Not unexpectedly, the news media embraced and eagerly reported the latest revelation about the health benefits of red wine. The study, published in the online journal PLoS One this week, hinted that resveratrol, an antioxidant compound found in the skins and seeds of wine grapes, can boost cardiovascular health and slow aging in mice at lower doses than previously thought. Earlier studies have suggested that resveratrol helped mice run farther, stay slender, and stave off diabetes and cancer.

This buzz about red wine reminds me of the media’s enthusiastic coverage of dark chocolate's effects. Several studies have suggested the antioxidant flavanols in dark chocolate can improve blood vessel function and reduce blood pressure.

Any story about red wine or dark chocolate, especially one that gives people an excuse to indulge, is going to be well-received. As I write this, the New York Times article on the recent red wine study has been hovering near the top of the newspaper’s list of most popular online stories.

But as we swash down red wine and gobble bon bons, we may be inclined to forget that, along with all those antioxidants comes a good dose of alcohol and saturated fat. Excessive alcohol consumption (more than two daily drinks for men or more than one daily for women) can lead to liver disease, according to the Centers for Disease Control and Prevention (CDC). And recent studies suggest that one or two drinks a day may increase the risk of breast cancer.

And don’t forget the caveats associated with some of these studies. In most of the resveratrol studies (a notable exception being the recent PLoS study) mice were given massive quantities of compound. A human would have to guzzle at least several bottles of red wine a day to obtain a similar amount. And to reap the benefits of cocoa, you have to eat dark chocolate (preferably containing 70 percent cocoa), which tends to be bitter. With creamier chocolate the milk binds to the antioxidant compounds, making them unavailable to the body.

Finally, it is worth noting that the recent red wine study was partially financed by the Swiss DSM Nutritional Products, “the world's leading supplier of vitamins, carotenoids and other fine chemicals to the feed, food, pharmaceutical and personal care industries,” according to the company’s website. Similarly, several studies on cocoa flavanols have been funded by Mars Inc., the maker of chocolate products. So while it's tempting to toast to the promising results from these studies, the bottom line is more bittersweet.

By Coco Ballantyne
Photo by miss karen

Posted by Coco Ballantyne at 04:47 PM | Permalink | Comments (0)

When I was a small child, I had an earache, so I asked my dad for a Band Aid. The source of my discomfort was an inner ear infection, so antibiotics would have been more on the mark—but a Band Aid seemed better than nothing. The placebo effect is powerful.

As reported in the New York Times this week, there is now a placebo pill designed for children that you can buy. The product is called Obecalp (placebo spelled backwards) and available online for $5.95 a bottle. Each cherry-flavored chewable Obecalp tablet is essentially a lump of sugar in a medicinal disguise. “Invented by a mommy,” says the website advertisement, featuring a headshot of the product’s inventor, a mother of three from Severna Park, Maryland. The implication is that, if a mom came up with the idea, then it must be okay to give fake meds to your children.

But how will mom (or dad) explain the situation when their children discover that the magical tablets they received for headaches, stomachaches and sore throats were always a hoax? The use of placebos sends an uncertain message to children. They will eventually know that their parents deceived them. Moreover, there is something unnerving about looking to pills for the answer to every ailment. There are other ways to comfort children. In some cases they simply need a dose of attention to feel better. Perceived physical ailments may also be a sign of emotional or mental distress that a sugar tablet cannot fix.

Doctors admit to prescribing placebos, according to a study published earlier this year in the Journal of General Internal Medicine. Researchers at the University of Chicago surveyed 466 physicians from three Chicago-area medical schools and found that nearly half of all respondents had used placebos in their clinical practice. One of their most common reasons for doing so: “to calm patients.” Something is wrong with a medical system in which patients need pills and injections to feel tranquil and reassured that they have received adequate care. It’s hard to imagine that adding more pills to the market, even if they are fakes, will help change this culture.

