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Wednesday, May 9, 2012

Ask Your Doctor if This Big Pharma Scam Is Right for You: The Dangers of a Drugged Up America



In medicated America, the fix for every problem is just a prescription away. Except that it's not.

Butterflies waft across a beautiful field of spring flowers. A delightful young family bicycles joyously down a country lane. A couple on a park bench leans sensually into each other. A 40-something woman's face radiates with both perfect beauty and internal happiness. "All's right with the world," is the message... as long as you've taken your dosages of Lunesta, Celebrex, Cialis, and Botox.

Welcome to medicated America, where the fix for every problem--from incontinence to erectile dysfunction, stiff joints to mood swings, weight gain to wrinkles-- is just a prescription away. Thus the beautiful images, stirring music, attractive actors, and soothing words in the omnipresent, multibillion-dollar kaleidoscope of drug advertising by Pfizer, Merck, Eli Lilly, Johnson & Johnson, and other giants of Big Pharma--all pitching their particular brand-name nostrum directly at us hoi polloi (the industry spends a fourth of its income on ads and other promotions, nearly double its expenditures on research and development). The corporate come-ons typically conclude with a phrase that has achieved cliche status in America's vernacular: "Ask your doctor if 'Suprema Wundercure' is right for you."

The better question, though, is one that cartoonist Dan Piraro expressed in one of his "Bizarro" panels: "Ask your doctor if playing into the hands of the pharmaceutical industry is right for you."

One would assume that in a rich, medically advanced, health-conscious nation like ours, dicey decisions about whether to allow a particular pharmaceutical product into our bodies would be among the most rational we make--as determined by (1) the best science available, (2) the strict moral duty of medical purveyors to "First, do no harm," (3) good government regulation, and (4) the profession's fear of public reproach and legal punishment. One would, however, be wrong on all counts:
  • Science has been supplanted by rank hucksterism
  • The strictest "moral duty" of corporate executives has been reduced to maximizing profits
  • A "good" regulation is one that's good for profit seekers
  • Public reproach is just a momentary embarrassment to be covered over by corporate image makers
  • Legal "punishment" never includes jail time, but only a fine that's easily absorbed as a necessary cost of doing business by these immensely profitable entities.
In the past three decades, America's healthcare system has radically metamorphosed from a public service network (largely run by independent physicians and nonprofit hospitals) into a corporate profit machine--one that Dr. Arnold Relman, the renowned former editor of the New England Journal of Medicine, calls the Medical-Industrial Complex. Drugmakers have been among the most ambitious, in-your-face pushers of this transmutation of medicine into just another commodity to be sold by hook or crook. In this system, the concept of "care" has been reduced to "caveat emptor," with the shareholders' interest in monetary gain overriding all other interests.

The DTC contagion

A fast-moving, systemic epidemic called DTC has swept across America, endangering public health, jacking up our costs, and weakening the curative connection between health professionals and patients. DTC stands for "Direct-to-Consumer" drug advertising. It's a plague of marketing, empowering profiteering corporations to short-circuit the judgment of doctors by using all of the tricks of Madison Avenue (including lies) to convince viewers and readers that (first) they're suffering from a particular malady, (second) the advertiser's brand-name medicine is the very best cure, and (finally) they must go to their doctors pronto to insist on getting a prescription for that specific drug. The essence of this marketing scheme is to turn consumers into sales representatives for drug peddlers. Brilliant.

Prescribing medicine through the television, radio, print, and internet ads of corporations (whose sole motive is to sell more pills) is so crass, so awash in conflicts of interest, and so inherently dangerous that only two countrieshave ever legalized it: New Zealand in 1981 and the USA in 1997.

In our country, the corporate-friendly government of Ronald Reagan first okayed DTC drug ads in 1985, but his Food and Drug Administration ruled that pages-long consumer warnings about health risks had to be included, so there were few takers. Then came Bill Clinton's corporate-friendly government, which issued a revised FDA rule in 1997 allowing drugmakers to dodge the full disclosure provision--as long as their ads met an "adequate" standard for informing consumers about risks.

Such squishy words (slipped into regulations by industry lobbyists) are a corporate wet dream. Thanks to the adequacy loophole, fluffy-puffy, no-worries prescription drug ads quickly mushroomed. In 1997, spending on DTC ads was only $220 million; by 2002, it was $2.8 billion; and it has kept a steady pace of roughly $3 billion a year ever since.

Corporations don't spend that kind of money to dramatize the severity of their products' nasty side effects. As two ad execs giddily put it in a 1998 report to the industry, "The ultimate goal of DTC advertising is to stimulate consumers to ask their doctors about the advertised drug and then, hopefully, get the prescription." Obviously, to "get the prescription," corporate ads don't stress such unpleasant outcomes as these (taken from the small print of full-page ads for just a half dozen heavily advertised drugs): very high fevers, confusion, uncontrollable bowel movements, trouble swallowing, lower sperm count, prostate cancer, loss of vision, suicidal thoughts... and, of course, death.
Side effects do have to be addressed, but not conspicuously--for example, it's "adequate" for an off-camera announcer to buzz through them with a muted, fast-paced delivery (usually while cartoon butterflies flutter playfully on-screen to distract viewer attention). It's a disgusting, dishonorable way to generate sales--but it works. In 2008, the House Commerce Committee found that every $1,000 spent on drug ads produces 24 new patients, and a2003 research report found that prescription rates for drugs promoted with DTC ads were nearly seven times greater than those without such promos. Ethics aside, these consumer hustles have proven to be profit bonanzas:

