Latest Drugwonks' Blog
FDA backs BPA as study links it to heart disease, diabetes
Really, and I thought it was the all the junk food the corporations put in the plastic bottles that were the cause of those diseases. I guess the evil corporations are just hell bent on killing people...and the FDA, which is "backing" BPA is just doing the bidding of it's corporate masters..
And most important a study in JAMA by David Melzer and crew that ostensibly links high levels of BPA with increased incidence of heart disease and diabetes supposedly proves that BPA causes these illnesses. The study found "that higher BPA concentrations were associated with diagnoses of cardiovascular disease and diabetes. We also found associations between higher BPA concentrations and clinically abnormal concentrations of the 3 liver enzymes examined, namely GGT, alkaline phosphatase, and lactate dehydrogenase. Importantly, we observed no associations with the other common conditions examined, suggesting specificity of the associations. A series of sensitivity analyses provided further support for the specificity of the associations found."
Which lead a BPA expert named John Peterson Myers to invoke THE PRECAUTIONARY PRINCIPLE in a side-by-side editorial in JAMA:
"It's impossible to say that BPA is safe,"
http://www.usatoday.com/news/health/2008-09-16-bpa-heart_N.htm
The problem is that the 2003-2004 National Health and Nutrition Examination Survey (NHANES) which were used to estimate daily intake of BPA, shows that most Americans, regardless of age, have a median intake have approximately three orders of magnitude below health-based guidance values of 50 mug/kg-day....
So Melzer et. al stacked the deck with respect to the BPA levels to demonstrate a correlation with self reported claims of having been diagnosed with diabetes or heart disease and snap shots of insulin and C-reactive protein levels...
http://www.ncbi.nlm.nih.gov/pubmed/18414515?ordinalpos=27&\
http://jama.ama-assn.org/cgi/content/full/300.11.1303#SEC5
http://jama.ama-assn.org/cgi/content/full/300.11.1353
Are we all on the same page now?
All good things.
The issue of companion diagnostics is particularly crucial or, more appropriately, critical (yes -- like in Critical Path) -- and not just for existing medications (warfarin and Herceptin come to mind) -- but also for pipeline programs. Are we approaching a time when the FDA might consider asking for companion diagnostics to be developed as part of the approval process for some products? That would be a 21st century personalized partnership, adding a whole different dimension to both safety and efficacy.
The FDA/Penn agreement also will faciliate interaction between the FDA and Penn students -- an important next step in the agency's urgent need to expand its recruitment efforts.
Particular congrats go out to Mary Poos, the FDA's Sultana of MOUs, for yet another job well done.
With all the focus on drug safety, what’s gotten lost in the shuffle is the issue of safe use.
Talk about putting profits before patients!
According to a Medical Society of the State of
Of the over 1200 physicians surveyed this month, 90% said they changed the way they treat patients based on restrictions from an insurance company, and 92% said incentives and disincentives offered by insurance companies regarding treatment options "may not be in the best interest of patients."
87% of physicians said they sometimes feel pressure to prescribe a treatment based on cost. About 93% of physicians said insurance companies have required them to change prescriptions in the past.
To see how that plays out when you extrapolate private greed to bureaucratic need, click here.
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.”
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.
