but two judges recently ordered them released.
In our second annual Healing Cancer World Summit, Mike Adams, activist and founder of “NaturalNews.com,” talked about pharmaceutical companies who have committed multiple crimes, yet seem to get away with it by paying fines and then going on with business as usual.
I posted snippets of my conversation with Mike—you can find those here: “The Dirty Business of Drug Companies, Plus Natural Healing Success.” I also talked last July about how British drug maker GlaxoSmithKline agreed to pay $3 billion in fines for promoting drugs for off-label uses, paying doctors to promote their drugs, and failing to report critical safety data related to their products.
Now we have another example of a medical company hiding important information about one of their products. If you use the NuvaRing contraceptive device—or if you’re just curious about the lengths these companies will go to in the name of profit—read on.
The NuvaRing is a soft, two-inch ring worn in the vagina to provide hormonal contraception. It slowly releases estrogen and progestins into the body, preventing ovaries from releasing eggs and thinning the uterine lining to prevent the implantation of a fertilized egg.
The FDA approved the NuvaRing for use as a contraceptive device in 2001. The device is made by Organon USA Inc, a subsidiary of Merck & Co. Just a few years after the product had been released on the market, women started reporting injuries related to blood clots, including deep vein thrombosis, pulmonary embolism, and stroke.
All hormonal contraceptives carry some risk of blood clots, and all provide a general warning about blood clots. The problem is that the NuvaRing and other newer birth control options, like Yaz and Yasmin, for example, contain what is called a “fourth-generation” progestin, which studies have linked to an increased risk of blood clots and related complications.
Studies Indicate Serious Risks
In October 2011, the FDA released the results of a study that found women using the NuvaRing had a 56 percent greater risk of blood clots—including deep vein thrombosis and pulmonary embolism—than women using older, more standard birth control pills. To date, the FDA has received over 1,000 adverse event reports related to the NuvaRing and blood clot injuries.
A few months later, in May 2012, the British Medical Journal reported that non-oral contraceptives, like the NuvaRing, increased risk of blood clots more than older birth control pills. Specifically, they found that those women using older birth control pills containing the progestin levonorgestrel had a risk 3 times as high as those using no birth control at all, while those using the NuvaRing had a 6.5 times greater risk. The researchers also noted that women using the vaginal ring had a 90 percent higher risk of venous thromboembolism than those taking the pills with levonorgestrel, and advised women to use standard birth control pills rather than patches or rings.
Taking it to Court
Notice that these studies came out in 2011 and 2012, ten years after the product was released on the market. One would think these sorts of studies should have been conducted before the product was released. Organon apparently did conduct some clinical studies to gain approval on the device. But now it seems that they may not have been entirely truthful about what those studies revealed.
In 2008, so many women had filed a lawsuit against the companies because of injuries suffered by the NuvaRing that the U.S. Judicial Panel on Multidistrict Litigation consolidated all federal cases into one court in 2008. Over 500 cases are now proceeding in the consolidated action in the Eastern District of Missouri. New Jersey has consolidated all New Jersey state NuvaRing lawsuits into one court, as well.
Two key decisions made by U.S. District Court Judges in these matters suggests that once again, we have a situation where a company fudged the data to ensure their bottom line.
First Key Decision
On October 22, 2012, New Jersey State Court Judge Brian R. Martinotti issued an order that allows public access to documents Organon had sought to keep restricted. Indeed, the defendants filed six motions to exclude certain testimony by plaintiffs’ experts, with similar motions filed in federal court.
The defendants argued that release of these documents would harm their reputation. Judge Martinotti, however, stated that in New Jersey, there is a presumption that the public has a right of access to judicial proceedings, which includes the public’s right to inspect judicial records.
Among those unsealed documents?
- Expert report by Shelley Ann Tischkau, Ph.D., pharmacologist, prepared for plaintiffs in the NuvaRing litigation. Dr. Tischkau analyzed one of Organon’s studies on the drugs—the only one where the company measured the levels of estrogen in the women using the ring. Dr. Tischkau notes that the drug maker concealed or misrepresented certain facts to the FDA and to doctors. For example, this particular test involved only 16 women, and the estrogen got so high in two women that the company just dropped them out of the study, without disclosing this reduction.
- Dr. Tischkau also reveals that the company found that the NuvaRing created “bursts” of estrogen that they could not control. Organon applied for a patent for a way to avoid the estrogen bursts, but did not follow through with it. In the end, they decided to do nothing about the bursts.
Why might Organon have tried to hide this information? Because the higher the level of estrogen in a woman’s body—or the more the levels vary from day to day—the greater the risk of blood clots and related complications.
Ironically, the device makers advertised the NuvaRing as providing the “least” amount of estrogen of any contraceptive. They added that unlike the birth control pill, the NuvaRing released that hormone steadily over the 21-day cycle.
Federal Judge Follows Suit
On October 25, 2012, U.S. District Judge Rodney W. Sippel made a similar decision for the consolidated federal cases. In the court order, he noted that Organon had asserted that the documents in question were potentially inadmissible and a release of the “misinformation” to the public may be damaging to their reputation.
The judge disagreed, and noted that, “Organon has not identified with particularity any trade secret which will be made public if the documents at issue are unsealed. The fact that the documents may call into question Organon’s research and marketing of its NuvaRing product is not an uncommon allegation in this type of litigation.”
Judge Sippel also denied Organon’s motions, and ordered the documents unsealed.
Give New Drugs Time
One of the things that Mike said in the summit that may have seemed a little harsh, but ultimately, may be true, was, “The truth is, corporations, when they get beyond a certain size, really do become sinister, because the profit becomes the only focus no matter what the cost.”
What can we learn from situations like these? Bottom line—you must become your own health advocate. Don’t be too quick to trust new medications. Wait a few years until all the studies have been done, all the lawsuits filed, and all the dust settled, so you can get the whole story. We think these companies have to prove their drugs safe before they sell them to us, but the reality in today’s world is that it’s just not the case.
Post-marketing reports of injuries and innocent people that end up being victims is business as usual for these companies. It also looks like fudging a bit on the numbers in pre-approval studies may also be happening more than we’d like to accept.
“They care about their bottom line, their shareholders, their market share,” Mike said. “That’s what drives corporations, period.”
Do you use the NuvaRing? What do you think of this latest report on their pre-approval studies?
“Combined Hormonal Contraceptives (CHCs) and the Risk of Cardiovascular Disease Endpoints,” CHC-CVD Final Report 111022v2, http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf.
Øjvind Lidegaard, et al., “Venous thrombosis in users of non-oral hormonal contraception: follow-up study, Denmark 2001-10, BMJ May 10, 2012;344:e2990, http://www.bmj.com/content/344/bmj.e2990.
U.S. District Court, Eastern District of Missouri, Memorandum and Order, 10/25/12, http://cdn.aboutlawsuits.com/wp-content/uploads/2012-10-25-NuvaRing-Order.pdf.