  • From 2000 through 2004, Merck & Co. poured more than $500 million into adverts promoting Vioxx, turning the pain pill into one of the "Top 100 Megabrands" listed by Advertising Age. The drug was meant for the relatively few people who can't stomach aspirin, but the PR push touted it to all arthritis patients, a much larger marketing pool. The campaign promised "everyday victories" over pain and immobility, featuring former Olympic skating champ Dorothy Hamill spinning effortlessly (and pain-free) on the ice. Merck's ads sold some 20 million Vioxx prescriptions, including to people who paid the ultimate price for buying the hype--a 2005 research report in The Lancet, the prestigious British medical journal, attributed as many as 140,000 sudden cardiac "events" in America to the use of Vioxx. In September of 2004, Merck took the pill off the market over "safety concerns." As an expert pharmacy consultant toldForbes magazine in 2006, "Vioxx wasn't a bad drug for everyone, it was a bad drug for certain patients. Unfortunately, people saw the ads and started demanding the drug from their doctors." That's the deadly power of mass advertising for drugs.
  • Some ads are simply frauds, including one that Pfizer ran on TV until 2006, hailing the prowess of the company's cholesterol-lowering drug, Lipitor. The star of the spot was Robert Jarvik, who was described as the well-known "physician" who was the "inventor" of the artificial heart. In a picturesque outdoorsy setting, he was shown vigorously rowing a boat across a lake--visual "proof" that his own heart was in robust condition thanks to his use of Lipitor. His tagline was: "You don't have to be a doctor to appreciate that." Good, because he doesn't practice medicine, and while he worked on the artificial heart, he did not invent it. Oh, he also wasn't rowing the boat--a double played that role. Embarrassed, Pfizer had to yank the ad--but it continues to merchandize Lipitor with some $250 million a year in commercials, generating about $11 billion a year in sales, more than any other pharmaceutical in history.   
  • Bear in mind that these pitches are being made to consumers who cannot just go purchase the product--only licensed medical professionals can diagnose and prescribe. But, again, the promotions work, as an industry spokesman happily affirmed: "There's a strong correlation between the amount of money pharmaceutical companies spend on DTC advertising and what drug patients are most often requesting from physicians." He also noted that the trumpeting of brand-name pills "is definitely driving patients to the doctor's office." No surprise, then, that prescription drug use has soared in the past decade, during which spending (by consumers, private health plans, and governments) more than doubled. A 2010 survey by the National Center for Health Statistics not only found that about 35 percent of Americans over 60 take five or more prescription medicines a day (more than twice the intake in 1999), but even 22 percent of children under age 12 are on at least one Rx regimen. "People may be taking too many drugs," deadpanned the NCHS leader. And in recent years, a whole new market has opened up for DTC hucksters: Medical devices. In 2007, Johnson & Johnson launched the first mass-audience TV commercials for highly specialized, complex therapeutic devices. This is beyond odd; it is dangerous. Only expert practitioners have the knowledge and experience to judge whether one brand-name medical gizmo is superior to another. Yet, here was J&J doing a pitch to us clueless consumers for "Cypher," a drug-coated coronary stent for opening closed arteries. I'm all for consumers getting more say in health care, but--come on!--how would I know enough about the efficacy of various stents to instruct my doctor to "Make mine Cyphers"?
The DTD contagion

In addition to getting you and me to push particular products on our doctors, the drug and device industry runs a massive, sophisticated, and relentless "Direct-to-Doctor" sales program that skates on the thinnest ethical ice and frequently plunges all the way into illegality. While these efforts, costing more than $6 billion a year, occasionally pretend to be "educational," they are in fact an elaborate exercise in medical flimflammery--nothing but a door-to-door ploy by each of the major makers to hoodwink your doctor into prescribing their brand-name pill, rather than a competitor's brand or a generic.

To do this, the biggest of Big Pharma deploy an astonishingly large force of "sales reps" all across the country--90,000 of them! That's roughly one for every nine physicians, and they swarm non-stop into doctors' offices--one Virginia physician says his office had to set a quota of three visits in the morning and three visits in the afternoon in order to get any doctoring done. They are highly trained in persuasive arts, motivated to make the sale at all costs, and alarmingly successful (a 2003 Blue Cross survey found that more than half of "high-prescribing" doctors relied on the reps as their main source of information about new drugs).


What occupational sub-group of Americans are, by far, the most heavily recruited to take jobs as drug reps? You might think pharmacists, marketing consultants, or even used car salesmen. All wrong.  


College cheerleaders.

Hey, the point is to "make the sale," to entice this mostly male profession to switch from A to B. Solid scientific evidence is one thing, but winks apparently work, too--and who's twinklier, prettier, more buffed, peppier, or more gregarious than cheerleaders? The University of Kentucky, which boasts champion-level cheerleading squads, has been one of the premier movers of talent from pompoms to Pharma. A UK "cheering advisor" notes that his perky collegians are naturals for sales rep positions: "Exaggerated motions, exaggerated smiles, exaggerated enthusiasm--they learn those things, and they can get people to do what they want." He says he routinely receives calls from drugmakers seeking to hire his graduates. "They don't ask what the major is," he says.

The demand is so high that an executive of a business that runs cheerleading camps set up a specialized employment firm in 2004 called"Spirited Sales Leaders." Based in Memphis, it funnels hundreds of former cheerleaders into drug sales.

"There's a lot of sizzle" in being a sales rep, he explains, and these experienced sizzle-generators can earn six figures a year, counting bonuses, for pep-talking doctors into writing more prescriptions for their companies' medicines.
Not that these upstanding corporate citizens would stoop to hiring salespeople based on their sex appeal. No, no, explained a top executive of Bristol-Myers Squibb: "[It] has nothing to do with looks, it's the personality."

