A Costly Drug, Missing a Dose of Disclosure
#1
I literally makes me sick to the stomach to see how much this drug is going for, seeing how it's a first-line drug for Infantile Spasms. Families are having to go without this drug because their drug plans won't cover it, and at $38,000 per vial it's out of reach for many families. For reference, a vial will last anywhere from a couple of days to a couple of weeks, depending on your dosage and where you are in the treatment regime. At our peak, a vial lasted us 5 days/doses. That's $7,600 a dose at the current price. Ten years ago when we took it, it was "only" $1,900 a vial, which seemed outrageous then.

This is on top of all the other expenses associated with the condition, which includes lengthy and frequent hospitalizations, rounds of MRI's and EEG's, copious amounts of bloodwork, frequent monitoring of vitals (we had to report to the local hospital 3x's a week once we were stable enough to go home-home to monitor blood pressure, etc), referrals to specialists like neurologists, genetics, nephrologists and audiologists to deal with the side effects of both the condition and it's treatment. And then once you finally get the epilepsy under control (assuming you can, without resorting to the keto diet, brain surgery, or both), you have years of therapy ahead of you. 90% of these kids end up with a disability of some kind, ranging from mild congnitive/learning dysfunctions to being unable to walk and talk and confined to a wheelchair. We've very blessed that we're somewhere in between - our daughter can walk, run, ride a three-wheeled bike and is toilet-trained. But she also suffers from serious cognitive deficiencies, significant fine and gross motor impairment, has difficulties communicating effectively and will never live independently.

Learn more about Infantile Spasms:
http://www.epilepsy.com/learn/types-epil...s-syndrome
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1464162/
http://www.aboutkidshealth.ca/En/Resourc...pasms.aspx



https://mobile.nytimes.com/2017/01/27/bu...sures.html

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Full and fair disclosure is at the heart of our nation’s securities laws. So red flags fly when a company is silent on facts of interest to investors.

That investing truth came to mind a little over a week ago, when the pharmaceutical giant Mallinckrodt Pharmaceuticals settled a yearslong investigation by the Federal Trade Commission. In the Jan. 18 complaint, the commission contended that Mallinckrodt and its Questcor subsidiary had engaged in anti-competitive behavior by acquiring the rival drug to their costly H. P. Acthar Gel — which goes for $38,000 a vial — and keeping it off the market to protect their profits.

Mallinckrodt disputed the F.T.C.’s conclusions but agreed to pay $100 million. It must also license the rights to the rival drug, known as Synacthen Depot, to a competitor for two indications. Synacthen is sold overseas for a tiny fraction of the price of Acthar (which has topped a list of the most expensive drugs covered by Medicare).

Both medications address a range of severe autoimmune conditions, such as spasms in infants and nephrotic syndrome, a kidney disorder.

Mallinckrodt said the settlement would not have an impact on its net sales. And a cheering section of Wall Street analysts agreed that the F.T.C. deal was a nonevent — and reiterated the buy recommendations on Mallinckrodt shares.

And yet, there is something troubling for Mallinckrodt shareholders in the antitrust settlement: Its facts underscore a disclosure lapse by the company during the summer of 2014 related to the F.T.C. inquiry. On June 11, 2014, Questcor had received a subpoena from the F.T.C., which was investigating it for anti-competitive activities. But investors didn’t learn about the subpoena until months later.

Why is a 2014 disclosure issue relevant now? Two reasons. First, it occurred in the middle of Mallinckrodt’s $5.6 billion bid for Questcor. The existence of a subpoena to Questcor would seem to have been of interest to Mallinckrodt’s shareholders as they mulled whether to approve the purchase of what was a one-drug company.

More broadly, the incident revealed a minimalist’s approach to disclosure at Mallinckrodt. This is worth knowing, given that United States Attorneys in two different districts are investigating Questcor’s marketing practices.

Let’s return to the events of 2014. That April, Mallinckrodt announced its bid for Questcor, a company with $800 million in revenues that came almost entirely from sales of Acthar, a 60-year-old, off-patent drug.

Questcor had bought the rights to Acthar for $100,000 in 2001 and soon began raising the price from $40 a vial.

In June 2013, when Acthar cost $28,000 a vial, Questcor paid $135 million to Novartis to purchase the rights to Synacthen, a synthetic, vastly cheaper competitor drug prescribed in Canada and Europe. Although Questcor said it would develop Synacthen for conditions where it “would potentially provide a clinical benefit over Acthar,” it did not follow through on that pledge. Synacthen stayed on the shelf, and Acthar’s price kept rising.

Less than a year later, Mallinckrodt came knocking for Questcor, offering its shareholders a 27 percent premium to the prevailing stock price before the merger announcement.

