Trip to Tijuana Mexico change my outlook forever

By far not a prefect system, 75% of all drugs do not make it through trials.  Where are all the poor patients who took trials that got no benefit now? Wait... one right here! Me! I'm not saying all trials are bad but someone has to be the paitents that did not get helped.  How do you know that person will not be you?

FDA Drug Approval Process under Scrutiny

The U.S. Food and Drug Administration (FDA) is facing renewed criticism over the process by which it approves drugs for market. Recent reports indicate many drugs are approved before they are proven safe, and problems with the agency's structure and processes prevent it from fulfilling its mission. Subsequently, Congress has started using its oversight powers to scrutinize the agency, and the clamor for FDA reform is growing louder.

The Federal Food Drug and Cosmetic Act requires FDA to ensure the safety of new drugs before the agency approves the drugs for market. However, operating within a provision of the law, FDA often approves drugs before safety is established. The agency then requires drug manufacturers to further study drugs while they are on the market. These "post-marketing commitments" serve to streamline the drug approval process.

FDA recently revealed that many of the post-marketing commitments go unfulfilled. On Feb. 2, the agency published a report in the Federal Register detailing the progress of post-marketing commitments, which in Fiscal Year 2006 numbered 1,259. As The NewStandard reported, FDA said drug companies "had yet to initiate 71 percent of outstanding 'post-market' safety evaluations." Meanwhile, only 11 percent have been submitted. These drugs remain on the market, yet neither FDA nor drug makers have proved their safety.

Congress also recently expressed concern over the FDA drug approval process. On Feb. 13, the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigation held a hearing titled "The Adequacy of FDA Efforts to Assure the Safety of the Drug Supply." The hearing occurred in response to recent regulatory failures that allowed dangerous drugs on the market, such as the highly publicized Vioxx incident.

Hearing witnesses testified that the FDA drug approval process is subject to industry influence and that agency managers sacrifice sound science in the name of expeditious approval. Ann Marie Cisneros, a clinical researcher, accused the pharmaceutical company Aventis of being complicit in a fraudulent clinical research project which Aventis had sponsored.

The testimony of Dr. David B. Ross, a physician and former FDA pharmaceutical reviewer, told the story of the antibiotic Ketek. Dr. Ross claimed Ketek was approved despite persistent warnings of its danger: "FDA managers were so bent on approving Ketek that they suppressed evidence of fraud and pressured reviewers - including myself - to change their reviews."

The criticism leveled at FDA is not new. The Government Accountability Office (GAO), the investigative arm of Congress, issued a report in March 2006 identifying significant gaps in FDA's ability to monitor and regulate post-market drugs. The GAO report mentioned organizational structure, insufficient oversight and poor data availability as some of the major problems facing FDA. GAO recommended Congress expand FDA's regulatory authority for post-market drugs.

In September 2006, the National Academy of Sciences Institute of Medicine also identified problems at FDA. Most notably, "FDA and the pharmaceutical industry do not consistently demonstrate accountability and transparency to the public by communicating safety concerns in a timely and effective fashion."

The mounting evidence in the case for FDA reform increases the likelihood of congressional action. Congress will likely take up the renewal of the Prescription Drug User Fee Act (PDUFA), which is set to expire this year. The legislation gives FDA the authority to require drug manufacturers to pay fees that the agency then uses to conduct drug reviews. In his proposed FY 08 budget released in early February, President George W. Bush called for new industry fees to further finance FDA. User fees from regulated companies would account for 21.3 percent of FDA's budget and pay for nearly 60 percent of reviews, according to USA Today.

FDA critics are skeptical of the industry-paid user fees. In the House hearing, Dr. Steven E. Nissen, chairman of the Department of Cardiovascular Medicine at the Cleveland Clinic Foundation, chastised PDUFA: "We started down the wrong pathway when we said that the regulated industry was going to pay the FDA to regulate itself."

