Steroids and Back Pain: Researchers Say Treatment is Over-prescribed

With the recent outbreak of tainted steroid compounds killing several due to meningitis, the over prescribed nature of steroid treatment for back pain comes under the magnifying glass... 

from the Dayton News

The New England Compounding Center certainly seems deserving of its current status as the prime culprit in a tragic outbreak that has killed 32 and sickened 438. The bottles of supposedly sterile steroid medication it shipped were reportedly so tainted that white fuzz could be seen floating in some vials.

But, experts say, the now notorious Compounding Center has a nationwide network of unwitting enablers and accomplices: There are the doctors who overprescribe an invasive back-pain therapy that, in studies, has not proved useful for many of the patients who get it. And there are the patients, living in an increasingly medicalized society, who want a quick fix for life's aches and pains.

The use of steroid injections to treat back pain has skyrocketed in the past 15 years -- out of proportion to growth in the number of patients with back pain, or the aging of the population. The frequency of steroid injections dispensed to Medicare patients rose 121 percent from 1997 to 2006. Washington state found that the use of back injections grew 12.6 percent between 2006 and 2009, at a cost to the state of $56 million. Some people received more than 10 shots a year.

The increase in treatment has not led to less pain over all, researchers say, and is a huge expense at a time of runaway health costs.

"There are lots of places doing lots of injections for conditions that haven't been shown to benefit," says Dr. Janna Friedly, a researcher at the University of Washington, who added, "Sadly, some of the patients who got meningitis were probably in that category -- they did not have conditions where steroid injections were indicated."

Studies are at best inconclusive about exactly which groups of back-pain patients are likely to benefit from steroid shots. Though some patients clearly get much-needed relief, health researchers are nearly unanimous that the treatment is vastly overused in the U.S.

But Dr. Laxmaiah Manchikanti, head of the American Society of Interventional Pain Physicians, said the increasing number of spine injections was just part of "an exponential increase in all interventional techniques" and is a good thing, reflecting a better understanding of chronic pain and patients' demands for improved pain relief.

Though doctors are still arguing, most academic researchers say there is no evidence that steroid injections are useful in easing straightforward chronic low back pain. Professional guidelines say such shots should generally not be used for back pain that is less than four to six weeks old, which studies show almost always gets better with noninvasive treatments. Although many Medicare patients get spinal injections to treat a condition called spinal stenosis, a narrowing of spaces between bones of the spine, Friedly said, shots are not used for that condition in many European countries.

Spinal injections, which can cost between $600 and $2,500, including the fees for treatment rooms, have been fostered and promoted by the rising number of pain clinics and pain specialists - - mostly anesthesiologists and rehab doctors -- who invest in extra training to learn procedures like spinal injections.

"There used to be only a small number of people who did this, but that's gone way up, and reimbursement has gone up, too," says Scott Forseen, a doctor who studies the treatment of back pain at the Georgia Health Sciences University. The number of spinal injections given in any geographical area correlates better with the number of local specialists trained in the procedure rather than the amount of back pain, Friedly says.

The shots -- which may include a steroid and an anesthetic -- are often dispensed at for-profit pain clinics owned by the physicians holding the needle. "There's a lot of concern about perverse financial incentive," Friedly adds.

Kinnaird's clients got their injections at the St.

Outpatient Neurosurgery Clinic, a limited-liability corporation half owned by doctors, which occupied a floor of one of Nashville's major hospitals. It gave 5,000 injections a year, or about 20 each business day, and epidural steroid injections are listed on its website as its "top procedure."

Since guidelines for injections are being disputed among doctors' groups, it is hard in most cases to say if a particular patient should or should not have been offered an injection, says Marc Lip- ton, a Michigan attorney who is representing more than 20 patients with fungal meningitis. Though he believes that steroid shots are overused, he says many of the patients he represents were treated appropriately, for example, receiving an injection for pain from a herniated disc in an attempt to stave off back surgery. He and other lawyers are, for now, targeting the Compounding Center in product liability lawsuits.

But, says Forseen: "You have to use injections selectively, and selectivity has gone way down. In some places, people get injections because they've walked in the door."

Patients have proved eager consumers of the new medical offering, desirous of a quick cure rather than waiting the weeks or months for the normal healing process to occur.

