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Sat, 20 Aug 2005 15:09:22 -0000

[sSRI-Research] " license to kill "

 

 

 

 

Serious ethical lapses in every aspect of the healthcare industry

have suddenly become commonplace as more and more people or companies

entrusted with the health and welfare of the public are being caught

in all types of highly questionable or even criminal conduct.

 

This conduct includes: duping seriously ill patients; withholding

negative information; altering or falsifying records thereby

jeopardizing the health of unsuspecting patients; Medicare fraud;

failing to report medical mistakes and even suspicious deaths;

violating federal and state laws; conducting misleading advertising

campaigns; and misleading federal regulatory agencies.

 

These betrayals of the public trust can be separated into the

following categories:

 

• Financial gain which relies upon: withholding negative information

(research, tests, reports, complaints, etc.); altering or fabricating

records; misleading or false advertising claims; or undue influence

or conflicts of interest.

 

• Fraud committed on Medicare or unsuspecting patient for financial

gain.

 

• Avoidance of liability or preservation of reputation by

questionable, unethical, or criminal conduct.

 

• Questionable research practices involving falsification or

alteration of data, ignoring the use of flawed data, questionable

interpretation of data, plagiarism, ignoring major aspects of rules

governing studies with human subjects, and changing the designs,

methods, or results of a study " in response to pressure from a

funding source. " This conduct can be for financial gain, avoidance of

liability, or advancement of reputation.

 

The Pharmaceutical and Medical Device Industries and Data Manipulation

The pharmaceutical and medical device industries often finds

themselves in conflict of interest situations when dealing with 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.

 

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; © prevented full disclosure about drug trials; (d)

withheld important data from the FDA and the public; and (e) engaged

in misleading, improper, and false advertising campaigns.

 

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.

 

Consider the following:

 

• A study published in the Journal of the American Medical

Association (JAMA) in 2004 found that 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.

 

• Federal law requires that pharmaceutical companies disclose all

trial results to the FDA so that they can be used by doctors and

academic scientists. There is yet to be a law that requires

pharmaceutical companies to disclose this data to the general public.

Some companies such as Eli Lilly have begun to post hundreds of trial

results on the web while other pharmaceutical companies are reluctant

to release that information.

 

Therefore, there is still no comprehensive database or list where the

general public can go to when they want to find out more about any

prescription drug. Patients simply do not have access to critical

information which can be hidden by any company wishing to withhold

unfavorable trial data.

 

• 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.

 

• Merck & Co. is in the midst of a debacle relating to its COX-2

inhibitor, Vioxx. Many of the allegations of wrongdoing on the part

of Merck relate to misrepresentation and suppression of clinical data

and internal reports which disclosed the increased risk of heart

attacks associated with the drug. Eventually, the risk was confirmed

and the Vioxx was withdrawn from the market. Of course, Merck made

billions of dollars from the sale of Vioxx while it was able to be

kept on the market.

 

• 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 been forced to issue 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.

 

Several times each year, the FDA issues warnings to pharmaceutical

manufacturers for a variety of reasons associated with their

advertising claims and marketing approaches. Unsubstantiated or

exaggerated claims of effectiveness, advertising a drug for

unapproved uses, minimizing or omitting information regarding side-

effects, and improperly casting doubt on similar drugs manufactured

by competitors are but some of the ways in which prescriptions drugs

are over-promoted.

 

• 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.

 

• In 1992, the FDA established an accelerated-approval program for

new drugs which requires 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 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

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 has now 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.

 

• Hitachi warned by FDA about serious reporting violations and

problems with respect to its MRI and PET equipment - On July 13, FDA

issued an extensive warning to Hitachi Medical Systems America, Inc.

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.

In March, a 21-year-old college student, Joshua Oukrop, who required

a defibrillator because he suffered from a genetic heart disease,

died while on a spring break bicycling trip. These events prompted an

investigation by the FDA.

 

As the story developed, however, the number of potentially defective

defibrillators still in use reached almost 50,000; the 28,900 with

the electrical problem and another 21,000 which could malfunction due

to a computer memory error. There had been 2 reports of failures

associated with these other models. Neither report involved injury or

death.

