Tag Archives: public policy

Should Triclosan Be Banned?

The EPA is now considering a proposal to regulate the ubiquitous antibacterial compound triclosan. That’s the stuff manufacturers have been pouring into everything from soap to toothpaste in order to market it to a germophobic public. As the EPA documents show, there’s a growing body of research showing that all that triclosan going down our drains might not be so great for the water supply, the environment, or human health.

Products for a germophobic public. Image courtesy Flickr user astrangegirl.

Products for a germophobic public. Image courtesy Flickr user astrangegirl.

If you’d like to comment on the petition, just read it first, then click the “Submit a Formal Comment” link on the Federal Register’s web site within the next two months. And, of course, wash your hands afterward.

Step Right Up, Get Yer Fresh, Hot Data

The Obama administration has announced the launch of a new website with troves of freely accessible data from across the government. The site includes major releases of several new datasets that agencies used to charge money for, as well as some that were simply unavailable to the general public. In addition, they appear to have collected direct links to a huge amount of information that was already online but hard to find, hidden behind the quirky site structures of individual agencies.

Even if you don’t need historical maps of mangrove habitats in the Southeast or detailed statistics on cancer incidence and population, it’s worth checking out the site just to get a feel for what’s now available. They certainly haven’t released everything about everything, but this is definitely a big step in the right direction.

Data.gov screenshot

Got data?

Cell Phones Are Good For You (If You’re a Mouse)

In research bound to haunt the nightmares of certain trial lawyers and state legislators, scientists at the University of South Florida have found that long-term cell phone use might actually be good medicine:

“It surprised us to find that cell phone exposure, begun in early adulthood, protects the memory of mice otherwise destined to develop Alzheimer’s symptoms,” said lead author Gary Arendash, PhD, USF Research Professor at the Florida ADRC. “It was even more astonishing that the electromagnetic waves generated by cell phones actually reversed memory impairment in old Alzheimer’s mice.”

Mouse cages around a cellular phone antenna. © Photo courtesy of University of South Florida

Mice were exposed to cell phone signals from a centrally-located antenna.

Arendash’s experiment involved housing wild-type and Alzheimer’s-prone mice in cages placed around an antenna, which emitted signals near cell phone frequencies for two one-hour periods each day over the course of several months. This appears to be the first time anyone has looked at such a chronic, realistic exposure level to the same frequencies used by cellular phones, in a controlled laboratory setting.

That said, the usual caveats apply. Mice are not humans, and the Alzheimer’s mouse model in this study is an inbred strain that mimics many aspects of human dementia, but not all. Also, the experiment wasn’t really set up to detect tumors, which are the real focus of litigators’ and legislators’ ire. While the researchers did not find any visible masses in the brains of dissected mice at the end of the study, the sample size and length of the test weren’t really adequate to assess the animals’ cancer risks.

So using a cell phone might or might not increase your risk for cancer, but it might also prevent or treat Alzheimer’s disease. Choose your poison, but don’t be surprised if it turns out to be nontoxic.

FDA Tries to Balance Risks in Drug Disposal

The FDA has just launched a new web page about medication disposal, focusing on the tricky problem of drugs that are too hazardous to throw in the trash. The page highlights the danger of Junior or Fluffy getting into a trash can and ingesting a dose of, say, granddad’s oxycodone. To avoid that, officials are now reminding the general public to flush such narcotics down the toilet:

The medicines on this list of medicines recommended for disposal by flushing are safe and effective when used as prescribed, but they could be especially harmful to a child, pet, or anyone else if taken accidentally. Some of the possible harmful effects include breathing difficulties or heart problems, possibly leading to death. For these reasons, FDA advises that flushing these medicines down the sink or toilet is currently the best way to immediately and permanently remove the risk of harm from the home.

Of course, as I’ve mentioned a few times, drugs in sewage may come back to haunt us in strange ways. Fortunately, the new FDA page spells out which drugs should be flushed, and emphasizes that all of the others should go into the regular landfill-bound trash instead. The new guidelines won’t solve the problem of pharmaceutical pollution, but it’s nice to see that they’re at least acknowledging it.

