The announcement comes as evidence mounts against Actos and its link to bladder cancer, heart failure and bone fractures, among other things. Nations around the world have already severely limited access to Actos or included grave warnings on the drug’s label regarding its side effects.

The college said that patients are unduly influenced by advertisements that lead them to think certain drugs are without risks or simply better. Indeed, when Actos was introduced to the market in the late 1990s, Takeda Pharmaceuticals, the drug’s maker, touted its safety over competing diabetes drugs.

The college recently teamed up with Consumer Reports magazine to launch a public education campaign called “High Value Care” in an effort to help patients curb health-care spending.

“In these days of crisis in health care costs, the medical profession should take its ethical and professional responsibility to do what we can to reduce costs while not compromising care,” said Steven Weinberger, the college’s CEO.

Dr. John Santa, who heads up Consumer Reports’ health rating center, said that metformin has been proven to work effectively. Other drugs, including Actos, include a host or risks and side effects.

“So here’s an example of an inexpensive, older drug, which the evidence has shown is the better choice,” Santa said of metformin. “We are jointly committed to putting the brakes on over-testing and over-treatment, and we agree that consumers will benefit when either patients or doctors initiate conversations about these delicate issues.”

The news from the college and Consumer Reports came during the college’s annual scientific meeting in New Orleans. Interestingly enough, in a courtroom just a short drive away former Actos patients have lined up by the hundreds to bring legal claims against Takeda Pharmaceuticals.

In the U.S. District Court in Lafayette, Louisiana, hundreds of Actos victims have joined in a multidistrict litigation (MDL) to sue Takeda and its subsidiaries. Patients, many who were stricken by bladder cancer after taking the drug for longer than a year, are attempting to recoup financial losses that accompany a serious illness.

At the same time, patients have filed suit against Takeda in California and Illinois state courts. All of the cases have been moving forward through the discovery phase.

Source: http://www.drugwatch.com/doctors-recommend-diabetes-patients-make-actos-last-choice.php

On April 16, Takeda officials penned a “Dear Doctor” letter to health-care professionals, warning them of the risk. The letter says, “findings from new studies reveal that there is a potential increased risk of bladder cancer in patients treated with pioglitazone-containing products.”

The letter points to several studies that indicate a higher bladder cancer risk for patients taking the diabetes medicine for longer than a year. Two three-year studies that used either pioglitazone or a placebo showed that there was a 44 percent incidence of bladder cancer in patients taking pioglitazone compared to 14 percent in patients not taking the drug.

All of this comes after the recent official announcement from Health Canada, the country’s national healthcare regulation group, that taking Actos for longer than a year is linked to bladder cancer. Although Takeda has repeated denied a link, the drug’s label now carries the warning in Canada and the United States. Other countries, such as Germany and France, pulled Actos from the shelves, making it only available with a special prescription.

The letter from Takeda to Canadian doctors goes on to say, “ Actos is now contraindicated in patients with active bladder cancer, a history of bladder cancer or under investigation for macroscopic hematuria (blood in the urine.)” The warning says patients should be assessed before taking the drug. Risk factors include age, smoking history, a family history of bladder cancer, cancer treatments, radiation treatments and chemical exposure.

Patients who are taking Actos and have blood in the urine or any symptoms of urinary problems are urged to seek immediate medical attention.

Source:  http://www.drugwatch.com/takeda-admits-to-actos-and-bladder-cancer-link.php

In an order issued Monday, U.S. District Judge Rebecca Doherty said she plans to appoint lead attorneys for the consolidated cases after the March 22 status conference in her Lafayette, La., courtroom.

In December, the U.S. Judicial Panel on Multidistrict Litigation assigned Doherty to preside over dozens of lawsuits against Actos maker Takeda Pharmaceuticals America Inc., which is based in Deerfield, Ill. Plaintiffs’ attorneys expect to file several thousand claims against Takeda and its related companies on behalf of people who used the drug.

Takeda’s Japanese parent company, Takeda Pharmaceuticals Co. Ltd., halted sales of Actos in Germany and France last year. The U.S. Food and Drug Administration issued a warning about the drug’s possible cancer risks in 2010 but allowed sales to continue.

