Latest Drugwonks' Blog
1. More new drugs are being yanked well before they enter clinical trials. A good thing that can be chalked up to thinning revenues, higher standards, harder targets and better development tools.
2. The safety delta on all drugs is higher. Not a good sign. REMS and Safety First means approval times are slower or drugs are not approved on the first go round.
3. Clinical development is becoming more a legal battle and less a scientific one. If you don't believe me read this article from www.ft.com where the CEO of Watson Pharmaceuticals says generic lawsuits are causing drug companies to stop innovating. He calls it "eating their young." /tinyurl.com/259ko9q
4. Compared to previous years there are still fewer new drugs being introduced and those are being slowed down as these drugs are now considered less special or non priority. As Ed Silverman at Pharmalot notes:
"Overall, there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications, or NDAs. First-cycle reviews for priority NDAs were 47 percent in fiscal year 2003 and continued to climb to 70 percent in fiscal year 2007, but have since slipped back to 53 percent in fiscal year 2009."
Ed goes on to quote Paraxel consultants:
"As for priority designations for original NDAs, fiscal year 2005 marked a high of 30 percent after running as low as 10 percent four years earlier. However, that fell back to 13 percent in fiscal year 2009. Parexel says the decline has been “most stunning” in for antiviral and oncology NDAs, which are the two therapeutic areas that have driven overall rates at the FDA’s Center for Drug Evaluation and Research in previous years.
Priority designation rates for cancer NDAs have been declining consistently for several years, from 65 percent of the NDAs submitted between fiscal year 2003 and fiscal year 2005, to 18 percent in fiscal year 2009. The decline in AIDS and other antiviral therapies fell from 95 percent in fiscal year 2006 and fiscal year 2007 timeframe to just 8 percent among NDAs submitted in fiscal year 2009."
www.pharmalot.com/2010/10/the-fda-review-process-and-the-new-normal/
Is the bar being raised at the FDA for drugs that are truly innovative and targeted? It is not the FDA's business to determine whether one medication is better than another. Each treatment has to stand on it's own risks and benefits with respect to the people it treats.. But:
“The FDA’s 13 percent priority designation rate for 2009 new drug applications mirrors the low rate at which some health care plans and other payers are finding value in newly approved drugs. This illustrates the need for companies to take into account market-based clinical concerns in the product development process market-based clinical concerns in the product development process,” according to Charles A. Stevens, Vice President and General Manager, Reimbursement and Market Access, PAREXEL Consulting."
tinyurl.com/32ycdww
The question is whether the clinical development process is the appropriate mechanism to taking these concerns into account or whether it comes at the cost of true value. And innovation.
NEWS FLASH: Americans don’t understand drug labels.
The IOM estimates that 90 million Americans can’t fully understand and act upon health information.
U.S. Pharmacopeia to the rescue.
Proposed USP standards could make label information and instructions more comprehensible. For example, instructions to “Take two tablets twice daily” can raise confusion; saying “Take 2 tablets in the morning and 2 tablets in the evening” makes the numbers more explicit and also specifies exactly when to take the medications. The recommendations also suggest that if it’s okay with the patient, labels should include the purpose of the drug, and in plain language, i.e. “for high blood pressure” rather than “for hypertension.”
It's okay.
The proposed standards recommend formatting that can make labels easier to read, including using regular sentence structure, and laying out labels so users don’t have to rotate the container to read them.
The USP is taking comments at 17PrescriptionContainterLabeling@usp.org until the end of March. When finalized, they could be adopted by state pharmacy boards or other authorities.
It’s about time that we stop talking about health literacy, compliance and adherence and start doing something about.
I think this is the beginning of a beautiful friendship.
Okay, maybe not so simple -- but certainly exciting.
Researchers at Massachusetts General Hospital have already developed a prototype of a microchip that can detect tumor cells at extremely low levels in the bloodstream. The effort to be announced today intends to draw on the expertise of scientists familiar with how to bring such technologies to patients and doctors.
By detecting cancer cells through a blood test, doctors could better follow the disease’s course — looking to see whether the level of cancer cells circulating drops with treatment. It would also allow doctors to test the genetics of the cancer cells, considered by doctors to be critical because many cancer drugs are targeted treatments that work against a cancer with a particular mutation.
To detect the extremely rare cells, the new technology uses minuscule channels carved into a silicon chip, coated with a special glue-like substance. When the blood filters through the channels the technology is able to pick up, on average, about 10 cancer cells per milliliter of blood in patients with metastatic cancer, disease that has spread from a primary tumor to other parts of the body.
But will payers pay for it? Early diagnosis means earlier treatment and better chances for prolonged survival. Good for patients. But will payers (and particularly Uncle Sam, MD) see it that way?
From today’s Wall Street Journal:
FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."
