Since "Admin" closed my last thread, let me try again. For some reason they thought this was a solicitation for a petition, WHICH IT IS NOT, so don't even recommend or mention it, otherwise this thread is likely to get "closed" too.

Let me repeat this is not a request for a petition or anything similar.



There have been many people voicing concern about the recent variations in adderall that everyone seems to recognize to some extent. I am trying to have a consumer group look into the matter. They have many resources (labs, Lawyers, etc.) so we can find out why exactly the recent changes/inconsistencies have occurred, who, if anyone, is liable, and how to fix it.

I thought this would be of interest to everyone. I am asking nothing more than for those people who have voiced concern in other threads within this forum to replicate their concerns and experiences here so we can have a broad and thorough place to reference instead of having it spread among 20 different threads. Additional comments are welcome.

-bkaguy

I just got off the phone with Thomas Martin, President of America's Watchdog. He has agreed to help us. He told me some pretty messed up stuff about some of the other medicines they were currently researching.


I am going to send him a 30mg and 20mg tablet manufactured by Barr.
They will be tested and at the University of (I think he said) Oklahoma.
He will then find out what exactly the pill was made with and how much of each ingredient was included. I will get the final report and then provide the findings here for everyone to see. If they are as we all think they are, he will launch a national report to the FDA and others. He also volunteered to have a colleague at Johns Hopkins who specializes in pharma forensics look into the correlations of the side effects for each manufacturer.


Address:

Thomas Martin
America's Watchdog
5505 Connecticut Ave NW #138
Washington, DC 20015

Is it legal to send controlled substances that way?

I have only used the shire so far, but testing that as a 'control' is not a bad idea.

Is it legal to send controlled substances that way?


No it's not. In fact it's illegal to give it to anyone, even someone with the same dosage perscription/formulation as you have. That's not to say you'll be caught though, but if you are sux4u :)

This is not science. It's bullcrap.

You're asking us to commit multiple felonies by sending controlled substances through the US Mail. You will have absolutely no way to verify which drugs came from which manufacturers and which dosages they are. You have no way to prevent contamination. There's no way to trace a sample back to a particular user, and thusly to a pharmacy and eventually back to a manufacturer. Unless, of course, you are going to be documenting everyone who sent you a sample, thusly exposing them to arrest and imprisonment. The lack of thoughtfulness and foresight displayed here is appalling. You are so gung ho on your quest that you are completely ignoring any consequences your actions and suggestions might have on anyone else.

Sorry, but no. Any results that come out of this will be completely flawed and absolutely useless to anyone. Anyone looking to dispute your findings will have absolutely no problem doing so because this "study" is being conducted in an amazingly amateur fashion. In all likelyhood, you will do more damage than help to your cause.

Frankly, I'm not surprised the admins shut the old thread down. I can't imagine that any respected and competent researcher would ever agree to conduct such a study this way. That leads me to believe America's Watchdog might be a little naive on how to conduct a valid scientific study. Either way, nobody should send you jack squat. In fact, I would advocate for the admins to lock, but not delete, this thread and remove the mailing address.

This is not science. It's bullcrap.

You're asking us to commit multiple felonies by sending controlled substances through the US Mail. You will have absolutely no way to verify which drugs came from which manufacturers and which dosages they are. You have no way to prevent contamination. There's no way to trace a sample back to a particular user, and thusly to a pharmacy and eventually back to a manufacturer. Unless, of course, you are going to be documenting everyone who sent you a sample, thusly exposing them to arrest and imprisonment. The lack of thoughtfulness and foresight displayed here is appalling. You are so gung ho on your quest that you are completely ignoring any consequences your actions and suggestions might have on anyone else.

Sorry, but no. Any results that come out of this will be completely flawed and absolutely useless to anyone. Anyone looking to dispute your findings will have absolutely no problem doing so because this "study" is being conducted in an amazingly amateur fashion. In all likelyhood, you will do more damage than help to your cause.

Frankly, I'm not surprised the admins shut the old thread down. I can't imagine that any respected and competent researcher would ever agree to conduct such a study this way. That leads me to believe America's Watchdog might be a little naive on how to conduct a valid scientific study. Either way, nobody should send you jack squat. In fact, I would advocate for the admins to lock, but not delete, this thread and remove the mailing address.

