My initial time frame was going to be after the Presidential election in November to see if the chronic pain community and other that should be aligned with the chronic pain community would be able to create some political unity. While there has been some attempts.. just like all the White House and other petitions that have been created over the last year +…I have seen little evidence of a sizeable cohesion.
The bureaucrats and the bureaucracy – IMO – are acting like the “school yard bully” and the rule that prevails in “the wild”… the most aggressive “take out” the weakest in “the herd”. To them, every causality/kill is a VICTORY.
All of those who should be allies or defenders of this pt abuse… are seemingly quite content to turn a blind eye or stand on the sidelines watching it all happen.
Our legal system has declared both that “opiate abusers” are criminals and those who are disabled, unemployable, elderly, etc… their “lives” have “little value” when it comes to damages for their lives or quality of lives being harmed that there is no financial upside for an attorney to take a case on a contingency basis. Justice is not only blind.. but.. it discriminates against a large segment of our population.
I expect that my posts will start containing more editorializing and quite critical of many of the parts of our system and our “civilized society”… that are involved in numerous human rights violations.
By pulling back posting on other sites… these more critical posts will not offend administrators of other sites or some of their readers and I don’t have to defend what I post.
Remember… if you DO NOTHING… you GET NOTHING… and PASSIVE PTS… normally get POOR OUTCOMES.
I just finished my fourth year as a blogger on this website… starting out with no particular set direction. Just by chance it was about the same time that the war on drugs/pts started ramping up. It quickly got to a point that I had more material to blog about than I had time.
The ensuing four years really has been a education in many areas… first of all that there are many laws on the books that no state/federal agency is interested in enforcing.. particularly when they revolve around the DEA and law enforcement in general.
I have tried several things to help the chronic pain to create some unity and I have come to the conclusion that the chronic pain community is so dis-jointed, unconnected, not paying attention or some other unknown reason.. unity within the chronic pain community continues to seem illusive
Over the years, I have watched the number of Face Book pages literally EXPLODE… in regards to those focused on chronic pain.
I have watched time and time again that people have put up a petition to the WHITE HOUSE and others…needing 100,000 signatures for them to even look at it – doesn’t mean that they will even do anything at that point.. and few – that I have seen – have exceed 1,000 signatures.. let alone 100,000.
Now it seems like two different groups are planning a rally/protest on THE HILL in Oct… on the SAME WEEKEND… but different days… While all the members of Congress are in recess and back in their home districts campaigning for re-election. They are going to have a rally in front of a EMPTY HOUSE.
Over the next 60 days I am going to start pulling back from cross posting on most/all of other chronic pain FACE BOOK pages. IMO, I am just encouraging all the dis-unity within the chronic pain community by doing so. I am going to continue to post on www.pharmaciststeve.com, my Face Book page https://www.facebook.com/pharmaciststeve and my twitter account @pharmaciststeve and anyone can use the RSS feed at the top of the blog to get a automatic email when something new is posted, or follow my FACE BOOK page or Twitter feed.
I will continue to be a advocate for the chronic pain community.. just what form/shape that takes has yet to be determined.
In 2011 the US poison control centers received 3.6 MILLION phone calls http://www.aapcc.org/press/11/ which included about ONE HUNDRED concerning Kratom. That is abt SEVEN PHONE CALLS EVERY SECOND – 24/7. It would seem that the Federal alphabet soup of agencies use “scientific fact” or lack of scientific fact to justify their agenda…which every suits the scenario they want. IMO, in this particular incident…it is all about the DEA creating a much larger “black drug market” and causing/forcing many Kratom users to head for the street to try and get something to help with whatever medical issue they were taking Kratom to treat. All the while, the FDA allows homeopathic or supplements to be sold on the market… that have no proven medicinal benefit and the labeling on such products plainly states that the product has not been tested/approved by the FDA as to its ability to treat/cure any disease state.
The US Drug Enforcement Administration (DEA) is planning to put Kratom, a widely used medicinal plant, on its most restrictive classification – the Schedule I.
Kratom is widely used in Southeast Asia because of its medicinal properties. David Kroll, a pharmacologist and medical writer, said that indigenous people have used the drug as a stimulant to increase work output or for relaxation. However, last August, the DEA announced its plan to classify the drug as a Schedule I drug. This is the same category where ecstasy, heroin, marijuana and LSD is placed. The classification is set to take effect by the end of September.
