House Call with Dr. Rothman

Let’s face it, there’s that kid in all of us who gets excited every time we hear of a new crisis coming down the pike. After you’ve been working in the same place with the same people for 20 years, it’s gotta be  a relief to finally have something exciting to talk about at the water cooler. In most cases of “pop crises” as I like to call them, there’s good money to be made—but only by a few select people. People like Orson Welles, who grabbed a ticket to fame after his scripted radio production of War of the Worlds sparked mass public panic—and eventually outrage (not to mention lawsuits) after a red-faced public realized they’d been duped.

Then you got the corporate executives in the bottled water, duct tape, and the freeze-dried food businesses who all bought themselves private jets—to fly back and forth to those private islands they all bought themselves after a champagne-drunk, red-faced public realized the whole Y2K doomsday deal was as much of a disaster as it was a disappointment. While this kind of stuff is fun to look back on as we point fingers at our friends for all the seemingly dumb “precautionary measures” they took in 1999, there is a more sinister side to some of the more recent crises that have come our way. And no, I’m not talking about rats breaking into your stash of freeze dried vegetables you’ve been keeping for the end of the world in 2012 (this time it’s real!)—those veggies are safe no matter where you store them.

What’s in a Name?

What I’m talking about is the latest buzz at the office water cooler: Swine Flu. Why they don’t just call it pig flu is beyond me. Maybe it’s because you just can’t cause a crisis with something called “pig flu.” At least not since the movie Babe.  It reminds me of another “pop crisis”—the one that was named “Avian flu.” You can’t get me to shudder at the thought of a sneezing chicken or a pig—but an avian or a swine? Nothing like science-talk to get us doing the pharmacy-walk.

But you know what really gets me worried, folks? It’s when the egg-heads come after us with all these fancy words for things that wouldn’t be as scary-sounding otherwise. And this time around, I’m seeing the same pattern all over again with swine flu. The latest warnings might all be for a good reason, or they might be overblown. In the end, I think reality is somewhere in the middle.  I’m not here to “take a side” or to make any specific recommendations. You’re not going to get

1.) an anti-government conspiracy theory rant

nor will you get

2.) a limited-time only deal, that if you schedule an office visit with me between now and the start of the flu epidemic, you’ll get 50% off your first visit plus a no-flu-death-guarantee or your money back

What I’m Here to Do

Honestly, if you’re worried about the flu, stick with your own doctor who ought to know you best. Your primary care doctor should know your health history and should be properly informed enough to give you a straight run-down of the risks and benefits of the flu vaccine so you, the patient, can make an informed decision about your health. I’m here to just help you to that end–arming yourself with the knowledge you need to make an informed decision with your doctor. As I said before, as much as we all enjoy making fun of past “crises,” this one has a darker side—one which exists on both sides of the debate. The take-home point is that there’s the potential for risk both with the flu vaccine and without the flu vaccine.

Follow the Money

In the interests of space, I’m going to assume you’ve heard the arguments in favor of getting the vaccine. What I want to do is clue you into the side of the news that is a little less exciting. Let’s face it, there’s no money to be made in NOT selling anti-viral drugs.  It’s also worth noting that the government has been stockpiling doses of those anti-virals at a cost of billions—doses that have either already expired or are set to expire soon.

In addition, the Department of Health and Human Services has already committed around $2 billion to pharmaceutical companies for the purchase of key ingredients in the manufacture of vaccines. I think we can all agree that preparation is always important. Let’s also assume that all top government officials, lawmakers, and pharmaceutical executives are all total saints, who’s interests are solely for the good of the people they serve. Sure, then I’d believe anything they’d say.

But let’s now at least bring the “powers that be” down to our level—people who have employees to pay, families to feed, and shareholders to please. They’ve all got to keep their jobs, and nobody keeps a job when they don’t help the company turn a profit. In much the same way, the government, while not a private corporation, is accountable to “we the people” who put them in office. If the people running the government want to keep running it, they can’t look like they’re wasting billions of dollars on preparing for a threat that really isn’t there, right? Maybe in times past, but not today, in the Age of the Town Hall! Nowadays the government has to show that they’re spending money only on important things, or they risk the wrath of angry mobs (all within the confines of the Town Hall meeting, of course). It’s in the government’s interest to encourage people to get vaccinated. Nobody’s going to fault the government for encouraging public safety and of course, the government wouldn’t mind getting its money’s worth for the vaccines.

