Conjuring Diagnoses for the Elderly

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In 2005, the FDA required atypical antipsychotics to carry a boxed warning that they had a higher risk of death related to use among individuals with dementia. In 2008, the FDA required the same warning with the older, typical antipsychotics. Antipsychotic use in nursing homes is now closely watched by government regulators, “who penalize and lower the ratings of facilities that overuse them.” This created an opportunity for the manufacturer of a little-used medication known as Nuedexta. Since 2012, there has been an increase of nearly 400% in the number of Nuedexta pills dispensed to long-term care facilities.

A CNN investigation reported on how “The maker of a little red pill intended to treat a rare condition is raking in hundreds of millions of dollars a year as it aggressively targets frail and elderly nursing home residents.” Nuedexta is approved to treat a disorder known as pseudobulbar affect or PBA. The disorder is a condition that causes sudden, uncontrollable crying and/or laughing. PBA afflicts less than 1% of all Americans and is most commonly found in people with multiple sclerosis (MS) or Lou Gehrig’s disease (ALS). The manufacturer of Nuedexta, Avanir, had its sales force focus on expanding the drug’s use with elderly patients struggling with dementia and Alzheimer’s disease. See the following graphic from CNN on the number of Nuedexta pills dispensed to long-term facilities.

Nuedexta is approved by the Food and Drug Administration (FDA) to treat anyone with PBA, including those with a variety of neurological conditions such as dementia. But geriatric physicians, dementia researchers and other medical experts told CNN that PBA is extremely rare in dementia patients; several said it affects 5% or less. And state regulators have found doctors inappropriately diagnosing nursing home residents with PBA to justify using Nuedexta to treat patients whose confusion, agitation and unruly behavior make them difficult to manage.

CNN identified dozens of examples across the country where the use of Nuedexta was questionable. In one Los Angeles nursing home, regulators found that 28% of its 162 residents had been placed on Nuedexta. A facility psychiatrist, who is a paid speaker for Avanir, had given a talk about the drug to nursing home employees. An employee at another Southern California facility admitted a resident was given a diagnosis of PBA in order to justify the use of Nuedexta, “even though its intended purpose was to control the resident’s “mood disturbances” and yelling out.” An Ohio doctor has come under investigation for allegedly receiving kickbacks for fraudulently diagnosing PBA in order to get Medicare coverage for Nuedexta.

The federal government foots the bill for a big portion of the money being spent on Nuedexta in the form of Medicare Part D prescription drug funding, for people 65 and over and the disabled. In 2015, the most recent year for which data is available, this Medicare program spent $138 million on Nuedexta — up more than 400% from just three years earlier.

The only FDA approved medication for patients with PBA is Nuedexta. “So experts say that Medicare coverage of the drug, which has been crucial to its financial success, relies on the diagnosis of this single condition.” Off-label prescribing of Nuedexta to treat patients with behavioral issues who were not diagnosed with PBA would likely not be covered. CNN analysis found that almost half of the Nuedexta claims filed with Medicare in 2015 “came from doctors who had received money or other perks from the company [Avanir].”

During the FDA approval process, two doctors on the committee raise concerns about Nuedexta being used for PBA in Alzheimer’s patients. “They both strongly recommended that Nuedexta only be approved for PBA in patients with MS or ALS.” Evidence, they argued, that it would be effective in other conditions was weak; and not enough was known about the safety of the drug in the elderly. Despite these concerns, the FDA did not limit its use as recommended. “The agency approved Nuedexta in 2010 for treating PBA in patients who have neurological conditions such as dementia.”

Soon after it hit the market, Neudexta was getting reports of potential harm, ranging from dizziness and falls to coma and death. “Nuedexta was listed as a ‘suspect’ medication in nearly 1,000 so-called adverse event reports received by the FDA detailing side effects, drug interactions and other issues.” It was listed by caregivers as a potential cause of 133 hospitalizations (which included 8 cases that also resulted in death), 51 deaths, 102 incidents of sedation and sleepiness and 101 of dizziness, confusion and falls. A nurse practioner reported on an 86-year-old Alzheimer’s patient who rapidly declined after Nuedexta was added to her Zoloft (an antidepressant), Xanax (an antianxiety medication) and Risperidone (an antipsychotic). Almost immediately she declined and became almost unresponsive, ultimately dying.

Nuedexta is a combination of two generic drugs, dextromethorphan and quinidine that are respectively a cough suppressant and antiarrhythmic drug (it slows rapid heartbeat and helps your heart beat regularly). They were once available from specialty pharmacists for less than $1 a pill. The FDA-approved medication now costs as much as $12.60 a pill; more than $9,000 a year. “Medicare Part D spending on the drug averaged $3,400 per patient in 2015.” It gained public attention through a television commercial featuring actor Danny Glover cycling through fits of laughing and crying.

Avanir executives have wanted to secure FDA approval for Nuedexta’s use to treat dementia patients who don’t have PBA, “setting their sights on the more widespread condition of agitation in dementia and Alzheimer’s patients, characterized by emotional and physical outbursts and restless behaviors.” A study has been completed that looked at the efficacy, safety and tolerability of Neudexta for the treatment of agitation in Alzheimer’s patients, but the results haven’t been posted. “Without additional FDA approval for the drug’s use in those conditions, salespeople cannot promote Nuedexta for that purpose. They can only market its use for dementia patients who also have PBA.”

Across the country, the use of Nuedexta in nursing homes has prompted concerns among state regulators whose job is to ensure adherence to federal guidelines and protect residents from being given unnecessary drugs — especially those used as chemical restraints. But to date, the red flags raised by these regulators have been largely left buried in nursing home inspection reports and have drawn little public attention.CNN identified more than 80 cases in 19 states since 2013 where inspectors cited nursing homes for inappropriate monitoring and use of Nuedexta — often because residents hadn’t exhibited any symptoms of PBA. Many of the cases — about 40% — were clustered in Southern California, where Avanir is based and where former employees said there has been aggressive marketing.

Currently there are no FDA-approved drugs to treat dementia-related agitation. But those who care for the elderly are eager to find tools to manage agitated and aggressive patients. Staff increases could reduce the need for medications. But these measures don’t always work and they are expensive. So some facilities use pharmaceuticals to help make their patients easier to treat. Helen Kales, a geriatric psychiatrist said: “”Rather than taking someone off an antipsychotic … providers search for a different ‘magic bullet.'”

McKnight’s Long-Term Care News reported that The Centers for Medicare & Medicaid Services said that it met its goal of reducing the national rate of antipsychotic use among long-term residents by 20% by the end of 2016. However, Winter et al. reported in Clinical Gerontologist there was a 12% increase for the combined rates of schizophrenia, Tourette’s and Huntingdon’s among long-term residents. The increase began in 2012 at a rate almost triple that of the general long-term nursing home population. Most of the increase was in the rates of schizophrenia reported. The increased “identification” of these psychiatric conditions seems new “and concentrated in residents on antipsychotics.”

Since antipsychotics prescribed for schizophrenia, Tourette’s, and Huntington’s are excluded from quality-measure auditing, apparent reductions in inappropriate long-stay antipsychotic use since the National Partnership may be exaggerated.

Sadly it seems that despite the clear evidence of adverse effects from antipsychotics and Nuedexta with the elderly, long-term care facilities have simply conjured up a diagnosis to justify their use.


Preying on Academics

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Seeking to test whether “predatory” journals would publish an obviously absurd paper, the science blogger Neuroskeptic wrote a Star Wars-themed spoof. His paper was about “midi-chlorians,” which in the Star Wars universe are entities that live inside cells and give the Jedi their powers. He filled the paper with other references to the “galaxy far, far away,” and submitted it to nine journals under the names of Dr. Lucas McGeorge and Dr. Annette Kim. Three journals accepted and published the spoofed article; another offered to publish it for a fee of $360.

Within six days of Neuroskeptic publishing his blog article describing what he did, “Predatory Journals Hit By ‘Star Wars’ Sting,” all three journals had deleted his online journal article. To generate the main text of the paper, he copied the Wikipedia page on “mitochondrion,” which actually do exist, and replaced all references in it with the Star Wars term “midichlorians.” He even admitted how he had reworded the text in the Methods section of his spoofed paper, saying: The majority of the text in the current paper was Rogeted from Wikipedia.” Oh, and “Dr. Lucas McGeorge” was sent an unsolicited invitation to serve on the editorial board of one of the journals. Some of clues within his article indicating it was a spoof included the following:

“Beyond supplying cellular energy, midichloria perform functions such as Force sensitivity…”“Involved in ATP production is the citric acid cycle, also referred to as the Kyloren cycle after its discoverer”“Midi-chlorians are microscopic life-forms that reside in all living cells – without the midi-chlorians, life couldn’t exist, and we’d have no knowledge of the force. Midichlorial disorders often erupt as brain diseases, such as autism.”

Neuroskeptic said his sting doesn’t prove that scientific publishing is hopelessly broken, but it does provide a reminder that at some so-called peer reviewed journals, there is not any “meaningful peer review.” This was an already known problem, but his sting illustrates the importance of peer review, which “is supposed to justify the price of publishing.” If you’re interested in reading the spoofed paper, there is a link in his blog article.

This matters because scientific publishers are companies selling a product, and the product is peer review. True, they also publish papers (electronically in the case of these journals), but if you just wanted to publish something electronically, you could do that yourself for free.

Neuroskeptic referred to another article found in the New York Times that was also about a “sting” operation on predatory journals. Here, a fictitious author, Anna O. Szust (Oszust is the Polish word for ‘a fraud’), applied to 360 randomly selected open-access journals asking to be an editor. Forty-eight accepted her and four made he editor in chief. She received two offers to start new journals and be the editor. The publications in her CV were fake, as were her degrees. “The book chapters she listed among her publications could not be found, but perhaps that should not have been a surprise because the book publishers were fake, too.”

