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DPMC Moderators: thegreenhand | tryptakid
LSD as Therapy? Write about It, Get Barred from US
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Kalash
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5-HT2 said:
All men are created equal, right?
That doesn't mean, "All men created inside the boarders of the USA" are created equal...
That's a really good point.
They're INTRISTIC rights - not rights granted by the government...
They Constitution just limits the government's ability to take them away.
The Constitution doesn't give the government power... it prevents them from taking it.
Ron Paul for president...
(Isn't he the only person running for the presidency of the USA? His campaign goal is to "Re-instate the constitution"... If the constitution isn't binding in this country right now, we don't have a country... The rest of the candidates are running for the shadow government and are trying to represent/run/control a false country for personal benefit...)
tobala
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Kalash said:
Of course, this line was written by men who bought and sold slaves. I guess they tried to rationalize this with intellectual diversions that enabled them to use skin color as trait disqualifying Africans from actually being "men."
So if a nation is founded by hypocrites, we shouldn't be too surprised if even 200+ years later it continues to operate with hypocrisy as a fundamental component of its infrastructure.
I'm convinced that the Constitution was designed to be much like a bone you throw to an angry dog to keep him from ripping your head off. It is so easily circumvented, with one example being the "Patriot" Act. The "drug war" has also enabled government to sidestep constitutional protections. Now it seems that even something as innocuous as Google is putting dents in the armor of the revered document.Kalash said:
The emergence of a police state can continue unfettered as long as the dog keeps chewing on the bone.
Kalash
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tobala said:
BBBZZZZZZZZZZZZZZZZZT!
Wrong!
It's just that the people have to stand up for what is right!
U.S. Supreme Court in Ex Parte Milligan 71 U.S. 2 (4 Wall.) (1866)
“Time has proven the discernment of our ancestors, for even these provisions, expressed in such plain English words that it would seem the ingenuity of man could not evade them, are now, after the lapse of more than seventy years, sought to be avoided. Those great and good men foresaw that troublous times would arise when rulers and people would become restive under restraint, and seek by sharp and decisive measures to accomplish ends deemed just and proper, and that the principles of Constitutional liberty would be in peril unless established by irrepealable law. The history of the world had taught them that what was done in the past might be attempted in the future. The Constitution of the United States is a law for rulers and people, equally in war and in peace, and covers with the shield of its protection all classes of men, at all times and under all circumstances. No doctrine involving more pernicious consequences was ever invented by the wit of man than that any of its provisions can be suspended during any of the great exigencies of government. Such a doctrine leads directly to anarchy or despotism, but the theory of necessity on which it is based is false, for the government, within the Constitution, has all the powers granted to it which are necessary to preserve its existence, as has been happily proved by the result of the great effort to throw off its just authority.”
The patriot act is illegal and needs to be repealed.
The drug laws are illegal and need to be repealed.
Etc...etc... blah... blah...
No one stands up for their rights because of government funded terror.
Fear is used to control the populace and keep them in their place.
I'm learning this the hard way - people don't WANT change.
I can talk to drug users about wanting to change the drug laws... and they tell me to shut up, quit trying to save my @$$, and go to jail already.
Change is scary because of what the government tells us change is.
Meanwhile, they have no right to be doing 90% of the things they're doing...
Fear is the tool being used to keep me from questioning the laws... taking my case to court...
They would rather offer me a plea bargain - something less than what I COULD WRONGLY FACE if I lose in court...
And they tell me my chances of winning are slim to none.
Fear.
They know their laws aren't legal.
They know they can't enforce them...
But they frighten us into submission.
The USA doesn't even exist anymore (a presidential candidate's campaign platform is to "reinstate the constitution" (Ron Paul)).
Without the Constitution, we have no country.
The plaintiff in my case doesn't even legally exist any more.
not_broken_420
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Wow, this article really blows my mind. I can't believe people can be so stupid. I suppose I will never know what is so terribly evil about drugs, especially hallucinogens.
Trogdor
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Kalash said:
Nowhere in the original text of the Constitution does it say that all men are created equal. You're thinking of a different, not-legally-valid document. (Sorry Mr. Jefferson but it's true.)
tobala said:
Fun fact: Up until the 14th amendment was ratified in 1868, slaves were legally counted as 60% of a citizen when determining apportionment:
"Representatives and direct taxes shall be apportioned among the several states which may be included within this union, according to their respective numbers, which shall be determined by adding to the whole number of free persons, including those bound to service for a term of years, and excluding Indians not taxed, three fifths of all other Persons."
