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Lowering the Bar: Medicine in the 21st Century

Clicks:Updated:2016-05-23 09:05:05

See the accompanying infographic “How Everyday Conditions Become Medical Disorders” here.
As many as 16 million Americans are prone to screaming and pounding on the dashboard when someone cuts them off in traffic. Another 7 million are fully capable of devouring a whole box of cookies in front of the TV.

There are 14 million men with low testosterone, 9 million women with low sexual desire -- and tens of millions of people with bladders that are too active and blood sugar that's a little too high.

The common thread: All have non-life-threatening conditions that for most of the 20th century were not considered a part of mainstream medicine. Some did not exist at all as formal disorders.

Each of the conditions, from intermittent explosive disorder to overactive bladder disorder, is the product of a new or expanded definition. These definitions come from medical societies or researchers who get money from drug companies.

Healthy Today, Sick Tomorrow
And those companies stand to profit when millions of people -- often overnight -- are labeled as ailing.

What's more, the drugs involved can be costly, can carry serious health risks, and often do not work well, a Milwaukee Journal Sentinel/MedPage Today investigation has found.

In 2003 and again in 2010, the American Diabetes Association tinkered with the definition of a condition known as prediabetes, which independent doctors say is an unneeded label that has led to overtreatment with drugs, exposing patients to risks without proof of real benefit.

The changes, which twice lowered the threshold for hemoglobin A1C, increased the number of people fitting the diagnosis from 17 million to 87 million. Indeed, a March report from the UCLA Center for Health Policy Research estimated that 46% of Californians -- 13 million people -- had prediabetes.

A Journal Sentinel/MedPage Today investigation found the ADA has long received more than $7 million in current annual funding. In addition, nine of the 14 experts who authored the 2010 change worked as speakers, consultants or advisers to companies that marketed diabetes medicines.

Asked if apparent industry-link may have influenced the ADA Robert Ratner, MD, chief scientific and medical officer of the ADA, said changes to the definition were done after consulting with the CDC and the National Institutes of Health. He noted the association recommends diet and exercise to treat prediabetes.

"The association did not and does not operate independently regarding diagnosis criteria and treatment guidelines," Ratner said in an email.

In 2006, just before the term "Low T" became a familiar term to many Americans thanks to a barrage of TV commercials, a pharmaceutical company that markets a testosterone replacement funded a national study of men conducted in doctors' offices. Suddenly, 38% of men age 45 and older were said to have the condition.

The five authors of that study all had financial ties to the testosterone company.
There are more, many more.

This is medicine in the 21st Century:
Too angry? It's IED, intermittent explosive disorder.

Too hungry? It's BED, binge-eating disorder.

Are you a woman with a low sex drive? It's HSDD, hypoactive sexual desire disorder (HSDD).

Having trouble focusing at work? It's ADHD, adult attention deficit hyperactivity disorder.

Have a frequent urge to urinate? It's OAB, overactive bladder disorder.

Can't function at some times of the month? It's PMDD, premenstrual dysphoric disorder.

How Sick Are We?
If you believe the current literature, those eight physical or psychiatric conditions alone affect more than 180 million Americans.

Independent experts say the numbers are suspect at best, the product of medical societies and advocacy groups that get pharmaceutical industry funding, researchers aiming to advance careers, or drug companies trying to boost sales.

Indeed, the conditions can be viewed as relatively common aspects of everyday life that have been turned into formal disorders, a process known as medicalization.

"There are powerful interests that want the numbers to be inflated," said Allan Horwitz, PhD, 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 BMJ Open, showed how diseases also can be created and defined by their times, noting that homosexuality still was labeled as a disease by the American Psychiatric Association until 1973 when it was removed from its diagnostic manual.

There's a playbook for selling disease, said Carl Elliott, MD, PhD, professor of bioethics at the University of Minnesota.

"You de-stigmatize the condition, 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," he said. "Then you're all set for selling your treatment."

It was in the late 1990s that a condition once known as 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 pushed related research that the new condition affected 33 million people.

One of the two urologists, Alan Wein, MD, PhD, 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, MD, PhD, a urologist and clinical epidemiologist at the University of Helsinki in Finland, researched overactive bladder and found the estimates of how many have it -- 17% of adults -- were vastly inflated. In his view, the real figure is less than half that.

While bigger numbers may lead some people to get earlier treatment, inflated numbers also can cause healthy people to think they are sick, said Tikkinen.

That can lead to the unnecessary use of drugs that might not be effective and subject patients potential harms and added cost, he said.

Who Wins?
For drug companies, bigger numbers mean larger markets and can put more pressure on the FDA to approve new products. For advocacy groups and medical societies, many of which get pharmaceutical funding, having more people with a condition can make it seem more mainstream.

And for university researchers, coming up with a big number can be good for your career.
That's according to Daniel Carlat, MD, professor of psychiatry at Tufts University School of Medicine and author of Unhinged: the Trouble with Psychiatry, a Doctor's Revelation about a Profession in Crisis.

"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," he said.

When it comes to psychiatric conditions, the Diagnostic and Statistical Manual of Mental Disorders (DSM) is considered the Bible for practitioners.

In the fifth edition of manual, which came out in 2013, binge-eating disorder, intermittent explosive disorder and adult ADHD were all altered in a way that increased the number of people with those conditions. Nearly 70% of the experts of the task force that produced that document had financial ties to the drug industry, according to a 2012 analysis in the journal PLoS Medicine.

It's Complicated
Psychiatrist Darrel Regier, MD, MPH, vice chairman of the task force, said members were not trying to medicalize everyday conditions. The goal 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."

He said the American Psychiatric Association tried to avoid drug company financial conflicts by limiting to $10,000 a year the amount that the experts could receive working as industry consultants, advisers, and speakers.

The association also said task force members could not 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; and there are still people who said we didn't do enough," he said.

Those skeptics include the authors of the PLoS Medicine study detailing the DSM-5 financial conflicts. The authors said such conflicts were a "pernicious problem," the amounts allowed were high, and that members should be free of any financial conflicts.

"It's not about research fraud," study co-author Lisa Cosgrove, PhD, a bioethicist at the University of Massachusetts, said in an interview. "It's just that we have a wealth of data now that clearly shows industry-funded researchers draw industry-friendly conclusions."

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