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WOMEN'S MEDICAL ISSUES, WOMEN'S HEALTH

HRT is safe--Scientific American

 

Fosamax:  what counts as proof???  The increased risk of 11 to 1 of lung cancer amounts to statistical proof that cigarettes cause it.  With Foxamax the increase risk it is 16 to 1.  (Merck sales of Foxamax were over $1.8 billion in 2008.)  These results have in other articles been generalized to the entire class of bisphosphonates.  This part of an every increase pile of evidence that its benefits do not outweigh the harm it causes.  Other study using the endpoint of bone fractures have failed to find any long-term reduction in fractures, hip replacement operations, and like--see other article in this section.  By using bone density, PhARMA has been able to rake in billions on a treatment that increases bone density by having the bisphosphonates absorbed but to no advantage to the patient and serious harm both from side effects which are common and financially.  Sales reps than push the results as though the increase in bone density is from calcium absorption--which it isn’t.  Bisphosphonates cause microscopic bone cracks (see below), which go unobserved giving standard imaging.   I wouldn’t rely on the press or even the journal for a fair overview since both are dependent of the industry they review for much of their funding, and journal favorable bias in a well designed study was shown to between 11% & 69% at http://healthfully.org/index/id9.html .     

 

FDA: Possible increased risk of thigh bone fracture with bisphosphonates

http://www.fiercepharma.com/press_releases/fda-possible-increased-risk-thigh-bone-fracture-bisphosphonates-0
 

More data suggests fracture risk with bone drugs

September 14, 2010 — 9:35am ET | By Tracy Staton


http://www.fiercepharma.com/story/more-data-suggests-fracture-risk-bone-drugs/2010-09-14?utm_medium=nl&utm_source=internal#ixzz11YY2BzXk

Remember the debate over femur fractures suffered by patients taking osteoporosis drugs? The controversy is heating up again, with new research from a task force assembled in 2009 to study a possible link between the bisphosphonate drugs--Merck's Fosamax, Warner Chilcott's Actonel, Roche's Boniva, and the like--and a rare type of upper-femur fracture.

A study published today in the Journal of Bone and Mineral Research looked at 310 patients who suffered atypical femur fractures, finding that 291 of them, or 94 percent, used bisphosphonate drugs. Most of them had been taking the drugs for more than five years. "There is no evidence that this is a causal link,* but there is an association so we need to have that information available saying there may be an increased risk," task force co-chair Elizabeth Shane, a professor of medicine at Columbia University, tells Bloomberg.

The researchers emphasize that women at high risk of fractures should continue using the osteoporosis meds. But they should watch for persistent pain in their upper thigh or groin; in many of the fracture cases, patients felt pain in those areas for a couple of weeks before the actual fracture occurred.

The FDA has done its own digging into a potential link between the femur fractures and the bisphosphonate class of drugs. Earlier this year, the agency said it had not established a link between the drugs and the fractures. The agency said at the time that it would continue working with the expert panel whose research has now hit. There's no word from the FDA about the new study--yet.

*Bull shit, those numbers are causal proof, a 16 to 1 ratio.  And Ms Shane works for the FDA (and who else) and she is a professor of medicine--jk

Drugs to Build Bones May Weaken Them

By TARA PARKER-POPE http://www.nytimes.com/2008/07/15/health/15well.html?_r=1&ref=health

New York Times Published: July 15, 2008, extracted by JK

But some experts are concerned that microscopic bone cracks that result from normal wear and tear are not repaired when the bone remodeling process is suppressed. A 2001 study of beagles taking high doses of bisphosphonates found an accumulation of microscopic damage, though there was no evidence that their bones were weaker.

Last September, the medical journal Bone reported on a study of 66 women, financed by Eli Lilly, that showed an association between Fosamax use and an accumulation of microdamage in bones.

 

Bone drugs get new fracture-risk warning

October 14, 2010 — 9:58am ET | By Tracy Staton

http://www.fiercepharma.com/story/bone-drugs-get-new-fracture-risk-warning/2010-10-14?utm_medium=nl&utm_source=internal

The FDA's review of bone-drug safety turned up enough evidence for a new warning about the risk of a rare-but-serious fracture of the thigh bone. There's been talk about a link between fractures and the popular class of osteoporosis drugs, known as bisphosphonates, for some time. But this is the first time FDA has required a new warning for the drugs' labels.

