THE BATTLE CONTINUES
VS
I had trouble getting these readable… bottom line .. Mark got a 30 day injunction and restraining order against the actions of the MT Medical Licensing Board.
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Imagine this… DOJ defends “illegal wiretaps” of the DEA ! Crooks defending Crooks ?
Posted on March 23, 2016 by Pharmaciststeve
Justice Department defends legality of vast DEA wiretap program
The Justice Department offered its first defense this week of a once-vast eavesdropping program carried out by federal drug agents in the Los Angeles suburbs over the objection of government lawyers who feared it was illegal.
The Justice Department urged a judge not to throw out a series of wiretaps agents used to arrest an accused marijuana trafficker, saying the surveillance was “authorized in accordance with state and federal law.” That defense came in a filing Monday in federal court in Louisville.
The Kentucky case is the first major challenge to a surveillance program by the U.S. Drug Enforcement Administration and prosecutors in Riverside County, Calif., so large that it once accounted for nearly a fifth of all U.S. wiretaps. Monday’s filing was the first time the Justice Department expressed an opinion publicly on whether it was legal.
In it, prosecutors offered a narrow defense of the halted wiretap program, arguing mainly that the accused trafficker’s lawyers had not offered up enough evidence that the particular taps used in that case violated federal law. But they attached evidence that could help the defense make that case.
The challenge follows an investigation last year by USA TODAY and The Desert Sun that found the DEA and prosecutors in Riverside County, outside Los Angeles, had constructed a vast and legally questionable wiretapping operation that secretly intercepted millions of calls and text messages with the approval of a single state court judge. Justice Department lawyers refused to use the results in federal court because they did not think the surveillance could withstand a legal challenge.
Last month, defense lawyers charged that Riverside’s prosecutors approved “illegal wiretaps with astounding frequency” and asked a judge to throw out recordings the government planned to use against Christopher Mattingly, who is accused of trafficking marijuana from California. “Riverside County made a mockery of individual privacy rights, ignored federal requirements limiting the use of wiretaps and permitted law enforcement to intercept telephone calls at their whim and caprice,” one of Mattingly’s lawyers, Brian Butler, wrote.
Federal law bars the government from seeking court approval for a wiretap unless a top prosecutor has personally signed off on that request, a requirement Congress added after the FBI wiretapped civil rights leaders in the 1960s. The only exception is when the district attorney is “absent” and has authorized someone else to act in his place, a federal appeals court ruled in 2013.
Riverside County’s former district attorney, Paul Zellerbach, has acknowledged that he allowed lower-level lawyers to do that job, saying he could not recall ever having reviewed a wiretap application himself. Four of the wiretaps in the Kentucky case were approved by one of Zellerbach’s assistants, and one was approved by an assistant to his successor.
Rather than defend that practice, the Justice Department argued Monday that Mattingly’s lawyers had simply failed to prove that Zellerbach was working on the days his subordinates approved the wiretaps prosecutors hope to use against Mattingly.
The defense, Assistant U.S. Attorney Larry Fentress wrote, “offers no evidence to support his argument, other than newspaper articles critical of the Riverside County District Attorney’s wiretap practices in general, but containing no specific information as to whether the DA was absent on the dates of the particular wiretap applications involved in the instant case.”
The government’s filing included copies of a calendar kept by Zellerbach’s assistant, which Fentress called the “best evidence” of the former district attorney’s whereabouts on the days the wiretaps were approved. Most of it suggests he was at work, listing appointments in or near his office.
Fentress said that even if the wiretap applications were deficient, the problems were minor enough that the judge should not block the government from using them as evidence. “Their response in a nutshell is that what was happening in Riverside wasn’t very good, but it might be good enough to get by,” Butler said Wednesday.
A Justice Department spokesman declined to comment.
Riverside County authorities authorized 624 wiretaps in 2014, three times as many as any other jurisdiction in the USA. The county’s new district attorney, Mike Hestrin, said last month that prosecutors had largely halted the eavesdropping program; By mid-February, his office had approved 14 wiretaps, compared with 126 in the first two months of 2015.
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How many people abusing opiates… reads FDA med package inserts for warnings ?
