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Wednesday, September 21, 2016

1500 Common Medical Practices Are Categorized As Having 'Unknown Effectiveness'


Once medical treatments have been dubbed ‘standards of care’ they tend to persist regardless of their efficacy. Preventing untested practices from becoming standard care seems simple - just test them first. But even when studies are conducted early on, what they actually measure can be part of the problem. Because it’s simpler and faster, researchers often look at "surrogate outcomes", not actual end points which has created hundreds of medical practices with unknown effectiveness at best. 
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The calibre of evidence can depend on who is paying for it. There are the perennial issues that plague medical research: the pressure on researchers to publish new and impressive findings, and medical journals’ tendency to publish positive results more than negative. But increasingly, the pharmaceutical and medical device industries - rather than public bodies - are funding clinical trials. Not only do they have vested interests in the initial outcomes needed to get drugs or devices approved, but once they are approved, little incentive to do the expensive, large-scale studies that could potentially upend their initial findings and hurt their bottom line.
The current medical mentality on pain management has spurred a multibillion-dollar industry for Big Pharma. However, studies show that long-term use of seemingly "harmless" over-the-counter pills, such as ibuprofen, can actually weaken your joints over time, and prescription pain pills have a well-established track record of causing serious damage and even death. You may recall the tragedy that unfolded around the FDA-approved painkiller Vioxx, which claimed as many as 55,000 lives (and possibly up to 100,000) before the FDA banned it.
The US Food and Drug Administration (FDA) approved it in 1999, but later the manufacturer, Merck, was accused of concealing risks discovered in early studies. By the time independent research showed that Vioxx increased the risk of heart attacks, 20 million people had prescriptions. It was withdrawn in 2004, but not before causing up to 140,000 preventable heart attacks. Merck pleaded guilty to criminal charges in 2011 and paid $950 million in fines.

That manipulation of inappropriately adjusting, excluding, altering, or fabricating data is rampant in medical research. More and more evidence is suggesting that peer-reviewed journals are increasingly having to retract reports due to erroneous or misleading data from Doctors and Scientists. 

"The medical journals are filled with interesting ideas that get tested and fail. That’s science," says Adam Cifu at the University of Chicago, who wrote a book called Ending Medical Reversal with Vinay Prasad. "The problem is when that new technology or treatment or surgery has actually gotten out and is being given to millions of people before it’s found to not work."

"We spend so much time training people first and foremost in how the body works and how it breaks. So we get why things should work, and then we tend to adopt things because they should work before we know if they actually do," says Cifu. 
It’s no small concern. An analysis by BMJ Clinical Evidence of 3000 common medical practices categorised half or 1500 as having "unknown effectiveness", and 3 percent as likely to be ineffective or harmful. Just a third were found to be "beneficial" or "likely to be beneficial".

A major problem is that we often do the studies only after practices are widely adopted. There is a well-trodden path to developing new treatments, says David Jones, a medical historian at Harvard University. Someone gets some promising early results, a lot of people get enthusiastic about the innovation and get on board. "Then it is successfully marketed to a willing audience of patients who are generally dissatisfied with existing treatments," says Jones.
Eventually, concerns surface and clinical trials are done. By then, though, the horse is out of the barn. People want innovation and ready access to new and better treatments. But, as Jones says, "it leaves open the door that you’ll get a lot of enthusiasm coming from small, poorly designed studies that drive unwarranted use of a new procedure before it has been fully validated."

It may be too much to ask for our doctors to follow every incremental change. But they should be willing to examine the benefits and drawbacks of the therapies they are offering, says Cifu. "It should be okay for doctors to discuss options with each patient and say, ‘Look, I’m not completely convinced about this therapy because the data isn’t so good but it’s low risk and I think there’s a chance it could work for you and here’s why.’ That way patients understand they are taking a little bit of a chance but there are potential benefits."

