Latest Drugwonks' Blog
According to an article in livemint.com (the Wall Street Journal’s news partner in India), “For the first time ever, a consensus has evolved on creating global patent databases, monitoring drug prices and encouraging companies to differentially price their drugs, as a burgeoning health care bill pushes governments towards sourcing cheaper medicines.”
Here's the complete livemint article:
www.livemint.com/2008/06/01232744/Draft-WHO-pact-on-drugs-cheere.html
It’s taken 20 years but Barack Obama has once and for all quit. Not Trinity United Church of Christ, but smoking, a habit he picked up around the same time he joined the controversial ministry.
To do so, he has been chewing Nicorette, the smoking cessation gum. And he’s been chewing it longer and in larger amounts than is on the label.
Is Obama’s off-label use bad or dangerous? According to the dictates of Tabloid Medicine, of course it is.
However, Tara-Parker Pope puts his Nicorette consumption in proper perspective:
“Mr. Obama has said he started using the nicotine gum Nicorette about nine months ago. That’s six months longer than the three months recommended on the gum package label. And Mr. Obama is not the only quitter who is still seeking a nicotine fix months after giving up cigarettes. A small percentage of the people who use nicotine replacement products like gums or lozenges end up hooked on a new habit, say doctors who specialize in smoking cessation…..”
However…
“The problem is not that people use it too much,'’ noted Lynn T. Kozlowski, interim dean of the school of public health and health professions at the University at Buffalo. “The greater problem is that they use it too little. People use it for a week, and then they are back smoking cigarettes.”
well.blogs.nytimes.com/2007/11/02/obamas-new-addiction/
Then there is the individual variation in nicotine dependence shaped by genetics. A paper entitled: "Single Nucleotide Polymorphisms, Clinical Trials, and Tobacco Research: The Search for the Smoking Gun," explored the associations between genetic variations, nicotine usage, and the potential effects on smoking cessation techniques according to a press release from the American Society of Clinical Oncology.
This explains differences in Nicorette uses and variations in response to Chantix.
Someone might want to send that paper to Senator Grassley and Alicia Mundy of the WSJ both of whom seem eager to blame side effects of Chantix on a FDA-Pfizer coverup instead of “genetic variations at the receptor level, the drug metabolism level, or both.”
Read ASCO Article
That would be intellectually honest
Samuel Johnson said that “the future is purchased by the present.” And that’s as good a place to start as any in a discussion of the impact of direct-to-consumer advertising on the elderly.
According to recent polls, older Americans are more distrustful of the pharma industry and the FDA than the general population—and even more so in the wake of the current debate over drug safety.
Seniors want safe drugs—and rightfully so—but why are they more negative than other groups of Americans? I believe it is because throughout the significant majority of their lives, their only information about the medications they took came from a single source—their doctors. And the only information offered was how to imbibe the pill (with water, with food, minus alcohol, and the occasional caveat against operating heavy machinery). There was no doctor/patient discussion and there was certainly no public conversation.
That was the environment in which today’s senior citizens were born, grew into adulthood, married, raised children and grew grayer.
It was an environment where doctors were gatekeepers and the gate was kept tightly padlocked and second opinions were considered an affront to Marcus Welby, MD.
According to Juvenal, “All wish to possess knowledge, but few, comparatively speaking, are willing to pay the price.” Today we must face up to that dilemma.
Like it or not, America’s senior citizens are 21st century empowered healthcare consumers. Today, the “learned intermediary” has been replaced by the Internet, the patient is the purchaser, and Dr. Welby is a vendor. Managed care directs, “serious and life-threatening” diseases have morphed from polio and diphtheria to cancer, AIDS and Alzheimer’s Disease. There really shouldn’t be any wonder why older Americans—indeed, most Americans—are frightened. The entire healthcare paradigm has changed.
Woody Allen said that “Change is inevitable – except from vending machines. Management guru W. Edwards Deming said that “Change is not required. Survival is not mandatory.”
