’re concerned that side effects, such as suicidal behavior and thoughts, that are linked to antidepressants can be misconstrued as part of the illness. As a result, they maintain parents may not have sufficient info to recognize troubling signals.

The bill is likely to be opposed again by the New Jersey chapter of the National Alliance on Mental Illness, a non-profit advocacy group. Phil Lubitz, the advocacy director for the chapter, which has accepted funding from drugmakers that sell antidepressants and antipsychotics, including Bristol-Myers Squibb, Eli Lilly, Glaxo, Pfizer, AstraZeneca, Wyeth and Johnson & Johnson, has yet to respond to a request for comment.

A new poll finds Americans greatly value the potential benefits of prescription drugs for their families, but most believe they cost too much money and many struggle to pay for needed meds. A campaign issue, perhaps?

Four in 10 Americans (and half of those regularly taking at least one medication) report experiencing at least one of three cost-related concerns in their family: 16 percent say it is a “serious” problem to pay for prescription drugs; 29 percent say they have not filled a prescription in the past two years because of the cost; and 23 percent say they have cut pills in half or skipped doses in order to make a medication last longer.

People are most likely to report one of these three issues if they lack drug coverage (52 percent), if they have low incomes (54 percent) or if they take four or more drugs regularly (59 percent), according to the survey, which was conducted jointly by USA Today and public opinion researchers at the Kaiser Family Foundation and the Harvard School of Public Health. They polled 1,695 adults ages 18 and older this past January.

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Under pressure from regulators, drug maker Roche has added stronger language to its Tamiflu label, warning of sometimes fatal psychiatric problems seen in a small number of patients, the Associated Press reports.

The drugmaker warned in a letter to docs that cases of delirium and self-injury have been reported among patients taking the prescription flu med. The older label mentioned reports of psychiatric problems, primarily seen among children in Japan. But the new label specifies that those problems sometimes proved to be fatal, which was recommended by an FDA panel at an advisory committee meeting last November. UPDATE: Glaxo also sent a letter concerning its Relenza flu med.

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The Health & Human Services Office of the Inspector General is likely to start requiring disclosure of consulting relationships with doctors as part of settlement agreements with drugmakers in the coming year, according to The RPM Report.

The arrangement will likely mirror what several device makers are now doing. You may recall that, last fall, four medical device implant makers - Zimmer, DePuy Orthopaedics, Biomet, Smith & Nephew - signed deals with the US Attorney’s Office in New Jersey to address allegations they used “consulting agreements, lavish trips and other perks” as marketing and sales tools. So they signed Deferred Prosecution Agreements and made payments of about $300 million.

But that wasn’t all. The prosecutors required them to create lists of all of their outside paid consultants and post it prominently on their websites. You can look here for their lists. And now RPM says the government wants to apply the same approach to drugmakers and their relationships with docs.

Greg Demske, assistant inspector for legal affairs at the HHS IG, told a Senate Special Committee on Aging hearing on February 27 that the OIG “is considering requiring similar disclosure requirements in future (corporate integrity agreements) with device manufacturers and pharmaceutical companies.” (This is his testimony). What’s your thought?

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You know the old saying: Just when you think things can’t get worse…they do. The latest malady confronting the drugmaker is a ruling by a federal judge that invalidated a patent on its Yasmin contraceptive pill, which gives Barr Laboratories a chance to sell a generic before the patent was set to expire in 2020. For now, Bayer retains exclusive distribution rights in the US to the newer and different Yaz pill until March 2009, just one year from now.

The news sent Bayer stock tumbling more than 5 percent, because Yasmin generated nearly $490 million in sales last year. But this is only the latest problem. On Feb. 18, Bayer ended a late-stage trial for its Nexavar cancer med after it failed to improve survival rates in lung-cancer patients. Although already approved to treat liver and kidney cancer, lung cancer offered the biggest market potential. Two days later, Novartis and Novo Nordisk filed a patent lawsuit, claiming Bayer’s Kogenate hemophilia drug infringes on their patents.

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