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The New York Times
January 17, 2005
Dispute Puts a Medical Journal Under Fire
Last year was an especially bad one for the pharmaceutical industry, which experienced controversies over how drug studies are disclosed and the implosion of the painkiller Vioxx. Now, as a result of the recent publication of an article about the antidepressant Prozac, it appears that the staid, usually methodical world of medical journals could suffer its own black eye.
On New Year's Day, the British medical journal BMJ published a news article suggesting that "missing" documents from a decade-old lawsuit indicated that Eli Lilly & Company, the maker of Prozac, had minimized data about the drug's risks of causing suicidal or violent behavior.
Within days, the article was cited in hundreds of television and newspaper reports. An outraged Washington lawmaker demanded to know if Lilly had hidden the information from the Food and Drug Administration. While company officials refuted the article's assertions, it was still repeatedly cited. And last Thursday, Lilly spent about $800,000 to run full-page advertisements in 15 major publications to dispute the article.
The incident may prove to be a messy one for the BMJ, which is based in London and owned by the British Medical Association, a professional group. Much of the journal, formerly known as the British Medical Journal, is devoted to research reports about medical issues that are reviewed by experts. But the BMJ, like some other medical journals, also has a separate news section that prints articles like the recent one about Prozac. As it turns out, some of the Eli Lilly documents, which the BMJ said it received from an anonymous source, have been circulating for years. And, Lilly officials said, the BMJ and its reporter declined to provide the company with copies of the documents at issue prior to the article's publication.
The American freelance reporter who wrote the article, Jeanne Lenzer, declined to be interviewed, referring all questions to the BMJ. Officials there did not respond to written questions, but a spokeswoman, Emma Dickinson, said in an e-mail message on Friday that the publication "takes this issue very seriously" and will address Lilly's concerns after reviewing them.
The BMJ, which is considered a leading medical journal, may have little choice. While Lilly has not taken legal action, its lawyers have notified the publication that the company considers the article to be "inaccurate and defamatory," asserting that the records were not missing and that all their relevant data had been previously submitted to the F.D.A. Also, Lilly issued an analysis last week of the 52 pages of records that the BMJ had received, which the company said supported its claims. Lilly said it got the documents from a congressman who received them from the BMJ.
"You put something out on the newswire with the imprimatur of a medical journal and people think it is fact," said Dr. Alan Brier, the chief medical officer of Eli Lilly, which is based in Indianapolis.
The article's appearance follows the recent controversy over whether drug makers adequately disclosed the risks that antidepressants like Prozac posed to pediatric patients. And its comes as a South Carolina teenager faces trial for murder as an adult on charges that he killed his grandparents when he was 12. The teenager, Christopher Pittman, has acknowledged the crime, but his lawyers have based his defense on the argument that he became violent after taking the drug Zoloft, an antidepressant similar to Prozac.
It was in a little-noticed article written by Ms. Lenzer in the Dec. 11 issue of the BMJ about the Pittman case that she first mentioned that the publication had received "a set of documents that mysteriously went missing from a U.S. mass murder case ten years ago."
That article did not go into specifics. But in her article on Jan. 1, Ms. Lenzer wrote that the documents in question were connected to a Prozac-related lawsuit that grew out of a shooting rampage in 1989 by a Kentucky man, Joseph Wesbecker, that left nine people dead, including Mr. Wesbecker.
Lawyers representing the victims sued Lilly, asserting that Mr. Wesbecker's killing spree was caused by Prozac, a drug he had been prescribed just before the crimes. During the 1994 trial of the case, Lilly pointed to Mr. Wesbecker's long history of severe psychological problems and said that Prozac was safe.
To combat those assertions, plaintiffs' lawyers introduced hundreds of Lilly documents. They argued that the records showed that Lilly had fully disclosed to the F.D.A. in the late 1980's the potential of Prozac to produce suicidal thinking or acts of violence, including all the reviews by drug regulators in Germany of the issue at that time. Lilly disputed that.
The jury found in favor of Lilly. But a legal controversy over the trial later erupted when it was revealed that plaintiff lawyers and Lilly lawyers had reached an undisclosed financial deal just before the case went to the jury to effectively settle by agreeing not to appeal the verdict.
