The Complete Patient

Mark McAfee had just a few hours to celebrate yesterday’s issuance of a temporary restraining order blocking enforcement of AB 1735--what he called “a big win for California raw milk and producers”—before he learned about the next phase of the government’s campaign against Organic Pastures Dairy Co.

It seems the U.S. Justice Department, in cooperation with the Food and Drug Administration, is conducting a grand jury investigation into OPDC’s sales of raw milk and colostrum sold as pet food to consumers around the country, outside of California. Two of OPDC’s employees have in the last two weeks each received a subpoena to testify in early April before a U.S. District Court grand jury for the Eastern District of California.

The employees, who take phone orders and help administer the dairy’s office, didn’t know what the subpoenas were for until after dinner last evening--just hours after the state superior court issued its temporary restraining order on AB 1735--when they received visits at their homes from two FDA special agents from its Office of Criminal Investigations.

In each case, the agents telephoned first, saying they were following up on the subpoenas, and then showed badges before asking to come into the employees’ homes and question them. The situation bears an eery resemblance to the visit by New York agriculture agents to Meadowsweet Dairy within hours of owners Barb and Steve Smith filing suit against the state last December.

Before I relate what the employees say happened next, I should say that I called one of the FDA special agents, Stephen Jackson, on his cell phone, obtained from the business card he left behind. After I identified myself and told him I was inquiring into the grand jury investigation into OPDC, he said, “I’d prefer you not call this number.” I then asked him if he could refer me to an FDA or Justice Department official who might be able to help me, but he said he couldn’t, and suggested I just call the main number of the U.S. Attorney’s office in Fresno.

One of the employees, Amanda Hall, who has worked for OPDC for about a year, said Jackson and his colleague kept inquiring into the sale of raw milk to customers outside California. “They kept saying, ‘Do you know it’s illegal to sell raw milk outside California?’” When she explained that the milk is labeled as pet food and thus okay, “They said, ‘Who told you that?’ I said I learned it from others in the office…They kept asking me if I knew it was illegal…At first they were nice and polite, but they kept getting more agitated. I think they wanted to hear about Mark.”

There was more to come. One of the agents played a tape recording of Amanda taking a phone order from an FDA agent posing as a customer, inquiring whether it was okay for the “customer’s” eight-month-old child to consume colostrum. “I said it was okay. The FDA has no regulations on colostrum. It’s a dietary supplement. And all products are labeled for pet consumption.”

And then even more: Before the agents left, “One of them asked me, ‘Would you ever consider wearing a wire? If you would wear it, you would be getting information from Mark. You could benefit. You wouldn’t be paid millions, but it would sure help you out.’” Amanda declined, and the agent left a card, saying that if she changed her mind, she should call.

The situation was pretty similar for Lizbeth Eugenia Valdes-Urbieta, who has been at OPDC for two years, except the visit seems to have been more traumatic for her than for Amanda. “I’m pregnant, and I’m a crybaby,” she says. Not only that, her husband, mother, and father were present in the house, and her mother was becoming ever more frightened as she heard the agents pressing their questions. “She asked my husband, ‘Is this legal?’ He told her it was.”

They went through the routine about it being illegal to sell raw milk outside California, she says, “And they told me, ‘Don’t worry, you’re not in trouble.’ Then they had a tape of me talking to a customer. He asked me if we ship outside California. He told me he had a son, one year old, and can he drink colostrum?” She says she told him that the children of OPDC employees consume colostrum. “They kept asking me, ‘Who told you about the pet food labels?’”

Maybe because she was so nervous, they didn’t ask her to wear a wire. “After they left, I was shaking,” Lizbeth says.

Mark says he had extensive communication with FDA officials about his pet food labeling back in 2003 and 2004, and that the agency eventually sent him an advisory in early 2005 that “there is no requirement that pet food products have premarket approval by the FDA.”

One last note: Grand jury investigations are normally secret events in which prosecutors try to convince jurors to vote criminal indictments. Witnesses who are subpoenaed have no right to have a lawyer present and can expect to be cross-examined by a skilled government attorney. The identities of jurors are kept secret as well. Mark says he and his employees decided to go public about the grand jury situation after a meeting this morning of the dairy’s dozen employees. “We’re a family here,” he told me. “We’re going to protect ourselves. Our only weapon is the truth.”

But he added that he’s being practical as well. “I’m ready for a raid right now. All the computers are backed up.”

