FTC to Food Marketers: Don’t Forget the “Q” in QHC

By Ricardo Carvajal & Riëtte van Laack – 

FTC filed a complaint in the district court of New Jersey alleging that certain of Gerber’s advertising claims for its hydrolyzed-whey-based infant formula constitute deceptive acts or practices and the making of false advertisements, in violation of the FTC Act.  FTC challenges as unsubstantiated Gerber’s claims that its formula reduce the risk of allergies in infants who have a family history of allergy.  FTC also challenges as false or misleading Gerber’s advertising of its qualified health claim (QHC).

In May 2009, Nestlé Nutrition submitted a QHC petition to FDA requesting that the agency exercise enforcement discretion for a QHC characterizing the relationship between consuming 100% whey-protein partially hydrolyzed infant formula and a reduced risk of atopic dermatitis.  FDA determined that the relationship was “uncertain, because there is very little scientific evidence for the relationship.”  FDA’s letter of enforcement discretion issued in May 2011 sets forth tightly worded qualified claims that are limited to one type of allergy, namely atopic dermatitis.

According to FTC’s blog posting, “Gerber took the FDA’s narrow letter and turned it into a prominent gold badge that read: ‘1st & Only Meets FDA Qualified Health Claim.’ The leap Gerber made from FDA’s cautious admonition to what the FTC says consumers would view as an FDA approval claim” is at the heart of one of the counts in the complaint.  The other count addresses Gerber’s allegedly unsubstantiated allergy prevention claims.  FTC requests permanent injunctive relief, consumer redress, and additional relief as the Court may determine to be just and proper.

Do we really want to get each other angry?

Bansky-Flower-Brick-Thrower.

Greg Williams says we need to get angry:

It is apparently OK for those family members to angrily demand a better response from the federal government to the current health crisis. But when the addiction recovery community — more than 23 million Americans and their families — gathers to walk, speak and put a face on recovery there doesn’t seem to be much anger at the current state of affairs that is costing us more than 100 American lives every day.

Apparently, anger is a frightening emotion for many in the recovery community. . . .

But how else are we going to collectively move the needle on the current epidemic without using the prime emotion that has been at the forefront of all other advocacy movements in American history

First of all, there are not 23 million Americans in recovery. That kind of truthiness is a good example of some of the risks of activism. It invites skepticism from anyone who looks into that number and invites argument about the definition of addiction and recovery within and and outside of the recovering community.

Floating balloons and celebrating that recovery is possible has been a great start in many communities. But when we look around at other marginalized health populations in history like the HIV/AIDs movement and the disability movement, they get a capital M on “Movement” in our cultural reflections only because they got angry.

. . .

As Stacia Murphy says in my documentary “The Anonymous People” about Marty Mann’s driving force (the first woman to ever achieve long-term recovery in Alcoholics Anonymous who chose to use her personal story publicly for social change), “Advocacy is about anger.”

Well, there are costs to that kind of activism. I have no idea if Marty Mann’s activism contributed to her relapse, but it’s pretty clear that her activism played a big role in her keeping it a secret. Fortunately, she was able to restabilize, but it’s pretty easy to imagine that secret being a big barrier to continuing her recovery.

Looking back on AIDS activism, are we ready for schisms and more radical groups, like ACT UP to become the most visible face of recovery activism? Thinking about the post-MLK/Malcolm X civil rights movement, are we ready for competition to be the face of this cause?

More importantly, what, exactly, are we supposed to get angry about? Williams references discrimination in housing, insurance, employment and access to health services. I’m not sure I know what he’s talking about.

I was reluctant to even comment because I don’t want to be a contrarian or inflict my political fatigue on others. The competition for recognition as an aggrieved class is fierce, ugly and I suspect a lot of us have no interest in recovery being associated with it.

Don’t get me wrong, I’m all for advocacy and I get mad too, but I’m not interested in getting angry, staying angry or getting others angry, especially when those grievances are not concrete and specific.

What comes to mind is this insight from Bill White and Bill Miller’s article on confrontation.

In its etymology, the word “confront” literally means “to come face to face.” In this sense, confronting is a therapeutic goal rather than a counseling style: to help clients come face to face with their present situation, reflect on it, and decide what to do about it. Once confronting is understood as a goal, then the question becomes how best to achieve it. Getting in a person’s face is rarely the best way to help them open up to new perspectives.

