Thursday, October 11, 2018
Fusion GPS Founder Will Plead The Fifth To Avoid Testifying To Congress
dailycaller
The co-founder of the opposition
research firm behind the Steele dossier, Glenn Simpson, will invoke his
First and Fifth Amendment privileges to avoid testifying before Congress
next week, his lawyer has told Congress.
According to The Hill, Simpson’s attorney, Joshua Levy, told House Judiciary Committee Chairman Rep. Bob Goodlatte that Simpson will not appear for a deposition because the congressional investigation “is not designed to discover the truth.”
The Virginia Republican subpoenaed Simpson on Sept. 29 after Levy said his client would not appear voluntarily for an interview before members of the House Judiciary and House Oversight & Government Reform committees.
Simpson’s firm, Fusion GPS, was hired during the 2016 presidential campaign by the law firm that represented the DNC and Clinton campaign. Fusion GPS hired former British spy Christopher Steele to conduct an investigation into Donald Trump’s possible links to Russia. The result of the probe was a 35-page report alleging collusion between the Trump campaign and Kremlin.
Republican lawmakers are interested in the dossier, largely because the FBI reportedly relied on the unverified document to obtain surveillance warrants against former Trump campaign adviser Carter Page.
In addition to investigating Trump and his associates, Fusion GPS has helped plant anti-Trump news stories with numerous news outlets. Simpson helped arrange meetings between Steele and journalists from The New York Times, The Washington Post, The New Yorker, and Yahoo! News.
Simpson has already testified before the House Intelligence and Senate Judiciary committees. But Republicans lawmakers hoped to depose him again to ask him about testimony provided by Bruce Ohr, a Justice Department official who was in contact with both Simpson and Steele.
Ohr’s congressional testimony has cast doubt on what Simpson told the House Intelligence panel last November.
Ohr testified on Aug. 28 that he met Simpson twice in 2016, before and after the election. The first meeting took place in August 2016 after Simpson emailed Ohr. Ohr’s notes show that he took notes related to the Trump investigation during his encounter with Simpson.
(RELATED: Bruce Ohr’s Congressional Testimony Undermined Glenn Simpson’s)
But Simpson testified that he met Ohr only after the election, and at Ohr’s request. And though Simpson acknowledged meeting Ohr, he did not tell congressional investigators that Ohr’s wife, Nellie, worked for Fusion GPS while the firm was investigating Trump.
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According to The Hill, Simpson’s attorney, Joshua Levy, told House Judiciary Committee Chairman Rep. Bob Goodlatte that Simpson will not appear for a deposition because the congressional investigation “is not designed to discover the truth.”
The Virginia Republican subpoenaed Simpson on Sept. 29 after Levy said his client would not appear voluntarily for an interview before members of the House Judiciary and House Oversight & Government Reform committees.
Simpson’s firm, Fusion GPS, was hired during the 2016 presidential campaign by the law firm that represented the DNC and Clinton campaign. Fusion GPS hired former British spy Christopher Steele to conduct an investigation into Donald Trump’s possible links to Russia. The result of the probe was a 35-page report alleging collusion between the Trump campaign and Kremlin.
Republican lawmakers are interested in the dossier, largely because the FBI reportedly relied on the unverified document to obtain surveillance warrants against former Trump campaign adviser Carter Page.
In addition to investigating Trump and his associates, Fusion GPS has helped plant anti-Trump news stories with numerous news outlets. Simpson helped arrange meetings between Steele and journalists from The New York Times, The Washington Post, The New Yorker, and Yahoo! News.
Simpson has already testified before the House Intelligence and Senate Judiciary committees. But Republicans lawmakers hoped to depose him again to ask him about testimony provided by Bruce Ohr, a Justice Department official who was in contact with both Simpson and Steele.
Bruce Ohr testified on Capitol Hill on Aug. 28, 2018. (Youtube screen grab/Fox News)
Ohr testified on Aug. 28 that he met Simpson twice in 2016, before and after the election. The first meeting took place in August 2016 after Simpson emailed Ohr. Ohr’s notes show that he took notes related to the Trump investigation during his encounter with Simpson.
(RELATED: Bruce Ohr’s Congressional Testimony Undermined Glenn Simpson’s)
But Simpson testified that he met Ohr only after the election, and at Ohr’s request. And though Simpson acknowledged meeting Ohr, he did not tell congressional investigators that Ohr’s wife, Nellie, worked for Fusion GPS while the firm was investigating Trump.
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Tags : christopher steele donald trump glenn simpsonWednesday, October 10, 2018
The Global ‘Mental Health’ Movement – Cause For Concern
madinamerica
Justin Karter 10/10/2018
This week, we present the first in a series of interviews on the topic of the global ‘mental health’ movement. These interviews will be led by our Mad in America research news team.
