I posted last year about all the trouble Pfizer got into by using Robert Jarvik, the developer of the artificial heart, as their spokesman for the most commonly prescribed statin drug Lipitor.  Pfizer has taken a new tack and is now bombarding the airwaves with yet another commercial for Lipitor using as their spokesman an actual victim of a heart attack.

They chose a 58 year old California ad man and talent agent named John Erlendson who did indeed have a heart attack at age 57, and who was not taking any cholesterol-lowering medicines prior to that.  As opposed to the Gollum-like Jarvik, Mr. Erlendson comes across as a sincere guy who is genuinely distraught over his medical condition.  He is easy to empathize with.

Pfizer spent $181 million advertising Lipitor last year, and if the frequency with which they are running their new ad is any indication, I’m sure they are not pinching pennies with their ad budget now. It’s difficult to have a television on for half an hour and not see Mr. Erlendson at least once.  But, hey, what’s a measly $181 million when you’ve got sales of $12.7 billion?  I’ll take that deal any day.

This recent ad is a prime example of how viewers are manipulated by clever ad people.  You’ve got to be able to interpret the ads just like you do the medical literature.  I want to walk through this ad with you, but first, just take a minute and watch it.

Click here to view the embedded video.

Makes you want to run out and grab some Lipitor quick, doesn’t it.  You don’t want John Erlendson’s fate to befall you, and based on his oozing sincerity, neither does he.

You know how the ad makes you feel.  Now let’s look at it line by line to see what it really says.

Mr. Erlendson looks out from the screen and says:

Talk about a wake up call.  I had a heart attack at 57.

Okay.  I’ll buy that.  It would be a wake up call.

My doctor told me I should have been doing more for my high cholesterol.

As it turns out, Mr. Erlendson did have high cholesterol before his heart attack, and his doctor probably did warn him about it. (Of course, 50 percent of people who have heart attacks have normal or low cholesterol, so his being high is not the danger sign so many think it is.)

What was I thinking?

What indeed?

But now I trust my heart to Lipitor.

There are several implications in the above dialogue that we all accept subconsciously.  First, that high cholesterol was the cause of this man’s heart attack.  Second, that had he taken Lipitor he would have prevented his heart attack.  And third that you, the viewer, can protect yourself against Mr. Erlendson’s fate if only you take Lipitor before it’s too late.

Notice how cleverly they got this message across without actually saying it?  That can’t make the claim that high cholesterol causes heart disease because, although the vast majority of people seem to believe it, that relationship has never been proven.  Pfizer would have had the FDA all over them had they tried to actually make the claim that Lipitor would have prevented Mr. E’s heart attack because they have no way of knowing that.  Based on the randomized clinical trials for statins, Mr. Erlendson was not in a high risk group, so there is no evidence that a statin drug would have done him any good whatsoever.  And the FDA would never have allowed Pfizer to actually say anything remotely like: Take Lipitor and protect yourself from Mr. E’s fate.  But, because of how cleverly this ad was written, this all comes across without it being said, so the FDA can’t lay a glove on them.

Next in the commercial, Mr. Erlendson carries on in the background and the announcer comes on in a voice over.

When diet and exercise are not enough, adding Lipitor may help.

Really?  Rubbing Vick’s Vapor Rub on your chest ‘may’ help too.  ‘May’ is a real weasel word that ad people use all the time.  They say ‘may,’ the listener hears ‘will.’

Interestingly, during the voice over part of the commercial Mr. Erlendson can be seen in the background riding a bike, which implies that he probably was exercising yet still had his heart attack. Or it implies that now that he’s on Lipitor, his life has changed for the better.  I can’t figure out which.

The voice over continues:

Unlike some other cholesterol-lowering medications, Lipitor is FDA approved to reduce the risk of heart attack, stroke and certain kinds of heart surgeries if you have several common risk factors for heart disease.

There is an entire daisy chain of weasel words.  The ad doesn’t say that Lipitor will reduce the number of heart attacks, stroke, etc., it says that it will reduce the risk IF you have several common risk factors.  No one knows what causes heart disease, so no one really knows what the risk factors are.  So we’ll take a bunch of what we think are risk factors, put them in tiny print at the bottom of the ad, and tell you that Lipitor reduces these risk factors.

