If you like playing the game “connect the dots,” you might find this one very interesting:

• 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.

• 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.”

• 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.

•  2004-2005 – Dr. Nissen remains uncharacteristically silent especially in light of his long-standing criticism of the COX-2 inhibitors and Vioxx.

• 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.

•  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.”

• 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.”

• 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.

• 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.)

• 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.

•  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.’

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.

The era of the COX-2 inhibitors appears to be coming to an end. Vioxx was removed from the market worldwide by Merck in September 2004. Pfizer has announced Celebrex is about to undergo new safety testing while the company’s other COX-2 inhibitor, Bextra, was removed from the market in April 2005.

The suspension of Bextra sales was due to safety concerns related to rare but serious skin reactions and cardiovascular problems. At that time, Health Canada issued a stop-sale order which ensured that Bextra (valdecoxib) would not be permitted to return to the Canadian market without further consultation with Health Canada.

The Canadian agency, which is the equivalent of the U.S. FDA, studied all of the available data on COX-2 inhibitors in general and concerning Bextra, specifically. Based on that review Health Canada has determined that “there is an increased risk of heart attack and stroke when these drugs are used for long-term treatment. Studies also showed that these side-effects can occur when Bextra is used for short-term pain relief following high-risk heart surgery. Bextra is also associated with a risk of rare but severe and potentially fatal skin reactions.”

The official announcement on the agency’s Web site (http://www.hc-sc.gc.ca/ahc-asc/media/advisories-avis/2005/2005_134_e.html) states:  “The decision to stop the sale of Bextra is based on information submitted by the manufacturer, Pfizer Canada Inc., and consultations with external experts and the public. Health Canada concluded that there is insufficient evidence to establish the safety of the drug for its recommended use.”

“As a result of this regulatory action, the manufacturer will not be able to bring Bextra back onto the Canadian market under its present conditions of use. Health Canada has sent a letter to inform Pfizer Canada Inc. of the status of Bextra.”

The advisory concludes by stating that: “Health Canada has completed the review and agrees with the panel that available evidence indicates that COX-2 selective inhibitors and all other non-steroidal anti-inflammatory drugs are associated with an increased risk of cardiovascular events when high doses are used for long periods. However, the exact nature of that increased risk may differ from one product to another. The panel also found that the overall risk versus benefit profile for Bextra does not support the marketing of this drug in Canada under its current conditions of use.”

A study published in the current issue of Archives of Internal Medicine reports that treatment with atypical, but not conventional, antipsychotics raises the risk of venous thromboembolism (VTE) in elderly patients.

Dr. Rosa Liperoti, from Universita Catolica del Sacro Cuore in Rome, and colleagues assessed VTE hospitalization among 19,940 nursing home residents taking antipsychotic agents and 112,078 residents not using these drugs.
The overall VTE hospitalization rate was found to be 0.91 per 100 person-years. That figure was comprised of about 78% venous thrombosis events and around 22% pulmonary embolism events. Relative to nonuse, atypical antipsychotic use was linked to an elevated risk of VTE, ranging from 87% for olanzapine, 98% for risperidone, to 168% for clozapine and quetiapine fumarate.

By contrast, treatment with phenothiazines or other conventional agents did not seem to increase the risk of VTE.
According to the study authors: "It seems advisable to be cautious when prescribing antipsychotic agents to elderly patients. However, the therapeutic choice should be individualized based on a careful evaluation of the benefits and risks of both classes of antipsychotic agents and patients’ risk profiles."

The CPSC and Advantage Publishers Group, of San Diego, California, are recalling some 41,000 Children’s Books because if the clear plastic container is removed from the book’s back cover or breaks, young children can access the beads in it. This poses a choking hazard to young children.

Consumers should stop using the recalled children’s books immediately and take them away from children who might still be.
The books were manufactured in Thailand and sold at national book chains, discount department stores, wholesalers and distributors, and membership warehouse clubs nationwide from May 2003 through November 2005 for about $16 for the activity books and about $6 for the board book.

To date, Advantage Publishers Group has received one report of a child accessing beads in the books’ clear plastic containers. No injuries have been reported.

