Zoster / Shingles Vaccine - Is it Necessary?

I often get questions about the zoster or shingles vaccine known as ZOSTAVAX. Shingles or zoster is the painful skin condition that typically occurs in older patients and is caused by the chickenpox virus. If you've ever had chickenpox, then you are at risk for developing shingles later in life.

Typical symptoms initially include painful area for a few days which may be related to viral like symptoms of muscle aches, low grade fever, and malaise. The painful area usually is on one side of the body (unilateral) and along a dermatome, a nerve distribution root. The pain can be excruciating and often described as burning and intense. Patients often do not like any clothing to touch the area.

After the pain appears, a few days later a small rash of clear small blisters, known as vesicles, erupted and are typically grouped together on a base of redness. The rash appears on the exact same area of the pain.

The vesicles eventually scab over and over a period of a few weeks and resolve. The pain typically goes away as well but can take longer.

However, in some patients, the pain continues and can be irritating enough that it interferes with people's lives. This condition is known as post-herpetic neuralgia (PHN) and is more common in individuals aged 60 and older and who have other chronic illnesses like diabetes.

This is why many patients are worried about shingles / zoster. A friend has suffered from PHN and has made sure everyone they know get the vaccine to decrease the risk of developing shingles and then potentially PHN.

So how good in the vaccine? Should you get it? How common is shingles?

It depends.

From the vaccine insert of ZOSTAVAX

The rate of getting zoster is WITHOUT the vaccine:
10.8 per 1000 people per year - aged 60 -69
11.4 per 1000 people per year - age 70-79
12.2 per 1000 people per year - age 80 and older.

This means about 1 percent of the population aged 60 and up will develop shingles annually.

The rate of getting zoster is with the vaccine
3.9 per 1000 people per year - aged 60 -69
6.7 per 1000 people per year - age 70-79
9.9 per 1000 people per year - age 80 and older.

Note the decrease of those developing shingles age 60 to 69, but that the vaccine's ability to prevent shingles diminishes. This isn't due to the vaccine per se, but the immune system's ability to mount a response. As we get older, the immune system is less effective.

As a result the vaccine effectiveness is as follows:

Effectiveness of Zoster vaccine is
64% for pt aged 60-69
41% pt age 70-79, and
18% for those 80 and older.

Also from the package insert although the vaccine did decrease the rate of PHN due to decreasing cases of shingles, other complications of shingles like zoster around the eye, pain, and scarring from the rash were unchanged.

ZOSTAVAX is only indicated for people 60 years and older. Some patients cannot get the vaccine so check with your doctor.

It is covered under Medicare Part D.

More at the CDC website.

Just Say NO to a Public Healthcare Plan

First let me be entirely clear. I agree that healthcare should be available to all and affordable. I agree that the current healthcare system is fragmented, not patient or doctor friendly, and is out of control (that is why I wrote my book to help every individual navigate our current nightmare we call the US healthcare system).

The problem is that fixing the healthcare system isn't simple and certainly shouldn't be done by the government. Plenty of myths exist including the following.

1. Medicare works. Why not expand Medicare for all?
One of the biggest myths is that Medicare is a success.

Hardly.

Medicare will become insolvent if nothing is done over the next 10 years. Patients who are on traditional governmental Medicare and not some complementary version of it via an insurance company (supplemental plan or Medicare HMO aka Medicare Advantage) are finding fewer and fewer doctors willing to take straight Medicare. Why? It doesn't reimburse enough to pay the bills. The program Medicaid, which serves the poor, is even worse. If patients do find a doctor who is taking straight Medicare or Medicaid there is often an intolerably long wait to be seen.

2. Government can squeeze costs out of the healthcare system by offering competition.

Sure, by playing hardball and setting prices which may be artificially low. The Obama administration should be commended for tackling the difficult problem of providing universal coverage (not to be confused with nationalization of healthcare) as well as making it affordable. President Obama can get there by setting reimbursement rates to fit his agenda. Whether the rates reflect reality is another question. This is why insurance companies are so concerned about a public plan.

Also, realize this. If there was an insurance company that was able to offer great coverage at a lower price, then why wouldn't it do so already? Typically low cost goods and services which are comparable to more expensive options do well in the marketplace. Why not with health insurance? Simple. Because there is no individual mandate, that is everyone needs to buy health insurance, health insurance is pricey as the young and healthy don't subsidize those who truly need it. As a result, the only purchasers are those who will use it causing costs to skyrocket.

If the government is so good at squeezing costs out, then why don't we have the government produce cheaper cars and set up an airline?