Here is my favorite.

Lipitor has been extensively studied with over 16 years of research.

Yes, but has this 16 years of research shown anything worthwhile?  It has shown that Lipitor and other statin drugs don’t reduce all-cause mortality (the statistic you should really care about) in women of any age, in men over 65 and in men under 65 with no history of heart disease.  Only in men under 65 who have actually had a heart attack have statins shown any benefit in reducing all-cause mortality.  And even that is minimal.  Mr. Erlendson falls into this last group, so he is one of the few people who may actually get some benefit from a statin.  But he didn’t fall into this group before his heart attack because he had no history of heart disease before his heart attack.  High cholesterol is a lab finding, not a history of heart disease.  In sum, the 16 years of Lipitor research have been pretty fruitless.  But that’s not the message you take away from this ad.

Then the voice over drones quickly through all the problems that one can experience with Lipitor.  Then it’s back to Mr. Erlendson.

I learned the hard way, but you may be able to do something.

There is our friendly weasel word ‘may’ yet again.  Implies, once more, that Lipitor will save your butt.

Then back to the voice over.

Have a heart to heart with your doctor about your risk and about Lipitor.

Okay, so the next time you go to your doctor, you inquire about your cholesterol and ask if Lipitor would work for you.  After all, you don’t want to learn the hard way like John Erlendson, do you?  Your doctor, being brainwashed as they almost all are, gives you a prescription for Lipitor because, hey, why not, it’s so good they’re talking about putting it in the drinking water.

You go away with a $150 a month drug habit that does you no good whatsoever.

The creative people at Pfizer have put together an ad that says nothing, but implies everything.  They stay out of hot water with all the regulatory agencies, yet the viewer takes away the exact message that the advertiser could never get by with saying explicitly.  Is it any wonder that half the country is on a statin?  Ain’t Madison Avenue grand?

And, by the way, you, too, can be in a Lipitor ad.  Click here to find out how.

In my mailbox today (click to enlarge)

If you don’t think high-fructose corn syrup is taking an economic hit, read on.

I went to the mailbox today and retrieved a package from the Corn Refiners Association (CRA), the lobbying group for high-fructose corn syrup (HFCS).  It was addressed to me in the same style that all my medical junk mail comes in, so I assume the above group bought a mailing list of primary care physicians from the American Medical Association, which sells such lists.  I tore open the large envelope and looked at the contents, which are all pictured above.  Having done a number of mailings in my lifetime, I’ve got a pretty good handle on what such a mailing costs.  I would reckon that in the volume they purchased, these pieces probably set them back at least a couple of bucks apiece.  Add the postage and the list rental and your probably looking at a couple of million dollars, if not more, to send this thing out to all the primary care docs in the country.

Inside this packet was a load of propaganda about the virtues of HFCS.  And buried in one of the pages was the following statement that was the dead give away as to why this advertising surge:

Consumption of high fructose corn syrup has been dropping in recent years…

Which lets us know why the CRA has also made a couple of TV commercials that have played around the country and are being sent around virally as well.  In case you haven’t seen them, these are presented below.

Click here to view the embedded video.

Click here to view the embedded video.

The main thrust of the ad package sent to me and these video commercials is that HFCS isn’t really any different than sugar.  And, as long as it’s used in moderation, it’s no more harmful than sugar.  Which, of course, is faint praise at best.  But is it true?

Here, for what it’s worth, is my take on the HFCS issue.

There are basically three versions of HFCS: one containing 42% fructose, another containing 55% fructose and one containing 90% fructose.  The most commonly used by far is the second, the one with 55% fructose.  Since sucrose (table sugar) is 50% fructose and 50% glucose, there really isn’t much difference, and most of the studies seem to bear that out.

There is one distinction between sucrose and HFCS, but in the studies I’ve seen, it doesn’t seem to make a big difference.  Sucrose is a disaccharide.  In other words, it is a molecule made of a molecule of fructose hooked to a molecule of glucose.  HFCS is a mix of monosaccharides (single sugar molecules): it has free fructose and free glucose.  You would think that the fructose would absorb better as a monosaccharide since it doesn’t have to be cleaved away from a glucose molecule first.  But, as I say, the majority of studies don’t seem to show any difference between the two in terms of blood sugar levels or metabolic effects.

