Monday, February 3, 2014

Get your opiates for free: Capitalism meets the zombie apocalypse

I think I have found a new low in the pharmaceutical industry: giving away a month's free supply of potentially lethal high-grade opiods.

This ambitious marketing strategy allows more than enough time and supply to create addicts.

The company is Galena Biopharma and their product, under the marketing name of Abstral is sublingual Fentanyl.

Fentanyl according to Wikipedia is a potent, synthetic opioid analgesic with a rapid onset and short duration of action. In other words you get really high, really fast and it doesn't last long. Also according to Wikipedia it is "one of a small number of drugs that may be especially harmful, and in some cases fatal, with just one dose".

Fentanyl has a legitimate use - for intense "breakthrough" pain spasms for someone already being treated around the clock with a heavy opiod like morphine. The legitimate user is probably a terminal cancer patient with bursts of pain so intense that morphine just doesn't cut it. In that case the seriously addicting properties of the drug are not particularly relevant and the benefit of use is indisputable.

Outside that it is hard to think of a good use for this drug.

The drug has killed plenty of people including a few notable rock-n-rollers. Read Wikipedia for the gory details.

Galena's hot new product is a sublingual version of an old drug. The marketing (on their website) argues this drug is really fast. To quote: "Patients preferred Abstral for speed".

However to give it that extra marketing pizazz they are giving it away. Here is the pitch - which I believe as a matter of policy should be criminalized.* [I note that tobacco companies are not allowed to give free samples of cigarettes - and it is curious that same does not apply here.]





The advert has an irony of its own. It shows a new-age style woman completely blissed out (with a smiling kid) and the slogan "time better spent".

We have US corporations doing hippy-alternative-lifestyle drug marketing for drugs that are especially effective in turning you into a zombie. Capitalism meets the zombie apocalypse.

It is as if Tim Leary was reincarnated as a cynical capitalist going for the mega-dollars.





John

I don't think I can overstate just how evil I think* this is. Fentanyl is very fast acting and is sometimes used in cutting heroin to make it more saleable. Drug dealers test the quality of heroin by "tasting" it. If it acts quickly then it is presumably good. [See Lou Reed singing about "sweet taste".]

Because Fentanyl is fast-acting it is sometimes cut in to make the taste more immediately effective. However because of Fentanyl's properties it can turn the batch of heroin deadly. There is a Fentanyl laced batch in the US at the moment - the latest victim was probably Philip Seymour Hoffman. See this story about a "killer" batch of heroin with about 100 victims.


It is a strange world where Herbalife is considered an unethical stock. I have met several people who (for good reason) claim their life was saved by Herbalife. Herbalife may be an insidious cult like AA. But like AA it makes people healthier.

This is a company which will end people's lives. Oh, and give away the product for free.


===

For the record, this is the company's black-label warning on Abstral:

IMPORTANT:

Do not use ABSTRAL unless you are regularly using another opioid pain medicine around-the-clock for your cancer pain and your body is used to these medicines (this means that you are opioid tolerant).
Keep ABSTRAL in a safe place away from children.
Get emergency medical help right away if:
  • a child takes ABSTRAL. ABSTRAL can cause an overdose and death in any child who takes it
  • an adult who has not been prescribed ABSTRAL takes it
  • an adult who is not already taking opioids around-the-clock takes ABSTRAL
These are medical emergencies that can cause death.
If possible, try to remove ABSTRAL from the mouth.

---

*Whether giving away highly addictive drugs should be criminalized was a subject of debate amongst people I ran this blog post past. The range of opinion was from libertarian to nanny-state. My strong view that this behaviour should be criminal is a political view that others I respect differ from. For some the attitude was that it is very nice of the company to give away the drug to people in terminal pain, and if it creates some addicts - well that is their fault isn't t.

65 comments:

Anonymous said...

You should leave Timothy Leary out of this. Opiates and hallucinogens are not even a little similar. Opiates act in ways that create compulsion, hallucinogens are essentially impossible to use regularly. And people don't die from hallucinogens.

Anonymous said...

I think freedom is the right thing; that all contracts must be voluntary an well-informed, except in self-defence.

This would argue then that these guys have to be absolutely full-on up-front about what their drug does, because its effects are so profound; anything less is properly tantamount to a non-voluntary contract.

There's a second issue though. As you say, this drug is and is only useful in pallative care. Given this, why on earth would this drug be given away to anyone else?

That clearly smacks of deceit. Motive is the determinant of whether an act is right or wrong; the act itself means nothing.

Let us consider a clearer case.

Imagine cocaine is legal and we had a company giving away cocaine, purely to get users hooked, so they can sell more product.

If the company is absolutely up-front about their product and what it does - gives you a high, makes you an addict, you'll be putting yourself into a situation where you *have* to buy more - and someone choses that, then I think that has to be considered freedom. The contract is up-front and totally clear and someone made a bad choice. Freedom includes the freedom to be stupid and incompetent; if it doesn't, it's not freedom. If someone else can chose for those people, they can chose for you and I, too.

