In addition to previously observed side effects of Fosamax, including osteonecrosis of the jaw, headache, nausea and rashes, doctors now report an increasing incidence of femur fractures among long-term users of the drug.

Although Fosamax is prescribed to strengthen bones in women suffering from osteoporosis, some doctors have noted that taking Fosamax for five years or longer may actually cause the bones to become more brittle, increasing some women’s risk of spontaneous fracture.

According to Dr. Kenneth Egol, a professor of Orthopedic Surgery at NYU Langone Medical Center, femur fractures have been experienced by “people just walking down the steps, patients who are doing low-energy exercise.” He characterizes such fractures as “very unusual” because “the femur is one of the strongest bones in the body.”

In 2008, the FDA contacted Merk & Co. — the pharmaceutical company that manufactures Fosamax — about the reports of femur fractures. Merck allowed 16 months to pass before adding fracture risk to the list of possible side effects of Fosamax.

Merck continues to insist that no causal link between Fosamax and femur fractures has been established. However, a study in Denmark reported a positive link between Fosamax and femur fractures in 2008. Additional research is expected to be published in March 9, 2010.

Although no recommendations were made for the length of treatment with Fosamax, some physicians are now suggesting that Fosamax treatment be limited to five years.

If you believe that you or a loved one has been harmed by side effects resulting from Fosamax, you may be entitled to financial compensation to cover medical bills, lost income or other expenses. Contact an expert personal injury attorney at (888) 255-2956. The AWKO team boasts some of the most experienced personal injury lawyers Pensacola, Florida has to offer.

Exposure to the industrial chemical tricholorethylene (TCE) is associated with a higher risk of developing Parkinson’s disease, according to a new study. TCE is a solvent once widely used in dry cleaning and to clean grease off metal such as auto parts. Its use has been curtailed due to concerns over its health affects.

In the study, researchers examined the job histories of 99 pairs of twins in which one of the twins had Parkinson’s disease. Those exposed to TCE in the workplace were five and a half times more likely to have Parkinson’s than those not exposed to the chemical. The twins who were exposed to TCE had job histories that included work as machinists, dry cleaners, electricians and mechanics.

Twins were used in the study because they are genetically similar and thus provide excellent subjects for evaluating environmental affects. The twins were men identified from a study known as the World War II-Veterans Twins Cohort study.

“This is the first time a population-based study has confirmed case reports that exposure to TCE may increase a person’s risk of developing Parkinson’s disease,” stated the author of the study, Samuel Goldman, MD. Dr. Goldman is affiliated with the Parkinson’s Institute in Sunnyvale, California, and is a member of the American Academy of Neurology.

The study will be presented at the American Academy of Neurology’s 62nd Annual Meeting in Toronto.

As pressure increases for the Merck or the FDA to act, doctors say they are seeing more patients coming to them with fractures that happen during normal daily activities, as Dr. Kenneth Egol, professor of orthopedic surgery at NYU Langone Medical Center explained to ABC News in a recent interview.

“We are seeing people just walking, walking down the steps, patients who are doing low-energy exercise,” said Dr. Ego. “Very unusual, the femur is one of the strongest bones in the body.”

“Over the last 18 months we are seeing this more frequently,” Dr. Ego said.

Doctors prescribe Fosamax to treat osteoporosis and osteopenia.  The drug is supposed to strengthen bones to offset bone-weakening problems.  Instead, the mounting evidence shows it can do exactly the opposite, causing serious injury.

Fosamax scrare strikes women with osteopenia ( ABC News)

Fosamax: Is long-term use of bone strengthening drug linked to fractures? (ABC News)

Will side-effect reports scare Fosamax patients? (ABC News)

The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) is actively engaged in defective drug litigation.  For more information about patients’ legal rights, Merck Fosamax patients and their families can contact the lawyers of AWKO Law at www.awkolaw.com (888-255-2956).

