Latest Drugwonks' Blog
SATURDAY, AUGUST 4, 2012
Why I've Always Written So Much With Such Intensity And why I won't stop now.
By Barry Rubin
Nothing is stranger than having a normal life and then within a few hours knowing that it might end at almost any moment. That’s what happened to me when I was just diagnosed with what is called inoperable lung cancer. I am still waiting final results of the tests and the choice of therapies.
I have no desire to make this my focus but it’s been suggested that I write something about it that might be of broader interest.
First, for those of us whose understanding of cancer is based on past information, it is very important to understand that a lot has changed. That diagnosis twenty or thirty years ago would have given a person only a few months to live. Today, with many of the new therapies invented, one has a fighting chance. Still, it is tough to have your life expectancy lowered from around twenty years to a minimum of two within moments.
People always asked me why I wrote so much and so intensively. I never told them one of the real reasons: I always expected my life would be limited. My grandfathers died, respectively, at 42 and 44, both of things that could have been cured today. My father died of a heart attack at 62, and his life probably could have been extended many years today by all the new tests and drugs available. But I felt that once I passed that birthday, less than a year ago, I might be living on borrowed time.
They say that when you are fighting cancer that becomes a full-time job in itself. Supported by my truly wonderful family, I’m working on it. Right away one starts paring things down: unsubscribing to lots of things; knowing that I will never again have time for hobbies. The decision to start reading a book is like a major life choice.
And I know I won’t be going canoeing down the Jordan River with an old friend in August. In fact, having passed out briefly about a half-dozen times—though we think we’ve solved that problem—I’ll probably never drive again nor, after cancelling two trips, travel internationally. In fact, the way things are going at the moment, I might never eat solid food again.
The best thing to do is to accept everything calmly—bargaining, hysteria, rage, won’t do any good--and then decide that one is going to fight with the object of beating the disease. Unlike much of political life, this is not caused by malevolent forces.
This is not, however, the only transformative event I’ve had this week. I don’t want this to come out wrong but I have been touched and encouraged by an outpouring of emails from friends, acquaintances, and readers about how much they appreciated my work. Up until now, I’ve really thought that my articles have gone into a void.
As you know, we live in an era where many ideas, much truth, and certainly the kind of things that I think are largely barred from the most prestigious (although daily less so) media and institutions. We are either ignored or vilified. Now, though, the counter-audience has grown so long and people are so hungry for accuracy and cutting through the nonsense that our ranks have grown into the millions. When someone tells you that you’ve helped them, informed them, encouraged them, or even changed their lives it is an immeasurable feeling.
And while I wouldn’t go so far as to say that the cost has been worth receiving these messages, it is closer than one might ever believe.
There are some constructs I’ve come up with that I find comforting. Briefly:
Every living thing that has ever existed has died, at least in terms of being on this earth. If they could do it I can do it.
I feel like I have been captured by an enemy force (you all can insert specific names) and they want to execute me. I hope to escape or to be rescued by my friends.
Even if I didn’t have this disease, I could leave life on any day due to many causes without warning.
For 2000 years my ancestors dreamed of returning to their homeland and reestablishing their sovereignty. I have had the privilege of living that dream. How amazing is that?
We have to judge ourselves by whether we’ve lived up to our ideals and done our best. Not by the accumulation of power, wealth or fame; not for failing to achieve the impossible.
A famous Jewish story about that is the tale of Rabbi Zosia who said that he did not expect God to berate him for not having been Moses—who he wasn’t—but for not having been Zosia.
To me, that means we must do the best to be ourselves while trying to make ourselves as good as possible. I’ve really tried to do that. I don’t have big regrets, nor bitterness, nor would I have done things very differently.
And I’ve discovered the brave community of those who are supporting and encouraging each other in the battle against this disease.
Finally, I find myself identifying with a poem by a Turkish writer named Ilhami Bekir that goes like this:
“Neither vineyards, nor gardens
Do I ask.
Nor horses, nor sheep.
Don't take my soul away,
O God!
I am curious.
I must see how this game ends!”
The game, of course, doesn’t end and I don’t expect to live to see utopia realized. But it would be nice to live long enough to see America and the world pass out from this current dreadful era, to see some restoration of sanity and reality, some kind of victory for goodness, some kind of restoration of intellectual standards, and a higher level of justice.
Some friends tell me they think we’ve turned the corner and that there’s real hope of beating the terrible forces that have messed up our societies and insulted our intelligence and tried to sully our reputations.
That’s something worth living for and fighting for. I hope to do it with you people as long as possible.
Just who are these “academic detailers” anyway? And what are their qualifications?
(For more on this topic see this article from the May 2012 edition of Drug Information Journal.)
