Latest Drugwonks' Blog

JAMA just released a study ahead of print publication on COX-2 drugs entitled Adverse Effects of Cyclooxygenase 2 Inhibitors on Renal and Arrhythmia Events: Meta-analysis of Randomized Trials. It is accompanied by an editorial from David Graham who cheerfully reminds us that the FDA is there to protect the public not corporate profits….

By now everyone knows the risks associated with taking COX-2 drugs. There is a whole cottage industry of so-called researchers who do nothing but recycle and reprocess earlier studies - good, bad and indifferent — on COX-2s designed to show how likely they are (take your pick, hazard ratio, risk ratio…can anyone tell the damn difference in the media) to have heart problems. And the studies keep on coming despite the mounting evidence that risk is associated with age, illness and genetic variations that metabolize drugs. But you don’t know any of this because the good folks at JAMA are not in the business of publishing such studies. Don’t generate enough media attention which in turn drives demands for reprints which are the bread and butter of JAMA’s business. And JAMA has to compete with NEJM for headlines so they are inclined to run with studies that can show quickly and with data easy to distill into a press release how dangerous drugs are or how dangerous drug advertising is. To call THAT hypocritical is too mild a term since both publications depend on drug ads and reprints for their survival.

In any event, when JAMA weighed with yet another warning about COX-2 drugs I was curious to know if it had published any findings about the products benefits or its risks relative to others NSAIDS or research that sought to put the risks and benefits in perspective.

JAMA published one of the original studies raising red flags about the increase in cardiovasular events back 2001. But since then, it has failed to shed little light on the relative risks and benefits of COX-2s or how they might fit into the pantheon of products.

For example recently

Another meta-analysis showed that high doses of two of the NSAIDs studied, diclofenac and ibuprofen, were associated with a similar increase in the risk of vascular events to COX 2 inhibitors, although the risks of high doses of another NSAID, naproxen, were smaller.

A recent study found that NSAID-associated GI complications and death have been decreasing since 1992, which we believe can be attributed to several factors: use of lower-dose NSAIDs; decreasing prevalence of H. pylori; increasing use of proton-pump inhibitors; and the introduction of NSAIDs with greater GI safety, such as coxibs

Harris and colleagues studied the use of celecoxib (Celebrex), rofecoxib (Vioxx), regular aspirin, low-dose aspirin, ibuprofen and acetaminophen among 323 women with breast cancer from 1999-2004.
studied the use of celecoxib (Celebrex), rofecoxib (Vioxx), regular aspirin, low-dose aspirin, ibuprofen and acetaminophen among 323 women with breast cancer from 1999-2004.

They compared the results with those from a control group of 649 cancer-free women matched for age, race and county of residence.

They discovered that women who used NSAIDs on a regular basis had less breast cancer. Specifically, they found that those who used celecoxib or rofecoxib for at least two years appeared to benefit the most, experiencing a 71 percent reduction in risk of breast cancer. Ibuprofen use over the same period was associated with a 64 percent reduction, while regular aspirin offered a 51 percent reduction in risk of the disease.

On the other hand, acetaminophen, which has a negligible effect upon COX-2 activity, and low-dose aspirin provided no significant change in the risk of breast cancer.

This case control study supports clinical trials which have found that COX-2 drugs work against estrogen receptors.

I could go on, but you get the drift: By now we all know that coxibs have some elevated risk for heart problems for some small percentage of people and while we have an idea who they still often got the drug and in any event their risk for heart problems with other pain killers might be higher or lower. You would think that as one of the flagship medical journals JAMA could take a more responsible position on the risks and benefits of medicines. But in an age where David Graham is a media star and hype sells reprints, that is asking way too much.

Margin Call

  • 09.20.2006

Yes, times are tough for everyone.

According to UBS, which looked at a handful of generic drug companies representative of the industry, gross margins fell to 47% in the second year compared to 52.2% a year ago.

That’s right, “fell” to 47%.

Nice work if you can get it.

Ireland: Medicines Board Halts Web Sales of Prescription Drugs

The Irish Examiner reported that the Irish Medicines Board (IMB) has closed down 4 overseas websites for illegally selling medicines to people in Ireland. According to the article, an investigation found that rogue websites are selling medicines like Viagra, antidepresants and valium to consumers without asking questions about the purchasers, who would be required to provide a prescription. The article included a statement by the IMB on its decision: “We co-operate with the authorities throughout Europe to combat the illegal supply of medicinal products and this strategy has been effective in closing down illegal websites in the past.”

(And, no, the Irish Minister of Health is not Donough Shillelah.)

Whole Nelson

  • 09.19.2006

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.

Pens & Sellers

  • 09.18.2006

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.,0,7496545.story?coll=la-opinion-leftrail

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.

Opportunism Knocks

  • 09.16.2006

Knock. Knock.

Who’s there?

David Vitter.

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?


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.

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