[Ed; at the link. Listen to interview]
In this episode, we interview Dr. Melissa Raven, who is a psychiatric epidemiologist, policy analyst and postdoctoral research fellow in the Critical and Ethical Mental Health research group at the University of Adelaide, South Australia. Originally qualified as a clinical psychologist, she then worked as a lecturer and researcher in public health and primary health care. Her current mental health research and advocacy is informed by a strong social determinants perspective and a strong critical orientation, which she applies to a range of topics, including suicide prevention, workplace mental health, (over)diagnosis, (inappropriate) prescribing, and conflicts of interest in mental health and the broader health/welfare arena.
On October 10th, 2018, World Mental Health Day, The Lancet Commission on Global Mental Health and Sustainable Development published a report outlining a proposal to “scale up” mental health care globally. At the same time, the UK government is hosting a Global Mental Health Ministerial Summit with the intention of laying out a course of action to implement these mental health policies globally.
In response, a coalition of mental health activists and service-users have organized an open letter detailing their concerns with the summit and report. The response has attracted the support of critical professionals, psychologists, psychiatrists, and researchers.
Thank You Mr Karter and MIA.
Justin Karter 10/10/2018
This week, we present the first in a series of interviews on the topic of the global ‘mental health’ movement. These interviews will be led by our Mad in America research news team.
[Ed; at the link. Listen to interview]
In this episode, we interview Dr. Melissa Raven, who is a psychiatric epidemiologist, policy analyst and postdoctoral research fellow in the Critical and Ethical Mental Health research group at the University of Adelaide, South Australia. Originally qualified as a clinical psychologist, she then worked as a lecturer and researcher in public health and primary health care. Her current mental health research and advocacy is informed by a strong social determinants perspective and a strong critical orientation, which she applies to a range of topics, including suicide prevention, workplace mental health, (over)diagnosis, (inappropriate) prescribing, and conflicts of interest in mental health and the broader health/welfare arena.
On October 10th, 2018, World Mental Health Day, The Lancet Commission on Global Mental Health and Sustainable Development published a report outlining a proposal to “scale up” mental health care globally. At the same time, the UK government is hosting a Global Mental Health Ministerial Summit with the intention of laying out a course of action to implement these mental health policies globally.
In response, a coalition of mental health activists and service-users have organized an open letter detailing their concerns with the summit and report. The response has attracted the support of critical professionals, psychologists, psychiatrists, and researchers.
Thank You Mr Karter and MIA.
Trump Signs Bills Lifting Pharmacist 'Gag Clauses' On Drug Prices
NBC news
Dartunorro Clark and Brenda Breslauer / Oct.10.2018 / 3:31 PM EDT / Updated 5:22 PM EDT
President Donald Trump signed two bills at the White House on Wednesday aimed at lowering pharmaceutical drug prices by promoting greater disclosure in drug pricing.
The two bills the president signed — the Know the Lowest Price Act and the Patients' Right to Know Drug Prices Act — are meant to prevent "gag clauses" in agreements between pharmacies and pharmacy benefit managers, the middlemen who administer prescription drug programs for insurance companies, which pharmacists say kept them from disclosing cheaper drug options to consumers.
"It's way out of whack. It's way too high," Trump said of the current state of drug pricing at the signing. "You look at prices in our country and for the exact same drug in other countries, it's much lower — made in the same plant by the same company — and I said, 'What's going on?'"
continue reading
And Here's Kaiser Health News on this, where you'll get a lot more background. (published Before Trump signed the bill)
No More Secrets: Congress Bans Pharmacist ‘Gag Orders’ On Drug Prices
For years, most pharmacists couldn’t give customers even a clue about an easy way to save money on prescription drugs. But the restraints are coming off.
When the cash price for a prescription is less than what you would pay using your insurance plan, pharmacists will no longer have to keep that a secret.
President Donald Trump was scheduled to sign two bills Wednesday that ban “gag order” clauses in contracts between pharmacies and insurance companies or pharmacy benefit managers — those firms that negotiate prices for employers and insurers with drugstores and drugmakers. Such provisions prohibit pharmacists from telling customers when they can save money by paying the pharmacy’s lower cash price instead of the price negotiated by their insurance plan.
The bills — one for Medicare and Medicare Advantage beneficiaries and another for commercial employer-based and individual policies— were passed by Congress in nearly unanimous votes last month.
“Americans deserve to know the lowest drug price at their pharmacy, but ‘gag clauses’ prevent your pharmacist from telling you!” Trump wrote on Twitter three weeks ago, shortly before the Senate voted on the bills. “I support legislation that will remove gag clauses.” The change was one of the proposals included in Trump’s blueprint to cut prescription drug prices issued in May.
Ronna Hauser, vice president of payment policy and regulatory affairs at the National Community Pharmacists Association, said many members of her group “say a pharmacy benefit manager will call them with a warning if they are telling patients it’s less expensive” without insurance. She said pharmacists could be fined for violating their contracts and even dropped from insurance networks.
According to research published in JAMA in March, people with Medicare Part D drug insurance overpaid for prescriptions by $135 million in 2013. Copayments in those plans were higher than the cash price for nearly 1 in 4 drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33 percent.
Yet some critics say eliminating gag orders doesn’t address the causes of high drug prices. “As a country, we’re spending about $450 billion on prescription drugs annually,” said Steven Knievel, who works on drug price issues for Public Citizen, a consumer advocacy group. The modest savings gained by paying the cash price “is far short of what needs to happen to actually deliver the relief people need.”
