Spoonful of Medicine - Blog Posts with Comments

The Oprah effect

cschubert — 2009-11-24T12:03:37-05:00

Jenny McCarthy: vaccine expert

When it comes to swine flu vaccine, US health officials seem to be fearing fear itself.

Unlike most countries, the US is not using adjuvants in its swine flu vaccine. To do so, US health authorities must approve them in the vaccine on an ‘emergency’ basis. Why haven't they?

One reason is that officials are concerned that people will reject the vaccine. That seems clear from recent congressional testimony by Anne Schuchat, head of immunization and respiratory diseases at the US Centers for Disease Control and Prevention.

Here is an exchange at a hearing last week between Schuchat and representative Bark Stupak:

Stupak: What is the problem with the adjuvant other than we haven't done the test here in this country? [Referring to data obtained in Europe on the safety of the swine flu adjuvant]

Schuchat: Well, you know -- as you know, the public's confidence in our vaccine system and in vaccines in this country -- very, very fragile.

Schuchat voiced similar concerns in an interview with Reuters. The decision surely weighs heavily on Shuchat and other health officials: if they had decided to use adjuvants, which reduce the dosage needed in a flu shot, the US would probably not be facing vaccine shortages—something I have blogged about before.

Other considerations, of course, factored into the decision. For instance, Jesse Goodman, an FDA official, told congress that the bulk of the safety data for the adjuvanted vaccine has been obtained in people over age 50, “So in terms of the kind of broad experience with millions of people that's only in the elderly who were not a focus population of this vaccine…we don't have enough data about those at this point or at the beginning of the pandemic for them to meet the standard of FDA licensure.”

Clearly, officials have the concerns and safety of the public in mind. It is also difficult to fault US agencies for considering the concerns of a public inundated with faulty information on vaccine safety, proliferating on the internet and aired by Don Imus, the Huffington Post and Oprah. Oprah, for instance, recently signed a deal with celebrity anti-vaccine activist Jenny McCarthy. The former playboy bunny is a regular guest on her show.

I wonder if Oprah has got her flu shot yet.

New HIV cases on the decline

edolgin — 2009-11-24T10:37:46-05:00

The death toll from AIDS has topped 25 million people, but new infections are dropping sharply, according to a report released today by the Joint United Nations Programme on HIV/AIDS (UNAIDS) and the World Health Organization (WHO).

First, the bad news: according to the new report, titled AIDS Epidemic Update 2009, last year some 2.7 million people became infected with the virus. That brings the total number of people living with the disease to around 33.4 million worldwide.

The good news is that this rate of new HIV infection has been reduced by 17% over the past eight years. Since 2001, HIV incidence has fallen by 15% in sub-Saharan Africa and 25% in East Africa. In South and South East Asia, HIV infections declined by 10% in the same time period.

The report also concluded that the number of AIDS-related deaths has dropped by more than 10% over the past five years. That change, it says, is due in large part to more widespread availability of life saving anti-retroviral treatments.

The report’s rosy glow is no license for complacency, however. "This is a sign that HIV infection prevention efforts are making a difference, but we're still not moving fast enough to break the trajectory of the virus," UNAIDS deputy executive director Paul De Lay said at a press conference.

For example, a new case study published in this month’s issue of the journal AIDS describes a particularly nasty strain of HIV that killed a previously healthy 20-year-old within 6 months of infection, even though the virus didn’t show up on standard antibody tests. So, while infections and deaths may be on the decline overall, clinicians and researchers need to stay vigilant to detect the next trick up HIV’s sleeve.

"It is now a morel imperative that we sustain and strengthen the global response to this epidemic," Teguest Guerma, acting director of the WHO's HIV/AIDS department, said at the press conference.

Image: UNAIDS

Cannabis for kiddies

rkhamsi — 2009-11-23T15:00:35-05:00

Posted on behalf of Elie Dolgin

It gives new meaning to term high school: Medical marijuana is reportedly being prescribed to teenagers who suffer from behavioral problems such as attention-deficit hyperactivity disorder (ADHD).

