OBOS has received funding to make blog entries available in Spanish. We hope to expand outreach efforts in the coming year.

Los bisfosfonatos (p.e. Fosamax, Boniva, etc.) son medicamentos para el tratamiento y la prevención de la osteoporosis en mujeres postmenopáusicas, pero hay preocupación por los posibles efectos secundarios causados por el uso de estos medicamentos por periodos largos.  Entre los posibles efectos secundarios se incluyen: fracturas atípicas de fémur (muslo), osteonecrosis (muerte de la mandíbula), y cáncer de esófago.

El otoño pasado, la FDA pidió cambios en las etiquetas de los bisfosfonatos para incluir advertencias sobre riesgos de fracturas, para explicar que no se sabe exactamente el tiempo que se debe consumir el medicamento, y recomendar que pacientes y doctores reevalúen periódicamente el uso del medicamento.

Recientemente, algunos comités de la FDA encargados de los medicamentos para la salud reproductiva y del manejo de la seguridad/riesgo de las medicinas, se reunieron para discutir el consumo extendido (>3-5 años) de bisfosfonatos, y sus posibles complicaciones.

En un documento informativo preparado para la reunión, la FDA revisó evidencias sobre estos relativamente raros pero preocupantes efectos, y concluyó: “La seguridad para el consumo prolongado de  bisfosfonatos aún no es clara, por cuanto los resultados de los estudios sobre la posible relación entre la osteonecrosis de la mandíbula, las fracturas atípicas de fémur, o el cáncer del esófago, y el uso de bisfosfonatos para la prevención y el tratamiento de la osteoporosis son conflictivos.”

La agencia concluyó que la evidencia sugiere un aumento en la incidencia de osteonecrosis de la mandíbula con un uso prolongado, especialmente de 4 años o más, pero que se necesitan estudios más profundos.  También dice, “Las fracturas atípicas….parecen tener una asociación importante con los bisfosfonatos, pero no hay actualmente consenso en cuanto a la manera como el uso acumulado de bisfosfonatos aumenta los riesgos de este tipo de fractura poco común.  Finalmente, no hay evidencia definitiva para apoyar la relación entre el cáncer de esófago y el uso prolongado de bisfosfonatos.”

En cuanto a los posibles beneficios resultantes del uso prolongado de bisfosfonatos para reducir fracturas relacionadas con la osteoporosis, la agencia no encontró beneficios evidentes.  “Los resultados sugieren que no hay ventajas de importancia en continuar usando esta medicina por más de 5 años.”

El New York Times también informa acerca de las recientes reuniones de la FDA, y destaca: “El comité convocó a más estudios para establecer la eficacia del medicamento en la meta deseada de prevenir fracturas.  Así mismo, los asesores recomendaron que la FDA examine la razón por la que el medicamento es recetado como medicina preventiva a mujeres que nunca han tenido osteoporosis.”

Para más información sobre este tema, vea nuestras previas entradas de blog, y la Red Nacional de la Salud de la Mujer (the National Women’s Health Network), la cual también pregunta si este producto debe ser comercializado y recetado como medicina preventiva para mujeres con buena salud.

Last fall, the FDA requested changes to bisphosphonate labels to warn of the fracture risk, explain that the optimal amount of time to take the drug is not known, and recommend that patients and their doctors periodically reevaluate whether the drug should be continued.

Recently, FDA committees on reproductive health drugs and drug safety/risk management met to discuss long-term (>3-5 years) use of bisphosphonates and these potential complications.

In a briefing document prepared for the meeting, the FDA reviewed evidence on these relatively rare but concerning effects, and concluded, “The safety of long-term bisphosphonate therapy continues to be unclear as study results are conflicting as to whether or not ONJ [jaw osteonecrosis], atypical femoral fractures or esophageal cancer are associated with use of bisphosphonates for the prevention and treatment of osteoporosis.”

The agency further concluded that the evidence suggests an increased prevalence of jaw osteonecrosis with longer use, especially of 4 or more years, but that larger studies are needed. It also writes that “Atypical fractures…appear to have a strong association with bisphosphonates but there is no current consensus on the extent to which cumulative use of bisphosphonates increases the risk of this rare type of fracture. Finally, no definitive evidence is available to support an association between esophageal cancer and long-term use of bisphosphonates.”

