It ain't over til it's over

01/10/2011 07:46 AM |

The Supreme Court will decide whether states may prohibit the use of drug prescription records for marketing purposes.

By reviewing a Vermont law that restricts commercial use of prescription records, the court will settle a split in lower courts about whether such laws violate the First Amendment.

The U.S. Court of Appeals for the 2nd Circuit in New York struck down Vermont's law. The U.S. Court of Appeals for the 1st Circuit in Boston upheld similar legislation in Maine and New Hampshire. Both the states and the companies on the other side of the conflict asked the high court to decide the issue.

IMS Health and other companies collect data from pharmacies on the drug-prescribing practices and histories of doctors. The records do not include information that would identify patients.

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Just don't ask about social media

01/07/2011 09:35 AM |

Peek-a-boo -- ICU

The Food and Drug Administration is launching a website explaining its regulations to companies as part of a broader effort to rebrand itself as a more transparent, accessible agency.

The website, dubbed "FDA Basics for Industry," features answers to frequently asked questions about the regulation of food, drugs and medical devices. The FDA also pledged to respond to questions from manufacturers within five business days.

For more info, see here.

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Take as directed -- really

01/07/2011 09:22 AM |

Those prescription drugs can be so gosh-darn expensive, but if you don’t buy them, you’ll just wind up paying more in medical bills down the road.

A new study in Health Affairs demonstrates that people with four common chronic illnesses saved themselves – and the healthcare system – significant dollars by taking being medication adherent.

The CVS Caremark-funded report, is based on an analysis of 135,000 patients with congestive heart failure, diabetes, hypertension and high cholesterol. The study found that people who took their meds made fewer visits to the emergency room and spent fewer days in the hospital. Specifically:

• Patients with congestive heart failure who took all their prescribed drugs saved $7,832 per year compared with those who didn’t.
• Patients with diabetes saved $3,756 by taking all of their meds.
• Patients with high blood pressure saved $3,908 when they filled all their prescriptions.
• Patients with high cholesterol saved $1,258 when they got the full benefit of pharmaceuticals.

A the study concludes:

“Our findings indicate that programs to improve medication adherence are worth consideration by insurers, government payers, and patients, as long as intervention costs do not exceed the estimated health care cost savings.”

Adding new meaning to the words "penny wise, pound foolish."

Words to the wise.

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Nissen To Replace Sharfstein: In Nissen's Dreams

01/06/2011 04:44 PM |

Is this a sign of desperation or an ego that out-lived it's self-awareness?

From something called medcitynews by someone called Brandon Glenn who plays a reporter there. 

Sharfstein’s FDA replacement: Why not Cleveland Clinic’s Steven Nissen?

He’s a long shot. But Cleveland Clinic cardiologist Dr. Steven Nissen may be exactly what the troubled U.S. Food and Drug Administration agency needs.

Conventional wisdom is that the departure of FDA Deputy Commissioner Joshua Sharfstein represents an olive branch to newly empowered Congressional Republicans, who viewed Sharfstein as hostile to the industry. Sharfstein sought to crack down on drug and device companies and was once a staffer with a Democratic Congressman. So it could be that Sharfstein’s replacement will be someone who’s viewed as more industry friendly and therefore more palatable to Republicans.

Sharfstein is leaving the U.S. Food and Drug Administration to head Maryland’s health department. John Taylor, the FDA’s top lawyer, has been appointed as acting deputy commissioner for 60 days, and may very well be eventually chosen for the permanent post.

Tapping Nissen, who’s essentially hated by Big Pharma, would signal the exact opposite from President Obama. A Nissen nomination would symbolically show that Obama won’t back down from a fight with Republicans — and perhaps temporarily quiet a liberal base that sees him as at best too willing to cave to the GOP and at worst weak, ineffectual and just another opportunistic politician without any strong core beliefs.

