Informed Consent Bill On Psychotropics Dies In NJ
Nearly three years ago, the FDA required makers of antidepressants to supply Med Guides along with their pills. That wasn’t good enough for a couple of New Jersey moms, who have been pushing their state legislature to go even further - 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. (Here it is)
The bill, which has been kicking around for about a year, made it to the state assembly and senate - until last week, when it died a quiet death. The senate health committee failed to list the bill on its schedule this week and for procedural reasons, this means the legislation would have to be re-introduced in another session or it fades from view. The state senator who heads the health committee, Joe Vitale, hasn’t returned several messages seeking an explanation. UPDATE: Vitale returned our call this evening to say “we want to research everyone’s opinion and then we’ll decide how to go forward. But there is no one issue that’s prevented us from moving the bill forward…I’m pretty sure that if we get to some consensus, it can move forward.”
The bill, which was controversial, was opposed by the New Jersey chapter of the National Alliance on Mental Illness, a non-profit advocacy group. “We had questions and it’s best to take a second look,” says Phil Lubitz, director of advocacy programs for the NJ chapter, which accepted funding for its 2007 convention from drugmakers that sell antidepressants and antipsychotics, including Abbott Labs, Bristol-Myers Squibb, Eli Lilly, Glaxo, Pfizer, AstraZeneca, Wyeth and Johnson & Johnson.
“One of our real concerns was that it singled out psychotropic medications and whether that was discriminatory. This requires a broader discussion to see if other medications should be included,” he continues. And the controversy over the Black Box warnings on antidepressants were another issue, he adds. “There were recent studies showing an uptick in suicides after the warnings were added,” says Lubitz. The studies themselves are controversial, though, due to a lack of long-term data. And while psychiatrists say the warnings scare away some patients, critics say a subsequent drop in scrips suggests pills aren’t being prescribed willy-nilly.
The bill’s supporters, meanwhile, are livid. “This bill would have addressed the knowledge gap that is present about children and drugs. Most parents are not aware of the lack of clinical trials with these drugs and are forced to assume that their doctor has a complete understanding of a drug’s function. Sadly, this is not the case,” says Laurie Yorke, a registered nurse and one of the NJ moms who pushed for legislation. “This bill would have at least given parents an unbiased risk list to balance out the biased, potentially dangerous, marketing of these drugs. Full disclosure is what parents need and want. That goal died with the death of this bill.”
Meanwhile, one of the co-sponsors in the state senate says he hopes to reintroduce the bill in the next session. “It’s an important issue,” says Leonard Lance, “and we have to keep working on it.”
Jane
Give me a break, “worried about discrimination”? The worries are all about people not taking these medications if they knew the truth about them. I’m sure my asthma medication would really be pissed off for not being included! Is this the best they can come up with.
Melody
I suppose when corporations were vested with all the rights of personhood, (in the pharma industry)products assumed anthropomorphic characteristics . . . and heaven forbid that a psychotropic med should be discriminated against. IF EVERY DRUG WITH A BLACK BOX WARNING IS NOT SUBJECTED TO THE SAME CAREFUL SCRUTINY AS PSYCHOTROPICS . . . that’s not fair! Boo-hoo! What part of INFORMED CONSENT do legislators/pharma lobbyists have such difficulty acknowledging as a desirable metric?
Laurie
While this is a setback, this is not an issue that is going away. The basic right of patients to be fully informed is not going to lose to political posturing.
One has to wonder what has doctors so up in arms about having informed patients? The lobbying against this bill has been huge. Pediatricians and psychiatrists top the list. This is about risk vs benefit, plain and simple. If doctors were providing this information to their patients now, this bill wouldn’t be necessary, but sadly they are not, and don’t want to.
This bill isn’t going away.
Bob
To Laurie, melody, and good ‘ol Lisa…
HAHAHAHAHAHAHAHA.
Immature yes, but the three of you deserve it for your constant slander of pharmaceutical companies.
Bob
I see the bill was sponsored by Ellen “Christmas tree” Karcher.
it’s nice to see a tax evader have their bill squashed.
James
Wow, Bob. Way to add to civilized discourse.
While you and Lisa have different viewpoints, your methods of debate are strikingly similar.
Laurie
James, Bob is not interested in civilized discourse. He puts his efforts into personal attacks. Yup, having ill informed patients is a laughing matter for Bob.
Brian
It would be nice to have a mature understanding of side effects in all medications. It seems that just new medication comes under scrutiny and I think it is related to the hatred for Pharmaceutical companies. No one laments the thousands of people that are injured or killed by aspirin, Tylenol and other generic NSAIDS. I would guess that more people have died due to the consumption of sugar than any other ingested chemical. While some have been injured by taking psychotropic drugs, many more have benefited. If you warn everybody away then more will be untreated and thus injured. Side effects of all technology are inevitable and advancements on this front have to be viewed from above not individual by individual. Don’t forget the efforts of scientists behind the walls of the companies you hate. They are working as hard as they can to prevent disease!
