What is CRO

Posted on August 8, 2017 by Pharmaciststeve

A cro is a clinical research organization by contract. It is a type of company that offers its clinical studies management services to the pharmaceutical, biotechnology, and medical device manufacturers mainly. The management of a clinical study is more complicated than it might seem since many actors are involved (manufacturers, promoters, ethical committees, competent authorities, Centers, Foundations, Researchers, legal departments, patients). Also, they must work under the rules of Good Clinical Practice and the Harmonization Guidelines (GCP-ICH Guidelines) that ensure the quality of the study. Being able to have a CRO as a partner to rely on the management of the study is essential and in this case, the clinical research organization by contract acts as a bridge between the promoter, the one who hires the services, and the rest of the actors involved in the clinical study.

clinical research organization

Services offered by a CRO:

Traditionally, CROs have been responsible for the implementation and monitoring of clinical trials, but more and more companies that offer all the services associated with conducting a clinical study are considered “full-service CROs.” The services that a CRO can offer can be divided according to the phase in which you are in the study:

clinical research organization
  • The implementation includes the development and review of protocols for trials, the adaptation of the necessary documentation to the legislation, the obtaining of the necessary approvals from the clinical research ethics committees and regulatory authorities, the design and the preparation of the data collection notebooks, the determination of the sample, the selection of the best researchers and research centers and the final negotiation of the contracts.
  • Once approval is approved and the trial begins, the clinical research organization by contract offers its services for monitoring, which consists of monitoring compliance with the protocol and with the procedures established for the development of the study. Likewise, pharmacy vigilance services include detection and action in case of the occurrence of an Adverse Event.
  • The last steps to ensure the success of any clinical study are the management of data, the generation of reports and the control and storage of documentation. Throughout the study, work is carried out by Good Clinical Practices (BPC) that ensures the quality of the study.

 Types of CROs

There are different criteria to classify CROs:

  • If you take into account the level of specialization of the company, you can find companies specialized in a type of study (clinical trials, research with health products or observational studies) and also CROs specialized in a therapeutic area, such as oncology or ophthalmology.
  • Taking into account the geographical area in which they move, you can classify CROs as local or global. Global companies are usually large companies that have offices all over the world, their coverage is greater, but they are usually less flexible than local ones, whose knowledge of the country’s peculiarities is greater, but their coverage is usually not as wide.

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Low Risk of Producing an Opioid Use Disorder in Primary Care by Prescribing Opioids to Prescreened Patients with Chronic Noncancer Pain.

Posted on August 8, 2017 by Pharmaciststeve

Low Risk of Producing an Opioid Use Disorder in Primary Care by Prescribing Opioids to Prescreened Patients with Chronic Noncancer Pain.

https://www.ncbi.nlm.nih.gov/pubmed/28379504

Objective. :

To examine the risk of developing aberrant behaviors that might lead to a substance use disorder (addiction) when prescribing opioids for the relief of chronic noncancer pain in primary care settings.

Design. :

Longitudinal, prospective, descriptive design with repeated measures.

Setting. :

Private community-based internal medicine and family medicine clinics.

Subjects. :

Patients with chronic musculoskeletal pain.

Methods. :

Standardized measures of patient status (pain, functional impairment, psychiatric disorders, family history) and treatments provided, urine drug monitoring, and medical chart audits (presence of aberrant drug-related behaviors) were obtained in a cohort of 180 patients at the time of initiating opioids for chronic noncancer pain and at three, six, and 12 months thereafter.

Results. :

Over the 12-month follow-up period, subjects demonstrated stable, mild to moderate levels of depression (PHQ-9 scores ranging from 9.43 to 10.92), mild anxiety (BAI scores ranging from 11.80 to 14.67), minimal aberrant drug-related behaviors as assessed by chart reviews, and a low percentage of illicit drug use as revealed by results of urine drug monitoring. Less than 5% of our study population revealed any evidence of substance use disorder.

