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

Ted Baker’s lawsuit resumed today in New Jersey. His is the first of 26,000 legal cases being brought against the British pharmaceutical giant AstraZeneca. Baker’s suit reflects the basis of most of the other cases. He contends that the company did not adequately inform patients and healthcare representatives of the risk of contracting diabetes from weight gain after taking the popular pill Seroquel, an atypical antipsychotic used to treat schizophrenia.

These are serious charges, because weight gain is a significant side effect. The lawsuits allege that the company knew about the of the side effects and still resisted changing their labeling. A study released in 2003 in the American Journal of Psychiatry found drugs like Seroquel were associated with an increased risk of diabetes.

Yet, even the Food and Drug Administration (FDA) has seemed to underscore the importance of the 2003 study. In their drug safety description of Seroquel provided to healthcare providers they mention weight gain, but nothing further related to the side effect, only that the patient should weight themselves.

The Experts Take the Stand against Seroquel

It’s becoming apparent that experts and ex-employees of AstraZeneca are going to have a significant role in the trial. If the trial turns out in Baker’s favor, that could be damaging to AstraZeneca.

One of those witnesses, Seroquel’s former global safety officer Dr. Wayne Geller, testified today that some colleagues fought his urgings in June of 2000 to strengthen AstraZeneca’s internal description of Seroquel’s weight gain side effects. He told the jury that all he and other researchers wanted was the word “limited” removed from the explanation of the drug’s potential for causing some users to gain weight.

“I did question why the word limited was not taken out of the core-data sheet” Geller said. “I found out there were people from the commercial side who opposed the change.”

Basically what that means is that the sales department thought it would be bad for business. Geller’s testimony shows a clear intent to sugar coat the seriousness of diabetes related to weight gain in Seroquel.

Geller pushed to change the language because after reading the AJP report and others since that show Seroquel could “produce significant weight gain in select individuals,” he felt that he had to say something.

Geller revealed that the reports showed that the average weight gain was 27 pounds. In some cases that can mean a significant raise in an individual’s body mass index. When accompanied with other side-effects of the drug not independent of the weight gain such as higher cholesterol and higher blood sugar levels, this is a perfect combination for diabetes. So, this shows that diabetes is not a secondary side effect, but because of the combination of side effects, it is a primary side effect. Seroquel causes diabetes and the label failed to warn of the risk.

Upon cross examination, AstraZeneca’s lawyers decided to focus on specific language. The initial report regarding Seroquel’s side effects written by Geller had the word “limited” in it. He admitted having mistakenly left the word in other reports since reading studies to the contrary.

Mike Brock, an AstraZeneca lawyer, asked Geller, whether the company ever used the “limited weight-gain” language in Seroquel’s  warning label in the United States. “It’s never been in there,” the doctor replied.

AstraZeneca Decides to Blame the Victim; Will it Work?

The company may be seeing the writing on the wall. They may be helping schizophrenics, but they’re also making them obese, which lowers their life expectancy considerably.

Officials at AstraZeneca indicated earlier today that they will end research and development into psychiatric medications at its United States corporate headquarters in Wilmington, Delaware, as part of a mass corporate restructuring.

They also announced that they would cut 11 percent of their workforce by the end of this year as part of the $2 billion restructuring, the bill for the whole shake up that’s happening between now and 2013.

The 11 percent cut means 550 jobs will be lost in Wilmington, Delaware. The loss of those jobs is obviously significant to the existence of the global conglomerate, but how it unclear. This is a corporation that made almost $5 billion off of Seroquel alone. The layoff may just a punishment to the United States.

In a classic tactic called “blame the victim”, lawyers for the company told jurors in opening statements that Seroquel doesn’t cause diabetes. They accused Baker (a Vietnam War veteran) that his weight-gain and disease stemmed from his lifestyle and diet. The lawyers went on to say that the company provided adequate warnings about the drug’s risks on the medication’s warning label and marketed it as according to clinical findings.

“From the very first label for Seroquel, AstraZeneca had in its label the risk of weight gain and the risk of diabetes,” Diane Sullivan, of the AstraZeneca legal team, told jurors in opening statements.