Sex appeal or not, the essence of the job is manipulation, and reps are highly trained and well armed to ingratiate themselves with each individual on their list of doctor-clients. Adriane Fugh-Berman, a doctor and professor at the Georgetown University Medical Center, is a drug company watchdog who has studied the doctor-sales rep relationship. In a 2007 article, she reported that the salespeople play to a doctor's feeling of being overworked and underappreciated: "Cheerful and charming, bearing food and gifts, drug reps provide respite and sympathy; they appreciate how hard doctors' lives are and seem only to want to ease their burdens. But every word, every courtesy, every gift, and every piece of information provided is carefully crafted, not to assist doctors or patients, but to increase market share for targeted drugs." Here are key elements of the DTD operation:

The file.

Each doctor is a mark, and drug reps are trained intelligence gatherers who build and constantly update a computerized corporate file on the doc's personality, preferences, interests, and any personal tidbits that might help them change his or her prescribing habits. The strategic goal of good reps is to become each doctor's trusted "friend"--not unlike the relationship that lobbyists try to cultivate with lawmakers.

The data.

How can pill peddlers know which ones your doctor is prescribing--isn't that a private matter? Not in today's bluntly intrusive world of commercial data mining. A majority of pharmacies sell their records of every single prescription written by doctors doing business with them. This vast trove of computerized info is bought by such data hawkers as IMS Health, which procures prescriptions from about 70 percent of US pharmacies. While the names of patients are deleted, the name of the doctor who wrote each prescription is easily discernible, so pharmaceutical giants pay millions a year to buy, slice, and dice the electronic data on exactly which medicines each doctor has ordered and in what quantities. This is regularly fed to the laptops, iPads, and even smartphones of the sales reps on the ground--allowing them to target their daily pitches, and to precisely and carefully track the slightest of changes in a doctor's prescribing habits.

The gift.

Reps don't go to a physician's office empty-handed. Gourmet donuts and lunch treats for the entire staff are daily routines, and doctors and key staffers are treated to dinners at fine restaurants, holiday gift baskets, tickets to a game or show, and such nice personal presents as a silk tie or a monogrammed golf bag. A New York Times report in January of this year says that two-thirds of doctors accept such goodies. For the heavy prescribers of a drugmaker's concoctions, the gifts grow ever-larger--a ski trip to Aspen, an invitation to make weekly paid "lunch and learn" presentations in other doctors' offices, an honorarium to make brief comments at a conference in some five-star resort (complete with an "educational grant" to cover the bar tabs and other incidentals), big-buck "consulting" contracts that require practically no work, and outright cash payments for prescribing particular drugs. The Times' January report found "that about a quarter of doctors take cash payments" and "that they are more willing to prescribe drugs in risky and unapproved ways."

The hoax.

Few doctors are experts in the chemistry and biological impacts of particular medicines, so they rely on honest studies and tests (as reported in credible medical journals) to give them an un-hyped, non-sales-rep picture of the pluses and minuses of the drugs they choose to prescribe to you and me. Unfortunately, this process, too, has been corrupted--drugmakers have regularly paid doctors and researchers to conduct studies and publish results without revealing their financial ties. Pfizer, however, sank this sales-over-science approach to new lows when it launched its antidepressant, Zoloft, in the 1990s. It hired an advertising firm to fabricate "studies," write them up as salutary reports about the drug, pay some big-name psychiatrists a couple of thousand bucks each to put their names on the reports, and convince major journals (read by thousands of doctors) to publish the ghostwritten "findings." About half of the medical articles about Zoloft at that time were ad agency fakes. Journal editors, embarrassed by being scammed, have since imposed safeguards, but many doctors and observers say that up to 20 percent of major journal articles are still being ghosted.

We can do better

DTC and DTD are just two surging branches of the central stream running through America's healthcare industry--an out-of-control stream that should be labeled DTP--"Direct-to-Profit." The very fact that healthcare, an essential human need, has been twisted into an "industry"--a commercial activity for the purpose of maximizing profits--is a damning measure of its moral bankruptcy.
As avaricious and monopolistic drug corporations have demonstrated again and again, "care" is treated, at best, as an externality to their real work of making money--and at worst as an impediment to that corporate imperative. Thus, top executives and boards of directors constantly seek ever more sophisticated forms of deception and manipulation to, at all costs, make the sale. In this ethos, such loathsome products as blatant price gouging, artificial shortages of vital medicines, deliberate promotion of pills that kill, falsification of medical research, and routine corruption of doctors are not merely tolerated, but expected and accepted as normal.

Is this the best that this great, super-rich country can do? Of course not--we Americans can, must, and will create a system that puts public need over private greed. This month's "Do Something" features some groups leading the way. I'll give the final word to Dr. Relman, the thoughtful, insistent, and unflagging voice for an ethical and sensible system of care built around the concept of "Medicare for all." A decade ago, he wrote that "our health policies have failed to meet national needs because they have been heavily influenced by the delusion that medical care is essentially a business... A different kind of approach could solve our problems, but it would mean major reform of the entire system... Since such a reform would threaten the financial interests of investors... the short-term political prospects for such reform are not very good. But I am convinced that a complete overhaul is inevitable, because in the long run nothing else is likely to work."

Jim Hightower is a national radio commentator, writer, public speaker, and author of the new book, "Swim Against the Current: Even a Dead Fish Can Go With the Flow." (Wiley, March 2008) He publishes the monthly "Hightower Lowdown," co-edited by Phillip Frazer.

