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How Dr. Whittlsey's Research was Used by Representative Z.

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Today, in the ex-modern year 2019, Americans expect to buy any drug or medical treatment we deem necessary or desirable without the intrusion of a prescription or an MD. Medical and legal wars still rage about opiates and some patented devices, but we have what we define as medical freedom. The change was precipitous, the advertising supporting it was persuasive, and after the deregulation war was won and analyzed, a new term was coined for the claims of the combatants: FictoFact. Yet few of us are aware of the nuts and bolts of how deregulated medicine came about. In truth, it resulted from a perfect storm of science, journalism, and politics, illuminated by lightning flashes of personal attraction and propelled by the winds of self interest.



Back in 2014, Dr. Edgar Whittlsey, the first link in the chain of medical deregulation, was researching the placebo effect. When asked to describe his work by relatives at family gatherings or colleagues at cocktail parties, Edgar carefully explained that placebo means 'I shall please' in Latin and that a placebo is a biologically inactive replacement for a medication or treatment that has the same positive effect on the patient. Generally, people rolled their eyes or yawned at that point, but that did not motivate Dr. Whittlsey to devise a different description. After all, what he said was true and it was important.

If Dr. Whittlsey's interlocutor inquired further about his research (an event that occurred with statistically insignificant frequency), he explained that his experiment was designed to answer the question, Can a placebo be as effective as morphine in post-surgical pain relief? He pointed out that he just asked a question, he did not hypothesize a cause. Then he described his experimental groups and quoted from his results: “Patients who were told they would receive a painkiller experienced the same relief whether or not they actually received one. Patients who were told no pain killer was necessary did not show a statistically significant difference in their experience of post surgical pain.”

Edgar's uncle Pete, a surgeon himself, said, “You should market that research of yours as a placebo sleeping potion. Maybe you could make some money, like a real MD.”

However, to Edgar's great satisfaction his paper was published in a prestigious journal.

The email:​

Edgar received an email from a stranger, Stella Lac, PhD., saying, Your recent publication is fascinating. My own research interest is in medical decision making. Why do doctors choose one treatment over another? Do non-medical considerations like cost, marketing, and popularity, make a difference? Based on your work, I could ask a related question: why do treatments become fashionable that are later shown to be no more effective than placebos? I would appreciate an opportunity to speak to you about this.

Edgar looked Stella Lac up on the web. She was an adjunct professor at a state university. Her photo was informal, and showed an Asian face, oval, delicate, smiling slightly, and bespectacled. Edgar thought she was lovely. He emailed an invitation to visit him at his office.

Edgar told his friends that his research was the anchor for his very rewarding life, but at alone at home at night, he wondered why he'd avoided the rutting behavior of     normal adolescence and early adulthood. He'd succeeded academically, certainly, but he'd neglected skills a man needs, such as the ability to tell if a woman likes you or finds you annoying. As a result, he'd reached the age of thirty-one without acquiring the pleasures of a wife or even a sweetheart. In his despairing moments, he told himself that he should be satisfied with the stimulation of research and the security of tenure. Most people spent most of their time working at boring jobs, whether or not they were married.

​

Edgar and Stella get together:

Stella Lac knocked on the frame of Edgar's opened office door. Inside, she saw the disheveled jumble of an insufficient space at mid-semester. A parsimonious linoleum floor showed between stacks of papers. On the window sill, a plant Stella could not identify looked vibrant and well tended. From behind an overburdened desk, a guy with the narrow build of a distance runner and poorly cut brown hair grinned at her.

Stella refused coffee, “or some other beverage,” accepted a chair, and sat precisely on the edge. While they exchanged predictable pleasantries, Stella wondered if Edgar could help her in her career. Edgar saw that Stella wore no wedding ring and wondered if she had a sweetheart. She was a delicate beauty in disguise, a woman who looked like she wanted to be taken seriously. She wore loose black cargo pants, a tight black tee shirt, and completed her ensemble with a Prince Valiant haircut and scholarly tortoise shell glasses. Edgar was utterly smitten.

Later, Edgar realized that Stella reminded him of an old photo of a Vietnamese his grandfather had taken while he was a young man in Paris. The woman's oval face looked golden in the shade of her parasol and she wore a graceful áo dài. When Edgar was fourteen he realized that the woman was beautiful and asked about her. His grandfather tried to explain the word “longing.” It was years before Edgar understood.

Like the woman in the Paris photograph, Stella's family had escaped a war in Southeast Asia. Growing up, she heard stories of burning villages, defoliated fields, and the devastation of the health care system. Those stories influenced her to study the sociology of health care. She aimed to do the research to support the non-medical changes that would make medicine more effective and less expensive. She was an idealist.



Stella thought Edgar looked very different in person from his head shot on the University web site. There was something familiar and too known about his wiry build and medium height. Really, he looked awfully Vietnamese for a Westerner and he had the stunned look of Asian guys who have done nothing in life but school work.

Edgar, ever polite, asked, “You know what I've been working on, but what have you been working on, yourself?”

