June 8, 2002

SPECIAL REPORT: part one

FRAUDULENT CONDUCT THAT TAKES LIVES: WHY CRIMINAL PROSECUTION OF MEDICAL RESEARCHERS WITH FINANCIAL CONFLICTS, WHO FABRICATE SAFETY DATA, HAS BECOME AN ESSENTIAL COMPONENT OF REGAINING THE INTEGRITY OF DEVICE AND DRUG RESEARCH IN THE UNITED STATES

Summary: In recent years, surgical instrument companies working through surgeons with concealed equity interests in devices, have created new procedures, to promote the sale of equipment. Corporations have created demand for new surgical procedures "through massive advertising campaigns to convince the public of [their] necessity." Rutkow, IRA, The Socioeconomic Tyranny of Surgical Technology. Archives of Surgery. Leading surgical researchers, with equity interests have fabricated surgical research to demonstrate the safety and efficacy of new procedures with device costs of $2,000-$5,000 per operation. One sales rep described his companies’ philosophy as "dollars per procedure." Although the device industry has generated tens of billions of dollars in revenue using these tactics, serious surgical morbidity from many new device dependent operations has multiplied. Treating MD’s and patients need law enforcement’s assistance in deterring fabricated research data published by research surgeons with concealed equity interests in expensive medical devices, and new drugs. The question raised in this analysis is whether fraudulent medical research is taking lives, and if so, how many.

I represent a surgical device salesman "whistleblower" who has worked for the two largest device companies in the United States. Another client is a surgeon who supervises the use of new surgical technology. Thousands of physicians have learned new surgical technology at the center. A third client clinically tests new medical devices for many instrument companies. A fourth client, a former Chief Medical Officer at the Devices Division of the FDA has found over 1,000 misreported device malfunctions. This report is about what law enforcement has not done - but can do to deter deaths and injuries from what Clients #1 and #2 refer to as "the medical mafia." The third client, a prominent surgeon, after finding that a new surgical device caused potentially fatal injuries in 3 of 18 patients - was persuaded to avoid testifying about the injuries he observed, by a company Chief Operating Officer. The device, which Client #3 told the Chief Operating Officer was a "lethal weapon," has since injured tens of thousands of patients, including an estimated 1,000-3,000 deaths. Doctor John Guerigian, an MD//biochemist who left the FDA after over 20 years says, "They’re killing people and no one’s going to jail." This document argues that some should. Fraudulent device researchers with equity interests in products, who count on law enforcements’ inaction - are doing serious harm with fabricated studies backing some of the new long stemmed devices that are "revolutionizing" surger

A COMFORTING MYTH ABOUT DEVICE AND DRUG RESEARCH

In 2001, Dr. Richard Horton, the Editor of Lancet, one of the world’s oldest and preeminent medical journals, published his conclusion that the "notion" that drug and device research still serves medicine is a "comforting but erroneous myth." The myth referred to by Horton is about more than questionable research choices. It's about using a portion of a 200 billion dollar plus annual revenue to pay some "leading researchers" multimillions to purchase safety data that is not valid. This permits a company to obtain FDA approvals, and promote products based upon invalid data. There is a growing body of evidence that misleading drug and device research in the burgeoning for profit clinical medical research system is multiplying, is undeterred, is now a threat to public safety that rivals firearms in magnitude, and should be criminally prosecuted. If fabricated and otherwise misleading research on new drugs and devices has contributed to over 100,000 deaths, as appears probable, prosecution of the most dangerous offenders must be considered. Fabricating positive drug and device research results can be extremely lucrative. Indeed, it can generate billions of dollars in sales. Some fraud in commerce is self policing through caveat emptor. However, the actual police are required when fraudulent medical research "backs" a new drug or device - precluding caveat emptor. Later in this document potential prosecutions of named fraudulent researchers are detailed, but a background discussion of systemic changes in for profit drug and device research since 1995 may be helpful prior to discussing specific cases.