Thursday, May 3, 2012

Hate Meat? It May Be in Your Genes

WebMD: Better information. Better health.

Healthy Eating & Diet

Hate Meat? It May Be in Your Genes

Study Shows Some People Carry Genes That Make the Smell of Meat More Intense and Unpleasant

WebMD Health News
grilled steak 
May 2, 2012 -- Whether we like or loathe the smell of a frying pork chop may depend on our genes, a new study shows.

The study, published in the journal PLoS ONE, is one of the first to show how genes may shape our food choices.

"People who are instinctively vegetarian or vegan or instinctively heavy meat-eaters, it could definitely have some sort of underlying biological component to it," says Kara Hoover, PhD, a biological anthropologist and assistant professor at the University of Alaska Fairbanks. She was not involved in the current research.

"When you consider that our food preferences are driven by flavor, which is the intersection of taste and odor, with a heavier emphasis on odor, clearly genetic variation in humans is going to make a difference in how we prefer food," Hoover tells WebMD.

How Genes Influence Smell

People detect odors thanks to tiny chemical receptors that sit on nerve cells inside the nose. In total, we have genes for about 400 different smell receptors that help sense about 10,000 different odors.

Some of those receptors detect the steroid androstenone, which is found in high concentrations in male pigs.

Farmers have known for some time that uncastrated male pigs can produce meat with a strong odor, so most commercially raised animals in the U.S. are castrated to get rid of the smell, which is known as boar taint.

Previous research found that people who have two copies of a gene that helps sense androstenone -- scientists think that's about 70% of the population -- are able to smell the chemical. These people can have a mixed reaction to the pork.
"For those who are very sensitive to it, it's really disgusting. It's a sweaty, urine-like odor," says researcher Hiroaki Matsunami, PhD, an associate professor of molecular genetics and microbiology at Duke University in Durham, N.C. "For others, you can smell it, but it's not as bad. Those people say it smells fragrant, chemical, or sweet."

In contrast, people with only one copy of the gene or who carry another gene variant for the receptor aren't as bothered by the aroma of androstenone. They find the odor to be weak or unnoticeable.

Genes and Food Preference

In the new study, researchers wondered whether a simple smell test could predict who carries the single copy of the gene, and whether the gene influences the sniffer's perceptions of cooked meat.

It wasn't an entirely academic question. Europe is considering banning a practice that allows farmers to control the amount of androstenone in pork by castrating male pigs. Farmers are worried that consumers will turn their noses up at meat that contains higher levels of the hormone.

For the study, researchers recruited 23 healthy participants: 13 average eaters and 10 trained "sensory assessors," people with sensitive noses that can reliably pick out certain smells.

First, researchers added purified androstenone to two of three cups of water. People were asked to smell each cup and pick out the one that was different. If they were right, researchers classified them as sensitive. If they were wrong, they were considered insensitive.

Next, researchers had the study subjects eat cooked ground pork that had varying levels of androstenone added to it. They kept the levels within the range that might be naturally found in meat.

People were asked to rate the smell and the taste of the meat samples.
Next, researchers tested their genes. They found that all the people who could smell the androstenone had two copies of the gene needed to pick up the scent. These folks were also more likely to rate the taste of the pork with added androstenone as bad.

And everyone who had one copy of the gene could not smell the hormone. They were more likely to say the pork tasted good.

Still, "for those who cannot [initially] smell androstenone, if you try to smell this chemical every day for three weeks, about half of these non-smellers can acquire the ability to smell it," Matsunami says.

That suggests the ability to smell things isn't driven entirely by genes, but also by experience.

But, "it's a gene that's certainly influencing this preference, and I think people need to consider that fact," he says.

Tuesday, May 1, 2012

Cancer Wars: An Outcast Researcher’s New Theory


Cancer Wars: An Outcast Researcher’s New Theory

The scientific community disowned Professor Peter Duesberg for denying that HIV causes AIDS. But is there something to his new theory on cancer?

Peter Duesberg, a professor at the University of California, Berkeley. (Timothy Archibald)

Compact and white-haired at 75, Peter Duesberg has wide-set blue eyes magnified by corrective lenses as thick as his German accent. He is the picture of a courtly Old World scientist. But Duesberg is given to through-the-looking-glass scientific theories, the most recent of which, about the origins of cancer, could turn an accepted truth of molecular biology on its head. Viruses like hepatitis C don’t cause cancer, he says, and neither do collections of mutated genes — as nearly every other scientist believes. Instead, he argues, cancer arises when the number and appearance of a cell’s chromosomes become disrupted, leading to a tumor that has, in effect, evolved into a parasitic new species.

Some scientists think he could have a point. “There is something to what Peter Duesberg says,” says Mark David Vincent, a Canadian researcher and oncologist whose own unconventional theories about cancer overlap with Duesberg’s. But most others are skeptical. One reason may be that Duesberg is a pariah for his​ tenaciously held theory that HIV does not cause AIDS.
Duesberg works in a shabby laboratory on the campus of the University of California, Berkeley. He runs his experiments virtually alone. He has no graduate students and little staff support, and virtually no research budget, apart from some limited private funding. Duesberg acknowledges that if he weren’t a tenured full professor, he probably would have been gone long ago.
Duesberg once was highly respected by his peers. After arriving at Berkeley in 1964 with a doctorate in chemistry from the University of Frankfurt, he, in short order, extracted the RNA of the Rous sarcoma virus, shown to cause tumors in chickens, and in 1970 co-discovered a viral gene that seemed to promote cancer. He also helped plot the retroviral genome and won election to the National Academy of Sciences. “For a while I was the blue-eyed boy,” he says. “Now I’m the traitor from within.”

