Biotech and mental health

[meistersinger]

After making my early (3:30 am ET) trip to the men's room, I turned on tv to the local NBC station and end up watching Jim Cramer's Mad Money (a show, incidentally, I detest, mostly because I have little respect for the market, let alone understand it.). Cramer was interviewing the CEO of an outfit called Alkermes, who supposedly has a drug for schizophrenia in the pipeline. Cramer was going gaga over this outfit. Any opinions?

[Altostrata]

It's speculative. See http://www.cnbc.com/id/47374771

 

Many drugs fail in clinical trials. This happens all the time.

 

Use Google to find out more about this particular research, and let us know what you find.

[meistersinger]

It's speculative. See http://www.cnbc.com/id/47374771

 

Many drugs fail in clinical trials. This happens all the time.

 

Use Google to find out more about this particular research, and let us know what you find.

 

Currently they have ALKS 5461 in Phase 2 trials. This trial is for Major Depressive Disorder as well as Cocaine Dependance. It is a combination of ALKS 33, a proprietary opioid modulator, and buprenorphine. I have not been able to find the particulars on this study.

 

The other antipsychotics new to the market is 1.INVEGA® SUSTENNA (paliperidone palmitate), a once a month injectable for the treatment of Schizophrenia. The Side Effects as copied from the web site (Jannsen is the marketer)

 

INVEGA® SUSTENNA® is not approved for the treatment of dementia-related psychosis in elderly patients. Elderly patients who were given oral antipsychotics like INVEGA® SUSTENNA® in clinical studies for psychosis caused by dementia (memory problems) had a higher risk of death.

 

Neuroleptic Malignant Syndrome (NMS) is a rare, but serious side effect that could be fatal and has been reported with INVEGA® SUSTENNA® and similar medicines. Call your doctor right away if you develop symptoms such as a high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness. Treatment should be stopped if you are being treated for NMS.

 

Tardive Dyskinesia (TD) is a rare, but serious and sometimes permanent side effect reported with INVEGA® SUSTENNA® and similar medicines. Call your doctor right away if you start to develop twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the total dose received. This condition can also develop after a short period of treatment at low doses, but this is less common. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped.

 

One risk of INVEGA® SUSTENNA® is that it may change your heart rhythm. This effect is potentially serious. You should talk to your doctor about any current or past heart problems. Because these problems could mean you're having a heart rhythm abnormality, contact your doctor IMMEDIATELY if you feel faint or feel a change in the way that your heart beats (palpitations).

 

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

 

High blood sugar and diabetes have been reported with INVEGA® SUSTENNA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or "pass urine" more often than usual, or feeling weak or hungry.

Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.

Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.

 

Some people may feel faint, dizzy, or may pass out when they stand up or sit up suddenly. Be careful not to get up too quickly. It may help if you get up slowly and sit on the edge of the bed or chair for a few minutes before you stand up. These symptoms may decrease or go away after your body becomes used to the medicine.

 

INVEGA® SUSTENNA® and similar medicines have been associated with decreases in the counts of white cells in circulating blood. If you have a history of low white blood cell counts or have unexplained fever or infection, then please contact your doctor right away.

 

INVEGA® SUSTENNA® and similar medicines can raise the blood levels of a hormone called prolactin, and blood levels of prolactin remain high with continued use. This may result in some side effects including missed menstrual periods, leakage of milk from the breasts, development of breasts in men, or problems with erection.

 

If you have a prolonged or painful erection lasting more than 4 hours, seek immediate medical help to avoid long-term injury.

 

Call your doctor right away if you start thinking about suicide or wanting to hurt yourself.

 

INVEGA® SUSTENNA® can make some people feel dizzy, sleepy, or less alert. Until you know how you are going to respond to INVEGA® SUSTENNA®, be careful driving a car, operating machines, or doing things that require you to be alert.

 

This medicine may make you more sensitive to heat. You may have trouble cooling off or be more likely to become dehydrated. Be careful when you exercise or spend time doing things that make you warm.

 

Some medications interact with INVEGA® SUSTENNA®. Please inform your healthcare professional of any medications or supplements that you are taking.

 

INVEGA® SUSTENNA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

 

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with INVEGA® SUSTENNA®.

