The FDA - like all corrupted 'health' regulators - moves at a snail's pace when getting rid of useless and dangerous drugs and vaccines

Makena, the only drug that has ever been approved to supposedly prevent pre-term labour - has just had its approval revoked by the FDA - 12 years after it was given the green light under an ‘accelerated approval pathway’.

Where’s the emergency?

Was there an emergency whereby this drug needed to be approved without proper long-term trials? Especially when it would be administered to pregnant women who had already had problems with early labour in prior pregnancies.

In a statement from the FDA and the Chief Scientist regarding this revocation, the agency stated that:

The FDA approved Makena under the accelerated approval pathway in 2011 based on a determination that the sponsor had demonstrated a drug effect on an intermediate clinical endpoint that was reasonably likely to predict clinical benefit.

There are some words here I think it is worth pointing out to you.

As stated above, this was approved under an accelerated approval pathway. This is a fast-tracked way to avoid all those messy and expensive long-term trials and randomised controlled studies that would normally be required to get the FDA to give a drug company permission to peddle their poison to the public.

Note that the sponsor (the company manufacturing and profiting from the drug) is the one who needs to demonstrate its usefulness and safety. The FDA, like Australia’s own Therapeutic Goods Administration (TGA), does not do such tests. It simply takes what the drug company tells it and approves it on that basis. Does that give you much confidence in the science behind drugs?

Gardasil was also fast-tracked and we know how that turned out!

Gardasil vaccine - supposedly to prevent the human papilloma virus (HPV) which has never been demonstrated to cause cancer of any kind - was also given a fast-tracked pathway. Despite the fact that cervical cancer in young women is extremely rare, there was supposedly an emergency to get this jab out that targeted young women. And even with the fast tracking, its approval was faster than it was supposed to be. Studies that were supposed to last for 3 years were instead, declared to be over in only 18 months.

The Gardasil story is a long one and not one that I wanted to cover in detail in this article. If you would like more information on how the science was corrupted to approve this deadly jab, I highly recommend Robert F Kennedy Jr’s excellent video, Gardasil: The Science as well as the books Gardasil: Fast Tracked and Flawed by Australian researcher Helen Lobato and HPV Vaccine on Trial by US Lawyer and legal advisor to the Children’s Health Defence, Mary Holland.

Accelerated approvals instead of duty of care

Once very rare, accelerated approvals are now much more common. One has to wonder how many palms at the FDA needed to be greased before this drug was approved?

On the FDA’s page regarding such approvals, it states that:

The FDA instituted its Accelerated Approval Program to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint.  A surrogate endpoint is a marker, such as a laboratory measurement, radiographic image, physical sign or other measure that is thought to predict clinical benefit but is not itself a measure of clinical benefit. The use of a surrogate endpoint can considerably shorten the time required prior to receiving FDA approval.

Drug companies are still required to conduct studies to confirm the anticipated clinical benefit. If the confirmatory trial shows that the drug actually provides a clinical benefit, then the FDA grants traditional approval for the drug.  If the confirmatory trial does not show that the drug provides clinical benefit, FDA has regulatory procedures in place that could lead to removing the drug from the market.

So 12 years later, after an unknown number of pregnant women were given this drug which had never been independently tested for its effect on either the women or their unborn babies, the FDA finally figured out that it doesn't work.

Approvals of these drugs have been withdrawn because the drugs are no longer shown to be effective and the benefits do not outweigh the risks for the indication for which they were approved.

No longer shown to be effective? That means one of two things - both related. Either the drug company originally lied about the effectiveness or the FDA didn’t require real evidence. Those are the only possible explanations. Because the drug itself didn’t change, and the physiology of pregnant women likewise is the same as it was 12 years ago.

As for why the drug is now being withdrawn, perhaps Covis Pharma (OMG - just realised how close to COVID that name is…), the manufacturer, could no longer afford its protection money? I don’t know. I just know that women were unnecessarily placed at risk by these unsafe, ineffective, untested poisons.

Same old, same old really.

The lessons of Thalidomide, DES, COVID jabs and a host of other drugs given to pregnant women and women of childbearing age continue to go unlearned by these self-appointed ‘protectors’ of our health. And so many of us continue to believe the lies they are peddling.

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