Re: most women don't need osteoporosis drugs



Terri wrote:
> The "National Osteoporosis Foundation," like the National Sleep
> Foundation is a marketing group.


Astro turf du jour.


Zee



>
>
> zwalanga@xxxxxxxxx wrote:
>
> > Disease expands through marriage of marketing and machines
> >
> > By Susan Kelleher · Seattle Times staff reporter
> > http://seattletimes.nwsource.com/html/health/sick3.html
> >
> >
> > After the FDA approved Fosamax for treating post-menopausal
> > osteoporosis, the drug's maker, Merck & Co., launched a marketing
> > campaign that seemed to target younger, healthier women.
> >
> > Every day in clinics and doctors' offices across the country, healthy
> > middle-age women slide their wrists into portable X-ray machines that
> > calculate bone density.
> >
> > If they get a low enough density score, they walk out with a
> > prescription that's supposed to prevent a hip fracture late in life by
> > adding bone tissue now.
> >
> > But there's a big problem with this familiar exercise, according to
> > some top osteoporosis experts: Most of these women don't need the drug.
> > They are wasting money and risking side effects for little benefit.
> >
> > "If you're a healthy 50-year-old - an average woman going through
> > menopause - your chances of getting a fracture ... are very low,"
> > said Dr. Susan Ott, a bone specialist at the University of Washington.
> > "Yet they are pushing the drug right at that age group."
> >
> > By targeting women in their 50s, manufacturers of drugs for
> > osteoporosis have helped transform osteoporosis from an underrecognized
> > disease in elderly women into what some say is a disease affecting tens
> > of millions.
> >
> > Drug companies and advocacy groups accomplished that by:
> >
> > · Expanding the disease to include a new condition, osteopenia, or
> > pre-osteoporosis, with boundaries so broad they include more than half
> > of all women over 50.
> >
> > · Promoting osteopenia and osteoporosis directly to these younger,
> > healthier women, telling them they are at risk and should consider
> > taking bone-strengthening drugs such as Fosamax.
> >
> > · Shaping the way osteoporosis and osteopenia are defined, with
> > readings from bone-density machines that the drug industry promoted,
> > subsidized and helped put in doctors' offices.
> >
> > All of this was done in the name of prevention. But Dr. Steven
> > Cummings, one of the world's experts on osteoporosis and the director
> > of the San Francisco Coordinating Center, a research center, says the
> > drug companies' push has been driven by marketing as well as medicine.
> >
> > "The word 'prevention,' which has become so popular, has also created
> > problems," Cummings said.
> >
> > "Drug therapy for women with osteopenia does do some good because it
> > reduces the risk of spine fractures, but women with osteopenia have a
> > low risk of those fractures. ...
> >
> > "So taking a drug for osteopenia probably does not improve the quality
> > of life for women with osteopenia. It does generate huge sales."
> >
> > For elderly women who suffer fractures, bone drugs such as Fosamax are
> > life-enhancing: strengthening bone, reducing chances of future breaks.
> >
> > Osteoporosis: Chronology of drug development and sales
> >
> > Who has osteoporosis
> >
> > Change a number, create a patient
> >
> > Top drug makers
> >
> > The bone-density X-ray machines promoted by Merck & Co. and other drug
> > companies also are powerful advances in treating the disease. Doctors
> > can use them to diagnose those truly at risk and track their recovery.
> >
> > But, as Cummings points out, the utility of the machines and the drugs
> > for middle-age women is unproven, unless they've had fractures
> > previously. Their growing use is another cautionary tale of the
> > influence of drug companies on the definition and treatment of disease.
> >
> > Even a former lobbyist for Merck concedes that the company's focus has
> > been on expanding the market for Fosamax, also known by its chemical
> > name, alendronate.
> >
> > "The goal is to make the uses as broad as humanly possible," said Kurt
> > Furst, who worked for Merck from 1997 to 2000. "Merck would tell you
> > virtually any woman post-menopausal should go on Fosamax. That's a heck
> > of a lot of women."
> >
> > By focusing on women 50 and older, Merck is following what other health
> > organizations recommend, a company spokesman, Skip Irvine, said.
> >
> > Experts devise a numerical measurement of bone density - and the
> > boundaries of a new condition.