“Type 2 diabetes and exercise.”

Edgar was surprised and said, “Didn't you say you were working on medical decision making?”

“I only said I was interested in that,” Stella said, a bit defensively. “I wanted to work on treatment failure for my thesis, but my adviser said no. He said I'd get myself in trouble, even if a treatment is no longer used. He said it doesn't help to look back; we should try to make things better going forward. So I quantified exercise benefits for diabetics: X amount of exercise results in Y financial savings and Z fewer complications. It's useful. A doctor or an insurance company can say to a patient, 'If you exercise you will pay X dollars less in co-payments because you will need less medicine.' Unfortunately, it's useful but it's not sexy enough to earn me tenure. Your work is both useful and sexy.”

“Sexy?”

Stella rolled her eyes mockingly. “You know. Sexy gets you noticed. Notice is important. Your work is sexy. You discovered that even a medication as tried and true as morphine works because people tell you it will.”

“No!” said Edgar. “Well, not exactly.”

He wanted to correct her misunderstanding but he did not want to offend her. “It's more like, for the pain of minor surgery a placebo in the form of assurance that you do not need a pain killer is enough. A doctor can say, 'Most people don't need anything more than aspirin. If you have a problem, let us know,' and that kills the pain for most people.”
“And that's much less expensive than medicine. Are you looking at placebos because of their cost efficiency?”

Stella relaxed, sat back in her chair, and tipped her head back thoughtfully.

Edgar admired her neck, her small ears that were revealed as her hair fell back, and thought, Oh, this girl was smart.

Edgar said, “Right. Mathematically speaking, the cost of healthcare is rising infinitely more quickly than the incomes of of most people.”

“That would be because the cost of healthcare as a percent of GDP is rising while real incomes for most people are not.”

“Correct.” Edgar grinned. He liked the feeling of colluding toward a result with Stella. “I hope to identifying conditions that can be treated inexpensively using placebos.”

Stella crossed her legs in her chair. She was thinking only of the topic of conversation and had relaxed completely.

Edgar looked at her slender legs, wondered how her knees could stand to sit like that, and said, “Do you know that false knee surgery can work as a placebo?”

“False knee surgery?”

“It's been done experimentally. A cut closed with stitches reduced the pain of rheumatoid arthritic as much as real surgery.”

“Huh!” said Stella. “I wonder if a dot made with a magic marker and the assurance that the micro surgery was successful would work. That would be even less expensive.”

Edgar was moved to say, “I don't usually talk about this, but my deep ambition is to help cure a disease of the healthcare system itself: the disease of using expensive drugs and procedures that turn out to work no better than placebos. I know it sounds grand.”

They sat in contemplative silence. Edgar was trying to invent the question that would engender the experiment that would lead him in that direction. Stella was thinking that research with such a result would be sexy enough to earn her tenure and more. It might even revolutionize medicine.

After another hour of talk, Stella and Edgar relocated to a bar, a cowboy themed establishment with rope lariat decorations, convenient to the University, inexpensive, and busy. They entered to the sound of murmuring voices punctuated by laughter, found seats at the bar, and ordered two mugs of the same beer and burgers: one cow, one veggie. Edgar was happy to sit next to Stella instead of across from her. He thought she smelled spicy, like nutmeg or cumin.

Stella watched the bubbles rise in her beer and thought about the laws of physical science as opposed to the non-laws of sociology. Maybe she should have gone into biochemistry.

While they waited for their food, Edgar said, “Take cholesterol. Say, a researcher discovers that heart attack victims have high cholesterol.”

“It's been done.”

“Eggs contain cholesterol, so, oh my god, we should stop eating eggs.”

“That's not a conclusion based on the research, but it's a reasonable precaution while more research is done.”

“Correct. Then further research shows that our bodies make cholesterol, it doesn't come exclusively from diet, and only one kind of cholesterol is bad.”

“Oh my god,” said Stella, and she threw up her hands. “Can we eat eggs again?”

“I'm glad you asked. An experiment might answer the question, Do eggs raise bad cholesterol levels in the blood? But an even better question, more to the point, would be Is there a correlation between eating eggs and heart disease? That is what we really want to know. Someone does the research and shows no correlation. Oh boy, we can eat eggs again!”

“The egg lobbyists make sure the media cover that research,” said Stella. “I can see the headline: Egg's Reputation Cleared!”

Edgar said, “The research showing the association of heart disease and high cholesterol wasn't wrong, just limited.”

The burgers came. Some college students started playing darts nearby. Edgar and Stella heard one of the guys say, “I like some prescription drugs better than grass. You can get anything if you know who to ask in the med school.”

Edgar said, “I hope my students don't think like that. Some of those prescription drugs are hell on your liver, much worse for your body than marijuana or opiates.”

Another dart player said, “...have you read the insert? What it can do to your mind is crazy.”

Another guy said, “I hear there's a drug lets you play darts all night and still get 'A's.”

“Yeah, it's called IQ,” the first dart player said and they all laughed.

Edgar and Stella smiled together.