The New York Times reports that a network of 20 clinics in Oakland, California has treated as many as 50 adolescents with ADHD. Up the bay, a Berkeley doctor was investigated by California’s medical board after he authorized the drug for a 16-year-old boy with the disorder.

Bestowing bud upon kids with terminal illnesses like cancer and AIDS is one thing. But with ADHD, the idea of smoking up children seems dazed and confused to many in the medical community. The drug has been linked to many psychotic symptoms, and is likely to aggravate the concentration problems seen in many ADHD kids.

Others don’t think that it’s such a half-baked idea. Marijuana might be safer than many psycho-active prescription drugs, such as Ritalin, often used to treat ADHD, some contend. And far from promoting drug use, a recent report from the Marijuana Policy Project Foundation found that teen dope smoking has not risen in states that have legalized the drug for medical purposes.

For a good round-up of peer-reviewed studies both supporting and opposing medical marijuana usage in children with ADHD, autism or cancer, see the debate at ProCon.org.

Photo by Torben Bjørn Hansen

Waiting it out

cschubert — 2009-10-29T15:46:11-05:00

The lines are long, and people have been turned away in droves. Only the lucky and persistent—including the Obama girls—have got their swine flu shots in the US.

The vaccine is late, and in short supply—just at the US epidemic may be hitting its peak (see this ominous interactive map from the Wall Street Journal.)

But there is no shortage of blame: slow-growing viruses, chicken shortages, and, according to one opinion piece, higher doses of vaccine going to women than they may need. So, why not add another culprit to the mix: the lack of adjuvants. These are substances added to vaccines to increase their potency and decrease dosage.

The US is not using adjuvants in swine flu vaccines, whereas European regulators have approved them. As a consequence, each US citizen lucky enough to get a shot will be injected with 3 times as much vaccine material than people in Europe (15 vs. 3.75 micrograms).

But there are some subtleties. For instance, not all manufacturers in Europe are producing adjuvanted vaccines. Glaxo Smith Kline and Novartis, companies with large research enterprises devoted to adjuvants, have put them in their swine flu shots. But other companies, such as Baxter International, have not. European health authorities, it seems, have not figured out how to get adjuvants into the non-adjuvanted vaccine—something that can be done at the sight of administration. The US was prepared to spike its vaccines with adjuvant, ordering more than $500 million of the stuff from Novartis and GSK in case it was needed.

Another factor that could affect global supply is that European regulators this week recommended two shots of the vaccine, while most people in the US will get just one. It seems US authorities are content with the less-than-perfect protection afforded by one shot, while European regulators may be reaching for air-tight immunity.

Meanwhile, the US Food and Drug Administration has just approved a vaccine—cervarix, the shot against cervical cancer—with a new generation adjuvant. It’s the first adjuvant to hit US soil since alum, more than 60 years ago. The approval could signal a change in mindset at an agency with a reputation for extreme caution on vaccines—but it comes too late for the swine flu.

Some critics have charged the FDA with being asleep at the switch while European regulators developed plans over the last few years to put oil-in-water adjuvants into pandemic flu vaccine should they be needed. Europeans readied the safety data and set the stage for quick, systematic, approval (see my story on adjuvants in the September issue).

It’s not clear what factors went into the decision not to use adjuvants in the US. But the swine flu vaccine works fine without them, and when the decision was made, supply seemed assured. And just typing ‘vaccine adjuvants’ into Google will tell you how freaked out people can be about vaccine safety.

A few months ago, when swine flu vaccine manufacturing seemed on track, some health experts criticized the US for being a bad global citizen in deciding not to use adjuvants, because its extra needs could drain the world’s supply. But now the decision seems to be coming home to roost.

Blame the chicken

Comment 1 (Waiting it out)

Annette Markus — 2009-10-30T13:35:33-05:00

Seriously, why is the vaccine still produced in eggs? Influenza viruses can grow in tissue cultures, but progress in bioreactor development seems a-w-f-u-l-l-y s-l-o-w... Must be money reasons, but it's hard to believe that gazillions of eggs would be cheaper than some big fermenters.

