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Roche knew Accutane Caused Depression-- Check out Doug Bremner's study (search doug bremner accutane on google) FDA DIDN"T DO THEIR JOB

The principal side effects of Accutane based on adverse reaction reports and published studies include general side effects such as photophobia, muscle and joint pain, insomnia, lethargy, central nervous system side effects such as pseudotumor cerebri, which is described as a serious condition involving swelling of the brain, visual disturbances, hearing deficiencies, malaise, drowsiness, amnesia, hallucinations, and psychiatric disorders, which include behavioral disorders, seizures, psychosis, schizophrenia, depression, suicide ideation, suicide thoughts and actions, and also as we all know, it's a teratogen.

What is Accutane? Accutane is an analog of vitamin A. It's likened to an overdose of vitamin A. There are many published studies showing that excess vitamin A causes a condition known as hypervitaminosis A. The study I mention here is a 1972 study, and it showed that the ingestion of large amounts of vitamin A is known to cause depression and psychiatric illness. In fact, we have also reports in the 1800s and the early 1900s of groups of people with high intake of vitamin A in their diet which caused major depression and psychiatric illness.

Therefore, the manufacturers of Accutane, Roche, would have been able to predict with reasonable certainty the main side effects caused by Accutane, including psychiatric side effects and teratogenicity. And that prediction could have been made with certainty prior to the drug ever being launched here in the United States or in other countries.

What do scientific literature reports say about Accutane? Well, there are a substantial number of published studies linking the ingestion of Accutane to the emergence of psychiatric disorders as far back as 1983, less than one year after the drug was released onto the market. I've only time to briefly refer to three of these studies.

The American Academy of Dermatology published a study in 1983 where the authors reported that 5.5 percent of patients experienced depressive symptoms while on Accutane. In the case of one 21-year-old man in that study, the symptoms of depression and forgetfulness were severe enough to cause withdrawal of the drug. So, within a few months of Accutane being introduced, the first independent study showed that 5.5 percent of patients experienced symptoms within 2 to 3 weeks of starting on Accutane.

Another published study in 1990 in the same dermatological magazine set out details of serious psychiatric disorders suffered by 7 patients where treatment had to be discontinued because of the severity of the side effects, and they were listed, including manic depression, suicidal thoughts, fear of going insane, et cetera. And remember, that was 1990.

Another study showed that adverse drug reaction reports for Accutane in the United States in the period from October 1982 to June 1985 represented the highest number of adverse drug reaction reports received by any agency for any prescription drug. It also stated that 22 percent of adverse drug reactions for Accutane relate to central nervous system disorders, such as headache, depression, dizziness, personality disorder, and pseudotumor cerebri. Now, that's 1985.

Sales of Accutane from 1982 to 1985 were very small in the United States because of publicity on the number and serious nature of birth defects caused by Accutane at that time. Accutane at that time had been likened to thalidomide. So, Accutane with small sales at that time was attracting more adverse drug reactions than any other prescription medicine, despite the fact that some of these other prescription medicines were being sold to not just tens but hundreds of millions of people.

In 1983, Dr. Bravard and two other French dermatologists published a paper where they set out details on three different people who attempted or committed suicide which they attributed to the taking of Accutane. The study resulted in a national inquiry in France between 1993 and 1994 in Montpellier, and the study was funded by Roche. The results of that study have still not been made available to us and have never been published. That's obviously something we're pursuing at present.

In 1998, we commissioned a study in order to determine whether five other prescription medications, representing 90 percent of the acne prescription market, were showing similar adverse drug reactions to those applicable of Accutane. Dr. T. Middelkoop, who is a research scientist, investigated these five prescription medications: minocycline, doxycycline, tetracycline, Dianette, oxytetracycline.

This table shows some of the data produced in the study. Now, you first of all must remember the data is May 1998, and therefore it's 2-and-a-half years out-of-date.

