Also, a series of letters to the editor of the NEJM brought up similar concerns, plus additional flaws, e.g., although the I-ELCAP study reported 10-year disease specific survival, it only followed patients for a median of 40 months, and less than one-fifth of subjects were followed for five years or more. A response by lead author Henschke and two other authors failed to reassure. It first seemed to simply deny the importance of lead-time bias,
Screening for cancer is supposed to provide for lead time in diagnosis and treatment. A bias is introduced when one compares relatively short-term survival rates as of diagnosis to assess the effectiveness of treatment with lead time relative to treatment without lead time. We did not do this.
Berg and Aberle remark that our study had no comparison group, but unlike interventional research, diagnostic research does not inherently require a comparison, much less a comparison group. The attainable frequency of diagnoses of stage I tumors can be assessed only in the framework of screening, and our principal diagnostic result was the 85% frequency of diagnoses of clinical stage I tumors among all diagnoses. The principal interventional result was the 92% cause-specific 10-year survival rate after prompt treatment of stage I tumors. The relevant comparison group would consist of patients who received early diagnoses but were treated late, principally to learn about the timing of deaths from lung cancer.
The leaders of a research consortium that advocates computed tomography scanning to detect early-stage lung cancer have built an estate of 27 patent applications worldwide covering technologies and methods of screening.
According to publicly available databases, the leaders of the International
Early Lung Cancer Action Project are listed as inventors on patent applications
and one issued U.S. patent that cover innovations in lung cancer screening,
from clinical trial methodology, to software for interpretation of scans, to
technology of biopsy needles.
The first of these patent applications was submitted on April 11, 2000. In the U.S., group leaders are listed as inventors on one patent and 10 published applications. At least one of the inventions has been licensed by General Electric, a maker of CT scanners, and, in another instance, patent rights were reportedly exchanged for stock of a start-up company that markets lung biopsy devices.
Disclosure statements that accompanied the publications by the group�s leaders didn�t reflect these activities as potential conflict of interest, a literature
search shows.
Both GE and Cornell declined to disclose the details of a licensing agreement covering Henschke�s and Yankelevitz�s inventions.
'We do have a license agreement with the Cornell Research Foundation for certain CT lung cancer patents,' Corey Miller, a spokesman for GE Healthcare Americas,
said to The Cancer Letter.
'The researchers�Henschke and Yankelevitz� have received some royalty payments from GE for a computer algorithm equation that they developed to detect lung cancer on diagnostic scans,' Miller said. 'That is, as far as I know, the extent of our relationship with those two.'
As they spar with skeptics, I-ELCAP scientists work closely with LCA, a group that advocates for screening former and current smokers in accordance with I-ELCAP protocols.
It comes after the drugs regulator announced GlaxoSmithKline would not face criminal proceedings over claims it withheld information on Seroxat.
But they warned GSK should have been quicker to raise the alarm on the risk of suicidal behaviour associated with the antidepressant in the under-18s.
GSK has rejected claims it improperly withheld drug-trial information.
The Medicines and Healthcare products Regulatory Agency (MHRA) received data from clinical trials in May 2003 showing that patients under 18 had a higher risk of suicidal behaviour if they were treated with Seroxat than if they received a placebo.
Data also showed that Seroxat was not effective for treating depression in children and adolescents.
But Professor Kent Woods, MHRA chief executive said they were disappointed GSK had not given them information earlier and that drugs firms had an "ethical responsibility".
"I remain concerned that GSK could and should have reported this information earlier than they did.
"All companies have a responsibility to patients, and should report any adverse data signals to us as soon as they discover them.
Health minister Dawn Primarolo said the government would take immediate steps to secure a strengthening of the law in the UK and Europe.
She also said they wanted to make it clear to all pharmaceutical companies that, "notwithstanding the limitations that may exist in the law, they should disclose any information they have that would have a bearing on the protection of health".
It is totally unacceptable to hear that, when information can be made available at speed, young people may have taken their own lives due to a lack of transparency by a pharmaceutical company.
I really feel there is an ethical obligation that pharmaceutical companies ought to recognise and it seems to have been lost. Twenty years ago I was a prescribing doctor and I took it for granted that if there was information relevant to the drug I was going to prescribe, then it would be available. We're talking about something which has direct relevance to health and safety.
New York City�s new rules for menu labels at chain restaurants have set off a food fight among the nation�s obesity experts.