Where there are injustices, I’d rather see advocacy that holds a mirror up to the culture that brings it face to face with the injustice and appeals to our shared values to correct the injustice.

I’m not saying it’s the right way or the only way. Maybe it’d be less effective, but it doesn’t demand anger and focusing on individual issues rather than an aggrieved “us” can help avoid the clamoring to be the recognized leader of the cause. (This might be better for the cause and for individuals.) I’m not an expert on the expansion of naloxone, but it’s my impression that success followed policy makers coming face to face with tearful parents who lost their kids who asked (not demanded) legislators to increase access to the drug.

I don’t think we should all take my path and I’m skeptical of certainty. I’ll go with MLK’s sincerity, determination,  faith and conscience, but I’ll take a pass on the anger.


Filed under: Uncategorized Tagged: addiction recovery, Greg Williams, Marty Mann, recovery community

Suboxone Makes Me Fat and Boring and Stupid

Originally posted 3/6/2013

A late post tonight, since my new exercise program has pushed my blogging back by an hour or so each night.  My suspicions about exercise were correct, by the way; it is much easier to suggest exercise to other people than it is to actually exercise.  I’ve been at it since the beginning of the year, and I at least feel a bit less hypocritical.

While I’m on the topic…  I’ve received many comments over the years from people complaining that they’ve been taking Suboxone or buprenorphine for X many years, and they have no energy, they feel stressed, they have gained weight, they don’t sleep well or they sleep TOO well… and concluding that all of the problems are from Suboxone.

Suboxone causes… everything!

They aren’t (from Suboxone).   Not at all.  But I wonder, at this point, if regular readers of my blog know EXACTLY what I’m going to say.  I’m tempted to stop typing and ask people answer so I get a sense of how predictable I’ve become.    But then I’d have to wait and then come back, read, and assess the situation….  I really can’t imagine much positive to come out of THAT experience, so I’ll just finish my thoughts, about the problems that people often blame on Suboxone.

The problems are the result of other things, including things that tend to occur naturally as our lives become less chaotic and more outwardly-secure.  The problems I mentioned above, for example, come from inactivity.  They come from thinking that we’ve ‘paid our dues’ at the age of 30, and it’s time to coast in life.  They come from failing to seek out challenges, and from failing to do our best to tackle those challenges.  They come from letting out minds be idle, smoking pot or watching American Idol  instead of responding to the naggings sense of boredom that ideally pushes people to join basketball, tennis, or bowling leagues.

Our minds and bodies are capable of SO much.  I (honestly) am not a network TV viewer, but I love the contrast of ‘before and after’ scenes on ‘Biggest Loser.’  People magazine (it sits in my waiting room) had a section a while back about people who lost half their body size, by exercise and dieting.  The part I found most interesting was the deeply personal answer that each person had to the question, ‘what was your turning point?’  Each cited an episode of humiliation or shame that lifted the veil of denial, and helped them do what they knew, all along, needed to be done.

We are not all capable of ‘Biggest Loser’ comebacks. But it is important for people to understand that feeling good, physically or mentally, takes work.   That incredible feeling of a ‘sense of accomplishment’ only comes when we accomplish something.  We don’t need to eliminate global hunger or cure cancer; sometimes we just need to shovel the driveway, mow the lawn, or do a crossword puzzle.  I’ve learned, as a psychiatrist, that the people who walk around with smiles on their faces usually did something that made the smile happen.  I’ve learned that ‘feeling happy’ does not just happen for most people.  And I don’t think I’ve ever met a person who answered, when asked about stress, ‘no—I don’t have anxiety.’

Once someone blames Suboxone for their problems, it becomes less likely that the real causes of those problems will become apparent. For example, If I think that my glasses are giving me headaches, I’m less likely to make changes in my diet that might make the headaches better.  Once we have something to blame, our problems become more and more engrained, and the real solutions become less and less evident.

I’m truly sorry if I am coming across as ‘preachy’; understand that I’m just trying to make my way through life like everyone else.  But I now take note of all those people power-walking at 6 AM, and I understand why they do it.  Some of them might be on Suboxone.  Some of them might not be.  But I respect all of them for opening their minds, and for their willingness to do the hard work that brings happiness—or at least points in that general direction.