There are a couple of things that I think are pernicious about HFCS.  First, it is a vastly superior food additive as compared to sucrose above and beyond its sweetening power.  It doesn’t crystallize, it mixes better, it provides more moisture, etc.  And, in this country at least (thanks to subsidies for corn and price supports for sucrose), it is much cheaper to use.  Consequently, HFCS finds its way into many products that contained no sweeteners before the advent of HCFS.  So, since it’s development, we are eating more sweeteners overall because HFCS is in so many things.  Second, the extra grams of fructose (as compared to glucose) don’t really matter all that much in people who don’t eat a lot of sweeteners, but it starts to add up as the sweet content of the diet goes up.

The last statistics I saw showed that the sweetener content of the average American diet was about 22 percent of calories.   If you consider that the average caloric intake is about 2500 kcal, then you can figure that represents roughly 140 grams of sugar per day, which calculates to 70 grams of fructose and 70 grams of glucose if all the sweetener is sucrose or table sugar (which is what it was pre HFCS).  Now, with about 70 percent of the sweetener coming from HFCS, these figures change.  Now the the 55/45 fructose/glucose ratio of HFCS comes into play, and the fructose goes from 70 grams to 75 grams per day – an extra 5 gm.  Does this matter?  Who knows?  But probably not.  However, since I eat no sweeteners throughout the day, someone else has to eat double to keep the averages the same.  And doubling all these figures gives an extra 10 grams of fructose per day.  And if you figure overall sweetener intake has gone up since the advent of HFCS (which it has), then the heavy sweetener users are probably eating an extra 20-30 grams of fructose per day as compared to what they would have eaten 30 years ago.  I suspect an extra 20-30 grams does make a difference.

If kids sit around MacDonald’s and slurp down a couple of Hugos, they could be getting an extra 10 or so grams of fructose right there, which is more than is found in a Paleo kind of diet in a day.  And that’s just the extra fructose as compared to the Hugo being made with sugar instead of HFCS.  It doesn’t count the 102 grams or so of fructose that would be the same if the drink were made with sugar.

Is it any wonder obesity is skyrocketing among teenagers?  As I’ve written in this blog often, I spent a lot of time at MacDonald’s during my teenage years from when I was a Junior in high school on.  But each drink I bought – there was only one size then, and it was tiny compared to the giant drinks of today – cost me an amount that was much higher in today’s dollars than it costs for one of the huge sodas available now.  And I got only one for that amount.  I couldn’t go back for refills.  Unlimited refills are a consequence of the substantially lower price of HFCS as compared to sugar.  Had I had access to unlimited refills, I wouldn’t have done any different than the kids today – I would have drunk one after another.  But I was limited by my pocketbook.

Just to add a little comedy relief to this dreary story of the advertising jihad of the Corn Refiners Association, here is a YouTube parody of the HFCS commercials.

Click here to view the embedded video.

Despite the fact that statin drugs are the best-selling medications in history, accounting for some $40 billion plus in sales world wide last year, they had a very bad week this past week. And it looks like their scrutiny is going to pick up a little.

The Vytorin trial that finally came to light late last week kicked off the cascade of bad news. It appears that the combination of a statin and Zetia, despite lowering cholesterol levels by 40 percent more than a statin, was no more effective than the statin alone in preventing problems. Which would lead anyone with critical thinking skills to wonder about the hypothesis that LDL-cholesterol is really a problem.

The next day the New York Times, in an article that wasn’t all that anti-statin, started thusly:

For decades, the theory that lowering cholesterol is always beneficial has been a core principle of cardiology. It has been accepted by doctors and used by drug makers to win quick approval for new medicines to reduce cholesterol.

But now some prominent cardiologists say the results of two recent clinical trials have raised serious questions about that theory — and the value of two widely used cholesterol-lowering medicines, Zetia and its sister drug, Vytorin. Other new cholesterol-fighting drugs, including one that Merck hopes to begin selling this year, may also require closer scrutiny, they say.