The number of people prescribed Accutane worldwide, according to Roche at that time, were 6 million. The number of people prescribed the other five medications was 300 million. In fact, it was more we subsequently discovered, but 300 million. So, you can see here that there were 170 cases of suicide, suicide attempt, and suicide ideation recorded at that time in connection with Accutane treatment, which we were told was 6 million people. The other medications produced no reported case of either suicide or suicide ideation, and 3 cases recorded for suicide attempt. And those are the medications, remember, that had been prescribed to 300 million people.

The study, which was published in 1999, also featured data for the United Kingdom. You see here that there were 23 case reports of suicide, suicide attempt, and suicide ideation for Accutane in the United Kingdom, but the number of prescriptions were shown at 12,400. The number of cases of suicide, suicide attempt, and suicide ideation for these other medications was nil. Not one case of suicide, suicide attempt, or suicide ideation, despite the fact that these other medications represent 90 percent of the acne prescription market. And yet, in this case you see 12,400 prescriptions, 23 cases of suicide, suicide attempt, and suicide ideation reports; 200 million prescriptions for the others, and no case.

The conclusion of the study was that Accutane is 900 times more likely to cause depression than the five other medications reviewed.

How many adverse drug reaction reports are there for Accutane? Well, in May 1998 Roche issued a letter to the Irish Medicines Board, which disclosed that there were 40,000 adverse drug reactions on the Roche database in respect of Roaccutane. A review of all ADR data recorded since that time suggests that there may well now be 50,000 to 55,000 such ADR reports for Accutane on the Roche worldwide database.

Studies show that only 1 in 10 serious ADRs are ever reported. In some countries, it may be only 1 in a 100. If we apply a factor of 10 to the number of adverse reactions recorded for Accutane, we get a figure of 500,000 or more, more than half a million people, which I think gives some idea of the number of people and the scale of suffering caused by this drug.

Roche have not provided a full list of all ADRs held in the Roche database for Accutane. The FDA and other national agencies have not received this full and detailed list of all ADRs, which I cannot understand. Dermatologists who prescribe this drug on a daily basis have not got the full list of adverse drug reactions worldwide in respect to this drug. Therefore, as I speak, I don't know and I doubt if anyone in this room, apart from the Roche people, knows the total number of suicides worldwide, suicide attempt, and suicide ideations recorded for the drug and also the number, up to tens of thousands, of psychiatric disorders recorded for the drug worldwide.

I'm just going to briefly mention Norway in reference to a group of 32 very courageous people in Norway who, in 1988, set up an Accutane support group and went to the media to highlight the terrible side effects caused by Accutane. We have the copy of the newspaper reports which are now 12 years out-of-date. They sought from the medical professional to devise proper medical treatment for people who had suffered this severe physical and psychiatric side effects which are listed in those publications in 1988.

As a result of this, the Norwegian Health Authority commissioned a study in 1992. The study was financed by Roche. The final report submitted to the Norwegian Health Authority in 1993 made no reference whatsoever to the scientific publications at that time linking the ingestion of Accutane and the emergence of psychiatric disorders and other items. They did not disclose the number or the nature of adverse drug reactions held on the Roche database at that time.

The French government health agency increased the label warnings for Accutane on the 3rd of March 1997 in order to feature suicide as a listed possible side effect. Roche did not inform the FDA or any other health agency that we've been in touch with of the increased label warnings applied by France featuring suicide as a possible side effect.

In the United Kingdom, Norway, Canada, Ireland, and many other countries, the label warning up to May 1998 simply featured possible mood change. So, people right up to May 1998 who took Accutane in Ireland, in the UK, and in other countries, when they opened the packaging, they got a label insert. The word "depression" didn't feature or other psychiatric illness.

Most countries applied the increased explicit label warning for Accutane in February to May 1998, featuring various psychiatric disorders, which are now pretty consistent, which say, on rare occasions, suicide, suicide attempt, and suicide ideation, as well as various psychiatric disorders.