Duesberg’s career took a turn in March 1987, when he published a paper in Cancer Research that made two sensational claims: One was that retroviruses did not activate cancer-promoting genes; the other was that the newly identified HIV retrovirus did not cause AIDS. It did cause minor mononucleosis-like illness, he conceded, but not the lethal AIDS symptoms. As he explains it, “These questions were lingering in my mind. Why do we say these retroviruses are so bad when they’re found everywhere and hardly anyone ever gets sick?”
He would subsequently argue that gay men were dying as a result of their allegedly prodigious drug use rather than AIDS. Later, as the HIV genome was sequenced and antiretroviral drugs were introduced, he contended that the drugs themselves were causing the symptoms attributed to AIDS. Hemophiliacs who became infected through blood transfusions were already sick, he argued, and in sub-Saharan Africa, where AIDS was spreading among heterosexuals, malnutrition and parasites were the real culprits.

These ideas were discarded as further research supported the HIV hypothesis. But Duesberg seemed immune to the evidence, raising ever-flimsier objections to each new finding. He argues, for example, that Africa’s population wouldn’t have continued growing over the past few decades if AIDS really is a lethal communicable disease. Other scientists stopped taking him seriously. His government research funding dried up, and, for many years, most peer-reviewed scientific journals refused to publish his papers. So he took his case to the public, publishing a book and developing a small but devoted following, particularly among conspiracy theorists.

One of those followers was South Africa’s President Thabo Mbeki, who, in 2000, invited Duesberg, among other HIV skeptics, to serve as a consultant in shaping his government’s AIDS policies. Over the next few years, government officials cited Duesberg when refusing to promote the use of antiretroviral drugs. A 2008 study by two Harvard School of Public Health researchers, Pride Chigwedere and Max Essex, estimated that more than 330,000 South Africans had lost their lives to HIV/AIDS between 2000 and 2005 because of these policies, and it mentioned Duesberg by name. “The science behind Mbeki was Duesberg and other denialists,” Chigwedere and Essex wrote in a 2010 follow-up article.
• • • • • • • • • • • • • • •
Duesberg remains unrepentant. And he’s been equally stubborn about his radical theories on the origins of cancer.

His research in the 1970s had focused on tumor viruses because they were thought to alter human genes, thereby causing cancer. But as other scientists found evidence that humans carried genes that could mutate and drive cancer, Duesberg grew skeptical. For one thing, an ever-growing number of mutations seemed to be needed — dozens, in some cases — which he found implausible. Meanwhile, in Duesberg’s view, the mutation theory was further undermined by studies showing that many known carcinogens did not cause gene mutations in the first place.

Billions had been spent on the war on cancer, yet scientists had made little progress toward a cure. Could the research establishment be on the wrong track? “Nobody asks these questions,” Duesberg says. “People are so well trained not to ask negative questions.”

His focus shifted to the abnormal number of chromosomes that virtually every cancer tumor has — an observation first made by German scientist Theodor Boveri in the early 20th century. Most human cells have 23 pairs of matched chromosomes, half inherited from each parent, for a total of 46. This pattern is preserved each time the trillions of cells in our body divide and replicate. But in cancer cells something goes awry: there might be three or four chromosomes where there should be a single pair, or the chromosomes might be abnormally foreshortened. Such cells are described as “aneuploid.”

In a paper he published last summer in the journal Cell Cycle, Duesberg theorized that carcinogens might cause chromosomes to divide abnormally during cell division, creating extra copies of thousands of genes and disrupting the cellular machinery — an idea with parallels to a theory floated by Julian Huxley in 1956. These aneuploid cells usually die, but every so often the new genetic arrangement — called the karyotype — might enhance a cell’s ability to survive and clone itself. As these clones multiply, a tumor can emerge with a new, stable karyotype. The way Duesberg sees it, that tumor would essentially be a unique species, a parasite that feeds off its host.

Duesberg’s model resembles ideas advanced by some other researchers, including Henry H.Q. Heng, a molecular geneticist at Wayne State University, as well as Mark David Vincent, who treats lung cancer patients at the London Health Sciences Centre in Ontario, Canada. Vincent, who has referenced Duesberg’s theory in his own papers, believes that cancerous cells exploit an ancient survival mechanism, reverting to the form of protozoa-like organisms from before the time when single cells began cooperating to create multicellular organisms like us. “It became clear to me that the process of carcinogenesis involved a form of life emerging that was different from the host,” Vincent says. “We sort of converged on the same thing but from a somewhat different perspective.” Vincent sides with mainstream researchers in believing that genetic mutations are one of the things that initially turn normal cells cancerous. But he agrees with Duesberg that aneuploidy, which can entail a rapid reshuffling of genes, likely helps drive the growth and spread of tumors.
Vincent, who says people have warned him that Duesberg is “radioactive,” disagrees with the Berkeley scientist’s HIV/AIDS claims. But, he adds, those ideas don’t make Duesberg’s cancer theories wrong. “Anybody who thinks courageously outside the box and in a different way is an extraordinarily important resource,” he says. Besides, whatever the error of Duesberg’s views, “we should not censor people intellectually.”
• • • • • • • • • • • • • • •
Duesberg sometimes seems to relish his status as an outsider, portraying himself as a victim of groupthink who has been persecuted for daring to question the status quo. Other times, he sounds almost wistful. “I was immensely popular,” he says of the days when he found the first cancer-causing oncogene in the Rous sarcoma virus. “I would have been served so much better if I had stayed with oncogenes as the cause of cancer.”