If the government wishes to expand healthcare, it must do the following at a minimum.

• Require everyone to purchase health insurance. With everyone participating, the costs of those who truly need it is spread across those who are healthy. Without an individual mandate, health care will be too expensive.
• Change the reimbursement structure on how doctors are paid. Massachusetts learned with their universal coverage that having insurance doesn't mean access and certainly doesn't mean better costs because doctors are paid to do more. A state panel recommended that doctors get paid a salary.
• Think seriously about capping damages for medical complications, malpractice, and misdiagnoses. Patients and families who are harmed should be adequately compensated, but not outrageous fees collected by lawyers, rather via an arbitration system. Too often, extraordinary damages may make the individual and family feel better, but often drive doctors out of the state. Many states have critical shortages of specialists for these reasons.
• Standardize benefits packages across the states. A health insurance plan for a healthy individual shouldn't vary significantly from San Francisco to New York any more than a car purchased on the different coasts are similar, but not identical. The large difference in health insurance costs for the same coverage is due to varying state requirements and simply adds more administrative costs and hassles with little benefit.

If the federal government wishes to get into healthcare, then it must do so by setting up a delivery system like the VA, which has consistently outperformed doctors and hospitals in the community.

Simply offering a public insurance plan is not the answer and will drive insurance companies out of business.

When the government needed to step up and help citizens of Hurricane Katrina, it failed miserably and although it could be argued it was due to incompetence of certain individuals, the reality is that FEMA doesn't know how to move goods and people quickly and efficiently.

Who succeed to do their jobs exceedingly well and become the unlikely heroes? The private sector - specifically Fedex and Wal-mart, two organizations whose livelihood depend on getting things moved quickly and reliably.

President Obama should be commended. His goal should focus on changing the parameters which the healthcare system operates. It should not however have a new public plan as that would be a disaster.

As a side note, the Republicans are in complete disarray arguing that the healthcare system doesn't need fixing. It is broken. Simply saying no, doesn't help anyone deal with a crisis that left unchecked will bankrupt our country.

Medicare Won't Cover Virtual Colonoscopy - the Right Decision

In a clear blow to CT device manufacturers like General Electric, the Centers for Medicare and Medicaid Services (CMS) has decided not to cover virtual colonoscopy, which is a non-invasive way of screening for colon cancer.

It's the right decision. Although virtual colonoscopy was recommended by the American Cancer Society (ACS) as a reasonable alternative to the more invasive flexible sigmoidoscopy and colonoscopy, the issue with virtual colonoscopy is radiation exposure when other ways of screening already exist. Certainly from the perspective of ACS, which is an organization focused on increasing cancer screening and awareness, I understand the reason for adding virtual colonoscopy as an option.

But in the reality of the healthcare crisis and the goal of President Obama to make healthcare more affordable for all, decisions like this are inevitable where someone won't be happy with the outcome, in this case CT device manufacturers. With the announcement earlier this week that hospitals, insurers, doctors, device manufacturers will decrease the rate of health care expenses by 1.5% per year over the next decade, tough decisions will be made. Private insurers often follow CMS decisions, so don't expect to have virtual colonoscopy covered by your insurance company to screen for colon cancer.

The funny thing is this decision by CMS will be one of the easier decisions to make because other, although less comfortable procedures exist to screen for colon cancer. (Note that the preparation for all three procedures is the same. One needs to take a laxative to clear the colon of stool so that colon polyps can be visualized).

The other is that CMS will be using guidelines from the US Preventive Services Task Force in basing decisions. USPSTF bases recommendations on scientific evidence and tends to be the most conservative of any organization, like the American Heart Association, American Cancer Society, and various physician organizations.

CMS left the door open for reconsideration of virtual colonoscopy in the future, which is reasonable. Certainly the technology may evolve where radiation exposure is minimal to justify exposing people of average risk to a modality that potentially could increase other forms of cancer.

Review my March entry - Virtual Colonoscopy - Just Say No.

