An alarming link to pancreatic cancer should prompt users of the new diabetes drug Januvia to seek safer alternatives, says renowned physician Chauncey Crandall, M.D.
Dr. Crandall’s advice for diabetes patients: First try to manage your health with improved diet and fitness, which can often be as effective as drugs. For those who require medication, choose an older drug — such as the longtime diabetes medicine metformin — as first-line defense. Only those who don’t benefit from older drugs with a long record of safety and effectiveness should consider a newer medicine like Merck's Januvia.
"I think the bottom line is that all drugs carry risks," Dr. Crandall tells Newsmax Health. "Many have great benefits, but all have side effects and risks. The longer I’ve been in medicine the more I observe this, so we always need to weigh the risk-benefit ratio."
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Dr. Crandall adds that he is particularly "suspicious"of new drugs, pushed by drug companies as better alternatives to tried-and-true treatments in heavy marketing campaigns aimed at doctors.
"We are constantly bombarded by drug companies and reps who come to our offices proclaiming their new medicine is the best, and many physicians are pushed to use newer agents because of the persistence of drug company reps. But I’m always trying to wait for a track record — a historical foundation that shows a drug is OK."
Renowned neurosurgeon Russell Blaylock, M.D., is also troubled by the new research findings and the implications for patients.
"Based on what I have read I would very concerned as a patient, " said Dr. Blaylock, a Newsmax contributor and editor of the Blaylock Wellness Report
"The defenders [of the drugs] were either those directly on the payroll of Merck or physicians who had multiple links to drug companies. When billions are at stake, the truth gets buried."
Dr. Crandall notes that a number of long-established treatments for diabetes — including the standby metformin — have "excellent track records and minimal side effects." He says that 90 percent of his Type 2 patients who lose weight and improve their diets can control their blood sugar without resorting to drugs of any kind.
"Lifestyle modification is always key for diabetics," he says. "Most cases are diet-related, obesity-related, and age-related. These people come in and they’re overweight, inactive, don’t eat correctly. For the majority of them, if you get their weight down and get them to eat a healthy diet, they don’t need to get on medicine."
For those who do require drugs, he adds: "We should always try to use older medicines first, and if we have a resistant case [that doesn’t benefit from longer-established drugs], then we can consider a newer medicine."
The doctors' recommendations come in the wake of the FDA’s announced plans to examine evidence that suggests a group of recently approved diabetes drugs, which includes Januvia, can increase the risk of pancreatitis and other problems that can lead to lethal pancreatic cancer.
Dr. Blaylock agrees. "Virtually everyone can prevent these diabetic conditions by following a healthy diet. Many supplements can correct insulin resistance safely," he says."If all dietary and natural supplements have failed or one ... needs emergency treatments, then use only drugs proven to be safe and efficacious by independent research."
The agency said samples of pancreas tissue taken from a small number of patients showed inflammation and cellular changes that often precede cancer. Researchers took the samples from diabetes patients who were taking the new drugs, after they died from various causes.
"FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer," the agency said in a statement. "At this time, patients should continue to take their medicine as directed until they talk to their health care professional."
The drugs under review reportedly include recently approved diabetes medications, including Merck's Januvia and Janumet, Novo Nordisk's Victoza and Bristol-Myers Squibb's Byetta and Bydureon, among others. All mimic natural hormones that spur insulin production after a meal. People with Type 2 diabetes are unable to break down carbohydrates, because their bodies do not produce enough insulin or they've become resistant to the hormone, which controls blood sugar levels. With more than 25 million diabetics in the U.S., drugmakers have launched lucrative new treatments in recent years, though safety questions have emerged.
The FDA previously added information about cases of pancreatitis, some of them fatal, to the labels of Byetta in 2007, and Januvia and Janumet in 2009.
But a more recent study of insurance records found the use of those drugs could double the risk of developing acute pancreatitis, according to the FDA. Peter C. Butler, M.D., who conducted some of the research that prompted the FDA reviews, told the New York Times this week that he was prompted to explore the issue after finding troubling changes in the pancreases of the rats that could lead to pancreatic cancer.
Dr. Butler, chairman of endocrinology at UCLA, did follow-up studies that now threaten the future of Januvia and other drugs in its class, which have sales of more than $9 billion annually.
Dr. Crandall, a renowned cardiologist and author of the Heart Health Report
newsletter, says the "take-home message" is that patients need to be more careful with newer medicines and recognize that all drugs carry potential risks. In addition, he says, doctors may not always have time to counsel patients to emphasize lifestyle changes over medication.
"We’ve being pushed to see larger volumes of patients and [accept] lower reimbursements, and we have less time to counsel the patients," he explains. "So less time is spent counseling and more time is spent prescribing medicine."
Dr. Blaylock also commends Dr. Butler for his research.
"Most physicians go for the drugs first and rarely really consider in-depth counseling on nutritional needs and use of supplements. A great number have never examined the research on these substances and their effects on insulin resistance and pancreatic health," he says.
"I have witnessed many such actions against noble and honest physicians and researchers such as Dr. Butler, who attempt to tell the truth about a product that makes billions for a company. Dr. Butler should be listened to. Research by scientists and physician receiving money from these companies is worthless until proven otherwise. There are numerous examples of this tainted research."