Blurring the line between best-selling novels and best-selling pharmaceutical drug ads, Merck Inc. disguised professional writers as Vioxx drug safety researchers.

As if their drugs were not scary enough, Merck brought in "ghostwriters" to sign off on research and pose as independent, primary authors on drug safety reports that amounted to nothing more than marketing propaganda. Though common in the pharmaceutical industry, this deceptive practice is normally difficult to prove.

However a team led by Joseph Ross, of Mount Sinai School of Medicine in New York, recently studied about 250 documents released to the courts by Merck during the Vioxx hearings. Many of the documents were discovered to have been ghostwritten by medical publishing companies. Merck defended itself, claiming things were taken out of context, but the implications are, well... spooky.

How the Ghostwriting Process Works

1.Drug companies write reviews of their own drugs, downplaying the risks. The information is presented as if it were a public service announcement from independent health safety experts concerned only with saving lives. In reality, the reviews are paid commercial advertisements.

2.Outside authors sign off as the primary authors of the reviews, implying they were there at the very beginning when in actuality they were only there at the very end of the study.

3.The drug company publishes the reviews in medical journals.

4.During the FDA drug approval process, the drug company references the reviews as clear evidence that independent, scientific research has validated the safety of their drug.

For example, two distinct versions of the Alzheimer's trial called Study 078 were found. The draft version listed "external author" in the space where the lead authors name would normally appear, while the published version listed the names of several academic researchers instead.

Scientific Evidence

Imagine if a pharmaceutical company was giving a presentation about the safety of a new drug to the FDA and they pulled out a TV remote and played their own commercial as evidence that the drug worked! Side effects would include nausea and vomiting. Yet this is almost exactly what really happens with ghostwriting. Pharmaceutical companies are presenting their own (written) commercial ads as scientific evidence. Meanwhile these same drug companies claim that herbs (which have been proven safe and effective after thousands of years of documented use) are actually unsafe due to lack of scientific evidence.

History of Vioxx

In 2004 in was discovered that tens of thousands of people worldwide suffered death due to heart failure related to the use of Vioxx, the brand name for Rofecoxib, then a best-selling drug of Merck. You may remember the TV commercials with a former Olympic skater:
Dorothy Hamill: "When I started skating at 8 years old, I thought I'd never experience the thrill of winning a medal. With all the great memories has come another thing I never thought I'd experience: the pain of osteoarthritis."

Voice over: "Vioxx is here... with one little pill a day, Vioxx can provide 24-hour relief."
Merck voluntarily withdrew the drug when it was revealed that Vioxx caused a significant number of heart attacks and strokes. FDA scientist and whistle blower Dr. David Graham, in testimony before the US Senate, estimated that 88,000 to 139,000 heart attacks occurred as a result of Vioxx and about 30%-40% of these resulted in preventable death. Thus it is estimated that between 27,000 and 56,000 Americans died as a result of Vioxx (for the sake of comparison, about 58,000 US Soldiers died during the Vietnam conflict).

Vioxx at its peak in 2003 was being taken by 20 million Americans, with 2003 sales of Vioxx totaling $2.5 billion. Merck later settled for $4.85 Billion with families of victims of Vioxx.

Conflict of Interest

In 2005, an FDA advisory panel ruled that it was safe to put Vioxx back on the market. A closer look at the votes revealed that 10 of the 32 members of the advisory panel had proven financial ties to Merck. Here is how the votes were split:

* 8 of 22 advisers without financial ties voted to return Vioxx to the market (36%)

* 9 of 10 advisers with financial ties voted to return Vioxx to the market (90%)

In 30 total votes (for Vioxx, Bextra and Celebrex), those with financial ties were roughly 8 times more likely to vote that their own drugs were safe (the votes were 28-2 versus 29-37 in favor, respectively). Yet the same advisers insist that their decisions are not influenced by these conflicts of interest.

The Future of Big Pharma

It is interesting to note that since the 2004 Vioxx scandal, the FDA has increased ties to the pharmaceutical industry, and now the FDA is claiming that companies like Merck should not be held liable for damage caused by any drugs that are FDA approved! This is the legal equivalent of "because I said so". While a recent survey on Natural News showed that 98% of readers feel that drug companies should be held liable for their own drugs, legislation such as Senate Bill 1959 (HR 1955) claim that any US citizen who speaks out against any government agency (like the FDA) is a "Homegrown Terrorist". This unholy alliance that exists between big business and big government is what Congressman Ron Paul (R- Texas) referred to as "The Medical (Congressional) Industrial Complex". It is part of the reason he sponsored HR 2117, The Health Freedoms Protection Act.

If companies like Merck (proven to endorse deceptive business practices) are relieved of all liability for their drugs (proven to be dangerous), what will their ghostwriters pen as a sequel to the best-selling Vioxx? I predict it will be a horror story.
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Recipe for Drug Disaster (Liability Free!) (Satire)

Ingredients:

* Greedy drug company executives.
* Corrupt FDA advisers.
* Conflicts of interest.
* Censored FDA scientists.
* Direct to consumer marketing of drugs.
* Gullible public.
* Limited liability for drug companies.

Instructions:

* Mix drug company executives with FDA advisers.
* Add conflicts of interest and stir.
* Ignore warnings from FDA scientists who may boil.
* Keep mixture in a dark environment until FDA drug approval is achieved (about 2-3 days).
* Advertise new drug on TV depicting emotional, rags-to-riches "miracle cure".
* Medicate millions in gullible public with new drug.
* Lobby Supreme Court to remove liability for damage caused by any FDA approved drug.
* When thousands become ill from drug, blame the FDA for approving drug in the first place.
* Sick public can be used as starter for the next batch.
* Makes about $6 billion profit.
* Serves 3-6 people.

About the author
Neil McLaughlin is a computer scientist and inventor specializing in 3d graphics and simulation.