-from the US Constitution - Article I, Section 2
To be fair, it was the slaveholding states that wanted slaves to be counted as whole people while the northern states wanted them not to be counted at all - three fifths was used as a compromise to balance the power in Congress between the northern and southern states, and any other percentage would have resulted in a disproportionate number of votes in Congress, although it would also have changed the amount of taxes the states were required to pay the federal government.
Here's something interesting I just came across: http://deoxy.org/comstock.htm
While we're on the topic of the subjugation of the black race, here's something interesting courtesy of wikipedia about the origins of the 'jack-in-the-box' toy:
"Another theory offered by investigative reporter Pete Patterson paints a much darker past in an article found here. According to him The original Jacks weren't actually clowns, but instead runaway slaves ("Jacks" in slang.) The first Jack in a box was actually a live captured runaway slave in a wooden box. Often children playing where they shouldn't, would jam sharpened wooden sticks though the knotholes of the boxes. In reaction the "Jack" inside would yelp, and often bust through the top of the box. John Schorne, inspired by his childhood antics, began hand crafting and selling Jack in The Boxes. The simple music box would crank and POP out came a crudely crafted black man on a spring. The idea quickly took off as one of the first novelty gifts. The black man in the box was gradually phased into a clown."
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Trogdor
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Kalash said:
We tried that once already, remember? Back in 1861..... but General Sherman came along a few years later and burned that dream to the ground.
The Confederate Constitution was actually quite similar to the US Constitution, only with line-item veto, stricter term limits, direct incorporation of the Bill of Rights (the US Bill of Rights postdates the US Constitution by 4 years), and a weakened commerce clause.
It's just too bad the Confederates were dead-set on the continuation of slavery or the Union may not have fought quite so hard to re-unite the nation.
Confederate Vice President Alexander Stephens said that the cornerstone of the South was "That the Negro is not equal to the white man; that slavery—subordination to the superior race—is his natural and normal condition."[61]
Jefferson Davis said slavery "…was established by decree of Almighty God… it is sanctioned in the Bible, in both Testaments, from Genesis to Revelation… it has existed in all ages, has been found among the people of the highest civilization, and in nations of the highest proficiency in the arts."[62]
http://en.wikipedia.org/wiki/American_Civil_War#Arguments_for_and_against_slavery
The Hoff Bomb
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America Government is so full of itself... I think A little acid use would fix alot of the worlds problems
Kalash
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The Hoff Bomb said:
People like Bush wouldn't be able to handle it.
They'd break.
Too much information challenging the beliefs they've worked their whole lives to build up.
Beliefs based on...
Well...
Personal profit.
And their efforts to make the world as it appears in their dreams...(i.e. delusions)
If all the closed minded people in the world snapped.......
It could be good.... it could be bad.
But at this point, pretty much any change is welcome.
Zagenth
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not_broken_420 said:
I don't really like the term "hallucinogen", I think "psychedelic" is far more proper in its description.
Psychedelics allow people to see things from a different point of view. The shepards don't want the sheep to start questioning their disposition as sheep, makes them harder to control.
On the other hand, irresponsible use of psychedelics can seriously scar people emotionally, so just handing every Joe Blow on the street some LSD and telling them to go have fun isn't a very good idea either.
*shrug*
Kalash
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Zagenth said:
But treating us all as if we had the IQ of Pres. Bush just isn't rational...
Or fair.
Or... sane.
Prescription drugs come with warnings...
Illegal drugs do not.
I'd much rather have an illegal drug than a prescription drug - if I knew for CERTAIN that it was in a clean/pure form... mostly because the side effects are so much LESS than the twakered chemicals the government allows companies to experiment on us with - for private profit gains, while charging the tax payers for the testing....
I don't think drugs should be patentable...
And if they are, a price cap of no more than a 100% markup allowed.
Seeing as how most drugs are marked up 30,000% as is right now, this would reduce the cost of health care by what? 29,000%?
Sounds like a good start to help those with less money be able to afford healthcare.....
vibr8tor
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motorcyclist
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Kalash said:
100% markup of what?
You got to remember that the drug companies spend billions on research, testing, FDA approvals and marketing. And like all companies, they must make a profit or there is no reason to even be in business. So a company spends millions of dollars bringing a product to market, with no knowledge of how many actual pieces of that products they will sell over time. So what to you set the price at?
