How the Death of Whitney Houston, and Countless Others, Could Have Been Prevented
My first reaction to the news of Houston’s death was to wonder if anyone ever taught her the basics of how-to-use-drugs-and-not-die. Essentially, we’re willing to let people die because we’re so fearful that teaching people how to use drugs in a less risky way “enables” them to keep using drugs. But shouldn’t we do whatever is necessary just to keep people alive? Alive long enough to help get them into drug treatment. Alive long enough to work through their troubles. Alive long enough to help them find some measure of peace in their lives.
Read the full editorial at:
AlterNet
NPR's This American Life Takes On The Police
Stories about people who have the right to remain silent... but choose not to exercise that right—including police officer Adrian Schoolcraft, who secretly recorded his supervisors telling officers to manipulate crime statistics and make illegal arrests.
MORE
"Attractive Undercover Cop Poses As Student And Entraps Teens To 'Sell' Her Marijuana"
Last year in three high schools in Florida, several undercover police officers posed as students. The undercover cops went to classes, became Facebook friends and flirted with the other students. One 18-year-old honor student named Justin fell in love with an attractive 25-year-old undercover cop after spending weeks sharing stories about their lives, texting and flirting with each other. One day she asked Justin if he smoked pot. Even though he didn't smoke marijuana, the love-struck teen promised to help find some for her. Every couple of days she would text him asking if he had the marijuana. Finally, Justin was able to get it to her. She tried to give him $25 for the marijuana and he said he didn't want the money -- he got it for her as a present. A short while later, the police did a big sweep and arrested 31 students -- including Justin. Almost all were charged with selling a small amount of marijuana to the undercover cops. Now Justin has a felony hanging over his head.
Tony Bennett is Right: Legalizing Drugs Would Save Lives
It doesn't matter if you're hooked on alcohol, Xanax or illegal drugs like heroin and cocaine -- prohibition for some drugs stigmatizes all people struggling with addiction. Period. Addicts are not defined simply by their drug of choice nor the drug that is or is not their ultimate cause of death. Their entire lives are tragically plagued by the stigma that criminalization heaps upon them, and the marginalized underworld prohibition thrusts them into.
That is a painful and deadly component of the experience of anyone unlucky enough to live with a disease that, unlike cancer, our government tries to battle with handcuffs.
Read the full editorial at:
Huffington Post
North America
In a shocking about-face, the administration has launched a government-wide crackdown on medical marijuana
"Over the past year, the Obama administration has quietly unleashed a multiagency crackdown on medical cannabis that goes far beyond anything undertaken by George W. Bush. The feds are busting growers who operate in full compliance with state laws, vowing to seize the property of anyone who dares to even rent to legal pot dispensaries, and threatening to imprison state employees responsible for regulating medical marijuana. With more than 100 raids on pot dispensaries during his first three years, Obama is now on pace to exceed Bush's record for medical-marijuana busts. "There's no question that Obama's the worst president on medical marijuana," says Rob Kampia, executive director of the Marijuana Policy Project. "He's gone from first to worst.""
Read more at
RollingStone.com.
Push To Privatize US Prisons Lurks in Corporate Investment Scheme
Firm will purchase facilities from states in exchange for guaranteed 90% occupancy rate.
The privatization of US prisons is in the news today after a close vote in the Florida state senate on Tuesday defeated an attempt to privatize a huge swath of correctional facilities in the southern state. Also, a report in the Huffington Post on Tuesday highlighted how Corrections Corporation of America (CCA , the nation's largest operator of private prisons, has a plan in place to purchase public prisons from 48 states.
Marijuana Law Reform at the Statehouse 2012
"Each year, these bills are easier to introduce, there is less controversy, and the media reaction is generally neutral to positive," said Allen St. Pierre, executive director of
NORML. "Baby boomers, medical marijuana, the Internet, and the state of the economy have all had an impact, even, finally, on legislators and their staffs," he explained.
"Before 1996, nobody invited NORML; now our staff is regularly going to meetings requested by legislators around the country," St. Pierre recalled. "First, we couldn't get them to return our phone calls; now they're calling us. Everything is in play because of activists around the country doing years of work."
Read the full article at:
Stop the Drug War
New Definition of Addiction Stirs Up a Scientific Storm
Indeed, the new neurologically focused definition debunks, in whole or in part, a host of common conceptions about addiction. Addiction, the statement declares, is a “bio-psycho-socio-spiritual” illness characterized by (a damaged decision-making (affecting learning, perception, and judgment and by (b persistent risk and/or recurrence of relapse; the unambiguous implications are that (a addicts have no control over their addictive behaviors and (b total abstinence is, for some addicts, an unrealistic goal of effective treatment.
The bad behaviors themselves are all symptoms of addiction, not the disease itself. "The state of addiction is not the same as the state of intoxication," the ASAM takes pains to point out. Far from being evidence of a failure of will or morality, the behaviors are the addict's attempt to resolve the general "dysfunctional emotional state" that develops in tandem with the disease. In other words, conscious choice plays little or no role in the actual state of addiction; as a result,
a person cannot choose not to be addicted.
Read the full article at:
The Fix
Should Officials Be Allowed to Search Students' Bras for Drugs?
A divided state Court of Appeals ruled 2-1 in favor of the student, finding the search was “degrading, demeaning and highly intrusive.” The state appealed that decision. The state Supreme Court decision is expected to affect 1.5 million public school students.
Powell said the search was not unreasonable because there was “a compelling governmental need” that outweighed the rights of individual privacy, she said. The school’s primary responsibility “was to promote the health and safety of students,” she said.
Read the full article at:
The Washington Post
Europe/UK
Health Alert Over Drug Sold as “Safe Ketamine”
Methoxetamine, known as MXE or "mexxy", mimics the effects of the banned anaesthetic ketamine, and its use has grown over the last six months in Britain as well as northern Europe, say charity workers.
A survey of drug trends published in November showed that the use of both ketamine, which is a class C drug, and methoxetamine, its "legal doppelganger", is on the rise in several areas of the UK.
