Folks who followed Michael Jordan's rise to basketball prominence have no trouble recalling his breakthrough moment: It was his sideways-moving jump shot from the top of the key over Craig Ehlo that sank the Cleveland Cavaliers in game 5 of a first round NBA playoff series in 1987. This poster shot has taken on iconic status.
Tonight, Lebron James danced through the key to hit the winning shot in game 3 -- always the crucial game in a 7-game set tied 1-1 -- to lift the visiting Cleveland Cavaliers over the Washington Wizards. It was his 40th and 41st points of the night, the most ever by a visiting player in his first NBA playoff game on the road.
But I doubt you will ever see it on television, the way we see Jordan's shot over and over again. Why? James walked.
This just out from Rep. Henry Waxman's (D-CA) office:
Rep. Waxman issued a Flash Report examining data released by the State Department and National Counterterrorism Center that shows that the number of reported global terrorism incidents has increased exponentially in the three years since the United States invaded Iraq--an increase of over 5,000% in the number of terrorist attacks and over 2,000% in the number of deaths in three years.The Administration claims that the 2005 data is not comparable with data from previous years because the rise in attacks is due to increased surveillance and better methodology. These are the same arguments the Administration made in 2003, when attacks rose to a 20-year high, and in 2004, when the number of attacks tripled in a single year.
When preparing this year's report, the Administration consulted with global terrorism experts who recommended that the Administration release data that could be compared to previous years. Professor David Laitin of Stanford University recommended that if the Administration changed its methodology, it should "recalibrate" data from previous years so "we do not lose a sense of the time trends." Not only did the Administration reject this recommendation, but officials denied the recommendation was ever made.
In response to the Administration's actions, Rep. Waxman stated: "For the third year in a row, the Bush Administration is playing games with the numbers to hide the truth: global terrorism has skyrocketed since the invasion of Iraq."
Researchers who need access to the Wisconsin stem cell lines (among the few the Bush Administration allows federally-funded researchers to use) are running into problems with the owners -- the Wisconsin Alumni Research Foundation (WARF).
WARF, which dates from the 1920s and is the nation's oldest university-based technology transfer organization, owns Dr. James Thomson's seminal patents on deriving stem cells from human embryos. WARF is charging academic researchers $5,000 and commercial firms $100,000 to use his original lines. Moreover, most medical technologies that use stem cells will have to license the WARF patents.
But, according to the latest Technology Review, WARF is placing onerous restrictions on its licensees:
The (WARF) license for the University of California, for example, permits scientists to use only a small number of embryonic stem cell lines. And the license granted to the Howard Hughes Medical Institute, a nonprofit medical research organization that funds scientists across the nation, prohibits scientists from accepting funding from or collaborating with commercial companies unless the company has a commercial license from WARF. (Some companies have chosen not to take a license because of the cost.) That could make it difficult for academics to partner with companies to develop their discoveries into products or therapies.
WARF denies it stands in the way of stem cell research, pointing to the scores of licenses issued to both firms and academic researchers.
Food and Drug Administration officials said they will make some subtle shifts in their proposed labeling guidelines for blood pressure pills. But at this morning's meeting of the Cardiovascular and Renal Drugs Advisory Committee, they indicated the changes will not be enough to stop the drug industry from using the new guidelines to market pricier drugs as superior even though they probably have no greater benefit than generics.
Robert Temple, chief of the new drugs division at FDA, said the redrawn Guidance will be published in the federal register, which will give the public time to comment. So I'll wait until that document becomes public before reaching any firm conclusions.
But Temple asked several pointed questions this morning that suggested where he is going with this Guidance. He wanted to know who would do trials about specific outcomes for specific patient subgroups if the FDA didn't provide incentives for the pharmaceutical industry. Specifically, he mentioned the HOPE trial, which was funded in part by companies that make an ACE inhibitor, ramipril. That trial, published in 2000, showed ramipril improved kidney function in diabetics. What that trial didn't ask was whether other drugs, either in its class or other classes like diuretics, did the same thing.
So there you have the bottom line. Unless Temple and his colleagues in the cardiovascular drugs division of FDA make more significant changes than they seemed interested in this morning, the Guidance will allow drug companies like King Pharmaceuticals, whose two patents on rampiril don't run out until 2008 and 2012, to market their drugs as better for diabetics compared to other drugs, even if those other drugs A) are cheaper; and B) are likely to be just as effective for diabetics. Alas, no one will test diuretics in that population since there's not much profit to be made from drugs that cost pennies a day, so we'll never really know.
Peter Lurie, Sid Wolfe and colleagues at Public Citizen published a paper in the current Journal of the American Medical Association that found only a tenuous connection between Food and Drug Administration advisory committee decisions and their members' financial ties to drug companies whose products were up for approval.
No shock there. Anyone who has ever sat through one of those meetings knows that serious differences on the committees are rare no matter who sits on the panels. Having attended plenty of these meetings, I've come to recognize that the core problem isn't financial conflicts but the fact that most of these committees lack overall balance. They are almost always made up of clinicians who treat patients and/or conduct clinical trials. They are usually on the lookout for the next new and hopefully better drug or device for their patients. It's only natural.
What the committees usually don't include are epidemiologists skilled in ferreting out the responses of groups that do not fare particularly well on the new drug. Or they don't include safety experts who are on the lookout for problems that have only been hinted at in the limited trials conducted for new drug approvals.
The Federal Advisory Committee Act, which was passed in 1972, requires that these panels exclude scientists with conflicts of interest (although it allows for waivers in case a person's expertise is needed, which the FDA uses liberally). It also requires that the panels be balanced.
Historically, the FDA, along with most other agencies of the government and the National Academy of Sciences, have interpreted that latter requirement to mean inclusion of the range of experts needed to get the job done. At the FDA, that might mean including a bunch of clinicians who treat patients, a biostatistician who can interpret data, a consumer representative and an industry rep, who usually doesn't vote. But the Government Accountability Office, in a critical review of advisory committees published in 2004, said that the balance requirement also refers to opinions, especially when the subject being discussed is controversial.
At tomorrow's Cardiovascular and Renal Drugs Advisory Committee meeting, which will discuss labeling antihypertensive drugs (see this GoozNews for a rundown of the issues), I will raise this point with the FDA during the public session (I'll post my full comments in the afternoon). The real problem with this committee is its lack of balance.
