Oxycontin to be pulled from the market in 2012

67 posts / 0 new
Last post
Sineed
Oxycontin to be pulled from the market in 2012

Before we start celebrating, Purdue is replacing it with another oxycodone formulation:

Quote:
Oxycodone is rapidly released when OxyContin tablets are chewed, crushed and then inhaled, injected or swallowed. This results in a heroin-like euphoria, with potentially lethal consequences. OxyNEO tablets are physically much harder than OxyContin, making them more difficult to crush or break. When mixed with water, OxyNEO tablets form a highly viscous (gel-like) matrix, which makes it difficult to extract oxycodone for injection purposes.

In the addiction treatment community, people are placing bets on how soon DIY chemists will crack that one.

http://www.cbc.ca/news/canada/newfoundland-labrador/story/2011/11/07/nl-...

On a pharmacist's site (can't link, behind a firewall; sorry!) there's this:

Quote:
What’s particularly interesting about the release of this new, ‘safer’ product is that OxyContin is just about to come off patent, so the company is positioning itself to avoid having its product deemed interchangeable with lower cost alternatives that will be brought to market once OxyContin loses its exclusive patent.

Pharmacists are such cynics Wink

M. Spector M. Spector's picture

Sineed wrote:

Quote:
What’s particularly interesting about the release of this new, ‘safer’ product is that OxyContin is just about to come off patent, so the company is positioning itself to avoid having its product deemed interchangeable with lower cost alternatives that will be brought to market once OxyContin loses its exclusive patent.

That's the real story here. Good catch, Sineed.

Sineed

Cheers, M. Spector.

The other consequence is that the new drug won't be covered by provincial drug formularies at first. So chronic pain patients on welfare and disability who have been on Oxycontin will be left with the prospect of no drug, or having to pay for an expensive new formulation.

I suspect I will see an uptick in methadone clients.

Sineed

M. Spector wrote:
That's the real story here.

Make no mistake: Purdue has made staggering sums off the massive diversion of Oxycontin. And it's come at a price: Ontario's chief coroner released a report last year which found that oxycodone toxicity deaths in Ontario exceed the number of deaths from HIV/AIDS.

6079_Smith_W

@ Sineed

Do you expect the government would not approve the sale of a generic OxyContin if someone decided to produce one anyway, or that it would not be stocked or prescribed?

 

Sineed

6079_Smith_W wrote:

@ Sineed

Do you expect the government would not approve the sale of a generic OxyContin if someone decided to produce one anyway, or that it would not be stocked or prescribed?

 

Health Canada may approve a generic Oxycontin; however, given the massive negative publicity, health costs and mortality rate deriving from the name brand product, political pressure on expert committees of provincial formularies may compel them to deny coverage (ie for people on welfare and disability, as well as the elderly). There is growing awareness that opioid use is massively higher in Canada and the US than the rest of the world combined. It's becoming increasingly difficult for physicians to justify prescribing oxycodone-containing drugs for long-term use. 

M. Spector M. Spector's picture

Why would a physician prescribe OxyContin in preference to OxyNeo? Wouldn't that border on malpractice?

6079_Smith_W

M. Spector wrote:

Why would a physician prescribe OxyContin in preference to OxyNeo? Wouldn't that border on malpractice?

Though if I get the gist of the article, the difference is not in its therapeutic effect, but the fact that it is more difficult to abuse.

and @ Sineed

Yes, it makes sense that would be where the roadblock would be set up. 

Sineed

M. Spector wrote:

Why would a physician prescribe OxyContin in preference to OxyNeo? Wouldn't that border on malpractice?

What 6079 Smith said; also, Oxycontin and OxyNeo (the oxycodone is in a gel matrix - geddit?) won't exist at the same time. Though it's true some enterprising manufacturer, looking to corner the long-term pain/diversion market, might make a generic to Oxycontin, since the brand name will cease to exist.

M. Spector M. Spector's picture

If the active ingredient is the same, why would a physician prescribe a version that is easier to abuse? Surely there are ethical considerations here.

