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The Evils of *Organized Medicine*
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Strange Goings On at the Cleveland Clinic: Mere Coincidences or Something
Far More Problematic?
Do Recent Developments and Disclosures Cast Doubt on the World-Famous
Clinic's
Reputation for Credibility and Independence as It Embarks on Pfizer's $100
Million Celebrex Safety Study?
Date Published: December 19, 2005
By Steve DiJoseph
If you like playing the game "connect the dots," you might find this one
very interesting:
a.. 2001 - Drs. Eric Topol and his associate (and subordinate) at the
prestigious Cleveland Clinic, Steven Nissen, jointly attack COX-2 inhibitors
and especially Vioxx The concerns arising out of the VIGOR study were
crystallized by Topol, Nissen, and Debabrata Mukherjee in JAMA in their
review paper specifically highlighting the cardiovascular side-effect
profile of COX-2 inhibitors. On August 22, 2001 a study published in Journal
of the American Medical Association by Drs. Topol, Nissen, and Mukherjee
indicated that Vioxx was linked to a 200% increase in blood clots, heart
attacks, and strokes based on their review of previous clinical trials.
b.. 2004 - Vioxx is pulled from the market and Dr. Topol goes on a
relentless attack along the lines of "I told you so" in articles and
comments such as the one to the Washington Post (10/1/04) where he stated
that Merck's action was "the right decision about three years too late. This
is the sort of thing that Merck should have studied earlier, but they were
too busy refuting the warning signs."
a.. 2005 - Vioxx court trials begin and Dr. Topol remains adamant about
the cardiovascular risks posed by Vioxx. He is the vocal face of the
Cleveland Clinic in the COX-2 saga and certainly the last person in the
world Merck or Pfizer would ever want to rely on as a last hope to salvage
the multi-billion dollar market for Vioxx or Celebrex.
b.. 2004-2005 - Dr. Nissen remains uncharacteristically silent especially
in light of his long-standing criticism of the COX-2 inhibitors and Vioxx.
c.. November 2005 - Under subpoena in the first federal Vioxx trial, Dr.
Topol pulls out all the stops and offers a three-hour videotaped deposition
(much of which was shown to the jury) attacking Vioxx as a dangerous drug
from a cardiovascular standpoint and accuses Merck of engaging in scientific
misconduct, suppressing clinical evidence and stifling medical discourse as
it promoted the painkiller. He also calls certain aspects of Merck's
behavior "repulsive" and "appalling." The deposition is shown to the jury on
Saturday, December 3, 2005.
d.. December 8, 2005 - Less than a week after his devastating anti-Vioxx,
anti-Merck testimony is shown to the jury (and in the midst of the NEJM
accusation that Merck manipulated the outcome of the VIGOR study by deleting
data relating to at least three heart attack-related deaths) the Cleveland
Clinic suddenly announces that Dr. Topol has been stripped of his
prestigious position as chief academic officer of the Clinic's medical
college. This significant demotion at a time when the Clinic was thrust into
the public eye by Dr. Topol's highly consumer-friendly testimony is
described as nothing more than part of a broader administrative
reorganization making his "position was no longer needed."
e.. December 9, 2005 - Dr. Topol states: "The hardest thing in the world
is just telling the truth, to do the right thing for patients, and you get
vilified. No wonder nobody stands up to the industry."
f.. December 13, 2005 - Pfizer announces a $100 million study will be
launched into the safety of its own drug, Celebrex. Amazingly (or maybe not
so amazingly at that) the Cleveland Clinic is to conduct the study and
leading the research will be none other than Dr. Nissen himself.
g.. With Celebrex as the only COX-2 inhibitor remaining on the U.S.
market, the multi-billion dollar blockbuster will either have the field to
itself or be declared no worse than its sister-drugs Vioxx and Bextra.
(Prior studies have already indicated that Celebrex was probably the least
risky of the COX-2s from a cardiovascular risk profile.)
h.. The $100 million study is little more than a prudent investment by
Pfizer. It makes the world's biggest pharmaceutical company look good from a
consumer standpoint. The outcome is thus, anticlimactic. COX-2s will either
be shown to be dangerous as a class, which is what most experts already
think now, or Celebrex will be vindicated as the safest of the three drugs
and remain the only COX-2 on the market.
i.. And, all of this (and $100 million of Pfizer's money) is being placed
in the hands of the Cleveland Clinic and Dr. Nissen.