Posted on March 23, 2016 by Pharmaciststeve
FDA Updates Misuse, Abuse and Death Warnings, Safety Labeling for IR Opioids
Adrenal Issues, Hormonal Deficits, Serotonin Syndrome Warned for Entire Opioid Class
The FDA has announced another “bullet” in its fight against opioid-related misuse, abuse and death, issuing several new safety warnings, black box warnings and other labeling changes for all immediate-release (IR) opioids.
The changes are very similar to those made in 2013 by the FDA for extended-release/long-acting (ER/LA) opioids, and as in that case, will require all IR opioids to carry a boxed warning about risks for abuse, misuse, abuse, addiction, overdose and death related to opioid use.
Specifically, IR opioids will be indicated for “pain severe enough to require opioid treatment and for which alternative treatment options (eg, non-opioid analgesics or opioid combination products, as appropriate) are inadequate or not tolerated,” according to the FDA. The new IR opioid labeling will also warn that use during pregnancy can result in the potentially life-threatening neonatal opioid withdrawal syndrome (NOW). Some IR opioids already carry that warning.
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The 2013 ER/LA opioid safety initiative also included a Risk Evaluation and Mitigation Strategy (REMS), which Douglas Throckmorton, MD, deputy center director for regulatory programs, FDA Center for Drug Evaluation and Research, said is still a possibility for IR opioids.
Immediate-release opioids, which are short-acting and generally taken every four to six hours, account for roughly 90% of the opioid market. One of the main reasons that ER/LA opioids were addressed first in 2013, according to Dr. Throckmorton, is that they have a disproportionate risk for death and overdose per tablet, given that they contain more medication than the IR formulations. Higher doses also make the ER/LA pills more attractive to abusers, said Dr. Throckmorton.
“We sought to remind prescribers that ER/LA opioids are powerful and need to be used with great care,” said Dr. Throckmorton, who added that the changes to the IR labeling have the same goal, specifically to reduce misuse and death, based on the most current data. “This is a reminder that IR opioids are also powerful drugs with important safety concerns and need to be used with great care, after discussions between patients and their physicians.”
Classwide Additions to Labeling
Several other new warnings will be included in the Warnings and Precautions section of the labeling for both ER/LA and IR opioids, as well as medication-assisted treatment drugs used to combat opioid addiction, such as methadone and buprenorphine.
These warnings include the risk for serotonin syndrome resulting from opioid drug interactions with antidepressants and migraine-specific medications in the triptan class. Serotonin syndrome occurs when high levels of the chemical build up in the brain, resulting in toxicity. Signs and symptoms of serotonin syndrome include agitation, hallucinations, rapid heart rate, fever, excessive sweating, shivering or shaking, muscle twitching or stiffness, trouble with coordination, and/or nausea, vomiting or diarrhea. Onset of symptoms ranges from several hours to a few days after taking an opioid along with another medicine that affects serotonin; dose increases also can trigger serotonin syndrome.
Cases of serotonin syndrome in the FDA Adverse Event Reporting System (FAERS) database were reported more frequently with the opioids fentanyl and methadone, used at the recommended doses. Some opioids, including tramadol, tapentadol (NuCynta, DepoMed) and meperidine, already have warnings about serotonin syndrome.
A warning about the rare but serious condition, adrenal insufficiency, due to lowered levels of cortisol, which helps the body respond to stress, in patients taking opioids will also be included in the Warnings and Precautions sections classwide. Adrenal insufficiency is marked by nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure.
The labels of some opioids already describe the possible risk for decreased sex hormone levels and symptoms such as reduced interest in sex, impotence or infertility. The FDA is now adding consistent information to the Adverse Reactions section of all opioid labels.
‘We’ll Do More If Necessary’
Robert Cardiff, MD, the FDA commissioner, stressed that the new warnings are one more step toward ending the opioid epidemic, but most certainly will not be the last.
“Going forward, we will continue to monitor the situation and will do more if necessary. No one, single action will address opioid abuse and misuse; this is one of several actions that need to be taken,” said Dr. Cardiff. “Changes to the label are one component to reach physicians. It’s one of dozens of things that need to be done; a critical element, but not enough by itself.”