Posted on behalf of Coco Ballantyne

Image by Fillmore Photography via Flickr

Posted by Roxanne Khamsi at 10:21 AM | Permalink | Comments (1)

Today's Boston Globe ran a profile of Ram Sasisekharan, the MIT-based senior author of the papers published on 23 April in NEJM and in Nature Biotech., identifying the contaminant in heparin that caused adverse effects and even killed scores of people earlier this year.

Through careful structural analysis, Sasisekharan and his colleagues found that the culprit was oversulfated chondroitin sulfate and that, owing to the chemical nature of the contaminant, conventional screening methods cannot differentiate between clean and tainted lots. Then, using in vitro and in vivo approaches, they went on to show that the mechanism of action of the contaminant involved the activation of the kinin-kallikrein and the complement systems.

It was an remarkable tour de force, particularly considering that, according to the profile, the FDA approached Sasisekharan with the project only in late February, the published submission date of the Nature Biotech. paper is 21 March, and the mechanistic work had apparently been finished by early April. Pretty impressive stuff that, I hope, will inspire those prospective Nature Medicine authors whom we invite to resubmit their work and, alas, are occasionally scooped.

Ram Sasisekharan (Photo: David Shopper, The Boston Globe)

Posted by Juan Carlos Lopez at 02:06 PM | Permalink | Comments (0)

The article and accompanying editorial published in JAMA earlier this week regarding the issue of ghostwriting made, yet again, a strong point about the influence of pharmaceutical companies on the communication of science.

In a nutshell, a series of primary and review articles authored by Merck regarding their drug rofecoxib were allegedly written by communication firms that provide writing services for companies and individuals. In addition, some articles were signed by academics who allegedly did not have much to do with the study, but were invited by the company to lend their name (and their prestige) to the papers.

There seems to be something seriously wrong with this picture, but let's go step by step. Is there anything wrong with companies that write papers for hire? The JAMA editorial seems to think so:

"...there was no disclosure that the manuscript had been written by Scientific Therapeutics Information Inc, a company specializing in [...] writing papers for a price. Perhaps some [...] would see little or no harm in this failed disclosure because all other disclosures were made. However, if there was nothing to hide, why were the names (and affiliations) of the individuals who actually wrote at least the first draft of the manuscript omitted? Experienced authors know that the initial draft (in this case paid for by Merck) sets the tone for the manuscript. Moreover, it is unfair to the authors of the first draft not to provide them with credit for their work. Another problem with failing to disclose "ghost writers" is that there is a reasonable assumption that the principal investigator was involved with writing the manuscript from the beginning."

Why were the names omitted and credit was not given to the ghost writters? I would probably ask the opposite: Why should they be included? Scientific Therapeutics Information entered into an agreement with Merck according to which STI would write the paper and Merck would pay -- that's their compensation. Why should they be also authors? It's like saying that papers should always include the names of all the technicians, as they did experiments that are reported in the manuscript. I'm sure many researchers would find this idea amusing.

Now, does the first draft really set the tone of the manuscript? What does that mean, anyway? In my experience, if the first draft of an article is bad, it will be discarded and people will start over. There's no such thing as an article's tone, at least not as something that the paper is born with from the time you first sit down in front of your computer and start typing.

And is there really an assumption that the principal investigator was involved with writing the manuscript from the beginning? I'd actually say the opposite -- my assumption tends to be that the PI more often than not sees a draft written by the postdoc. In fact, many senior PIs would not dream of writing a first draft, but would impose it on junior researchers to get the paper into very good shape before they get involved.

This point is relevant to the second crime of which the Merck people stand accused -- getting senior PIs to be authors in papers for which they didn't do much work. These researchers are a little like those PIs who get involved in reading the paper once the draft is essentially final. And yet, we don't often hear people asking for those PIs not to sign those papers.

Of course, this example is dumb -- those PIs did contribute with the money to support the lab, and they may even have provided some intellectual input to the work (although, again, there are some senior PIs that let the lab in the hands of their postdocs, who pretty much decide by themselves what project they want to pursue). But even if the example is dumb, it does raise the point of what threshold must you cross to become the author of a paper.