> >
> > A generation ago, doctors diagnosed osteoporosis only "after the fall"
> > - once an elderly patient broke a hip or developed a "spinal hump."
> > There were few effective treatments for the crippling, costly
> > condition.
> >
> > As women began living longer, frustrated physicians saw more and more
> > cases. In 1984, the National Institutes of Health (NIH), the federal
> > medical-research agency, sponsored a conference of bone experts to
> > discuss possible ways to prevent osteoporosis.
> >
> > Scientists knew that adding calcium to diets could build bone. What
> > they did not know: whether adding thickness alone would reduce the
> > chances of fractures later on.
> >
> > Bone strength, it would turn out, depended not just on density but on
> > heredity and "bone quality" - the shape and number of spindly
> > bone-cell connections inside the bones.
> >
> > Experts at the conference opted to focus on bone size, the only aspect
> > of bone health with existing treatments. They recommended that women
> > consume more calcium. That decision "turned out to be quite a big
> > industry," said Dr. Lawrence Shulman, a former NIH institute director
> > who organized the conference.
> >
> > Sales of calcium supplements skyrocketed. Media interest intensified.
> > And drug companies, recognizing the market opportunity, began
> > developing more drugs to increase bone density.
> >
> > They supported new medical societies focused on osteoporosis and pumped
> > money to doctors and scientists for research.
> >
> > Meanwhile, the World Health Organization (WHO), the medical agency of
> > the United Nations, decided to figure out if health-care systems could
> > save money by preventing fractures instead of paying to treat them
> > after they occurred.
> >
> > The WHO sponsored an osteoporosis conference in Rome in 1992,
> > partnering with the International Osteoporosis Foundation, a nonprofit
> > organization with a corporate advisory board that currently consists of
> > 31 drug and medical-equipment companies.
> >
> > The central issue of the conference was whether osteoporosis could be
> > identified before a patient broke a bone, not after. That required a
> > different way of looking at the condition, a definition based on a
> > numerical measurement of bone density.
> >
> > But what would the magic number be? Everyone loses bone mass as they
> > age. How would "normal" be defined, and what would be the threshold for
> > prescribing drugs?
> >
> > Experts at the conference, which was sponsored by two large drug
> > companies and a drug-company foundation, decided that "normal" would be
> > the bone density of a woman at age 30, roughly the age when bone mass
> > peaks for most people.
> >
> > Any difference between a woman being measured and the established
> > standard would be reported as a "T-score." The T-score of a 70-year-old
> > would reflect a comparison to a woman 40 years younger.
> >
> > The next step was even trickier: How far below normal would density
> > have to fall before it was considered osteoporosis? What T-score would
> > define the disease?
> >
> > The researchers turned to an analysis of women in Rochester, Minn.,
> > that showed about 16 percent of post-menopausal women in that city
> > would sustain a hip fracture in their lifetime. Looking at years of
> > bone-density scores, the WHO committee calculated that 16 percent of
> > post-menopausal women had bone-density readings of -2.5 or worse.
> >
> > So under the new definition, anyone with a spinal fracture or a -2.5
> > T-score or worse had osteoporosis, the doctors decided. That score
> > roughly translates into bones that are 32 percent less dense than those
> > of the average 30-year-old woman.
> >
> > The WHO committee went even further. It said scores between -1 and -2.5
> > were the boundaries of a new condition, "osteopenia," or low bone mass.
> >
> > In a single conference, one disease - osteoporosis - had been
> > expanded from an elderly person with a fracture to anyone who had a
> > -2.5 T-score. And another condition, osteopenia, was created.
> >
> > An important result: Doctors could bill insurance for the bone-density
> > test, which insurance typically had not covered.
> >
> > Not everyone looked favorably on the developments.
> >
> > Dr. Leo Lutwak, a retired U.S. Food and Drug Administration scientist
> > who attended the conference, had argued against creating a diagnosis of
> > osteopenia. He feared that the condition would be used incorrectly to
> > label patients as having a disease, making it easier to treat them with
> > new bone drugs.
> >
> > The National Osteoporosis Foundation, another nonprofit backed by drug
> > firms, estimates that 10 million Americans now have osteoporosis and
> > that the disease is "a threat for an estimated 44 million Americans, or
> > 55 percent of people 50 years of age and older."