This is the only prescription medication that I'm aware of sold by a pharmacist which features on the label insert suicidal thoughts and actions as a possible side effect. And we've done extensive studies in many countries just to see is there any other product with a label warning which features suicide.

Up to the last time of checking earlier this year, the Canadian label insert for Accutane contained no reference to depression, psychiatric disorders, or suicide. The Canadian label warning simply featured mood change as a possible side effect. So, despite the existence of label warnings in France for the past 3-and-a-half years, since March 1997, featuring suicide and psychiatric side effects, despite similar type increased label warnings in the United States and other countries since the area of 1998, it seems that Roche did not see the need to upgrade label warnings in Canada or to advise those patients in Canada who are taking this about current indications. It seems to me that since 1982, Roche applied the minimum label warnings it could get away with. Increased label warnings, of course, affect sales and they also affect profits.

Following the increased label warnings introduced by the FDA in February 1998, Roche placed advertisements in the media indicating that Accutane could alleviate depression. That was their reaction. On the 8th of March 1998, the FDA sent warning letters to Roche ordering them to withdraw the promotional material stating that they were false and misleading and promote Accutane for an unapproved use.

Roche used similar procedures or maybe tactics in the United Kingdom, but time does not permit me to just deal with those in detail at the moment.

Also, Roche used similar advertising tactics in Ireland after the increased label warnings were applied and a feature on that is by Drs. Bickers and Jacobs. And when we looked who were Drs. Bickers and Jacobs, we found that they had been employed by Roche in 1997 in order to try and persuade the FDA not to bring in increased label warnings.

It came to our attention that Accutane was for sale on the Internet. Now, as far as we can determine -- and we've been monitoring the Internet for many years -- the drug was not sold on the Internet prior to the increased label warnings, featuring psychiatric illness and suicide. To investigate the ease with which Accutane could be obtained online, we placed orders under the names of boys and girls in their teens. Within 10 days, we were supplied with the drug from South Africa with a prescription from a doctor with a South African address. Despite the restrictions for the prescribing of Accutane, such as blood tests, pregnancy tests, it is possible to get Accutane without a medical consultation. All you need is a credit card. No medical consultation. No meeting between patient and a doctor. No blood tests. No birth control safeguards. No monitoring of patients.

Now, Roche profits from sale of Accutane via the Internet could be in tens of millions and perhaps even hundreds of millions of dollars.

I would like to briefly refer to Roche pretrial studies for Accutane, which involved putting people on the medication and reporting on the results as part of the process for obtaining license in different countries, the United Kingdom, the States, different countries.

In one such study, 3 out of 76 subjects who developed adverse drug reactions to it were excluded from the results allegedly because they were dose-related. So, here you have a situation, 76 people put on the drug. 3 of them we are told developed side effects, but they were excluded. The side effects suffered by these 3 patients have never been disclosed to us, but we have investigated them and we are investigating them, as well as other pretrial studies in other countries.

I find it extraordinary that apparently the Roche pretrial studies in so many different countries, as part of a procedure to obtain a license, did not show up depression and psychiatric side effects. Yet, the first independent study within actually months of the drug being introduced come up that 5.5 percent of people on the drug developed depression within 2 to 3 weeks. And this was followed by other studies, putting certain numbers of people on the drug and showing X percent and Y percent that they had suffered side effects, that the side effects are very real, that people who suffered the side effects were taken off the drug, psychiatric side effects taken off the drug, left for 8 to 10 weeks, put back on the drug, and then within a matter of weeks or months, those same serious side effects, including suicidal thoughts and actions, came back.

Studies need to be undertaken by Roche or dermatologists to elucidate the mechanisms by which Accutane interacts with the central nervous system and other systems in the body. This will give us an insight into the causes of the specific side effects and hopefully leading to developing proper medical treatment for the tens of thousands, if not hundreds of thousands, of people who have suffered and continue to suffer severe side effects from this drug.

