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www.sciencebasedmedicine.org/
The lame protectionist statement from the genetics counseling trade group sounds a lot like the whining from HIV clinics who opposed home HIV tests (protecting patients, not their monopoly on testing). "National Society of Genetic Counselors issued a statement saying that receiving genetic information without input from a doctor "increases the chance for misunderstanding or misinterpretation of results."
Really? Seems to me that it will lead people to contact doctors and make lifestyle changes...just as the spread of the home HIV test. Paternalism persists.
I guess the agency has nothing better to do...
articles.latimes.com/2010/may/13/business/la-fi-dna-kits-20100513
From 1998 to 2003, the budget of the NIH—which supports such research at universities and medical centers as well as within its own labs in Bethesda, Md.—doubled, to $27 billion, and is now $31 billion. There is very little downside, for a president or Congress, in appeasing patient-advocacy groups as well as voters by supporting biomedical research. But judging by the only criterion that matters to patients and taxpayers—not how many interesting discoveries about cells or genes or synapses have been made, but how many treatments for diseases the money has bought—the return on investment to the American taxpayer has been approximately as satisfying as the AIG bailout. "Basic research is healthy in America," says John Adler, a Stanford University professor who invented the CyberKnife, a robotic device that treats cancer with precise, high doses of radiation. "But patients aren't benefiting. Our understanding of diseases is greater than ever. But academics think, 'We had three papers in Science or Nature, so that must have been [NIH] money well spent.'?"
More and more policymakers and patients are therefore asking, where are the cures? The answer is that potential cures, or at least treatments, are stuck in the chasm between a scientific discovery and the doctor's office: what's been called the valley of death.
And wither the Reagan/Udall Foundation?Just sayin ...
According to the Pink Sheet, “A particularly public pre-emptive stance” by FDA's in vitro diagnostics oversight office halted Pathway Genomics' plans this week to start selling genetic screening test sample collection kits out of Walgreens stores, but the office's director stresses the move signals no changes to its enforcement policy for laboratory-developed tests.
Walgreens' decision came after FDA sent Pathway a letter questioning the approval status of the tests and after Alberto Gutierrez, director of FDA's Office of In-Vitro Diagnostic Device Evaluation and Safety, provided explicit statements to national media outlets that Pathway was flouting FDA regulations.
The firm, which already sells similar sampling kits and services to consumers over the Internet, says it does not need FDA go-ahead because the offerings qualify as traditionally non-agency-regulated laboratory-developed test services and the company is not making diagnostic claims that require FDA oversight.
But, per Gutierrez, the crucial factor is that once a patient, rather than a physician's office, is tasked with taking the sample, all arguments that a product is not an FDA-regulated IVD go out the window.
He added, however, that there is no need for the agency to buck precedent on lab-developed test oversight to go after Pathway, or, likely, other companies that sell similar genetic screening services over the Internet, including 23andMe and Navigenics.
Hm.
Mr. Pot meet Ms, Kettle.
The Israeli drug giant filed the letter in November after its initial attempt failed earlier in 2009. The FDA rejected the second petition for the same reason as the first, because it would be "premature and inappropriate" to grant Teva's requests, but gave a detailed response that rejects many of the company's arguments against the generic approval.
The Irish Medicines Board has decided to support generic substitution.
According to IMB Chief Executive Pat O'Mahony, "While the IMB ... has no involvement in product pricing structures or agreements, we welcome any initiative that improves value for money and ensures the continued provision of innovative medicines as they become available.”
“Value” to whom? And, last time we looked, such a policy actually strikes against innovation.
Mr. O’Mahony would be wise to remember the old Irish proverb, “Everyone is wise until he speaks.”
In the meantime, just across the Irish Sea in Great Britain, our regulatory cousins at the MHRA have are concerned about generic substitution as well – specifically for oral tacrolimus. The MHRA says it has received 12 case reports of prescribing or dispensing errors associated with the immunosuppressant, oral tacrolimus, which has a narrow therapeutic index.
There are three different oral formulations of tacrolimus available in the UK, but they are not interchangeable, and switching between them should only be performed under the close supervision of a transplant specialist, the MHRA recommends. The reports have included four cases of acute rejection reaction, three cases of increased drug levels, and two cases of increased creatinine.
