Latest Drugwonks' Blog
Representative Henry Waxman (D-CA),
A modest proposal.
And caveat emptor.
http://www.nypost.com/seven/09142008/postopinion/postopbooks/autisms_false_prophets_128960.htm
Meanwhile the NEJM/media's war against Gardasil's approval for use in women up the age of 26 failed...
Gardasil Approved to Target More Cancers
Sept. 12, 2008 -- The FDA today announced that the vaccine Gardasil may be used to prevent some cancers of the vulva and vagina in girls and women ages 9-26.
Gardasil is already approved to help prevent a leading cause of cervical cancer in women of that same age range.
Gardasil targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer. Two of those HPV strains can also cause some vulvar and vaginal cancers.
"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, says in a news release.
"While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV," Goodman says.
http://children.webmd.com/vaccines/news/20080912/gardasil-approved-to-treat-more-cancers
Yeah, well to the media it's all just "hype".
http://well.blogs.nytimes.com/2008/08/29/blaming-the-media-for-gardasil-hype/
Have a look at our latest newsmaker interview with Representative Joe Pitts (R,PA).
AP reports that Food and Drug Administration has recently hired more than 1,300 professional staffers in a move that “officials hope will help it better protect the public health amid rapid technological and scientific change.”
40% or so of the total positions are paid for via PDUFA fees; ergo the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.
That’s great news. But where are they all going to park? White Oak isn’t even finished yet and already it’s looking like the seating charts will have to be rearranged – particularly since CDER is getting 663 new staffers.
It's a good problem to have.
CFSAN is slotted to get 104 -- a 10% increase (a good start – but not enough). And ORA will grow by 245. Good news.
1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors.
Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement.
But it’s not all rosy and it’s not as easy as reporting numbers.
The FDA hired nine cancer specialists, but another 20 rejected offers. "They could not make the money they would be making on the outside if they came into public service," said Kimberly Holden, the FDA’s senior manager directing the recruitment initiative. The agency could offer as much as $275,000 a year, she said, but oncologists can make $400,000 annually outside of government service.
All-in-all, it’s a good start. But it’s just the end of the beginning -- and just barely.
Here’s the first paragraph from the story in today’s Wall Street Journal on the continuing controversy swirling around academic research and pharmaceutical industry funding:
"Starting today, the NIH could send a signal that business as usual is over … The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."
The Senator is right. But the issue is quickly morphing beyond mere issues of filling out the required forms in at timely manner.
Consider the comments of Jerome Kassirer, the purer-than-pure (despite mega-millions in pharmaceutical advertising revenue), former editor of the New England Journal, "Universities have been treading on dangerous ground with their increasingly complex financial ties to industry. They are worried that these things could ultimately affect their tax-free status."
Get the picture?
(Note to Jerry – you may be next.)
For more on the COI controversy, please attend our September 22nd conference, "Industry Support for Continuing Education of Health Care Professionals: An Evidence-Based Evaluation." There's no cost -- and here's the complete invitation.
In keeping with that metaphor, comes news that Germany’s IQWiG (the Institute for Quality and Efficiency in Healthcare) is preparing to test a new cost-benefit methodology towards the end of this month. The test will last for about four months.
To do this it has had to draft a cost-benefit methodology. A first version was put out for public consultation earlier this year and drew many comments (not all laudatory) from stakeholders. Some were critical of the proposed "efficiency frontier analysis" the institute plans to use as the basis of cost-benefit assessments. IQWiG claims that efficiency frontier analysis can be "used in a very flexible manner to compare the cost-benefit relation of any number of therapy alternatives.”
“Flexible” is in the eyes of the beholder.
IQWiG´s new methodology will help determine an “appropriate ceiling” price for drugs that are reimbursed by the statutory health insurers but cannot be included in a reference price group. IQWiG’s assessment will also include a budget impact analysis that can be used in estimating how a decision may affect expenditure in the health care system as a whole.
The cross-channel (and potential cross-Atlantic) implications are especially timely coming on the heels of the Baucus/Conrad bill and while experts are predicting a meltdown of Britain’s NHS.
The answer? According to Sir Michael Rawlins, chairman of the National Institute for Health and Clinical Excellence (NICE), draconian rationing. As he said earlier this week, "Rationing is a necessary evil. We have to do it. There will be losers and winners." That's "universal" health care in its true guise of cost-based "government" health care.
As Tom Lehrer sang, “Once the rocket goes up who cares where it comes down. That’s not my department says Wernher von Braun.”
But where are the front page stories? Where's the outrage?
Where's the justice?
Here's the complete editorial:
Debunking an Autism Theory
The initial paper, published in The Lancet, the prestigious British medical journal, drew an inferential link between the vaccine, the gastrointestinal problems found in many autistic children and autism. In later papers, researchers theorized that the measles part of the vaccine caused inflammation in the gastrointestinal tract that allowed toxins to enter the body and damage the central nervous system, causing autism.
