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Tyrone Bigguns
09-02-2008, 07:49 PM
Drug firm opts out of cheaper eye medicine
Genentech makes 2 Rx's for ailment causing blindness, at $60 and $2,000
By Kevin Freking
The Associated Press
Tucson, Arizona | Published: 08.28.2008

WASHINGTON — What does a company do when there's anecdotal evidence that two of its drugs are equally effective in treating a leading cause of blindness in the elderly, one costing patients $60 per treatment and the other $2,000?

In the case of Genentech Inc., nothing.

The company declined to seek federal approval for the cheaper drug, Avastin, to treat the wet form of age-related macular degeneration.
Nor would it help finance — or cooperate with — a National Eye Institute study comparing the effectiveness and safety of Avastin, a cancer drug, and the more expensive eye drug, Lucentis.

The financial stakes stemming from the study are huge. Medicare officials estimate there could be 50,000 or more additional cases of macular degeneration a year.

Treating just one year's worth of new patients with Lucentis would cost $1.2 billion a year, compared with $60 million if they're treated with Avastin, Medicare officials said.

Genentech is making no promises that it will act on the trial's final results, which are expected in two to three years.

The company has raised concerns that safety issues were not properly addressed.

In particular, the trial doesn't have enough patients to show some of the rare but serious side effects that could occur with the cheaper drug, the company contends.

"No matter the outcome, we continue to believe Lucentis is the most appropriate treatment for wet AMD," said Krysta Pellegrino, a company spokeswoman.

Wet AMD occurs when abnormal blood vessels leak blood and fluid affecting the part of the eye that allows you to see fine detail.

Many eye doctors believe Avastin works just as well in treating macular degeneration even though it hasn't been approved for that purpose.

It's not unusual for drugs to be used off-label — treating diseases other than ones the drug was approved for.
Both drugs target a protein that causes blood vessels in the back of the eye to grow, but Lucentis is a much smaller molecule. It was specifically designed — at great expense — to penetrate the retina.

Companies routinely help finance clinical trials, but such trials almost never pit two products from the same company against each other.

"It's a very unusual situation where a company would be trying to compare its own drugs," said Dr. Frederick Ferris, director of clinical research at the National Eye Institute.

"I'm not sure usual situations are all that relevant in this particular case."
Still, health officials pleaded with Genentech to participate in the clinical trial comparing the two drugs. At one point, the company considered doing so by providing the medicines in masked, identical vials, according to e-mail exchanges obtained by the Senate Special Committee on Aging.
"Good news is that the board supports the proposed studies," said one e-mail sent in June 2007 from Charlie Johnson, a company vice president, to Dr. Daniel Martin, chairman of the study who works at the Emory University School of Medicine.

In the end, the board did not support the study. Martin made a final plea.
"The fact that we are comparing your drugs and you are not involved is very awkward and can easily give way to anti-Genentech sentiments," Martin said.
"The leaders of this study are only interested in answering the many scientific and patient-management questions that we face with our patients every day, but some investigators and the press want this study to be more than that. Your involvement would be very helpful to both of our causes."
Genentech routinely provides financial support for clinical trials, Pellegrino said in an interview. But in this case, she said, "Our resources would be better spent looking at other diseases where there are no treatments.
Dr. Philip Rosenfeld, who has treated hundreds of eye patients in South Florida with Avastin, said Genentech had little economic incentive to help finance the trial — unless it was confident Lucentis was truly superior.
"By fact that they didn't support the clinical study leads me to conclude that in reality there is no difference between the two drugs," Rosenfeld said. "The result is clearly not in Genentech's best interest."

HowardRoark
09-02-2008, 07:54 PM
Is this a poll?

Tyrone Bigguns
09-02-2008, 08:00 PM
Is this a poll?

No.

mraynrand
09-02-2008, 08:05 PM
There's no surprise here. This IS one of the reasons healthcare is expensive. Another example would be that orthopedic surgeons often use more expensive implants to fix fractures when cheaper types will do the same job just as well. When the consumer has no incentive to choose the cheaper type, they will typically pick the 'cooler, more advanced' device. In your story, anyone who wants to can test the two drugs - that is, carry out the study. Clearly, the company is more interested in recouping the research money they spent on the eye drug, than showing that a cancer drug can do the same thing. It's obviously not in their best interests. But someone should do the study, even if it's a retrospective study. Prospective studies with drugs designed for different purposes are much harder to gain approval for studies on humans - the IRBs (instututional review boards) are extremely tough on research of this type.

Tyrone Bigguns
09-02-2008, 08:15 PM
There's no surprise here. This IS one of the reasons healthcare is expensive. Another example would be that orthopedic surgeons often use more expensive implants to fix fractures when cheaper types will do the same job just as well. When the consumer has no incentive to choose the cheaper type, they will typically pick the 'cooler, more advanced' device. In your story, anyone who wants to can test the two drugs - that is, carry out the study. Clearly, the company is more interested in recouping the research money they spent on the eye drug, than showing that a cancer drug can do the same thing. It's obviously not in their best interests. But someone should do the study, even if it's a retrospective study. Prospective studies with drugs designed for different purposes are much harder to gain approval for studies on humans - the IRBs (instututional review boards) are extremely tough on research of this type.