Substantial lay media coverage of medical researchers’ financial conflicts - including equity conflicts - in drug and device research began in 2000 following the death of research subject Jesse Gelsinger at the University of Pennsylvania. Gelsinger was a healthy young man who, like many other research subjects, presumably takes a risk to benefit science not to increase the value of a researchers concealed equity interests in a device or a drug. The media learned and reported that University of Pennsylvania researcher James Wilson, M.D. was a major stockholder in the company sponsoring the research. Dr. Wilson’s share, when the company was sold was $13.5 million, according to an April 22, 2002 cover story in Time magazine. Shortly after Jesse Gelsinger’s death, there were similar revelations at the "Hutch," a prominent research facility in Seattle. Reportedly, 80 of 82 studied patients died before researchers’ (including a Nobel winner’s) equity conflicts were uncovered by the Seattle Times. It appears likely that dozens of those patients would be alive today, had they not been included in a study a researcher had a financial interest in continuing - until it "succeeded." The Seattle Times has suggested that many patients would never have joined the study if they had known the facts re: financial conflicts and survival rates. Following these public revelations, the scientific community began, for the first time, to widely debate the effects of financial conflicts on the integrity of research backing new drugs and devices.

The interest of leading researchers in device and drugs they "study" have become so substantial in the past five years, that treating physicians across the country are beginning to question the integrity of research on new drugs and devices. Treating physicians are asking whether new therapies researchers advise them to employ are safe. (e.g. one recent book, "Dispensing with the Truth": included a chapter titled "Spin Doctors" which named the physicians who promoted a diet drug - since recalled for causing heart valve damage.) Treating MD’s are becoming concerned about the data backing new therapies being provided to them by researchers with equity interests in products:

In August 2000, a first of its kind conference on financial conflicts and device and drug research integrity attended by over 500 scientists was convened by the Department of Health and Human Services (DHHS). Participants agreed that existing safeguards fail to protect the integrity of research on new medical devices and drugs.

The Boston Globe’s report on the DHHS conference added that "participants described doctors eager to collect stock options, potentially compromising the validity of studies." The Globe also described Dr. Bodenheimer’s "whistleblowing" on research articles favoring new treatments ghostwritten by company employees, but signed by doctors "who had nothing to do with the study." Similarly, Lancet published a 2001 editorial asking researchers to keep their hands "firmly in their pockets," condemning "atrocious venality" in research, and observing that researchers’ findings "can be bought by the highest bidder."

In another first of its kind declaration, in September 2001, the editors of 13 medical journals (including JAMA, NEJM and LANCET) co-authored a joint statement, highlighting their concerns about financial conflicts in device and drug research. The Editors began the article with "the publication of clinical research…is the ultimate basis for most treatment decisions." The editors observed that, "We are concerned about the current intellectual environment" citing industry’s use of clinical research "primarily for marketing." The editors noted that published clinical research can "change standards of care" resulting in "substantial financial gains for the sponsor." The editors further observed that the results of studies funded by device or drug companies "may be buried rather than published if they are unfavorable to the sponsor’s product."

CHANGES IN DEVICE AND DRUG RESEARCH IN THE PAST DECADE

In the past decade, systemic changes in clinical research on drugs and devices have included:

• The identities of researchers. (In 1992, fewer than 1,000 "private" physicians performed clinical drug research. Now, it’s closer to 10,000.)

   

• The locations of research. (In 1992, over 80% of clinical research was conducted and monitored in academic centers. Now 65%-70% of clinical research is in private offices or community hospitals.)

   

• The amount of money paid researchers by industry (up to $6,000 per patient recruited for a study).

   

• The identity of individuals selecting researchers by industry. (In 1992, 20% of clinical research was placed by "for profit" contract research organizations - now it is closer to 70%.)

   

• Many, perhaps most, companies now prohibit researchers, by contract, from publishing negative safety findings on a drug or device. (In at least one case, a company threatened to sue a researcher if she published adverse data - which showed liver toxicity of a new drug.)

   

• An increasing number of "leading researchers" - opinion makers for entire clinical specialties hold equity interests (sometimes in the tens of millions of dollars) in products they research and/or promote to thousands of doctors at huge medical conferences chaired by those same leading researchers.

