R.V. Doon's Blog, page 7

The Doon Sleuth & Setting Book Review

Every Thursday this blog will feature a Sleuth & Setting review from cozy mystery books I’ve finished reading.

Several things collided in the Doon universe, and I got a great blog idea. One, I’m an author writing and reading in many genres so, I don’t want to be in violation of Amazon’s rules regarding one author reviewing another. Then, one day I was deleting in excess of 20 books (not a typo) and I don’t know, but I kind of felt sick to my stomach. (I do this to completed books because I don’t want a Kindle with a hundred pages). Back in the day, I used to donate paperbacks to local nursing homes or leave them in the employee lounge at my hospital. There’s no recycling an e-book and it bummed me out.

Later in the afternoon I dropped into a Books a Million, and I heard two women trying to find a cozy mystery series for their hospitalized mother. Their mother wanted a “certain kind of sleuth” and the girl in the bookstore couldn’t help them. The roiling in my stomach from book deletion calmed, and I realized a review of a mystery’s sleuth & setting might be useful or entertaining.

Being a Type A personality, that I’ve spent a lifetime denying, I knew the Doon S&S review had to match the standard of other book reviewers. I remember too well filling out the description for Body Wave and wishing I had something to put into the editorial description until the first review rolled in. I’m hoping the Doon Sleuth & Setting review can assist new indie authors when they upload their first cozy. I also hope the review will assist readers in finding the right book for friend’s and family.

Hopefully blog readers may find the Doon review entertaining. I feel really good about this because I’ll be reviewing cozy’s I’ve read, and hopefully hitting that delete button will no longer give me nausea. Tune in tomorrow!

Tuesday will be my regular blog post day and Thursday will be a Doon S&S review.

 

Clinical Drug Trials in Double Blind: A Medical Thriller

The normal steps in Clinical Drug Trials plays a significant role in my novel Double Blind. In the book, eyedrops, nicknamed EZ by the research volunteers, is suddenly fast-tracked to prescription. The fast-tracking of  ZeNovo’s EZ eyedrops is a catalyst for Claire Carter, the main protagonist. Claire’s so angry she climbs inside an obscure research building’s air duct to film a board meeting. She’s appalled that while she waits to hear from the Department of Justice on her whistleblower status, she’s yanked into court by ZeNovo for corporate espionage. The poor girl has no idea her lawyer held back data from the DOJ review. She’s doomed to fail and doesn’t know it. But Claire isn’t a quitter, no, she plans to film and upload to YouTube because truth shouldn’t be hijacked.

I don’t go into the clinical trial process much in the book, but I thought readers might be interested in the process. Every drug goes through a pre-clinical (before a human takes it) process. This part covers the drug’s discovery and the researchers are trying to get safety information and efficacy data. (efficacy means a drug produces the intended and desired results). There is a lot of animal research in this stage. I know, I hate this stage too, but the purpose is ultimately to do no harm to humans. Just know it takes ten or more years in this stage before the new drug goes to human trials. (Yes, Zenovo the rotten corporation cheated in this phase in the book). Once safety & efficacy is ensured new drugs progress to human trials.

Phase I Clinical Trials

During this phase the new drug is given to a human for the first time. These studies are safety studies and enroll a small number of healthy volunteers. The research subjects are given increasing doses of the test drug until the side effects reach a point that the subject can no longer tolerate them. Lots of college students sign up for this type of testing. At the end of this trial the PIs (Primary Investigators) know a lot about the drug’s safe dose range and adverse side effects. Assuming there are no deaths or loss of limbs and if the FDA agrees, the drug goes to the next step. All Phase one studies must be concluded before going to Phase II.

Phase II Clinical Trials

These studies are described as rigid and well-controlled studies in a small number of patients who have the symptoms the drug will treat like say for diabetes. The patient subjects all have the target disease but without co-diseases. So the patients enrolled might have well controlled diabetes but no heart disease or cancer. In this phase PIs work with double-blind studies, using a placebo or other comparator drug, or both. The entire purpose of this type of drug trial is to determine if the new drug, now called the investigational drug, works as stated within the safe dose range. Safety is always a big issue and it’s examined closely in all research trials. The FDA must approve the next step or they can request more Phase II studies. Here, EZ was fast-tracked straight to prescription because of its stellar but tainted results.

Phase III Clinical Trials

These studies aren’t done if the outcomes in Phase I or II were poor.  To reach this stage the drug has a proven safety profile and evidence of proven efficacy. These studies enroll thousands across the country and internationally. Information in the phase is used to demonstrate the safety (few side effects) and efficacy to assess the risk/benefit relationship for the intended use of the drug. Phase III studies gather the information that goes into a drug product’s package insert. These trials last for years as I can personally attest. After the successful conclusion of this phase, the new investigational drug goes to prescription but may not be approved for special populations, like children.