If they set the price at 100% markup over the actual cost to produce, then it will take far too many years to cover the costs of bringing it to market. They'll never break even. Nor would they ever have enough cashflow to continue research and development for future medications.
Kalash
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motorcyclist said:
Some of the research and studies are funded by government grants...
Yes... the research costs are insane, but the way things are currently, there is no push for a CURE for any disease...
The drug companies don't WANT cures... they want life time users.
Post Traumatic Stress Disorder - the only viable (legal) treatment is Zoloft...
A daily regimen FOREVER... costing over $200 per month.
MAPS research - MDMA, an unpatentable drug with a cost of about $0.20 per pill, with an average treatment of 5 doses - is working 500X better than Zoloft in general - and the only people qualifying for the study are people Zoloft didn't work for.
Suppression of the facts and a lot of money goes into keeping certain drugs illegal.
Stevia v. sweet and low, equal, etc....
The artificial sweetener industry has prevented stevia from coming to the market.
It's illegal to sell as a sweetener...
It's natural (comes from a plant) and has been used for over 3000 years in Japan and other countries with no known side effects, no reports of adverse reactions, and it's diabetic safe.
These profits prevent competition... they prevent CURES from coming to the market...
They prevent better products from getting to the people.
And with most of the research money coming from the taxpayers in general.....
The drug company's profits don't measure up to their actual costs.
Look at the ads on tv? The cash payments to doctors that prescribe their drugs?
That there are no cures for ANYTHING this day and age - other than penicillin which isn't patentable..... and a hundred thousand other anti-biotics with more side effects.... that cost more, and are pushed more than penicillin...
(Granted, penicillin isn't for everyone or every case, and widespread misuse has decreased its efficiency, but still...)
They aren't paying for research for better drugs...
They're paying doctors to prescribe what they've already made...
They're paying for advertising to get people to TAKE drugs they may not have a need for.
And if you look at the last decade and count the prescription drug related deaths and IRREVERSIBLE SERIOUS health damage caused by them - they're pushing their stuff through the FDA and doing tests on the general public then getting sued if their products have problems... but the drugs stay on the market because they can afford the lawsuits and continue to pay off the FDA.
Kalash
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http://www.aarp.org/bulletin/prescription/double_taxation.html
Once Should Be Enough
American consumers often pay twice for their prescription drugs—first to the U.S. government in the form of taxes spent on research, then to drugmakers holding lucrative patents. Why?
By Katharine Greider
May 2006
How do Americans pay for progress? If progress is measured in new drugs to combat disease, we pay in two basic ways. First, as taxpayers, we support research directly through the National Institutes of Health (NIH) and through federal tax deductions of 39 percent on the research and development (R&D) costs of the pharmaceutical industry. Then, as consumers, we also support R&D through high prices made possible by patents, the government-granted monopolies that reward innovation. While many have called this multifaceted R&D apparatus the best in the world, it also has become increasingly expensive for American families.
Take the new cancer drug Avastin. Avastin is what you might call an R&D success story—the fruit of cross-fertilization between private and public sectors, basic and applied science, shareholders' and taxpayers' commitment of resources to smart people who doggedly pursued results in labs and clinics.
Judah Folkman, M.D., likens his founding of the scientific theory underlying Avastin's development to building "a little tiny model of the first car with paper and sealing wax." Director of the vascular biology program at Children's Hospital in Boston and a long-time professor of cell biology at Harvard Medical School, Folkman established that tumors cannot progress unless they stimulate the growth of nourishing blood vessels, a process known as angiogenesis. NIH—via taxpayer dollars—began supporting Folkman's research before he published his seminal hypothesis in 1971, and continued its support through years of skepticism about his ideas, and into the '80s and '90s.
It was Napoleone Ferrara, M.D., a young Italian researcher working for the California-based biotechnology company Genentech, who turned Folkman's theory into a drug. Beginning in 1989, Ferrara and his team identified a key angiogenic protein, then discovered an antibody that blocks its action. In 2004 a human trial sponsored by Genentech showed that Avastin, when taken along with standard chemotherapy, extends the median survival of patients with advanced colorectal cancer, albeit by only five months. The U.S. Food and Drug Administration (FDA) swiftly approved it.