Read the full article at:
The Independent
Mobsters Without Borders [documentary]
This documentary film investigates the European leader’s cocaine importing network stretching from Calabria to Milan, Italy and from Costa del Sol, Spain to Ruhr Valley, Germany. Infiltrating sectors such as real estate and healthcare to government contracting and marketing to laundering illegal drug trafficking and weapons smuggling profits, Calabrian mobs permeate economies across the European Union.
Latin America
Mexico Seizes 15 Tons of Methamphetamine
“The big thing it shows is the sheer capacity that these superlabs have in Mexico,” said Rusty Payne, a spokesman for the
Drug Enforcement Administration. “When we see one lab with the capability to produce such a mass tonnage of meth, it begs a question: What else is out there?”
Read the full article at:
New York Times
Off the Beaten Path, Chile Still Caught in Drug Supply Chain
Sharing a border with two of the world's top cocaine producers -- Bolivia and Peru -- makes Chile's involvement in the narcotics trade a virtual inevitability. However, unlike its northern neighbors, Chile is strictly a drug-consuming nation. With Brazil and Argentina, it accounts for two thirds of cocaine consumption in Latin America and the Caribbean. Alone, it makes up 10 percent, according to the
UN's 2011 World Drug Report.
Read the full article at:
InSight
Middle East
No Help for Kashmir's Female Drug Addicts
"Keeping in view the social stigma which female drug addicts face, it is important to set up a de-addiction centre for them," said Sameena (name changed , a 22-year-old college student and former drug addict.
Sameena said she began with glue sniffing "for fun" during her school days and then moved on to opiates. Fear of social stigma and lack of facilities forced her parents to take her outside Kashmir for treatment. Sameena has been under medication for 11 months now.
Read the full article at:
IPS News
Other News
New Exile Nation Video: Lynette Shaw
Lynette Shaw was the owner of the very first legal cannabis dispensary in the State of California, which she opened in Fairfax in the early 1990s. A key figure in the fight to legalize medical cannabis, Shaw's life as an activist began when her home was raided by police, after a dealer turned her in. But that's only one small aspect of her extraordinary life story, recounted here, which at one point saw her living underground while authorities scoured the world for her, after she became a suspect in the 1980 overdose death of actor John Belushi.
Lynette Shaw from
Charles B Shaw on
Vimeo.
View the entire extended interview archive for The Exile Nation Project.
Newsletters and Weekly Features
BBC News says we are a step closer to microchips that can be “implanted under a patient’s skin to control the release of drugs”.
The news was based on a study that tested the use of advanced microchips containing tiny drug reservoirs that can be remotely triggered to release medication into the body. Creating workable drug-release chips has long been a goal of researchers, as it could help people take the correct dose of vital medicines such as insulin.
In this particular trial, reported to be the first of its kind, eight women were given the chips filled with a drug to combat osteoporosis. The drug, teriparatide, is normally delivered by daily injection, but researchers found that using the chips produced similar physical results to injections. Also, there were no toxic or adverse events, due to either the microchip or the drug, and all the patients reported that it did not impact on their quality of life.
This study throws up a range of possible uses for microchip-based drug delivery, which could one day be used for the treatment of wider conditions that require frequent, scheduled dosing, particularly where standard treatment is through injection.
However, much more testing of the technology will be needed to firmly establish its safety, and to see whether there could be wider applications. One key consideration though, would be whether the use of this advanced technology can actually prove better or cheaper than the use of injections.
Where did the story come from?
The study was carried out by researchers from MicroCHIPS, Inc, (a private company producing medical microchips ; the Harvard Medical School; Case Western Reserve University; On Demand Therapeutics, Inc, and the Massachusetts Institute of Technology. It was funded by MicroCHIPs, Inc.
The study was published in the peer-reviewed scientific journal Science Translational Medicine.
The results of this study have also been presented at the annual meeting of the American Association for the Advancement of Science (AAAS .
The story appeared on the BBC and a number of newspapers, including the Daily Mail, the Daily Mirror and The Independent.
Most of the coverage of the story was good. However, alongside The Independent’s main article the newspaper featured an opinion-based section discussing potential uses of the device, including allowing psychiatrists to trigger doses in schizophrenic patients when they resist injections of medication. There is a distinct difference between using medical devices to structure the delivery of medication and using them to force people to take medication against their will.
It seems unlikely that medical groups would find this theoretical use to be ethically acceptable, and it should be noted that the treatment of mental health problems was not assessed in the study or in other coverage.
The Independent also used a photograph of a distressed man huddled on the floor wearing no shoes, intended to illustrate schizophrenia. While the condition can certainly involve periods of acute problems and distress, it seems to a rather extreme and particularly negative depiction of someone with schizophrenia.
What kind of research was this?
This was a small cohort study of a drug delivery microchip, implanted under the skin. The microchip contains tiny drug reservoirs and can be programmed to wirelessly release discrete doses of a medication.
This particular study used the drug teriparatide, prescribed by specialists only for the treatment of severe osteoporosis (bone weakening . It is normally delivered by daily injection and given for a maximum treatment period of two years only.
The researchers aimed to see whether the drug released from the device had similar ‘pharmacokinetics’ (adsorption, distribution, metabolism and excretion and biological effect to the drug administered by standard injection. They also monitored how reliable and reproducible drug release from the microchip was, and if there were any side effects of the implant.
This was the first clinical trial of this microchip. As the researchers state, further development is required to ensure proper operation of implanted devices, and devices containing more reservoirs will be needed if the device were to provide regular doses over one or more years. In addition, before this technology becomes available, it will have to be tested in larger, controlled trials.
What did the research involve?
Eight women with osteoporosis, aged between 65 and 70, were recruited for the study. The drug delivery microchip was implanted under the skin, just under the waistline. The devices were implanted for four months. Eight weeks after implantation, the microchip started releasing daily doses of teriparatide for a period of 20 days. Blood samples were drawn regularly to monitor the pharmacokinetics and to determine levels of bone markers. A safety assessment was also performed.
After the 20 days of drug release from the device, the researchers administered the osteoporosis drug by injection, and again took blood samples, so that release from the microchip and from the injection could be compared.
