We also need to keep in mind that the current marketing practices for pharmaceutical companies significantly drive up prices. There is a balance to be struck between educating consumers and physicians by television commercials and promotional materials about the availability of new therapies to treat disease and conditions and cost containment. The truth is that agressive marketing practices are designed to garner a larger share of the market--and a larger share of the profits, not to benefit consumers.
Dick Gaffron can give better, more detailed information, but I was able to find the National Institute on Drug Abuse site, listing phases of human clinical trials for new drugs.
You should be aware that years of research and development (and expenses) take place before reaching Phase 1 clinical trials.
I opened the link as a text doc. but also cut and pasted below. Here's the link:
http://frwebgate.access.gpo.gov/cgi-bin/get-cfr.cgi?TITLE=21&PART=312&SECTION=21&YEAR=2001&TYPE=TEXT
(a) Phase 1. (1) Phase 1 includes the initial introduction of an investigational new drug into humans. Phase 1 studies are typically closely monitored and may be conducted in patients or normal volunteer subjects. These studies are designed to determine the metabolism and pharmacologic actions of the drug in humans, the side effects associated with increasing doses, and, if possible, to gain early evidence on effectiveness. During Phase 1, sufficient information about the drug's pharmacokinetics and pharmacological effects should be obtained to permit the design of well-controlled, scientifically valid, Phase 2 studies. The total number of subjects and patients included in Phase 1 studies varies with the drug, but is generally in the range of 20 to 80. (2) Phase 1 studies also include studies of drug metabolism, structure-activity relationships, and mechanism of action in humans, as well as studies in which investigational drugs are used as research tools to explore biological phenomena or disease processes. (b) Phase 2. Phase 2 includes the controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug. Phase 2 studies are typically well controlled, closely monitored, and conducted in a relatively small number of patients, usually involving no more than several hundred subjects. (c) Phase 3. Phase 3 studies are expanded controlled and uncontrolled trials. They are performed after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather the additional information about effectiveness and safety that is needed to evaluate the overall benefit-risk relationship of the drug and to provide an adequate basis for physician labeling. Phase 3 studies usually include from several hundred to several thousand subjects.
Terri Hyle
From: "Robert P Kaldunski" <[EMAIL PROTECTED]>
To: "Dick Gaffron" <[EMAIL PROTECTED]>,"Fellman's" <[EMAIL PROTECTED]>, <[EMAIL PROTECTED]>,"Dwayne Voegeli" <[EMAIL PROTECTED]>
Subject: Re: [Winona] Insurance Execs Bribing Democrats AND Republicans?
Date: Sat, 15 Nov 2003 09:31:14 -0600
[Winona Online Democracy]
The Pharmacist have a viable interest in telling the Federal Government to Straighten out the FDA. I fail to understand the reason for testing people other than the
the intended people who would use the drugs in order to get approval, and why can't the FDA make use of the same approval strategy that is used in other countries to get a drug approved. This would help lower the price, give the Mfg's a better profit while keeping the price affordable to the persons on a fixed income. Bob Kaldunski ----- Original Message ----- From: "Dick Gaffron" <[EMAIL PROTECTED]> To: "Fellman's" <[EMAIL PROTECTED]>; <[EMAIL PROTECTED]>; "Dwayne Voegeli" <[EMAIL PROTECTED]> Sent: Saturday, November 15, 2003 7:18 AM Subject: Re: [Winona] Insurance Execs Bribing Democrats AND Republicans?
> [Winona Online Democracy]
>
> Just a post from a pharmacy perspective about Canadian Drugs. Some of the
> savings we are seeing on drugs from Canada have to do with the exchange
> rate. The manufacturers will point this out also. At last report, the
> exchange rate was 75-76 cents giving an automatic 24-25% savings. Also,
> Canadian pharmacies only purchase drugs from the government and the
> inventory in those pharmacies is "on consignment". The pharmacies do not
> pay for the drugs until they are sold. In contrast, most US pharmacies
have
> to carry well over $100,000 in inventory to satisfy the needs of our
> patients.