In a March 6 letter to doctors, DePuy admitted that the “metal-on-metal” ASR hip implant has a high failure rate and should not be used in traditional hip replacements.  A DePuy statement to the press admitted that “this is new and important information surgeons who continue to use ASR should have to inform their clinical decision making.”

The ASR model is often used in “hip resurfacing,” which is an alternative to traditional hip replacement. However, this method is not approved for use in the United States. The FDA has only approved the ASR for use in traditional hip replacement.

The FDA has received about 300 complaints about the ASR since 2008. Most of the patients lodging complaints had undergone an operation to replace the implant.  It was only after Johnson & Johnson saw slowing sales of the hip implant that they made the announcement that the device is unsafe.

Some surgeons have long said they believe the ASR design is defective and is prone to problems.  Orthopedic experts had recently been very critical of the hip implant, saying DePuy should have stopped selling the device much sooner.

DePuy withdrew the ASR from the Australian market in December, but kept it on the American market until the March 6 announcement.

The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in defective medical device litigation for years.  For more information about patients’ legal rights, DePuy ASR patients and their families can contact the lawyers of AWKO Law at www.awkolaw.com (888-255-2956).

County officials in Santa Clara County, in northern California, say they believe this is the first time a government body has sued GSK over Avandia.

The lawsuit follows the release of a U.S. Senate report last month charging that Glaxo minimized Avandia’s safety risks and withheld data from the Food and Drug Administration.

The lawsuits seeks restitution of expenses for all Avandia purchasers in California, including individuals and health care providers.

AP News story (March 2, 2010)

Voice of America story (March 2, 2010)

AboutLawsuits.com (March 2, 2010)

Avandia details & lawsuit information (www.awkolaw.com)

Numerous Avandia users have filed lawsuits against GSK over the past several years, as more patients suffer heart attacks, heart failure, and other problems after using Avandia. The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in the litigation for years, including a leadership role in the national Avandia multi-district litigation (MDL), which consolidates thousands of lawsuits to streamline the information discovery process.  For more information about patients’ legal rights, Avandia users and their families can contact the lawyers of AWKO Law at www.AWKOLAW.com (888-255-2956).

“Many physicians have stopped prescribing Avandia,” Dr. Nissen said.

Dr. Nissen points out, in a recent US News column, that the American Diabetes Association guidelines do not recommend taking Avandia.  A different drug, marketed as Actos (pioglitazone) treats diabetes in the same way, without the same heart attack and heart failure risks posed by Avandia, said Dr. Nissen. Actos is made and sold by Takeda, a Japanese company. Avandia is sold by GlaxoSmithKline (GSK).

“In July, the FDA will convene an advisory panel to consider what action to take, including the possibility of removing the drug from the market,” Dr. Nissen said.

A recent Senate report harshly criticized GSK for hiding information that shows Avanida causes heart attacks and heart failures.

The content of Jim’s recent blog is copied here for all viewers to read (or click here):

After Taking $3.6M From Its Maker Glaxo
By | Feb 26, 2010
Jim Edwards

The American Heart Association said that the data are “inconclusive” on whether GlaxoSmithKline (GSK)’s diabetes drug Avandia carries an increased risk of heart problems. But the organization’s statement does not disclose the fact that GSK gave AHA more than $3.6 million in donations since 2006.

The AHA has slipped up on disclosure issues before. In 2008, the company put out a statement saying it did not believe Vytorin was “unsafe” after a study of the cholesterol drug found it did not reduce artery plaque. Only later did it highlight the fact that Schering-Plough and Merck (MRK), Vytorin’s marketers, were big donors to AHA.

Getting to the bottom of whether Avandia does or does not increase heart attacks in its patients is crucial, both for the thousands of patients who still take the drug and for GSK, which earned $310 million in revenues on Avandia in Q4 2009. The data are, indeed, confusing, and you can cherry-pick arguments from them that support both sides.