What were the basic results?
In one patient, feedback from chip indicated that the drug was not being released. The results from this patient were excluded.
Drug released from the microchip in the seven other patients had similar pharmacokinetics to drug administered by injection, and bone markers indicated that drug released from the microchip increased bone formation as expected. However, the effectiveness of medication released from the microchip was not compared to the effectiveness when given by injection.
There were no toxic or adverse events due to the device or drug. Patient response to the implant was also favourable, stating that it did not impact upon their quality of life.
How did the researchers interpret the results?
The researchers concluded that the programmable implant was able to deliver teriparatide at scheduled intervals, with pharmacokinetics similar to injections ‘without the pain and burden of daily injections’.
Conclusion
This study was a small clinical trial, performed in eight women, of an implantable microchip-based drug delivery device. It found that the microchip could deliver the osteoporosis drug teriparatide with similar pharmaceutical properties to injections, including adsorption, distribution, excretion and metabolism by the body. There were no toxic or adverse events due to either the microchip or the drug, and the patients all responded favourably to the implant, stating it did not affect quality of life.
Larger controlled trials comparing this device with conventional injected teriparatide would be needed to confirm the safety and efficacy findings. Furthermore, trials may need to assess use of the chip over a longer period - on prescription, teriparatide may be administered by daily injection for up to two years.
The findings also suggest that this microchip-based drug delivery device may have the potential to be used for the treatment of wider conditions that require frequent, scheduled dosing, particularly where standard treatment is through injection. However, much more testing of the technology will be needed to see whether there could be wider applications.
Analysis by Bazian
Links To The Headlines
Dawn of the age of wireless medicine. The Independent, February 17 2012
'Wireless medicine' helps solve one of doctors' biggest problems - getting patients to take drugs. The Independent, February 17 2012
New microchip will let doctor administer drugs into your body over the phone. Daily Mirror, February 17 2012
'Pharmacy on a chip' gets closer. BBC News, February 17 2012
Links To Science
Farra R, Sheppard NF, McCabe L, et al. First-in-Human Testing of a Wirelessly Controlled Drug Delivery Microchip. Science Translational Medicine. Published online February 16 2012
Healthcare in America is in shambles. Can tech start-ups come to the rescue?
It’s shaping up to be the year of the health tech start-up.
When I came up with the list of entrepreneurs for my recent
Women to Watch in Tech list, a full one-third of the chosen ladies came from the health sector. One of them, Halle Tecco, is playing a big role in helping to spawn more digital health-related start-ups—that's the exclusive focus of her seed accelerator Rock Health. Last year 13 new companies went through its program. Nearly half of them have received VC funding and one—
Skimble, which makes fitness apps—is already profitable.
What’s with the focus on health? Given that the system in the U.S. is more or less a train wreck, there are simply a lot of problems that technology can fix—or at least that's what a new crop of entrepreneurs are hoping.
Think about it, Americans are as fat and unhealthy as ever. What might help, if the masses can be persuaded to try them out, are the scads of gadgets that let people monitor
body metrics. They were everywhere at CES last month.
Another problem: More people are suffering from chronic diseases such as diabetes and cancer. These patients might benefit from health platforms like the newly launched
Careverge, which uses an intelligent engine to provide personalized news, forums, and rewards for healthy living, as well as places to set health goals and compete and connect with others who are living with the same conditions.
Then there's health insurance, which is not only exorbitantly expensive for self-employed people and business owners, but it’s also a machine seemingly pitted against people who actually need to use it. How much of your deductible have you used? Which of the many bills arriving in your mailbox should you pay? Are you getting overbilled by your doctor? Is there a cheaper plan you could be paying for?
Cake Health is a Web platform designed to answer such bothersome questions. It took part in the TechCrunch Disrupt competition in September during which co-founder and CEO Rebecca Woodcock explained Cake Health’s mission of helping people better understand and manage their health costs.
The judges ate it up.
"This is the best presentation,"
said judge Brad Garlinghouse, who was then an executive at AOL and is now an
angel investor. "[It's] the most viable business, the biggest market. I think this is meant for this space. [Healthcare] is a disaster currently. I try not to deal with it when I get those [bills] in the mail. I have no idea what they say."
He’s right—many aspects of healthcare in America are in shambles, and have been for some time. Health tech start-ups that fill a real need may do very well right now, in spite of
a report from the National Venture Capital Association that the future of VC investment in med-tech start-ups is grim, largely due to the costly and slow process of getting approval from the U.S. Food and Drug Administration.
That report focuses mostly on the outlook for biotech and medical device companies. But entrepreneurs who are trying to solve problems in the healthcare system with software aren't convinced the outlook is so dour.
According to Frank Moss, director of new media medicine at MIT’s Media Lab, told the audience
at a GigaOm conference in November that now is a great time for health start-ups for three main reasons.
First, young doctors are much more comfortable with technology than their older counterparts. “Now if you go to Harvard Medical School, it looks like a cafe in Silicon Valley or Austin. Everyone’s got an iPad,” he said. It stands to reason, then, that as more start-ups seek to get patients and doctors using their platforms and devices, there may be less push back.
He also said start-ups can benefit from the fact that employers can’t afford for their employees to be sick. As a result, business-to-business health tech start-ups can have an edge if they can show the business sector their products or services keep employees healthier.
Moss also said that a business-to-consumer window will be opening soon.
Which health tech start-ups are you watching?
MENLO PARK, Calif. - February 17, 2012
Corcept Therapeutics (NASDAQ:CORT announced today that the U.S. Food and Drug Administration (FDA has approved Korlym™ (mifepristone 300 mg Tablets as a once-daily oral medicine to control hyperglycemia secondary to hypercortisolism in adult patients with endogenous Cushing's syndrome who have diabetes mellitus type 2 or glucose intolerance and have failed surgery or are not candidates for surgery.
"We appreciate the FDA's diligent attention to our NDA and its grant of approval on the PDUFA date," said Joseph K. Belanoff, M.D., the company's Chief Executive Officer. "We plan to make Korlym available to patients by May 1 through a distribution system designed to support both patients and prescribers."