Dr. Fraud received some tempting offers. She was invited to organize a conference, whose papers would be published. She would get 40% of the proceeds. Another journal invited her to start a new journal and offered her 30% of the profits. The investigators who conceived this sting operation told the journals that accepted Dr. Fraud that she wanted to withdraw her application to be an editor. “Dr. Fraud remains listed as a member of the editorial boards of at least 11 of those journals.”

Dr. Pisanski and her colleagues wrote about their sting operation in the journal Nature: “Predatory Journals Recruit Fake Editor.” Pisanski et al. said they became increasingly disturbed at the number of invitations they received to become editors or to review journals that were outside of their field. They learned some colleagues, mainly early-career researchers, were unaware of these predatory practices and had fallen for these traps.

So, in 2015, we created a profile of a fictitious scientist named Anna O. Szust and applied on her behalf to the editorial boards of 360 journals. Oszust is the Polish word for ‘a fraud’. We gave her fake scientific degrees and credited her with spoof book chapters. Her academic interests included, among others, the theory of science and sport, cognitive sciences and methodological bases of social sciences. We also created accounts for Szust on Academia.edu, Google+ and Twitter, and made a faculty webpage at the Institute of Philosophy at the Adam Mickiewicz University in Poznań. The page could be accessed only through a link we provided on her CV.

The aim of their study was to help academics understand how bogus versus legitimate journals operate—not trick the journals into accepting them as an editor. So if journals did not respond to her application, they did not email them again. “In many cases, we received a positive response within days of application, and often within hours.” They coded journals as “Accepted” only when a reply to their email explicitly accepted Szust as an editor or if Szust’s name appeared as an editorial board member on the journal’s website.

The laudable goal of open-access publishing gave birth to these predatory journals. Traditional academic journals raise support by subscription fees, while authors pay nothing. “Open-access journals reverse that model. The authors pay and the published papers are free to anyone who cares to read them.” For example, the Public Library of Science (PLOS) journals (which are credible open-access journals), charges between $1,495 and $2,900 to publish a paper. Predatory journals exist by publishing just about anything sent to them for a fee, often between $100 and $400, according to Jeffrey Beall, a scholarly communications librarian at the University of Colorado.

Beall does not believe that everyone who publishes in these predatory journals is duped. He thinks many researchers know exactly what they are doing when they publish an article there. “I believe there are countless researchers and academics, currently employed, who have secured jobs, promotions, and tenure using publications in pay-to-publish journals as part of their credentials and experience for the jobs and promotions they got.” So it now requires some due diligence on the part of academic employers to ferret out those questionable publications.

In “Science is Broken,” Siddhartha Roy and Marc Edwards, noted how over the past fifty years, “the incentives and reward structure of science have changed, creating a hypercompetition among academic researchers.” Universities are now using part time and adjunct faculty for up to 76% of their academic labor force. This makes tenure-track positions rarer and more desirable, as universities operate more like businesses. This academic business model has also led to an increased reliance on quantitative performance metrics “that value numbers of papers, citations and research dollars raised has decreased the emphasis on socially relevant outcomes and quality.”

There is growing concern that these pressures may encourage unethical conduct by some scientists. It certainly has contributed to the replication problem with published studies. See “Reproducibility in Science” for more on the replication problem. Roy and Edwards said: “We believe that reform is needed to bring balance back to the academy and to the social contract between science and society, to ensure the future role of science as a public good.” Predatory journals have entered into this changing structure of the academic business model, seeing the opportunity to take advantage of the “publish or perish” pressure on academics to secure jobs, promotions and gain tenure. The result has been an undermining of the university system and the practice of science as a public good.


Violence and the Brain

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Reporting for the Las Vegas Review-Journal, Jessie Bekker said Stanford University would begin a targeted autopsy investigation on the brain of Las Vegas mass shooter Stephen Paddock. Experts have already expressed doubt that an autopsy alone will uncover clues as to why Paddock did what he did. A University of Utah neuropathologist said a pathologist could look for evidence of something like dementia or CTE—chronic traumatic encephalopathy. I wonder if they will look for a possible connection between his violence and a diminished metabolic capability with his cytochrome P450 gene family.

Yolande Lucire, a forensic psychiatrist with fifty years of experience, has been investigating this possibility for a number of years. I first heard of her and her work at a conference presentation she made in March of 2012 on “Akathisia Homicides.” You can watch a video of her 35-minute presentation at the conference here on YouTube. She’s not anti-drug, but believes a disregulation with the cytochrome P450 gene family, which produces drug-metabolizing enzymes, could be a factor in akathisia-related violence and suicide. In other words, there can be an adverse reaction to psychiatric medications when the cytochrome P450 family of enzymes fail to metabolize those psychiatric medications.

This adverse reaction could lead to akathisia, a state of “increased tenseness, restlessness and a feeling of being very uncomfortable.” There can also be irritability and/or insomnia. An estimated 20% of people on an antidepressant will have significant symptoms of akathisia and at least 50% of individuals on an antipsychotic with symptoms of akathisia. On higher doses of antipsychotics, that percentage can increase to 80% or more.

In an open access journal, Epidemiology, Dr. Lucire published an article titled “Phramacological Istrogenesis: Substance/Medication-Induced Disorders That Masquerade as Mental Illness.” She described how information on the safety and efficacy of psychiatric medications has been manipulated to favor the “pseudo-scientific ideology of the pharmaceutical industry.” Adverse side effects from the medication becomes misinterpreted to justify ongoing treatment with the very medications causing the problems; or to justify treatment of the adverse events with another medication. “There was a pill for every ill and another for each side effect.”

Misinformation has resulted in prescribing practices that produced an epidemic of akathisia-related suicide and homicide as well as substance/medication-induced conditions mimicking the mental illnesses that the drugs were supposed to cure or prevent.

Lucire said the dominant view of how to practice psychiatry has come from the pharmaceutical industry and its agents. Regulatory bodies reinforce this view when they recommend the continued use of antidepressant medications in cases where individuals only became suicidal or psychotic after taking their medication. “Their members have no comprehension of Cytochrome P450-based interactions described in product information and refuse to countenance drug company fraud.” She further observed:

A Medical Board has determined that medications and doses that had caused people to commit suicide and homicides were ‘standard psychiatric treatment’ even when the consequence had been fatal. Akathisia cases were not investigated or given any credit. Coroners sitting on five cases of antidepressant-akathisia-related suicides brought before them refused to hear this evidence.

She co-authored another article that described three cases of what authors believed were instances of antidepressant-induced akathisia-related suicide: “The relevance of cytochrome P450 polymorphism in forensic medicine and akathisia-related violence and suicide.” They also had “diminishing mutations in the CYP450 family of metabolizing enzymes and all were taking medicines that further decreased metabolism by inhibition.” None of the three knew they were supposed to take their medications regularly or how to stop taking them safely. None of them improved on the medications and none of their prescribers recognized their complaints as adverse drug reactions. See: “Psych Drugs and Violence” for more on this article. You can also explore more on Dr. Lucire’s work on her website.

Dr. Lucire’s work is not without its detractors. An earlier 2011 article she co-authored, “Antidepressant-induced akathisia-related  homicides  associated  with  diminishing   mutations in metabolizing genes of the CYP450 family,” was critiqued by Loonen and Verkes in a letter to the editor of Pharmacogenomics and Personalized Medicine. They thought the population of that study was too heterogeneous and poorly characterized from a phenomenological perspective. They also suggested her use of the term “akathisia” was not defined well and could result in a false interpretation between aggression and akathisia. See a copy of their critique and Lucire’s reply here.

Yolande Lucire replied to the critique by noting how their paper pointed out how akathisia has been correlated with aggression, suicide and homicide as far back as the 1950s. In response to their curious criticism of her article not providing a definition for akathisia, she said akathisia could range in intensity from mild discomfort to “the most painful and dangerous mental state known to psychiatry.” She said the DSM-III defined akathisia as “a subjective desire to be in constant motion caused by drug sensitivity.” She also referred to the DSM-IV, which said the condition fluctuated with the subjects describing bouts of restless legs, twitching, toe turning, pacing and other activities, that occurred outside of the interview hours.

She then commented how the FDA’s restriction to indentify akathisia “only when its physical manifestations appeared in front of the interviewer” led to under diagnosis of the condition. Professor Loonen’s sense, that akathisia should be limited even further to what has been observed within a circumscribed timeframe, would result in even more cases being missed “with tragic consequences.”

Akathisia is rarely monocausal in clinical practice. It is dose related and cases formerly thought to be idiosyncratic are now known to be associated with diminished cytochrome metabolism, the co-prescription of cytochrome inhibitors, the removal of inducers, competition from polypharmacy for enzymatic substrate, diet and age of the patient, and their general and liver health.

Dr. Lucire’s work with diminished cytochrome metabolism isn’t the only voice raised in concern over a connection between antidepressants and violence or suicide. Dr. Peter Breggin has been warning of this issue since the first edition of his book, Toxic Psychiatry, in 1991. Dr. Breggin wrote of a February 7, 1991 New York Times article, “Suicidal Behavior Tied Again to Drug: Does Antidepressant Prompt Violence?” The article referred to cases of suicidal ideation that had been described in a letter in the New England Medical Journal. The individuals reportedly had not had previous signs of wanting to kill themselves. More than fifty lawsuits were filed against the manufacturer, Eli Lilly, at the time. “Other lawsuits blame Prozac for driving patients to mutilate themselves and even to commit murder.”