Over the next few months, as Mallinckrodt shareholders weighed whether to approve the deal, they received company filings that detailed the risks in the acquisition. Nowhere did the F.T.C. subpoena come up — it was the proverbial dog that did not bark.

Mallinckrodt shareholders approved the deal in August 2014. But it wasn’t until November that they learned about the subpoena Questcor had received from the F.T.C. in June 2014. In a Mallinckrodt 10-K filing, they were told that the F.T.C. sought materials and information from Questcor about whether its acquisition “of certain rights to develop, market, manufacture, distribute, sell and commercialize Synacthen Depot from Novartis violates the antitrust laws.”

About a week after this disclosure appeared, Matthew K. Harbaugh, Mallinckrodt’s chief financial officer, told participants at a Piper Jaffray Healthcare Conference that the company had included the information about the F.T.C. subpoena in the 10-K “just to make sure that it is fully transparent to investors.”

We now know that the F.T.C. concluded that Questcor, and subsequently Mallinckrodt, engaged in anti-competitive conduct.

Investors, especially those considering a corporate merger, expect a company to disclose meaningful information that could change their views on the deal. Central to such disclosures is the concept of materiality; if a company fails to disclose material information, it could run afoul of the securities laws. Companies must make determinations on materiality regularly, and people can disagree on these assessments.

So this raises a question for Mallinckrodt shareholders: Should their company have told them about the subpoena as they considered approving the Questcor deal?

“In my opinion, yes,” said Lewis D. Lowenfels, an authority on securities law and an adjunct professor at Seton Hall University Law School. “There are two tests for materiality in disclosure: whether there is a substantial likelihood that a reasonable shareholder would have considered the information important in deciding how to vote, and/or whether a reasonable investor would have viewed the undisclosed information as having significantly altered the total mix of information made available.”

“Under either test,” he added, “I think the existence of an F.T.C. subpoena within the factual context of this merger is material.”

A spokesman for Mallinckrodt, Daniel Yunger, said it had “complied with all legal and regulatory requirements in all public disclosure decisions related to the F.T.C. matter.”

Further, he said that the company “continues to strongly disagree with allegations outlined in the F.T.C.’s complaint, believing that key claims are unsupported and even contradicted by scientific data and market facts.”

Remarkably, the decision to stay mum about the F.T.C. subpoena came even as Mallinckrodt and Questcor were responding to concerns expressed by the Securities and Exchange Commission about inadequate risk disclosures in their merger documents.

For example, federal filings contain S.E.C. letters to Mallinckrodt and Questcor on June 19, 2014, asking for additional disclosures. One area of interest to the S.E.C. was what the companies told investors about the risks of lower reimbursements on Acthar by private insurers because of its high cost. The S.E.C. also asked the companies to provide more information about adverse medical reactions among Acthar patients, such as deaths or disabilities, that had been detailed a few days earlier in an article in The New York Times.

“We urge all persons who are responsible for the accuracy and adequacy of the disclosure in the filing to be certain that the filing includes the information the Securities Act of 1933 and all applicable Securities Act rules require,” the S.E.C. told the companies.

Both Questcor and Mallinckrodt responded to the S.E.C. by expanding their disclosures. But because the S.E.C. does not post this correspondence on its website until months after it is written, investors did not learn about the regulator’s concerns until Feb. 2015.

It is probably fair to say that investors will always prefer more robust disclosures from companies than management wants to give. Still, it’s good to know when a company seems to believe that “less is more” where disclosure is concerned. That way, at least, investors can steel themselves for unpleasant surprises.
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#2
(01-30-2017, 12:53 PM)PrairieMom Wrote: I literally makes me sick to the stomach to see how much this drug is going for, seeing how it's a first-line drug for Infantile Spasms.

The pharmaceutical industry long ago sold their soul.  By no means do I expect drugs to be free, but at the same time...

On a semi-related note:

http://www.nydailynews.com/news/national...-1.2947136
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#3
I can but sympathize with you, PM, and echo jeeter's comment above.

It's not a panacea, but have you thought of homeopathic treatment?
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#4
(01-30-2017, 03:00 PM)J Michael Wrote: I can but sympathize with you, PM, and echo jeeter's comment above.

It's not a panacea, but have you thought of homeopathic treatment?

We've tried some with moderate success many years ago. We undid some of the vaccine damage from it using thuya (and we actually have vaccine damage - her cumulative record reflects not one but TWO incidences of adverse reaction, neither of which were reported by me to the government, so it was reported by a physician at some point), but the damage was already done. The disorder basically scrambles their brain, and short of surgery to excise out the damaged part there's no treatment except to manage the ongoing seizures.

Our pediatrician explained to us early on that while vaccines aren't a cause, it's suspected to be a trigger for kids who are predisposed. That was us. Her initial bout was within days of her getting her third dose of DaTP (I only learned after-the-fact that the risk for side-effects, including seizures, increases with each dose). After getting it under control and successfully getting her off *all* meds (a small miracle) and her making good gains, her relapse was within days of her MMR+varicella, which I allowed myself to get talked into. I regret that deeply, because we never recovered from that.