Is it enough to be the owner of the lab for you to sign everything that comes out of it? Some would probably agree, even though no-one would dream of splitting the credit for painting the Sistine Chapel between Michelangelo and the Pope just because the latter "owned" the chapel. What if you "just" gave the mouse used for the experiments? Would you want to be author or not? Opinions will vary, but it's not necessarily outrageous to appear in a paper for giving people such a crucial reagent. And what if you only gave intellectual input? Again, opinions will vary, but some people will value this kind of contribution more than giving the mouse or being the owner of the lab space.

So, why are we horrified about the idea that someone approached by a company to author a paper agrees to do it? After all, this kind of guest authors are often told that they are welcome to change anything they don't like in the paper they are given. So, depending on how serious you are about this task, you may end up being really comfortable to give your name to a manuscript if you really worked hard on it. In fact, who hasn't heard of cases in which someone ends up in someone else's paper because of extensive discussions throughout the preparation of the manuscript?

I think that a crucial point in this discussion is included in the JAMA editorial: "...it is clear that at least some of the authors played little direct roles in the study or review, yet still allowed themselves to be named as authors". Sure, but how little is "little"? In fact, some of the people who have been identified as guest authors have disputed the allegation precisely by stating that they did have a lot to do with the preparation of the manuscript. The same question goes for them: how much is "a lot"?

So, to my mind, the problem here are not so much the pharmaceutical companies for approaching people to author their papers, but how much people think they need to work to feel comfortable as authors of manuscripts of which they were not the leaders. Unfortunately, as I illustrated above, there's no simple answer to this question, because there are many pathways that you can follow to end up being guest author in a paper -- sheer seniority and ownership of the lab, sharing a key reagent or giving vaulable discussion.

The one thing that is different in this case is that money is exchanging hands -- the pharma company allegedly offered money in exchange for the scientist's name. So, if you just took the cash and signed the manuscript without even looking at the paper, sure, that's clearly unethical. But if you did work on it, is it still inappropriate to charge a fee for your input? It may be against the rules of your institution, but I wonder if it's inappropriate from a strictly ethical standpoint.

So, in the Merck case, if I were the Dean of any of the people who have been named as ghost authors, I would take the problem very seriously and launch an investigation to ascertain how much they really worked on the study. If they did, in fact, contributed enough (acknowledging that the definition of "enough" will vary depending on who you ask) and they didn't break any rules of their institution, the institution needs to make this very clear to the community. And if it turns out that the authors really just took the money and ran, then disciplinary action must surely follow.

I share the view expressed in the JAMA editorial that integrity in medical research is paramount. However, I disagree with overarching, one-size-fits-all decisions about how to handle situations as complex as the issue of authorship. To my mind, these decisions can trivialize the problem by offering solutions that are a bit too simplistic and may end up being regarded as empty rhetoric.

Posted by Juan Carlos Lopez at 03:04 PM | Permalink | Comments (5)

...would seem to be the message from three papers published over the past few days in different venues.

First, the NEJM published this past weekend a report showing that using a cholesterol-absorption inhibitor (ezetimibe) in combination with statins reduces LDL below what each drug achieves on its own but, alas, there is no similar additive effect on the progression of atherosclerosis.

Then, JAMA published today that rimonabant, the cannabinoid receptor inhibitor that promotes weight loss, has no effect on the progression of atherosclerosis either, although the authors do warn that more studies are needed before we know for sure if this is the case.

Last, a study in PLoS Medicine published yesterday claims that people with Alzheimer's disease are better off without neuroleptics for the treatment of their psychiatric symptoms. These drugs seem not to have significant beneficial effects to outweigh their side effects.

It would seem that every time we look at a drug using higher-magnification lenses we uncover something to discorage us from its use. At this rate, I don't look forward to a future in which the only thing you can buy safely from a drugstore will be aspirin.