Conclusions. :

This prospective study suggests that patients without a recent or prior history of substance use disorder who were prescribed primarily short-acting opioids in low doses for chronic noncancer pain have a low risk for developing a substance use disorder. This finding supports the importance of prescreening patients being considered for opioid therapy and that prescription of opioids for noncancer pain may carry a lower risk of abuse in selected populations such as in private, community-based practices.

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The Justice Department has dropped its appeal of a key disability rights lawsuit

Posted on August 8, 2017 by Pharmaciststeve

Is This an ‘Ominous’ Message for the Disabled Under Trump?

http://www.thedailybeast.com/is-this-an-ominous-message-for-the-disabled-under-trump

The sudden dismissal of an Americans with Disabilities Act lawsuit in Virginia has advocates concerned that a systematic weakening of the federal law has begun.

Betsy WoodruffBetsy Woodruff

08.07.17 1:00 AM ET

The Justice Department has dropped its appeal of a key disability rights lawsuit—and advocates say they fear this means people with disabilities could see their rights rolled back under President Donald Trump.

The lawsuit at issue is in Richmond, Virginia, where a sheriff’s deputy, Emily Hall, had to temporarily leave her job to get surgery for a heart condition in September 2012. After her surgery, she tried to return to work but wasn’t physically capable of taking her old position. The sheriff’s department told her she could apply for a less strenuous job. When she applied, she didn’t get that position, according to court documents.

So Hall sued the sheriff’s department, charging it violated the Americans with Disabilities Act (ADA) by failing to accommodate her disability. The Justice Department initially joined her effort. Then-Attorney General Loretta Lynch, Civil Rights Division head Vanita Gupta, and U.S. Attorney Dana Boente—now a senior DOJ official under Attorney General Jeff Sessions—all signed on.

When a federal judge in Virginia ruled that the sheriff hadn’t violated Hall’s rights, Hall and the Justice Department appealed the ruling to the Fourth Circuit Court of appeals.

But on July 28, the Justice Department moved to dismiss its own appeal, and the court granted the dismissal.

Top officials who worked in the Civil Rights Division under Obama say that may be an ominous sign—an indicator that Sessions’ Justice Department may be far less aggressive in defending the rights of people with disabilities than President Barack Obama’s. They fear the dismissal could be the beginning of a shift away from the prior administration’s energetic stance.

“I’m very pessimistic,” said Sam Bagenstos, who was second-in-command in the Civil Rights Division during the Obama administration. “I think this administration is likely to slow down very substantially their enforcement of the ADA. But I’d like to be proven wrong.”

The Justice Department has already changed its position on some voting rights litigation and is reconsidering the Obama-era efforts to make troubled local police departments change their practices.

Lauren Ehrsam, a spokesperson for the Justice Department, said it is firmly committed to enforcing the ADA.

“This administration and Department of Justice are strongly committed to protecting the rights of people with disabilities,” she said, noting that since January the department has entered 17 settlement agreements around the country to help people with disabilities go to restaurants, vote in polling places, and communicate with doctors.

But disability rights’ advocates say they’re worried the department is moving in the wrong direction.

“It’s unfortunate and worrisome that the Civil Rights Division, having come this far, chose to suddenly withdraw its appeal from this terribly reasoned decision,” said Sasha Samberg-Champion, formerly a top attorney in the division during Obama’s presidency. “With the division currently staking out retrograde positions on LGBT issues, racial diversity in education, and elsewhere, disability rights advocates are watching closely to see whether the division will continue to forcefully protect the rights of people with disabilities such as Ms. Hall. The decision not to pursue her case further is grounds for concern.”

Bagenstos added that this case could be a leading indicator that Trump’s Justice Department could handle disability issues quite differently from Obama’s.

“It’s a very troubling data point,” he said. “It creates a lot of doubts under that the DOJ under Sessions will vigorously enforce the ADA. But a lot remains to be seen.”

