[paula_w]

Just got this one from Carolyn's feed.

Patent System For Drugs 'Morally Unacceptable'

18 Jul 2008

Major drugs companies are using fierce lobbying tactics to protect a pharmaceutical patent system that is "simply morally unacceptable", a world-leading political philosopher told a major meeting of UK and European pharmacologists.

Addressing an audience that will include senior figures from the pharmaceutical industry, Thomas Pogge, Professor of Philosophy and International Affairs at Yale University in the United States, argued that international rules on intellectual property "violate the human rights of poor people by denying them access to vital medicines".

http://www.medicalnewstoday.com/articles/115379.php

[chasmo]

bcause having that exclusivity is the way that big pharma finances their research. I know it is the popular view that life-saving drug therapies shouldl be available to anyone who needs them. ( A view that I am in agreement with)
Perhaps we need to rethink our whole pharma system. This is one of the few places that I think government control MAY be warranted. In any event, it is a BIG problem with no obvious fix.

Charlie


http://health.groups.yahoo.com/group/DBSsurgery/

[Stitcher]

They developed a "new and improve" replacement:


Pristiq versus Effexor XR
by John M. Grohol, Psy.D.
March 4, 2008
http://psychcentral.com/blog/archive...us-effexor-xr/

What is Pristiq (desvenlafaxine)? The newest antidepressant approved by the U.S. Food and Drug Administration (FDA), which will hit the U.S. market in a few months. Pristiq is a drug similar in composition to Wyeth’s existing antidepressant, Effexor XR (which loses its patent protection in 2010, 2 years from now). It is Wyeth’s hope that Pristiq, therefore, will replace Effexor XR in a few years’ time. Why? Because Effexor XR makes $3.8 billion (with a ‘b’) a year in sales.

Pristiq has shown the same level of effectiveness as many other antidepressants on the market today — about a 2 point difference in a depression rating scale, compared with a placebo. This is the same 2 point difference that research last week showed wasn’t all that clinically significant in older new generation antidepressants (SSRIs like Prozac and Paxil).

Strangely enough, lower doses (50mg) of Pristiq proved more effective than higher doses (100mg). I believe this is the first time where a drug company has shown in their own data that less of their drug works better than more of it (at regular dosing levels)!

Pristiq, compared with Effexor XR, should be seen for what it is — an evolution in an existing chemical compound, trying to address some of the concerns with the current drug. Time will tell whether the side effects are more tolerable than those associated with Effexor XR or not. Because unless Wyeth releases the drug at a lower price point than Effexor XR (which is highly unlikely), Pristiq will have to prove itself as more than just another antidepressant.

The New York Times: F.D.A. Approves Wyeth Antidepressant

Dr. Carlat’s take: Top 5 Reasons to Forget about Pristiq

My comment to the Blog:

I will be scripted Pristiq this Thursday. I find the reason I will be receiving Pristiq to be very interesting and a good bit disturbing.

I have Medicare Part D and by May of each year I go into the The Gap and can’t afford Brand meds. So, I seek out samples from the docs. One sample has been Effexor. How interesting that the psychiatrist that oversees my Effexor MUST change me to Pristiq ONLY because the slaes rep will no longer supply the clinic with Effexor. ONLY Pristiq will be supplied as samples.

I am NOT happy about this!

Have you read “Dr. Carlat’s take: Top 5 Reasons to Forget about Pristiq” at the bottom of the article above…the top of the comment section. If not, maybe you should.

Hard to know who is right! I only see Wyeth as covering the profitable ***** since Effexor’s patent will be ending soon. They needed something to replace Effexor with. Did they do a simple reformulation and rename the medication? Now there is a question.

[Stitcher]

Top 5 Reasons to Forget about Pristiq

The Carlat Psychiatry Blog
Supporting the search for honesty in medical education

Saturday, March 1, 2008
http://carlatpsychiatry.blogspot.com...t-pristiq.html

Yesterday, the FDA gave official approval to Wyeth's antidepressant Prisiq. Here are the top 5 reasons for doctors to keep it off their prescription pads.

1. It’s a blatant patent extender. Effexor XR, which brought in $3.8 billion for Wyeth in 2007, is losing patent protection this year, and Wyeth is introducing desvenlafaxine, which is simply Effexor’s main metabolite, as a “novel antidepressant.”There’s nothing novel about it. Every patient who takes Effexor produces Pristiq in their own body, at no additional charge.

2. It’s not very effective. In the studies released so far, Pristiq just barely squeaks by placebo on the Hamilton Depression scale. In the U.S. study, Pristiq decreased the HamD by only 2 points (-11.5 vs. -9.5 for placebo), and in the European study, the differences was 2.5 points. And for the higher 100 mg dose, there was no difference between drug and placebo for U.S. patients.

