The Great Cancer Hoax: The Brilliant Cure the FDA Tried Their Best to Shut Down...

[bcl05]

I think his complaint is in fact the deluge of information. I think he is saying that there should be a single main Vioxx web page that is easily understandable to the general public.

He doesn't want to see 867 hits. He wants one hit that is simultanously simple, but also connected to all of the relevant information.

The FAQ (top link) works remarkably well for that. If you want an overview, its there. If you want details, those are available too. I'm not sure how they could do that better. Maybe animations?

[zoony]

so, dockeryfan, I'm curious to know which Gov Regulatory Agencies you feel do a superb job.

[dockeryfan]

The FAQ (top link) works remarkably well for that. If you want an overview, its there. If you want details, those are available too. I'm not sure how they could do that better. Maybe animations?

No. It does not. PeterMP understands what I am trying to say.

I have no idea why you think the FDA website is easy to navigate in terms of information. I have been using it for years, and I think it stinks.

[PeterMP]

You and I disagree. There is profit being made. If it poses a risk, the err should be on safety, not on status quo. That is how I feel. If the drug is not approved for children, I would love the FDA website to state that clearly. BTW, your link to NIH brought up treatment for depression, not ADHD. The average parent does not know how to interpret that page, and it's a summary page.

My NIH page talked about depressents because we were talking about antidepressents.

Doing a similar search including ADHD and dropping out antidepressants bring this up as the top hit:

http://www.nimh.nih.gov/health/publications/mental-health-medications/what-medications-are-used-to-treat-adhd.shtml

"Attention deficit/hyperactivity disorder (ADHD) occurs in both children and adults. ADHD is commonly treated with stimulants, such as:

Methylphenidate (Ritalin, Metadate, Concerta, Daytrana)

Amphetamine (Adderall)

Dextroamphetamine (Dexedrine, Dextrostat).

In 2002, the FDA approved the nonstimulant medication atomoxetine (Strattera) for use as a treatment for ADHD. In February 2007, the FDA approved the use of the stimulant lisdexamfetamine dimesylate (Vyvanse) for the treatment of ADHD in children ages 6 to 12 years.:""

"FDA warning on possible rare side effects

In 2007, the FDA required that all makers of ADHD medications develop Patient Medication Guides. The guides must alert patients to possible heart and psychiatric problems related to ADHD medicine. The FDA required the Patient Medication Guides because a review of data found that ADHD patients with heart conditions had a slightly higher risk of strokes, heart attacks, and sudden death when taking the medications. The review also found a slightly higher risk (about 1 in 1,000) for medication-related psychiatric problems, such as hearing voices, having hallucinations, becoming suspicious for no reason, or becoming manic. This happened to patients who had no history of psychiatric problems."

The problem is you think of safety in only one direction, the effect of the drug. You never think of safety in the other direction- the people taking the drug that it is working for.

I've had the discussion going the other way with ACW. He'll cite studies about the people that have died because drugs weren't approved. That the drug didn't benefit a large enough part of the population or were dangerous for enough people that the FDA didn't think they should be approved, but for some people they were safe and affective, and those people ended up suffering.

The FDA is walking a tight rope. They get criticisms from both directions. I do think there are things that could be done better, and they are things that I have mentioned here before and now, again in this thread.

[MassSkinsFan]

My personal experience? I think there is a major failure in terms of the FDA and drugs for SSRIs and depression. I see kids that take Wellbutrin. Ask yourself if it is approved for kids? No. Are they even on it for depression? No. They're on it for ADHD.

A lot of these drugs are not approved for use in children, and they are prescribed every day.

The FDA is not supposed to monitor the MDs. They are supposed to ensure that pharma companies present proper evidentiary data to ensure the safety and efficacy of their products throughout the development life cycle. Once that is demonstrated, the FDA may approve a product. The approval includes specific information on the "on-label" use of the product, based on data from human clinical trials. Once the product is approved, the FDA then is reponsible for periodic inspection of the company to ensure they continue to comply with requirements that ensure safety and efficacy.

As far as I know FDA is not in the business of enforcing presecription of approved drugs for only "on-label" indications, and also AFAIK MDs can prescribe for off-label use based on their expertise and professional judgment.

So I'm not sure how FDA is responsible in a situation such as the example above. I agree that it is not a good idea, but wouldn't say it's FDA's fault that it is happening.

I don't necessarily think the FDA does a good job because as I stated in my original post, they don't have an investigative/prosecutorial arm. They don't have the ability to pull employees from Pharma out of their homes or work and question them. They don't have the ability to threaten people with real criminal charges for failing to supply information or cooperating with investigations.