The National Cancer Institute (NCI), part of NIH, had been running trials on bevacizumab (Avastin's generic name) for more than five years. "We get involved in the development of drugs at various stages," explains Michaele Christian, M.D., director of NCI's Cancer therapy evaluation program. "And the reason we do it is because we think the drug has tremendous potential and that we can expand and accelerate its development, to the benefit of patients." Indeed, NCI is sponsoring more than 30 clinical trials using Avastin, and recently produced trial results establishing the drug's efficacy (when combined with chemotherapy) in advanced lung and breast cancers.
The FDA has approved Avastin only for colorectal cancer, at a cost of about $50,000 a year at its present unit price. If the drug is approved by the FDA to treat breast and lung cancers, the annual cost (or unit price) could be twice as much, because the doses are higher. Sensitive as of late after a rain of criticism in the press and from patient advocate groups regarding Avastin's cost, Genentech's director of government affairs, Walter Moore, insists the company is struggling with the question of unit price for lung and breast cancer treatments if approved.
But when asked in a recent interview with Business Week online to "explain why it may be necessary to boost the cost of Avastin," Genentech's CEO Arthur Levinson replied, "Selling twice as much of the drug means it's going to cost us twice as much in production expenses."
Meanwhile, people eligible for treatment with Avastin face copayments that can run well into the thousands of dollars annually. Insurers are balking at covering the drug in cases that don't fit the FDA-approved indication. Patients have declined treatment with Avastin due to expense, says Deborah Schrag, M.D., M.P.H., an oncologist at Memorial Sloan-Kettering Cancer Center. "It's much more common that people get it, and then they struggle under these big payments," she says. "And these people are dying, so I also worry about their families' [financial stress]." In a survey published in February in the journal The Oncologist, only a quarter of cancer doctors said they felt Avastin offered "good value."
Government Funding: A "Push" for Innovation
Just how much does the federal government contribute to drug R&D? Broadly speaking, if talking in terms of roles, the government is more involved in basic research and private companies, in applied research on particular drugs. But even here there are areas that overlap. One study found that of 21 therapeutically important drugs introduced between 1965 and 1992, 15 were developed with substantial input from public research.
The industry group Pharmaceutical Research and Manufacturers of America (PhRMA) reports its members spent almost $40 billion on R&D in 2005. NIH also spends billions—$8.4 billion in 2003—on clinical research, testing health interventions in real people. NIH is particularly involved in the study of severe illnesses such as AIDS and cancer.
Increasingly, nonprofits also are stepping in to fund R&D aimed at diseases affecting the world's poor, who cannot reward corporate investment with high sales figures. The Bill & Melinda Gates Foundation, a major player, has poured $6 billion into global health initiatives since 1994.
Patents: the "pull" for innovation
Are high drug prices the result of the U.S. system of drug R&D working as it is designed to do? That system revolves around the patent, a promise to the owner of an invention: If you can get the product to market, you will be rewarded with a temporary monopoly, which allows a drug to be sold at prices many times the cost of production.
Once a patent is awarded, shareholders expect companies to fully exploit the promise inherent in patent protection. Sales of oncology drugs, including the newly launched Avastin, helped drive up profits for the pharmaceuticals division of Roche—the Swiss-based multinational pharmaceutical corporation that owns a majority share in Genentech and markets Avastin outside the U.S.—37 percent in 2005. Profit as a percentage of sales was 27.4 percent.
Another, perhaps bitter, irony is that although a U.S. company discovered Avastin and U.S. taxpayers have supported its underlying science and ongoing development, it was introduced at lower prices in Canada, Germany, and the United Kingdom. In Roche's home country of Switzerland, the drug was priced at more than 25 percent less than even the discounted U.S. price, which is available only to federal purchasers such as the Department of Veterans Affairs. In the absence of government regulations to restrain prices—such as those in place in the countries mentioned above—the upper bound on the U.S. price is simply the point at which people are unwilling or unable to pay it.
Bayh-Dole and "Technology Transfer"
Before 1980 the federal government retained rights to research conducted under its grants. That year, reacting to concern that few government-owned inventions were being made into usable products, Congress passed legislation that transformed the research landscape. The Bayh-Dole Act gave universities and other grantees the right to license inventions developed under government grants to private companies, in exchange for royalties. The government too can license inventions developed by its scientists, alone or in collaboration with industry, to private enterprise.
The Bayh-Dole Act promoted the commercialization of government-funded research, and partnerships between business, academia and the federal government. One measure of this trend: universities received 264 patents in 1979; in 2003 they received 3,259. But in at least a few contentious cases, lawmakers and consumer advocates have cried foul when a drug developed largely at public initiative and expense was later offered at a price that made it inaccessible to many Americans.
