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December 6, 2012

Pharma Shrugs

The Scientist;

Drugmakers are currently in survival mode as patents on existing blockbuster drugs expire, forcing Big Pharma companies to parachute off the proverbial patent cliff. This legal escarpment means the end of patent protection on various blockbuster drug products, opening the market to generic substitutes. What makes the current timing so interesting is the large quantity of hugely profitable drugs whose patents have expired in the last few years or will expire soon. Over the past few years, the patents have expired for Enbrel, Zyprexa, Plavix, Arimidex, and Lipitor. This year, Seroquel, Actos, Singulair, and Lexapro have gone or will go off patent. In the coming two years, drugs including Oxycontin, Cymbalta and Nexium will expire. With the loss of patent protection on so many blockbuster drugs, Big Pharma’s financial outlook is unsteady.

Oh, boo hoo! More cheap generics!

Posted by Kate at December 6, 2012 12:53 PM
Comments

I applaud and thank big pharmaceutical companies for the many advances they've made. They've brought about significant improvements in our quality of life. I do not begrudge their profits one bit, and I hope they find ways to make even fatter profits in the future.

And I thank them even more when their technologies are finally released into the public domain.

Posted by: rabbit at December 6, 2012 2:26 PM

Yeah well,........

Big Pharma seems to have found that their previous solutions to patent expiry...namely chnaging the formulation slightly and introducing the result as a new drug....has failed because generics of the original are on the market.

The problem with generics is their predominently 3rd world sources....for example, there have been instances of generics having ground glass in them.

Posted by: sasquatch at December 6, 2012 2:33 PM

Sasquatch:

Depends on what you mean by "fail".

They are intended, I presume, to squeeze some extra profits out of a drug rather than extend the original profitability of the drug indefinitely.

And they likely often succeed in that.

Posted by: rabbit at December 6, 2012 2:46 PM

What? No mention of V i@gr@ going off patent?

Gives new meaning to "Rise up!"

Posted by: KevinB at December 6, 2012 3:07 PM

Generics are not the same as the brands either. I have to have brand Singulair. The generic dropped my blood pressure 20 to 30 points. It was pretty scary. I don't know what "filler" they used but it wasn't good for me

Posted by: Another Kate at December 6, 2012 4:14 PM

Big Bacterium is paying CLOSE attention to the prospective downfall of Big Pharma! One can only await a huge rush of Schadenfreude
as more and more people die because their greed and stupidity have shut down the search for new antibiotics.

Posted by: John Lewis at December 6, 2012 4:17 PM

Yes! Coming SOON to your neighbourhood! The untreatable infection!

Posted by: John Lewis at December 6, 2012 4:19 PM

KevinB @ 3:07, I saw an ad in the National Post this morning that mentioned something about a price reduction to compete with generics. ;-)

Posted by: Ken (Kulak) at December 6, 2012 5:46 PM

http://commonground.ca/2012/01/prescription-drug-deaths/

Posted by: Kevin at December 6, 2012 5:47 PM

This is seriously scary. Anyone with a knowledge of chemistry can copy a drug, but it takes a well-funded research lab with top-shelf talent such as the big pharma companies have to design and test new drugs. There are a number of nasty bacterium such as C. Difficile, gonorrhoea, etc out there that are immune or becoming immune to the standard antibiotics. If big pharma can't fund those research labs due to reduced profits it will cost lives.

Posted by: Al_in_Ottawa at December 6, 2012 6:20 PM

That article has outdated information .... some of those drugs listed as comming off patent protection in the next few years .... already are off the patent price fix.

Nexium is being replaced by a generic on prescriptions as if this fall. Over the counter price on the generic is only 15% less than the brand.

I'm pretty sure that AstraZenica can afford to cut their wholesale price enough for pharmacies to match that.

Posted by: OMMAG at December 6, 2012 6:21 PM

OMG you can't have profits. It should be government's job to pay for the billions in research and development, just like solar power.

btw, an excellent segue is the latest aboriginal rant that the government shouldn't allow a generic Oxycontin on the market as First Nations have a problem with it's addiction already. Some chiefs have called it "an insult to our Nation" although I don't think Deputy Grand Chief Alvin Fiddler meant a nation as in Canada.

Posted by: Texas Canuck at December 6, 2012 7:16 PM

Texas Canuck, just out of curiosity, does Deputy Grand Chief Fiddler also think we should ban alcohol because his 'nation' has a problem with it?

