Latest Drugwonks' Blog
FDA Announces Renowned Pediatric Ethicist Robert M. Nelson, M.D., to Join Office of Pediatric Therapeutics
The FDA has announced that on October 16, Robert M. Nelson, M.D., M.Div., Ph.D. will join FDA’s Office of Pediatric Therapeutics and will be responsible for providing guidance and advice on ethical issues related to pediatric clinical trials and other pediatric issues involving any product regulated by FDA.
“We are extremely pleased to welcome Dr. Nelson to the Agency. His expertise and experience further bolster our ability to ensure the highest level of scientific and ethical rigor in pediatric clinical research” said Dr. Andrew C. von Eschenbach, Acting Commissioner of Food and Drugs. “Dr. Nelson’s insight and knowledge, both of medicine and ethics, are exceptional and will be of enormous benefit to FDA as we continue to improve our scientific understanding of the medical needs of children, and assure that research activities are conducted according to the best ethical and medical principles.”
Over the past decade, Dr. Nelson has been a consultant on ethical issues in research to the National Institutes of Health, the Environmental Protection Agency, FDA, the U.S. Department of Health and Human Services, and the Institute of Medicine, an independent national advisory organization.
For the past two years, Dr. Nelson has chaired FDA’s Pediatric Advisory Committee, and prior to that he chaired the committee’s Subcommittee on Ethics. He has been a member of several data and safety monitoring boards, and is a reviewer and editorial board member for a number of peer-reviewed journals. Dr. Nelson is also a former Chair of the Committee on Bioethics of the American Academy of Pediatrics.
We all owe the FDA a “thank you” for their timely and robust approach to the current E. coli outbreak.
Special kudos to agency expert David Acheson for his (as usual) high quality media performance (both form and substance).
I am pleased that there has been no reference to the agency being in the pocket of “Big Spinach.”
At least not yet.
An editorial in this past Saturday’s Los Angeles Times is the worst kind of holier-than-thou pronouncement — ill informed, full of unintended consequences, and bombastic.
A few select snippets:
“WHEN A PATIENT GETS a prescription from her doctor, she shouldn’t have to worry that the drug was selected because of a pharmaceutical company’s marketing skills. That’s why Stanford University Medical Center’s announcement this week that it’s no longer allowing physicians to accept gifts from pharmaceutical sales representatives is so refreshing. No more free lunches. No drug samples. Not even those cute mugs. It’s an austere measure that other medical centers should follow.”
No more free lunches. No more cute coffee mugs. No more pens. Big deal. No more free samples — that’s a serious disservice to the public health. Just ask any … doctor. Clearly the LA Times had neither the time nor the inclination to do so. Pity.
‘The drug industry says such bans, which also have been enacted in the last two years by Yale University and the University of Pennsylvania, will make it more difficult for doctors to interact with and learn from sales representatives. This is true. But so what? Drug reps typically keep physicians up to speed on pharmaceutical pipelines and medical research, something research shows doctors don’t do enough on their own. But physicians, who control patients’ lives with their decisions, must be held to the highest ethical standards possible to ensure that those decisions are based on the best empirical knowledge, not personal gain or social proximity.”
Yeah, “so what.” Who needs educated doctors anyway. And yet, in the same paragraph, the editorial speaks to the need for “the best empirical knowledge.”
But it’s much more important to punish the evil pharmaceutical industry than to ensure patient care, right?
“This won’t be cheap. Stanford estimates that making up for all those ‘free’ lunches and drug samples could cost the medical center millions. But when it comes to patient safety, and the fundamental importance of trusting your doctor for impartial information, it’s money well spent.”
Except who do you think will end up paying for this short fall of “millions.”
Here’s a link to the entire editorial.
There’s a lot of talk about how our use of pharmaceuticals needs to be “more efficient.”
But what does “efficient” mean?
Does it mean more cost-effective or more medically efficient? Does it mean either?
Let’s call a spade a spade — “efficient” means short-term savings for payors (although, as we shall see in a moment, only in penny wise but pound foolish ways). Restrictive formularies (in the US both public and private) and health care systems (in the EU, Canada, and elsewhere) that deny access to the right drug for the right patient at the right time but pay for more expensive and invasive procedures later on have their priorities upside down.
