Lawsuits Pile Up Over Diabetes Drug

August 22nd, 2011

The Huffington Post

By: Linda A. Johnson

The maker of the world’s best-selling diabetes drug is facing hundreds of lawsuits and likely a big sales drop as suspicion grows that taking the pill for more than a year raises the risk of bladder cancer.

In June, Takeda Pharmaceuticals Co. Ltd. halted sales of Actos, its top drug, in Germany and France after pressure from regulators.

Since then, both the U.S. Food and Drug Administration and the European Medicines Agency have issued warnings about the cancer risk based on new research, but they have allowed sales to continue. Doctors are being told not to prescribe Actos for people who have or have had bladder cancer.

The warning will limit patient choices and could spell the end for a once-promising class of Type 2 diabetes drugs that debuted more than a decade ago amid heavy promotion.

The once-a-day pills were appealing. They helped control blood sugar tightly, had few side effects in most patients, boosted the effects of some other diabetes drugs, worked by a new mechanism – improving the body’s sensitivity to insulin – and even allowed patients to reduce or delay use of injected insulin.

Actos, despite links to heart failure risk and other serious side effects, became the No. 1 diabetes pill after Avandia, the only other drug in that class, was found in 2007 to sharply increase risk of heart attacks. Avandia’s use was banned in the EU and sharply restricted here. Actos sales jumped from about $2.9 billion in 2006 to more than $4.3 billion last year.

Now those billions may well shift to Takeda rivals.

In the past week, the first of what lawyers predict will be thousands of lawsuits were filed in courts across the country. They allege Actos triggered bladder cancer, in some cases fatal, in clients who took the pills daily for years.

Nancy Rios, 54, is suing Takeda, blaming her recurrent bladder cancer on Actos, which she took for more than a decade. Rios, a hospital secretary, was diagnosed with bladder cancer in 2009. In June, she had her second surgery to remove tumors. Rios, who lives in Reading, Pa., is worried about missing more work and being able to pay her medical bills. Next month, she will learn whether more treatment is needed.

“I could lose my bladder and possibly need chemo,” she said.

Her attorney, Paul Pennock of Weitz & Luxenberg, said the firm already represents another 104 clients, has about 120 more expected to pursue lawsuits and is getting 30 to 40 possible new cases a week.

“When a manufacturer distributes a drug, they owe it to the public to ensure that their product is safe for use and it appears that Takeda Pharmaceuticals failed to fulfill that fundamental duty,” Pennock said.

Other large law firms are evaluating potential cases by the dozen or more. More than 20 firms, from Florida to Washington state, are advertising for clients on the Internet or in newspapers, a standard practice in personal injury law.

“We don’t think it’s a coincidence that we’ve been contacted by so many people who have been taking Actos and have bladder cancer,” said Marc Jay Bern of Napoli Bern Ripka Shkolnik & Associates. “We have more than 100 (cases) that we’ve confirmed and many more that we’re evaluating.”

Takeda declined to comment on the lawsuits. The company, which is based in Japan, has issued statements that it’s committed to keeping Actos available for patients who need it.

Spokeswoman Elissa Johnsen noted an April study in the journal Diabetes Care found Actos “use for more than two years was weakly associated with increased risk.”

However, the FDA analyzed data from the first five years of a 10-year Actos safety study Takeda begun in 2002 and concluded this June that risk of bladder cancer was 40 percent higher for patients taking Actos for at least a year, although still small: an extra 28 cases a year for every 100,000 people taking it.

Erik Gordon, an analyst and professor at University of Michigan’s Ross School of Business, said Friday that the new safety questions are “a big deal” for Takeda, particularly since the Actos patent expires in August 2012. They mean Actos won’t make as much money as expected in the final months, and they dampen prospects for two experimental drugs Takeda was hoping would succeed Actos.

“One, alogliptin, has been stuck at the FDA over safety concerns, and the other, a combination of alogliptin and Actos, now looks doomed,” Gordon said.

Alogliptin is an experimental drug in the same class as Merck & Co.’s blockbuster Januvia. Those drugs increase production of insulin, which breaks down sugar in the blood, and reduce glucose production in the liver.

Les Funtleyder, an analyst and portfolio manager for the Miller Tabak Health Care Transformation fund, said Januvia is likely to gain sales as patients defect from Actos.