If we want to get serious about drug safety, we should prosecute Pharma executive and researchers who have broken the law, including things like manslaughter charges (or whatever the actual crime would be for deaths when taking a drug for which Pharma wasn't being honest about the drugs effects), and I've said that here before.

However that level of security is beyond the FDAs current mandate, which the FDA can't control. Given their mandate and abilites, I think they do a pretty good job of walking the line between getting things approved and on the market and safety.

The FDA should have the ability to do those types of things, or work very closely with a special branch of the Justice Dept. that can..

Actually, they can do some of these things. Certainly they can and do pull pharma employees out of work to question them. In fact, this is a major part of any pre-approval or routine GMP inspection and it is standard practice in the industry. I've never heard of anyone being pulled out of their home, but that's because everyone is typically available at work and generally more than willing to cooperate. If you had an uncooperative person, I have no doubt FDA would find them outside of work.

A big part of our inspection readiness training is getting across to people the notion that FDA inspectors are law enforcement officials. (We tell anyone who will potentially be interviewed that they should show the same degree of respect, honesty and cooperation that they would afford a police officer conducting an investigation.) They have discretion to shut or seize a facility if they observe conditions indicating a danger to the public.

There is also some enforcement, though it is typically limited to observations, warning letters, consent decrees, and/or seizure or closure of businesses. I don't understand the legal or organizational bureaucracy that leads to prosecution, but some pharma executives have been prosecuted for either hiding relevant data or encouraging off-label uses that they knew were risky. However, that action might have been handed off by FDA because it was out of scope of their mission. I don't know for sure.

[dockeryfan]

The problem is you think of safety in only one direction, the effect of the drug. You never think of safety in the other direction- the people taking the drug that it is working for.

Not for ADHD, no I don't. Not for acid reflux. For cancer? Yes. AIDS? Yes. I already stated that they revamped the tracking system for drugs, and that I think they are trying to do a better job of getting drugs to market for what they consider to be high risk high reward conditions.

But you are right, I do look at safety in for the most part one direction, simply because of do no harm. I do not see that mindset changing. Add profits to the mix and you can see how that can become a conflict of interest.

[Mad Mike]

I have only one thing to say about this. If the man has a real cure for cancer, NOTHING in this world could stop it from coming to light. The FDA doesnt like it? Take it to Europe or Asia. Someone somewhere will prove it works and it will be the top story in the world within 24 hours.

In other words, I call :bsflag:

[PeterMP]

Not for ADHD, no I don't. Not for acid reflux.

Things like ADHD and acid reflux can have serious consequences.

http://www.ncbi.nlm.nih.gov/pubmed/17303170

Not allowing somebody to take medication that potentially will work for them should be taken seriously.

The FDA can't live by the moto of do no harm because there are a lot of really good drugs that harm some people. Do no harm works well on an individual level. Not at a population based level, which is where the FDA functions.

---------- Post added June-13th-2011 at 11:29 AM ----------

Actually, they can do some of these things. Certainly they can and do pull pharma employees out of work to question them. In fact, this is a major part of any pre-approval or routine GMP inspection and it is standard practice in the industry. I've never heard of anyone being pulled out of their home, but that's because everyone is typically available at work and generally more than willing to cooperate. If you had an uncooperative person, I have no doubt FDA would find them outside of work.

A big part of our inspection readiness training is getting across to people the notion that FDA inspectors are law enforcement officials. (We tell anyone who will potentially be interviewed that they should show the same degree of respect, honesty and cooperation that they would afford a police officer conducting an investigation.) They have discretion to shut or seize a facility if they observe conditions indicating a danger to the public.

Based on your comments, I'm going to assume that you actually go through this process, but my understanding from talking to the people that I know that work in Pharma was that interviews of Pharma employees essentially always occured a their work. on site.

That they weren't pulled out of work and taken to another site to be questioned like the police would do with respect to a crime.

[lovetoaster]

Someone gets a hold of it and develops a generic form, the government up here just got done slapping down the big pharms in order to cut prices and the pharms threatened all sorts of things and preached doom and gloom and it did not happen

You say they just got done. It takes a while for "doom and gloom" to happen. I think the drug companies certainly have some significant issues, but if you take away the financial incentive to develop and research drugs, then nobody is going to have much interest in putting in what is a hell of a lot of work to find new cures. There is a considerable amount of time and money that goes into research and education from the front end before we even know that a drug exists. Let's be honest, I am sure that the satisfaction that you get from possibly saving a human life is amazing, but if you take away the financial reward for doing so, a lot of people would not be interested.