And I realize that OxyNeo would replace OxyContin; what I assumed was the scenario posited by 6079 when he suggested there could be a generic version of OxyContin coexisting alongside of OxyNeo. I thought that if physicians were unlikely to prescribe the more easily abused version, then generic drug makers would be discouraged from trying to market it.

My post #6 was in response to post #4, not post #5. Sorry if I confused.

 

6079_Smith_W

@ M. Spector

Yes, that is what I meant, and think we both have the same question about it - I just don't think it falls under malpractice. 

Of course it is a complicated issue, because how much of the process would be driven by legitimate public safety and harm reduction, and how much by profit and control?

It is impossible to say, because the first point is a perfect ulterior motive.

 

Sineed

It's cogent points you're both making. Regulatory bodies don't always make decisions based on optimal therapeutics. And there would be huge financial incentive for somebody to make a generic version of the original Oxycontin.

 

M. Spector M. Spector's picture

Sineed wrote:

And there would be huge financial incentive for somebody to make a generic version of the original Oxycontin.

But only if doctors were willing to prescribe it (which was my point), since it wouldn't be available over the counter as a generic. It's always been my understanding that most medical licensing/regulatory bodies have guidelines for the prescription of narcotics and other controlled drugs, precisely because of concerns about drug abuse by patients. Following the guidelines becomes a recognized standard of care for the medical profession; doctors who ignore those guidelines can get in trouble. Hence my above reference to malpractice.

Tommy_Paine

Here in London, due to previous problems, doctors are under such scrutiny now that many have stopped prescribing oxycontin altogether. 

Sineed

Tommy_Paine wrote:

Here in London, due to previous problems, doctors are under such scrutiny now that many have stopped prescribing oxycontin altogether. 

That's good news, Tommy. There's all those people with orthopedic injuries who could have been managed with short-term painkillers after the initial injury, and perhaps physiotherapy thereafter, who instead have been turned into chronic "pain patients," prescribed long-term Oxycontin. A shortcoming in our healthcare system is the preferential reimbursement for doctors who see lots of patients in a short time and prescribe lots of drugs while reimbursement for physiotherapy was limited. And Purdue stepped in that gap and made millions. Many have died, and thousands have been turned into opioid addicts.

Great article in the National Post today about the dubious ethics of the marketing of Oxycontin:

http://news.nationalpost.com/2011/11/12/the-selling-of-oxycontin/

Quote:
It was a pleasant, informative break from the grind for a crowd of local doctors: lunch and a series of lectures at Vancouver’s chic Four Seasons Hotel, all presented free by Purdue Pharma, which had just rolled out a new pain drug called OxyContin.

The specialists Purdue paid to speak at the 1997 forum, including Toronto’s Dr. Brian Goldman, who now hosts a popular CBC-Radio show, encouraged doctors to overcome fear of such “opioid” medicines and consider them even for patients with chronic non-cancer pain.

 

Similar, Purdue-sponsored talks were held across the country in the following months and years, while sales reps fanned out to visit family doctors and others, promoting the drug’s continuous-release convenience and its supposedly low potential for abuse...

Sineed

Government coverage to be terminated for oxycodone-containing products

http://www.theglobeandmail.com/news/national/provinces-clamp-down-on-oxy...

Quote:
Ontario confirmed Friday that, starting at the end of the month, OxyContin – and its replacement, OxyNEO – will no longer be covered under the province’s general benefits plan...Other provinces are making similar moves. Prince Edward Island, which already had special criteria for OxyContin prescriptions, has no plans to pay for new OxyNEO prescriptions. Manitoba only pays for OxyContin in exceptional circumstances and, along with British Columbia, has yet to make a decision on whether to pay for the drug’s replacement. Saskatchewan will make a decision on paying for the new drug as early as next week.

Awesome news! Though I anticipate an uptick in demand for methadone maintenance treatment in the next couple of weeks.

I was chatting with an addiction medicine dr who opined that if folks can't get Oxycontin, they'll go back to heroin. This may be true in the cities, but Oxycontin's status as a legitimate pharmaceutical meant that it had market penetration into remote areas, ie northern reserves, such as you didn't see with heroin. Late last year, I travelled to Thunder Bay, attended a couple of methadone clinics, and spoke with methadone patients there, mostly natives, and I asked about the availability of drugs of abuse where they come from. It was Oxycontin all the way.