I don't think there's much difference between giving a pallative care drug to non-pallative users and simply selling them cocaine. There's perhaps deceit in the first case, but perhaps they are acting this way because they must, because of the law which bans addictive drugs such as cocaine.

If however the nature of the drug is willfully masked, then this immediately is wrong, because the contract is non-voluntary.


John Hempton said...

I didn't suggest that Tim Leary would ever do something like that. He was into drugs as a form of enlightenment not a form of enslavement.

This is a enslavement.

Anonymous said...

John,

The advertisement clearly states that the free offer is only valid with a prescription. The prescribing doctor has a duty of care to ensure this is only prescribed to a patient already using another opioid pain medicine around-the-clock for their cancer pain. Net result, this is not an offer available to any druggie off the street. That's not to say that it can't be fraudulently obtained, but I think that is a different discussion to this one about the pricing.

Where you see a "new-age style woman" I see somebody who last all her hair from chemo treatment.

Anonymous said...

The woman who looks blissed out has no eyebrows. I think she's supposed to be a cancer patient enjoying what is left of her life.

This is an extremely common marketing ploy, actually, and it is targeted. The "fast acting" drug is patent protected, and most health care companies will only pay for the generic. It is common (including in controlled substances - I've seen it done in Schedule 2s repeatedly) for drug companies to offer a discount card that makes up most of the difference between what the insurance company will pay and the out-of-pocket cost of the patented drug vs. the generic. There are many arguments why this might be wrong, but no one is getting this without a prescription, I guarantee you. If you have a legitimate prescription, this can make up the difference between being able to use the fast-acting version your doctor prescribed and the generic your insurer will pay for.

The pharma industry is evil, as is the insurance industry, but I think you may be missing the point of this particular ad.

John Hempton said...

Of course it is only open with a valid prescription.

But this is a drug for which the main legitimate users will be dead in 30 days.

30 days free is targeted at a whole new class of users.

J

John Hempton said...

Or lets put it another way. Methadone is given on prescription in most countries to people addicted to methadone. So how would you feel about the drug company giving the first dose free to patients that claim to be in pain?

Anonymous said...

I can only comment on Abstral and my personal feelings why Galena will (and is) making Abstral a force to be reckoned with against all other cancer breakthrough pain within this class of medications. I even believe Abstral will ultimately gain acceptance for other immune-related diseases that cause severe pain. I have a niece w/RA, I see her suffer in ways that are not limited to cancer patients but that's just my .02. Sadly cancer is growing and I challenge anyone to say they don't know someone affected by it personally and as the baby boomers age, the rate of cancer continues to rise w/it. Then there is finally the acceptance of treating pain as the "fifth" vital sign whereas in the past, a majority of doctors didn't treat pain effectively due to the fear of addiction and b/c if the astonishing lack of education regarding pain mgmt. in medical school. Cancer patients are finally achieving amazing quality of lives, it's no longer anything like it was, i.e., Terms of Endearment. If you walked by me, guarantee you wouldn't have any idea I am sick. All I can say personally is Abstral gave me my life back and the will to fight. Again, I am a personal investor, not by any means a large investor that would cause me to write so frequently on this topic. I am not compensated by anyone in anyway related to Galena, I'm just extremely passionate and grateful they made this drug available via trials, the free 96 pill deal brought up elsewhere which is true and via coupons (have you never used a pizza coupon, why do they offer them, restaraunts via Groupon, it's a great way to gain market share and exposure, it's marketing 101). I wouldn't throw this sum of money at anything that I couldn't try first. Now pain receptors are complicated business, I'll leave that to the experts, I just know that there are very few of these medications that work for patients for any length of time and stopping pain before it gains momentum is why I think Abstral is so successful.

Anonymous said...

Anyone suffering from break-through cancer pain will be dead within 30 days.

Really ???

kristiina said...

How interesting. And speaks volumes about our culture. Seems like this is the direction capitalism is taking: crime, prostitution and drug dealing. They are, after all, probably the most profitable businesses that exist.

How strange that these things are also strangely perverted forms of those most coveted achievements of religions. Abundance of love, sharing of everything without regard to ownership, extatic bliss - these are fruits of spiritual practices. Of course, prostitution is not quite love, but sort of in that direction. And getting what you want through crime is not sharing, but you're getting what you want without having to earn or work for it. And drugged stupor is not extatic joy but supposedly feels like it.

Can't help wondering where do the people come from who drive this kind of business?

Anonymous said...

my friend, breakthrough cancer pain does not occur merely in patients with end stage disease. You paint a picture of this patient group that gives the impression that they are bed ridden and in hospice, waiting to die. Not true in the majority of cases. See prevalence data referenced by the WHO. Most patients in fact live for quite a long time with quite a lot o pain. I am a biotech guy, so do not view these companies as negatively as some. http://www.whocancerpain.wisc.edu/?q=node/219

Anonymous said...

John, as people already wrote, you might be missing a point here. "Free" doesn't make it more accessible control-wise to people who shouldn't have it (e.g. most of everyone but patients with high amounts of chronic pain, likely oncology). Repeat, you still need a valid prescription.

