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There is no drug rep involved.
Problems with generic stimulants
- Thread starter PikminOC
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Is there more than one generic for adderall xr?
For adderall?
Any complaints about either generic?
For adderall?
Any complaints about either generic?
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There is more than one generic manufacturer for Adderall XR, as well as for Adderall. Even if there weren't, it is almost always clinically uninformative when a patient complains about a switch from brand to generic, for all the reasons already discussed in this thread, and in particular for psych indications that do not have good objective measures of effectiveness.
What exactly are your patients' complaints? Does the generic not work at all? Does the XR wear off sooner than it used to? Do they score differently on rating scales for ADHD (e.g. ASRS or CAARS)? What exactly are they reporting?
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This backs up Grover.
http://thepigeonpost.org/2010/06/09/teva-pharmaceuticals-and-poor-quality-generic-drugs/
"With the costs of name-brand drugs rising exponentially over the past 20 years, resulting in higher premiums and co-pays, US citizens have, to a large extent, been able to count on lower-priced generics to sway the high costs of name brand drugs. Generics have always been assumed to be the same as their name-brand equivalents by both the public and the Doctors prescribing them and Insurance companies requiring them.
This is not the case anymore as Teva Pharmaceuticals, based in Israel, has been swallowing up many of the leading generic drug manufactures over the past 10 years, making them the sole producer of many of the important generics that so many of us count on for a myriad of medical conditions.
The fact that Teva is buying up the competition is not the focus — though corporate monopolies are never good for consumers. It is the fact that so many of Teva’s generics are poorly produced in third-world countries and are not the same as their brand-name equivalents. While the main chemical components of their drugs are technically the same, or bio-equivalent (according to the FDA), as the main chemical compound of the name-brand, it is the low-quality precursor chemicals, inferior manufacturing facilities and lack of production oversight that is causing adverse and harmful reactions in consumers that have begun taking generics produced under the Teva Umbrella.
Teva takes over
Teva was officially created in 1976 after the merger of three pharmaceutical companies created in Israel by European Immigrants. In 1982, the FDA approved its main manufacturing plant — and so began the path to market domination.
Teva is not solely interested in generics as they have produced some very effective and useful proprietary drugs such as Copaxone and Azilect. Despite their own research and development, Teva’s meteoric rise atop the pharmaceutical food chain has come through buying and merging with other large drug manufacturers. Most recently, the acquisition of Barr Pharmaceuticals in 2008 for over 7 billion dollars has further entrenched them in generic manufacturing.
Barr had been the largest generic manufacturer in the world when they were acquired by Teva. This, in and of itself, is not necessarily earth-shattering information — big company acquires other big company, making bigger company; the way of capitalism. The relevance of the Barr acquisition lies in the history of Barr–a history of corruption and inferior production standards. Teva, as far as pharmaceutical giants go, has typically been considered a quality developer and producer of proprietary drugs up until the past few years. It is their acquisitions over the past ten years — Barr in particular — and their quest to cheaply produce generics to make even more money that has brought their quality standards under scrutiny.
Lowering the Barr
Barr was an outsider looking in for many years, trying desperately to get FDA approval for its generics. But this quest was deterred by the FDA, who was approving generics and other drugs for the highest bidder.
The company earned notoriety during the late 1980s, when its founder testified before a congressional committee about bribes between generic drug producers and U.S. Food & Drug Administration officials. Funding Universe
This testimony would actually set Barr back a bit throughout the 80s and into the early 90s as the FDA, in possible retaliation, stonewalled the approval for many of Barr’s bio-equivalent manufacturing requests. This would change in the mid 90s when Barr became more aggressive in its approach. With a team of highly paid attorneys, Barr set out to find loopholes in the patents of many popular name-brand drugs. One of the more notable patent challenges came against Eli Lilly’s Prozac in 1996.
Challenging existing patents with a “dream team” of patent layers would become Barr’s main focus in the late 90s and throughout this decade. Considering Barr had smoothed over relations with the FDA in the 90s, getting bio-equivalency approval after winning patent challenges in court was a quick and easy process — unlike the 80s which led Barr to testify against the FDA in the first place. Now, Barr was in the driver’s seat as they swallowed up other generic manufacturers and continued to win patent suits and gain first rights to bio-equivalency claims of expiring patents.
When Barr was acquired by Teva in 2008, a string of voluntary re-calls would soon follow. Despite Barr’s unscrupulous business history, quality-control of their drugs was never a big issue. With Teva’s acquisition and control of Barr and its wide scope of generic manufacturing, the quest to make their drugs at the cheapest price possible has resulted in the use of low-quality precursor chemicals and a complete lack of manufacturing oversight. Just nine months ago, Barr’s genericAdderall was re-called because they were distributing batches at four to five times the listed dosage. Considering Adderall is a blend of amphetamines, this resulted in an array of cardiovascular and psychological problems for those unfortunate enough to take these potent Adderall pills.
