The H1N1 Flu Vaccine: Who Should Get It?

In April I co-authored, Swine Flu Vs. Soap:  Our bet’s on the soap! with pediatrician, Dr. Gwenn O’Keefe, founder of Pediatricsnow.  We gave a brief overview about the swine flu H1N1 and discussed preventative measures.

While the information remains the same in our post, I’d like to now add a little info about the the H1N1 flu vaccine.

Health information about H1N1 is circulating the web faster than tweets zip through cyberspace and it can be very confusing.

It’s like you’re stuck in a maze and you don’t know which way to go to get out.  Information about the swine flu is circulating so quickly that it can even be frightening.  It’s really important that you don’t panic.

Gather your information and talk with you doctors and nurses.

Information about the H1N1 flu vaccine

Many people are wondering about the H1N1 vaccine.  They are wondering if they need to get the H1N1 vaccine, and if there are any side effects.

The Centers for Disease Control (CDC) offers very helpful information, and here are the recommendations from the CDC for the group of people who should get the H1N1 vaccine and those who shouldn’t.

Who should get the H1N1 flu vaccine

• Pregnant women
• Household contacts and caregivers for children younger than 6 months of age
• Healthcare and emergency medical services personnel
• All people from 6 months through 24 years of age
• Persons aged 25 through 64 years who have health conditions associated with higher risk of medical complications from influenza.

While a shortage of the H1N1 vaccine isn’t expected, availability and demand can be unpredictable.  So here’s the CDC recommendation for who gets the H1N1 vaccine first.

Who Gets the H1N1 Vaccine First

• pregnant women
• people who live with or care for children younger than 6 months of age
• health care and emergency medical services personnel with direct patient contact
• children 6 months through 4 years of age
• children 5 through 18 years of age who have chronic medical conditions

People who should NOT receive the vaccine the H1N1 flu vaccine

People who have a severe (life-threatening) allergy to chicken eggs or to any other substance in the vaccine should not be vaccinated.

H1N1 Flu Vaccine Safety – Is the H1N1 flu vaccine safe?

The CDC expects that the H1N1 flu vaccine’s safety will be comparable to the seasonal flu vaccine.

What are the side effects from the H1N1 flu vaccine?

According to the CDC the side effects following the flu vaccine are mild and they include soreness, redness, tenderness or swelling where the shot was given, fainting (mainly adolescents), headache, muscle aches, fever, and nausea.

If any of these side effects occur, they usually occur right after the shot was given and last 1-2 days.

It is rare that there are any life-threatening allergic reactions to vaccine, but if they do occur, it is usually within a few minutes to a few hours after the shot is given.

“The Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) will be closely monitoring for any signs that the vaccine is causing unexpected adverse events and we will work with state and local health officials to investigate any unusual events.”

After you receive the H1N1 flu vaccine – important information

“After vaccination you should look for any unusual condition, such as a high fever or behavior changes. Signs of a serious allergic reaction can include difficulty breathing, hoarseness or wheezing, swelling around the eyes or lips, hives, paleness, weakness, a fast heart beat or dizziness. If any unusual condition occurs following vaccination, seek medical attention right away. Tell your doctor what happened, the date and time it happened, and when the vaccination was given. Ask your doctor, nurse, or health department to report the reaction by filing a Vaccine Adverse Event Reporting System (VAERS) form. Or you can file this report yourself through the VAERS Web site at www.vaers.hhs.gov. You may call 1-800-822-7967 to receive a copy of the VAERS form. VAERS is not able to provide medical advice.”

[The novel H1N1 vaccine is not intended to replace the seasonal flu vaccine. It is intended to be used alongside seasonal flu vaccine to protect people.  Seasonal flu and novel H1N1 vaccines may be administered on the same day].

For more info talk to your doctors and nurses and for further information from the CDC, you can check their website.

*This blog post was originally published at Health in 30*

Making Health Care Affordable From The Bottom Up

Health care’s most important problem (and repeat ad nauseam) is the cost. How do we make health care affordable, cost less, and not inflate three times faster than the background economy?  While politicians and insurance companies rant and rave about saving health care from the top down, there is a nascent movement of doctors who are approaching the same puzzle from the bottom up.