Dr. Eric Topol has been Provost, Cleveland Clinic Lerner college of
Medicine, Chief Academic Officer and Chairman, Department of Cardiovascular
Medicine, and Professor of Medicine and Genetics, Case Western Reserve
University. He was appointed to the Cleveland Clinic in 1991 after a f
ellowship at Johns Hopkins Hospital, an internship at university of
California-San Francisco School of Medicine, and a residency at University
of California-San Francisco School of Medicine. He attended university of
Rochester School of Medicine and Dentistry in Rochester , New York . He is a
specialist in interventional cardiology, thrombolytic agents, arterial
biology research, and restenosis.
Dr. Steven Nissen currently has no supervisory position or department level
chairmanship at the Cleveland Clinic. His appointment to the Clinic was in
1992 after a fellowship at the university of Kentucky Chandler Medical
Center, an internship at university of California Davis Medical Center, and
a residency at the university of California Davis Medical Center. He
attended the university of Michigan Medical School. His specialties include
intravascular ultrasound, digital angiography and computer image processing,
and coronary intensive care.
It seems quite odd to many observers that the doctor with the superior
qualifications would have his leadership position done away with as part of
an administrative reorganization making that position "no longer needed" at
a time when he would be the ideal person to lead the independent study of
Celebrex.
Dr. Topol, however, is hardly the type of professional who could be expected
to play a subservient or submissive role and that could have made his
participation in the study problematic for his superiors who did not need
added attention at a time when the Clinic's independence and credibility are
being questioned.
The prestigious Cleveland Clinic Foundation is a prominent medical center
regarded as one of the nation's best. Over the years, however, The Clinic's
need to cultivate a workable relationship with the pharmaceutical companies
and medical device manufacturers that fund independent studies and other
programs became more and more at odds with Dr. Topol's consumer-oriented
image as a crusader against potentially dangerous drugs and their
manufacturers.
Dr. Topol's recent criticisms extended to drugs other than Vioxx. His
candor, however, while admired by his supporters is viewed as quite
unscientific to his targets and his detractors. His demotion also came at a
time when his ongoing dispute with Dr. Delos Cosgrove had become a
distraction at the Clinic.
Dr. Cosgove is Chief Executive Officer, Chairman of the Board of Governors,
CCF. His appointment to the Cleveland Clinic came in 1975 following an
internship at the university of Rochester-Strong Memorial Hospital and
residencies at Children's Hospital of Boston, Massachusetts General
Hospital, and university of Rochester-Strong Memorial Hospital. He attended
University of Virginia School of Medicine Charlottesville and specializes in
the surgical treatment of thoracic and cardiovascular diseases, mitral and
aortic valve repair, minimally invasive valve surgery, thoracic aneurysms,
homografts, use of alternative conduits in coronary artery surgery, and
blood conservation.
Dr. Topol has, for now, retained the position of chairman of cardiovascular
medicine at the Clinic, but his demotion has drawn attention to the mounting
tensions between the Clinic's research mission and its deep ties to the
businesses that finance that research. This rift may lead to Dr. Topol's
eventual departure from the Clinic.
The unrest at the Cleveland Clinic is far more than simply a power struggle
between Drs. Topol and Cosgrove, however. It is symptomatic of the continued
controversy created by the many longstanding corporate ties at the clinic.
Those business links involve staff doctors, researchers, Dr. Cosgrove, and
the Clinic's board.
The potential for conflicts of interest at the Clinic is illustrative of the
way pharmaceutical and medical device companies and the investment community
work closely with medical researchers and doctors to develop and promote new
medicines and technologies.
Such relationships raise concerns about potential conflicts of interest that
could unduly influence medical decisions as to treatment selections or even
bias the results of medical research itself.
The pharmaceutical and medical device industries often find themselves in
conflict of interest situations when dealing with "independent" research
facilities, the FDA, and when releasing critical data and information about
specific drug trials, adverse reactions, defects, and malfunctions.
