35 AG’s seeking $$$ from pharmas because they have a profitable product ?

pilingon1Virginia Attorney General joins lawsuit to make opioid treatment drug more available

http://wric.com/2016/09/23/virginia-attorney-general-joins-lawsuit-to-make-opioid-treatment-drug-more-available/

 

Yesterday it was Minnesota’s AG Is our “FREE MARKET PLACE” under attack by the bureaucracy ?

Today it is Virginia… along with a total of 35 states and DC … at some time.. it is going to become unprofitable to produce a medication/product or line of products and then what are those people who have a medical necessity going to do ? Does this really have something to do with the profits of the company making this company or that the company used existing laws to extend the “profit life” of a product… or that the people using this product is according to our court system in 1917… are CRIMINALS… and the legal profession has a problem with the legal treatment of criminals using controls ?

goldrules

RICHMOND, Va. (WRIC) — Virginia Attorney General Mark Herring and 35 other attorney generals throughout the country filed an antitrust lawsuit in federal court against the makers of Suboxone.

Suboxone is a prescription drug used to treat opioid addiction.

In the suit, the attorney generals claimed that the companies engaged in a “product hopping scheme,” where small changes were made to the product to block generic competitors and cause purchasers to pay artificially high prices for an important addiction treatment medicine.

Reckitt Benckiser Pharmaceuticals and Indivior are accused of conspiring with MonoSol Rx to switch Suboxone from its tablet version to a film that dissolves in the mouth, with the goal of delaying generic alternatives to maintain monopolistic profits.

The companies are accused of violating state and federal antitrust laws.

Herring said he is participating in the lawsuit because he thinks it will aid in resolving the opioid abuse epidemic.

“For many Virginians struggling with an addiction to heroin and other opioids, Suboxone can be an important part of a treatment plan that allows them to manage their substance abuse disorder,” Herring said. “After extensive investigation, my colleagues and I have reason to believe that these monopoly practices violated the law and made this important medication more expensive and more difficult to obtain.”

Suboxone is a brand-name prescription o buprenorphine and naloxone that is used to treat heroin addiction and other opioid addicitons by easing addiction cravings. No generic alternative for Suboxone film currently exists.

The attorneys general allege that consumers and purchasers have paid artificially high monopoly prices since late 2009 when generic alternatives of Suboxone might otherwise have become available. During that time, annual sales of Suboxone topped $1 billion.

The lawsuit, filed in the U.S. District Court for the Eastern Division of Pennsylvania, accuses the companies of violating the federal Sherman Act and state antitrust laws. In the suit, the attorneys general ask the court to stop the companies from engaging in anticompetitive conduct, to restore competition, and to order appropriate relief for consumers and the states, plus costs and fees.

Thirty-four additional states and the District of Columbia have joined the lawsuit including Alabama, Alaska, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Illinois, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Rhode Island, South Carolina, Tennessee, Utah, Vermont, Washington, and Wisconsin.

The “worse” for chronic pain pts… may still be over the horizon ?

Could Pharmacy Schools Go the Way of Law Schools?

http://www.pharmacytimes.com/contributor/fred-eckel-rph-ms/2016/09/could-pharmacy-schools-go-the-way-of-law-schools

Right now we have a growing surplus of Pharmacists and the average “new grad” is coming out of school with abt $150,000.  Has had been stated before… the majority of Boards of Pharmacy are stacked with non-practicing corporate Pharmacists… so as their chain employer pushes for more authority granted to technicians.. they will either have to agree – as board members… or end up being replaced.. since the board position are generally appointed by the Governor of the state.  Contributions to re-election campaigns can get political favors like the preferred appts to the board of pharmacy. Technicians will have to probably have to rely highly on the pharmacy computer system as to what to do or not do … in regards to filling or not filling prescriptions for pts.  Their education will be at a “lower level” and they will not have – or be able to develop or use – clinical experience to assist the pt. The pharmacy computer will be the final word as it is programmed according to the corporate guidelines… as to what the tech is allowed to do. Throw on top of that dictatorial edicts of the Prescription Benefit Managers (United Health, CVS Health, Express) being the major players as of now.