An early case was AZT, the first AIDS drug. Burroughs Wellcome, NIH's partner in developing AZT, introduced it in 1987 at $8,000-$10,000 a year. Outrage over the price—protesters shackled themselves inside the New York Stock Exchange and staged other attention-grabbing stunts aimed at the company and regulators—led to an attempt in 1989 to require so-called reasonable pricing in products developed under partnership contracts between NIH and private industry, known as Collaborative Research and Development Agreements (CRADAs). The intended pricing language, never decisively enforced, apparently discouraged would-be collaborators with NIH. The number of CRADAs dropped off sharply. NIH nixed the clause in 1995, and public-private partnerships—like the one that is accelerating the development of Avastin—rebounded.
Another high-profile case involved the cancer drug Taxol; the government initiated a study of the drug's therapeutic value, but eventually needed industrial partners to help commercialize it. One of these partners was the pharmaceutical company Bristol-Myers Squibb (BMS).
According to a 2003 report by the U.S. General Accounting Office, NIH spent about $484 million between 1977 and 2002 on research related to Taxol. BMS reported having spent $1 billion developing the drug. Once it hit the market in 1993, Taxol garnered the highest sales figures of any cancer drug in history, with worldwide revenues through 2002 topping $9 billion, partly on the strength of a $1,000-a-dose U.S. price. Primarily through Medicare, the federal government has been a major purchaser of Taxol, spending $687 million on the drug from 1994 through 1999. In comparison, as of 2003, NIH has received $35 million in royalty payments from BMS.
Best Alternative? Or Broken?
The argument for this R&D support system goes that without the fabulous "upside" potential of sales under patent, no company would take the enormous risks required to bring a drug like Avastin to market. Neither would companies engage in collaborations with government if that meant limits on prices. "It has consistently been shown that the ability to capitalize on invention is a tenet of innovation," says Caroline Loew, Ph.D., PhRMA senior vice president for scientific and regulatory affairs. If drugs are unaffordable to some, this argument suggests, that is a problem that should be addressed through more and better insurance coverage and charitable programs to assist the indigent. American pharmaceutical companies say they're doing their part by handing out free prescriptions—28 million last year in the United States—to poor patients.
On the other hand, some in Congress and in policy circles are convinced the system is indeed broken, and that its fundamental mistake is to use high, patent-protected prices as the reward for and principle stimulus of R&D. Supporting R&D with high prices at the pharmacy, say these critics, not only rations drugs according to ability to pay but encourages companies to
* spend huge sums on marketing the most lucrative patented products.
* develop patentable but therapeutically unimportant variations on existing products.
* protect product portfolios by keeping research, especially unfavorable results, secret.
Says Jamie Love, director of the Consumer Project on Technology, an organization concerned with intellectual policy and practices, and an expert on the economics of the drug industry, "When the price of a drug becomes like the price of a house in some cases, people are beginning to ask, is this really the best we can do?" [See sidebar, "Bringing Competition to Market," on new legislative proposals to overhaul the current system.]
Innovations on a Professor's Salary
The last half-century has birthed a panoply of new medical technologies. It has also seen the growth of health care costs from 5.9 percent of gross domestic product (GDP) in 1965 to 16 percent of GDP in 2006.
Over these same decades, Judah Folkman has been a veritable font of innovation, not only launching the field of angiogenesis research but also helping develop the first cardiac pacemaker and pioneering controlled-release technology found in the contraceptive Norplant. And he's done it on a professor's salary. Folkman has seen a small number of colleagues find success by founding start-ups; a few have failed. "It's a different kind of career," he remarks.
Even so, at 73, Folkman would dearly like to see the angiogenesis blocker he discovered, endostatin, fully tested, manufactured and made available to the ill patients who constantly call him seeking help. The small biotech firm EntreMed dropped endostatin in 2003, citing the high cost of manufacturing it. Now colleagues in Folkman's lab have altered the molecule to make it easier to produce. Folkman adds that their discovery has not yet been used to lower the manufacturing cost here in the United States, but the Chinese have come up with a different method that has already resulted in cheaper production. And his institution, Children's Hospital, is in possession of what in today's R&D world is an indispensable tool. "If you don't hold a patent," says Folkman, "they won't even talk to you."