 

Then, a third problem came to light with respect to another potential

short-circuit risk associated with two other models. Out of those

16,000 devices, 15 reports of failures had been received including

one involving a death on May 30.

 

As a result, Guidant issued recalls for all of these devices. Many

experts are now questioning a monitoring system which essentially

leaves the question of disclosure, with respect to potential flaws in

such critical medical devices, entirely to the manufacturer.

In the Guidant case, it seems clear that the impending expose? by the

New York Times, instead of 2 deaths and 45 reported failures,

prompted the manufacturer's belated revelations. Attorneys who are

suing Guidant as well as many of their clients see Guidant's long

delay as a damaging admission by the company which they believe must

be held accountable for its actions. None of this, however, even

begins to address the problem of some 50,000 heart patients with

implanted defibrillators being very jittery about their safety since,

if normal heart rhythm is not restored, death will result within

minutes.

 

Fraud

 

Fraud has always been an especially dangerous practice when it

invades the healthcare profession. Insurance fraud, improper Medicare

bills, or the substitution of real treatments with bogus ones are all

examples of fraudulent practices that occur within the healthcare

industry. Sometimes the fraud costs money and sometimes the fraud

injures or kills. Either way, the public suffers for the greed of

others.

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• In Southern California, doctors gathered hundreds of people, many

of whom were recent immigrants, to voluntarily undergo routine

medical procedures such as endoscopies or colonoscopies. Insurers

were then billed tens of thousands of dollars for each routing

procedure, the total amounting to somewhere around $500 million.

Insurers became suspicious when they observed that the patients in

question had traveled hundreds or thousands of miles to undergo such

routine procedures. Twelve Blue Cross and Blue Shield health-

insurance plans sued the health care-clinics, physicians and others

involved in this fraudulent practice. This is one of the first

insurance fraud cases where individual doctors are named.

Perhaps the most disconcerting aspect of this fraud case is that

these patients had to undergo procedures that exposed them to medical

risks. Some of the volunteers received free or discounted cosmetic

surgery while others got cash for their role in this fraudulent

occurrence which is highly illegal with or without insurance fraud.

 

• As is often the case, money is also part of the problem. Simply

stated, no medical facility wants to get rid of a good earner and, as

luck would have it, doctors with disciplinary problems are often

among the top third of moneymakers at their given hospitals. Doctors

who are consistent and plentiful income producers are often praised

for their ability to provide a constant patient stream to the

hospital while actually avoiding punishment for any questionable

practices resulting in preventable medical errors.

 

In this regard, consider the chilling situation that occurred at

Redding Medical Center in California. One particular cardiologist was

single-handedly responsible for making his small, rural hospital one

of the most lucrative business enterprises for its owner, Tenet

Healthcare. Unfortunately, the doctor was only able to do this by

intentionally making false diagnoses of heart-related problems in

order to justify performing hundreds, if not thousands, of

unnecessary procedures and surgeries.

 

While other staff members were suspicious of the goings on at the

hospital, their concerns were dismissed by their superiors until the

scheme was exposed by one patient, a 55-year-old reverend, who sought

a second opinion after he was told he needed emergency triple bypass

surgery. A highly qualified cardiologist was shocked by the diagnosis

and told the patient that his heart was in perfect shape.

 

Federal agents raided the hospital and Tenet was eventually forced to

pay $54 million in penalties for the unnecessary heart procedures.

This, however, does not change the fact that this single doctor was a

staple at the Redding Medical Center for almost two decades and was

being protected by his superiors who were only concerned with the

enormous annual revenue he produced and not the quality or legitimacy

of his practice.

 

• In 2001, chiropractors received almost $285 million in improper

Medicare payments. Medicare is only supposed to cover chiropractic

care when there is a " reasonable chance of correcting a problem or

improving the patient's ability to function. " Yet the majority of the

ineligible payments, totaling almost $186 million, were for routine

maintenance treatments given to many people for the purpose of

maintaining mobility and reducing pain.

 

• A federal grand jury in California recently indicted Orange County

physician Dr. George Kooshian and his assistant, Virgil Opinion, for

intentionally giving AIDS patients lower than the prescribed doses of

medications while billing insurance companies for the cost of full

treatments.