Laurie
Just because “some” do well on a drug, doesn’t mean that you don’t warn against risks. This is basic medical ethics. Surgeons include the possibility of death on the majority of surgical consents, regardless of the low percentage of actual deaths. The same standard applies to medications. Not disclosing risk for the sake of compliance is a very slippery slope in medical treatment.
No physician has the right to pick and choose what risks he should be presenting to his patients.
This standard of care is especially critical when the “efficacy” is determined by the patients behavior, which can also be a sign of an adverse reaction. You cannot embrace positive behavior,post medication, as efficacy and then deny negative behavior, post drug, as “the disease”. Both effects can be drug related and must be treated as such.
Brian
You understand risks for surgery, driving automobiles or dodging meteors. Why not understand risks for medications. Why is that scarier? What will they tell you that is helpful.. You can die from taking aspirin..I bet you’re still not afraid. You can die on vioxx….Now that’s scary!! My guess it is the lure of money from litigation…Am I right?
Laurie
Their are risks with any drug. With Aspirin the risk is clearly spelled out and understood. Bleeding is objective and easily identifiable by testing.
Vioxx….that risk is “now” recognized and warned about.
The risk with psychotropics is not so cut and dried. Actually, litigation would be decreased if the risks were well known by the patient. You cannot sue, IF you were given all of the information prior to taking the drug. So, this legislation would decrease the litigation possibility. This isn’t about sueing, this is about being informed. As it stands today, if a doctor doesn’t warn a patient about the suicide risk, they are liable. This Bill would have solved that dilemma.
Brian
The risks are not always well known and can be patient dependent. Data is not always clear and we have to use human patients as there are no effectively universal models to assess treatment. Some scientists interpret data one way and the others disagree. The safety of any drug balances risks and benefits. Litigation drills into the consensus to find the minority opinion which is not really fair as the minority opinion was not strong or effective enough at the time to stop the drug’s progress. It is hard to deny that with most any drug there is a high level of safety and a minority of drug related issues. It is true for aspirin, ibuprofen and yes even vioxx. It takes years for science to address deficiencies of nature and you can’t preside over that process with litigation. The political process evaluates the drug discovery process by vilifying one of the participants in a man-made battle unrelated to the issues of science and medicine. It has the effect of slowing the process and limiting the participants to huge organizations that can weather the blows laid on them by single individuals or small groups. This is not an efficient way to advance medicine. The Doctor’s creed: “First do no harm†means we are likely to be on the sidelines for the treatment of cancer, alzheimer’s, depression and addiction. Meanwhile the untreated suffer or die and there is no court in the land that will hear that case.
Laurie
“The political process evaluates the drug discovery process by vilifying one of the participants in a man-made battle unrelated to the issues of science and medicine. It has the effect of slowing the process and limiting the participants to huge organizations that can weather the blows laid on them by single individuals or small groups. This is not an efficient way to advance ”
Well I agree with one part of the above statement. The FDA is a political process. Advancement without full disclosure is not advancement, it is using the general public as a clinical trial, without their consent. If a patient is fully informed of risk and benefit, then science is served. If only benefit is highlighted, then the public is put at risk. Many are willing to take that risk, if divulged, but just as many are not.
A cancer/alzheimers patient would probably be willing to take on considerably more risk, due to lack of options. A parent with an anxious child should be aware of all of the risks of the drug that the child is being prescribed. In this case there are other options for treatment that may be chosen over drugs.
Brian
Well now you know. There are always going to be risks. Very anxious children should confine their treatment to well-known less effective non-invasive measures. Plenty of children treated in this way end up injured. Sure the first waves of patients on newly released drugs are taking slightly less risk than the patients in the final phase III clinical trial. Given the amount of money and time that has been spent on an ever constricting amount of patent life just how much free data are you willing to ask for. If drug trials required a phase IV FDA designed trial with 50 thousand patients or more who should pay? These already cost $$800 mill - 1 billion to finish phase I- III. I would caution that unless a clinical trial is designed properly, it can give ambiguous results even ambiguous results on side effects. What concessions is your political process willing to advance to make that happen? How about more patent life or what kind of tort reform do you think you could concede to achieve your goal of total knowledge or how about protection from generics or a trade policy that requires wealthy nations to pay their fair share of discovery costs.. Call your legislator with anyone of those!!