Safety first

cschubert — 2009-10-01T22:18:42-05:00

I got a phone call tonight from the US Centers for Disease Control, asking if I was planning to vaccinate myself and my child against pandemic H1N1 'swine' flu.

The woman on the line said that the agency was conducting the survey to find out more about attitudes towards vaccination, trying to find the demographic of people reluctant to vaccinate.

I could point them to one demographic: one of my local online parents' groups. “Don’t get your kids vaccinated!” warned one poster. “The risks outweigh the risks of the illness.” She said, citing unnamed ‘sources’ at NIH.

Apparently that mom is not alone in her safety concerns. A recent poll from Consumer Reports finds that just 35 percent of parents were sure they would get their children vaccinated, while 14 percent of parents would ‘definitely’ not. Even more disturbingly, a separate survey found that only 38 percent of health care workers were planning to get vaccinated. You can read more about the polls at the Los Angeles Times blog “booster shots.”

With the first swine flu shots coming on deck next week, the CDC does not have a lot of time to figure out how to get safety messages out to the public. Its website does a decent job, but it might be appropriate to link to a web page with a more detailed message outlining results of clinical trials with flu vaccines and explaining exactly how the vaccine is made. Or perhaps the agency has consciously chosen to go with a simple message.

My feeling is the agency might be facing some powerful anti-vaccine sentiment in the this country. I hope that the agency is ready with smart, detailed and to the point explanations. My phone call last night indicates they are at least thinking about how to craft their public health message on vaccine safety.

You can see the CDC website here. What do you think? Does it do a good job of explaining why the agency expects the vaccine to be safe?

Super-stretching the pandemic vaccine supply

cschubert — 2009-09-15T19:02:01-05:00

The data are piling in, and it looks like one shot of H1N1 pandemic flu vaccine is enough to protect most healthy adults. And today, the FDA announced it has approved the vaccine.

That’s better news than expected—many experts had predicted two shots would be needed, putting pressure on tight supplies. But there clearly will still not be enough vaccine to go around, particularly in poor countries.

In the US, it is conceivable that high-risk populations like pregnant women might get vaccinated before the flu season hits full force, and most people could ultimately get the shot. That’s because the US has bought billions of dollars of vaccine--a price many countries cannot pay for such a limited commodity. Today the head of the World Health Organization, Margaret Chan, said she expected this “virus of extremes” to cause far more deaths in poor countries than in affluent ones.

The dosage in a single shot is 15 micrograms. But there is a way to bring down the dosage and further stretch the supply—using oil-in-water adjuvants, which have been approved for seasonal flu vaccines in Europe. Glaxo Smith Kline (GSK) recently showed that, with its AS03 adjuvant, a 5.25 microgram dose will protect 98 percent of adults (95 percent of the adults in its trials were protected with unadjuvanted vaccine at a 15 microgram dose). Stretching supplies further, GSK says it plans to sell shots with 3.75 microgram.

That’s a substantial reduction in dosage. But as I report in the latest issue of Nature Medicine, US regulatory authorities have not seemed eager to exercise their option to approve adjuvants in pandemic flu vaccine on an emergency basis—a decision that could have implications for global supply.

What do the recent data and vaccine approval mean for the prospects of using adjuvants in the US? I asked Amesh Adalja, a fellow at the Center for Biosecurity in Pittsburgh, Pennsylvania and a physician at the University of Pittsburgh Medical Center.

“I think the approval means that the pandemic vaccine will not be adjuvanted,” said Adalja.

Nonetheless, clinical trials are on deck at NIH to test adjuvanted vaccine. Adds Adalja: “I think that there is enough clamor about adjuvants that maybe we will see some trials using adjuvanted vaccine. The GSK adjuvant, AS03, can be mixed with some of the other manufacturers' vaccines after production and we might get enough data for an approval (but probably too late for this flu season)."