Kinnaird, the lawyer, says, "If I hurt my back in the '70s, my doctor would say, 'Go to the beach; get a few beers; relax; you'll be fine.' Now if you hurt your back, you go to the doctor and right away there's an MRI, and they need to fix something. Maybe you should take an injection."

And steroid shots are not a cure-all, even for the conditions for which doctors agree an attempt is worthwhile: low back pain accompanied by signs of nerve injury like tingling or weakness in a leg. One-third of such patients will get better, one-third will show some improvement and some will show no improvement at all, Forseen said

When Oregon's Health Evidence Review Commission earlier this year explored narrowing reimbursement for injections to certain conditions, it got an earful of public comment from groups like the International Spine Intervention Society.

"Obviously they are not utilizing the literature correctly," said Manchikanti, adding that attempts to limit the shots were motivated in part by an effort to control costs and by competition from other medical specialties.

Private insurers vary considerably in coverage for the procedure, though some will pay after two weeks of back pain.

Back pain is, of course, a debilitating condition. And modern medicine has produced some miraculous cures. But from now on when doctors and patients are tempted to say "what's the harm in trying an injection" to dispense with a nagging back -- they will be more aware of just how big the risk can be.

Reassessing the Flu Shot. Does it work, and at what cost?

From the New York Times: 

It’s flu-shot season, and public health officials are urging everyone over 6 months of age to get one. Many businesses provide on-site flu shots, and some hospitals have told staff members that they have to wear masks if they do not get the vaccine. By 2020, United States health leaders want 80 percent of the population to get yearly shots.

For vaccine manufacturers, it’s a bonanza:Influenza shots — given every year, unlike many other vaccines — are a multibillion-dollar global business.

But how good are they?

Last month,, in a step tantamount to heresy in the public health world, scientists at the Center for Infectious Disease Research and Policy at the University of Minnesota released a report saying that influenzavaccinations provide only modest protection for healthy young and middle-age adults, and little if any protection for those 65 and older, who are most likely to succumb to the illness or its complications. Moreover, the report’s authors concluded, federal vaccination recommendations, which have expanded in recent years, are based on inadequate evidence and poorly executed studies.

“We have overpromoted and overhyped this vaccine,” said Michael T. Osterholm, director of the Center for Infectious Disease Research and Policy, as well as its Center of Excellence for Influenza Research and Surveillance. “It does not protect as promoted. It’s all a sales job: it’s all public relations.”

Read more: 

http://well.blogs.nytimes.com/2012/11/05/reassessing-flu-shots-as-the-season-draws-near/

New Moffitt Research: Supplements may help prevent "Chemo Brain"

Oct. 22--As an environmental consultant, Miriam Zimms was known for her iron-clad memory.

Juggling multiple projects, spreadsheets and scientific data were all in a day's work. "My clients have always said I was Fort Knox," she says.

But that all changed the moment Zimms' doctor said she had breast cancer. For a full year, the 43-year-old's world was taken over by her treatment: chemotherapy, a double mastectomy and reconstructive surgery.

Fighting for survival was distracting enough, but Zimms also found herself irritated by a growing inability to hold together information in her mental vault. The frustration has grown as the forgetfulness has persisted, two years later.

"It's like someone opened my brain like a jewelry box, put in a tube and filled it with air," Zimms says. "There was a film of air between my brain and skull."

Chemotherapy is the culprit behind Zimms' cognitive struggles. The mental fogginess impairs a cancer patient's ability to process or verbalize ideas and words, for months, even years after treatment ends, says Nagi Kumar, director of nutrition research at Tampa's Moffitt Cancer Center.

"It's a serious problem. Ask any breast cancer survivor," says Kumar, who is about to launch a scientific nutritional study at Moffitt to tackle the "chemo brain" condition. "Some are almost resigned to it."

Oncologists -- and most patients -- are understandably so focused on treating tumors that addressing side effects can become secondary. But as the number of long-term breast cancer survivors has ballooned to 11.7 million, more are paying attention to a condition that affects between 30 and 80 percent of them, Kumar says.