Corcept will be the sole marketer of Korlym. "A relatively small number of endocrinologists regularly treat patients with Cushing's syndrome," added Dr. Belanoff. "These doctors can be reached without a large sales and marketing infrastructure." The company has begun hiring Medical Science Liaisons to inform practitioners about the drug, which will be dispensed by the leading specialty pharmacy company CuraScript SP, a subsidiary of Express Scripts.
"Korlym is a significant advance in the treatment of patients suffering from the debilitating symptoms of Cushing's syndrome," said Robert L. Roe, M.D., Corcept's President. "For the first time, these patients have access to an approved therapy when surgery has failed or is not an option."
Korlym clinical trial investigator Amir Hamrahian, M.D., Department of Endocrinology, Diabetes and Metabolism at the Cleveland Clinic said, "There are not many effective treatment options for patients with Cushing's syndrome. Although surgery is standard first line treatment for the disease, it is not always successful and not all patients are candidates. As part of the clinical trial, I have used Korlym successfully and my patients continue to do well on the medicine. I'm excited to be able to continue using Korlym in these patients and others who need it. This medicine's approval gives me a much needed tool to better treat patients."
Dr. Hamrahian's comments were seconded by Maureen V., a patient in Corcept's Phase 3 clinical trial: "I had pituitary surgery to treat my Cushing's syndrome. Unfortunately, my surgery wasn't successful. I was lucky to get into the study and get Korlym treatment. I have been taking the medicine successfully for over a year, and I am extremely happy that it was approved by the FDA. Now I know I'll be able to keep taking it. It has made a big difference in my life."
Clinical Trial Results Supporting FDA Approval
The clinical data supporting the FDA approval of Korlym resulted from an uncontrolled, open-label, multi-center, 24-week phase III study of 50 patients who had endogenous Cushing's syndrome and were either not eligible for or had relapsed from surgery and were either glucose intolerant (29 patients or had hypertension (21 patients . Within the glucose intolerant group, 60 percent of patients had a greater than 25 percent reduction from baseline in the area under the curve in the oral glucose tolerance test. In this group, mean hemoglobin A1C (HbA1C was reduced from 7.4 percent to 6.3 percent. All 14 patients with above-normal HbA1C levels at baseline experienced reductions. Eight of these 14 normalized their HbA1C. Antidiabetic medications were reduced in seven of the 15 patients with diabetes mellitus type 2 and remained constant in the others.
Patients who responded to therapy were allowed enrollment in an extension trial. Eighty-eight percent of the patients who completed the trial chose to do so.
A peer-reviewed analysis of the study results will soon be published in a leading journal.
Patients in the study started Korlym treatment on a dose of 300 mg administered once daily. Their dose was then titrated to maximum clinical effect. As indicated in the medicine's label, physicians prescribing Korlym may determine the appropriate dose for each patient by assessing tolerability and degree of improvement in Cushing's syndrome manifestations. In the first six weeks, these manifestations may include changes in glucose control, anti-diabetic medication requirements, insulin levels and psychiatric symptoms. After two months, assessment may also be based on improvements in cushingoid appearance, acne, hirsutism, striae, decreased body weight, along with further changes in glucose control.
About Korlym™ (mifepristone 300 mg Tablets
Korlym is a once-daily oral medication that blocks the glucocorticoid receptor type II (GR-II to which cortisol normally binds. By blocking this receptor, Korlym inhibits the effects of excess cortisol in Cushing's syndrome patients.
The FDA has designated Korlym as an Orphan Drug for treatment of the clinical manifestations of endogenous Cushing's syndrome. Orphan Drug designation is a special status designed to encourage the development of medicines for rare diseases and conditions. Because Korlym is an Orphan Drug, Corcept will have marketing exclusivity consistent with the FDA's designation until February 2019.
About Cushing's Syndrome
Endogenous Cushing's syndrome is a rare and life-threatening endocrine disorder that results from long-term exposure to excess levels of the hormone cortisol. This excess is caused by tumors that usually occur in the pituitary or adrenal glands that over-produce, or prompt the over-production of, cortisol.
Although cortisol at normal levels is essential to health, in excess it causes a variety of problems, including hyperglycemia, upper body obesity, a rounded face, stretch marks on the skin, an accumulation of fat on the back, thin and easily bruised skin, muscle weakness, bone weakness, persistent infections, high blood pressure, fatigue, irritability, anxiety, psychosis and depression. Women may have menstrual irregularities and facial hair growth, while men may have decreased fertility or erectile dysfunction. More than 70 percent of Cushing's syndrome patients suffer from glucose intolerance or diabetes.
The treatment of an endogenous Cushing's syndrome patient depends on the cause. The first-line approach is surgery to remove the tumor. If surgery is not successful or is not an option, radiation may be used, but that therapy can take up to ten years to achieve full effect. Surgery and radiation are successful in only approximately one-half of all cases.
If left untreated, Cushing's syndrome has a five-year mortality rate of 50 percent.
An orphan disease, Cushing's syndrome occurs in about 20,000 people in the United States, mostly women between the ages of 20 and 50.
Conference Call Information
Corcept will hold a conference call on Tuesday, February 21, 2012 at 9:00 a.m. Eastern Time (6:00 a.m. Pacific Time to discuss this announcement. To participate in the live call please dial 1-800-264-7882 from the United States or +1-847-413-3708 internationally. The pass code is 31838602. Please dial in approximately 10 minutes before the start of the call.
A replay of the conference call will be available through March 6, 2012 at 1-888-843-7419 from the United States and +1-630-652-3042 internationally. The pass code is 31838602.
IMPORTANT SAFETY INFORMATION
See full prescribing information for complete boxed warning.
has potent antiprogestational effects and will result in the termination of pregnancy. Pregnancy must therefore be excluded before the initiation of treatment with Korlym, or if treatment is interrupted for more than 14 days in females of reproductive potential.