The recalled children’s activity books are multi-colored with holes in the pages to touch a variety of fabrics and to push a squeaker toy, flaps to lift, and a clear plastic container with beads. The “Amazing Baby Look and Play” activity book has a yellow star on the cover. The “Amazing Baby Touch and Play” book has a brown bear on the cover.

The activity books measure about 11-inches by 11-inches, and are for children ages 12 months to 24 months. The recalled “Rattle, Rattle” board book has a magenta car on the cover. The board book measures about 5 1/2–inches by 5 ½-inches, and is intended for children ages 6 months to 18 months.

Consumers should immediately take these recalled activity and board books away from young children and contact the company for a replacement book.

For additional information, contact Advantage Publishers Group toll-free at (866) 748-3731 anytime or visit the company’s Web site at www.advpubgrp.com.

The Consumer Product Safety Commission (CPSC)  and Celebrate Express Inc., of Kirkland Washington, have announced the recall of about 21,100 Mystery Drawer and Dice Tunnel Magic Party Favors and 25,500 Costume Shields because the magic party favors and the dragon ornament on the shield could break or crack, exposing sharp points that could cut or lacerate children. Consumers should stop using the recalled product immediately.

The products were manufactured in China and sold through the Celebrate Express’ Birthday Express and Costume Express online and catalog.

The recalled Mystery Drawer and the Dice Tunnel Magic Party Favors were sold as part of the Magic Favor Box from January 2005 through August 2005.

The Magic Favor Box sold for about $3. The recalled Costume Shields were sold from April 2004 through September 2005 as part of various costume sets. The costume sets sold for about $5 to $36.
No injuries or incidents have been reported to date.

The recalled Mystery Drawer is a black plastic rectangular box with a movable drawer. The Dice Tunnel is a blue or red plastic rectangular box with one die. They were sold along with other party favors in an assortment known as the Magic Favor Box (Item #E4696).

The plastic shield is silver and gold and is about 11-inches long. The shield was sold as part of the following costume sets: Sword and Shield Set (Item #7014), Sword and Shield Set – 8 (Item #8006), and the Cape, Helmet, Sword, and Shield Set (Item #E8520). The item number is located on customer invoices.

Consumers should take the recalled magic party favors and costume shield away from children immediately and contact the company for a refund. Celebrate Express has directly contacted all purchasers of the products by mail.
For more information, consumers should call Celebrate Express at (888) 551-3995 between 4:30 a.m. and 10 p.m. PT Monday through Friday, or visit the firm’s Web site at www.celebrateexpress.com.

The Consumer Product Safety Commission (CPSC) and Maxim Enterprise Inc. of Lakeville, Massachusetts, have announced the recall of some 12,000 Little Tree Mini Learning Cubes because small wooden pegs in the top corners of the toy can come loose thereby posing a choking hazard to young children.

Consumers should stop using the recalled products immediately.

The toys were manufactured in China and sold at Target stores nationwide from June 2005 through November 2005 for about $15.

Target has received three reports of incidents including two reports of children mouthing pieces of the learning cube. In one incident, an 18-month old girl swallowed a piece of the recalled learning cube after one side came loose. The piece became stuck and she had to have it removed in a hospital emergency room.

In a second incident, a child started choking when she put two of the toy’s wooden pegs in her mouth. In the third incident, a consumer reported the wooden pegs popped out of the learning cube. No injuries were reported in that incident.

The recalled learning cube is an 8-inch square wooden box with a different activity on each side, including an abacus, blocks with apples and bananas, shapes that can be moved in a zigzag cutout, and a blackboard. The wooden cover has spiral bead maze with wooden beads that slide up, down and around.

Consumers should immediately take the recalled cube away from young children and return it to Target for a $15 gift card plus applicable state tax.

For more information, consumers should contact Target at (800) 440-0680 between 8 a.m. and 7 p.m. CT Monday through Friday, or visit Target’s Web site at www.target.com.

In the largest settlement involving a civil administrative penalty under any federal environmental statute in agency history, the Environmental Protection Agency (EPA) has announced that DuPont will pay $10.25 million in fines and $6.25 to fund environmental projects to settle allegations that the company withheld information about the dangers of the toxic chemical, PFOA.

