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CMPI Videos
Video Montage of Third Annual Odyssey Awards Gala Featuring Governor Mitch Daniels, Montel Williams, Dr. Paul Offit and CMPI president Peter Pitts

Indiana Governor Mitch Daniels

Montel Williams, Emmy Award-Winning Talk Show Host

Paul Offit, M.D., Chief of the Division of Infectious Diseases and the Director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, for Leadership in Transformational Medicine

CMPI president Peter J. Pitts

CMPI Web Video: "Science or Celebrity"
Tabloid Medicine
Check Out CMPI's Book
A Transatlantic Malaise
Edited By: Peter J. Pitts
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Getting Slimed by the Slime Specialists
"I must be doing something right. Yesterday, after I provided some free publicity for an upcoming "evidence-based" evaluation of industry funding of CME, I received the following comment from the Vice President of CMPI, Robert Goldberg:
Apparently you are the only pure one left on the planet. You have no biases or opinions that color your judgment or clinical practice. And of course your opinion about the negative pharmaceutical industry's impact on research -- none of which can be demonstrated through the traditional scientific methods but only appeals to emotion -- are right and everyone else is wrong. But that's not bias. Apart from the fact that the Sourcewatch material is three years old and outdated (which means you didn't even bother to check the facts since our 990 is readily available) you don't even have the intellectual or moral courage to engage on the merits of the issue CME or more generally the relationship between industry and academia. Rather, you resort to the oldest rhetorical trick in the book: attacking the character or motives of a person who has stated an idea, rather than the idea itself. That's the sign of a bully and a coward. If you had any integrity or guts at all you would show up at our session (the very thought of it must give be keeping you up nights!!) engage in reasoned discussion. But I doubt you will.
In this response, Mr. Goldberg demonstrates exactly why his organization and his blog have become notorious for perfecting the art of personal-attack-as-policy-discussion. Those who want to find example after example of Mr. Goldberg's and Mr. Pitt's inimitable rhetorical style should read this expose recently published in opednews.com. Here Danny links to the ravings of Evelyn Pringle....a most reliable and objective source of information...
Some of their pit bull (sans lipstick) pronouncements:
--"Sidney Wolfe, Public Citizen’s General Secretary of Junk Science..."
--"Not the real FDA - a Grahamatization" (referring the David Graham, the FDA analyst who revealed the extent of the Vioxx health risks)
--"That's the sign of a bully and a coward," describing me. We've descended to that level of name-calling now?
If Mr. Goldberg would like to engage in the merits of the CME discussion, he merely has to read dozens of my prior postings, in which I comment ad nauseum on the innumerable developments, debates, and policy pronouncements in the world of CME. If he would like concrete examples of commercially biased CME, I have provided them in spades.
Unlike the speakers at his conference, I don't have Fortune 500 companies standing in line ready to pony up for a trip to Washington D.C. at a moment's notice. If CMPI really wanted to engage in an "evidence-based" discussion, they would have invited speakers with alternative points of view, but they didn't, and because of that, the conference is a charade and is merely an opportunity for networking among those who profit mightily from industry-sponsored CME. "
And here's the psychiatrist's temperate posting of the previous day....
Wednesday, September 17, 2008
Jurassic CME Park comes to Capitol Hill