I'm concerned about the lack of availability of treatment for people in northern areas. Here in Toronto, addiction medicine clinics will be able to absorb extra patients with some hassle, but in the north, the options are much more sparse. Withdrawal from opioids isn't physically dangerous, but it does put people at risk of suicide. Pregnant women going through withdrawal are at risk of miscarriage.

They need to make treatment options available. There aren't going to be more methadone clinics opening up north in the next couple of weeks, but what they could do is liberalize the coverage of Suboxone, a drug that treats opioid addiction, and is safer than methadone and easier to prescribe.

Just some random thoughts...

M. Spector M. Spector's picture

[url=http://www.cbc.ca/news/canada/story/2012/02/17/oxycontin-warning-first-n... OxyContin health crisis[/url]

Quote:
An Ontario First Nations leader says a catastrophe is looming with the decision to stop manufacturing the drug OxyContin.

Nishnawbe Aski Nation Chief Stan Beardy says thousands of residents of Ontario reserves are addicted to the drug, which is up to twice as strong as morphine. The organization, which represents 49 First Nation communities in northern Ontario, estimates close to half its members are addicted to OxyContin....

Beardy says addicts will go into withdrawal, and that scares him.

Benedikt Fischer of the Centre for Applied Mental Health and Addictions at B.C.'s Simon Fraser University says there will be a lot of sick people.

He says without treatment to help deal with the addiction, a public-health catastrophe is imminent.

Dr. David Juurlink, an internist and head of the division of clinical pharmacology and toxicology at Sunnybrook Health Sciences Centre in Toronto, said there are two ways to abuse long-acting opioids such as OxyContin....

For chronic OxyContin users to stop, they will either have to replace it with something else or go into withdrawal, Juurlink said.

"That will be quite a miserable and prolonged illness," he told CBC News.

Withdrawal affects people differently, but it typically lasts for several days, Juurlink said.

"It's horrible. Imagine the worst flu you have ever had multiplied by 20," he said. "Severe nausea and vomiting and diarrhea and disabling abdominal pain are just part of the symptoms these patients go through...."

Dr. Claudette Chase, a family doctor who works on the Eeabmatoong First Nation in northern Ontario, said that without additional support to help with an imminent rise in patients suffering from OxyContin withdrawal, an already desperate situation will get out of control.

Chase predicts potentially upwards of 9,000 people will be withdrawing, while an already overworked medical staff in the north struggles to keep up....

Health Canada said there is support available through the NIHB program for those dealing with withdrawal issues. The program provides coverage for methadone and suboxone, which are drugs that are used for the treatment of opioid withdrawal, it said. Methadone is available and reimbursed under the program with no, or minimal, restriction. Suboxone is available for those who cannot take methadone due to conflicting medical conditions.

However, Health Canada said it recognized that limited access to methadone, particularly in remote communities, could be a problem.

"In such instances, the NIHB Program reviews requests from health providers on a case-by-case basis and will provide coverage for suboxone to help ensure First Nations clients have access to this drug without leaving their community," it said.

Sineed

Yes. In remote areas, there will be a surge in demand for methadone or Suboxone that will greatly exceed capacity. My prediction: physicians will be faced with hoards of angry miserable sick people and will prescribe morphine instead, which is still covered. After all, the reason some physicians prescribed Oxycontin in the first place is it's the easiest quickest way to get somebody out of your office. So morphine will replace Oxycontin up north.

M. Spector M. Spector's picture

[url=http://apihtawikosisan.com/?p=1237]From emergency to catastrophe. Lack of addictions programming a national shame.[/url]

Sineed

A point made in M. Spector's link:

Quote:
How withdrawing OxyContin from the Drug Benefit List will in any way address abuse is unclear.

Not to those of us who work in addiction treatment. The major source of Oxycontin is legal prescriptions written to patients receiving government-funded drug benefit programs who resell their pills. And Oxycontin, being a legal pharmaceutical, achieved market penetration into remote parts of the country where heroin did not go. So it created addicts who may not have otherwise become addicted. 

