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Yeah, because there's no reason to worry about vegetables causing illnesses.

Yeah, because there's no reason to worry about vegetables causing illnesses.

makers of the cancerous Aspartame

Not according to the FDA or ACSH. But at least The Holistic Healing Web Page is of that belief. In general, you should beware of medical advice that has its origins in fowarded emails.

While I'm glad these guys were shut down, Mastercard and Visa shouldn't have had to do it. This case constitutes outright fraud, and the perpetrators should be punished like other criminals: with handcuffs, a jury, and iron bars.

We used to have strong consumer protection agencies. Then something happened. How many more electronic Elixir Sulfanilamide incidents (or real ones for that matter) do we need before we re-create the strong and sensible regulatory bodies that used to protect us?

The article is inflammatory BS. You don't go to prison for misdemeanors. You go to jail for misdemeanors. They are entirely different places and if you had been to either, you would know how different they are. The six months sentence hanging over his head will not be a prison sentence at all and that is half the maximum time which is also the minimum time anyone can face for a class A misdemeanor offense. (1 year for federal misdemeanors and mostly 6 months max for state misdemeanors)

Now according to the original offense which wasn't a misdemeanor, it was a felony charge, he could have been facing 10 years in prison (not jail), because of the supposed retail value of the songs he distributed or caused to be distributed.

The was actually a treated as a mass bootleg case and not a file sharing case because he supposedly "willfully infringed a copyright for purposes of commercial advantage or private financial gain." The problem he laid in front of them is that he admitted to doing it and helped identify where he got the files from. But this case isn't the ordinary "junior put the new album on the lime wire interweb".

His lawyer has a different take on it which would follow the pre-sentencing guidelines that recommended 1 years probation. He makes some pretty good points in it and I think this will probably be closer to what happens.

You have to understand that this case is a big political charade. Obama has brought in some RIAA lawyers to help run the hope and Change you can believe in but I don't think they are the problems here (could be but it's just me). It's more of a- they made a big issue out of his site being a commercial venture in order to force information out of him. They offered a reduced charge based his cooperation in telling them everything he knew to help the government in finding who originally released the songs. (according to his lawyers, it could have been the record industry itself or axel rose himself). He took the deal and now in order for there to be a "deterrent" the government has to appear like they are wanting the most they can get in order to have the deterrent factor be present. The judge will likely claim that his cooperation with investigators and mitigating factors like his actions to prevent down-loaders supersedes the Deterrent factor and sentencing guild lines and either negate any jail time with probation or list his jail time as the time he spent waiting bail after they raided him and credit him with time served. If he spent a week in jail, he would probably get 7 days- time served and 1 year probation or possibly 6 months suspended sentence on the completion of 1 years probation or something of the sort. But the point is to keep up appearances. The judge has quite a bit of leeway on this despite that class A misdemeanors have a minimum of 6 months.

There are ways to import drugs to the US if you're looking for cheaper meds. Of course that has its own risks and also doesn't apply to controlled substances. Lots of people do buy and import controlled drugs though like benzos and opiates simply because customs can't catch them all.

Check the FDA guidelines here http://www.fda.gov/ora/import/pipinfo.htm if you want to see what it specifically says.

The problem is that the FDA needs someone to fuck over in the case that a medical device glitches out.

The device we were working back when I had a job was only a class 2, and still the restrictions were insane.

http://www.fda.gov/CDRH/devadvice/3132.html

Even beyond code version control, we needed to have every aspect of the design and even testing under version control, which was constantly monitored, along with email communications, by FDA auditors. I even had to get FDA approval for tools I was using like nmap, webscarab, and wireshark.

I always thought how great it would be if there were more medical devices that were open source, but after working on this project, I can see why it's not so popular. Even if a team of brilliant hobbyists wrote the cleanest and most useful open source apps for hospital usage, it would never be allowed into hospitals because it could never get FDA approval.

I don't think there exists free tools that allow you to leave an audit trail detailed enough to please the FDA. They have to start following you at the beginning of the design cycle, and the moment they think something is out of order, they can shut the project down.

I see nothing in these rules that would preclude Free Software. Indeed, they would seem to favor Free Software as it is the device manufacturer, not the software vendor, who must see to it that the software complies.

BTW Free Software is not the same as Copyleft Software. Much of your proprietary software (and all versions of Unix) contain bits of Free Software, such as the BSD TCP/IP stack. See the Free Software Defintion.

"Wow, this is a ridiculous comparison. Maybe they should outlaw cars too? They kill and hurt a lot more people than games do."

http://en.wikipedia.org/wiki/Vehicle_inspection

"How about we outlaw stairs? Single story buildings ONLY. Stairways kill and hurt more people than games do!"

http://www.communities.gov.uk/planningandbuilding/buildingregulations/

"While we're at it, let's outlaw solid food. People choking on solid foods have a higher mortality rate than people playing a video game."

http://www.fda.gov/

You were saying?