He doubts the cost of the bladder cancer litigation will hit the level of Vioxx. That’s the painkiller that Merck pulled off the market in 2004 because it doubled risk of heart attacks and strokes – triggering more than 50,000 lawsuits and, eventually, a $4.85 billion settlement to end most of them.

Whatever the outcome of the Actos litigation, diabetes patients and their doctors will be considering their options now.

Dr. Harlan Krumholz, a Yale School of Medicine professor who directs its Center for Outcomes Research and Evaluation, said more long-term data on the effects of Actos is needed.

“It’s not clear if this (bladder cancer) risk is real,” but Actos and Avandia both are linked to heart risks, weight gain and possibly bone loss and fractures, he said. “The consensus already is that (Actos) should only be considered … after patients have exhausted all other options.”

Click here for the full report from The Huffington Post

New Diabetes Drug Linked to Infections and Cancer

July 6th, 2011

Natural News

By: Jonathan Benson

Tests on a new diabetes drug being developed by drug giants Bristol-Myers Squibb and AstraZeneca have revealed that the new class of drug may be linked to causing urinary tract and genital infections, and several forms of cancer. Add to that dapagliflozin’s many other known side effects, and the experimental drug fares even worse than metformin, the more-common drug for treating type 2 diabetes.

The two-year study found that out of 5,478 patients treated with dapagliflozin, nine of them developed bladder cancer. Only one patient in the control group of 3,156, on the other hand, developed bladder cancer. Based on these results, a person taking dapagliflozin appears five times more likely to develop bladder cancer than a person not taking the drug.

The results were similar for cases of breast cancer. Nine out of 2,223 women taking dapagliflozin developed breast cancer, while only one of 1,053 in the control group developed breast cancer. These figures point to women taking dapagliflozin being more than four times more likely than women not taking the drug to develop breast cancer.

The way dapagliflozin works is that it blocks glucose from being absorbed into the bloodstream through the kidneys, and instead dispels it directly through the urine. By artificially flooding the urinary tract with excess sugars in this way, the urinary tract and genitals become far more prone to bacterial infections than if the sugar was processed in the normal way, and the negative effects of this were observed in the trials as well.

According to data presented at the annual meeting of the American Diabetes Association (ADA), other serious side effects associated with taking dapagliflozin include back pain, influenza, diarrhea, headache, nasopharyngitis, upper respiratory tract infection, renal impairment or failure, and hypoglycemia.

Ultimately, there is no need for diabetics to take dangerous drugs like dapagliflozin and risk complicating their condition with new ones. Reversing and curing diabetes is fully possible, and it can be done safely and naturally without the use of drugs.

Click here for the full report from Natural News

Diabetes Drug May Promote Bladder Cancer

December 27th, 2010

Natural News

By: David Gutierrez

The FDA has begun investigations into whether the widely used diabetes drug pioglitazone (marketed as Actos) may increase the risk of bladder cancer.

Actos is already known to carry a risk of “serious side effects on the liver,” writes Phyllis A. Balch in the book Prescription for Nutritional Healing, 4th Edition. Nevertheless, the drug has remained one of the top-prescribed diabetes drugs because although it also increases patients’ risks of heart failure, it is only half as likely to produce heart attacks as its primary competitor Avandia (rosiglitazone).

Following years of controversy, the FDA recently prohibited the prescription of Avandia except as a last resort in cases where all other diabetes drugs and treatments have failed.

According to a five-year study by Actos manufacturer Takeda Pharmaceuticals, patients taking the drug had a non-statistically significant, 20 percent higher risk of bladder cancer diagnosis. The risk was higher among patients who had been taking the drug for more than two years, and was highest among those who had been exposed to the highest levels.

Although the results of this study did not reach statistical significance, they were enough to spur the FDA to investigate further. Two prior clinical trials and a laboratory study in rats have also pointed to a link between the drug and bladder cancer.

Rates of Type 2 diabetes continue to rise worldwide with worsening diet and an ensuing higher prevalence of obesity. Studies have linked higher consumption of red and processed meats, eggs and fruit juice with a higher risk of the disease. Higher intake of coffee, fish, garlic, brown rice, turmeric, omega-3s and certain micronutrients have been linked with a lower risk.