In addition to PDUFA reauthorization, two Senate bills aim to enact reforms within FDA. A bill introduced by Sens. Charles Grassley (R-IA) and Christopher Dodd (D-CT) would separate FDA's drug safety office from its drug approval office, thus elevating FDA reviewers to the same status as managers who approve drugs, according to Congressional Quarterly (subscription). In an attempt to improve post-market regulation, a bill introduced by Sens. Edward Kennedy (D-MA) and Michael Enzi (R-WY) would focus more on the drug safety processes as they are currently used. Both bills are currently in committee.

It is unclear whether the drug approval process at FDA will be subject to reform. However, with the safety of many post-market drugs unknown, the issue is unlikely to go away. In his testimony, Ross chided his former employer: "Overall, there is a culture of approval [at FDA.]" He indicated that approval, not safety, is the top priority, adding, "If you can get a product on the market...then you find some way of doing it."

Report faults FDA oversight of drug trials

WASHINGTON (Reuters) - A report to be released on Friday finds the U.S. Food and Drug Administration does very little to ensure the safety of patients who help test drugs in clinical trials, The New York Times reports.

It quotes Daniel Levinson, the inspector general of the Department of Health and Human Services, as saying FDA officials do not know how many clinical trials are being conducted and have audited fewer than 1 percent of the testing sites.

FDA inspectors often show up long after the tests have been completed, the Times quotes the report as saying.

HHS is the parent department of the FDA, which, among other duties, approves new drugs. Clinical trials -- those involving real human patients -- are a key part of this approval process.

But the FDA has been accused of lax oversight of drug trials in general. The agency has said it lacks the resources to do the job properly.

It has 200 inspectors who are responsible for 350,000 testing sites, the Times said.

The report found that top drug officials in Washington downgraded negative findings from these inspectors 68 percent of the time.

The FDA disqualified researchers from conducting further clinical trials 26 times from 2000 to 2005 and disqualified their data twice, although it found serious problems at trial sites 348 times, the newspaper quotes the report as saying.

Levinson recommended that the agency create a registry of all continuing clinical trials.

President George W. Bush signed a measure into law on Thursday that will give the FDA more power and money to do this as part of better policing of reports of dangerous side effects from prescription drugs after they reach the market.

The legislation is largely a response to a string of drug safety controversies, including the 2004 withdrawal of Merck & Co Inc's widely used arthritis pill Vioxx after it was linked to heart attacks and strokes.

Well - as I've posted before - I saw first hand how the FDA stopped an unscrupulous doctor from falsifying patient records and the company I worked for lost MILLIONS of dollars spent on researching this drug. So..............yes, the FDA needs to improve it's oversight - perhaps we can raise taxes for that purpose although I doubt that will happen any time soon - but as faulty as the FDA is - it's better than NOTHING - which is the problem with some of the so-called "cures" offered in clinics in Tijuana and other areas of the world. We need to apply the same legislative scrutiny to ALL manufacturers of drugs AND therapies that line the pockets of the greedy and rich at the expense of the sick and dying.

Edited to add - look, the same thing is being discussed in another forum - the FTC is cracking down on manufacturers who falsely claim their products cure cancer!

http://community.breastcancer.org/forum/73/topic/721458

Shirlann these are your personal concerns. Other have to make their own decision. Again I have a huge open greenish pusy cancer that has burst through my breast and I have been in conventional treatment for three years. Three top clinic!  And Yes the GOD of cancer clinics MDAnderson. Who has shown me and many other's with stage iv disease anything but empty promises?  Please explain to me why I have this on my chestwall still???  Do you know some miracle cure that the doctor's don't know? The moral of the story is still conventional does NOT know how to treat stage IV disease.  How many on this site is cure at stage IV.... maybe 2%. Why do other demand that alternative cures your disease when you don't require of conventional medicine? It's about quality of life while fighting your disease.