After the FDA approved Actos in 1999, Takeda co-promoted the drug in the U.S. with Eli Lilly & Co. Takeda took over responsibility for the drug’s marketing when the agreement between the company ended in 2006, attorneys for the companies said in court papers.

An FDA spokeswoman says information about a possible risk of bladder cancer associated with the use of Actos has been on its label since the drug was approved for treating Type 2 diabetes in 1999.

Takeda released a statement on Tuesday saying that it works hard to evaluate any potential risks associated with its products.

“Takeda is confident in the therapeutic benefits of Actos and its importance as a treatment for type 2 diabetes. As a science and evidence-based company, Takeda firmly stands behind the substantial data available confirming the positive risk/benefit profile of Actos, which includes twelve years of clinical and patient experience with the product,” the statement said.

The first lawsuit linking Actos to bladder cancer was filed against Takeda and Eli Lillly in July 2011, according to the companies’ lawyers.

Paul Pennock of Weitz & Luxenberg, a New York firm that represents dozens of people with Actos-related claims, said Judge Doherty is now handling roughly 150 of these suits. Thousands more could have federal claims filed in or transferred to Lafayette by the end of the year, he said.

“People should not run the risk of getting bladder cancer from treating their diabetes given the many other excellent therapies available,” Pennock said.

Thousands of other claims involving Actos are expected to be heard in California and Illinois state courts.

The lawsuits claim researchers have found that people who take Actos for more than a year are at increased risk of developing bladder cancer. The suits also accuse Takeda of concealing their knowledge of the cancer risks and failing to adequately warn consumer and health care providers.

Actos sales in the U.S. fell by roughly 3 percent last year, but the drug remained the best-selling Type 2 diabetes drug on the market, according to the health care information firm IMS Health. The firm says Actos accounted for $3.4 billion in sales in 2011, or nearly 84 percent of sales among drugs in the same class.

Source:  http://www.cbsnews.com/8301-505245_162-57377764/judge-sets-1st-hearing-for-diabetes-drug-lawsuits/

A Note From Jim Guest, President, Consumer Reports:

It’s a nightmare scenario. The implant that fixed your knee or your heart may actually be a ticking time bomb that could disable or kill you.

This isn’t science fiction. Millions of medical devices including artificial hips, contact lens solution, heart stents, and pacemakers are being recalled - 700 different products a year.

And the vast majority of recalled products were never safety tested in humans, because the manufacturers claimed they were “similar” to products already on the market.

 Tell Congress we don’t want to be guinea pigs anymore!

Every new prescription drug must undergo rigorous testing on humans before it can be sold, even if it is similar to another drug already in use. Not so with medical devices. Because of this loophole in our safety laws, more than 90 percent of medical devices aren’t safety tested before being sold nor are they routinely tracked afterwards to identify safety problems.

For example, a metal hip implant marketed by Johnson & Johnson was approved in 2005 without first undergoing clinical safety trials. It was recalled five years later after having a 1 in 8 failure rate in the UK, and releasing potentially toxic metals into the body. Countless patients had to undergo a second, painful ‘revision’ surgery.

It’s time safety standards for medical devices are as strong as those for prescription drugs! E-mail your members now!

The device industry has unleashed an army of lobbyists and they don’t want things to change. It will take a wave of consumers weighing in to make sure medical devices are safe and effective. Please take action, then forward this to friends and family. Thank you!

Sincerely,

Jim Guest
President, Consumer Reports
101 Truman Ave
Yonkers, NY 10703

If you have been a victim of a defective product, please contact an attorney at Slater Slater Schulman LLP  at (800) 251-6990 today to discuss your legal rights and options.

Dr. Georgiou’s advice? “Demand (don’t request) the genetic blood test to determine whether Plavix can be metabolized.“

Watch the entire video to learn more: http://www.myfoxtwincities.com/dpp/buzz/Plavix-Prescription-Perspective-Dr.-Georgiou-nov-29-2011

The benefits of pioglitazone, the active ingredient in Actos and other diabetes treatments, outweigh its risks in a limited group of patients with Type 2 diabetes, the London-based agency’s Committee for Medicinal Products for Human Use said yesterday in a statement on its website.