A recent report by the Clayton Christensen Institute observed the following about the law education climate:

Facing dramatic declines in enrollment, revenue, and student quality at the same time that cost structure continues to rise and public support has waned, law schools are in crises. A key driver of the crises is shrinking employment opportunities for recent graduates, which stem in part from the disruption of the traditional business for provision of legal services. Although this root problem will soon choke off the financial viability of many schools, most law schools remain unable or unwilling to address this existential problem in more than a marginal way, as they instead prefer to maintain the status quo and hope that the job market soon improves.1

Now, I know it’s not politically correct to raise concerns about pharmacy education, but as I read the report on law schools, I couldn’t help but think a similar report could easily be generated about our industry. I’ve heard from faculty in many schools that the quality of applicants seems to be declining, as is the number of applicants. I heard of one school hiring a high-level marketing expert to try to increase its applicant pool to address the problem.
 
Could there be a bigger issue in pharmacy that increasing applicants won’t correct, at least in the short run? Let me suggest 2.
 
The current reimbursement model doesn’t pay well for the provision of clinical services that student pharmacists are being trained to do. Not many employers can afford to hire these graduates for these new roles because they aren’t receiving reimbursement for such services. At the same time, the reimbursement for providing dispensing services is also being cut. This is forcing employers to automate as much as possible and find ways to use technicians in greater numbers.
 
Yes, Board of Pharmacy laws and regulations limit that role now, but will the move by the Pharmacy Technician Certification Board to require formal education for pharmacy technicians by 2020 lead to efforts to use technicians for the dispensing role, thereby putting further pressure on the pharmacist job market? I know that isn’t what most individuals want to think, but the “tech-check-tech” movement suggests it’s as safe as “pharmacist-check-tech” systems. If all pharmacy techs are program graduates, they’ll also put pressure to become recognized and given advanced responsibilities, just as pharmacists have been working to gain their own advanced roles.

Does this suggest pharmacy education needs to change to prepare a different kind of graduate for new roles? I think so. Will we need as many schools to train these new graduates? I don’t think so. It looks to me like we’ll see a major disruption in both pharmacy practice and education over the next 5 years. When that happens, what will happen to those trained and practicing under the old model?
 
Reference
1. Pistone MR, et al. Disrupting law school: how disruptive innovation will revolutionize the legal world. Clayton Christensen Institute website. christenseninstitute.org/publications/disrupting-law-school/. Accessed September 9, 2016. 
– See more at: http://www.pharmacytimes.com/contributor/fred-eckel-rph-ms/2016/09/could-pharmacy-schools-go-the-way-of-law-schools#sthash.md9bnOBK.dpuf

Is our “FREE MARKET PLACE” under attack by the bureaucracy ?

Minnesota Attorney General Lori SwansonMinn. AG sues drug companies over opioid treatment

http://www.mprnews.org/story/2016/09/22/opioid-treatment-drug-makers-sued

 

When “do no harm” flips from pt focused to physician’s livelihood ?

When treating chronic pain, don’t compromise your principles

www.kevinmd.com/blog/2016/09/treating-chronic-pain-dont-compromise-principles.html

One of the most difficult things I deal with as a physician is patients’ demands for pain medications. I treat patients with cystic fibrosis, a genetic disease present at birth with no cure, and its issues are indeed complex. There are legitimate causes for misery from the chronic coughing, abdominal pain, and joint pain recognized as common symptoms of the disease.

But the associated issues of depression, stress with family, and money make giving out narcotics problematic. There is also intense pressure on a physician in the CF community, as there is in many other practices, to retain your patients. Having a patient leave you for another provider is painful, and feelings of failure and a sense of letting somebody down pervade.

Treating pain and relieving suffering are an inherent part of what is expected of us as healers. The Hippocratic oath was written in 400 BCE, and is one of the most enduring and momentous codes of ethics ever written. The Yale University version of the Hippocratic Oath explicitly mentions relieving pain and suffering in the third sentence. As gatekeepers of medicine, it is within our power to both give and refuse potent medicines.

My perspective on pain medications is similar to that of many of my colleagues in mid-career. I attended medical school in the 1990s, when the whisper that physicians weren’t treating pain turned into a thunderous roar. Pain became the fifth vital sign, no longer a symptom but something as important to a patient’s life as their heart rate and blood pressure.

Unfortunately, somewhere along the way something bad happened. Really bad. The country got hooked on pain medications. We turned into a nation of pill poppers, and when that got too expensive for people, heroin came back. The stories of drugs ruining people’s lives began to show up not only in arrest reports, but also in obituaries. There was simply too much access to these drugs, and the country was clearly suffering. Many addictions could be traced back to a single prescription for a narcotic for a tooth removal or after a minor surgical procedure.

