Tag Archives: medical

How a medical device maker kept U.S. hospitals in the dark about deadly infections

The hunt for a deadly superbug that sickened 22 patients at a Dutch hospital began just before noon on a spring day in 2012.

Inside a lab in the tiny hamlet of Zoeterwoude, a technician carefully peeled back the tip of a state-of-the art medical scope. Watching him intently was a small group of hospital officials and executives from Olympus Corp., the maker of the device.
A 2012 inspection by Olympus and Dutch hospital officials revealed a brown film inside a duodenoscope. (Arjo Loeve / Delft University of Technology).
The Olympus technician found trouble right away. He spotted a brown, grimy film inside parts of the flexible, snake-like scope — parts that were supposed to be sealed. A rubber ring designed to keep bacteria out was cracked and worn. The same bacteria that had sickened the patients were found on the scope.

An investigator hired by Olympus and the hospital concluded that the scope’s design could allow blood and tissue to become trapped, spreading bacteria from one patient to another. In his report, he called on Olympus to conduct a worldwide investigation and recall all its scopes if similar problems turned up.

Over the next three years, 21 people died and at least two dozen more became ill from infections related to scopes in Pittsburgh, Seattle and Los Angeles. An unknown number of other patients have been infected. The Food and Drug Administration has identified 10 outbreaks, seven of which involve Olympus scopes.

Even as patients died and others were put at risk, Olympus continued to sell the device and failed to warn U.S. hospitals that the scopes were tied to dangerous infections, according to interviews with dozens of hospital officials, doctors, regulators and former Olympus employees.

After each outbreak, Olympus contended that its scopes did not cause the infections and blamed the hospitals for not cleaning them properly. The company treated each case as an isolated incident, not telling the U.S. hospitals that they weren’t alone.

“Olympus’ silence on this important issue was unethical, irresponsible and dangerous,” said Dr. Andrew Ross, chief of gastroenterology at Virginia Mason Medical Center in Seattle, where 18 patients sickened by tainted scopes died and 21 more were infected.


Olympus’ silence on this important issue was unethical, irresponsible and dangerous.

— Dr. Andrew Ross, chief of gastroenterology at Virginia Mason Medical Center in Seattle
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Olympus controls 85% of the U.S. market for gastrointestinal scopes. U.S. prosecutors and congressional investigators are looking into how Olympus and two smaller scope manufacturers responded to the superbug outbreaks.

The investigations were launched after the Los Angeles Times reported in February about an outbreak that claimed three lives at UCLA Ronald Reagan Medical Center.

The day after the article, regulators issued a warning to all U.S. hospitals that an increasing number of infections across the country might be related to the design of the scopes.

Olympus declined to answer specific questions from The Times about the scope’s role in patient infections and its handling of the outbreaks.

“We have expressed our sympathy to patients and families who have experienced or have been affected by infections,” the company said. “We continue to work closely with the Food and Drug Administration in an effort to understand and address potential root causes.”

A robust business
Many people think of cameras when they hear the name Olympus. Doctors know it as a medical device giant, one with a reputation for engineering expertise and a close working relationship with healthcare professionals.

Olympus medical sales by fiscal year and percentage by region

Medical devices today account for nearly 75% of the Tokyo company’s $7 billion in annual revenue. Sales of its scopes surged 18% to $1.4 billion for the six months ending in September, and overall company profit jumped 60% to $294 million.

Olympus worked with doctors to invent the device called a duodenoscope more than four decades ago. It is used in a procedure known as ERCP, or endoscopic retrograde cholangiopancreatography. Doctors thread the flexible scope down a patient’s throat and into the digestive tract, where cancers, gallstones and other conditions can be diagnosed and treated, without the complications of more invasive surgery.

Physicians perform nearly 700,000 of those procedures annually in the U.S., and 2 million worldwide, Olympus said. Many of those patients have serious illnesses, making them more vulnerable to infection.

By 2010, two Olympus rivals, Pentax and Fujifilm, were selling a redesigned scope that they said was easier to clean because a crucial section of the device was sealed to keep bacteria out.

Olympus introduced a similar model, known as the TJF-Q180V. The company touted the $40,000 scope as a technical triumph designed to give doctors the ability to perform more complex procedures.
An Olympus sales brochure touting the design of its duodenoscope in 2010. See the full document
The Olympus sales force also pitched its new scope as being easier to clean. That appealed to hospitals where nurses and staff were under pressure to quickly disinfect the devices, a process that could take as long as an hour.