A Lilly spokesman, Phil Belt, said that Ms. Lenzer, who lives in Kingston, N.Y., first contacted the company on Dec. 13, a few days after her article about the Pittman case appeared.
Mr. Belt said Ms. Lenzer asked where a published report about the data in a specific 1988 internal Lilly report had appeared. At that time, she also requested an interview with the company's chief executive, Sidney Taurel, to discuss what she described as "missing" Lilly documents, Mr. Belt said.
Mr. Belt said the company told Ms. Lenzer that Lilly needed to see the records at issue before it proceeded. He added that Ms. Lenzer later told Lilly that she could not do so, saying that the source of the documents was anonymous.
As the Christmas and New Year's season approached, Mr. Belt said that Ms. Lenzer told Lilly officials that they could pick up the issue after the holidays.
At some point in December, however, Ms. Lenzer or her editors apparently sent the documents it had received to Congressman Maurice Hinchey, Democrat of New York, and to the F.D.A. And a few days before New Year's, the BMJ distributed Ms. Lenzer's article to other news organizations with the provision they could not write about it until its publication date on Jan. 1 - a practice known as an "embargo."
That article carried the headline, "FDA to Review 'Missing' Drug Company Documents," which caught the attention of other news organizations. Mr. Belt said that when Lilly became aware of the embargoed news release, it tried to reach editors at BMJ but was unsuccessful. Both Ms. Lenzer and the BMJ did not respond to written questions about the publication's interactions with Lilly, including why the documents were not shown to the drug maker.
The only Lilly document specifically mentioned in the BMJ article was a 1988 report that stated that 38 percent of depressed patients taking Prozac during clinical trials experienced side effects like agitation, insomnia and nervousness, a rate twice that of those taking a placebo.
Such side effects, which are sometimes referred to as "activation," reflect the fact that some depressed patients who take Prozac and drugs like it often experience a surge of physical energy well ahead of psychological recovery. Some experts have long expressed concerns that such reactions can be so severe in a few patients that they may ultimately act on suicidal or violent impulses.
For procedural reasons, the 1988 Lilly memo itself was not introduced as evidence in the Wesbecker case, said Nancy Zettler, one of the two plaintiffs' lawyers involved. But Ms. Zettler said that one of her expert witnesses, Dr. Peter Breggin, testified extensively about its contents at that trial.
Ms. Zettler said that she was so perplexed by the BMJ article that she contacted Ms. Lenzer after it appeared. "Her original article made it seem like we had deep-sixed some of this stuff and I was curious," she said.
Both Ms. Zettler and Paul Smith, the other plaintiffs' lawyer in the Wesbecker case, said that Ms. Lenzer did not contact them prior to the article to talk about the records or ask for others from that case.
Another plaintiffs' lawyer who has used Lilly documents in other lawsuits, Arnold Vickery, also said he did not discuss the records with Ms. Lenzer prior to her report. Mr. Vickery and another lawyer are representing Christopher Pittman.
Dr. Breggin has written articles arguing against the use of Prozac and other drugs and has mentioned the 1988 Lilly memo in his writings; he is scheduled to be an expert witness in the Pittman case.
Several pages sent to the BMJ were not produced by Lilly but are photocopies of slides produced by an F.D.A. official who presented them at a 1991 public hearing that reviewed the possible suicide risks of Prozac. After its review, that agency panel decided not to issue any additional warnings.
Ms. Zettler said she still thinks the issue of what Lilly told the F.D.A. in the mid-1980's about Prozac's potential risks is unsettled. But after more than 15 years of the drug's use, numerous lawsuits and public reviews, it may also be largely moot.
As a result of the recent controversy about the potential suicide risks posed by antidepressants to children and teenagers, the F.D.A. last week sent out final new labeling language about those dangers to all makers of such drugs, including Lilly.
A spokeswoman for the agency, which is still reviewing the records sent to BMJ, said that it had not yet found anything new in them. Ms. Dickinson, the publication's spokeswoman, said that it was reviewing Lilly's rebuttal to its article.
But we will do what ever it takes, including legal action, when facts are deliberately omitted, misrepresented and distorted and then willfully repeated to set the record straight.
