e-mail de cachet

05/24/2010 08:54 AM |

Badges?  We don’t need no stinking badges.

Compliance through secret commination is a bad idea that may very well be an unintended consequence of the FDA’s nascent “Bad Ad” program.

Anonymous e-mails from people who may or not be physicians denouncing ads and sales presentations to a FDA star chamber?  Really?  Whatever became of transparency.  What’s next? Anonymous adverse event reporting?

The “Bad Ad” program is a bad idea for so many reasons – not the least of which is that it seeks to deputize people who don’t understand the law.  In the Old West this was more generally referred to as a posse, or worse – a lynch mob.

For more on this issue, see this new article from Advertising Age.

Secret e-mails are nothing short of electronic lettres de cachet and have no place in official FDA policy.

  Read More & Comment...

Olio Folio

05/21/2010 08:19 AM |

To CER with Love

WellPoint has released guidelines for the submission and evaluation of comparative effectiveness research that it will use in reviewing drugs for its formulary.

The guidelines state that, "while randomized, controlled clinical trials remain the gold standard for producing reliable efficacy and safety data, WellPoint recognizes that there are circumstances in which RCTs may not be sufficient alone for decision-making. Accordingly, a well-conducted CER or observational study may complement RCT-based information by providing effectiveness data, or data on outcomes achieved in a 'real-world' setting."

The guidelines explain that "observational studies provide information regarding product safety, cost-effectiveness, budget impact, and the validation of key assumptions used in cost-effectiveness and budget impact models. Furthermore, WellPoint may want to gain more insight regarding drug comparisons not found in the literature, such as off-label use and use in sub-populations."

Should a drug sponsor desire to submit results of a CER study, the guidelines list 20 specific criteria relating to the study for which information should be included. These are to include not only details of the study design, patient population and results, but a discussion of potential bias, the limitations and validity of the conclusions, and the relevance of the findings to WellPoint's patient population.

Food for Thoughtless

From CQ: "Sen. Byron L. Dorgan of North Dakota has his eye on the food safety bill as a vehicle to revive his proposal to allow the importation of US-made prescription drugs from Canada and other countries." Dorgan "says he is determined to press for another floor vote on the 'reimportation' issue when the food safety measure (S 510) moves to the floor. The bill was slated for possible action this month, but has been nudged aside in the rush to complete a fiscal 2010 war supplemental bill and a package of tax cuts and social spending by the Memorial Day recess." Notably, "Majority Whip Richard J. Durbin of Illinois says he's concerned that the Dorgan proposal could complicate the food safety bill." Um, yeah.

And a Pair of Tube Socks

Via AFP comes the report that British supermarket chain Asda plans to sell cancer drugs at cost price and called on its peers who make massive profits on the treatments to follow suit.

The group, owned by the world's biggest retailer US supermarket giant Wal-Mart, said its initiative follows the success of a similar scheme by Asda for in-vitro fertility (IVF) treatments.

"The crippling cost of paying privately for cancer treatment has forced many people to spend their savings or even re-mortgage their house to pay for these essential drugs," said John Evans, superintendent pharmacist at Asda.

"We are the first retailer to recognise this injustice and to do something about it and we are calling on other retailers to follow our lead."

  Read More & Comment...

The fault, dear Brutus ...

05/20/2010 08:16 AM |

Blame the FDA. It’s a staple of industry communications that when a company receives a complete response letter. And it’s easy to do since such communications are “commercial confidential.” Not that the agency doesn’t often deserve blame – but there are generally two sides to every story and complete response letters are rarely (if ever) released to the media by the recipient.

Some companies will blame the FDA with excuses like, “The FDA won’t allow us to discuss the letter” or “The FDA will be upset if we release the letter.” Hogwash.

Here it is straight from the Bob Temple:

“If I were a reporter, I would say, ‘if you don’t show me the letter I don’t even want to talk to you.’ That’s what I would say.”

Wisdom of Temple or Temple of Wisdom, no matter how you slice it, it equals the FDA’s strong support for transparency. Easier said than done? Sure. But let’s stop with the lame “We’ll make FDA angry” excuses.

Which brings us to the issue of “spin.” Since the sponsor controls what is and is not shared, the sponsor controls what is and is not known.
And let’s face it, that can quickly slip/slide into spin. At a certain point the sponsor has to make a tough call – is less information better? There’s no hard and fast rule. Yet.