With the drug overdoses piling up, the medical establishment began to take notice. The pendulum had swung too far to the side of easy narcotic prescriptions. At the same time, data began emerging that opiates were not an effective treatment of chronic pain. We were doing more harm than good with these drugs, and the medical societies began to act. In 2016 the CDC came out with new guidelines highlighting the importance of attempting to limit the use of narcotics for chronic pain.

But making a change in practice patterns overnight is never easy. It is a process. The CDC guidelines were not a recommendation to switch from using one antibiotic to another for a pneumonia, or to use this blood pressure medicine instead of that one because of side effects. These changes got very deep into issues of relieving suffering.

Recently I had struggled with the help versus harm conflict of prescribing opiates these issues. A few of my patients began asking for opiates for their chronic pain, and asking insistently. As usual, their situations were complex. They had real reasons for pain, but mixed up with them were depression, a chronic illness, and sometimes a history of drug abuse. I tried to steer them to non-opiate pain relievers, as well as yoga, exercise, and counseling to help treat them. They looked at me like I had asked them to grow a third eye.

I was confused about my role as healer. Pain has been described as the physical sensation of discomfort, while suffering is the story we tell ourselves about the experience. There was no doubt my patients were suffering, but I wasn’t convinced pain medication was the answer.

I took my concerns to a seminar on the psychological aspects of cystic fibrosis. When it came time for the question-and-answer session, I was ready.

“What should I do when my patients ask me for pain medications, and they aren’t indicated, and I think they’re going to do more harm than good? I’m afraid to lose them to another center, or have them get their meds off the street. Wouldn’t it be better just to treat them in a controlled setting?”

The speaker looked me in the eye. “Michael,” he said, “you simply cannot compromise your principles for fear that somebody is going to reject you or buy illegal drugs off the street.”

He elaborated, but that first statement was all I needed. They were the right words at the right time, and put everything into perspective for me: Decide if you think the medicine is going to do more good than harm. If you don’t think it is, then you simply do not prescribe it. You cannot sacrifice your ethics for fear of rejection, and what that patient decides to do from there is not your responsibility.

Since then, I’ve had patients hate me and leave me. I know most of the time they are going to another provider and getting what they want, or, worse, going to the street to get what they want. Hopefully, sometimes they focus on other ways to ease their chronic pain. And sometimes I’m sure I’m wrong, and with luck, they do find the right practitioner to give them what they need — I’m not a pain doctor.

The elephant in the room is that we don’t have a great answer for the millions of Americans who suffer from chronic pain. It doesn’t seem as if opiates are our answer. I still do prescribe opioids occasionally, but try to keep it short term, constantly evaluating if the patients are more functional or less functional on their medications. But I’ve gotten away from the mindset of prescribing for chronic pain, and psychologically I’m back in line with being able to say no. And with that, I feel like I’m back in line with another part of the Hippocratic Oath: to abstain from doing harm.

Michael J. Stephen is an pulmonary physician and adult program director, cystic fibrosis program, Drexel University College of Medicine. Philadelphia, PA.

Governor creates task force on opioid abuse

Governor creates task force on opioid abuse

Do you know what you get when a person in the position of power/influence and has a loved one suffering from the mental health disease of addictive personality disorder ?  You get policies/laws/rules/regulations that focus on the needs of the FEW and SCREWS the needs of the MANY

http://www.weau.com/content/news/Governor-creates-task-force-on-opioid-abuse-394452671.html

MILWAUKEE (AP) — Gov. Scott Walker says that although the state has taken steps in the past to combat opioid abuse in Wisconsin, there’s more to be done.

Walker on Thursday signed an executive order creating a task force to make additional recommendations on fighting abuse of pain relievers, such as oxycodone and hydrocodone and methadone.

Walker says the task force will be led by Lt. Gov. Rebecca Kleefisch and Rep. John Nygren, whose daughter has struggled with drug abuse.

Walker signed the order at a Walgreens drug store in Milwaukee to highlight the chain’s drug take-back disposal program at 18 pharmacies in Wisconsin. Citizens can drop off unused medication, including controlled substances by placing them in a disposal kiosk.