The blame the victim tactic has not gone well in the past for other legal cases. It tends to alienate the jury. Some high profile cases have had disastrous results because of it, an example was RJ Reynolds during their unprecedented $144 billion tobacco lawsuit loss. People feel alienated from massive global conglomerates as it is, being British and eliminating American jobs in the process doesn’t help their public relations. We shall see.

Seroquel and the Side Effects

According to both AstraZeneca and the FDA the list of side effects remains the same and there is no warning or even acknowledgement of the many studies showing of significant chance of diabetes.

Some of the side effects include:

• Difficulty swallowing
• Long lasting and painful erection
• Increases in liver enzymes
• Increases in prolactin levels
• Abnormal thyroid tests
• Seizures
• Cataracts
• Low white blood cell count
• Increases in blood pressure in children and teenagers.
• Orthostatic hypotension (decreased blood pressure)
• Tardive dyskinesia uncontrolled movement in face, tongue, or other body parts
• Increase in weight (weight gain)
• HDL (good) cholesterol.
• High blood sugar (hyperglycemia
• Neuroleptic malignant syndrome (NMS) A rare and serious condition that can lead to death.

The FDA also mentions that there is a chance of suicidal thoughts. Not a welcome side effect for a drug that is taken for schizophrenia.

Protect Yourself

The massive legal teams that can be accumulated by a company that makes 5 billion dollars per year off of a single pill amongst in their extensive line of pharmaceuticals can seem disheartening and slightly overwhelming. That makes some patient’s feel as if they can’t be represented or it just isn’t worth it. That is not true if the legal council representing the case is experienced with defective drug litigation.

If you or a loved one has been seriously injured or killed by a defective drug or pharmaceutical company negligence then call Phillips Webster for a consultation on your legal options.

Learn More About:

• Yaz, Yasmin, Ocella
• Provigil
• Meridia

The first trial is under way in a lawsuit filed by former Seroquel user Ted Baker, of Bastrop, Louisiana, are set to begin Monday in state court in New Brunswick, N.J.

Baker’s lawsuit is just a drop in the bucket for AstraZeneca’s legal woes. It is just one of about 10,400 lawsuits against the British company pending in U.S. courts. Many of these lawsuits allege that users of Seroquel contracted diabetes or other injuries by taking it. Up until now, AstraZeneca has been successfully engaging in Matrix-like bullet dodging to avoid defending itself before a jury. In some instances they even conviced judges to dismiss lawsuits before trials were scheduled to begin.

Up to this point AstraZeneca has incurred more than $650 million in legal defense costs for the Seroquel litigation. Of course, its ultimate liability could go higher if juries award damages or if AstraZeneca settles lawsuits.

Now, that legal account has been stretched even further. The company last year put aside $520 million for a looming settlement of a government investigation into allegedly improper sales and marketing practices for Seroquel.

What is Seroquel?

Both Seroquel and Zyprexa are known as atypical antipsychotics, designed to avoid some of the side effects of older drugs that treated schizophrenia and bipolar disorder. If you noticed the irony of a drug that is supposed to avoid side effects causes a life threatening side effect, give yourself a hand.

Seroquel, approved by the U.S. Food and Drug Administration in 1997, had 2009 sales of $4.87 billion, or 15% of AstraZeneca’s revenue.

With that kind of annual income, 10,400 lawsuits and $1.5 billion in legal costs doesn’t seem so bad. Investors are the only ones who are shedding a tear for AstraZeneca whose American depositary shares recently declined 26 cents to $43.65. Not much of a decline, but as the profits start hemorrhaging under legal costs, settlements, and judgments, they may seem a little despondent. Perhaps they will need some Seroquel of their own.

Some of the side effects of the drug that’s supposed to avoid side effects listed by the FDA are:

• Neuroleptic malignant syndrome (NMS) These may be symptoms of a rare and serious condition that can lead to death.
• High blood sugar (hyperglycemia) High cholesterol and triglyceride levels in the blood (fat in the blood).
• Increases in total cholesterol, triglycerides and LDL (bad) cholesterol and decreases in HDL (good) cholesterol.
• Increase in weight (weight gain)
• Tardive dyskinesia uncontrolled movement in face, tongue, or other body parts
• Orthostatic hypotension (decreased blood pressure)
• Increases in blood pressure in children and teenagers.
• Low white blood cell count
• Cataracts
• Seizures
• Abnormal thyroid tests
• Increases in prolactin levels
• Increases in liver enzymes
• Long lasting and painful erection
• Difficulty swallowing

Not a pretty list of side effects. In fact, the list is actually longer than most drugs.

