Archive for May, 2010


Doylestown Chiropractor    
Release Date: 03/17/2010
Consumer Reports Health News — March 2010
Welcome to Consumer Reports Health News for health and medical journalists. Consumer Reports, Consumer Reports on Health, and cover issues pertaining to the efficacy and safety of prescription and non-prescription drugs (including natural medicines), mental health, diet and nutrition, food safety, and fitness. Consumer Reports tests health and fitness products, rates the effectiveness and affordability of prescription drugs, and evaluates the claims made by drug companies and the health care industry—all without commercial agendas or advertiser influence.

A recent analysis by Consumer Reports Best Buy Drugs found that use of muscle relaxants for back pain and stiffness was relatively ineffective and potentially dangerous. Michael Jackson and Anna Nicole Smith, for example, reportedly abused the muscle relaxant carisoprodol (Soma and generic), in combination with other drugs. Consumers should avoid carisoprodol because it may be more likely than other muscle relaxants to lead to addiction and abuse. Muscle relaxants can also cause sedation, which increases the risk of car crashes, falls, and other accidents.

Spasms, stemming from back or neck pain, fibromyalgia, headaches, or other forms of musculoskeletal pain, often respond to heating pads or hands-on therapies such as massage or spinal manipulation. Chiropractic care, for example, was the most effective treatment for lower-back pain in a recent Consumer Reports survey. Other research suggests that acupuncture, biofeedback, progressive muscle relaxation, and yoga may help some people, too. If those nondrug measures don’t help, over-the-counter acetaminophen (Tylenol and generic) or ibuprofen (Advil and generic) generally work as well as muscle relaxants. If these options don’t work, then it’s worth exploring the use of a muscle relaxant. Consumer Reports Best Buy Drugs recommends generic cyclobenzaprine. Log on to and click on “Prescription Drugs” to access Consumer Reports Best Buy Drugs.


2% of Prescriptions Filled Are Not Approved By The FDA

Doylestown Chiropractor,, via Dr. Gary Puckrein, Special to AOL News.
Each day, about two out of every 100 prescriptions filled at pharmacies around the country are for drugs that have never — repeat, never — been approved by the Food and Drug Administration.

These unapproved drugs often make unsubstantiated claims not supported by scientific data or laboratory testing. Many of them are wrongly deemed safe and are often incorrectly labeled as “generics.” None of them has ever seen the light of an FDA laboratory.

As a result, patients often end up taking drugs unaware that by doing so they are putting themselves at risk of a dangerous side-effect or potentially life-threatening adverse drug interaction.

Here in the 21st century, in the country with the best health care in the world, where patients assume that any prescription drug has been cleared by the FDA, it’s hard to imagine that this goes on. But it does.

To respond to patient concerns over the potential dangers of taking unapproved drugs, the FDA established its Unapproved Drugs Initiative in 2006. This important step specifically encourages pharmaceutical companies to get their unapproved drugs into the agency’s pipeline for testing and, if found to be safe and effective, approved. And to encourage drug companies to do so, the FDA also started removing unapproved drugs from pharmacy shelves.

To date, however, many remain.

Especially troubling are the unapproved drugs that remain on the market and are used by unsuspecting patients, even though a tested, safe and FDA-approved alternative is available. For example, versions of oxycodone, thyroid medication, ephedrine, codeine, acetaminophen, hydrocodone, colchicine, nitroglycerin and morphine have been approved; yet, dozens of unregulated versions of these drugs are still available.

The FDA’s stamp of approval is backed by its unmatched pharmacological drug analysis and testing procedures, which implant the world’s gold standard to any FDA-approved drug.

It gives patients and doctors the assurance that their medicine was made using the best ingredients, with sterile equipment, packaged in safe and tamper-resistant containers, and will act as predictably as science can determine. It guarantees that each product is properly labeled to reduce the risk of adverse reactions but also recorded and tracked so that any side effects can be properly cataloged and used for further study.

Conversely, unapproved drugs fly under the agency’s radar, so adverse reactions remain unknown — allowing preventable reactions to go unexposed, waiting to claim other potential victims.

Recently, regulators have signaled they are willing to re-engage and reprimand companies that produce, distribute and sell unapproved drugs. The FDA is sending letters to manufacturers of some of these illicit products urging them to stop producing, distributing and selling them. This must continue, since patients and many doctors incorrectly believe that if a drug is readily available, it must be FDA approved.
Public and private sectors alike need to work together to ensure a safe and effective prescription drug supply. Policymakers, physicians and other health care professionals, patients, the pharmaceutical industry and drug store chains should all work together to ensure that the prescriptions people take will heal them — not harm them. Physicians should not write prescriptions for unapproved drugs, especially when ones already cleared by the FDA are available.

