OCTOBER 15, 2004. Below is a release from the Alliance for Human Research and Protection. It concerns the marketing ploy Merck used to get all that Vioxx out to consumers, while it was still on the market, while it was causing thousands of heart attacks and deaths.
The ploy involved a powerful subsidiary of Merck which was able to SWITCH PRESCRIPTIONS on patients, so they ended up with Vioxx instead of some other pain med.
This release also reveals how simple it would have been for Merck to track adverse effects. But it never happened.
This is a rare glimpse into the actual ground-level mechanics of scummy drug-dealing (the legal kind):
ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness and Full Disclosure
www.ahrp.org
FYI-
Vioxx: A case study in how a lethal drug is marketed and dispensed�without MINIMAL safeguards to protect people�s lives.
Merck marketed and sold billions of dollars worth of Vioxx through MEDCO--the largest Medicare Pharmacy Benefit Manager (PBM) in the world�covering 62 million patients.
MEDCO happened to be a mail order subsidiary of Merck until fall of 2003, when Merck spun off Medco.
What makes this unique and what the federal investigators are paying close attention to, is the way that Merck leveraged Medco to bundle and promote Merck products such as Vioxx.
How did the thousands of heart attacks in patients taking Vioxx go unnoticed by either Merck or MEDCO?
Medco was accused of switching patients from physician prescribed drugs to Merck products. In business parlance, this form of fraud is often called �vertical integration.�
The two companies parted just as two dozen state and federal regulators were closing in on Medco for drug switching, bundling, and consumer fraud and anti-trust violations. On April 26, 2004, nineteen state attorneys general settled with Medco for $29 million. However, just as [NY District Attorney] Eliot Spitzer settled the criminal fraud case against GlaxoSmithKline�without regard for victims of the alleged fraud, neither did the MEDCO settlement provide any relief to the patients and families who were victimized�some of who died from the drug. http://www.oag.state.ny.us/press/2004/apr/apr26b_04.html
How did the thousands of heart attacks in patients taking Vioxx go unnoticed by either Merck or MEDCO?
Merck, like all drug manufacturers, is supposed to have an adverse reporting system in place�but the FDA never enforced the requirement. One would think that both Merck and Medco had direct adverse reporting systems in place.
In fact, the Vioxx recall is due to a study, not due to pharmacy and PBM adverse event reports.
We�ve been advised by experienced consumers that every Medco customer would instantly know why no one tracks adverse drug effects.
Medco customers�patients and physicians--cannot reach a Medco pharmacist.
If a Medco patient seeks counseling, or has questions or concerns or would like to report an adverse event, that patient would:
(1) be shuffled from voicemailbox to voicemailbox by Medo's phone system or
(2) have to leave a voice mail message on a Medco voice mailbox.
The FDA will be the first one to admit that the agency does NOT regulate either pharmacies or Pharmacy Benefit Managers such as MEDCO.
It is left to state pharmacy boards which are undermanned and outgunned by PBM executives and attorneys.
This means that there is no national drug monitoring agency and no national platform for pharmacy and PBM to report adverse drug reactions.
Many of the larger pharmacies claim to have internal reporting mechanisms in place, but there is no regulation mandating that these adverse events must be reported to the FDA--and there is no universal reporting standard.
It is striking that drug companies such as Merck spend hundreds of millions of dollars marketing and tracking drug sales�but fail to track lethal drug effects:
For example, a drug company representative can, in most cases, tell you how much of their drug was dispensed w/in the last 24 hours.
He can tell you which pharmacy or PBM dispensed it; and which physicians are prescribing their drug�and how many times.
Why is it that a company such as Merck--whose marketing and sales tracking methods that monitor both physicians and pharmacies, garnered them $2.5 billion in Vioxx sales--was not required to have a universal adverse event reporting system in place?
The UK has improved their �Yellow card� adverse drug reporting system, why has the FDA failed to initiate new safety measures or even to enforce existing reporting requirements?
Why is there no mandatory adverse drug effect reporting requirement in place�even for lethal drug effects?
The technology is in place�drug sales data is meticulously tracked.
If such a reporting system were in place, hundreds of thousands of lives would be saved.
Contact: Vera Hassner Sharav
212-595-8974
[email protected]
end of release
Let me point out that the FDA and other government health-regulatory bodies are famous for letting toxic drugs slip through the cracks. It's a combination of inattention, sheer stupidity, and what is generously called "conflict of interest." In truth, there is no conflict. The FDA is a revolving door. Its employees in key positions move in and out, to and fro. FDA, drug companies, FDA, drug companies.
The underlying and unspoken rule is BUYER BEWARE. If you think the federal government is going to protect you against toxic drugs, you are inviting disaster. And if you think the drug companies themselves are going to safeguard you, you're living on the wrong planet.
JON RAPPOPORT www.nomorefakenews.com
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