(01-30-2017, 02:52 PM)Jeeter Wrote: By no means do I expect drugs to be free, but at the same time...

I don't think anyone expects it, and it's not like it's a new drug. It's been in use since the 50's I think as a front-line treatment, and is still the best ones out there. Part of the issue is that they applied for, and received, orphaned drug status a few years back, allowing them to charge basically whatever they want. Orphan drug status is good in that it theoretically increases availability of drugs used to treat rare conditions by making them financially viable, but at the same time it seems the process is often abused.
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#5
(01-30-2017, 04:09 PM)PrairieMom Wrote:
(01-30-2017, 03:00 PM)J Michael Wrote: I can but sympathize with you, PM, and echo jeeter's comment above.

It's not a panacea, but have you thought of homeopathic treatment?

We've tried some with moderate success many years ago. We undid some of the vaccine damage from it using thuya (and we actually have vaccine damage - her cumulative record reflects not one but TWO incidences of adverse reaction, neither of which were reported by me to the government, so it was reported by a physician at some point), but the damage was already done. The disorder basically scrambles their brain, and short of surgery to excise out the damaged part there's no treatment except to manage the ongoing seizures.

Our pediatrician explained to us early on that while vaccines aren't a cause, it's suspected to be a trigger for kids who are predisposed. That was us. Her initial bout was within days of her getting her third dose of DaTP (I only learned after-the-fact that the risk for side-effects, including seizures, increases with each dose). After getting it under control and successfully getting her off *all* meds (a small miracle) and her making good gains, her relapse was within days of her MMR+varicella, which I allowed myself to get talked into. I regret that deeply, because we never recovered from that.

The US gummint has paid out millions of dollars to victims of vaccine damage.  Is there no such program in Canada? 

Saying that "...vaccines aren't a cause, it's suspected to be a trigger for kids who are predisposed..." is kinda like saying the trigger on a gun isn't responsible for the damage done by the bullet when it hits a human being.  Well...no...it isn't.  But if no one takes aim and pulls the trigger, then no damage is done.  The biggest problem apart from the vaccines themselves is that no one seems to know (or even care all that much) which kids are predisposed.  Oy vey!!

Ongoing homeopathic treatment (by a qualified, experienced homeopath) *might* be able to help with the continuing seizures.  I think it's very much worth your while looking into this.  Don't know where you are in Canada, but you might want to check out Dr. Andre Saine and the Canadian Academy of Homeopathy.  In my opinion, he is one of the foremost homeopaths in the world today.
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#6
(01-30-2017, 04:42 PM)J Michael Wrote: The US gummint has paid out millions of dollars to victims of vaccine damage.  Is there no such program in Canada? 

No. Basically the health care system assumes the costs and a notation if made in the vaccination file.

Quote:Saying that "...vaccines aren't a cause, it's suspected to be a trigger for kids who are predisposed..." is kinda like saying the trigger on a gun isn't responsible for the damage done by the bullet when it hits a human being.  Well...no...it isn't.  But if no one takes aim and pulls the trigger, then no damage is done.  The biggest problem apart from the vaccines themselves is that no one seems to know (or even care all that much) which kids are predisposed.  Oy vey!!

The one-size-fit-all vaccine policy is definately problematic, precisely because there's very little knowledge or political will to be able to identify these kids. But probably a more apt analogy would be the gun is an issue only if you're standing in the room. If a gun fires in an empty room (no predisposition), then it's not an issue that it's been fired. The gun in that case isn't dangerous. But we can't always tell if there's a kid in the room when the gun is fired (having a predisposition). It's a subtle but important difference, because it's not about the gun, but about where the human is in relation to the gun.

I've come to understand over the years that vaccination isn't the whole story in our daughter. In doing geneaology, we've uncovered evidence that suggests my husband had an great-uncle that died in infancy from this condition (although our proof is not conclusive, it is strongly suggestive), in a time and place before vaccination were available. There's also a history of childhood epilepsy in my family in that same generation. I've also come to understand how the Autism genes express themselves in our family (and again, specifically my husband's family) in subtler ways than what our daughter has. It's very possible she would have been on the spectrum anyway, even if she never was vaccinated. As it is, I'm pretty sure our son and possibly even my husband himself and my FIL might be very-high-functioning on the spectrum. There's also at least one first-cousin to our daughter that has been assessed multiple times for the disorder, only to be screened out as being too high functioning (the official diagnosis was "eccentric", although I find it obvious that he's somewhere on the top end on the spectrum).