The fact that the AHA — which millions trust for its advice on heart health — has not properly disclosed its apparent financial conflict of interest in either its press release or its full statement in the journal Circulation, is therefore disappointing. (I’m not suggesting that the authors of the statement have let money get in the way of their science, just that appearances of conflicts ought to be disclosed.) The AHA said:

The data are inconclusive on heart risks from a class of blood sugar-lowering drugs called thiazolidinediones (TZDs) such as pioglitazone (Actos) or rosiglitazone (Avandia), but the medications should be used with close monitoring from healthcare providers

In AHA’s 2008-2009 fiscal year, the last period for which numbers are available, the organization received $131 million in funding from drug and medical device companies. Of that, $600,000 came from GSK. Historically, the company has been a generous donor to AHA:

GSK donations to AHA by year:
$600,000 in ‘08-’09
$940,353 in ‘07-’08
$2.055 million in ‘06-’07
Total: $3.6 million

Today, a Pensacola Jury returned a verdict of over $2.1 million dollars in favor of the plaintiff in a case related to injuries sustained in a 2007 accident when the plaintiff was stuck while riding his motorcycle on northbound New Warrington Road. The verdict included compensation for past and future medical expenses, lost wages, property damage, and pain and suffering damages. The jury trial, which lasted three days was presided over by the Honorable Kenneth Williams, Circuit Judge. Bobby “Brad” Bradford, Litigation partner at Aylstock, Witkin, Kreis & Overholtz, represented the Plaintiffs. According to Mr. Bradford, the evidence showed that the defendant, who was driving a Ford Taurus, ran the stop sign at Martha Road, flew through the median, and pulled out in front of the plaintiff who was traveling northbound, without ever looking back. The defendant had been cited in the accident for failure to yield the right away, but neither this fact, nor the accident reports were admitted into evidence under Florida law regarding civil lawsuits. Mr. Bradford said that his client suffered significant injuries including broken bones in his legs, insertions of multiple rods, pins and screws, and will require in the future several more surgeries, and at least two knee replacements. Despite these injuries, Mr. Bradford said his client, a 20 year Navy retiree, returned to work several months after the accident as a military contractor at Hurlburt Field. Mr. Bradford said he was pleased with the jury’s verdict and was happy to see the justice system work so well.

Edwards’ scathing editorial comments on BNET detail how GSK uses money and aggression to control doctors and public perception.

Some of the past agressive tactics, according to Edwards:

• GSK spent $900 million on lawyers in 2009.
• GSK utilizes its blog to knock down reports it believes are false.
• When the FDA issued a caution about its weight-loss drug Alli, GSK’s statement insisted in essence that the FDA was wrong — not only was there no evidence linking Alli to liver problems, GSK said, but there was no possible way that could happen.
• GSK once used (but has now abandoned) a ghostwriting program, titled “Cassper,” to help friendly doctors write trivial studies that showed its drugs in a positive light.
• The company ignored its own ethics code in an attempt to reduce its tax bill.
• A GSK executive wrote to the governor of Massachussetts threatening to end its businesses there unless the state did its bidding.
• When GSK needed a new corporate counsel, it hired the most vehement anti-regulation lawyer in America, Daniel Troy.
• And it was GSK, including Sanofi’s Viehbacher at the time, who sued Nelson Mandela to keep the price of HIV drugs high in South Africa (a move that Viehbacher now admits was a mistake).

Edwards has covered drug marketing at Brandweek for four years, and is a former Knight-Bagehot fellow at Columbia University’s business and journalism schools.

BNET: Secret Tapes Lay Bare Glaxo’s Scorched-Earth Corporate Culture, by Jim Edwards

In 2007, GSK executives flew to Ohio to meet with Dr. Steven E. Nissen, a cardiologist at the Cleveland Clinic who had conducted a landmark study suggesting that the best-selling diabetes drug Avandia raised the risk of heart attacks. The study was published in The New England Journal of Medicine shortly after the meeting.

The executives, and the rest of the GSK group, did not know that Dr. Nissen was recording the meeting, as allowed by Ohio law, which allows recording of private conversations by one party without telling the other parties in the conversation. Dr. Nissen recorded the meeting because he “[feared] he would face pressure and criticism from executives,” according the report in The Times.