DEA plan calls for the need to better educate the public on the dangers of pain pill reliance

Major federal anti-heroin effort coming to Louisville

http://www.sanluisobispo.com/news/health-and-medicine/article103400177.html

Is this a Freudian slip ?  the plan calls for the need to better educate the public on the dangers of pain pill reliance.  More change in the nomenclature of no more addicts/junkies .. just those that suffer from a “opiate use/abuse disorder”  They are also going to “fight crime”… but.. if we treated those who are abusing opiates.. as the people with mental health issue of addictive personality disorder.. there would be less crime, violence and deaths… and LESS NEED FOR LAW ENFORCEMENT… if the cartels had no customers… there would be no need for a war on drugs ?

Louisville has been chosen for a federal pilot program aimed at combatting heroin and prescription drug abuse as well as related violent crime.

Federal and city officials announced Wednesday that Louisville will be part of what the federal Drug Enforcement Administration is calling a “360 Strategy” to curb the opioid crisis, news outlets reported. The program is already in place in Pittsburgh, St. Louis and Milwaukee.

Federal funds will be used to form a Heroin Investigation Team consisting of Louisville police detectives and DEA agents that will investigate heroin overdoses as crime scenes.

Investigators are planning to crack down on local drug dealers, larger suppliers and track doctors at the center of pill mills.

Dealers whose drugs cause overdoses will now face a minimum 20-year prison sentence without parole, U.S. Attorney John Kuhn said.

“Our targets are not addicts … but the dealers who are willing to destroy lives for the sake of profit,” Kuhn said.

In addition to aggressively prosecuting dealers, the plan calls for the need to better educate the public on the dangers of pain pill reliance. One way in which the DEA has recently been trying to accomplish that goal in Pittsburgh is by staging a play that educates students about the dangers of experimenting with pills and other drugs, The Courier-Journal reported (http://cjky.it/2dnarg2).

“Who would think the DEA would be putting on plays, but it works,” said DEA Special Agent Patrick J. Trainor, spokesman for the administration’s Philadelphia Division, which includes Pittsburgh. “It’s effective in getting the word out. We’re ramping up awareness like never before.”

Jefferson County had 268 drug overdose deaths last year, more than any other Kentucky county. Of those deaths, 131 were heroin-related.

Stanford Researchers Seek People Living with Chronic Pain for Survey

Stanford Researchers Seek People Living with Chronic Pain for SurveyStanford Researchers Seek People Living with Chronic Pain for Survey

nationalpainreport.com/stanford-researchers-seek-people-living-with-chronic-pain-for-survey-8831499.html

By Beth Darnall, PhD

Chronic pain can have a very big impact one’s life, including one’s thoughts and feelings. In order to help people suffer less, we are studying the emotional impact of pain. In our first study, we are collecting “daily snapshots” about thoughts and feelings experienced by people with chronic pain.

You will be asked to complete a short daily online survey, approximately five minutes long, for a period of 14 consecutive days. Compensation of up to $15 may be provided.

Information we learn from these daily snapshots will help us understand how thoughts and emotions about pain fluctuate on a day-to-day basis. Ultimately, the information will be used to develop treatments that help people with pain suffer less.

To participate you must have current chronic pain, be at least 18 years of age or older, and have daily access to internet.

Your contribution is extremely valuable – it will help us improve future research and pain treatment for patients like yourself!

To get started and learn more about this research study please click the button (it is a secure link).

click-here-to-take-surveyThank you for helping us advance research and clinical care – your assistance is greatly appreciated!

If you have questions about this study, call the study coordinator, Anu Roy, at (650) 724-2811 or email her at anuroy@stanford.edu.

Beth Darnall PhD is Clinical Associate Professor in the Division of Pain Medicine at Stanford University and treats individuals and groups at the Stanford Pain Management Center. She is and author and has been a leading voice in arguing for the importance of more access to pain psychology services for the nation’s large chronic pain population.

 

 

The best therapy that the lowest priced medication can provide ?

UnitedHealth trims drug coverage, including Sanofi insulin

http://www.msn.com/en-us/money/companies/unitedhealth-trims-drug-coverage-including-sanofi-insulin/ar-BBwssH0

UnitedHealth Group Inc, the largest U.S. health insurer, will stop covering several brand-name drugs as of next year, reinforcing a trend of payers steering prescriptions to lower-priced options.

 In a bulletin seeking client feedback by Sept. 28, UnitedHealth said it is changing reimbursement terms for long-acting insulins and will no longer cover Lantus, the main insulin drug sold by Sanofi SA.

The insurer said Basaglar, a cheaper biosimilar insulin sold by Eli Lilly & Co would be covered as “Tier 1,” meaning the lowest out-of-pocket costs for members. Levemir, produced by Novo Nordisk A/S, will move from Tier 1 to Tier 2.