Ebola and Workplace Drug Testing Programs

IMG_0752The Ebola Virus Disease (EVD) is an infectious disease that has rapidly spread in parts of West Africa. In recent weeks, cases of infected individuals have been reported in the United States. A consequence of the high profile of the virus has been the heightened need for workplaces to react appropriately in order to help ensure the health and safety of their employees.

The majority of workplace drug testing is performed on urine specimens collected at collection sites like our Quest Diagnostics Patient Service Centers (PSCs). In a statement released on October 23, Quest Diagnostics assures that our priority is the health and safety of our employees, donors and patients.In an abundance of caution, we will not collect specimens from suspected Ebola patients at our Patient Service Centers and in-office phlebotomy sites. We will not accept or process specimens from known or suspected Ebola patients. Once a suspected Ebola patient is confirmed to be Ebola-negative, specimens from that individual may be sent to Quest Diagnostics.

For those specimen types that are self-collected at the place of employment like oral fluid, the risk of transmission of the Ebola virus is reported to be minimal by health authorities. Earlier this month the World Health Organization stated that although contact with saliva and tears may carry some risk, studies implicating these bodily fluids were extremely limited in sample size, and as such the science is inconclusive. Furthermore, in various reports, the presence of the Ebola virus in saliva was found most frequently in patients at severe stages of the illness, thus, it appears to be highly unlikely that an individual would be able to present themselves for drug testing. In short, the risk to employees of our oral fluid drug testing clients is extremely low. In all cases, it is imperative that proper collection procedures, in which the donor is the only individual in contact with the sample, are consistently applied. That said, while the risk of transmission from collecting oral fluid drug testing specimens may be low, it is our recommendation that our employer clients not collect specimens from known and suspected Ebola patients. As stated above, we will not accept or process these specimens in our laboratories.

Once a suspected Ebola patient is confirmed to be Ebola-negative, specimens from that individual may be sent to Quest Diagnostics. Learn more about how we are handling the Ebola outbreak by reviewing our Frequently Asked Questions.

The Quest for Serenity

It seems in life that we all want to find serenity at some level. Whether it is for a moment or whether we are striving for a day of serenity or a life of serenity. I think I took the feeling of serenity for granted before I found myself trapped in the craziness of the disease of addiction with my loved one. It was almost like waking up one day and feeling like I was in some sort of crazy dream nothing short of a nightmare. Where do I turn? How do I get out? Will this dizzy feeling ever stop? It reminded me of the kids program from when I was growing up where they suddenly exasperated ‘Help Mr. Wizard!!’ Only in my dream there was no Mr. Wizard it was my reality.

How did I regain my serenity or even pieces of it at first? I began by citing the serenity prayer in my mind to try to replace the obsessive thoughts of my daughter – ‘God, Grant me the serenity to accept the things I cannot change, the courage to change the things I can and the wisdom to know the difference.’ This helped to calm my mind and my nerves during stressful times. Then I moved on to creating boundaries around my day and activities. I made sure I took care of my priorities and didn’t let someone else’s crisis become my own. I lovingly let my daughter know that she was responsible for the consequences of her actions, not me. Eventually, little by little, I regained the sanity that then lead to serenity. I don’t take my serenity for granted anymore and I know when I am getting off track that I need to stay centered on what’s important and how I take care of myself.

Alcoholism as a Reward System Dysfunction

Alcoholism and other addictive behaviors often occur together within individual patients.

For example, individuals with alcoholism commonly also are smokers and meet criteria for a diagnosis of nicotine dependence.

This co-occurrence suggests multiple types of addiction may share genetic and environmental risk factors. Additionally, there might be a common neurobiological mechanism in play for many addictions.

Kenneth Blum and other leading alcoholism researchers recently published a review that proposed a theory of addiction they labelled the "Reward Deficiency Solution System".