That reactionary unthink tank, Center for Medicine in the Public Interest (CMPI), is sponsoring what they are calling an "Evidence-Based Evaluation" of industry support of continuing medical eduation. You can view their invitation here.
For those who have not yet learned about CMPI, go to Sourcewatch for as much information about them as you can stomach. Essentially, they are a front group for the pharmaceutical industry, the CME industry, and whatever other stakeholding company is willing to fund them according to this menu of donating options. For example, $10,000 buys you a "corporate sponsorship" and up to four meals with "CMPI research scholars," $25,000 nets you a seat in the "Chairman's Circle" and an invitation to a "summit," and big spenders can go whole hog with a $100,000 membership in the "President's Club," and a "personal briefing."
Joining with this den of integrity will be none other than George Lundberg, M.D., editor-in-chief of Medscape. Dr. Lundberg embarrassed Medscape and the entire medical community recently with this video editorial in which he responded to the CME concerns of the nation's top medical organizations by saying: "We are just going to keep doing what we are doing. It is good. We are clean. Our work is transparent.”
Other participants, all of whom will examine the issue from a balanced and "evidence-based" perspective, are:
--Roger Meyer, MD, listed on the brochure as "Clinical Professor of Psychiatry at Georgetown University and Adjunct Professor of Psychiatry at the University of Pennsylvania." Unfortunately, there just wasn't room to disclose the fact that he is actually the CEO of a company called Best Practice, which helps companies market their drugs via CME and provides a roster of "key opinion leaders" for hire.
I've only scratched the surface here, folks. There are many more speakers scheduled, all of whom are similarly dispassionate observers of the CME scene, and are equally scrupulous in their disclosures.
If you do go, I have a word of advice. Be careful around the speakers. Dinosaurs bite.
Read More & Comment...
Mission accomplished.
Read More & Comment...
A question I get asked a lot these days is – Who should be on the short-list for FDA Commissioner?
Henry Waxman isn’t on my list – but he sure sounds like he wants the job.
According to Alicia Mundy at the Wall Street Journal, “In a letter sent today, Waxman, a California Dem who chairs the House oversight committee, demanded that the agency explain its priorities and accused it of carrying water for the drug and device industry."
His specific accusations surround the issues of pre-emption and the dissemination of medical journal articles that discuss off-label use. (For more on pre-emption, see here and here. And on the issue of off-label, see here and here.)
This most recent episode of the Waxman Inquisition really goes beyond the pale. In his letter,
(1) He once worked at, among other places, Hudson Institute and (2) Because his brother is Dan Troy.
Well, I worked with Tevi at
As to Dan Troy, I can personally attest from confidential knowledge that they are, in truth and in fact, brothers. So what? What is Mr. Waxman implying?
Shameful. Cowardly.
It’s also disappointing (but not surprising) that Mr. Waxman chose to release the letter to the media before it arrived at the FDA.
Maybe next time
From the Financial Times:
“A legal battle between GlaxoSmithKline and Greek wholesalers over parallel trade in drugs – which could have implications for the price of medicine - ended with a mixed result on Tuesday morning at
The European Court of Justice ruled that if a dominant company refused to meet “ordinary” orders for medicinal products, because it wanted to put a stop to parallel exports, it was breaching EU competition law.
But the judges said that it was up to individual countries’ courts to decide whether orders were “ordinary”. They would need to look at both the previous business relations between the drug company and the wholesalers concerned, and the size of the orders in relation to market needs in the country concerned.
Drug prices in
As a result, in 2000, GSK changed its Greek distribution system, and supplies to wholesalers were interrupted. The wholesalers complained that this amounted to anti-competitive conduct and an abuse of a dominant position.
In April, a senior legal adviser at the ECJ largely ruled against the company. Tuesday’s full court decision significantly qualifies that position.”
And via Bloomberg, this add:
“The court ``has confirmed that companies must be able to take reasonable and proportionate steps to protect their own commercial interests, even if they hold a dominant position and such steps must be assessed in the light of the ordinary requirements of the markets,'' London-based Glaxo said in a e-mailed statement.”
Is this the beginning of the end of pharmaceutical parallel trade in the EU? It depends. But one thing is certain, if nations such as the
No matter -- if the EU decides to act in its own best interests perhaps the next Congress can design a plan where we import cheaper drugs from ... India.
The House Energy & Commerce Committee needs to help fix the problem, not the blame.
Statements coming out of the committee like -- “The FDA has refused to take meaningful regulatory action despite the fact that, for the past three years, it possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices.” -- is not being fair to an agency that at the time under debate and yet today is under-funded and under-staffed.
But when the committee says -- “The FDA, for example, conducted preapproval inspections for only 17 percent of the Ranbaxy applications approved since January 2005. It also allowed Ranbaxy to perform the key bioequivalence studies for generic drug approvals in facilities owned by the firm and conducted by clinicians employed by the firm.” – they’re right. The same rule that holds true for innovator companies must also applied to generic drug manufacturers – otherwise the public’s queasiness about the quality and character of generic drugs will continue.
But Representative John Dingell, who chairs the committee, goes to far when he says, “The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud. This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health.”
That’s not true. It’s not fair. And it’s not helpful.
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.
Read More & Comment...
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).
Read More & Comment...
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.”
Read More & Comment...
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.
Read More & Comment...
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.
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"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!!
..http://online.wsj.com/article/SB122083992345509015.html
Read More & Comment...
Yep. But what's implicit in what Dr. Varmus says is -- since we're not dying of heart attacks and strokes (thanks largely to pharmaceutical interventions) -- we're living long enough to get cancer. (Also -- NewsWeek fact-checkers please note -- Varmus wasn't the "former director of NCI," he was the former director of the NIH.)
So, are more people getting cancer? Yes. Are more people dying of cancer? Yes. Does that mean that we are "losing" the war on cancer? Not necessarily.
Meager? Really?
Is there cause for hope? Absolutely. And no better reason to embrace and fund the Critical Path program.
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