While on the subject of Adderall, it is of importance to note the complacency of many of the major brand-name drug manufacturers in allowing their proprietary formulas to be produced in a manner inconsistent with their own production standards. Shire pharmaceuticals, the original producer of Adderall, has recently granted Barr/Teva the right to be the sole manufacturer of Extended Release Adderall, which is still under patent.
The reason for this is of course profit. Shire has a large stake in the growing ADHD market, and are pushing their new ADHD drug Vyvanse as the be all and end all of ADHD medication. Essentially, they have given up any concern over the quality perceptions of the very popular and widely used Adderall to push Vyvanse; which is simply Dextro-Amphetamine (Dexidrine) with lysine bonded to it, supposedly creating a less abusable prodrug of something that has been around for over a hundred years. I’ll save my critique of the ineffectiveness of Vyvanse for another time as that would involve delving into some complicated bio and neuro-chemistry.
In addition to the Adderall recalls, there have been others just in the past two years since Barr was acquired by Teva. Obviously, recalls and production errors happen, but Teva seems to make more mistakes than what one would consider acceptable when dealing with drugs that are used to treat life-threatening illnesses. The pharmaceutical industry as a whole, has historically shown indifference to their actual consumers for the sake of generating more profit.
With Teva taking over such a large portion of the generic drug market, this could be a scary proposition for those who depend on affordable drugs for treating a variety medical conditions. The FDA, the federal administration responsible for overseeing the safety and effectiveness of these medications has continued to turn a blind eye to the issues of Teva — and every other drug manufacturer with deep pockets. Considering the FDA’s history of corruption and the fact that it is made up largely of former pharmaceutical executives and representatives, their apathy toward consumers in favor of these corporations should come as no surprise. If the FDA cannot be cleaned up, big pharma companies like Teva will continue produce medication not fit for public consumption; the consequences of which could be quite devastating — they already have been for millions of individuals worldwide."
Written by Todd Curl on 09 June 2010
http://thepigeonpost.org/2010/06/09/teva-pharmaceuticals-and-poor-quality-generic-drugs/
"With the costs of name-brand drugs rising exponentially over the past 20 years, resulting in higher premiums and co-pays, US citizens have, to a large extent, been able to count on lower-priced generics to sway the high costs of name brand drugs. Generics have always been assumed to be the same as their name-brand equivalents by both the public and the Doctors prescribing them and Insurance companies requiring them.
This is not the case anymore as Teva Pharmaceuticals, based in Israel, has been swallowing up many of the leading generic drug manufactures over the past 10 years, making them the sole producer of many of the important generics that so many of us count on for a myriad of medical conditions.
The fact that Teva is buying up the competition is not the focus — though corporate monopolies are never good for consumers. It is the fact that so many of Teva’s generics are poorly produced in third-world countries and are not the same as their brand-name equivalents. While the main chemical components of their drugs are technically the same, or bio-equivalent (according to the FDA), as the main chemical compound of the name-brand, it is the low-quality precursor chemicals, inferior manufacturing facilities and lack of production oversight that is causing adverse and harmful reactions in consumers that have begun taking generics produced under the Teva Umbrella.
Teva takes over
Teva was officially created in 1976 after the merger of three pharmaceutical companies created in Israel by European Immigrants. In 1982, the FDA approved its main manufacturing plant — and so began the path to market domination.
Teva is not solely interested in generics as they have produced some very effective and useful proprietary drugs such as Copaxone and Azilect. Despite their own research and development, Teva’s meteoric rise atop the pharmaceutical food chain has come through buying and merging with other large drug manufacturers. Most recently, the acquisition of Barr Pharmaceuticals in 2008 for over 7 billion dollars has further entrenched them in generic manufacturing.
Barr had been the largest generic manufacturer in the world when they were acquired by Teva. This, in and of itself, is not necessarily earth-shattering information — big company acquires other big company, making bigger company; the way of capitalism. The relevance of the Barr acquisition lies in the history of Barr–a history of corruption and inferior production standards. Teva, as far as pharmaceutical giants go, has typically been considered a quality developer and producer of proprietary drugs up until the past few years. It is their acquisitions over the past ten years — Barr in particular — and their quest to cheaply produce generics to make even more money that has brought their quality standards under scrutiny.
Lowering the Barr
Barr was an outsider looking in for many years, trying desperately to get FDA approval for its generics. But this quest was deterred by the FDA, who was approving generics and other drugs for the highest bidder.