But the redesign had created a new problem.

A ‘nightmare’ bacteria
The 2012 outbreak in the Netherlands, at Erasmus University Medical Center in Rotterdam, was the first sign of trouble.

“You only need one bacteria to get inside and multiply,” said the Dutch investigator, Arjo Loeve, a mechanical engineer at Delft University of Technology. “You shouldn’t find anything on the inside.”

After Loeve’s report linked the bacterial outbreak to its scope, Olympus alerted European hospitals about potential contamination. But it didn’t issue a similar warning in the United States, its biggest market.

Federal reports of duodenoscope-related infections and contamination

*Through Feb. 17, 2015. Note: One report can involve numerous patients.
Just a few months later, patients at the University of Pittsburgh Medical Center began testing positive for a superbug known as CRE. That superbug is so resistant to antibiotics that health officials call it the “nightmare bacteria.” As many as half of infected patients die.

The Pittsburgh hospital discovered that many patients infected with the superbug had been treated with an Olympus scope. The hospital quickly pulled its Olympus devices out of service, alerted the company and tested them for the bacteria.

Five of the hospital’s 31 scopes came back positive for bacteria — even after being scrubbed by hand and machine-washed with a powerful disinfectant, the hospital said. One device contaminated with CRE was originally linked to 18 sick patients. The hospital later said it could definitively tie only one case to the Olympus scope because some patients underwent procedures at other hospitals.

An Olympus representative who reviewed the test results told doctors that the scopes might not be getting completely cleaned because the hospital was using the wrong type of automatic washer, the hospital said. The representative persuaded the hospital to replace its cleaning machine with an Olympus model, which can cost about $25,000.

But another scope tested positive for bacteria even after it was cleaned in the new machine. The medical center began sterilizing scopes with a toxic gas, a costly, more time-consuming method. Because of the longer cleaning time, Pittsburgh ordered more scopes from Olympus, doubling its supply.

Another scope, similar infection worries
By Chad Terhune and Melody Petersen
Long before the recent superbug outbreaks, Olympus Corp. drew national attention for a faulty device tied to patient infections.

Read more
Deflecting blame
A few months later, in October 2013, patients undergoing operations with Olympus scopes at Virginia Mason Medical Center in Seattle began to develop serious infections. Eighteen of those infected eventually died.

Hospital officials summoned Olympus.
A sample is taken from inside an Olympus scope during a Netherlands outbreak investigation in 2012. (Arjo Loeve / Delft University of Technology)
A company service representative watched hospital employees wash the scopes and raised no concerns, said Dr. Andrew Ross, the hospital’s chief of gastroenterology. Over the next several weeks, Virginia Mason sent its eight scopes back to Olympus, one by one, for inspections. Olympus never told the hospital about the Rotterdam and Pittsburgh infections, he said.

In 2014, nearly a year later, Olympus told the FDA that no Virginia Mason devices were returned for evaluation. The company also said that it had offered an on-site visit but that the hospital declined.

That account was at odds with that of the hospital, and Virginia Mason is suing Olympus for fraud, arguing that it “deceptively concealed … the risks and flaws of the scopes.” Olympus denies the allegation, contending that the hospital failed to follow the instructions for cleaning the scope.

An investigation by federal, state and county officials concluded this year that the hospital followed proper cleaning procedures and that the Olympus cleaning instructions were insufficient. In a report, the health officials called that “disturbing.”

Salesman’s denials
When doctors at UCLA’s Ronald Reagan Medical Center began to suspect that they were using tainted scopes in December 2014, they called their Olympus salesman, Vincent Hernandez.

Hernandez was one of the company’s top salesmen; he boasted on LinkedIn about securing $14.6 million in new business during 2014. He had spent much of that summer with UCLA doctors and administrators, wrapping up a major sale of Olympus scopes.

Hernandez and Olympus technicians visited the hospital. Company representatives watched UCLA employees clean the scopes. None of them raised concerns about the cleaning or mentioned the previous outbreaks, according to UCLA officials involved in the investigation.

Olympus told the FDA, though, that one of its employees had noted “inconsistencies” in the hospital’s cleaning practices. In court filings, Hernandez and two other employees said they couldn’t have warned UCLA about outbreaks linked to the scopes in the Netherlands, Pittsburgh or Seattle because they weren’t aware of them.