Biosimilars are cheaper copies of protein-based biotech drugs such as Lantus, which are no longer protected by patents. They cannot be precisely replicated like conventional chemical drugs but have been shown to be equivalent in terms of efficacy and side effects.

The insurer also said it will exclude from coverage Amgen Inc’s white blood cell-boosting drug Neupogen, in favor of Zarxio, a biosimilar sold by Novartis AG.

UnitedHealth last year bought Catamaran Corp for $12.8 billion, making it the nation’s No. 3 pharmacy benefit manager after Express Scripts Holding Co and Caremark, which is owned by CVS Health Corp. 

Does this represents a conspiracy or collusion ?

stevemailboxThis is a email that I received today and it is similar to multiple emails that I get every week.

First of all there is no black/white definition of what “disabled” really is. If you can’t perform “normal” daily functions without your medications.. then, most likely, you are disabled… If you believe that you are disabled.. then let “the other side” prove that you are NOT DISABLED.

This particular email is from Florida and in 2015 there was a new pharmacy board regulation that was passed http://floridaspharmacy.gov/latest-news/validate-pain-medication-prescriptions/

that went into effect the last of December 2015. How or if the FL Board of Pharmacy (BOP) is enforcing this new regulation… is still a question.

Personally, I have problems with mail order pharmacies, first of all all medications have a required temperature storage range .. normally 59F -86F and many times of the year and many sections of the country… medication is exposed to temperatures outside of these ranges. Those requirements apply to the manufacturer, wholesaler and pharmacy ..HOWEVER… once the pharmacy turns the mail order package over to the carrier service… the storage requirement no longer applies. Secondly, do you really know who you are talking to on the other end of the phone with a mail order service ? If needed are you actually able to talk to someone in authority – a Pharmacist – or just someone who claims that they are a Pharmacist and whose job it is .. to just say “NO” and get the pt off the phone. They mail order pharmacies are huge highly automated places.. filling more prescriptions EACH DAY that a community pharmacy will fill in a YEAR OR TWO… If your paper prescription gets “lost” … it is just one of hundreds of thousands that are stacked up in the que. Most mail order pharmacies are “days behind” and if you get your necessary medication in a couple of days or a couple of weeks.. they are still several days behind … won’t change their day to day job… and if they lost your paper Rx… if they get it back to you in a few days or a few weeks… what are you going to do.. you are thousands of miles away..

You can complain to the corporate HQ, but typically they will tell you that they stand behind their Pharmacist’s decisions. They are correct they cannot force a Pharmacist to fill a prescription, the corporation only has a permit of operate a Rx dept.. if they have licensed Pharmacists operating it. Of course, they don’t have to continue to employ Pharmacists that are refusing to fill legal prescriptions, but if they continue to employ Pharmacists that refuse to fill legit Rx…

You can complain to the Board of Pharmacy (BOP) , but the majority of BOP’s are stacked with non-practicing Pharmacists who draw their paycheck from the same chains that they are suppose to oversee. Some of us believe that there is a lot of “conflicts of interest” among the BOP members, but since generally the BOP members are appointed by the Governor… and we all know that contributions to political reelection campaigns often get repaid by political favors

I recommend that EVERYONE audio/video recording all their interactions with Rx dept staff. If they will mis-represent (lie) about having your medication in stock, or that the insurance company refused the claim… who is to believe that they will tell the truth of what was said/not said… done or not done when push comes to shove. Normally, the PIC (Pharmacist in charge) of any store can be found on the BOP’s website and/or there should be in “public view” within the store.. the pharmacy permit with the name of the PIC listed on it.

Independent pharmacies are typically ran by the Pharmacist/owner and unlike the chain Pharmacist does not get a paycheck every two weeks, regardless if he/she fills your prescriptions. They depend on filling prescriptions to put bread/butter on their table. Some Pharmacists when handed a prescription start looking for a reason NOT TO FILL IT… and if you start with that attitude… typically .. a reason can be found to not fill it… Generally, a independent Pharmacist will start by looking for reason to fill the Rx and/or be able to adjudicate anything that may appear to be a “red flag”.

With the existing systems and processes in place, it is normally easier for the pt to “switch than fight”. Why would anyone patronize a store that wants you to BEG them to let them take your money, when there are 22,000 independent Pharmacists that would welcome your business ? Here is a link to help pts find a local independent pharmacy http://www.ncpanet.org/home/find-your-local-pharmacy

I need your guidance/help with some information.