Now, he says, even his Berkeley colleagues largely shun him. As recently as 2010, he says, the university investigated complaints that he had published a paper containing false claims—a response of sorts to the Chigwedere and Essex findings — in a non-peer-reviewed publication. A university spokesman says no action was taken because tenured faculty members are guaranteed academic freedom to advance their theories — with the peer-review process serving to safeguard accuracy.

He hasn’t trained any graduate students in 15 years and only recently was permitted to begin teaching an undergraduate course called “The Cancer Karyotype: What It Is and What It Does.” He runs a few experiments in his lab, almost single-handedly (sometimes with help from an undergraduate student or two), but it’s evident the fall has been painful.

“I think I was even close to a Nobel,” Duesberg says. “If I had just shut up, I would have been much better off.”

Without prompting, he ticks off the names of scientists who’ve won Nobel Prizes for contributing to the standard mutation model of cancer genetics. “All the sheep think the same thing: mutations cause cancer, and HIV causes AIDS,” he says. But he maintains that in his acid skepticism he’s upholding the purity of the scientific method. “Science is absolute,” he says. “You question things that you were taught or were told by your priest, your führer, or your teacher — or anyone.” Whenever a scientist worries about what others will think or the moral implications of his work, “it’s not good science anymore,” he asserts. “It should be amoral — without morals.”

This article appeared in the May-June issue of Pacific Standard under the title “The Heretic.”

Turning Diabetes Treatment Upside Down


Turning Diabetes Treatment Upside Down

Dr. Jay Shubrook is flipping conventional insulin treatment upside-down — with startling results.

Jay Shubrook
Dr. Jay Shubrook

There is something eerily familiar about Athens, Ohio, even if you grew up in New York City. It’s the accessible beauty of Appalachia, which surrounds the town — the gentle hills, the long, flat fields, the meandering brooks and neat, smallish farms.

It’s something more nefarious as well: the profound rural poverty vivid in the mini-malls and convenience stores on the outskirts of town. It’s the curse of plenty — the deal with the devil that this area made long ago with large mining corporations and fast-food chains. And it’s the number of overweight and obese people of all ages in stores and on the streets. People in Athens are pleasant and helpful, but they seem exhausted and desperate, both from generations of poverty and hard physical labor on farms and in mines, but also from the hard work of moving with extra weight. The self seems buried, like a trapped animal, in the body.

The data is mind-numbing: two-thirds of all Americans are overweight or obese, putting them at increased risk for diabetes. Many of us already have the disease and don’t know it. It’s an epidemic: according to the Centers for Disease Control and Prevention, in 2010, one in 10 Americans had type 2 diabetes. And roughly one in every 10 health-care dollars is spent on diabetes every year.

Today, if you’re diagnosed with type 2 diabetes — the most common form — your treatment would likely go like this: Your doctor would tell you to change your lifestyle, exercise more, lose weight, eat more fruits and vegetables. You’d be given a device to check your blood-glucose levels, and you’d be told to come back in a couple of months. After an average of two years of checking your glucose levels, you’d be put on metformin, the most common medicine for type 2 diabetics. Then the disheartening process of “stacking meds” would start. In addition to metformin, which lowers blood sugar by reducing the amount of sugar produced by the liver and helps the body better use its own insulin, you’d be put on sulfonylureas, drugs that stimulate the pancreas to release additional insulin. As this combination became ineffective, you would be put on any of nine other classes of drugs, an average of one additional med every two years. At the end of 10 years, you’d finally be shown how to inject insulin several times a day to lower your blood sugar. If you’re like most patients, this is when you’d feel like a failure. And you’d have spent 10 years thinking you were the victim of a disease.

But Athens resident Jay Shubrook, an associate professor of family medicine and director of clinical research at Ohio University Heritage College of Osteopathic Medicine, is developing another story.
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When Shubrook goes to the grocery store, people stop him in the aisles to ask questions, or often to just say thank you. Although his two teenage daughters have come to dread these trips (a run to the store is never quick), he doesn’t mind: the encounters mean his patients trust him. And trust is critical for doctors working with patients who have a chronic disease, because success depends on the patients’ ability to manage their own health.

That ability is particularly important to Shubrook, because the multipronged approach he’s taking in his research on diabetes is revolutionary. He refuses to treat his patients as passive victims. He asks them to fight — to take certain risks, and face deep fears. And he is turning the practice of stacking meds upside down.
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In 1991, fresh out of the University of California, Santa Cruz, with an undergraduate degree in psychobiology, Jay Shubrook got on his bike and pedaled to Appalachia and Ohio University’s medical school. Shubrook can seem Zelig-like. With his blond hair, boyish face, and freckles, he’d fit right in on the beaches of Southern California. His succinct delivery wouldn’t be out of place in a fast-paced city. But he chose small-town Athens because Ohio University had an osteopathic medical school where the students were trained to look at the whole person rather than the specific problem or disease.

When he was a fourth-year medical student, Shubrook did an endocrinology rotation with Frank Schwartz, a doctor in private practice in nearby West Virginia. It was a pivotal meeting for Shubrook: Schwartz had spent almost two decades helping people with diabetes. “I loved my time with him,” Shubrook says. So much so that, in 1998, as a resident, Shubrook requested another rotation with Schwartz.

At the time, many people saw diabetes as a hopeless death sentence. “When I was in school, and even after, the more chronic the disease was, the less sexy — precisely because there is no magic pill,” Shubrook says. “My predecessors were fascinated with medicines. No one wanted to work on diabetes.”