Once Should Be Enough
American consumers often pay twice for their prescription drugs—first to the U.S. government in the form of taxes spent on research, then to drugmakers holding lucrative patents. Why?
By Katharine Greider
May 2006
How do Americans pay for progress? If progress is measured in new drugs to combat disease, we pay in two basic ways. First, as taxpayers, we support research directly through the National Institutes of Health (NIH) and through federal tax deductions of 39 percent on the research and development (R&D) costs of the pharmaceutical industry. Then, as consumers, we also support R&D through high prices made possible by patents, the government-granted monopolies that reward innovation. While many have called this multifaceted R&D apparatus the best in the world, it also has become increasingly expensive for American families.
Take the new cancer drug Avastin. Avastin is what you might call an R&D success story—the fruit of cross-fertilization between private and public sectors, basic and applied science, shareholders' and taxpayers' commitment of resources to smart people who doggedly pursued results in labs and clinics.
Judah Folkman, M.D., likens his founding of the scientific theory underlying Avastin's development to building "a little tiny model of the first car with paper and sealing wax." Director of the vascular biology program at Children's Hospital in Boston and a long-time professor of cell biology at Harvard Medical School, Folkman established that tumors cannot progress unless they stimulate the growth of nourishing blood vessels, a process known as angiogenesis. NIH—via taxpayer dollars—began supporting Folkman's research before he published his seminal hypothesis in 1971, and continued its support through years of skepticism about his ideas, and into the '80s and '90s.
It was Napoleone Ferrara, M.D., a young Italian researcher working for the California-based biotechnology company Genentech, who turned Folkman's theory into a drug. Beginning in 1989, Ferrara and his team identified a key angiogenic protein, then discovered an antibody that blocks its action. In 2004 a human trial sponsored by Genentech showed that Avastin, when taken along with standard chemotherapy, extends the median survival of patients with advanced colorectal cancer, albeit by only five months. The U.S. Food and Drug Administration (FDA) swiftly approved it.
The National Cancer Institute (NCI), part of NIH, had been running trials on bevacizumab (Avastin's generic name) for more than five years. "We get involved in the development of drugs at various stages," explains Michaele Christian, M.D., director of NCI's Cancer therapy evaluation program. "And the reason we do it is because we think the drug has tremendous potential and that we can expand and accelerate its development, to the benefit of patients." Indeed, NCI is sponsoring more than 30 clinical trials using Avastin, and recently produced trial results establishing the drug's efficacy (when combined with chemotherapy) in advanced lung and breast cancers.
The FDA has approved Avastin only for colorectal cancer, at a cost of about $50,000 a year at its present unit price. If the drug is approved by the FDA to treat breast and lung cancers, the annual cost (or unit price) could be twice as much, because the doses are higher. Sensitive as of late after a rain of criticism in the press and from patient advocate groups regarding Avastin's cost, Genentech's director of government affairs, Walter Moore, insists the company is struggling with the question of unit price for lung and breast cancer treatments if approved.
But when asked in a recent interview with Business Week online to "explain why it may be necessary to boost the cost of Avastin," Genentech's CEO Arthur Levinson replied, "Selling twice as much of the drug means it's going to cost us twice as much in production expenses."
Meanwhile, people eligible for treatment with Avastin face copayments that can run well into the thousands of dollars annually. Insurers are balking at covering the drug in cases that don't fit the FDA-approved indication. Patients have declined treatment with Avastin due to expense, says Deborah Schrag, M.D., M.P.H., an oncologist at Memorial Sloan-Kettering Cancer Center. "It's much more common that people get it, and then they struggle under these big payments," she says. "And these people are dying, so I also worry about their families' [financial stress]." In a survey published in February in the journal The Oncologist, only a quarter of cancer doctors said they felt Avastin offered "good value."
Government Funding: A "Push" for Innovation
Just how much does the federal government contribute to drug R&D? Broadly speaking, if talking in terms of roles, the government is more involved in basic research and private companies, in applied research on particular drugs. But even here there are areas that overlap. One study found that of 21 therapeutically important drugs introduced between 1965 and 1992, 15 were developed with substantial input from public research.
The industry group Pharmaceutical Research and Manufacturers of America (PhRMA) reports its members spent almost $40 billion on R&D in 2005. NIH also spends billions—$8.4 billion in 2003—on clinical research, testing health interventions in real people. NIH is particularly involved in the study of severe illnesses such as AIDS and cancer.