These industries are bound by federal law and ethical standards to be
forthcoming and honest about all relevant details concerning their products,
even if unfavorable. Yet, exhibiting remarkably human-like behavior, they
often withhold, misrepresent, delay, and otherwise improperly manipulate
negative information in order to minimize or avoid harmful financial and
legal consequences.
The recent revelations concerning Merck's alleged manipulation of the VIGOR
study by deleting critical data concerning cardiovascular-related deaths are
but a window into a world few people are aware even exists.
That world, however, is replete with situations where pharmaceutical
companies have: (a) ghostwritten medical journal articles relating to drug
safety and trials; (b) delayed the completion of market studies and the
subsequent release of the data related thereto; (c) prevented full
disclosure about drug trials; (d) withheld important data from the FDA and
the public; (e) engaged in misleading, improper, and false advertising
campaigns; and (f) pressured the FDA and research facilities to take
retaliatory actions against employees who expressed opinions detrimental to
a drug or device under review or study.
Fast-track approvals, which are usually based on short-term testing of small
test groups, have had disastrous results when used for drugs which are
specifically designed for long-term or lifetime use by large segments of the
population.
Medical device manufacturers are no more credible or trustworthy than their
drug manufacturing counterparts and have been caught engaging in similar bad
acts.
Some of the more egregious recent examples of this type of objectionable
behavior include a study published in the Journal of the American Medical
Association (JAMA) in 2004 that found 65% of findings of harmful effects
were not fully reported in medical-journal articles. Results are often
"cherry-picked" so that only the positive data is published.
The JAMA study also found that 62% of trials had at least one piece of data
or one result that was changed, added, or omitted to make the drug appear
better.
Recently, Eli Lilly came under scrutiny for suppressing reports relating to
the potential increased risk of suicide risk suspected during early clinical
trials. Current clinical trial data that has confirmed this elevated suicide
risk.
One trial showed that 3.7% of Prozac users attempted suicide while less than
1% of participants on non-SSRI depressants exhibited the same behavior.
Thus, it is reasonable to assume that had there been full disclosure of the
early trial data and reports, lives could have been saved.
Johnson and Johnson's heartburn drug Propulsid has been linked to 80
heart-related deaths and 341 injuries. Despite the adverse effects
associated with the drug, Johnson and Johnson did not conduct safety studies
and pushed to keep Propulsid on the market. Even with strong black-box
warnings on the drugs label, Propulsid was prescribed inappropriately to
both adults and children.
After five years of reported problems, Propulsid was pulled from the market
in 2000. In 2004, Johnson and Johnson agreed to pay up to $90 million to
settle pending claims relating to deaths and injuries from Propulsid.
In the past few years, the FDA has issued dozens of warning letters to
pharmaceutical manufacturers. The FDA Division of Drug Marketing,
Advertising and Communications has about three dozen employees to review
30,000 to 40,000 Direct-to-Consumer (DTC) ads each year. Lester M. Crawford,
then Acting Commissioner of the agency noted that "our patience is sometimes
worn thin" by all the advertising claims.
In another shocking disclosure, Adrienne Fugh-Berman, a professor of
alternative medicine at Georgetown University, claimed that she was asked to
write an article for AstraZeneca about the adverse interactions associated
with the combination of Coumadin, a blood-thinner, and dietary supplements
and medicinal herbs. AstraZeneca hoped that this information about Coumadin
would help them begin to market their own experimental blood-thinner,
Exanta.
Fugh-Berman claimed that AstraZeneca then sent her the completed article
with her name already on it, before she agreed to write anything.
AstraZeneca denied the charge. Later on, Fugh-Berman was asked to review a
paper for a medical journal which turned out to be the same paper she was
previously asked to pass off as her own.
When the FDA established an accelerated-approval program for new drugs in
1992 it required pharmaceutical companies to continue studying and
monitoring a drug even after its market approval. Yet a review by Rep.
Edward J. Markey, (D., Mass.) showed that pharmaceutical companies have not
completed about half of these studies.
The Markey report indicated that out of 91 studies on 42 different products
that were approved from 1993 to October 2004, 46 were completed, 42 were not
completed, and three were delayed. Markey argued that "it is outrageous that
drug companies and the FDA have been dragging their feet when it comes to
conducting required post-marketing studies." Markey plans to introduce a
bill that would allow the FDA to state in a label whether or not a drug has
received this accelerated approval so that the public is aware that the drug
is still undergoing additional studies.