Business groups—which argue the Justice Department sometimes takes too broad a view of the ADA—could be pleased with some changes.

Karen Harned, an attorney at the National Federation of Independent Businesses, said her group doesn’t believe companies should be required to give new jobs to employees who get disabilities while working there. She said her group’s view is that while employees in Hall’s situation should be able to apply for jobs that could accommodate them, they shouldn’t necessarily have a right to those positions.

“It’s good to see that they’re not trying to push a theory that has already been rejected by other courts,” she said, citing the fact that some circuit courts have rejected similar lawsuits. “If a statute doesn’t say it clearly, small business owners shouldn’t be held to these new crazy theories.”

During the Obama administration, the Civil Rights Division moved to aggressively enforce the ADA—looking to craft new regulations on businesses and bringing lawsuits based on a broad view of their jurisdiction. Disability rights advocates say they hope Sessions’ Justice Department will be just as aggressive.

Trump’s record on disability rights won’t reassure them, as Trump companies have faced numerous lawsuits alleging they didn’t accommodate people with disabilities.

“We are watching them very closely to make sure they continue the aggressive enforcement of the ADA despite the change in administration,” said Curt Decker, who heads the National Disability Rights Network. “The issues have not changed. The need for protection for people with disabilities remains the same.”

 

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Doubled Since 2007, Hitting a 40-Year High – where is the media coverage ?

Posted on August 7, 2017 by Pharmaciststeve

Teen Girl Suicides Doubled Since 2007, Hitting a 40-Year High

http://www.acsh.org/news/2017/08/03/teen-girl-suicides-doubled-2007-hitting-40-year-high-11651

It’s not easy being a teenager. Since time immemorial, teens have had to grapple with the raging hormones and quest for self-identity that are hallmarks of this stage of life. However, coming of age in an era of social media — in which every moment of a person’s life can be live-tweeted and publicly scrutinized — makes an already difficult situation that much worse.

New data released by the CDC highlights the hardship of modern teenage life. Since 2007, the suicide rate among boys aged 15 to 19 has increased by 31% (from 10.8 to 14.2 per 100,000), while the suicide rate among girls has more than doubled (from 2.4 to 5.1 per 100,000). In fact, the suicide rate for teenage girls is at a 40-year high*.

The authors do not explain the reasons behind this increase, but it is tempting to speculate that social media may be playing a role. Facebook was founded in 2004, Twitter in 2006. Over the past several years, multiple anecdotes have linked teenage suicides to social media bullying.

Of course, anecdotes are not data. A closer examination into the cause of this recent surge in teen suicides is needed. However, linking them to social media is certainly a tempting hypothesis.

Suicide Is Not Just a Problem for Teens

Complicating the picture is the fact that, according to other data from the CDC, suicide rates have increased for all age groups in the United States, with the lone exception of those aged 75 and older. The surge in suicides for people in their 60s, for instance, is not likely attributable to social media.

Additionally, rural Americans have been hit hardest by the suicide epidemic, witnessing an increase of 40% in 16 years. Once again, this would argue against social media as an explanation.

What Is Causing the Surge in Suicides?

Obviously, people commit suicide for various reasons: Depression, loneliness, mental illness, drug addiction, relationship trouble, financial hardship, and bullying have all been implicated. Determining the predominant causes of suicide in each age and ethnic demographic would be a major step toward reversing this troubling trend.

Note: The data in this study only goes back 40 years. The current 40-year high could actually stretch back further in time.

Source: “QuickStats: Suicide Rates for Teens Aged 15-19 Years, by Sex — United States, 1975-2015.” MMWR 66 (30): 816. Published: 4-Aug-2017. DOI: 10.15585/mmwr.mm6630a6.