The unfortunate part is that we didn't know about any of this when she was born. I might have made different choices for her had I known. The good thing is that her pediatrician is aware of her link with vaccination, and has actually gone to bat for me when I've gotten pressure from other members of the medical community to update her vaccines.

Quote:Ongoing homeopathic treatment (by a qualified, experienced homeopath) *might* be able to help with the continuing seizures.  I think it's very much worth your while looking into this.  Don't know where you are in Canada, but you might want to check out Dr. Andre Saine and the Canadian Academy of Homeopathy.  In my opinion, he is one of the foremost homeopaths in the world today.

We're trying to decide what to do next. Her seizure activity is increasing with her growth spurt and beginning puberty. I hate the idea of just increasing her meds because they affect cognitive and executive function, yet the risks of stopping meds is considerable (a big reason why we've never attempted chealation therapy even though she has a known heavy-metal shedding problem).
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#7
PM, I know this isn't the Oratory, but I'll keep y'all in my evening Rosary intention.

Also, it sounds like a good poo flinging is in order.
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#8
(01-30-2017, 08:12 PM)Jeeter Wrote: PM, I know this isn't the Oratory, but I'll keep y'all in my evening Rosary intention.

Also, it sounds like a good poo flinging is in order.

Thanks.

Send me some sheep poo, will ya?
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#9
(01-30-2017, 08:15 PM)PrairieMom Wrote:
(01-30-2017, 08:12 PM)Jeeter Wrote: PM, I know this isn't the Oratory, but I'll keep y'all in my evening Rosary intention.

Also, it sounds like a good poo flinging is in order.

Thanks.

Send me some sheep poo, will ya?

I could send some. Or...

https://www.ipoopyou.com

http://www.poopsenders.com

So wrong. Yet somehow so funny. :LOL:
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#10
(01-30-2017, 06:49 PM)PrairieMom Wrote:
(01-30-2017, 04:42 PM)J Michael Wrote: The US gummint has paid out millions of dollars to victims of vaccine damage.  Is there no such program in Canada? 

No. Basically the health care system assumes the costs and a notation if made in the vaccination file.

Quote:Saying that "...vaccines aren't a cause, it's suspected to be a trigger for kids who are predisposed..." is kinda like saying the trigger on a gun isn't responsible for the damage done by the bullet when it hits a human being.  Well...no...it isn't.  But if no one takes aim and pulls the trigger, then no damage is done.  The biggest problem apart from the vaccines themselves is that no one seems to know (or even care all that much) which kids are predisposed.  Oy vey!!

The one-size-fit-all vaccine policy is definately problematic, precisely because there's very little knowledge or political will to be able to identify these kids. But probably a more apt analogy would be the gun is an issue only if you're standing in the room. If a gun fires in an empty room (no predisposition), then it's not an issue that it's been fired. The gun in that case isn't dangerous. But we can't always tell if there's a kid in the room when the gun is fired (having a predisposition). It's a subtle but important difference, because it's not about the gun, but about where the human is in relation to the gun.

I've come to understand over the years that vaccination isn't the whole story in our daughter. In doing geneaology, we've uncovered evidence that suggests my husband had an great-uncle that died in infancy from this condition (although our proof is not conclusive, it is strongly suggestive), in a time and place before vaccination were available. There's also a history of childhood epilepsy in my family in that same generation. I've also come to understand how the Autism genes express themselves in our family (and again, specifically my husband's family) in subtler ways than what our daughter has. It's very possible she would have been on the spectrum anyway, even if she never was vaccinated. As it is, I'm pretty sure our son and possibly even my husband himself and my FIL might be very-high-functioning on the spectrum. There's also at least one first-cousin to our daughter that has been assessed multiple times for the disorder, only to be screened out as being too high functioning (the official diagnosis was "eccentric", although I find it obvious that he's somewhere on the top end on the spectrum).

The unfortunate part is that we didn't know about any of this when she was born. I might have made different choices for her had I known. The good thing is that her pediatrician is aware of her link with vaccination, and has actually gone to bat for me when I've gotten pressure from other members of the medical community to update her vaccines.

Quote:Ongoing homeopathic treatment (by a qualified, experienced homeopath) *might* be able to help with the continuing seizures.  I think it's very much worth your while looking into this.  Don't know where you are in Canada, but you might want to check out Dr. Andre Saine and the Canadian Academy of Homeopathy.  In my opinion, he is one of the foremost homeopaths in the world today.

We're trying to decide what to do next. Her seizure activity is increasing with her growth spurt and beginning puberty. I hate the idea of just increasing her meds because they affect cognitive and executive function, yet the risks of stopping meds is considerable (a big reason why we've never attempted chealation therapy even though she has a known heavy-metal shedding problem).

Yeah, stopping her meds, especially without close medical supervision, would really be unwise.  A good homeopath would not do that, though they might want at some point to possibly begin reducing the meds.--again, under close supervision.
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