We have repeated address to any "new people" to do their own research. This thread is not about new people.  It's about patients who don't want to chose more empty promises that we most be toxic to fight stage iv disease. This thread has not been all along about Mexico this is just a location. We are discussing these treatment options that were not offered to everyone. Most of this research goes back sixty to seventy years.  Chemo in it's current form has only been around for something like 40+ years.  How do you think people treated cancer before chemo?

Flalady

Can you please let me know which Isacdor your wife is taking and how many shots per week for how long? my email ewaczarnobil@gmail.com

Thank you Ewa

konakat, Please go sign up for a Phase I trial ASAP. Than come back and discuss your protocol.  I've been there and done that.  I also a research many trials and the data that come from them.  Most trails have less than 5% response rate. You are very missed informed about drugs trials.  Perfect example is us TN ladies.  Most new trials are pulling old drugs out of the closet and dusting them off and shooting them into people to "see if they get response"??????? I have been told this by three top clinic's.  They do not have news drugs lined up.  They are EXPERIMENTING on all stage iv patients.  Why do you think less than 90% will die in less than five years.   You call this hope?  You are willing to die from toxicity of chemo before cancer get's you.  Yes! that is your choice. Alternative do not make decision off one brochure.  Guess what...you have to make a effort and take charge and not just show up for more chemo.

Do to insurance that leave many with no choices but chemo, we will all die this way as stage iv patients.

Flalady

FlaLady:  I truly understand your frustration; it does seem as though the pharmaceuticals are grasping at straws, instead of coming up with new, effective treatments.  But I do want to note something interesting about using old drugs in new ways.  Do you remember thalidomide?  It was prescribed for pregnant women some 40 years ago to relieve nausea (I think).   But it turned out that it caused horrible physical disfigurements in many, many children.

Now thalidomide is being used to significant effect in the treatment of multiple myeloma, prostate cancer, renal cell carcinoma, and graft vs host disease in transplant patients.

You are absolutely right that we patients have to take control of our lives, do our "due diligence" (research) and ultimately do what we feel is right for us. 

With good wishes, Linda

konakat, I agree with flalady that your understanding of drug trials sounds uninformed.  What you state sounds reasonable and rational, and one would like to think this is how the pharma industry conducts itself.  Reading I've done truly shows the opposite.  Trials typically do not compare the new drug with existing standard protocol.  Benefits are 'shown' by comparing the new drug with NOTHING, or perhaps a placebo.  Just read the fine print on some boxes in over-the-counter cold medicines.  It will say something to the effect, compared NOTHING, this product is beneficial. 

Also, drug companies typically are the funding sources for the last phase of testing.  On one hand they complain about the high cost of research, yet a lion's share of that research comes from publically funded sources.  Only the final phase of testing is typically paid for by the drug companies.  And for this reason, a lot of study results never see the light of day.  Results which are unfavorable to the company's product tend not be published.  Some of these products go to market anyway and the company makes a few buckets of money before the product gets yanked.  Surely you've noticed that a number of pharmaceuticals have been pulled from the market in recent years.

As for why drug companies aren't 'all over' things that work, it appears to boil down to money.  Take hormone replacement therapy just for an example.  Women who take HRT medications are typically consuming products which are derived from the urine of pregnant horses.  Pharmaceuticals have made buckets of money from these products because they have patents on the synthetic hormones. Women have a choice of taking bioidentical hormones, which are made at a compounding pharmacy and have no known negative sides effects.  The pharmaceuticals can't put a patent on a hormone, so the opportunity to make buckets of money is absent with the bioidenticals. 

If you want to be skeptical, I would encourage you to ask yourself, why would ANYONE want a woman to take a synthetic hormone when a bioidentical hormone without side effects is available?

Also, the majority of 'new' drugs over the last decade or two have been 'me too' drugs.  Most patents are reincarnations of existing drugs already on the market.  The drug companies also file several patents on each product to prolong the amount of time they can reap their top dollar benefits. Companies attempting to produce generics are often sued in order to keep the generic drug unavailable.  So, PLEASE, BE skeptical.  Just please examine where you're placing your faith.    

