Drugs/Medical Archive

Forced Drugging of Kids Needs to Stop

June 23rd, 2011. By AbiK

 

Sometimes a child’s voice can be the voice of sanity and the impetus for change in the fight against a seemingly overwhelming foe. In this case, the foe is the mandated psychiatric drugging of our children with any of a number of drugs—Ritalin, Adderall, Risperdal to name a few. And the child, is a high school senior whose comment I came across on the Ablechild.org Facebook page.

The young man’s comment said that he has a nephew who is being forced to take medication—and that his nephew’s mother runs the risk of getting “screwed” should she not give the child the meds. He goes on to mention a friend who’s been on Ritalin his whole life and is “following a pathway to drug addiction and it is happening before my eyes.”

Given the recent study in the Journal of the American Academy of Child & Adolescent Psychiatry showing that childhood attention deficit hyperactivity disorder (ADHD) increases the risk that a child will smoke cigarettes or abuse drugs or alcohol in early adulthood, and that intervention with stimulant drugs was not found to conclusively alter or reduce that risk, either this kid has done his homework and/or he’s seeing a medical experiment play out in front of his very eyes.

Regardless, the comment he made that really caught my eye and stuck with me the most was this: “I wanna do something to stop this but I don’t know where to start I’m just a senior in high school.”

Just a senior in high school.

As someone who’s now well beyond high school and a parent to three, it’s a heart-wrenching plea to hear from someone so young, and clearly not so naive. Heart-wrenching because it’s compounded by the advice of the Ablechild.org FB page moderator to take advantage of the Hatch Amendment and the Medwatch form for reporting any adverse drug reactions to the FDA. Yes, a parent should be aware of both and should utilize both (along with pushing to be an active participant in any Section 504 considerations for their child)—but it’s not enough.

What if the “adverse reaction” is more than a low-grade fever. What if it’s sudden death—as was allegedly the case with 14-year-old Matthew Hohmann in 2004? As reported at the time at abcnews.go.com, his parents are convinced that Matthew’s Adderall XR is responsible for his death. And what of the FDA’s Medwatch reporting system then? No, what you need then is an attorney.

What if it’s Maryanne Godboldo of Michigan who’s fighting for her custody of her daughter following a drawn out battle with CPS (Child Protection Services) over her stopping her daughter’s use of the psychotropic drug, Risperdal?

And see, Godboldo’s story didn’t start there—it started when she and her daughter wanted to enter the public school system after several years of homeschooling—and the school required immunizations. Godboldo noticed uncharacteristic behavioral changes in her daughter within two weeks of the immunizations. And she began—as any responsible parent would—to try to seek help for her child.

Her suspicion that the immunizations might be the cause of the behavioral change was dismissed, and doctors prescribed psychotropic drug therapy for her daughter, which Godboldo later discontinued. The result? Health care providers claiming Godboldo medically abused her daughter, and CPS stepping in to remove the child from the home.

Godboldo is now facing criminal charges for allegedly firing a gun shot at police when they came to take her daughter away. If indeed she did take aim, who as a parent among us can not sense her frustration, her desperation and her lack of any other recourse to have her voice heard?

Ditto Jim Kaiser, who actually felt he had no other option than to kidnap his own son a few years back in order to keep his child from being forced to take Adderall (see video above). What you don’t see in the video report on Kaiser is what he shares on his website, MyNameisBen.org, where he shares that his child’s mother has been diagnosed with bipolar disorder and he also shares “words that she personally wrote” in her journal about her feelings and her ability (or lack thereof) to take care of her son. Reading this, if indeed true, provides a bit of backstory to Kaiser’s fight for his son and, as with Godboldo above, would make any parent understand what drove him to kidnap his own child to save him from being drugged.

And, with the statistics for ADHD diagnosis on the rise—according to the CDC (cdc.gov), parent-reported ADHD diagnosis rose twenty-two per cent between 2003 and 2007—this is not an issue that’s going away any time soon.