Posted by: Al_in_Ottawa at December 6, 2012 7:49 PM

Oh I think things are not as bleak as one imagines. Pharmaceutical companies brought forth a whole slew of new drugs 15-20 years ago as new understanding of biology and receptors were discovered.

Now we have genomic medicine and other advances which will bring about another new boom. We are just in the interregnum.
http://www.pharmalot.com/2012/11/crystal-balls-says-been-down-so-long-looks-like-up/

Having said that, Big Pharma became corporatized and as a result lost its mission, resulting in deceptive marketing, even criminal activity and 6 billion dollars in fines paid so far in the US in 2012. They need to get rid of the lawyers and masters of the universe MBAs running pharma and get back to the science and their mission of saving lives IMHO.

Al_in_Ottawa. You do not know of what you speak. It is relatively easy to copy a chemical. It is not that easy to make a pharmaceutically pure drug product which meets good manufacturing practices and are consistent batch to batch within strict limits. Witness the fungal meningitis outbreak in the US.

Posted by: Valencia at December 6, 2012 8:13 PM

John Lewis, as I see it, the issue of drugs to treat infections was lost when the government violated the Cipro patent in 2003 to stockpile against the anthrax scare (which never materialized.) Is antibiotic research even a viable investment any longer?

Posted by: Regina Chick at December 6, 2012 8:29 PM

The Pharma companies get no sympathy from me. They have abused their patents.

No issues with recovering research costs, or with making a profit, but there is absolutely no way the pill I take cost $3 each.

Similarly, take a look at glaucoma medication: 0.5 cc of a solution which contains 0.004% active ingredients (yes, four one thousandths of one percent) -- about 125 micro-grams, costs $90.

But a similar solution, exactly the same ingredients, used for cosmetic purposes costs 10x less.

The cosmetic version is sold that uch cheaper because it would not sell at $180/cc, but if your vision depends on it ...

Posted by: Philip at December 6, 2012 8:46 PM

Everyone can relax. A rosy financial outlook for the pharmaceutical sector is ensured by simple demographics. Given the disease burden related to overtreatment , particularly with the elderly, and given that associated costs have run government debt and deficits to the brink of doom, folks should be getting down on their hands and knees and thanking God every time a drug goes generic. Those of you who think you are defending free enterprise here; that age has long past us. I remember a few years ago sitting in my accountants office, picking up a copy of the erstwhile Alberta Report, and reading a special section detailing the major donors for the election campain for every MLA in the province. You'd think energy, right? Nope. Virtually every one was a pharmaceutical. Why? Well today a sbustantail minority of the provinces children (and a substantial majority of children we would consider disadvantaged) are now on psychiatric medications we should assume may well significantly alter brain development (no one has ever bothered to check). Profits are in the billions and many of these kids will unfortunately be customers for life. How the political connection helped this along is too large a story for here. My point, I guess, is that pharma will be OK and that for the most part there is no more "free enterprise" to defend. Big government and big busines, left right or center, are a single symbiotic entity.

Posted by: Wes at December 6, 2012 8:55 PM

Wes has a pretty good point about big pharma buying themselves governments. When Mulroney went to the private sector looking for campaign contributions to support the "Yes" side of the Charlottetown Accord, by far the biggest donors was big pharma. They all chipped in many millions, over $50 million in total among them.

Charlottetown may have been defeated, but big pharma was owed. As a result, Benoit Bouchard delivered the legislation that gave a very large extension to patent protection.

It should also be remembered that back in the early '90s, most of big pharma was in Quebec, while most of the generics was in Ontario.

A double win for Quebec PCs.

Posted by: cgh at December 6, 2012 9:47 PM

Ask Daryl Katz....300,000 to the PC party of Alberta...your drug money at work.

Posted by: funnymoney at December 6, 2012 9:47 PM

Does anyone else remember how it was that aspirin was approved as a "quick heal" for heart attacks? The approvals process was so long and the cost so high that no company would seek to get approval because there was no profit in it BECAUSE THERE WAS NO PATENT PROTECTION. It is neither easy, nor cheap, to get a new drug approved. Even when you do, you risk a Vioxx situation where a previously undetected (or low incidence) side effect can cause a total ban regardless of the will of the consumers.

Oh, and does aspirin help for heart attacks? Yes, but it's not done here, so you couldn't list it for a long time. Here's the take in 2003
http://heartdisease.about.com/cs/heartfailure/a/FDAaspirin.htm

My point? The profit motive has given us many new drugs. Approving a new drug is costly and certainly not guaranteed. I try to not buy generics. If the company doesn't do research, I won't support them. Who knows, I might need a miracle drug someday. If I do, I hope it has been developed in time.

