HHS encourages obesity research
A new study released by the Centers for Disease Control and Prevention shows that deaths due to poor diet and physical inactivity rose by 33% over the past decade and soon may overtake tobacco as the leading preventable cause of death.
In an effort to deal with the growing problem of obesity in this country, HHS Secretary Tommy G. Thompson announced a new national education campaign and a new NIH research agenda.
The NIH strategy will intensify research to better understand, prevent and treat obesity through:
- behavioral and environmental approaches to modifying lifestyle;
- pharmacologic, surgical, and other medical approaches;
- breaking the link between obesity and diseases such as Type 2 diabetes, heart disease and some forms of cancer.
The draft strategic plan, available at http://obesityresearch.nih.gov, is open for public comment until April 2, 2006.
Current year NIH funding for obesity research is $400.1 million, up from $378.6 million in fiscal year 2003. The budget request for fiscal year 2005 is $440.3 million, a 10% increase from the current year.
NIH finalizes new ethics guidelines
Pulling back slightly from an earlier plan, NIH last week unveiled final conflict of interest regulations on its employees, which turned out to be less restrictive than those first enacted six months ago.
The new restrictions vary, depending on the employee’s role at the public health agency. For example, senior management and others who play roles in research decisions must meet a higher standard of disclosure and divestiture than those who don’t. Such a concession, which is less limiting than rules put in place in February, reflects thinking that NIH employees must be allowed interaction with professional associations, participation in public health activities and genuine teaching opportunities to advance science and keep on the cutting edge of research.
"Our research should be based on scientific evidence that is not influenced by any other factors," NIH director Elias Zerhouni said during a conference call. "The trust of the public and the ability for us to provide scientific advice that’s untainted is the No. 1 goal of all of our efforts."
The final rules still prohibit outside consulting by NIH staff to substantially affected organizations, such as pharmaceutical, biotechnology or medical device manufacturing companies, health care providers or insurers and supported research institutions.
But a number of caveats are built into the remainder of the guidelines, based largely on employee status.
All senior employees, a group of about 200 that includes Zerhouni, the heads of each institute and others with decision-making responsibilities, must divest all $15,000-plus holdings per company in organizations that do business with the NIH. That rule also applies to their spouses and minor children. Other employees also could be required to divest if, after review, a potential conflict resulting from their holdings or those of their spouses and minor children would impede their ability to do their government job.
Outside monetary awards will continue to be contingent upon prior approval and be limited to awards that are determined through a pre-screening process. The regulations will bar senior employees from receiving cash components of such awards offered by donors who have matters pending under their official responsibility.
Employees who file either public or confidential financial disclosure reports, and those nonfilers who serve as clinical investigators identified on an NIH clinical study, are required to report their interests in organizations that do business with the NIH, as well as those of their spouse and minor children, and to indicate the amount held in such investments.
Lastly, to facilitate academic and scientific interactions, the final regulations will allow outside activities with professional or scientific organizations, service on data and safety monitoring boards, lectures and scientific grant review, as well as maintaining current provisions that permit NIH scientists to engage in compensated academic outside activities, such as teaching courses at universities, writing general textbooks, performing scientific journal reviews or editing and providing general lectures as part of continuing professional education programs. NIH scientists also can engage in the practice of medicine and other health professions with prior approval and in accordance with existing rules.
Zerhouni stressed that the final guidelines reflect an effort aimed at "our ability to continue to attract and retain the best scientists and staff."
The regulations were developed by the Department of Health and Human Services, in close collaboration with NIH, and with the concurrence of the Office of Government Ethics, the federal agency that prescribes executive branchwide ethics standards. The rules also follow comments about the interim ethics regulation submitted by NIH staff, the public and scientific organizations.
"We’ve done what we said we would do, and that is that we would listen and reach at the end what is the right way to serve the public," said Zerhouni. "That’s to have a set of rules that absolutely and positively protect the integrity of the agency, while at the same time not imposing burdens that are not necessary to maintain the mission of the agency."
The NIH is made of 27 institutes and centers and is a component of the U.S. Department of Health and Human Services.
Congress calls for probe on trial leaks
News that clinical trial investigators have been leaking study data to Wall Street traders has prompted a congressional call for a Securities and Exchange Commission investigation into the practice, though many who see it as commonplace have written it off as part of the game.
Sen. Chuck Grassley (R-IA), the chairman of the Senate Finance Committee, expressed shock at what allegedly has become a routine method of profiteering for trial investigators and their stock-selling cohorts. The former are paid for their inside scoops, which critics say compromises their confidentiality agreements by giving trends on ongoing studies that lead to early outcome projections, while the latter earn on trades triggered by such tips.
"These biotech stocks are generally cheaply priced and highly speculative," said Kerry Fields, an associate professor at the University of Southern California’s Marshall School of Business in Los Angeles. "Due to the nature of the stock, it encourages the use of this insider information. It’s the modern gold rush."
He described a system that has developed in which pressures to achieve top investment results have driven traders to push ethical boundaries in seeking clinical trial disclosures in an effort to forecast stock activity.