Dr. Throckmorton pointed to a May 3-4 FDA advisory committee meeting, in which participants will look at trends over the past several years related to the ER/LA opioid safety initiative and other measures, to determine among other things if the ER/LA opioid REMS is working. A possible REMS for IR opioids will be discussed at that meeting, said Dr. Throckmorton. Patient Medication Guides, which were also part of the ER/LA safety initiative in 2013, will also be developed for IR opioids.
“This is one of the most devastating health crises facing our country, and there is no one cause and no one single solution, no ‘magic bullet,’” Dr. Throckmorton noted. “Our hope, and our plea, is that the changes we announce today will help physicians make better decisions regarding the use of opioids for chronic pain.”
Dosing changes will depend on the individual product, said Dr. Throckmorton, but there will be a “digital guidance” for prescribers on how to determine initial doses and how to monitor and manage patients with regard to changing doses over time.
The new opioid labeling changes will be complicated by the fact that much of the information will be product specific, explained Dr. Cardiff, who added that when including both trade name and generic medications, more than 100 labels will need to be updated. “With different labels and indications already, it’s a pretty massive effort,” he said. “We are not asking for sympathy, but the complexity of the different uses of opioids [is] substantial and worth keeping in mind.”
Dr. Cardiff stressed that all of the changes and warnings should not be seen as the FDA taking clinical control out of the hands of the prescribing physician.
“Prescribers still have to use clinical judgment; labeling is just providing information to help prescribers make these decisions,” said Dr. Cardiff. “The FDA has a role to play, but we don’t regulate medical practice. If you are a patient with chronic pain, you want your doctor to treat you based on your specific circumstances. There are many different types of pain and pain patients. We have to depend on medical practice to do a good job.”
More Information Means Better Treatment
Joseph V. Pergolizzi Jr., MD, adjunct assistant professor in the Department of Medicine, Johns Hopkins University School of Medicine, in Baltimore, and a Pain Medicine News editorial advisory board member, commended the FDA’s efforts.
“The IR labeling seems to align with the ER/LA labeling,” said Dr. Pergolizzi. “‘Primum non nocere—do no harm’ is the principal driver when deciding potential therapies for our pain patients. The more education health care professionals have regarding the side-effect profiles of the various analgesics, particularly related to precautions and warnings, the better analgesic decisions can be made. This information can help guide loose-dose analgesic drug combinations with respect to drug–drug exposures that can result potentially in higher rates of side effects. Single-entity, central-acting agents that provide multimechanistic analgesia might present a more rational option.”
More potential prescriber warnings may be on the horizon: The FDA announced it is also reviewing scientific data on adverse outcomes related to interactions between benzodiazapines and opioids, and will announce any measures related to that analysis if and when they are needed.
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Ibsen heads to India to practice medicine
Posted on March 23, 2016 by Pharmaciststeve
Ibsen heads to India to practice medicine
(MTN News-Helena) After Dr. Mark Ibsen’s two-year battle with the state, the final action regarding his license to practice medicine was Tuesday afternoon. However, officials have not disclosed their ruling.
Ibsen, accused of over-prescribing pain killers to 9 patients, has been the subject of an inquiry by the board of medical examiners since 2013. His license to practice medicine is at stake.
More than a dozen of supporters crowded into the board’s meeting where the panel voted unanimously on a final action in the case until the order was signed by the board chair.
Ibsen told the news station that his license will be suspended. In order to be reinstated, he’ll be required to take a records keeping class and be under the supervision of another doctor.
Ibsen says his lawyer will appeal the ruling while the doctor moves to India to practice medicine.
Ibsens’ lawyer says he already has an appeal prepared to be filed in district court.
“But I’ve successfully weaned people off of opiates,” said Ibsen.
“And my patients have done well. And since I haven’t been seeing patients, they haven’t done well. And I’m good at what I do. And I wanna keep doing it. So I’m gonna keep using my skills the rest of my life. I’m a professional. Just taking my license doesn’t mean I’m not a healer,” said Ibsen.
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The DEA managed to highlight 20 years of their own abject failure to enforce federal drug laws with a single tweet Tuesday.
Posted on March 22, 2016 by Pharmaciststeve
DEA Admits Total Failure To Fight Heroin In One Stunning Tweet
The Drug Enforcement Administration (DEA) managed to highlight 20 years of their own abject failure to enforce federal drug laws with a single tweet Tuesday.