After the president signs the legislation affecting commercial insurance contracts, gag order provisions will immediately be prohibited, said a spokesman for Sen. Susan Collins (R-Maine), who co-authored the bill. The bill affecting Medicare beneficiaries wouldn’t take effect until Jan. 1, 2020.
But there’s a catch: Under the new legislation, pharmacists will not be required to tell patients about the lower cost option. If they don’t, it’s up to the customer to ask.
The Pharmaceutical Care Management Association, a trade group representing pharmacy benefit managers, said gag orders are increasingly rare. The association supported the legislation. Some insurers have also said their contracts don’t include these provisions. Yet two members of Congress have encountered them at the pharmacy counter.
At a hearing on the gag order ban, Collins said she watched a couple leave a Bangor, Maine, pharmacy without their prescription because they couldn’t afford the $111 copayment and the pharmacist did not advise them about saving money by paying directly for the medicine. When she asked him how often that happens, he said every day.
“Banning gag clauses will make it easier for more Americans to afford their prescription drugs because pharmacists will be able to proactively notify consumers if a less expensive option may be available,” she said last week.
When Rep. Debbie Dingell (D-Mich.) went to a Michigan pharmacy to pick up a prescription recently, she was told it would cost $1,300. “After you peeled me off the ceiling, I called the doctor and screamed and talked to the pharmacist,” she recalled during a hearing last month. “I’m much more aggressive than many in asking questions,” she admitted, and ended up saving $1,260 after she learned she could get an equivalent drug for $40.
While the legislation removes gag orders, it doesn’t address how patients who pay the cash price outside their insurance plan can apply that expense toward meeting their policy’s deductible.
But for Medicare beneficiaries there is a little-known rule — not found in the “Medicare & You” handbook or on its website —that helps people with Medicare Part D or Medicare Advantage coverage. If they pay the lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation to their plan, insurers must count it toward patients’ out-of-pocket expenses.
The total of those expenses are important because that amount affects the drug coverage gap commonly called the “doughnut hole.” (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
And beneficiaries don’t have to wait until the gag order ban takes effect in two years.
The Medicare rule also says that if a senior asks about a lower price for a prescription, the pharmacist can answer.
Rep. Buddy Carter (R-Ga.), a pharmacist who sponsored the Medicare gag order bill, said he wasn’t surprised by the bipartisan support for the legislation. “High prescription drug costs affect everyone,” he said.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
[Update: This story was updated at 10 a.m. ET on Oct. 10 to note that President Donald Trump’s schedule included his plans to sign the bills that day.]
Thank You President Trump, KHN, and NBC.
Dartunorro Clark and Brenda Breslauer / Oct.10.2018 / 3:31 PM EDT / Updated 5:22 PM EDT
President Donald Trump signed two bills at the White House on Wednesday aimed at lowering pharmaceutical drug prices by promoting greater disclosure in drug pricing.
The two bills the president signed — the Know the Lowest Price Act and the Patients' Right to Know Drug Prices Act — are meant to prevent "gag clauses" in agreements between pharmacies and pharmacy benefit managers, the middlemen who administer prescription drug programs for insurance companies, which pharmacists say kept them from disclosing cheaper drug options to consumers.
"It's way out of whack. It's way too high," Trump said of the current state of drug pricing at the signing. "You look at prices in our country and for the exact same drug in other countries, it's much lower — made in the same plant by the same company — and I said, 'What's going on?'"
continue reading
And Here's Kaiser Health News on this, where you'll get a lot more background. (published Before Trump signed the bill)
No More Secrets: Congress Bans Pharmacist ‘Gag Orders’ On Drug Prices
For years, most pharmacists couldn’t give customers even a clue about an easy way to save money on prescription drugs. But the restraints are coming off.
When the cash price for a prescription is less than what you would pay using your insurance plan, pharmacists will no longer have to keep that a secret.
President Donald Trump was scheduled to sign two bills Wednesday that ban “gag order” clauses in contracts between pharmacies and insurance companies or pharmacy benefit managers — those firms that negotiate prices for employers and insurers with drugstores and drugmakers. Such provisions prohibit pharmacists from telling customers when they can save money by paying the pharmacy’s lower cash price instead of the price negotiated by their insurance plan.
The bills — one for Medicare and Medicare Advantage beneficiaries and another for commercial employer-based and individual policies— were passed by Congress in nearly unanimous votes last month.
“Americans deserve to know the lowest drug price at their pharmacy, but ‘gag clauses’ prevent your pharmacist from telling you!” Trump wrote on Twitter three weeks ago, shortly before the Senate voted on the bills. “I support legislation that will remove gag clauses.” The change was one of the proposals included in Trump’s blueprint to cut prescription drug prices issued in May.
Ronna Hauser, vice president of payment policy and regulatory affairs at the National Community Pharmacists Association, said many members of her group “say a pharmacy benefit manager will call them with a warning if they are telling patients it’s less expensive” without insurance. She said pharmacists could be fined for violating their contracts and even dropped from insurance networks.