Allegedly, Kooshian ordered Opinion and other staff members to

administer medication at 50% or even 25% of the prescribed dosage. In

some cases, he is even accused of ordering saline or water injections

be given in place of actual medication. An investigation into

Kooshian's offenses did not begin until after Opinion left her job in

2001. At that time, Opinion and a former patient Bryan Noble filed

lawsuits stating that Kooshian charged as much as $7,000 dollars for

treatments of saline. In a 2001 interview with the OC Weekly, Opinion

made the accusations public.

According to U.S. Attorney Jeannie Joseph, the law suits were settled

for an undisclosed amount. Joseph argues that while Kooshian's

actions may not directly have caused deaths, his preying upon

vulnerable and suffering patients caused unnecessary distress for

those who put their care in his hands. She remarks " We can't say with

any certainty that what he did caused anyone's death, but it

certainly affected his patients' quality of life. "

• In what can only be described as a despicable crime, two Canadians,

Michael Reynolds of Toronto and John Armstrong, of Penticton, British

Columbia, have been charged with promoting a worthless cancer

treatment and bilking some 850 cancer patients around the world out

of millions of dollars.

The treatments, which cost as much as $20,000, were marketed through

seminars, brochures, telemarketing, and on the company's website,

which has now been dismantled. The so-called cell-specific cancer

treatment, or " zoetron therapy, " was supposed to treat lung, breast,

prostate, skin, colon, and brain cancer by targeting and eliminating

cancer cells without destroying healthy ones.

Patients were placed in machines that resembled those used for MRIs.

However, Mark Stainsby, acting assistant deputy commissioner with the

Competition Bureau's Ontario branch confirmed that: " We've had a

number of experts look at the equipment, and . . . that machine can't

do any of those kinds of things that they've claimed, "

The former company, called CSCT, was based in Kitchener, Ontario, and

Penticton, with out-patient clinics in the Dominican Republic,

Mexico, Switzerland, and Spain. Authorities estimate that the company

cheated unsuspecting and often desperate cancer patients out of

$12.75 million from August 1996 to February 2003. Some 37 of the

victims of the scam were Canadian. Many of those victimized have

since died.

The two men are each charged with 10 counts of knowingly or

recklessly making representations to the public that were false or

misleading as well one count each for defrauding the public of more

than $5,000. The reports of this disgraceful scheme have prompted

outraged health-care activist groups to speak out. Joel Alleyne,

executive director of the Canadian Health Care Anti-Fraud Association

said: " To have somebody that is doing this at this time of people's

lives, preying on them both financially and . . . offering them false

hope in this way, it's just unconscionable. "

• UnumProvident, which is a giant conglomerate of Unum Life Insurance

Company of America, The Paul Revere Life Insurance Co. and The

Provident Life and Accident Insurance Co., has been repeatedly

accused of wrongfully and systematically denying legitimate claims

for which policyholders should have been covered.

Unum gave excuses to thousands of policyholders simply heard the same

excuses as to why Unum had denied their claims such as allegedly

failing to receive documentation on time and allegedly failing to

receive medical reports to the condition involved was no longer a

covered disability. Unum would also pay far less than a

policyholder's regular income and then tell the policyholders they

were never disabled and threaten that, unless the policy was

surrendered, Unum would sue for all prior payments.

A class-action lawsuit was commenced and charged that UnumProvident

operates " disability denial factories, " wrongly denying disability

claims by its policyholders. Some 2,500 individual policyholders also

filed their own actions against UnumProvident. The lawsuit also

claimed Unum used non-medical personnel to decide which claims to

deny and then used its staff of 100 doctors to create a " paper trail "

justifying the decision.

Last November, UnumProvident, Unum Life Insurance Co., The Paul

Revere Life Insurance Co. and The Provident Life and Accident

Insurance Co. agreed to settle a multi-state investigation affecting

some 215,000 disability insurance claims denied by these companies

since 1997. The settlement requires UnumProvident and its

subsidiaries: (1) to reassess approximately 215,000 claims that

previously had been denied; (2) to completely restructure their claim

handling procedures to ensure objectivity and fairness; and (3) to

pay a $15 million fine.

• The FBI, the Florida Department of Health, and local law

enforcement agencies are investigating allegations that some

storefront clinics in Broward County are paying HIV-positive homeless

people $100 to $300 to undergo expensive and unnecessary medical

tests which the clinics then bill to Medicare for reimbursement.