   

Industry is compensating leading drug and device researchers, directors of large medical conferences (and perhaps some editors of medical journals) with stock options, royalties, hundred thousand dollar plus annual consulting fees, equity interests in drugs and devices, lavish trips, and other benefits. Due to these sometimes immense financial conflicts, the Director of Federal Human Research Protection opined in August 2000 that "the entire endeavor" is now at risk. The argument infra, is that law enforcement’s awareness and involvement is essential to remove this risk.

MONEY FOR DOCTORS FOR DRUGS AND DEVICES

On February 21, 2002 ABC News.com provided insight into one small town doctor’s four month $10,000 interaction with industry.

If a small town doctor receives $10,000 in incentives in four months to influence prescriptions, what do researchers who create the safety and efficacy data used to promote new therapies receive? The Gelsinger case unearthed a 13.5 million dollar equity interest. The New York Times described other equity relationships between researchers and industry. Dr. Spencer King, past president of the American College of Cardiology was "a large shareholder in Novoste," whose "stock climbed 55%" on the day Novoste announced the results of Dr. King’s study of a new device" (New York Times, November 30, 1999). The Times further noted that:

Dr. Martin Leon runs a conference attended by over 5,000 physicians, annually. The Times wrote:

In 2001, the U.S. Attorney in Boston settled a Federal False Claims Act Case ("Qui Tam") against TAP Pharmaceuticals for nearly 900 million dollars. One fraud? Kickbacks to MD’s to prescribe Lupron, a drug, which can cost a patient up to $1,000 per month. In an April 26, 2002 Chicago Tribune article, TAP Vice President Douglas Durand, who blew the whistle on TAP kickbacks, blamed a "raucus cowboy culture" at the company. Lupron has spawned a "Lupron victims" Internet group with thousands of women members who say the drug has harmed them or their babies. One of TAP Pharmaceutical’s leading Lupron researchers - Boston gynecologist Andrew J. Friedman, fabricated clinical research to expand the off label market for this prostate cancer drug, to include uterine fibroids (over 10,000,000 women have fibroids - far more than men with prostate cancer - which Lupron was approved to treat). Among other fabrications, it was noticed that "studied" patient’s initials, listed on Friedman’s data sheets matched the initials of doctors at the hospital. In a second Friedman study, it was found that patients were named after doctors applying for fellowships at Harvard. Those "studied" patients, too, did not exist. Following discovery of the fraud, Dr. Friedman was not prosecuted. He left his division directorship at Womens and Brighams Hospital in Boston to take a job full time with a pharmaceutical company. Why would a pharmaceutical company hire a researcher whose medical license was pulled, for fabricating safety data?

44,000-98,000 UNNECESSARY DEATHS PER YEAR FROM MEDICAL INTERVENTIONS

In 2000, the National Institutes of Medicine estimated unnecessary deaths from medical interventions at 44,000-98,000 per year. At the upper estimate the number of avoidable deaths from medical interventions exceeds deaths from homicides, auto accidents, and air crashes combined. How many of these deaths are due to dissemination of unsafe devices or drugs via fabricated research? How many medical research frauds are investigated by law enforcement? Although the number of unnecessary deaths from unsafe drugs or devices, promoted through misleading or fabricated research is unknown, there is evidence that tens of thousands of deaths were related to research which did not accurately predict the effects of a drug or device in the general population.

In Deadly Medicine, Thomas Moore makes the case that over 40,000 patients died unnecessarily, from one drug (i.e. double the annual death toll from violent homicides). In reviewing Deadly Medicine, the Cleveland Plain Dealer reported the "incestuous" relationships between industry and "leading doctors" that made the tragedy "possible and perhaps inevitable." Recently, in only a ten month period, there were an unprecedented five drug recalls due to deaths and injuries at frequencies apparently not predicted by the research data provided the FDA by manufacturers. Business Week reported that "its almost a grim routine now. After the FDA gives the go ahead for a new drug, the product is yanked from the market when some unforeseen problem occurs." In "Prescription for Disaster," Thomas Moore makes the case that over 75,000 Americans die from adverse drug reactions each year. A recent article in the Journal of the American Medical Association estimated that 100,000 patients die from adverse drug reactions in a single year. Over 20 million Americans have taken a "recalled" drug since 1997. Total spending on prescription drugs reached 155 billion in the U.S. in 2001 - double 1997 totals. In May 2000, the Washington Monthly reported, "A new drug culture requires our attention. The pushers in this culture wear lab coats and business suits and move their product through HMO’s and family doctors." Fabricated drug and device research has not just the potential - but the likelihood of eventually touching every American family, in some, perhaps thousands of cases, fatally.

