DrugWonks on Twitter
Tweets by @PeterPittsDrugWonks on Facebook
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
Download the E-Book Version Here
CMPI Events
Donate
CMPI Reports
Blog Roll
AHRP
Better Health
BigGovHealth
Biotech Blog
BrandweekNRX
CA Medicine man
Cafe Pharma
Campaign for Modern Medicines
Carlat Psychiatry Blog
Clinical Psychology and Psychiatry: A Closer Look
Conservative's Forum
Club For Growth
CNEhealth.org
Diabetes Mine
Disruptive Women
Doctors For Patient Care
Dr. Gov
Drug Channels
DTC Perspectives
eDrugSearch
Envisioning 2.0
EyeOnFDA
FDA Law Blog
Fierce Pharma
fightingdiseases.org
Fresh Air Fund
Furious Seasons
Gooznews
Gel Health News
Hands Off My Health
Health Business Blog
Health Care BS
Health Care for All
Healthy Skepticism
Hooked: Ethics, Medicine, and Pharma
Hugh Hewitt
IgniteBlog
In the Pipeline
In Vivo
Instapundit
Internet Drug News
Jaz'd Healthcare
Jaz'd Pharmaceutical Industry
Jim Edwards' NRx
Kaus Files
KevinMD
Laffer Health Care Report
Little Green Footballs
Med Buzz
Media Research Center
Medrants
More than Medicine
National Review
Neuroethics & Law
Newsbusters
Nurses For Reform
Nurses For Reform Blog
Opinion Journal
Orange Book
PAL
Peter Rost
Pharm Aid
Pharma Blog Review
Pharma Blogsphere
Pharma Marketing Blog
Pharmablogger
Pharmacology Corner
Pharmagossip
Pharmamotion
Pharmalot
Pharmaceutical Business Review
Piper Report
Polipundit
Powerline
Prescription for a Cure
Public Plan Facts
Quackwatch
Real Clear Politics
Remedyhealthcare
Shark Report
Shearlings Got Plowed
StateHouseCall.org
Taking Back America
Terra Sigillata
The Cycle
The Catalyst
The Lonely Conservative
TortsProf
Town Hall
Washington Monthly
World of DTC Marketing
WSJ Health Blog
DrugWonks Blog
Per the FDA’s list of Canadian Internet pharmacies that are selling counterfeit drugs, Andrew Strempler, founder of Mediplan (considered the first Internet pharmacy), says the FDA allegations are false.
Strempler : “We test our products and stand behind our products.”
drugwonks.com: “Put up or shut up.”
Governor Schwarzenegger is supporting pharmaceutical price control legislation that the people of California have already rejected once — and recently. Unless cooler heads prevail it could very well be hasta la vista medical progress.
Here’s what I had to say about it in the Orange County Register:
http://www.ocregister.com/ocregister/opinion/abox/article_1258737.php
As California goes so goes the nation? We should all hope not.
Read More & Comment...Counterfeit drugs are a serious danger.
Senator Vitter, et al., who think “from Canada” always means “from Canada” need to pay attention to the facts, reconsider their position — and put the public health in front of political posturing.
A good place to start would be to read the lastest FDA news release. Here it is.
FDA Warns Consumers Not to Buy or Use Prescription Drugs
from Various Canadian Websites that Apparently Sell Counterfeit Products
The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter.
FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market.
Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed.
DRUG NAME
USE(S)
LIPITOR
Cholesterol disorders
CRESTOR
Cholesterol disorders
ZETIA (US name) / EZETROL (Canadian name)
Cholesterol disorders
DIOVAN
High blood pressure
HYZAAR
High blood pressure
ACTONEL
Osteoporosis in postmenopausal women
NEXIUM
Gastroesophageal reflux disease (GERD)
CELEBREX
Arthritis-related pain
ARIMIDEX
Breast cancer
PROPECIA
Male-pattern baldness
Some of the websites that are operated by Mediplan or that have order fulfillment through Mediplan are:
www.RxNorth.com;
www.Canadiandrugstore.com;
www.Rxbyfax.com;
www.Northcountryrx.com;
www.Canada-pharmacy.com;
www.My-canada-pharmacy.com;
www.NLRX.com;
www.Canampharmacy.com;
www.Canada-Meds-For-Less.net; and
www.Canadian-safe.com
As a general matter, FDA advises consumers to use caution when buying medical products online. Although a website may appear reputable and similar to legitimate retail pharmacy websites, many actually operate from outside the U.S. and provide unapproved drugs from unreliable sources.
For example, in August of 2005, FDA conducted an operation at New York, Miami, and Los Angeles airports which found that nearly half of the imported drugs FDA intercepted from four selected countries were shipped to fill orders that consumers believed they were placing with “Canadian pharmacies.” Of the drugs being promoted as “Canadian,” based on accompanying documentation, 85 percent actually came from 27 other countries around the globe. A number of these products also were found to be counterfeit. These results demonstrated that some Internet sites that claimed to be “Canadian” were, in fact, selling drugs of dubious origin, safety and efficacy.
Today’s announcement is consistent with FDA’s earlier message of the dangers posed by such websites and the need for caution on behalf of the public.
Drug counterfeiting is illegal for good reason. Drug counterfeiting defrauds consumers and can expose them to products containing unknown, ineffective, or harmful ingredients. Counterfeit drugs may be toxic or contain doses that are too small to treat a medical condition, or so large that they could endanger the health of the user. Because of the dangers posed by counterfeit drugs, the FDA aggressively investigates all instances of drug counterfeiting.