Stella said, “Health-wise, the campaign against eggs was harmless, but when the standard medical advice is to take a drug that's later shown to be ineffective, that can be very harmful. Take a look at the insert in the drug packaging and see the side effects.”

“Exactly,” said Edgar. “That's what those guys should be looking at.” He watched the dart players abstractly. He said, “Can you imagine if new research shows that warfarin, a danged dangerous drug, is no more effective to prevent strokes than no treatment? What if the damage done by warfarin is equal to the damage done by extra strokes that occur without warfarin?”

“That's impossible to investigate, though. It would be considered immoral to ask patients to go without warfarin.”
Edgar and Stella talked on like that into the night, and he finally invited her to close the evening with a glass of wine at his house. He wanted to show it to her. It was a city residence on a small lot, but it was an authentic craftsman cottage, with great proportions and lovingly restored woodwork.

Stella did not seem to notice the architecture or the interior, though: she barely looked around and asked only, “Is that your dog barking?”

It wasn't.

Stella explained that she lived with her parents. She said, “I don't make much money, it's convenient, and I get home cooked food, but the truth is my parents would think it was both strange and insulting if I didn't live with them. From their point of view, only very unfortunate people who have suffered many deaths in their family live alone. A daughter stays with her parents until she marries. A roommate? A roommate is a stranger. How could you trust such a person or have any fun with her? A male roommate is unthinkable. So you see, if I didn't live with my parents they'd worry about my mental health.”

Stella had spent some time developing this little speech to explain her situation to white bread Americans. Immigrants and second generation people understood without explanation.

“Ah,” said Edgar. “It's an old world idea. How do you feel about it?”

“I'm old world and new world. I understand it and I enjoy my parents, but I want more privacy. I want to assert myself like an American. Here, people don't think you're grown up until you have a place of your own.”

“Hmm,” said Edgar. He waited, but Stella was done talking about herself. He said, “To non sequiturize, I understand why journalists and science-gentiles are swept away by new ideas in science, but what about the scientists? Why do they allow themselves to go for unproven ideas and to accept badly researched results?” 

“It's always an idea that sounds like it will revolutionize something. Cold fusion was one of the weirdest science fads.”

“People thought, or at least fantasized, that would revolutionize energy production and make big money.”

“People love their own ideas. Scientists are people, therefore... Besides, you don't get tenure for failed experiments,” said Stella. She raised her eyebrows. “Did I mention that I want tenure?”

“You seem fairly obsessed.”

“I am.”

Edgar wanted to help Stella get tenure. Now that he'd met her, he wanted her to have a secure job near him. He did not want her to have to decamp to a university in, say, Iowa or Istanbul.

“It's time for me to go,” Stella said. It was just nine o' clock, but they'd met early and she suddenly felt they'd been together quite long enough.

Edgar wondered if he should ask her to go out again, right then. While he was thinking about it, they said a few conventionalities and she left.

By the next Tuesday, Edgar had an idea how he could both help Stella and spend more time with her. They had not exchanged phone numbers so he emailed:

I've come up with a research question: Do experiments that get false positives (results that are later proven later to be wrong) have common flaws? Is something identifiably screwed up in their structure? This seems related to your interests, too...

And there he stopped. How far should he go? Oh well, he thought, It's easier to be rejected by email than in person and it's easier to offer to work with her than to ask her for a date.

He wrote: Might you like to work on this with me?

Stella answered: Absolutely. It would require analysis and comparison of structures. What could we analyze?

Edgar wrote: There is something we might be able use, and it involves placebos. I don't want anyone to hear about this until we have results, or at least a good research project that is getting results. Don't talk to anyone about it. Let's meet at my house to talk.



Edgar and Stella sat on opposite sides of Edgar's kitchen table on a Saturday morning with a stack of research papers between them. Light washed the room and made the pale green paint look bright spring-grass green in the corners.



Hoping Stella would notice the virtues of his kitchen, Edgar explained that the dark counter tops collected passive solar heat in winter. Stella glanced around vaguely.



Stella accepted a mug of green tea. Edgar drank coffee. Edgar said, “I'd like to work on the clinical trials of Prozac and similar antidepressants that have already been collected for a meta-analysis by a group led by Irving Kirsch, PhD[2] . They included trials that failed and were suppressed at the time of the FDA approval.

“Wow,” said Stella.

“Yeah. It should give us plenty of questionable research to look at. I've printed the papers.” He gestured at the stack between them. “We can begin by looking at the structure of each experiment. We need a standard way to describe them.”

Stella picked up the top paper and read the abstract. She shook her head and said, “This may require potato chips.”   
Edgar handed her a legal pad.

When Stella finished the paper, she made an attempt to diagram its structure and then pushed it away and said, “We're going to need a statistician.”

Edgar held up his pad, covered with lists and drawings trying to describe the trial he was reading about, and said, “This has headache written all over it.”

Stella pursed her eyebrows. To Edgar, they looked like the graceful wings of a bird in the distance.

“But I think it can be done,” she said.