Here are some of my notes on the key points outlined in their literature review:

Introduction
  • The goal of the review was to find common mechanisms for addictions--both those related to a substance and those not substance related, i.e. obesity or pathological gambling
  • Genetic studies linking alcoholism to the dopamine 2 receptor (DRD2) date back to 1990
  • Over 3000 studies have been published on the DRD2 receptor and addictions since 1990
  • Studies have not universally supported a DRD2 link to addictions but many do support the link

Is Dopamine Deficit or Over Supply at Fault?
  • Dopamine transporter gene one (DAT1) deficit status has been linked to obesity possibly through a dysregulation in food reward
  • Polymorphisms that involve D2 and D4 reduce reward response to food and lead to weight gain
  • fMRI research in children and adolescents have shown that an increased dopamine-related neurotransmission in the striatum may be a risk factor for obesity
  • So, both deficit and oversupply of dopamine may influence addiction risk including risk for obesity

Is There a Solution to Reward Deficiency Syndrome (RDS)?
  • Dopamine antagonists such as naltrexone and acamprosate have had limited success
  • Studies of a newly developed drug KB220Z, a dopamine agonist are promising
  • KB220Z studies in mice show increased brain enkephalin and reduced alcohol-seeking behavior 
  • KB220Z studies in humans has been linked to reduced alcohol withdrawal, lower addiction treatment drop out rates and reduced craving scores across multiple substance types including alcohol, cocaine, heroin and nicotine
  • KB220Z activates the brain reward center known as the nucleus accumbens and increases activation of the prefrontal-cerebellar-occipital brain circuit

Genetic and Functional Mechanisms in RDS
  • We lack understanding of how genes regulate functional networks related to addiction circuitry
  • Addicts do show reduced fMRI resting state network connectivity
  • KB220Z appears to reverse these resting state connectivity deficits in addicts
  • Studying genomic contributions to brain connectivity patterns in reward may be a powerful strategy for addiction drug development

My Comments: This review highlights the weakness of our current state of knowledge for understanding how genetics, brain neurochemistry and brain circuitry influence addition. However, I do agree with the reviewers that progress is being made and that brain circuitry imaging may be a valuable tool in future progress.

Readers with more interest in this topic can access the free full-text manuscript by clicking on the PMID link in the citation below.

Molecular model of dopamine is from a Wikepedia Commons file authored by sbrools

Follow the author on Twitter @WRY999

Blum K, Febo M, McLaughlin T, Cronjé FJ, Han D, & Gold SM (2014). Hatching the behavioral addiction egg: Reward Deficiency Solution System (RDSS)™ as a function of dopaminergic neurogenetics and brain functional connectivity linking all addictions under a common rubric. Journal of behavioral addictions, 3 (3), 149-56 PMID: 25317338

Feeling Dissed, Amgen Sues After Sandoz Abandons the BPCIA Patent Dance Procedures for NEUPOGEN Biosimilar; Alleges Unfair Competition, Patent Infringement, and Theft

By Kurt R. Karst –      

Ever since the July 2014 announcement by Sandoz Inc. (“Sandoz”) that FDA accepted the first ever application for a biosimilar biological product submitted pursuant to Section 351(k) of the Public Health Service Act (“PHS Act”) – in this case, a biosimilar version of Amgen, Inc.’s (“Amgen’s”) NEUPOGEN (filgrastim) approved under BLA 103353, and which 351(k) application could be acted on by May 2015 under the performance goals agreed to as part of the Biosimilar User Fee Act of 2012 – we wondered how the so-called “patent dance” procedures added to the law by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”) were progressing (or not).  Apparently Amgen has been left on the dance floor without a partner.  And Amgen doesnt take rejection well.  Feeling dissed and spurned, last week Amgen filed a Complaint in the U.S. District Court for the Northern District of California alleging that Sandoz has unlawfully refused to follow the BPCIA’s patent resolution procedures, and is seeking declaratory and injunctive relief. 

By way of background, the BPCIA lays out a multi-step “patent dance” at PHS Act § 351(l) for an applicant seeking approval of a biosimilar version of a reference product: Step 1 – Transmission of Biosimilar Application; Step 2 – Reference Product Sponsor’s Paragraph 3(A) Patent List; Step 3 – Biosimilar Applicant’s Paragraph 3(B) Patent List; Step 4 – Reference Product Sponsor’s Response; Step 5 – Patent Resolution Negotiations; Step 6 – Patent Resolution If No Agreement; and Step 7 – Filing of the Patent Infringement Action.  Under Step 1, not later than 20 days after FDA informs a 351(k) applicant that its application has been accepted for review (i.e., filed), the applicant must provide to the reference product sponsor “a copy of the application submitted to the Secretary under subsection (k), and such other information that describes the process or processes used to manufacture the biological product that is the subject of such application” (PHS Act § 351(l)(2)(A); 42 U.S.C. § 262(l)(2)(A)) and “may provide to the reference product sponsor additional information requested by or on behalf of the reference product sponsor” (PHS Act § 351(l)(2)(B); 42 U.S.C. § 262(l)(2)(B)). 

