Letter 12: December 11, 2012
When the FDA announced that there would be a public meeting to discuss whether Yaz
and similar drugs should be taken off the market, Dad and I were hopeful that sharing
your story would make a difference. We were only given a few precious minutes to tell
them how we felt. Here’s what we said:
Testimony of Annie's mom:
Would you like your healthy daughter killed by taking an FDA approved medicine for a condition where she was not seriously ill? That is what happened to us. Our Annie’s life was taken away too soon. She had just been admitted to the Maryland Bar. She was a physical trainer, a runner, a librarian, and a healthy eater. She trusted the FDA and took her YAZ for eight months for irregular periods. It killed her in her sleep on November, 7, 2009. The medical examiner found a microscopic myocardial infarction but no other heart abnormalities or disease, and nothing else of significance. I suspect hyperkalemia was involved due to an October 2009 lab report showing her having high potassium levels.
We spoke at the December drospirenone hearing and are here to plead for you to tell the FDA to finally put safety first and take all drospirenone birth control pills off the market.
We first thought that Annie’s death must have been an anomaly. It was not. We learned that thousands of FDA MedWatch reports had been received about drospirenone-induced blood clots. Our family is horrified.
We learned that Bayer knew drospirenone was more dangerous in the early 2000s, but obscured the dangers, according to David Kessler, then FDA commissioner. The FDA operates primarily through user fees, making its goal to grant approval quickly so profits can start. Everyone knows the safety process is broken.
FDA-approved labels remain inadequate and do not reach patients. They result from negotiations with the drug companies, as the recent Yaz revisions show, so anything that discourages use doesn’t make it in. Many women, including our Annie, don’t even get the FDA warnings, but only nonstandard pharmacy versions. Annie was a nonsmoker. Doctors often get their information from the drug detail person, who subtly encourages off-label use and downplays the dangers. Amazingly, when Annie consulted an endocrinologist, the doctor never considered if her symptoms were related to Yaz. Instead, she told Anne to keep taking it because it was good for an off-label condition that her autopsy showed she didn’t even have!! In spite of the odds, Annie put it together with her last refill two weeks before she died. She called her OB/GYN to report having problems with Yaz. They merely gave her an appointment, proof that the doctors don’t recognize the dangers. She never got to the OB/GYN - the next doctor who saw Annie was the medical examiner.
Post-market monitoring is broken. Drug companies don’t pay for it and don’t want it, so it doesn’t get done. Americans trust the FDA’s stamp of approval and that dangerous drugs won’t get or stay on the market. But there’s no way to prove the danger, and that’s how the drug companies want it: Med Watch reports aren’t mandatory and most resolved blood clots are attributed to genetics and never reported at all; the CDC prohibits medical examiners from reporting prescribed drugs in cases of unexplained deaths and protocols discourage them from looking for the root causes; birth control is an adult private medication, so the family may not make the connection; and there is no effective post-market monitoring or study mechanism. The pharmaceuticals spend their money challenging the studies that do get done or ensuring that required post-market studies are slanted. There will always be less certainty in post market studies because they are harder to control, and not setting up monitoring makes doing studies nearly impossible. Nevertheless, those independent studies are better than the clinical trials that are shaped by the drug company and withheld if they don’t produce the desired results.
The casualties are not a few out of ten thousand - the Med Watch reports of drospirenone deaths to the FDA are just the tip of the iceberg of women’s deaths and injuries. When there have been tens of millions of users, then even a small percentage will produce hundreds of thousands of casualties. Nearly every young woman I tell about Annie’s death has had problems with Yaz or knows someone who has.
Removing drugs is well-nigh impossible. Even when a rare advisory committee review is held, it is controlled by the drug company – the “sponsor”: the wrong questions are asked, conflicts of interest are ignored, and votes certain to be unfavorable to the drug company are denied. We witnessed this at the December hearing.
I am struggling for time here-unlike Bayer who has the ear of the FDA anytime it wants. Our questions to the FDA went unanswered until we involved our Senator. Our letter to Commissioner Hamburg after the December hearing has gone unanswered.
You learn a lot while grieving. I have learned that I cannot rely on the FDA. The similarities here help me understand better how the Holocaust happened in a civilized society, except here it is naked capitalism that has run amok. I have learned that thousands of graves throughout the US contain the bodies of young women that YAZ and its sister drugs killed. Thomas Jefferson stated that “The truth will keep you safe.” Until my death I will grieve the loss of our beloved Annie. Her headstone reads: Anne Ammons : loving daughter, loyal sister, cool aunt, fun-loving friend, Yaz Victim. Please keep this truth from going on more headstones.