The settlement stems from the EPA’s action against DuPont, for allegedly withholding information about the potential health and environmental risks posed by perfluorooctanoic acid, or PFOA (C8), under provisions of both the Toxic Substances Control Act and the Resource Conservation and Recovery Act.

The EPA charged that the company knowingly withheld information for more than 20 years about the health effects of PFOA and about the pollution of ground water supplies around DuPont’s Washington Works plant near Parkersburg, West Virginia.

As we have previously reported, for  the past two years, there has been a growing concern over the safety of the manmade chemical known as C8 or PFOA which can be found in everything from bread to birds, green beans to ground beef, dolphins to drinking water, and in the blood of up to 96% of the population of the United States.

The acid is used to manufacture Teflon coating for cookware and hundreds of other products like telephone cables, carpets, clothing, computer chips, chemical piping, and automobile fuel systems. Teflon currently nets DuPont a reported $200 million in profit a year.

Because there are no known “natural” sources of C8, scientists are curious as to how the chemical enters the environment. C8 has also contaminated the groundwater in areas where Teflon is manufactured.   

DuPont, which also pioneered the development of PFOA and continues to dominate its use, claims that the chemical is harmless to humans. It also disputes that C8 is released during normal cooking (as opposed to overheating).

Others are not so sure that either assertion is true. Studies have concluded that C8 is one of several toxic gases released by Teflon when it is heated to temperatures which, at their low end, are only slightly above normal cooking temperatures.

C8 has been shown to cause tumors in rats and fumes from Teflon coated cookware can cause what is known as “polymer fume fever,” a condition which has been shown to kill birds even at low temperatures but which DuPont claims is harmless to humans if the cookware is used at a temperature of up to 500F. When Teflon is overheated (above 700F), fatal cases of polymer fume fever in humans have occurred (at 842F).

Last August, DuPont agreed to pay up to $343 million in settlement of a class action arising out of the contamination of drinking water in Ohio and West Virginia linked to its plant near Parkersburg, West Virginia.

Of that amount, most of the $107 million to be paid for damages to the water supply of some 50,000 people living near the plant will be used to fund a detailed scientific review and a landmark community health study with respect to the dangers posed by C8 in the six Ohio and West Virginia water districts covered by the settlement.  

Up to another $235 million is to be set aside for future medical monitoring if the studies find C8 can make people sick.

So far, some 43,000 individuals have signed up for the health study with more than 17,000 having been tested since August. There is a waiting list of about 26,000 people. Eventually, up to 60,000 people are expected to take part in the study. Each person who completes the screening will be paid $400.

Beginning in 2006, a court-appointed panel of three epidemiologists will begin reviewing the results of the screening project.

Although DuPont continues to claim that there is no confirmed danger posed by C8, the company announced that it plans to dramatically decrease the use of PFOA in Teflon coatings by the end of 2006.

Earlier this year, however, the EPA stated that tests on laboratory animals linked PFOA to liver, pancreatic, and testicular cancer, reduced birth weight, birth defects, and immune suppression.

The agency also found that elevated cholesterol and triglycerides were a risk of exposure to C8. As a result, the EPA stated that low-level exposure to PFOA could pose a “potential risk of developmental and other adverse effects” in humans.   

The EPA has released a draft assessment of the chemical used in the production of Teflon which, based on animal studies, found “suggestive evidence” that the substance may be a human carcinogen.

In May, the Justice Department issued grand jury subpoenas seeking documents from DuPont with respect to PFOA and related chemical compounds. The suspicion was that DuPont withheld critical information concerning possible health risks posed by PFOA.

A 1961 internal document indicated that DuPont scientists had already warned company executives to avoid human contact with PFOA. DuPont faced more than $300 million in fines if it was found guilty of withholding such information.

In August of this year, a draft report released by an independent EPA scientific advisory board which reviewed the earlier EPA assessment and which will now be submitted to the EPA, concluded that PFOA (C8) is “likely” to be a human carcinogen and, as a result, the EPA should conduct cancer risk assessments for a variety of tumors found in rats and mice exposed to it.