In the face of all this money ready to change hands, can you see why the powers that stand to benefit from this money might not necessarily want to “make a big deal” out of the possible risks? Some of them probably genuinely believe they’re doing the public a service by presenting a serious scenario that pushes people out the door and into their doctor’s office to get vaccinated. Maybe in their own minds, any possible risks of the swine flu vaccines are just too low to matter in comparison to the horrors of the 1918 flu epidemic.

And I would agree. That flu affected about 500 million people (about the third of the world’s population), killing about 50 to 100 million. Scientist now speculate that many of those deaths were caused by strep throat, spread by the unsanitary conditions of World War I hospitals where people were kept in very close quarters. Strep throat was once a deadly outlaw, but that was before the good sheriff penicillin took the stage.

A Little Perspective

What if I told you there’s a disease caused by a virus, spread simply by coughing and sneezing, which has killed over 13,000 Americans just since January, kills on average 36,000 Americans a year, and kills 250,000 to half a million people every year worldwide. Worst of all, it’s incurable since there are no antibiotics effective against viruses. What if I told you about another virus, one that’s killed 688 Americans so far with over 4,100 worldwide. Which one would you guess is swine flu?

Actually, the first virus is the regular flu—the normal, “human” flu… the one we don’t blame some poor random farm animal for. The second set of statistics belongs to the apparently much more-dreaded swine flu. But in fact, the regular flu now kills on average more Americans per year than does AIDS! Now of course, any death is a tragedy. But in any medical decision, we have to weigh the possible benefits against the possible costs. With this vaccine, we have several factors that make it difficult to accurately estimate the possible costs. We know that the pharmaceutical companies have been given permission to “fast-track” the release of the vaccines, meaning that the vaccines will not undergo some of the more rigorous testing required of other vaccines, due to the immense time constraints placed on them by governments who are (rightfully so) planning ahead for a possible serious strain of swine flu. Whether or not that “serious strain” will actually ever materialize is something that’s very difficult to predict.

We also know that adjuvants may be added to the vaccines to make each dose more powerful, requiring only one per person. However, there remain questions about the possible side effects of these adjuvants, many containing the compound squalene, which may have links to neurological diseases later on. However, it’s difficult to establish a conclusive link, for reasons I will go into later.  In fact, on the website of one of the vaccine makers, GlaxoSmithKline, we have a warning:

The total population studied in clinical trials will be limited due to the need to provide the vaccine to governments as quickly as possible. Additional studies will therefore be required and conducted after the vaccine is made available.

It’s worth noting that the FDA actually very recently approved the swine flu vaccine from 4 vaccine makers. Since the news is so recent, it’s hard to know all the details, but it seems the vaccines they have approved not only work with just one dose, but do so without the use of adjuvants like squalene. While the FDA approval should be taken into account, the long term effects simply can’t be tested for without long term studies. I’ll get into some of the possible effects next.

The vaccine might still be safe for you and your loved ones. Again, it’s all about weighing what could be very good benefits against the risks—the probabilities of which we might not fully know due to the fact that this vaccine has not received the same level of testing as traditional flu vaccines.

As far as traditional flu vaccines go, I came across a study that tracked an estimated 747.1 million doses of the traditional flu vaccine in the US from 1990 to 2005. It found about 24.4 adverse events per million doses, with about 14% of those, or 3.4 per million, being classified as serious reports. In this classification, the Vaccine Adverse Event Reporting System used “serious” reports to include deaths, life-threatening events, hospitalizations, or prolongations of hospitalization, and persistent or significant disabilities. Guillain-Barr Syndrome (GBS), which I’ll describe later, was identified as the most frequently-occurring event among the serious reports, with a reporting rate of about 0.7 per million vaccinations. Another study showed a four-fold decrease in GBS within this time frame, from 1994-2003, lending support to the conclusion that the traditional flu vaccine may be getting safer.