What I mean by the bottom up is that doctors and patients are working together to build an independent system whereby they solve the typical day-to-day, or primary care, problems of health care without anyone else’s help or permission. From the bottom up also means that patients expect to be in control of their day-to-day care. This means paying for the service directly, which is the only real way to gain control. It means doctors are employed by the client, have transparent pricing, look the patient in the eye to explain the charge, and are better able to justify the cost. For the bottom-up means competition and a drive towards quality improvement and pricing that will cost a lot less than having ten people between you and getting what you need.

Here’s a simple example. You have a bladder infection. You had these exact symptoms a year ago so you know what’s wrong and what you need. Yet you’re held hostage by the health care “system” and are unable to get the medicine that has worked in the past.  You’re not alone: these type of infections account for 8.3 million doctors visits a year, primarily among women of reproductive age.

Here are three potential ways that this common problem could be handled:

1. The Existing Model: Your symptoms of burning and frequent urination coupled with barely being able to leave the bathroom are funneled though the appropriate gauntlet: receptionist, scheduler, in window, nurse, doctor, out window, billing specialist, insurance company, payment administrator, adjustor, and finally paperwork mailed to you acknowledging  payment.  Along the way you’re likely to get a urinalysis and several urine cultures.

Since you’re not paying for these tests, under insurance you don’t mind and consider this “good care.”  Your co-pay is $20. The insurance company pays $60 for the visit and the lab tests add another $30. You’re given three days of antibiotics and the problem’s resolved. The cost is $110.00 and 5 hours of your time assuming no major delays in getting into the office.

2. The Reformed Model: This would look very similar to the above system, but might include layers of oversight, fraud detection, pay-for-performance measurers, and “quality” assessment reviews, if one is to believe the rhetoric of people talking about “fixing” health care. Universal coverage likely will delay the wait time to be seen. The current delay for seeing a family practice physician in Massachusetts (the closest thing we have to Universal Coverage) is 63 days.

It’s difficult to believe that this added oversight can reduce costs but let’s pretend it pays for itself  by eliminating the unnecessary labs that evidence based standards repeatedly say provide no added benefit to outcome for simple bladder infections. Cost: at minimum $110.00 and your time: at least 5 hours for a three day treatment of antibiotics.

3. The Bottom-Up Model: Patient calls her doctor who answers the phone and listens to the story. This diagnosis repetitively has been shown to be most accurately diagnosed through history alone. Exam without other contributing factors is not helpful. Urine and cultures are not more sensitive or specific than the history.  The antibiotics are called to the pharmacy. Because you and your doctor know each other and work together to get you the best health care at the best price … and you care about the price …  your doctor might say “By the way I’ll call in a ten-day supply of antibiotics so you can keep a reserve treatment in the future whenever you get this again. This would give you two additional treatments in the future.

Before the conversation with your doctor, he sends you a follow-up email offering an overview of the diagnosis and complications when you should contact him. Cost: $45. Time from call until taking the first pill:  1 hour.

Do the math. Eight million cases times $110.00/ UTI infection case/year. Don’t forget the human toll of  40 million human hours/year wasted in the funnel (link).  The lawyers will want to add a value for pain and suffering too.

Compare this to a direct pay system — innovation wave one from the bottom-up, where you can reach your doctor day or night or even a weekend, take your dose of a prescription within an hour of calling, and have a reserve treatment for the future when inevitably you get the infection again. Imagine being treated like an adult. Frankly, $45 for the convenience is a steal compared to what’s being subsidized now.

Not all cases of bladder infection are cured through this simple formula, but seeing them in the office doesn’t reduce this chance either.  Conservatively, more than half of the cases could be done this way, meaning hundreds of millions of dollars saved  each year on this diagnosis alone. Don’t forget the guesstimated 20 million hours of lost productivity, plus the lost opportunities of railing about how someone else should “fix my health care.”

Going forward, we’ll see what the bottom up has to say about upper respiratory illness, poison ivy, low back pain or tick bites.

Until next week, I remain yours in bottoms-up primary care,

Alan Dappen MD

Management speak strikes again

Des Spence, a general practitioner in Glasgow, has revealed a memorandum that was allegedly leaked from the Department of Health. It was published in the Britsh Medical Journal (17 June 2009, doi:10.1136/bmj.b2466, BMJ 2009;338:b2466). It seemed to me to deserve wider publicity, so with the author’s permission, I reproduce it here. It may also provide a suitable introduction to a forthcoming analysis of a staff survey.