Significantly, the FDA has funded the fast-track approval program with
hundreds of millions of dollars in order to ensure that potential
blockbuster moneymaking drugs get to market on an accelerated basis. Thus,
FDA has placed itself in a compromising position by accepting these huge
sums of money from the pharmaceutical industry to fund the agency's Office
of New Drugs which is now expected to "fast-track" drugs to market.
That division has about 740 employees. Unfortunately, no such funding is
given to the FDA for post-approval monitoring of adverse reactions and
side-effects by the Office of Drug Safety which only has about 112
employees.
On May 19, Able Laboratories stopped all shipments of its products. Four
days later Able recalled its entire product line, suspended all
manufacturing and withdrew seven approved applications to market various
medications. The massive recall was based on what the FDA itself stated were
"serious concerns that they (all of Able's products) were not produced
according to quality assurance standards."
The FDA eventually revealed that its drastic enforcement action was the
result of agency inspectors having found massive record falsification and
mismanagement by Able in order to elude FDA detection of several defective
medications.
Some of the violations included alteration and falsification of test data
and covering up deficiencies by changing results. Able has been effectively
put out of the pharmaceutical business as a result of its highly improper
conduct.
On July 13, the FDA issued and extensive warning to Hitachi Medical Systems
America, Inc. for serious reporting violations and problems with respect to
its MRI and PET equipment. The warning followed inspections of Hitachi's
medical device manufacturing facilities by an FDA investigator with respect
to the magnetic resonance imaging (MRI) systems manufactured by Hitachi
Medical, Tokyo, Japan which are medical devices as defined in section 201(h)
of the Federal Food, Drug and Cosmetic Act (the Act).
The above inspection revealed that Hitachi's devices are misbranded in that
the company failed to furnish material or information required under the Act
and the Medical Device Reporting (MDR) Regulation. Specifically, Hitachi had
received complaints relating to four separate events for which it failed to
submit an MDR to the FDA within 30 days of receiving information that the
devices may have caused or contributed to a death or serious injury.
On May 24, Guidant Corporation disclosed for the first time that it had
waited three years before disclosing it had been aware of the electrical
problem that had caused some 28 of these defibrillators to malfunction. The
revelation came in the form of an alert to physicians which was not issued
until Guidant learned that The New York Times was about to publish a story
on the defibrillator. There is no doubt among experts that the delay
probably caused unnecessary deaths.
When the FDA held hearings in February of this year supposedly to determine
if the COX-2 inhibitors were safe enough to remain on the market, more signs
of a system with widespread conflicts of interest became disturbingly clear.
Of the 32 government drug advisers who would vote on the issue, 10 had
consulted for Merck (Vioxx) or Pfizer (Celebrex and Bextra) in recent years.
When the votes were tallied, the results were shocking to many but not to
those who decry the cozy relationship between "independent" researchers, the
FDA, and the industries that are supposed to be under scrutiny.
While the committee voted unanimously that all of the drugs significantly
increased the risk of heart attack and stroke, Vioxx, a drug pulled from the
market by its own manufacturer (Merck) only 3 months before miraculously
rose from the ashes on the wings of a 17-15 vote. (Without 9 of the 10
"questionable" votes going in favor of the drug, however, the committee
would have voted 14-8 to ban Vioxx).
Bextra, a drug which had even more serious risks associated with it than
Vioxx, survived by a margin of 17-13-2 (abstentions). (That vote would have
been 12-8 against Bextra without 9 favorable votes from the 10 advisers in
question). Bextra was pulled from the market less than two months later.
Celebrex survived by a 31-1 margin (even though the evidence against it was
equally compelling). (The vote still would have been an amazing 21-1 in
favor of Celebrex without the 10 "interested" voters).
Although two of the three drugs have been pulled from the market and the
third is about to undergo a major safety study, the panel merely recommended
all COX-2 inhibitors carry "black box" warnings.