Edgar thought, And I get to do it with Stella. I wonder if I should ask her out to dinner.

He said, “Then let's do it.”



A journalist discovers Edgar and Stella:


Edgar and Stella had worked together for a few months, had figured out a way to analyze their data, and were getting results. One day Stella called Edgar and said, “I had the most amazing phone call. A journalist wants to talk to us. I said yes. This could be really good for me.”

Stella had texted Edgar before, sending cold, science-y notes, but this was the first time she'd phoned. On his side, Edgar had not-invited Stella out after each time he decided he would invite her. Emboldened by the call, Edgar said, “Tell me about it in person. I'll take you out to dinner.”

After Stella hung up, Edgar wondered how the guy heard about them. They weren't supposed to talk about their project.

​

Edgar secured a desirable booth in a Thai restaurant he liked, and when Stella arrived he waved enthusiastically. She was not thrilled about the attention his gestures attracted. Incidentally, as she took off her jacket she noticed that his ears protruded.

Edgar noticed that Stella was wearing tight jeans that revealed all of her curvy curves.

Stella slipped into the booth and said, “You won't believe what's happened. This journalist, David Lutz, thinks we're doing cutting edge work on placebos. That's not right, but I like the sound of 'cutting edge.' I hope he keeps thinking that way.”

“What kind of journalist?” asked Edgar.

“Witty. Not too knowledgeable about science but intelligent enough to understand. He has a nice voice. I told him our work involves placebos, but not the way he thinks.”

“What kind of journalist? Who does he write for?”

“Magazines and newspapers. Freelance. I told him we're at an early stage. So far, we have nothing but questions and ideas. He wants to talk anyway. He said he can interview us again, later.”

The waiter came and asked if they needed more time, but Stella said, “No. I know what I like.”

As soon as the waiter was gone, Stella said, “The attention would be good for me. Tenure, you know.” She smiled.
“How did he hear about us?”

“Oh, I must have said something vague to Emma Lu. Nothing specific, you understand. Her guy is in journalism school. Something like that.”

Edgar wanted to say, We agreed not to talk about this project, but he swallowed the words. He didn't want to accuse Stella; he wanted her to have a lovely evening with him. He said, “Sure, we'll talk to the guy.”

Edgar wanted to help Stella, but he wanted something for himself, too. He said, “Would you like to do something together Saturday? Maybe a walk in the botanical garden and lunch? We can listen to warblers in the trees, feed goldfish in the pond, study the flowers, and even eat outside.

Edgar felt as nervous as if he'd asked Stella to marry him. Without looking up from her vegetarian noodle soup, she said, “I have papers to grade. I should do that.”

There was a silence and Stella looked up. She saw Edgar's downcast expression, was touched, and said, “But I'll need a break. What time?”



The journalist texted Stella that he'd meet them for drinks.

If, metaphorically speaking, Edgar had worked through his youth like an ant, with his nose to the ant path and not a glance at the alluring dissipations to his right and left, then David Lutz had misspent his youth like a grasshopper. Not until he was thirty did it dawn on him that if he wanted to continue to indulge in sex and drugs and rock-and-roll, and especially in sex, he had better find himself a career. In middle age, a man's attractiveness can no longer be founded on good looks and promise. So he'd made a late entry into the world of journalism.

Edgar and Stella met David in a fashionable hotel bar, a room of wood, tile, and textures, discretely divided into sections offering privacy or publicity. Entering with Edgar, Stella looked around at the men and women dressed in business chic and wished she'd worn something flashier than black slacks and a jacket. Ah, well.

A handsome guy sitting alone at at table smiled when he noticed Stella. He looked completely at home in the rather posh bar. Stella touched Edgar's arm and they moved toward the table.

Edgar noted David's Teutonic blond hair, square jaw, and athleticism, and concluded that the guy just did not look very intelligent.

After some introductory unraveling of how David had heard about them and ordering of drinks, David said, “I'm sure you're both busy, so let me get to the point. I hear that you're collecting research studies where medications currently in use are shown to be no more effective than placebos.”

Edgar said, “Not exactly,” and he looked uncomfortable.

“If I got it wrong, I'm not surprised,” David said. “What are you doing?”

Edgar said, “It's hard to know how to synopsize, especially at this early stage.”

He thought he should have realized the journalist would ask that. He should have had an answer ready. Instead, he struggled to form his complex thoughts about their research into an answer. He looked at Stella despairingly. She frowned and looked into her drink for a moment. She turned to David and said, “OK. Imagine you are a pharmaceutical company and your drug, say, Amnesiac, was FDA approved years ago and has become the preferred treatment for... marital disharmony. As a matter of fact, it has earned a nickname: the forgive and forget drug. Unfortunately, recent research indicates that it is no more effective at promoting marital harmony than a placebo.”

Stella looked promptingly at David. He said, “So, why does everyone think Amnesiac works?”

David looking admiringly at Stella. Edgar hoped it was because of her clever explanation.