DEA HQToday’s heroin at the retail level costs less & is more potent than the heroin that DEA encountered two decades ago. http://go.usa.gov/c7FbJ
“Today’s heroin at the retail level costs less & is more potent than the heroin that DEA encountered two decades ago,” the agency declared on Twitter. The DEA also linked to a Department of Justice document on America’s “heroin epidemic.”
Despite decades of seizures, raids, community work, and billions of tax payer dollars, the DEA admits that heroin being sold in the US is cheaper and stronger than it was 20 years ago.
“The government arrested tens of millions of people and wasted more than a trillion dollars yet drugs are still cheap, potent, and readily available in every community,” said Bill Piper, Senior Director of National Affairs for the Drug Policy Alliance.
“It is good that the DEA is admitting that supply side efforts have failed; would be even better if they admitted that they have done more harm to communities than the drugs themselves.”
According to the DEA, drug overdoses eclipse deaths from car crashes and firearms, accounting for more then 47,000 deaths in 2014 or approximately 129 per day. More than half of these overdoses involved the use of heroin of a prescription opiod.
The number of people who used heroin at least once over the course of the year jumped from 373,000 in 2007 to 914,000 in 2014. Most of the heroin that ends up in the US originates in Mexico and Colombia.
The past several years have seen increased cultivation and heroin production, with a subsequent rise in trafficking from Mexico to the US, says the DEA.
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all medical error that is preventable, is the fourth leading cause of death in our country in 2016
Posted on March 22, 2016 by Pharmaciststeve
TV-6 Investigates: QCA lacks public medical mistake databases
http://kwqc.com/2016/03/21/tv-6-investigates-qca-lacks-public-medical-mistake-databases/
DAVENPORT, Iowa. (KWQC) – Wrong site surgeries are what doctors call never events, they should never happen. But it’s tough for patients in the Q.C.A. to find out if their hospital had any. Earlier this month TV-6 investigates revealed a state inspection citing Genesis Health System for failing to protect patients from wrong site surgeries at its hospitals. Genesis has since submitted a plan of corrections to fix what the inspector found. But patients have no way to find out how common wrong site surgeries are at any Iowa or Illinois hospital.
Half of the states across the country have some type of public reporting system for never events. These systems typically gather data on wrong site surgeries, patients given the wrong medication, and patients with tools left in their body after surgery. Illinois created a reporting system over a decade ago, but it’s still not operational because the state has never funded it. Iowa came close to implementing a system, but a state board never voted on it.
Patient safety expert Dr. David Nash said, “The public deserves complete and thorough transparency and accountability, from the medical system, I’m an absolute strong believer in that and always have been.”
Nash is a patient safety expert and an advocate for public reporting systems. He’s the editor in chief of the American Journal of Medical Quality. He was one of the first to publish a study comparing Philadelphia hospitals against their track records for open heart surgery. He says public data improves care.
“We also have had literally two decades of public reporting, maybe not always about wrong site surgery but certainly about the outcomes of many different types of surgery, so I firmly believe that reporting has contributed mightily to reducing wrong site surgery, reducing post operative infection,” said Nash.
State adverse event reporting systems were created in response to reports studying preventable medical errors. A Health and Human Services Inspector General study measured medical errors in Medicare patients who went to the hospital in October 2008. Of the one million Medicare patients discharged during that month, the HHS Inspector General found one in seven experienced an adverse event.
Nash said, “Medical error, all medical error that is preventable, is the fourth leading cause of death in our country in 2016, is hard to believe.”
The former director of the Iowa Department of Inspections and Appeals, Dean Lerner, tried to create a public adverse event reporting system in the state.
Lerner said, “I thought it would be a really good idea for Iowa to expose to the public in a very scientific and straightforward way one that had been approved by 20 other states, and make those kinds of events transparent.”
The Iowa Department of Inspections and Appeals inspects hospitals. Lerner believed implementing mandatory public reporting would improve health care in Iowa.
Lerner said, “If you ask any Iowan whether having this information would be valuable and important in the scheme of things in terms of their care, they will tell you yes.”