Medicare officials became aware of this rip-off in 2003 and have been

attempting to end it ever since. The scam begins when clinic

recruiters go to homeless shelters and drug treatment programs in the

Fort Lauderdale area to find poor people who are HIV-positive. Many

of these unfortunate souls already qualify for Medicare.

The recruiters offer these " patients " cash to board vans to travel to

the clinics for injections costing up to $6,000 a session. The

investigation has led to three arrests at the R.A. Medical Center in

Little Havana, Miami-Dade County. In addition, Medicare has blocked

$214.5 million in claims from these clinics and suspended more than

24 providers.

Many of the clinics are still open for business, however. ''I don't

see why this isn't being yelled from the rooftops,'' said Ken

Fountaine, a staff member at Shadowood II, a Fort Lauderdale shelter

for the homeless with HIV/AIDS. ``They're taking advantage of the

lowest of the low. . . . I don't understand why they can't go there

and shut them down right now.''

The Miami Herald has been following this story. Medicare's computers

have been set up to ''red flag'' and block certain providers and

patients connected with this investigation. In the five months these

new programming protocols have been in place, Medicare has stopped

$144.5 million in payments to suspect clinics.

One bogus patient showed the Miami Herald bills that show she was

given injections of immune globulin at $6,000 each. Medicare paid for

at least two at $4,092.96 each. The patient said she and others were

paid $100 each time they visited the clinic.

Many activists and AIDS specialists believe any clinic that pays

people to become patients should be immediately suspect. Some doctors

are even aware that their patients are being paid up to $300 a visit

for one to three unnecessary trips a week to clinics. Desperation

drives many of these homeless people into the scam.

 

Avoidance of Liability

Although avoiding liability is a prime objective of most businesses,

the practice can be quite dangerous when it is committed by

pharmaceutical companies, medical device manufacturers, hospitals, or

doctors. Since all of these entities are extremely concerned with

protecting their reputation and financial wellbeing, they will often

to go great lengths to avoid liability by not reporting adverse

reactions, medical errors, defective equipment, and even suspicious

deaths.

• A recent survey of more than 200 hospital executives in six states

found that the majority believe that mandatory public reporting of

medical errors made in hospitals would lead to fewer errors being

reported and would not improve patient safety.

These executives also claimed that full disclosure of medical errors

made by hospital personnel would only lead to more lawsuits. Some

hospitals have voluntary reporting systems while others have begun to

use a mandatory reporting system.

Advocates of patient-safety have argued that medical professionals

need to be more accountable to the public for their errors. In 1999,

a study at the Institute of Medicine found that between 44,000 and

98,000 patients die in hospitals every year as a result of medical

mistakes.

• In April 2005, the prestigious New York-Presbyterian/Columbia

Hospital admitted that a patient's death in March 2005 it had

originally claimed had not been caused by Legionnaires' disease was,

in fact, caused by that very illness. The hospital was forced to

reverse itself on April 26, 2005 when an autopsy showed that the

disease had indeed led to the death. The hospital also said that the

bacteria associated with the disease were found in the water supply

of two of its buildings even though the water was routinely treated

to kill the bacteria.

 

• On May 24, Guidant Corporation, manufacturers of an internal heart

defibrillator, disclosed for the first time that it had waited three

years before admitting it had been aware of the electrical problem

that had caused some 28 of these defibrillators to malfunction. At

least two people died as a result of the defects and tens of

thousands more remain at risk by keeping these flawed products which

should have been pulled from the market as soon as Guidant became

aware of the danger.

 

• In the last decade, 84% of Health Maintenance Organizations (HMOs)

and 60% of hospitals failed to report medical errors to the

government, allowing many health care professionals to literally get

away with murder. Many experts see this disregard of reporting

requirements as being as close to having a " license to kill " as you

can come without being James Bond.

 

Consider the recent case of Charles Cullen, a registered nurse who

may have killed as many as 40 patients at 10 hospitals in New Jersey

and Pennsylvania over the course of 16 years. Although Mr. Cullen was

investigated on a number of occasions with respect to misusing

potentially lethal drugs and was fired or allowed to resign from a

number of hospitals, he was permitted to " hopscotch " from hospital to

hospital without the slightest difficulty.