Patients can visit Drugs@FDA or the Did You Know Project to learn more about approved and unapproved drugs. They can also ask their doctors and their pharmacists about their medications to ensure they are FDA approved and won’t interact with their other treatments. Ultimately, drug store chains and distributors should clean their aisles of unapproved drugs.

Until unsafe, unapproved and potentially harmful drugs are taken out of the marketplace, there will always be the risk that another patient will lose her life, unnecessarily, because we didn’t do enough.

Risky Back Surgeries!

Dr. Jeff McQuaite, Doylestown Chiropractor, via Copyright 2010 The Associated Press

A study of Medicare patients shows that costlier, more complex spinal fusion surgeries are on the rise — and sometimes done unnecessarily — for a common lower back condition caused by aging and arthritis.

What’s more alarming is that the findings suggest these more challenging operations are riskier, leading to more complications and even deaths.

“This is exactly what the health care debate has been dancing around,” said Dr. Eugene Carragee of Stanford University Medical Center.

“You have one kind of operation that could cost $20,000 and another that could cost $80,000 and there’s not good evidence the expensive one is being used appropriately in the majority of cases,” Carragee said.

Add to that the expense for patients whose problems after surgery send them back to the hospital or to a nursing home and “that’s not a trivial amount of money” for Medicare, said Carragee. He wrote an accompanying editorial in the Journal of the American Medical Association where the federally funded study appears Wednesday.

The cost to Medicare, just for the hospital charges for the three types of back surgery reviewed is about $1.65 billion a year, according to the researchers.

All the patients in the study had stenosis in their lower backs, a painful squeezing in the spine that’s most common in people over 50. The researchers compared the risks for three different types of surgery for the condition: decompression, simple fusion and complex fusion.

“All operations aren’t the same and some seem to be associated with higher complication rates than others,” said lead author Dr. Richard Deyo of Oregon Health and Science University in Portland. “It’s not necessarily true that the more aggressive surgery is better, at least in terms of safety.”

There’s little agreement about the best way to treat chronic lower back pain, and much depends on what’s causing the pain.

Patients should ask their doctors about alternatives to complicated operations, Deyo said. Could steroid injections and physical therapy be tried? Would a simple decompression procedure be as helpful as a spinal fusion and with less risk?

In a decompression procedure, the simplest method in the Medicare study, a surgeon cuts away part of the bone that’s painfully pressing on nerves. It can cost about $30,000 in hospital and surgeon fees.

For a fusion, a surgeon binds two or more vertebrae together using a bone graft, with or without plates and screws. The researchers defined a complex fusion as one involving three or more vertebrae or more than one side of the spine. Fusions cost $60,000 to $90,000.

The researchers analyzed data on more than 32,000 Medicare patients who had one of the three types of surgeries in 2007.

About 5 in 100 patients who had simple or complex fusions suffered major complications such as stroke compared to 2 in 100 with decompressions. The risk of death within 30 days after surgery was different too: 6 in 1,000 for complex fusions compared with 5 in 1,000 for simple fusions and 3 in 1,000 for decompressions.

The study didn’t address how successful the various types of surgeries were at relieving pain.

More than half the patients who had complex fusions had a simple stenosis, which usually calls for decompression alone. They did not have the curvature of the spine or a slipped vertebra — additional conditions that might suggest a fusion is needed. There’s not much evidence for doing a complex fusion for a person with simple stenosis, Carragee and other experts said.

“It certainly looks like there’s more complex surgery being done than we have very good evidence to support,” Carragee said.

Rates of complex fusions in Medicare patients rose 15-fold from 2002 to 2007, while decompressions and simple fusions declined, the study found. Although the overall procedure rate fell, hospital charges grew 40 percent.

Aggressive marketing of devices used in complex fusions is likely playing a role in the increase, Deyo said. The marketing includes ads in medical journals and lectures by surgeons on the payroll of device manufacturers.

Allegations of kickbacks to spine surgeons for using products and questionable financial arrangements to doctors as consultants have plagued the multibillion-dollar industry. One company, Medtronic Inc., reached a $40 million settlement with the U.S. Justice Department in a whistleblower case that included allegations the company paid doctors to use its spine surgery products. The company denied any wrongdoing.

Dr. Charles Rosen, a spine surgeon at the University of California, Irvine, founded the Association for Medical Ethics to nudge doctors toward scientific evidence over vested interests. Forty-nine spine surgeons have joined, pledging to refuse any type of compensation or earnings from companies for using a product.

Rosen applauded a provision in the new health care law that requires device makers and others to file annual reports to the government on their financial ties to doctors. Patients will be able to look up possible conflicts in a government database.

“Too much fusion surgery is done in this country and often for inappropriate reasons,” Rosen said. While complex fusions are needed for some conditions, he said, patients “should not hesitate to get a second opinion.”