P.S. Who comes up with the names of these clinical trials? ENHANCE and STRADIVARIUS? You must be joking! If only their outcomes were as uplifting as their names...

Posted by Juan Carlos Lopez at 07:27 PM | Permalink | Comments (1)

Today is the 10th anniversary of the FDA's approval of sildenafil nitrate for the treatment of erectile dysfunction. A decade and over 30 million users later, there's very little left to say about Viagra that hasn't been said before. Maybe that's why the media coverage of the anniversary has been somewhat modest. I nevertheless found this pretty neat graphic in the Spanish newspaper El Mundo. It's, of course, in Spanish, but I hope you get the gist of it.

After this anniversary, Pfizer probably won't be looking forward to future ones; their patent on the drug is set to "go limp" between 2011 and 2013.

Image by n3wjack's world in pixels

Posted by Juan Carlos Lopez at 09:59 AM | Permalink | Comments (1)

What's the drug of choice in your city? Cocaine? Methamphetamine? Or a simple cup of java?

Turns out it's a lot easier to find out than lurking in alleyways or crashing hipster parties. Scientists from Oregon State University have figured out a way to test an entire city for its drug use — legal and illegal.

The scientists sampled about a teaspoon of water from the sewers — because that's eventually where what people consume ends up — of 10 American cities and tested them for 15 different drugs.

The results, which they presented the Amercan Chemical Society meeting in Boston on Tuesday, are not all that surprising in the end. Here are a few gems:

Most Americans are not too wild and crazy, and their drug of choice is caffeine. People in the midwest are a little more conservative and don't seem to indulge too much in meth use. One city with a heavy gambling industry — Las vegas, anyone? — shows meth levels five times higher than other cities.

I have no doubt New York has its share of drug use, what with all our models, actors and and hyperactive investment bankers. How do you think your city would fare?

Posted by Apoorva Mandavilli at 03:35 PM | Permalink | Comments (0)

You know that really, really fast rattling off of side effects at the end of every drug ad on TV? That's there because companies are requried to present a "balanced" picture of the risks and benefits.

But seriously, who can understand a word beyond the rapid-fire "You may experience nausea, headache, blah blah, blah" or read fast enough to decipher the side effects that rapidly scroll down?

Well, apparently the FDA is planning a study with 2,000 people to see whether people are too distracted by the cheery ads to notice the risks. To which I say, Duh. This is such a sadly obvious stalling tactic: "Look, we're doing this study, and we can't take any action till our analysts have told us what it all means."

It's also damage control. Last week, a report in the New England Journal of Medicine said that in 2006, the FDA sent 21 warnings to companies about their ads, down from 142 in 1997. The amount companies have spent on ads went up a whopping 330% during that same time.

Here's another sad little fact that the Associated Press mentioned in its coverage of this issue: The U.S. is one of two industrialized countries that permit TV drug ads -- the other is New Zealand.

Posted by Apoorva Mandavilli at 03:22 PM | Permalink | Comments (2)

One of the biggest problems of the Food and Drug Administration (FDA) is the limited postmarketing surveillance of its approved medicines. It is widely believed that cases such as the Vioxx fiasco could have been avoided if the effects of drugs continued to be carefully monitored after they find their way to the market.

It is therefore good news that the US Senate is supporting a bill that would give the FDA power to require postmarketing studies, the publication of negative clinical trials to bolster transparency, and the authority to fine companies that don't comply with these requirements. Unfortunately, as highlighted by a recent New York Times editorial, the success of the proposed reforms depends on hefty fees imposed on drug manufacturers. Such dependence is problematic, as it might increase the influence of the pharmaceutical Industry over the decisions of the FDA.

There is, however, a more immediate problem: the bill may not be approved at all, as the White House is already threatening to veto it. The point of contention is a proposal to allow the importation of cheaper prescription drugs from Canada and other countries into the US. Critics of this idea argue that it is dangerous for the public to gain access to foreign drugs that may not meet the same safety standards of the FDA or may even be counterfeit.