On the device research side, a disposable surgical instrument used in approximately half of the four million laparoscopic procedures performed in the U.S. each year is in the news. During a 2001 ABC television interview, the researcher who tested the device called it a "death machine." This researcher’s clinical testing, which yielded three potentially fatal injuries in 18 patients, was concealed from the FDA, by the manufacturer. An estimated 20-40 million of these devices have been sold - and used during surgical procedures. In November 2001, a former chief medical officer of the FDA devices division estimated that this device has injured 40,000 surgical patients in ten years (Smart Money, November 2001). It appears that the device may have caused 1,000-3,000 deaths - many through punctures of the aorta, iliac arteries or vena cava, which can fatally wound a patient in the first five minutes of even a minor operation. Thin women are disproportionately at risk of death from this device. Statements by surgeons who researched and/or taught doctors to use this device - by a field rep who sold it and by a former chief medical officer at the FDA Devices Division, revealing the fraudulent concealments behind this device are at p. 46 et. seq. This device, which need not be used at all, has impaled every organ and major vessel in the abdomen, according to reports filed with the FDA.

The National Institute of Medicine’s estimate, in 2000, of 44,000-98,000 unnecessary annual deaths from medical interventions is consistent with an earlier study of deaths in New York. In the largest study of its kind, Public Health physicians from Harvard reviewed medical records from 51 New York hospitals. Following that study, the Harvard MD’s estimated that 27,179 injuries, including 6,895 hospital deaths in New York, in a single year, were avoidable. (NEJM, 1991; 324:370). Extrapolating this data, 101,356 avoidable hospital deaths occur nationally each year. The Harvard investigators found that half the hospital deaths they reviewed (51.5%) were avoidable. Their conclusion was "there is a substantial amount of injury to patients from medical management."

THE "REVOLUTION" TO REMOTELY PERFORMED ABDOMINAL SURGERY

One of general surgery’s deans, Professor Cushieri of Scotland has called the "revolution" in a new abdominal surgical techniques and devices "the greatest unaudited free for all in the history of medicine." Columbus, Ohio Chief of Surgery, Francis Barnes wrote to an Editor that "the biggest problem with these new [surgical] techniques is that there are gurus putting on very expensive seminars selling their procedures almost as though they were some type of tele-evangalist." Some of these "gurus" have concealed equity interests in devices. Lahey Clinic Surgeon John Braasch summarized the factors driving the revolution in abdominal surgery:

• Promotion by the medical-device industry.

   

• Efforts by surgeons to expand market share.

   

• Hospitals desiring their operating rooms to be "full."

   

Dr. Braash noted that other beneficiaries of the revolution are "anesthesiologists who benefit from longer operating times" and "lawyers whose personal injury suits are numerous."

OLD CONCERNS PALE BY COMPARISON

As a Hospital Risk Manager in the 1980’s, my primary concerns were a limited number of dangerous individual practitioners and flawed hospital systems that unnecessarily increased risk. There were no concerns that entire standards of practice re: procedures and drugs were based on fraudulent research. That risk materialized in the 90’s, due to "leading researchers" equity interests in devices and drugs.

VAST WEALTH IN RETURN FOR RESEARCHERS’ POSITIVE FINDINGS

In November, 1999, the New York Times revealed multimillion dollar equity interests of leading cardiology researchers in devices they studied then promoted at huge medical conferences they directed - without disclosing their equity interests. These $2,500-$5,000 devices have been implanted in over a million patients. They reportedly cost less than $50 to manufacture. In reporting on the tangle of financial conflicts between "leading researchers" and the device industry, The Times concluded:

In November 2001, Smart Money, reported that "manufacturers vie furiously for leading doctors to endorse their wares. You wanted a big doctor to endorse your trocar, said [a salesman]. It was like getting Michael Jordan to say your basketball shoes were better." (This device is described at p. 46 et. seq.) Similarly, in July 2001, a California newspaper reported:

Dr. Michael Baggish, the editor of the Journal of Surgery, has written of surgeons who do the "bidding" of device companies and the replacement of "time proven techniques" with the "latest trendy operation," requiring the use of expensive disposable devices. In commenting on one new surgical technology that can add up to $5,000 to the cost of an operation, the New York Department of Health found was causing a 35 fold increase in serious injury including injuries "rarely or never reported before," Dr. Harvey Bernard, a New York Health Department spokesman cautioned surgeons attending a convention on the new technology that "we have to be reasonably sure that it’s not related to one of medicine’s black beasts - ignorance, arrogance, intellectual dishonesty and greed."

On May 15, 2002, the New York Times reported that one drug/device company’s internal memo "listed doctors the company considered to be movers and shakers at prestigious medical schools." The Times indicated that a lawsuit in Boston accuses this company of "paying dozens of doctors to speak to their peers, some garnering tens of thousands of dollars per year" to push product. The Times reported that marketing firms were hired to write medical journal articles, at $12,000 per "scientific" article, then find doctors to sign their names as authors at $1,000 per signature.

A 1999 New York Post article exposed industry benefits provided to "prominent" state psychiatric researchers. Doctor Adil Shamoo, a bioethicist, commenting on the immense sums paid to "leading researchers" told the Post:

Not only did the Post find "a dozen key state researchers who profited from drug firms," it also found that the state psychiatric institute "did non therapeutic research on children with fenfluramine, which was subsequently yanked off the market." The Post reported that New York hadn’t imposed strict financial conflict rules on state psychiatrists because they are "fearful it could alienate the drug firms" (March 1, 1999).

In April 2001, writing for his Fort Worth area medical society, Doctor Timothy Gorski warned of researchers’ "million dollar deals with pharmaceutical and surgical instrument companies." Also in 2001, USA Today reported on Dr. James Rowsey’s use of an investigational medical device he had an equity interest in. Rowsey projected $112 million in sales in five years, if the FDA approved the device. In pursuit of approval, Rowsey "performed unaopproved research on more than 60 people, including children." Nine year old Joanne Cassidy and 85 year old Harry Rodgers have sued, one claiming decreased vision, the other alleging legal blindness. USA Today noted that the University which also had an equity interest in the device, "did not monitor his work." USA Today quoted one patient’s counsel: "I call it Nasdaq medicine. It is not scientists racing for a cure. It is scientists racing each other for the money." Rowsey told USA Today that he didn’t inform patients of his financial interests because they were "speculative."

Yale professor Cary Gross, citing vast differences in reported results, depending on who sponsors and funds drug research, observed in the Journal of Philosophy, Science and Law that the "foundations of medical research in the United States have been shaken." A recent study at Northwestern found that negative results on new therapies were reported 5% of the time when industry paid for the study v. 38% when the research was not industry funded. On April 22, 2002, Time magazine reported "96% of researchers who were supportive of [a controversial therapy] had ties to companies that manufactured it, and only 37% of these critical of the drug had such ties." Dr. Jermone Kassirer asked, in an American Journal of Law and Medicine article on research, "How large is the hidden epidemic of financial conflict of interest and what impact does it have on the practice of medicine?"

WHY FINANCIAL CONFLICTS - AND THE INTEGRITY OF DRUG AND DEVICE RESEARCH ARE OUT OF CONTROL

One medical reporter has described the assumption which permitted drug and device researchers multimillion dollar equity conflicts which would be unacceptable in any other profession.

The assumption that medical researchers are more trustworthy than anyone else is belied by surveys of medical school students - including one showing that 88% of medical school students cheat, and a recent survey of students in Toronto. 62 of 102 students observed their instructors engage in unethical (not poor) practices. The failure to prohibit ownership interests by researchers in drugs and devices they study is based on a false assumption. Because truth telling is related to accountability, an argument could be made that researchers with financial conflicts are less apt to be truthful than those whose business is conducted in the open.