Headlines claim that CMS spent $275 million on a quality demonstration project to measure cancer care that proved nothing…
Here’s the lede of the story as reported by AP
Report questions millions spent on effort to measure patient care
Wednesday, August 30, 2006
Kevin Freking
Associated Press
Cancer doctors received about $275 million from the federal government and the elderly last year as part of a yearlong research project that many doctors believe won’t produce any useful findings.
Under the program, the federal government paid $130 each time a chemotherapy provider assessed a Medicare patient’s pain, fatigue and nausea. The payments were designed to encourage doctors to report information that might one day lead to improved care for cancer patients….
Iowa Republican Sen. Charles Grassley, chairman of the Senate Finance Committee, said taxpayers and beneficiaries were “bilked” because they paid for services that physicians are already supposed to provide. …”
Let the record show that ” Senator Chuck Grassley (R-Iowa) and Senator Max Baucus (D-Montana) have presented a bill that entitles providers that report quality data and satisfy particular quality standards to obtain full Medicare reimbursement along with bonuses. Providers who do not report data will only receive Medicare reimbursements at the full rate of inflation minus two percentage points…”
If someone can explain the difference between what Medicare is doing and what Grassley has proposed, please comment….
Meanwhile, as to the OIG claim that the data is useless, let the record show that CMS will reimburse physicians who report whether their treatment of patients adheres to recommendations in nationally recognized practice guidelines published by either the National Comprehensive Cancer Network (NCCN) or the American Society of Clinical Oncology. The demonstration will focus on thirteen cancer types that account for at least 80% of all patients with cancer in the United States. ” Now this might not be outcomes data but at least it is a start…a baseline for measuring the transition to products that don’t produce such side effects and don’t require hospitalizaton…get it? Such measures are important since you would be astounded how many people don’t complete cancer care because of pain, fatigue and nausea and therefore die as a result. So compliance with protocols to reduce such feelings matter a hell of a lot. And the payment for collecting such data is less this year, a little fact that both OIG and news accounts forgot to include.
Shame on Grassley for grandstanding and being so grossly hypocritical in the process.
Read More & Comment...As we were saying … Case in point, today’s article in The Washington Post by left wing and fringe group shill Shankar Vedantam (he who quotes nutcases from the Alliance for Human Research Protection without revealing their biases)
Group Says FDA, Advisory Panels Show Bias Toward Drug Approvals
By Shankar Vedantam
“The panels of experts assembled by the Food and Drug Administration to advise it on whether to approve new drugs and medical devices are often biased in favor of recommending approval, according to a consumer group’s analysis released yesterday …”
Shankar goes on to note that the report was put out by “the National Research Center for Women & Families, a policy research and advocacy group.”
Well they are, sort of, if you also think that Moveon.org is a policy research and advocacy group. The Center, which claims to receive funding from NCI, also received money from the Tides Foundation, an organization that gives money to some of the most radical left wing organizations in the world including The Ruckus Society, a radical antiglobalization group. One of the Tides Foundation’s principal recipients is the National Lawyers Guild (NLG) ‘March 20 [2004] call to End Colonial Occupation from Iraq to Palestine Everywhere” organized by International ANSWER (a Stalinist front group). Immediately after 9/11, Tides formed a “9/11 Fund” to advocate a “peaceful national response” to the opening salvos of war. The Foundation replaced the 9/11 Fund with the “Democratic Justice Fund,” which was established with the aid of George Soros’ Open Society Institute.
(Soros, a currency speculator and drug legalization advocate, is a major contributor to Tides, having donated more than $7 million.)
Tides has also given grant money to the Council for American-Islamic Relations (CAIR), which recently sponsored a National Press Club briefing for the Stephan Walt and John Mearsheimer, the two ‘academics’ who blame the “Israel lobby” (Jews) for terrorism.
Does this mean that the National Center is just as bad as the rest of the Tides bunch/ No. But it gives you an idea of how they lean which in turn shapes the conclusion of any report they wrote about the FDA — so well timed for the confirmation vote of Dr. von Eschenbach. And since Tides is just a pass through, just who is really given them the dough?
Lazy and biased reporting by Shankar. And as for the Center, lLike we said, the opposite of anti-industry is objective.
Springfield, MA — the small town that started a big problem finally threw in the towel yesterday and said it would stop treating it’s municipal employees like second class citizens by making them get their drugs from so-called “Canadian” pharmacies.
And then they lied.
According to a story in the Boston Globe, Springfield officials claim that on $5 million spend, they saved $3 million annually by doing business with profiteers masquerading as pharmacists.
Not even real Canadian drugs are that inexpensive. That’s wrong by a wide margin — and the Globe didn’t press for evidence to support such an absurd claim.
Typical? Unfortunately yes.
Another misleading comment in the story (written by the usually on-target Chris Rowland) repeats the canard that prescription medicines are “typically less expensive in Canada and elsewhere because government controls limit profits.”
Not accurate. What governments in Canada and elsewhere control are prices. Big difference in practice and in theory. (Not to mention that it also makes the practice sound a lot better for grandstanding politicians.)
Adieu Springfield.
Here’s a new way to think about whether or not FDA’s Critical Path initiative is important …
… Ask yourself, “What if it was my child?”
And then read this article from today’s edition of the New York Times.
A Conversation With Mary V. Relling
Saving Lives With Tailor-Made Medication
By CLAUDIA DREIFUS
MEMPHIS — In Mary V. Rellingé¾ office in St. Jude Children’s Research Hospital sits a small ceramic statue of St. Jude Thaddeus, the patron saint of impossible causes.