The company earned notoriety during the late 1980s, when its founder testified before a congressional committee about bribes between generic drug producers and U.S. Food & Drug Administration officials. Funding Universe
This testimony would actually set Barr back a bit throughout the 80s and into the early 90s as the FDA, in possible retaliation, stonewalled the approval for many of Barr’s bio-equivalent manufacturing requests. This would change in the mid 90s when Barr became more aggressive in its approach. With a team of highly paid attorneys, Barr set out to find loopholes in the patents of many popular name-brand drugs. One of the more notable patent challenges came against Eli Lilly’s Prozac in 1996.
Challenging existing patents with a “dream team” of patent layers would become Barr’s main focus in the late 90s and throughout this decade. Considering Barr had smoothed over relations with the FDA in the 90s, getting bio-equivalency approval after winning patent challenges in court was a quick and easy process — unlike the 80s which led Barr to testify against the FDA in the first place. Now, Barr was in the driver’s seat as they swallowed up other generic manufacturers and continued to win patent suits and gain first rights to bio-equivalency claims of expiring patents.
When Barr was acquired by Teva in 2008, a string of voluntary re-calls would soon follow. Despite Barr’s unscrupulous business history, quality-control of their drugs was never a big issue. With Teva’s acquisition and control of Barr and its wide scope of generic manufacturing, the quest to make their drugs at the cheapest price possible has resulted in the use of low-quality precursor chemicals and a complete lack of manufacturing oversight. Just nine months ago, Barr’s genericAdderall was re-called because they were distributing batches at four to five times the listed dosage. Considering Adderall is a blend of amphetamines, this resulted in an array of cardiovascular and psychological problems for those unfortunate enough to take these potent Adderall pills.
While on the subject of Adderall, it is of importance to note the complacency of many of the major brand-name drug manufacturers in allowing their proprietary formulas to be produced in a manner inconsistent with their own production standards. Shire pharmaceuticals, the original producer of Adderall, has recently granted Barr/Teva the right to be the sole manufacturer of Extended Release Adderall, which is still under patent.
The reason for this is of course profit. Shire has a large stake in the growing ADHD market, and are pushing their new ADHD drug Vyvanse as the be all and end all of ADHD medication. Essentially, they have given up any concern over the quality perceptions of the very popular and widely used Adderall to push Vyvanse; which is simply Dextro-Amphetamine (Dexidrine) with lysine bonded to it, supposedly creating a less abusable prodrug of something that has been around for over a hundred years. I’ll save my critique of the ineffectiveness of Vyvanse for another time as that would involve delving into some complicated bio and neuro-chemistry.
In addition to the Adderall recalls, there have been others just in the past two years since Barr was acquired by Teva. Obviously, recalls and production errors happen, but Teva seems to make more mistakes than what one would consider acceptable when dealing with drugs that are used to treat life-threatening illnesses. The pharmaceutical industry as a whole, has historically shown indifference to their actual consumers for the sake of generating more profit.
With Teva taking over such a large portion of the generic drug market, this could be a scary proposition for those who depend on affordable drugs for treating a variety medical conditions. The FDA, the federal administration responsible for overseeing the safety and effectiveness of these medications has continued to turn a blind eye to the issues of Teva — and every other drug manufacturer with deep pockets. Considering the FDA’s history of corruption and the fact that it is made up largely of former pharmaceutical executives and representatives, their apathy toward consumers in favor of these corporations should come as no surprise. If the FDA cannot be cleaned up, big pharma companies like Teva will continue produce medication not fit for public consumption; the consequences of which could be quite devastating — they already have been for millions of individuals worldwide."
Written by Todd Curl on 09 June 2010
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Does it though? Seems like an awful lot of speculation.
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This is a big problem.
http://www.raps.org/Regulatory-Focu...rma-API-Manufacturers-Refuse-FDA-Inspections/
http://www.raps.org/Regulatory-Focu...ese-Drugmakers-for-Data-Integrity-Violations/
http://www.in-pharmatechnologist.co...PI-makers-for-quality-systems-and-data-issues
The big generic manufacturers like Teva get their APIs from places like this. That could be why generics aren't as effective. How can the FDA control this? It's all offshore.
http://www.raps.org/Regulatory-Focu...rma-API-Manufacturers-Refuse-FDA-Inspections/
http://www.raps.org/Regulatory-Focu...ese-Drugmakers-for-Data-Integrity-Violations/
http://www.in-pharmatechnologist.co...PI-makers-for-quality-systems-and-data-issues
The big generic manufacturers like Teva get their APIs from places like this. That could be why generics aren't as effective. How can the FDA control this? It's all offshore.
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You do know the FDA has international duty stations and also has investigators/consumer safety officers that do international inspections, right?