The entire article from the Associated Press follows:

Tue May 12, 10:18 pm ET
WASHINGTON – Medicare won't pay for the so-called virtual colonoscopy procedure, concluding Tuesday that there's inadequate evidence to support the cheaper, less intrusive alternative to the dreaded colonoscopy.
Some experts had hoped that popularizing the X-ray procedure would boost screening for colon cancer, the country's second leading cancer killer. Screening to spot early cancer or precancerous growths has resulted in fewer deaths over the last two decades.
But in a decision posted on its Web site, the Centers for Medicare and Medicaid Services said that the test does not qualify for Medicare coverage. The memo noted that the procedure is performed on people without symptoms and cannot, in itself, rid a patient of precancerous growths, like a regular colonoscopy can.
Medicare does cover regular colonoscopies, in which a long, thin tube equipped with a small video camera is snaked through the large intestine to view the lining. Any growth can be removed during the procedure.
CT colonography, also known as virtual colonoscopy, is a super X-ray of the colon that is quicker, cheaper and easier on the patient, but involves radiation. Both procedures involve preparation to clean out the bowels.
The Medicare memo notes that the virtual colonoscopy has shown better precision in detecting larger polyps than smaller ones.
There's been some division of opinion in the medical community over the virtual colonoscopy. Some doctors question its utility since, if a polyp is found, a regular colonoscopy would typically have to follow, anyway.
Others support it, saying it can result in early cancer detection. The American Cancer Society recommends it as an alternative to a regular colonoscopy.
A concern for Medicare officials, according to their decision Tuesday, was the effectiveness of the procedure for the Medicare population — people 65 and older — as opposed to younger patients. More data is needed to answer that, Medicare said.
The U.S. Preventive Services Task Force opted last fall not to give its stamp of approval to the virtual colonoscopy, citing the risk of radiation among other factors. Medicare said it took that decision into account in reaching Tuesday's determination, which is final.
Some private insurers cover the virtual procedure but others don't. Colonoscopies cost up to $3,000 while the X-ray test costs $300 to $800.

Virtual Colonoscopy? Just Say No

The Center for Medicare and Medicaid Services -- CMS -- is asking for public input on whether virtual colonscopy - CT scanning of the colon -- should be a covered benefit in Medicare to screen for colon cancer.

In early 2008, the American Cancer Society (ACS) added virtual colonoscopy as well as stool DNA testing on its list of suggested screening methods for colon cancer. Screening for colon cancer is recommended for all adults 50 years and older. Besides these two options, the others are:

• fecal stool testing (FIT or FOBT) annually
• double contrast barium enema every 5 years
  
• flexible sigmoidoscopy every 5 years
• colonoscopy every 10 years

While I understand why ACS recommended adding virtual colonoscopy to its list, I don't agree with them. Although it is not as invasive as a sigmoidoscopy or colonscopy since patients lay on the CT scanner table while an x-ray technician works the machines to allow xrays to peer into the body, the colon preparation as well as the insufflation of air to distend the colon, is still required. Also, there is exposure of radiation which increasingly a question doctors are facing. Is doing a scan worth the risk of radiation exposure and potentially higher risk of cancer?

More importantly, if a colon polyp or growth is seen on the virtual colonoscopy, patients still need to have an invasive procedure - sigmoidoscopy / colonoscopy - to do a biopsy or removal of the lesion in question. At least these procedures don't involve any radiation as the instrument is essentially a fiber optic cable.

With the healthcare crisis upon us and the nation asking itself what is affordable and reasonable and what is not, CMS hopefully will not recommend virtual colonoscopy to be added to its list of covered benefits. While the technology is attractive, there are other proven screening tests that albeit uncomfortable are life-saving and don't subject people to unnecessary radiation.

Book Review - Critical: What We Can Do About the Health-Care Crisis

I had high hopes for this book. Except for the one innovative idea, the creation of a Federal Health Board, this was an average book compared to the many available which detail the challenges of our dysfunctional healthcare system far better. The book is an easy read, doesn't cover much in depth, but highlights all of the key points one needs to know to speak intelligently about the healthcare system (and presumably to be Secretary of Health and Human Services).

It is unclear whether creation of a Federal Health Board will be able to provide the impetus needed to make the American healthcare system higher quality, less costly, and more inclusive with universal coverage. One thing is clear from his book and that is Americans want a better healthcare system than currently exists. It won't be a pure single payer government run system. It won't be a free market private industry program. It will be a hybrid. What type of hybrid? Time will tell.

The book is divided into five parts. Part One details the healthcare system in crisis filled with individual anecdotes on how it has bankrupted, failed, and at times killed people without adequate insurance coverage or financial means to pay for care.

Part Two talks about the history of healthcare reform, which covers the beginning of the twentieth century. It highlights efforts by President Truman, Medicare and Medicaid legislation, as well as attempts in the 1970s, 1980s, and the early 1990s.

In Part Three, Daschle looks at why reform hasn't occurred. He begins to build his case for creating a new entity, a Federal Health Board, which is modeled after the Federal Reserve as well as the British National Institute for Health and Clinical Excellence (NICE).

