February 27, 2012
By Mark Hyman. M.D.
This week, in an act of desperation to turn back the tide of the obesity epidemic that now affects almost seven out of every 10 Americans and more than 80 percent of some populations (African-American women), the advisory committee to the Food and Drug Administration (FDA) voted 20 to 2 to recommend approval of Qnexa, a “new” obesity drug that is simply the combination of two older medications, phentermine (the “phen” of phen-fen”) and topiramate (Topamax).
It is a misguided effort at best, and a dangerous one at worst. Mounting evidence proves that the solution to lifestyle and diet-driven obesity-related illnesses including heart disease, diabetes, dementia, and even cancer won’t be found at the bottom of a prescription bottle.
By 2020, more than 50 percent of the U.S. adult population will have Type 2 diabetes or prediabetes, with annual costs approaching $500 billion. By 2030, total annual economic costs of cardiovascular disease in the U.S. are predicted to exceed $1 trillion. By 2030, globally we will spend $47 trillion, yes trillion, to address the effects of chronic lifestyle-driven disease.
Prescription medication for lifestyle disease has failed to bend the obesity and disease curve. Statins have been recently found to increase the risk of diabetes in women by 48 percent. And large data reviews by independent international scientists from the Cochrane Collaborative found that statins only work to prevent second heart attacks, not first heart attacks, which means they are not helpful and most likely harmful for 75 percent of those who take them.
Avandia, the No. 1 blockbuster drug for Type 2 diabetes, has caused nearly 200,000 deaths from heart attacks since it was introduced in 1999. The drug was designed to prevent complications of diabetes, yet heart attacks are the very disease that kills most Type 2 diabetics. In 2011, the FDA issued stricter prescribing guidelines for Avandia, but the drug is still on the market.
The large ACCORD trial found in more than 10,000 diabetics that intensive blood-sugar lowering with medication and insulin actually led to more heart attacks and deaths.
Something is deeply wrong with our medical approach.
The problem of chronic disease, including obesity, diabetes, and heart disease, is not a medication deficiency, but a problem with what we put at the end of our fork.
The emperor truly has no clothes. Why would good men and women of science vote to approve a medication for a condition that is a social disease and requires a social cure? The social, environmental, economic, and political conditions of America and increasingly the global community have created an obesogenic environment.
Clearly we need to do something. But it is not better medication or surgery or more angioplasties and stents, which have no proven benefit in more than 90 percent of those who receive them. The data show they work for acute coronary events, but not stable angina or blockages.
We continue to pay for expensive treatments for chronic disease, despite the fact that they don’t work, while insurance does not pay for nutrition counseling unless the patient has kidney failure or diabetes.
Chronic disease is a food-borne illness. We ate our way into this mess and we must eat our way out.
October 10, 2011
Regular aerobic exercise worked just as well as relaxation therapy or the anti-epileptic drug topiramate in preventing migraine headaches in a Swedish trial.
“This non-pharmacological approach may therefore be an option for the prophylactic treatment of migraine in patients who do not benefit from or do not want daily medication,” wrote Dr. Emma Varkey and her colleagues from the Institute of Neuroscience and Physiology, University of Gothenburg, in the journal Cephalalgia.
Varkey’s team randomly assigned their subjects to one of three regimens for three months: aerobic exercise on a stationary bike (40 minutes three times per week), a standard form of relaxation therapy or daily topiramate.
Previous studies have shown that relaxation therapy and topiramate are both effective for migraine prevention, the investigators note in their paper.
The 91 women in the trial were all from a single headache clinic in Sweden. They were between 18 and 65 years old, had neurologist-diagnosed migraine, with or without aura, and got headaches two to eight times per month.
All three treatments reduced the frequency of some women’s migraine attacks by as much as three quarters, although the average reduction was more modest.
In an e-mail to Reuters Health, Varkey admitted that she was a bit surprised by the small between-group differences.
“Topiramate is a drug of first choice which has shown great effects in studies. It was a bit surprising and very interesting that the change in number of migraine attacks was almost similar in all three groups,” she said.
“The only parameter where topiramate was better compared with exercise and relaxation was the reduction of pain intensity,” Varkey added. “On the other hand, the non-pharmacological options were free from adverse events and the exercise group increased oxygen uptake, which is very positive.”
