![[dr. bob]](/dr-bob-sm.gif)
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.orgShown: posts 1 to 3 of 3. This is the beginning of the thread.
Posted by AndrewB on November 25, 2000, at 22:46:17
The following excerpt details the lack of availablity of many good drugs in the US and goes on to explain why this has occurred and suggests a means of rectifying this unfortunate situation. To view the full article (entitled, "The Economics of Psychotropic Drug Development") go to www.acnp.org/G4/GN401000182/default.htm.
---------------------------------------
Psychopharmacological innovations are not disseminated to all countries at even roughly the same time. In some instances, the lag between the availability of a psychotropic drug in two countries is substantial. A number of studies have specifically examined the availability of new drugs in the United States in relation to other industrialized countries. Wardell (44) documented a U.S. lag with respect to the United Kingdom in the availability of new drugs introduced in either market during 1962 to 1971. He found that, of 28 psychotropic NCEs approved in either country, 13 were exclusively available in the United Kingdom, while only four were exclusively available in the United States.Later studies updated the Wardell analysis for more recent periods. Wardell (45) examined NCEs approved in the United States and the United Kingdom during 1972 to 1976. Of the 14 psychotropic NCEs made available during this period, eight were exclusively available in the United Kingdom and three were exclusively available in the United States. The most recent update in this series (25) found that, of 29 psychotropic NCEs made available during 1977 to 1987, 12 were exclusively available in the United Kingdom and five were exclusively available in the United States. Of the 12 psychotropic NCEs that were mutually available during this period, nine had been introduced in the United Kingdom first.
More recently, Kessler et al. (29) of the FDA compared the availability in four countries (United States, Germany, Japan, United Kingdom) of drugs introduced onto the world market from 1990 to 1994. The therapeutic value of these drugs was assessed based on the FDA’s therapeutic rating system and the expert judgment of the study’s authors. Overall, the availability of drugs that entered the United States market and the markets of at least one of the other three countries was obtained more quickly in the United States than in Germany and Japan. The speed with which drugs entered the U.S. and U.K. markets was similar.
Moreover, in two-country comparisons of drugs that were available in one country but not the other, the authors found that the United States had more exclusively available important drugs when compared to each of the other countries. However, when we examined the drugs in the Kessler et al. (29) sample that were available in the United States and not in one of the other three countries (as of April 1995) we found few psychotropic drugs. Of the 18 drugs that were available in the United States but not the United Kingdom, none are psychotropics. Additionally, of the 31 drugs that were available in the United States but not in Germany, three are psychotropics (nefazodone, sertraline, and venlafaxine). Finally, of the 62 drugs that were available in the United States but not in Japan, five are psychotropics (nefazodone, paroxetine, risperidone, sertraline, and venlafaxine). Among the psychotropics that were available in the United States and not in at least one of the other three countries, the United States was the first market worldwide for only one (venlafaxine).
The availability of psychotropic drugs was the focus of two recent studies. Vinar et al. (43) surveyed clinical pharmacologists about the usefulness of 50 psychotropic drugs that were either marketed or in late stage clinical trials in Europe, but not available in the United States, for therapy or as a research tool. Twenty of these drugs were judged to be of particular interest after experts rated the drugs on the basis of novelty of mechanism of action and probable safety in comparison with drugs available in the United States. Some of the drugs have been available in Europe for decades. As of the end of October 1998, none of these drugs had been approved in the United States.
Many of the drugs in the Vinar et al. (43) list have lost, or are close to losing, patent protection. They therefore likely have limited economic potential. Vinar et al. argue for the creation of a board of pharmacological experts that would make recommendations to the FDA about foreign drugs that should be considered for accelerated regulatory review and, like compounds now given orphan drug designation, be granted a period of marketing exclusivity.