The problem with the lame “follow the process” process to documenting a child’s diagnosis (or misdiagnosis, as with ADHD can be the case) and treatment is that, as a parent, there is no real recourse as Godboldo and Kaiser have found out. Following the rules and trying to do the right thing nets nothing except an up-to-date file in some school office somewhere. And it nets a young man—truly no longer a child, though legally so—reaching out on a Facebook page in a plea for help and a desire for action, somehow, some way.

My advice to this young man is this: Continue to question. Continue to vocalize. Continue to fight. You will be heard. File the reports and the paperwork to CYA (cover your a**)—or advocate for those you love to do so. Follow the “drugging our kids” stories that are garnishing national attention, and don’t be afraid to speak with an attorney who specializes in civil rights—or, though I hope it doesn’t come to this as it would mean injury is involved, pharmaceutical litigation or medical malpractice (lest we forget little Rebecca Riley).

And for the rest of us, it’s time to take note of this young man’s plea and do something.

Tags: Ablechild.org, Adderall, ADHD, Jim Kaiser, Mandated Drugging, Mandated Testing, Maryanne Godboldo, Matthew Hohmann, MyNameisBen.org, psychiatric drugs, psychotropic drugs, Rebecca Riley, Risperdal, Ritalin
Posted in Drugs/Medical | 2 Comments »

Biz as Usual: Novo Nordisk Settles re NovoSeven, Seeks Brand Manager

June 14th, 2011. By AbiK

In case this one slipped under your radar, Danish drug company Novo Nordisk agreed to a settlement to the tune of $25 million to put to bed whistleblower allegations that it wrongly marketed its drug, NovoSeven (aka recombinant human coagulation Factor VIIa, or simply, Factor VII) as a treatment for traumatic bleeding due to injury.

Of course, outside of hemophiliacs—the obvious and intended audience for such a drug—who else could such a drug be marketed to? Well, gee, who might bleed a lot…let’s see…uh…well, there’s been a war going on over in Iraq and Afghanistan…maybe NovoSeven could be used to stop a soldier’s bleeding…whatdya think?

Sure, I’m being facetious here as I’m wont to do—but could such a scenario have really been all that far off—even if Novo Nordisk claims otherwise?

And ordinarily, this might have a shred of altruism to it—who wouldn’t want to help our soldiers? But here’s the catch: it seems that, according to The Baltimore Sun, NovoSeven was “a largely experimental drug” and it lacked FDA approval for combat wounds. According to the article, Novo Nordisk began promoting NovoSeven to military doctors way back in 2000, and by 2006, “Army protocol in Baghdad called for injecting it into virtually every casualty with signs of serious bleeding. Some Special Forces units in Afghanistan supplied combat medics with the drug, to inject in the field.”

Sounds like fairly extensive and routine use to me. 

Add to this that studies have shown that off-label use of NovoSeven—which not only includes using it to treat combat wounds but also using NovoSeven for intracranial hemorrhage, cardiac surgery and aortic aneurysm, liver transplants and prostatectomy—has not translated to a reduction in mortality rates, and the use of NovoSeven for heart surgery and intracranial hemorrhage actually increased the risk of thromboembolism.

And this is how we want to treat our soldiers’ combat wounds?

I use the term “treat” a bit loosely—The Baltimore Sun had profiled three soldiers who’d been “treated” with NovoSeven in a series of articles written back in 2006. Sadly, two of those three soldiers later died as a result of complications related to blood clots. (Post script, the FDA has since added a warning to NovoSeven.)

Regardless, Novo Nordisk claims no wrongdoing (of course) in the NovoSeven settlement and, as business must keep on movin’ on, it appears Novo Nordisk is now seeking a new Senior Brand Manager for NovoSeven (see job posting above).

