What in the hell is Osteopenia and how did it become a multibillion dollar profit machine for Merck?

I am not talking about Osteoporosis, that is a disease that causes bones to become thinner, more porous and break more easily. That is actually a disease that mostly affects elderly women, who can be devastated by a fall that breaks their hip. In fact, I learned, one in five elderly women who break a hip will die within a year. The same bone density tests that are used to properly diagnose Osteoporosis are also used to diagnose the more shadowy condition called Osteopenia. This new condition, Osteopenia, is a perfect example of a made up thing and this crazy train started in 1995. As it turns out Osteopenia is a slight thinning of the bones that occurs NATURALLY, as women get older. It DOES NOT typically result in disabling bone breaks, as does Osteoporosis. The woman who was being interviewed, Katie Benghauser’s doctor recommended that she go on treatment for this condition she had never heard of. After Benghauser asked around her office she found that 4 of the seven women in her office take medication for it. Half of those 7 women are in their 20’s and 30’s, which is long before normal Osteoporosis may be expected to strike.

I was intrigued with the story and listened on, the story was on NPR. Interesting enough this was a story of how pills for Osteopenia have ended up in millions of women’s medicine chest. When I say millions just as a reference in the 90’s when Flomax was introduced sales were zero, and by 2004 sales had topped 3 BILLION, yes billion with a B. How could it be that a disease that previous to 1995 did not exist create such GIGANTIC sales numbers for the supposed cure? This is the story of how the definition of what constitutes a disease evolves, and the role that drug companies can play in that evolution and it is CRAZY. Osteopenia is a condition that only recently started to be thought of as a problem that required treatment. After all the human race is so fragile to have only made it this far in our evolutionary arc. It is after all part of the normal aging process. Osteopenia was transformed from a non problem into something that is now requiring millions of women to swallow pills for treatment. The story went back to the beginning, to a place very far away from any sane persons rational thought processes may take them.

It all started, we are told in the NPR story, in a small hotel on top of the Spanish Steps in Rome in 1992. That was when a group of osteoporosis experts gathered under the auspices of the World Health Organization. The meeting had been organized because professional opinion about how to diagnose and measure osteoporosis was all over the map. Doctors and researchers didn't even have a shared view of how osteoporosis should be defined. All well and good so far I thought, trying to forward diagnosis and treatment of a real disease. In the days before the 1990’s, all the way back to the early days of evolution, or when Eve of Adam and Eve fame got it all started the only way for doctors to properly diagnose osteoporosis was to look at the inside of the broken bone, after a woman had broken it. Through a miracle of modern medical technology in the early 90’s we were able scan bones. Anything that would allow us to potentially diagnose osteoporosis before a broken bone would be fabulous. The main question before the experts in Rome was simply, after the age of 30 all bones lose density, how much bone loss was normal? They were trying to determine a baseline. Once a baseline is established they would then needed to determine when, exactly, would the risk be high enough to be considered someone having osteoporosis.

There needed to be a line drawn that said, here is the point that we will call it osteoporosis. It Ultimately was just a matter of – the line needs to be drawn somewhere. Anna Tosteson, a professor of medicine at the Dartmouth Institute for Health Policy and Clinical Practice and Dartmouth Medical School was in attendance in that meeting acting as an expert. And she recalled, it was very hot in the meeting room, and people were in shirt sleeves and, you know, it was time to kind of move on, if you will. She can't quite remember who it was who stood up and drew the picture and said, 'Well, let's just do this. I bet she can but has decided not to recall the name. So there in the hotel room someone literally stood up, drew a line through a graph depicting diminishing bone density and decreed: Every woman on one side of this line has a disease. Seemed pretty arbitrary to me. Especially since the original idea was to develop a baseline. Being an engineer I know a thing or two about baselines and there is a methodology in their development. I can’t imagine just arbitrarily deciding where the baseline is. It would literally invalidate everything that happened from that point on, if the baseline if wrong nothing else will work. Seems to me, just like we use a methodology to develop a baseline there is a similar path that the outcomes will follow if you bullshit the baseline. That is what happened with the arbitrary line on a graph.