3. It is not more easily dosed than Effexor XR. The main Wyeth marketing point for Pristiq is that patients can get better by taking the beginning dose of 50 mg, eliminating the need for a complicated upward dose titration process. Sorry, but this is not different from Effexor. If you look at one of the original fixed-dose studies of Effexor, comparing patients taking 75 mg, 225 mg, or 375 mg, you’ll find that the 75 mg dose separated from placebo as well as Pristiq’s 50 mg. Psychiatrists typically begin Effexor at either 37.5 or 75 mg/day. At least with Effexor XR, when you keep increasing the dose, efficacy improves, meaning it actually has an efficacy advantage over Pristiq, because when you increase the dose of Pristiq, you lose efficacy, according to the U.S. study data.

4. It has no meaningful metabolic advantages. Wyeth will highlight the fact that Pristiq is not metabolized by the P-450 system and therefore does not have any drug-drug interactions. Well, guess what, Effexor has no clinically meaningful drug-drug interactions either.

5. Wyeth’s own lead investigator is unimpressed. I spoke briefly with Dr. Michael Liebowitz, the Columbia University psychiatrist who led the major Pristiq trials. Pristiq, he said, “is another SNRI--it is not a revolutionary drug.” It may be more tolerable at the starting 50 mg dose, he said, but only time will tell if it truly is clinically useful. “If it is useful, then it will make money for the company, and if it is not, it won’t.”

Posted by Daniel Carlat, M.D. at 8:31 AM
Labels: Patent Extenders, Pristiq, Wyeth Pharmaceuticals

[Stitcher]

A Desperate Wyeth: Get Your Pristiq Cheap Here!
3 Comments

By Ed Silverman // April 22nd, 2008 // 11:51 am
http://www.pharmalot.com/2008/04/a-d...iq-cheap-here/

Facing a pipeline that can’t compensate for the looming patent expirations of its biggest products, Wyeth hopes to generate revenue with a special introductory offer for it Pristiq antidepressant - when the pill launches next month, the price will be up to 20 percent less than the cost of Wyeth’s existing Effexor antidepressant. Pristiq is, essentially, a revamped version of Effexor XR, a $3.8 billion seller that loses patent protection in 2010, if not sooner.

Read entire item

941_rouge350.gif

Wyeth Receives Approvable Letter from FDA for Pristiq for the Treatment of Vasomotor Symptoms Associated with Menopause

http://www.drugs.com/nda/pristiq_070724.html

COLLEGEVILLE, Pa., July 24 /PRNewswire-FirstCall/ -- Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), announced today that it received an approvable letter from the U.S. Food and Drug Administration (FDA) for Pristiq (desvenlafaxine), a serotonin-norepinephrine reuptake inhibitor (SNRI), currently under review as a treatment for moderate-to-severe vasomotor symptoms (hot flashes and night sweats) associated with menopause.

In its letter, the FDA said that before the application could be approved, it would be necessary for Wyeth to provide additional data regarding the potential for serious adverse cardiovascular and hepatic effects associated with the use of Pristiq in this indication. The Agency requested that these data come from a randomized, placebo-controlled clinical trial of a duration of one year or more conducted in postmenopausal women. The Agency also requested that Wyeth address certain CMC (Chemistry, Manufacturing and Controls) deficiencies prior to approval.

The FDA also made additional clinical and chemistry requests, which the Agency stated were not approvability issues.

"Wyeth remains committed to the development of Pristiq as a potential treatment for moderate-to-severe vasomotor symptoms associated with menopause," says Gary L. Stiles, M.D., Executive Vice President and Chief Medical Officer, Wyeth Pharmaceuticals. "We will work with the Agency to satisfy its requests for additional data and move the medicine forward in the FDA review process."

On January 22, 2007, the Company received an approvable letter for Pristiq for the treatment of Major Depressive Disorder (MDD), which did not require submission of additional clinical studies prior to approval for this indication. As previously announced, Wyeth intends to submit its complete response to the MDD approvable letter at the end of August, and the Agency is expected to act on the application during the first quarter of 2008.

[paula_w]

Thank you Doc John...also known as Dr. John M. Grohol, Psy.D.

http://psychcentral.com/blog/archive...us-effexor-xr/

[reverett123]

From a book review at http://www.wanttoknow.info/truthaboutdrugcompanies
<quote>
Marcia Angell is a former editor in chief of the prestigious The New England Journal of Medicine. She is currently a senior lecturer in social medicine at Harvard Medical School. Her latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It.
<Note- Make that editor in chief for TWENTY years>
"In the past two years, we have started to see, for the first time, the beginnings of public resistance to rapacious pricing and other dubious practices of the pharmaceutical industry. It is mainly because of this resistance that drug companies are now blanketing us with public relations messages. And the magic words, repeated over and over like an incantation, are research, innovation, and American. Research. Innovation. American. It makes a great story.