I concur! I just don't have the balls to flame a stranger who doesn't do so to me first ;x

Are you people crazy?

Who the hell would take you to court for wanting to know if what you were taking was safe? I doubt you would get the same medication if you were to ask the manufacturers to provide a sample for you to test. Plus it is for your safety. Wake up people:


FDA drug oversight plan falls short


by Robert Cohen/The Star-Ledger Wednesday April 23, 2008, 6:00 AM



The Government Accountability Office said yesterday the FDA slightly increased inspections of foreign drug plants last year, but does not have enough resources to do the job. The GAO, an investigative arm of Congress, said the FDA faces many obstacles, including the lack of accurate information on precisely which firms actually make drugs sent to this country.

"Given the growth in foreign drug manufacturing for the U.S. market and the current large gaps in FDA's foreign drug inspections, FDA will need to devote considerable resources to this area if it is to increase the rate of inspections," Marcia Crosse of the GAO told the House Energy and Commerce subcommittee on oversight and investigations.

"However, FDA plans currently call for incremental increases that will have little impact in the near future," she said.

Concerns about the foreign inspection program have increased sharply in recent months with the disclosure contaminated doses of the blood thinner heparin were made with raw ingredients from China...

...The FDA said the contaminated heparin has been linked to hundreds of serious adverse reactions and as many as 81 deaths in the United States, although the Chinese dispute the contaminant caused the deaths.

http://www.nj.com/business/index.ssf/2008/04/fda_drug_oversight_plan_falls.html



Furthermore, when I spoke with Thomas Martin Today, he told me about a few of the medicines they were researching. He said that the analysis found everything from sheetrock to Gypsum to tar and plenty of other random "materials" considered far from ingredients. He also said they have personally inspected many facilities in india and China. What they found was, that operations are supervised for about 8 hrs and not for 8 hrs. Employees are either paid from outsiders to manufacture counterfits or insiders encorage or turn a blind eye for cheaper filler substitutes. Also many of the main plants are very high quality but there are many, many more owned by the same company that ae more along the lines of an auto manufacturing plant.


however you are entitled to your opinions.

you want more? You got it.

FDA Inspection of Foreign Drug Companies

Jesse C. Vivian, BS Pharm, JD
Professor, Department of Pharmacy Practice
College of Pharmacy and Health Sciences
Wayne State University
Detroit, Michigan



US Pharm. 2008;33(6):53-57.

Have you ever wondered how well the FDA is doing at protecting the American public from harmful drugs? As pharmacists, we are educated to believe that the FDA is the oversight agency charged with making sure we have access to drugs that are safe and effective for intended purposes, and that pharmaceutical companies are only allowed to market drugs in a manner approved by the FDA. We know that the manufacturer's labeling that accompanies all drugs sold in this country has the blessing of the FDA. We know that the FDA inspects drug plants fastidiously and that all drugs produced in this country must be manufactured in conformance with the FDA's Current Good Manufacturing Practices regulations.1 We know the FDA requires pharmaceutical companies to subject new drugs to years of arduous testing before the first drug product is sold or distributed. However, we also know that in recent years the FDA has made tremendous blunders that shake our core beliefs in the sanctity of the drug-marketing system. It is therefore appropriate to look at just how good a job the FDA is doing and what can be done to improve the odds that patients will not suffer harm as a result of consuming FDA-approved drug products.

The real challenge is to understand that a very large percentage of bulk medicines that go into pharmaceutical products sold in this country originate in foreign markets. The question then becomes, just how safe are these products, and what is the FDA prepared to do to keep Americans from harm's way?

The FDA's Position
On April 24, 2008, during Senate hearings on the heparin fiasco, Janet Woodcock, MD, the Director of the FDA's Center for Drug Evaluation and Research (CDER), testified before the Senate Education, Labor, Health, and Pensions Committee, and stated, "We cannot be the quality-control unit for the world." She also said that the increasingly large number of pharmaceutical ingredients manufactured abroad makes it nearly impossible for the agency to ensure the safety of all drugs sold in the United States. She argued that additional resources are necessary to help improve efforts to stop contaminated drugs from coming into the country. However, in what can only be described as a curious position, she also stated that manufacturers must assume greater responsibility for the quality of their products. Isn't that a bit like having the fox guard the chicken coop? Baxter International's contaminated heparin, imported from China, is being blamed for at least 81 deaths and scores of other serious complications.2