He brought his proposal to the hospital licensing board back in 2010. The minutes of two meetings show the board had a lot of questions. How would this data improve care? What had other states experienced? How would the data be used? The former chairman of the hospital licensing board Bob Miller said those were critical questions.
“It did not appear to us that there was a plan for what to do with the information to be gathered,” said Miller.
He said the board also felt a state-run public reporting system was redundant.
“We felt that there was a lot of reporting going on through the collaborative, required by CMS, and for our relicensure, Joint Commission,” said Miller.
The Iowa Healthcare Collaborative has gathered data voluntarily from all hospitals in the state since 2007. Its CEO, Dr. Tom Evans said the group publishes a report comparing hospital performance across the state.
“The never events are a starting point, they were a very popular thing to start talking about in the early 2000’s but we’ve moved so far beyond that,” said Evans.
He said the Collaborative’s report has flaws. It’s very technical, so patients in the state may not understand what is being compared and why those comparisons are important. He says they’re working on improving it.
“We want consumers to be engaged with meaningful information so we have other things, tracking infection rates and antibiotic usage and falls and pressures sore,” said Evans.
Evans believes focusing on never events like wrong site surgeries is distracting.
“I want consumers engaged, I want them looking at this information, and we want to be transparent, but we’ve got to give consumers meaningful information that they can make good healthcare decisions based upon,” said Evans.
Miller said those concerns were key in the discussion.
“Is it going to improve quality of care of is it going to penalize an error,” said Miller.
Lerner said he needed the board’s support to move forward with a state public reporting system. He planned to answer questions as they came up.
“We didn’t want to jump with both feet before we carefully analyzed everything was to take this one step at a time, and I honestly thought that would help industry to adjust and get comfortable with the change,” said Lerner.
At the meeting back in 2010, chairman Bob Miller twice called for a motion on the proposal to create a public adverse event reporting system. No one on the board made one. The idea died without anyone casting a vote.
Never events at Iowa hospitals continue to remain hidden from public view. Iowa hospitals are not required to publicly report never events to anyone. Patient safety advocate David Nash said adverse events should be public knowledge.
“If we’re going to have consumer engagement in health care and consumers having more skin in the game with higher deductibles, they have every right to be able to connect the dots between what hospital is in my network and what are the outcomes of care for procedures that I may need, or family members may need in those institutions,” said Nash.
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“ADDICTED” to campaign contributions?
Posted on March 22, 2016 by Pharmaciststeve
Florida Attorney General Pam Bondi becomes latest victim of the Trump Curse.
Executive summary: Florida Attorney General Pam Bondi in 2013 was considering joining in a lawsuit against Trump University. Shortly thereafter, a check for $25,000 was sent to Bondi’s campaign political action committee [electioneering communications organization] “And Justice For All” by the Trump Foundation. AG Bondi (who has since endorsed Trump) ended up not joining in on the Trump University lawsuit. So far, so bad: but here’s the wrinkle: the left-wing government transparency group CREW (Citizens for Responsibility and Ethics in Washington) today noted that the Trump Foundation is a 501(c)(3) nonprofit organization, and is thus not permitted to make campaign contributions*. Nobody noticed at the time because while the Trump Foundation reported the contribution properly on Florida campaign finance disclosure forms, it reported it to the IRS as a contribution to “Justice For All,” which is a non-political, pro-life group out of Kansas. Justice for All has confirmed that they never got that money; CREW has now lodged a formal complaint with the IRS.
Now, I have a powerful advantage over many people when it comes to this sort of thing: a very smart, aggressively apolitical, and nigh-infinitely sensible wife. I often use her as a check on my enthusiasms; she has accurately forecast the limits to many a political scandal that I have pitched to her, over the years. But when I described this one to her, she looked at me as if either I was joking, or I had left something out, or both. But no, I had not. The bottom line is, the Trump Foundation shouldn’t have offered that contribution and Bondi’s PAC ECO shouldn’t have taken it. And it looks really, really bad that it just happens that the IRS got told wrong information that just happened to keep the IRS’s own internal watchdogs from independently starting an investigation into a potential violation of campaign finance law**.