Phase IIIb Clinical Drug Trials

Some of the drug studies may not have completed because the FDA requested more safety studies, or the FDA ordered extra testing in special populations like the elderly or children. Mostly they are gathering additional data here, but this step doesn’t stop the new, investigational drug from going to prescription market.

 

Phase IV Clinical Trials

These studies are done after the FDA has approved the new drug for marketing. The company may have gotten the go ahead to market as long as they continued drug studies in this phase. Here the FDA wants long-term safety studies to compare to the short-term safety studies of Phase II. They may be testing the new drug against its older and established competitor drugs.

 

Double Blind means neither the patient or the PI and his team members know if the patient is taking a placebo or active drug. To find out, the blind must be broken and this is discouraged unless the patient is hospitalized.

 

 

Check out Double Blind at 0.99 cents for its birthday launch!  Subscribe to my New Book Release Email.

 

 

 

 

 

 

 

 

 

 

 

Get Swarmed! A Halloweenpalooza Giveaway

I’m guest blogging on Thursday the 17th for the month long Halloweenpalooza event. I share my foray into ghost hunting and that story relates to a cold-case storyline featured in Double Blind: A Medical Thriller.

Swarmers takes place around Halloween, but it’s not about scary ghosts. Swarmers gets right to the scary action and leaves you gasping. If it sounds like a book, you’d like to try, go to Halloweenpalooza on FB on the 17th to register, because I’m giving away 5 free e-copies of Swarmers as gifts.  There are a lot of free giveaways throughout the month, so consider following the event until Halloween. Other authors have been blogging, so don’t miss out!

Double Blind: A Medical Thriller is scheduled to launch for 99 cents on Amazon starting October 16th. Sign up for my new novel book release emails.

Double Blind Launched on Amazon

Amazon surprised me and made Double Blind for sale in under twenty hours! I’m still calling October 16th its due date, but the story made its debut early. I’m launching it at 99 cents for a short time.

Claire Carter, a young whistleblower and clinical research nurse, climbs into a company air duct to steal secrets and a few hours later her face is on billboards wanted for murder. All Claire wants is justice for her dead friend and to protect the public health. She’s not prepared for the lengths a shady, mob-connected pharmaceutical company will go to in order to keep her quiet. Check out Double Blind in you love medical thrillers.

Highlighting and Adding Notes on Kindle

So there I am chatting like I know what I’m talking about at Panera Bread while waiting for a take-out. I’ve confided that I’m self publishing a book on Wednesday and a stranger behind me asks, if I could show her how to highlight text on her Kindle. She’s been waving her finger over the words like you can do on a smart phone and nothing is happening. “Well, it’s a Kindle Touch ” I said, and show her how to press her finger pad down until the highlight comes up.

She’s amazed, and then asks if that’s how people share the highlights on the book’s Amazon page. I showed her the share screen and mentioned if she wanted to make the highlights public like on the Amazon page, she’d have to register her Kindle with Twitter or FB. I then showed her the menu screen and the Notes and Marks. Clearly, when the highlight attempts failed, she’d never explored the Kindle Menu.

I helped her register and said, “Ta Da! You’re good to go.”

She was under the impression that only the Kindle Fire could share highlights. The woman had over a hundred books on her Kindle too. Then she said, “Thank you for your help, but I don’t buy self published books.”

Is this some type of bad karma smacking me? Now, I started to be snarky, Reece Carson, my amateur sleuth in Body Wave would have said, “Bless your heart for buying books when you can’t read.”

I mean how hard is it to explore the tabs on a Kindle you’ve owned for two years? But, I didn’t say anything even though my soup got cold!

My takeaway is this: Knowledge doesn’t have the same power it used to have. Sort of like, no good deed goes unpunished. This encounter brings up another takeaway point: If you buy someone a gift this holiday season, which requires pushing more than one button, either review the product’s features or download a “how to” page.

Sign up for my New Book Subscription Page or consider purchasing Double-Blind on its birthday launch on October 16th.

Dawn of the Dead: Launching an Indie Book

For two days in a row, I’ve awakened to the feeling that I’ve missed a deadline. This is akin to dreaming about being naked in a crowd, okay?

I haven’t felt raw terror like this since I stopped teaching. And here I thought Indie writers had a stress-free life. No…I knew it wouldn’t be easy, but I have to say I wouldn’t have made it without my friend’s help. So what’s making me crazy? Read at your own risk.

I’d already written a guest blog post for Halloweenpalooza, and I was letting it sit for a few days. For a few terror seconds, I’d thought I’d missed my deadline! Man, I jumped out of bed feeling terrible. When I checked the calendar, I’m fine. I decided to get the post off to the administrator the same day, so I’d stop with the stressful dreams.  But no, the big event taking every waking minute is Double-Blind. I’m already 12 days beyond my self-imposed deadline with its birthday launch. So what happened?