It’s also worth noting that during the 1976 swine flu administration, the incidents of swine flu were a bit more than 1 in every 100,000. For all you math whizzes out there, yes, that is indeed still only 10 GBS cases per every million vaccinations. While that may still seem like a risk worth taking, when the numbers of people who died from the vaccine vs. those who died from the 1976 swine flu itself were tallied up, hindsight showed that maybe the ’76 flu vaccine had not been worth the risk. But I’m jumping the gun here—more about the 1976 swine flu vaccine later. The point is that while we can’t expect the government to be able to predict the future, we can at least expect to have the benefit of looking back over years of records and clinical tests to inform ourselves as best as we can about the risks of vaccinations. While we have plenty of that sort of retrospective evidence with the traditional flu, we can’t say the same about the newest version of the swine flu.

You’re probably already hearing through the media that due to the use of the adjuvants, only one dose will be needed to build up immunity to the virus. As I said before, the good news is that the tests of the swine flu vaccine so far has shown that one dose is all that’s needed to build up immunity—and those were the doses without any adjuvants. But some drug companies are still pushing for the inclusion of adjuvants into the swine flu vaccine and the government may consider it if it looks like we need to “stretch out” the remaining supply of doses. What you might also hear is that according to a recent study in the New England Journal of Medicine, about 45% of people given the test vaccine experience mild to moderate symptoms including nausea, headaches, and general general discomfort. While these are not much worse than a regular flu vaccine, the media will rarely go past that point. What I want to emphasize is that there’s still enough to hold the FDA back from fully licensing proposed adjuvants like squalene, as they are still in the testing phase. In fact, only one adjuvant (alum) has been approved for use in the U.S. in the last 80 years.

The use of adjuvants like squalene have been in use in Europe since 1997, with about a total of 40 million doses having been administered since then without any significant reporting of adverse auto-immune responses in people who received those vaccines. However, as the New York Times article reports, Dr. Fauci of the National Institute of Allergy and Infectious Diseases, said the adjuvant had been used mainly among the elderly, with less data on its use among children, younger adults and pregnant women. All of those groups may have immune responses which differ from those of the elderly.

So while there are definitely some positive signs as to the safety and efficacy of the flu vaccine, with and without the use of adjuvants, you’ll get plenty of that from the media. I’m just presenting some of it here so I don’t come across as one-sided. My goal is just to show you a little of what’s on the other side of the story, which may not receive as much media coverage.

Gulf War Syndrome

During the first Gulf War in 1991, about 41% of U.S soldiers were vaccinated with a squalene-containing Anthrax vaccine. Back then, the vaccine had not undergone the normal testing by the FDA. Since then, Gulf War veterans have reported experiencing a range of neurological symptoms—symptoms which have become so well-known and widespread among Gulf War vets that it’s got it’s own name: Gulf War Syndrome (GWS).  These symptoms include chronic fatigue, loss of muscle control, headaches, dizziness and loss of balance, memory problems, muscle and joint pain, indigestion, skin problems, shortness of breath, and even insulin resistance. In addition, brain cancer deaths, amyotrophic lateral sclerosis (also known as Lou Gehrig’s disease) and fibromyalgia are now recognized by the Defense and Veterans Affairs departments as potentially connected to service during the Persian Gulf War.

Some possible causes include exposure to nerve gas medications, pesticides, chemical weapons. However, the anthrax vaccine remains in focus, especially in light of the fact that it has been found that the Pentagon never told Congress about 20,000 hospitalizations involving U.S. troops who were administered the anthrax vaccine from 1998-2000. Furthermore, in 2004, a U.S. federal judge found sufficient reason to believe the vaccine was harmful, ordering the Pentagon to stop administering the vaccine. The ban was eventually lifted and the vaccine finally gained FDA approval, although it’s worth noting that the FDA-approved vaccine of today is not the same formulation as the one possibly linked to the range of GWS symptoms.

Who’s Immunity Are We Talking About?