According to the American Kratom Association, the plant contains alkaloids that bind to the same opioid receptors as morphine that is why it can be used to treat pain. In small doses, it can also be used as a mild stimulant that can help alleviate depression, anxiety, post-traumatic stress disorder (PTSD), and can even addiction.
Ever since the announcement was published in the Federal Register, a community of Kratom users who use the drug as a painkiller have voiced objection to the move. Critics say that the move may hinder research into the potential uses of Kratom as an anesthetic.
Brad Burge, the director of communications and marketing at the Multidisciplinary Association for Psychedelic Studies (MAPS), said that “The Schedule I status has historically made it more difficult for researchers to gain access to the compounds.”
Meanwhile, Mitul Mehta, a researcher at King’s College, said that Kratom is a promising target for research because of its uses. But, restricting the research can affect the potential for scientists to discover compounds that could help people who are severely ill.
Despite its medicinal properties, authorities do not consider Kratom to be valuable.
Amid concerns about new medical marijuana regulations in Colorado, an alliance of healthcare professionals, researchers and patient advocacy groups are joining forces to defend their access to cannabis as a medicine.
“Most patients turn to medical marijuana out of desperation when traditional medications have failed to relieve their suffering. When they find relief, they learn their fight is really just beginning because of the stigma they now face in their community” said Stacey Linn, a founding member of the IMPACT Alliance and Executive Director of the CannAbility Foundation – known for helping pass Jack’s Law, which ensures medically fragile children have access to medical marijuana at school.
The IMPACT Alliance members believe new regulations on medical marijuana by the Department of Revenue’s Marijuana Enforcement Division (MED) could restrict research and development on cannabis as medicine, and reduce outreach and education to patients.
“The Marijuana Enforcement Division met with government regulators and other stakeholders to determine the fate of patients, but did not talk to patient groups for input on how the rules would impact them,” said Bridget Seritt of Cannabis Patient Rights Coalition.
“We ask that the MED hold final adoption until the patient voice is represented in this discussion.”
The alliance claims that the “Department of Public Health’s Board of Medical Examiners (BME) has begun pulling the licenses of physicians who are recommending a patient try medical marijuana for severe medical conditions that require extended plant counts.”
Michele Ross, Ph.D. and cannabinoid medicine expert says, “They used no scientific evidence or research to support the decision to pull these physician’s licenses, nor have they offered guidance on what plant counts they believe are appropriate for each condition so physicians have guidance moving forward.”
In an announcement, the alliance noted that the Department of Health issued a statement last year restricting physicians from recommending cannabis to more than 30% of their patients or potentially face action against their license.
“How do you make a doctor choose which 3 out of 10 cancer patients deserve access to cannabis treatment?” questioned Dr. Ross. “What is the scientific basis for this decision?”
The IMPACT Alliance believes chronically ill people should have the right to grow their own medicine without having elected officials disrupt the doctor-patient relationship. They note that the dispensary model can be unaffordable for many ill patients, so growing plants provides access to needed medicine.
“We are here to be a resource to policy makers. We want to work together to protect our communities and patients,” said Ms. Linn. “We are asking for inclusion, reason and compassion in this discussion.”
The Clinton Foundation’s health initiative “likely increased” the risks of morbidity and mortality for HIV/AIDS patients in sub-Saharan Africa by distributing “watered-down” drugs, a report said.
A draft of a congressional report obtained by The Daily Caller News Foundation cited the Clinton Foundation’s “decade-long relationship with a controversial Indian drug manufacturer called Ranbaxy,” which the Clinton Health Access Initiative (CHAI) used as one of its main distributors of HIV/AIDS drugs to third world countries.
The congressional report, titled,“The Clinton Foundation and The India Success Story,” was initiated by Rep. Marsha Blackburn, a Tennessee Republican and vice-chair of the House Energy and Commerce Committee.
The report also cited the work of Dinesh Thakur, a former Ranbaxy employee “who became a star whistleblower, permitting the U.S. government to launch a landmark lawsuit against the Indian firm. The company was vulnerable to U.S. prosecution because it also sold its generic drugs on the U.S. market,” the Daily Caller noted.