In the American Journal of Psychiatry, “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment” reported how six depressed patients, “free of recent suicidal ideation, developed intense, violent suicidal preccupation after 2-7 weeks of fluoxetine treatment.” This persisted for a range of 3 days to three months after fluoxetine treatment was discontinued. Breggin added:

The report estimates that 3.5 percent of Prozac users were at risk. While denying the validity of the study, Dist Products, a division of Eli Lilly, put out a brochure for doctors dated August 31, 1990, stating that it was adding “suicidal ideation” to the adverse events section of its Prozac product information.

So what happened? According to David Healy in “Vampire Medicines,” the Teicher et al. article (“Emergence of Intense Suicidal Preoocupation During Fluoxetine Treatment”) offered undeniable evidence that SSRIs can cause suicide and hearing were convened to discuss the need for warnings.  “But coincident with these hearings, BMJ [British Medical Journal] published a meta-analysis of Prozac trials which Lilly claimed showed Prozac was not linked to suicidal events.”

The published data showed an increased risk on Prozac, which Lilly and BMJ ignored, claiming nothing was statistically significant.  Beyond this, Lilly played some of the tricks other companies later played – the small print shows the only placebo event hadn’t happened on placebo, so that technically there was a statistically significant  infinitely greater risk on Prozac.The way this played in public was that the stories of suicides on Prozac were tragic but anecdotal.  The scientific evidence demonstrated that patients and doctors just can’t believe the evidence of their own eyes and ears. They have to be told what’s what by experts.This dangerous and misguided message triumphed with regulators, and later in Courts.This message killed any interest journals like AJP and BMJ had in taking Case Reports. Besides companies didn’t buy reprints of these, whereas they handed over huge amounts of money for reprints of ghost-written fraudulent RCTs with zero access to data, and even more for the best science money could buy – meta-analyses of these trials. Evidence Based Marketing was here.

So what happens when there is a mass shooting like that in Las Vegas with Stephen Paddock, or with Devan Patrick Kelley in Sutherland Springs Texas? The possible connection between gun violence and psychiatric medications like antidepressants in the media is voiced by individuals like Kristie Alley (see here) and Pat Robertson (see here) who can be dismissed or marginalized by readers and viewers for their religious stands on Scientology and evangelical Christianity respectively. Additionally, they have no personal scientific or medical credibility. Individuals like Yolande Lucire, Peter Breggin or David Healy who do have medical and/or scientific credibility are not the go-to “talking heads” in main stream media outlets on the possible connection between psychiatric medications and violence, especially gun violence.

It’s not too late to prevent the trap on unsuspecting brains from being sprung. Yolande Lucire’s research findings and the critiques of Peter Breggin and David Healy should not be dismissed as fringe science. There have been reports of akathisia associated with aggression, violence and suicide from the 1950s. Peter Breggin was pointing out a similar connection from the honeymoon time with the first SSRI, Prozac. David Healy has been pointing out the connection between antidepressants and violence for years (See this link to a search on his website for “antidepressants violence”).

Not every instance of gun violence or mass shooting can be attributed to diminished cytochrome metabolism or akathisia-induced violence. But when the total number of incidents of gun violence in the US from January 1 to December 1 of 2017 was 56,355, and the number of mass shootings for the same time period was 324, there is a good chance an investigation would confirm an association in many of them. Below is a graphic taken from the website Gun Violence Archive that shows the geographic distribution of the 324 incidents of mass shooting. Also see: “Iatrogenic Gun Violence” on this website.

Post Script. The number of incidents of reported gun violence in the U.S. on Gun Violence Archive rose from 56,355 on December 1st, 2017 to 61,418 on December 31st, 2017. The number of mass shootings increased to 345. The 2018 totals were 2,628 incidents of gun violence and 12 mass shootings on January 20th, 2018. Go see where the totals are when you read this.


Biomedical ‘Big Brother’

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The FDA approved a new pharmaceutical product that combines technology and medication: Abilify MyCite, “the first drug in the U.S. with a digital tracking system.” The pill contains a sensor that tracks whether or not a patient has taken their medication. The pill’s sensor sends a message to a wearable patch, which then transmits the information to a mobile app, enabling the patient to track their ingestion of the medication on their smart phone. Patients can also “consent” for others to access the information through a web-based portal. As more than one person observed, the old hide-the-pill-under-your-tongue trick doesn’t work with the new technology.

Science Alert said the sensor, called an Ingestible Event Marker (IEM) is about the size of a grain of sand. It’s made of safe levels of copper, magnesium and silicon.  When the pill and IEM are swallowed, stomach acid activates the sensor, which sends an electrical signal to the patch. “The patch records the date and time the pill was ingested, and relays this information to a smartphone app.”

A New York Times article on the approval, “First Digital Pill Approved to Worries About Biomedical ‘Big Brother,’ noted where experts estimate nonadherence or noncompliance with medications costs about $100 billion per year. Much of that cost is said to be due to patients getting sicker and needing additional treatment or hospitalization. Dr. William Shrank said: “When patients don’t adhere to lifestyle or medications that are prescribed for them, there are really substantive consequences that are bad for the patient and very costly.”  Ameet Sarpatwari said while the pill has the potential to improve public health, “If used improperly, it could foster more mistrust instead of trust.”

The IEM could be used to monitor medication compliance with post-surgical patients or for individuals required to use a digital medication as a condition for release from psychiatric facilities. “Asked whether it might be used in circumstances like probation or involuntary hospitalization, Otsuka officials said that was not their intention or expectation, partly because Abilify MyCite only works if patients want to use the patch and app.”

Nevertheless, Abilify was said to be an unusual choice for the first sensor-embedded medication. As an antipsychotic or neuroleptic, Abilify is approved for treating schizophrenia, bipolar disorder and as an adjunct for major depression. Some of these individuals may have delusions or become paranoid about their doctor or what the doctor intends. How receptive will they be to using a system that monitors their behavior and then potentially signals their doctor?

Dr Paul Applebaum of Columbia University’s psychiatric department said: “You would think that, whether in psychiatry or general medicine, drugs for almost any other condition would be a better place to start than a drug for schizophrenia.” Dr. Jeffrey Lieberman said many psychiatrists will likely want to try Abilify MyCite, but it has not yet been shown to improve medication adherence. “There’s an irony in it being given to people with mental disorders that can include delusions. It’s like a biomedical Big Brother.”

Many patients aren’t compliant with neuroleptics because of the side effects. These side effects can include: weight gain, diabetes, pancreatitis, gynecomastia (abnormal breast tissue growth), hypotension, akathesia (a feeling of inner restlessness), cardiac arrhythmias, seizures, sexual dysfuntion, tardive dyskinesia, anticholinergic effects (constipation, dry mouth, blurred vision, urinary retention and at times cognitive impairment). For more on the adverse effects with Abilify and other antipsychotics, see (“Abilify in Denial,” “Broken Promises with Abilify,” “Antipsychotic Big Bang,” “Wolves in Sheep’s Clothing,” and “Downward Spiral of Antipsychotics”).

Otsuka, the pharmaceutical company with the patent rights to distribute Abilify MyCite, has not set a price for the drug yet. Although Abilify alone is now off patent, Otsuka will have a new patent time frame for Abilify MyCite. Here may be the reason that Otsuka invested so much capital into Proteus Digital Health, the California company that developed the IEM technology. Profits from Abilify will continue to be made by Otsuka with the newly patented formula.

The labeling information for Abilify MyCite notes the ability of the product to improve patient compliance hasn’t been demonstrated yet. Additionally, it should not be used to track drug ingestion in “real-time” as detection may be delayed or may not occur. Robert McQuade, an executive vice president for Otsuka, confirmed the company does not have current data to say it will improve adherence. But they will likely study that after sales begin.

How patients themselves view Abilify MyCite is mixed. One person who takes Abilify for schizoaffective disorder participated in the clinical trial for Abilify MyCite. Compliant with his medication, he doesn’t think he needs digital monitoring. He hasn’t had paranoid thoughts for a long time. If he had a chance to take ‘digital Abilify,’ “I wouldn’t take it.” Another person who sometimes will stop taking his medication thought the idea behind Abilify MyCite was “overbearing.”

A third person reported his use of Abilify for 16 years to prevent recurrence of episodes of paranoia. He thought some people might use the new drug to avoid the injections of Abilify if they were noncompliant with their pills. But he said he would not use the digital Abilify. He didn’t want an electrical signal, strong enough for his doctor to read, coming out of his body. “But right now, it’s either you take your pills when you’re unsupervised, or you get a shot in the butt. Who wants to get shot in the butt?”

The above are the milder responses to the FDA’s news about Abilify MyCite. What follows are the thoughts of Michael Cornwall. He is a Jungian/Langian psychotherapist who specializes in providing psychotherapy for people in psychotic states (which he refers to as ‘extreme states’) without the use of medication. He has his own website and commented there how digital Abilify “can now automatically send signals to your doctor, family members and the courts, to show them when you comply and swallow the pill.”  Not one to pull punches, his article on Mad in America was titled: “The Orwellian New Digital Abilify Will Subjugate Vulnerable People across the US.”

He predicted there will be tragic personal injury coming from the use of Abilify MyCite to control people’s dosing compliance, “something that I believe would even make dystopian visionaries George Orwell and Aldous Huxley shudder.” Singling out California as an example, he said the state was ripe for an even more oppressive mental health “best practice” service model and standard of care for people in “extreme states” who are receiving forced in-home treatment. Like California, most states now have some version of in-home compulsory court-ordered medication treatment. Research has shown that 74% of people prescribed antipsychotic medications who are in extreme state stop taking their medications by 18 months. Pro-medication people find this unacceptable.