If you're gonna link scientific literature, try to at least link the full article so people can see who funded their research. I'll do it for you: http://www.geosc.psu.edu/~kkeller/Kraepiel_est_03.pdf

"Tuna sampling and analysis was organized and paid for by the USTF (United States Tuna Foundation)"... They happen to be the guys who's job it is to whine when the FDA does its job by telling women to avoid types of fish which are known to have higher concentrations of methylmercury (like tunas): http://www.cfsan.fda.gov/~acrobat/hgstak58.pdf
"Based on a United States Tuna Foundation (USTF) and National Fisheries Institute (NFI) joint evaluation on methylmercury in fish advisories, we believe it is premature to adopt the Environmental Protection Agencyâ(TM)s (EPA) reference dose (RfD) as a basis for consumer advice".

Yeah, they sound like a great source of unbiased scientific funding eh?

Is it any surprise that they chose to do their research off of Hawaii, when "Environments that are known to favor the production of methylmercury include certain types of wetlands, dilute low-pH lakes in Northeast and Northcentral United States, parts of the Florida Everglades, newly flooded reservoirs, and coastal wetlands, particularly along the Gulf of Mexico, Atlantic Ocean, and San Francisco Bay." (http://www.usgs.gov/themes/factsheet/146-00/)
Notice Hawaii wasn't in there. Using exceptions to prove rules isn't usually a sound idea.

Sorry, mercury in marine fish does not come from coal fired power plants [cosis.net], or for that matter almost any other human activity (except in special cases like Minimata).

Ice core data disagrees with you: http://upload.wikimedia.org/wikipedia/commons/2/26/Mercury_fremont_ice_core.png

Freshwater contamination by Hg is solely a result of improperly dumped industrial liquid waste.

Any reason you're trying to omit marine considerations when you selected the word "freshwater"? I mean, that is where we get our tuna isn't it? Not to mention most of the other contaminated fish.

there is the issue you are selling things for consumption...you don't think the FDA will require you to get a distribution license?

The FDA does not license farmer's markets or Farmers markets. Some states do though, apparently New Mexico does. Now that's not to say a license is not needed, a farmer may need a business license to operate such a market.

Falcon

there is the issue you are selling things for consumption...you don't think the FDA will require you to get a distribution license?

The FDA does not license farmer's markets or Farmers markets. Some states do though, apparently New Mexico does. Now that's not to say a license is not needed, a farmer may need a business license to operate such a market.

Falcon

Or from the FDA itself: http://www.fda.gov/oc/history/elixir.html

The public outcry that you'll have the first time a hospital administers medication that a patient is allergic to because the IT staff is still in the middle of restoring backups will (or at least should) be epic.

This kind of thing already happens ALL THE TIME. Stopping preventable medical errors is one of the huge reasons hospitals install EMRs in the first place. Here is the first article I found on this topic (not necessarily the best)

As likely as your scenario is that the doc doesn't know the patient is allergic because the clinic never sent over the part of the chart that had that in there, or the allergy was diagnosed at a different hospital.

Lastly, hospitals have carefully implemented procedures to deal with server outages, for exactly those reasons.

Not really. Phenylpropanolamine causes hemorrhagic stroke -- aka bleeding in the brain. That's why it's "hard to come by these days."

This will often be the case, but i think they can be other reasons.
Just look at the Side effects sections on the wiki page for SSRI. This stuff is exactly the right stuff for many people, and helps them tremendosly. But how exactly the brain works isn't fully understood, and it will be prescribed to people where messing with the seratonin levels does more harm than good. Would you like to be told eat some substance that will mess with your mind?

Found this link on the SSRI wiki page:
relationship between antidepressant drugs and suicidality in adults
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4272b1-01-FDA.pdf
page 112 shows the suicidality by age group, when compared to placebo

Orrin Hatch and his 1994 Dietary Supplement Health and Education Act which did the following:
It expanded the types of products that could be marketed as "supplements." The most logical definition of "dietary supplement" would be something that supplies one or more essential nutrients missing from the diet. DSHEA went far beyond this to include vitamins; minerals; herbs or other botanicals; amino acids; other dietary substances to supplement the diet by increasing dietary intake; and any concentrate, metabolite, constituent, extract, or combination of any such ingredients.
Since its passage, even hormones, such as DHEA and melatonin, are being hawked as supplements.
DSHEA also prohibits the FDA from banning dubious supplement ingredients as "unapproved food additives." Before DSHEA's passage, the FDA considered this strategy more efficient than taking action against individual manufacturers. Now the only way to banish an ingredient is to prove it is unsafe. Ingredients that are useless but harmless are protected. Nor is there any practical way for the FDA to ensure that the ingredients listed on product labels are actually in the products.

All of these quotes are pulled from Quackwatch but If you want to look up more information about it, it's pretty widely attacked for what it allows Supplement suppliers to pawn off as safe/effective. Another movie that mentions it is "Bigger, Stronger, Faster" (which is about steroids mostly) where they fill pills with sugar and trace amounts of compounds and then could legally sell it on the market without any real label information, other than "contains:".

Don't blame the parents or doctors for putting the girl on dangerous SSRI and anti-psychotic drugs.