Late this afternoon, FDA officials sent me an email indicating that the chairman of the committee, whom the Center for Science in the Public Interest exposed as having conducted clinical trials on hypertension drugs for Bayer Pharmaceuticals, will not take part in the meeting, nor will another scientist whose research for drug companies directly pertained to aspects of the labeling controversy. Yet the pared down roster still does not include any of the physicians who played key roles in conducting the best antihypertension research of the past decade (the so-called ALLHAT trial) or participated in writing the National Institutes of Health-funded clinical practice guidelines for physicians treating people with hypertension.
FDA advisory committees should not be confabs of the like-minded. They should be a forum where the best minds in a field can openly debate the pressing issues daily practitioners face. No matter what the committee decides tomorrow -- and I'm hopeful that despite the myriad conflicts of the members who remain that they will suggest significant changes to the FDA proposal -- the FDA needs to do some serious rethinking about how it chooses its outside advisers.
I let this pass last week, but I've been meaning to come back to it when I got a few spare moments (which inevitably come around 10:30 p.m. at night when I'm having a glass of red wine to help me get ready for Jon Stewart's Daily Show).
While a few of the newspaper accounts about the FDA statement on medical marijuana (in response to pressure from Capitol Hill) mentioned this fact, it bears repeating: the FDA has already approved the active ingredient in pot as a drug. Unimed's Marinol (dronabinol) is the chemical THC. It's been approved to combat AIDS wasting and as an anti-nausea agent for people on chemotherapy.
Hmmm. It gives you the munchies and settles your stomach. Sounds like pot to me.
A careful reading of the FDA-approved label (reprinted here), however, provides good reason for testing whether smoking dope may have advantages over using its chemical extract. The clinical trial proving it rebuilt appetites for people suffering from AIDS wasting showed that the effects of the pill version did not kick in until two weeks after the onset of therapy. In other words, there's a trade off. You get lung cancer-causing tars with the dope, but you get the munchies a lot quicker. That's a cost-benefit analysis suitable for FDA analysis.
If I were dying of AIDS or cancer, it would seem like a reasonable trade off to me. Indeed, I spent some time this year with a friend who smoked a lot of marijuana to reduce his need for heavy narcotics as he lay dying of pancreatic cancer. It gave his family many more positive moments together during his final months than would otherwise have been the case. I doubt that would have been the case had he been taking THC as an antiemetic.
Tons of press coverage for this morning's Government Accountability Office report criticizing the Food and Drug Administration's safety system. Much of the critique hinged on three easily rectifiable problems: a lack of independence for the too small safety office (its paltry staff is currently housed within the new drug approval division); a lousy post-marketing monitoring system; and a lack of resources. In other words, the FDA cannot fix its own problems. Only Congress, which controls the purse strings and the agency's legislative authority, has that power.
Bottom line: If you're worried about drug safety, remember to vote this November.
I was intrigued by one comment, though, which was contained in the Washington Post coverage. Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA, the industry trade group), defended the FDA's record by saying only 3 percent of all aproved drugs were later withdrawn for safety reasons.
Hmmm. What other industry is proud of a 3 percent defective rate? Automakers or electronics equipment manufacturers, who expect 6 sigma quality from their suppliers? (That's 3.4 errors per million or 3.4 ten-thousandths of a percent.) Your favorite local restaurant? (Hey, you can't shut us down. Only 3 percent of our customers got food poisoning last week). How about the kid who mows the lawn? Okay, if he gets 97 percent of the grass, I'm satisfied.
Heart-stopping Failure to Balance Cardiovascular Drugs Committee
The Center for Science in the Public Interest has called on the Food and Drug Administration to postpone the April 26 Cardiovascular and Renal Drugs Advisory Committee that has been called to consider controversial new labeling guidelines for blood pressure control drugs. Fully three-fourths of the 12-member panel received conflict of interest waivers.
Physicians can choose from at least seven classes of drugs to treat the 65 million Americans with hypertension, which is often caused by obesity, excessive salt consumption, and lack of exercise and is a major contributor to heart disease. Many of the 35 million Americans on antihypertensives take more than one drug. Drug labels - and the permissive statements those labels allow drug salespersons to make to physicians - can have a major impact on prescribing patterns.
Guidelines developed by the National Institutes of Health in 2003 suggested cheap, generic diuretics, which have been around since the 1950s, "have been virtually unsurpassed in preventing the cardiovascular complications of hypertension." Those guidelines, which, if followed, could save consumers, insurance companies and the Center for Medicare and Medicaid Services billions of dollars, also state that "diuretics should be used as initial therapy for most patients with hypertension, either alone or in combination with one of the other classes." The guidelines specifically recommend against using calcium channel blockers (Pfizer's Norvasc, a calcium channel blocker, is the world's best-selling anti-hypertensive drug) in patients with congestive heart failure.
The FDA's proposed label, on the other hand, states only that "numerous drugs from a variety of pharmacologic classes, whose only common property is to reduce blood pressure, have been shown to reduce cardiovascular morbidity and mortality." The accompanying discussion does not include congestive heart failure among its primary heart disease endpoints. "This document is written so industry can go out and say that it doesn't matter which drug you use," said Curt Furberg, a hypertension expert at Wake Forest University who sits on the FDA's Drug Safety committee. He wasn't invited to be part of this panel.
Several of the physicians who will play key roles in the committee's deliberations have conflicts of interest that relate directly to the labeling discussion. For instance, committee chair William R. Hiatt, a professor of medicine at the University of Colorado, has conducted research for Bayer Pharmaceutical showing the benefits of controlling blood pressure in diabetics with peripheral arterial disease. The label guidelines suggest secondary benefits like improved PAD can be used as a basis for recommending one drug over another. None of the 11 physicians associated with the National High Blood Pressure Education Program Coordinating Committee, which wrote the 2003 peer-reviewed guidelines, was chosen for the FDA panel.
The CSPI letter to acting commissioner Andrew von Eschenbach called on the FDA to balance the panel with experts familiar with the 2003 guidelines and experts on dietary approaches to controlling blood pressure. The group also recommended adding language to antihypertensive drug labels reminding consumers and physicians that "weight loss, diets rich in vegetables and fruits, and diets low in salt are simple ways of treating high blood pressure. Lowering your blood pressure through such changes could save you the cost and side effects of this (and possibly other) medications."
