Pharmacy board member fined for conflict of interest

http://www.ibj.com/blogs/17-the-dose/post/61158-pharmacy-board-member-fined-for-conflict-of-interest

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Sugar Is the New Tobacco, so Let’s Treat It That Way

http://www.medscape.com/viewarticle/871064

I was recently asked to speak at the UK parliamentary “Sugar Summit.” This event was convened by Rend Platings, a mother so disturbed by England’s chief medical officer’s revelation that, as a result of obesity, today’s generation of parents may be the first to outlive their children, that she launched a campaign, Sugarwise, to help consumers identify foods with added sugar.^[1]

Keith Vaz, chairman of the All-Party Parliamentary Group for Diabetes, chaired the event, whose audience was made up of a number of representatives from such high-profile UK retailers as Tesco, Caffè Nero, and the Jamie Oliver Group, as well as such influential stakeholders as the UK Department of Health, Public Health England, the British Soft Drinks Association, and the Food and Drink Federation.^[2]

I began by welcoming the UK government announcement of an introduction of a 20% tax on sugar-sweetened beverages in 2017. I similarly welcome the recent statement calls by the World Health Organization (WHO) to tax sugary drinks by at least 20% in order to curb the global epidemics of obesity and type 2 diabetes. We mustn’t forget that the substantial decline in tobacco consumption in the past three decades, which was the single most important factor driving a decrease in cardiovascular mortality during that period, only happened after legislative measures that targeted the affordability, availability, and acceptability of smoking.^[3]

Health Effects

Oxford researchers have estimated that a 15% reduction in sugar consumption through such a tax would prevent 180,000 people in the UK from becoming obese within a year and a larger number from becoming overweight.^[4] But the scientific evidence reveals that the positive health benefits for the whole population of such a tax goes beyond a mere reduction in calories:

• An econometric analysis of 175 countries (considered the highest quality of study with the exception of randomized controlled trials) revealed that for every additional 150 sugar calories available for consumption, there was an 11-fold increase in the prevalence of type 2 diabetes in the population. This is compared with 150 calories from another source such as fat or protein and independent of body mass index (BMI) and physical activity levels.^[5]
• The prevalence of type 2 diabetes in the US population between 1988 and 2012 increased by 25% in both obese and normal-weight populations,^[6] which goes to show that type 2 diabetes is not a condition related purely to obesity.
• A high-quality prospective cohort study revealed a trebling in cardiovascular mortality among US adults who consumed more than 25% of calories from added sugar versus those who consumed less than 10%, with consistent findings across physical activity levels and BMI.^[7]
• The positive health effects of reducing sugar intake appear to be quite rapid. In a study of 43 Latino and African American children with metabolic syndrome, keeping total calories and calories from carbohydrate identical, a reduction from a mean of 28% of calories from added sugar to 10% significantly reduced triglycerides, LDL cholesterol, blood pressure, and fasting insulin within just 10 days.^[8]
  

  How Much Sugar Is Safe?

  So, how much sugar do we need? For the purpose of health, the optimum consumption is zero. Added sugar has no biological requirement and is, therefore, not by any definition a “nutrient.” It is the fructose component (sucrose is 50% glucose and 50% fructose) that fulfils four criteria that justify its regulation: toxicity, unavoidability, the potential for abuse, and its negative impact on society.^[9]

  How much sugar is safe? The consumption of just small amounts of free sugar, which includes all added sugar and sugar present in fruit juice, syrups and honey, on a daily basis, has a deleterious impact on the most common noncommunicable disease globally: tooth decay. Treatment of dental disease is responsible for 5%-10% of health expenditures in industrialized countries, and in the UK, tooth decay is the number-one cause of chronic pain and hospital admission in young children.^[10,11]