From the third grade Megan had been under the care of a psychiatrist. She had been prescribed Celexa, Concerta and Geodon

http://en.wikipedia.org/wiki/Megan_Meier

The FDA and other bodies have found that SSRI medications cause increased suicide and agression in people under the age of 24.
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4272b1-01-FDA.pdf
http://en.wikipedia.org/wiki/Ssri#Adverse_effects
http://ssristories.com/

Blame someone else, its the [new] American way!

Blaming SSRIs is so stupid. What are they supposed to do? Let her live out her life in misery?

SSRIs can also cause liver damage, but you don't see people suggesting that this risk means they shouldn't be used. It's an ADVISEMENT that the doctors should consider the person's state before prescribing them.

Actually, the presumption on SSRIs here is that people will come out of a deep depression, and begin rationalizing suicide. Not that SSRIs actually cause the suicidal intents on its own.

Don't blame the parents or doctors for putting the girl on dangerous SSRI and anti-psychotic drugs.

From the third grade Megan had been under the care of a psychiatrist. She had been prescribed Celexa, Concerta and Geodon

http://en.wikipedia.org/wiki/Megan_Meier

The FDA and other bodies have found that SSRI medications cause increased suicide and agression in people under the age of 24.
http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4272b1-01-FDA.pdf
http://en.wikipedia.org/wiki/Ssri#Adverse_effects
http://ssristories.com/

Blame someone else, its the [new] American way!

No, this is just marketing FUD. We've been able to do these quick tests in the United States legally since 2004. And the test kit that the parent seems to be talking about is much more recent, and it's only been tested on 322 people -- which is not nearly enough to make any kind of determination on it.

This is probably the test kit that the parent talks about. Notice the actual number of subjects this device was tested on. And notice, that the testing was done by the company itself, and that its results haven't been published in a peer-reviewed journal as of yet, year 2008.

Then notice that in the US, we've had this type of quick testing device already available since 2004. It has been approved for blood testing for HIV-1/2. And it has even been approved for saliva testing (at least for HIV-1, not HIV-2, for the saliva)

Ever also thought about a relation of food and pharma industry?

The United States has a Food and Drug Administration. Think about it.

I agree with you for the most part. However, this case had A LOT OF EMOTIONAL BAGGAGE attached to it.

Also, she didn't "innocuously" join a website under a false name. She did it for one purpose. To harass and bring emotional damage to a child, an emotionally unstable child at that.

I also blame the parents of Megan for even letting her get on anti-depressants at such a young age. Those meds are harsh and should be only used under the care of a very, very good psychiatrist, note that I did NOT say psychologist. Huge, huge difference. I noticed a trend where a lot of non-medically trained psychologist are making recommendations about MEDICATIONS to their clients (they call them patients). This is very scary. Only a MEDICAL doctor should make those calls. Yet parents hear crap like ADD or ADHD from just a psychologist and run to their primary care doctor and tell him/her and bam the child is on very harsh drugs that DO have long-term effects and have been shown to cause suicidal thoughts. SSRI's.

Hell, I am only 35, I was never drugged out by my parents for "mood swings" or my "lack of attention". I spent most of my time in high school with a boner and looking out the window. I turned out OK and with a good career.

"Modern" parents, stop, stop, stop, drugging your kids because they don't fit into some model mold you created in your head. They are freaking kids for crying out loud.

Would Megan still be alive if she never took SSRI's? No one could say that. However, I personally believe she would.

Should we make this skank mother pay for what she did to Megan? No. She didn't break any laws, so let's not create new ones just for this waste of life.

I personally don't want to have to worry about criminal charges because I didn't adhere to some big corps. EULA. Jeez.

According to wikipedia Meier was taking Celexa, Concerta, and Geodon.

Celexa is an SSRI anti-depressant medication. SSRI meds are associated with the following side effects:

Manic Reaction (Mania, e.g., Kleptomania, Pyromania, Dipsomania)
Abnormal Thinking
Hallucinations
Personality Disorder
Amnesia
Agitation
Psychosis
Abnormal Dreams
Emotional Lability (Or Instability)
Alcohol Abuse and/or Craving
Hostility
Paranoid Reactions
Confusion
Delusions
Sleep Disorders
Akathisia (Severe Inner Restlessness)
Discontinuation (Withdrawal) Syndrome

On September 14, 2004 the FDA added a Black Box Warning in regard to antidepressants & suicidality in those under age 18
http://www.fda.gov/ohrms/dockets/ac/04/slides/2004-4065s2.htm

On September 14, 2004 the FDA mandated that pharmacies provide to all parents or guardians for those younger than 18 an Antidepressant Patient Medication Guide. This guide reads (in part) "Call healthcare provider right away if you or your family member has any of the following symptoms: Acting aggressive, being angry, or violent & acting on dangerous impulses." This Antidepressant Patient Medication Guide also states "Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms."

On December 13, 2006, the Black Box Warning for suicidality was updated to include those under age 25. The Black Box Warning is included in the insert to the drugs and in the Physicians' Desk reference.

Note how Meier was also taking Geodon, which is used for schizophrenia, acute mania, and mixed episodes associated with bipolar disorder. She was clearly being affected negatively by the anti-depressant Celexa. Instead of taking her off the medication her doctors gave her more medication!