Dr. Steven E. Nissen weighed in with his interview with Katie Couric on CBS that I posted earlier.

And the Wall Street Journal in it’s Health Blog anticipated a slew of lawsuits against the makers of Vytorin and maybe other statins to follow.

But the big daddy of them all has yet to hit the newsstands but has already been blasted over the internet. The next issue of Business Week, due to hit the stands next Monday, has been up online for the past few days, and it contains several articles, including the cover article, that are devastating for the makers of statin drugs.

The cover article titled Do Cholesterol Drugs Do Any Good starts right off in lock step with what I wrote in my Queen Mother of all statin posts a year or so ago. The Business Week piece starts with an interview with James M. Wright, a professor at the University of British Columbia and the director of the Canadian government-funded Therapeutics Initiative, an agency that analyzes drug data to see how well they actually work. Dr. Wright had one of his patients – Martin Winn – on a statin for a mildly elevated cholesterol level when the light bulb flashed on.

Wright saw, the drugs can be life-saving in patients who already have suffered heart attacks, somewhat reducing the chances of a recurrence that could lead to an early death. But Wright had a surprise when he looked at the data for the majority of patients, like Winn, who don’t have heart disease. He found no benefit in people over the age of 65, no matter how much their cholesterol declines, and no benefit in women of any age. He did see a small reduction in the number of heart attacks for middle-aged men taking statins in clinical trials. But even for these men, there was no overall reduction in total deaths or illnesses requiring hospitalization—despite big reductions in “bad” cholesterol. “Most people are taking something with no chance of benefit and a risk of harm,” says Wright. Based on the evidence, and the fact that Winn didn’t actually have angina, Wright changed his mind about treating him with statins—and Winn, too, was persuaded. “Because there’s no apparent benefit,” he says, “I don’t take them anymore.”

As I reported in my post the only evidence that statins produce any decrease in all-cause mortality is in men under the age of 65 who have established heart disease. For women of all ages with and without heart disease and for men of all ages without heart disease, these drugs don’t bring about a decrease in all-cause mortality.

And in that small subset of people for whom they do work – men under the age or 65 with a history of heart disease (not a history of high cholesterol, but a documented history of having experienced a heart attack), the evidence is that they don’t work all that well.

What do you mean they don’t work all that well? Robert Jarvik tells us in the ubiquitous Lipitor ads that the drug reduces the risk of heart disease by 36 percent in these people.

The dramatic 36% figure has an asterisk. Read the smaller type. It says: “That means in a large clinical study, 3% of patients taking a sugar pill or placebo had a heart attack compared to 2% of patients taking Lipitor.”

Now do some simple math. The numbers in that sentence mean that for every 100 people in the trial, which lasted 3 1/3 years, three people on placebos and two people on Lipitor had heart attacks. The difference credited to the drug? One fewer heart attack per 100 people. So to spare one person a heart attack, 100 people had to take Lipitor for more than three years. The other 99 got no measurable benefit. Or to put it in terms of a little-known but useful statistic, the number needed to treat (or NNT) for one person to benefit is 100.

Compare that with, say, today’s standard antibiotic therapy to eradicate ulcer-causing H. pylori stomach bacteria. The NNT is 1.1. Give the drugs to 11 people, and 10 will be cured.

A low NNT is the sort of effective response many patients expect from the drugs they take. When Wright and others explain to patients without prior heart disease that only 1 in 100 is likely to benefit from taking statins for years, most are astonished. Many, like Winn, choose to opt out.

Plus, there are reasons to believe the overall benefit for many patients is even less than what the NNT score of 100 suggests. That NNT was determined in an industry-sponsored trial using carefully selected patients with multiple risk factors, which include high blood pressure or smoking. In contrast, the only large clinical trial funded by the government, rather than companies, found no statistically significant benefit at all. And because clinical trials themselves suffer from potential biases, results claiming small benefits are always uncertain, says Dr. Nortin M. Hadler, professor of medicine at the University of North Carolina at Chapel Hill and a longtime drug industry critic. “Anything over an NNT of 50 is worse than a lottery ticket; there may be no winners,” he argues. Several recent scientific papers peg the NNT for statins at 250 and up for lower-risk patients, even if they take it for five years or more. “What if you put 250 people in a room and told them they would each pay $1,000 a year for a drug they would have to take every day, that many would get diarrhea and muscle pain, and that 249 would have no benefit? And that they could do just as well by exercising? How many would take that?” asks drug industry critic Dr. Jerome R. Hoffman, professor of clinical medicine at the University of California at Los Angeles.