Roche have stated publicly for the past 17 years in every country -- because we followed the PR statements from Roche and they're all the same, and they haven't changed, by the way, since 1983 -- we do not know the mechanism by which this drug works. Therefore, there's no proof that Accutane causes depression or psychiatric disorders. And they have no shortage of medical people and others who will go up with this statement.

So, here we have a product. We know it causes the side effects, but why do they cause them? Well, that's not our problem. We don't know how it works. Therefore, don't ask me about the psychiatric side effects and don't ask me about all the many, many, many physical side effects. We as an organization now have to go out and are now spending our money because we know, of course, that the mechanism can be determined.

The final thing. The license for Accutane states that it should only be used for severe recalcitrant cystic acne as a treatment of last resort when all other treatments have failed. And that's the position in most of the countries, if not all of the countries. We believe that more than 80 percent of patients prescribed Accutane have mild or moderate acne, which is in violation of the license. Prescribing doctors should be required to certify that patient's acne is within the license guidelines.

I'll just mention. There was a survey on several hundred dermatologists, conducted by a professor well-known to this side of the house, which showed that 74 percent of patients were prescribed Accutane for mild or moderate acne. We have other studies in France, and if anybody wants to have a look at them, we would provide them -- showing that between 70 and 80 percent of people prescribed Accutane have mild or moderate acne. Of course, Roche know that. Everybody knows that. It's produced for severe nodular cystic acne. Unfortunately, the FDA and other national agencies say that they really can't do anything about it. It's the prerogative of the doctor.

Patients should have all the proper tests, blood tests, pregnancy tests, and so on which should be properly monitored.

Sale of Accutane on the Internet should be immediately prohibited.

Patients should be psychiatrically assessed, using the Hamilton Scale of Depression or a similar questionnaire, before and during Accutane treatment.

Independent studies urgently need to be carried out to establish exactly the mechanism by which this drug causes so many side effects.

An appropriate medical treatment -- this is probably the most important -- must be devised to counteract the side effects and to provide treatment for the many tens and hundreds of thousands of people who have suffered severe side effects from this drug.

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The principal side effects of Accutane based on adverse reaction reports and published studies include general side effects such as photophobia, muscle and joint pain, insomnia, lethargy, central nervous system side effects such as pseudotumor cerebri, which is described as a serious condition involving swelling of the brain, visual disturbances, hearing deficiencies, malaise, drowsiness, amnesia, hallucinations, and psychiatric disorders, which include behavioral disorders, seizures, psychosis, schizophrenia, depression, suicide ideation, suicide thoughts and actions, and also as we all know, it's a teratogen.

What is Accutane? Accutane is an analog of vitamin A. It's likened to an overdose of vitamin A. There are many published studies showing that excess vitamin A causes a condition known as hypervitaminosis A. The study I mention here is a 1972 study, and it showed that the ingestion of large amounts of vitamin A is known to cause depression and psychiatric illness. In fact, we have also reports in the 1800s and the early 1900s of groups of people with high intake of vitamin A in their diet which caused major depression and psychiatric illness.

Therefore, the manufacturers of Accutane, Roche, would have been able to predict with reasonable certainty the main side effects caused by Accutane, including psychiatric side effects and teratogenicity. And that prediction could have been made with certainty prior to the drug ever being launched here in the United States or in other countries.

What do scientific literature reports say about Accutane? Well, there are a substantial number of published studies linking the ingestion of Accutane to the emergence of psychiatric disorders as far back as 1983, less than one year after the drug was released onto the market. I've only time to briefly refer to three of these studies.

The American Academy of Dermatology published a study in 1983 where the authors reported that 5.5 percent of patients experienced depressive symptoms while on Accutane. In the case of one 21-year-old man in that study, the symptoms of depression and forgetfulness were severe enough to cause withdrawal of the drug. So, within a few months of Accutane being introduced, the first independent study showed that 5.5 percent of patients experienced symptoms within 2 to 3 weeks of starting on Accutane.