Fair enough. In fact, officials have been making a similar point since the days of the Clinton administration, stating that they couldn't possibly guarantee the safety of an imported drug. Nevertheless, those in favor of lifting the ban on drug importation dismiss these arguments as mere stratagems of the pharma industry to protect their interests.

But ultimately the pressing question is: should the bill be put at risk of being vetoed for the sake of this evidently controversial issue? It doesn't look like the Senate is going to back down, and we are already painfully aware of how stubborness of the White House. What gives, then? Hopefully not the interests of the public.

Posted by Juan Carlos Lopez at 11:27 AM | Permalink | Comments (2)

Conflict of Interest is a touchy matter. Just crack open the pages of Nature Medicine and you’ll see that scientists who publish topnotch research regularly declare financial conflicts. It’s a fact that drug companies seek out the best physician-scientists—and so do agencies in need independent scientific advice, such as the US Food and Drug Administration (FDA).

So what to think of the new FDA proposal limiting conflict of interest on its advisory panels? The proposal would prevent researchers from serving on panels if they receive more than $50,000 from a company or competitor whose product is being discussed. Those who receive less than that amount can participate in the committee but cannot vote.

The agency is in a tough position: it’s been slammed repeatedly over lax conflict of interest rules. Yet agency officials are right when they say that the best advisors may often have financial conflicts.

The Institute of Medicine recognized this dilemma in its recommendations for FDA reform last fall. They recommended capping the percentage of individuals with a ‘significant’ financial conflict of interest at 60 percent.

The proposed guidelines seem to follow the spirit, if not the letter, of this recommendation. It’s possible the guidelines go too far--considering that it seems that no one with any conflict whatsoever can vote—or that the guidelines will lose their teeth after the 60 day comment period. For a breakdown of the pros and cons, see Derek Lowe’s blog “In the pipeline.”

Either way, it’s good to see the FDA is responding to legitimate criticism of its current system, as well as threats from Congress to impose more draconian conflict of interest rules through legislation.

Posted by Charlotte Schubert at 09:05 PM | Permalink | Comments (0)

People being treated for cancer often become anemic, meaning their blood oxygen levels fall too low, which is partly why they feel exhausted during treatment. To ease the anemia — and the fatigue — doctors prescribe erythropoietins, which stimulate the production of red blood cells.

On Friday, the Food and Drug Administration warned that these drugs, sold under the brand names Epogen, Procrit and Aranesp, are doing more harm than good in some cases. Doctors have apparently been over-prescribing the drugs, using them to reverse anemia, instead of just alleviating it enough to avoid blood transfusions.

The agency says that the drugs carry a higher risk of blood clots in the legs and the lungs, could make tumors grow faster, and could even cause people being treated for cancer to die more quickly. The drugs will now be sold with a black-box warning that highlights these risks.

Here's what I don't understand: we first reported on the risks with these drugs in 2003, when a couple of trials unexpectedly showed that people taking erythropoietin died faster than those taking the placebo.

We quoted experts who had found that many tumor cells have receptors for erythropoietin and that the cells grow faster in response to erythropoietin, and we reported — perhaps naively, in retrospect — that the mounting evidence might have an effect on how the drugs are prescribed.

As I said, that was in December 2003, more than three years ago.

Why has it taken so long for the FDA to act?

Posted by Apoorva Mandavilli at 03:27 PM | Permalink | Comments (3)

What are FDA officials thinking?

The FDA is poised to approve a front-line antibiotic used for mengingitis and other human infections for use in cattle, according to a report in Sunday’s Washington Post. Approval of the antibiotic could lead to antibiotic resistance developing in animals, and then spreading to people.

Apparently the agency is not thinking; it seems instead to be following a ‘guidance document'.

And that document goes against the advice of the agency’s own scientific experts, the American Medical Association and about a dozen other health groups.

These health groups point to evidence that antibiotic use in animals is linked to the development of antibiotic resistance in the human population. In fact, an FDA advisory committee voted 6 to 4 against approving animal use of the antibiotic, cefquinome, a fourth-generation cephalosporin.

