A new trend in big pharaceutical companies called friggin GREED

Thelma · 03-14-2007, 10:37 PM

Negotiated settlement between Insmed Corporation and Tercica(and Tercica's associated licensing companies Genentech and Cephalon) has devastating impact on ALS Patients worldwide. Iplex, (an IGF-1 medication with an IGF-3 binding protein component), produced by Insmed, has been taken off the market. This drug, given by injection once daily, is the first to show benefit for ALS, HIV-Aids, Myotonic Muscular Dystrophy and burn victims. Because of a patent infringement, the settlement winner Tercica, is pulling all Iplex off the market and replacing it with their own inferior product, Increlex, which offers little or no benefit for these patients. Even at an astronomical cost to patients, ( $9500 a month) the demand is great, the supply unavailable. In fact, Tercica is recommending that all remaining supplies be destroyed rather than providing it to those in dire need. The bottom line is money over life-the obvious 21st century mantra for the pharmaceutical industry.

Increlex is IGF-1 only and the protein is distributed throughout the body and does not attach to the muscles affected by ALS or other conditions. Consequently more of it must be administered (twice a day injections) and less of it is delivered to the areas most in need. By contrast, Iplex (IGF-1 with binding protein IGF-3) attaches to the muscles most needing IGF-1 and is delivered far more rapidly (requiring one injection daily).

Increlex is the same drug as its earlier incarnation, Myotrophin, which showed limited success, if any, for ALS. That is the drug now being tested (again) at Mayo Clinic in Rochester and has been tested on again/off again for 13 years. It fails for the reason stated above.

There is clear evidence from previously completed clinical test studies demonstrating the superiority of Iplex over the less effective Increlex for severe short stature syndrome. There is clear and overwhelming evidence of the ability of Iplex to benefit those with Myotonic Muscular Dystrophy per the recently completed University of Rochester test study. There is no evidence yet published to suggest that Tercica's lesser product Increlex will benefit any of these conditions: ALS, HIV-AIDS, severe burn, fractured hip, Myotonic Muscular Dystrophy. And there is clear evidence that Increlex is less capable than Iplex for those with severe short stature syndrome.

We need your help in placing pressure upon Tercica to stop ignoring requests for Iplex, begin distribution immediately and continue to provide the Iplex product to the ALS and other communities who have already experienced positive affects.

INSMED Contact:
Administrative office
Phone: 804-565-3000, Fax: 804-565-3500
Ronald Gunn, Chief Operating Officer
Dr Kenneth Attie, Medical Affairs
Dr Geoffrey Allan, President, CEO

TERCICA Contact:
Administrative Office 866-837-2422
Dr. George Bright, Pediatric Endocrinologist
Dr. Sandra Blethen, Pediatric Endocrinologist
Thorsten von Stein, Senior VP, CMO
Fredik Wiklund, Investor Relations/Media
John Scarlett, President, CEO
_________________

paula_w · 03-15-2007, 08:03 AM

Thelma,

I could say nothing here and you would still know that I sympathize with the people in this situation 100%. This is a sick person's worst nightmare and I'm living it personally. As more evidence emerges of the importance of GDNF, it remains unavailable. I wonder if any of the people involved in this deal have ever met a person with ALS?

paula

jeanb · 03-15-2007, 08:41 AM

I hope everyone who visits this message board will call today. We must stand united with the ALS community.

TERCICA Contact:
Administrative Office 866-837-2422
Dr. George Bright, Pediatric Endocrinologist
Dr. Sandra Blethen, Pediatric Endocrinologist
Thorsten von Stein, Senior VP, CMO
Fredik Wiklund, Investor Relations/Media
John Scarlett, President, CEO

fredrik.wiklund@tercica.com
650-624-4992

thank you, Thelma

Jean B

jeanb · 03-15-2007, 08:46 AM

RICHMOND, Va.--(BUSINESS WIRE)--Insmed Incorporated (NASDAQ: INSM) has been requested by the Italian Ministry of Health, to make its drug, IPLEX™ (rhIGFI/rhIGFBP-3), available to physicians in Italy to treat patients with Amyotrophic Lateral Sclerosis (ALS), also known as Lou Gehrig’s Disease.

The request comes as a result of several Italian Court rulings ordering the Italian National Health System to provide the drug to specific ALS patients who have petitioned the Court. Through an agreement with Cephalon, which holds European patent rights to IGF-1 pertaining to the treatment of ALS, Insmed will be able to provide IPLEX to physicians in Italy. IPLEX will be distributed through an expanded access program, with Insmed receiving payment for drug from the Italian Health Authorities.