By late January of this year, the relationship between Olympus and UCLA had grown testy. University doctors had taken two scopes linked to patient infections out of service and asked Olympus to lend them two more. Olympus asked for the scopes to be returned before replacements would be sent. UCLA declined.

The hospital soon faced a shortage of scopes because new cleaning methods were taking longer. When the university asked about buying more scopes, Olympus said the price had increased since the hospital had purchased scopes a few months earlier, according to hospital officials. The company also said it couldn’t promise when the devices would arrive because the outbreaks had increased demand.

Dr. Raman Muthusamy, UCLA’s director of endoscopy, said he hadn’t been aware of the Netherlands case while his hospital was investigating the infections. When he read the Dutch investigator’s report, he was struck by the similarities.
Jeffrey Hughes, 11, at UCLA Medical Center in November 2014. (Hughes family photo) The Hughes family pictured at their home in Santa Monica. (Robert Gauthier / Los Angeles Times)
“Pittsburgh was established. We had Virginia Mason. We had Rotterdam,” he said. “You wonder, why didn’t they get on this earlier? I had no inkling this was an issue.”

The family of 11-year-old Jeffrey Hughes, from Santa Monica, says they deserved to know about the potential risks. Jeffrey, who had been fighting cancer for three years, was treated with an Olympus scope at UCLA during the outbreak and developed an infection. The sixth-grader died a month later.

His parents have sued Olympus in federal court in Los Angeles, blaming the scope.

“To put something in him that could risk his life — yeah, I would have wanted to know that,” said his mother, Annie Hughes. “Olympus knew about this in 2012. At least tell us.”

Olympus has denied liability in the boy’s death, saying it could have been caused by preexisting conditions.

Late reports
Although Olympus did not alert U.S. hospitals to previous outbreaks, it was required to file reports to federal regulators. Most of those reports suggested culprits other than its scope, including poor cleaning procedures.

The company’s reports didn’t suggest a link among the cases; instead, they were each reported as separate, unconnected incidents.

The FDA issued no warnings based on those reports. Following federal rules, it didn’t publicly identify the hospitals.

Olympus waited until 2015 to file a detailed report on the 2012 Netherlands outbreak. In it, the company again contended that the hospital may have not cleaned the scope properly.

“The cause of the patient infection could not be conclusively determined,” Olympus concluded.
Hard questions
In February 2015, immediately after the UCLA outbreak was reported, Olympus sent an alert to customers. It disclosed, for the first time, that it was aware of 95 complaints tying its scope to patient infections.

A former top Olympus executive familiar with the inner workings of the company said the previous scope models logged far fewer complaints.

“This rash of incidents couldn’t be explained away,” this former official said, asking not to be named out of fear it would damage career prospects in the medical industry. “They should have pulled the scope.”

In May, the FDA convened a panel of medical experts at its headquarters outside Washington to examine the scope-related infections.

Doctors from Rotterdam, Seattle and Los Angeles gathered in a large, wood-paneled auditorium during the two-day hearing. One by one, they described how their outbreaks unfolded.


A solution must be found in changing the design. I think many transmissions will occur … This is the tip of the iceberg.

— Dr. Margreet Vos, Erasmus University Medical Center in Rotterdam
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Dr. Margreet Vos, an infectious diseases doctor at the Rotterdam medical center, showed regulators and medical experts the photos taken inside the Olympus lab after the Dutch outbreak three years earlier.

She pointed to the brownish debris that Olympus employees had found behind the glass cover of the scope’s camera — an area closed off from cleaning.

She put an image of the rubber seal on a giant screen. It was worn down with rough edges and a tear on the bottom left side.
Carla and Bill Warner. (Photo courtesy of Carla Warner)
“A solution must be found in changing the design,” Vos told the audience. “I think many transmissions will occur.… This is the tip of the iceberg.”

Then FDA officials invited the public to speak. Carla Warner stepped out of her seat on the aisle and walked to the microphone to share her family’s story.

The North Carolina widow said her 55-year-old husband, Bill, was treated with an Olympus scope at Carolinas Medical Center in Charlotte. He died of an infection in November 2013.

His family sued Olympus, alleging wrongful death, in federal court last month in Philadelphia.

“Olympus knew of the risk and hid the infections,” Warner said, sobbing. “My husband should be alive today.”