Well, here’s an actual job description as created by Total Therapeutics Management, the company AHRQ is paying $11,680,060 to recruit, train, and field what we should more appropriately call “government detailers.”
Patient Centered Outcomes Consultant
Our Part-Time Patient Centered Outcomes Consultant positions provide a distinctive opportunity for pharmacists looking for the perfect balance between professional challenge and work/life without practicing in a traditional healthcare workplace. This part-time position provides flexibility and is perfect for self-motivated individuals who thrive in a fast paced environment with an emphasis on personal accountability. Your success will be determined by the number and quality of the details you achieve, not only the amount of time you log.
Essential Job Duties and Responsibilities:
* Schedule and conduct 250 details annually to targeted healthcare providers
* Develop relationships to facilitate ongoing success of academic detailing program
* Document meeting & communication feedback in relationship management software
* Complete accurate and timely administrative reports and required documentation requests.
Minimum Qualifications:
* Pharmacy, degree with current, active license.
* Five years clinical experience.
* Therapeutic competency.
* Personal computer skills including advanced knowledge of word processing, database management, and reporting is required.
* Excellent scientific presentation and public speaking skills.
* Ability to plan, prioritize and execute multiple responsibilities.
* Ability to travel 60%-70% day travel; some overnight possible
* Clean and valid driver's license.
* Dedicated home office with internet and phone connectivity.
250 details annually? Sounds more like academic retailing. Are former pharmaceutical company representatives welcome to apply?
According to a new IMS report (funded by the Generic Pharmaceutical Association) use of generic medicines has reduced U.S. health care spending by more than $1 trillion over the past decade.
The report notes that using inexpensive generic versions of pricier brand-name prescription drugs now saves the country about $1 billion every other day. Drugs for heart conditions and central nervous system disorders such as depression and convulsions account for 57 percent of the annual savings.
What’s missing in the report is a big “thank you” to the innovator companies who, through their scientific ingenuity, perseverance, and financial investment made the generics industry both possible and profitable.
Just sayin'.
Silent gratitude isn’t much use to anyone.
-- Gertrude Stein
According to DSHEA, dietary supplements are foods. And now a food (or in this case, a fruit juice) is behaving like a dietary supplement -- making false health claims.
Makers of POM Wonderful (a pomegranate juice drink) have been warned by both the FDA and the FTC to stop making unsubstantiated claims about the drink's health benefits.
Among the claims made by the company is that POM is "40% as effective as Viagra" because it improves blood flow and promotes healthy blood vessels. The firm also claim POM is "proven to fight cardiovascular, prostate and erectile health" and that "clinical studies prove that POM Juice prevents, reduces the risk of, and treats, erectile dysfunction."
A randomized, placebo-controlled, double-blind, crossover pilot study examined the efficacy of pomegranate juice versus placebo in improving erections in 61 male subjects. The study did not achieve overall statistical significance, but the authors (from the Keck School of Medicine, University of Southern California,) conclude that additional studies with more patients and longer treatment periods may in fact reach statistical significance.
And then again -- it may not.
The Federal Trade Commission has filed a lawsuit against the makers of POM Wonderful. This comes six months after the FDA told POM to stop misleading consumers with claims of “super health powers.”
http://abcnews.go.com/Health/Wellness/whooping-cough-vaccine-effective-early-form-study-finds/story?id=16898211#.UBmQU8j3v5h
Jonca Bull returns to the agency after stints at Novartis and Genentech to become director of the Office of Minority Health.
Great choice.
Good luck, Jonca.
Doctors behaving badly -- very badly.
The FDA has sent a warning letter to Lap-Band VIP warning them to change their billboard and television marketing or face disciplinary action. Lap-Band VIP, based in Tarzana, has promoted its weight-loss surgery on television, the Internet and freeway billboards throughout Southern California. One billboard featured a photograph of a thin woman with the pitch: "Tiffany lost over 100 lbs. Actual patient. Results may vary."
Those ads were misleading, the FDA said in a June 25 letter, because they failed to include adequate warnings about the surgery's risks. The agency said Lap-Band VIP "should take prompt action to correct the violations" or risk "regulatory action."
Dr. Shahram Salimitari, a co-owner of Lap-Band VIP, told the Los Angeles Times that the company was pulling the billboards down. "Most of my patients come through referral," Salimitari said. "We don't need to advertise like that to get patients. We do it by taking care of patients."
It seems that Dr. Salimitari has an interesting way of taking care of thngs.
He’s described on the Lap-Band VIP website as a specialist in "gastric banding procedures," but the website does not mention that Salimitari was arrested by Los Angeles County sheriff's deputies in 2008 and charged with threatening to kill a sheriff's deputy and a flower shop owner.
Talk about violative behavior!
The trouble started after the store owner asked Salimitari to move his black BMW 323i, which he had double-parked outside her store in a Valencia strip mall, according to a sheriff's arrest report.
