The Complete Patient

It’s an article of faith among consumer goods companies that the best way to create long-term customers is to get them while they are children. Companies from McDonald’s to Apple Computer to Coca Cola have long followed this dictum, with great success.

The big pharmaceutical companies have begun to catch on, with significant success of their own, getting children onto drugs for attention deficit disorder and depression. Now, though, they are ramping up big time, as they encounter safety and government approval problems for their adult products.

Like a lot of people, I did a double-take as I half-listened to the national news last night. The big story was about a recommendation by the American Academy of Pediatrics (“Academy” sounds so official and scientific) that children as young as eight years old could be candidates to take statins for countering high cholesterol readings. These are the drugs that produce liver problems and muscle weakness in many adults.

I gave the program my full attention as anchor Charles Gibson quizzed Dr. Timothy Johnson, the Marcus-Welby-like guru doctor, and actually asked one penetrating question. “Will children who take statins have to take them for the rest of their lives?” Dr. Johnson seemed taken aback, stumbled a bit, since doctors tend not to think in such terms. After all, the Academy is the Academy.

“Well, yes,” he finally said.

(The segment I saw seems not to be available on the ABC News site, which has other items about this medical development.)

The other part of this story is that some kids as young as age one are being encouraged to consume low-fat milk. Seems even the pediatricians have long recommended whole milk for kids until at least age three.

How can physicians, who take an oath to “do no harm,” countenance such mass-scale drug taking for children using drugs that have been shown to have serious side effects for adults? They say that initially the statins will only be used on children with very high cholesterol readings, and a family history of heart problems. But we all know where this all ultimately leads—to wider and wider dissemination, as the “standards” are adjusted to encompass more and more children.

I had a physician explain how they rationalize it longer term. In their view, most people won’t take the life-style steps in terms of diet and exercise to improve their health (even allowing for the fact that there’s much disagreement on just what the diet steps should include). So doctors are simply responding to our instant-results, convenience-oriented society, and trying to alleviate a crisis situation.

The doctors seem to forget, in all their rationalizations, that they are simply the distribution network for the drug companies.

We’ve been very fortunate on this blog to have had a number of people willing to share their experiences and knowledge around food-borne illness.

First, there’s Mark McAfee of Organic Pastures Dairy Co. Mark is open almost to a fault. He can’t resist commenting, and in so doing, turns himself into a lightning rod. He discussed his views of what happened regarding the illnesses of the six children, ad nauseum.

Then there’s Mary McGonigle-Martin, mother of Chris Martin, followed by Melissa Herzog, mother of Lauren Herzog. They both discussed the situations from their perspectives, to the point of exhaustion for many readers.

And finally, we’ve had any number of extremely well informed participants in these debates—Miguel, Dave Milano, Steve Bemis, Sylvia, C2, Kirsten, milkfarmer, and many others too numerous to mention.

Now, we can dispute these individuals—especially Mark, Mary, Melissa—in terms of what they said, how they said it, when they said what, and so forth, but the simple fact that the discussion took place is highly unusual.

The reason it’s so unusual is that, despite the fact that millions of people (the CDC says 77 million) are victims of food-borne illness each year, there are three huge obstacles that prevent the kind of discussion that took place here.

The first obstacle is the legal/public relations obstacle. There are very very few business executives who, when their companies are identified as possible sources of foodborne illness, are willing to candidly talk about it. Most fear the Bill Marlers of the world, and are advised by their attorneys not to say anything because it could be held against them in a court suit. Mark is very much the exception, for any number of reasons.

The second obstacle is the privacy obstacle. Patient privacy is protected, as well it should be, and so it’s difficult for the media to locate victims of food-borne illness. Many of these victims don’t want to get in the middle of media debates about the topic. In the September 2006 California case, only two of the six have come forward—Mary, to the extent she shared many personal and painful details of her family’s ordeal.

The third obstacle is that our government officials and their scientific advisers refuse to be candid about the subject. So we are left with documents like those produced by California public health department and the CDC that raise more questions than they answer.

