Latest Drugwonks' Blog
There has been a lot of mis-reporting about which think tanks take what position on Wal-Mart policies…Here is one position we support..Wal-Mart’s program to make generic drugs even cheaper for millions of Americans and for most of its associates. As for Wal-Mart itself, can’t beat the prices on most items and now that goes for a lot of medicines. The Wal-Mart press release is below:
BENTONVILLE, Ark. â Sept. 21, 2006 â As part of its ongoing commitment to providing more affordable healthcare for Americaâs working families, Wal-Mart Stores, Inc. (NYSE: WMT) today announced that it will make nearly 300 generic drugs available for only $4 per prescription for up to a 30-day supply at commonly prescribed dosages. The program, to be launched on Friday, will be available to customers and associates of the 65 Wal-Mart, Neighborhood Market and Samâs Club pharmacies in Tampa Bay , Fla. area, and will be expanded to the entire state in January 2007.
âEach day in our pharmacies we see customers struggle with the cost of prescription drugs,â said Wal-Mart CEO H. Lee Scott, Jr. âBy cutting the cost of many generics to $4, we are helping to ensure that our customers and associates get the medicines they need at a price they can afford. Thatâs a real solution for our nationâs working families.â
Key components of the program include:
* The $4 pricing will be available to all pharmacy customers with a prescription from a doctor that can be filled with a covered generic medicine.
* This program will be available to the uninsured.
* Insurance will be accepted.
* The program presently covers 291 generic medications from many of the most common therapeutic categories.
* The medicines represented are used to treat and manage conditions including allergies, cholesterol, high blood pressure and diabetes. Some antibiotics, antidepressants, antipsychotics and prescription vitamins are also included.
* The program will be available statewide in Florida in January 2007.
* Wal-Mart intends to take the program to as many states as possible next year.
âCompetition and market forces have been absent from our healthcare system, and that has hurt working families tremendously,â Scott said. âWe are excited to take the lead in doing what we do best â driving costs out of the system â and passing those savings to our customers and associates.â
The program will help alleviate a major challenge for seniors who have fallen into the âdoughnut holeâ coverage gap in their Medicare Part D prescription drug plans and now find themselves responsible for paying 100 percent of their prescription medicine costs.
âThis act of good corporate citizenship will help consumers manage healthcare costs, while benefiting Florida âs growing population,â said Florida Governor Jeb Bush. âIn addition to providing a great service, Wal-Mart is encouraging important conversations between patients and their doctors about the cost savings associated with generic prescriptions. I am pleased Wal-Mart chose Florida to launch this initiative where our large population of seniors will greatly benefit.â
âFifty-bucks for a yearâs supply of prescription drugs is a pretty darn good deal for consumers,â said U.S. Senator Bill Nelson (D-FL), an outspoken proponent of giving people access to lower-cost prescriptions. âBecause Wal-Mart has the ability to shape the market, maybe other retailers will follow suit.â
In addition, the program provides a solution for the nearly 2.7 million uninsured Floridians who may also avoid filling prescriptions and remain untreated. Wal-Mart estimates that the program will save the stateâs Medicaid program hundreds of thousands of dollars annually.
In announcing the program, Bill Simon, executive vice president of the Professional Services Division for Wal-Mart, noted that purchasing a 30-day supply of the popular diabetes drug, Metformin, for $4 represents a nearly 50 percent savings from the cost of the brand name version of the drug. In addition, purchasing a 30-day supply of the brand name blood-pressure drug typically costs $12. Getting the generic, Lisinopril, for $4 saves customers nearly $100 annually.
âThese are medicines for diabetes, cardiovascular disease, asthma, colds and infections â the kinds of medicines that working families need so they can treat illness, manage conditions and stay well,â said Simon. âRising healthcare costs are eating up more and more of familiesâ budgets, so this program brings a lot of value to our customers, associates and communities.â
Generic medications contain the same active ingredients as their âbrand-nameâ counterparts and are equally effective, but cost significantly less. Consumers interested in saving money on prescriptions through the program should ask their doctor if a generic is available for their prescription and is right for them. At this time, the $4 prescriptions are not available by mail order and are available on-line only for in-person pickup in the Tampa Bay, Fla. area. Not all generics in each therapeutic category are included.
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.
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.)
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.”
Duh.
Here’s a link to the entire editorial.
http://www.latimes.com/news/opinion/la-ed-stanford16sep16,0,7496545.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.
http://www.nytimes.com/2006/09/16/opinion/16avorn.html
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.
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.
