Decades of Devastating Data, Yet This Drug Is Still On The Market

by FedUpTexasChick

Same playbook. Here we go again. Pfizer knew about issues with one of its blockbuster drugs, and did nothing. This time around, we’re talking about Depo-Provera, the contraceptive marketed to women as a major convenience. Don’t worry about taking a pesky pill every day. Instead, just take the Depo-Provera injection once every three months. Ah, the convenience of not having to take a pill every day.

Pfizer’s marketing campaign worked well. One in four American women have used Depo-Provera, known generically as medroxyprogesterone acetate. The medication is a hormonal contraceptive to prevent pregnancy. It contains no estrogen, and is a synthetic form of progesterone that prevents pregnancy by stopping ovulation, thickening the cervical mucus to make it more difficult for sperm to reach the egg, and thinning the uterine lining to reduce the likelihood of implantation.

But Depo-Provera has a problem. A big problem. It greatly increases the likelihood of women developing a certain kind of brain cancer. A new study shows the correlation. In a massive study of 61 million women, Depo-Provera increased the risk of a brain tumor called meningioma by a whopping 240%. In other words, for every 1,152 women given the Depo-Provera injections, one is expected to develop a meningioma directly attributable back to the injection. Women over age 31 who had used Depo-Provera for 4+ years were found to be at the highest risk.

What is a meningioma?

Meningioma is a slow-growing brain tumor that can cause seizures, paralysis, and vision loss.

And “follow the science” Pfizer should have known better. Both the company and the medical community in general have known for decades that certain types of tumors are very receptive to progesterone. Meningiomas are on that list. It is well known that these tumors are hormone-sensitive and that they grow in response to synthetic hormones like progestins. What makes Depo-Provera
particularly bad is the dose given. Because it is given every 3 months, a high and sustained dose is included in each injection, and it remains active in the woman’s body for quite some time. By comparison, oral contraceptives are a much smaller dose of daily hormones. With Depo-Provera, a woman’s hormone-sensitive tissues are constantly bathed in the hormone. The high dose combined with the long-duration exposure is a recipe for disaster that drastically increases the likelihood of tumor growth.

There’s so  much science on this. It is well known, but was simply ignored by Pfizer. With annual revenues around $200 million for the drug, perhaps we’ve found the reason for Pfizer sticking its proverbial head in the sand.

Women Are Fighting Back

Nearly a thousand women want justice, and are suing Pfizer over the issue. It is an uphill battle, but they want Pfizer to have some accountability. It’s the same story – the same playbook – we’ve heard over and over from Big Pharma. Here’s the playbook.

#1 Big Pharma plays dumb. Still to this day, Pfizer argues there is no definitive link between their drug and the brain tumors. This is ludicrous given all the science that has been amassed to date on this topic, particularly the newest study in JAMA Network.

#2 The drugs must undergo placebo-controlled randomized trials, but Dr. Tenpenny has already educated all of us on the fallacies of placebo testing.  Dr. T has also educated all of us on the importance of the package insert (here is the one for Depo-Provera.) 

#3 The clinical trials are typically not long enough to expose these types of problems.

#4 Failing to take any responsibility has been perfected to an art form by Big Pharma, and Pfizer plays the game, of course and pushes the blame on the FDA.

Depo Provera did not have an easy route to approval. The shot was first tested in the 1970s on poor women in developing countries. It’s sad but true. This happens way too frequently. Despite the plethora of adverse events reported in those trials, Depo-Provera was fast-tracked for approval in the US. How did this happen?

Pfizer used short-term efficacy studies to present to the FDA, and the FDA bought it. FDA could have made Pfizer prove long-term neurological safety but the agency didn’t. Pfizer then adds insult to injury by using the lack of long-term testing as a way to escape accountability. With the lack of long-term trials, Pfizer uses that as grounds to argue no definitive link between their injection and the tumors. It’s a disgusting loophole but it is used all the time. Their bank account benefits and women suffer.

It is truly heartbreaking to hear the stories. The women thought it was safe. It was marketed to women with busy lifestyles, and they believed Big Pharma. They believed their doctors. They read the package insert, which said nothing about brain tumors (that’s how the above loophole works.)

Women who have taken the injections had severe blurred vision, debilitating headaches, seizures, and memory loss – all caused by the meningiomas growing in their brains. Many of the plaintiffs in the case have had multiple brain surgeries, and some have suffered permanent neurological damage after those surgeries. The damage doesn’t stop once women discontinue Depo-Provera use, either. Even after the women stopped the shots, the damage continued.

We Need Accountability

Pfizer and the FDA seem to have a symbiotic relationship that suits both parties. The only people that don’t win are the women harmed by these injections. On one hand, Pfizer hides behind the FDA. The company says it gave all the data to the FDA to make the decision. But in reality, Pfizer gave such a small smattering of data to the FDA. And we know that the FDA does not perform its own testing, so the agency is totally reliant on Pfizer’s own data. There are no checks and balances, so if Pfizer lies or manipulates their data, the reviewer will typically green light the drug as safe. The FDA knows the racket – they’re in on it.

Pfizer has the authority to update its own label as soon as they find a risk. Typically, pharma companies don’t even bother, but if they do decide to update their label, it can drag out over multiple years. They do it on purpose and meanwhile, the drug is being sold with the same old label – with no brain cancer risk warning in sight. If Pfizer gets pressure over the label, they blame it on FDA’s multi-year process. It’s a game, and FDA is in on this.

The lack of label change is even more infuriating because international regulators have already changed their labels. Europe, Canada, and Australia all require the Depo-Provera label to carry a warning about meningioma risk. Use of the contraceptive is restricted in France after evidence from several studies came to light. But here in the US, it’s business as usual – no warning label, and doctors continue to prescribe it. Women still think it is safe because there is no word otherwise.

How many more horrific cases do we have to read about like this before we demand that pharmaceutical companies have accountability? They must take care of the people they’ve injured. We cannot continue on the path of zero accountability.