Stella said, “Good question. Because placebos work. Perhaps Amnesiac's apparent effect is caused by the patients' commitment to marital harmony, as demonstrated by going to a therapist and paying for the drug.

“After the trials that seem to show that Amnesiac is not biologically active, a scientist designs a meta-analysis to look at all the double-blind Amnesiac trials and crunch the numbers. However, she discovers a wrinkle: there were trials that were not included in the original FDA approval in 2007. She wonders why, and requests the full data from the FDA under Freedom of Information Act. Including that data, the meta-analysis finds that Amnesiac is no more effective than a

placebo.”

David frowned, then said, “I see how it works, but Amnesiac is not a real drug.”

“No,” said Stella, “but Prozac is, or rather Prozac and its class of antidepressants. The meta-analysis has been done. It was published as Listening to Prozac but Hearing Placebo: A Meta-Analysis of Antidepressant Medication 2 (lead scientist, Irving Kirsch, Ph.D.)”

“What about the trials the FDA used for approval?” asked the journalist. “Why did they seem to show the drugs were effective?”

“That is exactly our question,” said Stella. “Why did those trials produced false positives? We are wondering if there were structural problems in those trials. If so, we hope to identify them. Then we hope our research can be used to improve the structure of medical trials. In a purely scientific sense, I mean. We can't address the social factors that might make false positives attractive to certain entities.”

David nodded thoughtfully. He said, “That's provoking, and provoking is great for an article.”

Edgar said, “That was a brilliant, Stella.”

“I do lots of teaching,” she said.

“You have a dynamic, journalistic way of explaining,” said David, and he looked at Stella with clear admiration. “The public has a right to know, but the telling is more effective if it's amusing, delightful, or horrifying.”

“Whose journalism do you like?” asked Edgar.

“Hunter S. Thompson,” said David, without a moment's thought or hesitation.

“He didn't do science, did he?” asked Edgar, thinking, He was the gonzo guy, right? Fear and Loathing in Las Vegas? The Hell's Angels?

“Also Susan Orleans. She'd great,” David added. “I want to write about what you're doing but I can't picture the structure of the article. Can I look at the material you're looking at?”

​

“The information is public,” said Edgar.



​“How common is it for placebos to work as well as drugs?”

“It sometimes happens even with surgeries,” said Stella, and she described the rheumatoid arthritis experiment.

Edgar, not wanting David to misunderstand, said, “The placebo effect is always there. Even with substances that are biologically active, patients are effected by the color of the pill, how often they take them, what the physician says, and other placebo-type factors.”

“That makes medicine seem pretty random,” said David.

Edgar frowned. “Getting well involves a complicated mixture of physical and mental factors. A drug only addresses part of that.”



The next day on the phone, Stella said, “David's bright and amusing. He understood what we said. I liked him. He's probably a good writer.”

“What could he write that wouldn't be premature?” asked Edgar.

“I think he wanted to make sure he was first to talk to us. You know how it works. If research looks important, there's a rush of journalists.”

“And they write ignorant articles that take the hypothesis for the result or blow the result all out of proportion,” said Edgar.

“Don't be negative.”

“Then the articles are challenged, without regard to the actual research, and there is a stampede of media in the opposite direction, shouting, “The research was wrong! This is terrible!”



“Yes, but still, don't be negative.”

“I'm sure you've read about the excitement over cancer-causing viruses in the 1970s,” said Edgar.

“Yeah, yeah,” said Stella. “A bunch of scientists lived well on all that stupid research money.”

“If viruses are the cause of cancer, the mechanisms are diabolically complicated. After all these years, and all that money, just a couple of cancer vaccines have been created, for hep B and human papilloma virus.”

“And wouldn't it be nice if cancer was caused mainly by a virus rather than pesky, complicated environmental factors? You can understand why non-scientists went for that idea, but what about the scientists?”

​

“Scientists can be just as self serving and wishful-thinking as anyone else.”



Stella was correct about David Lutz. He wanted to be the first journalist to talk to them in case there was a scoop to be had. Like Stella, he wanted tenure, or rather, a tenure-like situation in the world of journalism, with a real salary instead of the peanuts he got as a freelancer, and some security. Benefits would be nice, too.

From what he'd originally understood, David had in mind an expose of medicines that do not work. He imagined a colorful sidebar listing them and their costs compared to sugar pills. It would be scandalous.

But that article was not to be. That was not what Edgar and Stella were working on. David texted Stella to ask for a second meeting. He wrote, “You mentioned experiments that include placebo surgeries. Can you show me some?” and of course they could.

After looking through surgery experiments whose journalistic potential had already been exploited, David said, “I'm bothered by the fact that placebos work.”

Stella said, “Whatever helps us heal is good.”

Edgar said, “If you're thinking negatively about medicine in general, you shouldn't be. There's lots of real progress. For instance, today a surgeon can work on your heart by going up through an artery in your groin, rather than sawing your chest open.”

“That's a relief,” said David. “Still, it's appalling that the FDA approves drugs and treatments that perform only as well as placebos, considering the expense and the side effects.”