Dr. Relling, the head of the department of pharmaceutical sciences at St. Jude, has a fondness for impossible causes.
Her own is pharmacogenetics, a clinical discipline in which doctors use high-tech genetic testing to custom-make drugs to patients’ individual needs.
Though pharmacogenetics is controversial and not yet widely done, Dr. Relling, 46, travels the country advocating its use. At St. Jude, patients with leukemia are now routinely given genetic tests to determine their individual response to a medication. “We’ve seen it save lives here,” she said. “That’s made me a believer.”
When hundreds of patients are given a drug, she continued, “some will get no benefit, others will have terrible side effects, and still others will get benefits with tolerable side effects.”
Gene variants may be the cause.
Q. How is this tailoring of drugs different from the way they’re currently ordered?
A. Till now, there’s been a one-size-fits-all approach. In most cases, an average dose of a medication is ordered, and then, if the patient suffers side effects, the dosage is adjusted. With gene testing, we can customize the prescription.
Here at St. Jude, we’ve been gene-testing every child who comes to us with leukemia. I study acute lymphoblastic leukemia — A.L.L., the most common childhood cancer. When a youngster comes in with A.L.L., we get a sample of their DNA. We put it on a special computer chip that scans a half-million different places on the genome. Mostly, we’re looking for unusual variations of the genes and misspellings of the genetic code.
We have a database from earlier patients that helps us predict a patient’s risk of relapse and which misspellings are likely to result in drug sensitivities.
Q. Are there other diseases where the process might be useful?
A. The same medicine we use to treat leukemia is also prescribed for Crohn’s disease and ulcerative colitis. So that same genetic test could be employed to reduce side effects with those conditions.
At the moment, there seems to be a lot of promise for pharmacogenetics in the treatment of arthritis, heart disease, colon cancer and even psychiatric diseases like depression and schizophrenia.
Q. One can almost hear economists everywhere groaning, “Oh, no! Not another test to add to health care costs!”
A. The basic research behind pharmacogenetics — figuring out which genes are important with the various drugs and diseases — is costly. But on the clinical level, you can save money. With leukemia, we’ve seen that testing costs are minor compared to the savings gained by avoiding drug reactions, blood transfusions and additional hospitalizations.
Q. How widespread is genetic testing for prescriptions?
A. It’s very rarely used. Most probably, you can find it at some academic centers in big cities. And, of course, for many medications, the research isn’t in yet about which genes are important and why. But even where tests have been approved, insurers don’t cover all the costs, and that’s hindered this from growing.
Most prescribers don’t understand genetics very well. The fruits of the Human Genome Project have only been out for about five years, and a lot of doctors and pharmacists did their training before that.
I’ve heard people say that medicine won’t change until there are major lawsuits against prescribers who fail to use tests to individualize therapy.
Q. How have the drug companies responded to the promise of pharmacogenetics?
A. Unfortunately, they are not set up for it. The big pharmaceutical companies have a different business model. They make their money from blockbuster drugs that reach millions of people with standardized doses. They don’t want their markets to fragment, which is the obvious effect of pharmacogenetics.
Genomic testing is going to mean that we define smaller and smaller markets for every drug. Instead of one medication for high blood pressure, a manufacturer will have to produce dozens of variants and combinations.
It’s already difficult to get drugs that benefit smaller numbers of patients. “Orphan” drugs are often not manufactured because they help only a small group.
In pediatric cancer, we see what happens to orphan drugs because children’s cancers are rare and, thus, orphan diseases. Of the nine drugs we regularly use for leukemia, seven have been unavailable for varying periods of time during the last decade.
Q. What can you do in that situation?
A. We’re trying to start making it here at St. Jude. We’re not a drug manufacturer, and it isn’t easy for us to do. We’re also working with pharmaceutical companies to see if we can’t help them make it available. But we can’t depend on market forces for our supply.
We’ve seen that the pharmaceutical companies, if they are interested in cancer drugs at all, are mostly concerned with adult cancers — the larger market.
Q. How did you become a pharmacist?
A. I attended the University of Arizona in the late 1970’s, as a French major. In my freshman year, I took the required chemistry course with a brilliant teacher, William Lippincott. He made chemistry come alive. Becoming a pharmacist seemed like a practical route to a chemistry career, with good job possibilities after graduation.
Even today, it’s a great profession for a young person to consider. There is a tremendous demand.
Q: According to the MSM, what is the opposite of “pro-industry?”
A: “Objective.”
Read More & Comment...Now that the confirmation of Andy von Eschenbach is on a fast track, expect the crazies to come out of the woodwork for the 15 nanoseconds of fame. We are expecting any day now for David Vitter — who has lent a helping hand to Hezbollah’s efforts to ship counterfeit drugs from Canada to the US by banning US Customs from inspecting packages of medicines (80 percent of which were fake and came from reliable sources such as Pakistan and Iran) — to put a hold on his nomination until there is a final vote on his proposal to weaken the defense of the homeland.