> The Minnesota Pharmacists Association has taken a position against
> the re-importation issue for several reasons. We can argue the safety
> issue, but I believe that is a weak point as all the drugs are made is US
> factories under FDA supervision. The real point is the inability of US
> pharmacies to purchase pharmaceuticals at the Canadian contract prices.
By
> allowing the sale of foreign drugs in this country and particularly this
> state, it is suggested by the Pharmacists Association that many Minnesota
> Pharmacies would be forced to close. With insurance being generally over
> 80% of the business pharmacies do, our margins have shrunk to 1/4 what
they
> were even 10 years ago. With a national shortage of pharmacists, labor
> costs also continue to rise. Somewhere the "rubber had to meet the road"
> and independent pharmacies will suffer the most. The Association claims
> that net profits for pharmacies is only about 2% and the loss of business
to
> Canadian and other countries would put pharmacies into the red and many
out
> of business.
> Personally, I think it's time the manufacturers were called to
task
> and forced to contract with States, as they have with Canada. I think the
> states should be the place for these negotiations, not the Federal
> government. Each state has unique populations and market influences and
> would be more appropriate. This idea as proposed in Minnesota in a
> legislative session a while back, and was soundly defeated by drug company
> lobbying. It would be worth a try again. Many people do not know that
> non-profit institutions such as some hospitals, nursing homes, and
"teaching
> clinics" now have group contracts for certain drugs at lower prices.
> Sorry for the lengthy post, but I think we need to look at the
> pharmaceutical issue from all angles. Finally, pharmacist contact with our
> patients is not only essential, but required in most cases. Medicaid
> patients must be counseled about their prescriptions. How can a foreign
> pharmacy give you the most accurate and personal information on your
> prescription? Your local pharmacies do and in a very professional manner.
> All of us are willing to answer questions and if we don't have an answer,
> know where to get that answer. Dick Gaffron
> ----- Original Message -----
> From: "Fellman's" <[EMAIL PROTECTED]>
> To: <[EMAIL PROTECTED]>; "Dwayne Voegeli" <[EMAIL PROTECTED]>
> Sent: Thursday, November 13, 2003 10:35 PM
> Subject: Re: [Winona] Insurance Execs Bribing Democrats AND Republicans?
>
>
> > [Winona Online Democracy]
> >
> > In answer to Dwayne's question about why drugs are so much cheaper in
> > Canada...... Could it be that because in their government run, single
> payer
> > system that healthcare is rationed and therefore the demand for drugs is
> > low....
> >
> > Just a thought, no real basis in fact.
> >
> > Greg Fellman
> >
> >
> >
> > ----- Original Message -----
> > From: "Dwayne Voegeli" <[EMAIL PROTECTED]>
> > To: <[EMAIL PROTECTED]>
> > Sent: Thursday, November 13, 2003 10:00 PM
> > Subject: Re: [Winona] Insurance Execs Bribing Democrats AND Republicans?
> >
> >
> > > [Winona Online Democracy]
> > >
> > > (First of all, I aplogize that the mysterious missing e-mails I had
sent
> > > over the weekend seemed to reappear from cyberspace limbo. I'm sorry
> for
> > > clogging up your in boxes with repetitive messages. Others seemed to
> have
> > > had the same problem. Solar storms? Soviets? Bad e-mail karma?)
> > >
> > > -----
> > >
> > > Back to John Finn's and Paul Double's E-mails about Health Insurance.
> > >
> > > -----
> > >
> > > John, I think I read the same article you did about the cash-payment
> only
> > > doctors. Was it in last week's Wall Street Journal?
> > >
> > > In any event, it is an interesting idea.
> > >
> > > You finished by saying, "the debate over what constitutes a living
wage
> > and
> > > which employers are 'good or bad' is muddled by having an employment
> based
> > > health insurance system." I completely agree. One of the biggest
> winners
> > > in a single payer system would be small and medium sized business
owners
> > > who would get the health care coverage monkey off their backs.