I understand the debate that almost everyone is having over healthcare and pharmaceutical companies, and sometimes I am not really sure where I stand on it. Many companies in these industries have become entirely too powerful, but we need to continue to encourage them to make advances that save and enhance lives. There needs to be a balance in there somewhere, but I am not sure that anyone has found the right answer.

[techboy]

I really hope you're not as big a tool as you project on this forum. I get the feeling you are however. Too bad

Well, I don't think so, but it's been my general observation that people who behave in this manner are often blissfully unaware of their own nature, so maybe? :whoknows:

[#98QBKiller]

I am an MD, and have worked with the FDA on a panel for new drug evaluation for my particular area of expertise. I've never found the FDA people to be anything other than completely professional and reasonable. They have been remarkably quick in approving drugs for certain untreatable, devastating diseases and have been appropriately careful and circumspect in approving alternative (non-superior) drugs for diseases with well-established effective treatments. I have gotten "compassionate use" approval for certain investigational drugs in emergent circumstances in a matter of hours.

I'm certain they've screwed up in the past, and no drug evaluation system will ever be foolproof, but I think overall they do a commendable job. The conspiracy theorists are just plain silly. Cancer treatment is getting better every year. The cure rate for the most common form of childhood cancer (a form of leukemia) has gone from zero to over 90% over the last 30+ years. All the studies to advance those treatments have been approved and monitored by the FDA.

I have been working in regulatory affairs for the last five years and deal with the FDA on an almost daily basis and I agree with these comments 100 percent.

[MassSkinsFan]

Based on your comments, I'm going to assume that you actually go through this process, but my understanding from talking to the people that I know that work in Pharma was that interviews of Pharma employees essentially always occured a their work. on site.

That they weren't pulled out of work and taken to another site to be questioned like the police would do with respect to a crime.

Yes, that's correct (on both counts). If they were to be pulled out of work for interrogation, it would be in an unusual case where there were very serious allegations. Sorry - I misunderstood your post there.

Bottom line is that FDA does have some enforcement discretion but, as you state (and with which I agree) it could be stronger and more visible. Certainly a system like the Qualified Person one in use in Europe would help make the accountabilities more visible.

---------- Post added June-13th-2011 at 11:44 AM ----------

I have been working in regulatory affairs for the last five years and deal with the FDA on an almost daily basis and I agree with these comments 100 percent.

Pharma RA? I'm pharma QA and I also agree with bcl05's statement.

[dockeryfan]

Things like ADHD and acid reflux can have serious consequences.

http://www.ncbi.nlm.nih.gov/pubmed/17303170

Not allowing somebody to take medication that potentially will work for them should be taken seriously.

Who says they aren't serious? Arthritis pain is a big deal to the person that has it. That doesn't mean you have to kill 100,000 people like what happened with Vioxx.

Just because acid reflux and ADHD are serious to the person that has it does NOT mean that the potential risk of a drug is worth it. Maybe you feel differently, but I do not.

EDIT: Please read my above posts where I already complimented the FDA of reclassifying their drug to market tracks before responding.

[LadySkinsFan]

Profit is one thing, but obscene profit is something else. And don't forget that taxpayers are contributing to R&D through government grants, so the costs that companies directly bear for R&D is not as much as people think. Not to mention that the researchers themselves (MAs, PhD students, and post Docs) are paid low wages for doing this work. The scientists who head up the research are often not the ones in the actual labs but they get the most pay.

[Dan T.]

Well, I don't think so, but it's been my general observation that people who behave in this manner are often blissfully unaware of their own nature, so maybe? :whoknows:

Don't sweat it, techboy. Chump is way off. You're as far from a "tool" as any regular on this board. And as a tool myself, I should know.

[Thiebear]

Techboy is absolutely a tool.

I read his stuff everytime i see it posted in a topic and it normally helps.

Ohhhhh....that kinda

[#98QBKiller]

Pharma RA? I'm pharma QA and I also agree with bcl05's statement.

I'm actually doing eSub but it falls under RA here, at my last company it was under Medical Writing. Definitely a good statement by bcl05.

[techboy]

Don't sweat it, techboy. Chump is way off.

Trust me, I'm not sweating it. My observation might be timely for others, though.

You're as far from a "tool" as any regular on this board.

Okay, now I'm sweating it.

And as a tool myself, I should know.

I was thinking about asking zoony under the "it takes one to know one" angle.

[zoony]

I was thinking about asking zoony under the "it takes one to know one" angle.

I am indeed an authority, and no, you're not. Dan T, however, is.

[Dan T.]

I was thinking about asking zoony under the "it takes one to know one" angle.

It makes sense to go to the master. On the tool scale, I'm simple, he's power.