In the meantime for your reading pleasure…here is a an oped from a complete kook..someone who insinuates that Andy is a Nazi (he’s German you know, born during the war). http://www.newstarget.com/020118.html
The author (and I use that term loosely) is Byron J. Richards who purports to be an expert on the role of leptin in obesity. A quick search of Richards BJ on medline comes up with a big fat zero in publications. That’s not surprising since BJ got his certification by taking an exam and paying $400. This kookery is being pushed by a group called the Alliance for Human Research Protection which was formed by Loren Mosher who believed that schizophrenia and other mental illnesses could be treated without any medication. The group is lavished with mainstream media attention and coverage because it froths at the mouth about suicidality and SSRIs. That is supposed be the result of some sort conspiracy between the drug companies and the FDA. The Alliance is dangerous to the extent that the media fails to investigate its history and underlying faith that mental illness can be treated without any medication. Now that Tom Cruise has been cut loose from Paramount, maybe he can join the anti-Andy kook campaign….
Read More & Comment...This is not a joke.
It is very scary.
Please pay attention.
The John D. and Catherine T. MacArthur Foundation , known for its $500,000 “Genius Grants,” has created a similar prize for nonprofit organizations.
Terrific right? Not so fast.
The prizes for nonprofits were given today to nine groups, including a reconstituted D.C. organization now known as Knowledge Ecology International — formerly the Ralph Nader-affiliated Consumer Project on Technology. That’s the group led by our pal, the patent-hating Jamie Love.
What “genius” thought up this one?
Love says his group is going to use this new infusion of cash to push for legislation in Congress next year to drive down the price of drugs by changing how research and development are financed. The goal would be for development to be based on drugs’ potential health benefits, not on their potential market value. If this “new paradigm” is successful with the U.S. pharmaceutical industry, Love says, the impact would be felt internationally as well.
That’s for sure. If by “impact” you mean the global destruction of pharmaceutical R&D.
The legislation, are you sitting down, is to be sponsored by none other than the Honorable Member from Ben & Jerry’s — Rep. Bernard Sanders (I-Vt.).
“We’re going to make a run [in Congress] on this new idea,” said Sanders. The lobbying focus, he said, will probably be on trying to develop a citizens movement similar to the one that supported importing “Canadian” drugs.
And we all know how well that worked.
BTW, isn’t it against the law for a not-for-profit to support and lobby for legislation? Or is that only if they’re, say, conservative or free-market?
KEI received $500,000 from the MacArthur Foundation to help with start-up costs associated with becoming an independent nonprofit.
“Start-up costs?” What are they starting up? A hedge fund?
CMPI (the public policy institute parent of drugwonks.com) will be submitting its MacArthur Foundation grant shortly.
Merrill Goozner criticized us (or me) for being pro-industry enroute to explaining why I did not post anything on the stem cell legislation vote last month. That logic is convoluted. Goozner is assuming that the drug industry is conservative, and therefore opposes stem cell research and that I am conservative and oppose stem cell research and that therefore as a tool of industry I did not write something that my minders would not like….. Actually, considering that industry supported the California bond initiative and would stand to benefit from stem cell research, that I wrote an oped in the Washington Times in favor of stem cell research Goozner’s logic is shall we say, about as good as his reporting? PS Merrill, CMPI is NOT part of the Manhattan Institute…or do facts not matter in your left wing world?
In any event, heres a post on stem cell research. The latest experiment coming from Advanced Cell Technology — a followup to it’s research with mice embryo’s demonstrate that it is possible to produce stem cells without harming or destroying embryos. According to an article on WebMD:
“ACT researchers Irina Klimanskaya, PhD; Robert Lanza, MD; and colleagues used a technique called preimplantation genetic diagnosis, or PGD; it is used during in vitro fertilization techniques. This basically means plucking out one of the eight cells from a blastomere, a very early stage of embryo development.
Such “biopsied” embryos are perfectly healthy and, after implantation in a woman’s womb, develop into normal fetuses. More than 1,500 PGD children have been born.
The researchers cultured 19 stem-cell-like “outgrowths” derived from these harvested stem cells. From these, they were able to get two stable lines of human embryonic stem cells. Under proper conditions, these cells showed the potential to become any cell type of the human body.
Klimanskaya and colleagues predict that the technique will become more efficient in the future.
“Blastomere-derived human embryonic stem cells could be of great potential benefit for medical research, as well as for children and siblings born from transferred PGD embryos,” they conclude.
The findings appear in an advance online issue of the journal Nature.”
For some, even this will be a bridge too far. But for the vast majority of Americans, this approach, if reproducible and usable will settle the debate since such biopsies are already done. Opponents will find themselves increasingly isolated because their position will have shifted to fit the shift in science. The NIH should at the very least provide federal funding to replicate the ACT research.
Read More & Comment...CMPI Board Member, friend and inspiration Suzanne Pattee is the July 2006 recipient of the Heroes of Hope Award. The award is given by The Heroes of Hope⢠Living with CF Program Advisory Panel. It is given to recognize people with CF who give hope and serve as role models to others. Chosen from a nationwide pool of candidates, Suzanne received the honor for her ability to inspire others with CF through her positive attitude, strong community outreach, and her outstanding commitment to proactively manage her health. Suzanne, a Virginia resident, will be joined by family, friends, and her CF care center team to receive her award today, on August 23,during a ceremony given in her honor at the Johns Hopkins Hospital Adult CF Program.
I have known Suzanne for over ten years. We have rarely talked about her illness. But she is a living example of what the combination of determination and medical innovation can do to provide people with longer and fruitful lives. We both remember the time that the Clinton folks — when they were planning to reinvent health care — told companies working on CF drugs that it would be more cost-effective to focus on diseases with larger populations. (That’s right people, it takes a village to ration care.) And even now, people with CF find their access to new medicines in Canada and Europe rationed and limited and delayed. Thankfully, Suzanne has fought against that dark movement here in America. Her accomplishments are many and I wish everyone that purports to care about medical progress had half her courage and passion!