Tags: Afghanistan, Factor VII, Iraq, Novo Nordisk, NovoSeven, NovoSeven Lawsuit, NovoSeven Settlement, Soldiers, Veterans, Whistleblower
Posted in Drugs/Medical, Veterans, Whistleblower | 1 Comment »

Midway Point for Heart Drug Plavix Statute of Limitations

May 20th, 2011. By AbiK

Plavix has started to appear in the news again. Word about Plavix lawsuits—as happens with many pharma tort cases—had died downed within a few weeks of the FDA’s announcement that it would place a black box warning on Plavix (clopidogrel bisulfate). That black box label change happened back in March, 2010—so for many, the statute of limitations for filing a Plavix lawsuit will be up as we approach April 2012—and that’s not as far away as it might seem.

Plavix, which is prescribed for patients at higher risk for heart attack or stroke, is an anti-platelet drug that works by helping to prevent blood from forming clots.

The issue with Plavix—and the reason for the black box warning—is that some patients are not able to metabolize the drug effectively once it’s in their system. The result is that the drug’s effectiveness is reduced. Which, for a person who may be prone to heart attack or stroke, could perhaps be life-threatening.

The patients identified as those at risk for lower metabolization of Plavix are those with an abnormal CYP2C19 genotype—those known as “poor metabolizers”; CYP2C19 is the drug-metabolizing enzyme that serves as the body’s catalyst to convert Plavix to its active (and effective) form.

Reports have indicated that potentially 2 to 14 percent of the population are “poor metabolizers”. Read the rest of this entry »

Tags: antiplatelet, black box warning, blood clots, blood thinner, clopidogrel bisulfate, CYP2C19, FDA, heart attack, Plavix, plavix_heart_attack_stroke, stroke
Posted in Drugs/Medical, Emerging Issues | 2 Comments »

FDA & Post-Market Testing of Hip Devices: Too Little, Too Late

May 16th, 2011. By Hunter West

The requirement by the FDA for post-market testing on metal-on-metal hips is a sign that the federal regulator may be finally coming to its senses over the longstanding invitation to manufacturers to escape the road of rigorous testing for some medical devices. 

It’s about bloody time. 

The FDA is both a regulatory body and a political body, with the majority of its power reserved for manufacturers of new drugs and new medical devices. To that end the FDA can play hardball and make a manufacturer jump through hoops until the agency is satisfied that a device or drug delivers more benefit than it does risk. 

Once a device is on the market however, the FDA has pretty weak powers. A letter, such as the one sent to about 20 manufacturers of metal-on-metal hips on Friday, is about the extent of the FDA’s post-market authority. 

Basically, the FDA has ordered all artificial hip manufacturers to conduct post-market testing of their devices, in light of the failure rate of various artificial hips. 

However, had this testing been conducted in the first place, hundreds if not thousands of patients with problematic hips would have been spared the pain and frustration that comes with having an allegedly defective hip placed inside your body—at great expense—only to have it fail within five years of an expected 15 to 20-year lifespan. 

A failed artificial hip needs, in most cases, to be replaced—along with more pain, more downtime, and more money. 

At least it can be replaced… 

Witness the situation over heart leads a few years ago. One brand of defibrillator lead, a wire Read the rest of this entry »

Tags: Defective hip replacement, FDA, hip implant, hip surgery, metal-on-metal hip
Posted in Drugs/Medical | No Comments »

Boomers at 65: Generation Alzheimer’s and No One to Care?

May 9th, 2011. By AbiK

It’s daunting to read some of the facts and figures from the Alzheimer’s Association. Stats such as this:

In the United States, an estimated 5.4 million people are living with Alzheimer’s disease, and someone develops the disease every 69 seconds. Unless something is done, as many as 16 million Americans will have Alzheimer’s in 2050 and someone will develop the disease every 33 seconds. In 2010, 14.9 million family members and friends provided 17 billion hours of unpaid care to those with Alzheimer’s and other dementias—care valued at $202.6 billion.

Or this:

Alzheimer’s is the sixth-leading cause of death in the country and the only cause of death among the top 10 in the United States that cannot be prevented, cured or even slowed. Based on mortality data from 2000-2008, death rates have declined for most major diseases while deaths from Alzheimer’s disease have risen 66 percent during the same period.