[MassSkinsFan]

Profit is one thing, but obscene profit is something else. And don't forget that taxpayers are contributing to R&D through government grants, so the costs that companies directly bear for R&D is not as much as people think. Not to mention that the researchers themselves (MAs, PhD students, and post Docs) are paid low wages for doing this work. The scientists who head up the research are often not the ones in the actual labs but they get the most pay.

R&D funding is not guaranteed to be available, and even when it is, it isn't often significant. The cost of human clinical trials is incredibly high. Compound that by the number of studies you'll need to run in order to build enough data for a licensure filing, and you're looking at millions and millions or more likely a few billion dollars. Also, given that roughly 10% of all drug candidates that make it to Phase 1 (safety) trials actually get licensed, and that the success rate for drug candidates that get to primate (non-human safety/toxicology) studies is much lower, the profit margin isn't as large as it seems to be.

When you're investing millions in projects that taken together have between 2 and 5% chance of getting to licensure, you need to make up for your losses through profit on anything that's successful. This creates a disincentive for big companies to fund internal R&D and has led many to "outsource" it by shopping for good ideas in smaller companies then licensing them or buying those companies outright.

I agree with your last statement though. It's depressing to see all the PhDs I work with being paid so poorly.

---------- Post added June-13th-2011 at 12:19 PM ----------

I'm actually doing eSub but it falls under RA here, at my last company it was under Medical Writing. Definitely a good statement by bcl05.

Cool - eSub (or what we call RA Ops) is in demand.

[mcsluggo]

the interwebz LUVS a good conspiract theory!

(or.. more generally... totally bogus ones...)

[Wrong Direction]

A few points:

1. FDA does have an OIG, and they do partner closely with DOJ for actual investigations. If a case comes up alleging a company misrepresented data to the FDA, it goes to law enforcement.

2. The problem with off label use of drugs (e.g., anti depressants for kids) is a congressional problem, not an FDA problem. Their mandate relates to safety and effectiveness for the studied population, with associated warnings and limitations. However, Congress allows coverage for indications placed on drug compendia, which are privately managed lists of drug-indication pairs. So, if some Dr. said lipitor cured breast cancer and could defend it enough to have that placed on a compendia, many insurance companies would basically be forced to cover it even without that indication being anywhere on the FDA label. That extreme case doesn't happen much, but it happens all the time with respect to minor changes like the allowable age on a label. In other words, privately run compendia with very little oversight greatly expand the allowable indications for FDA approved drugs well beyond the approved FDA label. This is standard, and legal.

3. The funny part is the DOJ can actually prosecute companies for marketing beyond the FDA approved label (e.g., marketing to compendia), but they can't actually stop legal prescribing of on-compendia drugs. The DOJ likes to go after Phrma though because the awards are potentially very large.

4. Peter's description of David Graham's position is spot on (e.g., drug approval needs to be separated from post-market surveillance/enforcement of safety). I agree with David on this.

5. The FDA can be slow to react to safety signals with things like black box warnings, removal from market. Also, they can load advisory panels with people from industry who don't necessarily have the best interests of the consumer in mind. This is a problem, but it doesn't get nearly to the level of preventing the cure for cancer to hit the market.

[Special K]

And I seriously doubt you're in a position to make an iota of difference in much of anything. My issues are with the advisory panel and the conflict of interest between the FDA & Pharmacuetical Industry which has been well established. But, you're right. It's all about protecting people and saving lives. What was I thinking? Nevermind the fact the good doctor was vindicated and is just making this up as he goes along. Iatrogenic deaths occur at an alarming rate each year. I want that to change and I want the focus to be on healing and not solely profits.

Of course I'm not in a position to make decisions within the FDA. But even us grunt workers are required to know how the FDA works, the ins and outs of the advisory panel process, and the legal aspects regarding actionable decisions based on advisory panel recommendations. Regardless, it doesn't take having to know these processes, having to participate in conference calls regarding advisory panel recommendations, etc. to identify the fact that your "argument" is complete conspiracy theory and it's sad people actually buy into this crap.

I just like that you used the word "scientifical".

Hey, it was late at night!!!! I'm going back and editing that, because that's just dang-well embarrassing, lol.

---------- Post added June-13th-2011 at 09:04 AM ----------

Yes, FDA people are evil - but I only say that because I HATE being inspected by FDA. They're brutal.

Hey, I'm a nice inspector Everyone still hates me when I step through their door though....oh well.

[MassSkinsFan]

Hey, I'm a nice inspector Everyone still hates me when I step through their door though....oh well.

Ha ha ha - I'm sure you're a nice one (many are) but you realize you scare the living **** out of us right? Besides, I'm in QA so people tend to flinch when they see me coming too...