The role that these drugs played in the suicide of this poor girl haven't been investigated. That doesn't excuse the behavior of the women, but does it warrant jail time and a large fine? Shouldn't her parents, doctors and FDA officials, pharma companies also be liable for putting her on these meds?

Race is a fiction with no scientific basis.

Tell that to the FDA: http://www.fda.gov/fdac/features/2005/505_BiDil.html I could give examples of tens of drugs more. I can talk about diseases that certain races are more prone to than others. But I think I have made my point.

Just saying "wrong" gives you NO creditability.

Just saying HFCS is in EVERYTHING gives you none as well.

Looking at the long-winded list of crap in this bottle of Centrum... there it is! "Less than .1% High Fructose Corn Syrup".

Huh.. well the One-A-Day men's I checked has none. So therefore, HFCS is not in everything, is it?

Imagine what is in those flintstone vitamins.

Funny, I took those as a kid, everyday, growing up. I was never fat. At least not until I started eating a lot of fried and other fat filled foods.

I am looking at Publix brand Double Chocolate pudding snack in my lunch. 2 Tablespoons, 4 servings.

And guess what, it's not random! http://www.cfsan.fda.gov/~dms/qa-lab18.html

The real trickery, just like the "fat free" label, companies DO NOT have to list ingredients below a certain percentage PER SERVING.

Serving sizes are not allowed to be arbitrarly made up by manufactors either. See the link, again. And what are you, 12? Your mommy still packing pudding in your lunch? Christ man..

Your loaf of bread likely has 16-24 servings in it. What do you honestly think the chances are that there is HFCS in there?

Zero. Looking beyond the nutrition panel, they must also list ingredients. Which is how I discovered there's no HFCS in it. Of course just because something is listed as "Sugar" doesn't mean it's HFCS. You see, wheat bread also has sugar in it naturally.

I am happy you lost that much weight, but that is by no means proof of your argument. At all. Especially when evidence to the contrary is right in front of my face, and everyone elses. I can always provide images of my proof... where is yours?

Ha. Look at the average American diet. Portions are huge, people are eating more and more, and doing less and less. I have loads of doctors on my side. Studies have shown that the people that lose the most weight and keep it off WRITE DOWN THEIR DIET. Gee, I wonder why that is?

http://www.msnbc.msn.com/id/25573436/

Oh, and you've not provided any evidence.. just spouted some nonsense you heard from someone else.

Well, there's also technical issues like these. One of those pesky little problems that crops up when you have a bunch of unlicensed devices using the same frequencies as high powered licensed devices.

It is when a new license costs $0.00. Other than deployment costs, there's no reason not to upgrade frequently.

There is always risk involved when upgrading or deploying systems. Businesses don't upgrade just for the sake of upgrading. They will weigh the risks against the benefits and proceed if there is a clear advantage to upgrading. Like the saying goes, if it ain't broke, don't fix it. The cost of licenses can be minuscule compared to deployment costs, so much so that many licenses might as well be $0.00. Deployment costs can be some of your largest costs. How many people will it take to upgrade? What is their cost per hour to the business? Multiply that by the number of people involved. Have you deployed on an identical test system and tested your software to ensure that it will continue to function as required on the new production system? Do you have test scripts so that you can validate that it performs as required? Will you have to make changes to software or hardware to accommodate the upgrade? Will you need to update your documentation? What is your contingency plan should the upgrade fail? What will be the cost to the business if the system is unavailable outside of the deployment window?

Some systems, like SAP, may take years to be deployed throughout an organization. Your favorite distro might reach the end of support before deployment even completes. For other systems, your time line for product upgrades and support may not be entirely within your control. What if your system is part of a product that needs approval from the FDA? With five years of support you may have eaten up three years of that during product development and FDA approval, leaving only two years of support for the OS on your products. That could leave you with a short product lifecycle or mean that you have to perform significant upgrades in the field.

Other operating systems, such as Solaris, Windows, AIX, and HP-UX are supported for 10 and sometimes 12 years. The only saving grace for these enterprise Linux distros is that the source is available. But when the five years are up, then what? Will you still be able to pay Red Hat or Canonical to support your end-of-life Linux distro? What if they have made a business decision not to support end-of-life distros no matter what? If they will support it, it's safe to assume that your support contract will cost more than it did during the previous five years. And if you go somewhere else and hire some linux experts to support your distro, they won't have access to the information that the distro creators have. They won't have the documentation about why certain patches were applied, or specific changes were made, or other internal decisions. You better hope that your new support company is very careful and thorough.

So then, would it have been a better investment to pay for Solaris and 10 years of support, pay for 10 years of Linux support, or pay to upgrade your systems every three to five years? I don't know. It depends on your goals. Clearly Wikipedia likes to move faster than the average business. They seem to be continually upgrading their wiki software and like staying on the leading edge. From reading about their server setup, they appear to have a lot of redundancy and can reduce their risk when upgrading. Three to five years of support for their operating systems is probably sufficient for their needs. But don't let that lull you into thinking that five years is long term.