The Baby Boomer generation hasn’t been about frailty. Since day one, they’ve had strength in numbers—able to go through life with the knowledge that—simply by those sheer numbers—they’d be the indomitable force at whatever life stage they’d be at. Which is why AARP probably uncorked some champagne once 1996 rolled around—the year the first wave of boomers became eligible to not only join the retired persons ‘club’ (senior discounts!)—but also add their collective boom to AARP’s advocacy efforts.

But lurking in the background—regardless of CNN’s display of boomer vitality presented on one of their lead stories today—is a darker side of being Boomer: Alzheimer’s.

With statistics such as those above, it’s hard to understand why, for so many of us, Alzheimer’sis someone else’s parent’s or grandparent’s disease. But as the video at top states, Alzheimer’s can happen to anyone—and 65 is the age at which things start to shift into higher gear for Alzheimer’s disease. In fact, according to the Alzheimer’s Association, the likelihood of developing Alzheimer’s doubles about every five years after age 65.

And this year, 2011, just so happens to be the year in which the first wave of Baby Boomers turn 65.

It’s a sad truth the Alzheimer’s Association has been aware of long before any public cognizance—and even now, many probably don’t have any sense of the devastating imprint Alzheimer’s is about to leave on our Boomer nation.

What doesn’t make the Alzheimer’s lottery any easier—for those who may be afflicted and for their loved ones—is news like that which was reported at NPR.org this past week. It’s the story of Aurora Navas, who just happened to develop Alzheimer’s disease. As the demands to care for her increased, her family had to turn to assisted care. They trusted the assisted care facility to care for Aurora. Instead, she wandered out of the facility to a nearby lake, and drowned in eighteen inches of water.

Elder care abuse, nursing home neglect, assisted care negligence appear to be more common than we’d like to be aware of. The NPR article mentions a joint study done by The Miami Herald and WLRN which focused on assisted care facilities in Florida. The findings were bleak: at least 70 questionable deaths found in FL assisted living facilities in the past decade.

And, sadly, that number—and not just in Florida—stands to grow given the aforementioned strength in numbers the Boomer generation presents, particularly when combined with the lack of awareness Alzheimer’s patients experience.

As caregivers, there are signs to be aware of when it comes to elder abuse or neglect. Please read our information on the signs of nursing home abuse—and what to do about it if you suspect it. There are lawyers who specialize in elder care abuse and they are there to help you.

For information on Alzheimer’s disease diagnosis, treatment options, statistics, information and advocacy, I can’t urge you enough to visit the Alzheimer’s Association website at alz.org. And be sure to check out the Celebrity Champion webpages where Anthony Anderson, Katie Armiger, Wayne Brady, Coach Frank Broyles, Kate Burton, Dominic Chianese, Dwight Clark, Dear Abby, Diamond  Jim, Olympia Dukakis, Hector Elizondo, Emerson Drive, Shelley Fabares, Jack Ford, Vivica A. Fox, Soleil Moon Frye, Peter Gallagher, Victor Garber, Phyllis George, Leeza Gibbons, John Glover, Bob Goen, Bryant Gumbel, Elisabeth Hasselbeck, Emma Mae Jacob, Matt Jenkins, Rafer Johnson, Lainie Kazan, Ricki Lake, The Marshalls, Kathy Mattea, Natalie Morales, Terry Moran, Kate Mulgrew, Terrell Owens, Stephen Pasquale, David Hyde Pierce, Tony Plana, Sarah Polley, Ahmad Rashad, John Runyan, Rex Ryan, Molly Sims, Jean Smart, Brent Spiner, April Taylor, Lea Thompson, Tracie Thoms, Dick Van Dyke, Anna Wilson and Whiskey Falls have lent their voices, their passion and their commitment to the fight against Alzheimer’s.

Please share this post with all those you love.

Tags: Aging, alz.org, Alzheimer's Association, Alzheimer's Disease, Assisted Care Abuse, Baby Boomers, Elder Care Abuse, Neglect, Nursing Home Abuse
Posted in Drugs/Medical, Elder Care Abuse | No Comments »