Therefore if you somehow obtain corrupted prescription, it's not their fault. Actually, if you are able to get said prescription without being in legit need, you already have "get drugs for free" ticket in your pocket, just the relative power of those drugs could differ (e.g. generic morphine you get from insurance or brand name fentanyl variant or whatnot).

If they really give high-class pain relief for free to people who "would be dead in a month", that particular action might warrant something entirely different then bouts of righteous wrath.

Regards,
Dmitry.

Tim Rigdon R.Ph said...

Obviously you have never seen a hospice patient in constant agony with total body convulsions dying from cancer. This drug would be a life saver as it would immediately stop the intense pain. Also, you are overlooking the fact that this drug requires a Schedule II prescription from a physician, so the patient would already be in pain and more than likely on longer acting opiates already. It's not like they are handing it out on the corner to healthy individuals

buyersstrike said...

I'm sure some entrepreneurial types will take advantage of GALE's sweet offer and divert some of this free Fentanyl to the street.

Anonymous said...

John, the bigger evil here is abuse of copay assistance in general - not to create addicts so much as to inflate revenues. Don't dare blog about it unless you want lots of C&D letters in your mailbox, but spend a few minutes on QCOR and the CDF....

Miguel Couceiro Neto said...

I Don't get your point... I would have no problema with it, as long as it was prescripted by a doctor

Drew Robinson said...

You do realize that most terminally ill cancer patients live much longer than 30 days past their diagnosis, right? Unfortunately you seem to have no medical knowledge of opiates at all, yet you write this nonsense. Also, methadone is given to those addicted to heroin, not methadone. Heroin crosses the blood brain barrier at a far higher rate than other opioids, so it is used to help wean the addiction.

Scott Brown said...

I don't think anyone, except for you apparently, would look at this ad and see a "new-Age" woman being depicted. I believe most everyone see's a cancer sufferer who just wants to spend what little time she may have left with her child in a pain-free environment.

FELIPE DINI said...

Mr. Hempton, if your mother had cancer and few times a day she had cancer pain climaxing several times a day how would you like to watch her suffer from it? For 5-10 minutes each time or 20-30 seconds each time?

Anonymous said...

There is NO generic equivalent that has produced these results. Talk about the need for criminalization John, you are simply toying with something so serious to take down a pharmaceutical company to better your stock position? That is appalling and you sir should be reviewed by the SEC for your motives and irresponsible reporting by cherry picking the facts that omit the truth. This is irresponsible reporting at it's all time height. Abstral is a HIGHLY regulated drug that is only given away WITH AN ACCOMPANYING SCHEDULE II PRESCRIPTION FROM DOCTORS &PATIENTS ENROLLED IN THE REMS PROGRAM with tight oversight via FDA and the DEA. The women depicted looks like me, I'm no hippie, just bald from chemo, I've got 6 mos. or so left to live and there is no high here for those of us suffering from unbearable malignant pain. You omitted too many points from the brochure (since that's all you've researched clearly), the risks stated and so called coupons offered are no different than ANY other medication, except that they are drug specific. Abstral is highly effective quickly defeating malignant pain cycles which works for 30 min. w/a quick onset of 3-10 minutes allowing patients to remain out of hospice and maintain some control of their quality of life and in MANY cases DEATH.

Scott Brown said...

John said "But this is a drug for which the main legitimate users will be dead in 30 days.

30 days free is targeted at a whole new class of users."

Cancer is not a death sentence. I know cancer sufferers who take fentanyl products and their prospects for recovery are positive.

Anonymous said...

I thoroughly agree with you that big pharma is evil.

However, palliative care is an entire discipline within medicine, and I would advise reading up about it before going off full bore. People who have not had the experience of chronic pain or pain associated with cancer treatment simply cannot understand, and will never understand, the necessity of treatment for that pain. Never. No, you don't "know how they feel," unless you heat a frying pan to white hot and touch it to your soul. It doesn't hurt anyone to throw every med you can at them to try and alleviate that. Addiction? They have much bigger problems, usually terminal problems, and it doesn't hurt anyone to give them what they need.

That said, what has happened with Oxycontin is a disgrace.

Anonymous said...

I lost my 39 year old wife and a mother of two to a recurrence of low HER2 expressing breast cancer. She was in excruciating pain from the cancer that had spread to her spine. No opiates were effective in reducing her pain. I wish there was a fast acting drug like Abstral available in the market in 2011.

I understand that you and your business associates like Adam F are only bashing the stock to make money of it. But everying is not about money. You need to think about whether you are abusing your position of influence to take down a company that seems to have a good shot at limiting the recurrence of cancer and is trying to finance it through a cancer pain management drug.

Keep in mind, it was my wife 2 years ago, it could be you, your wife, your daughter, Adam F's wife or daughter next.

Please make money on other stocks. There are plenty in the generic space or spaces where alternative cures are sought. Leave alone small oncology companies that are collaborating with leading cancer research institutes to advance promising treatment alternatives.

This is a request.

Thank you
AB

Anonymous said...

