Luke Skywalker
Super Moderator
{vb:raw ozzmodz_postquote}:
Know someone who shouts and pounds on the steering wheel when cut off in traffic?
They might be one of 16 million Americans said to suffer from "intermittent explosive disorder."
Can you polish off a box of cookies while watching your favorite TV show?
Could be a sign of "binge-eating disorder," said to afflict 7 million Americans.
Another 14 million men are said to have clinically low testosterone, 9 million women are said to suffer from low sexual desire, and tens of millions more are said to have bladders that are too active or blood sugar that is a little too high. That blood sugar level used to be considered normal. Now it makes you a candidate for treatment with expensive medication.
None of these conditions was considered part of mainstream medicine just 20 years ago. But thanks to new definitions or lowered thresholds, millions more people — overnight — fit the criteria of having treatable disorders.
Many independent doctors and researchers are skeptical, saying the new conditions are the product of medical groups that get pharmaceutical industry funding, researchers looking to advance their careers and drug companies aiming to broaden the market for expensive new products.
On top of that, the drugs sold to treat these newly defined — and not life-threatening — conditions often carry serious health risks, a Milwaukee Journal Sentinel/MedPage Today investigation has found.
An examination of eight common new conditions found the changes all went in the same direction — toward expanding the number of people who could be treated with expensive drugs.
Pre-diabetes: Twice in the past 13 years, in 2003 and again in 2010, the American Diabetes Association lowered the threshold for blood sugar levels used to define "pre-diabetes." Doctors without ties to the drug industry, including those who have done research in the area, say pre-diabetes is an unnecessary label that can lead to the overtreatment of patients with drugs, exposing them to risks without proof of real benefits.
Indeed, a major study published in 2002 had shown that a combination of diet and exercise reduced the odds of pre-diabetes becoming diabetes by 58%, while use of the drug metformin only reduced it by 31%.
Yet the two adjustments to the definition of pre-diabetes increased the number of people said to have the condition fivefold, from 17 million to 87 million. In March, a report from the UCLA Center for Health Policy Research estimated that 46% of all Californians, 13 million people, now have "pre-diabetes."
Nine of the 14 doctors who made the 2010 adjustment in blood sugar levels worked as speakers, consultants or advisers to drug companies that make products to treat diabetes, an earlier Journal Sentinel/MedPage Today investigation found. Disclosure statements were never made public for the 2003 panel.
The American Diabetes Association itself has long received financial support from drug companies, including more than $7 million from current donors. The actual amount may well be higher, since the website only lists donors by minimum amounts, such as "Banting Circle Elite members" who contribute at least $1 million. The $7 million alone is more than enough to cover the pay and benefits for the 17 highest paid executives listed in the association's tax forms.
Robert Ratner, chief scientific and medical officer of the association, said changes to the definition were done after consulting with the U.S. Centers for Disease Control and Prevention and the National Institutes of Health. He noted the association recommends diet and exercise to treat pre-diabetes.
"The association did not and does not operate independently regarding diagnosis criteria and treatment guidelines," Ratner said in an email.
'Low T':Just before the term "Low T" became omnipresent on nightly TV commercials, a company that sold testosterone products funded a national study of men, conducted in doctors' offices. Suddenly 38% of all men age 45 and over in America were found to have a condition that could be treated by the company's product.
All five of the study's authors had financial ties to Solvay Pharmaceuticals, which marketed the testosterone gel. This included a consultant, an employee and three who worked for a company hired by Solvay to do the study.
[h=3]BED, IED, ADHD and more[/h]There are more, many more.
Too angry? You may have IED, intermittent explosive disorder. Too hungry? It may be BED, binge-eating disorder.
There's female sexual interest/arousal disorder (low sex drive in women) and adult ADHD (a lack of focus). There's overactive bladder disorder (you go to the restroom...a lot), and premenstrual dysphoric disorder (a severe form of premenstrual symptoms).
If you believe the medical literature, those six conditions, plus low testosterone and pre-diabetes, affect more than 180 million Americans, a figure equivalent to 77% of the adult population in the United States.
But the conditions can also be viewed as relatively common variations between people that have been redefined into formal disorders, a process known as medicalization. The result: Increased drug sales.
For instance, sales of the drug Vyvanse, approved to treat adult ADHD and binge-eating disorder, more than doubled from 2010 to 2014, going from $986 million to $2.1 billion.