I don't quite understand how a "Stage 1, 1 cm, grade 1,with no node involvement" can push a diet

that heals the body and soul from the ravages of cancer, on a Stage IV BC patient. HELLO.......is this even remotely close to a comparison here???? Yikes!

Whenever I hear about macrobiotics I cringe.  My best friend died about 10 years ago when she was told it would cure her.  They (her "Nutrition Counselor") gave her such hope she didn't do much in the way of conventional treatment.  

You early stages girls talk the big talk...let's see what you willing to research and do to extend your life if you progress to stage IV. You still have hope in a broke system.  Please spend time on the recurrence site and is how poor mainstream medicine curative rate is.  Why do you expect alternative to cure everyone and conv. med. as less than .05% or curing stage iv? or that matter stop any progression on disease. Surgery is the key to beating most cancer not chemo! I have read and spoke to other who have been healed using alternative protocol's.  But they dare not stay on this site do to back lash.  I have spoken to two ladies on this site that were ran off early this year that was healed using alternative protocols.  How are they doing... we will never know because they were not welcome on this site.  Has chemo extended my life? I don't think so...Surgeries have extended my life.  For me chemo has effect for about two to four months if I'm lucky.  And with that a more damaged body, with each chemo and failure my disease becomes more powerful and more resistant to treatment. I chose to fight chemo damage with alternative treatments to keep my body from being destoryed by chemo.  If my disease was not eating away my skin , I would not be doing chemo again.

Please show us the great stories of conventional treatment and progression of disease? Is it that  we now last four to five years, instead two or three years with side effects eating away at our quality of life?  Wow! what great advancements...NOT!

Yes there are a few who Thank GOD that win...but the history of chemo and bc is not that great. Thankfully with early detection and surgery you can have a excellent chance of being cancer free.

Don't close door's just because you must take time to educate yourself about your body and work outside of a system that other's are to scared to understand because it's different.

We must fight with everything.  

Flalady 

Hi Anom,

Sorry to hear about your aunt's passing.  And, thanks for the insight.  As you said, my judgement is probably impaired as I just have this one bad example.  I just wish my friend wouldn't have used it as her only treatment.   But as your quote shows, we have to respect other people's choices.  Maybe my friend's experience is one of the reasons I jumped on the chemo wagon so easily.

Lisa 

Floridalady.. I have a question...

For someone like me, finishing chemo now... chemo shrunk the beast tumor to 1cm now and no cm in node. ( I have 3 more chemo's to go.) Tumor was almost 4 cm. 

After this I will have the full surgery to remove all breast tissue they can and nodes.

Radiation to follow.

I follow strict nutritional guide lines I eat mostly veg , fruits with veg..beans and fish for protien..etc..... And will begin again, supplements after chemo/rad treatment.

In your studies, have you seem where chemo first with those like me, where the cancers is annihilated( as far as Mri's and pet scans can see) and full surgery ( aggressive surgery) after... has seen to do a lot.

I agree with you about surgery and nutrition.

Anyway, I would love to have your thoughts.

TY

Laura

Thank you,  

I have a few things lined up , supplemental, after all the treatments now. I felt that my treatments now were doing the very best for me now, and I am trying to stay that aggressive route, with all the medical science now, and nutritional science after.. mixed with medical.

I just like to hear all different perspectives on it. All the ladies here are just awesome. Some agree with others, some do not.. but the main goal we all want is health and long life., so I like the support here with so many different ways we all get there.

Ty,

Laura

I've listed a number of my sources in a number of threads in this section where books are discussed.  Perhaps you'd like to list something specific here, or link to another thread where you mention your reading materials. 

Dang, I was just looking at your diagnosis.  I had lobular also.  I don't know what LVI positive means. So sorry about your mets to the liver.  Was that also found in 5/07 or later?