In discussing whether long-term use of bisphosphonates would have a benefit of reducing osteoporosis-related fractures, the agency found no clear benefit of continuing, stating, “These results suggest no significant advantage of continuing drug therapy beyond 5 years.”

The New York Times also has coverage of the recent FDA meeting, and notes: “The committee also called for more study of the overall effectiveness of the drugs in their desired goal of preventing fractures. And the advisers recommended that the F.D.A. take a close look at why the drugs are prescribed as preventive medicine for women who do not even have osteoporosis.”

For more on this topic, see our previous posts, and the National Women’s Health Network, which also raises the issue of whether these drugs should be marketed and prescribed for prevention to healthy women.

Today, NPR’s Morning Edition has a good overview of this topic, noting the dilemma for women weighing whether to take such drugs. Bisphosphonates can help some women prevent serious hip fractures, but they may be associated with a increased risk of other atypical fractures in some women, especially those who use the drugs long-term.

There’s a new study on this topic in the Journal of the American Medical Association as well. The study found that treatment with a bisphosphonate for more than five years was associated with an increased risk of subtrochanteric or femoral shaft fractures, though the risk of these fractures is low.

The FDA announced a labeling change to the drugs in October 2010 to note the possible risk of thigh bone fractures.

• The effect of the “doughnut hole” in Medicare Part D coverage should be reduced through a 50% discount on brand-name prescription drugs in the coverage gap. Senate Democrats are focusing on this benefit as one that should not be repealed by the new House and are vowing to block any such repeal.
• Free preventive services, such as cancer screenings and annual wellness exams, will be available for seniors on Medicare.

Another expected benefit looks like it will be reversed:

• The New York Times reports that Medicare regulations are being revised “to delete references to end-of-life planning as part of the annual physical examinations covered under the new health care law, administration officials said Tuesday.” This is the provision which would have paid for the visits for Medicare recipients to talk to their physicians about their end-of-life wishes, which was distorted into political talk about “death panels.” The administration is citing a lack of public comment opportunity on the provision for its reversal.

An overview of other newly available healthcare benefits is available here.

Random Aside: does the generic descriptor “older Americans” bother anyone else? It always makes me ask, “Older than what/who?”

A Hot, Hot Summer: By a 31-28 vote, the House Committee on Energy and Commerce on Friday approved a health reform bill that would cover about 95 percent of Americans. It includes the so-called public option, a government insurance plan that would compete with private insurers. The bill allows the federal government to negotiate with drug companies for lower prices under Medicaid and limits how much insurers can increaes premiums. Subsidies would be provided to lower-income families to help cover the cost of insurance.

Two other committees — Ways & Means, and Education & Labor – approved legislation in mid-July. The full House will take up the bill, HR 3200, when it returns from August recess. Now everyone’s waiting on the Senate Finance Committee, chaired by Sen. Max Baucus (D-Mont.), to move its health reform bill out of committee — a move that isn’t likely to happen until after summer recess. Lawmakers and experts weigh in on what’s slowing everything down.

The Energy and Commerce committee vote was largely along party lines, with five Democrats joining all 23 Republicans opposed to the bill. In a story about how the White House might be ready to move forward without building broader bipartisan support, The New York Times notes that lobbying efforts are going to be “unusually heavy” this month. Indeed, House Republican leader, Rep. John Boehner of Ohio, has promised a “hot summer” for Democrats.

How much hotter than health reform = death can it get? Opposition to health reform already has become increasingly vocal, what with conservative talk radio fueling fear among senior citizens that healthcare reform will lead to end-of-life “rationing” and “euthanasia.” Ceci Connolly of the Washington Post writes:

Not since 2003, when Congress and President George W. Bush became involved in the case of Terri Schiavo, who lay in a vegetative state in a hospice in Florida, have lawmakers waded into the highly charged subject, said Howard Brody, director of an ethics institute at the University of Texas Medical Branch at Galveston.