Glick et al. (17) examined the controlled clinical trial literature and surveyed 61 expert clinicians (from six West European and two East European countries), European regulatory authorities, and representatives of the pharmaceutical industry to identify psychotropic drugs with apparent advantages over conventional treatments that are available in Europe but not in the United States. The authors identified 12 compounds, eight of which had been approved in three or more of six countries whose approvals were examined. As of this writing, none of the 12 drugs have been approved for marketing in the United States. As in Vinar et al. (43) the authors recommend that a board of experts be established in the United States that would be empowered to extend marketing exclusivity for promising compounds (if approved by the FDA) that are available abroad. Additionally, for compounds that have lost patent protection they suggest government support of clinical trials in academic centers.
Many of the psychotropic drugs that do make it to the U.S. market have had lengthy periods of prior foreign marketing. The CSDD database on NCEs approved in the United States contains information on the country in which the NCE was first marketed and the date of first marketing. Figure 10 shows how psychotropic NCEs approved in the United States are distributed according to the number of years of prior foreign marketing. The United States was the first market for only 29% of the drugs. The proportions of drugs approved first in the United States or within one year of approval in the
United States are similar for all NCEs as for psychotropic drugs (33% approved in the United States first and 15% approved within one year of first foreign marketing for all NCEs). Proportionately many more of the psychotropic drugs that have been approved in the United States, however, have been available in a foreign market for a very long time. Only 10% of all NCEs have six to ten years of prior marketing, and 9% of all NCEs have been marketed in another country for more than ten years prior to U.S. approval. The lengthiest periods of prior foreign marketing for the psychotropics were for some of the most innovative drugs in this class. Clozapine was available in a foreign market (Switzerland) 17 years prior to U.S. approval, and clomipramine was first available 20 years before U.S. approval (Finland).
Posted by stjames on November 26, 2000, at 3:33:35
In reply to Good Foreign Drugs Not Available in the US, posted by AndrewB on November 25, 2000, at 22:46:17
Intresting. In the US we seem to benifit from stringent
drug lisence laws. There were no flipper babies in the US because of them. In the case of AIDS it seemed prudent to
some to speed up the approval process. It makes sense, people could die
while we waited 5-10 years to prove saftey and effectiveness. Speeding things up did mean
we had less data on when and how much to use. AZT and others were not used till late stage, while now we
know they are better given sooner. To be fair, this fact is more due to advancement in knowlage of AIDS itself.
We assumed AIDS lay dormant till someone was sick, this proved to be incorrect.James
Posted by JohnL on November 27, 2000, at 5:42:46
In reply to Good Foreign Drugs Not Available in the US, posted by AndrewB on November 25, 2000, at 22:46:17
Very interesting. I remember reading in a magazine somewhere that the French are way of ahead of the USA in terms of psychiatric drug research. The first SSRI came from them.
I think it's an absolute disaster that Adrafinil and Amisulpride are not available in the USA.
My father is a retired surgeon and believes strongly in the FDA drug approval process. I tend to disagree somewhat, for several reasons:
1) Even with the scrutiny and approval by the FDA, there have been blunders that later proved dangerous. The FDA makes mistakes. Sometimes they underestimate the risk of a drug and approve it anyway. Sometimes they overestimate the risk of a drug and don't approve it. Either way, suffering is increased instead of helped. For the most part they do a good job, but I think they are way to slow and way too political.
2) Many drugs, such as mentioned in this article, have already had extensive testing as well as extensive real-world utilization in other countries. They have such a solid history it almost seems redundant that the FDA would have to study them as if they were somehow new drugs.In any case, I think the FDA is way way too slow. In their effort to prevent suffering, I think they actually increase it instead. There are, in my opinion, drugs out there in the world that totally blow our USA drugs in the weeds. And they've been in use for decades. They should be here by now. Geez. Oh well. Anyway, as with any drug decision, there is a risk/benefit choice that has to be made. I think the doctor and the patient are the ones to make that decision, not the FDA. Of course, there are exceptions to every rule, but that's generally how I feel.
Thank goodness for international pharmacies!
John
This is the end of the thread.
Psycho-Babble Medication | Extras | FAQ
Dr. Bob is Robert Hsiung, MD,
bob@dr-bob.org
Script revised: February 4, 2008
URL: http://www.dr-bob.org/cgi-bin/pb/mget.pl
Copyright 2006-17 Robert Hsiung.
Owned and operated by Dr. Bob LLC and not the University of Chicago.