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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
All three profit from promoting this position. Goozner peddles his wares via book sales, lectures, etc. And Lurie and Wolfe have co-authored something called Worst Pills, Best Pillsm which ,I kid you not , was once offered as a the perfect holiday gift.
"All three have or had direct influence on the FDA's decisions on medicines and establishing the risk-benefit tolerance of the agency. Gooz and Wolfe were or are on FDA advisory committees. Lurie is now in the FDA's Office of Policy in Peggy Hamburg's shop.
Lurie, a physician, will be the third person with ties to Public Citizen to be engaged by the FDA. Sidney Wolfe, former head of Public Citizen's Health Research Group and editor of Worst Pills, Best Pills (http://worstpills.org/; Nat. Biotechnol. 26, 149, 2008) has been a member of the FDA Drug Safety and Risk Management Advisory Committee since 2008. Also Joshua Sharfstein, the FDA's current principal deputy commissioner, has early ties to Public Citizen from an internship in 1992. Before joining the FDA, Sharfstein developed a reputation as a reformer and an industry critic through his advocacy work in the field of HIV/AIDS and his efforts to limit marketing of pediatric cold remedies."
No conflict or coverage thereof?
Only sweet sounds are heard about their appointments:
“It can't hurt to have smart people—who may be a little controversial—in government. People [in government] can go into this deep inertia of making only small, incremental movement...you can take [Lurie's] energy and his desire to improve the process to help move things forward.”
Which brings me to the comments of Wolfe and Goozner and the manufactured hit job they help lead against another smart, controversial person, Scott Gottlieb, who is a real doctor who sees real patients, unlike Wolfe or Goozner.
Here's what Goozner said about Scott's appointment to Alicia Mundy, who is now the go to source for those inside FDA seeking to make life miserable for Janet Woodcock, John Jenkins and others:
"I've never heard of anything like this," said Merrill Goozner, a director at the liberal Center for Science in the Public Interest.
"If he's had dealings regarding companies whose products are up for review at the agency, it strikes me as a potential conflict of interest. You want a barrier between the regulated and the regulators. It's fundamental," Goozner said.
What about intellectual bias? Note how the Gooz cut himself yards of slack, with Mundy giving him room to do so. I guess neither knew or cared about the FDA's equally strict restriction on using one's position to skew or bias proceedings to fit a particular, uh, narrative. Or book sales. Or continued existence as Project Director at certain advocacy groups...Or whatever:
But intellectual bias is a big problem. Bigger than financial conflicts because, as Aaron Wildavsky observed in Risk and Culture, the adherents of organizations that individuals such as Lurie, Goozner, Wolfe and Alicia Mundy have worked for and work for need enemies, corporate enemies to unify and motive a base sharing a deep cultural bias about the inherent dangers of technology. To suggest this bias does not exist or is an articulation of objective reality is to cede control of the political and social institutions that regulate all human activity to the aforementioned since their goal is not this regulation or that, but to "break the stranglehold which they consider such interests have on society." tinyurl.com/33vyzj5
All the more reason that the FDA in it's small way has sought to put a leash on such totalitarian behavior:
"Within the Center for Drug Evaluation and Research, there are provisions stating that members participating on advisory panels should be free from intellectual bias. According to the FDA document, the appearance of intellectual bias is an issue if the member is identified as a "primary advocate" or is "so strongly associated with a position on a matter" that concerns could be raised about his or her impartiality and objectivity.
Also, intellectual bias may exist if "statements of record have been made by that member concerning an issue to be considered by the committee that draw conclusions or strongly appear to draw conclusions to a degree that would appear, to informed experts, to preclude an impartial and objective evaluation of information on that matter presented to the committee." These statements could be taken from legal cases, other regulatory agencies, or even from the media.
As Jenkins told heartwire last week, members are welcome to bring differing perspectives and to ask tough questions, "But at the same time, we want the committee members to come to the table with an open mind, so they can give us advice based on the data, the presentations, and the discussions that are held at the committee meeting itself."
www.theheart.org/article/943511.do
And finally here is Lurie essentially shooting himself in the foot by acknowleding that financial "conflicts" are easily spotted whereas intellectual bias can be disguised as just scientific disagreement:
"Frequently, one hears that there are both financial and intellectual conflicts of interest; somehow this argument is offered as evidence to downplay the importance of the financial conflicts. While intellectual conflicts are important, they can readily be distinguished from financial ones. Financial conflicts of interest are extrinsic to the scientific endeavor, whereas intellectual conflict is the very way science moves forward. Financial conflicts can occur at variable levels – some people have them, some people don’t – and they can be quantified, whereas intellectual conflicts are ubiquitous and not susceptible to quantification in the same way. Moreover, in the context of debate on an advisory committee, for example, it is unlikely that the financial conflict information will naturally emerge, whereas it is likely that any relevant intellectual one will. There are relatively straight-forward methods to alleviate financial conflicts, whereas it’s not nearly as clear how one should approach intellectual conflicts. Finally, our legal system has long recognized the distinctions between the two.
brodyhooked.blogspot.com/2008_03_01_archive.html
Indeed, it has. The intellectual bias is much more problematic:
"Two of these definitions are: an individual has a COI when there is a conflict between his/her private or institutional interest and his/her official duties in a position of responsibility or trust; or, an individual is in conflict if he/she owes a duty of loyalty or responsibility to two distinct entities or individuals, both of which are likely to be affected by the scientific activity in which the individual is engaged. The term "interest" can refer to a financial (i.e., employer, employee, consultant, stockholder, investor, etc.) or a non-financial interest/relationship (i.e., family member, mentor, mentee, professional colleague, co-author, etc.). Most existing COI policies address financial but not non-financial conflicts of interest; however, non-financial conflicts of interest are equally common and important, and they warrant, and will likely receive, more attention and a higher degree of scrutiny in the future."
toxsci.oxfordjournals.org/cgi/content/full/87/1/11
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.