Tremendous pressure, I believe, will also be exerted by mental health care providers for people to voluntarily accept taking the new digital Abilify. I see that pressure being put on people seeking discharge from in-patient units, and pressure will be put on people in extreme states or with such histories, who will be involved anywhere on the spectrum of community mental health services and in jails and prisons too. In both mental health and penal systems, medication compliance, not providing humanistic care, is clearly the highest priority.

Yet there is reliable evidence suggesting long-term use of antipsychotics like Abilify is not necessary. Robert Whitaker wrote a paper, “The Case Against Antipsychotics” where he critiqued the research cited by psychiatry as evidence for long-term use of antipsychotics. Additionally, he presented a history that tells how antipsychotics, on the whole have actually worsened long-term outcomes. Whitaker described a long-term study by Harrow that followed an original group of patients for 20 years (and counting) after their initial hospitalization for schizophrenia.

Harrow discovered that patients not taking medication regularly recovered from their psychotic symptoms over time. Once this occurred, “they had very low relapse rates.” Concurrently, patients who remained on medication, regularly remained psychotic—even those who did recover relapsed often. “Harrow’s results provide a clear picture of how antipsychotics worsen psychotic symptoms over the long term.” Medicated patients did worse on every domain that was measured. They were more likely to be anxious; they had worse cognitive functioning; they were less likely to be working; and they had worse global outcomes. Also see “Worse Results With Psych Meds” for more on the Harrow study.

Returning to the thoughts of Michael Cornwall, he said treatment with Abilify MyCite was “a morally bankrupt approach that ensures a soul-numbing, hi-tech compliance-monitoring device be in the digestive tract of every DSM-labeled person in an extreme state, in order to keep them in line.” It places the controlling impulse of psychiatric care “within our very guts.” To the uninitiated, Cornwall’s rhetoric may sound extreme. But I suspect that for individuals wanting to cope with their “extreme state” without medication or struggling to live with the side effects from antipsychotics, it is spot on. Clearly as the technology behind the IEM improves, it will be used to “convince” individuals that using a digital antipsychotic like Abilify MyCite is in their best interests, particularly if they want to be discharged from a psychiatric facility, or to continue living outside of one. The first Biomedical Big Brother has arrived.


In the Dark About Antidepressants

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In 2011, antidepressants were the third most commonly prescribed medication class in the U.S. Mojtabai and Olfson noted in their 2011 article for the journal Health Affairs that much of the growth in the use of antidepressants was driven by a “substantial increase in antidepressant prescriptions by nonpsychiatric providers without an accompanying psychiatric diagnosis.” They added how the growing use of antidepressants in primary care raised questions “about the appropriateness of their use.” Despite this concern, antidepressant prescriptions continued to rise. By 2016, they were the second most prescribed class of medications, according to data from IMS Health.

A CDC Data Brief from August of 2017 reported on the National Health and Nutrition Examination Survey. The Data Brief provided the most recent estimates of antidepressant use in the U.S. for noninstitutionalized individuals over the age of 12. As indicated above, there was clear evidence of increased antidepressants use from 1999 to 2014. 12.7% of persons 12 and over (one out of eight) reported using antidepressant medication in the past month. “One-fourth of persons who took antidepressant medication had done so for 10 years or more.”

Women were twice as likely to take antidepressants. And use increased with age, from 3.4% among persons aged 12-19 to 19.1% among persons 60 and over. See the following figures from the CDC Data Brief. The first figure notes the increased use of antidepressants among persons aged 12 and over between 1999 and 2014. You can see where women were twice as likely to take antidepressants as men.

Figure 1

The second figure shows the percent of individuals aged 12 and over who took antidepressant medication in the past month between 2011 and 2014. Note how the percentages increase by age groups for both men and women, with the highest percentages of past month use for adults 60 and over for both men and women.

Figure 2

The third figure shows the length of antidepressant use among persons aged 12 and over. Note that while 27.2% reported using them 10 years or more, 68% reported using antidepressants for 2 years or more. “Long-term antidepressant use was common.” Over the fifteen-year time frame of the data, antidepressant use increased 65%.

Figure 3

The widespread use of antidepressants documented above is troubling when additional information about antidepressants is considered. A February 2017 meta-analysis done by Jakobsen et al., and published in the journal BMC Psychiatry, found all 131 randomised placebo-controlled trials “had a high risk of bias.” There was a statistically significant decrease of depressive symptoms as measured by the Hamilton Depression Rating Scale (HDRS), but the effect was below the predefined threshold for clinical significance of 3 HDRS points. Other studies have indicated that differences of less than 3 points on the HDRS are not clinically observable. See “Antidepressant Scapegoat” for more information on the HDRS. Jakobsen et al. concluded:

SSRIs might have statistically significant effects on depressive symptoms, but all trials were at high risk of bias and the clinical significance seems questionable. SSRIs significantly increase the risk of both serious and non-serious adverse events. The potential small beneficial effects seem to be outweighed by harmful effects.

In his review of the Jakobsen et al. study for Mad in America, Peter Simons noted where these results add to a growing body of literature “questioning the efficacy of antidepressant medications.” He pointed to additional studies noting the minimal or nonexistent benefit in patients with mild or moderate depression; the adverse effects of antidepressant medications; the potential for antidepressant treatment to potentially worsen outcomes. He concluded:

Even in the best-case scenario, the evidence suggests that improvements in depression due to SSRI use are not detectable in the real world. Given the high risk of biased study design, publication bias, and concerns about the validity of the rating scales, the evidence suggests that the effects of SSRIs are even more limited. According to this growing body of research, antidepressant medications may be no better than sugar pills—and they have far more dangerous side effects.

Peter Gøtzsche, a Danish physician and medical researcher who co-founded the Cochrane Collaboration, wrote an article describing how “Antidepressants Increase the Risk of Suicide and Violence at All Ages.” He said that while drug companies warn that antidepressants can increase the risk of suicide in children and adolescents, it is more difficult to know what that risk is for adults. That is because there has been repeated underreporting and even fraud in reporting suicides, suicide attempts and suicidal thoughts in placebo-controlled trials. He added that the FDA has contributed to the problem by downplaying the concerns, choosing to trust the drug companies and suppressing important information.

He pointed out a meta-analysis of placebo-controlled trials from 2006 where the FDA reported five suicides in 52,960 patients (one per 10,000).  See Table 9 of the 2006 report. Yet the individual responsible for the FDA’s meta-analysis had published a paper five years earlier using FDA data where he reported 22 suicides in 22,062 patients (which is 10 per 10,000). Additionally, Gøtzsche found there were four times as many suicides on antidepressants as on placebo in the 2001 study.

In “Precursors to Suicidality and Violence in Antidepressants” Gøtzsche co-authored a systematic review of placebo-controlled trials in healthy adults. The study showed that “antidepressants double the occurrence of events that can lead to suicide and violence.” Maund et al. (where he was again a co-author) demonstrated that the risk of suicide and violence was 4 to 5 times greater in women with stress incontinence who were treated with duloxetine (Cymbalta).

Although the drug industry, our drug regulators and leading psychiatrists have done what they could to obscure these facts, it can no longer be doubted that antidepressants are dangerous and can cause suicide and homicide at any age. Antidepressants have many other important harms and their clinical benefit is doubtful. Therefore, my conclusion is that they shouldn’t be used at all. It is particularly absurd to use drugs for depression that increase the risk of suicide when we know that psychotherapy decreases the risk of suicide. . . . We should do our utmost to avoid putting people on antidepressant drugs and to help those who are already on them to stop by slowly tapering them off under close supervision. People with depression should get psychotherapy and psychosocial support, not drugs.

Peter Breggin described “How FDA Avoided Finding Adult Antidepressant Suicidality.” Quoting the FDA report of the 2006 hearings, he noted where the FDA permitted the drug companies to search their own data for “various suicide-related text strings.” Because of the large number of subjects in the adult analysis, the FDA did not—repeat, DID NOT—oversee or otherwise verify the process. “This is in contrast to the pediatric suicidality analysis in which the FDA was actively involved in the adjudication.” Breggin added that the FDA did not require a uniform method of analysis by each drug company and an independent evaluator as required with the pediatric sample.

Vera Sharav, “a fierce critic of medical establishment,” the founder and president of the Alliance for Human Research Protection (AHRP), testified at the 2006 hearing. She reminded the Advisory Committee that the FDA was repeating a mistake they had made in the past.  She said in the past the FDA withheld evidence of suicides from the Advisory Committee. German documents and the FDA’s own safety review showed an increased risk of suicides in Prozac. “Confirmatory evidence from Pfizer and Glaxo were withheld from the Committee.”  Agency officials “obscured the scientific evidence with assurances.”

What the FDA presented to you is a reassuring interpretation of selected data by the very officials who have dodged the issue for 15 years claiming it is the condition, not the drugs. What the FDA did not show you is evidence to support that SSRI safety for any age group or any indication. They are all at risk. They failed to provide you a complete SSRI data analysis. They failed to provide you peer-reviewed critical analyses by independent scientists who have been proven right. FDA was wrong then; it is wrong now. Don’t collaborate in this. [But they eventually did]

Breggin commented that the FDA controlled and monitored the original pediatric studies because the drug companies did not do so on their own and failed to find a risk of antidepressant-induced suicidality in any age group. “Why would the FDA assume these same self-serving drug companies, left on their own again, would spontaneously begin for the first time to conduct honest studies on the capacity of their products to cause adult suicidality?”

In a linked document of two memos written by an Eli Lilly employee in 1990, Dr. Breggin noted where the individual questioned the wisdom of recommendations from the Lilly Drug Epidemiology Unit to “change the identification of events as they are reported by the physicians.” The person went on to say: “I do not think I could explain to the RSA, to a judge, to a reporter or even to my family why we would do this especially to the sensitive issue of suicide and suicide ideation. At least not with the explanations that have been given to our staff so far.” Those suggestions included listing an overdose in a suicide attempt as an overdose, even though (here he seems to be quoting from a policy or procedural statement) “when tracking suicides, we always look at all overdose and suicide attempts.” Eli Lilly brought the first SSRI, Prozac, to market in 1986.