“It's the nature of science to make mistakes and correct them,” said Edgar.

“That's not reassuring.”

“People who want to be reassured should not look at medicine too closely,” said Edgar. “Medicine is messy. For that matter, they shouldn't look at the rest of messy reality too closely.”

​

The article:

David's thesis was that medicine was rife with guess work, opinion, and inaccurate research, all presented to the public as scientific certainty. He did not state this bluntly but led the reader with questions: how often are FDA approved medications later judged ineffective or too harmful to use? How often do the preferred treatments for common problems, like back pain, turn out to be worthless or harmful?

Having created a thesis, David felt invested in it and looked for support. If he'd been a Star Trek character of the Vulcan race, he would have looked at all the available evidence impartially, but Vulcans do not write impassioned articles about the breakdown of medicine in America. Besides, Vulcans are a fiction, just a rational ideal created by humans.

Writing the article was far more interesting than David's typical free lance assignment. He reported on boring city council meetings and investigated fires, traffic accidents, and depressing accidental deaths. David especially hated house fires. Too often, he had to ask a woman who'd just lost everything, even her children's baby photos, if there could have been a meth lab on her property and whether she knew her husband's whereabouts.

David titled his article Scientists' Research Shows the Unreliability of Scientific Research and added a warning: If you like to believe that medical decisions are clear and simple, do not read this.

Besides a description of the Prozac research Edgar and Stella were mining, David pointed out:

1) That hospital acquired infections, HAI, are among the top causes of US deaths. [3]
2) The prevalence off-label use of pharmaceuticals, meaning their prescription for non-FDA approved purposes. “How is that different from prescribing a non-approved drug?” the journalist asked.
3) The common use of less expensive drugs imported or re-imported from other countries.
4) That medical tourism for surgery, especially to countries like India, by Americans who could not afford medical care at home.

David presented facts, examples, and anecdotes. He concluded that the main effect of medical regulation was to reassure people that they were receiving treatment that was proven, but that was often far from true. “Maybe being reassured by medical professionals that ineffective drugs work has a laudatory placebo effect, but it is awfully expensive,” he wrote.

Scientists' Research Shows the Unreliability of Scientific Research ran in Inside Magazine, a more prestigious 'zine than any that had previously published David's writing. Its first beneficial result was that a literary agent phoned and offered to represent him. The agent said, “Your article is electrifying. You understand how to engage readers.”

David was elated, but he found that he was in no hurry to call Stella or Edgar with his good news. Finally, he emailed, with mitigating statements: “This is not about your work, but I did mention you in relation to other concerns. I'll certainly write about your work as soon as it is complete.”

Stella and Edgar read the article together at a coffee shop. Stella said, “Is this a general attack on medicine, or on science?”

Edgar said, “At least the subtitle is good: reader, beware.”

“Beware of the writer! This is totally one-sided.”

“I hope other scientists don't blame us for this.”

“It could wreck the usefulness of our work,” Stella said. “People will think we're attacking medicine. He's betrayed us.”

“Well, it's not like he promised us anything.” Edgar wondered at Stella's vehemence. Weren't journalists usually like that? He said, “I always thought the guy was a jerk.”

“Dang, I can just see the tenure committee reading this. Our department is endowed by medical interests.” Stella frowned. “Can we do anything?”

“We could ask the magazine if we can write a rebuttal.”

“Our rebuttal wouldn't be of the article David wrote. That's not what we're working on. Don't you feel betrayed?”

“Not really.”

“He used us.”

Edgar did not understand why Stella was so angry, but he felt for her. She was worried about their research, she was worried about tenure, and she was worried about her future. He was so concerned about her and so engrossed in her problems rather than his own, that he reached out and took her hand.

Stella had been brooding. She looked up at Edgar with a happy expression of wonder.



A politician notices the story:

In Las Vegas, a young staffer for Representative Z., Evelyn Reed, read David's article while she ate a Starbuck's egg salad sandwich at her desk. When she finished, she walked down the hall to her boss's office, found him watching a news show on his computer, and said, “Have you seen this about the placebo effect and medicine? It sounds as if the results of medical research are pretty random. So why do scientists claim their experiments show the truth about the physical world?”

“Mmmm,” The Representative said. He represented Nevada as a member of the No Such Thing as a Free Lunch Party, the libertarian group that had metamorphosed into a viable third party by creating local franchises that were free to be socially conservative or liberal. Truth was, the Representative hoped to be a presidential contender. As he glanced at the magazine Evelyn held, he noticed the way the ruffle of her blouse framed a hint of her cleavage. She was an attractive young woman, he thought, built with Nordic splendor. She would make a nice treat for a mature and deserving man such as himself, a sublime afternoon dalliance. Unfortunately, she was religiously and socially conservative, and you could not alienate that wing of the No Free Lunch Party if you wanted to prosper within it.

Evy noticed the Representative's notice. Her mother had explained the facts of life to her before she moved to Nevada: from the Representative, she would getting experience and a fine resume item. In return, h was likely to want something physical from her, oogling at least, a caress or a kiss, and so on. It was Evy's job to make him feel satisfied with as little as possible.