I was discussing this topic with some of my methadone patients on Monday, and other than sharing how they might crack the new OxyNeo to get the drug out of the matrix (I'll not share those thoughts here), one of them said that Oxycontin gets people into trouble quickly. "You do it three days in a row, and you want to keep doing it," he said.

M. Spector M. Spector's picture

Sineed wrote:

And Oxycontin, being a legal pharmaceutical, achieved market penetration into remote parts of the country where heroin did not go. So it created addicts who may not have otherwise become addicted.

And now, as you note above, morphine will replace it up north. Is this progress?

 

 

Sineed

M Spector wrote:
And now, as you note above, morphine will replace it up north. Is this progress?

I'm predicting that morphine will replace Oxys in the short-term to deal with all the Oxycontin addicts cut off their drug of choice. But in the longer-term I believe reducing access to Oxycontin will reduce the number of people diagnosed with opioid dependance disorder. Our experience in the past decade or so suggest strongly that Oxycontin has more of an abuse potential than morphine. After all, morphine has been around for decades and is available without restriction on all drug plans.

The Oxycontin abuse problem in North America represents the intersection of several problems: the propensity for abusing opioids in Canada in the US - we use more opioids than the rest of the world combined. Also, there's the way doctors are compensated, which encourages the proliferation of "pill mills," or these lucrative so-called "pain clinics" where they write tons of prescriptions instead of taking the time with patients to see if they can get at the root cause of their pain. A doctor told me yesterday that if you do an MRI on people's spines, just about everybody will have some sort of abnormality. If a patient is claiming pain, and there's an abnormal MRI, there's a diagnostic tendency to attribute the pain to those abnormalities. And there's limited coverage of non-drug treatments for chronic pain.

Michelle

I'm learning so much from this thread - it's great to have Sineed here, and I'm enjoying your posts too, M. Spector.  Reading that article where they estimate that half the residents of northern First Nations communities have been turned into oxycontin addicts due to physicians over-prescribing it - it's shocking.  I had no idea.

I noticed that in that same article, it said above that Oxycontin is twice as strong and addictive as morphine.  I have no idea whether that means it would be progress for morphine becoming the drug of choice - I'm kind of horrified that doctors prescribe oxycontin just to get patients out of their offices and that this could just change to morphine instead.  Seems to me that going after doctors who do this could be the best deterrent to addiction issues.  That, and, of course, a huge increase in methadone programs to deal with the havoc that has been created.

I have had chronic back pain since falling down a flight of stairs about two and a half years ago.  The acute pain felt quite severe to me during the first few months after the fall, and then it started leveling off to a duller chronic pain.  Eventually the pain mostly went away, but I have never been back to normal and have never been able to walk long distances since without developing acute pain. I was initially controlling the acute pain after the fall with extra strength ibuprofen gelcaps.  (I take the same thing for migraines when I get them.)  Luckily, they were sufficient to control the pain.

With the ibuprofen, I was extremely careful about the dosage and timing and followed the bottle directions religiously, because I have known people who have increased dosages beyond the directions and built resistances.  That, and I have an aversion to taking pills anyhow and find it hard to remember to take medications on schedule.  But even though I was very careful of the dosage, I found that if I took the dosage on the pill bottle, it gave me side effects such as stomach cramps and digestion issues.  So I found those side effects to be a strong deterrent to taking painkillers, and even now, I have a real aversion to taking painkillers and will only take them if the pain is really bad. 

Over the past month, my lower back pain has been recurring, and I'm not sure what has triggered it.  I haven't taken anything for it yet, but I might need some sort of solution soon.  Reading about the way oxycontin is prescribed for pain by doctors with revolving doors, I'm realizing how lucky I am that my doctor didn't control my pain by prescribing that to me.  I didn't know anything about oxycontin before reading this thread other than simply recognizing the word, and I'm really glad to be better informed about this, in case I run into any doctors in the future who want to try to control my pain with such a drug.