Next time you hear someone say that the FDA studies only showed increased suicidality in children and young adults as opposed to adults, remember that the adult studies, unlike the pediatric studies, were not controlled, monitored or validated by the FDA. This is one more example of the extremes the FDA will go to in order to protect drug companies and their often lethal products.

The problems with antidepressants, most of which are SSRIs—selective serotonin reuptake inhibitors—were at least partially known as Prozac and its cousins were being developed and brought to market in the early 1990s. As the above discussion indicated, there seems to have been a disregard of the potential for multiple negative side effects from their use, up to and including the various forms of suicidality. The sleight-of-hand done by the drug companies, and apparently the FDA, means that many individuals are in the dark about the adverse side effects stemming from their SSRI medications.


Give MDMA a Chance?

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In August of 2017 the FDA designated MDMA-assisted psychotherapy as a breakthrough treatment for PTSD. Bringing MDMA to market as a legal, legitimate therapeutic agent has been the goal of Rick Dobin, the Executive Director of MAPS (Multidisciplinary Association for Psychedelic Studies), since he founded the nonprofit in 1986. That was one year after the DEA classified MDMA, better known as the street drug ecstasy, as a Schedule I controlled substance. Dobin said: “For the first time ever, psychedelic-assisted psychotherapy will be evaluated in Phase 3 trials for possible prescription use, with MDMA-assisted psychotherapy for PTSD leading the way.”

The MAPS press release said the Phase 3 trials will assess the efficacy and safety of MDMA-assisted therapy in 200-300 participants with PTSD in the U.S., Canada and Israel. Two Phase III clinical trial studies will begin enrolling participants in the spring of 2018. Randomized participants will receive three day-long sessions of either MDMA or placebo in conjunction with psychotherapy over a 12-week treatment period. There will also be 12 associated 90-minute nondrug preparatory and integration sessions. Now that the FDA is onboard, Dobin said MAPS plans to start negotiations with the European Medicines Agency.

Speaking for MAPS, Amy Emerson, said the Phase 2 data was extremely promising. Out of 107 participants, 61% no longer qualified for PTSD after three sessions of MDMA-assisted psychotherapy two months after treatment. Then at the 12-month follow up, 68% no longer had PTSD. “All Phase 2 participants had chronic, treatment-resistant PTSD, and had suffered from PTSD for an average of 17.8 years.” The Phase 2 trials are being prepared for publication.

The willingness of MAPS to use the existing clinical trial process to scientifically validate the potential therapeutic benefits of MDMA is encouraging. Running the FDA gauntlet for drug approval, for better or worse, is the most effective process we currently have to prevent a return to the days of patent medicines, when anything and everything was promoted as “cures” and “treatments” to an unsuspecting public. Those were the days when cocaine was in tonics (Coca Cola); heroin was in cough suppressants and teething medication; and the typical heroin addict was a middle class woman in her forties.

At least one individual at John Hopkins has referred to the recent interest of MAPS and others into the therapeutic effects of psychedelic substances as a “psychedelic renaissance.”  Writing for Massive, Benjamin Bell said: “Astounding preliminary research suggests psychedelics may yet revolutionize mental health care.” His historical gloss painted the history of the medical use of psychedelics as going from a potential revolution in psychotherapy during the 1950s to drug-addled lunacy by 1968. The culprits responsible for this change, according to Bell, were Timothy Leary and Richard Alport. “Although the pair began as respected researchers at Harvard, their firing coincided with their choice to promote hallucinogens in unique, and distinctly non-academic, ways.”

Unwittingly, when Harvard psychologist Timothy Leary signaled springtime for the “Summer of Love,” promoting LSD as a means to achieve cosmic connection, he also drew closed the curtain on academic research into a class of substances which held massive promise.

Richard Nixon labeled Leary as “The most dangerous man in America.” Alport went to India and a spiritual quest and changed his name to Ram Dass. In 1968, the US government outlawed all hallucinogens, universally restricting research on the substances. In the early 1980s, there was a brief time of psychotherapeutic research with MDMA. “But recreational use quickly captured the spotlight, and MDMA was classified as a Schedule 1 drug” in 1985. This was what motivated Rick Doblin to found MAPS.

According to The Washington Post, Dobin used LSD “as a rebellious, long-haired college freshman in the 1970s.” He believes it helped him see the world and himself in new ways. He wanted to become a therapist and use psychedelics to help others achieve similar insights, but he couldn’t because LSD was banned. When MDMA was criminalized, he realized psychedelics were too much on the fringe of culture to win public support. “The flaw of the early psychedelic movement was that they made it countercultural, a revolution. . . . Culture is dominant. Culture is always going to win.” He decided he had to bring psychedelics as therapeutic agents into the mainstream.

Dobin was admitted to the public policy PhD program at Harvard, shaved off his moustache, cut his hair and “learned to navigate the federal bureaucracy.” He laughed about how simple it was. “You put on a suit, and suddenly everyone thinks you’re fine.” Instead of fighting government officials, he sought to use science to win them over. So MAPS was born. And it was no accident the organization chose PTSD as its initial foray into its quest to end the government ban on psychedelics. Dobin said: “We wanted to help a population that would automatically win public sympathy. . . . No one’s going to argue against the need to help them.”  He added that if you were going to design a drug to be used as an adjunct in psychotherapy to treat PTSD, “MDMA would be it.”

But his dream extends beyond just developing a treatment for PTSD. Rick Dobin dreams of a time when psychedelic treatment centers are in every city. People could go there for enhanced couples therapy, spiritual experiences and personal growth. “These drugs are a tool that can make people more compassionate, tolerant, more connected with other humans and the planet itself.” He thinks they can help address homelessness, war and even global warming. Needless to say, this kind of talk makes others nervous.

Despite its promise, there are risks. What’s sold on the street as “molly” is often not MDMA See “MDMA—Not!” for more on this topic. At high doses, it can cause the body to over heat.  It can cause anxiety and increase stress. Chronic use can cause memory impairment. But there are additional concerns with MDMA not mentioned in The Washington Post.

The National Institute on Drug Abuse (NIDA) related the following in its article on MDMA (Ecstasy) Abuse. MDMA was said to affect the brain by increasing the activity of at least three neurotransmitters: serotonin, dopamine, and norepinephrine. “Like other amphetamines, MDMA enhances release of these neurotransmittersand/or blocks their reuptake,resulting in increased neurotransmitter levels within the synaptic cleft (the space between the neurons at a synapse).” Releasing large amounts of serotonin causes the brain to become depleted of this neurotransmitter, contributing to the negative psychological aftereffects some people experience for several days after taking MDMA.

Low serotonin is associated with poor memory and depressed mood, thus these findings are consistent with studies in humans that have shown that some people who use MDMA regularly experience confusion, depression, anxiety, paranoia, and impairment of memoryand attention processes. In addition, studies have found that the extent of MDMA use in humans correlates with a decrease in serotonin metabolites and other markers of serotonin function and the degree of memory impairment. In addition, MDMA’s effects on norepinephrine contribute to the cognitive impairment, emotional excitation, and euphoria that accompanies MDMA use.

So despite the optimism of individuals like Rick Dobin and Benjamin Bell, there are clear dangers with a renaissance of psychedelic psychotherapeutics. Attributing objections and concerns to over fifty years “of drug prohibition and abstinence-only education,” as well as “a culture that has shaped the negative stigma of all psychedelics,” is disingenuous and dismissive of the legitimate concerns. Should there be further research into the potential for MDMA-assisted psychotherapy as a breakthrough treatment for PTSD? If all they are saying, is give MDA a chance, then absolutely. See the photo in Bell’s article of Timothy Leary singing, “Give Peace a Chance” with John Lennon and Yoko Ono.

But let’s not run ahead of the science to treat other emotional or psychiatric problems; or apply psychedelics to resolve the problems of world peace, homelessness and global warming just yet.


Head of a Snake

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As a result of a Washington Post and “60 Minutes” investigation, Representative Tom Marino withdrew his name from consideration for the position of “drug czar,” Director of National Drug Policy. As the investigation showed, Marino had been the primary force behind what became the “Ensuring Patient Access and Effective Drug Enforcement Act of 2016.” Marino spent several years trying to get the legislation through Congress, and was finally successful when Senator Orin Hatch negotiated a final version of the bill with the DEA. What wasn’t readily apparent by the title of the bill—and sunk Marino’s chances of approval as the new drug czar—was that instead of ensuring effective drug enforcement, it hobbled the DEA’s ability to go after the drug companies suspected of enabling the widespread distribution of prescription pain medication.

The law was the crowning achievement of a multifaceted campaign by the drug industry to weaken aggressive DEA enforcement efforts against drug distribution companies that were supplying corrupt doctors and pharmacists who peddled narcotics to the black market. The industry worked behind the scenes with lobbyists and key members of Congress, pouring more than a million dollars into their election campaigns.

The DEA had opposed the legislation for years, but was finally outmaneuvered by the nation’s major drug distributors and a few members of Congress. The new law made it effectively impossible for the DEA to stop suspicious narcotic shipments from the companies. Despite being fined, some drug distributors had repeatedly ignored warnings from the DEA to shut down suspicious sales. “Overall, the drug industry spent $102 million lobbying Congress on the bill and other legislation between 2014 and 2016, according to lobbying reports.” Through various political action committees, the drug industry contributed over $1.5 million dollars to the 23 lawmakers who sponsored or co-sponsored four versions of the bill. Marino received $100,000; Hatch $177,000. See the following chart from the Washington Post article.