Nonetheless, Stephen Sundloff, the head of the FDA’s Veterinary Medicine Center, told panel members that their vote was “not binding”. Instead, he told the committee that the FDA was bound by “Guidance for Industry #152” which limits bans on antibiotic use in animals; the details are a bit mind-numbing but it seems that it’s only easy to ban an antibiotic for animal use if the drug threatens treatments for food-borne illnesses.

That’s way too narrow a definition, given the ability of bacteria to exchange resistance genes. Let’s hope that, in the end, the FDA is able to make a common-sense and scientifically sound decision.

Posted by Charlotte Schubert at 06:11 PM | Permalink | Comments (3)

Almost any day of the week in Washington, DC you can go to a public hearing—and if you’re lucky you’ll be entertained at the sight of some harried public servant squirming under the relentless questioning of our elected representatives. Last week’s intended victim was Andrew von Eschenbach, head of that beleaguered agency, the US Food and Drug Administration.

Von Eschenbach appeared before Senate and House appropriations subcommittees to defend the proposed 2008 FDA budget. On Wednesday I wandered down to the capitol—source of straitjacket dull fashion and casualty of a recent impertinent smoking ban, courtesy of Nancy Pelosi—to check out the action at the House.

I have to admit that I should have taken better notes. But every time von Eschenbach opened his mouth I wanted to fall asleep; he must have used the word “system” about 18 times and “process” at least 22.

Still, I woke up when representatives began grilling von Eschenbach about news reports that he planned to cut funding for the FDA’s Office of Women’s Health—ostensibly in retaliation for the office’s support for over-the-counter “Plan B” contraception.

He called the reports, “inaccurate.” but he failed to assuage the committee, saying, “I haven’t made that decision yet.” Congress will have to wait till March 15 to learn if funding will be retained. I must admit I was a bit disappointed: He obviously wasn’t squirming enough.

Von Eschenbach also faced a phalanx of representatives concerned about food safety. He could not say when a long-overdue report on this summer’s spinach outbreak would appear, had no opinion on whether irradiation was underused to zap food, and I'm still not sure what he would do if he was, hypothetically, given $20 million more for food safety. But he did use one of those words again. How to shore up the food supply? “This is a systems problem that requires a systems approach.”

Representative Sam Farr from California’s spinach district was not impressed, “It’s a mystery why they [the FDA] would come before us with so few concrete answers,” he said in a press release.

Committee members also did not let von Eschenbach off lightly when it came to drug safety, grilling him about the approval of the antibiotic Ketek—itself a subject of separate hearings. Von Eschenbach defended the FDA’s record on conflict of interest among members of its advisory committees, saying it was broadening access to experts and that the agency “Is taking a process improvement approach to this.”

The committee’s chair, Rosa DeLauro from Connecticut, seems like the smartest of the bunch, bristling with sharp questions and a record of sponsoring a measure to grant the agency greater authority over post-marketing surveillance.

She and other committee members could be strong advocates for positive change at the FDA, especially if von Eschenbach begins to work better with the congressmen who have authority over his budget. Now that’s a process worth improving.

Posted by Charlotte Schubert at 04:32 PM | Permalink | Comments (0)

Something strange--and embarassing--has happened in India.

For the past few weeks, Novartis has been fighting a lawsuit in India that could affect the availability of cheap drugs worldwide. The lawsuit challenges India's decision to interpret WTO rules and only honor patents on drugs that are entirely new, not just derivatives or variations of existing drugs.

This clause allows Indian companies to make cheap copies that they then sell all over the world. The case is still being heard, although high-profile voices, including nonprofit group MSF (Doctors Without Borders) and Henry Waxman, chair of the influential US House Committee on Oversight and Government Reform, have asked Novartis to drop the suit. More than 250,000 people have signed the MSF petition.