First, my normal editor had an emergency. The next four I contacted were booked.  I went with a new one who took longer. Then my computer had a viral attack which took days to resolve. Afterward, I downloaded Double-Blind to my Kindle and wham>>>new formatting was required. The one thing that went off without a hitch was the cover art. Still, I’d planned to launch the e-book and the paperback at the same time. Not going to happen. However, Double-Blind will be published for Kindle on October 16. The paperback will follow in a month.

I’m exhausted and bleary eyed, but I’m almost there! Today I finished the newsletter that goes out to my subscribers. Who knew you had to have a PhD to make one? Hopefully, I get better at it. What have I learned for the next launch?

10 Steps to Avoid Looking Like An Indie Zombie During Book Launch 

1. Stock up on Visine.

2. Limit your commitments or take mega doses of B vitamins.

3. Book your editor a year ahead of time.

4. Shred your production schedule or get used to waking up naked in a crowd.

5. Take a Spa Day the week before launch.

6. Cruise the unemployment lines for a handmaiden, um, a writer’s assistant.

7. Get a PhD in MailChimp wizardry prior to launching any book.

8. No matter how bad it gets be sure to go out in the sunshine for a few minutes.

9. Ask for a little help from your friends.

10. Keep a step by step log for the next birthing.

 

Well, I feel better. Sign up for my new book subscription notification to see my creation. Be sure to drop in on Double-Blind’s birthday on October 16th.

 

 

 

 

Double-Blind: A Medical Thriller-Description

DoubleBlind’s final edit polish before going to formatting is almost complete. So far, I’ve shared the title, the cover, and now I’m adding the description.

****

 In Double-Blind, a medical thriller with corporate conspiracy overtones, a lone whistleblower discovers she may not live to reveal the truth.

Claire Carter watched her best friend die a slow, horrible death. She wants justice for what she considers a medical crime. Claire’s goal is to force the pharmaceutical company to pull their new wonder drug, EZ, off the prescription market.

A Looming Public Health Disaster

When legal options crash because her proof is tainted, she steals more company secrets to force out the truth. Gateway, a private Witness Protection team, promises a new life, but when Claire realizes there is a list of well-known people bribed to fasttrack EZ to the market, she doesn’t run. True justice requires a face to face confrontation.

A Fight to Do the Right Thing

 Dodging hit men, betrayals, and weird flashbacks of a childhood she doesn’t recognize, Claire forms a bold plan. Steal the bribe list at the company’s party during Mardi Gras in New Orleans, offer the new information to a Pulitzer prize-winning reporter, and then escape with the man she loves before becoming chum.

What she doesn’t count on is the data she steals points straight to a coup ďétat, not by bombs or bullets, but by eyedrops.

Double-Blind is a medical, suspense thriller with a wicked twist of revenge.

****

Okay, give me some feedback on DoubleBlind. It’s also got its own hashtag on Twitter if you’d like to comment. #DoubleBlind.

Please share in your social media by hitting the share key on the bottom of this post.

 

 

 

 

 

 

Double Blind: A Medical Thriller-Cover Reveal

Wow! Today I got my cover back, and I’m anxious to see what you think. I tried to get a cover that conveyed the genre and the theme. I’m still completing the editing polish, so I don’t have the publishing date set, but it’s close. I’ll probably launch the e-book without the paperback. I’d planned to do both together, so I apologize because I’m still learning how to roll a book out. Meet Double-Blind’s cover:

Double-Blind: A Medical Thriller

On my last post announcing my new book, I revealed the title, Double-Blind, A Medical Thriller. Instead of introducing characters, I think I’ll cut and paste the first page.

My thanks to the fabulous Page Pounders for helping me get this behemoth whipped into service for readers. Behind every thriller writer must be a group similar to the Page Pounders.

You may know them by their words, their mantra, their tag line, and they’re two-word motto which they scream in unison, “More Conflict!” Thanks, guys!

Hope you enjoy the short teaser excerpt.

 

DyNovo Clinical Research Enterprises

Mobile, Alabama

 

 

Chapter One

Stealing company secrets never gave Claire Carter a rush or a thrill, but the desperate urge to pee and puke became constant companions. As she tried to suck air into her screaming lungs, she wondered what justice would feel like. The sense of being swallowed by the coffin-like duct had turned her muscles to jelly and released sweat by the bucket. I can’t breathe.

On her stomach with her arms in front of her pushing the camera, she felt squeezed, a weird dry-drowning sensation. All forward progress slowed because the duct narrowed. She tasted panic—a cross between sour milk and burnt chili—when her hands-free headlight dimmed. Claire belched a long, stinky exhaust of defeat. I’m trapped.