How did we get from there to here? The answer to that question starts with a man named Jeremy Allen. He has a long history in the pharmaceutical industry and in 1995 the drug company Merck approached him. This is where things started down that wrong path. The pharmaceutical giant had just released a new drug called Fosamax. A drug that represented a sea change in osteoporosis treatment. It was the first nonhormonal drug that could credibly make a claim to stop the progress of osteoporosis. Fosamax could become a blockbuster drug, if only people would take it. According to Allen after its release Merck wasn't selling the drug. David Anstice, the president of Merck America, came to him with a proposition: Figure out this problem and then fix it – so says Allen. He also claims his job description read: Provide some out of the box thinking. He knew the way to get sales up was to get more women to get their bones scanned and diagnosed –with something. Not as common in 1995 as it is today. At that time ehe machines were rare and as such the procedure was expensive. Allen needed to get the number of machines up, which would reduce the cost of procedure. Allen, now armed with the firm conviction that he was about to do good in the world, and coincidentally sell a ton of drugs for Merck. His out fo the box thinking lead Allen to completely rework the way the American health care system measured bone density.

He quickly realized the first thing he needed was an institution, an entity whose mission was not just to sell drugs, but to serve the public good. Some slick sounding things that brought credibility to the project. He decided to create one and in 1995 he persuaded Merck to establish a nonprofit called the Bone Measurement Institute. On its board were six of the most respected osteoporosis researchers in the country. But the institute itself had a rather slim staff, there was no payroll, there was no building, there was no office with the name 'Bone Measurement Institute on it. A complete sham that was being backed by the drug company with the most to benefit. Makes me wonder how many other named institutions are shams as well. Now on to the cost of machines, it had to come down. How to do that? He determined it could be done with machines called peripheral machines. These machines were small, often portable units that measured bone density in the forearm, heel, wrist or finger rather than the hip and spine. At the time, few bone measurement companies manufactured the machines, because they didn't measure the hip and spine. From Allen's perspective, they were the perfect solution: They wouldn't take up much office space and they cost only a fraction of the big machines, which meant that doctors would be able to afford them.

Allen started a campaign to ensure that peripherals were both manufactured and promoted. Several of the machine manufacturers were less than enthusiastic about this seemingly nefarious activity. According to Allen, two of the big dogs in the medical equipment manufacturers were downright hostile. One company, Lunar, was not about to go ahead and tell physicians to use the new smaller and less featured diagnostic equipment simply because Merck wanted them to., Richard Mazess, founder of the Lunar Corp Mazess says because Lunar refused to cooperate and his company was threatened. He says Merck told him, You're not going to get support from Merck and we will support your competitors, and we will tell people working with Merck not to use Lunar machines. The long and short of it Merck got its way and the machines were made and proliferated. This was a Tipping Point for Osteopenia, Merck's work to restructure the market didn't stop there. Merck worked to change the very economics of measuring bone by getting bone scans reimbursed by Medicare.

So what we have is a drug company deciding baselines, creating organizations that seem independent - when they are not, manipulating manufactures, creating hysteria, and selling a TON of drugs. All that for a non-problem, for something that happens as the normal aging process in women. Because of the fear mongering we now have what appears to me a pandemic. Seems crazy to me that this insane series of events lead to millions of women being diagnosed with normal aging. It lead to BILLIONS in profit for the drug company. This is another example of how crazy the world is and how much power big pharmaceutical companies actually have. What ya bet there is no verbiage in the current health care bill that will address this kind of nonsense. This is a lot longer story than I have condensed here, you can research it for yourself. It is crazy.

Of course this is compiled information I gathered from the internet and it could all be nonsense and if you are Merck - I am harmless.