 

Do not drink alcohol while you are taking INVEGA® SUSTENNA®.

 

In a study of people taking INVEGA® SUSTENNA®, common side effects in the treatment of schizophrenia were reactions at the injection site, sleepiness, dizziness, feeling of inner restlessness, and abnormal muscle movements, including tremor (shaking), shuffling, uncontrolled involuntary movements, and abnormal movements of the eyes.

 

This is not a complete list of all possible side effects. Ask your doctor or treatment team if you have any questions or want more information.

 

If you have any questions about INVEGA® SUSTENNA® or your therapy, talk with your doctor.

 

They pull the old chemical imbalance in the brain to describe how this poison works.

 

Just what we need: a drug with side effects worse than Viibryd.

 

They have also just introduced, again through Jannsen, RISPERDAL® CONSTA®, for maintenance of Bipolar I, as an injectible. Again, the side effects as copied from the website:

 

Elderly Patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared to placebo. RISPERDAL® CONSTA® (risperidone) is not approved for the treatment of patients with dementia-related psychosis.

 

Neuroleptic Malignant Syndrome (NMS) is a rare and potentially fatal side effect reported with RISPERDAL® CONSTA® and similar medicines. Call your doctor immediately if the person being treated develops symptoms such as high fever; stiff muscles; shaking; confusion; sweating; changes in pulse, heart rate, or blood pressure; or muscle pain and weakness. Treatment should be stopped if the person being treated has NMS.

 

Tardive Dyskinesia (TD) is a serious, sometimes permanent side effect reported with RISPERDAL® CONSTA® and similar medications. TD includes uncontrollable movements of the face, tongue, and other parts of the body. The risk of developing TD and the chance that it will become permanent is thought to increase with the length of therapy and the overall dose taken by the patient. This condition can develop after a brief period of therapy at low doses, although this is much less common. There is no known treatment for TD, but it may go away partially or completely if therapy is stopped.

 

Atypical antipsychotic drugs have been associated with metabolic changes that can increase cardiovascular/cerebrovascular risks. These changes may include:

 

High blood sugar and diabetes have been reported with RISPERDAL® CONSTA® and similar medicines. If you already have diabetes or have risk factors such as being overweight or a family history of diabetes, blood sugar testing should be done at the beginning and during the treatment. The complications of diabetes can be serious and even life-threatening. Call your doctor if you develop signs of high blood sugar or diabetes, such as being thirsty all the time, having to urinate or “pass urine” more often than usual, or feeling weak or hungry.

 

Changes in cholesterol and triglycerides have been noted in patients taking atypical antipsychotics. Check with your doctor while on treatment.

 

Weight gain has been reported in patients taking atypical antipsychotics. Monitor weight gain while on treatment.

 

RISPERDAL® CONSTA® and similar medications can raise the blood levels of a hormone known as prolactin, causing a condition known as hyperprolactinemia. Blood levels of prolactin remain elevated with continued use. Some side effects seen with these medications include the absence of a menstrual period; breasts producing milk; the development of breasts by males; and the inability to achieve an erection.

 

Some people taking RISPERDAL® CONSTA® may feel faint or lightheaded when they stand up or sit up too quickly. By standing up or sitting up slowly and following your healthcare professional’s dosing instructions, this side effect can be reduced or it may go away over time.

 

Blood problems such as low numbers of white blood cells have been reported in patients taking risperidone and similar medications. In some cases it has been serious and life-threatening. Depending upon your medical condition, your doctor may choose to test your blood as you start therapy with RISPERDAL® CONSTA® .

 

RISPERDAL® CONSTA® may affect your alertness or driving ability; therefore, do not drive or operate machinery before talking to your healthcare professional.

 

RISPERDAL® CONSTA® should be used cautiously in people with a seizure disorder, who have had seizures in the past, or who have conditions that increase their risk for seizures.

 

Painful, long-lasting erections have been reported with the use of RISPERDAL® CONSTA® . Call your doctor immediately if you think you are having this problem.

 

Extrapyramidal Symptoms (EPS) are usually persistent movement disorders or muscle disturbances, such as restlessness, tremors, and muscle stiffness. If you observe any of these symptoms, talk to your healthcare professional.