Here’s more about this remarkable woman from the press release issued about her award:
“Suzanne has grown to be an extraordinary leader in the CF community,” said Robert J. Beall, Ph.D., president and CEO of the Cystic Fibrosis Foundation who has been a colleague of Suzanneâs for more than 20 years. “The depth and richness of her experience, including her law degree and previous work with the biotechnology industry, has contributed to her skills to benefit the CF community at large. Never have I known a more intelligent, quick-witted and above all, determined individual â Suzanne is clearly an inspiration to us all.”
Suzanne has faced CF head-on since she was diagnosed at 6 months of age after experiencing common symptoms including pneumonia and failure to thrive. At that time, the median age of survival for someone with CF was five years. According to the CF Foundation’s National Patient Registry, the predicted median age of survival is now 36.8 years. Today, at the age of 43, Suzanne realizes that her experience with CF is not typical and feels extremely lucky in her life. She views having CF as a surmountable hurdle and, at times, a blessing in disguise as it allows her to interact with and be inspired by others with CF whom she might never have had the chance to meet.
Not one to take a back seat approach to issues she is passionate about, Suzanne first began educating others about CF as a CF Foundation poster child at age six. She has worked with the CF Foundation for 14 of the past 20 years, and leverages her insight as an attorney in her current position as the CF Foundationâs Vice President of Public Policy and Patient Affairs. In this role, she advocates for people with CF with the U.S. Congress and the Administration, and spearheads the CF Foundationâs focus on adults with CF.
“The Heroes of Hope Living with CF program is proud to recognize Suzanne for her tireless dedication to providing legal and emotional support to those with CF who desperately need it,â said Lisa Yourman, Heroes of Hope Living with CF Advisory Panel member and CF advocate. âBy promoting the rights of CF patients nationwide and selflessly dedicating her life to help others overcome and persevere through CF and other challenges, Suzanne is an ideal recipient of the Heroes of Hope award.â
Through her steadfast work with the CF Foundation, Suzanne is faced daily with the trials CF brings to children, adults and families. She uses this as her inspiration to help lessen the burden of CF on others by fighting for federal and state policies to ensure access to life-saving CF medication and specialized CF care. Suzanne has been a leader in bringing adult-related CF issues to the forefront of the CF communityâs agenda, and was an initiator of the CF Foundationâs infection control policy guidelines that seek to reduce the risks to people with CF from potential cross infection.
Suzanne strives to live every day with meaning and passion. Suzanne recognizes the critical importance of consistently following her daily medical regimen, which consists of inhaled medications, antibiotics, digestive enzymes, nasal irrigation and chest physical therapy. Suzanne makes regular physical exercise a part of her routine, including activities like dancing and swimming, and is careful to monitor and care for her CF-related diabetes.
She also enjoys spending time with her friends and family, including her 11 nieces and nephews, playing with her dog, Daisy and singing along with Broadway musicals.
.
Read More & Comment...When Arnold Schwarzenegger returns to the silver screen, his first movie should be called Total Lack of Recall.
Last November, citing his support for the free market, the Governor campaigned against Proposition 79, a plan that would have placed price controls on prescription medicines. Prior to that, in his State of the State speech and in a widely discussed letter to Congress, Schwarzenegger pointed out that it is unfair and inappropriate that American consumers bear a disproportionate share of the cost of developing new medicines that benefit the whole world. He encouraged the Congress to demand an end to price controls in foreign countries and vigorously support those pharmaceutical and biotech companies who refuse to sell their products to countries imposing price controls.
Today he supports a plan almost identical in its folly to Proposition 79. Yep, in a strange rhetorical twist, he was against it before he was for it.
Total Lack of Recall. But that was then and this is, well — closer to the Governor’s battle for reelection.
“This (the Governor’s initiative) is a huge victory for the needy,” said Assembly Speaker Fabian Nunez (D-Los Angeles). “This goes a long way toward correcting the wrong that was done at the ballot box in November.”
“Correcting the wrong?” What Speaker Nunez means is that it goes a long way to legislating something the citizens of California voted down only 10 months ago. So much for the will of the people.
Or, for that matter, the needs of the people — particularly the most needy.
Under the proposal, doctors who wanted to prescribe de-listed drugs would first have to obtain specific permission from Medi-Cal — a bureaucratic burden. Though they are supposed to receive such authorization within 24 hours under federal law, some doctors say the actual process is far more tortured.
“Docs in community mental health are besieged with clients. They’ll have hundreds of clients with severe psychiatric disabilities assigned to them,” said John Buck, chief executive of Turning Point Community Programs, a Sacramento-based mental health nonprofit. “There’s always somebody in a crisis, and you’re talking about filling out more paperwork?”
For that reason, according to an article in today’s LA Times, advocates for the poor object to the involvement of Medi-Cal.
Loretta Jones, executive director of Healthy African-American Families, a nonprofit group based in Los Angeles, called the plan “abominable.”
“We’re taking our poorest population — which are usually women and children — and you’re making decisions about their healthcare that you would not make for a Blue Shield or a Health Net” population, she said.
With California’s new program, the Governor’s new moniker could be “the Abominable No-Man.”
Actor Schwarzenegger’s Total Recall might have been a hit, but Governor Schwarzenegger’s Total Lack of Recall is a dangerous, shortsighted miss.