Needless to say, the vote was met with shock and outrage by activists,
medical experts, and researchers alike. Several highly reputable news
agencies like CBS News, The New York Times, and Forbes, for example, also
questioned whether the panel had been "stacked" in favor of the
pharmaceutical companies with advisers who had significant "conflicts of
interest."
Undue influence has often been exerted in ways that have compromised the
impartial functioning of the FDA and its researchers and doctors.
In 1997 Rezulin was approved to treat Type 2 diabetes. The drug, known
generically as troglitazone, was made and marketed by Parke-Davis, a
division of Warner-Lambert Company of Morris Plains, New Jersey.
Rezulin was removed from the market by the FDA in March of 2000 as a result
of having been linked to a mounting number of cases of serious liver damage
and death. The drug had already been removed from the market in England in
December of 1997 where officials have refused to allow its reintroduction.
Only eight months after Rezulin was marketed in the United States, the FDA
announced that the drug had been linked to illness and death from liver
failure. For this reason, the FDA recommended frequent monitoring of liver
function in patients taking Rezulin.
Significantly, these problems had been apparent while the drug was being
tested according to Dr. Anne Peters, an endocrinologist at the university of
California at Los Angeles. Dr. Peters noted that the abnormal test results
were so extreme they should have been regarded as a "red flag."
Dr. Peters, and others, believed that Rezulin should have been marketed from
the beginning with strong warnings and the requirement that those taking the
drug have frequent tests of liver function. Instead, the drug was marketed
without any recommendation for liver monitoring.
Unfortunately, the injuries and deaths continued. Surveys showed that few
patients were being properly monitored. Labeling changes ordered by the FDA
did nothing to remedy the situation and soon, serious divisions developed
within the agency itself.
By the beginning of 2000, four senior FDA physicians as well as Dr. Robert
I. Mishbin, the FDA Medical Officer most closely involved with the
government's approval and continued support of Rezulin, were strongly urging
its withdrawal from the market.
In fact, in a January 24, 2000 e-mail to his superiors, Dr Mishbin stated:
"I see no reason why any well-informed physician would continue to prescribe
[Rezulin]." In warning that "additional cases of preventable liver failure"
may occur, Dr. Mishbin also stated that he did not see "any reason why FDA
should delay in taking steps to remove [Rezulin] from the market."
The FDA's response was to threaten Dr. Mishbin with disciplinary action or
dismissal from federal service.
Although the director of the FDA's drug review center, Dr. Janet Woodcock
claimed in a March, 2000 prepared statement that the FDA still believed the
benefits of Rezulin to outweigh its risks, a member of the FDA Advisory
Committee stated that he was "not surprised" to hear of the dramatic
increase of reported liver-failure cases associated with the drug.
Moreover, even long before Dr. Mishbin's change of position, two other FDA
physicians had raised serious questions concerning Rezulin. In October,
1996, FDA Medical Officer, Dr. John L. Gueriguian recommended Rezulin not be
approved because of potential liver and heart toxicity.
Dr. Gueriguian was the FDA Medical Officer initially in charge of reviewing
the Rezulin New Drug Application (NDA). He was a twenty year veteran of the
FDA, but was removed from the project in November, 1996, only weeks before
the FDA's Medical Advisory Board was set to consider whether to recommend
approval of the drug.
The removal came at the request of Warner Lambert, ostensibly because he had
used intemperate language in describing the safety and efficacy profiles of
the drug. Significantly, this medical Officer had concluded that Rezulin was
no more effective in treating diabetes than other drugs already on the
market yet it had potential hepatic (liver) and cardiac (heart) side
effects.
That same month, Dr. Gueriguian was stripped of further involvement in
reviewing Rezulin and his negative review purged from agency files.
In 1999, Dr. David J. Graham, a senior FDA epidemiologist, publicly warned
the agency's Advisory Committee that every Rezulin user was at risk for
sudden liver failure. In fact, Dr. Graham presented data indicating that,
even with monthly monitoring, Rezulin patients still ran the risk of
spiraling into sudden liver failure.
Dr. Topol, himself caught up in the problem created by these relationships,
announced he would cut all ties to industry, which included relationships
with Eli Lilly, deCode Genetics, and the Medicines Company notwithstanding
that many doctors at the Clinic and elsewhere have similar consulting deals.