As I Was Just Saying…

A couple of posts ago, I referred to the “echo chamber” problem in emergency communications. If you doubted the existence of that phenomenon, this news should settle the issue:

A Coast Guard training exercise in the Potomac River near the Pentagon sparked confusion amid Friday’s commemorations of the Sept. 11 anniversary. Media reports that shots were being fired in the river sent FBI agents scrambling to the scene and led the nearest airport to briefly ground flights.

No shots were fired as part of the exercise, Coast Guard Chief Keith Moore said later Friday.

The Coast Guard said it would review how its exercise led to TV news reports that were “based on overheard radio calls made over a training frequency” normally used only by the Coast Guard.

I suspect we’ll be seeing more of this sort of thing in the future.

Calling Shenanigans on Patent Medicines, Again

Gerald Weissmann, editor-in-chief of the FASEB Journal, has a good editorial in the journal’s current issue. While it doesn’t break any new ground, it does provide an excellent history of the vast “dietary supplement” industry:

If our economy tanked because of subprime mortgages, perhaps the time has come to look at subprime drugs. (I’d call drugs “subprime” if they affect bodily functions without having undergone tests of safety and efficacy by the FDA.) Unfortunately, the $24 billion/year “dietary supplement” industry peddles subprime concoctions that can only be recalled after someone blows a whistle. Case in point: A class-action law suit filed in Atlanta by the Falcons’ Grady Jackson finally led the FDA to recall StarCaps slimming capsules and over 60 other dietary supplements because of unlisted and/or dangerous ingredients. Among the covert ingredients of these over-the-counter nostrums was bumetanide, a potent diuretic (5).

This was not the first time a court in Atlanta has heard accusations of hidden ingredients in a patent medicinal. In 1902, an Atlanta courtroom heard evidence that a medicinal “stimulant,” Coca-Cola, was liberally laced with caffeine and undetermined amounts of cocaine. The ensuing uproar over secret components, especially cocaine, in patent medicines led to passage of the Pure Food and Drug Act of 1906, provisions of which still guide the FDA. Follow-up litigation ensured that today’s Coke no longer contains coke (6)

Weissmann goes on to trace how this legislation evolved, and how hucksters and quacks continue to circumvent it. My prediction: the editorial will draw intense fire from the hucksters and quacks, who will continue to use their political leverage to block meaningful regulation. It’s a good read, though.

Coast IRB Stings Congressional Investigators

This is pretty amusing. A few days ago, I got a press release from an Institutional Review Board (IRB) contractor called Coast IRB. IRBs are the organizations that monitor human clinical research to make sure everything is done in accordance with modern ethical standards, so ideally these folks would take their jobs pretty seriously. Apparently Coast IRB does:

On Friday, March 6, 2009, Coast IRB, an Independent review board, discovered that a protocol submitted to it for review of a medical device called Adhesiabloc by a Device Med Systems of Clifton, Virginia, was in fact fraudulent in violation of federal and state law. Upon receipt of proof of the fraud, Coast IRB and its CEO, Daniel Dueber, ordered the immediate termination of the clinical trial, referred evidence to federal and state authorities for investigation and prosecution, and instituted measures to prevent a recurrence.

So far, so good. They found out that someone was trying to set up a shabby clinical trial, and they called shenanigans. Today, though, Coast IRB felt the need to issue a new press release:

In a press release issued on March 10, 2009, Coast IRB informed the public that it had discovered what appeared to be a fraudulent clinical trial submitted to that Independent review board for evaluation. Coast IRB has since learned that the fraudulent trial was apparently commenced as part of a congressional “sting” operation. Apparently at the behest of the U.S. House Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce, agents submitted false credentials and clinical trial data to Coast IRB and possibly other IRBs to induce them to perform reviews. Evidence of the progress of the trials could then form the basis for arguments critical of the FDA and in favor of greater regulatory oversight.

