So the manufacturer paid a researcher to conduct a formal university study to SHOW Synthroid was better. And guess what? The study showed Synthroid wasn't better -- it was merely equivalent to the other, less expensive brands. So the manufacturer shelved the study, suppressed the release of the results, denigrated the quality of the research, and said it couldn't be published. That way, they could protect market share, and not let out any information that might jeopardize the reputation of Synthroid, or the ability to continue charging more.
The researcher herself, Betty Dong, wasn't pleased, nor were a few of the more enlightened members of the medical community, and eventually, with a lot of resistance from the manufacturer, the study WAS published in the Journal of the American Medical Association. The study showed that Synthroid wasbioequivalent to other brand name levothyroxines. And as a result, within a few weeks of the spring 1997 publication, a large class action lawsuit was filed on behalf of patients who had taken Synthroid during the 1990s. The lawsuit charged that for the years the study wasn't published, patients overpaid for a drug that was supposed to be better than its competitors, but wasn't.
Because Synthroid wasn't better -- it was just more expensive.
Sound familiar?
Now, ten years later, the majority of thyroid patients are still on Synthroid (some estimates say that two-thirds of all thyroid patients take Synthroid), and Synthroid is STILL more expensive than other brand name levothyroxine drugs and the generics. So naturally, insurance companies want to contain costs and so many are saying they'll cover only the less expensive brands or generics. And patients who have to pay for their own drugs frequently want to save money by switching to one of the less expensive options.
So there is intense financial pressure for people to switch from Synthroid to less expensive levothyroxine drugs.
But this isn't good for Synthroid, so they need a reason to prevent those patients who take Synthroid from switching. They need a reason for doctors who are writing new prescriptions to keep specifying Synthroid. They need a reason to justify the higher price of Synthroid. They need to justify to insurers why they should cover the higher price of Synthroid. They need you to be willing to shell out of your own pocket if your insurer won't cover your higher-priced Synthroid prescription.
And so they've come up with a new take on the old bioequivalence issue.
The "Anti-FDA Levothyroxine Bioequivalence Fiasco"
And there we have it: the "Anti-FDA Bioequivalence Fiasco" -- this decade's answer to the 1990's Synthroid Bioequivalence Study Fiasco. The PR moguls, pharma folks and various organizations have apparently joined forces to create an entire campaign to promote the idea that "the brand of your thyroid hormone medication should always stay the same" because the FDA's method of determining bioequivalence is flawed.
Their entire argument rests on the assertion that, as they say in their "Joint Position Statement," "Uncorrected," the FDA's methodology may lead to the conclusion that preparations that differ by as much as 33% are equivalent...." And where does this "proven data" come from? It comes from research whose primary investigator and author, Vicky Blakesley, is a key employee at, where else, Abbott Labs, working on, guess what product: Synthroid!
It's true that the FDA's way of measuring the bioequivalence of levothyroxine is flawed. It doesn't take into account TSH level. And it doesn't take into account your own thyroid's production of hormone. These are both flaws in the methodology. But the methodology has been flawed for decades. It was flawed 10 years ago. It was flawed 5 years ago. That hasn't changed. A good doctor has always determined whether you are responding to your thyroid medication based on a combination of various blood levels and symptomatic response. And other the argument these groups are making -- that when switching drugs, you may encounter different potencies that can affect your TSH level -- was also true before. That's nothing new either.
Ultimately, this campaign is not about patient awareness at all ---- it's a war between the maker of Synthroid (backed up by the groups and doctors with financial ties to the drug) versus your insurance companies and HMOs (who want to specify the cheaper generics or cheaper brands as the levothyroxines they will cover.) It's also about the bickering that goes on between drug companies and the FDA.