Whether or not Donald Trump survives this one is, alas, open to debate: after all, the man routinely survives worse. But it really doesn’t look good for AG Pam Bondi. I mean, why did her PAC ECO take a campaign contribution from a 501(c)(3) nonprofit? Did they figure that it wouldn’t get noticed? – Although, to be fair: if Trump hadn’t run for President, it might not have…
*Exact text is “Organizations that are exempt from income tax under section 501(a) of the Internal Revenue Code as organizations described in section 501(c)(3) may not participate in, or intervene in (including the publishing or distributing of statements), any political campaign on behalf of (or in opposition to) any candidate for public office.”
**There’s a certain karma here, given that this entire affair was made possible by a bad law created in large part by Senator John McCain. Still, bad law or no: one should never give the impression that one is trying to flaunt [that you’re breaking] the rules.
[Some mild editing, after the fact. Most pertinently, Bondi used an Electioneering Communications Organization {ECO}, not a PAC; it can coordinate with the candidate, but has a more limited scope and cannot operate at certain times during the election cycle. It is definitely not a Super PAC. – ML]
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FDA:We are going to be dealing with opioids every day
Posted on March 21, 2016 by Pharmaciststeve
The Senate last month confirmed Dr. Robert Califf to run one of the world’s most influential health agencies, the U.S. Food and Drug Administration. The 89-4 vote followed a delay by a handful of lawmakers who had turned President Obama’s nomination into a proxy fight over the FDA’s willingness to approve opioid pain-killers, despite a growing problem with addiction nationwide. Opioid addiction will be a major priority, Califf says, but it is just one of the items on his to-do list. As commissioner of the FDA, his responsibilities extend from the safety of the U.S. food supply to the regulation of drugs, some produced through scientific advances that were unimaginable even a few years ago.
Prior to his appointment, Califf was professor of cardiology at Duke University School of Medicine and has led numerous landmark clinical trials and served on many pivotal committees, including one charged with developing recommendations for identifying and preventing medication errors.
In his first in-depth interview since taking office, Califf spoke with U.S. News about his agency’s efforts to fight the opioid epidemic, the future of cancer research and other priorities. Excerpts:
Your nomination was held up by senators concerned about the opioid epidemic. How is FDA responding to their concerns?
We are going to be dealing with opioids every day, until everyone’s convinced that the tide has turned and the problem is receding significantly. It’s a very big problem and we’re going to stay hyperaware and focused on it.
We are working in conjunction with [the U.S. Centers for Disease Control and Prevention] to support their guidelines. The fundamental issue right now is over-prescribing and FDA has a major role to play. The guidelines say prescribe fewer opioids. Don’t neglect people in significant and chronic pain, but prescribe fewer opioids
You’ve advocated the development of abuse-deterrent forms of pain-killers that make it more difficult for abusers to crush pills so that they can inject the medicine. Critics say this won’t solve the problem. What’s your response?
We completely agree that if you take an abuse-deterrent formulation, it doesn’t change the risk that you could get addicted. But formulations that work may still prevent some forms of abuse. It’s early days. There’s a lot of technology development to do. It’s a very high priority for us to work with industry to come up with effective abuse- deterrent formulations.
What is at the top of your agenda for FDA?
The workforce. We have a tremendous workforce that has done a pretty amazing job across the ecosystem from agriculture to medical products. We’re going to need to reinforce that by hiring really good people and creating the best possible environment to retain the really great people that we have. The expertise you need to be great at FDA is the same expertise needed in cutting-edge companies that are developing new medical products or health related information technology – or figuring out ways to get higher yields in agriculture with better nutrition.
You’ve long been an advocate of rethinking the studies that we use to approve drugs and draw conclusions about public health. How do you see these changing?
In the way we generate [scientif
ic] evidence. The FDA does really well when it has high quality evidence. It’s really good at making decisions that benefit the public health. When decisions have to be made without the highest quality evidence, it’s not ideal. What’s really great now is that – with over $50 billion invested in electronic health records and with multiple other sources of data, from social media to high-end computation to devices that are implanted or wearable – we’ve got an amazing opportunity to increase the evidence that will drive good decisions.