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But it is the scope of the problem that is really beyond the FDA's control. Take a gander at this.
http://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm291803.htm
When you dig down thru the page it's a little scary. A lot of bureaucratic happy talk.
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Holy crap! I would have imagined at least 50 or even a hundred staffers, but this?
http://www.raps.org/Regulatory-Focu...-in-China-An-Analysis-of-Form-483s-from-2015/
http://www.raps.org/Regulatory-Focu...-in-China-An-Analysis-of-Form-483s-from-2015/
Don't think we haven't noticed that all your posts are pushing conspiracy theories about the FDA and IRAs.
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Gee, I back up my stuff with links to articles, videos, and even govt websites and all you can do is spout socially-engineered pablum. What happened to people? Why can't people think anymore? Sometimes I feel like I'm living that movie The Big Short on this forum. I can really relate to what Burry and Baum went through.
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Then how in good conscious can you sell medications as a pharmacist ?
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Well for one thing you can start taking seriously patients' claims about a generic's inefficacy and not just blow them off. Pass the complaint up the chain, do a little hound dogging after hours about a certain generic to see if there is a history of complaints and see if there is an alternative without such problems. Contact the manufacturer about the sourcing of APIs. See if you can get an alternative generic to be ordered. There once was a time when Jedi pharmacists did this, before the dark times, before the empire.
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The manufacturer's name (possibly abbreviated) should be on the label on their bottle.
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They don't bring me the bottle
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I imagine they have it. Are they not involved in this?
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I don't have them bring it to appts
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http://www.wcpo.com/news/health/hea...ion-reveals-problems-with-generic-medications
http://www.medschat.com/Discuss/Adderal-manufactured-by-Teva-not-working-226334_s2.htm
http://www.goodrx.com/blog/recall-generic-adderall-tablets/
http://thepigeonpost.org/2010/06/09/teva-pharmaceuticals-and-poor-quality-generic-drugs/
...
This is all I could find which is why I came to this board. I will talk to a local pharmacist too
http://www.medschat.com/Discuss/Adderal-manufactured-by-Teva-not-working-226334_s2.htm
http://www.goodrx.com/blog/recall-generic-adderall-tablets/
http://thepigeonpost.org/2010/06/09/teva-pharmaceuticals-and-poor-quality-generic-drugs/
...
This is all I could find which is why I came to this board. I will talk to a local pharmacist too
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It's not about who is right or wrong. It's about helping patients
Wait wait... on a unrelated note someone brought up Synthroid. Is there any evidence at all that Synthroid is more effective? This is by far the most common DAW. In some cases the patient is switched to brand before they have even taken it long enough for it to reach full therapeutic effect which really makes me question this...
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Interesting article
http://www.worstpills.org/public/page.cfm?op_id=47
The Levothyroxine (SYNTHROID) Scandal
Boots Pharmaceuticals, which became the Knoll Pharmaceutical Company of Mt. Olive, New Jersey, in March 1995, suppressed publication of scientific research for more than two years in order to perpetuate the incorrect public impression that their brand-name version of levothyroxine(SYNTHROID) was more reliable than generic levothyroxine products from three competing companies. The cost to the American public in excessive charges for Synthroid over these two years has been estimated to be $800 million.
Research that contradicted the Boots/Knoll superiority claim was finally published in the April 16, 1997, issue of the Journal of the American Medical Association. It found four generic and brand-name drugs—Synthroid and the three competing levothyroxines—to be bioequivalent by current FDA standards and interchangeable without loss of therapeutic efficacy in the majority of patients for treatment of hypothyroidism (low thyroid).7
Knoll’s predecessor, Boots, contracted with a faculty member and researchers at the University of California at San Francisco (UCSF) in 1987 for a bioequivalence study comparing Synthroid with three competitors’ levothyroxine products. The company paid the researchers $250,000 to do the study. In this case, a finding of bioequivalence would justify the use of less-expensive, equally effective generic products instead of Synthroid. Boots’s expectation was that the study would find Synthroid to be superior to the generics.
The contract contained a clause giving Boots veto power over publication of the study’s results. The problems began in late 1990, when it became known that Synthroid and the other three levothyroxines were the same.