ALS is a neurodegenerative disorder that causes progressive muscle weakness and loss of motor neurons. IGF-1 is a neurotrophic factor essential for normal development of the nervous system. In animal models and cell culture systems IGF-1 protects motor neurons and promotes muscle and nerve regeneration.

“We are very pleased that the Italian ministry has approached us to help in treating this devastating disease,” said Geoffrey Allan, President and CEO of Insmed. “We greatly appreciate the fact that Cephalon has collaborated with us in this effort. We hope that data collected from this expanded access program will be useful for the further clinical development of IPLEX for this indication,” he added.

In Italy, there are an estimated 1000 new cases of ALS per year. The Ministry of Health has tried for several years to provide IGF-1 to these patients and in doing so has contacted several pharmaceutical companies worldwide.

“We are very pleased that Insmed responded to our request and are willing to provide IPLEX,” said Carlo Tomino of the Italian Ministry of Health/AIFA.

http://www.equitygroups.com/nasd/ins...ges/95493.html

jeanb · 03-15-2007, 09:01 AM

john.scarlett@tercica.com
sandra.blethen@tercica.com
george.bright@tercica.com

All,

There is no evidence yet published to suggest that Tercica's product Increlex will benefit any of these conditions: ALS, HIV-AIDS, severe burn, fractured hip, Myotonic Muscular Dystrophy.

PLEASE stop ignoring requests for Iplex, begin distribution immediately and continue to provide the Iplex product to the ALS and other communities who have already experienced positive affects.

Thank you,

Jean B

prattb · 03-17-2007, 12:18 AM

I just finished a clinical trial out of the University of Rochester. I have myotonic dystrophy and found great success using IPLEX. My terrible gastro-intestinal problems disappeared, my fatigue decreased, the myotonia effecting my face and hands decreased as well. I had no side effects whatsoever.

According to Dr. Moxley, none of the other test patients had side effects, and most found great benefits, including increased focus, strength and decrease in depression.

I've been attempting to find any way to continue using IPLEX. There is no other treatment for MMD. My sister has a congential form and I'm certain Iplex could help her. My father has a severe form of the disease and won't leave his house because of his horrible gasto-intestinal problems and of course his loss of almost all muscle tone in his body.

Fortunately for me, I haven't been severely effected yet, and I hoped to keep it that way, possibly even improve and Iplex gave me great hope. This news is devastating to me and my family. Please, anything anyone can do to keep this drug from being destroyed or taken off the market would be so much appreciated.

B. Pratt

Jaye · 03-17-2007, 10:18 AM

Quote:

Marcia Angell is a Senior Lecturer in Social Medicine at Harvard Medical School. A physician, she is a former Editor in Chief of The New England Journal of Medicine. Her latest book is The Truth About the Drug Companies: How They Deceive Us and What to Do About It. (June 2006)

Volume 51, Number 12 · July 15, 2004 [The New York Review of Books]

Feature

The Truth About the Drug Companies

By Marcia Angell

1.

Every day Americans are subjected to a barrage of advertising by the pharmaceutical industry. Mixed in with the pitches for a particular drug—usually featuring beautiful people enjoying themselves in the great outdoors—is a more general message. Boiled down to its essentials, it is this: "Yes, prescription drugs are expensive, but that shows how valuable they are. Besides, our research and development costs are enormous, and we need to cover them somehow. As 'research-based' companies, we turn out a steady stream of innovative medicines that lengthen life, enhance its quality, and avert more expensive medical care. You are the beneficiaries of this ongoing achievement of the American free enterprise system, so be grateful, quit whining, and pay up." More prosaically, what the industry is saying is that you get what you pay for.

Is any of this true? Well, the first part certainly is. Prescription drug costs are indeed high—and rising fast. Americans now spend a staggering $200 billion a year on prescription drugs, and that figure is growing at a rate of about 12 percent a year (down from a high of 18 percent in 1999).[1] Drugs are the fastest-growing part of the health care bill—which itself is rising at an alarming rate. The increase in drug spending reflects, in almost equal parts, the facts that people are taking a lot more drugs than they used to, that those drugs are more likely to be expensive new ones instead of older, cheaper ones, and that the prices of the most heavily prescribed drugs are routinely jacked up, sometimes several times a year.....

