You may have seen famous actress Sally Field sitting on a couch or walking on the pier of a peaceful lake talking about the benefits of Boniva. She tells us that she has osteoporosis and that her doctor told her that Boniva could not only stop bone loss, but make bones grow denser. It turns out the opposite is true.

Today the Food and Drug Administration (FDA) announced that it will look into links alleged between the use of certain osteoporosis drugs such as Fosamax, Actonel, Boniva, and Reclast and a particular type of leg fracture. This follows extensive review of a study published in the Journal of Bone and Mineral Research.

Dr. Bo Abrahamsen of Department of Medicine and Endocrinology F, Copenhagen University Hospital in Denmark headed up the study, which did an analysis of data from two large observational studies on patients with osteoporosis.

In the study the authors concluded that atypical femur fractures that happen right below the hip had many similar features in common with classical osteoporotic hip fractures. These include the patient’s age, gender, and trauma mechanism (cause of the injury).

They came to these conclusions because the data showed that patients taking bisphosphonates (a class of drugs that prevent bone loss) and those not taking bisphosphonates had similar numbers of femur fractures in the same place in the femur relative to classical osteoporotic hip fractures.

Side Effects Hit the Headlines

Today ABC News reported that numerous cases of women who had taken Fosamax (one drug in a class of bisphosphonates that also include Actonel, Boniva, and Reclast) for a long periods of time experienced their femur bones had just snapping while doing little more than taking a walk.

“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center. “Very unusual, the femur is one of the strongest bones in the body.”

This is not the first time that doctors have reported an opposite effect for Fosamax. The drug, made by Merck, has already been linked to severe musculoskeletal pain, as well as to a serious osteonecrosis, a depletion of bone density in the jaw. You may remember Merck from their expensive and embarrassing recall of Vioxx in 2004. After taking a $5 billion PR bloodbath, Merck is still arguing against the settlement as if it would matter.

Defective Drug Denial

As early as 2008, the FDA sent a letter to Merck about the reports of bone fractures. It took Merck 16 months to add those reports to the list of possible side effects included in the drug’s package insert.

“Nothing is more important to Merck than the safety of its medicines,” said Merck. “As part of our commitment, Merck closely monitors post-marketing data and reports that information to FDA and other regulatory agencies.”

“A causal association has not been established between long-term bishphosphonate use and low energy femoral shaft and subtrochanteric fractures,” it said. “In clinical studies, Fosamax (alendronate sodium) has not been associated with increased fracture risk at any skeletal site.”

The company reported femoral fractures had been discovered in non-bisphosphonate users also. They are doing further investigation. The problem with this is that they have a history of foot dragging, particularly related to the highly profitable Fosamax.

The FDA doesn’t seem to be conducting themselves in the best manner either. After the Merck misconduct, the FDA turned around and rewarded them by approving the generic version of Fosamax. There’s a term for this in the pharmaceutical industry for this. It’s called, “cha-ching.”

Patients Speak Out

Stephanie George, a 67-year-old retired college teacher from Frisco, Texas, took Fosamax for eight years. She said she was advised not to have dental surgery for an abscess on her wisdom tooth until she had been off the drug for five years.

“They said there was a rare, but real chance that my bottom jaw would become infected and might have to be removed,” said George.

If that’s not scary enough, George is joined by literally millions of post-menopausal women, who were treated with bisphosphonates for low bone density.

Jeanett McLearen of Warren, Michigan is perplexed by the news. Her doctor wants her to have further injections for bone loss, but upon hearing about the risk, she cancelled her first appointment this week.

In an interview with ABC she said, “I am scared and I am confused. I don’t know what I think. I don’t know what to do.”

This is understandable. Women are told to check bone density and trust what their doctors say. Their doctors in turn must trust that the FDA is up to date on the most recent studies on the thousands of types of drugs. And the drug companies are supposed to closely monitor specific studies and warn the FDA of results. Yet there is a major flaw at every level of the chain. The drug companies make too much money to report, the FDA is too under-funded to adequately report, and it is impossible for doctors to fill the gaps.

Treatment vs. Natural Occurrence

Dr. Nortin Hadler is a professor of medicine and microbiology at University of North Carolina. He is opposed to the treatment of osteopenia. He claims it is just part of the natural course of aging.

“We have a history of over treatment and over-medicalization of people in this country and we need a discussion that’s out loud and up front,” said Hadler, author of “Worried Sick”. He went on to contend, “For those who are in their 50s and otherwise healthy, there is no reason to have a bone density test.”

In some cases testing is important, especially for people who are prone to osteoporosis because they take steroids, struggle with nutritional issues, or have inflammatory bowel disease.

“Our nation has been taught to fear the consequences of our thinning bones,” he said

Dr. Ethel Siris is the professor of clinical medicine at Columbia University’s College of Physicians and Surgeons and director of the Toni Stabile Osteoporosis Center, and she agrees that not all women with osteopenia need to be treated with bisphosphonates, but the issue is complicated.

“When we get stuff like this on the news, we get millions of calls and people with bad osteoporosis on the drug and at risk for fractures throw away the drugs and are afraid,” she said.

“First of all, these are unusual fractures and hard to interpret and a fair number occur in people without bisphosphonates,” she said. “This is a rare complication.”

Patients Need to Be Protected

Amongst all of the disputes, the warnings, the studies, and the different treatment methods, the ones who seem to suffer the most are the very people who are suffering in the first place; the patients. When it comes down to it, patients who are suffering from bone density are being told by celebrities on television that they can reverse the serious problem and the patient is getting worse.

This class of drugs have been on the market and tested for almost two decades, but yet a side effect that can manifest itself within five years and neither the drug companies nor the FDA did anything about the complaints until now. That is not acceptable when it affects millions of women.

If you or a loved one are taking this class of bisphosphonates it is important that you contact your doctor. Then protect yourself by contacting legal council that has experience in protecting patients from giant pharmaceutical companies. Call Phillips Webster for a consultation on your legal options.

Learn More About:

• Defective Drugs
• Product Liability
• Defective Medical Devices