Archive for the ‘Medicine’ Category

Phillip Seymour Hoffman did not have choice or free will and neither do you.

In ADHD, Anxiety, Brain imaging, Brain studies, Child/Adolescent Psychology, General Psychology, Medicine, Mood Disorders, Neuropsychology, Neuroscience, Psychiatry on Tuesday, 11 March 2014 at 12:37

one of the best things about this subject that i’ve read in a long time.  give it a read. it makes you think.

Phillip Seymour Hoffman did not have choice or free will and neither do you..

Drug Firm Pays Billions for Misbranding Antipsychotics

In Medication, Medicine, Psychiatry on Thursday, 5 December 2013 at 10:04

December 04, 2013

Drug Firm Pays Billions for Misbranding Antipsychotics

Vabren Watts

Johnson & Johnson was sued for failing to report data suggesting increased risks for stroke and diabetes associated with the antipsychotic Risperdal.

Pharmaceutical giant Johnson & Johnson (J&J) announced November 4 that it will plead guilty to a single misdemeanor charge that it misbranded the atypical antipsychotic drug Risperdal for uses not approved as safe and effective by the Food and Drug Administration (FDA).

A part of one of the largest health care fraud settlements in U.S. history, the pharmaceutical company has agreed to pay $2.2 billion to resolve criminal and civil investigations, the U.S. Department of Justice announced.

Risperdal (risperidone)—a dopaminergic antagonist—was FDA approved to treat schizophrenia in 1993 and approved in 2003 to treat mixed episodes associated with bipolar I disorder. A complaint filed by the U.S. Court for the Eastern District of Pennsylvania alleged that Janssen Pharmaceuticals, a J&J subsidiary and Risperdal’s developer, began to market the drug from 1999 through 2005 to remedy agitation associated with dementia in the elderly and psychiatric disorders in children—indicating to physicians and other prescribers that Risperdal was safe and effective for these unapproved indications and populations.

According to the FDA, J&J received several warnings regarding its misleading marketing tactics targeted to physicians and consumers. After a whistleblower complaint was filed, the FDA Office of Criminal Investigations initiated a probe concerning J&J’s alleged misconduct.

“When pharmaceutical companies ignore the FDA’s requirements, they not only risk endangering the public’s health but also damaging the trust that patients have in their doctors and their medications,” said FDA Commissioner Margaret Hamburg, M.D. “The FDA relies on data from rigorous scientific research to define and approve the uses for which a drug has been shown to be safe and effective…. Pharmaceutical manufacturers that ignore the FDA’s regulatory authority do so at their own peril.”

The Department of Justice further alleged that J&J was aware that Risperdal posed serious health risks, including increased risks for the onset of diabetes, breast development in boys, and strokes in elderly patients.

During the investigation, a physician who worked on a J&J study claimed that the company was “purposely withholding the findings” that showed that Risperdal increased risk for stroke in elderly patients after the company combined negative data with other studies to make it appear that there was an overall lower risk for adverse events. In addition, the company promoted Risperdal as “uncompromised by safety concerns (does not cause diabetes),” ignoring data that indicated otherwise.

As a result of its practices and misconduct, the company has agreed to submit to stringent requirements under a corporate integrity agreement with Department of Health and Human Services Office of the Inspector General. The agreement is designed to increase accountability and transparency and prevent future fraud.

Psychiatric News contacted J&J to ask how the company plans to regain trust among clinicians and consumers. Michael Ullmann, J&J vice president and general counsel, replied in a statement saying, “This resolution allows us to move forward and continue to focus on delivering innovative solutions that improve and enhance the health and well-being of patients around the world. We remain committed to working with the U.S. Food and Drug Administration and others to ensure greater clarity around the guidance for pharmaceutical industry practices and standards.”

Though J&J acknowledged that it improperly marketed Risperdal to older adults for unapproved uses, the pharmaceutical firm admitted to no wrongdoing for accusations that it promoted drug use in children and the developmentally disabled and that it provided kickbacks to doctors and pharmacists in exchange for writing more prescriptions.

The agreement will also resolve similar misbranding accusations for the company’s heart failure drug, Natrecor, and newer antipsychotic drug, Invega.