According to research published in JAMA in March, people with Medicare Part D drug insurance overpaid for prescriptions by $135 million in 2013. Copayments in those plans were higher than the cash price for nearly 1 in 4 drugs purchased in 2013. For 12 of the 20 most commonly prescribed drugs, patients overpaid by more than 33 percent.
Yet some critics say eliminating gag orders doesn’t address the causes of high drug prices. “As a country, we’re spending about $450 billion on prescription drugs annually,” said Steven Knievel, who works on drug price issues for Public Citizen, a consumer advocacy group. The modest savings gained by paying the cash price “is far short of what needs to happen to actually deliver the relief people need.”
After the president signs the legislation affecting commercial insurance contracts, gag order provisions will immediately be prohibited, said a spokesman for Sen. Susan Collins (R-Maine), who co-authored the bill. The bill affecting Medicare beneficiaries wouldn’t take effect until Jan. 1, 2020.
But there’s a catch: Under the new legislation, pharmacists will not be required to tell patients about the lower cost option. If they don’t, it’s up to the customer to ask.
The Pharmaceutical Care Management Association, a trade group representing pharmacy benefit managers, said gag orders are increasingly rare. The association supported the legislation. Some insurers have also said their contracts don’t include these provisions. Yet two members of Congress have encountered them at the pharmacy counter.
At a hearing on the gag order ban, Collins said she watched a couple leave a Bangor, Maine, pharmacy without their prescription because they couldn’t afford the $111 copayment and the pharmacist did not advise them about saving money by paying directly for the medicine. When she asked him how often that happens, he said every day.
“Banning gag clauses will make it easier for more Americans to afford their prescription drugs because pharmacists will be able to proactively notify consumers if a less expensive option may be available,” she said last week.
When Rep. Debbie Dingell (D-Mich.) went to a Michigan pharmacy to pick up a prescription recently, she was told it would cost $1,300. “After you peeled me off the ceiling, I called the doctor and screamed and talked to the pharmacist,” she recalled during a hearing last month. “I’m much more aggressive than many in asking questions,” she admitted, and ended up saving $1,260 after she learned she could get an equivalent drug for $40.
While the legislation removes gag orders, it doesn’t address how patients who pay the cash price outside their insurance plan can apply that expense toward meeting their policy’s deductible.
But for Medicare beneficiaries there is a little-known rule — not found in the “Medicare & You” handbook or on its website —that helps people with Medicare Part D or Medicare Advantage coverage. If they pay the lower cash price for a covered drug at a pharmacy that participates in their insurance plan and then submit the proper documentation to their plan, insurers must count it toward patients’ out-of-pocket expenses.
The total of those expenses are important because that amount affects the drug coverage gap commonly called the “doughnut hole.” (This year, the gap begins after the plan and beneficiary spend $3,750 and ends once the beneficiary has spent a total of $5,000.)
And beneficiaries don’t have to wait until the gag order ban takes effect in two years.
The Medicare rule also says that if a senior asks about a lower price for a prescription, the pharmacist can answer.
Rep. Buddy Carter (R-Ga.), a pharmacist who sponsored the Medicare gag order bill, said he wasn’t surprised by the bipartisan support for the legislation. “High prescription drug costs affect everyone,” he said.
KHN’s coverage of prescription drug development, costs and pricing is supported in part by the Laura and John Arnold Foundation.
[Update: This story was updated at 10 a.m. ET on Oct. 10 to note that President Donald Trump’s schedule included his plans to sign the bills that day.]
Thank You President Trump, KHN, and NBC.
Weekend reads: Views on the “grievance studies” hoax; universities play “pass the harasser;” what next for NEJM?
OK. So it's not the weekend. Our bad. Better late than never.
Retractionwatch
Before we present this week’s Weekend Reads, a question: Do you enjoy our weekly roundup? If so, we could really use your help. Would you consider a tax-deductible donation to support Weekend Reads, and our daily work? Thanks in advance.
The week at Retraction Watch featured questions about what should happen to a paper published by Theranos; a replication of a famous paper on treatment of writer’s block that led to — well, you’ll see; a researcher joining our leaderboard’s top 10; and a data faker who became chief scientific officer of a cannabis product company. Here’s what was happening elsewhere:
Thank You Retraction Watch.
Retractionwatch
Before we present this week’s Weekend Reads, a question: Do you enjoy our weekly roundup? If so, we could really use your help. Would you consider a tax-deductible donation to support Weekend Reads, and our daily work? Thanks in advance.
The week at Retraction Watch featured questions about what should happen to a paper published by Theranos; a replication of a famous paper on treatment of writer’s block that led to — well, you’ll see; a researcher joining our leaderboard’s top 10; and a data faker who became chief scientific officer of a cannabis product company. Here’s what was happening elsewhere:
- They’re at it again: A group of authors has undertaken a “project to study, understand, and expose the reality of grievance studies, which is corrupting academic research.” In other words, a sting. (Areo Magazine)
- “We’ve learned that when you send in a convincing paper full of fake data, you can get it published. But we’ve known that for decades.” Our Ivan Oransky weighs in on the “grievance studies” hoax. And so does Dan Engber of Slate.