M. Spector M. Spector's picture

If the oxycontin addiction problem is in large part a function of medical carelessness, I'm not at all sanguine about the prospects for treating the addiction problem with methadone (which is not per se addictive), much less with morphine (which is addictive), without a major change in the way physician care is delivered. A methadone treatment plan is long-term and requires careful and intensive monitoring, as far as I understand it. I'm not sure that the same physicians who have been pushing Oxy on their patients to get them out the door are going to be very effective in weaning their patients off opioids.

I think that without a big increase in addiction treatment specialists in the north the native populations are going to suffer greatly, both medically and socially, in the near future.

Michelle

I agree that huge resources poured into increased addiction treatment is what is going to have to happen.  You're absolutely right.  And just like housing and clean water, there will likely be nothing of the sort.  It's much easier to send doctors up there who get half the residents addicted.

Sineed

There's already been a death when a physician switched a man from Oxycontin to another opioid. And dwindling stocks of Oxycontin in Toronto are making retail pharmacists very nervous. On the upside, referrals to methadone clinics are up, and Ontario Drug Benefit is revisiting the coverage of Suboxone, that treatment for Oxycontin addiction that currently isn't covered.

And yeah, Michelle; part of the problem here is the lack of coverage for non-drug treatments for back pain. Back pain is practically normal in folks over 30; a few years ago, I went for physiotherapy for chronic mid-back pain that now seems to stay at bay if I do yoga and core strengthening exercises, and I've had to pay for these myself.

M. Spector, you make good points about methadone. Currently it can only be prescribed by doctors who have received special training in methadone maintenance. I've been dispensing methadone for a number of years and it's a very protracted process to get off it; people lose patience. I'd like to see coverage of Suboxone, as it's safer than methadone and easier to kick.

Sineed

Methadone requests spike after Oxycontin delisting

http://www.cbc.ca/news/canada/toronto/story/2012/03/07/toronto-oxycontin...

Quote:
Toronto Public Health says demand for referrals to methadone clinics in the city has tripled in the last week, after the prescription painkiller OxyContin was discontinued.

"Normally, we would see maybe five or six people coming in in a week asking for methadone treatment, and now we're seeing about three times that number," said Dr. Rita Shahin, an associate medical officer of health.

Today I contacted a couple of folks in Thunder Bay, who said they've seen a spike in new methadone clients, though not as much as they expected thus far. Possibly the calm before the storm, once all the Oxycontin runs out...

Tommy_Paine

There's been a lot said about northern communities, but I wonder how many politicians and notables will suddenly be dissapearing for three months.  Or how many are currently scrambling for discrete methadone therapy.

Oxy has infiltrated all walks of life, and the end of the oxy era is going to be interesting in the unfortunate sense of the word.

I know that a few years ago, the Ontario government got a settlement from Perdue, similar to the one the U.S. government got in the States, likely because if they didn't, Perdue would have been investigated fully for racketeering or treated as any other drug gang.

A good question to an M.P.P. or our Health Minister, Deb Mathews might be what happened to that money, and how was it directed to re-hab clinics.

 

Tommy_Paine

http://www.volunteertv.com/health/headlines/7447871.html

"Purdue Pharma L.P., its president, top lawyer and former chief medical officer will pay $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications, U.S. Attorney John Brownlee said in a news release."

Hmm. I can't find any story, but I'm pretty sure that at about the same time as this story, Perdue agreed to pay a small sum to the Ontario government also.

If anyone with better search skills than mine can find it, I'd really appreciate it.

If nothing else, googling Perdue and Ontario government shows how deep their claws are into us.

Scary shit. 

Sineed

Well, there's still the OxyNeo, that isn't covered by public drug plans, but probably is affordable by the notables and/or is covered by private drug plans.

I found this story, about a class action lawsuit filed against Purdue in Canada in 2007. The comments are heartrending.