“These medicines remain a valid treatment option for certain patients with type 2 diabetes,” though there is a small increased risk of bladder cancer, the agency said. The risk could be reduced by “appropriate patient selection and exclusion,” including regular reviews of how well the drug is working for individual patients, the agency said.

The European agency’s backing supports the decision made by the U.S. Food and Drug Administration that Actos wasn’t linked to an overall increased cancer risk in all patients who took it. Actos had sales of 387.9 billion yen ($5 billion) in the last fiscal year, accounting for 27 percent of revenue. That makes it the best-selling product for Osaka, Japan-based Takeda, Asia’s largest drugmaker.

The European agency has been reviewing the possible cancer risk of Actos and other medicines containing pioglitazone since March. France’s drug regulator in June said it would pull Actos from the market, and its counterpart in Germany recommended that the EMA suspend marketing approval for the diabetes medicine throughout the 27-nation European Union. Actos was suspended in Mauritius.

Shares Gain

Takeda rose as much as 0.5 percent in Tokyo trading, and was 0.3 percent higher at 3,725 yen at 9:09 a.m. local time. The benchmark Topix Index advanced 0.9 percent. The shares have declined 6.8 percent this year.

Actos, which faces competition from cheaper, generic versions next year, became the world’s biggest-selling diabetes drug after a 2007 study linked rival pill Avandia, sold by London-based GlaxoSmithKline Plc, to a higher chance of heart risks. The EMA in September suspended sales of Avandia, while the U.S. regulator decided the medicine could continue to be sold with new warnings.

Both pills belong to the same drug class as Rezulin, which was made by Warner-Lambert Co. It was pulled from the market in March 2000 because of risks of liver cancer and sudden death. The Glaxo medicine had revenue of $680 million last year, less than half its peak in annual sales.

‘Stop Taking Actos’

Some doctors have already stopped prescribing Actos and other so-called thiazolidinediones, or TZDs, partly because patients are nervous about the risks.

Besides heart risks, the drugs have also been associated with fluid retention, weight gain and bone loss, said Neale Cohen, an endocrinologist at the Baker IDI Heart and Diabetes Institute in Melbourne.

“I don’t think doctors are going to continue to prescribe TZD-class drugs, and as far as my practice is concerned, I will tell my patients to stop taking Actos,” said Albert Levy, an endocrinologist at Mount Sinai in New York, in an e-mail. Levy has already taken his patients off Avandia, he said.

Deciding how to assess the benefits versus risks of TZDs is key, said David Kendall, the chief scientific officer of the American Diabetes Association. Patients who can’t control their blood sugar are at risk for more-serious complications of diabetes, such as blindness and the loss of limbs, Kendall said.

VAGINAL MESH BACKGROUND

Surgical Mesh is commonly used in pelvic floor surgery to treat both incontinence and prolapse. “Vaginal mesh kits” were introduced approximately seven years ago in an attempt to simplify and standardize the technique of vaginal mesh placement. Recently, however, the safety of these mesh kits has been called into question.

MESH INJURIES

Once the mesh is implanted it can move around the body, its frayed edges cutting through tissue and sometimes puncturing nearby organs. Some women have become septic, suffering infections so bad that the entire torso turns a deep purple. These infections attack a body from the inside, and if not treated promptly can lead to death. At least 10 women have reportedly died as a result of a punctured bowel and resultant septic infection.

Other more common injuries being reported due to vaginal mesh exposures are:

Prolapse recurrence

Infection

Erosion into vagina

Dyspareunia (painful sexual intercourse)

Internal bleeding

Vaginal scarring

Vaginal wall-narrowing

Urinary problems

Punctured bladder

Punctured uterus

Chronic postoperative pain

Incontinence

These injuries are caused by frayed edges of the mesh material and by movement of the patch within the body.

WHAT CAN BE DONE TO AVOID OR MINIMIZE THE INJURY?

First and foremost, alert your physician if you suffer any complications or symptoms that you think could be related to the placement of the mesh implant. We suggest you follow the advice of a qualified physician.

Failed mesh implants commonly require removal of the mesh. Unfortunately, this is much easier said than done. To remove the mesh, doctors must perform multiple surgeries as the mesh has to be taken out in pieces. Occasionally, it is impossible to remove all of the mesh because the mesh is impossible to separate from body tissue. In these cases, some or all of the mesh remains implanted for life.