 

Questionable Research

 

Another major problem facing the public today is the apparent

regularity and ease with which scientific research is tampered with,

falsified, and manipulated. Pharmaceutical companies have also

engaged in highly questionable practices in order to influence the

creation of and conclusions reached in reports and studies involving

their own (or even competitor's) products. This is by far one of the

most disconcerting and frightening practices occurring in the medical

profession.

 

• Chester Douglass, a professor at the Harvard School of Dental

Medicine was accused of covering up data that suggested a link

between fluoridated tap water and osteosarcoma, a rare form of bone

cancer, in adolescent boys. He is currently being investigated for

claiming that there is no correlation between fluoride and

osteosarcoma when previous research and data suggests otherwise.

 

In fact, his own doctoral student came forward with data from

Douglass's study which concluded that: " Among males, exposure to

fluoride at or above the target level was associated with an

increased risk of developing osteosarcoma. The association was most

apparent between ages 5-10 with a peak at six to eight years of age. "

Douglass' attempt to falsify and cover-up his data is an incredible

breach of the public trust. In addition, Douglass was editing a

newsletter funded by Colgate-Palmolive Co. which creates a serious

conflict of interest since Colgate-Palmolive manufactures toothpaste

with fluoride.

 

• In 1996, Dr. Andrew Friedman was caught faking data in some of his

studies that had been published in medical journals. Investigators

found that he had been making up information relating to hormonal

treatment for gynecological conditions and this information had

passed through peer reviews to become published data. He agreed to be

excluded from working on federally funded research for three years.

 

• This past year, Eric Poehlman, a professor at the University Of

Vermont College Of Medicine, was charged with falsifying research

data on issues like menopause, aging, and hormone supplements in

order to receive millions of dollars in grant money from the federal

government.

 

• In November 2004, Dr. Ali Sultan was discovered to have plagiarized

tests and data in his malaria study but substituting results from one

type of malaria for another. When charged, he placed all the blame on

a postdoctoral student. He later resigned and became a faculty member

at the Cornell Medical College in Qatar.

 

• Anne Butkovitz, a coordinator at a pediatric practice involved in

an FDA approved clinical study, has been charged with falsifying data

with respect to follow up contact information she was supposed to

obtain directly from the parents of children vaccinated with an

experimental rotavirus vaccine. Rotavirus causes severe diarrhea in

infants. The purpose of the follow-ups was to determine if there had

been any serious adverse experiences (SAEs).

 

It is alleged that Ms. Butkovitz did not make the required contacts

and yet claimed that she had on report forms. In one case, she is

accused of having actually falsified information with respect to the

SAEs of a patient enrolled in the clinical study. As a result of Ms.

Butkovitz's actions, the pharmaceutical company involved removed the

pediatric practice she was employed by from the study and disregarded

the data it had generated.

 

• A 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) is conducting an internal

review with respect to consulting payments from pharmaceutical

companies to scientists employed by the agency. Of the sample, more

than half (44 of 81) admitted to conduct which violated one or more

NIH rules. Of those, 36 are still employed by the agency and were

referred for possible disciplinary action. Nine of those 36 have also

been 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 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.

 

Conclusion

 

The above examples of unethical, dangerous, and criminal conduct,

although extensive, only tell a small part of the story. Many more

similar situations have occurred and are presently occurring. Many

more will never come to light.

 

The public has suffered and continues to suffer from this complete

breakdown in ethical and moral standards throughout the healthcare

field. Each act of wrongdoing either costs members of the public vast

sums of money or threatens their very lives.

 

Whether for financial gain, avoidance of liability, or advancement of

reputation, none of this outrageous conduct can be justified in the

slightest. In the end, this behavior is no different than the

highwaymen of old demanding " your money or your life. "

 

Please contact Parker & Waichman for a free and thorough case

evaluation at: http://www.yourlawyer.com/contact/newcase.htm.

 

 

 

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Clients' Rights

 

Please note that you are not considered a client until you have

signed a retainer agreement and your case has been accepted by us.

 

 

 

 

 

 

 

 

 

Drug-Free School Zone? Just Say NO to Prozac for Children.

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