Industry-funded Docs Define Mental Disorders
Nearly a third of the physicians and psychiatrists who define mental illness for the medical profession had undisclosed financial ties to at least one pharmaceutical company, a new study released last week showed. And panels that defined severe disorders like schizophrenia in the Diagnostic and Statistical Manual of Mental Disorders (DSM) were entirely made up of members financially affiliated with drug companies. The manual is used by the almost one-half million mental health professionals in the U.S. Sheldon Krimsky of Tufts University, who co-authored the study in the Journal of Psychotherapy and Psychosomatics, concluded that the investigation "demonstrates that there are strong financial ties between the industry and those who are responsible for developing and modifying the diagnostic criteria for mental illness." The authors call for transparency for future DSM panel members.
Allergy Journal Strengthens Conflicts of Interest Disclosure Policy
The Journal of Allergy and Clinical Immunology (JACI), an Elsevier publication, will require greater financial disclosure from authors and automatically publish those disclosures, the editor said. Two mold experts, Dr. Abba Terr and Dr. Andrew Saxon, failed to disclose their roles as defense witnesses in mold exposure liability lawsuits when publishing a review in the journal earlier this year that downplayed the risks from household mold exposure. Editor Donald Leung said future author conflict of interest forms accompanying JACI submissions will now include "specific questions" about expert witnessing and the journal will "ensure that all published manuscripts will carry a conflict of interest statement regarding each author."
Industry Consultant on NAS Panel Reviewing OMB Risk Rules
Claiming the agency was unable to find another qualified candidate, the National Academy of Sciences has included one of the founders of ENVIRON International, a prominent industry consulting firm, on a new panel that will evaluate the Office of Management and Budget's proposed risk assessment guide released in January. Six federal agencies including the Environmental Protection Agency have asked the NAS to review the OMB proposal, whose time-consuming data review requirements would make it far more difficult to approve new health and safety regulations. The NAS waiver went to ENVIRON founder Joseph V. Rodricks, who is one of the eighteen members on the committee. NAS is "unable to find another individual with the equivalent combination of scientific credentials and expertise," the waiver stated.
Transcript Shows Bias in CDC Vaccine Study, Parent Group Alleges
Advocates for Children's Health Affected by Mercury has released a transcript of a conversation between the chair of an Institute of Medicine (IOM) study on the side-effects of vaccines and the study director at the IOM that suggests the study's outcome was predetermined. A Medscape article reported the transcript, which was posted on an activist group's website earlier this month. It includes a statement by Dr. Marie McCormick, Harvard researcher who chaired the IOM committee, to IOM's Kathleen Stratton that "we are not ever going to come down that [autism] is a true side effect." CDC spokesman Tom Skinner said the emails had been taken out of context. The agency takes its scientific credibility very seriously and "in no way" tried to influence IOM experts, he said.
Industry-Funded Scientists Spin Aspirin Debate
A Wall Street Journal article today describes the hidden financial ties between big drug companies and researchers involved a debate over "aspirin resistance." Aspirin, the anti-clotting drug taken by millions of Americans, has been shown to help reduce the risk of heart attack and stroke by as much as 25 percent. An article published in Physician's Weekly last July by Daniel Simon, associate professor at Harvard Medical school, stated that as many as 30 percent of the 25 million aspirin-taking Americans were aspirin resistant, at higher risk for heart attacks and strokes, and may need other anticlotting drugs. According to the Journal, "the article didn't mention that Dr. Simon receives research funding from Accumetrics Inc., a privately held San Diego company that makes a test to measure aspirin resistance, and from pharmaceuticals maker Schering-Plough Corp., which sells a drug being tested as a potential benefit for patients deemed aspirin-resistant." Physician's Weekly managing editor Keith D'Oria said he knew about Simon's role with Accumetrics, but the weekly does not tell its readers about contributors' conflicts of interest.
The article also discloses that Dr. Eric Topol, a booster of the aspirin-resistance hypothesis who is now at Case Western Reserve University, consulted for Accumetrics and advised another aspirin resistance-testing firm, Aspirin Works, a division of Creative Clinical Concepts Inc. of Denver. He previously served as a consultant to companies that make aspirin alternatives including Bristol-Myers, Sanofi-Aventis and Eli Lily & Co. Topol told the New York Times last year that he has since cut his ties to drug manufacturers.
Is it possible that a federal agency can, in the name of improving public health, make a decision that will not only make things worse, but cost consumers billions of dollars in the process? Not only is it possible, you can watch it happen next week by tuning into a Food and Drug Administration advisory committee meeting that will consider how drug companies label blood pressure control pills.
First some background. Fighting high blood pressure is big business. Over 65 million Americans suffer from hypertension. Well over half of them are already on medication, most on more than one drug. Pricetag? Well over $15 billion. And with the 77 million Baby Boomers heading into their high blood pressure years, the sky is the limit.
There are at least seven classes and more than 60 drugs to fight this symptom (high blood pressure by itself is not a disease; it causes heart attacks, strokes, congestive heart failure and many diseases associated with cardiovascular ill-health, such as kidney failure). Some blood pressure reducers like diuretics – the so-called water pills – have been around since the 1950s and have long been generic. Guess what? There aren’t any perky drugs salespersons out there pushing diuretics.
On the other hand, antihypertensive classes like calcium channel blockers (Pfizer’s Norvasc is the best-selling antihypertensive in the world) and angiotensin II receptor blockers (so-called ARBs) have been around for about a decade and are still on patent. There’s even a new class – the plasma renin inhibitor -- in the pipeline, promising its promoter (Novartis) many years of patented profits from treating high blood pressure.
It would be easy and tempting to say (especially for a cost-conscious consumer like me) that all these drugs are the same. As long as they lower blood pressure, what’s the difference? Go with a generic. But in fact, a lot of government-funded research in recent years has uncovered crucial differences between these various classes. While they are all fairly effective in lowering deaths from heart attacks and reducing overall mortality, some are more effective than others in reducing the number of strokes. Some are worse than others in slowing the arrival of congestive heart failure. And some don’t work as well in African-Americans.
There’s a lot of scientific speculation about the reasons for these differences between drugs. But there’s not much explanation beyond the simple fact that the differences are statistically significant when tested in controlled clinical trials.