Salimitari swore at the woman and said, "If you do anything to my car, I'll kill you," the store owner, Myra Harbour, testified at a hearing in Los Angeles County Superior Court in San Fernando. The woman later obtained a restraining order, which is still in effect, that prohibits Salimitari from coming within 100 yards of her.
Sheriff's Deputy Thomas Babiracki said Salimitari threatened to kill him after he arrived at the flower shop. The deputy said he used pepper spray to control the irate surgeon and that he needed another deputy's help to handcuff the 220-pound Salimitari.
"I felt threatened," the deputy testified. "He's larger than I am."
Results, it seems, may vary.
Massachusetts has lifted its ban against pharmaceutical co-pay coupons.
State Representative Steven Walsh, a Lynn Democrat who chairs the Legislature’s Joint Committee on Health Care Financing and leads House efforts to tamp down health costs, supported lifting the ban. He believes it is wrong to deny patients access to the coupons, even for a limited time. “To not allow families to get coupons ... for life-saving drugs seems pretty Draconian,” Walsh said.
Co-pay coupons are prohibited if a generic is available.
The law expires in 2015 unless it is renewed. Under it, the state must conduct a detailed analysis to determine if health care costs rise after the lifting of the coupon ban. The review will examine whether patients are more faithful about taking their medications and whether there are changes in the use of generic, versus brand name, drugs.
The Mandate. It sounds like an epithet from Jersey Shore.
It’s time to stop debating (or celebrating or bemoaning) the legality of the individual mandate. The Supremes have spoken. Now it’s time to start discussing, seriously discussing, why it’s important – and flawed.
You can’t have an insurance-based healthcare system without healthy young people in it. We have many millions who are not and many of them can well afford it. They choose not to have coverage. The mandate’s penalty (or, if you prefer, the tax) is a limp noodle. It’s less than the cost of an annual premium. And to further weaken the desire of healthy young adults to buy health insurance – they can’t be denied if and when they get ill.
This important cohort isn’t going to be threatened into the insurance pool. They are going to have to be enticed. Alas, that’s not something Uncle Sam is very good at -- but the private sector is. And since insurance companies can’t sell policies across state lines (a travesty that should be fixed) it’s going to have to happen on a state-by-state basis.
We can evolve healthcare by recognizing that it must be done locally — state-by-state. When it comes to reform, states are the laboratories of invention.
If the key goal of healthcare evolution is broader coverage at lower costs, one national program that offers valuable lessons for the path forward is Medicare Part D (the Medicare prescription drug benefit). Part D applies free-enterprise principles to the nation's health care system (letting competition drive down prices and increase choice and quality) rather than operating it like a government-managed utility. That’s the fundamental debate.
When it comes to the future of the Affordable Care Act (or, if you prefer, ObamaCare) there are many crystal balls.
But what we need are balls of a different consistency.
Regulators (especially those of the FDA variety) love ambiguity – because ambiguity is power. But regulatory ambiguity invariably leads to mission creep.
Presented for your examination, this short codicil from the recently signed PDUFA legislation:
SEC. 311. EXTRATERRITORIAL JURISDICTION.
‘‘There is extraterritorial jurisdiction over any violation of this Act relating to any article regulated under this Act if such article was intended for import into the United States or if any act in furtherance of the violation was committed in the United States.’’
Whether this was written incorrectly or intentionally written in an overbroad fashion, it’s now the law of the land. But what does it mean?
To answer that question we need to address ambiguity’s regulatory cousin -- intent. Here’s a what-if scenario:
Acme Pharmaceutical Company has a drug that is both EMA and FDA approved. Acme wants to report on the results of a new clinical trial conducted for EMA appraisal. The clinical trial is for a use not currently approved by the FDA. Acme sends out a press release to European media. The story runs in European newspapers. The New York Times (via its London bureau) picks up the story.
Could Acme (because of the story in the New York Times) be accused by the FDA of off-label promotion?
Here’s the key question – was Acme’s intent to have the story picked up by a US media outlet?
Internal company debates often focus on responsibility for an FDA violation after the fact. Section 311 makes it clear that more wide-ranging discussions need to happen beforehand. What is the intent? Is it marketing-driven or is it being done in the best interest of a patient or the broader public health? (PS/ these two things are not mutually exclusive.) Intent counts. Just as the FDA has asked whether or not the speaker and the audience matters when it comes to the issue of “scientific exchange,” so too is this relevant in helping to determine “responsibility” for “extraterritorial” off-label conversations.
As the FDA asked in its December Federal Register notice, “How do companies generally separate scientific roles and promotional roles within their corporate structures?” How indeed?
To paraphrase the proverb, ““The smallest intention is more important than the greatest deed.”
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.