So they stung the sting operation, and by sending out a press release about it, blew the cover off the whole thing. Was that wrong? Well, the folks at Coast aren’t taking any chances – they’re going on the offensive:

Unless pursuant to a court order or under the auspices of the Department of Justice, the sting could be illegal, violating wire fraud, mail fraud, and state laws against fraud and false credentialing.

First you bust an apparent fake clinical trial, then you out a Congressional sting operation, and now you’re arguing that Congress actually broke the law by initiating the sting. Is this really the right tone to take? At least the parties will have an opportunity to discuss the matter further:

Coast IRB CEO Daniel Dueber had been asked by subcommittee staff to submit to an informal interview prior to giving testimony before the committee on March 19. Following notice from Coast IRB that the fraud had been detected, committee staff informed Coast that the hearing would be postponed until March 26, 2009 and that the chairman of Coast IRB and possibly another Coast official would now have to appear for a “transcribed interview” with committee staff.

Um, did we do something wrong? Did you? Let’s not take any chances – try reminding everyone that we’re on the same side:

“We are doing our level best to ensure protection for subjects of clinical trials under our review, an objective we share with the Food and Drug Administration,” said Daniel Dueber, CEO of Coast IRB.

Honestly, I wish the folks at Coast IRB the best of luck. They’ll probably need it.

From Jamaica Ginger to Vicks VapoRub

A new paper in the journal CHEST presents the case of a toddler who went into respiratory distress after receiving a smear of Vicks VapoRub under her nose. To figure out what happened, the researchers replicated the treatment in ferrets, whose respiratory systems are a good model for humans. The results were not exactly consistent with the Vicks “Breathe free” slogan:

[VapoRub] stimulates mucin secretion and [mucociliary transport] in the … inflamed ferret airway. This set of findings is similar to the acute inflammatory stimulation observed with exposure to irritants, and may lead to mucus obstruction of small airways and increased nasal resistance.

In an accompanying press release, the investigators elaborate:

“The ingredients in Vicks can be irritants, causing the body to produce more mucus to protect the airway,” said Bruce K. Rubin, MD, FCCP, the study’s lead author from the Department of Pediatrics at Wake Forest University School of Medicine, Winston Salem, NC. “Infants and young children have airways that are much narrower than those of adults, so any increase in mucus or inflammation can narrow them more severely.”

“I recommend never putting Vicks in, or under, the nose of anybody—adult or child. I also would follow the directions and never use it at all in children under age 2,” said Dr. Rubin. Even when directions are followed, VVR may make people with congestion feel more comfortable, but it does nothing to increase airflow or actually relieve congestion. “Some of the ingredients in Vicks, notably the menthol, trick the brain into thinking that it is easier to breathe by triggering a cold sensation, which is processed as indicating more airflow. Vicks may make you feel better but it can’t help you breathe better.” Dr. Rubin also feels that although the study only tested Vick’s VapoRub, similar products, including generic brands, could cause the same adverse reaction in infants and toddlers.

This news follows a similar dustup last year, when the US Centers for Disease Control highlighted the dangers of giving over-the-counter cough syrups to toddlers, and separate research demonstrated that plain old honey was superior to those products anyway.

How did we get here? Aren’t Federal regulators all over drug makers? Didn’t Robitussin, Vicks, and similar products have to pass rigorous trials for safety and efficacy before getting to market? In a word, no.

Jamaica Ginger extract; image courtesy Wikipedia

The problem is that when our current drug regulatory system came into force, there was already a thriving drug industry, able to apply considerable leverage on politicians. A 1906 law reined in the free-for-all of 19th century patent medicines, but still didn’t require careful testing or set detailed manufacturing standards for drugs.

As often happens, some people had to get hurt to reveal the need for industry regulation. Twin disasters in the 1930s, one involving a barely legal Prohibition-era libation called Jamaica Ginger and the other a prescription antibiotic called Elixir Sulfanilamide, did the trick. The former left an estimated 30,000-50,000 people paralyzed or “Jake-legged,” while the latter killed at least a hundred. Congress was finally forced to act, and they expanded FDA powers enormously.

