Latest Drugwonks' Blog
This just in from the WSJ.
And it’s astounding.
Scientists Use Gene Therapy
To Shrink Malignant Tumors
For the first time in the history of treating cancer, gene therapy has apparently succeeded in shrinking and even eradicating large, metastatic tumors.
The therapy worked in only two of 17 patients who were treated. But many researchers are hailing the study, which was published Thursday in the online edition of Science, as groundbreaking because it provides compelling evidence in human patients that gene therapy can be effective against one of the toughest challenges in medicine: terminal cancer.
Moreover, the technique used in this pilot study — genetically altering immune-system cells so that they target tumors — could eventually apply to many different kinds of cancers, not just the cancer that afflicted patients in this trial, which was melanoma.
Here’s a link to the entire article:
http://www.wsj.com/article/SB115704231287350662.html?mod=home_whats_news_us
We’re waiting to see what Senator Grassley has to say.
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.
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.
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.”
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….
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.