Given those differences, the 11 physicians on a review panel established by the National Institutes of Health made the unambiguous determination in December 2003 that “diuretics have been virtually unsurpassed in preventing the cardiovascular complications of hypertension.” This 7th Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure concluded “diuretics should be used in drug treatment for most patients with uncomplicated hypertension, either alone or combined with drugs from other classes.”
When it came to patients who already suffer from the various complications of untreated high blood pressure, the guidelines turned quite specific. Calcium channel blockers (can you say Norvasc?) are singularly less effective in preventing congestive heart failure. After a heart attack, you’d probably want to start a patient on a beta-blocker or a ACE (angiotensin converting enzyme) inhibitor. Suffer from recurrent strokes? Diuretics and ACE inhibitors (both classes almost entirely generic) are best. How about diabetics? They all work about the same.
My point is not to turn you into a hypertension expert, but simply to call attention to some of the complexities that underscore why the FDA’s draft “Guidance for Industry for Labeling for Outcome Claims for Drugs to Treat Hypertension,” which will be discussed next week by the Cardiovascular and Renal Drugs Advisory Committee, is such a curious document. It isn’t so much that it is wrong. It’s what it leaves out and, more importantly, what it puts in that makes one wonder if the agency has sold its soul to the drug industry.
In its key paragraph, the draft essentially says that drug manufacturers can claim that all drugs work about the same. “Numerous single studies and pooled analyses have tested whether drugs given to achieve the same blood pressure goals have the same clinical benefits. To date, such studies have not distinguished the effects of different treatments on the (emphasis added) major hypertension-related outcomes (strokes, myocardial infarction, and cardiovascular mortality).” Note what they left out on those “major” outcomes: congestive heart failure. One can almost hear the officials at Pfizer saying thanks.
Next, the guidelines state that other properties of antihypertensive drugs (e.g., effects on heart failure or diabetic nephropathy) will often be a reasonable basis for deciding which drugs to use or to use first.” While in theory this could be a positive thing if applied to agents that are less effective in reducing heart failure, it opens the door for labeling abuse.
The medical literature is filled with industry-funded studies that measure the antihypertensive effects of specific agents on patients that have other problems like kidney disease or peripheral arterial disease. These trials, which are sometimes referred to as “seeding trials,” are a way to highlight one drug within this crowded field by getting articles about it published in specialty journals. If the FDA allows these trials to be included on labels, it allows drug detailers to mention that “benefit” to physicians. In essence, it puts the FDA imprimatur on some of the most abusive sales tactics in today’s pharmaceutical marketplace.
Some might argue this is only guidance. Companies don’t have to follow it. Physicians and patients don’t read labels anyway. All true.
But the savvy marketing arms of the major drug companies know what’s at stake. Combine a failure to distinguish between drugs with the right to put the misleading claims of seeding trials on labels and what you’ve given them is a blank check to suggest their pricey patented drugs are superior to generic diuretics, even though the government guidelines say just the opposite. The net effect of this Guidance could be a huge setback for public health and the public purse.
Two new government-funded studies, which will appear tomorrow in the Journal of the American Medical Association, found that children whose teeth were filled with mercury-based dental amalgam suffered no IQ loss compared to children that used other types of fillings. The National Institute of Dental and Craniofacial Research put out a press release suggesting the findings "should be reassuring for parents, children, and dental professionals."
Yet the journal that published the studies wasn't so sanguine. JAMA invited Herbert Needleman, the University of Pittsburgh psychiatrist who fought a 20-year battle to make the nation aware of the neurotoxic effects on children of low-level lead exposure, to write an accompanying editorial. Here's what he had to say in part:
"It is predictable that some outside interests will expand the modest conclusions of these studies to assert that use of mercury amalgam in dentistry is risk free. This conclusion would be unfortunate and unscientific. The conclusions that can be extrapolated from these 2 studies are constrained by several factors.First, the follow-up duration is limited to 5 years in the study by Bellinger et al and 7 years in the study by DeRouen et al. Although these follow-up periods are noteworthy, the delayed effects of early toxic exposure on health later in life, which are a subject of growing interest, are not, as acknowledged by the authors, addressed in these reports. The hints that mercury has an effect on the aging brain emphasize the salience of this question.
Second, although both studies were sufficiently powered to rule out clinically important neurocognitive effects, the statistical power may be insufficient for detecting smaller effects. . . The estimated amount of mercury used in amalgam production each year is 100 tons, and the number of children with amalgam fillings is estimated to exceed 50 million. If mercury caused subtle effects in 1% of those exposed, up to 500 000 children could be affected."
I have no idea if the press will cover this story tomorrow. But if they do, it would be a shame if they did not prominently feature the important caveats expressed by this pioneering physician.
As many of you know, I spent a quarter century in the ink-on-paper news business, mostly covering business and economic issues, before being relegated to minor league status on the Internet. Unlike many bloggers, I try to do my own reporting before I go on at length about one thing or another, a trait that is sadly lacking in most of cyberspace. That's why I am more sanguine about the fate of so-called mainstream media than many of my former colleagues in the press (not to mention the know-it-alls on the web). Hard-working reporters cannot be replaced by opinion-mongers who think reporting is reading the headlines in the morning paper and starting to type before they get to the jump page.
That said, I'm less sanguine about the fate of health care reporting, the field I gravitated to about five years ago when I took up writing about pharmaceuticals. So much of what appears in the media is so bad that it fails the basic test of providing the blogosphere with raw material for commentary. When was the last time you read a single online post about a Time magazine cover story about the "new brain chemistry"? Most medical "news" competes for readers attention with the mountains of self-promoting advertorials masquerading as "objective" health care information that already appears on the web. (One of the reasons I grit my teeth every time I hear the phrase "consumer driven health care" is that I know that most of the information consumers get about health care these days comes from the web, and much of that information has the integrity of a late night huckster selling erectile dysfunction supplements.)
A perfect example came at the top of the fold in this morning's Washington Post. Reporter Rob Stein in breathless prose reported a National Cancer Institute study showing that regular use of Eli Lilly's osteoporosis drug Evista (generic name raloxifene) gave postmenopausal women "a powerful way to protect themselves against breast cancer." "Terrific" and "good news" said the above-the-fold quoted experts, including one from NCI. While a few commentators, including one from the National Breast Cancer Coalition, urge caution, our reporter immediately switches back to the data to report that it cuts the risk "by about half."