Olympus executives sat silently in the back of the room. None of them rose to speak.

Contact the reporters

Times researcher Scott Wilson contributed to this report.

Timeline
Recent events involving scope-related outbreaks of antibiotic-resistant superbug infections

2010
August Japanese device maker Olympus Corp. introduces its TJF-Q180V duodenoscope.

2012
April 23 An Olympus employee dismantles a duodenoscope suspected of infecting 22 patients at a Netherlands hospital.

June 27 An independent expert’s report on the Netherlands outbreak calls on Olympus to conduct a worldwide investigation and possibly recall the scopes if more contaminated devices are found.

Dec. 4 Olympus visits the University of Pittsburgh Medical Center after being alerted to apparent scope-related infections.

2013
January Olympus issues “important safety advice” in Europe for the TJF-Q180V duodenoscope after infections in the Netherlands. There’s no notification in the U.S.

November Olympus visits Virginia Mason Medical Center to review the Seattle hospital’s scope cleaning practices; an outbreak is later confirmed.

2014
August Olympus sends a second safety alert in Europe after receiving complaints about tainted scopes.

Oct. 3 A UCLA patient carrying the CRE superbug undergoes a scope procedure with an Olympus device; the instrument remains contaminated after cleaning.

Dec. 14 UCLA begins investigating a superbug infection in a female patient who was treated with an Olympus scope.

2015
Jan. 28 UCLA ties patient infections to the Olympus devices, temporarily halts use of the scope.

Feb. 18 Los Angeles Times first reports the UCLA outbreak. Read more »

Feb. 19 The Food and Drug Administration warns U.S. hospitals about scopes spreading deadly bacteria. Read more »

March 4 Cedars-Sinai Medical Center reports four patients who had been infected by Olympus scopes. Read more »

March 26 Olympus issues new cleaning instructions to U.S. customers, similar to its European guidelines in 2013. Read more »

May 8 The U.S. Justice Department is investigating Olympus’ role in outbreaks, the company confirms. Read more »

May 15 An FDA panel says that duodenoscopes are unsafe but that they should remain in use because no alternative is available. Read more »

June 9 Sen. Patty Murray (D-Wash.) demands details from Olympus on its response to infection reports, as part of a congressional investigation.

Aug. 17 The FDA cites Olympus and two other scope manufacturers for safety violations, including the failure to report potential injuries and deaths within 30 days. Read more »

Aug. 19 The Times reports that Huntington Memorial Hospital in Pasadena is investigating several patient infections tied to Olympus scopes. Read more »

Sept. 17 The FDA expands its warning, saying contaminated bronchoscopes made by Olympus and other companies may pose a risk to patients. Read more »

Sources: Olympus, Times reporting, hospitals

Design and development by Lily Mihalik and Evan Wagstaff. Graphics reporting by Angelica Quintero. Sources: FDA, FactSet Research, Olympus. Lead photo: An Olympus scope under examination during the Netherlands outbreak investigation in 2012. (Arjo Loeve/ Delft University of Technology)

Marijuana Medicine 




MDC has stated for years about the health benefits of marijuana and we share additional research.

Marijuana is one hundred percent a form of medicine, researchers conclude in a bombshell series of reports released today by the Journal of the American Medical Association.

Cannabis — which has been used medicinally for thousands of years — reduces nausea, and vomiting, and pain, as well as spasticity, a panel of researchers conclude, after reviewing a total of 79 trials.

“Use of marijuana for chronic pain, neuropathic pain, and spasticity due to multiple sclerosis is supported by high-quality evidence,” one of the reports found.

Researchers bemoaned the lack of high-quality trials of marijuana. That situation that can be laid at the feet of cannabis prohibition. The federal government maintains cannabis is a highly dangerous drug with no medical use. Researchers must cut through more red tape to research a pot plant than any other substance on the planet, doctors say.

However, this week, the federal government slightly reduced the regulatory hurdles to study cannabis — down from eight layers of review, to seven.

More than 750,000 Americans will be arrested for cannabis this year. The Obama administration has spent an estimated $300 million interfering with state medical marijuana programs and patients, including arresting and prosecuting patients and caregivers. Thirty-five states have medical cannabis laws, and some members of Congress are working to de-fund federal attacks on medical marijuana.


Marijuana for Medical Care says Surgeon General

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MDC says, the top doctor on Wednesday suggested an openness to wider use of medical marijuana, saying the drug might offer some medical benefits.