Over the next four years, Boots waged a calculated campaign to discredit the researchers and their work. Once it was clear that the study would not support the claim of Synthroid’s superiority, Boots alleged scores of deficiencies and errors in the study. The university conducted an investigation of how the research was done and found only minor and easily correctable problems. Some members of the investigating panel found Boots’s interactions with the researchers to be “harassment” and characterized the company’s actions as “deceptive and self-serving.” The university concluded that the study was carefully done and complied fully with the terms of the contract.8
The results of the study were submitted to the Journal of the American Medical Association in April 1994. The study was sent to five experts for peer review and was accepted for publication in November 1994, with its publication scheduled for the January 25, 1995, issue of the journal. On January 13, 1995, the researchers suddenly withdrew the study from publication, citing as the reason “impending legal action by Boots Pharmaceuticals, Inc. against UCSF and the investigators.” Because of the clause in the contract giving the company veto power over publication, UCSF said it would not defend the researchers if the study was printed without the company’s permission.8
Then, in a move striking at the very core of ethical scientific standards, the company’s senior director for medical research took the study results and, without giving credit to the UCSF researchers, published a misleading version in an obscure journal of which he was also an associate editor. The new version was used to support the company’s previous assertion of Synthroid’s superior reliability.
Six years after it was known that there was no difference between Synthroid and generic levothyroxine products, and more than two years after the UCSF research should have been published, the Journal of the American Medical Association published the research just as it would have appeared in January 1995, had it not been for Boots’s interference.
To sum it all up, generic drugs are just as effective and safe as brand-name drugs. Unless you want to waste quite a bit of money, ask your pharmacist to fill your prescription with a generic drug. If the brand-name drug is not yet off patent, your pharmacist will advise you of this. See the table on p. 881 for some examples of generic savings.
http://www.worstpills.org/public/page.cfm?op_id=47
The Levothyroxine (SYNTHROID) Scandal
Boots Pharmaceuticals, which became the Knoll Pharmaceutical Company of Mt. Olive, New Jersey, in March 1995, suppressed publication of scientific research for more than two years in order to perpetuate the incorrect public impression that their brand-name version of levothyroxine(SYNTHROID) was more reliable than generic levothyroxine products from three competing companies. The cost to the American public in excessive charges for Synthroid over these two years has been estimated to be $800 million.
Research that contradicted the Boots/Knoll superiority claim was finally published in the April 16, 1997, issue of the Journal of the American Medical Association. It found four generic and brand-name drugs—Synthroid and the three competing levothyroxines—to be bioequivalent by current FDA standards and interchangeable without loss of therapeutic efficacy in the majority of patients for treatment of hypothyroidism (low thyroid).7
Knoll’s predecessor, Boots, contracted with a faculty member and researchers at the University of California at San Francisco (UCSF) in 1987 for a bioequivalence study comparing Synthroid with three competitors’ levothyroxine products. The company paid the researchers $250,000 to do the study. In this case, a finding of bioequivalence would justify the use of less-expensive, equally effective generic products instead of Synthroid. Boots’s expectation was that the study would find Synthroid to be superior to the generics.
The contract contained a clause giving Boots veto power over publication of the study’s results. The problems began in late 1990, when it became known that Synthroid and the other three levothyroxines were the same.
Over the next four years, Boots waged a calculated campaign to discredit the researchers and their work. Once it was clear that the study would not support the claim of Synthroid’s superiority, Boots alleged scores of deficiencies and errors in the study. The university conducted an investigation of how the research was done and found only minor and easily correctable problems. Some members of the investigating panel found Boots’s interactions with the researchers to be “harassment” and characterized the company’s actions as “deceptive and self-serving.” The university concluded that the study was carefully done and complied fully with the terms of the contract.8
The results of the study were submitted to the Journal of the American Medical Association in April 1994. The study was sent to five experts for peer review and was accepted for publication in November 1994, with its publication scheduled for the January 25, 1995, issue of the journal. On January 13, 1995, the researchers suddenly withdrew the study from publication, citing as the reason “impending legal action by Boots Pharmaceuticals, Inc. against UCSF and the investigators.” Because of the clause in the contract giving the company veto power over publication, UCSF said it would not defend the researchers if the study was printed without the company’s permission.8
Then, in a move striking at the very core of ethical scientific standards, the company’s senior director for medical research took the study results and, without giving credit to the UCSF researchers, published a misleading version in an obscure journal of which he was also an associate editor. The new version was used to support the company’s previous assertion of Synthroid’s superior reliability.
Six years after it was known that there was no difference between Synthroid and generic levothyroxine products, and more than two years after the UCSF research should have been published, the Journal of the American Medical Association published the research just as it would have appeared in January 1995, had it not been for Boots’s interference.
To sum it all up, generic drugs are just as effective and safe as brand-name drugs. Unless you want to waste quite a bit of money, ask your pharmacist to fill your prescription with a generic drug. If the brand-name drug is not yet off patent, your pharmacist will advise you of this. See the table on p. 881 for some examples of generic savings.
Last edited:
Dispense as written; aka no generic substitution
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This is why we don't trust subjective reports of efficacy.