  As pointed out by researchers from the London School of Hygiene & Tropical Medicine, there is a powerful argument that the WHO should recommend a maximum limit of sugar consumption to make up no more than 3% of daily calories (about three teaspoons).^[12] The average UK and US citizen, however, consumes at least four to seven times that amount.^[13,14] This is perhaps not surprising when one acknowledges that it has been almost impossible for the consumer to avoid sugar, as it is so prevalent in the food environment and much of it is hidden. In the United States, almost half of all sugar consumption comes from foods one wouldn’t normally associate as having added sugar, such as ketchup, salad dressings, and bread. A third of sugar consumption comes from sugary drinks, and a sixth from foods that people normally perceive as junk, such as chocolates, cookies, and ice cream.^[14]

  In the United States, there isn’t any reference dietary intake for sugar on food labels. In Europe, the labelling exists but doesn’t differentiate between children and adults. One can of regular cola contains nine teaspoons of added sugar, which is triple the 2009 upper limit intake suggested by the US Department of Agriculture for an 8-year-old child. The UK Guideline Daily Amount label describes these nine teaspoons of sugar as 39% of the guideline daily amount. On the basis of this false reassurance, it would be understandable for parents to believe that it is safe for their child to drink two and a half cans per day.^[15]

   

  The food industry often argues that the public should have a “personal responsibility” when choosing what foods to eat, which deflects blame from their own culpability in the obesity epidemic to the consumer. The truth is that the public lacks knowledge because of confusing food labels, and the public lacks choice because sugar is added to approximately 80% of processed foods.

  Big Tobacco, Big Sugar

  The fact that it took 50 years before the first links between smoking and lung cancer were published in the British Medical Journal and before effective regulation was introduced is testament to how Big Tobacco was able to defend its practices. Key to the strategy was denial, planting doubt, confusing the public, buying the loyalty of scientists, and giving ammunition to political allies.^[16]

   

  The similarities between Big Tobacco and the sugar industry are disturbing. As a recent publication in JAMA Internal Medicine showed, the sugar industry paid three influential Harvard scientists to downplay sugar’s role in heart disease and to shift the blame to fat.^[17] Last year, the New York Times exposed that the Coca-Cola Company paid millions of dollars to fund research that downplayed the role of sugary drinks in obesity and push lack of exercise as the main factor.^[18] And, according to one former UK shadow health minister, the incorrect advocacy of a low-fat, high-carbohydrate, and high-sugar diet by “morally corrupt scientists and politicians who allowed themselves to be manipulated by food suppliers” is to blame for global obesity.^[19]

  The recent calls by the WHO to tax sugary drinks are very welcome news for health campaigners. The public health messaging, however, has to be more clear. There is nothing wrong with the occasional treat, but sugar has no place as part of a “healthy balanced diet.” Similar to smoking, any further regulatory measures to reduce sugar consumption, such as banning of sugary drink advertising and dissociating sugary drinks with sporting events, will have a further impact on improving population health within a short time. The science is more than sufficient; the case against sugar is overwhelming. Sugar is the new tobacco, so let’s start treating it that way.

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DEA Posts Significant Change to Registration Renewal

http://www.natlawreview.com/article/dea-posts-significant-change-to-registration-renewal

The US Department of Justice Drug Enforcement Administration (DEA) recently posted to its website notice of a significant change to its registration renewal process. This change eliminates the informal grace period which the DEA had previously allowed registrants to renew their registrations.

The DEA announced that, starting January 1, 2017, it will send only one renewal notification to each registrant. The renewal notification will be sent to the registrant’s “mail to” address approximately 65 days prior to the expiration date. No other reminders will be provided by DEA.

Most significantly, the DEA noted that a failure to file a renewal application by 12 am EST of the expiration date will result in the “retirement” of the registrant’s DEA number. Any registrant who fails to meet the deadline will be required to apply for a new DEA registration and will receive a new DEA registration number.

In addition to the direct implications for any registrant who fails to renew in a timely fashion, this change in DEA’s longstanding approach will also have implications for pharmacies and others in the supply chain. All such entities, which are required to validate DEA numbers in the ordinary course of performing their own roles, will need to exercise additional diligence.