Shannon Brownlee and Jeanne Lenzer did a smear job on Peter and Dr. Fred Goodwin in Slate ...
www.slate.com/id/2190775/pagenum/all/#page_start
... for a segment on the Infinite Mind, called Prozac Nation Revisited ...
www.lcmedia.com/mind524.htm
The Infinite Mind is an award winning NPR show that has covered a wide variety of topics about the brain and cognition for over a decade with foundation funding, private donation and some corporate contributions directly generated by a production company. Of course none of that information made it into Slate piece. What's more, the piece never challenged the central thesis of the experts, are SSRIs as dangerous as many in the media have made them out to be, i.e., that they cause suicidality and suicides. Rather, as is their wont, they shift the line of attack to who has funded them, as if Goodwin (a friend and board member, something that we have made public for years) who has been ranked as one of the world's leading clinical researchers in depression and manic depression is just some industry tool.
Two can play at that game. Turns out that Lenzer has been on somewhat of a jihad against SSRIs, "reporting" on their dangers as a free lance journalist with the British Medical Journal for several years. What prompted the Slate article was likelly the fact that the Inifinte Mind segment questioned whether people in the media like her and members of Congress hyped up SSRIs dangers to the point that the number of kids taking the drugs declined and in turn suicides went up. That's a point Peter and I made in a Washington TImes article. The fact that we were targets for Lenzer, along with Fred, who has been fearless in speaking out for the safety of SSRIs in no surprise.
Neither is Lenzer's attack since she was a close ally of Peter Breggin, a vehement opponent of SSRIs who has it out for Fred Goodwin. You don't need a financial tie to be biased and Lenzer has lots of reasons to go after Goodwin and Peter. She also has plenty of bias and a track record of twisting the facts. BMJ was forced to retract one of her articles and admit she slipped court documents to trial lawyers (perhaps via Breggin) in an unethical fashion. Here is the BMJ retraction AND apology as it pertains to Lenzer's unethical and sleazy behavior.
"BMJ 2005;330:211 (29 January), doi:10.1136/bmj.330.7485.211-a
Correction and apology, Lenzer, BMJ 330 (7481) 7Correction and apology
Eli Lilly: Correction and apology
An article by Jeanne Lenzer in our 1 January issue (BMJ 2005;330:7) reported that the US Food and Drug Administration was to review confidential Eli Lilly documents that had been sent to the BMJ by an anonymous source.
The article stated that these documents had gone "missing" during a 1994 product liability suit filed against Eli Lilly.
That statement has been the subject of a detailed investigation conducted by the BMJ following a complaint by Eli Lilly. That investigation has revealed that all of the documents supplied to the BMJ that were either Eli Lilly documents or were in the hands of Eli Lilly had in fact been disclosed during the suit.
At the end of the trial, all the documents were preserved by Court Order or were disclosed by Eli Lilly to the plaintiffs' lawyers in related Prozac claims.
The BMJ did not intend to suggest that Eli Lilly caused these documents to go missing. As a result of the investigation, it is clear that these documents did not go missing. The BMJ accepts that Eli Lilly acted properly in relation to the disclosure of these documents in these claims. The BMJ is happy to set the record straight and to apologise to Eli Lilly for this statement, which we now retract, but which we published in good faith.
The same article described Dr Peter Breggin as "the medical witness for the Wesbecker case." He was, in fact, the expert witness for the plaintiffs."Oh, and Jeannie also works for the plaintiff lawyer funded Government Accountability Project. ... no disclosure there.
As for Ms. Brownlee, she is a fellow at the New America Foundation that has funding from the Soros folks and is pushing a VA health system approach on everyone.
Now that's context for you.
Chinese regulators are accusing Baxter of failing to co-operate in an investigation over deaths linked to impurities in blood thinner heparin.
The State Food and Drug Administration,
Denial, as my mother used to say, is more than just a river in Egypt.
Baxter replied: “We have been co-operating with all parties in the heparin situation including SFDA and the Chinese government. We plan to continue co-operating with them to help move the investigation forward. We will seek to understand any concerns to the contrary.”
Here’s the rest of the story, courtesy of the Financial Times:
http://www.ft.com/cms/s/0/3587b9b0-1ba7-11dd-9e58-0000779fd2ac.html
Per the larger issue of “tainted” vs. “counterfeit” ingredients, consider the comments of Robert Parkinson, Baxter’s chief executive, who said that the issue in question “appears to be the target of a deliberate adulteration scheme.”