Testimony of Annie's dad:
We drove to our daughter’s grave in Cincinnati to honor her in death last weekend. However, we don’t want your sympathy, but your action. You asked for a signal before and you’ve received several. Here’s one more.
I will make well-founded assertions, be blunt and candid, not clinical. Detailed justification is already well-documented. If you don’t know in five minutes what the issue is, what should be done, how important it is to act and what you need to do, I have failed.
As Doctors Miller and Ouellet-Hellstrom’s July review found, those in danger include your patients – and probably at a higher rate than others taking Beyaz. It also affects some of your other patients - the children who are left motherless or with an invalid mother after she resumed DRSP COCs.
All the FDA’s drug processes are set up to benefit the pharmaceutical industry. Profit comes out ahead of the health and safety of Americans. The cards – actually, the money - seem hopelessly stacked. That is the core of the problem my wife described: In spite of good and honorable FDA people, the drug industry has played the game well on all fronts and now effectively runs the show.
Big money shapes studies to ensure favorable results. PDUFA and the FDA culture of serving the drug companies make keeping drugs off the market extremely difficult. Inadequate post market monitoring, loads of money spent by the drug companies to stall and mislead, materials improperly labeled proprietary, and a toothless FDA all ensure drugs remain on the market until widespread catastrophe occurs.
We have a torrent of money rushing downstream at us as we struggle to help protect women like our daughter. Annie’s mother donates her entire annual salary to a nonprofit group promoting health for women and children. I’m sure that’s less than Bayer paid one doctor to talk at the December hearing.
It is frustrating, but we cannot give up. We could not sleep wondering if there was anything more we could have done to keep another woman from dying or being crippled from an embolism or thrombosis next week, next month or next year. Could you, knowing what Hippocrates would expect you to do?
Can you and we be the exception that proves the rule – maybe we can help get this drug off the market.
One example particularly illustrates many of the issues.
On 8 December, the FDA asked the joint committee to advise if DRSP-based COCs were more dangerous than pregnancy. If decided unfavorably, this question might have resulted in pulling the drug’s approval. The committee narrowly found that DRSP was not more dangerous than pregnancy. Everyone knew the issue was the comparison of DRSP vs. other COCs, so why was the wrong question asked?
Secondly, they were asked if the FDA’s standard warnings for COCs adequately represented the dangers of DRSP COCs. The committee overwhelmingly found that the warnings were inadequate. Why did the FDA not recognize that this meant that DRSP COCs were more dangerous than other COCs?
The lead Bayer spokesman admitted at the hearing that DRSP-based COCs confer no additional benefits, but only after challenging the FDA study and extended prevarication, obfuscation and tap-dancing and only when faced with a direct, unavoidable question. Yet the new warnings say: “consider the risks and benefits of a DRSP-containing” COC before starting or switching to it. Why allude to unproven benefits and apply it only to those starting DRSP?
Why would the FDA continue to allow pills to remain on the market that most studies except Bayer’s found to be at least twice as dangerous?
Why did the FDA approve a dangerous COC when there were already so many safer ones, especially after Bayer’s alleged obscuring of the dangers became known to the FDA?
Why, why, why? Is the FDA incompetent? Careless? Stupid? Not paying attention? Or is it that the pharmaceutical industry has so much influence over the FDA? Only Bayer benefited from the way this turned out.
Profits drive business decisions. To expect otherwise is stupid, but with the industry effectively controlling the FDA, does the FDA pledge to promote and protect the health of the American people mean anything?
We can’t ask you to change the FDA and its culture. That is too large a task requiring legislation, changing funding and a host of other things. But we can ask you to tell the FDA to do what it should have done years ago: take all forms of this unnecessarily dangerous drug off the market.
What is going on is unconscionable and horrifyingly, it s not accidental. The FDA and Bayer know this drug is more deadly. They are consciously choosing profits over the lives and health of American women.
Send a message to the FDA, that this is not Nazi Germany, where Bayer was part of the company that made the gas for the Holocaust death camps. The Allies broke up IG Farben after WWII, but one of its Bayer division executives became chairman of the new Bayer’s board after he served the war crimes sentence handed out at Nuremberg. And now, Bayer’s drugs are killing in the United States and around the world, when Bayer itself agrees the drug is more dangerous and has no more proven benefits than other birth control pills. How can the FDA condone and enable this? America should not provide the freedom for pharmaceutical companies to kill and maim indiscriminately in the naked pursuit of profits.