"I think there's a real problem in academics today," he told The New York
Times in January 2005. "There's a very close-knit relationship with
industry, and it's too close when any individual can derive a profit from
that relationship."
A recent survey involving 3,247 scientists who were based in the United
States and who had received funding from the National Institutes of Health
revealed that about 33% of the participants stated that, within the previous
three years, they had engaged in at least one practice that could get them
into trouble.
The types of questionable conduct included circumventing minor aspect of
rules for doing research on people (8%) and ignoring another researcher's
use of flawed data or questionable interpretation of data (about 13%). Less
than 2% admitted falsifying data, plagiarism, or ignoring major aspects of
rules governing studies with human subjects. Surprisingly (or maybe not so
surprisingly), almost 16% admitted they had changed the designs, methods, or
results of a study "in response to pressure from a funding source."
The National Institutes of Health (NIH) conducted an internal review with
respect to consulting payments from pharmaceutical companies to scientists
employed by the agency. Of the initial sample, more than half (44 of 81)
admitted to conduct which violated one or more NIH rules.
Of those, 36 were still employed by the agency and were referred for
possible disciplinary action. Nine of those 36 were also referred to the HHS
Office of Inspector general for further investigation. The 8 who left the
agency are not subject to administrative action.
The House Energy and Commerce Committee requested the review after comparing
NIH records to consulting agreements maintained by 20 pharmaceutical
companies. The Committee found 81 cases between 1999 and 2004 where the
agreements were not listed in the NIH records provided to the committee.
Excerpts from the findings of the investigation, provided by NIH Director
Elias A. Zerhouni to three members of Congress included the following
statement: "We discovered cases of employees who consulted with research
entities without seeking required approval, consulted in areas that appeared
to conflict with their official duties, or consulted in situations where the
main benefit was the ability of the employer to invoke the name of NIH as an
affiliation."
Although Zerhouni requested the release to Congress to be treated as
confidential, Committee leaders released it as a matter of compelling public
interest.
Thus, can anyone really look at the Pfizer (Celebrex) study involving the
Cleveland Clinic (without Dr. Topol in the lead) as purely coincidental and
beyond the possibility of bias and conflict of interest? Hardly.
If anyone needs additional evidence of the potential for a problematic
outcome to this latest study, consider the Washington Post report of August
5, 2001. That article, entitled "Missing Data on Celebrex" (by Susan Okie),
sounds eerily similar to the recent revelation by the New England Journal of
Medicine (NEJM) with respect to Merck's conduct involving Vioxx study data.
"When editors of the Journal of the American Medical Association sent
medical expert M. Michael Wolfe an unpublished study on the blockbuster
arthritis drug Celebrex last summer, he was impressed by what he read.
Tested for six months in a company-sponsored study involving more than 8,000
patients, the drug was associated with lower rates of stomach and intestinal
ulcers and their complications than two older arthritis medicines --
diclofenac and ibuprofen.
JAMA's editors wanted to rush the findings into print, and Wolfe and a
colleague provided a cautiously favorable editorial to accompany it. But in
February, when Wolfe was shown the complete data from the same study as a
member of the Food and Drug Administration's arthritis advisory committee,
he said he saw a different picture.
'We were flabbergasted,' he said.
The study -- already completed at the time he wrote the editorial - - had
lasted a year, not six months as he had thought, Wolfe learned. Almost all
of the ulcer complications that occurred during the second half of the study
were in Celebrex users. When all of the data were considered, most of
Celebrex's apparent safety advantage disappeared.
'I am furious. . . . I wrote the editorial. I looked like a fool," said
Wolfe, a Boston university gastroenterologist. "But . . . all I had
available to me was the data presented in the article.'
JAMA's editor, Catherine D. DeAngelis, said the journal's editors were not
informed about the missing data. 'I am disheartened to hear that they had
those data at the time that they submitted [the manuscript] to us," she
said. "We are functioning on a level of trust that was, perhaps, broken.'
The study's 16 authors included faculty members of eight medical schools.
All authors were either employees of Pharmacia, Celebrex's manufacturer, or
paid consultants of the company.
***With inclusion of the later data, 'the actual difference between Celebrex
and [the other drugs] are not as wide as they were at six months," he
acknowledged. "But I think in the end, it does show that Celebrex has a
superior safety profile.'