I give Abstral to my dying mother, "blessed out" is not how I'd describe her agonizing screams that no other pain medication helped. I had a hard enough time getting this drug, nearly impossible. But thank goodness for her Oncologist as no I can help my bald browless mother FINALLY have a measure of comfort. Heroin and Fentanyl? What are you talking about, how do you know this because I showed this to our hospice nurse who I quote said "this is NOT a fentanyl that can be easily obtained AT ALL PERIOD". At such an expensive cost, how does a malignant pain patient manage their own pain? Why would anyone want a drug that lasts 20-30 minutes tops at such a high price? Did my own research, what heroin addicts can afford this drug b/c it's not cheap? Lastly, my 92 year old mother had to take a $1200 drug screen before being prescribed this medication, everybody is screened. My point is the risk for abuse/diversion is EXTREMELY low which has nothing to do with the efficacy of this medication (not drug, because you are using that word the incite).

Anonymous said...

Noone has even mentioned the fact that the card says "free" product for Medicare patients. Isn't this a violation of kickback statute?

John Hempton said...

The Galena stock promoters are out in force.

J

Anonymous said...

I just got a coupon to help make up the difference in my high blood pressure medication as the generic was not working and a sample showed the brand name did. This is an industry standard as insurers look to approve not the most effective medications, but the cheapest. It's not like this company is doing anything differently than other drug companies but I take issue w/your calling the woman on the cover a hippie as she clearly is hairless from chemotherapy as is my best friend who has a daughter right around that age. You must be very healthy because getting these non-genetic drugs is costly WITH the coupons so for now Ill take Pharma's coupons so I can get cutting edge treatment versus what insurance is willing to pay, which is just about nothing for everything. Stay well my friend, it's tough for those of us that are ill.

Anonymous said...

The very comparision of tobacco company in this regards is absurd.
As this case is prescription based. The patient gets free sample only after prescription by doctors. In that case it just saves the patient some money and helps him in immense pain relief. I really don't understand the whole logic in this report.

AG said...

I think that, if I had a terminal cancer with intractable pain, I would be happy to have the possibility to get a sublingual Fentanyl available for free.
Pain makes patients zombies much, much more than Fentanyl.

MortyLong said...

Hey John, you good friends with Chet/Matt Gravitt, by chance - s this all an elaborate attempt to short a stock? Anonymous post discussing my niece is simply MY OPINION, which we both have a right to but this shows MANIPULATION and collusion against Galena, not to mention using a medical novices words to make a company look like their end game is drug dealing, disgusting tactics. I am not a doctor and yes currently on this drug for CANCER BREAKTHROUGH PAIN. What is your real motive or are you concerned that your puts aren't solid enough? SHAME ON YOU. This is purely conjecture and I couldn't give a darn other than you are jeopardizing my right to use this highly effective medication. You are crossing a line because you omit everything that matters, i.e., the very difficult and controlled route required to fill this prescription not to mention the price tag! Fair and balanced please John, really. I am issued a coupon for an RX'd inhaler too, do they want to enter the heroin world or possibly offer asthma patients a chance to use a bronchodilator that doesn't make their heart race as much as traditional therapies (which is terribly uncomfortable by the way)?

Anonymous said...

Author's comment - "Of course it is only open with a valid prescription.

But this is a drug for which the main legitimate users will be dead in 30 days.

30 days free is targeted at a whole new class of users."

If the subjects die in 30 days..then new patients come .. and they are given free again .. DO you think Galena will make any money with this strategy ???

EIther GALENA Should be absolutely dumb with this strategy or you are missing something terribly ???

Please clarify

Anonymous said...

Author's comment - "Of course it is only open with a valid prescription.

But this is a drug for which the main legitimate users will be dead in 30 days.

30 days free is targeted at a whole new class of users."

If the subjects die in 30 days..then new patients come .. and they are given free again .. DO you think Galena will make any money with this strategy ???

EIther GALENA Should be absolutely dumb with this strategy or you are missing something terribly ???

Please clarify

MortyLong said...

THERE IS NO FREE PRODUCT FOR MEDICARE PATIENTS, I WOULD KNOW ABOUT IT! I pay a sizeable sum for this drug , after my $500 coupon which I then can't use Medicare D's RX plan. We need to help patients with medication costs until this is brought under better control. Prices are out of control. I volunteer in a low-income center and I see elderly, really patients from all walks of life who can't afford their medications so they don't take them, John, the majority of drug companies offer patient assistance, just some are better run. We should all be very concerned though with stifling drug innovation as you don't want to have your loved one unable to gain access to life saving or life altering therapies due to cost constraints.

Anonymous said...

Kudos dude for the price action! People are soo stupid! This "shocking practice" is FYI completely normal!! Check out what their fentanyl competitor is offering: "Patient Co-Pay Savings Program
Start saving with the SUBSYS Effective Dose Savings Program. Patients can receive free product and up to $500 off each additional prescription. This program is for commercially insured and cash paying patients only." Source: http://bit.ly/1et4Ld6 -Kinda ruins your premise, don't you think?!