Contraindications
- Pregnancy
- Use of simvastatin or lovastatin and CYP 3A substrates with narrow therapeutic range
- Concurrent long-term corticosteroid use
- Women with history of unexplained vaginal bleeding
- Women with endometrial hyperplasia with atypia or endometrial carcinoma
Warnings and Precautions
Adrenal insufficiency
: Patients should be closely monitored for signs and symptoms of adrenal insufficiency.
Hypokalemia
: Hypokalemia should be corrected prior to treatment and monitored for during treatment.
Vaginal bleeding and endometrial changes
: Women may experience endometrial thickening or unexpected vaginal bleeding. Use with caution if patient also has a hemorrhagic disorder or is on anti-coagulant therapy.
QT interval prolongation
: Avoid use with QT interval-prolonging drugs, or in patients with potassium channel variants resulting in a long QT interval.
Use of Strong CYP3A Inhibitors
: Concomitant use can increase plasma levels significantly. Use only when necessary and limit dose to 300 mg.
Adverse Reactions
Most common adverse reactions in Cushing's syndrome (≥ 20% : nausea, fatigue, headache, decreased blood potassium, arthralgia, vomiting, peripheral edema, hypertension, dizziness, decreased appetite, endometrial hypertrophy.
To report suspected adverse reactions, contact Corcept Therapeutics at 1-855-844-3270 or FDA at 1-800-FDA-1088 or
www.fda.gov/medwatch.
Drug Interactions
- Drugs metabolized by CYP3A: Administer drugs that are metabolized by CYP3A at the lowest dose when used with Korlym
- CYP3A inhibitors: Caution should be used when Korlym is used with strong CYP3A inhibitors. Limit mifepristone dose to 300 mg per day when used with strong CYP3A inhibitors.
- CYP3A inducers: Do not use Korlym with CYP3A inducers.
- Drugs metabolized by CYP2C8/2C9: Use the lowest dose of CYP2C8/2C9 substrates when used with Korlym.
- Drugs metabolized by CYP2B6: Use of Korlym should be done with caution with bupropion and efavirenz.
- Hormonal contraceptives: Do not use with Korlym.
Use in Specific Populations
- Nursing mothers: Discontinue drug or discontinue nursing.
Please see the accompanying full Prescribing Information including boxed warning at
www.corcept.com/prescribinginfo.pdf
Please see the accompanying Medication Guide at
www.corcept.com/medicationguide.pdf
About Corcept Therapeutics Incorporated
Corcept is a pharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of severe metabolic and psychiatric disorders. Korlym, a first generation GR-II antagonist, is the company's first FDA-approved medication. The company has a portfolio of new selective GR-II antagonists that block the effects of cortisol but not progesterone. Corcept also owns an extensive intellectual property portfolio covering the use of GR-II antagonists, including mifepristone, in the treatment of a wide variety of psychiatric and metabolic disorders. The company also holds composition of matter patents for its selective GR-II antagonists.
Statements made in this news release, other than statements of historical fact, are forward-looking statements. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. For example, there can be no assurances that clinical results will be predictive of real-world use, or regarding the pace of Korlym's acceptance by physicians and patients, the reimbursement decisions of government or private insurance payers, the effects of rapid technological change and competition, the protections afforded by Korlym's Orphan Drug Designation or by Corcept's other intellectual property rights, and the cost, pace and success of Corcept's other product development efforts. These and other risks are set forth in the Company's SEC filings, all of which are available from our website (www.corcept.com or from the SEC's website (
www.sec.gov . We disclaim any intention or duty to update any forward-looking statement made in this news release.
CONTACTS:
Charles Robb
Chief Financial Officer
Corcept Therapeutics
650-688-8783
Media Contact
Alissa Maupin
Communications Strategies, Inc.
973-635-6669
From
http://www.corcept.com/news_events/pr_1329524335
Devices Are the Future of DrugsBy: Norbert Sparrow 30 January, 2012
Last week, I posted an article on medtech insider that listed five reasons why medical device manufacturers should consider attending Pharmapack Europe in Paris on 15 and 16 February 2012. One of those reasons was a conference session titled, Why Medical Devices Are the Future of Drugs. The topic intrigued me and I wanted to know more, so I called up Dr. Yves Tillet, CEO of Paris-based consultancy White-Tillet, who will be addressing this subject on 16 February. Here’s a preview of the case he will make to Pharmapack Europe conference attendees.
Most drugs are administered via a systemic route, says Tillet, and to ensure that the medication reaches the target site, it is administered in large concentrations. “If you are able to target just the tumour, for example, you can use much smaller quantities of the drug, and thus improve the risk-benefit ratio,” explains Tillet. Moreover, drugs that did not get past phase 2 of the drug development process “because of toxicity issues can be rehabilitated by being administered locally,” he adds. Introduced into the body in much smaller quantities and precisely delivered to the target site, the drug no longer poses a threat to healthy cells.
During his presentation, Tillet will describe various types of innovative drug-delivery systems that are transforming the practice of healthcare. I asked him if there were any that he finds especially promising. After some thought, he pointed to microsphere technology and phototherapy.
“For cancer treatments, the microsphere carries the drug to the target site and isolates the tumour by preventing blood from getting to it. The cytotoxic agent acts on the tumour, which can’t spread,” says Tillet. Phototherapy is also very promising, he adds, because a laser is used to activate the drug only after it has reached the target site.
Traditionally, drugs have been formulated for delivery via a systemic route, notes Tillet, and this can cause a number of issues. At the Pharmapack Europe conference, Tillet will explain in some detail how combination products can eliminate these problems and fundamentally change the way in which serious conditions are treated.
FDA NEWS RELEASE
For Immediate Release: Feb. 17, 2012
Media Inquiries: Morgan Liscinsky, 301-796-0397;
morgan.liscinsky@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA approves Korlym for patients with endogenous Cushing’s syndrome
Today, Korlym (mifepristone was approved by the U.S. Food and Drug Administration to control high blood sugar levels (hyperglycemia in adults with endogenous Cushing’s syndrome. This drug was approved for use in patients with endogenous Cushing’s syndrome who have type 2 diabetes or glucose intolerance and are not candidates for surgery or who have not responded to prior surgery. Korlym should never be used (contraindicated by pregnant women.
