Healthcare Business

Spine-health launches new Web site design

Carolyn — Thu, 29 May 2008 07:46:06 -0700

May 29, 2008
by: Stephanie

Spine-health is very pleased to announce the release of our newly designed Web site. In February, we launched part one of our new site focusing heavily on the behind-the-scenes technology platform to enable dynamic content serving, increase site speed, and other enhancements. Today’s release marks the first wave of usability enhancements – new design, new functionality and enhanced navigation. Go ahead and take it for a test drive. The Spine-health library of more than 2,000 doctor written and reviewed articles is now even easier to search and navigate, and we have made important upgrades to our popular Pain Blog, Chats, and Message Boards to improve the user experience for our 10,000+ registered members and regular contributors.

Please email us at admin@spine-health.com with your comments on what you like and your suggestions on how to better improve the site. Keep looking, as there will be a lot more to follow in the coming months.

Have a great day!

Stephanie Burke
CEO, Spine-health

Is Your Pain Medication Prescribed Off-Label?

Mon, 01 Oct 2007 14:46:35 -0700

October 1, 2007
by: Sylvia Marten

Experts estimate that 21% of prescriptions for common drugs are written for off-label uses. According to a study on Off-Label Prescribing published in the Archives of Internal Medicine, three-fourths of those prescriptions were for off-label uses that lacked scientific support. What's going on?

First, let's talk about what we mean by on "label" drugs. In the U. S. , the FDA requires that drug makers submit, test and get approval from the FDA for specific uses of their product before the product can ever be marketed. To obtain approval, pharmaceutical manufacturers must submit extensive study data demonstrating safety and effectiveness, a process which usually takes several years and millions of dollars. When a product is approved by the FDA, a specific "label" for that product is approved too. The label must include the product's approved indications, dosage and method of administration, and use in specific populations.

So, what is "off-label"? After the FDA approves a drug for its specific use, physicians can prescribe the product for uses not covered by the approved label. This is "off-label" use. Off-label uses include:a drug prescribed to patients with conditions not listed on the approved label; departure from the approved drug dosage, method of administration, or patient population; and unapproved product combinations, such as using two different drugs to treat a single condition. This practice is perfectly legal but it lacks any kind of oversight.

"Off-label" drugs for back pain. Among the types of drugs commonly prescribed off-label, most common were heart drugs and anti-convulsants (indicated for seizures). For example, gabapentin, brand name Neurontin, had one of the highest proportions of off-label use among specific medications, namely for neuropathic pain (it is only indicated for use in controlling epileptic seizures and in pain from post-herpetic neuralgia). Neurontin also happens to be a quite commonly prescribed drug for people diagnosed with chronic back pain or chronic low back pain. This of course means the drug is being prescribed off-label in the back pain patient population.

Patients should always consider carefully all medications that are prescribed to them. It is fair for patients to ask their doctors whether a prescription is on or off-label, and this can be easily and more thoroughly researched on reliable health information websites that address medications, such as MedlinePlus, the FDA, or condition-specific sites. If off-label, it is important to know whether there is sufficient data to support its use or if the practitioner's decision is based on anecdotal evidence. The patient should weigh off-label recommendations against the alternatives with his/her practitioner, and ultimately decide if he/she is comfortable with an off-label drug for the specific health issue being addressed. It is important for patients to keep in mind that a drug prescribed off-label to them is a drug that has not been approved by the FDA for some element of their specific health situation.

Is "off-label" drug prescribing good or bad? There isn't a clear cut answer. Anecdotally, many of my colleagues and personal circle of friends have experienced off-label drug use with positive results. For example, our children have been prescribed albuterol for various severe pulmonary episodes (not asthma, for which it's indicated) with much success. The Spine-health.com message boards are full of stories of people taking medications off-label for back pain or [url:887,type=|node|,content=|leg pain|] as prescribed by their doctors, with many experiencing much needed pain relief not possible with approved drugs. So, off-label use can be positive in that it expands access to important health benefits that may not be possible with alternatives. On the flip side, concerns and warning bells should go off with respect to safety and the long-term impact of a drug use that has not been extensively studied.

The study authors cited several reasons as to why the high percentage of off-label prescribing is occurring, with some reasons being legitimate and others not. The practice itself raises issues that require addressing, including a better/faster process for getting legitimate additional uses for a drug indicated, but also for ensuring patient safety for patients dutifully following an off-label treatment protocol as prescribed by physicians they trust.

Posted by: Sylvia

Additional reading:

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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
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Posted by: Sylvia

New Hope for Smokers with Back Pain

Wed, 08 Aug 2007 15:15:12 -0700

August 8, 2007
by: Sylvia Marten

There’s a unique drug now on the market for smokers trying to quit - Chantix (manufactured and distributed by Pfizer). It was actually approved by the FDA in May 2006 and given priority FDA review because of its significant potential benefit to public health.

Chantix, a prescription drug indicated for smoking cessation, is different because it acts on the brain in two ways: by providing some nicotine effects to ease withdrawal symptoms and by blocking the effects of nicotine from cigarettes if patients resume smoking.