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DEA cancels hearing, wants to pull pain doctor’s registration

http://www.seattletimes.com/seattle-news/health/dea-cancels-hearing-wants-to-pull-pain-doctors-registration/

Already ONE DOCUMENTED SUICIDE  Just another STATISTIC of the WAR ON DRUGS ? how many suicides goes unreported ?     Because of the actions of the DEA in closing down this medical practice.  But DEATHS from DEA/Judicial’s actions… are just COLLATERAL DAMAGE ?  8000 opiate dependent chronic pain pts being thrown to “the curb” …how many more SUICIDES will there be… and how many will we not hear about ?

Federal Drug Enforcement Administration (DEA) officials have canceled a Tuesday hearing to consider a Seattle pain doctor’s ability to prescribe powerful narcotics, recommending instead that Dr. Frank Li’s privileges be revoked.

The former medical director of Seattle Pain Centers, a chain of Washington clinics, had been set Tuesday to defend his right to retain his DEA registration, which allows prescription and distribution of all controlled substances, including opiate painkillers.

The federal Controlled Substances Act requires that medical providers who prescribe controlled substances be appropriately licensed.

Through lawyers, Li had previously said that he would contest the revocation of his DEA registration because his medical license is merely suspended and could be reinstated. A lawyer representing Li did not immediately respond to questions about the proposed revocation.

State Medical Commission members suspended Li’s license in July amid charges that care by Li and Seattle Pain Centers providers MAY have contributed to the deaths of at least 18 patients since 2010.

California medical-board officials took similar action within weeks.

Li, 48, is accused of failing to properly monitor patients taking high doses of opiate painkillers.

Following the charges, the eight Seattle Pain Centers sites across Washington were closed, leaving an estimated 8,000 opiate patients and as many as 25,000 patients seen since 2008 in need of care.

The move threw the state’s pain-care system into chaos, leaving many patients without care and providers scrambling to help them. One former patient committed suicide and blamed the loss of Seattle Pain Centers in a note left behind.

Li is scheduled for a hearing before the Medical Commission next April.

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DEA asks appellate court to overturn judge’s ruling requiring warrants for Oregon prescription database

http://www.oregonlive.com/portland/index.ssf/2016/11/dea_asks_appellate_court_to_ov.html

The U.S. Drug Enforcement Administration wants an appeals court to overturn a judge’s ruling that requires federal agents to get a search warrant to access information in an Oregon database that tracks doctors and the narcotics they prescribe to patients.

The federal drug agency’s “administrative subpoenas” are valid and sufficient to get the information, said Samantha Lee Chaifetz, a lawyer for the U.S. Department of Justice. The subpoenas don’t require probable cause or a court order ahead of time.

An attorney for the state countered Monday that the subpoenas conflict with Oregon law.

The Legislature created the Oregon Prescription Drug Monitoring Program database in 2009 to log prescriptions filled by pharmacies in the state, the physicians who prescribed the narcotics and the patients who use them. The state included privacy protections, calling for a court order to allow law enforcement access. The database went live two years later.

The Drug Enforcement Administration claims it can use administrative subpoenas under the federal Controlled Substances Act.

The state sued the Drug Enforcement Administration after it issued three subpoenas for database information. The American Civil Liberties Union joined the case on behalf of four patients and a doctor, taking the state’s argument one step further in contending that federal agents must have probable cause and a signed search warrant for the information.

The subpoenas could violate a person’s Fourth Amendment right to privacy and unreasonable search and seizure, the ACLU argued.

U.S. District Judge Ancer L. Haggerty ruled in 2014 that patients have a reasonable expectation of privacy for their prescription records and that law enforcement must seek a warrant to obtain information from Oregon’s database.

The Drug Enforcement Administration appealed, and a three-member panel of the 9^th U.S. Circuit Court of Appeals heard arguments Monday in Portland’s Pioneer Courthouse.