So even those for whom the statin drugs do show some benefit, that benefit just isn’t all that much in the great scheme of things. And if this tiny, tiny benefit is all that is shown in those for whom the drugs are beneficial, why in God’s name would anyone not in this group even think about taking these drugs? Yet they are prescribed by the millions for just those people. Young people, old people, people who have never had documented heart disease, people whose only problem is a mildly elevated cholesterol level are being browbeaten by their physicians to to on these drugs that are not particularly benign. And with no evidence to prove that the drugs do anything at all to help. It is shameless.

This excellent article should be read in its entirety by anyone contemplating a statin drug. And the two accompanying articles should be read as well. One discusses the many side effects of statins that all too many prescribing physicians want to pretend don’t exist.

In clinical trials of statins, side effects were relatively rare. But many doctors believe they are more common in the real world, afflicting perhaps as many as 15% of patients. After muscle aches, prominently mentioned on Lipitor’s label, common complaints include cognitive problems ranging from mild confusion to loss of memory. Former astronaut and retired family doctor Duane Graveline says that he “descended into the black pit of amnesia” both times he was put on Lipitor, prompting him to write a book and set up a Web site on statins’ side effects.

The other gives the lie to the idea that statins are protective against Alzheimer’s disease.

The sad, sad part of this story as far as I’m concerned is that it has taken the business press instead of the medical press to expose the statin story. Why? The article says it all.

The NCEP’s 2004 guideline update garnered headlines by recommending lower targets for bad cholesterol, which would put more Americans on the drugs. But there was also a heated controversy in the medical community over the fact that 8 of the 9 experts on the panel had financial ties to industry. “The guideline process went awry,” says Michigan State’s Barry. He and 34 other experts sent a petition of protest to the National Institutes of Health, saying the evidence was weak and the panel members were biased by their ties to companies.

As I wrote: sad, sad, sad.

But if there is even one little flicker of humor in this entire situation, it can be found in the many full-page ads the makers of Vytorin have been running in the New York Times and other national newspapers the past week or so in an effort to talk people out of quiting their drugs.

Says the ad:

Are you taking Zetia or Vytorin?

If so, you may be worried about recent news stories questioning the benefits of these medicines…on the basis of a single study that has generated a lot of confusion.

This is a fine load of bull coming from pharmaceutical companies that are more than willing to have you taking all these medications on the basis of a single study. I guess it all depends upon whose ox is getting gored.

All I can say is thank God I morphed out of my regular medical practice and into nutritional medicine before the legalization of drug advertising on television. I watch very little TV – mainly NFL games, and usually only those I have a bet on – but even with the minimal amount I do watch I’m exposed to a ton of pharmaceutical ads.

These ads play on the relationship between patients and their doctors to make the drug company cash registers go ching ching ching.

Here is the way the system works. A person watching TV sees an ad for, say, a ‘new’ sleep medication promising a restful night’s sleep. This usually doesn’t prompt a call to the physician for a prescription, but during the next visit to the doc this person says, Hey Dr. So and So, I saw an ad for that new sleep medicine Lunesta. I’ve been having a little trouble sleeping, so could I give that a try? Most physicians will go ahead and write a prescription for that drug. Problem is, the drugs advertised on TV are typically much more expensive than the older drugs that may have gone off patent already and can be had as generics. And the new drugs aren’t any more efficacious than the old drugs. It doesn’t cost the doctor any money to write these prescriptions, so he/she will usually do it. The patient gets a medicine that costs him/her (or the insurance company) a lot more money for a drug that works no better than a cheaper one. So who wins in all this? The drug company, of course.

Any medication you see advertised on television has a less expensive counterpart out there. And typically the less expensive counterpart has had many more years of patient experience without problems or it would have been pulled from the market, so it can be considered even safer as well.

