by Andrea Doria
Disclaimer: This is a work of fiction written by a non-doctor and non-lawyer even by a non-English speaker. Any glaring language, medical or judicial mistakes are mine. The story involves a physical relationship between two women. But you knew that, that's why you are here ;) Feel free to send me your thougts: firstname.lastname@example.org
Tabernash, Colorado, March 2006
Around 4.30 a.m. Mo had finally convinced Ann to go upstairs and lie down on the bed in the guest room.
- Don't worry, I'll need your help getting Fran out to where the helicopter will collect her, they can't land, it will be a winch up.
Ann had gratefully wrapped herself in the down comforter on the bed and drifted off to sleep immediately.
So it felt like she had only just closed her eyes, when Mo gently shook her shoulder.
- Helicopter will be here in 25 minutes, I need your help!
She felt groggy, as she staggered into the bathroom. Fortunately her clothes were dry, so she dressed and left the grey sweats neatly folded on top of what she took for the laundry basket.
Downstairs Mo was wrapping Fran in thermal blankets, almost trussing her like a chicken. Once in a while Fran would murmur vaguely.
Mo told Ann to check if Fran wanted a small sip of water while she went to the shed to get a board to carry her out on.
Ann felt a cold rush from the door when Mo went outside. She shivered in her fleece jacket.
Fran looked a lot better than last night. She had regained some of her color and her lips had normal lip color.
Ann bent down towards her ear and asked if she was thirsty. Fran nodded almost invisibly.
It was hard getting an arm under Fran's torso to elevated her head a bit but finally she was satisfied that most of the water would hit Fran's mouth and not go down the front of the thermal blankets.
- Has she said anything?
The question was barely audible, but it made Ann just as mad as the similar question Ortiz has asked last night on the phone had.
For a moment she considered just dropping the maddening woman, but she controlled herself.
- She has been too busy saving your life!
Just then the door opened and another cold blast entered in front of Mo.
- This will have to do.
She was carrying a large sheet of plywood. And together they pushed the board under Fran and lifted her up.
She wasn't exactly heavy but Ann's knee immediately made it's presence known. Also it was a bit hard getting a good grip on the board with no kind of handle on it. Ann just hoped Mo had chosen a spot close to the house for the hoist up.
Mo was slowly backed them towards the door and that's when Ann heard the cats meowing from the kitchen.
- I figured we don't need them running around out feet when we carry her out, and I bet the helicopter will scare them with the noise and all the snow whirling around, Mo said.
Outside the day was only just dawning, but there was no wind, and everything looked serene and beautiful.
They were standing on the front porch the board with Fran on it was resting across the corner of the railing.
Mo had chosen a spot close to the house, she had marked it with a red cross made from two skis. Around the cross she had stuck three huge maglites into the snow. The daylight was stealing the powerful beams from the flash lights.
- Listen, they are almost here!
Ann could hear it too, the rythmical sound of a rotor, and a moment later the helicopter was hovering right over Mo's designated spot.
They walked off the front porch and into the powerful search light from belly of the helicopter.
Soon a stretcher was being winched down. Mo had halted them on the perimeter of where the gust from the helicopter was most powerful. When the stretcher gently made contact with the ground they crouched low and rushed towards it.
Mo unhooked the stretcher and the guy operating the hoist winched the hook up far enough to not be a danger to them.
The stretcher had a build in thick fleece blanket that Mo zipped Fran into after they had lifted her into the oddly shaped contraption.
Ann thought it had the same rhomboid shape as old fashioned coffins from cowboy movies.
Mo's voice dragged her out of her morbid fantasy.
- You can go back to the house now.
Ann got up and walked back to the porch.
Mo signaled to the guy in the open door of the helicopter and the hook was precisely winched into her outstretched hand.
Ann saw her test the hook a few times, then she signaled again and the stretcher immediately lifted off the snow.
In no time Fran was level with the open door and pulled inside. Mo was still stading right below the helicopter.
The guy manning the hoist gave her a thumbs up and closed the door, at the same time the helicopter banked right and flew back in the same direction it had come from.
They stood together on the porch for a while and listened until all noise died away. The whole thing had taken no more than 15 minutes.
- Let me just get the board, if the wind picks up.
- Let me help you.
Ann gathered up the maglites and the skis while Mo got the board. It all had it's place in the shed.
Once back in the cabin Ann finally noticed how tired Mo looked.