The attacks on talk radio began when Betsy McCaughey, who helped defeat President Bill Clinton’s health-care overhaul 16 years ago, told former senator Fred D. Thompson (R-Tenn.) that mandatory counseling sessions with Medicare beneficiaries would “tell them how to end their life sooner” and would teach the elderly how to “decline nutrition . . . and cut your life short.”

House Minority Leader John A. Boehner (R-Ohio) and Republican Policy Committee Chairman Thaddeus McCotter (Mich.) said they object to the idea because it “may start us down a treacherous path toward government-encouraged euthanasia.”

Lawmaker, Protect Thyself: House Speaker Nancy Pelosi (D-Calif.), according to the NYT, “distributed cards outlining key points of the House’s health care approach” to all 256 Democrats heading to their home districts for August recess. She might want to send them home with their own personal armor.

Politico reports on growing incivility at town hall meetings led by Democratic representatives: “Screaming constituents, protesters dragged out by the cops, congressmen fearful for their safety — welcome to the new town-hall-style meeting, the once-staid forum that is rapidly turning into a house of horrors for members of Congress.”

Think Progress notes that “much of these protests are coordinated by public relations firms and lobbyists who have a stake in opposing President Obama’s reforms.”

The lobbyist-run groups Americans for Prosperity and FreedomWorks, which orchestrated the anti-Obama tea parties earlier this year, are now pursuing an aggressive strategy to create an image of mass public opposition to health care and clean energy reform. A leaked memo from Bob MacGuffie, a volunteer with the FreedomWorks website Tea Party Patriots, details how members should be infiltrating town halls and harassing Democratic members of Congress.

Visit Think Progress for the memo, which Lee Fang says “resembles the talking points being distributed by FreedomWorks for pushing an anti-health reform assault all summer.”

All this makes the 1994 version of Harry & Louise look like the nicest, most honest couple you’d ever meet (funny how life repeats itself, with a twist).

Center of Debate: Back to the legislation approved by the Energy & Commerce committee … By a vote of 30 to 28, the committee approved an amendment (pdf) that states abortion would not be included in the “essential benefits package” to be defined by the government.

Dan Gilgoff at U.S. News & World Report explains the details:

The amendment, proposed by Democratic Rep. Lois Capps, prohibits the federal government from compelling private providers participating in the federal healthcare exchange to cover abortion. But it also bars the government from prohibiting those plans from offering such coverage. And it requires that at least one of the private plans participating in the exchange cover abortion—and at least one of the plans to not. [...]

Democratic defenders of the Capps amendment say it applies the Hyde Amendment, which for more than three decades has prohibited Medicaid from funding abortions except in very limited circumstances, to the new government-controlled healthcare. Private healthcare providers are free to cover abortion, but not with federal funds. The public plan would cover abortion, but not with federal funds; a Capitol Hill aide tells me money for abortions would come from what participants pay into the public plan.

Abortion has been the political football since the debate over healthcare commenced this year.

“One of the very real dangers in the debate on how to fix American healthcare is that women’s health will become a bargaining chip, with the GOP and anti-abortion forces trying to frame healthcare reform as an endrun to government ‘interference’ in our lives by ‘mandating’ abortion and gasp, contraception,” writes Lucinda Marshall.

And over at RH Reality Check, Amanda Marcotte looks at how the media has been reinforcing unexamined arguments against public funding for abortion, and she explains the true story:

Here’s the unvarnished truth: There is no way that any kind of public health care plan will have elective abortion coverage. Nor is there any real chance of abortion becoming mandated coverage. It’s more likely that breast implants will be paid for by tax money. It’s more likely that a public insurance option will provide everyone wth an iPod Touch. Believe me; even most pro-choicers gave up a long time ago on hoping that we could overturn the Hyde Amendment that bans women who are on federally funded insurance programs from getting elective abortions covered, and there’s no way that this will change if the number of women on federally funded health insurance grows. And even though it would only be fair and cost-effective to mandate coverage for elective abortion, in this country that’s sadly a pipe dream.