CONTRACT RESEARCH ORGANIZATIONS (CROS)

Contract Research Organizations (CROs) contract with drug and device companies to perform clinical research, and place the research through networks of physicians in private offices, community hospitals and other locations. Approximately 65-70% of clinical research in the U.S. is now conducted by for profit contract research organizations ( v. 21% in 1991). USA Today reported that "Marcia Angell, former editor of the New England Journal of Medicine fears that some CROs, dependent on a particular company for survival, might bury study results."

Between 1992 and 1998, the number of private practice physicians involved in recruiting research subjects increased from 988 to 5,380 according to a report by HHS’s inspector general. The total may exceed 10,000 by now. (Ads by the Pharmaceutical Manufacturers Association indicate they work with 50,000 "researchers.") The Boston Globe has described this evolution:

There are now over 1,200 CROs. The largest, Quantiles Transactional Corporation, broke the one billion dollar revenue mark in 1998, an increase of 39% in one year with an increase in net income of 50%.

POSITIVE DEVICE AND DRUG RESULTS ONLY

One medical writer described the negative reinforcement tactics used by industry to thwart adverse safety data by researchers not yet on the drug or device "team."

Similarly, an article by Dr. Thomas Bodenheimer in the New England Journal of Medicine reports interviews with six researchers who maintain that a company halted publication of or altered their studies. In some cases, researchers were informed that their work would not be funded again, after they reported adverse reactions, to the studied drug. Bodenheimer quotes one researcher, "Companies play hardball. It’s tricky for those who need more money for studies."

An April 14, 2002 Lancet editorial did not mince words about the lethal effects of suppressing adverse safety findings.

Time magazine’s April 22, 2002 cover story on clinical research addressed the concealment of adverse study results.

On February 21, 2002, Dr. Arnold Relman, Professor Emeritus of Social Medicine at the Harvard Medical School, former Editor-in-Chief of the New England Journal of Medicine, and one of the leading critics of financial conflicts in research, spoke to the Canadian Senate about the effects of the commercialization that yields a research system where companies prohibit publishing of an investigator’s adverse safety results, by contract.

New drugs recalled for lethal effects, liver toxicity, heart valve damage, etc. in recent years were not essential therapies. They were for pain, heartburn, weight loss and diabetes - conditions with safe and effective therapies, already on the market. These drugs were aggressively promoted as "breakthrough" therapies but were not. They were however, more lethal than predecessor drugs. (e.g. the April 22, 2002, Time cover story on clinical research refers to "pharmaceutical companies looking for a share of the blockbuster drug market pump[ing] out copycat medicines that no one really needs.") A new drug - backed by misleading safety data and accompanied by aggressive direct to consumer advertising plus incentives (including kickbacks) to MD’s, sells in the U.S. - even if its deadly enough to be recalled. In a year or two, a heavily promoted new drug can yield several billion dollars in sales (in Europe consumers are more skeptical of "new").

Complaints by critical researchers that their work is altered, buried, or distorted by the device and drug industry - or that they are terminated as investigators - are ironic. The industry’s image is built on the benefits of research - presumably conducted to obtain valid data on what helps and what hurts.

DEVICES V. DRUGS

Despite physicians’ concerns about data distortion by what Lancet calls "big pharma," there is at least some FDA oversight of drug research. The FDA does audit over 5% of drug studies at clinical testing sites. However, virtually no device research is audited by the FDA at clinical testing sites. (i.e. no one looks at patient records to see if they match what the researcher reports in the scientific literature about the effects of using the device.)

The current regulatory framework typically provides device investigators complete freedom from FDA investigation, oversight, and regulation. This is so because a loophole in the FDA’s "510-K" approval process grants approval to market a new device prior to presentation of either working models or clinical research data (v. new drugs where data is always required by the FDA). Approximately 97% of medical devices applications are approved through the 510K process. Even the 3% that are approved via a more stringent process, are only sporadically audited. Using the 510-K process, a company typically first obtains approval to market a device based on drawings, then conducts its first clinical study, for promotional purposes, after the FDA grants approval to market the device. (The device can be approved before it exists.) By using "strategy," the company can completely avoid FDA oversight of its initial clinical study of the device. Devices are then marketed using "post approval" clinical studies. The FDA does not audit these studies. (It appears that few - perhaps no new medical devices are marketed without a clinical "study" by a "leading researcher" to present to prospective purchasers showing advantages and/or superiority.) Further, the Hospital’s Institutional Review Board - which is supposed to monitor research - typically does not monitor a post FDA approval surgical device study either (even when the study is the first clinical study ever conducted on the device). As such, the regulatory system permits fabricated device studies for promotional purposes, with virtually no risk of detection - or correction. These studies are device companies’ primary marketing tools. Deterrence of fraud in promotional device studies is more sorely needed than in drugs because fabricated device studies are virtually immune from audit in the current system.