I am a chronic pain patient with valid scripts for controlled substances who lives in Florida. I am disabled however I have chosen not to go through disability and to continue working in the healthcare field for more than 10 years. I have been in 7 major car accidents over the course of 20 years. I have permanent damage to my neck, shoulder and back. I have all the appropriate documentation, have followed all the rules set forth by Florida and also by the mail-in pharmacy organization I use, CVS Caremark.

I have been having issues with CVS Caremark recently that I feel have bordered on illegal, unethical, and inappropriate in my opinion. I have a valid/on-time prescription written by a licensed medical professional with no sanctions in my state of Florida. The dosage and amount are at the recommended allowed dosages. I have been told by CVS Caremark on several occasions to “find another doctor”, “drive out of state to manually fill my prescriptions”, to fill out “this new form” or “that new form” stating that they are mandatory but not requiring them each and every time. I have had prescriptions withheld causing my body to detox unnecessarily for multiple reasons. The most recent was CVS stated my prescription in July had the wrong year on it (2001 was what they quoted) but when I reviewed copies of it from my doctor’s office, it had 2016. This month (September) it is because of a form that I have never had to fill out and they state has been required each time from the doctor’s office; yet when I call my doctor they state they have only had to fill out the form once when I first began using mail-in service. There local branches won’t fill them in my county because my doctor resides in another county. My doctor’s county won’t fill them because I live in another county. I have even been sitting with my doctor and had him call and speak with the pharmacy team in the controlled substances department and he was provided no concrete answers, and was given reasons like “I don’t know but we can’t fill it” or “I am not really sure about that, I will have to check with another pharmacist and get back to you” when he was speaking with a pharmacist. I am at my wits end.

 

  • I have been reading your article and not sure how to proceed against the mail in part of this big corporation. How would I find out the permit holder/store owner, the pharmacist in charge, the pharmacist who refuses to fill a prescription, and/or the wholesaler information when they keep that information “close to the vest” whenever I have called to complain before? If I am not on disability, would that negate my ability to file a complaint with the ADA? Should I hire an attorney for the undue hardship and medical complications this poses for my life and health? Which states do I file these complaints in since I use the mail-in pharmacy service while residing in another state?

 

If you can help me at all, I would appreciate all the information you can give me. I have hit a wall and don’t know where else to turn.

 

Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back

Bad science misled millions with chronic fatigue syndrome. Here’s how we fought back

www.statnews.com/2016/09/21/chronic-fatigue-syndrome-pace-trial/

Problem is, the study was bad science.And we’re now finding out exactly how bad.

Under court order, the study’s authors for the first time released their raw data earlier this month. Patients and independent scientists collaborated to analyze it and posted their findings Wednesday on Virology Blog, a site hosted by Columbia microbiology professor Vincent Racaniello.

The analysis shows that if you’re already getting standard medical care, your chances of being helped by the treatments are, at best, 10 percent. And your chances of recovery? Nearly nil.

The new findings are the result of a five-year battle that chronic fatigue syndrome patients — me among them — have waged to review the actual data underlying that $8 million study. It was a battle that, until a year ago, seemed nearly hopeless.

When the Lancet study, nicknamed the PACE trial, first came out, its inflated claims made headlines around the world. “Got ME? Just get out and exercise, say scientists,” wrote the Independent, using the acronym for the international name of the disease, myalgic encephalomyelitis. (Federal agencies now call it ME/CFS.) The findings went on to influence treatment recommendations from the CDC, the Mayo Clinic, Kaiser, the British National Institute for Health and Care Excellence, and more.

But patients like me were immediately skeptical, because the results contradicted the fundamental experience of our illness: The hallmark of ME/CFS is that even mild exertion can increase all the other symptoms of the disease, including not just profound fatigue but also cognitive deficits, difficulties with blood pressure regulation, unrestorative sleep, and neurological and immune dysfunction, among others.

Soon after I was diagnosed in 2006, I figured out that I had to rest the moment I thought, “I’m a little tired.” Otherwise, I would likely be semi-paralyzed and barely able to walk the next day.

The researchers argued that patients like me, who felt sicker after exercise, simply hadn’t built their activity up carefully enough. Start low, build slowly but steadily, and get professional guidance, they advised. But I’d seen how swimming for five minutes could sometimes leave me bedbound, even if I’d swum for 10 minutes without difficulty the day before. Instead of trying to continually increase my exercise, I’d learned to focus on staying within my ever-changing limits — an approach the researchers said was all wrong.