The warning will be added to those bone drugs approved for osteoporosis, whether oral--such as Merck's Fosamax, Roche and GlaxoSmithKline's Boniva, and Warner Chilcott's Actonel and new drug Atelvia (a next-generation version of Actonel)--or injectable, such as Novartis' Reclast. It won't apply to bisphosphonates marketed for cancer patients or Paget's disease, such as Novartis' Zometa.

FDA is asking doctors to keep a close eye on patients who've used bisphosphonates for longer than five years, because the fracture risk appears to be related to long-term use. The agency is continuing its safety review of long-term use of the drugs; so far, a causal link between the drugs and fractures hasn't been proven. Meanwhile, European regulators recently launched their own probe of the drugs and their possible link to stress fractures.

Reuters notes that the FDA warning could inspire patients to switch to Amgen's new bone drug, Prolia, which isn't a bisphosphonate. One analyst notes that Prolia sales could get a bump as early as next quarter. "Today's label change is likely to raise the level of concern among patients about the safety of bisphosphonates significantly," Bernstein & Co.'s Geoffrey Porges says in a research note.

But some experts are concerned that microscopic bone cracks that result from normal wear and tear are not repaired when the bone remodeling process is suppressed. A 2001 study of beagles taking high doses of bisphosphonates found an accumulation of microscopic damage, though there was no evidence that their bones were weaker.

Last September, the medical journal Bone reported on a study of 66 women, financed by Eli Lilly, that showed an association between Fosamax use and an accumulation of microdamage in bones.

 

 

 

Another Big PhARMA profit ploy that is counter to our health.  Bisphosphonates don’t work, and this is in a study which they manipulated the data to make it seem as an effective treatment. 

 

http://www.worstpills.org/member/newsletter.cfm?n_id=618

 

Worst Pills (by Public Citizen) is a site which using the available scientific information in a far and balanced way exposes the drugs that don’t work and their risks. 

 

Osteoporosis Fracture Prevention: What You Need to Know about Drugs and other Measures - Part 2

 

(part 1 was about bone mineral density screening—published here) 

 

Drugs for Osteoporosis

Several classes of drugs have been developed to treat osteoporosis. These vary in their effectiveness in reducing the risk of fractures.

Bisphosphonates (see Box 1) have become the mainstay of osteoporosis treatment because, among the available medications, they have the best risk-benefit profile. For example, older drugs for preventing fractures, such as estrogens, increase the risk of breast cancer as well as heart disease, and their risks outweigh their benefits. The bisphosphonates are also very heavily advertised.

Bone is constantly being absorbed and reconstructed, a process called “remodeling.” Reconstruction predominates into our 20s, when bone quantity and quality peak. After that, the quantity and quality of our bones begins to decrease and the risk of fractures may therefore increase. In women, the decline becomes more pronounced after menopause.

Bisphosphonates work by interfering with cells that absorb bone.

When to Use a Bisphosphonate

Before beginning any medication, it is important to know how much you stand to benefit because you may be exposing yourself to dangerous side effects. (See the November 2008 issue of Worst Pills, Best Pills News for a review of ways of determining your risk of bone fractures.)

Bisphosphonates are intended to prevent fractures. But the benefit is not the same for all people. A straightforward way to think about how a bisphosphonate might benefit you is in terms of primary and secondary prevention of fractures — when used to prevent a first fracture from occurring, it is called primary prevention; when used to prevent a subsequent fracture from occurring in someone who has already sustained a fragility fracture, it is called secondary prevention.

Sometimes the existing data about a drug make it difficult to understand its effects in straightforward terms. Reflecting this difficulty, a recent analysis of all major clinical trials of alendronate using a slightly different (and technically confusing) definition of primary and secondary prevention, provides a relatively straightforward assessment of its benefits:

Patients taking alendronate for primary prevention (first fracture) had the same number of hip fractures as those taking a placebo; in other words, alendronate made no difference for the most serious type of fracture. Over five years, only two fewer patients out of 100 suffered a vertebral fracture if they took alendronate.

Risedronate (ACTONEL) did not decrease the risk of any fractures for primary prevention. Studies of primary prevention with ibandronate (BONIVA) and zolendronate (RECLAST) have yet to be performed.