Anonymous said...

All drug promoters are out in force, try again. Ever sit in a doctor's waiting room, I work for a physician and they are sitting all over our waiting area waiting to see our docs. Unfortunately this is the system we have and I am always happier to be able to sample patients (not with narcotics, we don't even have nor RX those), who won't be able to afford their prescriptions otherwise. We just had a patient, 52 high cardiac risk that couldn't afford the $180/mo. for his heart medication and he refused patient assistance (he referred to it as charity too). He is being buried this week leaving his wife and 3 children behind. Something's got to give and it's happening 5-10 times a day everyday, it's got to change. We need to find a way to promote innovation while allowing doctors to heal patients rather than spending 40% of their time fighting to get their patients the right treatment plan! which may not be the cheapest. Come to our practice and we'd do the same for you and your family John.. Our healthcare system is broken, that is the real issue.

Anonymous said...

this article is one of many that are totally irresponsible. The author should be stricken with the disease, and find out it costs 4k for a 30 day supply and there are no freebies to hold you over, by your oncologist....drop dead bronte, youre a disgrace.

Anonymous said...

John, you say "Galena stock promoters are out in force". Obviously, Bronte Capital is only stating this to make money by shorting the stock. It would be a perfect irony if, some day, your mother is saved from recurrence of cancer due to Neuvax, and is spared the cancer pain due to Abstral.

I read your biography and the monthly letters on your website. It is obvious that Bronte capital is fine with unethical investing, would make money selling illegal drugs if you could and the team seems to be high from the monthly letters too.

Anyone who researches your background will not take you seriously. BTW, your fund will go belly up sooner or later because most of your investment strategies are flawed. You generate sub-market returns. The market will size you up sooner than later.

Anonymous said...

John, you know me commenting occasionally with this signature, I hardly ever care about Galena stock. It's just that you have accustomed us readers to much better writing then this.

How giving this potentially abusable drug for free to people with all proper prescriptions and with all other control methods in place differs materially from them getting generic opiates, morphine and whatever other potentially abusable substances are used as medications "for free" off their insurances?

If there is a well-grounded argument here, I fail to spot in in the post, so you might want to at least clarify.

Regards,
Dmitry.

MortyLong said...

And what are you promoting John? Your short position in GALE? What did you make off the combined efforts b/w you and Matt from SA? I agree w/poster AB, PLEASE leave the small oncology companies trying to bring treatment options to cancer and short a bigger company. Have you no soul? I want to live, I have the right to do so out of agony. Why don't you go and try to get yourself a prescription for Abstral and then come back and tell us how free and easy it is. You may be required to have a bone marrow biopsy and insurance no longer pays for sedation. Might hurt a bit, having an apple corer shot through your hip bone, but you'll get Abstral so I'm sure it's worth further your short. I respectfully ask that you stand down for AB's children, for all of the patients that are literally dying for innovation.

Anonymous said...

This is a drug for breakthrough cancer pain, a drug to replace what currently exists. Offering penetration pricing to get doctors and patients who need the drug to try this version is not unethical or immoral. It is standard operating procedure for those who would like their product sold to those who need it. This is NOT a recreation drug. And all medicines have side effects and some are addictive to the patient. It is up to the doctor and patient to monitor and prescribe as needed. You are off base with your 'assessment', IMO.

Anonymous said...

Gents all,

Can we leave off accusing or asserting JH is bashing the stock for personal profit.

Anonymous said...

From the Abstral Website:
The voucher offer is valid for up to 3 boxes maximum (96 tablets) within the first 30 days. The co-pay portion of the offer covers up to $500 off a co-pay for ABSTRAL. Redeem this coupon ONLY when accompanied by a valid prescription for ABSTRAL. Offer valid for patients 18 years and older. The co-pay portion of the offer is not valid for prescriptions reimbursed under Medicaid, a Medicare drug benefit plan or other federal or state programs (such as medical assistance programs). If you are eligible for drug benefits under any such program, you cannot use the co-pay portions of the coupon. Offer expires 5/31/2014. Product dispensed pursuant to the program rules and federal and state laws. Void where taxed, restricted, or prohibited by law.

Anonymous said...

""Can we leave off accusing or asserting JH is bashing the stock for personal profit. ""

Well, he is isn't he? And he certainly does not know how promotions work in health care, as witnessed by the fact that the competitor product Subsys is doing the same promotion, which tells me that Subsys maker is worried about the competition from Abstral. The fact that Bronte did not know or did not reveal this Subsys promotion tell me that Bronte is either dishonest or lazy in their due diligence.

Anonymous said...

Wow. A fund manager talking about 'cynical capitalist going for the mega-dollars.' Talk about a highly developed sense of hypocrisy.

Anonymous said...

MortyLong you got gypped, as the card clearly says "free" product for medicare patients. Look at the left side.

MortyLong said...