From Albert Einstein:
Insanity: doing the same thing over and over again and expecting different results.
And onwards to PDUFA V.
Hyperbole and misdirection aren’t going to solve the problem of the slippery slope towards government-run health care – it’s going to hasten it.
No – not “death panels” (although this Palinian shibboleth certainly falls into this category) but rather statements to the effect that the FDA’s decision to remove Avastin’s breast cancer indication was “a crude cost calculation.” Not true. Not helpful.
In today’s Wall Street Journal, David Rivkin and Elizabeth Foley write that, “The FDA made a crude cost calculation; as everyone in Washington knows, it wouldn't have banned Avastin if the drug cost only $1,000 a year, instead of $90,000.”
“Everyone?” Not really. For those who understand what actually goes on at the Food & Drug Administration it’s not about “cost” as much as it is about “choice.” And on that note Rivkin and Foley get it right:
“The Avastin story is emblematic of the government's broader agenda to ration care based on cost and politics. Once ObamaCare comes into full force, such rationing will be pervasive. When the government sees insufficient benefit, all but the wealthiest and most politically connected will have to go without.”
We are being railroaded down the tracks towards Uncle Sam, MD – but the FDA’s ruling on Avastin (whether you agree with it or not) was based on the agency’s reading of the science. Trying to tag the FDA with a decision based on cost may be convenient – but it’s wrong.
Such hasty proclamations trivialize the urgent and legitimate arguments against the current cost-versus-care direction of American health care – and makes it all the more difficult to counter and correct.
Per the new HHS regulation that pays for “voluntary” end-of-life counseling as part of seniors' annual physicals – just what makes it voluntary? Does a person need to ask for it? Will there be a discussion guide? If so, who will prepare the talking points? When are such conversations "appropriate?" And since physicians are being incentivized to provide this service, where are the "best practice" guidelines? These are only a few of many unanswered questions.
The Wall Street Journal reports that:
The office of Oregon Democrat Earl Blumenauer, the author of the original rider who then lobbied Medicare to cover the service, sent an email to supporters cheering this "victory" but asked that they not tell anyone for fear of perpetuating "the 'death panel' myth." The email added that "Thus far, it seems that no press or blogs have discovered it, but we will be keeping a close watch.
The Journal continues,
The affront is that Medicare needs to sneak around in order to offer a type of care that is routine in private insurance. If the medical experts in Congress haven't decided that some treatment or service is worthy of the fee schedule, then the program won't pay for it even if it is in the best interests of patients.
Set your TiVo for CSPAN.
DDMAC is conducting a study of how consumers and physicians understand the information in print ads and drug labels. But it’s got a fatal flaw – it’s not double blind.
In comments on the proposed study design, Merck suggested removing statements from the draft physician questionnaire that the drug is fictitious on the grounds that this might bias the results and instead label it a "potentially new drug." FDA rejected this idea for physicians, though it agreed to a bit of deception on the consumer questionnaire. And they’re right. Alas, the FDA disagrees.
"FDA had many internal discussions regarding this issue and decided that because of the particular [physician] sample, it is necessary to be upfront with them about the nature of the drug," the agency states in a notice scheduled to be published in the Federal Register on Dec. 23.
"Physicians will be more savvy about the particulars of the chemical entities and the realism of the clinical benefits and we do not wish to make them skeptical of our purposes," FDA states. "We agree that this approach is preferable for consumers and so we will inform them that this is a potentially new drug in that part of the study."
The consumer survey will present identical safety information under one of two randomly chosen headlines - "Important Safety Information" or "Important Risk Information" - to see whether that makes a difference in the respondents' understanding.
General practitioners will be asked to look at a label for one of the fictitious drug and answer questions designed to show how they use the prescribing information - which sections of the label they choose to read, for how long, and in what order. They will be asked how they perceive the drug's efficacy and how well they can recall the claimed benefits, and their answers will be compared with those of the consumers.
In other words, the GPs will know this is a test. Isn’t it likely then, that they will pay closer attention to the details? Isn't it just as important to learn how much (or how little) physicians really understand the information presented in the P.I.? In fact -- isn't it more important since they are the "learned intermediaries?"
Comments from Eli Lilly & Co. suggested that benefits and risks be viewed together and in a similar format so as not to bias the results. FDA agreed that "the benefits and risks should be evaluated together and [we] have several measures to investigate both. ...[but] because of the complexity of DTC ads, we cannot manipulate both benefits and risks at the same time."
Hm.
Alas, the editorial buried the lead in the final paragraph:
"Genentech plans to request a hearing with the F.D.A. to argue the case for retaining Avastin’s status as an approved breast cancer treatment. It should focus on proposing ways to identify the subset of women who can really benefit from Avastin."
The full editorial can be found here.
Burying the lead is one thing. Prematurely burying patients is something altogether different.
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.