And this:

Quote:
The nature and scope of of Purdue Pharma's deceit in the marketing of OxyContin became publicly known only in May 2007, when the company and three of its current and former executives - Michael Friedman, Howard Udell and Paul Goldenheim, MD pleaded guilty in Federal Court in Virginia to criminal charges that it had misled doctors and patients when it claimed the drug was less likely to be addictive or abused than traditional narcotics. Before the guilty plea agreement with U.S. Attorney John Brownlee, Purdue Pharma had successfully covered up its misdeeds and obtained dismissal of over a thousand OxyContin related lawsuits in the United States.

http://www.salem-news.com/articles/december122010/oxycontin-canada-ms.php

And here's a class action lawsuit against Purdue filed in Toronto on July 25, 2011:

http://www.wagners.co/docs/20110725_letter.pdf

The entire motion of record is here, but it's a fat file.

http://www.wagners.co/docs/20110725_motionrecordv2.pdf

At this site, they list numerous lawsuits against Purdue in various provinces:

http://www.monrecourscollectif.ca/2275/#.T1fk0xwZ5oY

Reese_Whiterspoon Reese_Whiterspoon's picture

About Time. 

~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~-.~

The views expressed here are not part of any group or organization.

 

Black Power

 

Sineed

Thus far, there's been a moderate uptick in referrals to methadone clinics both in Toronto and Thunder Bay, but not as much as we expected. 

About the OxyNEO, here's an excerpt from an email from someone working in Toronto Public Health:

Quote:
Though OxyNEO is said to be more difficult to abuse, clients can still take large amounts of the tablets orally. There are also several side effects and warnings in using the drug. In particular, clients are warned to take only one tablet at a time, and not to wet or lick the tablets prior to putting them in their mouth as thick gel forms when wet. Incidents of choking and gagging have been reported.

I'm not surprised by this. The main change is the lack of coverage of OxyNEO by Ontario Drug Benefit, so people on welfare, Ontario Works, and ODSP (disability) won't get it paid for.

From an email from an activist in the addictions community:

Quote:
Discrimination

  • working ontarians will retain full access to the new drug, oxyneo
  • Welfare ontarians won't retain full access to oxyneo and will have to apply under stringent conditions for an exception under a very narrow scope.

M. Spector M. Spector's picture

CBC's The Fifth Estate did a show on Oxycontin this week. Canadians can view it online [url=http://www.cbc.ca/fifth/2011-2012/timebomb/]HERE.[/url]

Boom Boom Boom Boom's picture

Thread drift: Libby Davies is on CBC in a minute to talk about drug shortages from Sandoz which controls 90% of the injection drugs in Canada.

ETA: That was a longer interview with Libby than I expected - here's what I can remember:

1. The NDP have an Opposition Day tomorrow and are filing a motion calling on the Cons to get involved in this file.

2. She syas the Health Minister is playing the game of blaming everyone except her own government where clearly most of the blame lies.

3. She is calling for bulk buying of medications - like Harper is doing with the F35s Laughing - because bulk buying is cheaper and ensures a guaranteed supply.

4. She is calling for more generics to be made available - doctors are reluctant to prescribe generics because the available supply runs out too quickly.

5. She calls for an end to 'voluntary' practices - such as voluntary reporting of coming shortages in pharmaceuticals.

There was more and I will add to this post as I recall them.

Libby is an amazing health critic and is clearly on top of this file - the same can't be said for the health minister.

M. Spector M. Spector's picture

Too bad she won't call for nationalization of the pharmaceutical industry. Then we could produce the drugs that are most necessary, rather than the ones that are the most profitable.

Boom Boom Boom Boom's picture

That sounds like a great idea, MS. Has anyone in Canadian politics today called for nationalization of the drug industry?

 

(I don't think Martin Singh will be here for a Q&A, but I'll ask him in the other thread if he supports nationalization, as he is a pharmacist after all)

Boom Boom Boom Boom's picture

I must admit I'm quite stunned to learn from Libby that Sandoz has a 90% monopoly on injectable drugs in this country (including morphine derivatives) - how the hell did that happen?

M. Spector M. Spector's picture

It happened because of lack of government regulation and oversight of the industry. We are left entirely dependent on the whims of multinational drug companies for our supplies. If it isn't profitable they cut back production and we suffer. If it's super-profitable, it will be pushed hard through physicians and advertising, and everyone will end up on Viagra, Oxycontin, Lorazepam, etc.

