Informed Consent Bill On Psychotropics Back In NJ
20 CommentsBy Ed Silverman // January 28th, 2010 // 7:57 am
Will the third time be the charm? Once again, the New Jersey legislature is being urged to pass a bill requiring a doctor or nurse to obtain informed consent from a minor’s parent before writing a prescription for any psychotropic that already carries a Black Box warning. The issue first emerged in the wake of the controversy over links between antidepressants and suicidal behavior in teens.
As with two previous efforts, the initiative is being pushed by several parents who believe that FDA-mandated Med Guides for antidepressants are insufficient. Their earlier attempts were thwarted by a state senator who repeatedly blocked introduction (see here and here), but the Senate health committee now has a new chair. The bill was recently introduced in the assembly and Senate support is being lined up.
“The importance of this bill is even more relevant today than when it was first introduced,” says Laurie Yorke, a nurse and one of the parents behind the effort. “It’s reported in the news on a daily basis how the overuse of psychotropic drugs in children is now coming to light. Informed consent would empower parents to ask questions and do the research and not blindly accept a drug as the only treatment for a troubled child. I would expect that this bill will be embraced as an important safety measure for the children of NJ.”
“Some doctors still are not taking the time to explain the risks associated with these meds,” says Robert Scott Fritz, another of the involved parents, who co-founded a non-profit called the Society for the Prevention of Teen Suicide after losing one of his children committed suicide. “One of the problems is that if a kid is feeling depressed and the parent is concerned, but hasn’t taken the time to investigate about what side affects there are, they don’t know what to look for when something goes wrong.”
Whether a bill would become law is unclear. Fritz and other parents note that Gov. Christopher Christie is reaching out to pharma veterans to join his administration - Richard Bagger, a former senior vp for worldwide public affairs at Pfizer, is chief of staff (see here) and, this week, Poonam Alaigh, a former national medical director at GlaxoSmithKline, was nominated to head the Department of Health and Senior Services (see here). As Fritz notes, informed consent is an extra hurdle to prescribing.
photo courtesy of lee nachtigal flickr creative commons
patrons99
“As Fritz notes, informed consent is an extra hurdle to prescribing.” Very true! A properly executed informed consent takes time. When “pre-screening” potential research subjects, prescribing psychotropics, administering “scheduled” vaccines, formal informed consent really ought to be performed. Otherwise, a patient may not ever realize that they had the right to refuse such “treatment”.
Sunshine
From the FDA review of asenapine by Dr. Ronald Kavanagh
http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM173877.pdf
Page 885
As I was writing the labeling and trying to figure out the drug interactions I realized that the information in the review indicates that asenapine causes pulmonary arterial hypertension and cardiac effects.
All of the cardiac and respiratory toxicities can potentially be explained by this, and appears to the mechanism for the death 2 months after adding an antidepressant and may be an alternative mechanism for several deaths including the patient with Quincke’s edema and the death of the neonate….
The metabolic scheme, the mechanism, and the observed toxicities along with the study designs used by the sponsor in the drug-drug interaction studies, and the lack of many specific pieces of information in the submission as well as other things indicate that the sponsor knew about this toxicity and specifically tried to prevent our detecting it….
I simply do not believe that there is anything we can do that would adequately educate physicians and patients to the risks and that with off-label use we will be looking at an epidemic of potentially lethal cardiac and pulmonary toxicities in children several years from now….
http://www.regulations.gov/search/Regs/home.html#documentDetail?R=09000064809e7abb
Page 104
RON KAVANAGH: My name is Dr. Ron Kavanagh. I am a pediatric clinical pharmacologist and I was an FDA reviewer for over 10 years, including over seven years reviewing psychiatric drugs….
Lisa Van Syckel
Sunshine,… Your point is,…. what?
Lisa Van Syckel
Gee Ed,… I wonder how much money Pfizer and GSK paid the Christie Campaigne for these prominent positions in this administration?
Amy Philo
Without information there is no consent. For as many people who have lost their lives to these drugs, especially children, an informed consent law like this is the least that the people deserve. Government is for the people, by the people and derives its power from the consent of the people. Informed consent in medicine makes the practice of medicine a free exchange between doctor and patient. Without informed consent prescribing dangerous drugs to a child becomes non-consensual for both the child and the parent, in short, any death resulting therefrom is equal to murder. Forced death by forced drugging.
What are the doctors so afraid of? If the drugs are really as great as they say then passing out information about them and obtaining written consent should be no problem. Or perhaps the doctors would prefer to be held accountable for malpractice.
You can’t have it both ways pharma. You can’t say that you are immune from liability because the doctor was the intermediary and also expect that the doctor should not be required to educate the patient on a drug that has a BLACK BOX SUICIDE warning and in some cases, a warning for HOMICIDAL IDEATION.
elmore
The reason it’s called informed consent is because people might not consent if fully informed. Or they might if they decide the benefits outweigh the risks. Parents are responsible for ensuring their children’s safety–and this would be a no-brainer if that was the only issue.
SteveM
I also see where the psychiatric practitioner is caught between a rock and a hard place. He knows that the placebo and nocebo effects are real. Side effect counseling throws a wrench in the positive suggestion machinery.
Still, I think that most consumers who have been beaten up by psycho-pharm without warning would have wanted the option not to take the stuff in the first place. So I think that informed consent, i.e., explicit side effect counseling by the physician should be mandatory.