Part Four he focuses in on how the Federal Health Board would be structured (a central board with several regional boards). As an independent body, it would recommend that only medications, treatments, and procedures backed by medical evidence and not by marketing be covered under government run insurance plans. It would also determine what criteria and benefits private insurers must offer to participate in expansion of the FEHBP (Federal Employees Health Benefits Plan). This new market would insure those unable to get employer-based or government run insurance programs currently.

Finally in Part Five, he makes the case on the likelihood for healthcare reform.

The best part of the book is Senator Daschle's perspective on the healthcare reform attempt by the Clinton administration, particularly how excitement and momentum moved the country towards reform only to see external events, special interest groups, as well as political missteps, caused it to die. Without a doubt, future leaders who hope to forward any healthcare reform package would best learn what not what to do.

Read my other healthcare / medical book reviews -
Overtreated -
How Doctors Think -
Medical Myths That Can Kill You
How To Save On Prescription Drugs

Where's the beef? Show me the money! Where's the evidence?

An excellent series by the NY Times, which is increasingly asking the right and hard questions about healthcare and its costs is in the column, the Evidence Gap. The most recent piece discusses the reimbursement by Medicare for prostate cancer using radiation treatment known as a CyberKnife. Although there is no evidence that is it any better than current therapies, whether you as a patient have the CyberKnife treatment covered is mainly based on where you live. Medicare doesn't reimburse for the procedure in California or Texas, even though it is a national plan.

Shocking? Hardly. These are the kinds of disparities that arise in our healthcare system everyday. Often the treatments aren't driven by science but by reimbursement.

When you get any treatment, ask your doctor, where's the proof that the treatment you offer is better than others? As the article implies, you may get a newer procedure not because it is necessarily better than others, but because someone, like Medicare will pay for it.

Kiss Healthcare Reform Good-Bye

I think we can safely kiss healthcare reform good-bye. We can thank the financial meltdown for this. With the most storied and large financial institutions like Lehman Brothers and Merrill Lynch folding as banks like Washington Mutual and Wachovia seek suitors like JP Morgan and Wells Fargo to bail them out, our economy has grinded to a halt. Banks don't want to lend money to businesses or consumers, even those with good credit, because they fear the borrowers won't return their money.

Homeowners have burned many banks by being unable to pay their adjustable rate mortgages and walking away from homes which are now worth far less than the loan amount. Certainly many of these homeowners were fooled into thinking they could purchase more than they could afford. Despite who was responsible for the mess, the reality is no one will lend money out which drives the economy.

To foster more lending and hopefully to improve trust between lenders and borrowers, Federal Reserve chairman Ben Bernake and Treasury Secretary Henry Paulson convinced Congress to give them authority to invest $700 to $800 billion to simulate the economy. The federal budget which ended September 30th resulted in a deficit of nearly $500 billion. Next year because of the action taken by the Treasury, the deficit will be far larger. With a predicted price tag of nearly $65 billion to implement Senator Obama's healthcare reform plan (note Senator McCain has not indicated the costs of his plan), it is highly unlikely that even with a presumably Democratic Congress that elected officials will agree to spend even more money despite the healthcare crisis.

The even bigger issue beyond reforming a poor performing healthcare system is what to do about the looming crisis in Medicare . With the first of baby boomers entering Medicare, benefit programs like Social Security and Medicare will dominate the federal budget. Both are underfunded with Medicare being worse of the two. Neither political party, Democratic or Republican, has dared attempted to make the gutsy and necessary changes to make these programs solvent.

What can you expect? Higher healthcare costs, more uninsured, and a general decline in the nation's health. A couple retiring this year must have about $300,000 available for future healthcare costs. With a stock market in freefall, it is clear people have less available than before. As a result they may unfortunately skimp on necessary preventive care and treatments. While decreasing their costs in the short-term, these choices will cause more expensive complicated problems down the road. The country will pay a price for this with a less healthy workforce or populace with increasing diability. In addition, individuals will discover what many have already which is the leading cause of personal bankruptcy is due to medical costs.

What can you do? Educate yourself. Find out how what medications are worth your money, what screening tests you must have, what you must do to stay healthy and well, and when to seek care and utilize the healthcare system. Our government doesn't have the financial resources or the leadership needed to truly overhaul our convoluted, frustrating, and fragmented healthcare system. This is one situation where only the informed and educated individual can make the difference between getting so-so care, which is the current state of affairs, and getting the right care which is what everyone deserves but increasingly will be unable to get.

Knowing How To Reform Healthcare Is Easy. Doing Is Hard.