The Representative said, “I'm not enthusiastic about Inside Magazine.

“Neither am I. But it says here that the FDA, a big, expensive bureaucracy for evaluating drugs, often gets it wrong. They approve things that don't work. It says, let's see, quoting an article from Wired, in an irritable bowel syndrome study where no patients got the real medicine, volunteers with more doctor interaction got as much relief as people who took the two leading prescription drugs for IBS.'”

Evy looked up, “And it says people spend more than $40 billion a year worldwide treating IBS.”

“Let's see that,” said Representative Z.

He pulled a chair as close to Evy as he could and read the article. Then he poked the magazine with his index finger and said, “This strikes at the heart of the way we regulate medicine. It strikes at the heart. All the talk about deregulation has been about the business side: who pays, limiting costs, controlling fraud, and so on. On the medical side, what do we do? We allow two monopolies, the FDA and the AMA, to run the whole shebang. And why? Because we assume that the FDA and the AMA are better informed than the rest of us.”

Evy was taken aback. From her point of view, the article seemed like a rebuttal of the claims of science in general, claims to study reality in ways that could discover truths apart from God's word. She said, “I thought it was about how science doesn't work, how it lies.”

The Representative slapped the page and said, “Seems like the FDA and AMA are more informed than the rest of us, but no better informed.

“Honey,” he said to Evy (he allowed himself that), “I think you've stumbled onto something important here.”

A week later, Representative Z. announced a press conference at which he would propose, “...A radical new approach to health care and a truly libertarian approach to healing our sick and bloated health care system.”

The Representative was escorted into the press conference by a small herd of aids and advisers, none of whom knew what he would say. He adjusted one of the microphones, made himself ostentatiously comfortable, looked down at the assembled journalists, and began, “We have listened to all kinds of proposals to reform medical care in this country and to slow its obscenely ballooning cost. Every one of those proposals has involved new regulations. No one wants to prune away regulations because some special interest benefits from each of them, and there are lobbyists being paid to support every one. Years ago President Eisenhower warned us about the military industrial complex, but today it is the medical industrial complex we should fear. Therefore, I will sponsor a bill to deregulate the medical industry completely.”

The Representative paused while a wave of talk swept the room: completely? What exactly did he mean?

“I do not mean just financial deregulation. Medicine is a monopoly, or rather two monopolies. It is a monopoly of a public bureaucracy, the FDA, and of a private organization, the AMA. Why do we tolerate these monopolies? Because they know more about medicine than the rest of us. That is certainly true. In trade for a more expensive medical system, we expect their superior knowledge to keep us safe.

“But do they keep us safe? What, in fact, do the FDA and the AMA base their opinions on, their decisions about which drugs and treatments we may have and who can deliver those services? Why, on medical research and accepted therapies. Well, my staff has been researching medical research, and has discovered some very disturbing facts.”

The Representative repeated his version of the information in David's article and said, “I was as surprised as you are. I have been duped and I'm angry about it. Many factors distort medical decisions, including fads in treatment, poorly designed research, suppression of undesirable results by pharmaceutical and medical device companies, the use of prescription drugs for non-approved treatments, mistakes in hospitals, and so on. Why, then, should two cartels control American medicine? Considering their record, who are they to say that a prescription drug is more effective for irritable bowl syndrome than having your tarot read, a nutritionist's prescription to eat more kale, or prayer?”

Representative Z. paused and enjoyed the laughter and noise of the crowd. Then he said, “Shouldn't the American people be trusted to choose their own care? Americans are already defacto doing that by purchasing drugs from other countries and traveling elsewhere for surgery. I propose that we deregulate medicine and let the individual have both the freedom and the responsibility to determine his own health care.”

The Representative held up a hand until the audience quieted again. He said, “Some of you will fret about the danger of the overuse of antibiotics and other concerns like that. Well, antibiotics are being overused all over the world. We can't stop that. Here, we give them to pigs and cows without a prescription, to fatten them for market, but a working mother cannot buy an antibiotic to treat her child's recurring ear infection without paying a pound of flesh to an MD and another to a drug company. Is that fair?

“Medical decisions should be in the hands of those they effect: the people. Thank you.”

A roar of questions erupted, but Representative Z turned and left, followed by his aids.

Back in his office, the Representative said, “I didn't want to answer questions. Let the media stew and speculate. They'll help us judge the public reaction. Whatever they say can only be good for me.”



David Lutz called Representative Z. to ask for an interview. He agreed to meet David and took Evy with him in a secretarial capacity. The Representative said to David, “I'm talking to you because your article was the seed of my proposal. This young lady brought it to my attention.”

“I don't think my article implied that completely deregulated medicine would be an improvement,” David said.

“That was a bold leap of imagination, I agree. You didn't see the bigger picture or the position of your research within the political landscape. That's not your job.”

“Wouldn't it be dangerous to deregulate medicine? Don't you think desperate people are easy victims, both financially and medically?”