You can access a great rundown of the new vaccine data by Adalja in his blog posting. Despite the new findings, he is skeptical about whether enough vaccine will be ready, even in affluent countries, by the time the peak of the pandemic is expected to hit.

H1N1 vaccine supply could potentially get boost from cervical cancer vaccine

cschubert — 2009-09-11T04:20:30-05:00

US regulators may allow the next generation of vaccines to pass their high bar for approval.

On Wednesday, an advisory committee to the US Food and Drug Administration recommended approval of the cervical cancer vaccine, Cervarix, which contains a new adjuvant-substances that give extra pep to vaccines.

If the agency follows through on the committee’s advice, Cervarix will be the first vaccine approved in the US with an adjuvant other than alum-an adjuvant based on aluminum salts used for more than 60 years. The agency is expected to issue a decision by the end of September.

But the big question is whether the US will consider using adjuvants in pandemic H1N1 flu vaccine, a decision that has serious potential to stretch a limited world-wide supply. A positive decision on Cervarix could change the way the agency perceives adjuvanted H1N1 pandemic flu vaccine, an option that does not seem to be its first-choice, as I report in a recent article on adjuvants in Nature Medicine.

Cervarix, made by Glaxo Smith Kline, has already been approved dozens of countries, as have other vaccines with next-generation adjuvants, including several vaccines for seasonal flu.

European regulators are poised to approve vaccines for pandemic H1N1 flu vaccine containing an oil-in-water adjuvant-the same adjuvant used in seasonal flu shots given safely to millions of people in Europe. But US regulators are widely perceived by public health researchers as much more cautious.

The agency, nonetheless, also gave the green light on Thursday to clinical trials of an adjuvanted hepatitis B vaccine, manufactured by the biotechnology company Dynavax. The FDA had put the trials on hold 18 months ago pending investigation into whether vaccination may have been linked to a rare autoimmune condition that had developed in a trial participant. Now the company can continue to test its vaccine in people with chronic kidney disease who do not respond well to the standard hepatitis B shot.

So, it’s been a good week for adjuvants at the US FDA. We will see what that means ultimately for pandemic flu shots.

Researchers at Novartis are still awaiting data on the degree to which adjuvants can cut down the dosage of pandemic H1N1 vaccine. Meanwhile, studies out Thursday in the New England Journal of Medicine suggest that one shot of vaccine may be sufficient. And this Friday the NIH will also discuss early results from its clinical trials. Stay tuned.

Bad brownies

rkhamsi — 2009-09-04T11:35:15-05:00

Yesterday, we told you about the new recommendations from the US Institute of Medicine aiming to keep junk food out of the hands of kids.

Today, a report published in Morbidity and Mortality Weekly Report gives another reason to keep sweets away from youngsters: inadvertent marijuana ingestion.

I think the journal's lay summary speaks for itself:

"It is beneficial for local health departments to establish good working relationships with law enforcement. In April, 2009, the Los Angeles Police Department and the Los Angeles County Department of Public Health launched a collaborative investigation concerning a group of preschool teachers with neurological and gastrointestinal symptoms after eating brownies purchased from a sidewalk vendor. This report summarizes the results of that investigation, which detected cannabinoids in a recovered sample of the brownies. Two patients sought medical treatment, and one patient’s urine and serum tested positive for marijuana metabolites. The findings demonstrate the utility of a collaborative investigation by public health and law enforcement and the importance of timely testing of clinical specimens after symptom onset. It also underscores the need to consider marijuana as a potential contaminant during foodborne illness investigations."

Image via Norwichnuts.

The best swine flu raps

rkhamsi — 2009-09-04T11:30:45-05:00

There may be no rhyme or reason to why the H1N1 swine flu emerged as a global threat last spring... but some doctors and health officials are using rhythm to explain how to best avoid this nasty virus.

The US government is asking the public to vote on their favorite H1N1 public service announcement. And while some rappers might want you to throw your hands in the air and 'wave'em like you just don't care', at least one hopeful contestant, Dr. Clarke, is hoping to you'll throw your hands into the sink and start washing them. He already is gaining a bit of a following.