Perverse in so many ways — not the least of which is that “savings” are entirely transitory.
Consider the facts. A longitudinal prospective study by Dr. Susan Horn, et al.*, examined the relationship between HMO cost-containment strategies and utilization and total cost of health care for a number of medical (non-psychiatric) illnesses. The study showed that the tighter the formulary restrictions, the higher the overall cost of care — and what drove the increased costs was the association between formulary restrictions and utilization of care. (Many thanks to Dr. Frederick Goodwin — a CMPI board member — for calling this study to our attention.)
A blunter way of putting this is that “efficient,” as the term has come to be defined, has nothing to do with patient care. “Efficient” is a cost-based word and patient-centric concerns be damned.
Welcome to the world of health technology assessment, aka evidence-based medicine, aka rational use of medicine.
And remember, you can’t spell rational without r-a-t-i-o-n.
* If you would like to see the full study, here’s the full citation: Horn SD, Sharkey PD, Tracy DM, et al., Intended and unintended consequences of HMO cost-containment strategies: results from the Managed Care Outcomes Project. Am J Managed Care 1996;2:253-264
Jerry Avorn, the man who would be FDA commissioner in a Democrat administration, tried to show those of us lacking in the intelligence and Olympian insights that only a physician and researcher of his stature possess that permits him to teach at the Harvard School of Public Health based on the data dredging of grad students could understand why it is so important that we let him — and him alone - decide what medicines to take and when.
Jerry used a charming parable called “The Sting of Ignorance” to teach us what evidence based medicine really and truly is. Written in the NY Times it was a story of Jerry frolicking in the ocean blue when —jeepers creepers — a mean old jelly fish bit our Homeric health care hero on the calf (I know there’s a more scientific term for that muscle mass but I a taking a page from Jerry and keeping it simple) . Well no one— I mean no one— not even the wise and worldly author knew what to do to treat the pain. It took a nurse who JUST HAPPENED TO WALK BY to tell Jerry and all the First Aid trained lifeguards to stop applying alcohol and ice and make sure the jellyfish stinger was completely out.
Now as an aside, I am not Harvard trained and nor do I teach at Harvard. But I had a Bubbie. (You see I can be colloquial too. That’s SAT speak for folksy.) And when I was stung by a bee, before putting an ice pack on my arm where I was stung…my Bubbie made sure the entire stinger was out. I was about six then and it was something that every camp counselor knew whether it applied to yellowjackets or jellyfish.
But not in Jerry’s world. In Jerry’s world regular folks are morons and he lumps himself in their to prove a point (That’s a strawman folks.) In his NY Times article Jerry goes to the internet to do a google search to find out applying cold to a jelly fish stinger only helps spread the neurotoxin…he does that to make a point…wouldn’t it be wonderful if we could do a Google search on diseases to get a instant print out of what drugs to prescribe in each and every case.???
Yes indeed. One press of a button and you would get the right medicine for every illness in the same way that Jerry found the answer to how treat a jelly fish stinger when the rest of the boobs were screwing things up. And best of all, Jerry has been toling away to give the world the information they need to usher in this evidence based Uber Alles.
Except here’s the problem. Either Jerry is dishonest or those jellyfish neurotoxins have travelled to those neurotransmitters that control his memory….Jerry is really keen on warning old people not to take Vioxx because of the risk of heart attacks but he forgets his own research and that of others demonstrating that older people with rheumatoid arthritis are at higher risk for heart problems. He loves to talk about how restrictive formularies that shove generics down people’s throats increase compliance with drug regimens but ignores the mounting research demonstrating that such limits combvined with tiered copays discourage people from taking needed medicines. And in touting ALLHAT and claming that diuretics are more effective that calcium channel blockers, he ignores new research demonstrating that many sub groups live longer on newer agents and are less likely to have diabetes and kidney failure.