In addition, the BPCIA provides that a 351(k) applicant must provide notice to a reference product sponsor “not later than 180 days before the date of the first commercial marketing of the biological product licensed under [Section 351(k)].”  After receiving that notice, a reference product sponsor may seek a preliminary injunction prohibiting the 351(k) applicant from manufacturing or selling its biosimilar product until a court decides the issue of validity, infringement, and enforcement of certain patents (PHS Act § 351(l)(8); 42 U.S.C. § 262(l)(8)).

Thus far, controversy surrounding the BPCIA’s patent resolution procedures has focused on whether or not a prospective 351(k) applicant can seek patent certainty by filing an action for declaratory judgment.  As we previously reported, in November 2013, in Sandoz Inc. v. Amgen Inc., Case No. 3:13-cv-02904-MMC (N.D. Cal.), the U.S. District Court for the Northern District of California granted Amgen’s Motion to Dismiss a June 2013 Complaint for Declaratory Judgment and Patent Invalidity and Non-infringement concerning two patents Roche licensed to Amgen that purportedly cover Amgen’s biological product ENBREL (etanercept).  According to the California District Court, “Sandoz does not contend, and cannot contend, it has complied with its obligations under [PHS Act §§ 351(l)(2)-(6)], because . . . it has not, to date, filed an application with the FDA.”  In addition, the court noted that “Sandoz cannot, as a matter of law, have provided a ‘notice of commercial marketing’ because . . . its etanercept product is not  licensed under subsection (k).’”  That decision was appealed to the U.S. Court of Appeals for the Federal Circuit where a decision is pending (see our previous post here).  Meanwhile, two other declaratory judgment complaints were filed.  Both of those cases involve REMICADE (infliximab) and Celltrion Healthcare Co., Ltd. and Celltrion, Inc.’s biosimilar version of the product (see our previous post here).  One of the cases was recently dismissed voluntarily (see here), while the other case is progressing and is in the Motion to Dismiss stage (briefs available here, here, and here).

In its October 24th Complaint, Amgen alleges that Sandoz received notice from FDA on July 7, 2014 that the Agency had accepted the company’s 351(k) BLA for a biosimilar version of NEUPOGEN, and that such notice should have triggered a cascade of events under the patent resolution procedures at PHS Act § 351(l), but did not because Sandoz failed to comply with the initial disclosure under PHS Act § 351(l)(2)(A).  According to Amgen:

Defendants are attempting to obtain the benefits of the BPCIA by filing their BLA under the § [351(k)] pathway without complying with the requirements that Congress also imposed through the BPCIA on biosimilar applicants.  For example, Defendants made a deliberate decision not to provide Amgen with a copy of its BLA, together with other information necessary to describe the process(es) for manufacturing the biosimilar product, within 20 days of receiving notification of FDA acceptance of their application.  Under [PHS Act § 351(l)(2)], Sandoz was required to provide Amgen with such materials by Monday, July 28, 2014.

Instead, Sandoz apparently proposed an alternative procedure in a July 8, 2014 letter to Amgen: that the parties exchange certain information without following the process at PHS Act § 351(l)(2).  Amgen rejected the offer.  Later, Sandoz letter sent Amgen another letter stating that Sandoz had decided “not to disclose our application to Amgen” and also  not to exercise the company’s “right to use the patent information exchange process of the BPCIA.”  Finally, in an October 20, 2014 letter, Sandoz allegedly reminded Amgen that Sandoz’s initial July 8th letter provided Amgen with Sandoz’s 180-day notice of commercial marketing pursuant to PHS Act § 351(l)(8)(A).  Amgen’s Complaint, which cites, among other things, the November 2013 decision in Sandoz Inc. v. Amgen Inc. for the proposition that the 180-day notice can come only after approval of a 351(k) BLA, followed a few days later. 