Now, why do the government officials and advisers—these lions of our scientific, public health, and medical establishment—resist being candid? As much as we want to blame conspiracies, I think the real reason is very simple: they don’t fully understand the problem of food-borne illness.

In fact, none of us fully understand it. If we did, we wouldn’t be having the debates we have here. Some of us think we understand it—I agree with those who see our obsession with pathogens and food sterilization as having created the unintended effect of weakening people’s immune systems. But I can’t prove it conclusively. The establishment view that we just need to tighten cleanliness up some more to completely rid ourselves of the pathogens holds sway. But they can’t prove their case conclusively either.

The government’s problem is that the officials are unwilling to admit they don’t have all the answers. There was an interesting exchange in Congress yesterday to this point, in hearings about the salmonella outbreak affecting tomatoes, reported by The Wall Street Journal. “Some lawmakers expressed exasperation with the (FDA). ‘The longer you sit on this committee, the more depressed you get, because the issues never get resolved and crop up again and again,’ said Rep. Diana DeGette (D., Colo.), who for years has urged the agency to develop a program to track food from the farm.”

We can argue about this legislator’s perspective all we want [just over the fact she wants a tracking system for all food], but the reality is she is frustrated because the scientists at the FDA won’t tell her/us they don’t fully understand the food-borne illness phenomenon.

The same frustration is spilling over onto this blog. There’s this feeling, I know I get it sometimes—why the hell don’t Marler and C2 and CP see the big picture? And they get frustrated with being labeled and mocked, and the beat goes on.

I’m not sure exactly why the scientific establishment can't bring itself to admit it doesn't fully understand what's happening. Maybe because Congress appropriates money and drug companies come up with highly profitable products and so on and so forth based on the conventional wisdom. To say you don’t know—as admirable a human trait as that might be--well, it doesn’t inspire the confidence that legislators and investors like.

In terms of this blog's etiquette, I urge people to be more respectful. In that vein, I strongly suggest avoiding identity switches. The most disrespectful individuals seem to be those hiding behind ad hoc signatures. Don't write stuff here you wouldn't say directly to another individual in conversation. The way most blogs counter such problems is to require signup info. Let’s see if we can avoid that.

I was curious to read Miguel's comment (on my Feb. 4 "From Nuts to Subversives" posting) that pigs are a major source of drug-resistant bacteria known as MRSA.

I had just read an article in the Financial Times last week about MRSA, but that publication focused on MRSA in hospitals, and didn’t make mention of the pig source. It seems that significant numbers of people are contracting this superbug when they are admitted to hospitals, ostensibly to get better.

Not surprisingly, the article’s main concern is whether and how pharmaceutical companies might be able to come up with new antibiotics to fight the so-called “superbug” that MRSA represents.

The financial interests tend not to care much about the source of the problem or its natural interrelationships, but mainly whether there is money to be made in a solution to the problem. Hence, the Financial Times’ emphasis.

But the Financial Times is not optimistic about whether Big Pharma can easily solve this problem. “The challenge in fighting bacteria with new drugs is that all the most promising avenues of development have been pursued, leaving today’s researchers with a much harder task.” And “much harder” tends to translate into “less profitable.”

MRSA illustrates the pickle we’ve gotten ourselves into via over-use of antibiotics, both among humans and animals. I learned of a vivid illustration recently in a discussion with a chicken farmer He recalled how he had, a few years back, obtained his first chickens, and realized he didn’t have feed for them.

He wanted to raise them naturally, but could only find at the local feed stores feed that contained antibiotics mixed in. Since he had to feed the chickens, he figured he’d give them the medicated stuff until he could find a med-free source. When he finally obtained his med-free feed, he gradually transitioned the chickens to the new feed, not knowing how they’d react to suddenly going off antibiotics. The results were breathtaking: he lost 25% of his chickens to disease from their compromised immune systems.

So as Miguel notes, people are now contracting MRSA from pigs, and spreading it around. I have a feeling that all doctors will be able to do is hold their patients' hands for this unfolding episode.