Yesterday, the FDA’s Transparency Taskforce recommended that the agency release more information about medical products and foods, including letters sent to companies about whether a product is approved or rejected. That’s right – the public release of complete response letters.

Another recommendation calls for the FDA to release safety information in cases where companies withdraw an application for a drug or medical device and a third suggests the agency release information about drugs for rare diseases, known as orphan drugs, in cases when the application was withdrawn for business reasons and not safety reasons. The agency could state that the proposed drug, if approved, would represent an advance for the treatment of a particular disease.

Don’t like these ideas? Blame the FDA? Perhaps. But the fault, dear Brutus …
  Read More & Comment...

BIO Break?

05/19/2010 08:10 AM |

Interesting overview of healthcare reform on the biologics business in the May edition of Nature Biotechnology.  Here's a sample:

"The healthcare reform bill ... includes key provisions that will lead to new and improved treatments, cures and cost-savings for patients, while driving job growth in our industry and maintaining our nation's global leadership in biotech innovation," says Jim Greenwood, president of the Biotechnology Industry Organization (BIO) in Washington, DC.  Peter Pitts, president of the Center for Medicine in the Public Interest (CMPI) in New York, agrees:  "This legislation will have a huge impact on biotech companies -- the  most affected of any industry."

And here's how the article ends:

Says Pitts of CMPI, "Industry lobbied hard for a good bill, but this bill is flawed in so many ways."  However, he adds, "It's time to realize that it's no longer just about selling drugs, but for providing healthcare -- and companies must walk the walk."

For the entire article, click here.
  Read More & Comment...

Orszag the Oracle

05/19/2010 01:43 AM |

  Read More & Comment...

Gene Acres

05/18/2010 08:54 AM |

The NIH is creating a public database that researchers, consumers, healthcare providers, and others can use to search for information submitted voluntarily by genetic test providers. The Genetic Testing Registry aims to enhance access to information about the availability, validity, and usefulness of genetic tests.

Currently, more than 1,600 genetic tests are available to patients and consumers (but not at WalGreens), but there is no single public resource that provides detailed information about them. The Genetic Testing Registry is intended to fill that gap.

The registry project will be overseen by the NIH Office of the Director. The National Center for Biotechnology Information, part of the National Library of Medicine at NIH, will be responsible for developing the registry, which is expected to be available in 2011.

(Psst -- just don't tell the FDA.)

  Read More & Comment...

Breathing Causes ADHD

05/17/2010 02:21 PM |

An "study"  (i.e. torturing data until it tells you what you want to conclude) showing that pesticides cause ADHD was widely reported in the news today.

Like previous studies claiming a link between cell phones, constipation, food additives, etc., this one is designed to provoke fear and not inform. 

I won't go into the many problems with this study, let alone the fact that it correlated an ADHD diagnosis with undetectable amounts of phosphate based pesticides in a kid's pee.   (How can you -- absent clinical markers -- measure something that is statistically undetectable?)  But how about these four facts to put this piece of garbage into context:

1.   The prevalance of ADHD, once adjusted for diagnostic accuracy, is about the same in the US as it is in Europe or South America. 

2.    Pesticide use in the US has decreased since 1970.   Meanwhile prevalence rates have remained the same or increased slightly. 

3.   ADHD can be geographically clustered and found more commonly in single parent families.     Where you live and your family life are associated with ADHD though the relationship is certainly not causal.   

4.    ADHD is highly heritable... up to 75 to 90 percent of ADHD among kids is associated with shared genetic traits...

5.   Articles reporting on the "study"  quote one of the authors as saying that the pesticides might cause ADHD because " the primary action of organophosphates is to inhibit acetylcholinesterase, and disruptions in cholinergic signaling are thought to occur in ADHD."  However, what little work on  acetylcholinesterase levels and ADHD suggest that higher serum levels are associated with ADHD, not lower.  If pesticides are inhibitors of serum production then they should be used as medication...   Indeed, inhibiting these levels is how Alzheimer's and autism can be treated...  

Has anyone in the media taken the time to do anything but spread the stupidity and fear?  Of course not.  


  Read More & Comment...