"There are powerful interests that want the numbers to be inflated," said Allan Horwitz, a professor of sociology at Rutgers University and author of "Creating Mental Illness." "All of these estimates push the numbers upward."
A 2012 survey of 6,200 doctors, nurses, lay people and legislators in Finland found wide disagreement over whether dozens of so-called "states of being" should even be considered diseases, including ADHD and overactive bladder.
The paper, published in the journal BMJ Open, showed how diseases also can be defined by their times, noting that homosexuality was labeled a disease by the American Psychiatric Association until 1973.
There's a playbook for selling disease, said Carl Elliott, a professor of bioethics at the University of Minnesota Medical School.
"You destigmatize the condition," he said. "Broaden it to include a much larger patient population, rebrand it or give it a name that is less embarrassing to people — people would rather have overactive bladder than be called incontinent.
"Then you're all set for selling your treatment."
It was in the late 1990s that incontinence or "unstable bladder" became the nicer-sounding "overactive bladder."
Two urologists thought the new name was "more intuitive" and sounded less like a psychiatric disorder. They convinced the International Continence Society to give it a new definition, and the two pushed related research that found the new condition affected 33 million people in the United States alone.
One of the two urologists, Alan Wein of the University of Pennsylvania, now acknowledges the estimates "overstate the market," but noted many patients do have bladder issues that require treatment.
Kari Tikkinen, a urologist and epidemiologist at the University of Helsinki in Finland, researched overactive bladder and found the recent estimates of how many have it — 17% of adults — were vastly inflated. In his view, the real figure is less than half that.
While inflated numbers may lead some people to get earlier treatment, they also can cause healthy people to think they are sick, said Tikkinen. That can lead to added costs and the unnecessary use of drugs that subject patients to potential harms.
[h=3]Expanding the market[/h]For drug companies, bigger numbers mean larger markets and can put more pressure on the U.S. Food and Drug Administration to approve new products.
For advocacy groups and medical societies, many of which get drug company funding, having more people with a condition can make it seem more mainstream and lead to more financial support.
And for university researchers, coming up with a big number can be good for your career.
"The more of a splash they make, the more likely they are to get papers published, to get hired by universities or to get promoted — and the more likely they are to get research funding," said Massachusetts psychiatrist Daniel Carlat, author of "Unhinged: The Trouble with Psychiatry — A Doctor's Revelation about a Profession in Crisis."
When it comes to psychiatric conditions, the Diagnostic and Statistical Manual of Mental Disorders, published by the American Psychiatric Association, is considered the bible for practitioners.
In the fifth edition of the manual, which came out in 2013, the definitions of binge-eating disorder, intermittent explosive disorder and adult ADHD were all altered in a way that could increase the number of people with those conditions.
Nearly 70% of the experts of the task force that produced it had financial ties to the drug industry, such as working as consultants and speakers, according to a 2012 analysis in the journal PLoS Medicine.
Psychiatrist Darrel Regier, vice chairman of the task force that updated the manual, said members were not trying to medicalize conditions. The goal, he said, was to focus on defining the symptoms of the disorders and not trying to get drugs approved to treat them.
"It is not quite so simple that these were always just normal conditions on the extreme end of normal," he said. "Some of these people had serious medical conditions and were stigmatized and not treated because nobody knew what to do with them."
The American Psychiatric Association tried to minimize financial conflicts, he said, by limiting to $10,000 a year the amount that panelists could have received from drug companies. In addition, task force members couldn't hold more than $50,000 in drug company stock.
"We did everything we could at the time to make known our concerns and to put limits on that were unprecedented," Regier said. "And there are still people who said we didn't do enough."
Those skeptics include the authors of the PLoS Medicine study detailing the conflicts, which they labeled a "pernicious problem."
"It's not about research fraud," said study co-author Lisa Cosgrove, a bioethicist at the University of Massachusetts, in an interview. "It's just that we have a wealth of data now that clearly shows industry-funded researchers draw industry-friendly conclusions."
John Fauber is a reporter for the Milwaukee Journal Sentinel. Kristina Fiore is a reporter for MedPage Today.
This story was reported as a joint project of the Journal Sentinel and MedPage Today, which provides a clinical perspective for physicians on breaking medical news at medpagetoday.com.
<span style="color: Red;">*</span>twitter.com/fauber_mjs <span style="color: Red;">*</span>[email protected]
Powered By WizardRSS.com | Full Text RSS Feed