Like most things in life there is a big difference between knowing and doing. Most of us know what to do to stay healthy. Don't smoke or quit smoking. Exercise regularly. Eat a diet balanced with all of the different food groups in reasonable portion sizes. Maintain a healthy weight. Get screened for various medical problems early. One study suggested that doing these simple interventions extended life by 14 years!

Yet despite these seemingly boring yet simple lifestyle changes, there obviously there is gap between knowing and doing. About two-thirds of Americans are either overweight or obese. This trend is now affecting children. We all know what to do, but often it is we don't go about doing it.

The same applies to healthcare reform. A recent editorial in the NY Times noted that the cost of providing high quality medical care varied substantially among hospitals. The least costly were the famed Mayo Clinic and the Cleveland Clinic. The most expensive? UCLA, John Hopkins, and Mass General. The reason was that doctors at the most costly hospitals were paid fee for service. Do more and get paid more. On the other hand, doctors at the Mayo Clinic were on a salary. Health outcomes were the same. If all hospitals performed at the level of Mayo Clinic, then Medicare would save billions.

At the same time an article on the Wall Street Journal blog noted that a congressional advisory committee recommended that Medicare should pay primary care doctors more and less to specialists because of a shortage of primary care doctors, which if unresolved will result in increasing healthcare costs and worsening outcomes. In other words, pay primary care doctors more but have specialists be reimbursed less for each procedure. What will happen? Specialists will do more procedures to maintain their standard of living.

If Mayo Clinic can attract doctors and patients to their system. If doctors are salaried and patients do as well at less cost, then doesn't it make sense to have doctors paid to think instead of simply doing procedures?

Medicare Restricts Reimbursement for Anemia - Better Patient Care?

A recent FDA advisory committee recommended that anemia medications, Procrit, Epogen, and Aranesp be not used in patients with breast cancer, head and neck cancers and used in patients with incurable cancers. These anemia medications are typically used to support cancer patients, who develop anemia, as a result of chemotherapy. This most recent FDA recommendation follows research studies which reported last year that these medications may have caused more deaths and contributed to tumor growth.

From the article:

• In its efforts to overturn Medicare's new reimbursement policy, Amgen Corp. spent more than $16 million on lobbying last year and nearly $700,000 on campaign contributions, according to the Center for Responsive Politics. Amgen manufactures all three of the anemia drugs involved — Aranesp, Epogen and Procrit. Johnson & Johnson markets Procrit.
• The aggressive lobbying campaign succeeded in generating numerous letters and speeches from lawmakers denouncing Medicare's actions and in legislation that would have voided the rule if passed.
• Many doctors and consumer groups joined in the criticism last year when Medicare made its decision to restrict when it would pay for treatments. Amgen and J&J argued again Thursday that the safety problems cited by FDA have been inconsistently reported across dozens of studies. And they pointed out that only studies involving higher-than-recommended dosing levels showed significant safety risks.
• The two drug companies have asked for more leeway from Medicare to reimburse doctors for maintaining hemoglobin levels up to 12. The Congressional Budget Office estimated that overturning CMS's decision could increase government spending by as much as $5.3 billion over the next decade.

What is fascinating isn't the science behind this, but the outcry from doctors, lawmakers, and the public when Medicare decided last year only to reimburse doctors if the medications were administered to patients with a hemoglobin of 10 or less (hemoglobin is a measure of the amount of red blood cells). A hemoglobin of 10 was derived from the research that suggested patients given these medications with higher hemoglobins did worse. Although the manufacturers argued that perhaps doctors were administering the medications at higher than recommended levels, doctors generally don't change practice behavior based on medication label warnings as quickly as they do when reimbursement is decreased or no longer covered.

Naturally everyone has a financial stake in seeing this ruling overturned. The pharmaceutical companies will see sales of their medications decrease as there are fewer indications (note their consumer-directed ads about these medications). Doctors will have their reimbursement decreased because they also will have fewer patients to give this medication to, even though the science suggests that many of these patients not only shouldn't get this medication but also that they could do harm. Patients, aligned with their doctors, will see this as a takeaway. Lawmakers, focused on getting re-elected would rather be seen on the side of their constituents, patients and doctors, and lobby against the FDA or Medicare as again taking a valuable benefit away.

Yet, when all is said and done, the heroes in the process, those that are protecting patients by altering doctors' behaviors to comply with the latest in research and those that are protecting the taxpayers by assuring that we are paying for the right care, are buried by massive lobbying and public relations campaigns. Perhaps this is why our healthcare system is in crisis because at the end of the day it isn't about the science, but about where the money goes.