To see all the videos up for vote, click here.

Meanwhile, a cartoon aired at the Shanghai airport has also put the dangers of H1N1 into a rap. To see a capture of the video, click here.

Have you seen any other H1N1 flu raps out there that strike your fancy?

Sizzling summer of fun

cschubert — 2009-09-03T12:09:07-05:00

A few weekends ago I made the mistake of volunteering for a fund-raising festival at the local toddler stomping ground. The afternoon hit 90 degrees, with full humidity. Determined to be a good mom, and a good citizen, I went to the park anyway.

The place was packed with kids, whining to ride a pony and eat pink cupcakes. The adults were sweaty, distracted and grumpy. But at least they did not have my job!

I got to feed little children this:

I knew, in a vague way, that mass-produced popcorn wasn’t a great thing. But this was in another realm entirely: a 2:1 ratio of popcorn to coconut oil, tinged with some yellow substance. My job was to extrude the pure supersaturated ooze into the sizzling machine and joyfully dispense the popcorn product.

Apparently it’s not too different from what kids must be eating every day. According to a September 1 report from the Institute of Medicine (IOM), “Local actions to prevent childhood obesity,” 16.3 percent of children and adolescents in the US between the ages of two and 19 are obese.

People started flocking to my hot corner of the playground. Parents tactfully steered their children clear of the plastic-colored cake items and to what they might have thought, in their harried state, looked a little more like normal food. Admittedly, the popcorn people did a good job with the artificial butter, it had a certain chemotactic pull.

Holding back an urge to run home fast, I instead carefully placed an unopened plastic pod of kernels on the table. Surely, with the goop right in front of them, people would hesitate before grabbing a bag of popcorn.

No such luck. Cranky parents yanked at the cheerful striped bags, shoving quarters in my hand. Grubby 8 year olds came back for seconds. It was like some sort of food hell. When a pregnant woman came up my frozen smile cracked:

“You might not want to eat that,” I said, imagining what Yellow #6 Lake (E110) did to embryonic digits. She was unfazed by my meddling, “Oh! It’s not for me! It’s for my son!”

My only conclusion from the experience is that kids will eat whatever is in front of them and that harried parents will do little to stop it. Parents are a poor filter against the proliferation of junk food targeted to children (my favorite is this baby-bottle-shaped candy, marketed by teeny bopper band the Jonas Brothers, in a wildly popular YouTube video).

If the IOM had its way I’d be prosecuted. One of their recommendations: “Implement local ordinances to restrict mobile vending of calorie-dense, nutrient-poor foods near schools and public playgrounds.”

During my hours pouring grease and yellow stuff into a machine, and inserting it into the veins of my neighbors’ children, only one child paused. He looked at the package, turned it over gingerly, and walked away.

I had poisoned many, and saved one. I went home with my two-year old, face flecked with neon frosting, to contemplate my crime.

Possums and toxins

cschubert — 2009-08-07T19:07:49-05:00

You can’t fault this years meeting of the Society for the Study of Reproduction for its lack of diversity. The lineup included scientists who study marsupial possums, environmental toxins, the mechanics of DNA silencing, and a cluster of Texans who keep a herd of sheep close at hand near their lab.

I am now a step closer to understanding the wonders of the pig uterus—which gestates an embryo that within a day goes from a 1 cm sphere to a 1 meter long thread (“Like dental floss,” explained one researcher.) I’m more wary than before of that uibiquitous stuff that lines food cans (bisphenol A; BPA). And I am threatening to turn into a scold against soy infant formula (studies at the meeting showed that estrogen-like compounds in the formula can shut down DNA in young animals in a process called methylation).

I’m late on the uptake blogging about the meeting—the usual excuses about trying to meet editing deadlines while attending the sessions, loose proofs, wayward authors. And I only went for two days—Monday, July 20 and Tuesday, July 21. But even belatedly, some of the highlights of the meeting, which took place in Pittsburgh, still seem worth touching on.