Another published study in 1990 in the same dermatological magazine set out details of serious psychiatric disorders suffered by 7 patients where treatment had to be discontinued because of the severity of the side effects, and they were listed, including manic depression, suicidal thoughts, fear of going insane, et cetera. And remember, that was 1990.

Another study showed that adverse drug reaction reports for Accutane in the United States in the period from October 1982 to June 1985 represented the highest number of adverse drug reaction reports received by any agency for any prescription drug. It also stated that 22 percent of adverse drug reactions for Accutane relate to central nervous system disorders, such as headache, depression, dizziness, personality disorder, and pseudotumor cerebri. Now, that's 1985.

Sales of Accutane from 1982 to 1985 were very small in the United States because of publicity on the number and serious nature of birth defects caused by Accutane at that time. Accutane at that time had been likened to thalidomide. So, Accutane with small sales at that time was attracting more adverse drug reactions than any other prescription medicine, despite the fact that some of these other prescription medicines were being sold to not just tens but hundreds of millions of people.

In 1983, Dr. Bravard and two other French dermatologists published a paper where they set out details on three different people who attempted or committed suicide which they attributed to the taking of Accutane. The study resulted in a national inquiry in France between 1993 and 1994 in Montpellier, and the study was funded by Roche. The results of that study have still not been made available to us and have never been published. That's obviously something we're pursuing at present.

In 1998, we commissioned a study in order to determine whether five other prescription medications, representing 90 percent of the acne prescription market, were showing similar adverse drug reactions to those applicable of Accutane. Dr. T. Middelkoop, who is a research scientist, investigated these five prescription medications: minocycline, doxycycline, tetracycline, Dianette, oxytetracycline.

This table shows some of the data produced in the study. Now, you first of all must remember the data is May 1998, and therefore it's 2-and-a-half years out-of-date.

The number of people prescribed Accutane worldwide, according to Roche at that time, were 6 million. The number of people prescribed the other five medications was 300 million. In fact, it was more we subsequently discovered, but 300 million. So, you can see here that there were 170 cases of suicide, suicide attempt, and suicide ideation recorded at that time in connection with Accutane treatment, which we were told was 6 million people. The other medications produced no reported case of either suicide or suicide ideation, and 3 cases recorded for suicide attempt. And those are the medications, remember, that had been prescribed to 300 million people.

The study, which was published in 1999, also featured data for the United Kingdom. You see here that there were 23 case reports of suicide, suicide attempt, and suicide ideation for Accutane in the United Kingdom, but the number of prescriptions were shown at 12,400. The number of cases of suicide, suicide attempt, and suicide ideation for these other medications was nil. Not one case of suicide, suicide attempt, or suicide ideation, despite the fact that these other medications represent 90 percent of the acne prescription market. And yet, in this case you see 12,400 prescriptions, 23 cases of suicide, suicide attempt, and suicide ideation reports; 200 million prescriptions for the others, and no case.

The conclusion of the study was that Accutane is 900 times more likely to cause depression than the five other medications reviewed.

How many adverse drug reaction reports are there for Accutane? Well, in May 1998 Roche issued a letter to the Irish Medicines Board, which disclosed that there were 40,000 adverse drug reactions on the Roche database in respect of Roaccutane. A review of all ADR data recorded since that time suggests that there may well now be 50,000 to 55,000 such ADR reports for Accutane on the Roche worldwide database.

Studies show that only 1 in 10 serious ADRs are ever reported. In some countries, it may be only 1 in a 100. If we apply a factor of 10 to the number of adverse reactions recorded for Accutane, we get a figure of 500,000 or more, more than half a million people, which I think gives some idea of the number of people and the scale of suffering caused by this drug.

Roche have not provided a full list of all ADRs held in the Roche database for Accutane. The FDA and other national agencies have not received this full and detailed list of all ADRs, which I cannot understand. Dermatologists who prescribe this drug on a daily basis have not got the full list of adverse drug reactions worldwide in respect to this drug. Therefore, as I speak, I don't know and I doubt if anyone in this room, apart from the Roche people, knows the total number of suicides worldwide, suicide attempt, and suicide ideations recorded for the drug and also the number, up to tens of thousands, of psychiatric disorders recorded for the drug worldwide.