“We have some preliminary data showing that for certain medical conditions and symptoms that marijuana can be helpful,” Surgeon General Vivek Murthy told “CBS This Morning.”

“So I think we have to use that data to drive policymaking, and I’m very interested to see where that data takes us,” he added.

His comments follow President Obama’s remark last year that marijuana is not “more dangerous than alcohol.

“As has been well-documented, I smoked pot as a kid, and I view it as a bad habit and a vice, not very different from cigarettes that I smoked as a young person up through a big chunk of my adult life,” Obama told The New Yorker magazine. “I don’t think it is more dangerous than alcohol.”

More recently, a number of Republican lawmakers have also admitted to smoking pot.

Murthy, who took over as surgeon general in December, appears to be softening his position on medical marijuana.

During his Senate confirmation hearing a year ago, Murthy told lawmakers, “Just like other drugs, I don’t recommend marijuana, and I don’t think it’s a good habit to use marijuana. If I had kids, I would tell them not to use it.”

Still, Murthy called for more research to “see what the science tells us.”

Marijuana advocates hope to use Murthy’s remarks to pressure the Justice Department into rescheduling marijuana so more studies can be done.

“My position is we have to see what the science tells us about the efficacy of marijuana, and I think we’re going to get a lot more data on that,” Murthy said.

Source; The Hill

Vape for Health

In a small study published in 2011, Abrams found that cancer patients taking morphine and oxycodone experienced greater pain relief at lower opiate blood concentrations when a vaporized form of marijuana was added to their drug regimen. He has just begun recruiting for a study that will explore whether the same formulation can reduce pain, inflammation and opiate doses in patients with sickle-cell disease.

But those who have opposed expanding access to medical marijuana said they were not persuaded that cannabis — a plant designated by the Drug Enforcement Agency as having “no recognized medicinal use” — is a safer alternative to opioids.

“Clearly the study raised an intriguing hypothesis, but many questions still need to be answered,” the National Institute on Drug Abuse said in a statement released Monday. The analysis “should not be oversimplified,” the statement warned.

It’s so apparent that our patients can decrease, diminish or wean themselves completely off of opiates, and that it improves their quality of life. – Dr. Donald Abrams, a UC San Francisco oncologist who was not involved with the study.

Patients in 23 states and the District of Columbia now have the option of seeking a prescription for medical marijuana. (Two of those states, Colorado and Washington, also allow recreational use of the drug.) Chronic pain is thought to be the leading indication for cannabis use.

The study authors, led by the University of Pennsylvania’s Dr. Marcus A. Bachhuber, focused on the years 1999 to 2010. The raw figures collected from states’ death certificatesshowed that rates of fatal opioid overdoses were higher in the states that had implemented medical marijuana laws than in those that had not.

But the researchers took those raw numbers and adjusted them so that it would be easier to make direct comparisons between the states. For instance, they accounted for the fact that each of the states that legalized medical marijuana during the study period did so on different schedules. In addition, they took into account a wide range of factors known to influence opioid abuse, including state unemployment rates and policies tightening access to prescription painkillers.

The results showed that after a state began to implement a medical marijuana law, the rate of its non-intentional opiate overdose fatalities fell compared to those of states without such laws.

And that comparative decline picked up steam over the first six years after the laws went into effect. On average, the statistical analysis showed, states passing medical marijuana laws saw annual reductions of roughly 25% in their opioid-related death rates compared to states with no such laws.

In their first year after implementation of the laws, the 13 states averaged an opiate-related fatality rate 20% lower than those of states without legalized medical marijuana. The average difference between the two groups of states widened at two and three years out, returned to 20% in year four, then rose to just over 33% in years five and six.

About 60% of the nation’s fatal opioid overdoses occur among patients who have legitimate prescriptions for their medications. The authors wrote that in states where access to medical marijuana is legal, legitimate opioid drug users may take lower doses of that prescription pain medication, making overdose less likely.

Others may use marijuana in place of benzodiazepine drugs — sedatives that make a fatal overdose much more likely. Still other patients who might initiate opioid medication use — and go on to risk overdose — may never start if they are able to get pain relief from medical marijuana, the study authors wrote.