Boom Boom Boom Boom's picture

That's good argument for nationalization, MS.

M. Spector M. Spector's picture

Shhh! don't say stuff like that too loud around here. You'll be deluged with right-wing social-democrats who insist that nationalization will bankrupt the country and that publicly-owned enterprises will fail unless they act exactly like privately-owned ones.

Sineed

Kudos to Dr. Brian Goldman for coming clean about his role as a shill for Purdue, yesterday in the Globe:

http://www.theglobeandmail.com/news/opinions/opinion/i-was-part-of-big-p...

Quote:
I have watched with great dismay the rising tide of prescription drug abuse in general, and OxyContin in particular.

In recent years, I’ve seen doctors overprescribe opioids to patients without screening or monitoring them for addiction. I’ve seen doctors prescribe powerful narcotics in assembly-line fashion at walk-in clinics.

I no longer believe it to be possible for educational courses paid for by drug companies to be free of corporate bias. But the practice of recruiting and paying doctors to give company-sponsored talks is alive and well – and the practice doesn’t end with opioid pain relievers. Blood-pressure pills, diabetes meds and cholesterol-lowering drugs are just some of the remedies for which doctors are recruited to influence their colleagues.

Part of the trouble here is the fee-for-service model that rewards doctors for writing scripts and seeing high numbers of patients, and punishes those doctors who spend more time with patients, finding a way to treat the cause of the pain instead of drugging them.

BTW, one of the reasons for the drug shortage at Sandoz is the FDA inspected one of their plants and found it didn't comply with American standards, so they halted production to spruce things up. I don't think nationalization of big pharma would have helped in this instance.

 

Michelle

Apparently there have been a rash of robberies on pharmacies due to the discontinuation of OxyContin - just saw it on the news today.  Made me think of this thread where you were saying that retail pharmacists are getting antsy - no wonder!

M. Spector M. Spector's picture

Sineed wrote:

BTW, one of the reasons for the drug shortage at Sandoz is the FDA inspected one of their plants and found it didn't comply with American standards, so they halted production to spruce things up. I don't think nationalization of big pharma would have helped in this instance.

I like to think that a nationalized drug company would comply as a matter of course with federal regulations and standards. After all, once you remove the profit motive as Job #1, you can make a priority of health, safety, and quality control standards.

 

Sineed

Michelle wrote:

Apparently there have been a rash of robberies on pharmacies due to the discontinuation of OxyContin - just saw it on the news today.  Made me think of this thread where you were saying that retail pharmacists are getting antsy - no wonder!

Word is that the price of Oxycontin is soaring as supplies dwindle.

Oddly, we haven't seen a big jump in methadone clients, regardless of what Toronto Public Health said. Some people have been asking me about Suboxone, but those are folks already on methadone. Turns out that Ontario Drug Benefit is "grandfathering" Oxycontin patients for one month, covering OxyNeo and giving these folks the time to get onto another drug that is covered.

M. Spector wrote:
I like to think that a nationalized drug company would comply as a matter of course with federal regulations and standards.

The federal regulations and standards of a foreign country? We answer to Health Canada, not the FDA.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm281843.htm

Quote:

WARNING LETTER

Public Health Service
Food and Drug Administration Silver Spring MD

The August 2011 inspection also revealed that Sandoz Canada Inc. failed to submit NDA Field Alert Reports (FARs) to FDA in compliance with 21 CFR § 314.81(b)(1)(ii), as required by section 505(k) of the Act [21 U.S.C. § 355(k)].

 

 

 

6079_Smith_W

M. Spector wrote:

Shhh! don't say stuff like that too loud around here. You'll be deluged with right-wing social-democrats who insist that nationalization will bankrupt the country and that publicly-owned enterprises will fail unless they act exactly like privately-owned ones.

Hey..  I knew I was forgetting something. Thanks Spector!

 

M. Spector M. Spector's picture

Sineed wrote:

M. Spector wrote:
I like to think that a nationalized drug company would comply as a matter of course with federal regulations and standards.