Increasingly, nonprofits also are stepping in to fund R&D aimed at diseases affecting the world's poor, who cannot reward corporate investment with high sales figures. The Bill & Melinda Gates Foundation, a major player, has poured $6 billion into global health initiatives since 1994.
Patents: the "pull" for innovation
Are high drug prices the result of the U.S. system of drug R&D working as it is designed to do? That system revolves around the patent, a promise to the owner of an invention: If you can get the product to market, you will be rewarded with a temporary monopoly, which allows a drug to be sold at prices many times the cost of production.
Once a patent is awarded, shareholders expect companies to fully exploit the promise inherent in patent protection. Sales of oncology drugs, including the newly launched Avastin, helped drive up profits for the pharmaceuticals division of Roche—the Swiss-based multinational pharmaceutical corporation that owns a majority share in Genentech and markets Avastin outside the U.S.—37 percent in 2005. Profit as a percentage of sales was 27.4 percent.
Another, perhaps bitter, irony is that although a U.S. company discovered Avastin and U.S. taxpayers have supported its underlying science and ongoing development, it was introduced at lower prices in Canada, Germany, and the United Kingdom. In Roche's home country of Switzerland, the drug was priced at more than 25 percent less than even the discounted U.S. price, which is available only to federal purchasers such as the Department of Veterans Affairs. In the absence of government regulations to restrain prices—such as those in place in the countries mentioned above—the upper bound on the U.S. price is simply the point at which people are unwilling or unable to pay it.
Bayh-Dole and "Technology Transfer"
Before 1980 the federal government retained rights to research conducted under its grants. That year, reacting to concern that few government-owned inventions were being made into usable products, Congress passed legislation that transformed the research landscape. The Bayh-Dole Act gave universities and other grantees the right to license inventions developed under government grants to private companies, in exchange for royalties. The government too can license inventions developed by its scientists, alone or in collaboration with industry, to private enterprise.
The Bayh-Dole Act promoted the commercialization of government-funded research, and partnerships between business, academia and the federal government. One measure of this trend: universities received 264 patents in 1979; in 2003 they received 3,259. But in at least a few contentious cases, lawmakers and consumer advocates have cried foul when a drug developed largely at public initiative and expense was later offered at a price that made it inaccessible to many Americans.
An early case was AZT, the first AIDS drug. Burroughs Wellcome, NIH's partner in developing AZT, introduced it in 1987 at $8,000-$10,000 a year. Outrage over the price—protesters shackled themselves inside the New York Stock Exchange and staged other attention-grabbing stunts aimed at the company and regulators—led to an attempt in 1989 to require so-called reasonable pricing in products developed under partnership contracts between NIH and private industry, known as Collaborative Research and Development Agreements (CRADAs). The intended pricing language, never decisively enforced, apparently discouraged would-be collaborators with NIH. The number of CRADAs dropped off sharply. NIH nixed the clause in 1995, and public-private partnerships—like the one that is accelerating the development of Avastin—rebounded.
Another high-profile case involved the cancer drug Taxol; the government initiated a study of the drug's therapeutic value, but eventually needed industrial partners to help commercialize it. One of these partners was the pharmaceutical company Bristol-Myers Squibb (BMS).
According to a 2003 report by the U.S. General Accounting Office, NIH spent about $484 million between 1977 and 2002 on research related to Taxol. BMS reported having spent $1 billion developing the drug. Once it hit the market in 1993, Taxol garnered the highest sales figures of any cancer drug in history, with worldwide revenues through 2002 topping $9 billion, partly on the strength of a $1,000-a-dose U.S. price. Primarily through Medicare, the federal government has been a major purchaser of Taxol, spending $687 million on the drug from 1994 through 1999. In comparison, as of 2003, NIH has received $35 million in royalty payments from BMS.
Best Alternative? Or Broken?
The argument for this R&D support system goes that without the fabulous "upside" potential of sales under patent, no company would take the enormous risks required to bring a drug like Avastin to market. Neither would companies engage in collaborations with government if that meant limits on prices. "It has consistently been shown that the ability to capitalize on invention is a tenet of innovation," says Caroline Loew, Ph.D., PhRMA senior vice president for scientific and regulatory affairs. If drugs are unaffordable to some, this argument suggests, that is a problem that should be addressed through more and better insurance coverage and charitable programs to assist the indigent. American pharmaceutical companies say they're doing their part by handing out free prescriptions—28 million last year in the United States—to poor patients.