Plus: For more on fact vs. fiction, read this AP story on distortions in the health care debate. Meanwhile, Princeton economics professor Uwe E. Reinhardt offers a glimpse of what a health reform bill would look like if it conformed with the American public’s idea of “common sense” in health care. And Bill Moyers on Friday re-aired a must-see interview with former insurance industry executive Wendell Potter. Watch it or read the transcript. You may come away mad, but you won’t be disappointed.

Want to Cut Costs? Over Here, Mr. President: Also at RH Reality Check, Jennifer Block, author of “Pushed: The Painful Truth About Childbirth and Modern Maternity Care,” writes about where healthcare cost savings can be found:

A new economic analysis forecasts savings of $9.1 billion per year if 10 percent of women planned to deliver out of hospital with midwives. (Right now, just one percent do). If America is serious about reform, midwifery advocates are saying, “Hey, how about us?”

Childbirth, in fact, costs the United States more in hospital charges than any other health condition — $86 billion in 2006, almost half paid for by taxpayers. This high price tag — twice as high as what most European countries spend — buys us one of the most medicalized maternity care systems in the industrialized world. Yet we have among the worst outcomes: high rates of preterm birth, infant mortality, and maternal mortality, with huge disparities by race.

Tell Me: What’s Wrong With Single-Payer Again?: David Brooks and Gail Collins try to figure it out. Collins starts with this set-up:

Since something like a third of the cost of health care is in administration, and the problem with reorganizing health care has to do with all the multitudinous plans and policies, a single-payer system would be far and away the most cost effective answer. We don’t talk much about it because it isn’t politically possible. But it isn’t politically possible because we don’t talk about it. The opponents of a public plan are afraid that people would all gradually migrate toward it, causing the insurance industry as we know it to wither away. Wouldn’t that be a good thing?

In Other News, Senate Committee Grasps Reality: It seems that funding for abstinence-only sex education is losing its luster. The Senate Appropriations Committee on Thursday approved its fiscal year 2010 spending bill (HR 3293) for health, education and labor programs, minus funding for the controversial program. The $730 billion bill, approved by a vote of 29-1, includes $104.5 million for a comprehensive “Teen Pregnancy Prevention” program and no funding for abstinence-only sex ed. Abstinence-only advocate Sen. Sam Brownback (R-Kan.) cast the only “no” vote.

“After more than a decade, Congress has finally begun to put teenagers’ health above politics and ideology,” Michael Macleod-Ball, acting Director of the ACLU Washington Legislative Office, said in a statement. “The Committee’s actions represent a looming victory for young people, parents and advocates of science-based approaches.”

The same statement notes that the measure must still go to the full Senate for a vote, “where misguided efforts to reinsert funding for abstinence-only programs are possible.”

Take Action
From the Big Push for Midwives, sign the “I pushed for out-of-hospital maternity care” petition in support of  including out-of-hospital maternity care and Certified Professional Midwives, who are specially trained to provide it, in federal healthcare reform legislation.

If you scroll down about 2/3 of the way through the transcript, you’ll find that Obama was asked and answered another question along the lines of the “health reform = death for old people” rumors Christine addressed in a recent post. The audience member says, “I have been told there is a clause in there that everyone that’s Medicare age will be visited and told to decide how they wish to die.”

The comment refers to a section of the House reform bill that would provide for consultation every five years about advance care planning, including explanations of things like living wills and power of attorney that people may want to consider, as well as information about end-of-life services such as hospice and palliative care.

As the moderator of the town hall noted, “This is being read as saying every five years you’ll be told how you can die.”

Obama replied:

Well, that would be kind of morbid. I think that the idea in that provision, which may be in the House bill — keep in mind that we’re still having a whole series of negotiations, and if this is something that really bothers people, I suspect that members of Congress might take a second look at it. But understand what the intent is. The intent here is to simply make sure that you’ve got more information, and that Medicare will pay for it.

So, for example, there are some people who — they get a terminal illness, and they decide at a certain point they want to get hospice care. But they might not know how to go about talking to a hospice, what does it mean, how does it work. And they don’t want to — we don’t want them to have to pay for that out of pocket. So if Medicare is saying you have the option of consulting with somebody about hospice care, and we will reimburse it, that’s putting more power, more choice in the hands of the American people, and it strikes me that that’s a sensible thing to do.