His theory for the government’s latest action: “Our sales are going through the roof. We’re doing $100,000 a week in sales—last quarter, it was $75,000. People are going nuts for raw milk. The FDA is going nuts the other way. I’m the snake. They want to cut off the head of the snake.”

Strange coincidence, these night-time visits by special agents to individuals' homes, just after OPDC wins a big court case. It’s a good thing Mark isn’t paranoid. He might otherwise think there were people out to get him.

About five months ago, when I had a physical exam, most everything seemed to come out well…except for one test that suggested something might be amiss. It was a test I hadn’t had, or even heard of, before--something known as a c-reactive protein (CRP) test.

This is a test, my doctor explained, that tests for “inflammation” usually associated with heart problems. I didn’t like the idea of “inflammation,” since it seems to be behind so many chronic diseases.

A normal reading, according to the printup of my tests, was less than 1 mg/L. My reading was 5. The chart showing my reading indicated that a reading of over 10 was cause for alarm. But what about a reading between 1 and 10?

My doctor didn’t seem very concerned. She suggested I come back for another test in six months, but didn’t offer any suggestions as to what I might do to counter the reading. Or if I should do anything.

When I went online, several sites suggested that any reading over more than 3 put me at “highest risk.”

Risk for what? Well, there the experts seem uncertain. An article on WebMD cited a study that suggested the CRP reading was more predictive of heart problems than cholesterol readings. There are also connections to macular degeneration and colon cancer.

I had a check-in with a nutritionist in I’ve previously consulted with, in early March, and she said she didn’t care for the reading. She recommended a combination of enzymes, along with CoQ-10. She told me to take the supplements for two months, and have the test again. (The WebMD article suggests taking aspirin and/or statins.)

I just had the test, and lo and behold, the reading was 0.2. It seems like quite a dramatic change. Now I wonder, was either the first test, or this test, improperly measured? Or was I missing certain nutrients from my diet that the enzymes and CoQ10 suddenly provided? Is the test really all that significant?

In that same WebMD article, I see there is something called an ultra-sensitive CRP, which provides even more insights into potential heart problems.

I guess I’m happy that my number improved. I'm also glad that statins never became an issue. It just seems that making sense out of these supposedly ever-more-sophisticated tests is difficult to do--for professionals and patients. I can’t wait for genetic testing.

I don’t like bullies. I don’t like it when government bureaucrats with nothing better to do kick around honest farmers. In the same vein, I don’t like it when private companies trying to maintain high profit margins kick around honest health-care practitioners.

I’ve been witness to this latest phenomenon in a complex affair involving a prominent supplement and herb producer, Standard Process, out of Palmyra, Wisconsin.

This is a special company, with a special history. The story of its founder, Royal Lee, sounds something like the story of Weston A. Price. Lee was a dentist who believed in the power of whole food nutrition. He started Standard Process in 1929 to create nutritional supplements made from whole foods, and in the 1940s actually purchased farmland so the company would be able to grow its own organic crops to use for making many of its supplements. The company continues today to grow many of the vegetables and herbs used to make its supplements.

Holistic practitioners love its products. I have taken a number of its products, on the recommendation of a nutritionist. But I am going to find an alternative, based on its recent behavior.

In a BusinessWeek.com article, I describe how it terminated a Long Island holistic health center, Northport Wellness, as a re-seller to patients because Standard Process suspected the center was supplying an online company on Long Island with Standard Process products. Standard Process has a strict policy against sales of its product online. If you read the article, you’ll see that there's a good case to make that the Long Island health center wasn’t supplying the online seller.

But when you are put on trial by a private company, there isn’t necessarily the same kind of appeals process we’re accustomed to in our courts. The Long Island center didn’t even have a chance to present a defense—it was just terminated because of Standard Process’ suspicions.

The situation is actually worse than what I describe in the BusinessWeek.com article. Because of space limitations, I couldn’t get into the fact that two other supplement manufacturers, Thorne Research and Designs for Health, also cut off Northport Wellness as a re-seller because of similar suspicions--that it was among several Long Island practitioners supplying the same online company. Like Standard Process, they don’t want to have their products sold on the Internet. (An official from Thorne told me, however, that it may have made an error in cutting off Northport Wellness, so presumably Thorne could reinstate the center.)