Plus, Nissen’s affiliation with the prestigious Cleveland Clinic, recognized as the nation’s top heart hospital for 16 consecutive years, only adds to his cachet. Obama has praised the Clinic for providing high-quality care for a low cost (and Obama also bench-pressed 260 pounds during a visit to the hospital’s gym).
 

Nissen declined comment through a Cleveland Clinic spokesman.  (My note:  Nissen declining to comment?  This was my clue that the article was a hoax.)

It’s not as if talk of Nissen joining the FDA is a new thing. Shortly after Obama’s election, industry insiders speculated that Nissen was among the leading candidates for the agency’s top job. “Big Pharma would go to the mat to stop Nissen, but he has plenty of cred on Capitol Hill after raising alarms about drugs, including GlaxoSmithKline’s Avandia, J&J’s Natrecor, and Pargluva, a diabetes medicine that Merck and Bristol-Myers Squibb failed to bring to market,” the Wall Street Journal reported at the time.

In particular, Nissen rose to national prominence as an early critic of Vioxx, a painkilling drug that Merck later pulled off the market. He also garnered attention by publishing a 2007 paper that argued that diabetes drug Avandia causes heart attacks. The FDA last year allowed Avandia to remain on the market, but with significant restrictions.

The public stands Nissen took against those drugs show he’s not afraid of a fight when he believes he’s right — something Obama’s critics on the left may not say about the president.

There’s at least one thing for Republicans to like about Nissen — like many GOPers, he’s been a harsh critic of the FDA. “I think the FDA has lost its way in terms of its mission,” he told the Plain Dealer two years ago. “It is truly a failed agency. We have to change the culture.”

And Nissen has been specific about some of the changes he’d like to see at FDA. He supports a fixed six-year term for the agency’s chief as a means of insulating the FDA from political pressure. He’d also like to see a change to the FDA’s funding mechanism. The FDA generates much of its budget through user fees imposed on drug companies that some critics believe give the industry too much influence.

And then there are the suggestions that really tick off Big Pharma. First, Nissen would like to see more transparency from the agency on its decision to approve or not approve drugs. He’s called on the FDA to publish the letters it sends to drugmakers that detail why a drug has or hasn’t been approved, as well as data from drugmakers’ clinical trials. Additionally, he supports giving the FDA the power to restrict direct-to-consumer advertising of drugs during their first two years on the market — a position that quite possibly may have resulted in his photo being placed on a few dartboards in Big Pharma boardrooms.

Alas, sadly for drug-industry critics, a Nissen nomination is likely not be. Taylor is already receiving support to be appointed Sharfstein’s permanent replacement, and with Taylor already holding down the spot on an interim basis, he appears the most logical and likely choice. And it certainly doesn’t hurt his case with Republicans that Taylor has worked in regulatory positions under both Bush administrations.

But if the Republicans are spoiling for a fight about the FDA, Obama shouldn’t balk from giving them one. Nissen has shown he isn’t afraid of a fight — and knows how to win them.

 

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End of End-of-Life Planning?

01/06/2011 08:52 AM |

At least, it seems, for the time being.

U.S. Alters Rule on Paying for End-of-Life Planning

WASHINGTON — The Obama administration, reversing course, will revise a regulation to delete references to end-of-life planning as part of the annual physical examinations covered under the new health care law, administration officials said Tuesday.

The full New York Times story can be found here.

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Jaunty John T.

01/06/2011 08:43 AM |

Pleased to report that Peggy Hamburg has asked John Taylor (currently serving as counselor to the commissioner) to serve as acting FDA principal deputy commissioner.

I served with John at the FDA and he is a talented, devoted public servant – and a real stand-up guy.

John will serve in FDA's number two position for 60 days while the Commissioner conducts a review of the agency's organizational structure. John served with distinction at FDA for 14 years before resigning in 2005 as associate commissioner for regulatory affairs. He was VP for federal government affairs at Abbott from May 2005 to September 2007and EVP for health at BIO before returning to the FDA in October 2009.