Care to tell me how one gets the two drugs to test them out?

bobblehead
09-02-2008, 09:51 PM
There's no surprise here. This IS one of the reasons healthcare is expensive. Another example would be that orthopedic surgeons often use more expensive implants to fix fractures when cheaper types will do the same job just as well. When the consumer has no incentive to choose the cheaper type, they will typically pick the 'cooler, more advanced' device. In your story, anyone who wants to can test the two drugs - that is, carry out the study. Clearly, the company is more interested in recouping the research money they spent on the eye drug, than showing that a cancer drug can do the same thing. It's obviously not in their best interests. But someone should do the study, even if it's a retrospective study. Prospective studies with drugs designed for different purposes are much harder to gain approval for studies on humans - the IRBs (instututional review boards) are extremely tough on research of this type.

Care to tell me how one gets the two drugs to test them out?

My mother tried something extreme....she asked her doctor for avastin and...drumroll....it worked and she saved money. If it hadn't worked she would have switched to the expensive drug as this isn't an overnight debillitating eye disease.

PS...if medicare wants to save the 960 million it might consider doing its own fucking study huh? I can see the conversation already.

MR. Genentech, we would like you to spend millions to prove that your cheaper drug works just as well so you can cost yourselves millions more in profits.

Well of course kind sir, we aren't out to make a profit or anything silly like that so we can research other life benefitting drugs....I'll get right on that study.

disclaimer: I own Genentech in my portfolio and if this conversation ever takes place I would dump it in a heartbeat.

Tyrone Bigguns
09-02-2008, 09:56 PM
Medicare do it's own studies. LOL Now, you want more of your money going to the gov't. I love you conservatives....free market when it suits you...socialism when it minimizes your costs.

Money: Yep, much better for the company it make money than it is for us to have a good product at a reasonable price.

Sounds like the free market ain't exactly working.

bobblehead
09-02-2008, 10:01 PM
Medicare do it's own studies. LOL Now, you want more of your money going to the gov't. I love you conservatives....free market when it suits you...socialism when it minimizes your costs.

Money: Yep, much better for the company it make money than it is for us to have a good product at a reasonable price.

Sounds like the free market ain't exactly working.

Medicare IS socialism, and I am against it on its face, thus the do your own fucking study attitude.

You seem to be missing the point here, the company created the drug...ie, free market, now you want to complain that it made too many of a good thing and they won't cut their own throat? edit: (I'm trying to figure out how the free market ain't working)

In case you haven't read any of my posts before it IS better for the company to make money than to give us the product and do the study to cut their own throat....why, cuz they will continue to make good drugs for us and benefit society. If you take the profit incentive away I doubt they will make much in the future.

Partial
09-02-2008, 10:04 PM
Also, wouldn't having government intervention requiring the company to sell the cheaper drug cut profits by a HUGE margin, thus limiting research for a clearly talented company.

Chain rule brah.

Tyrone Bigguns
09-02-2008, 10:41 PM
Also, wouldn't having government intervention requiring the company to sell the cheaper drug cut profits by a HUGE margin, thus limiting research for a clearly talented company.

Chain rule brah.

Yeah..they only have that one drug. They will clearly go broke.

mraynrand
09-02-2008, 10:58 PM
There's no surprise here. This IS one of the reasons healthcare is expensive. Another example would be that orthopedic surgeons often use more expensive implants to fix fractures when cheaper types will do the same job just as well. When the consumer has no incentive to choose the cheaper type, they will typically pick the 'cooler, more advanced' device. In your story, anyone who wants to can test the two drugs - that is, carry out the study. Clearly, the company is more interested in recouping the research money they spent on the eye drug, than showing that a cancer drug can do the same thing. It's obviously not in their best interests. But someone should do the study, even if it's a retrospective study. Prospective studies with drugs designed for different purposes are much harder to gain approval for studies on humans - the IRBs (instututional review boards) are extremely tough on research of this type.

Care to tell me how one gets the two drugs to test them out?

In a retrospective research study, you really don't need to get a hold of any drugs now, do you?

In a prospective study, you do what I do, you WRITE A GRANT, get it funded and pay for the drugs straight up. Or you write prescriptions to get them like any patient would.

Patler
09-02-2008, 11:28 PM
Why do so many automatically assume that the more expensive drug is the more profitable drug for the manufacturer? Granted, with the huge disparity in cost it probably is, but the difference in profit might not be anywhere close to the difference in cost to the patient.

"Regular" companies who supply products constantly try to direct the market to their products in specific ways. They also try to maximize their profits. If drug companies or oil companies do it, they are looked at as evil.