A simple nutritional solution is at the heart of the small Moffitt study. Kumar's team created a plant-based and omega-3 fatty acid supplement they hope can improve the cognitive health of breast cancer survivors. The idea is that these supplements thought to be beneficial to people with dementia could lessen the negative effects of chemo brain.

Click to read more ...

Use of Antibiotics in Animals for Food Use now at Alarming New Levels, and Avoid Scrutiny.

"The numbers released quietly by the federal government this year were alarming. A ferocious germ resistant to many types of antibiotics had increased tenfold on chicken breasts, the most commonly eaten meat on the nation’s dinner tables."

With a quote like that you would expect that a regulating government body would be overseeing this circumstance and asking more questions. However at present, much of this food-drugging has escaped scrutiny. 

"Many drugs are sold freely over the counter through feed suppliers, something the agency is trying to curb. In April, it proposed eliminating the use of certain antibiotics to stimulate growth in animals, and requiring meat and poultry producers to obtain a prescription before giving certain antibiotics to their animals. The agency just finished taking public comments to update the requirement. The scale of the problem became clear in 2010 when the F.D.A. began publishing total pharmaceutical company sales of antibiotics for use in animals raised for human consumption. It turned out that an overwhelming majority of antibiotics produced went to animals, not people. But there is still a glaring lack of information about how the drugs are used, scientists say." 

Read more: 

http://www.nytimes.com/2012/09/04/health/use-of-antibiotics-in-animals-raised-for-food-defies-scrutiny.html?_r=2&ref=science

Radiation's benefits come with serious potential side effects.

Radiation, like alcohol, is a double-edged sword. It has indisputable medical advantages: Radiation can reveal hidden problems, from broken bones and lung lesions to heart defects and tumors. And it can be used to treat and sometimes cure certain cancers.

But it also has a potentially serious medical downside: the ability to damage DNA and, 10 to 20 years later, to cause cancer. CT scans alone, which deliver 100 to 500 times the radiation associated with an ordinary X-ray and now provide three-fourths of Americans’ radiation exposure, are believed to account for 1.5 percent of all cancers that occur in the United States.

Recognition of this hazard and alarm over recent increases in radiological imaging have prompted numerous experts, including some radiologists, to call for more careful consideration before ordering tests that involve radiation.

“All imaging has increased, but CTs account for the bulk of it,” said Dr. Rebecca Smith-Bindman, a specialist in radiology and biomedical imaging at the University of California, San Francisco. “There’s clearly widespread overuse. More than 10 percent of patients each year are receiving very high radiation exposures.”

The trick to using medical radiation appropriately, experts say, is to balance the potential risks against known benefits. But despite the astronomical rise in recent years in the use of radiation to obtain medical images, this balancing act is too often ignored. The consequences include unnecessary medical costs and risks to the future health of patients.

-Read More Here: http://well.blogs.nytimes.com/2012/08/20/medical-radiation-soars-with-risks-often-overlooked/?ref=science

Study links blood pressure drugs with Celiac disease symptoms.

Dr. Joseph Murray of the Mayo Clinic, has published a study linking the drug, olmesartan, to a potentially life-threatening gastrointestinal condition that mimics celiac disease.

Murray found that the pill, which is sold in the United States under the brand name Benicar, was associated with severe nausea, vomiting, diarrhea and weight loss in a group of 22 patients from 16 states, according to a report published online in Mayo Clinic Proceedings.

Some of the patients had been told - apparently mistakenly - that they had celiac disease, a severe intestinal disorder. A number were so sick that they were hospitalized repeatedly, he said, including one person who lost 125 pounds over the course of a year.

"Their symptoms substantially improved when they stopped the olmesartan," Murray said at a press briefing Thursday at Mayo.

Murray said this is the first study to find such a connection, and he stopped short of saying the drug caused the symptoms. He also said the condition appears quite rare.

"The vast majority of patients on this medication should not change," he said, but those with symptoms should talk to their doctors.

The drug's manufacturer, Daiichi Sankyo, issued a statement saying that it is reviewing the Mayo report, but that its own analysis in 2009 concluded "that a causal relationship between exposure to olmesartan and celiac disease is very unlikely." The company does, however, list several gastrointestinal symptoms, such as abdominal pain and nausea, among the drug's possible side effects.