HPV does not cause cervical cancer and FDA documents admit it.

The FDA news release of March 31, 2003 acknowledges that "most infections (by HPV) are short-lived and not associated with cervical cancer", in recognition of the advances in medical science and technology since 1988. In other words, since 2003 the scientific staff of the FDA no longer considers HPV infection to be a high-risk disease when writing educational materials for the general public whereas the regulatory arm of the agency is still bound by the old classification scheme that had placed HPV test as a test to stratify risk for cervical cancer in regulating the industry.

http://www.fda.gov/ohrms/dockets/dockets/07p0210/07p-0210-ccp0001-01-vol1.pdf

As the reclassification petition reveals, HPV infections are naturally self-limiting -- meaning that they are controlled naturally, without requiring intervention with drugs or vaccines. It is not the HPV virus itself that causes cervical cancer but rather a persistent state of ill-health on the part of the patient that makes her vulnerable to persistent infections.

As the petition states:

Based on new scientific information published in the past 15 years, it is now generally agreed that identifying and typing HPV infection does not bear a direct relationship to stratification of the risk for cervical cancer . Most acute infections caused by HPV are self-limiting [1, 4-7]. ...Repeated sequential transient HPV infections, even when caused by "high-risk" HPVs, are characteristically not associated with high risk of developing squamous intraepithelial lesions, a precursor of cervical cancer.

A woman found to be positive for the same strain (genotype) of HPV on repeated testing is highly likely suffering from a persistent HPV infection and is considered to be at high risk of developing precancerous intraepithelial lesions in the cervix . It is the persistent infection, not the virus, that determines the cancer risk."

Taking Gardasil can actually make you 44.6% more likely to get pre-cancerous lesions if you already have HPV (many sexually active people do).

PCR-based HPV detection device with provision for accurate HPV genotyping is more urgently needed now because vaccination with Gardasil of the women who are already sero-positive and PCR-positive for vaccine-relevant genotypes of HPV has been found to increase the risk of developing high-grade precancerous lesions by 44.6%, according to an FDA VRBPAC Background Document : Gardasil HPV Quadrivalent Vaccine. May 18, 2006 VRBPAC Meeting. www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4222B3.pdf

Not only that, but cervical cancer is one of the most treatable forms of cancer out there. If you are healthy and get regular testings you should have no problem. There is no need for this vaccine.

This guys work was done in the early 80's and is obviously out of date.

Where is my Nobel Prize? :)

Yeah, because we all know vegetables can't make you sick.

I'm mind of the old saying: What do you mean there's an *acceptable* level of rat feces in (insert food product here)!

Try this. Rat feces is listed as "Mammalian excreta", so just search for some rather eye opening food facts.

I work for a large biotech's regulatory department, and my job is to ensure we remain compliant with federal regulations vis a vis software development.

I want to underscore something that electroniceric touched upon: You work in a regulated industry, and your firm's practices are not compliant with federal regulations.

Your biotech firm's lack of SOPs and BPs on software development is in direct violation of the Code of Federal Regulations. If the FDA audits your firm and finds this lack of compliance to 21CFR820, then the FDA can issue a Warning Letter, which will absolutely have an adverse effect on the company. Warning letters always hurt the company's stock price; investors take WLs as a sign that the company is being mismanaged.

If your CEO doesn't want to believe this, then he or she shouldn't be in that position.

FYI, here's one example of a medical device company that received a warning letter from FDA for failure to properly document software development:

http://www.fda.gov/foi/warning_letters/s6752c.htm [fda.gov]

But Warning Letters aren't the worst thing that FDA can do. For failing to follow CFRs, FDA can determine that drug products (small and large molecule) or med devices are misbranded or adulterated and can demand the company recall said products. This will destroy a start-up or small company....

Good luck with this issue.

I want to underscore something that electroniceric touched upon:

Your biotech firm's lack of SOPs and BPs on software development is in direct violation of the Code of Federal Regulations. If the FDA audits your firm and finds this lack of compliance to 21CFR820, then the FDA can issue a Warning Letter, which will absolutely have an adverse effect on the company. Warning letters always hurt the company's stock price; investors take WLs as a sign that the company is being mismanaged.

If your CEO doesn't want to believe this, then he or she shouldn't be in that position.

FYI, here's one example of a medical device company that received a warning letter from FDA for failure to properly document software development:

http://www.fda.gov/foi/warning_letters/s6752c.htm

But Warning Letters aren't the worst thing that FDA can do. For failing to follow CFRs, FDA can determine that drug products (small and large molecule) or med devices are misbranded or adulterated and can demand the company recall said products. This will destroy a start-up or small company....

Good luck with this issue.

One route to making people serious about IT processes is to relate it to relevant federal regulations.

For example, we've been doing work that will eventually involve us as a partner in upcoming clinical trials. There's a bunch of federal regulations about IT processes connected to clinical trials, and it has been easy to get management to accept that while our current processes can be as ad-hoc as we like, at some point having compliant processes will be essential to continuing the work we do, so we may as well get it right the first time rather than have to reimplement years worth of ad-hoc development somewhere down the track.