The cutoff of these supplements affects hundreds of patients, including 350 children who are autistic or "on the spectrum" and are patients of Northport Wellness, says Mariahel Sammis, a naturopath at Northport. "Once children on this spectrum are introduced to products, it is difficult to stop or change since some of these children...become dependent on them."

In my judgment, Standard Process' real goal here is two-fold:

First, and most immediately, Standard Process wants to set an example of Mariahel and Northpoint Wellness, in case any other practitioners should get crazy ideas about re-selling their supplements to places like the online seller. We’re talking about intimidation, pure and simple, much the same as the Michigan Department of Agriculture wanted to use Richard Hebron as an example to warn other farmers against pursuing the growing raw milk market.

Second, and longer term, it wants to keep its products off the Internet. The Internet represents price competition, and Standard Process will do everything in its power to avoid such competition in pricing of Standard Process products.

Wouldn’t the Internet offer Standard Process the opportunity to expand its sales? you ask. Yes, certainly, but Standard Process cares much less about increasing sales than it does about maintaining the high prices and attractive margins it currently enjoys.

I know all the rhetoric about making sure that Standard Process products are recommended by practitioners, about avoiding patients self prescribing. That’s not what this current episode is about. What we’re talking here is business hardball, associated with keeping prices and margins as high as possible. It’s not unlike what Big Pharma does.

You might say, Well, this is a free market. Why doesn’t Northport Wellness just buy its supplements somewhere else? It will do that, but transitioning to new supplements isn’t so simple for patients who grow accustomed to certain formulas, as Mariahel described earlier in this commentary.

Will Standard Process' thousands of committed practitioners let the company sacrifice a few equally committed practitioners and their patients to set an example? Much as I would love to be proven wrong and see practitioners exit Standard Process in protest, I suspect they will stay, because they want to maintain their own high margins as much as the company wants to maintain its margins. It's part of the dynamic of health care in America.

I’ve been trying to catch up on some of my reading over the past holiday week, and one of the publications I went through is Life Extension Magazine, a holistically-oriented publication from the Life Extension Foundation.

You’d think that because it’s published by a foundation, the magazine would be nonpartisan in its reporting on holistic health approaches. But it’s not. The magazine presents much interesting research about how nutritional supplements can help alleviate various conditions more effectively than pharmaceutical products, but there's always a sales pitch close behind.

As one example, the current winter edition features an in-depth article about new research strongly suggesting that pomegranate is such a powerful antioxidant that it can reverse atherosclerois and slow the progression of prostate cancer. This last finding is especially intriguing, since the only conventional treatment available to men with advancing prostate cancer is hormone treatment that suppresses production of testosterone. It only works for a few years—sometimes eight or ten years—but then it stops working and the jig is up.

But what does Life Extension Magazine do with these findings? It uses them to sell its various capsules, pills, and concentrates containing pomegranate. It does this with just about all the research it publishes, and it feels like a letdown every time it happens. It undercuts magazine's credibility as a journal of valuable research. The conventional medical community is skeptical to begin with of alternative providers, and when it sees Life Extension essentially do the same thing as Big Pharma—try to push pills—well, it’s hard to see the organization as special or different.

I understand that Life Extension needs to generate cash, some of which it says is used to sponsor research. But why does it need to be so in your face?

Wal-Mart is already the nation's largest seller of groceries, but still, there's something disconcerting about the recent news that it plans to introduce a wide range of organic food products beginning this summer. The problem is that when Wal-Mart enters a market, its basic approach is to squeeze suppliers to bring down prices. One of the big reasons farmers have switched to growing organic foods is that profit margins are higher than growing conventional produce. Once Wal-Mart gets through with them, they'll just be selling another commodity. When suppliers get squeezed, they find ways to cut costs, and often quality.

Another disconnect in the Wal-Mart push into organics is that you know Wal-Mart cares not a bit about nutrition. So its suppliers will slap the word "organic" on everything containing ingredients grown without pesticides--including pasta, chips, carbonated drinks, and sweet children's cereals. One of the big attractions of Whole Foods and its reliance on organic food was its refusal to allow Coke, Pepsi, Frito-Lay and Kellogg's into its aisles because of their heavy use of sugar, artificial sweeteners and transfatty acids (even though Whole Foods over the years has become ever more lax in its standards).

A New York University nutritionist quoted in the NY Times story I linked to in the first paragraph stated that the Wal-Mart move represents "a ploy to be able to charge more for junk food." Ah, organic junk food...what a warm, fuzzy thought that is.