Translation: Counterfeiting.
There are a lot of issues here that need to be addressed – most notably criminal opportunism.
Consider the Chinese proverb, “Flies never visit an egg that has no crack.”
We must seal the cracks.
In our post-SiCKO, sound-bite-centered politically-charged environment, we’re hearing a lot about the “wonders” of “European-style” healthcare models.
Well, if we’re going to look at Europe – let’s really look. And let’s start with some recent news from London.
Late last week consumer group campaigners won a landmark victory in the fight to overturn a ban on Alzheimer's drugs for tens of thousands of patients.
The Court of Appeal in London said that NICE (the National Institute for Health and Clinical Excellence) the agency that evaluates the cost-effectiveness of drugs -- had acted unfairly by not fully disclosing how it evaluated Alzheimer's drugs.
In 2006, NICE ruled that drugs such as Aricept, Reminyl and Exelon don't benefit some patients enough to be worth their cost and recommended that the state health service pay for the drugs only in patients with moderate rather than mild Alzheimer's disease.
The Court of Appeal decided the process used by the Government's rationing body to ban use of the drugs - which cost only £2.50 a day - was unfair.
The case could pave the way for the drugs to be re-instated for newly diagnosed patients with 'mild' symptoms of the disease.
The three judges yesterday ruled NICE must release a full version of the economic model which it used to produce the guidance restricting access to the drugs.
By refusing to do so, NICE had put those taking part in consultation - including the Alzheimer's Society - at a significant disadvantage in challenging its reliability.
Experts said the ruling could have wider implications because it showed a key part of NICE's work is secretive, undermining confidence in guidance that has led to other drugs being rationed.
Dr Susan Benbow, former chairman of the Faculty of Old Age Psychiatry of the Royal College of Psychiatrists, said: "The next stage should be to overturn the guidance which was not only reached during an unfair process, but is inequitable on grounds of human justice to patients who should have access to these drugs."
The cost of prescribing the drugs to a patient with the early symptoms of Alzheimer's is £2.50 a day, or around £1,000 a year - but the potential savings to taxpayers and families are huge.
Studies show that full-time care for an Alzheimer's patient is £25,000 a year, or around £520 a week.
But the National Institute for Health and Clinical Excellence used a much lower figure of £18,500 - less than £369 a week - for the costs of full-time care when calculating whether the NHS could afford to fund treatment with the drugs.
For some sobering American pharmaco-economic data, have a look at the CMPI report, “Alzheimer’s Disease and Cost-effectiveness Analyses: Ensuring Good Value for Money?
Professor David Wilkinson, a leading old-age psychiatrist, said: "These drugs can stabilise patients for two or three years and it's perfectly possible for those who respond to gain six months or a year living at home.
Professor Wilkinson said that under the ban, some newly diagnosed patients were being told by their doctor to come back in six months' time, by when their symptoms would have got worse and they would be eligible for treatment.
"Doctors have been put in an impossible position - it goes against everything in our medical training,' he added.
If we’re going to look to Europe – then let’s really look. And if we’re going to talk about comparative effectiveness – let’s really talk.
Most notable is the following excerpt -- the importance of individual differences -- which the comparative effectiveness crowd in the US blindly and blithely ignores:
"The new treatment approach is to treat early and aggressively to achieve minimum disease progression and ideally remission, a strategy that achieves the best long-term results. However, there is currently no gold standard to define remission. Progression and response to treatment are extremely variable between patients. A substantial proportion of patients (up to 30%) is not adequately controlled with currently available treatment strategies of non-biological disease-modifying antirheumatic drugs and TNF a inhibitors."
UK, 5/5/2008 - The Lancet has been a longstanding supporter of the National Institute for Health and Clinical Excellence (NICE) in the UK. Its procedures are rigorous, scientifically driven, and publicly accountable. NICE is widely admired by many other western European nations. But consternation and disappointment characterised the reaction by patient groups and the British Society for Rheumatology to NICE's latest judgment. On April 23, NICE rejected an appeal on abatacept for patients with severe rheumatoid arthritis brought by the drug's manufacturer Bristol-Myers Squibb, the British Society for Rheumatology, the Royal College of Physicians, the National Rheumatoid Arthritis Society, and the Royal College of Nursing. The appeal committee upheld NICE's decision of October last year, and the only next possible step is an application to the High Court.