Retrieved from: http://psychnews.psychiatryonline.org/newsarticle.aspx?articleid=1788265

weed…it’s not just for breakfast anymore…

In Alternative Health, General Psychology, Medication, Medicine on Wednesday, 21 August 2013 at 08:21

i have always respected sanjay gupta and appreciate that he, unlike MANY others in medicine and related fields, is able to apologize and say he was wrong and has researched the topic and come up with his professional opinions based on data and experience. we put so many legal drugs into our systems with serious side effects but think nothing of it since they are prescribed by doctors. perhaps it is time to look at alternative medicine. especially that that is natural and not chemically manufactured. how many times do we hear about drugs recalls based on serious side effects (including death) that have been prescribed or the misuse and abuse of “legal” drugs. we have bigger problems than “weed.” as for recreational drugs, alcohol kills from accidents, abuse, overdose, etc., but there are no discussions to go back to prohibition. very interesting article.


musings on…primum non nocere

In Medicine, Musings, Philosophy on Tuesday, 26 February 2013 at 07:04

for years, I have been hearing people “quote” a portion of the hippocratic oath that referencing “first do no harm” as the main point and an exact quote.   while not the type to directly correct someone, especially about something that i think a majority of people believe,  and it just makes me look like a philosophical snob or elitist.  that said, i heard someone mentioning the “first, do no harm” portion in conversation and ascribing it to the hippocratic oath again yesterday which precipitated this posting.  i don’t believe that people deliberately want to misquote or mislead others as this seems to be a generally held belief.

for the record, the original version of the hippocratic oath is as follows:

“I swear by Apollo the Physician and Asclepius and Hygeia and Panaceia and all the gods and goddesses, making them my witnesses, that I will fulfill according to my ability and judgment this oath and this covenant:

To hold him who has taught me this art as equal to my parent and to live my life in partnership with him, and if he is in need of money to give him a share of mine, and to regard his offspring as equal to my brothers in male lineage and to teach them this art—if they desire to learn it—without fee and covenant; to give share of precepts and oral instruction and all other learning to my sons and to the sons of him who has instructed me and to pupils who have signed the covenant and have taken an oath according to the medical law, but to no one else.

I will apply dietetic measure for the benefit of the sick according to my ability and judgment; I will keep them from harm and injustice. I will neither give a deadly drug to anybody if asked for it, nor will I make a suggestion to this effect. Similarly I will not give a woman an abortive remedy. In purity and in holiness I will guard my life and my art.

I will not use the knife, not even on sufferers from stone, but will withdraw in favor of such men as are engaged in this work.

Whatever houses I may visit, I will come for the benefit of the sick, remaining free of all intentional injustice, of all mischief and in particular of sexual relations with both female and male persons, be they free or slaves.

What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account one must spread abroad, I will keep to myself holding such things shameful to be spoken about.

If I fulfill this oath and do not violate it, may it be granted to me to enjoy life and art, being honored with fame among all men for all time to come; if I transgress it and swear falsely, may the opposite be my lot.

Hippocrates (c. 460–c. 370 B.C.).  The Oath and Law of Hippocrates.
The Harvard Classics.  1909–14.

as one can see in the oath the passage “I will use treatment to help the sick according to my ability and judgment, but never with a view to injury and wrong-doing” and “In whatsoever houses I enter, I will enter to help the sick, and I will abstain from all intentional wrong-doing and harm” (pp. 299, 301) IMPLIES to do no harm but the exact wording “first do no harm” (in latin, “primum non nocere”) is not in the hippocratic oath.

Hippocrates (c. 460–c. 370 B.C.).  The Oath and Law of Hippocrates.
The Harvard Classics.  1909–14.

clearly, there is an explicit and implicit understanding in the oath to “first do no harm” however, this is not part of the hippcratic oath.  the mention not doing harm IS in the hippocratic corpus.  not that there isn’t controversy surrounding the corpus as its true authorship is a much-debated topic, but we will ascribe it to hippocrates as some of the greatest philosophic scholars can not say for sure.  it has actually been postulated that many ‘authors’ had their hand in writing the many books of the corpus.  even so, the corpus is largely associated with hippocrates and we may never know for sure whose work it was or who contributed to it.

alas, for now, I leave you with the part most have come to accept of as one of the main points of the hippocratic oath:

in  latin, “primum non nocere” which literally means “first do no harm” is seen in one of the books of the corpus .  “As to diseases, make a habit of two things—to help, or at least to do no harm. The art has three factors, the disease, the patient, the physician. The physician is the servant of the art. The patient must co-operate with the physician in combating the disease.”

Hippocrates, Epidemics, book 1, section 11.—Hippocrates,trans. W. H. S. Jones, vol. 1, p. 165 (1923).

so, now you know if you didn’t already!