Donna
Brian,
The problem is most people being prescribed these medication’s are’nt being made aware of the possible side effect’s, they have no idea…until they either do well or horrible, can they say one way or another, we all on here no better and to ask question’s most people just trust their doctor and take what they give them, doctor’s need to be informed on what they prescribe and pass that on to their patient’s…is that too much to ask…
Brian
Let’s say 0.1% of 1 million paitents on a drug have a side effect (ie 1000 people). In a clinical trial of 5,000 people 0.1% would be a total of 5. You might reasonably have 2 or 3 people that were on the placebo with the same side effect. What would you say? Is this real? Now multiply that times every possible side effect you can think of.. Pretty hard to conclude anything..Then you run a clinical trial for each one of these side effects to see if they are real.. Lot’s of money and time. Who would volunteer for a clinical trial designed to find a side effect..Time to get real
Jane
Wow, Brian once you put it in an understandable lite and knowing most side effects are controlled for, thats a lot of people having side effects-I want informed consent!
Laurie
“Who would volunteer for a clinical trial designed to find a side effect..”
So let just release it to the general public and cross our fingers? Finding those side effects is what clinical trials are all about!! The suicidality rates in the clinical trials on kids were low, BUT they were there. These were in screened, non suicidal applicants. So any percentage of suicidality occurance was significant. Now add on the ADR reports of suicidality since wide spread use of ssri’s and now you’ve got at least a start at the real numbers.
So, do we ignore these? NO, we warn about this potential reaction.
The bottom line is that the warnings are there. FDA warnings! For doctors to NOT make this information available to their patients is negligent.
No one here is calling for a ban here. Informed consent is the gold standard for patient education. Our children deserve nothing less.
I don’t understand the resistance to having an informed patient. If a parent decides to not medicate their child, based on these warnings, that is their choice to make. If they decide to medicate despite the warnings, they have the information they need to watch for adverse reactions. What reputable doctor would fight this? And if they do fight it, why?
Brian
No resistance to informed consent. But the data is not reliable enough. Need much larger patient populations to address tiny groups of patients with adverse effects..Everyone ignores my question of who pays the exponential increase in costs and where do you find these patients?? I know you would volunteer your child but who else? BTW any child who needs these drugs has a higher likelyhood of suicide. No way around that. That’s why they are potential patients. If the drug doesn’t work for them, the rate goes up even more..make sense? You need to be better informed. Plenty of free literature out there for you to read. If it’s compensation you want, I think it would be better spent on research.
Bob
Sure, let’s remove all personal responsibility from the patient/parent.
if people continue to not educate themselves, it’s their own fault.
Rita
I agree, informed consent is what is needed. As for costs for research, if Pharma stopped wasting money hiding clinical data/buying people off, it would avoid legal suits… should be enough to go around.
Bob, look up the word slander. No one is making false claims against the pharmaceutical companies. Pharma is building their own reputations as time and again their corruption is made available to the public.
Lisa Van S
Ed,
You should have asked the Good Senator how much money he received from Lobbyists to kill this Bill…
The Real Reason this Bill wasnt heard:
http://www.namipharma.org/photos-1.html
A Study of Pharmaceutical Industry Campaign Contributions and Policy Influence:
http://www.njcitizenaction.org/drugcampaignreport.html
Lisa Van S
Maybe Mr. Lubitz should take a more careful look at S2364:
It States: Parental Informed Consent for “MEDICATIONS” that carry a Black Box Warning.
He must be Hallucinating.The word “psychotropic”, clearly isnt there.
Bob,
Do you really find the death of NJ’s children so funny. The Industry must cringe everytime you open your mouth.
Lisa Van S
James,
Bob and I have strikingly similar methods of debate, how funny is that!!
Nathan
I think “informed consent” is a great idea. However, I think that once someone signs an “informed consent” document, it should absolve the company of all responsibilities for any of the side effects mentioned in the informed consent document. This should significantly lower lawsuits, right? If a drug company told you that there is a very small (but real) chance that you could get have a stroke by using the drug in question, you should be prohibited for suing the company if you do, in fact, have a stoke while on the medication.
“Informed consent” should be designed to protect both the patient AND the drug company.
Sheila Matthews
Letter to the Editor,
CT Mental Health Transformation Grant to pay for Party, while suicides continue to take place in facilities.
CT is one of 9 States to receive a portion of a $95 million dollar Grant funded by the American people to transform the Mental Health System. Ablechild participated in this grant by attending several mental health transformation meetings, and brought vital data to the committee relating to the dangers associated with psychiatric drugs being given to children. The FDA has placed a black box warning on antidepressants relating to increased risk of suicide.
Ablechild requested that all Grant Committee meetings have a stenographer present to ensure accountability to the taxpayers on what reforms would be put in place on informed consent and the right to refuse psychiatric services. Ablechild wanted the citizens of CT to know how the money would be spent and to achieve meaningful mental health reforms.
It is with great disappointment that our request for a stenographer was denied. Yale University took the minutes and is a State Vendor that will receive these grant funds.