> >
> > With osteopenia, what patients had were measurements, not disease, said
> > Cummings, the University of California expert.
> >
> > "A lot of people who have an average risk of fracture for their age are
> > told they have a disease," he said. "The average person doesn't know
> > how that came to be or what it really means. But what some women worry
> > what this means is you're at risk of falling apart. You're going to
> > break everything. Doctors began to believe that's what it means."
> >
> > In 1995, the FDA approved the much-anticipated Fosamax, which
> > essentially adds mineral to bone, fossilizing it and making it harder.
> > The drug's possible side effects include upper gastrointestinal
> > irritation, ulcers of the esophagus, skin rash, low blood calcium and,
> > in rare instances, necrosis of the jaw.
> >
> > Merck launched a marketing juggernaut around bone-density testing.
> > Marrying machine to medicine, Merck promoted portable bone-measuring
> > devices that doctors could use in their offices to identify those with
> > bone loss.
> >
> > The company also bought the exclusive rights to one company's
> > bone-testing technology, gave a loan to another company to help develop
> > a different machine, and financed two other firms in order to increase
> > the number of machines in doctors' offices.
> >
> > Merck also created the Bone Measurement Institute, a nonprofit
> > subsidiary with the goal of increasing the use of density-testing
> > machines.
> >
> > The goal wasn't only to sell the drug to the elderly who had
> > osteoporosis. Merck officials said they were aiming for the 40 million
> > post-menopausal women in America, according to a Columbia University
> > Business School study of the company.
> >
> > "They intended to turn Fosamax into a primary care product in the long
> > run," the study said.
> >
> > When Merck started its push in 1995, there were 750 bone-measuring
> > devices in the United States. By 1999, there were between 8,000 and
> > 10,000, according to Merck.
> >
> > "The drug companies started to make machines available to doctors'
> > offices and enter into big agreements to reimburse them for scans,"
> > said Dr. Andrea LaCroix, senior investigator for the Center for Health
> > Studies at Group Health Cooperative in Seattle.
> >
> > "We were all keenly aware of it. If you were in clinical practice, you
> > could get the machines relatively cheap."
> >
> > Doctors found themselves pressured to provide the density tests.
> >
> > "From the marketing point of view, if you're a provider, you're facing
> > a groundswell of demand for testing," LaCroix said. "We know it's not
> > doing a lot of good, but we can't deny them because" otherwise the
> > patients would "go someplace else."
> >
> > The number of people tested on the machines rose to about 3.5 million a
> > year, a Merck official said.
> >
> > The U.S. Food and Drug Administration warned Merck in 1997 to stop
> > implying that all women develop osteoporosis at menopause.
> >
> > In its letter, the FDA noted that twice before it had advised the
> > company about proper wording.
> >
> > In 2001, the FDA warned Merck that its Fosamax Web site "overstates the
> > benefits while minimizing the risks associated with the drug."
> >
> > 1997 and 2001 letters [PDF]
> > "Compare the facts" campaign [PDF]
> >
> > Merck targeted ads and brochures directly at younger women, telling
> > them that "menopause is the single most important cause of
> > osteoporosis."
> >
> > But the FDA ordered the company to stop using that phrase in its ads.
> > In a July 1997 letter, the agency told Merck that the claim "overstates
> > the population eligible for therapy with Fosamax by implying that all
> > women develop osteoporosis at menopause."
> >
> > Meanwhile, Merck's lobbyists helped to persuade Congress to pass the
> > Bone Mass Measurement Act in 1997. It authorized Medicare to reimburse
> > doctors for performing bone-density tests, opening the door to coverage
> > by other insurers.
> >
> > Merck was so successful in marrying its marketing to the measurement
> > that its Fosamax campaign was adopted by the industry as a
> > "best-practices" model for other drug companies looking to expand their
> > markets.
> >
> > Various machines mean varying results, critics say.
> >
> > But skepticism quietly took hold in some corners of the medical
> > community.
> >
> > "It's a violent storm in a very small puddle," said Dr. Brian Garra, a
> > professor of radiology at the University of Vermont who chaired a
> > gathering of experts who talked about scrapping the T-score measure in
> > 1999, even though many of them had long associations with drug
> > companies making osteoporosis treatments.