- What happens to taxpayer money when scientists are faced with accusations or findings of wrongdoing? (Francie Diep, Pacific Standard)
- What’s next for the New England Journal of Medicine, as its longtime editor Jeffrey Drazen is retiring?
- It’s “neither wise nor fair to expect self-motivated data vigilantes to police scientific flaws,” writes Keith Baggerly, who was instrumental in uncovering the issues in work by Anil Potti. (Nature)
- “Who Says You Need Permission to Study Yourself?” The Karolinska Institutet does, reports Emily Mullin. (NEO.LIFE)
- A project aims to determine, among other things, “how can society as a whole maintain confidence in a sector more and more suspected of treachery and how is this reflected in funding programs and policy as a whole?”
- “Dr. Oransky said that while Dr. Wansink’s behavior was egregious, it is not something that is isolated to nutrition.” (Anahad O’Connor, New York Times)
- “Editors of book series stop publishing with Springer Nature to protest its acquiescence to Chinese government censorship demands.” (Elizabeth Redden, Inside Higher Ed)
- When Elsevier and Springer Nature work together on retractions.
- A group of authors has written an open letter “to highlight editorial bias at the [British Journal of Sports Medicine] evidenced by a lack of robust and transparent governance of the decision-making processes of the Editor in Chief.”
- “A leading London university is planning to publish annual data on harassment, bullying and sexual misconduct after investigations by the Guardian and the Observer revealed the scale of these issues at top British institutions.” (Sarah Marsh and Hannah Devlin, The Guardian)
- “Around 20% of the articles were written about women, with the highest share of 24% in Arts and Humanities. Both male and female authors write more often about men than about women, a stable situation for the last 70 years.” (Scientometrics)
- Bad Science: PeerJ’s Jason Hoyt talks to Corina Logan.
- “We find that between 1974 and 2014 0.1% of publications in the top 50 economics journals were replication studies.” (Research Policy, sub req’d)
- “I reached out to both the authors and the editors of PLOS, but to date, there are no updates or corrections on the article itself.” Zad Chow on why it’s so difficult to correct the scientific record.
- The CNRS is punishing two scientists for misconduct. (Jef Akst, The Scientist)
- “For most but not all papers in the literature there is only one α-author.” A new way to measure scientific leadership? (J.E. Hirsch, arXiv)
- Six months after the U.S. ORI announced findings in the Murthy case, and almost a decade after the University of Alabama said he likely fabricated a dozen protein structures, Biochemistry has retracted two of Murthy’s papers.
- Sometimes, apparently, retractions need to be corrected. (Cancer Biotherapy & Radiopharmaceuticals)
- “How a failed psoriasis study pushed a whole field forward.” (Sam Herron, Salon/Massive)
- “Science has big plans for the social sciences, including an increased emphasis on interdisciplinarity, methodologically rigorous research, and increased transparency.” Of note: Tage Rai, the incoming editor of the subject for Science, posted this in PsyArXiv.
- CERN has suspended a physicist “after he allegedly denied that physics suffers from a male gender bias and criticized affirmative-action policies,” Davide Castelvecchi reports. (Nature)
- “Must academic evaluation be so citation data driven?” Steve Fuller says “we might wish to consider whether the tail is wagging the dog in the case of academia’s fixation on citations as a measure of intellectual value.”
- When it comes to using the h-index to judge research, “Unfortunately, Indian regulatory and funding agencies have institutionalised such misuse,” writes Vimal Sinha. (Research Matters)
- A social worker was struck from the UK’s Health and Care Professionals Council after “it was found she had plagiarised a colleague’s assignment and lied to her employer about completing and passing the task.” (Luke Haynes, Community Care)
- “I think there are a lot of reasons why researchers should be very hesitant to invoke The Incentives as a justification for why any of us behave the way we do.” (Tal Yarkoni, Citation Needed)
- “I have done reviews on Christmas Day, New Year’s Eve, and pretty much every other day of the year.” And Jay Van Bavel says he is not alone. (Dalmeet Singh Chawla, Undark)
- Tilburg University is investigating a recently awarded PhD to see if “there has been a violation of generally accepted principles of scientific integrity and good scientific practice.” (university statement)
- “In the original version of these 14 articles the reference list was unfortunately not represented according to the journal’s new bibliographical style, which should have been implemented from January 2018.” (Food Science and Biotechnology)
- Could a universal database of conflicts of interest be in the works? (Joyce Frieden, MedPage Today)
Thank You Retraction Watch.
How Well Do Neuroleptics Work?
madinamerica
Sandra Steingard, MD October 9, 2018
I recently received an email from Psychiatric Times highlighting current articles. Psychiatric Times is a newspaper that is distributed for free to psychiatrists in the US. To put this in context, the paper appears to be heavily subsidized by pharmaceutical company advertising, and its former editor, Ronald Pies, is a psychiatrist who has been critical of views expressed on Mad In America.