...Furthermore, in one of the more perverse of the pharmaceutical industry's practices, prices are much higher for precisely the people who most need the drugs and can least afford them. The industry charges Medicare recipients without supplementary insurance much more than it does favored customers, such as large HMOs or the Veterans Affairs (VA) system. Because the latter buy in bulk, they can bargain for steep discounts or rebates. People without insurance have no bargaining power; and so they pay the highest prices.

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 a 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....

If prescription drugs were like ordinary consumer goods, all this might not matter very much. But drugs are different. People depend on them for their health and even their lives. In the words of Senator Debbie Stabenow (D-Mich.), "It's not like buying a car or tennis shoes or peanut butter." People need to know that there are some checks and balances on this industry, so that its quest for profits doesn't push every other consideration aside. But there aren't such checks and balances.

2.

What does the eight-hundred-pound gorilla do? Anything it wants to.
What's true of the eight-hundred-pound gorilla is true of the colossus that is the pharmaceutical industry....

[historical background - see full article]

...there are very few drugs in the pipeline ready to take the place of blockbusters going off patent. In fact, that is the biggest problem facing the industry today, and its darkest secret. All the public relations about innovation is meant to obscure precisely this fact. The stream of new drugs has slowed to a trickle, and few of them are innovative in any sense of that word. Instead, the great majority are variations of oldies but goodies—"me-too" drugs.

Clearly, the pharmaceutical industry is due for fundamental reform. Reform will have to extend beyond the industry to the agencies and institutions it has co-opted, including the FDA and the medical profession and its teaching centers. In my forthcoming book, The Truth About the Drug Companies, I discuss the major reforms that will be necessary.

For example, we need to get the industry to focus on discovering truly innovative drugs instead of turning out me-too drugs (and spending billions of dollars to promote them as though they were miracles)....

....Drug companies have the largest lobby in Washington, and they give copiously to political campaigns. Legislators are now so beholden to the pharmaceutical industry that it will be exceedingly difficult to break its lock on them.

But the one thing legislators need more than campaign contributions is votes. That is why citizens should know what is really going on. Contrary to the industry's public relations, they don't get what they pay for. The fact is that this industry is taking us for a ride, and there will be no real reform without an aroused and determined public to make it happen.

...
...

See full article at http://www.nybooks.com/articles/17244

ashleyk · 03-17-2007, 03:49 PM

There is a report from Australia on a few people with ALS and PLS who have been taking low dose naltrexone in the hope of halting disease progression. It gives mixed results but it's should be of interest to anyone who knows someone or has one of these diseases.
Since dextromethorphan, DM, (see Dextromethorphan thread here) is in the same class as naltrexone it could be worth looking at. I don't believe any doctor would recommend going down that route but who knows.
Ashley

Look at: NEW 2007 Update ALS & PLS
http://www.lowdosenaltrexone.org/others.htm#PLS2007

lou_lou · 03-19-2007, 12:22 AM

In my naivety in the very beginning of this illness,
I believed that - big pharmacy and the doctors were there to help us -
get well again...
unfortunately, in reality some are trying to help the people -yet
big pharma is a corporation, and corporations make money -and that is the
bottom line...
palliative medicines, not cures...
the doctors that are brilliant will use the education of what they were taught
and use their own talents to think on their own,
my dentist is from england - he told me if dentists worked like MD's
we would all lose our teeth! *lightbulb - he said the medical profession
is palliative at best. - he is a great man and outside of the box thinker...

Halliberton sp? who cares...

- if I dare say, created a war to build a big corporation, to make big money to make millionaires richer?

http://iraqforsale.org/video_lesar.php

and in doing so, our young men and women have come home, with no arms or legs - and have come home to poor VA dirty hospitals.
I have no faith whatsoever in big government -it is just big organized ? business telling lies.

we the people according to the US constitution run the government.
but I was questioned while in DC long ago, if I really believed that...
and I cried because, that was what I was taught but the reality of many things - are not in the teaching but are seen by what they are doing.

wake up America...

fayeforcure · 03-19-2007, 10:56 AM

Quote:

Originally Posted by jeanb

john.scarlett@tercica.com
sandra.blethen@tercica.com
george.bright@tercica.com

All,

There is no evidence yet published to suggest that Tercica's product Increlex will benefit any of these conditions: ALS, HIV-AIDS, severe burn, fractured hip, Myotonic Muscular Dystrophy.

PLEASE stop ignoring requests for Iplex, begin distribution immediately and continue to provide the Iplex product to the ALS and other communities who have already experienced positive affects.

Thank you,

Jean B

Thanks Jean,

I just e-mailed them!

Faye

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