It isn't until the 15th paragraph that readers learn that of the nearly 20,000 postmenopausal women in the study, only about 320 or 1.6 percent were expected to get breast cancer in the first place. By taking Evista, the number was reduced to 167 or 0.8 percent. In other words, 193 women will have to take this drug for five years to eliminate one case of breast cancer, which is fatal in one in five cases. The cost of preventing this case, by the way, would be about $864,000 ($75 per month for the drug for five years for all 193 women). While the data to make the above analysis was in Stein's story, none of it was clearly spelled out.
There are some objective reasons for failures like this. Health care reporters who are on daily or even weekly deadlines are usually being thrown at topics they know very little about. Yet with a few hours reporting, they are expected to sound authoritative. That may work in covering politics or business, but it fails miserably when confronted by the complexities of science and health.
Given that kind of pressure, the best most can do is come up with the conventional wisdom. They rely on sources who have been elevated into positions of authority by organizations (corporate, institutional, professional) that have a vested interest in one treatment or another. The most depressing phone calls I take each day are the ones from reporters looking for a quick quote to "balance" a story that has already been weighted to the point of view of the drug company that sponsored the study or the regulatory official whose decision reflected some special interest.
Sadly, most of these reporters are not even very good at gathering lots of information quickly and putting it into a coherent story. I've talked about these issues before but they bear repeating: how many times do you read a story that gives the absolute risk of the disease in question instead of relative risk (if a new drug cuts deaths from a disease by 50 percent, how significant is it if the number of people who died from it fell from 2 in 100 who took the drug to 1 in 100?). How does this new technology compare to older, cheaper technologies already deployed? How serious is this problem? Is this horrible condition (restless legs syndrome?) nothing more than "disease mongering" by researchers on a drug company's payroll?
In that sense, most health care reporters lag well behind their peers on the political or business pages, where a healthy skepticism is the order of the day and the knowledgeable reader at least gets enough information to form their own opinion about what's going on. Most consumers of health care news simply don't know enough to know when critical parts of the story have been left out; or when the facts have been arranged in such a way that getting real insight is virtually impossible. Health care news -- like pills -- is almost always swallowed whole.
That's why I'm hoping a new effort by journalism professor Gary Schwitzer of the University of Minnesota has some impact on the profession. Using funding from the Foundation for Informed Medical Decision Making (which insists on its website that it takes no money from any corporation that sells health care or health care technologies like drugs or medical devices), Schwitzer has set up a new website called HealthNewsReview.org to monitor and grade health care coverage in the mainstream media.
He's deployed several graduate students to monitor stories in dozens of newspapers and broadcasts and grade them with one to five stars -- just like the movies! By hacking around his website for a few minutes, I quickly discovered that the grades were based on solid, objective evaluation criteria. Any reporter looking to see why their work earned a poor rating could learn a lot by delving into the details of the critique.
Schwitzer, a former journalist who works closely with the Association of Health Care Journalists, goes to great lengths to explain that he isn't trying to belittle the reporters whose work is highlighted (I saw at least one got five stars). "We hope that U.S. journalists find our reviews helpful and accept the constructive criticism," he writes. "This project is intended to support excellence in health and medical journalism."
I wish him well in his efforts. Health care journalism has to get off the dead end track of reporting the latest study du jour, which is a one-way ticket to flacking for the drug industry. If there are any reporters reading this blog, I encourage you to check out his site. It will be interesting to see how they grade Stein's story.
DOE Disbands Science Advisory Panel That Includes Exxon-Mobil CEO
Secretary of Energy Sam Bodman last week announced plans to disband a 16-year-old scientific advisory board that has only four independent scientists on its roster. The 28-member panel includes Lee Raymond, CEO of Exxon Mobil, Thomas Kuhn, president of the Edison Electric Institute, Michael Williams, chairman of the Texas Railroad Commission, and Daniel Yergin, president of Cambridge Energy Research Associates among its many corporate executives and consultants. The group, which will dissolve May 20 after it finishes a report on math and science education, advised Bodman on research, education and laboratory policy. DOE spokesman Craig Stevens said that SEAB will no longer be needed because the department's future work will be guided by presidential initiatives. While several environmental groups criticized the department's decision as an attack on science, there's little evidence from the panel's makeup to suggest the SEAB offered the secretary of energy objective scientific and technical advice or the Department of Energy made any effort to follow the Federal Advisory Committee Act in setting up the committee. For more on Lee Raymond and Exxon Mobil's efforts to debunk global warming science, see today's column in the New York Times by Paul Krugman (subscription required).
Science to Publish Legislator's Slam of Salvage-Logging Paper
Rep. Brian Baird (D-WA) has joined the attack on the Oregon State University study that showed negative effects from salvage-logging in burned-over forests. In a technical comment that will appear in Science, Baird, who has a doctorate in psychology, accuses lead author Daniel Donato of "having a political agenda" and criticizes the graduate student's statistical methods. The nation's leading science magazine will also publish a rebuttal from the Donato group, the Columbian News reports. A Baird-sponsored bill expanding salvage-logging is headed for a House floor vote later this month, and environmental groups have been using the Donato study to fight the legislation. Responding to Baird's new attack on Donato, the enviros point to a statement Baird made at the 2004 Center for Science in the Public Interest Integrity in Science conference. "We did not think it wise for Congress to get into a habit of condemning peer reviewed research findings for political purposes," Baird said.
Conflicts of Interest on the Agenda at Medical Publication Conference
The International Society for Medical Publication Professionals (ISMPP), a non-profit organization "dedicated to the best practices of the medical publishing sector," will hold its second annual conference April 24 through 26. Thomas P. Stossel, M.D., a Harvard Medical School professor, will offer the keynote address on "The Medical Media and Promotion of the Conflict of Interest Culture." Writing last September in the New England Journal of Medicine, Stossel concluded that "the intense energy currently dedicated to demonizing academic-industrial research relationships should be redirected toward developing better ways to identify and facilitate the type of partnerships that have brought more good, by far, than harm." At the end of that sounding board article, Stossell disclosed he has received consulting fees from ZymeQuest, owns stock options in ZymeQuest and Biogen, and has pending and issued patents, owned by Brigham and Women's Hospital, some of which are licensed to ZymeQuest. Corporate sponsors for ISMPP's meeting include Amgen, AstraZeneca, Pfizer, and Merck among others.