I'm just going to briefly mention Norway in reference to a group of 32 very courageous people in Norway who, in 1988, set up an Accutane support group and went to the media to highlight the terrible side effects caused by Accutane. We have the copy of the newspaper reports which are now 12 years out-of-date. They sought from the medical professional to devise proper medical treatment for people who had suffered this severe physical and psychiatric side effects which are listed in those publications in 1988.

As a result of this, the Norwegian Health Authority commissioned a study in 1992. The study was financed by Roche. The final report submitted to the Norwegian Health Authority in 1993 made no reference whatsoever to the scientific publications at that time linking the ingestion of Accutane and the emergence of psychiatric disorders and other items. They did not disclose the number or the nature of adverse drug reactions held on the Roche database at that time.

The French government health agency increased the label warnings for Accutane on the 3rd of March 1997 in order to feature suicide as a listed possible side effect. Roche did not inform the FDA or any other health agency that we've been in touch with of the increased label warnings applied by France featuring suicide as a possible side effect.

In the United Kingdom, Norway, Canada, Ireland, and many other countries, the label warning up to May 1998 simply featured possible mood change. So, people right up to May 1998 who took Accutane in Ireland, in the UK, and in other countries, when they opened the packaging, they got a label insert. The word "depression" didn't feature or other psychiatric illness.

Most countries applied the increased explicit label warning for Accutane in February to May 1998, featuring various psychiatric disorders, which are now pretty consistent, which say, on rare occasions, suicide, suicide attempt, and suicide ideation, as well as various psychiatric disorders.

This is the only prescription medication that I'm aware of sold by a pharmacist which features on the label insert suicidal thoughts and actions as a possible side effect. And we've done extensive studies in many countries just to see is there any other product with a label warning which features suicide.

Up to the last time of checking earlier this year, the Canadian label insert for Accutane contained no reference to depression, psychiatric disorders, or suicide. The Canadian label warning simply featured mood change as a possible side effect. So, despite the existence of label warnings in France for the past 3-and-a-half years, since March 1997, featuring suicide and psychiatric side effects, despite similar type increased label warnings in the United States and other countries since the area of 1998, it seems that Roche did not see the need to upgrade label warnings in Canada or to advise those patients in Canada who are taking this about current indications. It seems to me that since 1982, Roche applied the minimum label warnings it could get away with. Increased label warnings, of course, affect sales and they also affect profits.

Following the increased label warnings introduced by the FDA in February 1998, Roche placed advertisements in the media indicating that Accutane could alleviate depression. That was their reaction. On the 8th of March 1998, the FDA sent warning letters to Roche ordering them to withdraw the promotional material stating that they were false and misleading and promote Accutane for an unapproved use.

Roche used similar procedures or maybe tactics in the United Kingdom, but time does not permit me to just deal with those in detail at the moment.

Also, Roche used similar advertising tactics in Ireland after the increased label warnings were applied and a feature on that is by Drs. Bickers and Jacobs. And when we looked who were Drs. Bickers and Jacobs, we found that they had been employed by Roche in 1997 in order to try and persuade the FDA not to bring in increased label warnings.

It came to our attention that Accutane was for sale on the Internet. Now, as far as we can determine -- and we've been monitoring the Internet for many years -- the drug was not sold on the Internet prior to the increased label warnings, featuring psychiatric illness and suicide. To investigate the ease with which Accutane could be obtained online, we placed orders under the names of boys and girls in their teens. Within 10 days, we were supplied with the drug from South Africa with a prescription from a doctor with a South African address. Despite the restrictions for the prescribing of Accutane, such as blood tests, pregnancy tests, it is possible to get Accutane without a medical consultation. All you need is a credit card. No medical consultation. No meeting between patient and a doctor. No blood tests. No birth control safeguards. No monitoring of patients.