Another startling revelation was reported in the Charleston Gazette on July 10. According to an April 2004 sworn statement by Dr. Bruce Karrh, DuPont’s former medical director, the company found similar birth defects in two of eight children born to women who worked at the Parkersburg chemical plant 25 years ago.

The Charleston Gazette also reported that: “A DuPont researcher said the number was ‘significantly greater’ than the expected rate of birth defects in the general population. In April 1981, the researcher proposed that DuPont do a detailed study to determine if exposure to the toxic chemical C8 was to blame. Three months later, DuPont officials dropped the study, a former top corporate doctor has testified.

Dupont officials also decided not to report its preliminary findings to federal regulators, according to the testimony, obtained under the Freedom of Information Act…‘To my knowledge, it was never reported to EPA, and, to my knowledge, I didn’t ask anybody whether it was reported,’ Karrh said of the birth defects data.”   

The study will look for a number of potential links involving C8; however, cancer and heart disease are of the greatest concern. Those results may take up to four years to report. Each sample taken from the test subjects is tested for the presence of C8 and for organ function.

While the EPA declared that the settlement "sends a strong message that companies are responsible for promptly giving EPA risk information associated with their chemicals;" DuPont has not admitted liability and continues to take the position that “there (are) no human health effects that we know about that are caused by PFOA. We’ve seen nothing."

Thus, with strong evidence against it and a downside risk of over $300 million in civil penalties for failing to report the substantial risks posed by PFOA, DuPont made the prudent business decision of settling the entire EPA case for a total of $16.5 million.

DuPont’s general counsel summed up the company’s position on the settlement by stating:  "Frankly, we could have litigated this thing for several years. We wanted to get this thing behind us so we could move forward."

A federal criminal investigation of DuPont’s actions with respect to PFOA is ongoing.

According to a report from WWAY News Channel 3 (www.wwaytv3.com) in Wilmington, North Carolina, a former gastric bypass surgeon, who is facing dozens of lawsuits for medical malpractice, has changed his name.

Formerly Dr. Steven Olchowski, Dr. Steven Hawkins made the switch so that he can have a fresh start, his attorney said. Although the attorney claimed that Olchowski has no intention of practicing medicine again under the name Hawkins, WWAY pointed out that there was no guaranty of that.

In the wake of a flood of malpractice lawsuits, Olchowski lost his medical license in both Michigan and North Carolina.

Former patients accused him of lying about the weight-loss procedures he performed on them. They claim that he performed a dangerous short-cut operation that caused life-threatening medical complications.

Olchowski (Hawkins) has yet to go to trial for medical malpractice.

Patients should be able to access accurate information on Dr. Olchowski on the North Carolina Medical Board website, by searching under his new and former names, officials say.

The consequences of the mistrial in the first federal Vioxx trial may turn out to be extremely serious for Merck in terms of the embattled company’s ability to mount a credible defense in future trials.

As the trial in Houston began, Merck was regarded as the heavy favorite to win the case for a number of reasons. Among the most obvious were: (1) the trial was in the traditionally less plaintiff-friendly venue of federal court; (2) the case involved short-term Vioxx use, which is generally regarded as more defensible than long-term use cases; and (3) Merck had just won a (short-term-use) case in New Jersey state court and so “momentum” was on the drugmaker’s side.

Those clear advantages evaporated, however, when the trial judge ruled that the plaintiff could introduce expert testimony that short-term use of Vioxx carried similar cardiovascular risks to long-term use. In addition, a damaging videotaped deposition of one of Vioxx’ harshest critics, Dr. Eric Topol (renowned cardiologist from the prestigious Cleveland Clinic) was shown to the jury.

Merck, however, presented a serviceable defense that included the credible testimony of Dr. Alise Reicin, a convincing witness who has an intimate knowledge of Vioxx gained through years of working with the marketing of the drug as a high level Merck employee.

Thus, as case went to the jury for deliberation only three possibilities existed; a verdict for plaintiff, a verdict for Merck, or a mistrial. The jury would not be privy to the unexpected turn of events that was about to take place and, thus, would not be basing its verdict on the evidentiary disaster that would irreparable damage Merck’s defense and impugn the credibility of its witnesses.