Abatacept is, with rituximab and tocilizumab, one of three new drug classes that have shown clinically significant improvement for the treatment of severe refractory rheumatoid arthritis. Abatacept acts as a selective T-cell co-stimulation modulator, designed to block a key co-stimulatory signal required for T-cell activation, a new approach to halt or reverse the inflammatory process. However, with an incremental cost-effectiveness ratio of about £37?000–£43?000, possibly even higher if different estimates are included in the model, abatacept did not provide cost-effective treatment according to NICE's threshold of £30?000 per quality-adjusted life-year (QALY) gained. Many of these estimates are no more than best guesses based on insufficient or incomplete evidence. The committee stated that “while recognising the innovative nature of the drug, the severity of the disease and the limitations around the use of the HAQ [health assessment questionnaire] in the economic modelling, …abatacept would not be a cost-effective use of NHS [National Health Service] resources for patients in whom rituximab failed or in whom rituximab is contraindicated”.
How does abatacept differ from rituximab? Rituximab, a chimeric human-mouse monoclonal antibody directed at the CD20 antigen expressed on mature B cells and pre-B cells, acts on a different pathway. Like abatacept, rituximab was shown to be effective in patients treated with methotrexate who had not responded adequately to an additional TNF a inhibitor. Again like abatacept, there are no good long-term data and no direct head-to-head trials comparing other strategies with rituximab, yet rituximab was approved in August last year. The simple difference is that rituximab is cheaper. Patients only need two infusions every 6 months compared with 14 infusions of abatacept in the first year and 13 thereafter. The incremental cost-effectiveness ratio of rituximab is estimated as somewhere between £12?000 and £30?000 per QALY gained.
Rheumatoid arthritis is common and debilitating. About 1% of the adult population in developed countries is affected, increasing to 5% for women older than 55 years. About 60% of people are unable to work and are severely restricted in daily activities 10 years after diagnosis. Although progress has been made in understanding the underlying pathogenic mechanisms, the cause of rheumatoid arthritis remains unknown. The new treatment approach is to treat early and aggressively to achieve minimum disease progression and ideally remission, a strategy that achieves the best long-term results. However, there is currently no gold standard to define remission. Progression and response to treatment are extremely variable between patients. A substantial proportion of patients (up to 30%) is not adequately controlled with currently available treatment strategies of non-biological disease-modifying antirheumatic drugs and TNF a inhibitors.
Any new and effective treatment for such a debilitating condition as rheumatoid arthritis should be welcomed with enthusiasm. But NICE is at the sharp end of husbanding NHS resources. It has to balance evidence with cost. And here there is a perilous conflict between its dual clinical and political purpose. There will be occasions when exceptions to strict cost-effectiveness guidelines must be made on clinical grounds. Abatacept is a strong candidate to be such an exception. Worse still, NICE's decision may unwittingly act as a disincentive to industry to develop new medicines in this neglected and poorly understood area. Although NICE will rightly say that it has followed the letter of its cost-effectiveness law, patients and the public may, with justification, feel that it has forgotten the spirit of those same laws—namely, that cost-effectiveness evidence needs to be interpreted with compassion as well as impartial science.
"American children take anti-psychotic medicines at about six times the rate of children in the United Kingdom, according to a comparison based on a new U.K. study. Does it mean U.S. kids are being over-treated? Or that U.K. children are being under-treated? Experts say that's almost beside the point, because use is rising on both sides of the Atlantic. And with scant long-term safety data, it's likely the drugs are being over-prescribed for both U.S. and U.K. children, research suggests. "
Beside the point? I mean, it sort of matters if there is over or under treatment. But then again, Tanner has already concluded that the drugs are over-prescribed. But what does a six times the rate mean?
"In the U.K. study, anti-psychotics were prescribed for 595 children at a rate of less than four per 10,000 children in 1992. By 2005, 2,917 children were prescribed the drugs at a rate of seven per 10,000 — a near-doubling, said lead author Fariz Rani, a researcher at the University of London's pharmacy school."