None of the women in the relaxation group or exercise group reported side effects, but eight women (33 percent) in the topiramate group did and three withdrew from the study as a result. The most commonly reported side effects of the drug included numbness or tingling, fatigue, depressed mood, vertigo and constipation.
Finding that exercise is not inferior to topiramate as a prophylactic measure is “of great value,” the researchers note in their report, because patients often seek non-pharmacological options for migraine.
“From a wider health-based perspective, it should be stressed that patients with migraine are less physically active than the general population, and that exercise has positive effects in terms of general well-being and the prevention of disease,” they added.
“Additional and larger studies are, of course, needed to verify our results and to gain evidence for exercise as migraine treatment, but our results are hopeful,” Varkey told Reuters Health.
August 31, 2010
by David Gutierrez
Popular anti-seizure drugs may seriously increase a patient’s risk of suicide and violent death, according to a study conducted by researchers from Brigham and Women’s Hospital and Harvard Medical School, and published in the Journal of the American Medical Association.
The drugs, known as anticonvulsants, were initially designed for the treatment of epilepsy but are now widely prescribed “off-label” for conditions such as bipolar disorder, migraine headaches and pain.
“We all know the range of uses of these medications is very, very wide,” researcher Elisabetta Patorno said.
The researchers examined the prescription and medical records of more than 300,000 people above the age of 14 who had been prescribed an anticonvulsant for the first time between July 2001 and December 2006.
All of the drugs, they found, significantly increased a patient’s risk of attempted or successful suicide, as well as violent death by other causes. During the course of the study, there were 801 attempted suicides, 26 successful suicides and 41 violent deaths.
“We found increased risk for suicidal acts beginning within the first 14 days after treatment initiation, opening the possibility that anticonvulsant medications could induce behavioral effects prior to the achievement of their full therapeutic effectiveness,” the researchers wrote.
Based on prior studies, the FDA ruled in 2008 that all anticonvulsants must carry labels warning that they double the risk of suicidal thoughts and actions. These older studies had not been able to determine if any drugs posed higher risks than others, however.
In the current study, researchers compared the rates of suicides and violent deaths among users of topiramate (sold generically and also marketed as Topamax), gabapentin (marketed as Neurontin), lamotrigine (marketed as Lamictal), oxcarbazepine (marketed as Trileptal), tiagabine (marketed as Gabitril) and valproate (marketed as Depakine and Epilim). They found that the risk was lowest in topiramate, and roughly equal in the five other drugs.
April 14, 2010
by Lauren Cox
A class of drugs prescribed to treat conditions including migraines, chronic pain and bipolar disorder may increase suicidal tendencies, a large study has found.
Government officials raised concerns about the class of drugs called anticonvulsants in 2008 because they appeared to double the risk for suicide in studies compared with patients taking a placebo. But the Food and Drug Administration did not have studies to compare which anticonvulsant had greater suicide risks.
Now in an article in the Journal of the American Medical Association, doctors crunched statistics on the suicide risk of nearly 300,000 people who started taking one of 13 anticonvulsants between 2001 and 2006. They found that 180 days after starting medication, 26 of the 300,000 people in the study committed suicide and 801 people attempted suicide.
Doctors found the drugs gabapentin (brand name Neurontin), lamotrigine (Lamictal), oxcarbazepine (Trileptal) and tiagabine (Gabitril), often prescribed for pain, bipolar disorder and epilepsy, appeared to increase suicide risk significantly while topiramate (Topomax), which is commonly prescribed for migraines, increased the suicide risk but less so than the other drugs.
Researchers called the study an “exploratory analysis” but also expected the results to influence medicine.
“I would say doctors should talk with their patients about the risk of these drugs and to try to evaluate if the patient is receiving the treatment he or she needs, and balance the risk and benefits,” said Dr. Elisabetta Patorno, lead author of the study and research fellow in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital in Boston.
Patorno said clear differences appeared between the drugs — gabapentin had 40 percent higher suicide risk compared with topiramate, for example — but that the overall risk for suicide was low enough that doctors might not pick up on it in their practice.
“I would say the risk is there, it’s probably not anything to expect the practitioner on his daily basis to detect this risk, and that’s why this study is so important,” Patorno said.
Yet doctors tasked with treating epilepsy, pain and bipolar disorder say the study raises more questions to research than it provides answers.