Jim Gottstein
Most of the psychiatric drugs given to children and youth and submitted to Medicaid are not allowable and thus constitute Medicaid Fraud. See, http://psychrights.org/Education/ModelQuiTam/ModelQuiTam.htm
For the drugs listed on http://psychrights.org/Education/ModelQuiTam/PediatricPsychotropicMedicallyAcceptedIndications.pdf if the diagnosis does not have a white background it is fraudulent.
pharmavet
I understand the argument, but if we required informed consent for every drug that carried a black box warning, doctors would have even less time to spend with patients. While I think that it’s a reasonable bill, we have to consider unintended consequences. It would logically follow that PI’s with bold-faced warnings might require consent, and so on and so forth.
Laurie
Pharmvet, the bill relates specifically to psychotropic drugs WITH a black box warning. Yes, it may require a doctor to spend more than 5 minutes with their patient, but that is their job.
Nurses are required to fully explain all prescribed drugs to their patients, the physician should be held to the same standard. Not enough time is not an excuse when the risks involved can be deadly.
SteveM
Re: Laurie “Not enough time is not an excuse when the risks involved can be deadly.”
Right. And how about when the psychotropic drug just destroys the patient rather than killing him you? Here’s a WebMD self-report of the rancid Lilly drug Cymbalta:
“I have watched this drug completely destroy my husband. He was initially put on it for depression, anxiety and chronic back pain. It made him lathargic, and the pain increased and spread toother parts of his body. Now that we are trying to wan him off, the withdrawals are horrible! The suffering this man has had to endure is inhumane at the least. I don’t believe the doctors were properly educated on this terrible drug so in turn patients aren’t able to make a clear educated decision as to take this medication to begin with. I have placed a complaint with th FDA as well as with Eli Lilly. I have also placed a complaint with his doctor. I am so angry and to know that the weaning process will takes months is just unacceptable to me. Get online and type in Cymbalta withdrawal and Cymbalta side efffects and see the other hundreds of people who are suffering with little to no help from the medical field. Also, you will see the desperate attempts of some who are trying to get off this drug. There WILL be a death as a result of some of these tactics and I forsee a class action law suit in he future for Eli Lilly and any of the medical professionals who refuse to hear the cries of so many desperate people.”
There are THOUSANDS of Cymbalta self-reports floating around the web.
Should that poor guy have been counseled, warned, whatever by his physician?
Laurie
Steve M…you’re preaching to the choir, when it comes to withdrawal. I have contact with hundreds of thousands of ssri users on my site, dealing with the horrible ramifications of getting off these drugs.
Withdrawal is rarely recognized for what it is, and sadly few medical professionals know what it takes to get someone off these drugs successfully.
Luckily, the past users of these drugs have taken the time to figure out how to do it safely …not without symptoms, but much better than any weaning schedule a doctor will give you.
Supremacy Claus
I thought this biased hate speech propaganda organ had died.
The disgruntled mental patients here are completely irresponsible, as is the legislator interfering with the doctor patient relationship. Should such a bill pass, the state should immediately be enjoined from enforcing it.
john c
I am emphathtic to those that have lost love ones related to their use of pychotropic drugs. However, my 21 year old daughter with bipolar disorder(diagnosed at 13) would not be alive today without them. I am also very grateful to the pychiatrist who prescribed them for her. I do agree that physicians should provide more info about the risks of these drugs.However, it is also a parents responsibility to be the expert for their child and do their own research.With so many resources available today, what more can we ask for? In addition, most states require pharmacies to offer patient couseling for new prescriptions and refills. This is the second opportunity a parent has to ask their questions.Unfortunitly many do not. More legislation is not the answer, greater parential involvement would help a great deal.
pharmavet
Supremacy and John: stay on these boards long enough and you will soon discover the apologists for the Scientiology industry who are anti psychiatryic drugs. Wouldn’t be surprised to find Travolta or Cruise trolling this site. This is only partially a patient-centered argument.
JaT
pharmavet,
Because people disagree with you does not make them wrong. We are all here for different reasons. You don’t have to be a scientologist, for instance, to know that prescribing epilepsy meds, antipsychotics, and anti-depressants, all for bipolar disorders, makes little or no sense. As an antidepressant would not necessarily treat epilepsy or psychosis. Still, this is exactly what is going on- which brings the whole topic to question. If we were not to question such things then we are putting our faith blindly into a system that is more than willing to take advantage. If you can show me how all of those compounds are similar enough to treat the same condition I might change my mind. I’m not a scientologist but I am painfully aware of the importance/ramifications of the Black Box for some uses and not for other uses- creating a bad situation for drug makers, doctors, & consumers.
Lisa Van Syckel
Pharmavet,.. The Scientology cry has been growing old for sometime now, and you use this as an excuse to,.. “Heck, If I cant defend the drug, lets attack the child, it didnt work in 2004, it wont work today”.
If you choose not to be an informed parent, thats your choice, but, please dont intrude on the rights of other parents.
Lisa Van Syckel
John C, I have a question for you,.. did your daughter’s bipolar diagnosis come before or after the initiation of an antidepressant, and please show me where in the DSMIV where it specifically states the criteria for diagnosing a bipolar disorder in someone as young as thirteen, and that the polypharmacy of multiple meds is safe and effective for your teen
Your decision to be ill informed, is yours, and yours alone. And its a shame, as you state you are a responsible parent, then why would you play russian roulette with you own child’s life, let alone shave 25 yaers off her life expectency.
JaT
I would just like to add that, while many epilepsy drugs are approved for bipolar disorders- these different drugs are not even appropriate for every kind of epilepsy. Very different designs even within one treatment area. But if you have a bipolar diagnosis any one of them is okay? How can that be?
Laurie
Pharmavet… the Scientology argument pharma wore out when the FDA put out the black box warnings. Time to get a new, fresh, nonsensical rebuttal, LOL.