The President went to Miinnesota to sign an executive order that will require federal agencies to ” compile information about the quality and price of care they pay for and share that information with their customers and each other. ”
In a statement made before the signing, Health and Human Services Secretary Mike Leavitt said, “It’s just the American way. We clip coupons. We check for bargain flights on the Web. We carefully research major purchases. But when it comes to health care, we lack the tools to compare either quality or the costs.”
Some might think the comparision facile. And to be sure, comparing the price of hip replacements is a bit different than comparing the price of flights to Florida. But, as the part D experience shows, it’s a start. And the Bush administration knows that price is not everything. Which is why, the prices will include all services requires for treatment — doctor services, drugs, rehab, etc — for treatment. Efforts are being made to organize comparisons around INTEGRATED care for disease or condition as well as prevention of illness or recurrence. Quality standards would have to adjust accordingly. As Alez Azar, the HHS Assistant Sec who is the point person on this initiative has noted, the Center for Medicare and Medicaid Services has ongoing efforts to measure quality and data collection efforts that private plans can already tap into or emulate as a platform. CMS has already provided a lot of information on prices and process measures that people can use to make comparative decisions. It just posted price information for 61 procedures in outpatient centers. ( http://www.cms.hhs.gov/apps/media/press/release.asp?Counter=1948) And this in initiative bolstered by the Bush exec order will roll out transparency efforts in six regions around the country.
Of course, there are many private quality initiatives. Aetna just announced it would post price data on common services and procedures. CMPI’s own board member, Susan Horn is a pioneer in the effort to integrate the continual measurement of quality into integrated care management. Go to www.isisicor.com for more info.
But the first step is to get the data systems up and running, online and as convenient to use as cellphones or ATMS. (Which means the same information has to be available in real time in California as it does in Maine.)
Linking payment to value and then to price…that’s something the market can and must do.
The bad news — as Peter notes — is that Avastin and Erbitux will not be made available to colon cancer patients in the UK because it doesn’t really prolong life. That is also what NICE said about Taxol, Herceptin and Gleevec by the way, all of which have been shown to increase survival and prolong life. The good news is, since NICE will not cover Aricept or other drugs for Alzheimer’s people with AD and colon cancer won’t know they are being denied Avastin and Erbitux.
Meanwhile, Madonna has told the Blair government that it should use mystical waters to clean up radioactive pollution. According to the Times of London she and husband Guy Ritchie “have been lobbying the government and nuclear industry over a scheme to clean up radioactive waste with a supposedly magic Kabbalah fluid.” The plan, just recently revealed, hinged on a “mystical” liquid that she says neutralized the radiation in a Ukrainian lake. Madonna, who studies Kabbalah, insists that the stuff is for real. The better news? NICE has already approved it for reimbursement because it’s cheap.
Read More & Comment...If you think that Big Government knows best when it comes to what medicines are best, this news from the UK should help disabuse you of that notion.
Unfortunately, it’s only the most recent example of what happens when saving money takes precedence over saving lives.
We must not allow “evidence-based” medicine to mean “cost-based” medicine. Evidence-based must mean Patient-centric.
From BBC NEWS
Anger at bowel cancer drug ruling
Charities have criticised a proposal to block the routine NHS use of two drugs for advanced bowel cancer. The National Institute for Health and Clinical Excellence (NICE) said there was insufficient evidence to recommend Avastin and Erbitux.
But charities say both drugs are the best option for seriously ill patients whose cancer has spread.
They say the drugs have been shown to extend life expectancy by four to five months in some patients.
A similar decision has already been made in Scotland.
Bowel cancer kills almost 50 people a day in the UK. Each year, there are about 18,700 new cases in men, and nearly 16,200 cases in women.
It is easily treatable, but only if caught in its early stages.
Both the new drugs are monoclonal antibodies - the same type of new generation “biological” drug as the breast cancer treatment Herceptin.
NICE considered their use in patients whose cancer had spread, usually to the liver, but sometimes to the lungs. This is known as metastatic cancer.
We feel extremely disappointed that bowel cancer - the second biggest cancer killer - is not being given the attention or funding it deserves.
Hilary Whittaker
Beating Bowel Cancer
Avastin, known technically as bevacizumab, works by starving cancerous tumours of blood, thus preventing them from growing in the body.
Research has shown it can extend life expectancy by an average of five months.
Lynn Novak, from Crawley, West Sussex, who has advanced bowel cancer, argued that Avastin had reduced the size of her tumours and helped to keep her alive.
However, the NICE decision could mean she will have to stop taking the drug, as she cannot afford to continue to fund it herself, having already spent thousands.
Her only hope is to convince her local primary care trust she is an exceptional case.
“I’m a different person, a different person. It’s just given me a new life,” she said.
“I was told I had six months to live in December 2005, but I’m still here, I’m back at work, I’m a productive member of society, and I feel really, really well.”
‘Scarce’ resources
It’s just given me a new life.
Lynn Novak, who takes Avastin
Erbitux (cetuximab) works by blocking the proliferation of cancer cells, and is usually used after chemotherapy has failed.
In tests, it was found to extend life expectancy by at least four months for 50% of patients, and to shrink tumours by 50% in a quarter.
However, both drugs are relatively expensive. Avastin costs on average 16,824 pounds per patient, and Erbitux 11,739.
Andrea Sutcliffe, NICE deputy chief executive, said the institute’s investigations had found that neither drug represented a good use of “scarce NHS resources”.
Andrew Dillon, the chief executive, admitted the drugs were of some benefit - but said there was uncertainly about how good they were compared with current standard treatments.