I could continue to point out the holes and exceptions and inaccuracies that, when woven together, make up Avorn’s ideologically-driven approach to evidence-based prescribing. But I couldn’t quite do it justice. It takes a degree of arrogance and condescension made possible only by repeated exposure to jellyfish neurotoxins.
David Vitter who?
David Vitter who doesn’t think that international drug counterfeiting is a problem.
Someone should put a hold on the junior senator from Louisiana — like a half nelson kind of hold.
I have repeatedly written that the Clinton-Murray hold on the von Eschenbach nomination would undermine the public health and FDA not because of the particular issue but because of the precedent of allowing a grandstanding senator to comingle politics with public healht by holding up the confirmation process. Well guess what? According to UPI:
“Fresh from giving the green light on Plan B in order to satisfy two Democrats holding up the nomination of Andrew von Eschenbach to head the FDA, two Republican Senators now say they have demands of their own that will have to be met prior to his elevation to the post. Senator David Vitter is demanding that the government provides a compromise agreement on importing drugs from Canada and Senator Jim DeMint is demanding that the abortion drug RU-486 is taken off the market, according to a report in The New York Times. Neither action is likely anytime soon and Vitter is predicting that Eschenbach’s nomination will remain in limbo until next year. Only yesterday, though, analysts were predicting clear sailing for his nomination in a vote scheduled for next week.”
Not this analyst. I had predicted that anyone who was intellectually feeble enough to strip law enforcement of the power to inspect pharmaceutical packages despite the fact it was an important part of the war against jihadists and organized crime (that’s Vitter) would hold the FDA commish nomination hostage until he got his way. The DeMint hold is the flip side of Plan B. I won’t get into the politics or the merits.. The DeMint stunt (why not just ban all forms of birth control while we are at it and roll back the availability of the HPV vaccine and medicines for STDs since they promote sexualy activitiy among minors?) .It is another step towards the political prostitution of the FDA. Will or does anyone have the guts to tell these granstanders to stand down? And when the will Senate put a limit on the use of holds for such destructive purposes?
I got a glimpse of what Medicare will be like after Mark McClellan leaves. There will be an emphasis on prevention, with a focus on using the drug benefit or rather tailoring it to the individual to keep people health and prevent chronic illness. Plans have responded to the desire to not only keep premiums low or avoid the coverage gap with new approaches. They are also developing — in cooperation with Medicare and thousands of volunteers and countless agencies — ways to coordinating the drug benefit so that it becomes a tool for preventing disease. McClellan and others discussed — at a My Health, My Medicare briefing at HHS — the importance of giving seniors the ability to obtain the best health value from the Medicare program. Ultimately, giving consumers control over health care dollars with the best clinical and cost information will make that possible. Medicare will drive this point home by making sure seniors get a checkup, flu and pneumoccal shots, colonoscopies and other preventive screens that are now part and parcel of the Medicare benefit. And all of this will be rolled out as seniors choose new plans during the month of October.
I can’t wait to see Democrats and the sourpusses at Families USSR try and scare seniors out of making these important decisions. Medicare has become a third rail of American politics again — but this time it’s because people feel a sense of ownership not entitlement as in the past. Watch when the D’s try to replace what Mark has helped create with a one size fits all price control system….
Yesterday the Washington Times ran an unsigned editorial pointing out that Move.org has a history of anti-semitism
Here is the editorial
September 13, 2006
In recent weeks, since drawing criticism for anti-Semitism on MoveOn.org’s Action Forum, the parent political organization has been finding a way to retreat without claiming responsibility for the thoughts and statements of its followers.
First, MoveOn.org decided to suspend the site’s operation until after the election to give the organization what it termed “a margin of safety.” When that looked too political, it restarted the site with a pledge to delay all postings by a day.
MoveOn’s political action director Eli Pariser insists that the organization knew nothing about the comments until they found out about them around Aug. 14.
Nice try. MoveOn itself notes it has full-time monitors who “spend the vast majority of their time looking for comments to pass on to the MoveOn team and doing weekly forum summaries.”