On Monday, researchers presented a cluster of studies where they attempted to freeze oocytes—the trendy way to promote fertility in countries such as Italy, where freezing of tiny embryos presents a legal quandary. No one has hit on the answer yet—upon thawing, the oocytes still seem to lose too many chromosomes. But some researchers are getting closer.

Theresa Woodruff, for instance, presented data on preserving fertility in women undergoing cancer treatment, showing how her group can culture human ovarian follicles that produce fully-sized oocytes. She hosted a conference on the subject in Chicago this July, the 'Oncofertility Reflections on the Humanities and Social Sciences ' bringing together religious and legal experts with ethicists and scientists to discuss the ramifications of the emerging technology. That seems like a smart thing to do for a researcher working a system that has the potential to bump up the upper age of female reproduction.

Much of the Pittsburgh meeting focused on reproductive toxins, not surprising given that chair of the meeting was Pat Hunt, known for her work suggesting that BPA may act through estrogen receptors to affect developmental processes such as the integrity of chromosomes in the oocyte.

She invited John Peterson, publisher of “Environmental Health News” to give a rundown of BPA research and government regulation. He pointed out that 90 percent of 232 animal studies funded by the government have found an effect of BPA at levels beneath that considered safe by the US Food and Drug Administration. He provided examples of industry influence at US regulatory agencies and argued they use outdated scientific standards to evaluate toxins. But I’m still not clear on why countries such as Canada have banned BPA in baby bottles while the FDA seems to be thinking about reviewing the data yet again.

That same evening organizers invited a firebrand who speaks up for animal research. Tom Holder, who founded the United-Kingdom-based group ‘Speaking of Research' looks about 18 and he speaks with the urgency of a politician gunning for office. He warned that the intimidation tactics of animal-rights groups in California threaten to turn the state ‘into the next Oxford’, known as a target of such groups. He showed how his organization is working to show the public in the UK how animal research help people, and directed scientists to his group’s website to learn of ways they can help.

To me, the poster sessions were the highlight. Along with the possum researchers, there were people working on fertility in elephants, cattle and manatees. "There is usually a bunchof panda people, but not this year," ’ lamented one researcher.

One poster caught my attention in particular. Swine researchers provide evidence that suckling pigs obtain a critical hormone, relaxin, through their mother’s milk—the hormone in turn seems to be required for the proper expression of developmental genes in the cervix. It may be a stretch, but perhaps the milk is helping to properly prepare the piglets to birth the next generation.

Comment 1 (Possums and toxins)

Robert Kavanaugh — 2009-10-03T05:23:38-05:00

" I’m more wary than before of that white stuff that lines food cans (bisphenol A; BPA). And I am threatening to turn into a scold against soy infant formula (studies at the meeting showed that estrogen-like compounds in the formula can shut down DNA in young animals in a process called methylation)."

Xenoestrogens from plastics like BPA are probably worse than anyone ever realized.

While soy phytoestrogens appear to be Sirtuin 1 activators, thus calorie restriction mimetics--great for fully matured adults; a proven anti-aging strategy, probable anti-cancer cell proliferation, including induction of protective antioxidant enzymes--I too an starting to have concerns about what influence any potential calorie restriction mimetics would have on very young children. I never worried about soy formulas for kids in the past, but many of the signaling molecules that convey information to cells during the control of cellular differentiation like growth factors, are down regulated in calorie restriction polyphenol mimetics. A good example would be resveratrol or soy. In theory, about the worst thing we could do would be to feed a kid soy formula from a hot clear plastic baby bottle.

Hogging antibiotics

cschubert — 2009-07-20T15:25:53-05:00

It’s tough for me to get to work in DC without seeing posters on the subway with pink rosy pigs, asking “Who’s hogging our antibiotics?”

The Pew Charitable Trusts has initiated a campaign to limit the use of antibiotics in livestock. As the ads point out, routine use of antibiotics in farm animals can foster the development of antibiotic-resistance bacteria than can infect humans.