But while the rhetoric is stirring, it has very little to do with reality. First, research and development (R&D) is a relatively small part of the budgets of the big drug companies—dwarfed by their vast expenditures on marketing and administration, and smaller even than profits. In fact, year after year, for over two decades, this industry has been far and away the most profitable in the United States. (In 2003, for the first time, the industry lost its first-place position, coming in third, behind "mining, crude oil production," and "commercial banks.") The prices drug companies charge have little relationship to the costs of making the drugs and could be cut dramatically without coming anywhere close to threatening R&D.

Second, the pharmaceutical industry is not especially innovative. As hard as it is to believe, only a handful of truly important drugs have been brought to market in recent years, and they were mostly based on taxpayer-funded research at academic institutions, small biotechnology companies, or the National Institutes of Health (NIH). The great majority of "new" drugs are not new at all but merely variations of older drugs already on the market. These are called "me-too" drugs. The idea is to grab a share of an established, lucrative market by producing something very similar to a top-selling drug. For instance, we now have six statins (Mevacor, Lipitor, Zocor, Pravachol, Lescol, and the newest, Crestor) on the market to lower cholesterol, all variants of the first. As Dr. Sharon Levine, associate executive director of the Kaiser Permanente Medical Group, put it:

"If I'm a manufacturer and I can change one molecule and get another twenty years of patent rights, and convince physicians to prescribe and consumers to demand the next form of Prilosec, or weekly Prozac instead of daily Prozac, just as my patent expires, then why would I be spending money on a lot less certain endeavor, which is looking for brand-new drugs?" [4]

Third, the industry is hardly a model of American free enterprise. To be sure, it is free to decide which drugs to develop (me-too drugs instead of innovative ones, for instance), and it is free to price them as high as the traffic will bear, but it is utterly dependent on government-granted monopolies—in the form of patents and Food and Drug Administration (FDA)—approved exclusive marketing rights. If it is not particularly innovative in discovering new drugs, it is highly innovative— and aggressive—in dreaming up ways to extend its monopoly rights.

And there is nothing peculiarly American about this industry. It is the very essence of a global enterprise. Roughly half of the largest drug companies are based in Europe. (The exact count shifts because of mergers.) In 2002, the top ten were the American companies Pfizer, Merck, Johnson & Johnson, Bristol-Myers Squibb, and Wyeth (formerly American Home Products); the British companies GlaxoSmithKline and AstraZeneca; the Swiss companies Novartis and Roche; and the French company Aventis (which in 2004 merged with another French company, Sanafi Synthelabo, putting it in third place). [5] All are much alike in their operations. All price their drugs much higher here than in other markets.

Since the United States is the major profit center, it is simply good public relations for drug companies to pass themselves off as American, whether they are or not. It is true, however, that some of the European companies are now locating their R&D operations in the United States. They claim the reason for this is that we don't regulate prices, as does much of the rest of the world. But more likely it is that they want to feed on the unparalleled research output of American universities and the NIH. In other words, it's not private enterprise that draws them here but the very opposite—our publicly sponsored research enterprise.

Over the past two decades the pharmaceutical industry has moved very far from its original high purpose of discovering and producing useful new drugs. Now primarily a marketing machine to sell drugs of dubious benefit, this industry uses its wealth and power to co-opt every institution that might stand in its way, including the US Congress, the FDA, academic medical centers, and the medical profession itself. (Most of its marketing efforts are focused on influencing doctors, since they must write the prescriptions.)"

<There's much more but take a deep breath before reading.>

[Fiona]

What makes the USA a worse climate for us is they allow advertising of pharmaceuticals on TV etc. - only one other country I think does this.

The whole fact that Amgen decided to scrap their GDNF trial partially for reasons that they could have discerned before they ever started their study, and now refuses to let anyone else license it and give it a try - well, isn't it obvious why? Cuz then we'd all be cured. Can't have that now, right???

[paula_w]

No, especially when you have to share the profits with medtronics.

paula

Originally Posted by Fiona

What makes the USA a worse climate for us is they allow advertising of pharmaceuticals on TV etc. - only one other country I think does this.

The whole fact that Amgen decided to scrap their GDNF trial partially for reasons that they could have discerned before they ever started their study, and now refuses to let anyone else license it and give it a try - well, isn't it obvious why? Cuz then we'd all be cured. Can't have that now, right???

[chasmo]

Originally Posted by paula_w

No, especially when you have to share the profits with medtronics.

paula

Did you know that DBS is not one of Medtronic's big money-makers??

the have made about 40,000 of them at 11K each for Soletra's and not quite double that for Kinetra's. Nice chunk of change don't you think??

Charlie