Most support the theory of the city�s health commissioner that forcing chain restaurants to list the calories alongside menu items � flagging that a Double Whopper With Cheese has 990 calories, for example � will make patrons think twice about ordering one. The rules are set to take effect at the end of March.
There is a countertheory, however, set forth by Dr. David B. Allison, the incoming president of the Obesity Society, a leading organization of obesity doctors and scientists. An affidavit he recently submitted to the United States District Court for the Southern District of New York has ignited a controversy within his organization.
In the filing, Dr. Allison argues that the new rules could backfire � whether by adding to the forbidden-fruit allure of high-calorie foods or by sending patrons away hungry enough that they will later gorge themselves even more.
It might be only a scientific debate among nutrition experts, except for the fact that Dr. Allison was paid to write the document on behalf of the New York State Restaurant Association, which is suing to block the new rules.
Dr. Allison�s role in the debate has angered some members of the Obesity Society, setting off an e-mail fury since word of his court filing began to circulate. Some have pointed to Dr. Allison�s other industry ties, which have included advisory roles for Coca-Cola, Kraft Foods and Frito-Lay.
Many of the group�s 1,800 members are �completely mad that a president-elect of the Obesity Society, an organization that cares about obesity and cares about healthy eating, wants to hold back information from people that helps them make healthy choices,� said Dr. Barry M. Popkin, a member of the organization, who is director of the Interdisciplinary Obesity Center at the University of North Carolina, Chapel Hill.
Dr. Allison, a professor of biostatistics and nutrition at the University of Alabama, Birmingham, is scheduled to start a one-year term as president of the Obesity Society in October. He has defended his affidavit. In a telephone interview, he said he did not take a position for or against menu labeling in the document but merely presented the scientific evidence that the labeling might deter over-eating but might not and, in fact, might be harmful.
He also defended his work for the restaurant industry, but would not disclose how much he was paid for his efforts.
�I�m happy to be involved in the pursuit for truth,� Dr. Allison said. �Sometimes, when I�m involved in the pursuit for truth, I�m hired by the Federal Trade Commission. Sometimes I help them. Sometimes I help a group like the restaurant industry. I�m honored that people think my opinion is sufficiently valued and expert.�
The executive vice president for the restaurant association�s metropolitan New York chapters, E. Charles Hunt, said that Dr. Allison was retained by the association�s lawyers. �Obviously, a lot of it was in favor of our position,� Mr. Hunt said, �although he didn�t come right out and say that.�
The relationship between academic researchers and industry is a front-burner issue in many fields. Several congressional inquiries are looking at drug-firm support for the American College of Cardiology, the national cardiology group, and the American Heart Association.
Compared with those groups, the Obesity Society, based in Silver Spring, Md., would seem like a tiny outpost with its $2.1 million budget. But the group's 1,800 members include many influential researchers, physicians and dietitians.
The society relies heavily on industry money, raising about $1 million in the last year from various companies, said Morgan Downey, the group's executive vice president. The biggest corporate donors were drugmakers sanofi aventis, GlaxoSmithKline and Allergan as well as the health-care conglomerate Covidien, he said.
About $230,000 of the corporate money funded a conference in September for health advisers to presidential candidates, Downey said.
A dispute over food industry influence has resulted in the resignation of the incoming president of the Obesity Society.
Dr. David B. Allison, who was to take over the society, a national group of obesity doctors and researchers later this year, submitted his resignation from that position on Friday.
Two cardiologists yesterday admitted signing on to high-paying, no-show jobs at the state's medical university in return for funneling patients to the school's troubled heart surgery program.
As part of the kickback scheme, the two were hired as clinical assistant professors at the University of Medicine and Dentistry of New Jersey, despite having no research credentials. They gave no lectures, taught no classes and acknowledged that they essentially did nothing more than refer patients for cardiac procedures while receiving hundreds of thousands of dollars in salary over three years.
The doctors -- Bakul Desai, 52, of Livingston and Laxmipathi Garipalli, 59, of Colts Neck -- are cooperating with the U.S. Attorney's Office and the FBI in a two-year criminal investigation that so far has implicated more than a dozen other part-time cardiologists and several top UMDNJ administrators. The scheme was hatched as part of an increasingly desperate effort to beef up a failing cardiac surgery program then on state probation, according to court records and reports by a federal monitor.
No university officials or any other physicians have been charged, although UMDNJ's chairman of medicine was forced to step down after the initial revelations became public.