Prior to FDA’s approval of Korlym, there were no approved medical therapies for the treatment of endogenous Cushing’s syndrome.
Endogenous Cushing’s syndrome is a serious, debilitating and rare multisystem disorder. It is caused by the overproduction of cortisol (a steroid hormone that increases blood sugar levels by the adrenal glands. This syndrome most commonly affects adults between the ages of 25 and 40. About 5,000 patients will be eligible for Korlym treatment, which received an orphan drug designation by the FDA in 2007.
Korlym blocks the binding of cortisol to its receptor. It does not decrease cortisol production but reduces the effects of excess cortisol, such as high blood sugar levels.
The safety and efficacy of Korlym in patients with endogenous Cushing’s syndrome was evaluated in a clinical trial with 50 patients. A separate open-label extension of this trial is ongoing. Additional evidence supporting the agency’s approval included several safety pharmacology studies, drug-drug interaction studies and published scientific literature. Patients experienced significant improvement in blood sugar control during Korlym treatment, including some patients who had marked reductions in their insulin requirements. Improvements in clinical signs and symptoms were reported by some patients.
The most common side effects experienced by endogenous Cushing’s syndrome patients treated with Korlym in clinical trials were nausea, fatigue, headache, arthralgia, vomiting, swelling of the extremities, dizziness and decreased appetite. Other side effects of Korlym include adrenal insufficiency, low potassium levels, vaginal bleeding and a potential for heart conduction abnormalities. Certain drugs used in combination with Korlym may increase its drug level. Health care professionals must be aware of the potential for drug-drug interactions and adjust dosing or avoid using certain drugs with Korlym.
Korlym should never be used by pregnant women. Although pregnancy is an extremely rare occurrence in Cushing’s syndrome patients because of the suppressive effect of excess cortisol on female reproductive function, Korlym will carry a Boxed Warning advising health care professionals and patients that the therapy will terminate a pregnancy.
The FDA has determined that a Risk Evaluation and Mitigation Strategy (REMS is not necessary for Korlym to ensure that the benefits outweigh the risks for patients with endogenous Cushing’s syndrome. Several factors were considered in this determination including the following:
- There are no other approved medical therapies for this debilitating form of Cushing’s syndrome and very sick patients would suffer if impediments to access were imposed.
- The number of Cushing’s syndrome patients who will require treatment with Korlym is small, with an estimated 5,000 patients being eligible for treatment.
- The number of health care professionals in the United States who would potentially prescribe Korlym is very small and highly specialized. They are familiar with the risks of Korlym treatment in the endogenous Cushing’s syndrome population and frequently monitor patient status.
- The risks of Korlym treatment in the intended population can be managed through physician and patient labeling. The risks associated with Korlym will be outlined in a medication guide for patients.
The company has voluntarily proposed distributing Korlym through a central pharmacy to ensure the timely, convenient and appropriate delivery of the drug to Cushing’s patients or to the health care institutions where this therapy may be initiated. Most retail pharmacies are unlikely to keep adequate supplies of the drug for this rare condition and central distribution will give patients with Cushing’s syndrome better access to Korlym.
Korlym is manufactured by Corcept Therapeutics of Menlo Park, Calif.
For more information:
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
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From
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm292462.htm
A Tasmanian initiative to prevent the abuse of controlled drugs such as painkilling prescription drugs will be rolled out nationally from July.
The Federal Government has announced plans to establish a $5 million national electronic records system that will enable pharmacists, doctors and other health authorities to monitor the real time prescribing and dispensing of addictive drugs.
The Electronic Recording and Reporting of Controlled Drugs system, which has been used in Tasmania for more than a year, will enable pharmacists to access a centralised database over a secure computer network containing prescription history records. Federal Health Minister Tanya Plibersek said the system would help monitor the drug misuse and diversion of controlled drugs including oxycodone, morphine and codeine.
“Abuse of these drugs can cause enormous harm and is a growing problem in the community,” she said.
Ms Plibersek said health professionals will be able to immediately detect people suspected of trafficking in painkillers, forging prescriptions and ‘doctor-shopping’.
“The new records system will be able to flag patients in real time who have repeatedly sought controlled drugs, helping to prevent people from inappropriately using the drugs or selling them to others.
“If a pharmacist determines it is not clinically appropriate to dispense a medicine to a patient, it is their duty of care to restrict access to that patient.” The system will replace paper-based prescription records still operating in some Australian states and enable pharmacists to check on prescription records from across the country.
The national scheme comes as figures show the amount of prescription opioids used in Australia is on the rise.
The total value of Pharmaceutical Benefits Scheme opioid prescriptions increased from $2 million in 1992 to $7 million in 2007, according to the Internal Medicine Journal.
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AN
ARTICLE in Sunday's
New York Times
by Binyamin Appelbaum and Robert Gebeloff on the expanding scope of the American "safety net" has generated some interesting comment. Government transfers flowing to middle-income households have increased relative to those going to lower-income households, as Messrs Appelbaum and Gebeloff maintain. However, as
Mike Konczal and
James Kwak have pointed out, much of the change may be due less to the creeping reach and open-handedness of the welfare state and more due to (a the mid-1990s reduction in welfare benefits, (b the fact that the huge baby-boom cohort has aged into Social Security and Medicare eligibility, (c the rising cost of health care, and (d the current recession, which accounts for recent, large and putatively temporary increases in the scope and generosity of earned-income-tax-credit and unemployment benefits.
These points are well-taken, though it is important to note,
as Casey Mulligan does, that it's a mistake to think that relaxing eligibility requirements and increasing benefits during a recession is just the safety net "automatically" doing its job. This is an elective expansion of the safety net. Moreover, Mr Mulligan notes that eligibility requirements for some programmes have been relaxed generally, and it's seldom politically attractive to ratchet programmes back once they've been ratcheted up. So it appears Mr Kwak is incorrect when he maintains, "The idea that politicians have expanded the safety net is just not true, with the exception of the Medicare prescription drug benefit and an expansion in Medicaid that hasn’t taken effect yet."