In addition to eating a balanced diet, more exercise and more time in the sun (leading to higher vitamin D levels) are among the most reliable ways to reduce diabetes risk.

Click here for the full report from Natural News

TSA Pat-Down Leaves Traveler Covered in Urine

November 22nd, 2010

MSNBC.com

By: Harriet Baskas

A retired special education teacher on his way to a wedding in Orlando, Fla., said he was left humiliated, crying and covered with his own urine after an enhanced pat-down by TSA officers recently at Detroit Metropolitan Airport.

“I was absolutely humiliated, I couldn’t even speak,” said Thomas D. “Tom” Sawyer, 61, of Lansing, Mich.

Sawyer is a bladder cancer survivor who now wears a urostomy bag, which collects his urine from a stoma, or opening in his abdomen. “I have to wear special clothes and in order to mount the bag I have to seal a wafer to my stomach and then attach the bag. If the seal is broken, urine can leak all over my body and clothes.”

On Nov. 7, Sawyer said he went through the security scanner at Detroit Metropolitan Airport. “Evidently the scanner picked up on my urostomy bag, because I was chosen for a pat-down procedure.”

Due to his medical condition, Sawyer asked to be screened in private. “One officer looked at another, rolled his eyes and said that they really didn’t have any place to take me,” said Sawyer. “After I said again that I’d like privacy, they took me to an office.”

Sawyer wears pants two sizes too large in order to accommodate the medical equipment he wears. He’d taken off his belt to go through the scanner and once in the office with security personnel, his pants fell down around his ankles. “I had to ask twice if it was OK to pull up my shorts,” said Sawyer, “And every time I tried to tell them about my medical condition, they said they didn’t need to know about that.”

Before starting the enhanced pat-down procedure, a security officer did tell him what they were going to do and how they were going to it, but Sawyer said it wasn’t until they asked him to remove his sweatshirt and saw his urostomy bag that they asked any questions about his medical condition.

“One agent watched as the other used his flat hand to go slowly down my chest. I tried to warn him that he would hit the bag and break the seal on my bag, but he ignored me. Sure enough, the seal was broken and urine started dribbling down my shirt and my leg and into my pants.”

The security officer finished the pat-down, tested the gloves for any trace of explosives and then, Sawyer said, “He told me I could go. They never apologized. They never offered to help. They acted like they hadn’t seen what happened. But I know they saw it because I had a wet mark.”

Humiliated, upset and wet, Sawyer said he had to walk through the airport soaked in urine, board his plane and wait until after takeoff before he could clean up.

“I am totally appalled by the fact that agents that are performing these pat-downs have so little concern for people with medical conditions,” said Sawyer.

Sawyer completed his trip and had no problems with the security procedures at the Orlando International Airport on his journey back home. He said he plans to file a formal complaint with the TSA.

When he does, said TSA spokesperson Dwayne Baird, “We will review the matter and take appropriate action if necessary.” In the meantime, Baird encourages anyone with a medical condition to read the TSA’s website section on assistive devices and mobility aids.

The website says that travelers with disabilities and medical conditions have “the option of requesting a private screening” and that security officers “will not ask nor require you to remove your prosthetic device, cast, or support brace.”

Sawyer said he’s written to his senators, state representatives and the president of the United States. He’s also shared details of the incident online with members of the nonprofit Bladder Cancer Advocacy Network, many of whom have offered support and shared their travel experiences.

“I am a good American and I want safety for all passengers as much as the next person,” Sawyer said. “But if this country is going to sacrifice treating people like human beings in the name of safety, then we have already lost the war.”

Bladder Cancer Advocacy Network executive director Claire Saxton said that there are hundreds of thousands of people living with ostomies in the United States. “TSA agents need to be trained to listen when someone tells them have a health issue and trained in knowing what an ostomy is. No one living with an ostomy should be afraid of flying because they’re afraid of being humiliated at the checkpoint.”

Eric Lipp, executive director of Open Doors Association, which works with businesses and the disability community, called what happened to Sawyer “unfortunate.”

“But enhanced pat-downs are not a new issue for people with disabilities who travel,” Lipp said. “They’ve always had trouble getting through the security checkpoint.”

Still, Lipp said the TSA knows there’s a problem. “This came up during a recent meeting of the agency’s disability advisory board and I expect to see a procedure coming in place shortly that will directly address the pat-down procedures for people with disabilities.”