> > >
> > > (There is a great article about the problems that soaring health care
> > costs
> > > are causing between workers and business owners in the Business
Section
> of
> > > the Sunday, November 2, 2003 edition of the Star Tribune. I would
have
> > > included the URL but I can not seem to access their archives even
though
> > > I'm a subscriber.)
> > >
> > > -----
> > >
> > > To Paul Double, you are scaring me. We're beginning to agree on a lot
> > when
> > > it comes to health care reform.
> > >
> > > ;->
> > >
> > > You're also starting to sound like a Teddy Roosevelt Republican.
Maybe
> > the
> > > Republic can be saved from the aristocrats who want to turn it into an
> > > Empire after all.
> > >
> > > About elections. You can't seperate health care reform from
democratic
> > > reform (read campaign finance reforms). Until and unless the
> Republicans
> > > and Democrats support the Fair and Clean Election (F.A.C.E.) bill in
the
> > > Minnesota Legislature, we will not see real health care reform in the
> > state
> > > because super-big drug and insurance corporations own both parties, at
> > > least the tops of both organizations.
> > >
> > > Publicly funded campaigns first. (they would be voluntary)
> > >
> > > Health care reform that truly benefits the public second.
> > >
> > > Again, why are drugs so much cheaper in Canada in the first place?
> > >
> > > Dwayne Voegeli
> > >
> > > ==================
> > >
> > >
> > > >From: "John N. Finn" <[EMAIL PROTECTED]>
> > > >To: "Online Democracy" <[EMAIL PROTECTED]>
> > > >Date: Wed, 12 Nov 2003 05:40:24 -0600
> > > >Status:
> > > >
> > > >[Winona Online Democracy]
> > > >
> > > >
> > > >----- Original Message -----
> > > >From: "Paul Double" <[EMAIL PROTECTED]>
> > > >To: "Online Democracy" <[EMAIL PROTECTED]>
> > > >Sent: 11 novembre, 2003 14:52
> > > >Subject: FW: [Winona] Insurance Execs Bribing Democrats AND
> Republicans?
> > > >
> > > >
> > > >................. What maybe will be different in the next two years
is
> > the
> > > >fact that the public conservatives, liberals and others appear to be
> > ready
> > > >to partner at
> > > >least on healthcare "solutions". .............
> > > >
> > > >----- Response -----
> > > >
> > > >I'm not sure how relevant this is, but I recently read an article
about
> a
> > > >doctor that runs a 'cash at time of treatment' clinic. That is, he
> > accepts
> > > >no insurance or third party payments, thus greatly reducing his
> paperwork
> > > >shuffling overhead costs. His customers include those lacking
> insurance,
> > of
> > > >course, but also some that are covered because his fees are often not
> > much
> > > >more that the co-pays they would have had to pay in their plan's
> network.
> > > >
> > > >Also, it seems to me that the debate over what constitutes a living
> wage
> > and
> > > >which employers are 'good or bad' is muddled by having an employment
> > based
> > > >health insurance system.
> > > >
> > > >
> > > >_______________________________________________
> > > >This message was posted to Winona Online Democracy
> > > >All messages must be signed by the senders actual name.
> > > >No commercial solicitations are allowed on this list.
> > > >To manage your subscription or view the message archives, please
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> > > >http://mapnp.mnforum.org/mailman/listinfo/winona
> > > >Any problems or suggestions can be directed to
> > > >mailto:[EMAIL PROTECTED]
> > > >If you want help on how to contact elected officials, go to the
Contact
> > page at
> > > > http://www.winonaonlinedemocracy.org
> > > >
> > >
> > > ------------
> > >
> > > Dwayne Voegeli
> > >
> > > Winona County Commissioner, District #2
> > >
> > > (507) 453-9012
> > >
> > > [EMAIL PROTECTED]
> > >
> > > 359 Pleasant Hill Dr.
> > > Winona, MN 55987
> > >
> > > ------------
> > >
> > >
> > > _______________________________________________
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> > > mailto:[EMAIL PROTECTED]
> > > If you want help on how to contact elected officials, go to the
Contact
> > page at
> > > http://www.winonaonlinedemocracy.org
> >
> > _______________________________________________
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>
>
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