Now, a team of researchers from
These researchers studied a group of 38 children with gastrointestinal problems, of whom 25 were autistic and 13 were not. All had received the vaccine for measles, mumps and rubella. The scientists found no evidence that it had caused harm. Only 5 of the 25 autistic children had been vaccinated before they developed gastrointestinal problems — and subsequently autism. Genetic tests found remnants of the measles virus in only two children, one of whom was autistic, the other not.
The new study adds weight to a growing body of epidemiological studies and reviews that have debunked the notion that childhood vaccines cause autism. The Institute of Medicine of the National Academy of Sciences, the C.D.C. and the World Health Organization have found no evidence of a causal link between vaccines and autism.
Meanwhile, the original paper’s publisher — The Lancet — complained in 2004 that the lead author had concealed a conflict of interest. Ten of his co-authors retracted the paper’s implication that the vaccine might be linked to autism. Three of the authors are now defending themselves before a fitness-to-practice panel in
Sadly, even after all of this, many parents of autistic children still blame the vaccine. The big losers in this debate are the children who are not being vaccinated because of parental fears and are at risk of contracting serious — sometimes fatal — diseases.
The headline of the AP story says it all, “Congress likely to delay health care overhaul.”
“As Congress returns from summer recess, lawmakers are expected to continue needling pharmaceutical makers and health insurers with investigations, while holding off on major health care reform until next year.”
That’s what this country needs – more needling!
But isn’t health care reform the driving domestic policy issue?
“Health care has fallen in importance as an issue to voters and that would make one question how aggressive action is going to be next year," said Lehman Brothers analyst Tony Clapsis.
Guess not.
“… analysts are not holding their breath for universal health care coverage, despite some recent rhetoric from the campaign trail.”
"Some" rhetoric? That's generous.
How about less needling, less rhetoric – and more focus on dealing with the problem. Which aspirant to the White House will have the courage to call for bringing all parties (drug companies, insurance companies, physicians, patients, hospitals, etc.) together to really begin addressing ways to provide access to excellence?
Reform by soundbite is insulting and dangerous.
The Kaiser folks wiped out the seniors who spent nothing to plump up the bottom line figure. Why is one level of spending any less or more important than any other. Indeed, when doing weighing of distributions you have to add those folks in so that decision was a political one to say the least, not a methodological imperative. Six percent is still 3 million people. And it doesn't take away from the fact that both studies found people who hit the hole -- up to one in 10 -- stopped taking their meds for diabetes, depression, Alzheimer's, hypertension and that more than half did not restart after getting catastrophic coverage.
The biggest problem with the Kaiser study is that it does not compare the behavior of seniors with and without gap coverage indeed the authors admit:
"The IMS database does not provide sufficient information about Part D plans (in particular, it does not distinguish among the multiple plan offerings of a single sponsor) to allow for identification of the small share of enrollees in plans with gap coverage, which prevents us from excluding them from the analysis."
http://www.forbes.com/forbeslife/health/feeds/hscout/2008/08/21/hscout618675.html
Small share? Actually over 60 percent are enrolled in plans in gap coverage.
The interesting policy question is what aren't more seniors choosing plans with gap coverage over the lowball premium plans?
A further policy question is whether encouraging seniors to switch from an existing medicine in a class -- generic or not -- to another drug is wise. Gail Shearer of Consumer Union sent a letter to the NY Times arguing that "taking the cholesterol-lowering drug simvastatin (the generic of Zocor) instead of Lipitor saves about $60 to $70 a month. Likewise, many people with acid reflux disease can save $150 to $200 a month by taking nonprescription omeprazole (the generic of former best-selling Prilosec) instead of the much-advertised Nexium. People should raise the issue of drug prices with their doctors to make sure they get prescriptions for medicines they can afford."
http://www.nytimes.com/2008/09/07/opinion/l07Medicare.html?scp=1&sq=gail%20shearer&st=cse
I am glad she urged people to raise the issue with doctors because switching drugs is something people should not do on their own. Direct to consumer information -- from any source -- should start with patient VALUE in the long term and work from there. Off the cuff money saving comments can be dangerously expensive otherwise.
"Little Trig Palin prompted more than delegate coos when he joined his mother on stage at the Republican convention. He also raised new questions among parents whose children have disabilities.
Was Alaska Gov. Sarah Palin simply including her 5-month-old son, who has Down syndrome, in a big family moment, or was she exploiting him in a tight presidential campaign? Would he help break down social barriers facing children with Down syndrome, or would those children now be drawn into the right-to-life debate?"
Wasn't it the media and the left wing blogosphere who raised all these questions and invaded her family's privacy? Of course it was and that's where Krumholz went for her "sources."
"Among bloggers' top concerns is a Bush administration measure that would trim Medicaid funding for community services for people with disabilities. Democrats have so far stalled the cuts, which advocates for the disabled said would force the disabled back into institutions.
Blogs also were filled with questions about Gov. Palin's record on services to the disabled during her two years in state office. This spring, Alaska agreed to almost triple its spending on special-needs children, to $73,840 each beginning in 2011. But Gov. Palin didn't help draft the legislation."
She didn't help draft the legislation?? Obviously a sign of neglect!!
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