It caught my eye when the first article mentioned had the title, “Antipsychotic Discontinuation: When is it OK?” I clicked on the link to find a slide show authored by Brian Miller, M.D., P.D., M.P.H. which was titled, “Antipsychotics – To Respond or Not to Respond?”
This was intriguing but confusing. Dr. Miller’s slides reviewed a paper just published in Schizophrenia Bulletin titled, “How Many Patients With Schizophrenia Do Not Respond to Antipsychotic Drugs in the Short Term? An Analysis Based on Individual Patient Data From Randomized Controlled Trials.” As pointed out in the slide show, the paper reported on a meta-analysis of 16 randomized controlled studies of antipsychotic drugs over the first 4-6 weeks of treatment. The authors found that a significant number of people do not respond or have relatively poor responses and the majority do not experience a remission of psychotic symptoms. While important, this article addressed short-term rather than long-term care. It is, nevertheless, informative. [Editor’s note: click here to see the MIA research news report on this paper.]
The senior author of the paper, Stefan Leucht, is a well-known and highly regarded expert in meta-analysis. As noted in the disclosures, he is also well-connected to many pharmaceutical companies. Meta-analysis is a statistical technique that allows for investigation of multiple studies. This provides a broader view of the available data in the field.
Since this was a study of response to drugs, it is important to understand how researchers define that term. When drug studies are conducted, subjects are assessed via rating scales which address the presence and severity of symptoms. A person is asked about a variety of experiences, such as hearing voices or feeling sad, and their responses are scored according to a predetermined rubric. Scores will thus fall on a continuum. The Positive and Negative Symptoms Scale (PANSS) is commonly used in antipsychotic drug trials. It includes 30 items and each can be scored on a scale of one (absent) to seven (extreme). Scores can therefore fall anywhere from 30 to 210.
There are many ways that researchers can analyze the myriad bits of data that are collected in these studies. Researchers are required to determine in advance how they will analyze their data, including what change would allow them to classify a person as a “responder.” Researchers can also define what would be considered a “remission.” To be counted as a responder, a person needs to have a certain percentage drop in the rating scale score from beginning to end of study. To be considered in remission, a person’s final score needs to fall below a set point on the scale. Unless one reads a study carefully, these distinctions can be missed and the notion of “response,” often cited in promotional material, can be misleading. Many studies consider a 20% reduction in score as a response. For some people, this can be a clinically insignificant change in symptoms. When large numbers of people are included in a study, it is easier to detect small differences among groups and these differences can reach statistical significance. A drug may be promoted as effective when what has been found is that the group of people who took it had a clinically minor reduction in symptoms as compared to the group on placebo.
The authors of this study, recognizing some of these challenges, set out to look more carefully at the range of response in the studies under review. They did this by not only reporting on the common 20% reduction often used as a marker for “response” but also 25%, 50%, and 75% reduction in the ratings.
The authors also analyzed the percentage of subjects who reached remission. In this case, remission was defined as not scoring above the “mildly present” rating on 8 key items of the PANSS.
The results:
Those who had no change or worsened – 19.8%
Less than 25% improvement – 43%
Less than 50% improvement – 66.5%
Less than 75% – 87%.
For those who were listed as “non-remission” – 66.9%.
To put this another way, only 33.1% of those in the studies were in remission. Only 33.5% had more than a 50% reduction in the rating scale.
The authors offer some insights into what I consider the paradoxes of common psychiatric practice as well as the problems with the way many research studies are conducted.
They begin their paper, “A considerable number of patients with schizophrenia do not respond to antipsychotic drugs.” They go on to cite what they describe as “vague statements” that “can be found in other reports and textbooks such as ‘most controlled trials continue to find a subgroup of 10-20% of patients who derive little benefit from typical neuroleptic drug therapy.’” They offer similar quotes from a variety of texts and conclude that “all of these statements are not based on firm evidence.”
In their discussion, the authors provide insight into the current state of pharmaceutical studies as well as offering their thoughts on why the response rates are so low:
“Pharmaceutical companies are trying to conduct large trials to assure statistical significance which leads to more recruitment pressure; the ‘patient clock’ is running down, thus patients are recruited quickly by professional centers; most of them are improved and stabilized on antipsychotics and enter an RCT after a short wash-out phase of a few days. As most of the antipsychotic effect occurs early on, further response may not be observed which could, at least partly, explain the relatively low number of responders. The increased ‘relapse’ rates on placebo also point to the direction that previous antipsychotics were beneficial.”
I found this rationale to be somewhat tortured. A major issue not addressed is that if people who are stabilized on neuroleptics are withdrawn abruptly and then restarted on drug or placebo, this would favor the drug since those given placebo would be experiencing withdrawal effects. But the authors bring up important issues about who gets recruited into studies these days and the extent to which they mirror the experiences of most people who are offered these drugs in clinical practice. Carl Elliott has written about this problem and it is critical to understand the context in which many drugs studies are conducted.