“That connection may be intrinsically appealing — some might view the idea that people could use a milder drug versus an opiate as an improvement,” said Kevin Sabet, director of the University of Florida Drug Policy Institute, in a statement. But the new study suffers from “too many uncertainties” to allow that conclusion, he said.

Dr. Mark Ware, a pain specialist and professor of family medicine at McGill University in Montreal, called the JAMA Internal Medicine study “very interesting, and methodologically robust.” But, he added, “there’s probably a temptation to extend the findings of this study to far broader conclusions than are justified.”

The United States “is conducting a natural experiment” on a national scale, said Ware, who is executive director for the Canadian Consortium for the Investigation of Cannabinoids, an advocate for more research on marijuana’s medical potential.

Before physicians and government officials can draw conclusions on the public health benefits of medical marijuana laws, he said, they need more detailed studies of how medical marijuana users take the drug and how its use affects physicians’ prescribing decisions, especially for patients with chronic pain.

Source: melissa.healy /latimes

Pot use Decreasing Domestically

A new study from the National Bureau of Economic Research contradicts lawmakers who say legalizing medical marijuana encourages more teenagers to use pot. According to the study’s results, there’s no indication that pot-friendly states have a higher incidence of high school students trying pot for the first time or regularly getting high.

“Our results are not consistent with the hypothesis that the legalization of medical marijuana caused an increase in the use of marijuana among high school students,” D. Mark Anderson of Montana State University, Daniel Rees of the University of Colorado and Benjamin Hansen of the University of Oregon wrote in their report, published Tuesday.

Researchers compared data from the Centers for Disease Control and Prevention on annual marijuana use by adolescents and found there was no significant increase in the probability that a high school student in states where medical marijuana is legal had used weed in the past 30 days compared to states where it is not.

As the U.S. increasingly moves toward adopting laws in favor of both medical and recreational marijuana, lawmakers against its acceptance have often used the argument that legal weed leads to an increase in underage use in debates. Opponents of legalization say they are concerned it will cause adolescents to pick up the habit, and previous research has at times seemed to support this notion.

In February, the International Journal of Drug Policy released a study that found 10 percent of high school students who were considered low risk for becoming marijuana smokers (a group defined by things like whether they smoke cigarettes, have strong religious beliefs or associate with non-marijuana smoking friends) say they would try pot if it was legal.

According to the National Institute on Drug Abuse, marijuana use among teens declined from the late 1990s until the mid-to-late 2000s. In 2013, 36 percent of high school seniors said they used pot in the past year, while 6.5 percent said they were regular users.

“Young people are showing less disapproval of marijuana use and decreased perception that marijuana is dangerous,” the institute noted. “The growing perception of marijuana as a safe drug may reflect recent public discussions over ‘medical marijuana’ and movements to legalize the drug for adult recreational use in some states.”20140731-231213-83533319.jpg

Epilepsy Supports Marijuana

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The Epilepsy Foundation has recognized medical marijuana as a treatment for epilepsy, calling for better access to the drug and more research into its possibilities.

“The Epilepsy Foundation supports the rights of patients and families living with seizures and epilepsy to access physician directed care, including medical marijuana,” said Philip Gattone, CEO and president of the Epilepsy Foundation, and foundation chairman Warren Lammert in a joint statement on Thursday.

The foundation also urged the Drug Enforcement Administration to end restrictions that limit clinical trials and research into medical marijuana as a treatment for epilepsy.

Under the federal Controlled Substances Act, marijuana is currently classified as Schedule I, along with heroin and LSD. Schedule I drugs, according to the government system, have high potential for abuse and no accepted medical use. The classification also stands in the way of federal funding for research into possible benefits of the drug.

Recently, 18 members of Congress wrote a letter to President Barack Obama demanding that he remove marijuana from a list of the most dangerous controlled substances.

Epilepsy patients around the nation, including some children, are ignoring the federal government’s stance and using medical marijuana to help treat their symptoms.

More than 100 families recently uprooted and relocated to Colorado to take advantage of the state’s robust medical marijuana laws, and to find Charlotte’s Web, one of the most coveted types of medical marijuana available.

Charlotte’s Web is high in CBD, the non-psychoactive ingredient in pot, and low in THC, the component that causes users to feel high. Developed by Colorado’s Realm of Caring non-profit group, it has effectively treated children who have debilitating illnesses and conditions.

Charlotte’s Web and similar strains are administered in liquid or capsule form and, according to doctors, produce few or no side effects. Because of the low THC count, users don’t experience the high associated with traditional marijuana.