“Being sick or injured is already dangerous. You pointed that out. Who has a greater interest in your recovery, you and your family or a doctor, hospital, insurance company, or government bureaucracy?

“You know,” said the Representative, “Car accidents are the most common cause of death in America and some cars are much more dangerous than others, yet we allow people to drive convertible sports cars or whatever else they want. Maybe we should prohibit things that can kill, but that is not what we do. If you want that, you have to go to a different country.”

“If your bill is passed,” David said, “how do you imagine medical care will be delivered?”

“I'm a libertarian populist trying to liberate medicine. I believe the free market will step in. If your ailment is simple or repetitive, you might find what you need on the web. A web site might advise you about what tests to get, or tell you to wait a few days to see if you get well, or to go to an emergency room. New businesses will spring up. If you prefer to see someone in person you might go to an MD, to a nurse, or even an herbalist. Entrepreneurs will develop subscription web sites that provide information. We may also see subscription urgent care centers. Who knows?”

After David's interview was published, Evy said to Representative Z, “I thought that first article read like ammunition for an attack on the National Science Foundation and the public funding of science.”

The Representative said, “The NSF is small potatoes, honey. Besides, they provide economic benefits. Research they support is used by private companies very successfully.”

“The pharmaceutical companies are big donors to political campaigns. If medicine is deregulated, won't that hurt them?”
The Representative scrutinized Evy. She had never questioned him so aggressively before. It was not attractive behavior. He said, “The drug companies will do fine as long as people buy drugs. The NSF is small potatoes.”



A response to the the Representative's speech:


A donor to Representative Z.'s campaigns, a libertarian entrepreneur, set up a meeting between himself, the Representative, and  “an interested party.” Evy was also present. She'd become the Representative's preferred note taker.

The donor said, “Representative Z., I'd like you to meet Mr. Miller. He has investments in a number of promising medications created by private companies that are not yet FDA approved.”

The Representative nodded, understanding the man's concerns but not understanding what he wanted. He said, “How can I enlighten you?”

“If this idea has legs, if it's going somewhere, it will pay to be ahead of the ball. There's no reason to initiate the expensive FDA process if that process is about to be abolished.”

“Ah,” said the Representative.

“We wonder what you believe will be passed into law, and how long it might take.”

“Well,” said the Representative, and he glanced at Evy. He had not thought to try to calculate that. “It will take very good communication to convince everyone necessary that it's a good idea.”

“I see,” said Mr. Miller. “I think you will find help with communication. Meanwhile, a time frame would be useful. You probably have not considered the details, that's not your job, but how will pharmaceuticals be delivered? Over the counter, certainly, and through the mail and on line. But will a small entrepreneur be able to buy in bulk and sell in small towns, like old time patent medicine salesmen? We've been taught to laugh at patent medicines, but some of them used biologically active herbs like willow bark, and some certainly worked by the placebo effect.”

The Representative nodded and Evy took notes. She was thinking that she'd seen the religious implications of David Lutz's article but had been blind to the medical implications.

Mr. Miller said, “You mentioned concern about the misuse of antibiotics and answered that concern very effectively. People will also be concerned about drug abuse and addiction. Currently, we track purchases of controlled substances such as the opiates and marijuana. That's expensive and would be totally contrary to the spirit of your proposal. I expect that after your bill passes, we'll be able to buy opiates freely, to ease the pain of the dying, for instance, but I would like to know for sure.

“I've asked these questions,” Mr. Miller went on, “because the answer to each will define advantageous new business niches, depending on the form the new health care system takes.”

Ah yes, thought the Representative, there's the heart of it. New businesses will create wealth, special interests, and political contributions. He said, “I don't have the information you want right here, but I'll get back to you.”

Evy was thinking too. She considered herself a thoughtful, moral, and compassionate person. She saw herself as an idealist who wanted to make things better. She'd instigated this, but things were developing in a way that was unexpected, disturbing, and possibly even dangerous to the average person's health care. She decided she should talk to her minister.

​

Notes:
[1] Bailey, Regina. "Cancer Viruses." About.com Education. About.com, n.d. Web. 05 Feb. 2010.
[2] Kirsch I,  Deacon BJ,  Huedo-Medina TB,  Scoboria A,  Moore TJ,  Johnson BT.  Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med. 2008;5:45
[3] Klevens RM, Edwards JR, Richards CL.  et al.  Estimating healthcare-associated infections and deaths in U.S. hospitals, 2002.  Public Health Rep. 2007;122(2):160-166
The CDC estimates that about 1.7 million HAI in 2002 caused or contributed to about 99,000 deaths. In 2002 a total of 2,443,387 deaths occurred, including all causes.
[4] Moseley JB, O'Malley K, Petersen NJ, et al. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med 2002;347:81-88
[5] Goldacre, Ben. "Don't Dumb Me down." The Guardian. Guardian News and Media, 07 Sept. 2005. Web.
[6] Goldacre. "Bad Science." Bad Science. N.p., n.d. Web. <http://www.badscience.net/>.