Every inch forward had decreased oxygen and the duct crushed the life out of her. As the light failed, sudden panic sent her fingers raking against the surface and her heart to skipping beats. She closed her eyes, panting. Outside, a thunderstorm raged. She chose to break in and use the storm as cover, but what if she got stuck? In the dark?

Crybaby tears threatened surrender to the duct and the dark. Breathe. Think.

She’d measured the length from the blueprints, but cramped inside the duct the span appeared longer than fifty-nine feet. Claire focused on her reason for breaking into the old research building. Erin Fuller’s smiling face came out of memory. Erin was her best—dead—friend, and Dymond Enterprises had killed her.

Dr. Brigham Dymond, CEO of Dymond Research Enterprises, had merged his company under ZeNovo’s umbrella. ZeNovo began as a generic drug company in New Orleans, but added a new drug development arm to their repertoire with the FDA’s blessing. The merge created a new wing called DyNovo. Dr. Dymond’s team would move into the new DyNovo building in New Orleans in late July.

Dymond’s team had performed benchmark research in Mobile on new drug, Quellarol, given as eyedrops. The research patients nicknamed the drops EZ, after the eye chart used in their weekly vision tests. A ZeNovo CEO claimed to a NYT reporter it came from The Big Easy, New Orlean’s nickname. Either way, EZ stuck and became an instant hit in clinical trials.

Claire gritted her teeth and inched forward. Her actions would give Erin’s sacrifice a voice. The psychopaths running DyNovo and ZeNovo Pharmaceuticals were responsible, and someone had to force them to acknowledge their popular drug’s dark side. The FDA showed no interest, so she filed whistleblower charges against ZeNovo, the parent company. I can’t breathe.

Do it for Erin.

She practiced meditation breathing and visualized the ocean outside her apartment in Destin. Her panic ebbed. Claire slithered the last twenty feet to the ceiling grate. Cooler air chilled her face as she drew nearer the vent. Made it. She inhaled the stale air like sweet perfume. The duct around the grate had widened as well. She removed the headgear and reached for the backup light in a leg pocket. Clamping a penlight between her teeth, she positioned a camera lens to record the empty conference room below and secured it. Sweat stung her eyes and her fingers turned clumsy. The icy fear of discovery raised its ugly head.

Focus, Claire. Focus.

DyZe, as she privately called both companies, was fighting to incarcerate her for stealing their blood samples and their secrets—and they kept many secrets. Whistleblowers were a dying breed and she knew why. Too late, Claire realized whistleblower protection laws were a farce and carried the same weight as air.

New Book Title Reveal: Double-Blind–A Thriller

Like plots, I’m beginning to think titles, have been done before…

I’m not complaining because this book has had 3 previous working titles, but Double-Blind, works on many levels.

Double-Blind is a term used in clinical drug trials. Neither the subject (patient or volunteer) nor the investigator knows which treatment is being received by the subject. The study could be testing a placebo against a new drug, or aspirin against a new drug for example. By setting up the blinding, investigators are trying to minimize bias. The investigator follows a map, and if there are many sites involved, all follow a specific map called a ‘Study Protocol.’ The protocol is the Bible of any clinical drug study.

I also chose Double-Blind as a title because eyedrops are used as the new drug. The study volunteers like the drug so much, they nickname it EZ, based on the eye chart in their weekly vision tests. So, overall I think I’ve got a good title in regards to the story line.  The main character, Claire Carter, is a whistleblower, and she finds out real fast that most whistleblowers don’t live to tell their truth. In fact, two things happened that made me write this story.

First, I worked in clinical trials and I got certified as a CRA, Clinical Research Associate. I already had several other nursing certifications and this test was hard, but not as difficult as the National Certification in Critical Care Nursing. So, one day I was sitting at a national meeting with other nurse researchers, and one related the story of a clinical trial that had some nasty side effects. They were so bad, she wanted to quit recruiting for the study. The patients with problems were withdrawn into the follow-up phase, and she was expected to ask new patients to volunteer. Again, everyone was blinded and this study had low dose, high dose, and a placebo arm. She spoke frankly of her conflicts.

At this same meeting an announcement was made about a new drug discovery, and the man announcing it claimed that serendipity played a role in the discovery. This happens quite a lot. A recognizable example is Rogaine. Rogaine, was being formulated as a antihypertensive drug, when serendipity struck, and someone noticed people talking about their fabulous hair growth. Naturally, as an in-the-closet writer, I filed away the idea that a drug is being developed for one thing and serendipity strikes.

In a few days, I’ll do a cover reveal and book description. Until then, I think I’ll write about clinical drug trials. Would you like to know more?

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