The federal regulations and standards of a foreign country? We answer to Health Canada, not the FDA.

Well, you are the one who said nationalization would not have helped in this instance because Sandoz didn't comply with FDA standards. If Sandoz Canada were a nationalized pharma company, it would be subject to Canadian regulations, not the American FDA.

And doesn't Health Canada have comparable standards to the FDA anyway?

Sineed

M. Spector wrote:
. If Sandoz Canada were a nationalized pharma company, it would be subject to Canadian regulations, not the American FDA.

If the US wants to send the FDA into Canadian manufacturing plants, I don't think they care whether they are nationalized or not. The head office of Sandoz is in Switzerland. Drug manufacturing plants adhere to the standards of the company they are in, regardless of where the central office is - that's why some American companies have moved plants off shore, to take advantage of less rigorous health and safety standards, for instance.

FDA standards would be similar to Health Canada standards. But I don't think nationalizing drug companies ensures their compliance with standards. Speaking as a civil servant, nationalizing doesn't automatically result in better oversight.

M. Spector wrote:
After all, once you remove the profit motive as Job #1, you can make a priority of health, safety, and quality control standards.

You'd hope so. But after 17 years of working in the public sector, I'd say people are equally capable of incompetence whoever the bosses are. In my experience, removing the profit motive is most consistent with keeping costs down, but ensuring quality is dodgier.

M. Spector M. Spector's picture

Sineed wrote:

M. Spector wrote:
If Sandoz Canada were a nationalized pharma company, it would be subject to Canadian regulations, not the American FDA.

If the US wants to send the FDA into Canadian manufacturing plants, I don't think they care whether they are nationalized or not. The head office of Sandoz is in Switzerland. Drug manufacturing plants adhere to the standards of the company they are in, regardless of where the central office is - that's why some American companies have moved plants off shore, to take advantage of less rigorous health and safety standards, for instance.

What you seem to have trouble acknowledging is that a nationalized Canadian drug company would not have a head office in Switzerland, the USA, or anywhere other than Canada. It would be solely governed by Canadian laws, as a 100% Canadian company.

Have you already forgotten what you posted above? "The federal regulations and standards of a foreign country? We answer to Health Canada, not the FDA."

Sineed wrote:
In my experience, removing the profit motive is most consistent with keeping costs down, but ensuring quality is dodgier.

My point was that the profit motive is often the cause of cutting corners, which reduces quality, safety, and compliance with regulatory standards. Removing it removes one of the main motivations for disregarding those things.

 

6079_Smith_W

Whether we are talking about government ownership, or just stronger government regulations, standards can still be disregarded. 

Harper was able to override our nuclear regulatory standards with the stroke of a pen.

And there is no way one central agency is going to be able to produce all the health care products which are currently available. Furthermore, there will always be a need for some imports. 

Sineed

M. Spector wrote:
What you seem to have trouble acknowledging is that a nationalized Canadian drug company would not have a head office in Switzerland, the USA, or anywhere other than Canada. It would be solely governed by Canadian laws, as a 100% Canadian company.

 

Have you already forgotten what you posted above? "The federal regulations and standards of a foreign country? We answer to Health Canada, not the FDA."

The FDA is inspecting plants in Canada because it's a requirement to sell drugs in the American market. The ownership of the plant/location of its central office has no bearing.

OTOH, I can see a scenario where a nationalized manufacturer would be inspected by Health Canada, with an agreement with the FDA that they would respect our inspection infrastructure to the extent that they wouldn't need to re-inspect...

6079SmithW wrote:
Whether we are talking about government ownership, or just stronger government regulations, standards can still be disregarded.

 

The massive diversion of Oxycontin occured despite our single-payor health care system and the oversight provincial governments have over this system. (Just dragging things back o/t Smile)

Sineed

So it's been almost two months since the discontinuation of Oxycontin, and the results so far have been the opposite of what I expected: I've got the fewest number of patients on methadone since 1999. Talking to a methadone patient today, he said, some people are going to heroin or other opioids, but "They aren't the same as Oxycontin. So people are kicking."

I remain cautiously optimistic.

 

Pages