Generic drugs are a hugely important part of the healthcare paradigm – but bioequivalence cannot be ignored.
Hence, the launch of Pathway Genomics gene test for drug response and disease risk via Walgreen's (and CVS) is most welcome. From what I can tell, Pathway's approach is medically and scientifically responsible. Their scientific management is top-notch and careful. And spreading the knowledge of what drugs or doses can help or hurt is, like cholesterol levels, information that can advance the public health.
But of course it will have it's critics. And enemies.
Which is why the FDA "investigation" of the Pathway product - now -- after it has been on the market for over a year should raise eyebrows. Given Peter Lurie's connection with Luddites like Goozner, Wolfe, Mahar, Diane Zuckerman etc. it would and will be interesting to see how these "experts" who of course have no bias whatsoever weigh in on the Pathway-Walgreen's alliance. And it will be interesting to see if the FDA, which seems to be involved in everything but advancing The Critical Path and regulatory science these days, makes a federal case out of a science-based effort to educate patients about the important role genes and genetic response plays in response to medicine and prospective health.
I have a hunch how Maggie Mahar will react.
www.pathway.com/more_info/health_test#q6
Just because you’re paranoid doesn’t mean they’re not out to get you.
FDA: ‘Bad Ad Program’ to Help Health Care Providers Detect, Report Misleading Drug Ads
The U.S. Food and Drug Administration today launched a program designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.
The Bad Ad Program is an FDA-sponsored educational outreach effort administered by the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research.
“The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” said Thomas Abrams, director of DDMAC.
The program will be rolled out in three phases. In Phase 1, DDMAC will engage health care providers at specifically-selected medical conventions and partner with specific medical societies to distribute educational materials. Phases 2 and 3 will expand the FDA’s collaborative efforts and update the educational materials developed for Phase 1.
The FDA’s traditional regulatory activities for monitoring prescription drug promotion primarily rely on review of promotional pieces submitted to the agency by sponsoring drug companies, industry complaints, and field surveillance at large medical conventions. Although these efforts are effective, the agency has limited ability to monitor promotional activities that occur in private.
Health care professionals are encouraged to report a potential violation in drug promotion by sending an email to badad@fda.gov or calling 877-RX-DDMAC. Reports can be submitted anonymously; however, the FDA encourages providers to include contact information so that DDMAC officials can follow-up, if necessary.
That was then, this is now.
At last week’s Windy City BIO bar mitzvah, Nicholas Dracopoli, VP-biomarkers at Centocor commented that all new drug candidate programs within J&J/Centocor (home to J&J's biotechnology, immunology and oncology drug R&D programs) will include a strategy for linking the medicine from its earliest inception to a biomarker that identifies the most appropriate treatment population.
According to Dracoploi. "We are now firmly committed in new programs entering into our portfolio that there is an integrated diagnostics strategy that is evaluated ... from preclinical into early clinical testing and into approval …We are looking to do selective partnering with companies, often for specific platforms, technologies and assays.”
And, per the Pink Sheet, “On the other hand, Dracopoli stressed that the company is not, in general, attempting to incorporate diagnostics into mid-stage development programs that got off the ground previously without a biomarker program. The history of trying to retrofit tests into already established R&D programs is not very successful, he said."
On the FDA front, Peggy Hamburg has raised expectations that a draft guidance addressing drug-diagnostic co-development will be issued by year-end. At BIO, FDA in vitro diagnostics office staffer Elizabeth Stafford said she and her colleagues are "very serious" about meeting that deadline.
Can you hear me now?
Along the way, diapers did get better at helping reducing the incidence and severity of diaper rash. " Infant diapering practices have evolved from the use of cloth (covered with plastic, impermeable over pants), to disposable diapers with a cellulose core and a plastic outer cover, to disposable diapers with highly absorbent polymers (known as absorbent gelling material and referred to as AGM diapers) and to AGM diapers with a permeable or 'breathable' outer cover."