Click here for the full report from MSNBC.com

Processed Deli Meat Could Cause Bladder Cancer

November 17th, 2010

Natural News

By: David Gutierrez

Processed meats have once again been linked with an increased risk of cancer — this time of the bladder — in a study conducted by researchers from the National Cancer Institute and published in the journal Cancer.

Researchers examined the diets of 300,000 adults in eight U.S. states, and used that data to estimate participants’ intake of nitrates and nitrites, which are used to preserve processed meat and have been implicated as carcinogens.

“Nitrate and nitrite are precursors to N-nitroso compounds (NOCs), which induce tumors in many organs, including the bladder, in multiple animal species,” the researchers wrote.

Participants were aged between 50 and 71, and were followed for eight years. The researchers found that while consumption of non-processed meat was not linked with bladder cancer, higher consumption of nitrates from processed meats increased the risk by nearly 30 percent.

High consumption of red meat (both processed and unprocessed) was associated with a non-Hispanic white ethnicity, being a current smoker, having a high body mass index (a measure of obesity), having a higher beverage and daily calorie consumption, less physical activity, lower educational level, younger age, and a lower intake of fruits, vegetables and vitamins C and E.

The study is only the most recent in a long chain of studies linking processed meat consumption to an elevated risk of numerous cancers.

“A recent study conducted at the University of Hawaii shows that even moderate consumption of processed meats causes a 6,700 percent increase in pancreatic cancer (that’s a 67-fold increase in cancer risk!),” writes Mike Adams in Spam Filters for Your Brain.

“Thus, consuming these foods causes cancer. Yet, these packaged meat products appear to be perfectly healthy, thereby distracting you from their true nature, which is that of chronic disease.”

Click here for the full report from Natural News

Processed Deli Meats Cause Cancer

August 4, 2010

Yahoo News

Red meat is being raked over the coals again.

Already linked with an increased risk of cardiovascular disease and certain cancers, including cancer of the pancreas, red meat was found by a team of US researchers to be a possible cause of bladder cancer, a study published in the journal Cancer said.

For those who can’t do without their bacon-cheeseburger, some good news: scientists found no associations between beef, bacon, hamburger, sausage or steak and bladder cancer.

But they did observe a “positive nonlinear association for red meat cold cuts” and bladder cancer, they said.

The culprits in the cold cuts are nitrates and nitrites which are added to meat when it is processed to preserve and enhance color and flavor.

“Nitrate and nitrite are precursors to N-nitroso compounds (NOCs), which induce tumors in many organs, including the bladder, in multiple animal species,” the study says.

For the study, scientists assessed the intake of nitrates, nitrites and other components found in red meat, in some 300,00 men and women aged 50-71 year, in eight US states, and its relation to cancer.

The study participants were followed up for up to eight years. During that time, 854 were diagnosed with cancer of the bladder.

The scientists found that people whose diets were high in nitrites from all sources, not just meats, and people who got a lot of nitrates in their diets from processed meats, like cold cuts, had a 28 to 29 percent greater chance of developing bladder cancer than those who consumed the lowest amount of either compound.

The scientists also found that people who ate the most red meat were younger, less educated, less physically active, and had lower dietary intake of fruits, vegetable, and vitamins C and E than those consuming the least red meat.

The researchers, led by Dr Amanda Cross of the National Cancer Institute, also found that the biggest carnivores among us were more likely to be non-Hispanic white, current smokers, to have a higher BMI, and to consume more beverages and total energy daily.

click here to read full article

Pool Chemicals Linked To Disease

July 26, 2010

Natural News

By: Jonathan Benson

A recent study out of the University of Illinois (U of I) links pool disinfectant chemicals with diseases like asthma and bladder cancer. According to researchers, pool chemicals react with organic matter in the water to form various toxic bonds that can lead to serious health problems.

“All sources of water possess organic matter that comes from decaying leaves, microbes and other dead life forms. In addition to organic matter and disinfectants, pool waters contain sweat, hair, skin, urine, and consumer products such as cosmetics and sunscreens from swimmers,” explained Michael Plewa, a professor of genetics at U of I.

Unlike drinking water, which is exposed to disinfectants once before reaching the public, pool water is exposed to a continuous stream of disinfectants that mix and match with various other chemicals and compounds to form an unknown number of potentially dangerous chemical bonds.

