Latest Drugwonks' Blog
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."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 …
"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.
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.)
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.
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.
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.