In the meantime, the Indian government had asked a high-level committee, including R.A. Mashelkar, who retired last year as Director General of India's Council of Scientific and Industrial Research and is arguably one of the most respected Indian scientists, to look into the patent issue. After nearly two years' deliberations, the committee produced a report on the law that is favorable to Novartis.

But get this: an Indian newspaper discovered that the crucial bits of the report were plagiarized from a paper published by a think tank in the UK and funded by INTERPAT, an association of pharma companies whose members include Novartis. Mashelkar says he didn't know about the plagiarism and has withdrawn the report, asking for three months to review it. I buy that he didn't know about the plagiarism and that it might have crept in when the "draft was being worked on by a sub-group" but the larger issue is the potentially biased source of the original conclusions.

The government hasn't yet said whether it will accept the revised report, but any way you slice it, this is a deeply embarassing incident for Indian science. Earlier this month, Nature challenged Indian scientists to speak up and help shape policies. This is an inauspicious start indeed.

Posted by Apoorva Mandavilli at 05:59 PM | Permalink | Comments (1)

The most popular news item on Yahoo yesterday was a Reuters article about a potential new cancer drug. Intrigued, I read the article but couldn't understand why it was news.

The article is a cutesy account of how the researcher, Katherine Schaefer, had mistakenly added massive amounts of a PPAR-gamma modulator to a cancer cell line and killed them. That apparently led Schaefer to test this substance as a cancer drug in various other cancer cell lines and in mice.

As most biologists can tell you, almost anything added in massive amounts will kill cells. It's fortunate that this one does seem promising, but let's be realistic. So far, it seems effective in mice, which are a far, far cry from humans. Even if everything works well, a less than 10% chance, it will be at least 15 years before a drug version sees the light of day.

This particular article was published in the International Journal of Cancer--and not in the fictitious International Cancer Research as the Reuters article said--but a quick PubMed search reveals that Schaefer first published a link between PPAR-gamma and cancer in 2005. So even that aspect wasn't new.

Although scientists do often hype their findings, Schaefer herself seems perfectly reasonable. When I told her I was surpised her paper had been covered so widely, she said, "You and me both." Apparently, this was the work of an energetic PR person at her university who, I must say, deserves to be congratulated. She spun the story admirably well as a tale of lucky accidents, a wire service journalist bit and bingo! I could say something here about the dangers of over-hyping science, but I'll restrain myself.

At least the publicity has already had one good outcome. Schaeffer says she's had emails from people she hasn't heard from in 15 years or more. Happy accident indeed!

Posted by Apoorva Mandavilli at 03:44 PM | Permalink | Comments (2)

If I smoked cigarettes I think I’d have to grow my own tobacco. There’s nothing inherently evil about the plant itself. The tobacco companies, on the other hand….but wait, I must retain my objectivity.

It’s tough to do that though with the most recent news. Harvard researchers have confirmed reports that the tobacco industry has raised the nicotine content of cigarettes steadily over the last several years—with the aim, of course, to get more people hooked on their product.

The recent study is sure to add fuel to efforts to bring tobacco regulation under the umbrella of the US Food and Drug Administration (FDA). Legislation to do just that failed last year but there are signs it will be reintroduced in the new, Democratic congress. But is it a good idea?

That effort is endorsed by many public health groups, David Kessler, the former FDA commissioner and anti-tobacco gadfly, as well as Phillip Morris itself (some speculate the tobacco giant would keep its industry lead in a clamped down advertising environment). Most recently, the New York Times and the Washington Post added their voices to the call for FDA oversight.

I had heard rumors that at least one leader in the tobacco control area, UC San Francisco professor Stan Glantz, was more skeptical. So I called him up.

Glantz clarified that in principle, FDA regulation is a good thing. He’s just worried about the details.

“I think it’s obscene that the FDA doesn’t have jurisdiction over tobacco,” he told me, “The real question is how you do it.”

He says the law must be written very strictly to make sure tobacco companies can’t manipulate the agency—which doesn’t exactly have an airtight reputation when it comes to resisting political influence (think plan B contraception).