In proceedings yesterday before U.S. District Judge Stanley R. Chesler in Newark, the doctors pleaded guilty to embezzling approximately $840,000 in payments from the university. The physicians stood quietly, answering questions with simple 'Yes' or 'No' answers. Both face possible jail time and suspension or revocation of their medical licenses.
U.S. Attorney Christopher Christie said others will be held accountable.
'UMDNJ has a culpable role in all of this,' Christie said. 'Don't take from these two guilty pleas today (the idea) that the institution itself is off the hook, because I will say quite clearly it is not.'
A university spokeswoman said UMDNJ and its board have 'worked aggressively' to restructure and reform the community cardiology program since concerns were first raised in 2006, including a reduction in the number of community cardiologists and changes in salaries and reporting requirements.
Desai and Garipalli should have known from the start that they were taking money for doing nothing, Christie said.
'They continued to do nothing and they continued to get paid in what is a classic New Jersey no-show government job scam,' Christie said during a news conference afterward. 'Extraordinary fraud and waste and abuse and illegality that was occurring with public money at UMDNJ.'
Harvard Medical School professor Douglas P. Kiel is facing a lawsuit because of an article he published in the July 2007 issue of the Journal of American Medicine (JAMA).
In the study, Kiel, a gerontologist, said that hip protectors are not effective in preventing injuries among elderly patients, a claim challenged by HipSaver, a popular hip protector manufacturer, in a suit filed in Norfolk Superior Court on Feb. 15.
HipSaver�s president, Edward L. Goodwin, said in an interview that it was scientifically inaccurate for the conclusions of Kiel�s study to be applied to hip protectors in general.
Robert L. Hernandez, who is representing HipSaver, described Kiel�s article as 'disparaging' and 'grandiose.'
In summary, this large multicenter clinical trial failed to demonstrate a protective effect of a hip protector on hip fracture incidence in nursing home residents despite high adherence, confirming the growing body of evidence that hip protectors are not effective in nursing home populations.
These results add to the increasing body of evidence that hip protectors, as currently designed, are not effective for preventing hip fracture among nursing home residents.
Any written or oral statement made to, or in connection with, a governmental proceeding is protected under the statute. In addition, any statement that is reasonably likely to encourage review of an issue by the government or enlist public participation is protected under the statute. Other important provisions of the statute include: (1) a special motion to dismiss; (2) an expedited review of the special motion to dismiss; (3) the government may defend or support the defendant in the special motion to dismiss; (4) all discovery is stayed upon the filing of the special motion to dismiss; (5) the burden shifts to the plaintiff to prove the statements were not protected by the statute; and (6) costs and reasonable attorneys� fees shall be awarded to a victim prevailing on the motion to dismiss.
Four makers of artificial hips and knees paid doctors more than $800 million in royalties and fees in four years to influence their choice of implants, a U.S. investigator told Congress.
The unidentified companies control about three-quarters of the $9.4 billion worldwide market for hips and knees, said Gregory E. Demske, an assistant inspector general at the Health and Human Services Department, at a hearing yesterday of the Senate Special Committee on Aging.
'Illegitimate' payments, the extent of which is unknown, influence orthopedic surgeons' medical judgment and are so common that it will be difficult to eliminate the practice, Demske and other witnesses said. The fees have enriched doctors and distorted the market by bolstering sales of lower-quality devices, they said.
'Industry and physicians are equally culpable,' said Sen. Herb Kohl (D-Wis.), chairman of the panel. 'Some physicians make it known to the companies that they will be loyal to the highest bidder. Where does the patient's well-being fit into the equation?'
It's clear the device companies went too far, said Chad Phipps, Zimmer's general counsel.
'In hindsight it now appears that as the industry expanded to meet patient needs, the use of consultants may have been excessive at times,' Phipps told the committee.
Wine-tasting outings to California's Napa Valley. Ski trips to Colorado. Tickets to sporting events. Gourmet meals at swanky restaurants. Forays to 'adult entertainment' clubs. Fat checks for what some see as questionable work.
Maybe I shouldn't be amazed that this story has provoked so little response, much less outrage. Even though some academic orthopedists were getting literally millions of dollars a year (see this post), very few seem worried that such fabulous payments might have had some influence on their clinical decisions, on what they taught their students or colleagues, or on their research.
In some cases, a company sales representative would spend one or two hours in an operating room watching a surgeon implant his company's device. The company would then pay the doctor for eight to 10 hours of 'training' services, according to findings that government investigators shared with the committee.