According to researchers, these bonds can cause gene mutation, birth defects, respiratory problems, accelerated aging and even cancer.

“Care should be taken in selecting disinfectants to treat recreational pool water,” urged Plewa. “The data suggest that brominating agents should be avoided as disinfectants of recreational pool water.”

Plewa suggests that public pools be treated with a combination of both chlorine and ultraviolet (UV) radiation rather than these other toxic agents, but other research suggests that UV treatment alone may be effective, at least for home pools.

In his book Bottom Line’s Health Breakthroughs 2007, Dr. Martin Schwellnus suggests that public pools using chlorine keep their chlorine levels below five parts per million (ppm). He also advocates for UV treatment as well.

Click Here For The Full Article

New research: probiotic found in breast milk benefits nerves in gut, calms digestive disorders

June 25, 2010

NaturalNews

By: S.L. Baker

Probiotics are beneficial microorganisms similar to the “friendly” bacteria found naturally in the body’s digestive system. According to the National Center for Complementary and Alternative Medicine (NCCAM), there’s evidence from a variety of studies that probiotic formulations can help treat diarrhea, urinary tract infections, irritable bowel syndrome and dermatitis (eczema) in children; probiotics may reduce the recurrence of bladder cancer, too.

Now Canadian researchers have published research in the Federation of American Societies for Experimental Biology (FASEB) journal that explains why certain strains of probiotics are particularly soothing to indigestion related problems. It turns out the probiotic strain Lactobacillus reuteri, which occurs in the gut of many mammals and is found in human breast milk, immediately and directly affects nerves in the gut.

For their study, scientist Wolfgang Kunze of the McMaster Brain-Body Institute and Department of Psychiatry at St. Joseph’s Healthcare in Ontario, Canada, and his research team took isolated pieces of small intestine removed from healthy and previously untreated mice. Then they added Lactobacillus reuteri to a warm salt solution which was sent flowing through the lumen, or hollow part, of the intestine. The pressure caused by natural contractions in the intestine sections was measured before, during and after adding the probiotic-containing solution. The scientists tested the electrical activity of single intestinal sensory nerve cells, as well.

The results? The researchers documented that the force of muscle contractions in the gut tissue decreased within minutes of exposure to the probiotic solution. This discovery explains why intake of probiotics can often alleviate symptoms of a whole host of digestive disorders such as irritable bowel syndrome, inflammatory bowel disease and constipation.

“Scientifically and evidence-based approaches to nutrition to correct potential bacterial imbalance in the intestine and thereby promote better health could possibly restore health in diseases associated with these imbalances,” Kunze said in a statement to the media.

This is the latest of a growing body of research backing up what many natural health advocates have said for decades — probiotics (which can be found in supplements and in many foods including yogurt, kefir, fermented and unfermented milk, miso and tempeh, as well as breast milk) can promote health and protect from illness. For example, as NaturalNews previously reported, researchers have found that taking probiotics may help people lose excess weight . And a study published in the journal Postgraduate Medicine concluded that taking probiotics regularly boosts the immune system in a specific way which helps the body fight off flu infections.

Click Here To Read Full Report

Eating Meat Linked to Bladder Cancer

April 29, 2010

NaturalNews.com

S.L. Baker

No one wants cancer served up with their steak or hamburger. But that’s just what you may be getting. As NaturalNews has previously reported, numerous studies have linked meat consumption with cancer. Now comes evidence from scientists at the University of Texas M. D. Anderson Cancer Center that eating meat frequently, especially meat that is well done or cooked at high temperatures, significantly raises the risk of developing bladder cancer.

These research cancer findings, recently announced at the American Association for Cancer Research’s 101st Annual Meeting held in Washington, D.C., indicate that heterocyclic amines (HCAs), substances formed when meat (including beef, pork, poultry and fish) is cooked at high temperatures, may be what links meat to malignancies. Earlier research found strong evidence that 17 types of HCAs contribute to cancer.

“It’s well known that meat cooked at high temperatures generates HCAs that can cause cancer,” study presenter Jie Lin, Ph.D., assistant professor in M. D. Anderson’s Department of Epidemiology, said in a statement to the media. “We wanted to find out if meat consumption increases the risk of developing bladder cancer and how genetic differences may play a part.”