Overseas Drug Manufacturing and Heparin
China has become one of the world's largest suppliers of pharmaceutical ingredients, but the country's questionable safety reputation, combined with reports of death and serious illness associated with Chinese products in the past year, has convinced some experts and industry members that North American governments need a more aggressive approach to overseas inspections and safety checks. 3 Enhancing review of Chinese plants may be even more imperative given a recent change in the way China deals with drug recalls. In December 2007, the State Food and Drug Administration (SFDA) for the Republic of China (that country's equivalent to the U.S. FDA) issued new guidelines that encourage drug companies to recall unsafe drugs voluntarily.4 The new regulation states that enterprises that voluntarily recall unsafe drugs will be subject to lesser, or even be exempted from, administrative punishment. Those who are aware of problems with their drugs but fail to issue voluntary recalls will face fines up to three times the value of the recalled drugs or even be deprived of drug-manufacturing licenses. The move by the SFDA comes in the wake of pressure on the Chinese government to overhaul the country's food and drug safety system following a series of drug-safety scandals over the past few years. One of the most notorious cases of substandard drugs was that of Anhui Huayuan Worldbest Biology Pharmacy Co., whose antibiotic injections were blamed for six deaths in 2006.5 The problem injections were found to be improperly sterilized, with both sterilization temperature and time being below the state-required safety level.

To put the scope of the potential for problems into perspective, one news agency surveyed five of the most commonly prescribed drugs (cholesterol-lowering Lipitor, narcotic pain reliever acetaminophen with hydrocodone, antibiotic amoxicillin, and high blood pressure fighters Toprol-XL and Norvasc) and found that three are manufactured overseas.6 The impending trouble may run even deeper. A November 2007 Government Accountability Office report showed that the FDA does not even know how many of these foreign plants are importing drugs and drug ingredients into the U.S. Agency officials could not give an exact number of overseas manufacturers, saying there were between 3,000 and 6,800.7 These companies make 80% of raw materials used to manufacture the drugs that are sold in the U.S. Thus, even if the product is made in the U.S., the ingredients in that drug could still have been made overseas.8

The FDA now says that the heparin problems may be the result of a counterfeit ingredient from China that was used in the drug. U.S. health officials had never inspected the Chinese factory owned by U.S.-based Scientific Protein Laboratories LLC, where some of the raw heparin ingredients were processed. When FDA inspectors finally visited the plant in February 2008, after several deaths were linked to heparin, they found evidence of quality control and hygiene problems.

Dr. Woodcock's remarks about companies assuming their own quality-control accountability seems to be at odds with long-standing FDA policy. On its Web site, the CDER is described by the FDA as "America's consumer watchdog for medicine."9 This report describes the FDA as "one of the nation's oldest consumer protection agencies." Employing approximately 1,700 physicians and other scientists, CDER is the largest of five centers organized around the FDA. With regard to protecting drug quality, the FDA states that as the pharmaceutical industry has become increasingly global, the agency is "involved in international negotiations with other nations to harmonize standards for drug quality and the data needed to approve a new drug." The FDA goes on to claim that "this harmonization will go a long way toward reducing the number of redundant tests manufacturers do and help ensure drug quality for consumers at home and abroad."10




REFERENCES
1. 21 CFR 820.1 et seq.

2. Carey MA. Drug safety rests greatly with pharmaceutical makers, FDA official says. Congressional Quarterly HealthBeat. April 24, 2008. www.cqpolitics.com/wmspage.cfm?parm1=1&docID=hbnews-000002710903#. Accessed May 2, 2008.

3. Drug recall puts overseas inspections in spotlight. Canada Pharmacy News. March 8, 2008. www.canadapharmacynews.com/2008/03/drug-recall-puts-overseas-inspections.html. Accessed May 4, 2008.

4. China issues new recall method, encouraging voluntary drug recalls. China View News. December 12, 2007. http://news.xinhuanet.com/english/2007-12/12/content_7235616.htm. Accessed May 4, 2008.

5. Health ministry demands daily reports on suspect antibiotic. Embassy of the People's Republic of China in Australia. August 9, 2006. http://au.china-embassy.org/eng/xw/t266786.htm. Accessed May 28, 2008.

