Step 1: A drug company runs an in-house study (using fraudulent study design from the start) to "prove" that their drug is both safe and effective. If the study produces negative results, it is thrown out. If it produces positive results, proceed to step 2.

Step 2: That same drug company uses in-house writers ("ghost writers") to write up the results of the study in a favorable light by discarding any data that doesn't fit the desired outcome. Note that these in-house writers are marketing people, not doctors or scientists, and they are on Big Pharma's payroll!

Step 3: The drug company contacts a noted doctor or academic and offers to pay them a bribe (a "writing fee") to put their name on the paper as if they were the original author. In reality, the paper has already been completely written and the doctor needs to write nothing.

Step 4: The paper is submitted to peer-reviewed academic journals (such as JAMA) for publication. Since the paper appears to have been independently written by an outside scientist or doctor, the journal is far more likely to consider it credible. Thus, it gets more easily published. The drug company reveals nothing about the true origins of the paper.

Step 5: The drug company that sponsored all this forwards the peer-reviewed, published study to the FDA, claiming this is now "scientific fact" that proves their drug is both safe and effective. Since the study was published in a peer-reviewed medical journal, it must be true, right?

Step 6: The FDA, which conducts no drug safety studies of its own, automatically believes the conclusions of the study (since it was published in a credible journal, after all), and therefore approves the drug for sale! From there, the FDA claims its decisions are based on the "gold standard of evidence-based medicine!"

Step 7: Once the drug is approved by the FDA, the drug company then claims the drug has been declared safe and effective by an independent government agency, and therefore the drug must indeed be both safe and effective. In other words, even though the drug company fabricated much of the evidence used by the FDA to make their approval decision, the drug company still claims that the FDA's decision is an independent, science-based approval of their drug! Furthermore, the drug companies are now arguing that FDA approval should immunize them from any lawsuits or claims of harm stemming from their drugs. Amazing, huh?

From here, doctors are medical personnel are taught that the drug is backed by good science and that the FDA has independently reviewed the evidence and approved the drug. Therefore, it's safe to prescribe to patients. What nobody has been told, however, is that the entire process -- from the drug studies to drug approvals -- was fabricated!

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"Great ideas often recieve violent opposition from mediocre minds"...................Einstein

Gine, I cant be bothered to address all of the lies that you see fit to quote on this forum, but the blow is part of my speciality, s olet me put a few things straight. Not that I expect you to enter a discussion, because you never do, but just for the record:

You forget: If the result is negative, discontinue the development of the drug, or improve it.

Actually, no. The marketing people only come in after the drug is approved. You see, the medical community is not so easily fooled, so it is only when you want to advertise for the general populace that the spin-doctors are useful.

If you can document such a case, I suggest you bring it to the attention of the proper authorities. That doctor will be in big trouble. They do, however, have ghost writers to do the basic writing, since being an excellen doctor is not the same as being good with words. The scientific content remains the responsibility of the doctor, and if he/she signs something that is false, he not only risks loosing his professional credibility and his job, he also faces legal actions.

The ghose writer's name will appear on the author list.

Wrong. The FDA (and authorities elswhere in the world) do not approve drugs based on articles in journals. The pharmaceutical company must forward all its original research results and reports to them. Nowadays, the FDA require this to be in electronic form, but formerly this would, for a new drug (as opposed to a copy of an already approved one), constitute hundreds of pounds of paper! The authority then audits this material, however, even if the material looks good, the company itself must also have an approval and be under regular audit.

No. See above.

That is amazing. And the courts seem unimpressed, as they certainly should.

It is not possible to fabricate all this. And the implications, if someone did and was found out, would be devastating.

Hans

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<i>You have a right to your own opinion, but not to your own facts.</i>

Not a fabrication
Lets look at just ONE EXAMPLE of drug fraud;
The Financial Times reported in January 2005 that the total number of Vioxx deaths may have been underestimated in this original FDA report. The FDA now reportedly estimates that the total number of US Vioxx deaths may be between 89,000 and 140,000. This data has not yet been officially published by the federal government, though top FDA experts have publicly acknowledged these Vioxx deaths estimates. Worldwide Vioxx deaths are estimated to be between 150,000 and 200,000, though these estimates have not been confirmed officially.
For years Merck had denied concerns that Vioxx posed a great threat to patient's cardiovascular safety. Had they acknowledged these concerns as they developed, many Vioxx deaths might have been avoided. Hundreds of suits have already been filed on behalf of those that have suffered greatly

The Annals of Internal Medicine has followed up on a study published earlier this year in JAMA by the same authors, detailing a specific account of how Merck fraudulently concocted a major Vioxx study as a marketing campaign.

Vioxx left tens of thousands of Americans dead.

The class action lawsuits around Vioxx have centered around financial compensation for individuals and families that can prove Vioxx was the cause of a heart-related problem – which is not that easy to prove even if it is true.
Merck has done everything in its power to limit the extent of the financial damage.
Much of the data in the new study comes from these legal cases, and many questions about Merck remain unanswered.

The researchers concluded the following about a key Vioxx study: “The trial was designed by Merck’s marketing division to fulfill a marketing objective;

Merck’s marketing division handled both the scientific and the marketing data, including collection, analysis, and dissemination;

and Merck hid the marketing nature of the trial from participants, physician investigators, and institutional review board members.”