 

Inform your healthcare professional if you become pregnant or intend to become pregnant during therapy with RISPERDAL® CONSTA® . Caution should be used when administering RISPERDAL® CONSTA® to a nursing woman.

 

RISPERDAL® CONSTA® may make you more sensitive to heat. You may have trouble cooling off, or be more likely to become dehydrated, so take care when exercising or when doing things that make you warm.

 

Some medications interact with RISPERDAL® CONSTA® . Please inform your healthcare professional of any medications or supplements that you are taking. Avoid alcohol while taking RISPERDAL® CONSTA®.

 

In a study of people taking RISPERDAL® CONSTA® , the most common side effects in the treatment of schizophrenia were headache, tremors, dizziness, restlessness, tiredness, constipation, indigestion, sleepiness, weight gain, pain in the limbs, and dry mouth.

 

In a study of people taking RISPERDAL® CONSTA® , the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and tremors (when used with lithium or valproate).

[Skyler]

In a study of people taking RISPERDAL® CONSTA® , the most common side effects in the treatment of bipolar disorder were weight gain (when used alone) and tremors (when used with lithium or valproate).

 

That's one amazzinggg list. WOW.. looks like they included half an internal medicine text to come up with everything. Impossible for some one to take this drug without developing significant side effects in the not so distant future. Very scary and attests to the willingness of society to subject those with mental illness to almost anything to silence.

 

Re: Cramer, I share your feelings.

 

Schuyler

[alexjuice]

It's not really relevant to the finance community if a drug benefits a symptom or disease. It is relevant if it can be marketed for that purpose. Then later on, litigation risk of the drug's undiscolsed side effects or complications becomes relevant. Finally, patent expiration watch begins.

 

At least in what I have observed.

 

After making my early (3:30 am ET) trip to the men's room, I turned on tv to the local NBC station and end up watching Jim Cramer's Mad Money (a show, incidentally, I detest, mostly because I have little respect for the market, let alone understand it.). Cramer was interviewing the CEO of an outfit called Alkermes, who supposedly has a drug for schizophrenia in the pipeline. Cramer was going gaga over this outfit. Any opinions?

 

I like Jim Cramer but not his silly show. I enjoyed his autobiography, Confessions of a Street Addict written before he became a large media personality.

 

Anyway, you probably know this already, but Cramer's level of excitment has to do with expectations related to what I wrote above which don't have anything to do with the effectiveness of a drug. Otherwise, my opinion is that it's probably not going to be an effective treatment relative to risk and alternative treatment.

 

There are lots of reason to dislike the market. I have a large problem with the influence of the finance cartel (the TBTF banks) which has enormous influence over monetary policy. Almost every Treasury Secy from Ruben (GS, Citi) to current, comes from the cartel, usually Goldman -- Geithner comes from this, tutored by Rubin and Larry Summers. (Paul O'Neill was an exception, he came from industry, and his more reasonable views are why he both didn't last long and wrote a book critical of Bush admin economic policy.)It's not uncommon to hear traders talk about Goldman as if they are in charge of the world more or less. Here, watch this and you'll hate the market even more and understand how independent professionals view the current mess.

 

Alex

[Skyler]

It's not really relevant to the finance community if a drug benefits a symptom or disease. It is relevant if it can be marketed for that purpose. Then later on, litigation risk of the drug's undiscolsed side effects or complications becomes relevant. Finally, patent expiration watch begins.

 

At least in what I have observed.

 

There are lots of reason to dislike the market. I have a large problem with the influence of the finance cartel (the TBTF banks) which has enormous influence over monetary policy. Almost every Treasury Secy from Ruben (GS, Citi) to current, comes from the cartel, usually Goldman -- Geithner comes from this, tutored by Rubin and Larry Summers. (Paul O'Neill was an exception, he came from industry, and his more reasonable views are why he both didn't last long and wrote a book critical of Bush admin economic policy.)It's not uncommon to hear traders talk about Goldman as if they are in charge of the world more or less. Here, watch this and you'll hate the market even more and understand how independent professionals view the current mess.

 

Alex

 

 

I only know Jim Cramer from his show, and I find him way over the top, his manic presentation and glibness wear me out. Thanks for the video, the guy takes ones' breath away. Old news that the biggest gimmes win, but the brazenness is still dumbfounding. ~S