There is currently a great way to ensure the right patients get these drugs. Google REMS and Fentanyl but I'll read you a tiny excerpt of the program for these specific medications. I feel it's critical for everyone to understand that it's not grabbing a script and filling it, not even close. I'll stick to the facts from FDA.gov or go to http://bit.ly/1cONMlA which controls not only the patient but doctor and pharmacy, all three must be enrolled to receive, script or dispense this type of medication. So you can't take your schedule 2 RX, if you were to get one, & have it filled, again all three are vetted and MUST be enrolled in the program. Per FDA.gov, small exact excerpt:
Healthcare providers prescribing TIRF medicines for outpatient use are specifically certified.
To become certified to prescribe TIRF medications, prescribers will be required to enroll in the TIRF REMS program. Prescribers must complete the following requirements to be enrolled:
You can go to the website to see exactly how many steps must be completed by doctors to simply RX this drug and every other immediate release fentanyl medication, including Subsys. It's quite a list so you must show absolute demonstration for need of this product.
The only way this drug will ever be diverted which is completely out of any pharmaceutical company's hands, is when mom or grandma dies and there's a few left, whomever's left to care for the patient could do something not so bright. But that's with everything, so tightly regulated. It's not right to make it sound like it's like all narcotics or schedule 2's, hence the strong warnings and the FDA knows exactly who and how much, via these programs, are being taking, where they are filled and WHO is writing these scripts, again only a TIRF registered, educated and approved doctor can even write for Abstral and like medications.
Which drug do you think pill mills will write for? The one that's thousands and last for 30 minutes and provides no "high" where they will be scrutinized so heavily and patients would likely drop dead from use or the usual Schedule 2's which again, the really sick patients are being punished for due to this type of scripting.
Medical records w/objective documentation must be submitted to gain access to this drug, only then are you allowed to use a coupon or trial to see if it works for you and again, co-pay assistance cards are used by all pharmaceutical companies because insurers only want to cover older and often less effective drugs. Why else would a patient spend so much on this drug if there are so many other effective CANCER BREAKTHROUGH PAIN MEDICATIONS that are remotely cheaper?
I'm sorry I know so much about this and hope none of you have to, however, this is important information to include when assessing the motives and value of a company based on the product they offer which in this case is Abstral.

Anonymous said...

40 plus comments in 12 hours with little concession that John's assertion that marketing a highly addictive and lethal drug to people using 'FREE' could be morally dubious? Yes you need a prescription but this advert and promotion is targeted at the patients effectively telling them to go and seek a prescription for an extremely dangerous drug on cost grounds. Not disputing that if the patient consult the doctor and it is decided that the patient needs the drug then the doc should prescribe it, but the patient should not be price incentivised to seek it out...

A more general point- john is perfectly entitled to his opinion. Yes, he may be short GALE which is presumably why he came across this campaign. He is evidently morally outraged by this and feels the need to speak out. He also says that, whilst he sees it in very black and white terms, people he has spoken to have seen it slightly differently. What on earth is wrong with any of this?! He makes it clear that he is criticising the pitch and not the drug. If you object, please do it calmly and in a reasoned way. From an outsider's perspective, such a vehement response does smell a bit like smeary stock promotion.

Anonymous said...

"according to Wikipedia" "Also according to Wikipedia"
"Read Wikipedia for the gory details."

What a scientific approach. I'll be sure to read WIkipedia.
The person who wrote this is a complete joke. Make no mistake, GALE is down because the Market is down. So John Hempton, please don't think that your "scientific article" had anything to do with it. I did laugh a bit.

Anonymous said...

Quote from a previous poster: "Yes, he may be short GALE which is presumably why he came across this campaign. He is evidently morally outraged by this and feels the need to speak out."

This is the funniest thing I've read in a long time. Really made my day. Yes I'm sure this guy, (who appears to be in a coordinated stock shorting campaign with the seeking alpha author and Adumb Fartstain) is "morally outraged" by this promotion. It's commonplace for drug companies to give out samples and discounts. You have to have a prescription. Thus, your doctor probably checks first to see that indeed you have terminal cancer with excruciating pain that is not being managed by morphine etc. As some of the other commenters have eluded to, it has to me, begun to seem immoral to attempt to do damage to a company that cancer victims have hope for.

David Stewart said...

John, I enjoy reading your posts and usually find them educational. On this one however I think you really missed the boat. I am a retired pharmacist and for people in need of this kind of medicine the company is simply offering to provide them help. Of course the drug is very dangerous in the wrong hands but so is a Mercedes Benz. We wouldn't fault them for having a year end sale would we?

Anonymous said...

Wow... Just wow. The ignorance in this blog post and your comments are completely overwhelming. You obviously don't know the first thing about pain management do you?

I'd like to know where you got your medical license that you can sit here behind your keyboard and pretend you know the first thing about what patients should be prescribed Fentanyl. Intense breakthrough pain doesn't just happen when you're dying. What about war veterans who have sustained major injuries, the type of injuries that will leave them in pain FOR THE REST OF THEIR LIFE? Surely you know better than all the doctors, so since they're not going to be dead in 30 days, they MUST NOT be prescribed Fentanyl.