The report of the secret tapes follows Saturday’s release of a Senate report harshly criticizing GSK actions to hide Avandia dangers and citing government health officials who want Avandia withdrawn from the market because of the drug’s dangers.

Among the GSK deceptions revealed by the secret tapes:

• GSK executives told Dr. Nissen they had data that would contradict his recently completed study. In fact, they did not.
• GSK executives told Dr. Nissen they intended to soon share the allegedly contradictory data with him and cooperate with him on a joint study. They never did share any such information or cooperate with Dr. Nissen after these statements.
• The Times reports that “during the meeting, Dr. Ronald L. Krall, GlaxoSmithKline’s chief medical officer, predicted almost exactly the results of another crucial study of Avandia that was two months from publication and whose results, according to scientific protocols and the company itself, should have been kept secret from the company.” (Dr. Krall told The Times he did not see the study results until “many days after the meeting.”)
• GSK executives spoke as if they had not yet seen the yet-to-be-published Nissen study. In reality, a journal reviewer who also worked as a consultant to GSK had secretly and inappropriately faxed a copy of the study to GSK, violating the rules of the journal and professional ethics. GSK admitted to The Times that GSK had received the fax and that some of the executives who met with Dr. Nissen had read it.
• GSK has publicly fought the Nissen study results, even though experts within GSK knew the results were sound. A GSK statistician stated that “there is no statistical reason for disregarding the findings” of Dr. Nissen’s study. GSK’s head of research, Dr. Moncef Slaoui, wrote that federal regulators, Dr. Nissen and the company’s own researchers all agreed that Avandia substantially increased the risks of death and heart attacks (ischemic events), finding an increased risk “ranging from 30 percent to 43 percent!” (exclamation in Dr. Slaoui’s text)
• GSK executives asked Dr. Nissen to hold off on publishing his study until he or GSK had also done an even more detailed “patient-level” analysis, even though GSK had already done such analysis — with frightening results — and had no intention of publishing the results in a medical journal. “It is the right approach,” Dr. Nissen said. “Now I’m going to be equally blunt: you should have done this a long time ago.”

An exchange between Dr. Nissen and GSK’s Dr. Krall during the meeting reveals just how profit-driven GSK officials were, in spite of the dangers they already knew:

Dr. Nissen lost patience regarding the increased risk of heart attacks, or myocardial ischemia, in Avandia patients. “I hope you guys understand how much trouble G.S.K. is in here,” he said. “You’ve got a bunch of people who are incredibly vulnerable to myocardial ischemia, and you’ve had evidence that you’re provoking ischemia in those people, and that is of grave public health consequences.”

Dr. Krall asked Dr. Nissen if his opinion of Avandia would change if the Record trial — a large study then under way to assess Avandia’s risks to the heart — showed little risk. Dr. Krall said he did not know the results of Record.

“Let’s suppose Record was done tomorrow and the hazard ratio was 1.12. What does…?” Dr. Krall said.

“I’d pull the drug,” Dr. Nissen answered quickly.

The results of the “Record” study were published two months later, showing an 11 percent increased risk of heart problems for Avandia users — a hazard ratio of 1.11. In spite of Dr. Krall’s prediction, GSK claims Dr. Krall and GSK did not have access to the study data until four days later. The study results were supposed to be kept confidential until that point, to ensure scientific validity.

Numerous Avandia users have filed lawsuits against GSK over the past several years, as more patients suffer heart attacks, heart failure, and other problems after using Avandia. The law firm of Aylstock, Witkin, Kreis & Overholtz (AWKO Law) has been actively engaged in the litigation for years, including a leadership role in the national Avandia multi-district litigation (MDL), which consolidates thousands of lawsuits to streamline the information discovery process.  For more information about patients’ legal rights, Avandia users and their families can contact the lawyers of AWKO Law at www.AWKOLAW.com (888-255-2956).