Decision ‘scandal’
Television presenter Lynn Faulds Wood, who beat the cancer and set up the charity Lynn’s Bowel Cancer Campaign, said the decision was “cruel” to patients.
Hilary Whittaker, chief executive of the charity Beating Bowel Cancer, said the decision was a “scandal” and the value placed on the lives of sufferers seemed to be “minimal”.
“We are now the only nation in the EU not to offer cetuximab and bevacizumab to bowel cancer patients in the disease’s advanced stages,” she said, urging Nice to review its decision.
“We feel extremely disappointed that bowel cancer - the second biggest cancer killer - is not being given the attention or funding it deserves.”
Ian Beaumont, of the charity Bowel Cancer UK, said: “NICE’s negative decision with regard to the biological agents Avastin and Erbitux is further proof that the NHS is simply not working for bowel cancer patients and is overdue a full and comprehensive review.”
Professor Karol Sikora, a cancer expert at London’s Imperial Colllege, said: “These drugs are expensive but they are effective, trials have shown them to be effective.
“The difficulty for the NHS is they are costly. The way it is done is simply to calculate the amount of cost for prolonging survival by one year.
“The average NHS limit is around 30,000 pounds. That’s what you and I are worth to the NHS for one year’s extension of life.”
Alan Maynard, professor of health economics at the University of York, said the problem was NICE was saying yes too much, adding to the financial pressure in the health service.
The NICE decision is now open to consultation before a final ruling is published in the autumn.
All three bowel cancer charities receive financial support from the drugs industry.
Read More & Comment...Tenth Circuit Ruling Upholds FDA Decision Banning Dietary Supplements Containing Ephedrine Alkaloids
Why is this important? Because it sends important messages to two different groups.
To those who would peddle dietary supplements as medicine the message is that the FDA has the authority to stop you if and when you cross the line.
And to the United States Congress the message is that DSHEA needs to be reformed — because the line has been crossed too many times.
Here’s the FDA statement …
Background: On Aug. 17, the U.S. Court of Appeals for the Tenth Circuit in Denver upheld the Food and Drug Administration’s (FDA) final rule declaring all dietary supplements containing ephedrine alkaloids adulterated, and therefore illegal for marketing in the United States, reversing a decision by the District Court of Utah.
The Tenth Circuit Court of Appeals’ ruling demonstrates the soundness of FDA’s decision to ban dietary supplements containing ephedrine alkaloids, consistent with the Dietary Supplement Health and Education Act (DSHEA) of 1994. The Tenth Circuit Court of Appeals also found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA.
FDA conducted an exhaustive and highly resource-intensive evaluation of the relevant scientific data evidence on ephedrine alkaloids before issuing its final rule, which became effective in 2004. The court found that the 133,000-page administrative record compiled by FDA supports the agency’s findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure.
No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to FDA enforcement action.
Amen.
Want to know what getting new drugs will be like if folks like Sid Wolfe, Chuck Grassley, Christoper Dodd get ahold of the FDA? Want an insight as to how a 21st century FDA will respond to the needs of patients if user fees are poured into more staff and reporting requirements for managing the risks of drugs after market? Read this article in the Chicago Sun-Times, Acne drug registry irritates patients: Rules for avoiding pregnancy delay treatment - 21 August 2006 Chicago Sun-Times - By Jim Ritter. Isotretinoin can wipe out severe acne but it can cause birth defects in pregnant women. “…Despite patient education efforts, at least 2,000 isotretinoin users have gotten pregnant over the years, “and this may be the tip of the iceberg,” according to March of Dimes.
Female patients must have pregnancy tests before, during and after taking isotretinoin, take two forms of birth control and answer questions on a Web site. Prescriptions last only 30 days, and must be filled within seven days of an office visit.
But critics say that iPledge, though well-intentioned, is cumbersome and poorly administered. Callers to the iPledge hotline have waited more than an hour to get through. Many patients have been unable to access their mandatory iPledge accounts. And even men and women who can’t get pregnant are required to enroll in iPledge, although their requirements are less stringent. In a recent letter to the U.S. Food and Drug Administration, Sen. Dick Durbin (D-Ill.) and seven other senators wrote: “Our offices continue to receive numerous complaints from doctors, patients and pharmacists about the inflexible and confusing requirements that have denied access to the drug to thousands of qualified patients.”
My advice: Don’t call Senator Durbin. Call Senator Grassley or Public Citizen or even Senator Enzi. If you think Ipledge is Irritating, just wait till it is applied for which every medicine the FDA thinks it needs political cover. Nothing like turning the Critical Path into an obstacle course for patients.
As someone who has benefitted enormously from the off-label prescribing of anti-convulsants, including gabapentin I find infuriating that this cadre of so-called researchers continue to imply that research conducted by private companies or on behalf of them is not only suspect but downright worthless and further, that off-label drug prescribing is based on an even more bastardized form such clinical information. That is not surprising since most, if not all, off-label uses are based upon clinical observations or a deeper understanding of disease mechanisms that are developed by the original use of the medicine. In fact, the critics — who have their own biases which are sustained by their own funding sources (thus, they too are financially conflicted) will be hard put to demonstrate any off-label use is any different than other domains of medical progress insofar as they are confirmed or disproved by clinical trials or rigorous observational data. People tend to forget that the first off-label use of a cancer drug (AZT) was critical in in the treatment of HIV patients or that the off-label use of thalidomide and Avastin have been associated with remarkable advances in treating cancer. The push to make off-label prescribing a criminal activity is a tragedy that will be measured in human lives…
Read More & Comment...Here’s an article from Drug Industry Daily that examines the often fine line between off-label promotion and the free and open dissemination of scientific information.
