Latest Drugwonks' Blog
I sympathize with those who say "it's my DNA" and I should do what I want with it but if you apply that logic to anything in life without some guideposts and limits, it leads to anarchy. Saying it's "my DNA" is actually like saying it's my way of doing arithmetric. If there is no way to validate my conclusions and apply them to the real world in a standard format chaos ensues.
My feeling, after reading Steve's post and discussing the launch with real doctors and geneticists, is that the path for Pathway needs to be more clearly marked to lead to personalized medicine but that it should be a path in the future.
Here is Steve's thoughtful and science-based take: thegenesherpa.blogspot.com/
Monday, May 24, 2010
DTC Genomics reviewed in Genetics in Medicine
I just received the May issue of Genetics in Medicine, only 24 days late. But it caught my attention for several reasons.
On Parenting
Study: Early Childhood Vaccines Don't Damage Kids' Development
Many parents worry that the vaccines recommended for a baby in the first year of life are just too much too soon for an infant's immature immune system. Those fears have fueled a growing trend of parents delaying or refusing to vaccinate their babies. But a new study in Pediatrics examined the long-term effects of delaying vaccines and found that children whose parents refused or postponed vaccines did no better than children who were vaccinated on time, when tested on things like speech, language, achievement, fine motor skills, attention, and general intellectual function seven-to-10-years later.
The news comes the same day that Andrew Wakefield, a British doctor who did more than any one person to propagate the belief that vaccines cause autism, was barred from practicing medicine in Britain. Wakefield's 1998 study, published in The Lancet, fingered the measles, mumps, and rubella (MMR) vaccine, as a cause of autism, though he looked at just 12 children. In February, The Lancet retracted his study, and Britain's regulatory group said Wakefield had been "dishonest" and "misleading" in conducting the research, including failing to disclose that he was working with lawyers who sought to sue vaccine manufacturers. Wakefield has moved to the United States.
WASHINGTON -(Dow Jones)- The U.S. Supreme Court on Monday asked the Obama administration for its views on whether generic drug companies can be sued over allegations that they inadequately labeled their products.
Generic drug makers are seeking to preempt a product liability lawsuit by a woman who allegedly developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan.
The woman alleged the drug posed more serious risks than drug makers indicated on their labels.
A trial judge had dismissed the woman's lawsuit but an appeals court reinstated it last year.
The generic drug companies, including Teva Pharmaceutical Industries Ltd. ( TEVA) and Mylan Inc.'s (MYL) UDL Laboratories, said the lawsuit should be preempted by federal law because it would require them to write labels that deviate from the brand-name drug's label.
In ruling against the generic drug makers, the St. Louis-based 8th U.S. Circuit Court of Appeals cited a 2009 Supreme Court decision against Pfizer Inc.'s (PFE) Wyeth unit that said Food and Drug Administration drug regulations do no protect a drug company from being sued under state law over drug labeling.
The 8th Circuit said Congress could have crafted a provision that preempted drug-labeling lawsuits against generic drug companies but chose not to do so.
In a short written order, the Supreme Court asked the U.S. Solicitor General's office to express the Obama administration's views on whether the court should consider the drug makers' appeal.
Take two tablets and call me in the morning.
The AMA has released its “Health Insurer Code of Conduct Principles.” There are 10 of them, but let’s focus on #5: “Medical Necessity.” Here’s what the AMA has to say:
Medical care is “necessary” when a prudent physician would provide it to a patient for the purpose of preventing, diagnosing or treating an illness, injury, disease or its symptoms in a manner that is: (a) in accordance with generally accepted standards of medical practice; (b) clinically appropriate in terms of type, frequency, extent, site and duration; and (c) not primarily for the economic benefit of the health plans and purchasers or the convenience of the patient, treating physician, or other health care provider.
And further do
Health insurers must not use financial incentives that discourage the rendering, recommending, prescribing of, or referral for medically necessary care.
And finally:
No care may be denied on the grounds that it is not “medically necessary” except by a physician qualified by education, training and expertise to evaluate the specific clinical issues.
“Health insurers should provide access to necessary health care, protect the patient-physician relationship and accurately process medical claims, but too often they are an obstacle,” said AMA President J. James Rohack, M.D. “The new Health Insurer Code of Conduct Principles will help protect patients and physicians from questionable insurance practices by holding the health insurance industry accountable.”
The AMA’s full statement along with a link to their new 10 Commandments can be found here.
And, let’s not forget who the nation’s biggest health insurer is – that’s right, Uncle Sam.
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.
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.)
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.