According to Amgen:

Each of [Sandoz’s] unlawful acts (violation of 42 U.S.C. § 262(l)(2)(A) and violation of 42 U.S.C. § 262(l)(8)(A)) independently deprive Amgen of the benefits afforded under the statute and which Congress provided to reference product sponsors.  Defendants’ failure to provide the BLA and manufacturing information to Amgen under 42 U.S.C. § 262(l)(2)(A) deprives Plaintiffs of the opportunity to seek a preliminary injunction enjoining Defendants from engaging in the commercial manufacture or sale of the Sandoz biosimilar product in time to prevent irreparable harm to Plaintiffs, i.e., after FDA approval of the Sandoz biosimilar product but before Defendants’ commercial marketing of the biosimilar product.  In addition, Defendants’ failure to provide a legally operative notice of commercial marketing deprives Plaintiffs of the opportunity to seek a court intervention to prevent Plaintiffs from suffering irreparable harm.  This too prevents Plaintiffs from enjoining Defendants in time to prevent irreparable harm.

Amgen asserts three causes of action: (1) unfair competition under Cal. Bus. & Prof. Code § 17200 et seq.; (2) conversion; and (3) infringement of U.S. Patent No. 6,162,427 covering a method of using NEUPOGEN to treat a disease requiring peripheral stem cell transplantation in a patient in need of such treatment. 

Amgen’s second cause of action – i.e., conversion – caught our attention.  It’s not a cause of action we see on a daily basis.  Conversion, better known as theft, is an intentional tort that consists of the wrongful exercise of dominion or control over personal property that so seriously interferes with another’s right to control the property that the converter (i.e., thief) is required to pay the other the full value of the property as damages for the conversion.  According to Amgen:

[Sandoz’s] use of the license for NEUPOGEN® (filgrastim) to obtain a governmental privilege (FDA approval to market, manufacture, import, and sell the Sandoz biosimilar product for use in the United States) for Defendants’ own benefit and profit is an act of conversion.  Specifically, Defendants filed a BLA for the Sandoz biosimilar product that intentionally uses Amgen’s prior demonstration of the safety, purity, and potency of NEUPOGEN® (filgrastim), but without Plaintiffs’ authorization or permission and without satisfying the mandatory provisions of 42 U.S.C. § 262(l) that apply to biosimilar applicants.  By filing their BLA for the Sandoz biosimilar product under the § 262(k) pathway rather than the § 262(a) pathway, Defendants seek to obtain a valuable benefit from the license for NEUPOGEN® (filgrastim).  Without Amgen’s efforts, the information relied on by Defendants for the safety, purity, and potency of the Sandoz biosimilar product would not exist. As a result, Defendants have converted property belonging to Plaintiffs.

Amgen is seeking declaratory and injunctive relief.  In particular, Amgen wants the court to enjoin Sandoz from “commercially marketing the biosimilar product until Amgen is restored to the position it would have been had Defendants met their obligations under the BPCIA” and until Sandoz provides Amgen with notice of commercial marketing “on or after FDA licensure of its biosimilar product (and no later than 180 days before first commercial marketing of the product by Sandoz).  In addition, Amgen wants an injunction preventing Sandoz “from continuing to seek FDA review of [the company’s 351(k)] application and/or compelling Defendants to suspend FDA review of [the company’s 351(k)] application until Defendants have obtained permission from Plaintiffs to use the NEUPOGEN® (filgrastim) license or require Defendants to restore to Amgen the benefits afforded to reference product sponsors in the statute,” and a judgment “[a]djudging and decreeing that Defendants have committed a statutory act of infringement under 35 U.S.C. § 271(e)(2)(C)(ii) of the’427 patent by submitting their BLA to the FDA for approval of the Sandoz biosimilar product without providing the required BLA and manufacturing information to Amgen.” 

Those of us who work in the Hatch-Waxman/BPCIA space predicted back in 2010 when the BPCIA was enacted that there would be a lot of controversy over the patent dance procedures (and even hesistance from some to go on to the dance floor in the first place).  We’re now seeing those predictions become reality, and in controversies that will shape the future of the biosimilar approval pathway for decades to come. 