Change is frightening. In the 21st century, we must all be pharmacenti. And that includes older Americans.
The Centers for Disease Control and Prevention National Health and Nutrition Examination Survey found that nearly one-third of people age 65 or older whom the survey found to have high cholesterol measurements said they had not before been told by a physician or other health professional that they had high cholesterol. Projected nationally, this percentage translates into about 2.1 million people who may have had high cholesterol without knowing it.”
Evidence is emerging that large numbers of elderly patients underuse needed medical care. According to a 2004 Health Affairs study that examined the “growing philosophical conflict over the abundance and inequities that characterize the U.S. health care system,” there is evidence of significant underuse of prescription drugs. The preponderance of published medical literature and clinical guidelines, according to the article, compels the expansion of pharmaceutical use among Americans.
This view is supported by a landmark RAND Health study published in The New England Journal of Medicine in June 2003, which found that prescription medications were underused in the treatment of seven conditions that clearly involve secondary prevention, including asthma, cerebro-vascular disease, congestive heart failure, diabetes, hypertension, and high cholesterol. These conditions produce many avoidable deaths, along with costly avoidable emergency room visits, hospitalizations, and nursing home admissions. Three of these conditions— diabetes, hypertension, and high cholesterol are now screened for under the new preventive services benefits now covered by Medicare.
Healthcare education and health literacy for older Americans is essential for both saving lives and saving our health care system. And the best way to do both is to get older Americans to talk with their doctors – precisely the proven result of pharmaceutical direct-to-consumer advertising.
Health care information is the consumer’s Rosetta Stone – but older Americans shouldn’t need a Rosetta Stone to understand the avalanche of health care information that is available to them today.
Dr. Ruth Day of Duke University speaks about the issue of “Cognitive inaccessibility” -- that health care information is disseminated in a way that is not only not understood by consumers but, worse, is misunderstood leading to unintended consequences. She reckons that only 20% of the information put out by FDA is properly comprehended. Her suggestion (among others) is that FDA initially focus on communicating better with health care providers.
When it comes to DTC advertising there is another type of cognitive issue – cognitive dissonance, specifically when it comes to information presented either via fair balance and adequate provision in television commercials, or the brief summary in print advertising. And you know what they say, the brief summary is like the Holy Roman Empire – it is neither brief nor a summary.
In FDA’s 1999 study, 56% of people who saw a DTC print ad said that they read the brief summary “not at all” or “a little.” In the 2002 study that number jumped to 73% -- a 17% increase. During that same three-year span, those saying they read “Almost all” or “All” fell from 26% to 16%.
In 1999 3% said they weren’t aware that there even was a brief summary. In 2002, that dropped a full decimal place to 0.3%. In other words, more people know the brief summary is there, and fewer people are reading it. More information often results in less comprehension and, even worse, less interest. When it comes to older Americans this is a crucial issue that must be addressed by academics, the pharmaceutical industry, and the FDA. “In compliance” and “user-friendly” must not be mutually exclusive terms for anyone – least of all older Americans.
Consider the question posed by T.S. Eliot who asked,
"Where is the wisdom we have lost in knowledge? Where is the knowledge we have lost in information?”
Call me naïve – but I still find this revolting.
According to many reports (this one from the Newark Star-Ledger), “A controversy over the cholesterol-fighting medicine Vytorin has spawned at least 33 lawsuits by consumers who are angry over the way Merck and Schering-Plough promoted the medicine to lower low-density lipoprotein.”
"By failing to timely release the results of the Enhance trial, which demonstrates that Zetia does not reduce or slow the build-up of arterial plaque, defendants reaped billions of dollars in profits that they otherwise would not have obtained," the lawsuits allege.
In addition, the plaintiffs claim they might not have purchased the pricey drugs if they had known they didn't work any better than the generic form of Zocor, which is much less expensive.