For years, microbiologists have raised their thin, meager voices against this practice. But now they seemed to be joined by some other voices that might carry wider impact. For instance, New York Times columnist Nicholas Kristof weighed in this March against rourtine use of antibiotics in agriculture. Last week Principal deputy FDA commissioner Joshua Sharfstein, testified before congress on the issue, saying:

"Purposes other than for the advancement of animal or human health should not be considered judicious use" says Sharfstein.

The problem is that many animals, raised in cramped quarters, receive antibiotics in their feed much of their lives. Cows that eat corn, instead of grass, are more susceptible to infection. Even the the family farm I took my kid to last month, the friendly one with the pettable happy cows, fed their chickens bags of “Medicated” feed.

Bills to restrict the practice have been kicking around the US Congress for years now, but agriculture interests have kept them from going anywhere. It’s conceivable this year’s version might have a better chance.

Comment 1 (Hogging antibiotics)

joe citizen — 2009-08-03T00:18:42-05:00

The practice of cramming pigs and chickens into small quarters/pens stops the pesky beasts from moving around and (god forbid) burning calories. Of course, you can pen ten times as many beasts in the same area;$$$$$. Their flesh with its lack of muscle tone resembles mush or should I say tender. I find this cramming practice immoral not because of the hideous lives for these unfortunate beasts; we do slaughter them ,but for the infectious risk. In the short term it's appropriate to feed antibiotics to reduce this risk. But this short term fix raises a bigger problem for society. This problem is that this practice makes our antibiotics ineffective. We are creating super bacteria. They are feeding our bacterial/medical breakthroughs to hogs and chickens. This, put franklu is really very stupid. We need to stop this before an infectious genie gets out of the bottle. This could be the calamity of the century. The CDC says we WILL have a pandemic. Should we be allowing the conditions for a PANDEMIC to thrive for the sake higher profits for a few family farm destroying companies. To explain, this pen cramming practice took the livelihood from family farms and de-populated rural America.
This practice could have benifits. The price to put weight on animals has dratically reduced, but the profit margin increased instead of the price at the grocery. We need to look at this much more closely.

Tax deductions for drug ads?

cschubert — 2009-07-14T10:27:08-05:00

Direct to consumer advertising of drugs has been a target of FDA and pharmaceutical company critics. After the debacle of Vioxx, in which the heavily advertised drug was pulled from the market, many called for stricter regulation of such advertisements, or an outright ban. There's been some tightening of drug advertising oversight by the FDA: for instance, the agency recently told General Mills to stop claiming that Cheerios is "clinically proven to reduce cholesterol."

But advocates for reform may have been missing an easy target: Pharmaceutical companies receive tax deductions for such advertisements. This week, congressman Charles Rangel proposed dropping this deduction, which could raise as much as $37 billion over 10 years--money he says could be put towards overhauling health care. The big four television networks oppose this idea, noting that advertising employs millions of people in the United States.

What do you think? Is this a worthy tax deduction, or is Rangel right to call for its elimination?

Comment 1 (Tax deductions for drug ads?)

Alan Dove — 2009-07-15T13:03:26-05:00

The whole direct-to-consumer drug ad binge of recent years has been a public health disaster. Unfortunately, it's also become a multi-billion-dollar industry during that time, so Rangel's proposal is going to draw lots of well-financed assaults from lobbyists.

From a strictly economic standpoint, the tax break doesn't make sense. A tax deduction is supposed to be used to support some specific social good, not provide corporate welfare for advertising products. The policy also fails a basic fairness test: other industries aren't allowed to write off their advertising expenses, are they?

Tumors take a blow

cschubert — 2009-06-11T12:16:08-05:00

Cancer breakthroughs often get their first airing at the annual meeting of the American Society of Clinical Oncology. This year’s meeting was no exception.

One finding getting a lot of press has its origins in a pair of studies in Nature in 2005. The studies showed how to selectively kill cancer cells deficient in BRCA1 and BRCA2, genes that are mutated in some of the deadliest breast and ovarian cancers.