What Merck needed was to win the case without the jury knowing the facts surrounding the rather shocking revelation by Dr. Gregory Curfman, executive editor of the New England Journal of Medicine (NEJM) that data linking Vioxx to increased cardiovascular risk was deleted (apparently by Merck researchers) from the VIGOR study two days before it was submitted to the NEJM for publication.  

As Dr. Curfman saw it: "I was somewhere between surprised and stunned. They allowed us to publish an article that was just incomplete and inaccurate in some respects and was misleading and may have contributed to the detriment to the public health."

The federal jury would never know (while deliberating, at least) that two Merck authors on the VIGOR study knew of three additional heart attacks among Vioxx patients in the study, which had not been disclosed to the NEJM. The heart attacks occurred in the final five weeks of the trial and in patients at low risk for heart problems or that a prior version of the manuscript revealed more cardiovascular problems potentially connected to Vioxx than those discussed in the published study.

Thus, what the jury had was defense testimony that dovetailed neatly with the published results of the VIGOR study thereby making Merck’s defense plausible and certainly able to pass the straight face test.

The deleted data, however, not only discredits the results and conclusions reached in the VIGOR study as to the safety of Vioxx, it also renders much of the testimony given by Dr. Reicin, and Merck’s other employee-witnesses highly suspect at best.

Obviously, the accusation by the NEJM that Merck knowingly withheld data on three fatal heart attacks and more, if true, significantly undermines the VIGOR study results as well as the entire premise upon which Merck has built its entire defense.

It would certainly call into question the study’s findings, which have been a central element in the three trials, as well as the testimony of one of the study’s authors, Dr. Alise Reicin, Merck’s vice president for clinical research, who claimed the company never misled doctors or the public about Vioxx studies.

When the NEJM revelations came to light, we asked a number of trial and appellate attorneys to offer their thoughts on what possible legal issues are raised by the Journal’s allegations. Of course, at that time, the jury was still deliberating and could have rendered a verdict despite what was taking place in the court and the media with respect to the NEJM charges.

After the mistrial was declared (based on the inability of the jury to agree on a verdict hung jury), we went back to those same attorneys to see what they thought the significance of that outcome might be in light of the Norm’s claim concerning the manipulation of the VIGOR study data.

Their responses were consistent in that they all saw the mistrial (under the particular circumstances) as being an extremely devastating blow to Merck.

Even though the mistrial was based on a “hung jury,” the attorneys we spoke with believed that Judge Fallon may have declared a mistrial on his own had there been a verdict in favor of Merck.

Plaintiff’s attorney had moved for a mistrial when the NEJM charges became public and Judge Fallon had reserved decision. Although he was free to decide the motion before the verdict, courts usually reserve decision on such motions until after the verdict to avoid the necessity of a new trial if an appellate court determines the motion was decided incorrectly.

Here, the missing data would have strengthened plaintiff’s case and severely damaged Merck’s defense including the testimony of its key witnesses. Thus, a verdict for Merck may have had to have been set aside anyway.

If the verdict is for the plaintiff, however, it would not have to be set aside although the court would then have to decide if the missing data would be admissible in the case for punitive damages.

Certainly, if the verdict had been in favor of Merck and the motion for a mistrial was denied, plaintiff would have the right to seek a new trial on appeal to the Circuit Court of Appeals.

Merck is also faced now with the problem of maintaining its credibility since there is a serious issue of whether any of its employee-witnesses committed perjury in this or either of the prior trials.

Obviously, if Merck employees deleted critical data, someone at Merck knew about it and may have even ordered it. Since a number of key Merck employees have testified about the study, it is impossible to believe no one knew of the deletion.

Moreover, Dr. Reicin, whose entire testimony has been repeatedly based on the accuracy and reliability of the VIGOR study, happened to have been one of the authors of the article in the NEJM. She is certainly one of the people who would have had access to the data files.

Even if she had no knowledge of the actual deletion of data, she may have known of the additional deaths. Thus, her testimony has become highly suspect since it is based on a study she may have known was inaccurate.

In addition, after Dr. Topol and his colleagues analyzed the VIGOR study and other data, they drafted their article and sent it to Merck expecting the company might be able to reconcile several major discrepancies between its data and that kept in the FDA database.