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Four minute video on pt abuse

Posted on August 5, 2017 by Pharmaciststeve

https://scontent-iad3-1.xx.fbcdn.net/v/t42.1790-29/20598995_1976618862621571_1591556524453396480_n.mp4?efg=eyJ2ZW5jb2RlX3RhZyI6InNkIn0%3D&oh=ae19269bd1cbd1ce8d97114c40f6f186&oe=59869A5C

 

Click on the above link to watch the video

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Patient of alleged Montgomery pill mill doctor speaks out

Posted on August 5, 2017 by Pharmaciststeve

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Another DEA failure ?

Posted on August 5, 2017 by Pharmaciststeve

This is a interview of a DEA agent in Florida back in 2015 by Matt Grant of WESH TV in Orlando.

In this interview, the DEA agent states that one of the responsibility of the DEA is to make sure that people who have a legit medical need for controlled substances that there is a adequate supply to meet that need.

Then we have this posted this week:

DEA proposes cutting production of some opioid painkillers

Where the DEA is proposing to cut Pharma’s  production quotas by 20% after cutting them by up to 35% in 2017.. which means that in 2018 abt HALF of the major opiate medications (Hydrocodone, Oxycodone, Fentanyl) will be produced than was produced in 2016.

Of course, if this causes more people to go to “the street” to get opiates to treat their pain and/or mental health issues… it would be just more job security for the DEA… and I suspect that is really what the real primary interest of the DEA’s employees really is

 

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Drug cartels will be “dancing in the street” over cuts in legal opiate production levels

Posted on August 4, 2017 by Pharmaciststeve

DEA Proposes Reducing Opioid Manufacturing for 2018

http://www.pharmacytimes.com/news/dea-proposes-reducing-opioid-manufacturing-for-2018

Officials with the US Drug Enforcement Administration (DEA) have proposed to cut the amount of controlled substances to be manufactured in 2018 by 20%, compared to 2017, according to a press release.

Under the proposed notice being published in the Federal Register, the DEA is taking steps to reduce more commonly prescribed schedule II opioid painkillers, including oxycodone, hydrocodone, morphine, codeine, meperidine, and fentanyl.

According to the press release, sales data obtained from IMS Health have indicated that demand for these pain medications has dropped.

The DEA considers data from the FDA, estimates of retail consumptions based on prescriptions dispensed, manufacturers’ disposition history and forecasts, as well as data from the DEA’s own internal system for tracking controlled substances transactions and past quota histories, to establish the Aggregate Production Quota (APQ) for the year.

The APQ determines the total number of controlled substances necessary to meet the estimated medical, scientific, research, industrial, and export needs for the year and for the maintenance of reserve stocks.

After setting the aggregate quota, the DEA allocates individual manufacturing and procurement quotas to manufacturers that apply for them. Additionally, the DEA may revise a company’s quota at any time during the year.

Reference
DEA proposes reduction to amount of controlled substances to be manufactured in 2018 [news release]. Washington, DC. DEA’s website. https://www.dea.gov/divisions/hq/2017/hq080417.shtml. Accessed August 4, 2017.  

The DEA’s primary charge is to arrest those who divert/sell illegal substances.. so if they cut the production quotas of legal opiate productions… it doesn’t take a group of Mensa people to figure out that this is going to mean that more people are going to be seeking/buying illegal drugs on the street.

More job security for the DEA and our judicial system..  Too bad that the vast majority of Congress is not bright enough to see thru this… or … maybe they are and since abt 40% of Congress is ATTORNEYS… They have no objection to funneling more money to the judicial system and their “fraternal brothers and sisters “

When the Control Substance act was signed into law in 1970 … it replaced the Federal Narcotic Bureau with a TWO MILLION dollar annual budget and created the BNDD ( Bureau of Narcotics and Dangerous Drugs) with a 43 million annual budget. Since then we have spent > ONE TRILLION fighting the war on drugs and continue to expend 81 billion/yr in fighting the war on drugs and Congress is discussing adding another 4.5 billion/yr  and we don’t know how many more billions AG Session and Chris Christie is going to add with their planned additional programs.