“The real risk is that you will end up with a process that will allow tobacco companies to claim that they have FDA approved cigarettes.” Unlike some tobacco control experts, Glantz is wary of efforts to create a special regulatory category for cigarettes, which he says could create room for a special brand of tobacco company mischief.

But he says there’s a better chance than last year that a good law will emerge, with a new party in charge. If congress does bring up the issue again, let’s hope it is serious about using the FDA to clamp down on cigarette companies.

Meanwhile, if you must smoke—I endorse backyard tobacco agriculture.

Posted by Charlotte Schubert at 12:13 PM | Permalink | Comments (1)

When I worked at Fred Hutchinson Cancer Research Center in Seattle I was struck by the chemicals researchers routinely tossed away—often down the drain. It seemed paradoxical that the attempt to understand cancer involved the manufacture of some nasty carcinogens.

Of course, in the big scheme of things the amount of chemicals used in cancer research is small. And almost any positive endeavor has its shades of grey.

Take the Bill and Melinda Gates Foundation. Its role in public health has been extraordinary—but as a report in the Los Angeles Times reveals, the financial arm of the foundation invests in companies that spew some pretty toxic stuff, and may otherwise undermine the mission of the foundation.

These investments include oil companies that pollute regions of Africa where the foundation operates and a health care company embroiled in lawsuits for allegedly unnecessary surgeries. The Times claims that at least 41% of the foundation’s assets, or $8.7 billion, are in companies that “countered the foundation’s charitable goals or socially concerned philosophy.

Unlike some other philanthropies, such as the Ford Foundation, the Gates Foundation has apparently set up a firewall between its investment and granting arms—to try to keep the fund as flush as possible.

It may be easy to quibble with some of the standards used by the LA Times to criticize the Gates Foundation. Nonetheless, with an endowment boosted by Warren Buffett to more than $60 billion, it seems that the foundation could wield its substantial investment power in ways more in keeping with its public health mission.

Posted by Charlotte Schubert at 05:33 PM | Permalink | Comments (1)

If you read our year-end issue, you know that we voted Andrew von Eschenbach "least likely to succeed" as the FDA's new chief.

But who asked us? After months of dilly-dallying, the Senate yesterday confirmed von Eschenbach as the new commish. Not that this is a plum job. The last chief, Lester Crawford, lasted exactly two months before he abruptly resigned--which all became more clear when a federal court charged him with lying about his shares in drug companies.

What the FDA needs is someone tough and smart, with enough integrity to stand up to drug companies and a clear plan for dealing with all the messy conflict-of-interest issues, not to mention the urgent scientific questions--like the one the new British panel will tackle.

It's a lot to handle, and I'm just not sure von Eschenbach is the man for the job. This is after all the same man who, as director of the National Cancer Institute, famously declared that we would cure cancer by 2015.

Overall, this has been a terrible year for the FDA. I hope it didn't just get worse.

Posted by Apoorva Mandavilli at 12:17 PM | Permalink | Comments (1)

Speaking of doses, there is news today from across the pond that the UK will set up a special panel to look at high-risk studies of drugs.

You'll remember that in March, German company TeGenero tested its monoclonal antibody TGN1412 on six healthy volunteers. Within hours, all six ended up in intensive care. Hindsight being 20/20 and all that, critics said later that the company should have given the drug to just one guy and proceeded with caution.

Apparently, this new panel will make sure those kinds of blunders don't happen again. A bit late for the men, one of whom swelled up to look like an 'elephant man', but a good move nonetheless.

Here's the thing, though: some of these ill-considered studies make it through because the reviewers are overburdened and don't have time for the details, or because they have conflicts of interest, or simply because science is unpredictable.

In the case of this drug, the preclinical work, which included data from monkeys, gave no hint that the trial might end disastrously. After all, this was not a 'first in class' drug.

So how would this panel have known to be more cautious?

But maybe I'm being too cynical--I'd love to be proven wrong.

Posted by Apoorva Mandavilli at 04:31 PM | Permalink | Comments (3)