Thread: SFBC Reportedly Threatened Drug Testers with Deportation

http://www.newsinferno.com/storypages/1 ... 5~002.html

SFBC Reportedly Threatened Drug Testers with Deportation for Disclosing Health Risks in Clinical Trials
Date Published: November 21, 2005
By Steven DiJoseph & Malika Crutchfield

Investigative Report by Bloomberg News is but the Latest Example of Ethical Deterioration in the Field of Medical Research

Bloomberg News is reporting that the largest private drug testing center in North America, SFBC International, threatened to have Latin American immigrant drug-test participants deported for disclosing health risks in clinical trials at the company's Miami facility.

The participants, who requested anonymity, say the SFBC officials isolated at least three drug-trial participants in different rooms in an attempt to coerce them into signing false statements. Chief Executive Arnold Hantman was allegedly among the company officials present.

Two weeks ago, Bloomberg News published a story revealing risks of injuries and death from drug testing. Over 15 scientists, doctors, and government officials said the drug-testing industry inadequately protected participants from injury and death risks. “The story also disclosed conflicts of interest in the drug-testing industry, including a company paid to monitor the safety of participants in some of SFBC's clinical trials that was owned by the wife of an SFBC executive,� according to Bloomberg.

According to the participants in question, Hantman and other officials bullied test participants and threatened to call the U.S. Department of Homeland Security to have participants deported if they did not sign statements denying the claims in the Bloomberg story.

The three men now fear that the company will continue the harassment if their names are published.

SFBC has performed clinical trials on five continents and in at least 25 countries.

SFBC President Lisa Krinsky, referring to the Bloomberg report, said: "Approximately 99 percent of the information that was documented regarding SFBC is a total fabrication, and the remaining 1 percent was entirely misquoted."

But federal officials are beginning to question the ethical standards in the drug-testing industry, which has increasingly shifted from research being carried out at universities and public research centers, to being done primarily by for-profit companies.

"The process which some of these companies are going through to test drugs on human beings is putting in jeopardy the life, and sometimes even taking the life, of some of these people," said U.S. Senate Finance Committee Chairman Charles Grassley, R-Iowa, after the Bloomberg story was published. "I'm going to make sure that the FDA does their job."

The abuses alleged in the Bloomberg report serve to once again call attention to a significant problem facing the public today, namely, the apparent regularity and ease with which scientific research is tampered with, falsified, and manipulated.



Questionable practices engaged in to influence the creation of reports and the conclusions reached reports and studies is one of the most disconcerting and frightening practices occurring in the medical profession. Consider the following events:

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 by 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, was 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 was alleged that Ms. Butkovitz did not make the required contacts and yet claimed that she had on report forms. In one case, she was 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 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.

Clearly, the last place one would expect to see a deterioration of ethical standards is in a field like medical research where the public’s health and wellbeing is involved. It is disturbing to see that this alarming trend is not only continuing but increasing in severity.

http://www.miami.com/mld/miamiherald/13409252.htm

Posted on Thu, Dec. 15, 2005
HEALTHCARESFBC refutes magazine chargesSFBC International attorneys respond to allegations made in a magazine article that the Miami drug-testing company acted improperly.
BY JOHN DORSCHNERjdorschner@herald.com

In a 19-page letter to a U.S. senator scheduled to be released today, two outside counsels hired by SFBC International, the Miami drug-testing company, disputed much of the information in a recent negative magazine article, but said one executive's behavior was ''inappropriate'' in threatening test subjects who talked to reporters.

The letter also recommends Congress adapt a database of persons who volunteer for drug tests so that subjects can't jump from one drug test to another without the testing companies knowing.

Several persons interviewed for the story that ran in the December issue of Bloomberg Markets said they lied to drug testers so that they could enroll in multiple drug studies at the same time, in violation of testing protocols. At present, no database exists so testing companies can check to make sure such violations don't happen.

The subjects are often the poor, trying to earn extra money. Bloomberg reported payments for having experimental drugs pumped into a subject's body can vary from $25 a day to up to $6,900 for a seven-month study.

''While the [Bloomberg] articles are flawed with unsupported allegations, the charges nevertheless raise important issues worthy of the industry's and Congress's attention,'' the letter stated.

The letter, to Sen. Charles E. Grassley (R-Iowa), was prepared by the law firms of Tew Cardenas and Winston & Strawn at the request of SFBC's board after the magazine published a 28-page special report, ``Big Pharma's Shameful Secret: Every year, scores of human test subjects are injured or killed.''

SFBC, the report's primary focus, saw its shares fall more than 20 percent after the article was published on Nov. 2. Grassley, chairman of the Senate finance committee and a crusader on healthcare issues, requested the company respond to the report's criticisms.

While the Bloomberg story did cite cases of deaths and injuries in drug-testing studies, all of them happened at facilities owned by other companies, and the letter states it was unfair to tie the death-and-injury headline to a photo of SFBC's facility on Biscayne Boulevard.

''SFBC's Miami facility has never had a participant death,'' the letter said, and while hundreds of participants have been tested at the facility, only three have claimed injuries in the past three years. Each claim led to a settlement of less than $13,000.

NEPOTISM

Another issue raised by Bloomberg: Southern Institutional Review Board, one of the outside firms that analyzes SFBC testing to make certain it was done properly, was owned by Alison Shamblen, wife of E. Cooper Shamblen, SFBC's vice president of clinical operations.

The letter stated Alison Shamblen was ''considered an administrative person'' and had no voting powers on panels reviewing SFBC studies. It said Cooper Shamblen had no role at SFBC in choosing independent review boards.

That explanation doesn't satisfy Ken Goodman, who runs the bioethics program at the University of Miami. ''This doesn't clear the arm's length test,'' he said Wednesday. 'Can you say, `Well, it's the boss's wife, and you can ignore that'? It's not clear how many degrees of separation there are. Who selects the review boards, all sorts of things.''

The letter by the SFBC counsels noted that, ``as of October 2005, Alison Shamblen is no longer affiliated with Southern IRB.''

Another issue: Bloomberg reported SFBC and similar companies are ''recruiting mills'' using ''poor desperate people,'' many of whom are illegal immigrants.

The letter's response: ``Our review revealed that SFBC requires valid Social Security or tax identification numbers, in order to ensure that its participants are legal United States residents.''

After the article was published, SFBC managers met with four test subjects interviewed by Bloomberg reporters.

In a follow-up story, Bloomberg reported that CEO Arnold Hantman, ''using profanity, said he would call the U.S. Department of Homeland Security to have the participants deported if they didn't sign statements refuting'' the original Bloomberg report.

ILLEGAL IMMIGRANTS

The counsels' letter said Hantman didn't meet with them, but SFBC executives did. They learned that two of the four ''were illegal immigrants who used fraudulent documents to gain entry'' into the SFBC studies.

'Our review reveals that, during these meetings, SFBC personnel, upset that the participants `gamed the system,' raised their voices and made reference to immigration officials. This behavior was inappropriate,'' the letter stated.

Jerry Seifer, vice president of legal affairs, told the outside counsel he made the following statement: ``Well, if you don't have your immigration, don't you know you can get deported? Are you legal or illegal? If you're illegal, immigration is down the street on 79th Street.''
Another manager recalled Seifer making the following statement: 'I have a friend in INS and I can ask my friend and I can deport you guys.' ''

After the threats, at least two of the four signed statements saying they were unaware they were talking to a reporter and refuted allegations in the article.