Conference Spotlights How Rx Firms Exaggerate Illness for Profit
The Public Library of Science online has published a report from this week's inaugural Conference on Disease-Mongering held in Newcastle New South Wales, Australia, created to discuss the trend of pharmaceutical companies "selling sickness" to increase their drug market. The authors of the report, David Henry and Ray Moynihan, said that drug industry-funded disease awareness campaigns often misrepresent risk factors like osteoporosis as diseases and amplify unfrequent conditions such as restless leg syndrome to expand the boundaries of illness and boost the market for those who sell and deliver treatments. PLoS has devoted its new issue to the topic.
And Four out of Five Dentists Agree
When drug companies pay clinicians to compare their drugs to other companies' drugs, 9 out of 10 studies show the better drug is the one produced by the company funding the study, a new review reveals. Psychiatrist John Davis, author of the study in the American Journal of Psychiatry, suggested "potential biases in design and interpretation" accounted for the results. For instance, clinical trials that focus on symptomatic relief rather than cures leave more flexibility in how results may be statistically analyzed and interpreted, he told the Washington Post. "A perfectly independent agency has to be set up that says, 'Here are the areas where trials must be done,'" said Drummond Rennie, deputy editor of the Journal of the American Medical Association. "There will be two classes of trials -- the believable ones and the non-believable ones."
An article with the above subhead caught my eye. You can find it in the current issue of PLoS Medicine, which is devoted to disease mongering. You won't find that affliction in the Physician's Desk Reference. But it ought to be there, because it is dangerous to your psychic health.
One article in the special issue focused on the media's role in disease mongering. Two Dartmouth Medical School physicians analyzed journalism coverage of restless legs syndrome between 2003 and 2005, a period when GlaxoSmithKline was marketing a Parkinson's disease drug for the disease. They found that virtually every article about the disease uncritically accepted its definition and its widespread incidence in the general population (would you believe one in ten people have it?).
After debunking those claims, they offered this advice for unwary journalists covering the latest medical epidemic that had previously gone unreported:
"If a disease is common and very bothersome, it is hard to believe that no one would have noticed it before. Prevalence estimates are easy to exaggerate by broadening the definition of disease. Journalists need to ask exactly how the disease is being defined, whether the diagnostic criteria were used appropriately, and whether the study sample truly represents the general population."
There's plenty to chew on in this issue of PLoS Medicine. I recommend it highly, and, unlike most leading medical journals, it's available free online.
This week's New England Journal of Medicine contained a provocative article attacking open access publishers like PLoS Medicine. After pointing out the tremendous sunk costs by for-profit publishers and non-profit professional societies that have enabled fast internet access to journal articles in the first place, Martin Frank, executive director of the American Physiological Society, asks who will pick up the estimated $3,000 cost of publishing in a first-tier journal like NEJM?
One obvious possibility is the government that funds much of the research in the first place. After all, most science and research grants range in the tens of thousands if not hundreds of thousands of dollars. How costly would it be to increase that by $3,000 IF something worthy of publishing comes out of the grant? NIH has already amended its policy to require researchers to deposit full text copies of articles in the PubMed database at the Library of Medicine (www.pubmed.org) one year after publication in the original journal (this was amended from six months after protests from journal publishers).
Frank estimates it would cost $200 million per year to move from a subscription and advertiser-driven model of science publishing to one that provided free internet access. He then goes on to ask: "Spending some $200 million in support of open access should give Congress pause, particularly since the NIH budget has been cut this year for the first time in 36 years. At a time of shrinking budgets for biomedical research, does it make sense to spend scarce dollars on publication costs instead of on research to develop treatments and cures for disease?"
Frankly, the answer to his question is an unequivocal YES. Disseminating knowledge widely will hasten the development of cures for disease.
Robert Kuttner has a new piece up on the American Prospect that skewers the new Massachusetts health care reform law, which would require all citizens to buy health insurance the way many states require drivers to buy auto insurance. He echoes my sentiments expressed here last week:
"As long as private insurers remain dominant to take their cut -- for profit, marketing, the costs of cherry-picking healthy customers, second-guessing doctors, and spewing paperwork -- the savings of market reform will remain modest. True market-reform would be single-payer coverage like Medicare, which is far more efficient than anything private insurers offer."
For his entire column, click here.
Industry-Funded Study: Sweetener Has No Special Link to Obesity
A new industry-funded study found that high-fructose corn syrup (HFCS) is similar to table sugar in its effects on the body. (That finding is not surprising, considering that HFCS is half glucose, half fructose, which is what table sugar is converted to in the body.) James Rippe, an associate professor of medicine at Tufts University, drew his conclusion after measuring the blood sugar, insulin and satiety hormone levels of 30 women who drank beverages sweetened with table sugar or HFCS over the course of a day. The study, presented this week at the Experimental Biology conference in San Francisco, was funded by the soft drink giant PepsiCo, which, like most soda manufacturers, uses high volumes of HFCS.
Rippe is founder and director of the Rippe Lifestyle Institute in Shrewsbury, Massachusetts. According to the Integrity in Science Database, the Institute's clients include over 40 industry and trade organizations such as Astra Pharmaceuticals, Pfizer, Novartis, Nabisco, Kellogg, General Mills and the National Cattlemen's Beef Association. Rippe makes frequent appearances on television and in the press, often without mention of his ties to industry.
Emails Show Forestry School Dean Went to Bat for Industry Officials
An Oregon State University dean discussed “damage control” with forest industry officials after a graduate student’s paper in Science Magazine showed logging in burned-over forests slowed restoration. According to the Portland Oregonian, Hal Salwasser, dean of the College of Forestry, then warned school administrators that the school’s fundraising would be hurt by Daniel Donato’s paper, which senior professors in the department had sought to squelch. “If there are no quality controls in place why give the college more money to keep doing more of this?” Salwasser wrote the administration. The emails were released in advance of a state Senate hearing this week investigating whether the forestry school’s ties to the timber industry have undermined academic freedom.
New FDA Drug Safety Board Officials Traveled on Drug Industry's Dollar
The Food and Drug Administration’s new Drug Safety Oversight Board has engaged in extensive travel at drug industry expense, a new study from the Center for Public Integrity revealed. At least 17 of 29 members on the DSOB, which was created after the uproar over Vioxx, took a combined 160 sponsored trips costing more than $220,000. Overall, the study showed that various nonprofits and universities with close ties to the pharmaceutical industry provided over $1.3 million for 3,600 FDA employee trips in the last seven years. Because these organizations define themselves as scientific groups supported by individuals instead of trade associations, they are able to dodge FDA regulations prohibiting industry from sponsoring travel directly. Top trip sponsors included the Drug Information Association, which has 13 board members who are employees or former employees of the drug industry, and the industry-funded research programs at the Rhode Island, Texas and Wisconsin.