Although medical marijuana appears to help many patients, some doctors are skeptical about its efficacy and safety.

“We don’t have any peer-reviewed, published literature to support it,” said Dr. Larry Wolk, the chief medical officer of Colorado’s health department, to the Associated Press.

Despite the lack of hard scientific data, Paige Figi, who works for Realm of Caring, told The Huffington Post that more than 300 patients currently use the Charlotte’s Web strain.

Her 7-year-old daughter, Charlotte, who inspired the name of the strain, used to suffer from hundreds of seizures each week. She was the first child in Colorado to be treated with cannabis and her recovery has been miraculous, her mother said. “She is getting a redo of all the years she was robbed by epilepsy.”

The Epilepsy Foundation plans to take the following steps:

Calling on the DEA to reschedule marijuana so it can be more easily accessible for medical research.

Supporting appropriate changes to state laws to increase access to medical marijuana as a treatment option for epilepsy, including pediatric use through a treating physician.

Supporting the inclusion of epilepsy as a condition that uses medical marijuana as a treatment option where it is currently available
Supporting research on multiple forms of cannabis and seizures.

“These organizations and the vast majority of Americans are sending a message to lawmakers that could not be any clearer — it is time to recognize the proven medical benefits of marijuana and make it legal for those who need it,” said Karen O’Keefe, state policies director for Marijuana Policy Project, in a statement. “Patients and their families should not have to move to other states or continue to suffer because their elected officials are still clinging to antiquated prohibition laws.”

Twenty states and the District of Columbia currently have legalized marijuana in some form and about a dozen more are expected to in the coming years.

According to the Epilepsy Foundation, 2.3 million Americans live with epilepsy, a neurological condition that includes recurring seizures; more than 1 million of those people live with seizures that don’t respond to traditional medication.

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Lucky 21

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MDC says, New York would become the 21st state to allow medical use of marijuana under an initiative Gov. Andrew Cuomo will unveil this week.

Cuomo plans to use administrative powers rather than legislative action to allow a limited number of hospitals to dispense marijuana for certain ailments. He will formally announce his plans in his state of the state speech Wednesday.

The New York Times first reported Cuomo’s plan Saturday. It represents an about-face by Cuomo, who had previously opposed medical marijuana. Administration officials told the newspaper the medical marijuana policy will be more restrictive than in states like Colorado and California and subject to New York Health Department standards.

In states that permit medical marijuana, it is commonly prescribed for chronic pain, nausea from cancer chemotherapy, glaucoma and some other conditions. Other controlled substances like narcotics are already authorized for medical use in New York.

Although marijuana remains illegal in New York, possession of small amounts has been reduced to a low-level violation subject to a fine.

The Drug Policy Alliance, which was briefed on the Cuomo plan Saturday, said it would be a huge change, but New York should still enact legislation authorizing a state medical marijuana program that has been blocked so far by the state Senate’s Republicans.

“This is a good development as an interim step,” said Gabriel Sayegh, state director of the Drug Policy Alliance. After the briefing, he said the timing was still unclear as well as precisely who will have access to the program.

The Cuomo administration did not respond to requests from The Associated Press for comment.

Source – ap

Assemblyman Richard Gottfried, a Manhattan Democrat, and Democratic Sen. Diane Savino of Staten Island have recently held hearings on a bill they are sponsoring called the “Compassionate Care Act,” which would regulate and tax medical marijuana. It has previously passed in the Assembly, but failed to get through the Senate.

State Sen. Liz Krueger, another Manhattan Democrat, has been pushing legislation to legalize and tax recreational use of marijuana, arguing state policy outlawing the drug has been costly in terms of law enforcement resources and the futures of people convicted of crimes.

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NYC Pot For Sale

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At a press conference on Wednesday, New York Assembly Health Committee Chairman Richard Gottfried (D-Manhattan) and state Senator Liz Krueger (D-Manhattan) announced their intent to introduce legislation to legalize the possession, cultivation, and retail sale of cannabis.

Speaking at the press conference, the Assembly bill’s sponsor Rep. Gottfried said, “We really need to move beyond our totally broken prohibition model to a sensible tax and regulate model. I think it’s widely recognized that marijuana is at most nowhere near as potentially harmful as alcohol and our law is dishonest.”