Ranbaxy pleaded guilty in 2013 to seven criminal counts with intent to defraud and the introduction of adulterated drugs into interstate commerce. The Department of Justice levied a $500 million fine and forfeiture on the company.
“This is the largest false claims case ever prosecuted in the District of Maryland, and the nation’s largest financial penalty paid by a generic pharmaceutical company,” said U.S. Attorney for the District of Maryland Rod J. Rosenstein when Ranbaxy pleaded guilty.
“When companies sell adulterated drugs, they undermine the integrity of the FDA’s approval process and may cause patients to take drugs that are substandard, ineffective, or unsafe,” said Stuart F. Delery, acting assistant attorney general for the civil division of the Department of Justice.
The Department of Justice stated in its final settlement, “alleged due to the company’s diluted drugs, it ‘subjected patients to increased risks of morbidity and mortality,’” according to the report.
“The question becomes, ‘how many people lost their lives, how many people found it was a false promise,’ ” asked Blackburn in an interview with the Daily Caller.
The congressional report also highlighted the “unseemly ties” between Bill Clinton and two Indian-Americans who have been investigated and sanctioned by the Food and Drug Administration (FDA) and the Securities and Exchange Commission.
“The most troubling revelations concern the Clinton Foundation’s vigorous promotion of Ranbaxy despite mounting evidence the Indian firm had persistently poor quality control and attempted to cover it up through either faulty or fraudulent reporting to the FDA,” the report said.
It is unclear at this juncture how many AIDS patients received the “watered-down” drugs.
“Substandard HIV medicines cause health problems for patients, perhaps even accelerating death from HIV-related infections,” Roger Bate, an economist at the American Enterprise Institute who researches substandard and counterfeit medicines, told the Daily Caller.
“CHAI was a part of the Clinton Foundation until 2010, when it spun off into a separate entity. The groups still have some overlapping board members and staff, and they continue to operate in close coordination. Bill Clinton, for example, is deeply involved with both organizations,” the Daily Caller report said.
The congressional report states that Bill Clinton may have relaxed quality standards in 2000 when he signed an executive order that “relaxed intellectual property policy standards,” promising the U.S. government “would not revoke or revise the intellectual property laws of any ‘sub-Saharan country’ relating to HIV/AIDS medicines or technologies.”
CHAI announced in October 2003 it was going to distribute generic, low-cost HIV drugs from four foreign drug manufacturers: Ranbaxy; Cipla of Mumbai, India; Matrix Labs of Hydrabad, India; Aspen Pharmacare of Johannesburg, South Africa.
CHAI’s endorsement also allowed Ranbaxy to manufacture HIV drugs that would be bought by the U.S. government under the President’s Emergency Plan for AIDS relief — a $15 billion initiative proposed by former President George W. Bush.
The flow of U.S. funds combined with Clinton’s endorsement allowed the four foreign drug manufactures to become “good acquisition targets,” according to the report.
The companies enjoyed great financial profits and they “exploded as they partnered with the Foundation for several years,” the report states.
Blackburn says the worst part of the story were the “false hopes” offered by the Clinton Foundation.
“You think about the emotional state of health care workers as they are dealing with these individuals and the emotional state of the patients. To me it’s disturbing and very sad,” she said.
IMO.. if this bill passes.. all it will assure is that the cost of prescription medications will INCREASE 10% per YEAR… because that is the “trigger” to justify price increases to HHS. That will mean that prescription prices will DOUBLE every SEVEN YEARS. Since about 90% of prescriptions are paid for by an insurance company… I am sure that the pharmaceutical industry will be quite happy to have a 10% across the board hike in prices.. regardless of what the rate of inflation is… in fact… it could cause the rate of inflation to take a UPTICK… as other companies seek to increase their profit by 10%.
For those who may be unfamiliar with the players in the pharmaceutical business, Mylan is a successful, midsized manufacturer of branded and generic drugs. One of their largest products is the EpiPen, which is an auto-injection device used to treat potentially fatal allergic reactions via a quick dose of the drug epinephrine.