Crazy Week for Suboxone

Originally Posted 3/3/2013

What a crazy week for buprenorphine.  I’ve written about the FDA slapping the face of Reckitt Benckiser by denying their Citizens’ Petition.  Adding insult to injury, the FDA then approved two generic formulations of Suboxone tabs (actually, the correct name is buprenorphine/naloxone combination tabs).  Stock in RB dropped about 5%, but shares regained most of their price within a couple days, reflecting the balance of pessimism vs. optimism in the company’s ability to maintain stellar profit growth going forward.

In case anyone is wondering, I do not own shares in Reckitt Benckiser, and I have never owned shares in Reckitt Benckiser.  One nice thing about NOT having significant savings, I supposed, is that I can report my holdings (or lack of holdings) without too much effort!

If I WAS an investor, though, I’d wonder about the future of Reckitt Benckiser’s Suboxone, now that two generic competitors are hitting the market.  Some patients clearly prefer the tablet over the film;  will state medicaid agencies go back to covering the tablet, which will likely be cheaper than the film?  Will insurers cover the tabs?  Or will both groups continue to buy into the marketing scheme of Reckitt-Benckiser, and the company’s claim that only the film is ‘safe’?

Many patients strongly favor the tablet over the film, and if given the opportunity to choose would definitely choose generic tablets over film.  So here is where things get interesting…..   if the generic tablets become popular, will RB go back to making tabs?  After their RADARS-assisted claim about the danger of tabs, such a move would be a clear indicator of the company’s truthfulness on the issue.

Reckitt Benckiser Citizen Petition for Suboxone: DENIED

Posted 2/23/2013

For those who missed my explanation, I’m adding these old posts to reconstruct the archive.  The site’s database was damaged by something, somehow… New posts coming soon.

Find a copy of the response here, or at this url:www.suboxonetalkzone.com/cpresponse.pdf

Bye, Dad

First Published 4/2/2013

My dad passed away two days ago, one day after his 89th birthday.  It doesn’t feel quite right to post something so personal.  But it feels more wrong to write about anything else.

Writing was a source of tension between us in some ways.  My perspectives on myself, my parents, and my upbringing have changed over the years, and I tried to share my observations with my dad in several short essays centered around memories from my childhood.  The efforts were a mistake.  I learned that insight develops in each of us at different rates and in different directions, and my ‘aha’ moments—realizations about how my dad shaped my development— felt to him like criticism.  I don’t think he fully realized that I accepted him, loved him, and respected him.

As for my ‘aha moments’, I don’t assume that my realizations and insights are accurate.  As my perceptions change over the years, I try to remain open to two alternate explanations for those changes—that with age I’ve learned, through wisdom, to see things more accurately, or that with age my thought process is becoming more rigid and any newfound ‘insight’ is an illusion, a product of that rigidity.

Photo of Robert Junig Sr.
Robert D. Junig Sr

My dad was an intellectual, who read more books about philosophy and theology each year of his adult life than I’ve read in my lifetime.  So when our understandings of the world differed, I had to at least consider that my own judgment was off, rather than assume that old age impacted HIS judgment.

So to sort things through, I wrote.  I honestly thought that with enough effort, we would fully understand how we each see things; not that we would necessarily agree, but that we would fully understand each other’s perspective.  But I eventually decided that at least for us, differences in our individual perspectives ran too deep for us to completely understand each other— no matter how hard we tried.

My dad grew up during the depression, fought in Germany during WWII, became an attorney on the GI Bill, and worked for the Atomic Energy Commission before settling down in private practice and raising a family. He studied Christian theology and practiced daily meditation.  The internet got going when he was about 70, and he had his own blog, email address and Facebook account.

He jogged since the time when people first started jogging, before someone invented ‘running shoes.’  He worked out at the Y throughout his life, even in the weeks before his death.  I worried that the care he took toward his personal health would eventually cause problems, leaving him without a graceful exit from this world.  But he suffered a brain hemorrhage two days before his death, losing consciousness while sitting in a chair, listening to music from his I-Pad.   The next day his children, grandchildren, and wife of 55 years sat at his bedside, shared memories and sang Happy Birthday.  He died a few hours after midnight, never being one to drag things out too long.

I’m sorry if readers find this to be cryptic or overly personal, but I was stuck, and I had to get these things out before I could move on to the usual stuff.  My dad reads my posts, and there were a couple things I needed him to know.