Type 1 diabetes, an autoimmune disease that accounts for 5 to 10 percent of all cases, is diagnosed most often in children and teenagers. In this form of the disease, the immune system mistakenly attacks the beta cells in the pancreas that produce the insulin needed to maintain normal blood sugar, effectively shutting down insulin production. But 90 to 95 percent of all diabetes diagnoses are type 2 — the kind that can be brought on by obesity. People with type 2 can produce insulin, but their cells don’t recognize it, so blood sugar isn’t metabolized properly and rises and falls to dangerous levels.

Frank Schwartz
Dr. Frank Schwartz in his lab at Ohio University in Athens. (John Sattler/Ohio University)

In reality, Shubrook explains, there are more than just two types of diabetes; there are many types — and many misconceptions about them. A lot of people think only adults get type 2 diabetes and only kids get type 1. And a lot of people think you can treat all kinds of diabetes the same way. “I have had some families think they can cure their child who has type 1 diabetes with diet and exercise,” Shubrook says, “and this is just not the case.”

Type 2 diabetes rates have increased for all ages in this country, and among people in their 30s, it has risen by 70 percent in just the past 10 years. That has meant increases in the ghastly problems that can accompany diabetes: dental disease, kidney disease, nervous-system disorders, blindness, limb amputation, heart disease, and strokes. Because of the nation’s high obesity rates, type 2 diabetes — once only seen in adults — has become a common diagnosis in teenagers. In Ohio, more than 10 percent of the population has diabetes, and in Appalachian Ohio, that rate can be twice as high as in other regions of the state.
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In 2003, Schwartz was asked by Ohio University to start a diabetes center — which gave him an opportunity to return to diabetes research. Looking to develop a diabetes practice that focused on health and prevention, Shubrook and Schwartz opened the Appalachian Rural Health Institute Diabetes/Endocrine Center.

Since then, Shubrook, Schwartz, and the teams they hired have been transforming diabetes care in Appalachian Ohio. With nearly $1.3 million in funding from the National Institutes of Health, they partnered with Mary de Groot, of the Diabetes Translational Research Center at Indiana University, to start Program ACTIVE, which combines talk therapy and exercise for patients with type 2. The team also opened Athens’s Diabetes Free Clinic for people without insurance. And Shubrook launched programs for health-care workers and educators, and for obese children and their parents.

Schwartz and Shubrook also pursued new research. In 2004, Schwartz and a team of computer engineers, biologists, endocrinologists, and others began working on, among other things, artificial-intelligence software and smartphone applications that will automatically detect blood-glucose problems and recommend solutions. In 2009, Schwartz and a team of researchers received nearly $900,000 to develop a natural compound called phenylmethimazole (C10), which blocks proteins that can trigger abnormal cell responses and that play a role in a number of diseases.

Their work has won some 30 awards in the past decade. “Frank is the gas, and I am the brakes,” Shubrook says. Shubrook’s energy never seems to lag, so this statement seemed questionable. But then I spent a day following Schwartz: a 6 a.m. lecture, followed by a seminar, followed by a development meeting, followed by a lab meeting where Schwartz, who’d had only one cup of coffee, quietly directed scientists, facilitators, and students.
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All the while, Shubrook was well aware that patients were frustrated with the stacking of meds and how long lifestyle changes can take to have an effect. “We were always a step behind,” he says. “We were chasing the disease. The burden on patients was significant.”

Diabetes doctors sometimes see patients with such high levels of glucose, or hyperglycemia, that the treatment has to be aggressive, which means insulin is the only option. “We had these people who were really hyperglycemic, so we knew meds would not work quickly enough,” says Shubrook. “We put them on insulin first. We knew it wouldn’t harm them.”

Artificial Pancreas
How the Artificial Pancreas Eases Diabetes Therapy
A handful of researchers in America and Europe aim to change type 1 diabetes treatment with a simple-sounding solution: an artificial pancreas.
(Click the image to read the story.)

Shubrook wondered whether using insulin first would also work in patients who weren’t severely hyperglycemic. “That made a lot of people nervous,” he says. “I was told, ‘You can’t do that, because [blood-glucose levels] will drop too low,’ ” making the patient hypoglycemic, the opposite of hyperglycemic. Other doctors and researchers saw it as a shockingly aggressive approach. Shubrook almost didn’t get funding for his Insulin First study, because funders thought he’d never find participants who were willing to try first what had long been a last resort. But Shubrook understood his patients in this corner of Appalachia; he knew they were ready to try something, anything, different.

In 2006, Shubrook began a series of trials with a group of patients who’d been newly diagnosed with type 2. Instead of 10 years to build up to insulin, they were taught to give themselves four shots a day almost immediately.

The results were undeniable. In six to eight weeks, the patients’ blood-sugar levels started to normalize. Shubrook and his team then, with close monitoring, started to withdraw the insulin. In three to four months, the patients no longer needed the injections to regulate their blood sugar. And many were able to stay off all medicines for up to three or more years. Shubrook asked people to work at maintaining a balanced diet and as much exercise as they could do, but, “We did not ask them to do any more than we ask of all our patients,” he explains.