There are a number of interesting issues at play here — not the least of which is how immediately defensive and uncomfortable pharma industry antagonists become when they are asked to be as open and transparent as the industry they so brutally attack.
Here’s an inconvenient truth — When the anti-pharma gang have their feet held to the fire they get hot under the collar.
Regulatory Changes to Drug Marketing Necessary, Journal Article Says
The FDA and other regulatory agencies must step up to stem the tide of unscrupulous drug marketing practices, an Aug. 15 article in the Annals of Internal Medicine says. But former agency officials challenge the constitutionality of the recommendations and whether the government is in the best position to police the system.
Pfizer subsidiary Parke-Davis instituted a wide-ranging strategy to promote off-label drug use in the 1990s, which is indicative of fundamental ethical problems with industry marketing, the authors wrote. The study also illustrates the failings of physicians, professional organizations and the pharmaceutical industry to police such practices, they said.
However, three of the authors of the article, Michael Steinman, Mary-Margaret Chren and C. Seth Landefeld, worked as expert witnesses in a lawsuit against Parke-Davis concerning that off-label use. Also, the data used in the article was obtained by a database set up by the attorney representing the whistleblower plaintiff in that case, the report’s disclosures show.
According to the study, “Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents,’ the company used advisory boards, consultants’ meetings and accredited medical education events to get doctors to prescribe its drug Neurontin (gabapentin), an anti-seizure medication, for off-label use.
These efforts, along with recruiting doctors to influence other physicians and developing research solely to boost market share of the drug, were done without proper disclosure, they said. For example, the company’s involvement with clinical trials, medical journal research and reviews, educational grants and continuing medical education was not provided, they allege.
These findings signal a need for change, the authors said. “There is widespread agreement that commercial interests should not influence the clinical decisions that physicians make on behalf of their patients.” To address this, a complex system has developed using disclosure and self-regulation by doctors, professional organizations and industry. However, these efforts have been “largely ineffective,” as illustrated by Parke-Davis’ promotion of Gabapentin, the study said.
Incremental changes will fail because “marketing is so deeply embedded” and “the borders between research, education and promotion are more porous than is commonly recognized,” the study added.
Instead, new approaches are needed, including “rigorous regulatory oversight, strict sequestration of commercial and scientific activities and a fundamental internal reevaluation of the interactions between individual physicians, professional organizations and industry.”
Consumer advocates agree that changes are necessary. There is a growth in off-label use, many times based on little or no scientific support according to William Vaughan, senior policy analyst for Consumers Union. “Fixing this problem has to be a major priority,” he told DID. In particular, the FDA must take a stronger oversight role of off-label use.
But Peter Pitts, director of the Center for Medicine in the Public Interest and a former FDA associate commissioner for external relations, disagreed. The FDA does not have the legal authority to restrict the dissemination of scientific information because doing so would be an unconstitutional restriction on First Amendment free speech protections, he said. In 1998, the Washington Legal Foundation successfully challenged the constitutionality of FDA restrictions on speech regarding off-label uses of FDA-approved products. This is a “closed issue,” he said.
Information also should not be discounted based on the motivations of an industry sponsor. “The public health can often coincide with private gain,” Pitts added. “Pure research is often done for a number of reasons.”
Another former FDA official, David Adams, chair of the law firm Venable’s FDA Practice Group and former director of the policy staff in the Office of the Commissioner at the agency, says that doctors should play a central role in preventing improper marketing, not the agency. “The government’s ability to regulate these interests is constrained by finite resources and constitutional protections,” he said.
“The most potent player in this arena is the physician. They have control over where they get their information on medical products, where and why they speak about medical products, who pays for their [continuing education] and what they call on regulators to do,” Adams said. “The signals are sometimes mixed.”
Pitts noted that the connection between the authors and plaintiffs in the lawsuit against Parke-Davis undermines their credibility, calling the link “extremely suspicious.” He also noted that as industry members on advisory boards have their industry connections scrutinized, industry critics should also face the same standards.
A Pfizer spokesman responded in similar fashion. “I think the financial and other connections between two of the authors of the study and a plaintiffs’ lawyer who has brought a lawsuit relating the marketing of Neurontin speaks
for itself,” said Bryant Haskins, director of corporate medial relations for Pfizer.
But Vaughan rejected this view, arguing that the facts themselves, not the background of the researchers are the issue. “It is a distraction to argue who or where the people writing the report came from,” Vaughan said.* “The proof is crystal clear: They got caught red-handed and are now using red herrings to divert people from the obvious documentation. It is an extraordinary treasure trove of documents that shows what lengths marketers will go.”
Pfizer agreed in 2004 to plead guilty to federal criminal charges, enter into a corporate integrity agreement (CIA) with the HHS Office of Inspector General and pay $430 million to settle allegations that one of its units caused doctors to submit Medicaid claims for unapproved uses of Neurontin. In 2003, sale of the drug accounted for almost $2.7 billion in profits.
_______________________________________________________________________________
Here is a link to the article: http://www.fdanews.com/did/5_161/
* The technical term for this is “pot calling kettle black.” (Note: This is my comment and does not appear in the article.)
Read More & Comment...
Social Networks
Please Follow the Drugwonks Blog on Facebook, Twitter, LinkedIn, YouTube & RSS
Add This Blog to my Technorati Favorites