Rachel Maddow last night had a segment on Republicans’ interpretation of the bill:

Here’s how it begins:

The actress Natasha Richardson died after falling skiing in Canada. It took eight hours to drive her to a hospital. If Canada had our healthcare she might be alive today. We now have helicopters that would have gotten her to the hospital in 30 minutes. Obama wants to have our healthcare like Canada ‘s and England’s.

In England anyone over 59 cannot receive heart repairs or stents or bypass because it is not covered as being too expensive and not needed.

I got this today and am sending it on. If Obama’s plans in other areas don’t scare you, this should. [...]

Please do not let Obama sign senior death warrants.

Everybody that is on this mailing list is either a senior citizen, is getting close or knows somebody that is.

Most of you know by now that the Senate version (at least) of the “stimulus” bill includes provisions for extensive rationing of health care for senior citizens… The author of this part of the bill, former senator and tax evader, Tom Daschle was credited today by Bloomberg with the following statement. Bloomberg: Daschle says “health-care reform will not be pain free. Seniors should be more accepting of the conditions that come with age instead of treating them.”

There’s more, and you can read it in its entirety at FactCheck.org, along with a point-by-point breakdown of all the incorrect information contained within.

For starters, here’s what FactCheck.org found when it looked into the claim about people over age 59 not receiving coronary care in England:

We called the United Kingdom’s Department of Health and a spokesman told us: “It is not true that anyone aged over 59 years cannot receive heart repairs, stents or bypass surgery on the basis of their age.”

He also said that medical procedures in the U.K. are not routinely denied for older people. The National Health Service, the U.K.’s public health care service, has a constitution which prohibits discrimination on the basis of age and other factors. “The NHS Constitution states that the NHS provides a ‘comprehensive service, available to all irrespective of gender, race, disability, age, sexual orientation, religion or belief,’ ” the spokesman said.

We also contacted a nonprofit group, England’s Age Concern and Help the Aged, which works to stop age discrimination in various facets of life, including employment and health care. Age Concern’s press office had never heard of any kind of prohibition on heart surgery for those 60 and older.

Women, who generally live five to 10 years longer than men, need to know that health care reform in the United States will not lead to a rationing of care for seniors. Here’s what FactCheck.org reports on the stimulus bill:

Some conservatives have said that a council overseeing the government’s funding of comparative effectiveness research (research into which medicines and procedures work best and are most cost-effective) will “ration” health care. But the council created by the stimulus legislation (now public law (pdf)) doesn’t have any power to do that. In fact, the legislation stipulates that “[n]one of the reports submitted under this section or recommendations made by the Council shall be construed as mandates or clinical guidelines for payment, coverage, or treatment.”

As for former Sen. Tom Daschle, he never said, “Seniors should be more accepting of the conditions that come with age instead of treating them.” Here’s the real deal:

Instead, those are the words of the former Republican lieutenant governor of New York, Betsy McCaughey, who wrote an opinion piece for Bloomberg News and offered her reading of comments in Daschle’s book. Back in February, we dissected McCaughey’s column, pieces of which have popped up in chain e-mails, and found it to be full of errors. McCaughey also passes off opinion as fact, and in the case of Daschle, she paraphrases him, which is clear from the lack of quote marks in the column.

What Daschle did say is a far cry from “seniors should be more accepting of the conditions that come with age instead of treating them.” Instead, he wrote (without mentioning age) in his book “Critical: What We Can Do About the Health-Care Crisis”: “The use and overuse of new technologies and treatments is grounded in American culture. … More so than people in other countries, [Americans] just aren’t inclined to fatalistically accept a hopeless diagnosis or forgo experimental interventions if there is even the slightest chance of success.”

If you see the “senior death warrant” email posted anywhere, please respond by posting this link:

http://www.factcheck.org/askfactcheck/is_it_true_that_persons_older_than.html

Plus: National Women’s Law Center is calling for a national call-in day on health reform on Tuesday, July 28 (that’s tomorrow). Call your U.S. representatives to tell them to support the House’s health care reform bill (H.R. 3200).