The company and its CEO are under fire for a recent price increase of the product. Since Congress likes nothing more than to jump on the bandwagon of public outrage, the House of Representatives has entered the conversation of “outrageous” prescription drug pricing.
The national legislature doesn’t just intend to talk about how Americans are being gouged by big pharmaceutical corporations, but it intends to do what it does best: legislate the problem away.
The recently introduced Fair Accountability and Innovative Research Drug Pricing Act of 2016, otherwise known as the FAIR Drug Pricing Act, seeks to force drug-makers to rationalize any price increase over 10 percent to the Department of Health and Human Services at least 30 days prior to the effective date of said increase.
The bill requires manufacturers to file a report outlining costs associated with the research and development, manufacturing, and marketing of the drug as well as any associated net profits. HHS will then make public all of the information contained in the report. According to the legislation, failure to follow the federal government’s prescription will cost pharmaceutical companies $100,000 for each day filings are late.
Many of the public-relations wounds suffered by the pharmaceutical industry are self-inflicted — including Mylan’s current situation — but bringing the entire industry one step closer to government price controls through this legislation is not the answer. It’s clear that prescription drug pricing controls are exactly what many proponents of the bill ultimately seek. The Campaign for Sustainable Rx Pricing calls the legislation, “a first step in repairing the broken prescription market.”
If you price a product too far above the cost of production, you’re inviting competition to enter the market, thereby offering consumers a potentially lower-priced alternative. In the pharmaceutical industry this is often difficult, not because there aren’t competitors willing to jump in, but because the barriers to entry imposed by the Food and Drug Administration are so high. The lengthy drug-approval process, the regulations governing product production, and the exclusive product marketing rights are just a few of the obstacles.
Should the government take this first step with drug companies, it will only be a matter of time until it turns its sights on other villains who are perceived to be price gouging the American people. Oil companies and their “obscene profits” would be next on the list, followed shortly by the “outrageous rates” of energy and utility companies, and on it would go.
Enhancing competition within the pharmaceutical industry, as with any industry, is the fastest way to impact pricing disparities. Instead of a slippery slope to price controls, Congress should look to the FDA with a message of “heal thyself.” The situation with Mylan’s EpiPen is just one symptom of a much larger sickness based in Washington.
Richard Kocur is an assistant professor of business at Grove City College.
INDIANAPOLIS (AP) – Indiana State Police has received nearly $1 million in federal funding to combat methamphetamine and heroin distribution and abuse.
The Indianapolis Star reports that the grant is part of a $12 million effort by the U.S. Department of Justice to curb the illicit drugs. Indiana received $350,000 from the department’s Anti-Heroin Task Force Program, and $600,000 from its Anti-Methamphetamine Program.
According to a Justice Department news release, state police will use the money “to address the significant increase in drug-related deaths in the state.”
There were 462 opioid-related deaths in Indiana in 2014, according to the Kaiser Family Foundation. And in 2013 and 2014, authorities seized more meth labs in Indiana than in any other state.
ARLINGTON, Va. (ABC7) — Phyllis Quarles like a lot of seniors drinks CVS Pharmacies Liquid Nutritional Shakes for her health. After consuming a few new ones she says she got sick.
Quarles, 79, who lives in Arlington, says “Just nauseous and wanted to make me vomit.”
Grandson Donny Watkins checked the bottles and discovered something alarming.
Donnie Watkins says “That the bottles were over a year expired and they were on sale too.”
Watkins claims he bought the bottles on August 25 from the CVS on Columbia Pike in Arlington that turned out to have expiration dates of August 4 of last year.
Over in Alexandria, Watkins says the bottles purchased at this CVS on North Quaker show a Sept, 18, 2015 expiration date.
Both City’s Health Departments say the two stores have no violations of expired products in the past year.
Watkins says he spoke with CVS earlier this year and was assured all expired products were removed.
He returned to the CVS store in Arlington and claims he found the same product past its expiration date on store shelves.
Watkins says “They didn’t clear the shelves and the products were still expired.”
ABC 7 News Investigator Scott Taylor asked “So twice you found this?”
Watkins says “Yes.”