This blog is a joke. This post is a joke. Every single one of your comments is a fucking joke. You're just another keyboard hero trying to stir up controversy where there isn't any. I hope one of your close families members loses their insurance and gets an injury so severe that they require Fentanyl to manage their pain. Maybe then you'll think twice about this "marketing tactic."

Anonymous said...

Your ignorance is staggering. I wouldn't be surprised if you have no problem with legalized recreational use of marijuana ( which does have negative side effects contrary to the "legalize dope" pushers statements) while you call for criminalization of a extremely useful pain medication that has uses beyond cancer pain relief. And people who need this drug are most likely very strapped for cash due to expensive medical treatments. Full disclosure- I do not own any Galena stock. Will you disclose your stock position?

MortyLong said...

John can be morally outraged and he's been allowed to voice his opinion. However did you know that Medicare patients may NOT use coupons w/o forgoing their insurance to avoid incentivizing any drug use?

Now that doesn't apply to any other patient, privately insured via individually or via their employer so he should understand the facts and that currently this uneven playing field only serves to deny many Medicare patients access to cutting edge therapies due to affordability.

Either it's all or none and his opinion is really focused on Abstral if you read the deeper connections here to other relationships and his openly stated position in his website to short this stock.. Where is his outrage with Insys? Same deal, but at $55/PPS I bet it's too risky and not nearly as lucrative, in fact yesterday over 10 times more lucrative.

Anonymous said...

JH clearly went overboard with the implication that the promotion is trying to make addicts outside of those with valid prescriptions. However the point that the promotion is deeply questionable is a good and valid one. Ahh the muddy waters of palliative care.

MortyLong said...

If insurers continue to enforce the most restrictive formularies, forcing the cheapest and not the most optimal medications on patients, then just how, other than promotion, will doctors and patients have a chance at providing/receiving the most efficacious treatments? Ahhh, the muddy waters of all care, however palliative is NOT the where cuts should be made. We show our animals more humane care. The dying and the sickest of the sick should not be left in agonizing pain without the relief they deserve. Until we resolve these issues, we need to make these choices known and available to patients and doctors in whatever way possible.

Anonymous said...

Unfortunately, regarding the very real problem of chronic pain, it will take more studies and time to determine whether Abstral will be the proper and useful choice for breakthrough pain such mentioned earlier in the instances of severely injured war veterans. The very real issue of overwhelming pain cycles is not only for the dying. I believe in time, this drug's effectiveness could show positive results for other severe and debilitating pain stricken patients, insured or not. Pain is complex and often only understood by the layperson in the context of malignant pain. Time will tell and only someone who has themselves experienced debilitating breakthrough pain that other narcotics don't address, will truly understand the frustration you feel for pain or diseases being prioritized, for lack of a better word.

Anonymous said...

I think I'm more outraged by the fact that drug companies are allowed to take non-novel compounds that cost nothing to make... find a new use for it, get a patent, and charge tens of thousands of dollars per course of treatment.

And I agree that "couponing" and "co-pay assistance" is very gray at best. If the patient paid for everything, then fine, it's a free market.

But when you get 3rd party payors involved, then the incentives get out of whack quickly.

MortyLong said...

I must agree, if we could lower all pricing, ensure patients take the necessary medications without affecting the introduction of new, innovative medications (I can't speak to this class b/c they aren't available w/o other inherent risks, i.e., severe dental decay). That would be the best solution indeed. Problem is, it's pharmaceutical/biotech companies in the United States that bring all drugs to market and other countries are not prohibited by any patent protection. They have the generics at the expense (any I mean that in every sense if the word), of U.S. citizens'/patients whom are often the ones left unable to afford these medications in the end (no pun intended, sadly that's true as well). Eventually this will become more widespread so if we don't resolve this issue now (which seems we should be cost-sharing w/other countries to cover R&D), soon innovation will be irrelevant & we will all find ourselves truly struggling to afford the often staggering costs of many of these medications for someone we know & love, if not just ourselves. There is NO safety net, it's a very misunderstood issue which is much bigger than the drug that started this whole conversation, and much more involved than stock prices.

Anonymous said...

Your article is trash. You say that the drug is legitimate for cancer patients, then turn right around and crucify them for using it.

Abstral contains a Schedule II drug. All Schedule II Drugs are tightly controlled at every step in the distributions process.

The fact that Galena is making the drug available for free for the first month doesn't change the control and reporting requirements for it. A DEA Form 222 is required for each distribution, purchase, or transfer of a Schedule II controlled substance. In addition, pharmacies are required to keep all Schedule II controlled substances locked away in a safe.

"[I note that tobacco companies are not allowed to give free samples of cigarettes - and it is curious that same does not apply here.]"

The fact that the drug is free to the patient, thank God, doesn't change the very controlled environment under which Abstral is distributed. You obviously were incompetent and didn't know the strict control and accounting required of Schedule II drugs when you wrote this piece of garbage.

Here, read up:
http://www.in.gov/pla/files/DEA_Pharmacist_Manual.pdf

Don Petty
Wichita Falls, TX

Lawmed said...