Federal law trumps state law, Chaifetz said. The ACLU also doesn’t have standing to argue a Fourth Amendment claim based on speculative allegations of possible future injury, she said.

Attorney Dustin Buehler, representing Oregon, said the state doesn’t object to the intervention of the ACLU, but isn’t making the constitutional argument. The state has focused on the conflict with Oregon law, he said.

The state took the Drug Enforcement Administration to court to seek guidance before turning over additional database records that could conflict with state statute, after receiving an initial subpoena from the DEA in January 2012, according to lawyers for the state and ACLU. The state had complied with one of the federal agency’s requests after a U.S. magistrate judge issued a court order on the DEA’s behalf in August 2012.

Nathan Freed Wessler, a New York-based attorney for the ACLU, pointed out that the Drug Enforcement Administration directs the state not to tell patients or doctors if they’re the subject of a subpoena so they would have no way of knowing that their privacy rights may have been violated.

The database contains “extraordinarily sensitive information” about people and their diagnoses, Wessler said, and that’s why Oregon law created the higher standard.

Chaifetz dismissed the ACLU’s claim about heightened privacy expectations, noting that both state and federal law anticipate that the database prescription information “may be shared with others — from regulatory boards to law enforcement officials and health oversight authorities.”

9^th Circuit Judges William A. Fletcher and M. Margaret McKeown asked why the ACLU should be allowed to make arguments in this appeal because they’re presenting a separate claim from the state.

The ACLU is raising a distinctive argument, not a separate claim, Wessler responded.

The civil rights organization represents an unnamed Oregon physician who specializes in geriatrics and end-of-life planning, two transgender men with testosterone prescriptions, a person who suffers from a blood disorder and relies heavily on prescription medication and a man prescribed narcotics for a kidney ailment.

These people face a “heightened risk” of scrutiny by the DEA and would have little opportunity to challenge any disclosure of their personal medical history in court if administrative subpoenas were allowed to stand, Wessler said.

Fletcher said it struck him as odd that the federal government would tell a state not to notify a doctor or patient who is the subject of a DEA subpoena. “That does not strike me as a very good way to run a system,” Fletcher said.

Chaifetz said administrative subpoenas are similar to grand jury subpoenas and are used in the course of a civil or criminal investigation when the investigators don’t want to tip off the subject of the inquiry.

The American Medical Association filed a friend of the court brief in support of the state, seeking to protect patient prescription data from becoming a “law enforcement tool” without “stringent legal requirements for disclosure.’

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 PBM Clawbacks Exposed in Minnesota and Louisiana
Another local TV station has investigated PBM clawbacks and how gag clauses forbid pharmacists from telling patients about insurance overcharges and less expensive alternatives. Reporter Jay Olstad of KARE 11 in Minneapolis aired his segment last Friday. Among his interviews was NCPA CEO B. Douglas Hoey, Pharmacist, MBA, who said two of the most active PBMs in employing clawbacks were OptumRx and Catamaran, both owned by United Healthcare, headquartered in a Minneapolis suburb. Class action lawsuits have been filed against the United Healthcare and OptumRx over clawbacks. The United Healthcare declined to comment on camera to KARE 11.

An attorney involved in one of the clawback lawsuits told the Louisiana Record Nov. 4 that the practice is “so unseemly that it’s hidden from customers on purpose—with the contracts that insurers sign with pharmacies for premium drug prices restricting the pharmacies from even disclosing the practice to their own customers.”

Hahnville, La.-based attorney Andrew Lemmon of the Lemmon Law Firm, further explained: “In real simple English, if someone had a $50 copay and the prescription only cost $10, Optum would claw back the $40 difference from the pharmacy. It’s fairly common in the industry. A lot of the big ones do it.”

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Stores selling expired children’s medicine

http://www.nbc12.com/story/33648460/stores-selling-expired-childrens-medicine

RICHMOND, VA (WWBT) –

When you buy milk, you check the expiration date and same with bread.

