Latest Drugwonks' Blog
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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.”
There was so much righteous rhetoric at yesterday’s New York City Board of Health hearing on the Mayor’s proposal to ban high calorie drinks that it was a miracle the floor didn’t collapse from all of the, um, earnestness.
The major sound bite for the pro-ban crowd seemed to be that the theses of the anti-ban representatives were “the same arguments used by Big Tobacco.” “Sugar,” they repeated ad nauseam, “is the new tobacco.” Sure.
Specifically the pro-ban zealots (led by that old war horse himself, Michael Jacobson) were referring to the “empty arguments” of jobs, choice, government intrusion, and economic impact.
The hearing also featured five New York City Council members and Brooklyn Borough President Marty Markowitz who all voiced their opposition to the proposed measure. Why, they asked, isn’t this measure up for debate and vote in front of the City Council – the elected representatives of the people of the City of New York?
The phrase “arbitrary and capricious” was mentioned more than once -- a lot more than once.
As Councilman Dan Halloran commented to me, “Mayor Bloomberg always knows best – just ask him.”
My testimony (which can be found here) concluded as follows:
New York City has not filed a physical education plan with the state since 1982. It’s time for Mayor Bloomberg to step down from the bully pulpit long enough to get our kids back into the gym.
It’s time for the Mayor to take a big gulp, stop talking about fizz and start focusing on phys ed.
The Mayor’s proposal will be voted on by the entire NYC Board of Health – all of whom are Bloomberg appointees.
Ladies and Gentlemen: The ends do not justify the means.
Here's the proposed reg again:
The limits would apply to cups and containers used for sugary drinks. The limits would
also apply to all self-service cups and containers, regardless of intended contents. Without such limitation,
a self-service cup exceeding the maximum size could be used for either non-sugary or sugary drinks. This
rule will not limit the amount of sweetener a customer may add to his or her own drink
So is using your own cup or container illegal? Would someone be fined for carrying a 20oz reusable (environmentally friendly!!) container.
The limits would apply to cups and containers used for sugary drinks. The limits would
also apply to all self-service cups and containers, regardless of intended contents. Without such limitation,
a self-service cup exceeding the maximum size could be used for either non-sugary or sugary drinks. This
rule will not limit the amount of sweetener a customer may add to his or her own drink.
The rule will not take effect until 6 months after adoption by the Board of Health. It establishes a fine of
$200 for each occasion that it is violated. By addressing the increasing size of sugary drinks and
reacquainting New Yorkers with more appropriate portion sizes, the City is taking an important step in
reducing sugary drink consumption and combating obesity and its resulting morbidity and mortality.
The following specific amendments are proposed:
Set a maximum size for sugary drinks: Non-alcoholic sugary drinks may not be offered or sold in
cups or containers that can contain more than 16 fluid ounces.
Set a maximum size for self-service cups: Food service establishments may not offer or sell selfservice cups that can contain more than 16 fluid ounces.
Set a fine for violations: No more than two hundred dollars for each violation as described in the
proposed rule.
Sometimes even “Big L” New York Liberals understand that more government isn’t always the answer. Here is a brief video offering a sample of the Big Apple’s opinion on Mayor Bloomberg’s suggested treatment for “Big Gulp Disease.
I am getting ready to testify today in front of the New York City Health Department on this issue. My takeaway message? The Mayor should focus less on fizz and more on getting New York City kids more phys ed.
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.
