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Opioid crisis helping Tufts Medical Center set new heart transplant recordVideo on web link … people who OD’s on opiates and other medications.. end up donating their heart for transplant
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45 Congressmen Ask DEA Not to Ban Kratom Next WeekLast week I posted about these 45 Congressmen – of both parties – sending the head of the DEA a letter requesting to put off the rescheduling of Kratom. The House of Representatives controls the purse strings of the ENTIRE GOVERNMENT.
I suspect that the DEA has at least 60 days to respond to that letter and JUST BY CHANCE that is AFTER THE ELECTION DAY.
If these Representatives were REALLY SERIOUS… maybe they should introduce a new bill that would cut the DEA’s budget… new fiscal year starts Oct 1, 2016 if they did not rescind the restricting of Kratom. Maybe because they know that the chairperson of whatever committee would handle this would not pass such a bill out of committee nor would Paul Ryan (Speaker of the House) would not bring such a bill to a vote before the House… and could there be NO ONE in the Senate that would introduce a complimentary bill ?
Could this just be a “slight of hand” by these 45 Representatives to make those chronic painers in their respective districts believe that they have a concern about the DEA’s rescheduling of Kratom… and once the election day has come and gone… and they get re-elected… their concern about this issue will nothing more than “we tried” and NOTHING HAPPENED ?
I am sure that enough Kratom users will be “suckered in” and fooled about their concern and re-elect them.. so that they can DO MORE in the days to come and continue the fight of the getting the DEA to back down on the re-scheduling of Kratom.
On the other side… there are 435 members of the House of Representatives… so these 45 representatives … only represents about ELEVEN PER-CENT of the House… does that mean that 89 PER-CENT of the House agrees with the DEA’s action on rescheduling Kratom ?
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http://www.newsmax.com/Health/Health-News/patient-privacy-violations-cvs/2016/09/23/id/749893/
The U.S. Department of Veterans Affairs and CVS Health lead the nation in federal citations for patient privacy violations, according to a new analysis.
The review, by the nonprofit journalism organization ProPublica found the VA and CVS received the most privacy complaints that resulted in corrective action plans or “technical assistance” provided by the U.S. Department of Health and Human Services from 2011 to 2014.
Thousands of times a year, the Office for Civil Rights of HHS privately resolves complaints about possible violations of the Health Insurance Portability and Accountability Act. It advises violators to fix purported problems and prods them to make voluntary changes.
CVS and the VA told ProPublica that they are committed to protecting patient privacy.
The VA said: “VA takes veteran privacy and the privacy of medical or health records very seriously.”
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http://citizensvoice.com/news/legislators-addressing-opioid-epidemic-1.2095244
Short Definition of Addiction: http://www.asam.org/quality-practice/definition-of-addiction
Addiction is a primary, chronic disease of brain reward, motivation, memory and related circuitry. Dysfunction in these circuits leads to characteristic biological, psychological, social and spiritual manifestations. This is reflected in an individual pathologically pursuing reward and/or relief by substance use and other behaviors.
Addiction is characterized by inability to consistently abstain, impairment in behavioral control, craving, diminished recognition of significant problems with one’s behaviors and interpersonal relationships, and a dysfunctional emotional response. Like other chronic diseases, addiction often involves cycles of relapse and remission. Without treatment or engagement in recovery activities, addiction is progressive and can result in disability or premature death.
If physicians are the primary reason for people addicted to opiates.. then someone needs to explain the reason that some people are addicted to:
Alcohol:… this is a state endorsed, condoned addiction… nobody hands out free samples of alcohol.. both the states and Feds tax this addiction… reportedly some 30 million participants abusing this substance and it use/abuse kills abt 85,000 annually
Tobacco/Nicotine:… this is another state endorsed, condoned addiction… nobody hands out free samples of tobacco products. Both States and Feds tax this product. Abt 20% of the adult population (abt 45 million) are smokers… and abt 450,000 die annually from this “addiction”
Gambling: Another State & Federal endorsed, condoned activity/addiction… some state have a large casino industry and yet others sponsor THE LOTTERY. How do addicted gamblers get started ? These “addicts” are relative small in comparison to other addictions with an estimated 130,000.