Details of the practice initially were published earlier this week by the Seattle Times reported more than two dozen cases in which doctors had provided ongoing drug research data to the Street — a practice know as channel check. While the report noted instances in which doctors are polled directly by securities firms, oftentimes the two parties are linked by way of third-party businesses that set up such relationships. Traders use information gleaned from multiple physicians to triangulate opinions on the prospects of a particular product to get a better handle on a business. Also, the drug companies themselves sometimes put buy- and sell-side analysts in touch with clinical trial investigators.
All sides have defended their actions, noting that such dealings operate outside federal securities regulations because existing laws categorize clinical trial investigators as experts, not insiders. Instead, that definition currently encompasses company directors, officers, employees and controlling shareholders.
"It’s highly unethical," commented Fields, who frequently comments on business ethics to professional organizations outside the classroom. "Politicians should urge the SEC and state regulators to declare this to be a true breach of fiduciary duties and liability for insider information."
He argued that experts involved in research and development projects for publicly traded companies should be held to a higher standard, that of an insider. The SEC’s web site labels insider trading as "buying or selling a security, in breach of a fiduciary duty or other relationship of trust and confidence, while in possession of material, nonpublic information about the security. Insider trading violations may also include tipping such information, securities trading by the person tipped and securities trading by those who misappropriate such information."
In the past, Fields said courts have ruled that experts are not considered insiders to preserve their independent contractor status, an exception that has allowed clinical trial investigators to operate in consultation with traders. But obviously that gray area has become murky.
Fields said it is routine for those who overstep ethical boundaries in the business world to rationalize their actions, claiming that by only providing clues at a certain time in a clinical study, they are not giving absolutes. That justifies the practice in their eyes.
"But in truth," he said, "it’s a complete dismissal of their ethical obligations, aside from their legal ones."
And Fields said the problem has rested on the shoulders of such clinical trial investigators, who have chosen to act in favor of taking a few carrots dangled by stock traders.
"Only if we impose civil liability on those experts, with insider trading liability, can we get rid of the problem," he said.
That could happen, analysts acknowledged, but the financial community would likely adapt to any restrictions. They said fund managers would continue to find a way to forecast good investment decisions for their clients — that’s their business.
Angry jurors hand down big award
In August, a jury handed down the first verdict against Merck & Co. Inc. related to Vioxx, its painkiller pulled from the market in 2004 due to safety concerns. The award was a whopping $235.4 million to plaintiff Carol Ernst.
But what might be more alarming for drug makers than the amount is the attitude of the jurors. Derrick Chizer, a juror in the case, told reporters that the award was a "message" to pharmaceutical firms. "Respect us," he said.
Ernst herself called the verdict a "wake-up call" for big pharma. It’s been an especially rude awakening for Merck, which faces more than 4,000 cases related to Vioxx and its link to heart attacks. Whitehouse Station, NJ-based Merck plans to appeal, but what kind of shape the company will be in when it all settles out is up for debate.
The disrespect jurors felt highlights just how much trouble the pharmaceutical industry is in. Once considered makers of life-saving and curative drugs, big pharma these days is seen as a collection of cutthroat businesses, ruthlessly chasing their bottom lines at the expense of public safety.
"This is an industry, which, quite frankly, has a poor reputation in the public’s viewpoint," Peter Claude, a partner at PricewaterhouseCoopers LLP, told BioWorld Today.
PricewaterhouseCoopers of New York City is putting together a series of reports on the public’s impression of big pharma and the life sciences industry. Their first publication, "Recapturing the Vision: Integrity Driven Performance in the Pharmaceutical Industry," includes a graph by Harris Interactive Survey, which showed that in 1997, nearly 80% of people questioned about pharmaceutical companies thought they were doing a good job serving their customers.
By 2004, that had fallen to slightly more than 40%, placing it well below computer hardware companies and car manufacturers. It still ranked above oil companies and the tobacco industry, though not by much — those industries hovered around 31% approval in 2004.
The angry Merck jurors bring forth memories of the big tobacco verdict in 2000 — an award of $145 billion to members of a class-action suit. Jurors then were seething, too, over an industry that hid safety data in order to better sell its products. But Claude said the analogy between tobacco and pharma is wrong, no matter what the public thinks.
"It’s an [incorrect] reference, because the issues surrounding tobacco have been known for years," and because smoking is a choice, he said. "With a pharmaceutical product, there’s an assumption, and it’s unfair, that everything taken is safe because it’s been cleared by the FDA."
But that isn’t the case — all drugs carry side effects, and when a drug is taken by hundreds of thousands of people, those side effects will show up. That doesn’t mean the drug provided no benefit to everyone else, so "any betrayal the public might be thinking is totally unwarranted," Claude said.
Still, unwarranted or not, a big tobacco-like backlash is "likely to occur," if pharma doesn’t publicly relate what good it provides, concluded Brian Riewerts, also a partner at PWC.
A new study released by the Centers for Disease Control and Prevention shows that deaths due to poor diet and physical inactivity rose by 33% over the past decade and soon may overtake tobacco as the leading preventable cause of death.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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