Government Websites Still Give False Information on Condoms, STDs
Federal and state governments continue to lie to the nation's women about reproductive health issues, the current issue of Glamour charges. The Department of Health and Human Services website for teen health falsely suggests condoms don't protect against several sexually transmitted diseases (STDs), including human papillomavirus, an infection that can cause cervical cancer. The issue came to light last July when Rep. Henry Waxman (D-CA) had four outside experts review the government website. Meanwhile, several state governments touting abstinence programs have created their own websites with links to www.abstinencedu.com, which falsely claims that HIV can penetrate condoms and that condoms do not reduce the risk of contracting STDs. Katharine O'Connell, an assistant professor at Columbia University who studies contraception, said the main reason behind government exaggeration of condom failure is to “manipulat(e) sexual practices…This is not about condoms. It's all about the sex.”
GAO Accused by One of Its Own Over Warheads Investigation
A senior analyst with the Government Accountability Office has charged his agency with "covering up scientific fraud" in his investigation of “Star Wars” interceptor rocket contractors. In a recent letter to Rep. Howard Berman (D-CA) and Sen. Charles Grassley (R-IA), who jointly requested the GAO study, Subrata Ghoshroy claimed the 2002 GAO report analyzing the $26 billion missile defense system disregarded doctored data and skewed test results by the two main contractors developing the weapon. "I'm concerned," he said, "that there's no one out there to oversee the overseer." The GAO denied the allegations. GAO chief David Walker, who is half-way through his 15-year term, called Ghoshroy “a relatively low-level, disgruntled employee” out of step with his technical peers.
Last year, I had the pleasure of working closely with Rep. Maurice Hinchey (D-NY), who managed to pass an amendment to the Food and Drug Administration appropriations bill that would ban scientists with ties to drug companies from serving on FDA advisory committee evaluating new drugs. It passed the House in a shocking upset, but was watered down in the Senate (see this GoozNews). Tonight, the Nation's on-line blogger John Nichols quotes Hinchey on the significance of the possibility that the President engaged in high crimes and misdemeanors:
"If what Scooter Libby said to the grand jury is true, then this latest development clearly reveals yet again that the CIA leak case goes much deeper than the disclosure of a CIA agent's identity to the press. The heart and motive of this case is about the deliberate attempt at the highest levels of this administration to discredit those who were publicly revealing that the White House lied about its uranium claims leading up to the war. The Bush Administration knew that Iraq had not sought uranium from Africa for a nuclear weapon, yet they went around telling the Congress, the country, and the world just the opposite" -- Rep. Maurice Hinchey
I'm starting to do my homework, and I will let you follow along if you're interested.
Joshua Micah Marshall of Talking Points Memo reports that:
"Scooter Libby has sworn under oath that Vice President Cheney told him that President Bush had authorized him to disclose classified information. Let's set aside the whole question of whether the president can do that or whether there's a specific procedure he has to follow. Just set that issue aside. If it isn't true that Vice President Cheney told him that, then Vice President Cheney must know that Libby has again perjured himself. I would think the Vice President has an affirmative duty to come forward and say that Libby's testimony is false.
So my initial understanding may be wrong. The Vice President stands between the President and allegations of criminality. If the press and/or Congress sweeps this under the rug, then we're doomed. This is Watergate redux. We'll be talking about nothing else for the next six months . . . and with the quagmire in Iraq showing no signs of ending, it's a good thing, too.
This afternoon, while driving my daughter to her orthodontist appointment, the radio told me that Vice President Cheney's former chief aide says President Bush authorized the deliberate leaking of classified national intelligence (erroneous as it turned out) to a New York Times reporter to build a public justification for the war in Iraq.
I have been busy preparing for a week trip to another part of the country. I have not read a single commentary anywhere else on the web, in a newspaper or, this evening, watched a single show on television or listened to follow-up on the radio. So this is my unvarnished reaction as a simple citizen of this country.
Isn't this a high crime, not to mention a misdemeanor? How does leaking classified information to justify an unjustifiable war compare to a blow job? If Congress doesn't deal with this issue, or the American people this fall don't elect a Congress that will deal with this issue, then we are no longer living in a democracy.
First Massachusetts passes a universal health care insurance mandate. Now comes this word from Oregon, where it appears former Gov. Tom Kitzhaber is leading efforts to enact a state-run insurance system (very different from a mandate that individuals buy insurance). This item from today's Kaiser Family Foundation report:
Former Oregon Gov. John Kitzhaber (D) held a forum on Sunday in Portland, Ore., to launch a grass-roots organization that will work to "spark a national debate" on health care reform, the Oregonian reports. Kitzhaber, who served as Oregon governor from 1995 to 2003, has called for ending Medicaid and Medicare in the state and redirecting the public funds used for those programs toward providing basic coverage for all state residents. Kitzhaber and his supporters had worked to put a universal coverage proposal on the state ballot for fall 2006, but the group has abandoned the initiative and will instead work toward drafting a proposal for the 2007 state legislative session, Kitzhaber said. The forum, which included about 200 people, focused on brainstorming ideas to attract more people to Kitzhaber's organization, called the Archimedes Movement. The organization, which was founded in January, has raised about $180,000 and has about 800 to 900 supporters, Kitzhaber said. Kitzhaber said at the forum that the current health care system defies "logic and common sense" by paying more for emergency care than preventive care. "It's a policy that says, in effect, we won't ensure that all the women in our communities have access to good prenatal care, but we'll be happy to pay the cost of resuscitating a 500-gram infant in a neonatal intensive care unit," he said, adding, "That should not be acceptable to any of us."
Can anybody enlighten me as to why he chose Archimedes, a Greek mathematician, as the namesake for his movement?
The Journal of the American Medical Association today reports on the latest obesity trends among Americans, based on a comparison of data collected in 1999-2000 and 2003-2004. Guess what the headline read in the Washington Post. "Obesity Among U.S. Women Leveling Off, Study Shows."