Breakthrough in biosensing: New virus detection method under development

In Fitness/Health, Medication, Medicine on Sunday, 16 December 2012 at 16:05

Breakthrough in biosensing: New virus detection method under development.

placebos and personality…

In Medication, Medicine on Wednesday, 21 November 2012 at 13:04

Personality Predicts Placebo Effect

People with certain personality traits are more likely to get pain relief from a placebo, a finding that could help improve clinical trials.

By Dan Cossins | November 16, 2012

Individuals who are altruistic, resilient, and straightforward show greater activity in brain regions associated with reward and are more likely to enjoy pain relief when a placebo is administered during a painful experience, according to a study reported this week (November 15) in Neuropsychopharmacology. The findings suggest that simple personality tests could be used to improve the accuracy of clinical trials by identifying people likely to skew results with high placebo responses.

“This is interesting because it’s one of the first studies to look at how personality traits are associated with placebo analgesia not only in terms of subjective reports of pain relief, but also with quite solid objective measures in key parts of the brain,” said Tor Wager, a neuroscientist at the University of Boulder, Colorado, who was not involved in the study.

Placebos are known to have strong analgesic effects. In 2007, neuroscientist Jon-Kar Zubieta of the University of Michigan showed that such effects were associated with activity in the nucleus accumbens, a brain region involved in reward and pleasure. That suggested that placebo analgesia might occur in part because positive expectations of reward (pain relief) spike dopamine levels in the brain and stimulate the release of endogenous painkillers called mu-opioids.

But individuals vary considerably in their responses, and some studies have suggested that personality traits such as optimism and anxiety may predict response levels. Others have found that a composite of personality traits—including novelty seeking, harm avoidance, fun seeking, and reward responsiveness, which are thought to be related to dopamine reward circuits—can predict a substantial portion of placebo analgesic effects. Still, “there was nothing terribly conclusive,” said Zubieta.

To better understand how personality is associated with placebo analgesia, Zubieta and his colleagues assessed the personality traits of 47 healthy volunteers. Then they asked each volunteer to lie in a positron emission tomography (PET) scanner for the duration of a standard pain challenge. First, painless isotonic saline was injected into the jaw muscle and, 20 minutes later, a pain-inducing hypotonic injection. Volunteers were told about these two conditions but not the order in which they would occur, allowing for expectation of pain in both conditions. The conditions were then repeated for another scan session but this time the volunteers were given a placebo consisting of intravenous infusions of isotonic saline every 4 minutes, which they were told would reduce pain.

The PET scan recorded the activation of endogenous opioid receptors in the brain, and blood samples were taken every 10 minutes to measure placebo-induced changes in the stress hormone cortisol. Meanwhile, the volunteers were also asked to rate the intensity of the pain they felt every 15 seconds.

The researchers observed significant reductions in pain intensity ratings in response to placebo, but found that expectation of analgesia—measured by asking the volunteers during the pain challenge—was not significantly correlated with response, suggesting that positive expectations alone are not enough for a placebo-induced pain response.

But they also found that people with certain personality traits—specifically, those who scored high on resiliency, altruism, and straightforwardness, and low on measures of “angry hostility”—were more likely to experience a placebo-induced painkilling response. Importantly, such individuals also had decreased cortisol levels and greater activation of endogenous opioid receptors in brain regions associated with reward.

“We were able to link some personality traits with analgesia response at the level of brain chemistry,” said Zubieta, as well as subjective feelings. In fact, statistical analyses showed that a composite of these four traits accounted for 25 percent of the variance in subjectively reported placebo analgesic responses, and for 27 percent of the variance observed in objective measures like the activation of endogenous opioid receptors.

“Studies like this are giving us a new set of candidate personality measures that can predict for placebo analgesia, and they’re mostly positive traits,” said Wager. “So placebo responders are being cast in a much more positive light, personality-wise, than they were a few decades ago, when they were thought to be hysterical and neurotic. ”

If replicated with larger sample sizes, the results suggest that these new measures could also help to improve the accuracy of clinical trials, Zubieta added. “One big difficulty is trying to control for people with very high placebo response,” he said. “Many trials fail not because the compound doesn’t work, but because placebos are also effective, which creates noise.” By using personality measures to stratify those more likely to exhibit a placebo effect and incorporate the likelihood of a placebo response into the data analyses, researchers may be able to more effectively identify a drug’s true effect, Zubieta said.