Spence added a footnote, Note: The BMJ’s lawyers have insisted that I make it clear that this is a spoof, just in case you were wondering.

Here are a few more

Follow-up

The General Chiropractic Council (GCC) wants to waive the rules

A flood of complaints against chiropractors has arrived at the General Chiropractic Council (GCC) in the wake of the British Chiropractic Association (BCA) v Singh affair. It is really rather beautiful that people have put some such enormous effort into writing complaints for no gain to themselves.

My own paltry two complaints to the GCC produced an interesting reaction. Yesterday I was told by the GCC

“Under the provisions of the General Chiropractic Council (Investigating Committee) Rules

2000 (”the Rules”), the Committee is required to invite you to make a statement of evidence in relation to your complaint by way of statutory declaration or affidavit. If you wish to, you can discuss your complaint with a solicitor who acts on behalf of the Committee who could help you draft a statement of evidence that meets the requirements of the Rules. The General Chiropractic Council will pay for the Investigating Committee solicitor’s costs and will reimburse you for any fee you subsequently pay for having your witness statement sworn at a location convenient to you.”

Naturally I shall take up this offer. If the same offer is made to everyone who complained (must be approaching 600), the legal fees incurred by the GCC would presumably be enough to bankrupt them. No wonder they are wriggling.

Here is a letter sent by the GCC’s Chief Executive and Registrar, Margaret Coats, a couple of days ago. It reached me by more than one route, but it is already on the web anyway, on Richard Lanigan’s site, Told you the General Chiropractic Council would find a way to dismiss the complaints. “Protecting the public” my arse! Protecting themselves more like it.. (The GCC has been under attack from within for some time, though mainly because some chiropractors think it regulates too much, not too little)

Download the whole letter.

The bit that is especially interesting is para 2

In quangos like the GCC, complaints don’t necessarily get considered at all. First they go to an investigating committee (IC) which has to decide if there is a ‘case to answer’. Now the GCC wants that criterion to be changed to ‘realistic prospect of success’. Given the GCC’s attitude to evidence it is hard to imagine that any complaint will have a ‘realistic prospect of success’.

The second idea is even more grotesque. The GCC want to be able to dismiss without consideration rafts of complaints where in their opinion, referral to the Professional Conduct Committee (PCC) ‘is not required in the public interest. Or, more likely, not required in the interests of the GCC.

Will the Privy Council acquiesce in this disgraceful attempt to evade complaints? Wel, until January 2008, Graham Donald was a senior civil Servant at the Privy Council bit he now works for the GCC. That must help.

The GCC has been contacted by several Trading Standards Offices too, after complaints made to them about chiropractors. . A response was sent by the GCC on 5 June [download the whole response]. It includes

“It is important to emphasise that the GCC doesn’t claim that chiropractors ‘treat’ asthma, headaches (including migraine) and infant colic. It is possible that chiropractic care may help to alleviate the symptoms of some of these conditions.”

What on earth is that meant to mean?

One hopes that Trading Standards officers are too smart to be taken in by weasel words like that.

The attitude of the GCC to evidence is amply illustrated by the fact that they have said that the rather crude myths known as craniosacral therapy and applied kinesiology fall within their definition of evidence-based care.

Any organisation that can say that is clearly incompetent.

Follow-up

Peter Dixon, chair of the General Chiropractic Council, seems to be a bit careless about evidence

Jump to follow-up

Peter Dixon is a chiropractor. He is chair of the General Chiropractic Council (GCC). He was also a member of the hotly-disputed NICE low back pain guidance group that endorsed (you guessed it) the use of chiropractic, a decision that has led to enormous criticism of the standards of the National Institute of health and Clinical Excellence (NICE).

As a consequence largely of the decision of the British Chiropractic Association (BCA) to sue Simon Singh for defamation, there has been an unprecedented interest taken in the claims made by chiropractors in general.

Peter Dixon has a problem because something like 600 individual complaints about unjustified health claims have been sent to the GCC. Even when a web site does not claim to be able to benefit things like asthma and colic, a phone call may reveal that claims are made in private (one of the many complaints to the GCC concerns such behaviour by two practices belonging to, ahem, Peter Dixon Associates).