No one is sure what the total number of addicts to just these THREE ADDICTIONS… because we know that some people have multiple addictions.. An educated guess is that there is a minimum of 45 million because we have that many addicted to Tobacco/Nicotine.
Maybe one of the reasons that these addictions/deaths are not considered addressable because of:
Former Speaker of the House (John Boehner) is a NICOTINE ADDICT ? An admitted long time consumer of Camel cigarettes.
Maybe there are enough members of the various legislatures that are “addicted” to something that they are able to discourage their colleagues to not pursue legislation against certain addictions and besides we don’t have another agenda that the whole judicial system seems to have a vested interest in… unlike the war on drugs
HARRISBURG — The fall legislative session is dominated so far by bipartisan calls to combat a deadly opioid abuse epidemic in Pennsylvania. The focus of proposals offered by Gov. Tom Wolf and lawmakers has been on the role of medical professionals in over prescribing narcotic painkillers, and thus, creating a pathway to addiction for drugs like heroin.
The governor urges final action on bills passed by either the House or Senate to put limits on how many painkillers emergency room physicians can prescribe and require doctors to check a new state prescription drug monitoring network when they write a prescription for painkillers.
Getting far less attention is the role of pharmaceutical companies in making addictive painkillers more widely available to patients in recent years.
That may be about to change.
The Associated Press and the Center for Public Integrity, a nonprofit group, have jointly published eye-opening articles looking at a link between the boom in sales of prescription opioids and overdose deaths in recent years. The articles examine how drug manufacturers have spent more than $800 million nationwide on lobbying and campaign contributions between 2006 and 2015 to stop or weaken bills that limit use of opioids. The drug industry has employed more than 1,300 lobbyists to influence the debate at the state and national level on opioid use, according to the articles.
In Pennsylvania, there have been a few voices and proposals targeting drug manufacturers for help in solving the overdose crisis.
During an opioid action rally at the Capitol last week, Rep. Gene DiGirolamo, R-Bensalem, chairman of the House Human Services Committee, called for state attorneys general to file a lawsuit against the drug manufacturers to recover the costs to taxpayers for treating addicts and overdose victims.
“They’ve (drug companies) created a lot of damage,” DiGirolamo said.
He compared the strategy to a multistate lawsuit against the tobacco industry in the 1990s. The lawsuit resulted in a settlement in which tobacco companies make annual payments to states for the costs to medical assistance and other public health programs for treating diseases caused by smoking.
Pennsylvania earmarks these annual payments for a variety of public health programs.
Absent a lawsuit, DiGirolamo has introduced a bill to impose a 10 percent impact fee on sales of opioids in Pennsylvania.
The fee could generate about $75 million annually, he said.
The revenue would go to support a state-run emergency addiction treatment fund and the new state prescription drug monitoring program. A share would go to counties to purchase Narcan for local police and emergency services agencies to attempt to halt overdoses and to support drug and alcohol counseling in county jails and help offset other criminal justice costs.
The Senate Democratic caucus has unveiled an opioid bill package that includes a 10 percent assessment on opioid sales in the state. The revenue under this proposal would go to purchasing naloxone for local law enforcement and supporting addiction prevention and treatment programs.
Robert Swift is Harrisburg bureau chief for Times-Shamrock Communications newspapers. Reach him at
rswift@timesshamrock.com.
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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.
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This is the last post that I am going to post on sites other than my own. www.pharmaciststeve.com
https://www.facebook.com/pharmaciststeve
Those who read what I post on my web venues are free to copy, share on other sites.
I welcome comments and willing to post opinion pieces by those in the chronic pain community and/or advocates for chronic pain… anonymously if you wish.
For those who wish to get email notification when new posts or comments are made.. there is a RSS feed icon on the header – top left.
I made a post almost a month ago stating that I was going to be Changing directions
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.
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nationalpainreport.com/co-patients-fight-against-state-regulations-on-medical-marijuana-8831523.html
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.”
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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.
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http://www.detroitnews.com/story/opinion/2016/09/23/one-step-closer-drug-price-controls/90989836/
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.
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