 

 

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Pfizer Agrees to Support CDC Opioid Guideline

Posted on August 4, 2017 by Pharmaciststeve

Pfizer Agrees to Support CDC Opioid Guideline

https://www.painnewsnetwork.org/stories/2017/8/4/pfizer-agrees-to-support-cdc-opioid-guideline

By Pat Anson, Editor

Since its release in March 2016, the CDC’s opioid prescribing guideline has had a chilling effect on chronic pain patients, as doctors, regulators, states and insurance companies have adopted the CDC’s recommendations as policies or even laws. As a result, it has become harder for many pain patients to get opioids prescribed or even find a doctor willing to treat them.

Now one of the world’s largest drug makers has agreed not to make any statements that conflict with the CDC guideline and to withdraw support for anyone who does.

In an agreement signed last month with the Santa Clara County, California Counsel’s Office, Pfizer promised to abide by strict standards in its marketing of opioids and to “not make or disseminate claims that are contrary to the ‘Recommendations’ of the Centers for Disease Control and Prevention Guideline for Prescribing Opioids for Chronic Pain.”

That voluntary guideline only discourages primary care physicians from prescribing opioids for chronic pain, but has been widely implemented by many doctors, regardless of specialty.

Pfizer also agreed to stop funding patient advocacy groups, healthcare organizations or any charities that make “misleading statements” about opioids that are contrary to the CDC guidelines. Pfizer notified Pain News Network by email today that it was rescinding a charitable grant recently awarded to PNN. Pfizer’s had been a sponsor of PNN’s newsletter for the past year.  

“This agreement is an important step in ensuring that doctors and patients in California receive accurate information about the risks and benefits of these highly addictive painkillers,” Santa Clara County Counsel James Williams said in a press release. “Such information is essential to curbing — and ultimately ending — the opioid epidemic plaguing Santa Clara County, the State of California, and many parts of the country.”

Santa Clara County was not pursuing any legal action against Pfizer, although it had filed a lawsuit against Purdue Pharma and four other opioid manufacturers, alleging that they falsely downplayed the risks of opioid painkillers and grossly exaggerated their benefits.

“We applaud Pfizer’s willingness to work with us to combat the dramatic rise in opioid misuse, abuse, and addiction in California and the corresponding rise in overdose deaths, hospitalizations, and crime,” said Danny Chou, an Assistant County Counsel for the County of Santa Clara. “Pfizer has set a stringent standard that we expect all other opioid manufacturers to meet.”

Opioids make up only a tiny part of Pfizer’s business. The company sells just one opioid painkiller, an extended release medication called Emedea.

As part of its agreement with Santa Clara County, Pfizer promised not to market opioids off-label for conditions they are not approved for and said it would “make clear” in its marketing that there are no long-term studies on the safe use of opioids.

Interestingly, the CDC guideline suggests the use of gabapentin and pregabalin as alternatives to opioids for treating pain. Pfizer makes billions of dollars annually selling both of those drugs, under the brand names Neurontin and Lyrica.

In recent years, Pfizer has paid $945 million in fines to resolve criminal and civil charges that it marketed Neurontin off-label to treat conditions it was not approved for. Neurontin is only approved by the FDA to treat epilepsy and neuropathic pain caused by shingles, but it is widely prescribed off label to treat depression, ADHD, migraine, fibromyalgia and bipolar disorder. According to one estimate, over 90% of Neurontin sales are for off-label uses.

Lyrica is approved by the FDA to treat diabetic nerve pain, fibromyalgia, post-herpetic neuralgia caused by shingles and spinal cord injuries. Lyrica is also prescribed off-label to treat a wide variety of other chronic pain conditions, including lumbar spinal stenosis, the most common type of lower back pain in older adults.

Since  I don’t receive any money from Pfizer – except for some dividends from some Pfizer stock that I have owned for nearly 10 yrs..  I can say whatever I think about this announcement..