Maybe they were taking a non-TEVA generic and were switched to the TEVA generic? Even still it's placebo, and I don't even know if there are other generics to be honest.
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No. If you follow the link, some people are saying they are doing much better on the brand name than they were on the Teva generic.
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It's the exact same compound. They are just paranoid.
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The more I dig down this rabbit hole, the worse it gets.
http://www.api-china.com.cn/apicdsen/index.htm
http://www.raps.org/Regulatory-Focu...I-Manufacturer-for-Serious-Data-Manipulation/
"FDA Warns Chinese API Manufacturer for Serious Data Manipulation
Posted 12 January 2016By Zachary Brennan
The US Food and Drug Administration (FDA) has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.
Specifically, the warning letter released Tuesday for the Chinese active pharmaceutical ingredient (API) manufacturer was for failing to stop unauthorized access or changes to company data, and failing to provide adequate controls to prevent the manipulation and omission of data.
During the inspection last March, FDA investigators discovered a lack of basic laboratory controls to prevent changes to the company’s electronically stored data and paper records.
The agency said the company also routinely re-tested samples without justification and deleted analytical data.
“We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs,” FDA said. “You are responsible for determining the causes of these deviations, for preventing recurrence, and for preventing other deviations from CGMP.”
In addition, one of Hisun’s analysts who generated the data submitted to FDA said another employee, who was no longer with the company, had disabled the company’s audit trails, failing to track the company’s original data.
“Your firm could not explain why the audit trail was disabled or why the original data was deleted, nor could you demonstrate whether the original results were within specification,” the agency said.
Raw data for a sample of 17 of 61 high performance liquid chromatography injections were deleted from a reported sequence as if the injections had never been performed, FDA found, and the investigator later discovered the missing data in a backup folder.
Meanwhile, from 2012 to 2014, several of Hisun’s customers complained that microbial results were out of specification (OOS) when they tested APIs upon receipt, though Hisun “concluded that the percentage of customer complaints reporting OOS microbial test results was insignificant. You attributed the customers’ OOS microbial results to test methods that differ from your own.”
A list of the company’s partners on its website include Pfizer, Sanofi, Merck and Eli Lilly.
FDA has in recent years been really cracking down on foreign manufacturers’ data integrity, with many of the warning letters similarly detailing firms’ inability to ensure their data is credible. "
http://www.api-china.com.cn/apicdsen/index.htm
http://www.raps.org/Regulatory-Focu...I-Manufacturer-for-Serious-Data-Manipulation/
"FDA Warns Chinese API Manufacturer for Serious Data Manipulation
Posted 12 January 2016By Zachary Brennan
The US Food and Drug Administration (FDA) has warned China-based Zhejiang Hisun Pharmaceutical, which established a joint venture with Pfizer in 2012, for data integrity violations more than three months after banning the company’s products from entering the US.
Specifically, the warning letter released Tuesday for the Chinese active pharmaceutical ingredient (API) manufacturer was for failing to stop unauthorized access or changes to company data, and failing to provide adequate controls to prevent the manipulation and omission of data.
During the inspection last March, FDA investigators discovered a lack of basic laboratory controls to prevent changes to the company’s electronically stored data and paper records.
The agency said the company also routinely re-tested samples without justification and deleted analytical data.
“We observed systemic data manipulation across your facility, including actions taken by multiple analysts, on multiple pieces of testing equipment, and for multiple drugs,” FDA said. “You are responsible for determining the causes of these deviations, for preventing recurrence, and for preventing other deviations from CGMP.”
In addition, one of Hisun’s analysts who generated the data submitted to FDA said another employee, who was no longer with the company, had disabled the company’s audit trails, failing to track the company’s original data.
“Your firm could not explain why the audit trail was disabled or why the original data was deleted, nor could you demonstrate whether the original results were within specification,” the agency said.
Raw data for a sample of 17 of 61 high performance liquid chromatography injections were deleted from a reported sequence as if the injections had never been performed, FDA found, and the investigator later discovered the missing data in a backup folder.
Meanwhile, from 2012 to 2014, several of Hisun’s customers complained that microbial results were out of specification (OOS) when they tested APIs upon receipt, though Hisun “concluded that the percentage of customer complaints reporting OOS microbial test results was insignificant. You attributed the customers’ OOS microbial results to test methods that differ from your own.”
A list of the company’s partners on its website include Pfizer, Sanofi, Merck and Eli Lilly.
FDA has in recent years been really cracking down on foreign manufacturers’ data integrity, with many of the warning letters similarly detailing firms’ inability to ensure their data is credible. "
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So we've got a physician that doesn't want to hear what we have to say. The village crazy blathering on about whatever in 6,000 word posts that nobody reads. Me (and others) already giving the correct answers that seem to be ignored by OP. All we need now is for Sparda to show up and make up some outlandish story and I think it's a wrap, folks.