The drug industry, the manufacturers, wholesalers, distributors and chain drugstores, have an influence over Congress that has never been seen before,” said Joseph T. Rannazzisi, who ran the DEA’s division responsible for regulating the drug industry and led a decade-long campaign of aggressive enforcement until he was forced out of the agency in 2015. “I mean, to get Congress to pass a bill to protect their interests in the height of an opioid epidemic just shows me how much influence they have.

Besides the sponsors and co-sponsors, few lawmakers knew what the impact of the bill would really be. Apparently, the same was true for the White House as President Obama signed it into law without any comment. “It sailed through congress and was passed by unanimous consent, a parliamentary procedure reserved for bills considered to be noncontroversial.” Michael Botticelli, who was the drug czar at the time, said neither the DEA nor the Justice Department objected to the bill at the time, which removed a major obstacle to the president’s approval. All this suggests there was some serious behinds-the-scene maneuvering going on. “Neither the DEA nor the Justice Department informed OMB about the policy change in the bill.”

The DEA’s top official at the time, Chuck Rosenberg, declined repeated requests for interviews by the Washington Post and “60 Minutes”; as did Loretta Lynch, then the attorney general and Tom Marino. A spokesperson for former President Obama referred reporters to Botticelli’s statement. Additionally, the DEA and Justice Department repeatedly denied or delayed over a dozen requests filed by the Washington Post and “60 Minutes” under the Freedom of Information Act for public records that could give additional information on what happened. “Some of those requests have been pending for nearly 18 months.”

Another key player in the “Ensuring Patient Access and Effective Drug Enforcement Act of 2016” was a former associate chief counsel for the DEA, D. Lindon Barber. While working for the DEA, he helped design and implement the early phases of the agency’s enforcement campaign against drug companies that were failing to report suspicious orders of opioids. Barber was also one of dozens of DEA officials recruited by the drug industry over the past decade. He brought first hand knowledge of the DEA’s strategy and how it could be countered when he went over to the drug industry in 2011. According to an internal Department of Justice email, Barber has a central role in crafting early versions of the legislation. “’He wrote the Marino bill,’ the official wrote in 2014.”

With a few words, the new law changed four decades of DEA practice. Previously, the DEA could freeze drug shipments that posed an “imminent danger” to the community, giving the agency broad authority. Now, the DEA must demonstrate that a company’s actions represent “a substantial likelihood of an immediate threat,” a much higher bar. “There’s no way that we could meet that burden, the determination that those drugs are going to be an immediate threat, because immediate, by definition, means right now,” Rannazzisi said.Today, Rannazzisi is a consultant for a team of lawyers suing the opioid industry. Separately, 41 state attorneys general have banded together to investigate the industry. Hundreds of counties, cities and towns also are suing.“This is an industry that’s out of control. If they don’t follow the law in drug supply, and diversion occurs, people die. That’s just it, people die,” he said. “And what they’re saying is, ‘The heck with your compliance. We’ll just get the law changed.’”

Sadly, the limitations placed upon the DEA by the “Ensuring Patient Access and Effective Drug Enforcement Act of 2016” were reported by the LA Times soon after the law was passed in 2016, but no consequences occurred until the Washington Post and “60 Minutes” investigation led to Marino withdrawing his name for the position of drug czar. The LA Times noted how the law was backed by some of the same wholesalers, manufacturers and pharmacy chains targeted by the DEA for not doing enough to monitor and restrict the overflow of pills. The stalled legislation also moved through Congress after the resignation of Joseph Rannazzisi from the DEA in October of 2015. He left, in part, because of his view that the bill was “misguided and would worsen the epidemic.” He said: “They are taking the word of industry rather than the government’s expert in diversion control.”

In 2012 the DEA took action against a major national wholesaler of pharmaceuticals and medical products, Cardinal Health, Inc. Data had shown enough pain medication was supplied to two CVS pharmacies in Sanford FLA for every person in the small city to have 59 doses. The DEA accused Cardinal and CVS of failing to maintain “effective controls” against diversion. “Cardinal was banned from shipping prescription drugs from a Florida facility for two years and CVS paid a $22-million settlement.” Note that CVS lobbying expenditures above were $32.5 million, second only to PHRMA, a trade group representing companies in the pharmaceutical industry.

The above are only the most notable and recent actions of the venomous pharmaceutical lobby. The Milwaukee Journal Sentinel published a two-part article on how drug makers work behind the scenes fighting against measures aimed at fighting the tide of prescription painkillers flooding our nation. Part 1 said there is a state level strategy where “hundreds of lobbyists and millions of dollars in campaign contributions” are used to weaken or kill measures aimed at turning back the opioid epidemic. The Associated Press and the Center for Public Integrity found they often use funded advocacy groups to fight limits of drugs such as OxyContin, Vicodin and fentanyl.

Between 2006 and 2015, drug makers spent more than $880 million nationwide on lobbying and campaign contributions — more than 200 times what those advocating for stricter policies spent. For comparison, it’s also more than eight times what the formidable gun lobby recorded for advancing its agenda through similar activities during that same period.

There have been hundreds of opioid-related bills introduced at the state level over the past few years. The few groups fighting for tighter prescription restrictions are primarily grass roots organizations formed by family and friends of individuals killed by opioids. “Together, they spent about $4 million nationwide at the state and federal level on political contributions and lobbying from 2006 through 2015 and employed an average of eight state lobbyists each year.” Compared to estimated lobbying of drug companies, they are being outspent 220 to one.

Part 2 of the Journal Sentinel article highlighted the efforts of a little-known group called the Pain Care Forum. The organization has worked at both the national and state level to communicate the message of the vital role played by painkillers in the lives of millions of Americans. The Pain Care Forum is a loose coalition of drug-makers, trade groups and nonprofits supported by industry funding. A 2012 Pain Care Forum “Meetings Schedule” listed about 64 participating organizations, a mix of medical organizations, advocacy groups and pharmaceutical companies. Among the pharmaceutical companies were: Abbott Laboratories, Allergan, Eli Lily & Company, Endo Pharmaceuticals, Johnson & Johnson, Merck, Purdue Pharma LP, and Teva.

 From 2006 through 2015, participants in the Pain Care Forum spent more than $740 million lobbying in the nation’s capital and in all 50 statehouses on an array of issues, including opioid-related measures, according to an analysis of lobbying filings by the Center for Public Integrity and the AP.The same organizations reinforced their influence with more than $140 million doled out to political campaigns, including more than $75 million alone to federal candidates, political action committees and parties.

Purdue’s Washington lobbyist co-founded the Pain Care Forum and coordinates the group’s meetings. The Pain Care Forum doesn’t have an online presence or a physical address, yet it hosts high-ranking officials from the White House, the FDA and other agencies at its monthly gatherings. While Forum members maintain it does not take policy positions, the AP and Center for Public Integrity have shown where the group’s participants worked together “to push and draft federal legislation, blunt regulations and influence decisions around opioids.” A major talking point is the false assumption of a conflict between reducing our dependence on opioids and improving care for patients with pain. “It’s an artificial conflict, but there are lots of vested interests behind it.”

Tom Marino will not be the new “drug czar,” and hopefully the media attention recently received by “Ensuring Patient Access and Effective Drug Enforcement Act of 2016” will result in Congress restoring the enforcement power to the DEA that the legislation removed. But since some legislators have been seduced by pharmaceutical money and influence, Congress may not have the collective will to resist the lobbying influence of Pharma companies. Therein lies the problem: how can you cut off the head of a snake if you depend on the snakes?


Pick Your Poison: Diabetes and Psych Meds

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The American Diabetes Association said 30.3 million Americans, 9.4% of the population, had diabetes in 2015. There are 1.5 million news cases of diabetes diagnosed each year. It is the 7th leading cause of death in the U.S. with 79,535 death certificates in 2015 listing it as the underlying cause of death. A total of 252,806 death certificates listed diabetes as an underlying or contributing cause of death. If the number of deaths from diabetes were equal to 252,806, it would be the third leading cause of death in the US, according to the CDC … and psych meds increase the risk for diabetes.

SSRIs have been associated with an increased risk of diabetes, as Yoon et al. noted in “Antidepressant Use and Diabetes Mellitus.” The researchers ruled out depression itself as a potential confounding variable in the relationship between antidepressants and diabetes. Their findings suggested that antidepressant drug treatment and not the depression increased the risk of diabetes mellitus (DM). “Given the widespread use of antidepressants, the implications of the increased risk are serious.”

The authors noted that while there is disagreement as to the reason for the association between antidepressant use and DM risk, some studies “propose that antidepressants may bio-pharmacologically affect glucose homeostasis and insulin sensitivity.” In “Use of Antidepressants Linked to Diabetes,” Peter Simons of Mad in America noted a study that has supported that hypothesis. A study led by Raymond Noordam and published in The Journal of Clinical Psychiatry, found the use of SSRIs in nondiabetic participants was associated with lower insulin secretion and an increased risk of insulin dependence in type 2 diabetes in older adults.

It is biologically plausible that SSRIs decrease insulin secretion and that this might, therefore, be a mechanism underlying the previously observed association between SSRIs and increased risk of type 2 diabetes. Consequently, type 2 diabetes patients treated with SSRIs might also have a higher risk to develop insulin dependence, a condition associated with an increased risk of mortality.

The researchers also found that participants already diagnosed with diabetes who were taking antidepressants were twice as likely to start insulin treatment than those who did not take antidepressants. They said: “our data might suggest that progression of type 2 diabetes during the use of SSRIs is accelerated.” Simons commented how the higher mortality rate for individuals who require insulin treatments made this “a particularly alarming finding.”