According to the Centers for Disease Control and Prevention (CDC), an estimated 44.5 million adults in the United States smoke cigarettes and more than 8.6 million of them have at least one serious illness caused by smoking. In particular, smokers are nearly 3 times as likely to develop chronic low back pain as non-smokers.

According to a user survey conducted on Spine-health.com, about 30% of the chronic back pain population self reports having a smoking addiction. Couple this with the fact that about 80% of those same people are candidates for [url:165,type=|term|,content=|back surgery|] – and we have trouble. Smokers are at higher risk for healing problems after fusion surgery, which means that potentially the chronic back pain problem and the smoking addiction will remain after surgery if smokers with back pain don’t quit.

It is common for back surgeons to ask their patients to quit smoking prior to surgery and commit to not smoking for at least three months after surgery (and hopefully longer, from an overall health standpoint). In recent months, we have heard anecdotally from some of our physician members that they have seen great results using Chantix with their back pain patients. Other smoking cessation aids include: [url:6745,type=|node|,content=|Zyban|] (pill), Nicotrol (nasal spray), Nicorette (gum), Nicoderm CQ (patches), Habitrol (patches), Commit (lozenges), and counseling and support groups.If you are a smoker with back pain, you should consider talking to your doctor about smoking cessation aids – to help you quit smoking and to ease your back pain.

Posted by: Sylvia

More reading:

Chantix patient information sheet at FDA
[url:1826,type=|node|,content=|Healing after spine fusion surgery|]
Varenicline (Chantix) shows greater continuous smoking abstinence

6 Sites for Checking Out Your Hospital

Sun, 15 Jul 2007 14:20:59 -0700

July 15, 2007
by: Sylvia Marten

Are you scheduled for [url:165,type=|term|,content=|back surgery|] or considering it? In addition to a thorough check of your surgeon, you should probably check out your hospital too. While the surgeon is arguably the key factor in the procedure itself, the hospital staff, environment, and guidelines can impact things like choice of medication and use of antibiotics – choices that can cause variances among different hospitals, such as post-op infection rates for back surgery patients.

The notion of “hospital quality” would have been nearly impossible for consumers to ascertain even a few short years ago. But now, as part of the push to improve health care quality and lower costs, hospital information is becoming public.

Thanks to Theo Francis at the Wall Street Journal for compiling a list of hospital comparison resources available to the public.

Two major categories of data cover:

Best practices - which tracks how often hospitals follow recommended guidelines for particular procedures. Online resources include:

Procedure outcomes - which tracks how patients that have particular procedures actually fare. This data often covers mortality rates, readmissions and complications. Online resources such as:

This hard data should be considered along side the qualitative data provided by talking to others:a hospital’s reputation for back surgery (and ideally, for the particular type of surgical procedure e.g., fusion surgery, artificial disc replacement) in the community, the experiences other patients have had at that hospital, what a hospital’s employees say, and what a prospective patient learns and feels by calling up the hospital’s quality department or talking with the medical staff.

What other resources have you found helpful in assessing hospital quality?

Posted by: Sylvia

More reading:

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For Health Information, Enter Wikipedia at Your Own Risk

spine-health — Wed, 20 Jun 2007 17:12:38 -0700

June 20, 2007
by: Stephanie

Thanks to KevinMD for highlighting a hilarious post by anesthesiology resident Michelle Au about residents using (aka misusing) Wikipedia to look up health information.

The idea behind Wikipedia is admirable, and I think it works well in many categories - looking up places, historical facts, etc. But in the areas of health - at least in the 100 or so pages I've worked on editing - it is such fodder for commercial interests it's scary.

For example, on the Back Pain page some phrases are clearly commercial - eg. "Dr. John Keating talks about some of the ways to treat the pain in this VIDEO LINK" (links to Youtube video of a dr. talking about his approach to fixing si joint dysfunction). Other interests are presented less obviously. Dr. Sarno's approach to treating back pain used to dominate the page and still keeps popping up from time to time.

But even if one were to zealously hunt out and delete the obvious commercial plugs, there are some intrinsic problems with Wiki that will always make it unreliable for health information.

Conflicting information. Example: the Back Pain and Low Back Pain pages give conflicting information - each presented by "authority" sources - about whether various treatments (spinal manipulation, epidural injections, acupuncture) work or not.
Lack of detail. I don't really care about the above conflicting treatment information, because it's so high level its moot. Who cares if epidural steroids "may be" beneficial for low back pain? Patients need to know what specific back conditions the injections work for - do they work for patients with low back pain from [url:815,type=|node|,content=|degenerative disc disease|]? Do they work for low back pain from muscle strain? Otherwise, who cares.
Poor writing. Typos, grammar problems, redundancy .... don't even get me started.
Lack of balance. Since anyone can insert (or delete) anything at anytime, the pages often come across as ramblings rather than anything cohesive. For example, on the degenerative disc disease page, following two very high level paragraphs about the full range of surgical and non-surgical treatments, there was a third paragraph that dives deep into osteopathic treatments and why it is preferable. I fully support osteopathic treatments for low back pain, but it is given way too much weight here.