Here’s a link to the complete article:
http://www.nj.com/business/ledger/index.ssf?/base/business-1/1212122169217600.xml&coll=1
In a statement, Merck said it would "vigorously defend" itself against the allegations.
And “amen” to that.
Per “Healthcare for Dummies,” (http://www.drugwonks.com/blog/healthcare_for_dummies/), I just received an “off the record” comment from a health care reporter I consider to be among the smartest and savviest around. He writes:
"The responsibility lies with editors. If editors rewarded careful, nuanced reporting and rejected crap, reporters would respond. For example, (name deleted) is smart and hardworking and capable of writing thoughtful stories. She also knows that a leak from a defense lawyer of a "gotcha" memo will land her story on the front page, while a careful analysis will go on page C400. And (second name withheld) knows that quotes from Sid 'I always cry' Wolfe will be accepted, so he doesn't have to work hard to seek other voices. A good editor would push for better sources."
An important op-ed from today's Wall Street Journal, penned by our friend Mark Thornton.
By MARK THORNTON
The news did not make it to the front pages, but on Feb. 28 a powerful member of the U.S. Senate launched an attack on the Food and Drug Administration, the drug companies and the desperate cancer patients they treat.
Charles Grassley (R., Iowa), ranking member of the Senate Finance Committee, requested that the Government Accountability Office launch an inquiry into whether the FDA behaved appropriately in granting the "accelerated approval" of Avastin, a drug for treating women with metastatic breast cancer. Mr. Grassley's action will have a catastrophic effect on America's ability to develop new drugs.
At issue is the concept of "surrogate endpoints" and the FDA's "accelerated approval" regulations. In the 1980s, at the height of the AIDS epidemic, AIDS activists were livid at the slow pace of development of new drugs to fight HIV. They lobbied heavily for changes in the law to allow an expedited pathway for the approval of new drugs for any disease deemed serious or life-threatening. The historic results were new laws and regulations that created an accelerated approval mechanism by which a drug could be allowed on the market if it showed early evidence of an effect on a surrogate endpoint. For cancer, examples of surrogate endpoints are tumor shrinkage or a delay in the disease's progression.
This kind of measurement – as opposed to an assessment of a drug's impact on a patient's overall survival – has dramatically increased the pace of cancer clinical trials. It also has won near-universal acceptance within the cancer community. The FDA does require follow-on studies to assure that a surrogate finding shows clinical benefit. But if all cancer clinical trials were required to show a survival benefit from the get-go, progress in cancer-drug development would slow to an absolute crawl.
Enter Mr. Grassley. It seems not a week goes by without him making a public accusation of evil doings within the drug industry or the FDA. Yes, Mr. Grassley did some good after the Vioxx episode, by focusing on the woeful manner in which postmarketing drug safety is managed and regulated by the FDA. But he and his staff should have kept their eyes on the ball. In the case of Avastin, the senator implied in his GAO request that something sinister occurred during the FDA's premarket deliberations, and that surrogate endpoints were the new bogeyman. Nothing could be further from the truth.
In February, the FDA approved Avastin despite a 5-4 vote by its Oncology Drugs Advisory Committee (ODAC) not to recommend approval. Meetings of this advisory committee address the most vexing issues that exist in cancer-drug development. The advice is usually helpful but never binding. Everyone who works at the FDA knows that the public only sees a fraction of what FDA insiders consider when they make their final decisions on products.
In the case of Avastin, additional data emerged late in the review process, after the ODAC meeting, that strongly supported accelerated approval. It became clear that Avastin had an enormous impact on the surrogate endpoint known as "progression-free survival." PFS is such a powerful measure that it is actually used as the basis for full approval in many cancer indications.
As part of the accelerated approval letter, the FDA also placed some of the most stringent postmarketing requirements in history for the drug's sponsor to gain full approval. No standards were lowered, and many women may now live much longer without their disease progressing.