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I had no idea the problem was this big. No figure, who sponsors 60 minutes and all the other news programs?
http://www.pharmtech.com/ensuring-supply-chain-safety
"Data integrity has become a huge problem, and CDER is now in a Catch-22 situation--either allow products into the country that could potentially violate requirements of the Federal Food,Drug,and Cosmetic Act and threaten to create a public health crisis, or put the manufacturers involved on import alert and potentially usher in drug shortages,” Schwartz says. Most common signs of poor data integrity include:
Topic:
International Pharmaceutical Supply Chain Imperiled Like Never Before
Recording date: Wednesday, June 22, 2016 5:00 pm
GMT Summer Time (London)
Panelist Information:
Duration: 1 hour 1 minute
Description:
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled like never before, what can drug manufacturers do to protect themselves?
This webinar will discuss recent pharmaceutical supply chain developments and what steps companies need to take to prevent and remediate compliance issues in the context of:
•The uptick in investigations in China and India.
•The potential impact of adverse regulatory actions against nonconforming facilities.
•Threats Posed by Bribery and Corruption.
•Anti-corruption compliance issues from U.S. and Asian perspectives.
•“War stories” from recent investigations.
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/06/index.html
http://economictimes.indiatimes.com...dian-drug-facilities/articleshow/53152779.cms
http://www.biopharmadive.com/news/two-more-chinese-drugmakers-run-afoul-of-fda-inspections/421893/
http://www.pharmtech.com/ensuring-supply-chain-safety
"Data integrity has become a huge problem, and CDER is now in a Catch-22 situation--either allow products into the country that could potentially violate requirements of the Federal Food,Drug,and Cosmetic Act and threaten to create a public health crisis, or put the manufacturers involved on import alert and potentially usher in drug shortages,” Schwartz says. Most common signs of poor data integrity include:
- Back-dating lab notebooks
- Hiding time and date settings on test results
- Re-integrating analyses to achieve passing test results
- Disabling system audit trails
- Fabricating data.
Topic:
International Pharmaceutical Supply Chain Imperiled Like Never Before
Recording date: Wednesday, June 22, 2016 5:00 pm
GMT Summer Time (London)
Panelist Information:
Duration: 1 hour 1 minute
Description:
In recent years, the level of scrutiny on foreign pharmaceutical manufacturing facilities in countries like China and India has skyrocketed—along with the demand and dependence of western countries on the supply of goods coming from those facilities. With the international pharmaceutical supply chain imperiled like never before, what can drug manufacturers do to protect themselves?
This webinar will discuss recent pharmaceutical supply chain developments and what steps companies need to take to prevent and remediate compliance issues in the context of:
•The uptick in investigations in China and India.
•The potential impact of adverse regulatory actions against nonconforming facilities.
•Threats Posed by Bribery and Corruption.
•Anti-corruption compliance issues from U.S. and Asian perspectives.
•“War stories” from recent investigations.
http://www.fdalawblog.net/fda_law_blog_hyman_phelps/2016/06/index.html
http://economictimes.indiatimes.com...dian-drug-facilities/articleshow/53152779.cms
http://www.biopharmadive.com/news/two-more-chinese-drugmakers-run-afoul-of-fda-inspections/421893/
- The Food and Drug Administration has warned two Chinese drugmakers of manufacturing lapses, citing Shanghai Desano Chemical Pharmaceutical and Chongqing Lummy Pharmaceutical for data irregularities and manipulation.
- A May 2015 inspection found Shanghai Desano, which works with GlaxoSmithKline's Viiv Healthcare, had conducted about 8,400 unofficial chromatographic analyses between 2012 and 2014. Desano indicated that some of these unofficial analyses were indeed out-of-specification.
- The Food and Drug Administration also warned Chongqing Lummy over extensive data manipulation, including setting computer clocks back to make tests appear as if they had been conducted earlier.
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Confirmational bias is a powerful thing.
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Okay so for a ANDA product they are assumed to be the same if they contain the same Active ingredient (API). What role , if any, do inactive/inert ingredients play such as fillers, binders, lubricants etc? Just curious....
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This has lots of good info and so do all the posts on here. I dont know if there is a concrete answer to this question. We can debate possibilities all day, put we must stand by the data and approval methods. Creating conspiracies with patients is not going to help the situation. There are way too many variables that play into an individuals response to a medication.
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Life is much better on SDN with Carol on "ignore" mode. Just a tip to the rest of you forum regulars. No more scrolling past multi paragraphs of unconcise nonsense. #winning
"Only the generic works, I don't want the brand name!"