FDA's Pathway Roadblock

05/17/2010 11:14 AM |

The FDA scotched the Pathway and Walgreens partnership by asking Pathway to prove it didn't need FDA approval as a medical device.  Someone should explain to me how gene tests are a medical device..I guess soap and bathroom scales are also medical devices (David Kessler once said the former was!) and should have FDA approval of some sort.   Meanwhile, clinical labs that are part of programs designed to test, diagnose and sell quackish treatments abound...

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




  Read More & Comment...

Into the Valley of Death

05/17/2010 09:03 AM |

A last gasp of sanity from Newsweek:

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 ...
  Read More & Comment...

Gene Genie

05/17/2010 08:12 AM |

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.

  Read More & Comment...

From the Taste of One’s Own Medicine Department

05/14/2010 04:11 PM |

Mr. Pot meet Ms, Kettle.

The Food and Drug Administration has again denied Teva's citizen's petition asking the agency to block approval of a generic version of its Copaxone multiple sclerosis treatment.

 

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.

  Read More & Comment...

Dublin Down

05/13/2010 08:30 AM |

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.

  Read More & Comment...

Pathway Genomics and Walgreens: New Path to Personalized Medicine?

05/12/2010 11:22 AM |

Anti-pharma Luddites -- in an ideologically induced haze -- can't decide whether to call for additionally safety studies (PPIs) or to call them off (Avandia) consistently ignore the value of using gene testing to personalize drug response and optimize care.  The reason is obvious.  Keeping people in the dark about whether a medicine will help a lot or a little, or help or hurt breed uncertainty and uncertainty is the wellspring of fear and fear is what allows the Luddites to continue their very profitable campaign against commercialization.  If people know or knew the relative risks and benefits of medicines, then the fearmongering would be ineffective..

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
  Read More & Comment...

Ipcress File Part 2

05/12/2010 10:42 AM |

Just because you’re paranoid doesn’t mean they’re not out to get you.

In keeping with yesterday’s announcement by the FDA that they’re going to enlist physicians in ferreting out “bad ads,” it’s worth revisiting the recent JAMA article by National Institute of Mental Health director Tom Insel, “Psychiatrists’ Relationships with Pharmaceutical Companies” (March 24-31, 2010).

To combat Pharma’s nefarious “culture of influence,” Dr. Insel wants the NIMH to develop an online curriculum that will sensitize psychiatric residents to Big Pharma’s nefarious “culture of influence.”

And, while we’re on the subject of content creation, maybe the FDA should consider publishing an annual report entitled, “Best ads, worst ads.”

On the other hand, maybe I shouldn’t give them any ideas.

  Read More & Comment...

And in your spare time ...

05/11/2010 01:09 PM |

Now that's what I call counter-detailing.

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.
  Read More & Comment...

They laughed when I sat down at the piano ...

05/11/2010 10:53 AM |

Two years and change ago, drugwonks raised the issue of companion diagnostics as part of the NDA process. The result was a collective yawn.

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?

  Read More & Comment...

Rash of Fearmongering About Diapers

05/10/2010 05:33 PM |

As someone who changed his share of diapers (with one hand, no less) I can attest to the shock and horror of dealing with your baby's diaper rash.  Back in the day it was a matter of if, not when, an infant would get a terrible rash, usually caused by way too much juice, not enough breast feeding, or being lazy about changing the diaper (I justified it by assuming that super asorbent diapers could hold 20 gallons of fluid).  And when the rash hit, it was a matter of keeping baby dry, using the right ointment and being more vigilant about changing diapers when wet.  

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
  Read More & Comment...

Wax On, Wax Off

05/10/2010 03:56 PM |

  Read More & Comment...

Hypocrisy on FDA Conflicts

05/10/2010 12:53 PM |

Merrill Goozner, Peter Lurie and Sid Wolfe.  All three have made it clear they believe FDA is simply a tool of Big Pharma, the monolith that according to all three produce huge profits and little public health by pumping drugs into the marketplace with little oversight from FDA on their making or marketing.

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

The trashing of Scott Gottlieb was part of a jihad against a particular approach to science and risk led by the same people who populate and are influencing the agency Scott served in.   Their cultural biases will and can have consequences for the public health if they are not made as transparent as financial biases. 








  Read More & Comment...

Getting the Finger

05/10/2010 12:00 PM |

I just returned from my annual physical where my internist learned a lot about me and I learned how unhappy she is about ObamaCare. While I was getting it where the sun don't shine, she recognizes that it's America's physicians who are getting the finger.  Read More & Comment...