More interesting than these wonkish details are Messrs Appelbaum and Gebeloff's miniature portraits of the uneasiness expressed by middle-class Americans who depend on government transfers. Mostly, they depict ordinary folks who would rather go without government assistance, but are anxiously baffled about how they would manage without it. Take the case of Gordy Peterson:
Gordy Peterson, 62, who has used a wheelchair for 30 years since a construction accident, has reluctantly reached a similar conclusion.
“I’m a conservative,” he said by way of introducing himself. He built his own house before his injury and paid for it in cash. He still thinks the government should operate that way. He never intended to depend on federal aid and said he sometimes felt guilty about it.
But for the last three decades, he has received a regular check from the Social Security disability insurance program, and Medicare has helped to pay his medical bills.
[...]
Mr. Peterson, an easygoing man who looks down when he thinks and smiles sheepishly when he offers an opinion, looked down after completing the story of his own dependence on the safety net.
“It’s hard to beat up on the government when they’ve been so good to you,” he finally said. “I’ve never really thought about it, I guess.”
Or take the case of Ki Gulbranson, whose family has benefitted from relaxed earned-income-tax-credit eligibility rules:
Instead [of paying more in taxes, Mr Gulbranson] said he would rather give up the earned-income credit the family now receives and start paying for school lunches for his children.
“I don’t demand that the government does this for me,” he said. “I don’t feel like I need the government.”
How about Social Security? And Medicare? Can he imagine retiring without government help?
“I don’t think so,” he said. “No. I don’t know. Not the way we expect to live as Americans.”
I think some readers detect a lightly mocking tone in this article, a subtle condescension toward the likes of Messrs Peterson and Gulbranson, who would like to do without government help, but can't quite see how that would work. I do think there's a whiff of this, though I doubt it's intentional. Mostly I find a faithful depiction of a common and interesting conflict within many Americans between their de facto dependence on government transfers and their closely-held ideals of independence and self-reliance.
To understand all this, I think it's important to acknowledge that our so-called "social insurance" programmes, such as Social Security and Medicare, produce a sense of dependency
by design
. Dependency is precisely what makes them politically self-reinforcing and thus
dependable—
credible as a sort of insurance. But, like it or not, many Americans do find this dependency humiliating. When it is understood that these programmes, as presently constituted, are fiscally unsustainable, the humiliation of dependency is often joined by the fear that one may not be able to really depend on them after all, or by guilt that one is in effect free-riding off future generations, who will have to pay more and get less in return. And then, on top of it all, there is frustration over the fact that one hasn't a clue what to do about any of it.
Defenders of the massive New Deal-Great Society entitlements are inclined to see hypocrisy or thick-headedness in those who oppose in principle programmes on which they in fact depend. A more generous way to understand this phenomenon is to acknowledge that the New Deal-Great Society social insurance institutions have proved successful in engendering economic dependence and, thereby, self-reinforcing political support, but they have failed to engender a corresponding shift in America's culture of self-reliance. This has left many Americans feeling divided against themselves. Instead of giving in to the ideal of in-it-together mutual dependence, millions have instead become almost manically vehement in their profession of the ideals of independence and self-responsibility.
One argument for transforming Social Security and Medicare into Singapore-style forced savings programmes is that a system which relies primarily on intra-personal transfers better suits America's ingrained ethos of individual responsibility and would thus help resolve the cognitive and emotional dissonance created by the status-quo system. We will never be Danes and we might as well accept it. I would add the conjecture that helping Americans find a sort-of inner political peace by redesigning the safety net to go with rather than against our culture's grain would reduce the felt need to lash out against the "socialism" of the residual interpersonal redistribution required to make the safety net really robust for all.
<1.0 g/dL (this value will be less than the bottom of the scale of most hand-held refractometers . Joint trauma and inflammation will increase the protein concentration of the synovial fluid. Therefore, an animal with rheumatoid arthritis will have an increased protein concentration in their synovial fluid.1,2 *Nucleated Cell Count* Only nucleated cells are counted either by manual methods or automated analyzer. Healthy dogs may have a synovial fluid nucleated cell count of up to 1,500 cells/µl. Rheumatoid arthritis is an inflammatory process, causing an inflammatory synovitis. The total number of nucleated cells in the synovial fluid is moderately to markedly increased in an animal with rheumatoid arthritis.2 *Cytologic Evaluation* The most important part of the synovial fluid analysis is cytologic evaluation. Often, only a small amount of synovial fluid can be obtained. In this case, it should be used for cytologic study in preference to other forms of analysis. A wedge smear is made of the synovial fluid and stained with Romanowsky stain. Normal synovial fluid contains many mononuclear cells including macrophages and a few small, well differentiated lymphocytes (Fig. 1 . Less than 10% of the total nucleated cell count consists of neutrophils. [TR] [TD]Image: http://www.vet.uga.edu/vpp/clerk/gronfeld/fig01.jpg [/TD] [/TR] [TR] [TD="width: 325"]*Figure 1.* Infrequent large mononuclear cell in the synovial fluid from a healthy dog (Wright stain .[/TD] [/TR] Depending on the cellular content, synovial fluid can be classified as one of the following: normal, degenerative, inflammatory, or acute hemorrhage. Synovial fluid with inflammation can be further classified as either infectious or noninfectious, depending on the presence of microorganisms and the appearance of the neutrophils. Noninfectious inflammation in small animals is often associated with trauma or an immune-mediated process. In rheumatoid arthritis, the nucleated cell count is markedly increased (from >10,000 cells/µl to 100,000 cells/µl . The neutrophil is predominant cell type found in the synovial fluid (Fig. 2 . Mononuclear cells also may be increased in number, but the neutrophil count alone can be >5,000 cells/µl.1,2 [TR] [TD="width: 325"]Image: http://www.vet.uga.edu/vpp/clerk/gronfeld/fig02a.jpg [/TD] [TD="width: 308"]Image: http://www.vet.uga.edu/vpp/clerk/gronfeld/fig02b.jpg [/TD] [/TR] [TR] [TD="colspan: 2"]*Figure 2.