There was a loophole, though. Medications that were already on the market, particularly over-the-counter remedies, were essentially “grandfathered” under the new regime. Taking its input from the industry, the agency published (and still publishes) monographs detailing formulations that are considered safe. Importantly, a product covered by an FDA monograph does not have to undergo the same rigorous testing as a genuinely new drug. Because the safety standards were written with adults in mind, they also don’t contemplate whether the monograph-covered compounds are safe for infants and toddlers.

Now, researchers are revisiting the safety and efficacy of these drugs, and reaching the unsurprising conclusion that some of them don’t work, and might not be entirely safe. Exactly the same thing often happens when products from the the multi-billion-dollar “supplements” industry get long-overdue testing. In both cases, we’re dealing with products that hit the store shelves before they hit the independent laboratory.

So what do you do if you or your kid catches a cold? Let it run its course, and stick to treatments we really know are safe:

“Cough and cold medicines and decongestants are dangerous and neither effective nor safe for young children. Medications to dry up nasal passages also have problems,” said Dr. Rubin. “The best treatments for congestion are a bit of saline (salt water) and gentle rubber bulb suction, warm drinks or chicken soup, and, often, just letting the passage of time heal the child.” Dr. Rubin also notes that if a child is struggling to breathe, it is a medical emergency and would require the child to be seen by a doctor as quickly as possible.

The Biogenerics Debate Heats Up

Yesterday’s Chicago Sun-Times brings news that should keep some biotech investors up at night:

Lake Forest-based hospital products maker Hospira Inc. said today it landed European authorization to market the biogeneric anemia drug Retacrit in Europe, making the medicine its first marketed biogeneric medicine.

Hospira said it will launch the product, used to treat anemia in cancer and dialysis patients, in Europe beginning with Germany in early 2008, but Hospira executives said earlier that the drug won’t have an impact on Hospira’s bottom line in the next few years.

Retacrit will compete with Amgen’s cash cow Epogen, which has been off patent for awhile now. Unlike conventional drugs, protein-based therapies like Epogen (recombinant human erythropoietin) haven’t had to face generic competition when their patents end. Biotechnology companies have acted accordingly, keeping the prices of protein-based drugs very high. This loophole exists because biological products have historically been things like plant extracts, which are virtually impossible to quantify and standardize, so regulators in most countries hadn’t contemplated anyone making biologically equivalent copies of these medicines. In Europe, at least, those regulations have now been revised to allow the introduction of “biogenerics,” and Hospira is taking advantage of that.

The US FDA is still debating the issue of biogenerics, and of course the makers of brand-name protein therapies have been lobbying hard to maintain the status quo. If Retacrit takes off in Europe next year, it will give biogenerics proponents more ammunition. I wouldn’t place bets on the final outcome of this fight, but I’m pretty sure it will be a boon to civil litigators in either case.

Polio Vaccination in Nigeria: WHO Just Can’t Win

The BBC is reporting another depressing development in the World Health Organization (WHO) campaign to eradicate polio:

Nigeria is fighting a rare outbreak of a vaccine-derived form of polio, says the UN’s World Health Organization. It says 69 children in the north have caught the paralysing disease from others who had already been immunised. The WHO says such rare outbreaks have occurred where immunisation campaigns did not reach enough of the population.

If you’re just tuning in, Nigeria is the same country that had a disastrous polio vaccine boycott in 2003, spurred by extremists who claimed the vaccine was part of a Western plot to eradicate Muslims. The rumor managed to shut down vaccination campaigns across wide swaths of territory, causing a predictable spike in polio infection rates shortly therafter. Now that there’s an outbreak of vaccine-derived polio, we can be sure the same scare-mongers will be claiming vindication. Would this be happening if we took a more integrated approach to poor countries’ public health problems, rather than focusing our energy and money on ego-driven eradication campaigns against individual diseases?