Mr. Pariser’s letter to the Anti-Defamation League claims MoveOn members “rose to sharply criticize the hate speech that was posted — even before it was brought to our attention.” But MoveOn monitors deleted criticisms from Bill Levinson of Israpundit.com well before it deleted anti-Semitic rants. Meanwhile, a post claiming “Jews control all the media” was made on Aug. 17, which is after MoveOn claims it “discovered” the problem.
Mr. Pariser tried to blame the comments “on a right-wing campaign to target the organization.”An Aug. 29 Op-Ed demonstrated that the forum’s anti-Semitism was just an extreme expression of what the most powerful radical-left political organization — one that gives money and support to Democrat candidates — really thinks and feels. Suggesting President Bush’s fight against terror is largely the result of excessive Jewish influence over Congress and the media is anti-Semitic. Asserting that Jewish policy-makers and Zionists in the Bush administration had a secret plan to invade Iraq and conquer the Middle East — a plan pushed by the all-powerful “Israel lobby” — is anti-Semitic.
MoveOn’s followers made that case time again, referring to “greedy Jewish pigs” and “Zionazis” in the process. And when a 2003 MoveOn position paper claims that Bush foreign policy advisers who supported the invasion of Iraq have “dual loyalties,” making policy decisions in the interests of Israel as much as the United States, it says the same thing with less colorful language.
Judging by its actions in the wake of this scandal and the tone of the paper, we can say with “a margin of safety” that MoveOn still has a Jewish problem. So do the candidates who fail to renounce the support MoveOn is giving them.
This from the NY Times
Stanford University Medical Center will prohibit its physicians from accepting even small gifts like pens and mugs from pharmaceutical sales representatives under a new policy intended to limit industry influence on patient care and doctor education.
….The move is part of a reaction against corporate influence on medicine at a time of growing concern over the safety and rising cost of drugs and medical devices. About 90 percent of the pharmaceutical industryÃ¢s $21 billion marketing budget is directed at physicians, according to an article by an influential group of doctors, scientists and lawyers in The Journal of the American Medical Association in January.
That article called upon academic medical centers to adopt policies like StanfordÃ¢s, saying that existing guidelines, like a prohibition of expensive gifts, did not go far enough. Some studies have shown that even small gifts create a sense of obligation, they wrote, while free drug samples are Ã¢a powerful inducement for physicians and patients to rely on medications that are expensive but not more effective.Ã¢
If someone can explain the relationship between concerns about drug safety and corporate influence — in the form of pens and advertising — please let me know. Does passing out pens corrupt the prescribing process, thereby completing the circle of companies shoving unsafe medicines and ineffective new medicines through the FDA (because of the cozy relation of course) which in turn are marketed through ads that dupe and lavish buffets and junkets that seduce, thereby driving up drug costs which in turn are driving medical costs sky high?
Oh, I forgot the clnical trial data and medical journal articles that are skewed to drug benefit when in fact there is none.
Taken together — since this mantra has been repeated and amplified since the the 1950’s — or rather since this passion play has been produced and reproduced over and over and over again one can only assume that no new drug has any really benefit since they are more expensive than its predecessor and all have been marketed. And moreover, in the past they were marketed more extravagantly and with nicer parting gifts than some cheap pen or mug (I remember a medical student friend of mine getting clocks and briefcases) . So by the logic of the conspiracy theorists, no medicines really should work because they have all gone through this sick, money driven combine and indeed, it should have been worse in the past because the misbehavior was worse years ago.
None of which explains increase life expectancy, declinining mortalility, the fact that drug costs are still the smallest share of the health care dollar and smallest contributor to premium increases or that most of the validated scientific advances — elucidation of biological pathways based on genomics and proteomics — are coming from the pharma and bio industry.
In any event, what will the know it alls do when drug spending increases after all there so-called reforms are implanted in the minds of medical students because the drugs actually work in the clinical setting and their efforts to manage cost without caring for the wellbeing of patients fail.
The attack on drug spending is political, driven by technocrats and arrogant leftists like Jerry Avorn who care nothing about the impact their jihad has on long term health. They want to replace the clinical judgement of doctors with the one dimensional and politically driven decisions of politicians who are more interested in screwing drug companies than they are in saving lives or investing in changes that really save money down the line.