- You should get some sleep, you look about to drop.
- Good idea.
They went up the stairs together but turned in opposite directions at the top.
Tabernash, Colorado, March 2006
The phone woke them both a little after 2.30 p.m.
Ann heard Mo run down the stairs to pick it up. She walked out on the gangway overlooking the living room.
- It was the hospital, everything is fine, she won't loose her leg.
Ann nodded and stretched.
- You up for some eggs and coffee?
Again she just nodded
After coffee and eggs Mo forced Ann outside for a small trip, to get her knee working again, and it had been fun to explore around the cabin with the cats right on their heels.
Her knee took it well and she felt the fresh air filling her with energy - and a bit of lightheadedness still because of the elevation.
Once back in the cabin Mo started a nice fire and told her to rest her leg while she fixed dinner. Ann used the time to arrange her tirp home.
They ate spaghetti and meatballs with French bread, a green salad and a nice glass of wine in front of the fire. Panda stared at her all through the meal and was finally allowed a small taste of a meatball that he gobbled up.
- Do you have any idea what Fran wanted from you, Ann suddenly asked.
- Probably a confession that I used their experimental drug outside the perimeters of what it was being tested for.
- What does that mean?
Mo took a deep breath and seemed to come to a quick decision to trust the other woman.
- Do you know anything about how FDA approves drugs?
Ann shook her head.
- OK, prepare to be bored
- You forget I'm a judge, boredom is my middle name.
Mo rewarded her with one of her amazing smiles that completely changed her face.
And then Mo gave her a quick education on the long and tedious process of drug approval. She explained how scientists first get an idea, that a certain chemical compound or a cocktail of several compounds might stop, start or emulate a process in the human body.
Once the theory was sound experiments on animals started. If those experiments showed promises, the drug was tested on more and often larger animals and this time with an emphasis on the dangers of an overdose and a look to possible side effects.
- And there are always side effects, but if the drug cures or controls a serious condition severe side effects are accepted, Mo added.
- But severe side effects of a mild pain killer is not acceptable? Ann asked.
- Exactly, Mo said.
- But isn't drugs tested on humans too?
Mo nodded. And went on to explain that once all testing on animals were finished and written up an application was sent off to the FDA for human testing. She also explained that in a perfect world all drugs would be tested in what's called a double blind situation. A group of patients, as similar as possible in everything from their disease to how they live their lives is split in two. One group gets the drug that is tested, the other group gets a harmless substitute. Neither the patients nor the doctors knows which patients gets what. Ideally this test last several years and the patients are closely monitored.
If the experiment shows a significant number of patients being cured or benefiting from whatever they are taking the people behind the test may break the code and seek information on whether or not this group have been taking the experimental drug. If that is the case they will submit their findings for final approval to the FDA.
- You say that's how it is in a perfect world, so it does not always happen that way?
Mo shook her head.
- No, for one thing patients have to give informed consent. If you suffer from something mildly irritating you might be noble enough to run the risk of being given a chalk pill every day for two years to help other people with that problem. But it's impossible to get a control group together for serious illnesses, Mo said.
- You mean no one with a brain tumor wants to end up with the chalk pills?
- Then what happens?
- Then you give it to those who dare take it after being informed about how many mice or monkeys died in the laboratory. All you can show then is a correlation.
- What does that mean?
Mo scratched her head, and smiled a little,
- Science theory is not part of the curriculum at law school?
- I think I was taught this in high school actually but I want to be sure I understand.
- A lot of people don't, even doctors and certainly journalists. Every time you read an article about this or that study proving that drinking beer cures athletes foot what the study really showed was correlation and not causality.
- It's usually all about studying numbers or graphs. The famous example is the graph for the sale of ice cream and the graph for drowning accidents. In a temperated climate these two graphs will look alike - low in fall, winter and spring and then peeking during the summer time. Only an idiot would assume ice cream makes people drown everybody knows that there's a third factor causing both of the graphs to rise.
- Sunshine, Ann laughed.
- Yep, there is a correlation between eating ice cream and drowning not a causality.
- How does that tie in with the drug against the brain tumor?
Again Ann could see that Mo took time choosing how to explain this to her,
- I wish I heard more expert witnesses as good at getting a difficult point across as you in my court room, she said.
- Your court room - isn't it the state of Florida's court room?
- Sure, but in lawyerspeak the room belongs to the judge, and the judge sets a precedent for what he or she will and will not tolerate.