Now, Roche profits from sale of Accutane via the Internet could be in tens of millions and perhaps even hundreds of millions of dollars.

I would like to briefly refer to Roche pretrial studies for Accutane, which involved putting people on the medication and reporting on the results as part of the process for obtaining license in different countries, the United Kingdom, the States, different countries.

In one such study, 3 out of 76 subjects who developed adverse drug reactions to it were excluded from the results allegedly because they were dose-related. So, here you have a situation, 76 people put on the drug. 3 of them we are told developed side effects, but they were excluded. The side effects suffered by these 3 patients have never been disclosed to us, but we have investigated them and we are investigating them, as well as other pretrial studies in other countries.

I find it extraordinary that apparently the Roche pretrial studies in so many different countries, as part of a procedure to obtain a license, did not show up depression and psychiatric side effects. Yet, the first independent study within actually months of the drug being introduced come up that 5.5 percent of people on the drug developed depression within 2 to 3 weeks. And this was followed by other studies, putting certain numbers of people on the drug and showing X percent and Y percent that they had suffered side effects, that the side effects are very real, that people who suffered the side effects were taken off the drug, psychiatric side effects taken off the drug, left for 8 to 10 weeks, put back on the drug, and then within a matter of weeks or months, those same serious side effects, including suicidal thoughts and actions, came back.

Studies need to be undertaken by Roche or dermatologists to elucidate the mechanisms by which Accutane interacts with the central nervous system and other systems in the body. This will give us an insight into the causes of the specific side effects and hopefully leading to developing proper medical treatment for the tens of thousands, if not hundreds of thousands, of people who have suffered and continue to suffer severe side effects from this drug.

Roche have stated publicly for the past 17 years in every country -- because we followed the PR statements from Roche and they're all the same, and they haven't changed, by the way, since 1983 -- we do not know the mechanism by which this drug works. Therefore, there's no proof that Accutane causes depression or psychiatric disorders. And they have no shortage of medical people and others who will go up with this statement.

So, here we have a product. We know it causes the side effects, but why do they cause them? Well, that's not our problem. We don't know how it works. Therefore, don't ask me about the psychiatric side effects and don't ask me about all the many, many, many physical side effects. We as an organization now have to go out and are now spending our money because we know, of course, that the mechanism can be determined.

The final thing. The license for Accutane states that it should only be used for severe recalcitrant cystic acne as a treatment of last resort when all other treatments have failed. And that's the position in most of the countries, if not all of the countries. We believe that more than 80 percent of patients prescribed Accutane have mild or moderate acne, which is in violation of the license. Prescribing doctors should be required to certify that patient's acne is within the license guidelines.

I'll just mention. There was a survey on several hundred dermatologists, conducted by a professor well-known to this side of the house, which showed that 74 percent of patients were prescribed Accutane for mild or moderate acne. We have other studies in France, and if anybody wants to have a look at them, we would provide them -- showing that between 70 and 80 percent of people prescribed Accutane have mild or moderate acne. Of course, Roche know that. Everybody knows that. It's produced for severe nodular cystic acne. Unfortunately, the FDA and other national agencies say that they really can't do anything about it. It's the prerogative of the doctor.

Patients should have all the proper tests, blood tests, pregnancy tests, and so on which should be properly monitored.

Sale of Accutane on the Internet should be immediately prohibited.

Patients should be psychiatrically assessed, using the Hamilton Scale of Depression or a similar questionnaire, before and during Accutane treatment.

Independent studies urgently need to be carried out to establish exactly the mechanism by which this drug causes so many side effects.

An appropriate medical treatment -- this is probably the most important -- must be devised to counteract the side effects and to provide treatment for the many tens and hundreds of thousands of people who have suffered severe side effects from this drug.

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Are there any updates to any of this information? How about alterations in sexual behavior or erectile dysfunction? Any other physically threatening or violent behaviors as a result of accutane usage?

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tl;dr

it's because of people like you that we are blessed with a government that can take advantage of us.

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