In just about every aspect of life, from the times we spill hot coffee on our laps to when our $54 million pair of pants goes missing, we’ve always known we could rely on the power of the almighty gavel. Lawsuits, as frivolous as they might sometimes seem, still serve as a tool for some people. In times when we suffer damages through no fault of our own, lawsuits are a way to make sure we have legal recourse for compensation. Such was the case in 1976, when a vaccine was developed for a different strainof swine flu. That year, 25 people died from respiratory paralysis following vaccination, while in comparison,  one person died from the swine flu itself.  Guillain-Barre Syndrome (GBS) was the disease blamed for the deaths, as it attacks the lining of the nerves, and may lead to paralysis and inability to breathe, which may eventually result in death. After 10 weeks and more than 500 diagnosed cases of GBS, the vaccine was pulled from mass public administration and the U.S. government paid out millions of dollars in compensation. 20/20 hindsight came too late for the 25 people who had died, but just in time for the lawyers.

That was a rather expensive and tragic mistake for the government and one which they didn’t want to make again. The thing to do would be to spend the time and money for the necessary testing beforehand, and if there’s not enough time to all that, at least make sure the public is well informed about both sides of the vaccine argument.

Instead, what’s actually happened is the Department of Health and Human Services (DHHS) has granted immunity from liability for makers of flu vaccines and drugs—that is, unless the plaintiff can prove clear evidence of willful misconduct that resulted in death of serious physical injury—and even then only with permission to sue from the DHHS secretary. How is this possible? Well in 2006, when the government was confronted with the potential epidemic of avian flu, which at that time had a death rate of about 70% (much higher than the swine flu’s current death rate of about 0.6%) it saw necessary to protect vaccine makers from the threat of lawsuits, especially since the vaccines had to be made quickly.

I’d agree that when the potential benefits so far outweigh the costs, it’s probably a good idea to do what needs to be done to be prepared for a worst-case scenario. However, the fact that this law is applying now, for a seemingly much-different scenario, is something to wonder about. It’s worth noting that viruses can become stronger over time, but we have yet to see anything even close to resembling that with the current swine flu.

It’s important to know that there’s no established link between squalene, other elements of the vaccine (such as mercury), and neurological diseases like GBS. There are theories that simply having the flu itself can cause GBS. And it’s true that the vaccine itself can cause the flu, since it contains live viruses in a weakened form.

The (Long-Awaited) Wrap-Up

So for those of you just tuning in (or just waking up with drool on your keyboard) I haven’t given you a whole lot to go screaming down the street with. The sky is not falling, although space junk might be. Here’s what I went over:

• crises sprout up all the time, and more often than not, they aren’t anything to worry about. Of course, it’s always good to be prepared

• swine flu may or may not be the next big crisis. So far, for it to reach “crisis level,” it’s got to at least overtake the regular flu in terms of deaths. And so far, it’s a far cry away from being as deadly as the regular, seasonal flu

• there’s lot’s of money to be made by drug companies who make swine flu vaccine and by the media, which loves a good story. Just like you. And me. And everyone else, whether or not they have an actual, functioning, water cooler in their place of work. And that’s the point.

• the mortality rate of swine flu, both in America and abroad, so far pale in comparison to the mortality rate for the seasonal flu. So if you’ve never felt the need to get vaccinated against the seasonal flu every year, I would worry about swine flu even less

• the FDA has very recently approved the swine flu vaccine. That’s good news, especially since the swine flu is made using a process similar to that of the seasonal flu, which studies have shown to have relatively minimal risks. Again, it’s all a matter of how you see those risks as compared to the risk of getting the flu—seasonal or swine.

• due to the wide-range of side effects that have been blamed on the vaccine, and how long they sometimes take to develop, it’s difficult to trace any of the sided effects back to the vaccine and draw any solid conclusions

• and in the event any strong conclusions ever can be drawn, vaccine makers have some pretty strong protection from lawsuits

Bottom line, there are risks and benefits to any medically-related decision, from choosing a food to eat to choosing what kind of a new nose you want to wake up with. How any decision will affect you will always depend on your unique body chemistry and the condition of your present health. As always, it’s helpful to do your own research beforehand. You might want to start with the links that I’ve inserted throughout the article. Sure, you can’t trust everything on the internet, but you can at least start there and come up with questions for your doctor. Your doctor, combining their knowledge of the complexities of the vaccine issue, along with their knowledge of your unique medical needs and issues, is the best person to work with you on coming to a decision.

As always, leave your questions and comments below, especially any requests for future articles!

Now for some freeze-dried steak. Hope it still tastes this good by the time December 21, 2012 comes along.