“I love taking people off medicine,” Shubrook says. When blood sugar gets high, he adds, it’s toxic to the pancreas; using insulin to get rid of that toxicity allows the pancreas to work again. “In the old way of thinking, it was just a matter of time before the toxicity would return. We believe that a pulse of 12 to 16 weeks of complete insulin replacement allows the pancreas to rest and recover. We see dramatic drops in glucose in the first few weeks.” He adds, “What is surprising is we tell patients that this may not last, and, at some point, we will likely need to treat them with some medications. But all of them have said they would prefer insulin if they need treatment. They like the lack of side effects and the control it gives them, and they prefer the notion of a ‘booster’ treatment.” Even if patients have to come in for insulin treatment every three to four years, he says, that’s still better than the slow stacking of increasingly ineffective meds.

Today, Shubrook is nearing the end of his second trial,  with 30 type 2 patients who were randomly chosen to receive either the standard care or a course of insulin replacement. Shubrook can’t release the full results until the summer of 2013, but he says that, so far, the rate of hypoglycemia, the dropping of glucose levels feared by doctors and funders, has been extremely low among the patients given insulin.

“We have learned that it is safe and effective to start with insulin,” he says. “We do not see increased rates of hypoglycemia, and we do not see the weight gain typically seen when insulin is used as a last treatment.”

What surprised Shubrook was that several of his other diabetes patients wanted to join the trial but didn’t want to run the risk of not getting insulin first by being randomly assigned to a meds-first group. Those patients are now part of his case-study work on insulin-first treatment. Their openness to using insulin as a first course of treatment amazed Shubrook and a lot of other diabetes health workers, because injecting insulin carries so much social stigma: it’s seen as a last resort and considered tantamount to an admission of failure.

“There’s always been a lot of fatalism in diabetes patients,” Shubrook says. “A kind of ‘it’s just a question of how long you keep them alive’ mentality. So many of our assumptions, including assumptions about the role of genes, no longer hold true. Many people assume that if they start on insulin, they’ll be on it for the rest of their lives. We don’t believe this is true.”

I got a sense of the shame that can come with diabetes when, as an experiment, a nurse at Shubrook’s clinic inserted a glucose sensor in my abdomen so that we could watch my blood-glucose levels for 24 hours. Keenly aware of the extra 10 pounds I was carrying, I kept a food and activity journal to see how I reacted to meals, exercise, and sleep. A glass of red wine caused a vivid spike on the graph that night, followed by a spike in the morning after coffee and a muffin. Normal, randomly taken blood-sugar levels range from around 70 to 145. My cup of coffee brought my blood sugar up to a whopping 170. Then Shubrook showed me how to inject myself (though not with insulin). The shot was painless, but there was a certain shame in grabbing the fat and puncturing it. I felt acutely aware of all the excesses in my life. I felt that I had abandoned my body, my health, for childish appetites and a lifestyle that wasn’t of my own design. I could imagine how closely depression and self-hatred might shadow this disease.
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Shubrook is “one of those oddballs that crosses disciplines,” says Darlene Berryman, associate professor of food and nutrition at Ohio University. “In just five years, he has brought these two cultures together.” She adds, “From a cultural perspective, it’s considered OK to be overweight here. There’s a real distrust of doctors. Jay is able to cross that barrier. He connects with the people in this community.”

On a crisp fall day, the Diabetes Center Clinic is in full swing by 7:30 a.m. Shubrook, who’s already been for a long run, has an appointment with the first patient in his second trial: Laura, a student who has type 2 diabetes. Laura went through the typical frustrating rounds with medication: she’d start on a new drug, but inevitably her blood sugar would go up again. “I felt like a failure,” she says. Shubrook put her on insulin, and her blood sugar stabilized. She’s now coming off the insulin trial, and Shubrook has put her on a brief fast. “Here, more than anywhere else, it’s not a blame game,” she says. “On the insulin, I felt energized, relaxed, and more able to focus. I ate better, exercised more because walking was easier, and I lost weight.”

Robert, another of Shubrook’s patients (a case-study patient), was put on insulin more than three years ago. Robert is a slurry technician in a brickyard, where a workday can include moving tons of shale manually. “Jay is an unusual doctor,” he says. “Old school. He doesn’t use big medical terms. He listens to me, and I can talk to him.” After six weeks of insulin shots, Robert says, he was sleeping better and had more energy. “We’re not calling it a cure,” he says. “We’re giving my pancreas a rest and calling it remission.”
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More-aggressive interventions at early stages of type 2 diabetes have gained in popularity, but Shubrook’s trials will need to be repeated and expanded before the use of insulin as a first response could be widely adopted. Finding better treatments is critical. Since Shubrook started studying diabetes, the number of people with the disease has only risen. The CDC predicts that by 2050, one in three Americans will develop diabetes if current trends continue. The rates probably will be higher in minority populations and in underserved areas such as Appalachia.

“We have our work cut out for us,” Shubrook says. “People have free will,” he adds, then shrugs. It’s an unusual gesture for such an impassioned man. “It’s not my disease. I give them information. I can’t do it all for them.”

Yet he’s committed to giving patients as much information as he can and to showing them how much they can do for themselves.

Shubrook and Schwartz dream of building a wellness center like the Joslin Diabetes Center in Boston or the International Diabetes Center in Minnesota. But they think their incarnation would be better. It would be a one-stop shop for people with diabetes. Patients would come in for several-hour appointments and leave with a medical strategy and a plan for changing their lifestyle. The clinic would be a place to exercise, read, learn to cook, undergo supervised physical activity in a gym. And there would be a restaurant with healthy choices and carbohydrate counts on the menu. There would be laboratories where researchers could do cutting-edge work, such as stem-cell research. There would be fellowships for visiting nurses and doctors. As Shubrook sums it up: “What if you came to the hospital four times a year to get well?”

This article appeared in the May-June issue of Pacific Standard under the title “Reversing the Course.”