The FDA is generally relegated to trusting data it is provided. It is also overwhelmed, and needs the assistance of Federal prosecutors in finding and deterring device research fraud. As the Washington Monthly reported:

That the FDA needs prosecutors’ help ferreting out device data fraud is demonstrated by the fact that while 72 FDA employees track the post market safety of thousands of drugs and devices that some believe take 100,000 lives per year, over 10,000 inspectors examine airplanes which, in aggregate, cause a five year average of fewer than 700 deaths per year. (Seven airplane inspectors per death. One FDA post market inspector per 1,000+ deaths.) In addition, as the LA Times reported in a Pulitzer prize winning story in 2000, the FDA is increasingly dependent on industry funding to do its job. This creates obvious oversight problems. The FDA needs federal prosecutors’ help (and independence) in finding and prosecuting device data fraud. (e.g. the device described at p. 46 et. seq. has injured an estimated 40,000 patients in a decade including an estimated 1,000-3,000 deaths. Its an optional device. Two companies sell it. One definitely concealed adverse data and the other allegedly used fabricated safety data to market the device.)

TIME FOR ACTION BY LAW ENFORCEMENT

A review of the literature since 1995 on drug and device research integrity, financial conflicts, product recalls, and patient deaths from drugs and devices demonstrates that NIH’s Greg Koski was justified in concluding that "during the last five years [conflicts] may have gotten out of control" - placing the entire research endeavor at risk. When the editor of Lancet concludes that the "notion" that drug and device research still serves medicine is an "erroneous myth," an unprecedented number of drugs are recalled in ten months because research data on safety did not predict what happened in the general population, a single drug causes an estimated 40,000 deaths and an estimated 40,000 more patients are injured/killed from a single elective surgical device, safety data reported by conflicted researchers can legitimately be termed a pressing public health issue. As Dr. Wortman recently told a California newspaper, influential device researchers - who often have concealed equity interests in devices they promote - have "unregulated power." And it’s a power that can lead to injury or death nationwide without accountability or correction, when unaudited safety data is fabricated to promote sales. This battle is between treating MD’s trying to help patients based on real evidence and "leading researchers" who have sold out. How many is unknown, but it appears to be more than suspected. (In the early 90’s, Congressman Dingell’s hearings on research integrity were met with doctors’ claims - but no evidence - that medical research fraud was "vanishingly rare.")

PROMOTION BY RESEARCHERS IS MORE VALUABLE TO INDUSTRY THAN INVENTION

A New York Times investigative report provided rare insight into the value to device companies of prominent researchers. Device researchers who also chaired large cardiology conferences were allocated five times the equity interests by the device company, as were allocated to the inventor of the device. When the Times provided these facts to Doctor John Wasson, a professor of medicine at Dartmouth, he said, "the conflicts are just overwhelming. If you can’t trust the opinion leaders, and worse, the studies themselves, what happens to the profession and what happens to patients." (Times, November 30, 1999) [emphasis supplied] Even the tobacco companies can purchase what they need - signatures of leading scientists.

The income tax system would fail without audits and prosecutions of the largest cheats. There is so much evidence and concern that a substantial portion of drug and device research has lost integrity, with no effective mechanism to reverse the trend, that the most rapid and perhaps the only effective method of deterring fabricated or misleading research to promote product, may be prosecution of those researchers who combine large financial conflicts with large research frauds. Recently obtained evidence indicates that the most substantial frauds in clinical device research and promotion may be three research surgeons (brothers) who have generated published data on over 30 new surgical devices and/or procedures which promote over $10 billion dollars in sales - obtaining personal revenues of up to $500 million in the process.

NEXT: A CASE OF FRAUD