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VIOXX - MERCK - MEDCO - A CASE STUDY VIOXX - MERCK - MEDCO - A CASE STUDY -- Posted by Dr. Jai Maharaj on 10-13-04 16:18
VIOXX - MERCK - MEDCO - A CASE STUDY
Forwarded message from "Vera Sharav"
[ Subject: VIOXX_Merck--MEDCO_ a case study
[ From: "Vera Sharav"
[ NNTP-Posting-Host: 128.206.49.147
[ Date: 13 Oct 2004 14:20:42 -0500
ALLIANCE FOR HUMAN RESEARCH PROTECTION
Promoting Openness and Full Discloure
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 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
veracare@ahrp.org
State Attorney General, Eliot Spitzer
Department of Law 120 Broadway New York, NY 10271
Department of Law The State Capitol Albany, NY 12224
For More Information:
(212) 416-8060
For Immediate Release April 26, 2004
NEW YORK, 19 STATES SETTLE DECEPTIVE TRADE PRACTICES CLAIMS AGAINST MEDCO
HEALTH SOLUTIONS
Medco to provide price information to doctors and patients and more than
$29 million to states
State Attorney General Eliot Spitzer today joined Attorneys General from
19 other states in announcing the settlement of claims under state
deceptive trade practices laws against Medco Health Solutions, Inc.
(Medco), for drug switching practices.
Medco is the world's largest pharmaceutical benefits management (PBM)
company, with over 62 million people covered. PBMs contract with health
plans to process prescription drug payments to pharmacies for drugs
provided to patients enrolled in the health plan.
According to a complaint filed in New York State Supreme Court and other
state courts, Medco encouraged physicians and other prescribers to switch
patients to different prescription drugs without disclosing that the
switches benefitted Medco by increasing rebate payments from drug
manufacturers. Medco represented to prescribers that a switch would
result in savings to patients and health plans when in fact at times the
drug switches increased costs, primarily in follow-up doctor visits and
tests.
For example, Medco switched patients from certain cholesterol lowering
medications, like Lipitor, to Zocor, which required patients to pay for
follow-up costs.
Attorney General Eliot Spitzer stated: "This case shows how
pharmaceutical benefit managers previously hid from consumers, doctors
and health plans that they were switching prescriptions to promote their
own profits. With this settlement, patients and doctors will have full
information and can make a decision based on the consumer's best
interest.
The settlement announced today prohibits Medco from soliciting drug
switches when:
* The net drug cost of the proposed drug exceeds the cost of the
prescribed drug;
* The prescribed drug has a generic equivalent and the proposed
drug does not;
* The switch is made to avoid competition from generic drugs; or *
It is made more often than once in two years within a therapeutic class
of drugs for any patient.
In addition, the settlement requires Medco to:
* Disclose to prescribers and patients the minimum or actual cost
savings for health plans and the difference in co-payments made by
patients;
* Disclose to prescribers and patients Medco's financial incentives
for certain drug switches;
* Disclose to prescribers material differences in side effects
between prescribed drugs and proposed drugs;
* Reimburse patients for out-of-pocket costs for drug switch-
related health care costs and notify patients and prescribers that such
reimbursement is available;
* Obtain express, verifiable authorization from the prescriber for
all drug switches;
* Inform patients that they may decline the drug switch and receive
the initially prescribed drug;
* Monitor the effects of drug switches on the health of patients;
and
* Adopt a specified code of ethics and professional standards.
Medco will pay more than $29 million to settle the deceptive trade
allegations. $20.2 million will go to states in restitution; $2.5 million
to the identifiable patients who incurred expenses related to a switch
between cholesterol controlling drugs; and $6.6 million to states in fees
and costs.
States may use the funds to benefit low-income, disabled, or elderly
consumers of prescription medications, to promote lower drug costs for
residents of the state, or to fund other programs reasonably targeted to
benefit a substantial number of persons affected by the conduct covered
in the complaint.
New York State's share of the $20.2 million is $2.23 million. New York
will use its portion to fund prescription drugs at community health
clinics and to explore the viability of a website and other
communications to publicize differences in drug pricing at New York State
pharmacies and the rights of insured consumers. New York State's share of
the $6.6 million in costs of investigation is approximately $410,000.
The multi-state investigation began two years ago in Arizona, California,
Connecticut, Delaware, Florida, Illinois, Iowa, Louisiana, Maine,
Maryland, Massachusetts, Nevada, New York, North Carolina, Oregon,
Pennsylvania, Texas, Vermont, Virginia and Washington.
Attachment:
* Order and Judgement [Not posted here]
End of forwarded message from "Vera Sharav"
Jai Maharaj
http://www.mantra.com/jai
Om Shanti
Hindu Holocaust Museum
http://www.mantra.com/holocaust
Hindu life, principles, spirituality and philosophy
http://www.hindu.org
http://www.hindunet.org
The truth about Islam and Muslims
http://www.flex.com/~jai/satyamevajayate
The terrorist mission of Jesus stated in the Christian bible:
"Think not that I am come to send peace on earth: I came not so send
peace, but a sword.
"For I am come to set a man at variance against his father, and the
daughter against her mother, and the daughter in law against her mother in
law.
"And a man's foes shall be they of his own household.
- Matthew 10:34-36.
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