The agent that does the killing is called a PARP inhibitor. And trial results released last week show some pretty promising results.

Olaparib, a PARP inhibitor under development by AstraZeneca PLC, shrank tumors in more than a third of women whose breast cancers had BRCA mutations. The trial did not have a control arm, but the data look encouraging, considering the agent was given alone, without other drugs, and that the subjects had already had an average of 3 chemotherapy regimens. A similar trial showed that the drug could also shrink advanced ovarian tumors in subjects with BRCA1 or BRCA2 mutations.

A truer test of whether a drug is likely to help patients is whether it can prolong survival. A randomized, controlled trial of BS1-201, under development by Sanofi-Aventis SA, examined this question in 116 women with some pretty nasty tumors: their breast cancer had metastasized to other parts of their body and was ‘triple negative’, meaning it lacked receptors on their tumors for estrogen, progesterone and HER2, each of which are targets for current therapies. The drug prolonged survival by three and a half months, to 9.2 months, when added to a standard chemotherapy regimen.

Bigger studies are needed, but the findings so far validate a concept with deep origins in basic research. BRCA1 and BRCA2 facilitate DNA repair, a function that emerged after years of painstaking research. PARP (poly(ADP)-ribose polymerase) mediates DNA repair also, but in a distinct way. The Nature studies exposed cells lacking BRCA1 or BRCA2 to PARP inhibitors and showed that these cells get nailed: their DNA is such a fragmented mess that they die.

Mice deficient in PARP are viable, fertile and tumor-free, which bodes well for the side effect profile of these drugs. Subjects who received the drugs reported only mild side effects, including nausea and fatigue.

Other highlights at ASCO include promising findings with multikinase inhibitors, which can block several types of proteins that go astray in tumor cells. Cancer vaccine approaches also got a boost with positive findings from trials in melanoma and non-Hodgkin’s lymphoma.

Comment 1 (Tumors take a blow)

Charlotte Schubert — 2009-09-10T13:09:19-05:00

some of the work has since been published at the New England Journal of Medicine

http://content.nejm.org/cgi/content/full/361/2/123

here is an associated commentary

http://content.nejm.org/cgi/content/full/361/2/189

Comment 2 (Tumors take a blow)

Isis Avent — 2009-09-05T06:03:14-05:00

Could you please share the link of Original article?

Dangerously close

cschubert — 2009-06-09T14:43:47-05:00

Swine flu is entering the mixing bowl. The virus that emerged this spring in Mexico is now reaching the place where it may have its greatest potential to mutate—the tropics. Cases have recently been identified in India, Vietnam and the Philippines.

Flu viruses circulate year-round in tropical regions, where they can mix with each other, mutate and spawn new strains. Two studies published last year outlined this process, showing how seasonal flu strains in the temperate regions originate in tropical regions.

Unfortunately, as Declan Butler at Nature reports, surveillance networks are often weak in tropical countries, so it may be difficult to monitor the evolutionary trajectory of the new H1N1 virus.

Vaccine experts breathed a sigh of relief when the first sequences of the new H1N1 virus revealed relatively little variability among isolates. That makes it easier for manufacturers to produce a vaccine that could work against all forms of the virus. But the virus may surprise us in the fall, popping up as a different sort of beast—or beasts.

There are also fears that the virus will wreak havoc in sub-Saharan Africa, where there are many people living with HIV, weakening their immune system and possibly increasing their vulnerability to swine flu.

Comment 1 (Dangerously close)

nasir james — 2009-07-25T02:09:05-05:00

At the moment the strain is not that dangerous to humans. It’s just being blown out of proportion by the media. It’s no more harmful than the common cold in my opinion. But if and when it mutates the new strain could be much worse.

I hope that the vaccines reach those in sub-Saharan Africa and bureaucracy does not get the better of them. Because lets face it if swine flu does reach the areas of Africa with high incidence of HIV, it would as you say wreak havoc on their vulnerable immune systems.

Could I also ask what the titles of these papers regarding the mutating strategies of viruses is, sounds like an interesting read

Thanks