This new study provides additional convincing evidence that although SSRIs are commonly believed to have fewer risks of adverse effects than TCAs, they still carry significant risk. This appears to be particularly relevant when it comes to patients with diabetes. Whenever antidepressant medication is considered, patients and prescribers should carefully weigh the potential risks and benefits.

There was an updated meta-analysis published in PLos One, “The Risk of New-Onset Diabetes in Antidepressant Users.” Their meta-analysis found an increased risk factor of 1.27 between exposure to antidepressants and new-onset diabetes. When they restricted the analyses to higher quality studies, the relative risk was higher. The researchers noted their findings were in line with tow previous meta-analyses that reported “a 1.5-fold increase of diabetes among AD [antidepressant] users.” In an interview with Endocrinology Advisor, the lead investigator of the study extrapolated that given a 13% prevalence rate of antidepressant use in the US, a 1.3-fold increase in diabetes risk would translate to over 1 million cases of diabetes that could be due to concurrent antidepressant use.

Pharmacy Times reported in “Atypical Antipsychotic-Induced Type 2 Diabetes” that patients with schizophrenia were at an increased risk of developing metabolic disorders like type-2 diabetes mellitus (T2DM). Schizophrenic patients had a number of risk factors for T2DM, including family history, increased body mass index (weight gain), a sedentary lifestyle and the use of atypical antipsychotics. There have been several proposed mechanisms for the association of diabetes and atypical antipsychotics, one being the weight gain associated with the medications.

A 2006 study by Alvarez-Jiménez et al. found that 78.8% of patients taking atypical antipsychotics experienced a weight gains greater than 7%, the cut off for clinically meaningful weight gain in the study. In 2004 the FDA required a warning be placed in the medication guides of all atypical antipsychotics warning of the increased risk of hyperglycemia and diabetes.

 Patients with schizophrenia are at increased risk of developing metabolic disorders like type 2 diabetes. This is due to a number of factors, including the treatment of schizophrenia with atypical antipsychotics. There are several potential mechanisms behind antipsychotic-induced diabetes, including the weight gain associated with these medications, the effects on pancreatic receptors and/or glucose transporters, or some other cause not yet discovered. Most likely, it is a combination of these effects. Of the atypical antipsychotics, clozapine [Clozaril] and olanzapine [Zyprexa] are associated with the highest incidence of metabolic dysfunction, whereas ziprasidone [Geodon] and aripiprazole [Abilify] are considered to be the least risky.

In “Antipsychotic-Induced Diabetes Mellitus” published in U.S. Pharmacist, Chhim et al. reported there are several metabolic consequences with antipsychotic use, including weight gain, hyperglycemia (abnormally high blood glucose) and dyslipidemia (an abnormal amount of triglycerides, cholesterol and/or fat phospholipids in the blood). The association of type 2 diabetes mellitus (T2DM) and antipsychotic use is supported by retrospective epidemiologic studies as well as post-marketing assessment. Data indicate the prevalence of diabetes and obesity is 1.5 to 2 times higher in people diagnosed with schizophrenia or affective disorders than the general population.

The authors noted that diabetes was reaching epidemic proportions worldwide, and the contributions of medications to the development of hyperglycemia and other metabolic problems was getting more attention.  “Pharmacists are in a unique position to counsel and encourage appropriate self-monitoring in patients receiving certain drugs, such as antipsychotics, that can contribute to the development of weight gain, hyperglycemia, and dyslipidemia.” They can encourage patients to report adverse events to other health care providers and seek therapeutic substitutions, counseling, and/or treatment for the adverse events.

Another resource addressing these concerns, one that was cited in “Antipsychotic-Induced Diabetes Mellitus,” is the “Consensus Development Conference on Antipsychotic Drugs and Obesity and Diabetes.” This is a joint consensus statement from the American Diabetes Association, the American Psychiatric Association, the American Association of Clinical Endocrinologists, and the North American Association for the Study of Obesity to help reduce the risk of developing diabetes, cardiovascular disease, and other complications of diabetes.

There was a large longitudinal study done in Denmark by Rajkumar et al. that found in addition to the high risk for diabetes conferred by schizophrenia on individuals, “the risk is further increased by both first-generation and second-generation antipsychotics.” Reporting on the study for Mad in America, Bernalyn Ruiz said the authors said the prevalence of diabetes was 4 to 5 times greater in people diagnosed with schizophrenia. “After adjusting for potential confounders, the risk was elevated threefold compared to those without a schizophrenia diagnosis.” No differences were seen between first-generation and atypical antipsychotics.

This large nationwide study confirmed endogenous risk for diabetes among individuals diagnosed with schizophrenia, with risks increasing significantly when antipsychotics are prescribed.

The bottom line is that in addition to their other adverse effects, there is credible scientific evidence that antidepressants and antipsychotics increase the risk of diabetes among individuals taking them. So when you’re advised to use one of these classes of psychiatric medications, it’s a bit like being asked to pick your poison.


“Cash Cows” for the Drug Industry

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The AARP, the American Association for Retired Persons, completed a report looking at the trends in the retail prices of prescription drugs used by older Americans between 2006 and 2015.  And the report’s findings were disturbing. Between 2014 and 2015, the retail prices of 268 widely used brand name prescription drugs increased by 15.5%, the fourth year in a row of double-digit increases. The increase was almost 130 times faster than that of inflation—15.5% to .1% for inflation. The average annual retail cost for one brand name drug was over $5,800 in 2015, almost $1,000 more than the annual cost in 2014. “For the average older American taking 4.5 prescription drugs per month, the annual cost of [drug] therapy would have been more than $26,000 for 2015—more than three times the cost seen 10 years earlier.

This was an industry-wide trend, as the prices of the identified drugs, from all 35 drug manufacturers with at least two brand name drugs assessed within the study, increased faster than the rate of general inflation in 2015. “All but one of the therapeutic categories of brand name drugs had average annual price increases over 5% in 2015. . . . The higher costs are typically passed on to the consumer in the form of higher cost sharing, deductibles, and premiums.”  These increases were far beyond the price increases for other consumer goods and services between 2006 and 2015. The following graph compares the annual price of brand name prescription drugs to rate of general inflation for the corresponding year.

The next figure illustrates how the average annual cost for widely used brand name drugs by older adults grew more than 300% from 2006 to 2015. The Medicare Part D program was first implemented in 2006. Older Americans fill an average of 4.5 prescriptions for medications per month. If they used brand name prescription drugs, their average annual retail cost for medications would be $26,132. “This annual retail cost of brand name prescription drugs exceeds the median annual income for a Medicare beneficiary ($24,150).”

It is no coincidence that these price increases for medications commonly used by older adults occurred after The Medicare Prescription Drug, Improvement, and Modernization Act” was approved in 2003. “It expressly prohibited Medicare from negotiating bulk prescription drug prices.” But the Veterans Health Administration and the Defense Department were allowed to negotiate lower prescription drug prices. Prohibiting Medicare from negotiating bulk drug discounts seems directly related to increases in medications noted above.

The AARP Public Policy Institute found there were six specific brand name drugs with the highest percentage changes in retail price from 2006 to 2015. FIVE of them were from the same pharmaceutical company—Valeant. One mg and two mg tablets of Ativan (for anxiety) increased 2,873% and 2,080% respectively in their retail price. Cara .5% cream (certain skin disorders) increased 2,395%. Wellbutrin (for depression) increased 1,185%. Zovirax 5% cream (certain skin disorders) increased 783%. Eli Lilly’s Humulin R (U-500) 500 units/ml, an insulin drug used to treat diabetes, ONLY increased 530%.

If recent trends in brand name drug prices and related price increases continue unabated, the cost of drugs will prompt increasing numbers of older Americans to stop taking necessary medications due to affordability concerns. Continued excessive brand name drug price increases will also lead to increased cost sharing and premiums, which could ultimately make health care coverage unaffordable and lead to poorer health outcomes and to higher health care costs in the future.Given that health care reform expanded the number of people using prescription drugs, it would have been reasonable to expect smaller brand name drug price increases. Instead, brand name drug prices have accelerated substantially. Clearly, the economics of the pharmaceutical market are not working as expected.

Andy Slavitt, when he was the acting administrator for the Centers for Medicare & Medicaid Services, told the pharmaceutical industry in November of 2016 at a conference that increased medication costs were pervasive. Total prescription drug spending in 2015 was $457 billion, 16.7% of health care spending. Mylan’s Epipen was not even in their top twenty list for high price increases for 2015. Specialty drugs (like hepatitis C drugs) were a big part of the cost increase. They accounted for 31.8% of spending, while representing only 1% of prescriptions. Out of the 20 drugs with the highest per-unity cost increases in Medicaid, seven were generic drugs. Those increases were not to recoup drug development expenditures. See “Pharma’s not Getting the Message” for more on this topic.

The NYT reported there has been a sharp rise in polypharmacy, the use of three or more psychotropic drugs, with older adults. Almost half of these patients DID NOT have a diagnosis for mental health or pain disorder on record. Dr. Maust, a geriatric psychiatrist and lead author of the study, told Psychiatric News: “This begs the question of why physicians are exposing patients to all the risks of these medications, but not for the diagnoses they are intended to treat.” He thought the pattern suggested some inappropriate prescribing. Dr. Dilip Jeste, a geriatric neuropsychiatrist and past president of the American Psychiatric Association, said he was stunned to hear “that despite all the talk about how polypharmacy is bad for older people, this rate has doubled.” Over 90 percent of the office visits examined in the study occurred outside the psychiatric setting.