It was then that Dr. Topol got a visit from the very same Dr. Reicin, a Merck researcher and chairman of its Vioxx Commercialization Committee. At that meeting she told Dr. Topol that it was the Cleveland Clinic team that had “gotten it wrong” and would be embarrassed if we published the paper. "I thought it was harsh," he said.
Obviously, if she knew about the additional deaths and/or the omission of data from the study, her meeting with Dr. Topol was disingenuous.

The mistrial also takes away from Merck the ability to “strike while the iron is hot” with respect to the short-term-use type of case it had prevailed upon in New Jersey and to build on its momentum.

More importantly, however, the mistrial may now jeopardize the outcome in the New Jersey trial wherein Merck prevailed. Since the verdict in that case was based solely on Merck’s claim that it did not know Vioxx was unsafe until September 2004, the allegations of withholding data and manipulating the central study Merck relied on in its defense would give Judge Higbee a strong  reason to set aside the verdict in favor of Merck and order a new trial.

In addition the same issue of possible perjury would exist. Even if Judge Higbee did not set aside the verdict, a New Jersey appellate court could based on the NEJM claims should they be proven to be true.

The attorneys we spoke with also believe that the failure of the federal jury to reach a quick and decisive verdict for Merck raises serious questions as to the ability of the company to overcome the mountain of evidence against it even in cases that were once thought to be eminently “winnable.”

Clearly, if the serious allegations involving deleting data are true, Merck witnesses will be the subject of some rather intense and damaging cross-examination at any future trials, In addition Dr. Reicin may have become a major liability to Merck instead of one of its star witnesses. She may no longer have the credibility she enjoyed in the first three trials and her involvement in the VIGOR study scandal may have made it impossible for her to hold her own on the witness stand.

The value of the VIGOR study itself is also in serious doubt now. Instead of being useful in certain ways to both sides, it may have now turned into an albatross for Merck. This is hardly the tone Merck wanted to set after repeatedly announcing its brash strategy of trying each of the remaining 7,000 plus cases to verdict.

As a late story in the Boston Globe points out that “plaintiffs’ attorneys say they will attack the credibility of Merck and its clinical trials leader, Reicin, as nearly 7,000 lawsuits are heard in federal and state courts. ‘As a general proposition, anything that smacks of manipulating studies or data is a potential bombshell,’ said Kendall Coffey, a legal analyst in Miami and a former US attorney. ‘’It’s the rare case where a cover-up is of no concern to a jury. The implications range from only somewhat harmful to potentially devastating.’”

Clearly, Merck cannot point to anything positive in the mistrial. It was a missed opportunity for the company to draw a line in the sand with respect to the thousands of remaining short-term-use cases. It also represents a serious stumble for Merck’s legal team and corporate management, which have steadfastly refused to entertain the idea of settling any case or engaging in talks to resole the litigation in a global settlement.  

The Consumer Product Safety Commission (CPSC) has announced that Winco Fireworks Inc., Winco Fireworks International LLC, and Winco Fireworks of Utah LLC, of Prairie Village, Kansas, and David Collar will pay a $600,000 civil penalty for importing and selling dangerous fireworks.

“The defendants, Winco Fireworks Inc. and company president, David Collar, had previously entered into a consent decree which required the testing of imported fireworks for compliance with U.S. fireworks laws and regulations, and prohibited the sale of devices that fail to comply with federal fireworks regulations.”

The CPSC alleged all of the defendants imported and sold banned or misbranded fireworks after they entered into this agreement, and also sold at least one type of fireworks device that posed a substantial product hazard.
“In addition to paying the civil penalty, the firms are required, under the modified consent decree, to have all future imports tested and certified to meet U.S. fireworks laws and regulations. The testing and certification must be conducted by the American Fireworks Standards Laboratory or another independent third party acceptable to CPSC.”

The complaint against the defendants alleged that they sold a device with “mortar tubes and shells that posed an unreasonable risk of serious injury.”  The CPSC claimed that the “tubes on this device could unravel during use, causing explosive material to escape out the side of the tube and injure bystanders.” In addition, the defendants failed to report to CPSC this defective product, as required by law.