In addition, ablechild just received an invitation to a party for all participants of the mental health transformation grant to be held at a Country Club here in CT. This party will be paid for by the mental health transformation grant. Meanwhile, another suicide of a 17 year old has been reported within a facility here in Connecticut. Ablechild is waiting for toxicology report to see if this child was receiving mental health treatment.
Ablechild is outraged that this grant will fund a lavish party for State employees and vested parties who are receiving these grant funds. Meanwhile, lawmakers continue to pass laws for more forced psychiatric treatments as basic informed consent and the right to refuse psychiatric treatments are pushed away as radical ideas.
Ablechild is currently in the process of placing a human rights watch on a young boy who was previously in the care of the State of Connecticut and was forced drugged with psychiatric drugs and abused within the facility. This single mother was coerced into placing her son into the care of the State while she was tending to her daughter who was in a car crash. She trusted the State to provide her son with mental health assistance.
When that boy returned home to her he was in worse shape than when he went in. He is now facing a 9 month plea sentence for larceny a crime he pled not guilty to when he was just 16. He is now 18 and graduates from High School on January 31, 2008 and has been accepted to Baron Institute of Technology. He is going into the same facility where a boy 17 just hung himself. Ablechild is writing a friend of the court letter to the judge asking for a Human Rights Watch to be placed on him. Our request is to provide this boy with a journal and access to non-psychiatric educational services. This facility has a shortage of educational resources for the inmates and they are in lock down most of the time. It is overcrowded with little State oversight.
While society might want to say throw these kids away, we must deal with these boys when they are released as men, what happens to these children within these facilities should be of concern to all of us. As we learned from the tragic Cheshire killings, mental health treatment facilities can be breeding grounds for those mandated into failed treatments such as psychiatric drug use and electric shock treatments. It is time we hold these mental health vendors accountable for the millions of dollars they are receiving and the failed and often deadly services they are pushing. It is time for the State to stop bending at the knee to the will of the mental health industry and starting looking out for the mental health clients. Open up choice within the mental health industry.
http://www.ablechild.org
Lisa Van S
Nathan,
The Industry has been absolved of all Lawsuits since FDA placed a Black Box Warning on antidepressants. The issue before us, is that Physicians and Special Interest Groups are lobbying our State Officials to prevent a Parent’s right to make an informed medical decision on behalf of their child.
Its hard to comprehend why these individuals would want to place a child or their the family in harms way.
Chris
Nathan,
The “informed consent†concept as absolving responsibility is interesting; however, what happens when the ‘very small’ risk of a given side effect really turns out to be not so small? Drug companies provide a litany of potential adverse effects of a drug in the prescribing information, fail to do additional research, and these effects turn out to be substantial. Should they then be absolved of all responsibility?
Laurie
Nathan, you hit it on the head. The informed consent would absolve pharma of the liability. But the reality is that they are absolved already with the black box warning. At least informed consent would give the patients the information that they need to make a decision.
The presence of an informed consent just might trigger parents to look more closely at the prescription being offered. This is what SHOULD happen! Lets face it…most patients take the prescription and go on their merry way. I have thousands of patients who have NO idea what they are taking, and are shocked when it is explained to them.
There is NO advantage for anyone having a patient who has no clue what they are putting in their bodies.
Now that pharma is off the hook for problem drugs, it falls to the doctor. Informed consent protects everyone, doctor and patient alike.
Patients don’t HAVE to take every drug that a doctor prescribes them…makes you wonder why doctors are so against this bill.
Nathan
One problem with “informed consent” is that for most people it will become just like most of the other legal documents in our lives: Who takes the time to read the “legal use” boxes that pop up when we install new software? Who reads their insurance policies word-for-word? Who takes the time to read all the loan documentation piled up in front of you when its time to close on a house?
Although I agree with it in principle, in reality most people probably will not take the time to read the documentation. It will likely be several pages at least. This is especially true when the medication is being provided to someone truely sick — I’m not going to take the time to sit in my hospital bed and read the “informed consent” documentation about the anethesia, antibiotics, and muscle relaxants being administered to me prior to my surgery. I’m going to trust the doctor to make the best decision he or she can. In that light, can “informed consent” really work? Maybe in the case of pysciatric drugs, lifestyle drugs, and cardiovascular drugs. But in most other markets, it just doesn’t seem practical.
Lisa Van S
Nathan,
An Informed Parent,.. is a Child’s best advocate.
Sheila Matthews
Editor Prints Ablechild’s letter: Ablechild Says State Grant Paid for Party, posted above. It light of the recent Mall Suicide Killings, ablechild.org dedicates this letter to all the victims of the shooting!
Lisa Van S
Sen Vitale ; NJHMA: Agree..Ok to drugging Infants in NJ Foster Care Program!!!!…