First of all … Santa Clara County, California has a population of about 1.9 million or about 0.5% of the population of the USA… which means that this county prosecutor in CALF has been able to impose his will, belief, opinions on the other 99.5% of the country’s population… 

WHAT A EGO.. and clearly demonstrates that our judicial system has gotten totally out of control. Just like recently AG Session wanted to be granted the power to allow him to impose his opinions on the entire population … especially when it came to the war on drugs.

The CDC ( Center of Disease Control) produced these “guidelines” and some believe that the CDC did not have the legal authority to do so…  Up until the release of these guidelines.. the CDC primary focus on communicable diseases and vaccines that help prevent communicable diseases and/or establish treatment plans to deal with communicable disease.

It has been stated that the studies/data that the CDC based it guidelines on were of the poor quality… with 1= excellent and 4 = unreliable and most of the studies they used had a rating of 3 or 4 and they refused to accept any anecdotal evidence of the benefit of opiates used long term in helping pts manage their chronic pain.

The head of the CDC at the time –  Tom Frieden – was quick to make public statements pointing out once these guidelines were released that they were merely GUIDELINES and did not bear the weight of law.

However, many entities – like the VA – was quick to adopt some of the most strict portion of the CDC guidelines and ignored some of the exceptions in order to properly manage the pain of chronic pain pts with more severe pain.

It amazes me that both the FDA and Pfizer does not recommend the use of one of Pfizer’s medications in ESI and all too many pts have been inflicted with Arachnoiditis https://en.wikipedia.org/wiki/Arachnoiditis     and meningitis and no one seems to be interested in this very popular procedure that may be considered insurance fraud and causing insurance companies expending untold dollars treating Arachnoiditis… which is both incurable, extremely painful and costly to treat.

It would seem that our judicial system is more interested in the loss of life from people abusing illegal substances than those pt losing their quality of life from physicians “pushing” procedures using medications in an unproved methodologies.

 

 

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They started drinking alcohol and smoking marijuana at a young age…it wasn’t enough

Posted on August 4, 2017 by Pharmaciststeve

Essentia Health Hosts Panel on Opioid Crisis

Business leaders gather to discuss ways drug epidemic can be solved

www.kvrr.com/2017/08/03/essentia-health-hosts-panel-on-opioid-crisis/

 

FARGO, ND — It’s a drug killing more than 90 Americans every day: opiates.

One mother understands that after sending her two sons to jail.

“I was trying to save their lives,” Mary Locken said.

Locken’s sons, 23-year-old Joe and 21-year-old Nicholas, were caught up in the storm of addiction.

They started drinking alcohol and smoking marijuana at a young age, but eventually, it wasn’t enough.

“The game changer for both of them, no mistake, [was] prescription drugs,” Locken said.

Essentia Health wants to change that.

They held a panel discussion for business leaders to address ways to combat opioid addiction in the community.

Essentia has already started to take more precautions in giving chronic pain patients prescriptions with opioids.

“We have an opioid agreement that spells out what their obligations are,” said Dr. Richard Vetter, who is Essentia Health’s clinical chief of primary care. “What the clinicians obligations are and really helps us have that conversation about risk benefits.”

According to the National Institute on Drug Abuse, about 21-29 percent of patients prescribed opioids for chronic pain misuse them.

Vetter said the panel is a good place to discuss further ways this crisis can be solved because it’s about working together.

“I think it’ll require a collaborative effort to really deal with this problem,” Vetter said. “But I think there’s hope. I think there’s a lot of hope because there are treatments out there that are effective. We just have to get them to the patients that need them.”

Locken has discovered that hope once again.

“Where I had given up hope for my sons, literally, I thought they were walking death, that they would not survive,” Locken said. “I now have hope for both of my sons.”

Locken’s son Joe was just released from prison, while Nicholas is still serving his sentence.

Joe will be attending Minnesota State Moorhead.

 

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