[RELATED: CDC Issues Guidance on Prescription Painkillers]
Another way to think abou
t this is that we’ve been very dependent on clinical [drug] trials as one key source of information. Clinical trials are very expensive; as we learn to use existing data sources better, the cost of clinical trials can come way down. This is also pertinent to food safety… If you think of the vast diversity and complexity of agriculture, there’s no way you can inspect every product, one product at a time. But when you use high-end analytics, one can [target] the more detailed inspections to where the problems are.
What about clinical trials specifically, the hugely expensive studies that examine the risks and benefits of medication?
In this era, genetic and genomic information have given us the opportunity to develop targeted therapy and treat rare diseases in ways that wouldn’t have been imaginable before. This also affects clinical trial design. In some cases, [involving rare diseases,] clinical trials may actually be a lot smaller and more targeted [than in the past]. In other cases, when therapy might be administered to millions of people on a global basis, they may need to be much larger and more inclusive.
How much influence does FDA have when it comes to shaping the design of these trials?
FDA gets to see all the trials before they’re started, if they’re done with the goal of gaining approval or changing the label. This is a very powerful position to be in, with a lot of responsibility. As you might imagine, people don’t want to do a trial that the FDA doesn’t like, if they need FDA’s approval when the trial’s completed.
After decades of relativ
e drought, there are dozens of cancer drugs in the pipeline. Have we turned a corner in cancer treatment ?
You’re right, if you went back a couple of decades, there was a lot of worry that cancer was an area where progress was slow. It was hard to find highly effective therapies. That’s totally reversed. The ability to implement targeted chemotherapy and immunotherapy appears to be revolutionary. But it appears that it is not a magic bullet.
[Cancer researcher Dr.] Bert Vogelstein at Johns Hopkins [University School of Medicine] has a tremendous lecture on this. He makes the point that we really are at war with cancer: We fire our salvo in terms of therapy, and the cancer responds by adapting and changing its tactics. Then we have to go after it again. For many kinds of cancer, we n
ow, for the first time, have effective treatments. But…many people need additional treatment as time goes on.
Our growing understanding of the human genome makes it possible to come up with precisely targeted therapies for many diseases, not just cancer. What does the precision medicine revolution look like from your perspective?
[PHOTOS: The Big Picture – March 2016]
It’s useful to think about precision medicine and the cancer “moonshot” [Vice-President Joseph Biden’s effort to accelerate research to find a cure] as being tightly integrated and overlapping. To me, of course, [the power of] genetics and genomics to help us understand the molecular basis of disease is crucial for being able to target therapies better than we could before. But it goes beyond genetics. If you look at the Precision Medicine Initiative [the White House plan to study one million people and precisely target therapies] the emerging use of wearable technology and social media allows us to understand things like patient prefere
nces and continuously record data that we couldn’t monitor before.
One part of precision medicine would be to say, “We understand you have gene that’s putting you at risk and we have developed a treatment.” Another would be to say, “Now that we can look at your blood pressure [24 hours a day, seven days a week] we understand you have a pattern that’s different. You need a treatment that is different.” Or, “We have three different treatments for your problem, and now that we can communicate with you about your preferences, we can make the treatment more precise to achieve the risk-benefit trade-off that’ s important to you.”
If you look at the Precision Medicine [million-person study] – the initial funding is underway now – it will be built along the whole spectrum from genes to patient preferences.
How does this affect FDA?
As you can imagine, this has major implications for FDA. As precision medicine therapies are developed, they still, like everything else, have to meet evidentiary standards to be put on the market and made available.
Do you have to create thes
e new standards out of whole cloth?
In many cases, they will be less different than people think. If we were restricted by paper records, as we used to be, we might say, “Gee if you’ve got a targeted therapy that pertains to a small part of the population you can’t possibly do a [large] clinical trial. But when everybody has an electronic health record and people can sign up on the web to be part of the Precision Medicine Initiative [research study] we may not be limited by the kinds of things that kept us from getting high-level evidence before.
In other cases?
There are areas that are entirely novel. One that’s getting a lot of our attention now is next-generation sequencing. Up until now, one worked in a lab [and developed one test at a time]. Next-ge
neration sequencing allows [us to decode] the entire genome all at once. Each one of us has three billion base pairs in our genome. You could say it’s like doing 3 billion tests at one time on each individual person.
