Will "sunshine" finally come to BC?

Exposing Big Pharma’s dark influence on doctors who diagnose and prescribe.

DAVID HUNTLEY HAD AN INFECTED TOOTH, so his dentist referred him to an oral surgeon who told David he needed surgery. But when David explained which drugs he was taking, the surgeon refused to do it.

I had never met David, an 81-year-old retired professor of physics who lives in Burnaby, but I knew pretty quickly why oral surgery wasn’t an option for him: He was being treated for osteoporosis, and had been prescribed denosumab to treat the disease, colloquially called the “silent thief,” which puts people at risk of fractures.

Now what does the bone-thinning disease have to do with dentists refusing to perform surgery? One of the most serious, but rare, adverse effects of osteoporosis drugs—known as bisphosphonates—is osteonecrosis of the jaw. If it sounds nasty, well, consider this: Osteo=bone + necrosis=death. The jaws of some patients taking bisphosphonates can literally fall to pieces.

Many adventures in the medical world often start with a trip to a specialist, which leads to a test, then a diagnosis, then a drug. David doesn’t remember why his GP sent him to get the initial X-ray, but that led to a referral to an endocrinologist in Vancouver who I’ll call “Dr X.”

Dr X used a specialized X-ray machine called a DXA, which measures bone density and spits out a figure known as a “T-score.” David’s T-score was -2.8, and he asked the doctor to explain what it meant. “After some questioning, [Dr X] mentioned ‘standard deviation,’ but beyond that, I don’t think he knows. Either he doesn’t know or he wouldn’t explain it,” David told me. Dr X told David that given his T-score, he had a “high probability of breaking something in the next several years.” He prescribed David a twice-yearly injectable bisphosphonate drug called denosumab (Prolia) and vitamins.

I have been more than a casual observer of the osteoporosis industry for over 20 years, and I can be confident about only one thing regarding this disease: Everything about it is controversial.

For starters, its very basis, the “T-score,” which defines what is and isn’t osteoporosis, was crafted during a critical meeting at the World Health Organization (WHO) in 1994. Attended by specialists in bone health—as well as various pharmaceutical company officials—that WHO meeting defined “normal” bone density as that of an average 30-year-old woman, which automatically meant that nearly 30 percent of post-menopausal women had the disease, and were hence deemed “high risk” of having a fracture.

After that crucial meeting, women who were 50, 60 or 70 years old, with normal bone density for their age, were told they had a disease. Some loss of bone density happens naturally over time, a process as natural as grey hair and wrinkles. Yet once it is measured, along comes a diagnosis, and then the drugs.

The bisphosphonates, which include drugs like Fosamax, Actonel and Zometa, are also controversial, due to their minimal effectiveness and toxicity. There’s very little evidence that they actually help patients avoid future bone fractures, and longer-term use of bisphosphonates actually increases one’s risk of bone fractures.

Having pharmaceutical companies sitting at the table defining disease usually ends the same way: The disease appears more common, bigger, more dangerous, and more likely to lead to some kind of drug therapy. By mid-1995, the world’s osteoporosis industrial complex was launched, boosted into orbit by major pharmaceutical company Merck, which bought up and distributed DXA machines around the world—while their bisphosphonate, Fosamax, became an über-blockbuster.

Fast-forward 20 years or so, and there are at least half a dozen bisphosphonates on the market, taken by millions of people. The most effective ones may help prevent one out of 100 women with established osteoporosis from having a hip fracture. Which is to say, on that function alone, they are 99 percent ineffective. And they make dentists nervous.

David didn’t recall being told about osteonecrosis of the jaw related to bisphosphonates, nor did he know that FDA warnings on bisphosphonates indicate they can cause severe and occasionally incapacitating bone, joint, and/or muscle pain, dangerously low levels of blood calcium, as well as serious infections of the skin, abdomen, urinary tract and heart valves.