I used to be very active with helping build Wikipedia. I thought the idea of so many people who were experts in a given field contributing to make a common, free educational resource was very exciting. Now I'm just frustrated.

All IMHO.

(P.S. Just went back and fixed the Degenerative Disc Disease page - couldn't resist!)

Posted by: Stephanie

Battling Chronic Pain at Work

Tue, 19 Jun 2007 19:33:46 -0700

June 19, 2007
by: Sylvia Marten

A recent "Pain in the workplace" survey (jointly sponsored by Ortho-McNeil and the National Pain Foundation) found:

Chronic pain in U.S. workers has risen nearly 40% in the past 10 years
More sick days are being taken due to the pain

Those living and working with chronic pain might find some useful nuggets in the Tips for Dealing with Chronic Pain, e.g., the Pain Profiler tool provides a helpful framework for describing pain to a physician.

Posted by: Sylvia

More resources:

Nationalpainfoundation.org
[url:1113,type=|node|,content=|Controlling back pain at work|]
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Hats Off to Spine-health.com’s Message Board Community

Fri, 15 Jun 2007 14:42:41 -0700

June 15, 2007
by: Sylvia Marten

The hundreds of registered users (and the hundreds of daily visitors) who contribute to Spine-health.com’s message boards have created a truly unique and beneficial resource for those who suffer from chronic pain. The passion within the community is immediately evident to even the casual observer. Well, the world is taking notice – and giving credit where credit is due. Forbes has listed Spine-health’s message boards as Best of The Web. What a great opportunity to touch even more lives and learn from their experiences.

Posted by: Sylvia

Resources:

Doctors: Take Control of Your Online Presence

Wed, 30 May 2007 11:25:42 -0700

May 30, 2009
by: Sylvia Marten

Doctors should Google themselves is the telling headline of a practicing physician’s recent blog post. And he’s right. Today, consumers fully expect to be able to research so-called “experts”, including professional services providers like physicians. The researching takes place in two major ways:

Via search engines, with Google as #1 for health searches
In the Find A Doctor directories on trusted health and condition-specific websites

According to PEW Internet Life, about 30% of the 113 million U.S. adults on the Internet have searched online for a particular doctor or hospital. 58% say the information they found affected a decision about how to treat an illness or condition. I think it’s safe to conclude from this that the old adage, “no news is good news”, doesn’t really apply here. If a prospective patient can’t find you online, they may very likely move on to a physician they can find. Patients are hungry for health information and are fast losing patience with anything that inhibits information accessibility – e.g., sites that don’t source their data, information behind a password or fee-based – and lack of a web presence is considered somewhat primitive. So the question for doctors and surgeons is: if you can’t find yourself online, how can anyone else?

Physicians should also be aware that if they aren’t in control of their online presence, someone else may control it for them. Many companies create “free” physician listings based on purchased lists or inaccurate web surfing, creating physician profiles that are incomplete and often grossly inaccurate, and then try to contact the physician to edit that listing (for a fee). As in any profession, legal action against doctors is a hot topic, and different rating/grading companies, e.g., HealthGrades, and online public legal records also make their way into the search engines. Do you want your initial online presence in Google to be about a lawsuit you’re involved in?

Physicians need to take control of their Internet presence to ensure prospective patients (and for that matter, prospective colleagues, nominating committees, associations, recruiters, the media, family members and friends) see them and their professional achievements in the best possible light. Spine medical professionals can check out Spine-health’s membership services to get a comprehensive physician profile and top rankings in Google. Additionally, physicians should periodically review any medical association profiles of themselves and make sure those are up to date and accurate.

Additional resources:

Posted by: Sylvia Marten, www.spine-health.com

Reversal: Now Milk Doesn’t Help With Weight Loss

Wed, 16 May 2007 19:12:49 -0700

May 16, 2007
by: Stephanie

The Federal Trade Commission has apparently advised US dairy producers to stop promoting the message that consumption of low fat dairy products spurs weight loss.

An advocacy group, the PCRM, said that two national dairy advertising campaigns overseen by the U.S. Department of Agriculture will stop claiming that dairy products cause weight loss because "such claims are not supported by existing scientific research."

The advocacy organization cited a May 3 letter from FTC, which stated that following discussions with the U.S. Department of Agriculture, it would "discontinue all advertising and other marketing activities involving weight loss claims until further research provides stronger more conclusive evidence of an association between dairy consumption and weight loss."

The PCRM claims that since 1989 there have been 35 clinical trials that have explored the relationship between dairy products and/or calcium supplements and body weight. Thirty-one found no relation; two indicated that milk and other dairy products actually contributed to weight gain. When I check the Journal of Clinical Nutrition Archives, the trial results that I viewed did not show any link between dairy consumption and weight.

My take? Always follow the money. Even in healthcare. "Non-profit" is a tax status, not an ethical standing, and even non-profit groups have to make money to pay employees, show membership growth, etc. The National Dairy Council had a job to do – stop the decline in milk consumption, and they used whatever science helped them with their marketing message. Maybe some day the science will show that there is or is not a link between dairy intake and weight loss, but to date it has not been proven.

Posted by: Stephanie

Additional Reading:

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