The crucial question is, as always, one of evidence. The BCA claim to have a plethora of evidence for their claims, but they have been strangely reluctant to produce it. In fact evidence is cited on the “Your first visit” page on Dixon’s site.

At the bottom we see “How effective is Chiropractic?”.

That sounds very impressive indeed: . ” . . . patients who received chiropractic treatment improved by 70% more than those given hospital out-patient.”

But hang on. If we look at the paper, Meade et al., 1990 [download reprint], we see that Figure 2 looks like this.

Several things jump out. First, the Oswestry disability index scale runs for 0 to 100, but scores are plotted only from 0 to 35, so the size of the effects are exaggerated. Second, there are no error bars on the points. Third there is essentially no advantage for chiropractic at all when all patients are taken together (top graph). Fourth, and most important, the patients who were followed up for two years (bottom graph) seem to show a slight advantage for chiropractic but on average, the effect is 7 percent (on the 100 point scale, NOT 70 percent as claimed on the web site of Peter Dixon Associates.

What sort of mistake was made?

The abstract of the paper itself says “A benefit of about 7% points on the Oswestry scale was seen at two years.” How did this become “improved by 70% more”?

It could have been simple a typographical error, but than seems unlikely, Who’d boast about a 7% improvement?

Perhaps it is a question of relative versus absolute change. The Figure does not show the actual scores on the 100 point scale, but rather the change in score, relative to a questionnaire given just before starting treatment. If we look at the lower part of the Figure, restricted to those patients who stayed with the trail for 2 years (by this time 28% of the patients had dropped out), we see that there is a reduction in score (improvement) of about 10 points on the 100 point scale with hospital treatment (not a very impressive response). The improvement with those sent to private chiropractic clinics was about seven points bigger. So a change from 10 to 17 is a 70 percent change. What’s wrong with that?

What’s wrong is that it is highly misleading, as relative changes often are. Imagine that the hospital number had been 7 points and the chiropractic number had been 14 (both out of 100). That would mean that both treatments had provided very modest benefits to the patients. Would it then be fair to describe the chiropractic patients as have improved by 100 percent more than the hospital patients, when in fact neither got much benefit? Of course it would not. To present the results in this way would be highly deceptive.

Put another way, a 70% increase in a trivial effect is still pretty trivial.

That isn’t all either. The paper has been analysed in some detail on the ebm-first site. The seven point difference on a 100 point scale, though it may be real, is too small to be ‘clinically significant’ In other words the patient would scarcely notice such a small change. Another problem lies in the nature of the comparison. Patients were, quite properly, allocated at random to chiropractic or to to hospital treatment. BUT the comparion was very from blind. one group was treated in hospital. The other group was sent to private chiropractic clinics. The trivial 7 point difference could easily be as much to do with the thickness of the carpets rather than any effect of spinal manipulation.

What this paper really tells you is that neither treatment is very effective and that there is little to choose between them.

It is really most unfortunate that the chairman of the GCC should show himself to be so careless about evidence at a time when the evidence for the claims of chiropractors is under inspection as never before. It does not add to their case for criticising Simon Singh and it does not add to one’s confidence in the judgement of the NICE guidance group.

Follow-up

The Pain Society revolt. A letter has been sent from several distinguished members of the British Pain Society to its President and Council.

“We, the undersigned, call upon the President of the British Pain Society to issue a statement to NICE and to the press condemning outright the conclusions of the recent UK National Institute for Health and Clinical Excellence (NICE) guidelines . . .”

The sigificance of this letter is that the present president of the British Pain Society is Professor Paul Watson who was a member of the NICE guidance group that produced the recommendations which have engendered such criticism. He was clinical advisor to the guidance group. There is a video of Paul Watson talking about back pain, that seems to me to illustrate very well the problem with the guidance. He says it is a huge problem (everyone knows that) and that something must be done, but he doesn’t say what. There is no admission that, in very many cases, nobody knows what to do. It is exactly this sort of hubris that that makes the NICE report so bad,

One caustic comment on the letter says

“We are led by a physiotherapist! A Professor who cannot even interpret straight forward evidence when it is presented to him on a plate.
Who’s going to be the next BPS President? A Hospital Porter?”