On the other hand, some in Congress and in policy circles are convinced the system is indeed broken, and that its fundamental mistake is to use high, patent-protected prices as the reward for and principle stimulus of R&D. Supporting R&D with high prices at the pharmacy, say these critics, not only rations drugs according to ability to pay but encourages companies to
* spend huge sums on marketing the most lucrative patented products.
* develop patentable but therapeutically unimportant variations on existing products.
* protect product portfolios by keeping research, especially unfavorable results, secret.
Says Jamie Love, director of the Consumer Project on Technology, an organization concerned with intellectual policy and practices, and an expert on the economics of the drug industry, "When the price of a drug becomes like the price of a house in some cases, people are beginning to ask, is this really the best we can do?" [See sidebar, "Bringing Competition to Market," on new legislative proposals to overhaul the current system.]
Innovations on a Professor's Salary
The last half-century has birthed a panoply of new medical technologies. It has also seen the growth of health care costs from 5.9 percent of gross domestic product (GDP) in 1965 to 16 percent of GDP in 2006.
Over these same decades, Judah Folkman has been a veritable font of innovation, not only launching the field of angiogenesis research but also helping develop the first cardiac pacemaker and pioneering controlled-release technology found in the contraceptive Norplant. And he's done it on a professor's salary. Folkman has seen a small number of colleagues find success by founding start-ups; a few have failed. "It's a different kind of career," he remarks.
Even so, at 73, Folkman would dearly like to see the angiogenesis blocker he discovered, endostatin, fully tested, manufactured and made available to the ill patients who constantly call him seeking help. The small biotech firm EntreMed dropped endostatin in 2003, citing the high cost of manufacturing it. Now colleagues in Folkman's lab have altered the molecule to make it easier to produce. Folkman adds that their discovery has not yet been used to lower the manufacturing cost here in the United States, but the Chinese have come up with a different method that has already resulted in cheaper production. And his institution, Children's Hospital, is in possession of what in today's R&D world is an indispensable tool. "If you don't hold a patent," says Folkman, "they won't even talk to you."
tobala
Bluelight Crew
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An interesting point you made about MDMA. Makes one wonder why in 1985 the DEA insisted on putting it in Schedule I even against the advice of its own administrative law judge Francis Young.
Could it be? An unpatentable phenethylamine was more effective than the monkey-molecules the pharmaceutical giants were bringing to market?
Could it be? That the imminent scheduling of 100 unpatentable phenethylamines "substantially similar" (lol) to those already in Schedule I will place them beyond the reach of most accredited researchers, ensuring that they will never be brought to market?
Could it be? That in a single legislative action, the DEA will both avenge the egg Alexander Shulgin put on its face, and bury his creations in the Schedule I wasteland, effectively terminating them as a market threat to Lilly, Squibb, et al?
Could it be? An unpatentable phenethylamine was more effective than the monkey-molecules the pharmaceutical giants were bringing to market?
Could it be? That the imminent scheduling of 100 unpatentable phenethylamines "substantially similar" (lol) to those already in Schedule I will place them beyond the reach of most accredited researchers, ensuring that they will never be brought to market?
Could it be? That in a single legislative action, the DEA will both avenge the egg Alexander Shulgin put on its face, and bury his creations in the Schedule I wasteland, effectively terminating them as a market threat to Lilly, Squibb, et al?
Kalash
Bluelighter
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tobala said:
Seems pretty blatant to me...
But then...
Who knows.
I wasn't until it gained popularity that it was outlawed...
Supposedly they didn't know it was being used in therapy...
I don't think it matters if they knew or not...
Once they found out, they should have taken a different approach to its scheduling.
You know though - the DEA has no legislative authority.
The whole thing is bunk.
Myillefexher
Greenlighter
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- May 5, 2007
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- 8
I'm glad I read this before posting in Trip Reports...
LSD psychotherapy
was a book published when i was a teen in late 60's early 70's american publisher so that lets you know a little about this place now. by the way, his parents miraculously returned from aushwitz becuase they escaped the typhus epidemic. I suggest you browse holocaust myth ands see the scientific on site with pictures analyisis of this event. best regards
was a book published when i was a teen in late 60's early 70's american publisher so that lets you know a little about this place now. by the way, his parents miraculously returned from aushwitz becuase they escaped the typhus epidemic. I suggest you browse holocaust myth ands see the scientific on site with pictures analyisis of this event. best regards