It is not our intent to sound an unnecessary alarm. Pelvic floor prolapse is a significant quality-of-life issue for many women. Some women have a good experience after their vaginal mesh placement surgery, without experiencing any of the above-listed complications or symptoms. However, the number of women with bad results appears to be significantly higher than what was originally disclosed by the manufacturers of these medical products. Accordingly, women with these products in their body should be aware of symptoms indicating movement of the patch so that they can know when to seek medical care.

Finally, if this has happened to you contact one of our attorneys today.

Cerebral palsy is a problem that involves brain function and nervous system responses which enable it to affect an troubled person’s thinking, listening to, sight and activity. One known result in is fetal hypoxia, which can end result when a baby doesn’t receive sufficient oxygen during the delivery process.

The nation’s Institutes of Wellbeing identifies other actual physical symptoms of the various forms of cerebral palsy, including:

- Small muscles and joints, which may bring about an abnormal running (walking on toes and fingers or with legs touching are common illustrations)
- Muscle some weakness, limited movement as well as paralysis
- Twisting, writhing or even jerking of extremities
* Loss of physical coordination

A comprehensive neurological exam is the cornerstone of a cerebral palsy diagnosis. While there is absolutely no cure for cerebral palsy, various treatments can help to make person more impartial throughout life. Which means having the resources to utilize speech, physical as well as occupational therapists and medical specialists in order that a child with cerebral palsy provides lifetime access to the right tools and flexible equipment.

Medical Malpractice Law firms Help Families Assess Liability for a Kid’s Condition

Cerebral palsy in newborns can result from problems made by obstetricians, maternal nurses and other health care professionals. The health care crew that attends the birth possesses numerous tools to provide dire warnings about specific problems that may develop through labor and during supply.

Assessing whether a great avoidable birth injury caused irreparable problems for a newborn involves complicated legal and health concerns. But medical data may include potential signs that a brain injuries occurred during work or delivery (the medical term will be “neonatal encephalopathy”), including low blood glucose levels, seizures, poor oxygenation of the blood, poor reflexes, poor color or perhaps subnormal consciousness.

A consultation by having a medical malpractice attorney of The Law Offices of Slater, Slater, Rosenberger & Schulman, P.C. can help a family comprehend their legal possibilities and help decide if something went completely wrong that should not have occurred. In most cases, personal injury lawyers deal with cases on a a contingency basis, meaning that the majority of the costs of lawsuit are paid for with the law firm based on a percentage of any damages or perhaps settlements recovered.

Despite the popularity of MoM devices in the past decade, research has shown that the implants are prone to early failure with the metal components rubbing against each other and releasing metal particles into the body. In the recalled DePuy hip replacement, the ball rides out towards the edge of the cup (called “edge loading”), shedding cobalt and chromium particles. The more loose metal ions found in the body, the more likely it is that the hip replacement has failed and needs to be removed.

The area surrounding the artificial hip joint is the first affected by metal particles. In some cases, damage to surrounding tissue and bone may contribute to the loosening of a hip device. The metal ions may also make their way into a patient’s blood stream. Studies have shown that, when large quantities of metal ions are flowing through the body, deafness, blindness, neurological problems, headaches, weakness, and heart problems may result. Initial studies of the effects of certain quantities of metal ions in the body, while not conclusive, suggest that high levels of metal ions in the blood are a cause for alarm.

Hip replacement recipients with MoM and especially MoM DePuy hip replacements should regularly have their blood tested by a doctor or lab center for concentrations of metal ions. The results will indicate whether the hip device is failing and allow doctors to take steps to prevent further damage.

Patients should seek the advice of their orthopaedic surgeon if blood tests reveal high levels of metal ions. If the orthopaedic surgeon confirms that the MoM hip device is failing, the patient should seek legal advice.

So, now Johnson & Johnson says their problems are behind them.  We hope so.  They have shuffled management and issued new safety guidelines.  But with $28 Billion in cash, J&J undoubtedly has the power to withstand any nuisances that these recalls and lawsuits may cause their balance sheets. William Weldon still has his job.  Maybe one of these recalls has finally got his attention, and that they put product safety on par with corporate profits.