The AARP Public Policy Institute reported that 65% of adults over the age of 65 reported using 3 or more prescription drugs in the past 30 days. Ninety percent reported using one prescription drug in the past 30 days, while 39% said they used five or more. See the following figure from “Prescription Drug Abuse Among Older Adults.”

Disturbingly, this study looked at polypharmacy with medications noted within the Beers Criteria, named after its originator with the American Geriatrics Society twenty years ago. The Beer Criteria lists dozens of medications and their mutual interactions that are potentially harmful when prescribed to older adults. “Geriatric medical organizations have long warned against overprescribing to older people, who are more susceptible to common side effects of psychotropic drugs, such as dizziness and confusion.” The Psychiatric News article linked above has a chart of the Beer’s list of CNS medications, their potential risks and alternative clinical recommendations. The classes of medications examined in the study include: antipsychotics, benzodiazepines, sedative hypnotics for sleep (like Ambien), antidepressants (tricyclics and SSRIs) and opioids. An article in the Journal of the American Geriatrics Society on the 2015 updated Beers Criteria is available here.

Data reported by the AARP Public Policy Institute in “Prescription Drug Abuse Among Older Adults” also noted that older adults has several unique risk factors making them particularly susceptible to misuse of prescription drugs. Misuse is defined here as “the use of prescription drugs in a way a doctor did not direct.” First, older adults use more prescription drugs than any other age group. They also have higher rates of pain, anxiety, and sleep disorders. There could be memory problems that interfere with taking medications at the right time and in the right doses. The high rates of polypharmacy can also lead to potentially dangerous drug interactions.

Age-related physiological changes can also increase the potential for prescription drug abuse. Changes in metabolism, weight, and body fat can affect how a medication works in the body, increasing the potential for misuse and abuse and potentially dangerous side effects. The combination of alcohol and medications can bring about particularly adverse reactions among older adults, as their bodies detoxify and eliminate medications and alcohol more slowly.

Recommendations to prevent drug misuse with older adults include: regular reevaluation of drug dosages to help compensate for physiological changes and declining drug metabolism. Monitor for any inappropriate prescribing of prescription medications. Use of the Beer Criteria discussed above would be helpful. here Because patients often see multiple healthcare providers and obtain multiple prescriptions, keep an eye on a patient’s entire regimen of prescription and nonprescription drug use.

It seems hard to deny that pharmaceutical companies corralled older adults over the past twenty years and branded them as “cash cows” for the drug industry.


Pharma’s Not Getting the Message

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In response to rapidly increasing prescription drug prices and congressional inability or unwillingness to intervene, individual states are attempting to address the issue. While Californians approved a ballot initiative for recreational marijuana in November of 2016, state voters also turned down one aimed at curbing the high cost of prescription drugs. The California Drug Price Relief Act, or Proposition 61, sought to limit the state’s health programs from paying more than the U.S. Department of Veterans Affairs (VA), which receives the steepest discounts in the country, according to Reuters. Pharma companies lobbying against Proposition 61 spent $100 million to defeat it.

Proposition 61’s opponents, led by global drugmakers such as Pfizer Inc and Amgen Inc, spent around $106 million. They argued that it would benefit only 12 percent of Californians, while putting the other 88 percent, and veterans across the country, at risk of higher drug costs.

The defeat of the measure: “reaffirms the power of the biomedical lobby,” according to Brian Abrahams, a Senior Biotechnology Analyst at CIBC World Markets. Stuart Schweitzer, a professor of health policy and management at the University of California, said the measure would have only had a modest impact on state drug costs. Nevertheless, “They wanted to draw a line in the sand.”  A similar proposition will be on Ohio’s 2017 November ballot.

U.S. New and World Report said New York State approved rules in April of 2017 that will put pressure on pharmaceutical companies if they want to continue doing business in the state. If Pharma companies don’t agree to voluntarily rebate or return money to the state if prescription medication spending is projected to exceed the sum of medical inflation plus 5 percent, New York State could initiate a series of reviews using scientific studies and other information to evaluate whether specific medications are overpriced. “Drug makers generally object to such reviews and often dispute their results.” The NY State Medicaid Director said the law created an incentive for pharmaceutical companies to collaborate and give the state rebates.

New York is not the only state taking action. Vermont lawmakers passed legislation requiring justification for price increases that are driving up spending in state programs like Medicaid. In March of 2017 Maryland lawmakers passed legislation, still not signed by the governor, directing Medicaid to notify the state attorney general when off-patent or generic drugs have “an excessive price increase.” The new law also sets financial penalties if the pharmaceutical company can’t justify the price hike. Louisiana officials are looking into whether a rarely used federal law could be used to “sidestep patents and allow government programs to get lower-cost generic versions of pricey hepatitis C treatments.”

In August of 2017, JAMA gave greater details about the New York legislation in: “Value-Based Pricing and State Reform of Prescription Drug Costs.” Hwang et al. said if the rate of drug spending growth exceeded the 10-year average inflation plus 5% in 2017-2018 or 4% in 2018-2019, the state department of health would be authorized to identify and refer high-cost drugs to a drug utilization review board to determine a target rebate amount. The provisions are likely to trigger a review this year. The board may consider the effectiveness of the drug, its therapeutic alternatives, and the seriousness and prevalence of the disease in formulating its recommendation for a value-based price.

If the state and manufacturer fail to agree on a rebate that is at least 75% of the difference between the drug’s current price and value-based price, the state may waive provisions that currently require managed care plans to cover medically necessary drugs in certain protected classes, including antidepressants, antiretrovirals, and hermatologic drugs. Furthermore, if total drug expenditures continue to increase faster than inflation despite these new rebates, the state may implement more aggressive actions to promote use of clinical alternatives, including directing managed care plans to remove drugs from their formularies that lack new rebate agreements.

The pharmaceutical industry is taking steps to prepare to do battle against these and other steps taken to rein in drug prices. The pharmaceutical lobby, PhRMA (Pharmaceutical Research and Manufacturers of America), is increasing membership dues by 50 percent to raise an additional $100 million PER YEAR to fund its ongoing fight over drug prices.  “PhRMA has consistently ranked among the biggest lobbying spenders in Washington over the past few years.” By August of 2016, it had already spent $11.8 million that year, making it the fourth-largest lobbying group in Washington DC. TV advertising in 2017 was to target how “new drugs could add years to patients’ lives, as well as the years of complex research needed to develop a drug.”

The Intercept reported that newspapers in the Washington D.C. area were getting swamped in April of 2017 with ads warning of the dire consequences of proposals to lower drug prices. The groups placing the ads had no obvious connections to pharmaceutical companies. The ads appeared in the Washington Post, Washington Times, Roll Call, The Hill and Politico just as legislators were taking up proposals to lower drug prices. As it turned out, the organizations had undisclosed financial ties to PhRMA.

A bill proposed by Senator Al Franken would reverse a 2003 law prohibiting Medicare from using its collective bargaining power to negotiate lower drug prices. Legislators who wrote the 2003 bill worked closely with PhRMA lobbyists while drafting the legislation. The bill’s sponsor later became the president of PhRMA.  Franken and others introduced the “Improving Access to Affordable Prescription Drugs Act” on March 29, 2017. Here is a five-page summary of the bill. A companion bill to “Improving Access to Affordable Prescription Drugs Act” was introduced in the House on the same day.

Some of its provisions would include several current problems with prescription drug costs. It would close the coverage gap in Medicare Part D coverage (known as the donut hole) in 2018, two years earlier than under current law. Tax credits given to pharmaceutical companies for their direct-to-consumer (DTC) advertisements would be eliminated. (WE WERE GIVING PHARMA COMPANIES TAX CREDITS WHEN THEY TRY TO GET US TO BUY THEIR DRUGS?) It would allow individuals, wholesalers and licensed U.S. pharmacies to import prescription drugs manufactured at FDA-inspected facilities from licensed Canadian sellers.

Significantly, Section 201 would allow the Secretary of Health and Human Services to negotiate with drug companies to lower prescription drug prices. It directs the Secretary to “prioritize negotiations on specialty and other high-priced drugs.” Under existing law, unlike Medicaid and the VA, Medicare is not allowed to leverage its purchasing power to negotiate lower drug prices.

STAT News reported that the Thursday before the November 2017 election, Andy Slavitt, the acting administrator for Medicare and Medicaid Services, said the rising costs for prescription drugs “will put unsustainable pressure on the Medicare program, and action is going to be necessary to address them.” He was addressing the BioPharma Congress, an industry conference. He said: “Drug costs have become the health policy issue Americans are most anxious to see us act on, and we have a responsibility to them to explore all the options available us to make their medications more affordable.” He told those at the conference that we could have both innovation and affordability. “These two goals shouldn’t be in opposition.”

In every-forward looking industry outside of health care, we see that competition actually fuels innovation, and affordability improves alongside the development of new technologies. . . . There are plenty of policy options and certainly a number of ways innovators like you can choose to respond – from disputing the math and fighting it, to looking for win-wins.

So far, it seems Pharma is ignoring the message. They are still trying to convince the American public and U.S. lawmakers that innovation in drug development will dry up if price caps are enacted.

The debate over the cost of drug development has been going on since the late 1950s, believe it or not. An often-quoted 2003 study, “The Price of Innovation,” which was published in the Journal of Health Economics, estimated it cost $802 million in 2000 dollars to bring a new drug to market. PhRMA’s 2014 profile found that estimate low and said it actually costs $1.2 billion to develop a new drug. However, “Demythologizing the High Costs of Pharmaceutical Research,” in the journal BioSocieties, suggested the true research and development costs were a median of about $43.4 million per new drug. That is about 5.4% of “The Price of Innovation’s” cost projection and 3.6% of the PhRMA estimate. See “Pharma and Its Golden Hoard” for a further discussion of what a new drug costs.