AstraZeneca Denies Seroquel’s Connection to Diabetes

Baker is a Vietnam veteran who suffers from PTSD and another major depressive disorder. He was prescribed Seroquel in 2001. He was diagnosed with type 2 diabetes in 2004, but continued taking the drug until 2006 when a correlation was made.

AstraZeneca of course rejects the plaintiffs’ arguments. “The heart of this case is unproven claims that Seroquel caused diabetes in an individual patient,” said company spokesman Tony Jewell.

AstraZeneca said in a statement that Baker can’t show his use of Seroquel caused any weight gain of the extent or duration enough to cause diabetes. The company says the drug’s product label has always contained language addressing the chance of weight gain.

Yet, miraculously, they seem to ignore the fact that the largest cause of diabetes is weight. If their product caused weight gain one would conclude that any adverse of effects of increased weight would b added to the list, but that’s not so in their minds.

Baker’s lawyers declined to comment.

Did AstraZeneca Know About These Problems?

Plaintiffs in the litigation allege AstraZeneca knew of the drug’s risks in the late 90’s early 2000’s, but failed to adequately warn patients and doctors.

As part of the litigation AstraZeneca was forced to release internal documents last year that plaintiffs’ lawyers said demonstrated the company knew about certain risks of the drug in the 1990s but sought to obscure them.

The company says it fulfilled it’s responsibly by providing data to the FDA to develop product safety label information to help doctors weigh the drug’s risks.

But in the early 2000s, it became apparent that all atypicals including Seroquel carried their own risks. A study released in 2003 in the American Journal of Psychiatry found atypicals were associated with an increased risk of diabetes. At the FDA’s request, manufacturers including AstraZeneca added warnings to the drugs’ prescribing labels, describing the increased risk of high blood sugar and diabetes.

AstraZeneca Takes Out the Pharma Litigation Playbook

Seroquel is one of the 10 best selling drugs in the world, but it belongs to a class of therapies that has come under fire for safety risks and questionable marketing practices. There is a lot of profit to protect regardless of the fact their product makes patients so fat they start losing limbs to diabetes.

This is the first of many high-profile sets of personal-injury lawsuits surrounding a major drug since Merck & Co.’s (MRK) Vioxx litigation in 2004. Rival Eli Lilly & Co. (LLY), another behemoth in the pharmaceutical industry, has shelled out more than $2.6 billion to settle product-liability claims and government probes of illegal marketing practices for its antipsychotic Zyprexa.

AstraZeneca has a plan. Their strategy is much like what Merck’s did for its former pain drug Vioxx. Merck pulled Vioxx from the market in 2004 after a clinical study showed it raised the risk of heart attacks and strokes. Despite the reserach, Merck argued to a judge that it was impossible to prove that an individual’s heart attack was caused by Vioxx use. They contended that the heart attacks could have been due to other risk factors. Merck won enough lawsuits that attorneys in all of the remaining lawsuits against Vioxx agreed to a settlement of $4.85 billion in 2007.

AstraZeneca’s Other Problems: Crestor

In addition to the Seroquel case, a patent-infringement trial for cholesterol drug Crestor is scheduled to begin Monday in federal court in Wilmington, Del. In that case, AstraZeneca is trying to defend the validity of its Crestor patent. They’re trying to fight off generic competition before the patent expires in 2016.

The judge’s ruling in the case is expected by the end of July.

Defective Drugs

There are tons of different medications and they all have slight side effects. Some of them haven’t been adequately tested and sometimes to fatal consequences.

If you or a loved one are going through an ordeal with defective drugs it is important to seek legal council as well as medical council. This way you can protect yourself legally as well as physically. Call Phillips Webster for a consultation on your legal rights.