The damage done by Mr. Grassley's decision to make an issue of this decision cannot be understated. Having served at the FDA during the Congressional hearings over the Imclone/Martha Stewart insider trading scandal, I can attest to how an action like this GAO inquiry will resonate within the halls of FDA. An extremely cautious and protective bureaucracy will respond to such intimidation by being even more protective.
The senator is demanding a full-scale review of each and every product ever approved, and is asking for a rejudgment by GAO "to ensure that drugs approved on surrogate endpoints are both safe and effective."
You can bet these bully tactics will have an effect. Look for greater demands by the FDA for cancer programs to not use the accelerated approval pathway. Just a few weeks ago, Medarex Inc. announced that the FDA will renege on a commitment to grant accelerated approval of a new product for skin cancer if its clinical trial showed benefit using the PFS endpoint. The FDA ordered a change toward the much stricter endpoint of overall survival, adding years to the time it will take to evaluate the drug's efficacy.
U.S. cancer-drug development stands on a precipice overlooking a new dark age in which each new product's development is longer and costlier than the last. Companies may decide it is not financially viable to even bother developing new drugs, and the pipeline for new products to treat cancer could slow even more. Mr. Grassley's legacy could be thousands of additional cancer deaths.
Advocates for all patients affected by Mr. Grassley's antidrug company demagoguery – including cancer patients, Alzheimer's patients, AIDS patients – must make their voices heard.
Dr. Thornton is a former medical officer in the Office of Oncology Products at the Food and Drug Administration. He volunteers as president of the Sarcoma Foundation of America.
Recently an organization representing major academic research institutions introduced a resolution proposing that such entities consider the moral and political implications of educational links with pharmaceutical and to discuss such association with individuals and institutions concerned, including researchers in industry with whom they are collaborating." It also called for a moratorium on research with industry because industry has damaged the fabric of academic medicine over the past 40 years.
Actually, the ban and the resolution came from the UK University and College Union and it applied to Israel, not Big Pharma. I have just returned from Israel and spoke to several of the world's leading researchers in their fields to -- who receive no pharma funding -- and have heard of how their research has been shunned, ignored, passed over by other academics in a corrupt, biased, small minded peer-review process. Being Jewish -- especially if you apply for funding in Europe -- does not help. So much for purifying academic medicine by driving pharma out!!
But I digress -- sort of. But the presumption of damage and the guilt by association -- and the unsubstantiated nature of it all fueled by a leftist hatred that is unbalanced and blinds the conflict of interest kapos to other forms of conflict that are more pervasive and corrupt that conveniently reward their cronies. Mitchell Cohen notes in Dissent regarding "Anti-Semitism and The Left That Doesn't Learn"
If you judge a Jewish state by standards that you apply to no one else; if your neck veins bulge when you denounce Zionists but you’ve done no more than cluck “well, yes, very bad about Darfur”;
if there is nothing Hamas can do that you won’t blame ‘in the final analysis’ on Israelis; you probably are an anti-Semite.
Similarly
if you judge pharmaceutical companies or those who receive pharma funding to support their research no matter how transparent or for whatever research that you apply to no one else; if your neck veins bulge when you denounce Big Pharma but you've done no more than tsk "well, yes, terrible about PBM drug switching or peer-review panels stacked with cronies";
if there is no medicine you can't write about without claiming it wasn't developed by pharma or is not really effective;
if your anger at drug companies doesn't sound any different from the unthinking American conservatives attacks towards those who support universal health care out of a true sense of compassion?
Then you are simply part of the group seeking to stifle and suppress and eliminate debate out of hate. As Labor MP Dennis McShane noted: “there is an anti-Jewish discourse, a mood and tone whenever Jews are discussed, whether in the media, at universities, among the liberal media elite or at dinner parties of modish London. To express any support for Israel or any feeling for the right of a Jewish state to exist produces denunciation, even contempt.”
The same tonality runs through the anti-pharma, conflict of interest blogs.
Birds of a feather.
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.