You may not like what Sermo Inc. is doing for a living, but you have to give the company credit for cutting to the chase in the medical information arena. It’s in the business of “information arbitrage,” which it explains as “the opportunity that arises when breaking medical insights intersect with the demand for actionable, market-changing events in healthcare.”

An example helps explain: A few physicians who prescribe Lipitor to many of their patients learn via feedback that Lipitor induces vivid and recurring nightmares in perhaps a third of their patients. The doctors shift these patients from Lipitor to other statin drugs (which reduce cholesterol levels). The drug’s manufacturer, Pfizer, may or may not know about this unusual side effect, but hasn’t published or otherwise disseminated information about it.

For investors, such information could be extremely valuable, since it suggests—before the information is disclosed by Pfizer—that Lipitor could well be losing market share. The professional investors can do the arithmetic to figure out a worst-case scenario based on Lipitor losing one-third of its existing users, and how many hundreds of millions of dollars a year that is worth. Perhaps they want to sell Pfizer stock short in anticipation of the Lipitor side effect becoming a market reality in six months or a year.

Sermo understands how valuable such information is, so it’s paying doctors $30 to $50 for their postings; on its site, it states it has paid out $132,145 for 3,578 observations, or an average of $36.93 each. It also says it has another $20,000 to hand out. Unfortunately, only physicians can register on the site.

So how much is Sermo charging the institutional and other big-time investors for access to the physician data? In a Boston Globe article Saturday, the company is quoted as saying it won’t divulge such information. Well, I don’t know the amount, either, but I do know this: those investors are being charged a lot, as in hundreds or thousands of dollars each month. I wouldn’t be surprised if eventually Sermo sells its data back to the drug companies as well.

Otherwise, why would venture capitalists put up $3 million to get this company going? Selling info Big Pharma would prefer to keep to itself is a potentially very lucratic business. It’s another way of profiting from America’s medical industrial complex.

Here's a suggestion for patients to get in on the action: If you take prescription drugs, next time you visit your doctor, ask if he or she is participating in the Sermo data collection scheme. If so, request a discount on your co-pay or fee, in consideration of information you are providing that your physician could use to collect extra cash from Sermo.

As I said at the start, you have to give Sermo credit. If they could just find a way to make such data available to the people who matter most—the patients—it would feel a lot warmer and fuzzier.

The cover of the current issue of BusinessWeek (Sept. 25) asks the question: "What's Really Propping Up the Economy?" Turns out it's the healthcare industry, which has added 1.7 million jobs since 2001, versus no job growth in the rest of the private sector. This article is worth a read to gain a sense of the dimensions of health care's influence on our economy. But it is also instructive in appreciating why the medical establishment, both in the U.S. and Europe,  approaches treatments the way it does.  Consider two random situations that just happened to come up in the media today:

--There's lots of excitement in Big-Pharma-land because of a drug being tested thathas shown evidence it can reduce the chances of developing Type 2 diabetes, according to a report in today's NYTimes. Big Pharma types see it as a new statin-type drug--the cholesterol-lowering drug class that is generating many millions in revenues because people take it forever, or otherwise till their livers give out. But a UK official of a diabetes advocacy group expresses concern: “We’re worried that people may think there’s a quick fix, when what is proved to work is lifestyle changes. For the moment, we don’t think we can solve this epidemic with a pill.” She doesn't get it, does she? If the drug generate big profits, who cares about silly matters like side effects or that patients remain susceptible to other lifestyle-related conditions, like arthritis? Oh, I forgot, there's Vioxx for arthritis.

--Kitty Dukakis, wife of the former Democratic presidential candidtate, Michael Dukakis, today in the Boston Globe Magazine describes her experiences using electric shock treatments to relieve her depression. She wonders why it's taken the medical establishment so long to re-accept shock, after it went out of vogue in the 1950s and 1960s. Well, one reason is that drugs for treating depression, taken on a daily basis, are much more profitable than some electric shock treatments administered every six months or a year.

The medical establishment hates it when you pursue treatments that don't require drugs or surgery. Those are where the money is. Everything else is chicken-feed.