Murray, a specialist in celiac disease, said he began his investigation in 2009 after the first patient told him about his experience in the hospital, and asked whether the pill could be at fault.

The very next day, he said, another patient raised the same question - and Murray learned they were both taking the same blood-pressure drug.

Eventually, Murray said, he studied 22 patients with similar stories. Although some had received a diagnosis of celiac disease, none responded to the typical treatments, such as a gluten-free diet. He also discovered that their blood tests did not match the diagnosis.

New Studies on Acid Reflux preventing drugs find serious side effects.

In an effort to prevent acid reflux, many turn to drugs promising a reduction or prevention of it entirely, but what they don't mention in the TV advertisements is the extent of the potential side effects. 

From the NYTIMES: 

Long-term use of the drugs, called proton pump inhibitors, or P.P.I.’s, can make it difficult to absorb some nutrients. Ms. Rudell, 33, has been taking these medications on and off for nearly a decade. Her doctor treated her anemia with high doses of iron, and recommended she try to manage without a P.P.I., but that’s been difficult, she said. “I’m hoping I’ll get off the P.P.I. after I complete my residency training,” she said, “but that’s still several years away.”

As many as four in 10 Americans have symptoms of gastroesophageal reflux disease, or GERD, and many depend on P.P.I.’s like Prilosec, Prevacid and Nexium to reduce stomach acid. These are the third highest-selling class of drugs in the United States, after antipsychotics and statins, with more than 100 million prescriptions and $13.9 billion in sales in 2010, in addition to over-the-counter sales.

But in recent years, the Food and Drug Administration has issued numerous warnings about P.P.I.’s, saying long-term use and high doses have been associated with an increased risk of bone fractures and infection with a bacterium called Clostridium difficile that can be especially dangerous to elderly patients. In a recent paper, experts recommended that older adults use the drugs only “for the shortest duration possible.”

Studies have shown long-term P.P.I. use may reduce the absorption of important nutrients, vitamins and minerals, including magnesium, calcium and vitamin B12, and might reduce the effectiveness of other medications, with the F.D.A. warning that taking Prilosec together with the anticlotting agent clopidogrel (Plavix) can weaken the protective effect (of clopidogrel) for heart patients.

Other research has found that people taking P.P.I.’s are at increased risk of developing pneumonia; one study even linked use of the drug to weight gain.

http://well.blogs.nytimes.com/2012/06/25/combating-acid-reflux-may-bring-host-of-ills/

New Study: Cannabidiol, a non- THC compound derived from Marijuana effectively treats schizophrenia.

A certain marijuana compound known as cannabidiol (CBD) can treat schizophrenia as well as antipsychotic drugs, with far fewer side effects, according to a preliminary clinical trial. Cannabidiol differs from THC which is the much publicized intoxicating chemical in THC. 

The research team, led by Markus Leweke of the University of Cologne in Germany, studied 39 people with schizophrenia who were hospitalized for a psychotic episode. Nineteen patients were treated with amisulpride, an antipsychotic medication that is not approved in the U.S., but is similar to other approved drugs.

The remaining 20 patients were given CBD, a substance found in marijuana that is considered responsible for the mellowing or anxiety-reducing effects. Unlike the main ingredient in marijuana, THC, which can trigger psychotic episodes and worsen schizophrenia, CBD has antipsychotic effects, according to prior research in both animals and humans.

Neither the patients nor the scientists knew who was receiving which drug. At the end of the four-week trial, both groups made significant clinical improvements in their schizophrenic symptoms, and there was no difference between those getting CBD or amisulpride.

“The results were amazing,” said Daniel Piomelli, Ph.D., professor of pharmacology at the University of California-Irvine and a co-author of the study. “Not only was [CBD] as effective as standard antipsychotics, but it was also essentially free of the typical side effects seen with antipsychotic drugs.”

Antipsychotic drugs may cause devastating and sometimes permanent movement disorders; they can also lower a patient’s motivation and pleasure. The new generation of these drugs can also lead to weight gain and increase the risk for diabetes. These side effects are well known as a major hindrance during treatment.

http://psychcentral.com/news/2012/06/07/marijuana-compound-may-beat-antipsychotics-at-treating-schizophrenia/39803.html