7 On Your Side reached out to CVS which emailed:
CVS Pharmacy has a clear product removal policy in place at all of its stores to help ensure that items are removed from store shelves before they reach their expiration dates. Any unintentional deviations from this policy that are brought to our attention are quickly rectified for customers.
We have apologized to our customer for the incidents at our stores in Arlington and Alexandria and we have requested copies of the documentation required to reimburse his grandmother for any related medical treatment. We have also followed up with our stores to reinforce adherence to our product removal procedures.
Donnie Watkins says CVS is now reaching out to him and his Grandmother.
He says “I’m very thankful you made some contact for us.”
We checked at the Arlington CVS and shelves are now stocked with current expiration dates on their Health Shake products.
A large and bipartisan contingent in Congress is asking the Obama administration to delay the sudden ban poised to take effect next week on possessing kratom, a Southeast Asian tree leaf product that supporters describe as a near-miraculous treatment for pain, depression and addiction to opiates and legal narcotics.
Reps. Mark Pocan, D-Wis., and Matt Salmon, R-Ariz., recruited 45 signers in the House of Representatives on Friday afternoon for two letters, which will be sent Monday to Chuck Rosenberg, acting administrator of the Drug Enforcement Administration, and Office of Management and Budget Director Shaun Donovan.
“This significant regulatory action was done without any opportunity for public comment from researchers, consumers and other stakeholders,” the lawmakers say in the letter to Rosenberg. “This hasty decision could have serious effects on consumer access and choice of an internationally recognized herbal supplement.”
The letter to Donovan asks him to overrule the DEA, which is invoking a rarely used emergency power with just 30 days notice, warning the action “will put a halt on federally funded research and innovation surrounding the treatment of individuals suffering from opioid and other addictions.”
Susan Ash, founder of the American Kratom Association consumer group, which organized a Sept. 13 protest at the White House, says she remains hopeful that the ban won’t go into effect for two compounds in kratom that would essentially ban the plant.
“I feel a lot of hope because the amount of congresspeople who are paying attention to this issue and the media and the public are really weighing in our favor – it’s finally coming to light who the average kratom consumer is,” Ash says.
Those users include recovering heroin, cocaine and alcohol addicts, fibromyalgia patients, and people with arthritis and cancer, according to a sampling of attendees at the White House protest. Some veterans with post-traumatic stress disorder and people with depression say it has helped them, too.
AKA Executive Director Paul Pelosi Jr. says he believes the DEA has been surprised by a deluge of user pleas to keep kratom legal and that “I think everyone’s looking for a way to save face – like, ‘How can we come back from this?'”
Pelosi has tried kratom but does not regularly use it. He says he believes that between 4 million and 5 million Americans may be using kratom – an estimate higher than the hundred thousand or so others offer, which he bases on his understanding of industry sales figures.
“It’s pretty safe. It may be slightly addictive, but there’s no overdose or safety issue, so I think the DEA was unaware people use it in a kava shop, a cafe and that veterans use the leaf naturally,” he says. “It’s not just a couple of teens trying to get high. There’s limited party use for this.”
Andrew Kruegel, associate research scientist at Columbia University, says research has shown significant differences between the two about-to-be-banned compounds – mitragynine and 7-hydroxymitragynine – and traditionally abused drugs that act on opioid receptors in the brain.
“Both mitragynine and 7-hydroxymitragynine are partial agonists of the mu opioid receptor, and that is the same target that heroin, morphine and fentanyl bind to,” Kruegel says. “But the key thing from the science side is they activate this receptor in a different way. For one, they are partial agonists, which means they stimulate the receptor to a lower level … no matter how high you go with the dose.”
“In animal studies, both mitragynine and 7-hydroxymitragynine produce almost no respiratory depression,” he adds. “Of course this hasn’t been rigorously studied in humans because there have been no clinical trials, but anecdotal evidence – which is quite substantial – suggests that people aren’t dying of respiratory depression.”
Kruegel says the reason for a lack of respiratory depression, a primary cause of death in heroin and other opioid overdoses, is that the compounds appear to be biased agonists that only trigger one opioid pathway – called the G protein pathway – and not another pathway associated with respiratory depression and constipation.
Kruegel says mitragynine and 7-hydroxymitragynine preliminarily appear “similar in terms of pharmacology” to a drug called Oliceridine that currently is undergoing Food and Drug Administration-approved phase three trials in humans.
