Health in the Media

What Back Pain Patients Should Know about Stop-Smoking Drugs Chantix and Zyban

cmaynard — Tue, 07 Jul 2009 11:43:47 -0700

July 8, 2009
by: Sylvia Marten

The U.S. Food and Drug Administration (FDA) just announced that a black box warning will be carried on two popular, “stop-smoking” drugs – varenicline (Chantix) and buproprion (Zyban, Wellbutrin) – following a report detailing some very significant side effects with their use.

According to the FDA’s adverse event reporting system, use of these two drugs has been linked with serious changes in behavior, including:

depression
agitation
hostility
thoughts of suicide.

More specifically, the report linked:

98 suicides and 188 attempted suicides to use of varenicline
14 suicides and 17 attempted suicides to buproprion use.

While noting the importance of getting people to quit smoking, the FDA added that it simply wants closer monitoring of these two drugs.

Consequently, the FDA is going to ask the manufacturers of Chantix and Zyban – Pfizer and GlaxoSmithKline, respectively – to conduct clinical trials examining behavioral changes with usage of these drugs.

Smoking has long been linked to causing back pain and is often a reason why surgeons may not want to perform spinal surgery on certain patients.

Since smoking can slow down the recovery time after back surgery, many patients may have to quit smoking prior to surgery.

If you have recently quit smoking in wake of a scheduled back surgery, or have stopped smoking following back surgery, it’s important that you know the risks of stop-smoking drugs, as the above information about Chantix and Zyban demonstrates.

And if you have used any of these stop-smoking drugs and noticed changes in your behavior similar to the symptoms listed above, get in touch with your doctor as soon as possible.

More on This Topic

[url:6767,type=|node|,content=|Chantix Helps Quit Smoking|]

[url:738,type=|node|,content=|Does Smoking Cause Low Back Pain?|]

[url:6679,type=|node|,content=|Quitting Smoking: A Must for People with Back Pain|]

[url:6742,type=|node|,content=|Ways to Quit Smoking|]

[url:6741,type=|node|,content=|Why It Is So Hard to Quit Smoking?|]

[url:6724,type=|node|,content=|Quitting Smoking before a Spinal Fusion|]

FDA Approves Third Cervical Artificial Disc: the Bryan Cervical Disc from Medtronic

mlepore — Wed, 03 Jun 2009 08:00:17 -0700

June 4, 2009
by: Spine-health Staff Writer

After long trials of deliberation, Medtronic’s Bryan Cervical Disc became FDA-approved on May 12, 2009. The Bryan Cervical Disc, designed to alleviate [url:149,type=|term|,content=|neck pain|] and related disability caused by degenerative disc disease, had received a favorable FDA recommendation back in July of 2007.

Although approved, conditions have been put in place for the approval of the Bryan for the next ten years. Medtronic will be conducting a post-market study, which will include tracking of patients' neck disability index scores, radiographic information, neurological status and a number of other outcomes in addition to data on adverse events and explanted devices.

What is unique about the Bryan is it is designed to better mimic natural disc shock absorption. It is made of titanium and polyurethane, which is softer than the nuclei of competitive discs, such as the Prestige’s metal on metal design. The polyurethane in the Bryan raised questions on wear debris during the FDA panel, but was determined to not be an issue for short-term use. Long-term use is an area of concern though, and will be under surveillance.

The Bryan (Medtronic), Prestige (Medtronic) and ProDisc-C (Synthes) are the only cervical [url:164,type=|term|,content=|artificial disc replacement|] options for the U.S., although there are expected to be more approvals and launches soon. At this point, Medtronic has not commented on the Bryan’s approval, or on projected launch dates when it will be commercially available.

Posted by: Spine-health Staff Writer

Additional Artificial Disc Replacement sources:

[url:1379,type=|node|]
[url:1380,type=|node|]
[url:1388,type=|node|]
FDA approves Medtronic’s Bryan Cervical Disc

First Cervical Disc Replacement Surgery with ProDisc-C

spine-health — Fri, 25 Jan 2008 07:01:34 -0800

January 25, 2008
by: Sylvia Marten

The very first ProDisc-C surgery was performed last week since the FDA approved the device in December 2007.