A disease ‘all in my head’?

The psychotherapy claim also made me skeptical. Talking with my therapist had helped keep me from losing my mind, but it hadn’t kept me from losing my health. Furthermore, the researchers weren’t recommending ordinary psychotherapy — they were recommending a form of cognitive behavior therapy that challenges patients’ beliefs that they have a physiological illness limiting their ability to exercise. Instead, the therapist advises, patients need only to become more active and ignore their symptoms to fully recover.

In other words, while the illness might have been triggered by a virus or other physiological stressor, the problem was pretty much all in our heads.

By contrast, in the American research community, no serious researchers were expressing doubts about the organic basis for the illness. Immunologists found clear patterns in the immune system, and exercise physiologists were seeing highly unusual physiological changes in ME/CFS patients after exercise.

I knew that the right forms of psychotherapy and careful exercise could help patients cope, and I would have been thrilled if they could have cured me. The problem was that, so far as I could tell, it just wasn’t true.

A deeply flawed study

Still, I’m a science writer. I respect and value science. So the PACE trial left me befuddled: It seemed like a great study — big, controlled, peer-reviewed — but I couldn’t reconcile the results with my own experience.

So I and many other patients dug into the science. And almost immediately we saw enormous problems.

Before the trial of 641 patients began, the researchers had announced their standards for success — that is, what “improvement” and “recovery” meant in statistically measurable terms. To be considered recovered, participants had to meet established thresholds on self-assessments of fatigue and physical function, and they had to say they felt much better overall.

But after the unblinded trial started, the researchers weakened all these standards, by a lot. Their revised definition of “recovery” was so loose that patients could get worse over the course of the trial on both fatigue and physical function and still be considered “recovered.” The threshold for physical function was so low that an average 80-year-old would exceed it.

In addition, the only evidence the researchers had that patients felt better was that patients said so. They found no significant improvement on any of their objective measures, such as how many patients got back to work, how many got off welfare, or their level of fitness.

But the subjective reports from patients seemed suspect to me. I imagined myself as a participant: I come in and I’m asked to rate my symptoms. Then, I’m repeatedly told over a year of treatment that I need to pay less attention to my symptoms. Then I’m asked to rate my symptoms again. Mightn’t I say they’re a bit better — even if I still feel terrible — in order to do what I’m told, please my therapist, and convince myself I haven’t wasted a year’s effort?

Many patients worked to bring these flaws to light: They wrote blogs; they contacted the press; they successfully submitted carefully argued letters and commentaries to leading medical journals. They even published papers in peer-reviewed scientific journals.

They also filed Freedom of Information Act requests to gain access to the trial data from Queen Mary University of London, the university where the lead researcher worked. The university denied most of these, some on the grounds that they were “vexatious.”

Critics painted as unhinged

The study’s defenders painted critics as unhinged crusaders who were impeding progress for the estimated 30 million ME/CFS patients around the world. For example, Richard Horton, the editor of the Lancet, described the trial’s critics as “a fairly small, but highly organised, very vocal and very damaging group of individuals who have, I would say, actually hijacked this agenda and distorted the debate so that it actually harms the overwhelming majority of patients.”

Press reports also alleged that ME/CFS researchers had received death threats, and they lumped the PACE critics in with the purported crazies.

While grieving for my fellow patients, I seethed at both the scientists and the journalists who refused to examine the trial closely. I could only hope that, eventually, PACE would drown under a slowly rising tide of good science, even if the scientific community never recognized its enormous problems.

But with the National Institutes of Health only funding $5 million a year of research into chronic fatigue syndrome, it seemed like that could take a very long time.

Then last October, David Tuller, a lecturer in public health and journalism at the University of California, Berkeley, wrote in Virology Blog a devastating expose of the scientific flaws of the trial. Tuller described all the problems I had seen, along with several more. The project was a remarkable act of public service: He isn’t a patient, yet he spent a year investigating the trial without institutional support, legal backing, or remuneration.

And, at last, the criticisms gained traction.

Racaniello and 41 other scientists and clinicians published an open letter to the Lancet calling for an independent investigation into the trial and saying “such flaws have no place in published research.” Rebecca Goldin, the director of Stats.org, an organization that works to improve the use of statistics in journalism, eviscerated the trial’s design in a 7,000-word critique.