In my case, one trivial example has been being able to implement gpg signing of documents as a consequence of setting up the infrastructure to be able to be quickly compliant with 21 CFR 11, which we'd need to do if we're part of a clinical trial.

Just thought of something, you might want to read up of FDA regulation CFR Part 11 which talks about the use of electronic records. With that you can provide examples of what could bit you during an audit.

I also work for a biotech (... this my other brother Darrell), and we're facing the prospect of FDA regulation as a device. So we're presently working our way through ramping up a formal (21CFR820) Quality System now. My boss happens to have been through this before and to be a pretty effective evangelist for the FDA's Quality System methodology, which is required for all medical devices and drugs. As he says, a Quality System is just putting to paper all the things you should be doing anyway. So one place you may want to start is by discussing the utility of complying with FDA regs with regard to software.

My boss also notes (on any occasion where there's an opening) that when the FDA introduced design controls, most companies complained they were going bankrupt (as companies are wont to do when regulation, merited or unmerited, is proposed). But when the FDA went around doing their roadshow to show that they weren't just making rules without listening to industry, people from the device companies gradually started to get up and explain how using a Quality System actually lowered their costs and decreased their time to market for revisions and product upgrades.

So as an evangelization tactic I'd look on the FDA's site for guidances relating to the introduction of the Quality System Regulation. For example, this guidance on general principles of software validation is pretty good. If you mentally translate into software industry language you can really see that they're trying to get you to do better engineering by thinking and documenting early, really getting straight what the software is trying to do, and being structured about showing that it does what it needs to do. The truth is that despite the startup effort of introducing documentation and procedures, controlled engineering methodologies work way better - they reduce requirements failure, increase code quality (and more importantly, design quality), and - though developers start out hating paperwork - even make the developers happier because more code works and sees real use. If the company plans to be in the software business for the foreseeable future, it's almost certain that the effort invested in good software practices will pay huge dividends down the road. The key is point out that quality is not an esoteric consideration, it's a driving cost and business risk consideration. Sooner or later the cost of low quality software shows itself.

One thing I will note is that the QSR is pretty waterfall oriented, both because it predates the formalization of iterative/agile methodologies, and because it's written for engineering of physical boxes that have to be released to manufacturing (which implies a fair bit of waterfallism). Part of our effort is to practice iterative development methodology while documenting to the FDA's standards.

Anyway, take a look at all that.

I also work for a biotech (... this my other brother Darrell), and we're facing the prospect of FDA regulation as a device. So we're presently working our way through ramping up a formal (21CFR820) Quality System now. My boss happens to have been through this before and to be a pretty effective evangelist for the FDA's Quality System methodology, which is required for all medical devices and drugs. As he says, a Quality System is just putting to paper all the things you should be doing anyway. So one place you may want to start is by discussing the utility of complying with FDA regs with regard to software.

My boss also notes (on any occasion where there's an opening) that when the FDA introduced design controls, most companies complained they were going bankrupt (as companies are wont to do when regulation, merited or unmerited, is proposed). But when the FDA went around doing their roadshow to show that they weren't just making rules without listening to industry, people from the device companies gradually started to get up and explain how using a Quality System actually lowered their costs and decreased their time to market for revisions and product upgrades.

So as an evangelization tactic I'd look on the FDA's site for guidances relating to the introduction of the Quality System Regulation. For example, this guidance on general principles of software validation is pretty good. If you mentally translate into software industry language you can really see that they're trying to get you to do better engineering by thinking and documenting early, really getting straight what the software is trying to do, and being structured about showing that it does what it needs to do. The truth is that despite the startup effort of introducing documentation and procedures, controlled engineering methodologies work way better - they reduce requirements failure, increase code quality (and more importantly, design quality), and - though developers start out hating paperwork - even make the developers happier because more code works and sees real use. If the company plans to be in the software business for the foreseeable future, it's almost certain that the effort invested in good software practices will pay huge dividends down the road. The key is point out that quality is not an esoteric consideration, it's a driving cost and business risk consideration. Sooner or later the cost of low quality software shows itself.

One thing I will note is that the QSR is pretty waterfall oriented, both because it predates the formalization of iterative/agile methodologies, and because it's written for engineering of physical boxes that have to be released to manufacturing (which implies a fair bit of waterfallism). Part of our effort is to practice iterative development methodology while documenting to the FDA's standards.

Anyway, take a look at all that.

I'll give you credit for consistency and civility. Nevertheless, I think you're describing a nightmare world.

When government tries to stop something, the laws they create end up creating more of what they wanted to halt. Drug wars = more drug use. Copyright laws = more unlicensed copying. It's the forbidden fruit syndrome: parents say "don't have sex," kids can't get enough of screwing around.

You and I had counterparts that had this argument nearly a century ago. My side won, mainly as a result of things like The 1937 Elixir Sulfanalamide Incident and The Triangle Factory Fire.

It's funny you mention the Sulfanilamide case. I was just talking about it with someone a few weeks ago. The FDA would probably have done nothing had it existed them. Take the recent Epogen, Aranesp and Procrit fiascos. Tested drugs that still ended up killing people. The FDA is so unsure of itself and the drugs it "approves" through bureaucratic processes that it even has a website dedicated to warning people about approved drugs. How lovely.