It is likely that this type of con game permeates the pharmaceutical industry and will continue to do so until drug company executives have criminal charges pressed against them by the Justice Department.

Until that time liability-related lawsuits are simply a cost of doing business and are built into the sale price of the drug. Sending executives to jail for involuntary manslaughter would send a different message to the executive ranks of these drug companies, and safety for patients would improve immediately.

Don’t expect help from the FDA, who let Vioxx on the market without proper warnings.

The FDA has sided with drug companies and wants to prevent all patient law suits against Big Pharma.

Since the Justice Department, FDA lawyers, and the White House are all on the same page – don’t expect justice any time soon. Vioxx has been off the market for some time. Merck is currently in the middle of trying to downplay its multi-billion dollar Vytorin fraud – the cholesterol-lowering drug that lowers numbers on paper and makes health worse.

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"Great ideas often recieve violent opposition from mediocre minds"...................Einstein

the drug companies are now arguing that FDA approval should immunize them from any lawsuits or claims of harm stemming from their drugs. Amazing, huh?

here is the bill:

HR.2900 S.1082

On Wednesday, July 11, 2007 the House passed HR.2900 Representatives Frank Pallone, Jr. (D-NJ), John Dingell (D-MI), Henry Waxman (D-CA), and others falsely proclaimed that they were doing America a favor by passing this sweeping FDA-supported legislation that grants the rouge agency more power and money, and even transforms it into a quasi drug company.

Both the House and Senate (S.1082) have made the fatally flawed assumption that the reason for so many deaths and injuries from drugs was due to the FDA's lack of resources. In reality, it is the INTENTION of FDA management that is the problem, combined with the simple fact that multiple drugs are extremely toxic and don't work as advertised. Giving the FDA more power and money will only cause the agency to speed more drugs onto the market faster with even less safety testing -- while abusing its power and actively stamping out competition to drugs.

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"Great ideas often recieve violent opposition from mediocre minds"...................Einstein

Lets look at another drug

February 17th, 60 Minutes.(Public Tv USA)
Randone was given Bayer Pharmaceutical's Trasylol to reduce blood loss during surgery. There are other reliable drugs that do the same thing at about $50 per unit but for some reason the $1,000 Trasylol was given.

Trasylol was taken off the market last November in what Mrs. Randone's attorney, Marc Bern believes may be the next case of Vioxx.


The FDA allowed the drug to stay on the market even after researcher Dr. Dennis Mangano warned an advisory committee that Trasylol doubled the risk of kidney and heart failure and had a 181 percent risk in the increase for stroke.

Dr. Mangano says between the time of his published study in January, 2006 and November, 2007 when Trasylol was finally taken off the market,

22,000 lives had been lost.

His study, published in the New England Journal of Medicine in January 2006........................................

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"Great ideas often recieve violent opposition from mediocre minds"...................Einstein

Well Gina, I don't have the energy, nor inclination to address all that. You can spam stuff faster than I can ever hope to answer.

Now, let's move on:

Let us say you have made your point about conventional medicine, and I will concede that while I find your claims grossly exaggarated, then certainly all is not as it should be in the pharma industry (nothing new in this, I have always agreed to that).

Now, please tell me:

1) Who write and design the trials for homeopathy?

2) Who approve those trials and their results?

3) Who keep track of adverse events for homeopathy?

There is more, but these will suffice for starters.

Now is your chance to show that you can do more than spam.

Hans

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<i>You have a right to your own opinion, but not to your own facts.</i>

Hans posted:
"I find your claims grossly exaggarated,....................................."


Merck Caught in Massive Scientific Fraud as In-House Authors were Disguised as Independent Scientists (opinion)

There is lots more Hans,not a problem digging it up for you
Merck
drug companies | statins | prescription drugs | prescription drug profits | medical racket | pharmaceutical companies | medical fraud | Pfizer | statin drugs | corruption | bad medicine | pharmaceuticals | pharmaceutical industry | drug company profits

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"Great ideas often recieve violent opposition from mediocre minds"...................Einstein

Yes, yes, I already noted that there is plenty of dirt to dig up. Now, would you care to answer my questions, above?

Hans

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<i>You have a right to your own opinion, but not to your own facts.</i>

Hans posted:
"You forget: If the result is negative, discontinue the development of the drug, or improve it."


Are you sure?

HPV Vaccine Victims Pile Up: $1.5B For MerckOctober 17, 2008Barbara Loe Fisher

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"Great ideas often recieve violent opposition from mediocre minds"...................Einstein

Is this true?
Is there an explanation as to how this has been allowed to happen? There can be no justification!
On so many occasions?
Surely once is tragic enough!
What steps is the pharmaceutical industry taking to ENSURE this sort of thing NEVER happens again?
What legislative safeguards are being put in place?

When we read statistics like these, it is all too easy to forget that each statistic represents a person with a life - with a family and friends.
HOW ON EARTH ARE THESE COMPANIES STILL TRADING?
By passing the cost on to the consumer?
Imagine if any other company was responsible for 89,000 deaths! - an airline for example!
I hope the individuals responsible for failing to prevent this tragedy were held suitably accountable!

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These are my personal views and not necessarily my professional views.The content is for informational purposes only and should not be construed as medical advice. ALWAYS CONSULT YOUR LOCAL PHYSICIAN.