***Meanwhile, the JAMA article and editorial have likely contributed to
Celebrex's huge sales. 'When the JAMA article comes out and confirms the
hype, that probably has more impact than our labeling does,' said Robert J.
Temple, director of medical policy at the FDA's Center for Drug Evaluation
and Research.
James Wright, a professor of clinical pharmacology at the university of
British Columbia, said he complained to JAMA after noticing differences
between the published report and the data presented to the FDA. He praised
the Public Citizen's Health Research Group, a consumer organization, for
filing a lawsuit that led to the agency's putting all drug studies presented
to its advisory committees on its public Web site.
'Otherwise, we still wouldn't know this,' Wright said. 'We would still be in
the dark.'" Click here
Why should anyone believe that anything has changed so dramatically that the
upcoming study will not be prone to the same misgivings by experts and
consumer advocates alike? All of the examples set forth above indicate the
possibility of another questionable study is more than just a remote
possibility especially with Dr. Topol on the outside looking in - the same
Dr. Topol who since he came to the Clinic in 1991 has been responsible for
establishing its medical school and significantly enhancing the reputation
of its cardiovascular medicine unit.
Dr. Topol has revealed that the Clinic's conflict-of-interest committee, on
which he served, had looked into the financial arrangements of other
doctors, including Dr. Cosgrove, as well as the fact that patients at the
Clinic were being used as subjects in tests of medical devices made by
companies in which the Clinic had financial interests.
One potential conflict at the Clinic involved the chief executive of
Invacare a major health care supply company. Invacare conducts about
$200,000 a year in business with the clinic and several people with Clinic
associations sit on the Invacare board.
They include Dr. Bernadine Healy, the former head of the Red Cross who is
married to Dr. Floyd D. Loop, the cardiac surgeon who led the Clinic until
he retired last year and was replaced by Dr. Cosgrove. Dr. Healy owns
options for 41,570 shares of stock in Invacare, according to a securities
filing from earlier this year.
As noted above, Dr. Cosgrove is a cardiac surgeon. He is quite familiar with
the role physicians play in industry since his inventions include the
Cosgrove-Edwards heart device. The device, marketed by Edwards Lifesciences,
is used at the Clinic. The Clinic has refused to discuss how or whether its
patients are informed of Dr. Cosgrove's connection to the device.
Last January, The New York Times discussed a number of companies in which
the Clinic had a financial interest (including AtriCure, a heart device
manufacturer).
On December 16, The Wall Street Journal ran a front-page article about the
Cleveland Clinic's financial ties with Cardio Vention, the maker of a
heart-lung machine blamed for the death of a Clinic patient in May 2002.
Press releases issued by the Clinic through Dr. Cosgrove that praised the
device in April 2002, failed to disclose that Dr. Cosgrove and the Clinic
had a financial interest in the company that ceased operations in 2003.
Several Clinic surgeons, including Dr. Cosgrove, were consultants to Cardio
Vention and received stock options in the company.
Dr. Cosgrove also has financial interests in a number of other companies
doing research at the Cleveland Clinic as a result of his investment in
Canaan Partners, a venture capital fund that also backed Cardio Vention.
Many medical ethicists believe that all of these entanglements may call into
question the Clinic's reputation as a world-class independent research
institution. "All of these pieces of information coming out bit by bit are
potentially damaging to the clinic's reputation," said Dr. Mildred K. Cho, a
medical ethicist at Stanford University.
Although the clinic claims its board of trustees has appointed an
independent group to review the Clinic's conflicts, Dr. Topol has been
removed from the conflict-of-interest committee, a position he held by
virtue of his leadership role at the medical college.
Thus, as the COX-2 saga continues to unfold (or unravel as the case may be)
will the Celebrex study live up to the hype already placed on it by Dr
Nissen who has stated: "There's only one way - through good science. We know
the burden is upon us to do this right."
Independent researchers are to collect and control the results and have
offered to make all of them public, not only the final conclusions. None of
the top researchers will be permitted to have financial ties to any
pharmaceutical company that manufactures painkillers.
The Celebrex study will be called PRECISION, for Prospective Randomized
Evaluation of Celecoxib Integrated Safety versus Ibuprofen or Naproxen.