Added Sen. Krueger, “I don’t believe a drug that is proven to be less dangerous, from a health perspective, than alcohol or tobacco should be under laws that actually criminalize and ruin lives when alcohol or tobacco are regulated and taxed.”

The proposed Assembly and Senate measures would allow adults over the age of 18 to possess up to 2 ounces of dried marijuana, 1/4 ounce of marijuana concentrates, and to cultivate up to 6 plants. The legislation would also establish regulations for state-licensed retail cannabis outlets throughout the state. Retail sales would be limited to adults over the age of 21.

New York City Comptroller John Liu estimates that taxing the commercial production and retail sale of cannabis to adults would yield an estimated $400 million annually, just in the city alone.

According to a 2013 ACLU report, no state arrests more of its citizens for marijuana possession than New York.

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Go Uruguay

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MDC informs on Uruguay being the first country to legalize marijuana.

Uruguay passed a law Tuesday legalizing the growth, sale and use of marijuana, making it the world’s first country to legalize marijuana, Reuters reports.

The bill aims to combat the illegal drug trade and take back the marijuana business from criminals.

“We’ve given this market as a gift to the drug traffickers and that is more destructive socially than the drug itself, because it rots the whole of society,” Uruguay’s leftist president, Jose Mujica, told Argentine news agency Telam.

Citizens over 18 years of age can buy 40 grams each month of Cannabis from state-regulated pharmacies, but they must register on a government database that monitors monthly purchases.

Fosamax Destroys

 

Medical professionals need to recognize that Fosamax has only been on the market for a little over a decade and other bisphosphonates for even less time. The injuries showing up now are often the result of massive marketing of this class of drugs to relatively young persons who in many cases did not need them to begin with.

Over the last 10 years, tens of millions of people have taken Fosamax believing it would prevent bone deterioration. The drug seemed safe enough at first but in recent years it has been linked to a serious disease that causes death to the bone in the jaw, called osteonecrosis of the jaw (ONJ). The disease is an extremely serious condition and symptoms include, but are not limited to:

Pain, swelling, or infection of the gums
Loosening of teeth
Poor healing of the gums
Numbness or the feeling of heaviness in the jaw
Partial or complete loss of the jaw bone

This is another case where the risks of a drug are high while the efficacy is questionable. Experts now say that Fosamax may improve bone density, but when it comes to fracture prevention, its benefits are minimal. In fact, some say that if taken for more than 10 years, the drug can actually make bones more brittle and increase the risk of fracture.

And stopping the drug is not the answer because Fosamax remains in the body for years after patients stop taking it. Some dentists are even refusing to treat patients who are on this class of drugs, fearful that dental work such as a tooth extraction may bring on a case of ONJ.

Fosamax has been on the market since 1995. Actonel came on the market in 2001 and Boniva arrived last year. As more Fosamax was sold and more bisphosphonates came on the market, more and more injuries showed up. Experts say to just wait and see what happens over the next 10 years.

Fosamax is the world’s top-selling bisphosphonate. It is Merck’s second best-selling drug, with sales in 2005 of $3.2 billion, according to the Associated Press. In the US alone, more than 22 million prescriptions were written last year, according to the drug research firm IMS Health.

After its launch, Actonel became the fastest product in Proctor & Gamble’s history to reach $1 billion in sales.

Boniva was developed by Hoffman-LaRoche, and is co-marketed with GlaxoSmithKline and can be taken once a month while its competitors must be taken weekly.

Novartis’s markets Aredia and Zometa, the two intravenous versions used in chemotherapy. Nearly 3 million cancer patients have been treated with intravenous versions of the drugs.

None of these greedy drug makers are going admit that these drugs cause ONJ and throw in the towel as long a $3 billion pot is up for grabs in the US alone. According to Business Week Online, on May 15, 2006, the “global osteoporosis market is at $6 billion in annual sales today, and with a rapidly graying population, it’s growing 25% a year.”

This class of drugs represents an infinite goldmine for their makers. Advertising to women in their 40s and on up to death, has created a massive market.

Attorneys say Merck is going to have a hard time trying to defend Fosamax cases by saying something else caused ONJ, as it has in Vioxx cases, because so few things cause the disease.

In a nutshell, the lawsuits against Merck allege that the company aggressively marketed Fosamax as safe, despite knowing about the potential and dangerous ONJ, without warning doctors and prospective patients about it.

 

Source = lawyers-settlements