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Wakefield's Lethal Legacy

01/06/2011 12:56 AM |

Andrew Wakefield’s Lethal Legacy

Yesterday, The British Journal of Medicine http://www.bmj.com/ published the first of several articles detailing the systematic fraud Andrew Wakefield engaged in to show that the measles-mumps-rubella vaccine triggered autism in 12 children who, Wakefield claimed, were perfectly healthy before being immunized.   The Lancet published Wakefield’s original article in 1998.  Though the paper’s weaknesses were evident back then, it was also clear – to Wakefield and the law firm who paid him millions to concoct and falsify both the research and conclusions – that it would be enough, once published in a major medical journal, to spread a wildfire of fear about vaccine safety.

And indeed that was one hypothesis that Wakefield did prove correct.   It took over a decade for The Lancet to retract the original publication and for Britain’s General Medical Council to strip Wakefield of his medical license.   During that time, despite the substantive questions about Wakefield’s research, untested theories, lack of medical training and source of funding, there was no serious challenge to Wakefield.  In spite of dozens of large studies showing no correlation – first between MMR and autism, then between thimerasol (a mercury-based vaccine preservative) and autism, and then the between whole array of childhood shots and autism — the myth that vaccines were permanently damaging kid’s brains persisted.  Wakefield and the movement he helped spawn, thrived and does so today.

Focusing on Wakefield’s fraud misses the point.  He succeeded because he created a narrative people wanted to believe.  It goes beyond parents seeking a cause for their child’s autism and finding some comfort in blaming vaccines. Wakefield’s theories were published by mainstream medical journals and championed by major media outlets.

Wakefield was a ‘visionary’ because he realized that by churning out a series of small studies and quickly putting them on the Web he and others in the anti-vaccine movement could have a powerful impact on public perception of risks.   Others used the Web to turn him into an ‘instant expert’ and characterize him as lonely crusader against evil drug companies on behalf of children with autism.  The scientists who defended the value and safety of vaccines were – and are – discredited for their “conflicts of interest” – that is, helping develop vaccines.

The BMJ editorial’s on Wakefield notes that while he might be exposed:  “Meanwhile, the damage to public health continues, fueled by unbalanced media reporting and an ineffective response from government, researchers, journals and the medical profession.”

Sadly, as I point out in my new book, Tabloid Medicine, the health damage is not confined to immunizations and the response is not only ineffective, it is shameful.  To be sure, confidence in all manner of vaccines among certain groups of parents is decline.  There is a corresponding spike in the number of kids killed and hospitalized by vaccine preventable diseases.   But in the past decade other groups and individuals have followed the Wakefield formula of hijacking medical science by spreading flimsy fears through the Web where it is only a matter of time that unbalanced media reporting, biased researchers and publicity seeking medical professionals will spread panic for their own agenda.

Today, anyone willing to pay for newsfeeds that continually distribute and obtain prominent placement in Google searches can have their medical scare stories and their half-baked research virtually circle the globe ten times over before the truth takes its first step.

As a result, Wakefield’s imitators are many and are damaging the public health in equal measure.  David Healy, another British physician doctor published a small study matching Wakefield’s 1998 research for shoddiness to spread panic about the link between suicide and a class of antidepressants called SSRIs.   It lead to a decline in the use the drugs and an increase in teen suicide.   David Graham, a Food and Drug Administration (FDA) researcher circulated an unpublished study through the Web claiming Vioxx was responsible for 100,000 deaths.  The rest is history.

In 2007, Steve Nissen rushed a study into online publication through the New England Journal Medicine claiming the oral diabetes drug Avandia was linked to heart attacks (even though a government clinical trial found Avandia managed diabetes well and reduced heart risks).  Overall use of oral diabetes drugs has declined.   Millions of women are avoiding hormone replacement therapy and mammograms because of misleading claims about the dangers of both.  As a result, the risk of breast cancer is higher than it should be.  In some of these cases the switch to a ‘natural’ treatment, often promoted by those who foster fear, has done more harm than good.