Results are expected in about four years. You can sell an awful lot of
Celebrex in four years, that's for sure.
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| Tim Dixon 2005-12-26, 12:53 am |
| QUIT CROSS-POSTING YOU IDIOT THIS IS A DENTAL GROUP NOT MEDICINE
REPORTED AS SPAM
"JanD" <JanD@insightbb.com> wrote in message
news:CJErf.656336$_o.261361@attbi_s71...
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"Tim Dixon" <timgdixon-no-spam@cox.net> wrote in message
news:YDGrf.18043$LB5.11670@fed1read04...
> QUIT CROSS-POSTING YOU IDIOT THIS IS A DENTAL GROUP NOT MEDICINE
Medicine concerns EVERYONE.
>
> REPORTED AS SPAM
Report away, if your chose to show your ignorance.
>
> "JanD" <JanD@insightbb.com> wrote in message
> news:CJErf.656336$_o.261361@attbi_s71...
>
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| Robert Morien 2005-12-26, 12:53 am |
| In article <CJErf.656336$_o.261361@attbi_s71>,
"JanD" <JanD@insightbb.com> wrote:
> Strange Goings On at the Cleveland Clinic: Mere Coincidences or Something
> Far More Problematic?
spam noted and reported
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| On Sun, 25 Dec 2005 20:41:04 -0800, Robert Morien wrote:
> In article <CJErf.656336$_o.261361@attbi_s71>,
> "JanD" <JanD@insightbb.com> wrote:
>
>
> spam noted and reported
Since a new thread was started (possibly by mistake) relevant information
is repeated:
http://www.newsinferno.com/storypag...9-2005~001.html
Readers can decide for themselves whether it is spam or not.
And another link to an article about the same events among other things:
http://groups.google.com/group/misc...87f1b3429548b41
(scroll to the word 'giant')
FAIR USE NOTICE: The link to the material at the above URL is provided
for educational purposes only.
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|
"mike" <xyz@xyz.com> wrote in message
news:pan.2005.12.26.05.54.15.348756@xyz.com...
> On Sun, 25 Dec 2005 20:41:04 -0800, Robert Morien wrote:
>
>
> Since a new thread was started (possibly by mistake) relevant information
> is repeated:
That's correct, but never mind, Robert,
That's the only four words, he knows.
Of course, he has been asked what spam and what exactly he reported that
broke any rule of my ISP, and he can not answer. In FACT, Robert can not
answer questions of any kind. His has spam on the brain. It appears it
rotted long ago.Robert is just a troll and harasser.
>
> http://www.newsinferno.com/storypag...9-2005~001.html
>
> Readers can decide for themselves whether it is spam or not.
>
> And another link to an article about the same events among other things:
> http://groups.google.com/group/misc...87f1b3429548b41
>
> (scroll to the word 'giant')
>
> FAIR USE NOTICE: The link to the material at the above URL is provided
> for educational purposes only.
| |
| Tim Dixon 2005-12-26, 10:53 am |
| quit cross-posting
"mike" <xyz@xyz.com> wrote in message
news:pan.2005.12.26.05.54.15.348756@xyz.com...
> On Sun, 25 Dec 2005 20:41:04 -0800, Robert Morien wrote:
>
>
> Since a new thread was started (possibly by mistake) relevant information
> is repeated:
>
> http://www.newsinferno.com/storypag...9-2005~001.html
>
> Readers can decide for themselves whether it is spam or not.
>
> And another link to an article about the same events among other things:
> http://groups.google.com/group/misc...87f1b3429548b41
>
> (scroll to the word 'giant')
>
> FAIR USE NOTICE: The link to the material at the above URL is provided
> for educational purposes only.
| |
|
| On Mon, 26 Dec 2005 06:46:22 +0000, JanD wrote:
>
> "mike" <xyz@xyz.com> wrote in message
> news:pan.2005.12.26.05.54.15.348756@xyz.com...
>
> That's correct, but never mind, Robert,
>
> That's the only four words, he knows.
>
Oops, it turns out it was Peter M did not start a new thread,
it was my news server that received the original posting 2 days
later than responses. Apologies to everybody.
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