I still work as a psychiatrist and I know people who appear to benefit from these drugs. However, I want to use them in a way that is most helpful and minimizes harm. I also want to share the available data since this is what constitutes informed consent. What seems equally important is to provide this information to the public, including policy makers, since common misconceptions have had great influence on the structure of our system of care. Deinstitutionalization was driven by many forces but it is sustained by the notion that most people have robust responses to these drugs. We have a system of care and a societal expectation that these drugs are highly effective. When people are struggling in the community, the common response is that we need to adjust “their meds,” even though this is only likely to be helpful in a minority of cases.
Many of my colleague tend to focus on the need to find better drugs or design better studies as a way to address this problem. We tend to overlook so-called “alternative approaches,” such as the Hearing Voices Network. Oddly, given the context of this blog, these approaches are often discounted because they lack an evidence base. Sadly, adequate money to develop an evidence base is not offered because, well, they lack an evidence base. I suspect there is another bias at play.
In another recent email, this time from Medscape, there was a link to a video, “How to ‘Brand’ Psychiatry Today.” In the video, Dr. Stephen Strakowski, chair of the Department of Psychiatry at Dell Medical School at the University of Texas in Austin, proposes this definition of the specialty: “Psychiatry is a medical specialty that studies and treats disturbances in brain function that predominantly affect behavior — behavioral brain disorders.”
I appreciated Dr. Strakowski’s attempt to define our profession and I think he captures the way most psychiatrists conceptualize the field. This is informative. He both touts but then acknowledges the risks of the medical model: “We need to be careful to not confuse the medical model with using only medication for treatment. Rather, the medical model uses the medical approach to define the treatment evidence base and decide on the treatment.” Dr. Strakowski also suggests some limits to what psychiatrists should be doing and urges psychiatrists to let others work at the top of their expertise, “to allow those who are the best therapists to be the therapy providers, for example.” My major disagreement with him is that he does not challenge some of the negative consequences of applying the medical frame so broadly; even when he suggests that we consider social factors and invite others to offer psychotherapy, it is all done in the context of a medical conceptualization of the problems at hand. But that is a subject for another time.
For now, I would call upon physicians who claim to value the medical frame “to define treatment evidence and decide on treatment” to do just that. The evidence base suggests that it is time for us to reappraise the effectiveness of these drugs and shift our practice patterns accordingly.
Previous articleTwo-Thirds of Schizophrenia Patients Do Not Remit on Antipsychotics
Thank You Dr Steingard and MIA.
Sandra Steingard, MD October 9, 2018
I recently received an email from Psychiatric Times highlighting current articles. Psychiatric Times is a newspaper that is distributed for free to psychiatrists in the US. To put this in context, the paper appears to be heavily subsidized by pharmaceutical company advertising, and its former editor, Ronald Pies, is a psychiatrist who has been critical of views expressed on Mad In America.
It caught my eye when the first article mentioned had the title, “Antipsychotic Discontinuation: When is it OK?” I clicked on the link to find a slide show authored by Brian Miller, M.D., P.D., M.P.H. which was titled, “Antipsychotics – To Respond or Not to Respond?”
This was intriguing but confusing. Dr. Miller’s slides reviewed a paper just published in Schizophrenia Bulletin titled, “How Many Patients With Schizophrenia Do Not Respond to Antipsychotic Drugs in the Short Term? An Analysis Based on Individual Patient Data From Randomized Controlled Trials.” As pointed out in the slide show, the paper reported on a meta-analysis of 16 randomized controlled studies of antipsychotic drugs over the first 4-6 weeks of treatment. The authors found that a significant number of people do not respond or have relatively poor responses and the majority do not experience a remission of psychotic symptoms. While important, this article addressed short-term rather than long-term care. It is, nevertheless, informative. [Editor’s note: click here to see the MIA research news report on this paper.]
The senior author of the paper, Stefan Leucht, is a well-known and highly regarded expert in meta-analysis. As noted in the disclosures, he is also well-connected to many pharmaceutical companies. Meta-analysis is a statistical technique that allows for investigation of multiple studies. This provides a broader view of the available data in the field.
Since this was a study of response to drugs, it is important to understand how researchers define that term. When drug studies are conducted, subjects are assessed via rating scales which address the presence and severity of symptoms. A person is asked about a variety of experiences, such as hearing voices or feeling sad, and their responses are scored according to a predetermined rubric. Scores will thus fall on a continuum. The Positive and Negative Symptoms Scale (PANSS) is commonly used in antipsychotic drug trials. It includes 30 items and each can be scored on a scale of one (absent) to seven (extreme). Scores can therefore fall anywhere from 30 to 210.
There are many ways that researchers can analyze the myriad bits of data that are collected in these studies. Researchers are required to determine in advance how they will analyze their data, including what change would allow them to classify a person as a “responder.” Researchers can also define what would be considered a “remission.” To be counted as a responder, a person needs to have a certain percentage drop in the rating scale score from beginning to end of study. To be considered in remission, a person’s final score needs to fall below a set point on the scale. Unless one reads a study carefully, these distinctions can be missed and the notion of “response,” often cited in promotional material, can be misleading. Many studies consider a 20% reduction in score as a response. For some people, this can be a clinically insignificant change in symptoms. When large numbers of people are included in a study, it is easier to detect small differences among groups and these differences can reach statistical significance. A drug may be promoted as effective when what has been found is that the group of people who took it had a clinically minor reduction in symptoms as compared to the group on placebo.