Often overlooked in discussions of the condition, however, are questions related to the efficacy and potential harms of the tests and treatments used to measure and prevent bone loss.  In particular, women’s health advocates have concerns about the overuse of medications in women who have risk factors for osteoporosis, but do not actually have the disease itself.

The April issue of the American Journal of Nursing (AJN) includes a piece, “The Marketing of Osteoporosis,” which comments on the promotion of drugs to symptom-free women for bone fracture prevention.

Author Maryann Napoli (of the Center for Medical Consumers) writes:

“In the name of prevention, millions of Americans have accepted the idea that it’s reasonable to treat a risk factor such as bone loss or high cholesterol as if it were a disease…More people should question the wisdom of starting long-term drug therapy. Often the magnitude of the risk factor has been overestimated, or the danger of the disease itself exaggerated, by people trying to sell you something-like a drug you must take for the rest of your life.”

She describes how what was once a risk factor (bone loss) came to be thought of as a disease (osteoporosis), and notes the role of pharmaceutical companies such as Merck in shaping this thinking, as well as in encouraging women to have bone density scans and take drugs as a “preventive” measure.

Napoli notes that as drugs such as alendronate came on the market, middle-aged rather than elderly women became the targets of osteoporosis-related advertising and drugs. She explains:

“A multipage glossy ad campaign that ran frequently in the Annals of Internal Medicine, for example, featured a thin, 40-something white woman with a crumbling ancient stone column in the background. “Don’t wait for a fracture…. No matter what her degree of osteoporotic bone loss.” I wrote to the editor-in-chief of Annals, pointing out that alendronate had no proven benefit in women in early middle age or in those without a history of fracture. I never received a reply, but the journal stopped running the ad about six months later….

Today, women in the osteoporosis drug ads are usually in their early 60s. The 2002 guidelines for osteoporosis screening from the Agency for Healthcare Research and Quality recommend that bone-density scanning not begin until age 65 (or 60 in some high-risk cases).”

Christine has previously written about the potentially serious side effects medications for postmenopausal osteoporosis and non-drug prevention options, and OBOS’s Judy Norsigian and Heather Stephenson addressed the issue in a commentary for Women’s eNews, “Let’s Make May the Month to Tame Osteoporosis Hype.”

Side note: The current cover of the AJN features a piece of art called Nursing Bra, part of the Artfull Bras Project, a collection of 50 bras created by the Quilters of South Carolina to raise breast cancer awareness.

The New York Times looks at a rare type of leg fracture in the upper thighbone — a fracture that typically affects people in car accidents or very frail older people — which is showing up in women who have used a class of bone-building drugs called bisphosphonates for five years or more. Tara Parker-Pope writes:

Some patients have reported that after weeks or months of unexplained aching, their thighbones simply snapped while they were walking or standing.

“Many of these women will tell you they thought the bone broke before they hit the ground,” said Dr. Dean G. Lorich, associate director of orthopedic trauma surgery at NewYork-Presbyterian/Weill Cornell and the Hospital for Special Surgery. Dr. Lorich and his colleagues published a study in The Journal of Orthopaedic Trauma last month reporting on 20 patients with the fracture. Nineteen had been using the bone drug Fosamax for an average of 6.9 years.

To be sure, the problem appears to be rare, notes Parker-Pope, and the drugs have proved useful for women with severe osteoporosis. But it’s enough of a concern that Merck, the drug company that makes Fosamax, said it will study whether the fracture is occurring more in bone-drug users.

Up to this point, “the fracture pattern did not emerge in placebo-controlled studies of bone drugs. But those studies have lasted only three to five years, although follow-up studies of the drug users have lasted longer. Now that the fracture pattern has been identified, researchers expect more doctors to publish reports,” writes Parker-Pope.

Meanwhile, studies show that there’s there’s not much to be gained by taking bisphosphonates for more than five years, and some doctors recommend that long-term users take a break from the drugs.

The story also notes another rare side effect associated with the drugs: osteonecrosis of the jaw, which destroys a patient’s jawbone. Though it mostly affects cancer patients taking an intravenous form of the drug, ordinary users have also reported the side effect.