6. Officials question safety of overseas drug manufacturers. April 1, 2008. www.nbc4.com/health/15765666/detail.html. Accessed May 4, 2008.

7. Audit: FDA hampered in review of imported drugs. USA Today. November 1, 2007. www.usatoday.com/news/health/2007-11-01-fda-imports_N.htm. Accessed May 4, 2008.

8. Schlafly P. It's still the economy, stupid. Free trade in dangerous drugs. The Phyllis Schlafly Report. February 2008. www.eagleforum.org/psr/2008/feb08/psrfeb08.html. Accessed May 4, 2008.

9. CDER Report to the Nation: 2000. April 27, 2001. www.fda.gov/cder/reports/RTN2000/rtn2000.htm. Accessed May 2, 2008.

10. Id.

11. Edney A. FDA chief defends agency's work before House panel. www.govexec.com/dailyfed/0408/042208cdpm2.htm. Accessed May 2, 2008.

12. House members criticize FDA failures in inspection of foreign drugmakers. Pharmaceutical Law & Industry Report. April 25, 2008. http://healthcenter.bna.com/pic2/hc.nsf/id/BNAP-7E5JF4?OpenDocument. Accessed May 2, 2008.

13. See note 4, supra.

14. Drug safety. Preliminary findings suggest recent FDA initiatives have potential, but do not fully address weaknesses in its foreign drug inspection program. April 22, 2008. www.gao.gov/new.items/d08701t.pdf. Accessed May 28, 2008.

15. See note 6, supra.

16. Mundy A. Democrats, FDA official at odds over inspection plan. The Wall Street Journal. May 2, 2008. http://online.wsj.com/article/SB120969159705761551.html?mod=dist_smartbrief. Accessed May 2, 2008.

17. Prescription drug user fees. www.fda.gov/oc/pdufa/. Accessed May 2, 2008. The Act has a sunset provision requiring Congress to renew it every 5 years. HR 3580 (2007).

18. Goldstein J. Should drugmakers pay FDA to inspect foreign factories? May 2, 2008. http://blogs.wsj.com/health/2008/05/02/. Accessed May 28, 2008.

19. Mintz C. Changes at FDA?--Janet Woodcock chosen (again) to head CDER. March 11, 2008. www.biojobblog.com/2008/03/articles/rants-and-raves/changes-at-fda-janet-woodcock-chosen-again-to-head-cder/. Accessed May 3, 2008.

20. Taylor N. Legislation proposed for FDA foreign inspections. April 22, 2008. www.in-pharmatechnologist.com/news/ng.asp?n=84815-fda-phrma-glycerol-heparin-dingell. Accessed May 3, 2008.

21. Mundy A. FDA to hire additional scientists to expand drug safety operations. The Wall Street Journal. April 30, 2008. http://online.wsj.com/article/SB120956615942356319.html. Accessed May 3, 2008.

22. HR 3580 and S 1082. FDA Amendments Act of 2007. www.govtrack.us/congress/bill.xpd?bill=h110-2900. Law strengthens FDA. www.fda.gov/oc/initiatives/advance/fdaaa.html. Accessed May 3, 2008.

23. HR 3610. Food and Drug Import Safety Act of 2007. www.consumersunion.org/pub/core_food_safety/004809.html. Accessed May 3, 2008.

24. See note 15, supra.

This thread will be locked until it can be handled effectively. Sending control medications through the mail in a ziplock bag is certainly not legal and is not condoned by ADDFORUMS.

This is being reviewed as of present - therefor at the very least I will close it pending this dyslexic moderator catching up -


bka have you considered providing the contact information for teh watch dog group and letting member contact them on their own accord as well as providing actual FDA records of fine and such - if indeed the FDA has intervened for one reason or another the records will be publicly available on-line. ..

mean while no one send any thing through the mail -

OKay guys before we tourch the new guy and begin saying the unkind I think he may have a point -

I am on this drug myself and have adjusted every thing but the kitchen sink

I thought it was perimenapause damn it :mad: and it may just be my medications - well I did find some hypothyroidism - they wondered how I did it with such a small shift. . . .

I am going to open the thread for any one who knows the proper US channels we can use to complain about our generic medications - this is a request to have the information provided so each member can file his/her own complaints as a personal choice

This can be a good thing but it must be done in a way that doesn't encourage illegal activity and does not threated our privacy as members here -

The way to do this is to provide information on how I contact some one should I believe my medications to not be as they should be leaves the ball in my court to choose to act.