M. Pecina et al., “Personality Trait Predictors of Placebo Analgesia and Neurobiological Correlates,” Neuropsychopharmacology, doi: 10.1038/NPP.2012.227, 2012

Clarification (November 16, 2012): The introduction was changed to more clearly reflect that both the greater activity in brain regions associated with reward and the reported pain relief resulted from the placebo administered to volunteers during a painful a experience.

Retrieved from: http://www.the-scientist.com/?articles.view/articleNo/33300/title/Personality-Predicts-Placebo-Effect/

early cancer detection coming soon…

In Medicine on Sunday, 11 November 2012 at 11:22

Scientists develop new method for ‘extremely’ early cancer detection

November 2, 2012

It may soon be possible to test a person for cancer with just a drop of their blood and a small machine. As part of a European research project, scientists have developed a device for detecting the HSP70 protein, which is over-expressed in patients with many types of cancer.

The objective: to make a diagnosis extremely early in the disease process, thereby improving outcomes for patients.

HSP70, a protein indicating stress in the human body, is a biomarker for prostate, colon, esophagus, lung, and brain cancer. Being able to track this protein in patients, making early diagnoses of these types of cancer much more likely, would therefore be very useful for doctors. As part of the “Spedoc” European Research Project, an EPFL team is developing an extremely sensitive, easy-to-use HSP70 detection platform. The device, which will be no bigger than a small suitcase, is expected to be on the market in 2014.

How does it work?

The Spedoc platform requires only a drop of the patient’s blood. The blood is inserted in a chip that contains many microchannels. Inside each of the channels are tiny and circular structures made out of gold, with a particular “anti-body” surface chemistry that is designed to “trap” HSP70. As the blood flows through the channels, the HSP70 proteins are trapped by the structures, of which there are thousands in the pathway that the blood follows through the chip.

The next step in the process involves advanced plasmonics, which the team uses to determine the number of HSP70 proteins trapped on the circular nanostructures. If HSP70 is in fact over-expressed in the blood sample, it would mean that the patient would require further tests to detect cancer cells developing somewhere in the body.

Light detection Two EPFL professors have joined forces on the HSP70 project. Sébastian Maerkl is head of the Laboratory of Biological Network Characterization (LBNC), which is developing the chip measuring 1 cm2. The chip contains layers of microfluidic channels that are no wider than a human hair. It is designed to break down the blood sample into its various components.

Olivier Martin’s Nanophotonics and Metrology Lab (NAM) is in charge of the detection side of the device-design process: the NAM team is developing gold nanostructures, as well as optimizing a process to identify the HSP70 protein. “Our technique involves shining white light on the microfluidic channels,” says Olivier Martin. “If a protein is caught on a nanostructure, we will observe small changes in wavelength as the light is refracted, compared with the initial light. In other words, there will be a change in color that can be observed with a spectrometer.”

This is due to what is known as a surface plasmon resonance, which occurs when the electrons of a metallic nanoparticle oscillate together when they are stimulated by light. Depending upon whether the nanostructure has an HSP70 protein on it, the oscillations will be measurably different, making it possible to determine whether a given nanostructure has trapped a protein or not. The physical phenomenon of resonance oscillation upon which all of this depends only occurs at very small scales. “The resonance is so sensitive that we can detect tiny quantities of a given molecule.”

Available soon at your doctor’s office? The Spedoc early detection method has many advantages: fast and non-invasive, it could replace costly cancer biomarker detection methods. “Cosingo, a Spanish company that’s involved in the project, has already built a prototype, but quite a few improvements still need to be made,” says Olivier Martin, who nonetheless can imagine a long-term scenario where such a test is widely used. “Doctors would use our platform as a cancer screening test during their patients’ regular checkups, which could lead to extremely early diagnoses.”Could this be the beginning of revolution in cancer treatment? The Lausanne University Hospital (CHUV) oncologist and Professor of Medicine Olivier Michielin takes a cautious stance, commenting, “The HSP70 test seems quite interesting. However, it will be a long time before it becomes a routine test, although this protein is in fact high in patients with many types of cancer. In particular, it still needs to be proven that early HSP70 detection can actually change the way patients are treated and lead to real improvements in outcomes for specific types of cancer.”Whatever the case may be for HSP70, however, the Spedoc platform will certainly prove to be useful.”Once we have worked out the general principle, the test itself can always be adapted for use on other biomarkers,” notes Sebastian Maerkl.

Provided by Ecole Polytechnique Federale de Lausanne

Retrieved from: http://medicalxpress.com/news/2012-11-scientists-method-extremely-early-cancer.html#jCp

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