In the meantime, a Freedom of Information Act request from Australian patient Alem Matthees was making its way through the legal system.

Matthees had asked for the anonymized data necessary to analyze the study using its original standards for success, but Queen Mary University of London had refused the request, arguing that malicious patients would break the anonymization and publish the participants’ names to discredit the trial. It again cited the death threats.

The court rejected these claims a month ago, calling them “wild speculations” and pointing out that the researchers themselves acknowledged in court that neither they nor PACE participants had received death threats.

Startling results from a re-analysis

Just before releasing the data,Queen Mary University of London did its own re-analysis on the question of how many patients got better, at least a little bit. Their data showed that using the study’s original standards, only 20 percent of patients improved with cognitive behavior therapy or exercise in addition to medical care, not 60 percent as claimed in the Lancet.

And even the 20 percent figure might be misleading, because the re-analysis also found that 10 percent of participants improved after receiving only standard medical care. That suggests that 10 percent in each of the treatment groups would likely have improved even without the exercise or therapy, leaving only 10 percent who were significantly helped by those interventions.

As for the claim that 22 percent of patients who received either treatment made an actual recovery? That went up in smoke when Matthees analyzed the raw data with the help of his colleagues and statisticians Philip Stark of the University of California, Berkeley, and Bruce Levin of Columbia University.

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Their analysis showed that had the researchers stuck to their original standards, only 4.4 percent of the exercise patients and 6.8 percent of the cognitive behavior therapy patients would have qualified as having recovered, along with 3.1 percent of patients in a trial arm that received neither therapy.

Importantly, there was no statistically significant difference between these recovery rates.The PACE researchers, the editor of the Lancet, and the editors of Psychological Medicine (which published the follow-up study on recovery) all declined to comment for this article.

Simon Wessely, president of the UK Royal College of Psychiatrists, defended the trial in an email exchange with me. He argued that some patients did improve with the help of cognitive behavior therapy or exercise, and noted that the improvement data, unlike the recovery data, was statistically significant. “The message remains unchanged,” he wrote, calling both treatments “modestly effective.”

Wessely declined to comment on the lack of recovery. He summarized his overall reaction to the new analysis this way: “OK folks, nothing to see here, move along please.”

‘A classic bad study’

But it doesn’t appear that outside researchers are ready to “move along.”

After reviewing the new analysis, Jonathan Edwards, a professor emeritus of medicine at University College London said he was unconvinced that these small subjective improvements indicated the patients genuinely felt better. “They’ve set this trial up to give the strongest possible chance of there being a placebo effect that you can imagine,” he said.

“This is a classic bad study,” said Ron Davis, director of the Stanford Genome Technology Center and director of the Science Advisory Board of the End ME/CFS Project. He emphasized an additional problem: The study used such a broad definition of the disease that it likely included many patients who didn’t truly have ME/CFS at all.

“The study needs to be retracted,” Davis said. “I would like to use it as a teaching tool, to have medical students read it and ask them, ‘How many things can you find wrong with this study?’”

Retractions are rare, however, and erasing the impact of this flawed research will take much work for years to come.

After a sustained effort by ME/CFS advocates, the federal Agency for Healthcare Research and Quality, just changed its recommendation to read that there is insufficient evidence to justify cognitive behavior therapy or graded exercise. But many more public health agencies continue to point patients toward them.

And efforts to propagate this approach continue: A trial of graded exercise in children with ME/CFS has recently begun, and patients are protesting it.

Watching the PACE trial saga has left me both more wary of science and more in love with it. Its misuse has inflicted damage on millions of ME/CFS patients around the world, by promoting ineffectual and possibly harmful treatments and by feeding the idea that the illness is largely psychological. At the same time, science has been the essential tool to repair the problem.

But we shouldn’t take solace in the comforting notion that science is self-correcting. Many people, including many very sick people, had to invest immense effort and withstand vitriol to use science to correct these mistakes. And even that might not have been enough without Tuller’s rather heroic investigation. We do not currently have a sustainable, reliable method of overturning flawed research.

And rectifying PACE will take more than exposing its flaws. The lingering doubt it has cast on the illness will only be fully dispersed when we’ve finally figured out what’s really going on with the disease.

For that, we need to invest in some serious, good science. The kind I continue to love.

Julie Rehmeyer is a math and science writer. Her memoir “Through the Shadowlands,” describing the science and politics of chronic fatigue syndrome and other poorly understood illnesses, will be published by Rodale in May.