* Numerous neutrophils in the synovial fluid of a dog with rheumatoid arthritis (Wright stain .[/TD] [/TR] *Serology* In addition to routine synovial fluid analysis, serology also can aid in the diagnosis of canine rheumatoid arthritis. Serology will detect the rheumatoid factors (RF; autoantibodies directed against the altered IgG . A RF titer = 1:16 is considered a positive test result that is suggestive of rheumatoid arthritis. Positive serological tests are found in 20-70% of affected dogs; however, false positive test results can occur in dogs with other systemic inflammatory disorders. For this reason, a positive RF titer is not a definitive diagnostic test for rheumatoid arthritis. All of the clinical signs and diagnostic findings must be taken into account when interpreting the serological test.1,3 *Summary* The earlier a diagnosis of rheumatoid arthritis can be made, the sooner treatment can begin. Early treatment is necessary to avoid irreversible damage to the joints. Medical treatment can involve the following: immunosuppressive drugs, gold salts, and/or nonsteroidal anti-inflammatory drugs. Aspirin has been used for palliative treatment. Immunosuppressive treatment usually involves the administration of prednisone and/or azathioprine or cyclophosphamide. Azathioprine is usually preferred as the second drug of choice because cyclophosphamide may have serious side-effects when used long-term. The dog should be re-examined and the synovial fluid should be re-evaluated 1 month after beginning treatment. Even with appropriate treatment, most dogs with rheumatoid arthritis will have a deterioration of their health status over time.3 Canine rheumatoid arthritis is an uncommon disorder in dogs. However, rheumatoid arthritis should be considered in any dog with a noninfectious, erosive polyarthritis. In addition to clinical signs, radiographic evidence of joint erosion, serologic testing, and laboratory analysis of synovial fluid may assist in disease diagnosis. Dogs with rheumatoid arthritis have synovial fluid that is thin and cloudy in appearance. Cytologically, rheumatoid arthritis is characterized by a noninfectious inflammatory appearance with the main cell type being neutrophils.
K. pneumoniae
Bacteria that have evolved defenses against antibiotics are something of a disaster waiting to happen. Whenever a new drug-resistant strain, or a gene that confers resistance, crops up in a new place—as when the NDM-1 gene, which confers resistant to up to 14 drugs,
showed up in drinking water in New Delhi—it’s another nail in coffin of a world in which we can heal nearly everything. Scientists are looking into how to get around that resistance, though, and there are some hopeful headlines now and then, including a
recent study from researchers at North Carolina State University in which they identified a molecule that can boost the efficacy of two antibiotics against bacteria 16-fold.
The molecule, which the researchers found by testing about 50 candidates to see if they could reduce the number of NDM-1-carrying
K. pneumoniae
by a significant amount, doesn’t have any antimicrobial properties of its own. It’s an
adjuvant, which means it has to be applied in tandem with another drug to have any effect—in this case, the antibiotics carbapenem and cephalosporin. The researchers checked a couple of different ways that it could be working, and found ...
The Missouri Department of Health and Senior Services received the following news release regarding seven lots, approximately 574,000 bottles, of Infants' TYLENOL Oral Suspension, 1 oz. Grape. The item was distributed nationwide.
The full recall product list is:
Product Name | Lot Numbers | UPC Code |
Infants' TYLENOL Oral Suspension 1oz. Grape | BIL0U00, BIL0V00, BIL3500, BJL2D00, BJL2E00, BJL2T00, BJL2U00 | 300450122308 |
The recall was initiated after receiving a small number of complaints from consumers who reported difficulty using the Infants' TYLENOL SimpleMeasure dosing system.
No adverse events associated with this action have been reported to date and the risk of a serious adverse medical event is remote.
Consumers can continue to use Infants' TYLENOL provided the flow restrictor at the top of the bottle remains in place. If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product.
Adverse events that may be related to the use of this product may be reported to U.S. Food and Drug Administration's (FDA MedWatch Adverse Event Reporting Program either online, by regular mail or by fax:
- Online:
www.fda.gov/medwatch/report.htm5
- Regular mail: Use postage-paid, pre-addressed Form FDA 3500 available at:
www.fda.gov/MedWatch/getforms.htm6. Mail to address on the pre-addressed form.
- Fax: 1-800-FDA-0178.
The full recall can be found at
www.fda.gov/Safety/Recalls/ucm292537.htm?source=govdelivery.
Source: MicroChips
Coming soon, whether we like it or not! The
Financial Times reports:
A wirelessly controlled implant, which delivers precise drug doses into the patient’s body, has had a successful first clinical trial, bringing the possibility of the “pharmacy on a chip” that could transform drug delivery closer.
Researchers used the microchip device to give seven women with osteoporosis daily doses of a bone-strengthening hormone that was normally injected. The results were announced at the start of the American Association for the Advancement of Science annual meeting on Thursday.
The device could transform drug delivery and help usher in a new era of telemedicine – delivering healthcare over a distance – said Robert Langer, a professor at the Massachusetts Institute of Technology where the project started 15 years ago.
“You could literally have a pharmacy on a chip,” he said. “You can do remote control delivery, you can do pulsatile drug delivery, and you can…
Category: Health News
Created: 2/16/2012 11:01:00 AM
Last Editorial Review: 2/16/2012
Category: Health News
Created: 2/16/2012 4:06:00 PM
Last Editorial Review: 2/17/2012
- Birth Defects Research Part B: Developmental and Reproductive Toxicology
- Birth Defects Research Part C: Embryo Today: Reviews
- Cell Cycle
- Clinical and Developmental Immunology
- Current Aging Science
- Drugs and Aging
- Evodevo
- Development Genes and Evolution
- Developmental Neurobiology
- Journal of Developmental Origins of Health and Disease
- Neurobiology of Aging
- Oxidative Medicine and Cellular Longevity
- Rejuvenation Research
- Teratogenesis, Carcinogenesis, and Mutagenesis
- Wormbook - The Online Review of C. Elegant Biology
Category: Health News
Created: 2/17/2012 11:00:00 AM
Last Editorial Review: 2/17/2012
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