Well we could use the direct approach

Barr Pharmaceuticals, Inc. is a holding company whose principal subsidiaries, Barr Laboratories, Inc. and Duramed Pharmaceuticals, Inc., develop, manufacture and market generic and proprietary pharmaceuticals. For more information about Barr, please visit Barr's website at

http://www.barrlabs.com.

{End Quote}

How generic drugs differ from brand name (http://www.wsbt.com/news/health/18045089.html)

"Everybody involved in this whole chain — pharmacists, physicians, insurance companies, drug-store buyers — assumes the FDA approves every single generic formulation to prove that it isn't harmful," says Mr. Graedon. "We learned last week that that's not the case."

The FDA explained that it didn't want to expose test subjects to the risk of seizures with the 300 mg dose. Bioequivalence tests are conducted on healthy people, not those who need the medication, and each gets just a single dose, so there is no chance to work up to 300 mg slowly, as actual patients are advised to do. Sandy Walsh, an FDA spokeswoman, says this is common procedure for testing antidepressants and antipsychotics.

"If we see scientific evidence that a product is not performing as expected, we will take action," Ms. Walsh says. "The FDA cannot offer examples where generics have not performed as expected because there have been none for the agency to report."{End Quote}

Those of not modest means could always request the brand name but it doesn't look like that will change much seeing that


Barr Cleared to Launch ADDERALL(R) IR (http://salesandmarketingnetwork.com/news_release.php?ID=2013836)

On August 14, 2006, the Company announced that it and Shire had signed an agreement that provided for Duramed to purchase ADDERALL (immediate-release mixed amphetamine salts) tablets. On August 28, 2006, Barr and Shire filed the agreement with the FTC pursuant to the Hart-Scott-Rodino Antitrust Improvements Act. On September 27, 2006, the initial 30-day HSR waiting period expired without further FTC action. The parties are therefore free to close.
{End Quote}

I do not see my doctor until next month and I have already filled a prescription however if these problem continue into this month and I am not completely broke and / or divorced I plan on asking to have my medication switched as much as I hate the very idea of changing medications - it took me forever to find one that worked - so there is always that route of asking to be switched to a different ADD medication. My husband agrees I haven't "been right" and he remembers several conversations where he has asked if I took my medications and I have said yes and he has said well take more or some thing else because you are acting like you are not all here . . . okay so I do not listen to him any more than he listens to me {sigh}

Here is a link to a consumer watch dog group - reader responsible for own research and decisions
The US DRUG WATCHDOG (http://usdrugwatchdog.com/)

Apparently Thomas Martin is a
Media Contact:according to this article (http://www.topix.com/content/prweb/2008/06/us-drug-watchdog-launches-a-national-investigation-into-and-wants-to) about the Digitek thing -
Looking up the FDA thing . . .

I left the name and address of Thomas Martin up and asked the member who wrote the initial post if there was a hyperlink -

The following is a FDA complaint site - yeah they may blow us off but then again when you say I won't bother because they won't listen you have to then admit to being part of the problem of complacency - all we can do is use the tools we have been given and go though proper channels - the more complaints they receive the more likely there will be some thing resembling an investigation - I don't expect a formal apology but having my medications working as they should will be thanks enough for me


FDA medi-watch (http://www.fda.gov/medwatch/index.html)


So for those of you who have believed for the last three month you were going through menopause or maybe you have noticed your medications not working right or have had a lab tell you your medications are not medications I have left plenty of hyperlinks to vent your frustrations upon - May I recommend politely as the rude and crude normally just get ignored and deleted . . .. the more of us follow up the better each of our chances. .. .

Thank you bkaguy for opening up this subject we got off to a rocky start but some times it is just a directional thing that need adjusting - :)

Sending medications via the U.S. mail is not, perhaps, a violation of law. We're not lawyers and we will not make recommendations as such.

What you do, as adults, is your choice. However, the ADD Forums will not participate, encourage or enable its members to send their medication to other individuals or organizations, for whatever purpose.

Should you wish to report an issue with your medication, please contact the FDA, your pharmacy and perhaps the associated pharmaceutical manufacturer.


This thread is now closed. Further posts soliciting medications will be closed. Repeat offenders may have further sanctions levied against them.