Tanner seems to be talking just about kids diagnosed with ADHD and autism. And she conveniently ignores the number of kids who take the drugs for the same diseases in the US. She also ignores the fact that extensive study has gone into use of these drugs for treating of certain aspects of both disorders. In the case of anti-psychotics, risperadone has FDA approval for use in treating irritability in children with autism from ages 5-16 which most certainly explains why the study in Pediatrics found most of the increase in use overall associated with Risperdal scrips. But you don't see that information in the Tanner article...No. What you get is the implicit accusation that drug companies are promoting unsafe and off-label use of the product. Disgusting. Misleading. Damaging to parents and kids alike.
news.yahoo.com/s/ap/20080505/ap_on_he_me/psych_drugs_children
Bizzaro non sequitor paragraph in today’s New York Times article on the the Genetic Information Nondiscrimination Act:
“Ultimately unlocking all these genetic secrets will make the whole idea of private health insurance obsolete,” said Karen Pollitz, director of the Health Policy Institute at Georgetown University.
The first is that we need to redesign our healthcare system so that we reward “value rather than volume.” No argument there. It’s also very much in keeping with what Senator McCain is talking about these days.
He then turned his attention to the HHS “efficiency roadmap.” Lots of good initiatives. (I know, there are always a lot of “good initiatives.”) What was missing, however, was how to overcome one of the most significant roadblocks – state lines. Specifically, in addressing a group made up of large employers, the Secretary didn’t discuss insurance deregulation as a strategy towards more affordable, accessible, and patient-centered coverage. This must be a key strategy in the “value vs. volume” proposition.
He spent the lion’s share of his remarks (and productively so) talking about the need for inter-operability of healthcare IT platforms – where HHS has helped to both design and implement some successful programs lead the still nascent national dialogue.
One comment he made is worth repeating for both its wit and honesty. Leavitt quipped that “the wonderful thing about healthcare standards is that there are so many to choose from.”
And may we all live in interesting times.
Credit must also be given to Congressman Dingell, Congresswoman DelLauro and staff for pressing hard for more funding and hiring authority. Sometimes people can work together for the public health.
www.reuters.com/article/latestCrisis/idUSN30551443
"The Gallup-Healthways Well-Being Index asks Americans to evaluate their lives by imagining a "ladder" with steps numbered from 0 to 10, where "0" represents the worst possible life and "10" represents the best possible life. Nationally, 49% of Americans say that they presently stand on steps 7 or higher of the ladder. When asked where they will stand about five years from now, Americans report that they expect to stand on steps 8 or higher. Gallup considers this group of Americans to be "thriving." Thriving Americans' have their basic needs (such as food and shelter) met, and they have higher incomes, are less burdened by disease, report fewer sick days, and have better work environments. While nearly half of Americans fall into this category, the percentage of citizens in the thriving group is down from 60% in 2006.
On the low end of the spectrum, 4% of U.S. residents say they presently stand on steps 0 to 4 of the ladder. When asked where they will stand five years from now, Americans in this group report that they expect to stand on steps 0 to 4 of the ladder, as well. Gallup considers this group of Americans to be "suffering." Suffering Americans report that they have less access to basic needs such as food, shelter, and healthcare. They are also more likely to be burdened by disease, report more sick days, and are more likely to be divorced or widowed."
So how does Gallup arrive at a definition of "struggling?"
"Americans that Gallup does not classify as thriving or suffering are considered to be "struggling." The percentage of U.S. residents who are struggling has increased to 47% from 37% in 2006."Hmmm. Has anyone at Gallup read Goldilocks and The Three Bears? Or is it just that Americans are and always have been a striving culture. Or is it a function of everyone pursuing happiness? In any event, none of it explains the comment by CDC director Julie Gerbeding who equates the state with the misleading factoid that the US health care system ranks 37th in the world/....who is writing HER speeches....
Meanwhile here is the most revealing finding of the survey:
"Americans' reported level of happiness and enjoyment peaked on Easter Sunday, March 23, with New Year's Day coming in a close second. Super Bowl Sunday, Feb. 3, was also among the top 10 days that Americans reported the highest levels of happiness and enjoyment."
To me and Peter, any day the Yankees win is a great day...Looks like we will be struggling or suffering through 2008.
www.gallup.com/poll/106906/Nearly-Many-Americans-Struggling-Thriving.aspx
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