Columbia University researchers currently are scrambling to complete research for a paper on kratom’s effects on non-opioid receptors, and are busily boiling leaf matter in alcohol to extract the mitragynine and use chemical reactions to convert it into non-Schedule I analogs.
“We obviously can’t have kilograms of kratom around here when the ban goes into effect,” Kruegel says.
If the ban does go into effect, Kruegel says he would like to apply for a special Schedule I license to continue research, but he points out the hoops to jump through are onerous – as marijuana researchers have lamented for years – including installation of a safe that costs about $10,000.
Despite the backlash, the DEA’s knees aren’t buckling, though sympathetic statements one spokesman offered the Washington Post last week gave some advocates hope. “I want the kratom community to know that the DEA does hear them,” spokesman Melvin Patterson told the Post. “Our goal is to make sure this is available to all of them.”
With a week to go before the ban is scheduled to take effect, however, spokeswoman Barbara Carreno says she has received no indication there will be a reversal.
“It’s not that the DEA is unsympathetic to people who have chronic pain or who are addicted to opioids,” she says. “We are people just like everyone else who get in a car accidents and break our femurs and get cancer and have surgery and are in need of pain medicine. … It’s just that science says this is a problem and we need to keep people safe.”
Carreno says “the analysis we did showed there is enough of a public health problem with kratom” to justify it being placed in Schedule I on an emergency basis, a classification that would last two or three years until removal, permanent listing or scheduling in a lower ranking based on additional research.
“I have not been advised it’s being reconsidered, but we have not gotten the congressional letter,” Carreno says.
The DEA said in its notice last month that it believes 15 deaths in the U.S. were associated with kratom. The AKA disputes this and says it hired a toxicologist who reviewed the cases and found that there was no evidence to support the assertion and that most, if not all, of the deaths may have been tied to other drug use.
In addition to the congressional letter, lawyers for the AKA are sending the DEA their own letter on Monday, Ash says, though there are no immediate plans for a lawsuit.
The AKA has received an influx in donations, Ash says, and the Botanical Education Alliance industry group is also working to combat the ban.
Pelosi, son of House Minority Leader Nancy Pelosi, D-Calif., says he’s a volunteer with AKA and that he focuses on the community-organizing aspect of advocacy, rather than lobbying members of Congress. His mother was not among the letter’s signers.
If the ban does take effect, it’s likely to wallop entrepreneurs who have invested hundreds of thousands – or millions – of dollars in the leaf matter, which generally is powderized for use in teas or pills.
Nu Wave Botanicals national sales manager Chris Kratom (a professional rather than legal surname) says he is winding down operations with a business partner. The men operate a warehouse in Utah and two in Texas, he says, and are shipping everything to one of the Texas locations to be cataloged.
Kratom, who primarily wholesales product sourced in Indonesia to other distributors, says he personally has more than $100,000 worth of product that he will be unable to sell. His partner has about $1 million worth of unsold kratom.
That puts the entrepreneurs in a pickle. Two other businesses with similarly large stockpiles are taking the product to Mexico or Canada, where the plant remains legal, Kratom has heard.
But Kratom, whose converts to the product include his Mormon father, currently is leaning toward turning over his supply to the DEA when the ban takes effect. He says he’s in contact with the local DEA office and that it’s his understanding his choices are to incinerate the supply or hand it over.
“I have a family and I don’t have an arrest record. … I’m going to keep it that way,” he says. “We want to work with the DEA so in case the hammer goes down on the 30th we have nothing to raid.”
Kratom says if he gives his product to the DEA he probably can write it off on his taxes and potentially get it back if the DEA decides to delay implementation of the ban. If he took it overseas, he says, he lacks the business connections to sell it and probably would have great difficulty repatriating it if the ban lapses.
“Rumor has it,” he say, “it doesn’t look like they’re actually going to do this on the 30th.”
Though the DEA says publicly it’s standing firm, Ash warns the stakes are high.
“A lot of people say they are scared to death of relapsing without [kratom],” she says. “And if this ban goes through there’s going to be an illicit black market, and who knows what people are going to be putting into this product, so deaths are going to increase by that in itself.”