Consumer Reports has started what they say will be a series of attacks on these drug ads. Their first venture is a jab at a drug ad we’ve all seen for the heartbreak of restless leg syndrome. (I’m not always a big fan of Consumer Reports. They do okay when their evaluating toasters to see which is best because there are specific tests the toasters can be put to in an effort to rank them. Where CR gets into trouble is when they start rating various diets using yardsticks that have no scientific merit.)

Link to the video. Sadly, they’ll probably never do one of these debunkings of a statin drug ad.

Warning. The woman who is the CR spokesperson in this video has one of the most annoying voices in the history of video. It has a teenspeak quality to it that just about drove me from the computer. I could barely get the thing watched. But that’s just me. It may not bother others.

While we’re on the subject of television drug advertising, have you been wondering why you’re seeing that Gollum-y Dr. Robert Jarvik touting Lipitor every time you turn on TV, pick up a paper or magazine or even look at the news online? Because the pharmaceutical giant Pfizer is in a blind panic. The New York Times tells why.

Lipitor and other cholesterol-lowering drugs, sometimes called statins, are the largest drug class, with spending of $22 billion last year in the United States alone. And they have been researched more thoroughly than any other group of drugs, making head-to-head comparisons easier.

Many doctors have come to see simvastatin as a viable substitute for Lipitor. Studies show that at commonly prescribed doses Lipitor and simvastatin are equally effective at reducing LDL cholesterol, the so-called bad cholesterol.

A big difference is that Lipitor costs $2.50 to $3 a day, while simvastatin sells for 75 cents to $1 a day at most retail pharmacies, and as little as 10 cents a day at discount pharmacies like Costco’s.

Each month, doctors with patients on Lipitor are switching tens of thousands of them to simvastatin. And simvastatin is also taking a growing share of the market for new patients who need a cholesterol drug. “Simvastatin is much less expensive to society over all and to patients,” said Dr. Thomas H. Lee Jr., a prominent cardiologist. “If you put patients on generics,” he said, “the chances that they’re taking their medications six months later are higher than on a brand name drug. I think that a few hundred dollars a year does matter.”

Simvistatin (Zocor) went off patent last year, you see, so it is now available as the generic. Pfizer, which makes Lipitor, is worried that many physicians will switch their patients from Lipitor to simvistatin, a move that could cost Pfizer hundreds of millions of dollars. (And save patients and insurance companies and therefor all of us the same hundreds of millions of dollars per year.) So, they are blasting the airwaves and print wherever and whenever they can to try to maintain loyalty. I guess we’ll see if it works.

I have a better and even less expensive solution: quit writing prescriptions for statins altogether. There is no real proof that they work for anyone except males under the age of 65 who have already had heart problems. And even then, they work minimally. So if you don’t fall into that category why spend even 75 cents per day for a drug that will do you no good and possibly great harm? Discuss it with your physician.

While we’re on the subject of television ads I’ve got to pass one along that’s one of the most pernicious I’ve seen in a long time. This one, sent to me by a reader, has to take the cake for being subtle, yet misleading and dangerous.

Television and print advertisers have long feed on the desire of young women to be thin, and have probably caused untold numbers to purge their way to anorexia. Now comes Proctor & Gamble encouraging them to purge from the other end.

Their new ad campaign for Metamucil is ostensibly aimed at women who want to lower their cholesterol levels, but I doubt that many women who are the ages of and look like the models in the ads give a flip about their cholesterol levels. I suspect that the brains behind the ads figure that women will buy into the hype to make their insides beautiful (read: empty and thin), which will somehow translate into outer thinness.

What will they think of next to prey on the gullible.

Click here to view the embedded video.

Unbelievable as it seems, this was a television commercial that ran in the early 1950s. We’ve come a long way, baby.

Click here to view the embedded video.

For those who didn’t grow up with it or those who did and just don’t remember, it’s hard to imagine how pervasive cigarette ads were in the 1950s, 60s, 70s, and 80s.

Here America’s cuddliest family lights up. Is it any wonder that everyone smoked back then?

Click here to view the embedded video.

Sometimes it seems as if things change slowly. This old Flintstones clip shows just how much things have changed over the past generation.

Click here to view the embedded video.