Have you ever, even once, heard a patient say this. No. This would inevitably happen, at least once, somewhere, if a difference existed between brand and generics.
Have you ever, even once, heard a patient say this. No. This would inevitably happen, at least once, somewhere, if a difference existed between brand and generics.
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I've heard it once. It was for some weird anti-seizure medicine like tegretol Xr or lamitical Xr or carbitrol or something. The erx had a note that basically said please dispense generic pt fails therapy on brand. It was like a great white buffalo
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But if they are reporting a problem, then have them check when they get home, or bring their bottle to the next appointment. As Zelman said, the name of the manufacturer is going to be on the label and it's probably on the info sheet given the patient as well. Generic manufacturers are not a secret. Even if they've thrown out their bottle and leaflet, you can still take the numbers/letters off the pill itself to find out who the manufacturer is. You can probably just google the letters/numbers to find out the manufacturer, but if not, whatever hospital you are associated with will have an identifying program and be able to look it up for you.
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I am a solo private practice doctor just trying to do my best
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You are unique, if I remember correctly, you said you don't have any office staff, so understandably you are getting pulled in all directions with all the different facets of running an office.
It can affect shelf life, time it takes to reach therapeutic level, and even absorption. For example, too much lubricant could increase the absorption time or even prevent some of the API from being absorbed at all. The thing is, as the other poster said, even the inactive ingredient must be shown to not affect the efficacy of the drug. So the drug companies can't just use whatever excipients that they feel like just because the API is the same.
I've used Teva and most recently KVK and both weren't only ineffective but gave me anxiety, headaches and made me very lethargic. Both times I contacted the manufacturer directly then switched to the name brand. I will not leave the name brand again and was annoyed when my doctor discussed his disdain for the hour it would take in paperwork that is required by my insurance. Being that our visits are never more than 10 minutes and my insurance pays him $180 on top of my $20 copay I wasn't concerned with his complaints. The pharmacy lectured me on the cost and I wasn't concerned and the entire process has decreased my faith in the pharmacists and my doctor. The only generic that's been effective for me was Watson and then Actavis but after a few months I noticed Actavis wasn't effective as long. I take 10mg IR and Actavis would begin to wear off at hour 2.5.
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Yup typical junky, if you were my customer your preferred brand would magically be on backorder indefinitely.
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N=1
I am sure your totally objective analysis more than justifies the time, effort, & frustration your MD has to go through to support your well backed claims. Why should you care if you waste his/her time (might be why you only get 10 minutes for your visit)?
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I've heard of people having issues when on certain bc generics ( I guess due to hormones) but 75% of the time when a pt asks for a specific color/imprint/brand on anything (especially psych or pain meds) they're just being sketchy, in my opinion
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So what you're saying is that Actavis isn't as effective as Watson brand?
That's fascinating, being as it's the same company.
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Isn't there any way we can filter out patients who mistake their personal mental health issues for adverse events?
They contribute literally nothing.
Last edited:
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Here's something your doctor and pharmacist know, that you don't know. The placebo effect is very strong. This has been shown in repeated studies. Even when people know they are getting a placebo, many will still have a positive effect from it. Even in studies of diseases such as HIV or cancer, around 30% of people will have a positive effect from a placebo (at least temporarily.) The "nocebo" effect is also very strong--this is like the placebo effect, except the opposite. With the nocebo effect, people get all kinds of negative side effects that they could not possibly be getting.
Statistically, you are most likely, that you are having a placebo effect with your preferred manufacturer, and a nocebo effect with your non-preferred manufacturers. The chance the you are having a reaction to 2 different manufacturer's, and not to the brand manufacturer, is so statistically unlikely, there is no reason why your doctor or pharmacist would even consider it. To be having such a reaction, you would have to be reacting to a dye or binder/filler used in the medication....in which case, you need to be figuring out which ingredient is in the 2 manufacturer's medicines that wasn't in the 3rd, because it's that ingredient that you need to be avoiding. Only using brand medications won't help, because the approved dyes/fillers/binders are used in brand name medications as well.
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Who was the guy selling placebo pills with cool designs, and openly acknowledging they're placebo.
He labels a snazzy gold capsule "focus", and people performed measurably better after taking it?
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Apparently people are color bias in how confident & compliant....white & yellow meds are the best supposedly.
Because we all know how much color really matters (><)...seriously had someone refuse to use (s)-omeprazole when it became generic because it was no longer the marketed "purple pill" (teal just didn't do it for him). **** you drug marketing departments everywhere
Because we all know how much color really matters (><)...seriously had someone refuse to use (s)-omeprazole when it became generic because it was no longer the marketed "purple pill" (teal just didn't do it for him). **** you drug marketing departments everywhere