The bottom line (no pun intended) is convenience. A recent WSJ blog about the displacement of cloth diapers with disposables put the shift in perspective:
"Cloth diaper options have also proliferated, as manufacturers make cloth diapers that are easier to change, with Velcro tabs like disposables. The jury is still out, however, on whether cloth is truly greener. While cloth diapers don’t hog up space in landfills like disposables, they suck up energy and water to launder. (A look at some of the research on the impact of cloth vs. disposables, and a review of some of the new easier-to-use cloth options, can be found in this Boston Globe article and this Wall Street Journal review.)"
So P&G launched a leaner diaper called DryMax to take up less landfill space and is more absorbent than Cruisers or Swaddlers.
In advance of the nationwide product launch, a handful of parents used facebook and twitter to claim that the new product was causing terrible diaper rash, and nothing else... not the poop, the pee or parental forgetfulness... Because parents have never tried to shift responsibility for things out of their control onto other people or corporations... It was probably not smart strategy for PG to simply switch a product parents like and trusted without a lot of advance notice or leaving the old one on the shelf. People don't like abrupt transitions.
But that has nothing to do with the specious claims that the new diaper is designed to cause diaper rash or the willingness of people to spread fear through the Web or the media to whip the fear up without putting the real risks or veracity into context....
Here's an example of one of 718 complaints on one website: "Both my kids had this same thing, but it was all over! Their leg area, butt, front end, just everywhere where the diaper touched."
A classic example of how a large corporation (P&G) is willing to produce and market a product that harms babies just to make a proft!
Except that complaint wasn't about Pampers Dry Max. It was about Huggies. In 2008.
Here's another: "My middle child had a similar problem with Huggies! However, he would get a rash in his entire diaper area. We used Pampers instead. After a few weeks I got brave and tried the Target brand, and they were fine.
My middle child was the only one that had a reaction to Huggies. (I have 3) So, yes, it is strange!
Since your son's rash is only around the elastic, maybe it's because he's hot. We've been in such a heat wave lately. "
www.mamapedia.com/article/anyone-tick-s-kids-have-rash-from-huggies
Want more? Here's one of a bunch blaming diaper wipes.
"Both of my girls developed diaper rash, I was using Huggies Natural Care Baby Wipes hoping they were gentle enough. My girls would scream and bleed when I would change their diapers and I just thought the diaper rash really hurt. We quit using these wipes and their rashes have started to heal up. We are using organic wipes, and they really seem to be helping. I think the Huggies may have alcohol in them or something. "
www.viewpoints.com/Huggies-Natural-Care-Baby-Wipes-review-b908
If you want to read the complaints about Pampers you can go to, of all places a pro-cloth laundry site or the website of a law firm seeking clients who want to sue P&G for bottom abuse:
dirtydiaperlaundry.com/pampers-dry-max-being-investigated-by-the-cpsc/
www.krclassaction.com/Default.aspx
And here is the AP's very helpful reporting on the matter:
"The Consumer Product Safety Commission started an investigation this week following complaints of babies and toddlers suffering severe and persistent diaper rashes and blisters that resemble chemical burns..."
I am not a doctor or play one... but blisters like that on a baby's tuchus are likely impetigo. Much like the festering pustules that blister and persistently eat away at objective science, impetigo is very common. But at least impetigo it treatable. The fearmongering and willingness to transmit it as "fact" by the media seems to be spreading.
What's next? Blaming disposable diapers for autism?
You bet..
"If the increase of autism started in the 70''s then you should also consider what other medications, additives etc was introduced at the same time. Most children get vaccines so sure that would be on the list but since the 70s more children are in daycare, wear disposable diapers etc. These are just things that are involving the child not the home as a whole. Microwave ovens could be on the list too. Fact is that it''s an idea but by no means a smoking gun. A lot of children are forgoing immunizations because fear of autism. Whether they are making the right choice or not is yet to be seen. My son has a mild case of PDD-NOS. He wasn''t beaten or traumatized. He got his regular shots like my other two children did and they experienced no problems at all. For all I know living by the airport might have caused his PDD-NOS. It''s not the only disorder to have skyrocketed over the last 20 years."
www.cbsnews.com/stories/2008/01/07/health/main3684105.shtml
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