The authors of this study, recognizing some of these challenges, set out to look more carefully at the range of response in the studies under review. They did this by not only reporting on the common 20% reduction often used as a marker for “response” but also 25%, 50%, and 75% reduction in the ratings.
The authors also analyzed the percentage of subjects who reached remission. In this case, remission was defined as not scoring above the “mildly present” rating on 8 key items of the PANSS.
The results:
Those who had no change or worsened – 19.8%
Less than 25% improvement – 43%
Less than 50% improvement – 66.5%
Less than 75% – 87%.
For those who were listed as “non-remission” – 66.9%.
To put this another way, only 33.1% of those in the studies were in remission. Only 33.5% had more than a 50% reduction in the rating scale.
The authors offer some insights into what I consider the paradoxes of common psychiatric practice as well as the problems with the way many research studies are conducted.
They begin their paper, “A considerable number of patients with schizophrenia do not respond to antipsychotic drugs.” They go on to cite what they describe as “vague statements” that “can be found in other reports and textbooks such as ‘most controlled trials continue to find a subgroup of 10-20% of patients who derive little benefit from typical neuroleptic drug therapy.’” They offer similar quotes from a variety of texts and conclude that “all of these statements are not based on firm evidence.”
In their discussion, the authors provide insight into the current state of pharmaceutical studies as well as offering their thoughts on why the response rates are so low:
“Pharmaceutical companies are trying to conduct large trials to assure statistical significance which leads to more recruitment pressure; the ‘patient clock’ is running down, thus patients are recruited quickly by professional centers; most of them are improved and stabilized on antipsychotics and enter an RCT after a short wash-out phase of a few days. As most of the antipsychotic effect occurs early on, further response may not be observed which could, at least partly, explain the relatively low number of responders. The increased ‘relapse’ rates on placebo also point to the direction that previous antipsychotics were beneficial.”
I found this rationale to be somewhat tortured. A major issue not addressed is that if people who are stabilized on neuroleptics are withdrawn abruptly and then restarted on drug or placebo, this would favor the drug since those given placebo would be experiencing withdrawal effects. But the authors bring up important issues about who gets recruited into studies these days and the extent to which they mirror the experiences of most people who are offered these drugs in clinical practice. Carl Elliott has written about this problem and it is critical to understand the context in which many drugs studies are conducted.
I still work as a psychiatrist and I know people who appear to benefit from these drugs. However, I want to use them in a way that is most helpful and minimizes harm. I also want to share the available data since this is what constitutes informed consent. What seems equally important is to provide this information to the public, including policy makers, since common misconceptions have had great influence on the structure of our system of care. Deinstitutionalization was driven by many forces but it is sustained by the notion that most people have robust responses to these drugs. We have a system of care and a societal expectation that these drugs are highly effective. When people are struggling in the community, the common response is that we need to adjust “their meds,” even though this is only likely to be helpful in a minority of cases.
Many of my colleague tend to focus on the need to find better drugs or design better studies as a way to address this problem. We tend to overlook so-called “alternative approaches,” such as the Hearing Voices Network. Oddly, given the context of this blog, these approaches are often discounted because they lack an evidence base. Sadly, adequate money to develop an evidence base is not offered because, well, they lack an evidence base. I suspect there is another bias at play.
In another recent email, this time from Medscape, there was a link to a video, “How to ‘Brand’ Psychiatry Today.” In the video, Dr. Stephen Strakowski, chair of the Department of Psychiatry at Dell Medical School at the University of Texas in Austin, proposes this definition of the specialty: “Psychiatry is a medical specialty that studies and treats disturbances in brain function that predominantly affect behavior — behavioral brain disorders.”
I appreciated Dr. Strakowski’s attempt to define our profession and I think he captures the way most psychiatrists conceptualize the field. This is informative. He both touts but then acknowledges the risks of the medical model: “We need to be careful to not confuse the medical model with using only medication for treatment. Rather, the medical model uses the medical approach to define the treatment evidence base and decide on the treatment.” Dr. Strakowski also suggests some limits to what psychiatrists should be doing and urges psychiatrists to let others work at the top of their expertise, “to allow those who are the best therapists to be the therapy providers, for example.” My major disagreement with him is that he does not challenge some of the negative consequences of applying the medical frame so broadly; even when he suggests that we consider social factors and invite others to offer psychotherapy, it is all done in the context of a medical conceptualization of the problems at hand. But that is a subject for another time.
For now, I would call upon physicians who claim to value the medical frame “to define treatment evidence and decide on treatment” to do just that. The evidence base suggests that it is time for us to reappraise the effectiveness of these drugs and shift our practice patterns accordingly.
Previous articleTwo-Thirds of Schizophrenia Patients Do Not Remit on Antipsychotics
Thank You Dr Steingard and MIA.
Monday, October 8, 2018
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