However, stores are selling expired children’s medicine — allergy relievers, cold medications, pain relievers.  

Over the summer, we went to 18 different drug and dollars stores across Richmond, Henrico, and Chesterfield.

We visited Walgreens, CVS, Family Dollar, Dollar Tree and Dollar General and looked at the expiration dates of every box of children’s medication on the shelves.

And 44 percent of all the stores we visited failed our check. They had at least one expired children’s medication for sale on the shelf.

We didn’t find a single out-of-date medication on the shelves of the CVS and Dollar Trees we visited.

But on multiple occasions at Dollar General, Family Dollar and Walgreens, we found several children’s medications on the shelves — expired, old, out of date. We discovered expired cold and cough meds from February, October, and November of 2015.

We even found meds dating back to 2014. The manager at a Family Dollar on Williamsburg Road actually asked us what we were checking and pulled every expired drug from the shelves immediately.

We tried to buy a few of the expired products at some of the stores and easily walked out with the medication.

Most of the time, nobody looked at the date and stopped us, but a few cashiers were paying attention.

A lady at a Dollar General on Hull Street in Chesterfield looked at the dates before I paid and said, “I can’t sell you that. It’s expired.”

At a Dollar General on Iron Bridge Road, the clerk stopped us. She labeled the medications as expired and pulled them off the shelves.

Do the expiration dates really matter? The Food and Drug Administration thinks so. It says selling expired medications is illegal, but the agency doesn’t enforce it. Instead, they leave that to the states. There’s a video on the FDA’s website all about why you should care about the dates.

Another article tells you to toss out-of-date drugs because of health risks.

“Always check the expiration date, particularly if you think it might take you a year to use that medication,” said Dr. Ruddy Rose. He helms Virginia’s Poison Control Center and stresses that he doesn’t think expired over the counter drugs are necessarily harmful, just less effective. 

“That’s really based on potency and not based on being toxic,” said Rose. He says there are several prescription drugs that do turn toxic over time, so getting in the habit of checking all your medications is good practice.

It’s very easy to check the dates — just turn the box upside down. It’s usually printed on the bottom.

In statements, Dollar General, Family Dollar Stores and Walgreens all told us they take expiration dates on medications very seriously. They’ve all taken the time to review procedures with store employees to make sure expired products are pulled from the shelves. 

Here is the statement from Walgreens:

We have procedures in place to routinely check the expiration dates on items, and we take those procedures very seriously. We have since checked the expiration dates at the stores in question and have reviewed our procedures with store employees.

Phil Caruso
Walgreens Media Relations

Here is the statement from Dollar General:

Dollar General is committed to providing its customers with high-quality, reliable products, which includes taking the necessary steps to ensure that products on our shelves are within their respective sell-by dates. We are disappointed to learn that out-of-date products were located on our shelves and have taken immediate action to address the situation.

Here is the statement from Family Dollar Stores:

Please know that the safety of our Associates and customers is our first priority, and we take situations like this seriously. As part of Family Dollar’s “freshness program”, we ask our Associates to check the dates on various items once a week when they re-stock shelves.

When items that are nearing their expiration or “best by” date are identified, they are either removed or marked down – depending on the item.

In this instance it’s evident that these items were missed by our store teams. We appreciate you bringing this to our attention. Please know that we will be reviewing these sections in all area stores to ensure we have identified any aged product. Additionally, we will use this opportunity to reiterate the details of our program to our Associates to ensure its importance is understood and that protocols are followed.
               
Bryn R. Winburn
Public & Media Relations Manager

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Guest speaker,

Dr. Ginevra Liptan, MD

www.livesupportgroup.com

We are honored and pleased to announce the return of guest speaker, Dr. Ginevra Liptan, MD.

Dr. Liptan is a renowned specialist / research expert on Fibromyalgia, Chronic Fatigue and associated symptoms, as well as a highly skilled M.D. Furthermore, she directs The Frida Center for Fibromyalsia and serves as the Medical Adviser to the Fibromyalgia Information Foundation.