When the FDA stamps an approval on a drug, it's rarely due to safety but due to lobbying for approval. The testing process is merely a step used to create monopolization in the pharma market. It's by no means safer. When a new drug comes out, the only importance is that patients know they're using something that their doctor recommends, or their insurance company pays for, or whatever. Restricting drugs on the market only restrict a patient and doctor's choice in how to handle a situation. With, or without testing, we're going to have deaths. But restricting the market means MORE deaths. That's been proven time and again with even harmful narcotics like heroin, marijuana, acetaminophen, etc. Why is it that more people die from Tylenol each month than from the Elixir you quoted?

As for the Triangle Factory Fire, that's more of a time-specific incident than a lack of specific safety standards. It's well known that New York City has always been a pro-cronyism market. Getting a permit to open a competitive business can be difficult today, and was even more difficult before. The #1 reason why employees receive foul treatment from a workplace is due to the lack of competition. Competition is regularly limited by cronyism when the local governments refuse to issue permits, or offer anti-competitive incentives for the strongest company in the market.

Also, during the time of this fire, they were using gas lamps as electrical bulbs were not readily available or cost effective. There've been many fires due to the use of gas lamp lighting combined with flammable products. Even today we have fireworks manufacturing plants and stores blowing up. Government's safety standards only set a minimum, but that minimum causes many companies to cut corners because they feel they're meeting the minimum requirements.

Most people aren't paranoid enough to suspect they're being sold fake, shoddy, or dangerous goods. And even if they were, it's utterly impractical for a private citizen or small company to test everything.

So I need to pay more because some people are to lazy? Let them die or have their skin fall off, that's Darwinianism at its finest. I shouldn't have to pay for another man's laziness or irresponsibility. I shouldn't have my choices limited because of their behavior.

On the other hand, there's a very strong profit motive for companies to cheat and deceive: just look at the patent medicine era. These companies are also run by people. They cheat and believe they won't get caught. Most of the time, they aren't. So they do it again, and eventually people die.

And the law won't stop this. A person can take their own precautions through insurance against negative outcomes, but such insurance policies are illegal in the U.S. Government would rather try to reduce problems than let individuals protect themselves.

And about your milk: if conventionally pas

I'll give you credit for consistency and civility. Nevertheless, I think you're describing a nightmare world.

You and I had counterparts that had this argument nearly a century ago. My side won, mainly as a result of things like The 1937 Elixir Sulfanalamide Incident and The Triangle Factory Fire.

Yes, individual liability would work in principle to discourage unsafe practices. But you ignore human psychology. Most people aren't paranoid enough to suspect they're being sold fake, shoddy, or dangerous goods. And even if they were, it's utterly impractical for a private citizen or small company to test everything.

On the other hand, there's a very strong profit motive for companies to cheat and deceive: just look at the patent medicine era. These companies are also run by people. They cheat and believe they won't get caught. Most of the time, they aren't. So they do it again, and eventually people die.

And about your milk: if conventionally pasteurized milk is unsafe, I'm sure the FDA would be interested in hearing your evidence. And if they aren't, your newspaper will be. People will read the newspaper article, and the FDA will be forced to update its standards. That's how things are supposed to work.

Maybe they don't due to the fact that medical equipment and lunar probes have a much more limited feature set than say Microsoft Word and they cost orders of magnitude more money to put together.

If you are ready to have a fairly limited in scope operating system running on "state of the art" hardware(read: created somewhere in the 1970) there are some option for you if you have the cash.

But of course you probably don't and you expect your operating system to run your crappy non fault-tolerant hardware, 20 bucks usb printer, subsidized phone with and half compliant bluetooth stack, play "stolen" music and video in 200 different codec, all the while browsing the web and playing flash games and maybe another 50 or so other applications Microsoft and Linus Thorvald have limited control over.

To put it in perspective again, your highly sensitive medical device, has been designed with custom hardware, most probably redundant , run on dedicated chipset with under 10k LOC, when it's not purely mechanical. It is rarely networked if ever and you will NOT be AUTHORIZED to use or service them without a Biomedical Equipment Technology Training.
Imagine how much you'd spend just to get one over to clean your keyboard from breadcrumb...
And.. it does fail from time to time as you can see here: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/medicaldevicesafety/mds.cfm?page=2&sort=2

When your average defibrillator or PET scan can browse youtube and play britney spear latest album I'll consider your "medical" arguments.

Trillions of dollars? I believe that low cost computers and softwares, including Microsoft's, have helped generate trillions of trillions of dollars through increased productivity. Just think about trying to design a modern airbus or a car without a computer. I am pretty sure that overall the profit/loss ratio due to microsoft/linux crashes is still in the five nine range.

Cheers.

Why do these terrorists (people who employ "the systematic use of terror especially as a means of coercion" - see wikipedia article on Terrorism) still abuse the term piracy? Neither the United Nations, nor the International Maritime Bureau define piracy as the downloading of files (see wikipedia article on Piracy).