The M.D. Anderson researchers studied 884 patients with bladder cancer and 878 people who were cancer-free. The research subjects were matched by age, gender and ethnicity and followed for about 12 years. Using a standardized questionnaire designed by the National Cancer Institute (NCI), the scientists documented each participant’s dietary habits. Those who ate the most red meat had about one and a half times the risk of developing bladder cancer than the research subjects who ate little or no red meat.

Beef steaks, pork chops and bacon raised bladder cancer risk the most. People who consumed a lot of well-done meat were at about twice the risk to develop bladder cancer as those who preferred rare meat. Even chicken and fish significantly upped the chances of getting cancer — but only if they were fried. The M.D. Anderson researchers also found that people with the highest estimated intake of three specific types of HCAs were more than two and a half times more likely to develop bladder cancer than those with a low intake of HCAs.

In addition, the researchers analyzed study participants’ DNA to see if there were genetic variations that would make some people particularly more likely to develop cancer if they ate red meat. The results showed that people with seven or more specific genotypes who consumed a diet full of red meat had five times the risk of bladder cancer.

“This research reinforces the relationship between diet and cancer,” lead author Xifeng Wu, M.D., Ph.D., professor in M. D. Anderson’s Department of Epidemiology, said in the media statement. “These results strongly support what we suspected: people, who eat a lot of red meat, particularly well-done red meat, such as fried or barbecued, seem to have a higher likelihood of bladder cancer. This effect is compounded if they carry high unfavorable genotypes in the HCA-metabolism pathway.”

Click here to read the full report

Overcooked Meat Doubles Bladder Cancer Risk

April 20, 2010

BBC News

Eating lots of meat, especially if it is overcooked, increases the risk of bladder cancer, say experts.

Frying, grilling and barbecuing until meat is charred can form cancer-causing chemicals, research shows.

In a study, people whose diets included well-done meats were over twice as likely to develop bladder cancer than those who preferred meats rare.

The research findings, based on over 1,700, people were presented at a US cancer research conference.

The University of Texas investigators found the risk was highest for those who ate well-done red meat such as steaks, pork chops and bacon.

But even chicken and fish, when fried, significantly raised the odds of cancer.

Three major types of the cancer-causing chemicals, collectively called heterocyclic amines (HCAs), raised cancer risk by more than two-and-a-half.

And some people appear to be genetically more susceptible to this diet-linked cancer risk, the researchers found.

In the study, which took place over 12 years, the researchers analysed the DNA of all the participants to look for any differences in the way individuals metabolised the cooked meat.

Having particular genes made some people almost five times as likely to develop bladder cancer when they ate a lot of red meat.

Stacking up risks

Lead author of the study, Professor Xifeng Wu, told the American Association for Cancer Research: “This research reinforces the relationship between diet and cancer.

“These results strongly support what we suspected – people who eat a lot of red meat, particularly well-done red meat, such as fried or barbecued, seem to have a higher likelihood of bladder cancer.”

According to the National Cancer Institute in the US, experts have identified 17 different HCAs that “may pose human cancer risk”.

Charred meat has already been linked to pancreatic cancer.

Cancer experts said that more research was needed before we can say for sure whether or not regularly eating red meat affects bladder cancer risk, and if the way it is cooked has an impact.

Slow-cook

Dr Panagiota Mitrou, of the World Cancer Research Fund, said: “When we looked at all the evidence on meat and cancer, it did not suggest meat increases risk of bladder cancer.

“There is, though, convincing evidence that red and processed meat increase risk of bowel cancer.

“This is why we recommend that people aim to limit consumption of red meat to 500g – cooked weight – per week and to avoid eating processed meat.”

Dr Alison Ross of Cancer Research UK said: “Smoking is the most important preventable cause of bladder cancer, so giving up is the best way to cut your chances of getting the disease.”

The UK Food Standards Agency says people can reduce their risk from chemicals that may cause cancer by not allowing flames to touch food when barbecuing or grilling, and cooking at lower temperatures for a longer time.

But warns that undercooked meat can cause food poisoning.

More than 10,000 new cases of bladder cancer are diagnosed each year in the UK.

Around 5,000 people die from it every year, and almost 90% of deaths are in people over 65.

Click here for the full report.

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