10 MAJOR REVERSALS IN MEDICAL PRACTICE


1. Whopping Cough Vaccines


Advice: Whopping Cough Vaccines are the best way to prevent Pertrussis.
Rationale: The pertussis vaccine is combined with other vaccines so a person can receive protection from several diseases with one shot.
Adoption: Millions of prescriptions in 1990s
Reversal: The OSMA Journal, the Journal of Pediatrics, the New England Medical Journal, the Journal of the American Medical Association and the British Medical Journal found that the pertussis vaccine may cause lasting brain damage, increased the prevalence of asthma and wheezing by 50%, increased sleep apnea, fivefold increase in febrile seizures and other adverse reactions. In 2013 the disease spread across the entire US at rates at least twice as high as those recorded in 2011 and epidemiologists and health officials admitted that the vaccines may have been the cause. Contrary to the evidence, officials at the U.S. Centers for Disease Control and Prevention (CDC) still say the best way to prevent pertussis is to get vaccinated.

2. Hormone replacement therapy


Advice: HRT for menopausal women
Rationale: Observational studies and animal trials suggested protective effect on heart and bones
Adoption: 1940s to 1990s
Reversal: In 2002, found to increase risk of breast cancer, heart disease and stroke. Largely discontinued.

3. Peanut allergy


Advice: Withhold nuts from young children
Rationale: For immature immune system, exposure increases allergy risk
Adoption: Widespread in Western countries
Reversal: Major trial found early exposure actually decreases allergy risk. New guidelines issued in 2015

4. Surgery for osteoarthritis of the knee


Advice: Surgical removal and smoothing of cartilage fragments
Rationale: Thought to reduce inflammation, improve motion and decrease pain
Adoption: By 2002, 650,000 surgeries per year in US
Reversal: Several trials found no benefit over physical therapy alone. Surgery still common, however

5. Cancer screening


Advice: Routine early screening
Rationale: Early detection is a chance to intercept disease
Adoption: Mammograms and the PSA test for prostate cancer became routine in 1980s
Reversal: As medical screening and mammograms increase for breast cancer, so does death. Early stage cancers do not always develop further, many treated unnecessarily. PSA test no longer recommended in US, age for routine mammograms raised from 40 to 50.

6. Heart stents


Advice: Stents for people with coronary heart disease and angina
Rationale: Clear benefit in cases of heart attack, so those with stable heart disease should benefit too
Adoption: Commonplace by 2004
Reversal: Shown not to reduce risk for future heart attack or death andmay cause harm. Practice remains common

7. Vertebroplasty


Advice: Inject medical cement to fix fractured vertebrae
Rationale: Thought to improve spine stability and reduce pain
Adoption: By 2009, 750,000 operations per year in US
Reversal: Although we now know the procedure is no more effective than a placebo, it is still widely carried out

8. Intensive blood sugar lowering for type 2 diabetics


Advice: Diet and drugs to get long-term blood sugar metric (glycated haemoglobin) below 7 percent
Rationale: 1997 study found lower risk for heart attack at 7 percent. Aim became lower the better
Adoption: By early 2000s, advice was often to aim for under 7 percent
Reversal: A 2008 study found that trying to keep levels too low increased risk of death. Aiming under 7 percent now seldom advised

9. Pre-implantation genetic testing


Advice: Screen embryos for older women doing IVF
Rationale: Genetic screening should reduce pregnancy failure due to chromosome abnormalities in embryos
Adoption: Common for older women undergoing IVF
Reversal: 2007 trial found screening decreased pregnancy rates and live births for older women

10. Ear tube surgery


Advice: Implant tubes in ears of children with persistent infection
Rationale: Fluid drainage would improve hearing and cognitive development, best to do surgery sooner than later
Adoption: Most often performed surgery in children
Reversal: Review in 2014 found no adverse effect on long-term child development if surgery is postponed. But surgery, which carries the risk of bleeding and ear drum damage, is still common in the early stages of infections

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