It’s obvious we can’t regulate that one test at a time. We’re working closely with the National Institutes of Health and others to develop…what’s called a data commons. You put the [sequence] data in a big database—which, by the way, would have been impossible three years ago, because you need cloud computing to do it. We can look at the database and see which tests are working and which aren’t. And we can label the tests appropriately, so that, when a doctor orders a test, there’s a much higher chance of understanding what the result means when the test comes back. It’s a whole new away of thinking about regulation, made possible by this amazing change in technology.
Everyone’s concerned about the high cost of drugs. Can FDA do anything about it?
The fact that over 90 percent of prescriptions are now [lower-cost] generics is a major victory. it’s critical for us to keep the pipeline of generics healthy.
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Converting a BRIBE into a CAMPAIGN CONTRIBUTION
Posted on March 20, 2016 by Pharmaciststeve
Filed under: General Problems | 1 Comment »
Congress continues to be in denial that drug abuse is a DISEASE ?
Posted on March 20, 2016 by Pharmaciststeve
Senate passes Ensuring Patient Access and Effective Drug Enforcement Act
WASHINGTON — The Senate this week unanimously passed the Ensuring Patient Access and Effective Drug Enforcement Act to help ensure that prescription drugs land in the hands of patients and not those who would abuse them.
The bill, authored by Sens. Orrin Hatch, R-Utah, and Sheldon Whitehouse, D-R.I. and advocated by the National Association of Chain Drug Stores, would clarify the standards companies must meet when protecting prescription drugs from being diverted toward improper uses and help protect patients from dangerous disruptions in the production and delivery of their prescription drugs.
The U.S. House of Representatives passed its largely similar version of the bill (H.R. 471) in April 2015. Congressional leaders will need to determine the best path to achieving passage of the exact same legislative language in both chambers, so the bill can advance to the President.
“Prescription drug abuse is a complicated and troubling trend that requires better coordination between drug manufacturers and law enforcement,” Hatch said. “The fact that prescription drugs can be abused should not prevent patients from receiving the medications they need. This bill takes a balanced approach to the problem of prescription drug abuse by clarifying penalties for manufacturing or dispensing outside approved procedures while helping to ensure that supply chains to legitimate users remain intact.”
“By offering better guidance for companies in the prescription drug supply chain, and by promoting better communication between those companies and federal regulators, this bill can help fight drug abuse and ensure that patients have access to their prescriptions,” Whitehouse added.
In late February, NACDS sent a letter to members of the U.S. Senate, urging the passage that was achieved yesterday. “NACDS appreciates the diligence that has brought this legislation to the brink of enactment,” commented Steven Anderson, NACDS president and CEO. “Throughout, NACDS has emphasized pharmacy’s commitment to a zero-tolerance for abuse and diversion, and a 100% commitment to patient care. This legislation will help to deliver on that vision.”
“The passage of S. 483, coupled with Senate’s approval of the Comprehensive Addiction and Recovery Act (S. 524), substantially enhances the range of tools now available to regulators, supply chain stakeholders and the broader healthcare community to effectively address the prescription drug abuse epidemic,” added John Gray, president and CEO of the Healthcare Distribution Management Association.
NACDS and HDMA have both expressed strong support for this legislation.
According to the Senators, the Controlled Substances Act currently does not make clear which factors the Drug Enforcement Agency should consider when deciding whether to register a company applying to manufacture or distribute prescription drugs. Hatch and Whitehouse’s legislation directs the DEA to use findings Congress compiled while drafting the CSA to define those factors.
The bill also describes the circumstances under which the Attorney General can suspend a company’s registration. Finally, it allows companies that violate the CSA an opportunity to work with the DEA to correct the violation before having their registration revoked.
NACDS has noted that the steady progress of the legislation in the Congress can be considered to be highly consistent with public attitudes. In an opinion study commissioned by NACDS last summer, likely voters who are engaged and aware when it comes to current events indicated through their responses an appreciation for the need to address drug abuse and drug access in a complementary manner.
Nearly 8-in-10 respondents agreed with the statement: “Pharmacies have a dual role when it comes to battling prescription drug abuse: They have to be part of the solution by working with law enforcement officials to stop prescription drug abuse, but they also have to maintain their responsibilities to patients by making sure they receive the medications they legitimately need.”
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