- Sort of the same way surgeons feel about their surgury.
Ann had a feeling that going a bit off topic was what Mo needed to keep talking. She understood why the other woman did not trust her completely but it still smarted a bit.
- Let me just tell you a bit more about the difference between corelation and causality.
And then Mo was on track again. She explained how all so called obesity science was about corelation and never causality. How most was based on a few huge emprical studies. Most obtained for something completely different and all of them containing self reported data.
- People report their daily intake of food and drink, Ann stated.
- Yes and we always lie. It's not concious it just happens. We down tone the bad stuff and add precieved good stuff. It's because we basically lie to ourselfs.
- So what happens with that data?
- Then someone get's an idea like: Milk makes you live longer. And then they do a data dredge.
- A what?
- A data dredge - they ask the computer to output everybody that consumes a certain amount of milk daily - then they look at this groups health status and longvivity, compare it with the rest of the group - those who don't drink milk - and bingo milk may become a life saver.
- But isn't that what the data shows if the milkdrinkers lives longer?
- No it shows corelation but no causality. There could be other factors. Milk drinkers could be wealthier than non-milk drinkers that's a major indicator for longvivity.
- Oh I see - they would need to do your double blind study to prove it.
- Yes and that is impossible - it would have to be a life long study and how to make sure that nobody in the non-milk drinking group starts to drink milk when they are told they are in a study to prove milk is healthy?
What Mo was saying was starting to make sense to Ann - she wondered how many news stories about stuff being healthy or unhealthy she had believed without a thought to what evidence they were based on.
- To get back to the theoretical drug against a brain tumor we were talking about a little while ago. If the animal tests look very promising the drug may get an approval for a small human test. In a couple of hospitals the drug will be offered to patients who consent to it. If more of these survive than patients with this diagnosis usually do and there is no other approved drug or treatment it may be approved by the FDA.
- On pretty thin evidence it seems.
- Yes and that scares the drug companys because they may get hit with huge law suits if some horrible side effect turns up a year after the brain tumor is gone. So they do a secret test in developing countries on the side.
- They send drugs to doctors in places like Africa and the Far East and tell them that they show great promises against this or that and then hope the doctors will use them and report back. Sometimes they even pay for it. They can't use the reports officially but they might pick up on side effects before the drug hits the market and save themselves a fortune and a dent in their reputation.
- Sounds pretty cynical.
- So what did PharmaMenta send you?
Mo looked away, then she got up and went over to tend to the fire that had collapsed into a gentle orange glow in the grate.
- You want some coffee?
Ann sensed she had better agree and let Mo have some time in the kitchen thinking over how to proceed. She actually had no idea what Mo's answer would be.
A couple of minutes later Mo came back into the room with two steaming mugs.
- I thought you'd prefer cocoa - I mean if we plan to get any sleep tonight.
- Cocoa is fine.
- PharmaMenta send me a drug they wanted tested on wounds. It was a blood clotting agent and they figured people in Africa was prone to accidents with bad tools, machetes and the like.
- Did you test it on anybody?
- Of cause not, No, but then I got to Gulu. One night when I was disgusted and overwhelmed by how many new patients was brought in that I day I remembered the drug and decided to do a test.
Ann felt the energy in the cabin change. Even the cats felt it. Panda lifted his head and Snowball scooted closer to Mo.
- I tested the drug on a blood sample from one of the patients and after just four hours later the destruction of the patients own clotting agent had stopped.
- That was a breakthrough?
- Yes, it meant that perhaps this drug could stop the effect of the Ebola virus in the blood stream before the victims turned into liquid blops and bled to death.
- Did you test it on any of your patients?
Mo gave her a long, hard stare. Ann had hoped she would have gotten a prompt denial.
- We talked about it Robert and I all night actually but in the end we agreed it would make us as cynical as the drug companies.
Ann was sure she was telling the truth.
- Instead we decided to do more testing on the blood samples and write it up, and then go to a conference and present our findings.
- But I still don't understand why PharmaMenta wouldn't be thrilled you had discovered this use for the drug.
Again a long, hard stare.
- There are no money in saving Africans from Ebola, also it would screw up their approval process with the FDA.
Ann was confused,
- But I thought there was no money in saving hemophiliacs either?
- Hemophiliacs, who's talking about hemophiliacs? The drug was supposed to stop cerebral hemorrhages.
To be continued in chapter 9
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