Wakefield may be discredited.  But as long as the Web is manipulated to discourage the use and development of medical innovations – and researchers, journalists and politicians – spread this misperception – his lethal legacy will endure.

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Disabusing Rosie

01/05/2011 11:44 AM |

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I hear Annapolis is very nice this time of year

01/05/2011 11:25 AM |

From the pages of Medical Marketing & Media ...

As GOP takes aim at FDA, Sharfstein bows out

The FDA's point-man on prescription drugs, principal deputy commissioner Joshua Sharfstein, is leaving the agency to head up public health in his home state of Maryland.

Sharfstein, who presided over a crackdown on drug and device marketing at FDA, will serve as Maryland's secretary of health and mental hygiene. He headed health in Baltimore before joining FDA in 2009.

Sharfstein's resignation comes amid saber-rattling from the incoming head of the Congressional Committee on Oversight and Government Reform, who has vowed in recent days to investigate the FDA. Rep. Darrell Issa (R-CA) called FDA “a broken bureaucracy” and said he would hold hearings on FDA failures.

High-pressure hearings are a game Sharfstein knows well, having previously served as an investigator for another Committee on Oversight chairman from California – Democrat Henry Waxman, an inveterate critic of industry promotion.

“He knows what it's like to be under the gun, over and over and over again, by a chairman of a committee trying to help his party regain the White House,” said Coalition for Healthcare Communication head John Kamp, himself a former FCC legislative liaison who remembers his old boss comparing a root canal favorably to oversight hearings.

“It's also just a good career move for a public health official,” said Kamp. “Great job, good jumping-off point to later head FDA, CMS or HHS.”

Former FDA associate commissioner Peter Pitts said the resignation of Sharfstein, whom Republicans view as an overzealous regulator hostile to industry, will make life easier for FDA ahead of contentious PDUFA reauthorization hearings.

“When Sharfstein testified before the 111th Congress, he basically sat down and the members put leis around his neck,” said Pitts. “They were very congratulatory. Had he stuck around, he would have faced some very harsh questions. Putting him up before the 112th Congress would have been very difficult for the agency.”

Pitts called PDUFA reauthorization “an opportunity for the new Congress to make its wishes known to FDA and influence the way PDUFA is written and reauthorized.”

“It's an opportunity to get back to the first principles of PDUFA, which are clarity and predictability versus ambiguity.”

 

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Shakespeare on Annapolis

01/04/2011 03:22 PM |

"Now go we in content
To liberty, and not to banishment."  Read More & Comment...

Does The New Normal of FDA Approvals Mean Less Innovation?

01/04/2011 02:12 PM |

2010 was a very bad year for new drug approvals.  The FDA approved 21 new products, the fewest since 2007.  Given that the number of new drugs in development have been increasing, it means three four things: 

1.  More new drugs are being yanked well before they enter clinical trials.  A good thing that can be chalked up to thinning revenues, higher standards, harder targets and better development tools.

2.  The safety delta on all drugs is higher.  Not a good sign.  REMS and Safety First means approval times are slower or drugs are not approved on the first go round.

3.  Clinical development is becoming more a legal battle and less a scientific one.   If you don't believe me read this article from www.ft.com where the CEO of Watson Pharmaceuticals  says generic lawsuits are causing drug companies to stop innovating.  He calls it "eating their young."   /tinyurl.com/259ko9q

4.   Compared to previous years there are still fewer new drugs being introduced and those are being slowed down as these drugs are now considered less special or non priority.  As  Ed Silverman at Pharmalot notes:

"Overall, there was a 25 percent decline in first-cycle approval rates for priority-rated new drugs and a 17 percent decrease in priority designations for new drug applications, or NDAs. First-cycle reviews for priority NDAs were 47 percent in fiscal year 2003 and continued to climb to 70 percent in fiscal year 2007, but have since slipped back to 53 percent in fiscal year 2009."