Michael E. Janssen, DO, a Denver surgeon and a Spine-health.com Member, became the first physician in the United States to perform two cervical disc arthroplasties using the ProDisc-C Total Disc Replacement System. The ProDisc is designed to treat patients suffering from cervical disc degeneration and disc herniation, which occurs when natural shock absorbers in the [url:1113,type=|term|,content=|cervical spine|] become worn and start to degenerate, often resulting in pain, discomfort, and impaired cervical mobility creating neck and upper arm pain.

One of the patients was an active 35 year old male with cervical disc degeneration that developed as a result of a traumatic hockey injury, causing pain, stiffness, and numbness in his left-hand. The second patient was a 53 year old female accountant who had been suffering with neck and upper extremity pain from a disc herniation compressing her spinal cord.

Both surgeries were performed on January 16, 2008, and both patients pre-operative symptoms were gone the following day. The patients were discharged from the surgery center on January 17, 2008 with minimal pain.

The full story is available here.

Additional resources:

[url:685,type=|node|]
[url:857,type=|node|]
[url:861,type=|node|]
[url:6001,type=|node|]

The Health Care Crisis

Thu, 27 Sep 2007 19:10:07 -0700

September 27, 2007
by: Peter

The uninsured population of the United States has perplexed our country and our leaders for several decades now. Many have termed this our national health care crisis, but it is not nearly as much a health care crisis as a health insurance crises. As medicine has gotten more technical and expensive, the affordability and availability of insurance has gone down. Health insurance affects our society in many different ways including cost shifting, job decisions, and actual availability of health care.

How we got to where we are is complicated and there are no easy answers as to how we can correct our problems. Opinions are very polarized as to whether or not national health insurance will correct all our problems, but the question is really not that easy. At the same time that many countries with national health insurance are trying to privatize large sections of the healthcare, we are trying to experiment with a whole new tax and guaranteed health care system.

As we taxpayers, patients, and citizens ponder this problem, we need to consider several different realities. Right now we pay 17% of our gross national product for healthcare. Everyone agrees that this is a substantial sum, but there is no agreement as to how to lower this amount while continuing to expand healthcare that is available today. Technology continues to increase not only the quality of care but the cost.

There are only two ways to ration healthcare or any other commodities; either the marketplace determines what is efficient, worthwhile and affordable, or the government creates an agency that artificially determines appropriate care and the appropriate reimbursement.

Neither method is perfect or a magic solution. Market based solutions can be inequitable, and government solutions can be very inefficient and even more cumbersome than the current disjointed private health insurance system.

I propose that we need to expand our thought process beyond just whether or not national health insurance is the problem. As a lifetime Republican voter I am personally very distrustful that a whole new government agency can be more efficient than a private health care system. After all, our military, post office and other governmental agencies are not exactly paragons of efficiency.

Two problems need to be addressed

Most of what has gotten us into the current state of affairs is the tax system. Fixing our tax system is more important than creating national health insurance. Right now most of us obtain our health insurance through our employer. If we leave our employer we no longer have health insurance. Any new system will have to make insurance owned by the employee and not the employer.
The next problem to solve is the fact that most patients who are not insured are so because they do not use much health care, whereas as we age we have a higher need for insurance and healthcare but can no longer afford the insurance. Insurance is designed to spread risk among many people and with 46-47 million uninsured people, the risk is spread right now only among a certain segment of the population. Any system that is designed needs to be all inclusive and compulsory for everyone.

If we could solve the two above problems we would be much closer to being able to provide for an equitable system that provides ownership in the health care system, and still allows patients flexibility in employment options. If congress cannot provide for a more reasonable tax system and more reasonable insurance options, then they will have to nationalize healthcare. However, if the politicians in this country cannot provide for reasonable playing field for a market based healthcare solution, I would be very dubious that they will have any really constructive or practical solutions as a government run agency.