> >
> > They were concerned about the reliability of the measures provided by
> > so many different machines with varying standards and accuracy. A
> > person could be measured on different machines and come up with widely
> > varying T-scores. The small, portable machines that tested density at
> > the wrist were not as reliable as the large machines known as central
> > DEXA, studies showed.
> >
> > The system of diagnosing osteoporosis with T-scores was in danger of
> > falling apart. The main reasons for keeping it, it seemed, hinged on
> > the fact that it had become so entrenched in the medical culture.
> >
> > Merck's Bone Measurement Institute director said as much during a FDA
> > hearing in May 1999.
> >
> > "We understand that the T-score is not an ideal measurement, but it
> > serves many, many valuable purposes," Dr. Lewis Sherwood told the
> > assembled experts. "Even more importantly, it is embedded so thoroughly
> > in many processes that are used widely."
> >
> > Dennis Black, a University of California, San Francisco statistician,
> > told the panel: "The manufacturers as well as the pharmaceutical
> > companies have been very successful in promulgating T-scores. So I
> > think there is a feeling that we can't abandon those T-scores totally."
> >
> > The experts at the FDA hearing agreed a better way than T-scores was
> > needed to assess someone's risk for fractures. They also agreed that
> > women were being prescribed drugs they didn't need.
> >
> > "If you abandon the one string that people hold onto, there will be
> > nothing to hold onto, and the disease won't be treated at all," Black
> > said in an interview. "It's better for people to do the wrong thing or
> > not optimal thing than to do nothing."
> >
> > Task force would reduce bone testing, rely on "evidence-based
> > medicine."
> >
> > Black and others are trying to move the field toward a measure of
> > "absolute fracture risk." Instead of just a T-score, a woman would be
> > told the likelihood, stated as a percent, of breaking her hip in the
> > next five years, given her age, race and overall health.
> >
> > For example, for a healthy, white 50-year-old woman with osteopenia,
> > the risk of a hip fracture over the next five years would be less than
> > 1 percent. Her lifetime risk for a hip fracture would range from 16
> > percent to 27 percent.
> >
> > But doctors need to be careful about not scaring patients with new
> > numbers, Cummings said. "We need to make sure people understand that
> > risk, not just that they receive another number," he said.
> >
> > Today, many physicians, scientists and osteoporosis experts are pushing
> > hard to scale back bone testing.
> >
> > Many of them embrace what is called "evidence-based medicine." It
> > relies less on treatment guidelines from expert opinions and more on
> > empirical studies based on tests, medical data and outcomes from
> > thousands of patients.
> >
> > In 2002, a federal committee chaired at the time by Dr. Al Berg, head
> > of the University of Washington's Department of Family Medicine,
> > developed recommendations that cut through corporate marketing and
> > focused instead on evidence for screening.
> >
> > The committee was part of the U.S. Preventive Services Task Force,
> > which bars members from having financial ties to drug makers. Its
> > recommendations are highly regarded in primary care and preventive
> > medicine.
> >
> > The committee recommended that bone testing be sharply targeted. Women
> > 65 or older should be tested, as well as those over 60 who weighed less
> > than 127 pounds and were not taking estrogen replacement. Testing
> > should be done at the hip with a DEXA machine, the committee said.
> >
> > The recommendations gave credence to those experts who had become
> > concerned that millions of women would be exposed to drugs for decades
> > at great expense and without evidence that the drugs were safe or
> > effective for them.
> >
> > Experts also said that some elderly women who need the drugs might not
> > be getting them.
> >
> > A recent study of 459 patients above age 60 who got chest X-rays in one
> > hospital emergency room in Canada showed that one in six had spinal
> > fractures that indicated osteoporosis.
> >
> > But in nearly half of those cases, radiologists didn't spot the
> > fractures or note them in their reports. Only 25 percent of the
> > patients were treated for osteoporosis, the study showed.
> >
> > As result, said Ott, the UW bone specialist, women who could have
> > benefited from drugs such as Fosamax weren't getting treated for the
> > disease.
> >
> > "What's happening is these women who need it are still being terribly
> > ignored," Ott said.
> >
> > "Meanwhile, the women in the advertising look like they're about 40
> > years old."
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> >
> > fairuse
> >

.