Guess what the 12th paragraph reported. "Obesity rates worsened for most groups, increasing from about 14 percent to 18 percent in boys ages 2 to 19 and from about 14 percent to 16 percent in girls of that age. The percentage of men age 20 and older who were overweight increased from about 67 to 71 percent."
Okay, overweight women stayed around 62 percent. But given those percentages, what do you think is the real story here?
In 1995 upon returning from four-year stint in Asia, I was privileged to spend a year as a Michigan Journalism Fellow at the Univesity of Michigan in Ann Arbor. Tonight, I learned by reading Juan Cole's essential Informed Comment blog (no one on the Internet covers the war in Iraq better) that my alma mater has launched a fundraising drive to bring Middle Eastern journalists to the U.S. for a fellowship year. Way to go, Charles! (Charles Eisendrath, who long ago was a Time Magazine correspondent, runs the program.)
I know this is not my usual m.o., but if anyone out there has a little extra cash and wants to support a worthy cause, I can't think of a better way than giving to this effort. You can learn more about what is now called the Knight-Wallace Fellowship Program by clicking here.
In a victory over the Bush administration's routine flouting of freedom of information act requests, a federal court has ordered the Internal Revenue Service to turn over audit statistics to the Transactional Records Access Clearinghouse. For over 30 years, the Syracuse University-based TRAC had published detailed analyses of IRS audits, documenting the agency's turn from going after the big guys.
TRAC is run by Susan Long and David Burnham, a former New York Times reporter. They use publicly available data to show how government regulatory agencies have retreated from performing their legislatively-mandated functions. In 2004, the Bush administration began denying their FOIA requests for data that had been routinely provided for decades. Their lawyers at Public Citizen sued to uphold the law.
Yesterday's decision in the western district of Washington by Judge Marsha Pechman is a welcome sign that the judiciary branch is starting to do its job. Someone has to rein in an administration that routinely breaks the law.
Former Senate Minority Leader Tom Daschle and three ethanol boosters made a convincing case this morning at the Center for American Progress. In the words of David Morris, vice president of the Institute for Local Self-Reliance, "ethanol is the perfect Trifecta." It cuts our reliance on unstable Middle Eastern oil, it reduces carbon emissions, and it provides the Democrats (I'd say any politician but we can't expect much for our oilman president) with a wedge issue in farmbelt red states.
I was especially pleased to hear Morris knock down the $4 gasoline tax proposal, whose chief proponent (at least in the media) is Tom Friedman of the New York Times. "I'm all in favor of it in theory and opposed in practice," he said. Why? First, it's a political loser that mobilizes the right-wing anti-tax crowd. Second, it's unfair because people who have to drive will just pay the tax and not reduce their driving. That's what happened in Europe (although it also made them opt for smaller cars). Finally, most of the money in the U.S. would just go to build more roads, which is mandated in many state constitutions and the federal gas tax formula.
Of course, it is possible to realign the formulas, but how likely is that in an environment where the proponents have already stirred up a hornet's nest of opposition to the imposition of the tax?
I was a little disappointed in the small bore proposals for reform from the group. Instead of mandatory fuel mileage standards (I proposed a 60 miles per gallon standard within six years in my article in The American Prospect), Morris proposed a carbon cap-and-trade system. Could work. But it would undoubtedly open up loopholes for big polluters to buy their way out of trouble.
As for ethanol, Rep. Stephanie Herseth (D-SD) pushed for higher renewable fuel mandates (where big refiners have to buy a set number of gallons of ethanol to mix into their blends) and shifting the producer tax credits so they benefit smaller, local ethanol refiners set up by farm co-ops instead of the huge ethanol refineries being set up by agri-giants like Archer Daniels Midland. Morris asked for Congress to mandate that automakers install flex-fuel gizmos in all vehicles rolling off assembly lines, which adds a mere $100 to $150 to the price of a new vehicle.
This is Clintonism at its worst. We need a major national commitment to wean the country from oil, which on the domestic front will be the number one national priority of the next administration. We must do it for national security reasons and we must do it for environmental reasons and, for both those reasons, we must do it fast.
Do we create "incentives" for Homeland Security? No. It's mandates and government contracts all the way. So why the double standard? Weaning ourselves from oil is an issue of national and global security. There is simply no way that business can be incentivized to achieve this goal through market mechanisms. Business will respond to mandates, and they will make a lot of money in the process, too. But they're going to have to be dragged kicking and screaming into the future.
You probably read about last week's study showing that moderate drinking did not, I repeat, did not improve health outcomes. The pooled analysis of dozens of studies showed that the slightly reduced heart attack rates that light drinkers enjoy is largely due to the fact that the teetolers in the comparison groups had stopped drinking for health reasons. In other words, these already sick people had more heart attacks anyway. Duh.
Now comes a new study from the Physicians Committee for Responsible Medicine in Nutrition Reviews that purports to show that vegetarian diets promote weight loss. According to the press release: "Vegetarian populations tend to be slimmer than meat-eaters, and they experience lower rates of heart disease, diabetes, high blood pressure, and other life-threatening conditions linked to overweight and obesity."
Even better, going Vegan will allow you to drop one pound per week no matter how much exercise or calorie-counting you do. The study's authors, Susan Berkow and Neal Barnard, say vegetarians in the 87 studies they reviewed had obesity rates ranging from 0 to 6 percent, far below the general population.
Since I work at the Center for Science in the Public Interest, where a significant number of staff are Vegan, I think I'm in a good position to testify to some confounding factors that may be skewing their claims. People who obsess about eliminating animals and dairy from their diet are far more health conscious than the rest of the general population, which makes them eat less, exercise more and avoid truly heart-stopping foods.
I'd bet my life that if one could conduct a truly objective experiment comparing two populations made up of physically and genetically matched people, both of which exercised regularly and kept their weight within certain bounds but one ate meat and the other was strictly vegan, we'd find very little difference in their heart attack rates.
In fact, I already have made that bet. I drink moderately. I eat meat. And I exercise regularly. My weight is quite normal for a man my size and build (5'10'', 161 pounds). Indeed, my weight is no different today than it was 30 years ago when I was 25 (full disclosure: I've lost 7 pounds since the first of the year despite my meat-eating ways, largely due to a slightly more rigorous exercise regimen).
If this blog stops suddenly, you'll know that the Vegans may be on to something.
Now that April Fools is past us, please be advised that our item on MoDeD was a joke. But disease mongering isn't. And if you want to learn more about it, click here.