Posted by: Peter Ullrich, MD

Lumbar Artificial Disc Replacement Not Covered In People Over 60

Mon, 27 Aug 2007 12:00:42 -0700

August 27, 2007
by: Sylvia Marten

Medicare has decided it will not pay for lumbar artificial disc replacements in people over 60 years of age. The reasoning for the CMS' (The Centers for Medicare and Medicaid Services) decision is the lack of data on using such devices in the 60+ population, according to Scott Boden, MD, a Spine-health.com Medical Advisor.

This August 2007 decision affects the Prodisc-L (made by Synthes), approved by the FDA in August 2006. The first lumbar artificial disc approved by the FDA in 2004, the Charite disc (made by DePuy Spine, a Johnson & Johnson company), was already covered by a similar decision made by CMS in May 2006.

Both the Prodisc and Charite disc FDA IDE clinical studies tested patients between the ages of 18 and 60. Based on the age limitations in these studies and in Medtronic’s Maverick lumbar disc study, CMS says it “is convinced that the indications for LADR will exclude the over age 60 population, and that these age limitations are not specific to one manufacturer’s disc implant.”

What about people under age 60 with pain and disability from lumbar degenerative disc disease, the prevalent and severe condition the artificial disc was designed to treat? It’s still left up to individual insurance companies to decide. The CMS acknowledged “some evidence does exist for patients age 60 and under” to benefit from artificial disk technology. However, it believes the ProDisc clinical trial design created more uncertainty in benefits and thus would not come forth with a statement supporting artificial disc replacement in the under age 60 population.

For those of you interested, the exact wording of the decision is below.

The original CMS decision about Lumbar Artificial Disc Replacement was made on May 16, 2006, and was specific to the Charite Disc, the only lumbar artificial disk available at the time:

“LADR with the Charite^TM lumbar artificial disc is not reasonable and necessary for the Medicare population over 60 years of age; therefore, LADR with the Charite^TM lumbar artificial disc is non-covered for Medicare beneficiaries over 60 years of age. For Medicare beneficiaries 60 years of age and younger, there is no national coverage determination, leaving such determinations to continue to be made by the local contractors. Medicare coverage under the investigational device exemption (IDE) for other lumbar artificial discs in eligible clinical trials is not impacted.”

On August 14, 2007, the CMS issued the following in its decision memo:

“The Centers for Medicare and Medicaid Services (CMS) has determined that LADR is not reasonable and necessary for the Medicare population over sixty years of age. Therefore, Section 150.10 of the Medicare National Coverage Determination (NCD) Manual is amended to reflect the change from non-coverage for LADR with a specific implant to non-coverage for the LADR procedure for the Medicare population over sixty years of age. For Medicare beneficiaries sixty years of age and under, there is no national coverage determination, leaving such determinations to be made on a local basis.”

Further reading:

CMS decision memo for Lumbar Artificial Disc Replacement
[url:1734,type=|node|]

Posted by: Sylvia

Osteopaths are Physicians

spine-health — Wed, 27 Jun 2007 18:01:41 -0700

June 27, 2007
by: Stephanie

With the recent press bashing of Paris Hilton's psychiatrist, an osteopathic physician, the American Osteopathic Association felt the need to issue a press release defending the medical training of osteopathic physicians. Seems that anything in the press associated with Paris has a downside these days.

Bottom line: Osteopathic physicians are real doctors and may specialize in any area and provide any treatments - including surgery - that medical doctors do.

Thanks to KevinMD for highlighting this.

Posted by: Stephanie

Read more:

[url:1959,type=|node|]

This Kind of Reporting is No Help to Back Pain Patients

spine-health — Tue, 19 Jun 2007 15:37:59 -0700

June 16, 2007
by: Stephanie

Kudos to Gary Schwitzer for humorously discrediting a recent article that needs to be discredited - "Chronic Back Pain Breakthroughs: end back pain agony" in the July issue of Reader's Digest.

This article hypes new technologies - such as a "magic spine wand" - using anecdotes and exciting quotes, and offering no research findings or evidence. Come on. Chronic back pain is a serious medical issue. Don't report on it with the same flippancy you would use in reviewing the latest celebrity antics or rehab stints.

Posted by: Stephanie