Ed goes on to quote Paraxel consultants: 

"As for priority designations for original NDAs, fiscal year 2005 marked a high of 30 percent after running as low as 10 percent four years earlier. However, that fell back to 13 percent in fiscal year 2009. Parexel says the decline has been “most stunning” in for antiviral and oncology NDAs, which are the two therapeutic areas that have driven overall rates at the FDA’s Center for Drug Evaluation and Research in previous years.

Priority designation rates for cancer NDAs have been declining consistently for several years, from 65 percent of the NDAs submitted between fiscal year 2003 and fiscal year 2005, to 18 percent in fiscal year 2009. The decline in AIDS and other antiviral therapies fell from 95 percent in fiscal year 2006 and fiscal year 2007 timeframe to just 8 percent among NDAs submitted in fiscal year 2009."

www.pharmalot.com/2010/10/the-fda-review-process-and-the-new-normal/

Is the bar being raised at the FDA for drugs that are truly innovative and targeted?  It is not the FDA's business to determine whether one medication is better than another.  Each treatment has to stand on it's own risks and benefits with respect to the people it treats..  But:

 “The FDA’s 13 percent priority designation rate for 2009 new drug applications mirrors the low rate at which some health care plans and other payers are finding value in newly approved drugs.  This illustrates the need for companies to take into account market-based clinical concerns in the product development process market-based clinical concerns in the product development process,” according to Charles A. Stevens, Vice President and General Manager, Reimbursement and Market Access, PAREXEL Consulting."

tinyurl.com/32ycdww

The question is whether the clinical development process is the appropriate mechanism to taking these concerns into account or whether it comes at the cost of true value.  And innovation.

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Chuck out of luck

01/04/2011 11:36 AM |

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if u cn rd ths rx

01/04/2011 09:42 AM |

I'm shocked, shocked to find that gambling is going on in here!

NEWS FLASH:  Americans don’t understand drug labels.

The IOM estimates that 90 million Americans can’t fully understand and act upon health information.

U.S. Pharmacopeia to the rescue.

Proposed USP standards could make label information and instructions more comprehensible. For example, instructions to “Take two tablets twice daily” can raise confusion; saying “Take 2 tablets in the morning and 2 tablets in the evening” makes the numbers more explicit and also specifies exactly when to take the medications. The recommendations also suggest that if it’s okay with the patient, labels should include the purpose of the drug, and in plain language, i.e. “for high blood pressure” rather than “for hypertension.”

It's okay.

The proposed standards recommend formatting that can make labels easier to read, including using regular sentence structure, and laying out labels so users don’t have to rotate the container to read them.

The USP is taking comments at 17PrescriptionContainterLabeling@usp.org until the end of March. When finalized, they could be adopted by state pharmacy boards or other authorities.

It’s about time that we stop talking about health literacy, compliance and adherence and start doing something about.

I think this is the beginning of a beautiful friendship.

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Blood Simple

01/03/2011 08:30 AM |

Okay, maybe not so simple -- but certainly exciting.

Researchers at Massachusetts General Hospital have already developed a prototype of a microchip that can detect tumor cells at extremely low levels in the bloodstream. The effort to be announced today intends to draw on the expertise of scientists familiar with how to bring such technologies to patients and doctors.

By detecting cancer cells through a blood test, doctors could better follow the disease’s course — looking to see whether the level of cancer cells circulating drops with treatment. It would also allow doctors to test the genetics of the cancer cells, considered by doctors to be critical because many cancer drugs are targeted treatments that work against a cancer with a particular mutation.

To detect the extremely rare cells, the new technology uses minuscule channels carved into a silicon chip, coated with a special glue-like substance. When the blood filters through the channels the technology is able to pick up, on average, about 10 cancer cells per milliliter of blood in patients with metastatic cancer, disease that has spread from a primary tumor to other parts of the body.

But will payers pay for it? Early diagnosis means earlier treatment and better chances for prolonged survival.  Good for patients. But will payers (and particularly Uncle Sam, MD) see it that way?