I told David that his story seemed so familiar because the industry around measuring and medicalizing bone density has been colonized by the pharmaceutical industry, and underwritten largely by those companies selling bisphosphonates. I really didn’t want to get into it, but I was pretty sure Dr X was on the pharmaceutical industry payroll.

WHY WOULD A PROMINENT VANCOUVER SPECIALIST be so swayed to prescribe denosumab to a relatively healthy man? Follow the money. Most of the major osteoporosis societies in the world receive substantial injections of funds from the makers of bisphosphonates, and, with some easy searching, I found Dr X sits on osteoporosis committees at the provincial, national and international level. He lobbies for the DXA scans and drugs to be covered. He also has extensive ties to global drug companies that make bisphosphonates. How extensive? One of his conflict-of-interest disclosures (taken verbatim from a peer-reviewed journal) reads: Dr X “consults for, receives research grants from, or is on speakers bureau for Procter & Gamble, Merck, Novartis, Eli Lilly, Wyeth, GlaxoSmithKline, Biosante, Servier, Amgen, Johnson & Johnson, and Pfizer.” Amgen, by the way, makes denosumab (Prolia).

We are all, in a way, like David, unaware of the possibility that the specialist giving us advice is also financially tied to the companies making the pills being prescribed. Here in BC, it appears we’ve banned big money in BC politics, and that’s a good thing. But have we banned big money in medicine? Not yet.

At the national level, a campaign called Open Pharma is calling for a “dose of transparency” (www.openpharma.ca) and wants “all drug companies with products listed on their formularies to publicly report any transfers of value, e.g., money, gifts, meals, made to doctors.” The issue here is not about disallowing payments between doctors and drug firms, but about making those payments transparent.

Right now, as a first in Canada, Ontario has introduced legislation forcing drug companies to divulge their payments to health professionals. As well, one drug company (GlaxoSmithKline) has started voluntarily disclosing payments to physicians and healthcare organizations. Ontario’s new legislation looks a bit like the US Physician Payments Sunshine Act, which forces medical and drug companies in the US to reveal their compensation to individual physicians, whether they sit on advisory boards, and so on. Some European countries, plus Australia and Japan, have sunshine laws. But mostly, in Canada, any money passing between a drug company and physicians remains largely secret.

Given the world’s attention on the opioid epidemic, and emerging evidence that opioid makers in the US and Canada spent millions of dollars to educate physicians about the alleged safety of opioids, you can understand why consumers might be alarmed. What if the specialists who are seeing us, testing us, and prescribing drugs are working “under the influence” of millions of dollars of pharma funding? As of now, BC has no “sunshine” legislation, but our Health Minister says it’s coming soon.

Here in BC, it’s clear our doctors haven’t gotten that memo. The Doctors of BC has no existing policy on this. As its communications spokesperson Sharon Store wrote in an email: “The closest we have is the following recommendation from one of our policy papers from a decade ago: The BCMA supports the CMA [Canadian Medical Association] guidelines on appropriate relationships between physicians and the pharmaceutical industry and encourages other health care providers to adopt similar guidelines.” To update that a bit, in 2012 the CMA’s General Council approved a motion calling on “pharmaceutical companies to make information concerning their relationships with all physicians receiving any financial or non-financial compensation publicly available.”

In my opinion, being transparent is only the start. The long-term goal should be to remove any corporate influence on prescriber education. Up to half of the funding for ongoing education of BC prescribers is coming from the pharmaceutical industry. We know, for example, that osteoporosis specialists, many of whom are highly financially conflicted, are often the ones who teach other doctors. Astonishingly, we allow this. Do our doctors learn of the controversies of the disease, the problems with the medicines, or the potential for serious adverse effects of the drugs? Some might, but that doesn’t seem good enough. 
We shouldn’t have to rely, as David did, on our dentist to inform us that yes, sometimes drugs have dangers.

Alan Cassels is a Victoria writer and health researcher.  His most recent of four books is The Cochrane Collaboration: Medicine’s Best Kept Secret.