Posted by: C_Miner at December 7, 2012 12:00 AM

I strongly suspect that many of the hospital drug shortages we're seeing now are primarily as a result of excess statist interference. Also, there's the lazy pharmacist component where pharmacists seem to have forgotten how to mix up iv drug solutions. A colleague of mine recently ranted at a pharmacist about how his patients have absolutely no problem producing injectable hydromorphone from crushed tablets yet the hospital has an injectable hydromorphone shortage. Needed some ketamine for a patient last week but there's a "critical shortage". A quick call to a compounding pharmacist I know revealed that there's no shortage of ketamine powder and that he'd be able to prepare iv solutions if I needed them.

Where the pharmaceutical industries have screwed up is in playing games with the patent system rather than producing new drugs. Astra-Zeneca had the patent on RS-omeprazole which became generic (and now is an OTC product in the US). Then, they patented S-Omeprazole (sold as Nexium) with the only difference being in separating the two isomers of RS-Omeprazole on an industrial scale. Similar things have occurred with introduction of S-citalopram (which is a better antidepressant than RS-citalopram) and D-venlafaxine. The maker of valcyclovir suddenly began pushing a vaccine for shingles once valcylovir went generic. Makes short term business sense but idiotic from the long term scientific viewpoint.

Canada has very expensive generic drugs which are always set at 65% of the original brand name drugs. Where drugs are really cheap is the US where Walmart will offer many generic drugs at $10 for 3 months - total cost, no dispensing fee like in Canada. Obviously hard to compete in this market but then many of these drugs are rather simple to synthesize.

Some of the brand name drugs were incredibly expensive. Olanzapine (zyprexa) went for $1/mg or a street value of $1 million/kilo. Now the "street" price has dropped to $650,000/kilo that it's gone generic. However, the generic manufacturers have been unable to duplicate the Zydis form of olanzapine which instantaneously dissolved when put under the tongue thus making it as effective as an antipsychotic sublingually as im.

When it comes to antibiotics, all drug companies are going in totally the wrong direction. The focus is still on free-living bacteria and killing them whereas the problem is bacterial biofilms. There's likely far more mileage to be had in pursuing biofilm disruption molecules (cinamaldehyde is one compound that does this), quorum sensing inhibitors and bacteriophages. Look for small startup drug companies to come up with the breakthrough drugs for treating drug resistant bacteria although they'll probably be snapped up by big pharma as soon as their drugs show any promise.

Posted by: Loki at December 7, 2012 12:13 AM

Treatments don't cure. All these pharmaceuticals treat symptoms, and of course cause more ailments or symptoms.

There seems to be no incentive to find cures as long as big pharma and its lap dog medical monopoly only sell lengthy expensive treatments.

Posted by: Occam at December 7, 2012 1:15 AM

I for one am glad that there are companies working on drugs to help those striken with cancer and other maladies. My wife of 27 yrs lived 4 years and 1 month vs the 8-10 months (some said 4 months) they gave her. Although the last 3 months were diffcult, her quality of life was good until the very end. With Obama care they would have said hell no to treatment...

Posted by: S Becker at December 7, 2012 6:03 AM

Regulations...a balancing act...

I recall a neighbour rather than sell his standing timber to a logger...cut it himself and had it made into planks...which he carefully stacked in a shed in anticipation of building a new building.

Along comes the building inspector...says no federal inspection stamp....can't use it.

Beautiful seasoned, hard maple planks....that sold well to the specialty furniture market. The proceeds bought all the actually inferior (certified/approved) spruce lumber required plus change...

But then unless yer a lawyer ya can't read, or an accountant ya can't add.....and so on....

Posted by: sasquatch at December 7, 2012 12:19 PM

The Wall Street Journal had a very interesting series of articles on generics. Even when not spiked with adulterating materials, they vary significantly from the original. My husband nearly died from his generic lopressor. I as a result only reluctantly went that direction when the price of my prescriptions reached into the triple digits. I did make it clear to the provider that if they fiddled with my thyroid medicine with unhappy results, I would own their business. Bottom line, the real deal is so cheap, they provide it. Good luck to others touting generics. As with dog food and toys, I'm not interested in anything coming out of third world countries.

Posted by: Mazzuchelli at December 7, 2012 3:39 PM

When King Barack the Magnificent and Moochelle Antoinette do the nasty, she's on top, so he can admire himself in the WH ceiling mirror.

mhb23re

Posted by: mhb at December 8, 2012 10:23 AM
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