The legality/illegality aside, the way they are handling physical piracy sure makes me confident they'll succeed in removing internet "piracy" in no time (here, here, here and here - I bet you didn't even hear that is a problem in other businesses, maybe with the exception of fashion and software).

Here's something to think about, dear G8. All of these products being copied have artificially high prices. Could it be that those prices should be adjusted down to make it non-profitable to copy them instead of using lots of taxpayers' money (who do you think will fund these new action programs against "piracy"? You thought it was the businesses involved? Wrong!) to fight an uphill battle (War On Drugs anyone?).

Well, it is tough to regulate speech in the US. Not to say they don't do it quite a bit and don't try to do it more, but it's not easy.

Alternative medicine is one gigantic - and very dangerous - scam.

They're also very careful about what they say. I'm sure you've seen the disclaimer on those commercials, close to:"This product is not intended to diagnose, treat or cure any disease." No matter what the product, no matter who the producer, distributor or creator, you get that same wording on the disclaimer. That's because they're legal keywords; anything intended to diagnose, treat or cure a disease is a drug according to federal law. As a drug it would be regulated by the FDA and actually have to, you know, have some backup for its claims.

They're usually careful about SAYING it does any of those things as well. You get things like "my friend had a broken leg and chewed some XYZ root and it was fixed!" Well, that's an anecdote your honor! Stupid? Yep. But that's how the legal system works, and it's not accident these people make their infomercials and commercials the way they do. Ever wonder why HeadOn is allowed to do business, despite it being essentially a ball of wax yet strongly implying it can cures headaches? Yeah, because strongly implying and stating are different things.

What about all the food product labeling - low fat, organic, and all that meaningless garbage that is totally deceptive?

If I remember my consumer education classes correctly (though they were yeeears ago!) many of these terms ARE regulated. I'm not sure about organic, but low fat definitely was. I can't find a specific list of what is regulated and what they mean, but I did find this article which states, in part: "This means that such products as 2-percent milk, which contains about 5 grams of fat per serving, cannot be labeled "low fat" because the fat content is more than 3 grams per serving, the upper limit permitted in food products labeled 'low fat.' [. . .] Although two-percent milk, with its 5 grams of fat, may not be called "low fat," the product does qualify for a "reduced fat" claim. "Reduced fat" means that the fat content of the food has been reduced by at least 25 percent per serving compared to the full-fat food."

So, in short, at least some of that is already taken care of. Some of it is people cleverly dodging laws, and presumably getting away with it because of free speech issues.

Oh yes, deal with consumers in a fair way indeed. I realize that those are isolated incidents, but they are the results of playing "fast and loose with the system". People DIE.

It's not misspelled, there are multiple spellings.

http://www.fda.gov/cber/vaccine/thimfaq.htm

Just fill in this form. Don't forget to mention you want to buy an ilegal drug. They do require you to include your name, adress and some prove of ID. Ask for their fax number and send a copy of some form of ID. They usualy have next day delivery, but as a word of advice, make sure your front door is unlocked as their deliverymen are somewhat inpatient.

Many people go to Mexico to do this, as there are many drugs that require prescriptions here but are available over-the-counter in Mexico, including the equivalent of Provigil.

Note that this generally does NOT include narcotics, and trying to buy narcotics without a prescription in Mexico and bring them into the US will get you into a LOT of trouble.

I'm not advocating this, and there may be some pitfalls.

The one saving grace of asbestos is that if you leave it alone, it'll leave you alone. The real problems kick in when you start prying it loose and moving it around.

Hugely useful but only when used within strict guidelines. As it turns out, one of its potential uses turned out to be a pretty bad idea so we don't use it that way anymore.

I'll give you that one.

The FDA insists that it is. Sure, it's possible that they're a wholly owned subsidiary of Searle or whoever else makes the stuff these days, but I still trust the FDA at least as much as the groups opposing it.

My wife's a doctor. She has patients who beg her to find old expired samples or any other source of the stuff she might know of. Those patients know that it possibly cause them harm, but it's so effective that they're willing to take that risk. If you have rheumatoid arthritis, would you rather have 50 years of crippling agony before you or 25 years of painfree enjoyment? Regardless of your answer, a lot of people wish they could pick the latter but that's no longer available to them.

I begrudge them acting to make it impossible for me to use whatever it is they're afraid of this week.

I wasn't trying to trap you, but by your response maybe I did?

Since we're trading silly insults, I've heard some surgeons don't really like any hint they might be wrong, about anything, even if its just a silly mistake or outside their field of expertise.

For your information (or rather for someone else reading this who is actually interested), Da Vinci appears to be fully FDA certified, NOT as a research device, for some procedures since 2000 or 2001. I believe they have been certified for some endoscopic cardiac procedures as well. Yes, here's an FDA press release about approval of the device for coronary artery bypass surgery: http://www.fda.gov/bbs/topics/answers/2004/ANS01298.html. (from 2004)

501(k) applications and decisions are here.

From the company's site, listing procedures for which the robot is certified: http://www.intuitivesurgical.com/products/fdaclearance/index.aspx.