Box 1. Bisphosphonates Approved for Prevention and/or Treatment of Osteoporosis

• Alendronate (FOSAMAX)
• Risedronate (ACTONEL)
• Ibandronate (BONIVA)
• Zoledronic acid (RECLAST)

When used for secondary prevention of fractures (subsequent fractures), the number of women who would need to be treated with alendronate for five years to prevent one hip fracture was 100. Six fewer patients per 100 sustained vertebral fractures if they took alendronate for five years; these findings are similar for the other bisphosphonates.

These results are not especially impressive. Moreover, little is known about the use of bisphosphonates for longer than five years. A 10-year study of alendronate concluded that patients receiving treatment beyond five years maintained an increased BMD compared to those who stopped at five years; however the number of hip fractures was not statistically different between the two groups. This means that although an indicator of osteoporosis (BMD) was improved, the outcome (the number of hip fractures) for the patients using alendronate was not better than for those who stopped using the drug after five years. Using risedronate for up to seven years maintained BMD, and vertebral fractures occurred at a rate similar to the previous year; however, there was no comparison group of patients who stopped risedronate after five years so there is no way to know if continuing is beneficial.

Box 2: Strategies to Decrease Falls:

  • Strength and balance training decrease fall-induced injuries, such as fractures.
  • Additional strategies that may decrease falls include:
  • Reducing medications that cause sedation
  • Treating heart conditions that may cause fainting (slow heart rate, orthostatic hypotension, etc)
  • Home hazard reduction (removing loose rugs and clutter, adequate lighting, keeping wires behind furniture, etc.)
  • Treating poor vision (cataract surgery)
  • Strategies to decrease the force of impact, such as hip protecting pads, in patients that are prone to fall can decrease fractures.

Serious Side Effects Associated With Bisphosphonates

Bisphosphonates, like all medications, have potential hazards.

Severe ulcers in the esophagus is a well-documented hazard. In order to decrease esophageal irritation and possible ulcers, bisphosphonates (alendronate, ibandronate and risedronate) must be taken with an empty stomach and a full glass of water.

You should remain in an upright position for at least 30 minutes after swallowing the medicine.

Osteonecrosis of the jaw (destruction of the jaw bone) is a very serious complication; it has most often occurred in cancer patients receiving intravenous bisphosphonates (ibandronate and zoledronate), but there are also many cases in people using drugs such as alendronate for treatment of osteoporosis. This side effect often occurs in the context of dental surgery/extractions...

Atrial fibrillation, an irregular and rapid heart beat, is a newly recognized risk being investigated by the Food and Drug Administration. Lastly, incapacitating bone, muscle and joint pain is another known hazardous side effect of bisphosphonates. Additionally, there is growing concern that prolonged interference with bone remodeling cells by long-term bisphosphonate use may actually lead to fractures. (See next month’s Worst Pills, Best Pills News for a more in-depth discussion of this topic.)

Non-Drug measures Can Decrease Fractures

Just as there are many factors that can lead to fractures, there are more options than just drugs for preventing osteoporosis-related fractures.

Falls are antecedent to most fractures. One’s risk of falling is a combination of intrinsic characteristics and extrinsic hazards, some of which can be modified. There are measures that decrease one’s risk of falling and can decrease fall-related injuries, including fractures (see Box 2).

In addition, smoking cigarettes and excessive alcohol consumption both negatively impact bone; quitting smoking and decreasing alcohol consumption can decrease fracture risk.

Bringing it together

Although osteoporosis is an important component of fracture risk, the single-minded focus on drugs for this condition risks neglecting other fracture-reducing interventions. We can achieve better application of limited health care resources with a more thoughtful approach to prevention, incorporating modifiable risks for falling and lifestyle modifications with prudent use of medications, like bisphosphonates, when evidence demonstrates a clinically important reduction in fractures.

 

At http://healthfully.org/highinterestmedical/id3.html, (taken from Nature) Ann Michaels, PhD points out that the ineffectiveness of Prempro was well known before the WHI study, and thus the reasonable conclusion is that NIH planned to go after hormone replacement therapy because Big PhARMA wanted to replace cheap propholatic generic ones with on patent drugs. 


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