Dr. Liptan will be discussing the above topics and there will be a Question and Answer segment. Dr Liptan is also a well known published author.

Don’t miss out on this amazing opportunity, that she has so graciously given our LiveSupportGroup Family of Friends! If you are not a member and would like to attend, please sign up below for your personalized invitation.

Our mission is to provide those with chronic disease and conditions an anonymous on-line support community, where they can realize that they are not alone and find support, answers and available resources to help them deal/cope with their disease/conditions that impact their lives and relationships.

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It is free, live, peer-to-peer sharing groups for chronic pain and health conditions A-Z in the comfort of your own setting.

We do this through live audio via telephone and computer lines. We hope to bring people together with similar experiences – to give hope and guidance to each other through open discussions. Subscribe Today and become a free member.

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Long-term oxygen therapy not beneficial for COPD patients with moderate desaturation

http://www.clinicaladvisor.com/copd-information-center/oxygen-therapy-not-effective-for-copd-with-moderate-desaturation/article/569005/

This study looks at “time to death or first hospitalization” … appears to have little concern that a COPD pt without supplemental oxygen will loose most/all of their ability to ambulate or have much activity without supplemental oxygen. Just like the CDC opiate dosing guideline recommendations… appeared to ignore the pt’s ability to optimize their quality of life and/or optimize their ability to have much activity… instead .. many will be physically confined to bed/chair/house because of the recommendations of REDUCED THERAPY ?  DEATH PANELS … ANYONE ?

Long-term supplemental oxygen does not provide any benefit regarding time to death or first hospitalization among patients with stable chronic obstructive pulmonary disease (COPD) and resting or exercise-induced moderate desaturation, according to a study in the New England Journal of Medicine.

Researchers originally sought to determine whether long-term treatment with supplemental oxygen would result in a longer time to death compared with no use of supplemental oxygen among patients with stable COPD and moderate resting desaturation (oxyhemoglobin saturation as measured by pulse oximetry [Spo₂], 89% to 93%). After 7 months with 34 patients, the investigators also included patients who had stable COPD with moderate exercise-induced desaturation (during the 6-minute walk test, Spo₂ ≥80% for ≥5 minutes and <90% for ≥10 seconds) and added the time to the first hospitalization for any cause into the new composite primary outcome.

Participants were randomly assigned to receive long-term supplemental oxygen or no long-term supplemental oxygen. In the supplemental-oxygen group, patients with resting desaturation were given 24-hour oxygen, and those with desaturation only during exercise were given oxygen during exercise and sleep.

The researchers followed 738 patients at 42 centers for 1 to 6 years. They found no significant difference between the supplemental-oxygen group and the no-supplemental-oxygen group in the time to death or first hospitalization (hazard ratio, 0.94), nor in the rates of all hospitalizations (rate ratio, 1.01), COPD exacerbations (rate ratio, 1.08), and COPD-related hospitalizations (rate ratio, 0.99). In addition, no consistent between-group differences were observed regarding measures of quality of life, lung function, and the distance walked in 6 minutes.

“We found that the prescription of supplemental oxygen for patients with stable COPD and resting or exercise-induced moderate desaturation did not affect the time to death or first hospitalization, time to death, time to first hospitalization, time to first COPD exacerbation, time to first hospitalization for a COPD exacerbation, the rate of all hospitalizations, the rate of all COPD exacerbations, or changes in measures of quality of life, depression, anxiety, or functional status,” the researchers stated.

“We found no effect on the primary outcome in subgroups of patients defined according to desaturation type, prescription type, or adherence to the regimen,” the investigators continued. “The consistency of the null findings strengthens the overall conclusion that long-term supplemental oxygen in patients with stable COPD and resting or exercise-induced moderate desaturation has no benefit with regard to the multiple outcomes measured.”

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