One need go no further than the first few paragraphs of this empty-headed article to know it is complete nonsense:

"I think I have found a new low in the pharmaceutical industry: giving away a month's free supply of potentially lethal high-grade opiods.

This ambitious marketing strategy allows more than enough time and supply to create addicts.

The company is Galena Biopharma and their product, under the marketing name of Abstral is sublingual Fentanyl.

Fentanyl according to Wikipedia is a potent, synthetic opioid analgesic with a rapid onset and short duration of action. In other words you get really high, really fast and it doesn't last long. Also according to Wikipedia it is "one of a small number of drugs that may be especially harmful, and in some cases fatal, with just one dose"."

The patients who receive this drug, free or paid for, are nearly all ALREADY addicted to opiates. The indications for its use make this a near certainty. You yourself then go on to acknowledge this:

"Fentanyl has a legitimate use - for intense "breakthrough" pain spasms for someone already being treated around the clock with a heavy opiod like morphine. The legitimate user is probably a terminal cancer patient with bursts of pain so intense that morphine just doesn't cut it. In that case the seriously addicting properties of the drug are not particularly relevant and the benefit of use is indisputable.

Outside that it is hard to think of a good use for this drug."

But you then inexplicably spend the rest of the article arguing complete nonsense about illicit street use of the drug and how "evil" the whole thing is because the drug is fast acting.

You seem to imagine that "free sample" means the company will hand out Abstral to anyone who wants it and that a free sample is somehow easier to obtain than a prescription for the drug. You are either unaware or do not care that both federal and state laws require free sample scheduled drugs to be inventoried and accounted for just like those which are bought and paid for. Free samples must be given to patients by their physician, same as prescriptions for drugs. This is not some secret black market for mood altering substances.

You should also know that this is nothing "new"...there have been plenty of scheduled drugs, that are addictive, that kill in an overdoes, which have been offered as free samples. Giving drugs away for free should be criminalized??? What have YOU been smoking?

And finally, I have yet to be impressed with an article that cites Wikipedia as their primary source of information.

Levi said...

Why the strongly emotive tone of comments? Is markedly different from regular comments -- I do wonder how many were whipped into a frenzy of righteous indignation by whatever page linked them here.

Qualifications: My wife was on fentanyl during labour so therefore I have my own anecdote and my opinion is valid.

Galena Unmasked said...

I would guess that the overly emotive response of comments on this post could be explained by the following article.

http://www.equities.com/editors-desk/stocks/healthcare/galena-biopharma-gale-plummets-on-revelation-of-potential-stock-promotion-scheme

JH could verify by looking at IP addresses, but its very possible that these are actually stock promoters as JH suggested.

MortyLong said...

For the record, I am a private investor, I do not work for ANY company related to Galena, Insys, any PR firms, or companies that hire people to promote/hype or sully the reputation of ANY company. I believe in every company's right to advertise and tout their "brand" and it's done thousands of times each day via pop-up adds, junk mail, product placement on TV/Cable/Movies. Then we have social media but when we enter the realm of pharmaceuticals that the ability to drastically improve the quality of one's life, whether it is beginning or ending, it doesn't sit well with me. Then there is the whole aspect of the potential financial betrayal potentially perpetrated on your loyal main-street investor believing they are investing wisely both ethically and fiscally. If this "collusion" which I began to sense, to short, to inflate, I just don't know as I fight for my life, it's hard for it not to be personal. If the BOD are cashing in at the expense of mine and so many other lives, I don't believe one can get much lower. Mark Ahn, how much money would be enough? You know the cost of your medication, rest easy knowing I can no longer afford mine, nor can the other patients whose families are already strained by catastrophic medical bills. I believe you get what you put into this world, maybe not immediately, but if this was just some game for you to add to your stacks of cash, your time to pay (in every way) is coming. Your silence is DEAFENING, Mr. Ahn, give us the courtesy of a reply as the items my family goes without to afford this drug keeps me up nights. Whether intended for me or someone else, I am invested in GALE, I pray the ship will right itself. However let me be abundantly clear, MY ETHICS NOR MY SOUL ARE FOR SALE (even if I could use the money desperately to buy my Abstral). I am in excruciating pain as I write this so if I've missed any updates, my apologies, it's simply the best I can do under the circumstances.

buyersstrike said...

John,

You should check the IP address records of your commentators, especially Mr. Don Petty.

GALE sock puppets abound.

http://buyersstrike.wordpress.com/2014/02/22/galena-and-the-epsilon-sock-puppets-gale/

Anonymous said...

An Insider's Tale of a Stock Promotion Plan
http://online.barrons.com/article/SB50001424053111904628504579437221467691900.html?mod=rss_barrons_most_emailed_week

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The content contained in this blog represents the opinions of Mr. Hempton. Mr. Hempton may hold either long or short positions in securities of various companies discussed in the blog based upon Mr. Hempton's recommendations. The commentary in this blog in no way constitutes a solicitation of business or investment advice. In fact, it should not be relied upon in making investment decisions, ever. It is intended solely for the entertainment of the reader, and the author.  In particular this blog is not directed for investment purposes at US Persons.