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Einstein at the FDA

12/31/2010 11:11 AM |

From today’s Wall Street Journal:

FDA spokeswoman Sandy Walsh said there's "no systemic change in how the FDA is approaching drug approvals."

From Albert Einstein:

Insanity: doing the same thing over and over again and expecting different results.

And onwards to PDUFA V.

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Two Wrongs

12/30/2010 09:42 AM |

Hyperbole and misdirection aren’t going to solve the problem of the slippery slope towards government-run health care – it’s going to hasten it. 

No – not “death panels” (although this Palinian shibboleth certainly falls into this category) but rather statements to the effect that the FDA’s decision to remove Avastin’s breast cancer indication was “a crude cost calculation.”  Not true. Not helpful.

In today’s Wall Street Journal, David Rivkin and Elizabeth Foley write that, “The FDA made a crude cost calculation; as everyone in Washington knows, it wouldn't have banned Avastin if the drug cost only $1,000 a year, instead of $90,000.”

“Everyone?” Not really.  For those who understand what actually goes on at the Food & Drug Administration it’s not about “cost” as much as it is about “choice.” And on that note Rivkin and Foley get it right:

 

“The Avastin story is emblematic of the government's broader agenda to ration care based on cost and politics. Once ObamaCare comes into full force, such rationing will be pervasive. When the government sees insufficient benefit, all but the wealthiest and most politically connected will have to go without.”

 

We are being railroaded down the tracks towards Uncle Sam, MD – but the FDA’s ruling on Avastin (whether you agree with it or not) was based on the agency’s reading of the science.  Trying to tag the FDA with a decision based on cost may be convenient – but it’s wrong.

 

Such hasty proclamations trivialize the urgent and legitimate arguments against the current cost-versus-care direction of American health care – and makes it all the more difficult to counter and correct.  Read More & Comment...

Black Ops

12/29/2010 09:09 AM |

Per the new HHS regulation that pays for “voluntary” end-of-life counseling as part of seniors' annual physicals – just what makes it voluntary?  Does a person need to ask for it? Will there be a discussion guide?  If so, who will prepare the talking points? When are such conversations "appropriate?" And since physicians are being incentivized to provide this service, where are the "best practice" guidelines? These are only a few of many unanswered questions.

 

The Wall Street Journal reports that:

 

The office of Oregon Democrat Earl Blumenauer, the author of the original rider who then lobbied Medicare to cover the service, sent an email to supporters cheering this "victory" but asked that they not tell anyone for fear of perpetuating "the 'death panel' myth." The email added that "Thus far, it seems that no press or blogs have discovered it, but we will be keeping a close watch.

So much for embracing transparency. “The regulatory process,” the WSJ opines, “isn't supposed to be a black-ops exercise.”
 

The Journal continues,

 

The affront is that Medicare needs to sneak around in order to offer a type of care that is routine in private insurance. If the medical experts in Congress haven't decided that some treatment or service is worthy of the fee schedule, then the program won't pay for it even if it is in the best interests of patients.

Under highly centralized national health care, the government inevitably makes cost-minded judgments about what types of care are "best" for society at large, and the standardized treatments it prescribes inevitably steal life-saving options from individual patients.

 

Set your TiVo for CSPAN.  Read More & Comment...

90 miles to a longer life

12/28/2010 07:21 PM |

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When is Science not Science?

12/28/2010 08:05 AM |

When is science not science?  When it's social science.

DDMAC is conducting a study of how consumers and physicians understand the information in print ads and drug labels.  But it’s got a fatal flaw – it’s not double blind.

 

In comments on the proposed study design, Merck suggested removing statements from the draft physician questionnaire that the drug is fictitious on the grounds that this might bias the results and instead label it a "potentially new drug." FDA rejected this idea for physicians, though it agreed to a bit of deception on the consumer questionnaire. And they’re right. Alas, the FDA disagrees.

 

"FDA had many internal discussions regarding this issue and decided that because of the particular [physician] sample, it is necessary to be upfront with them about the nature of the drug," the agency states in a notice scheduled to be published in the Federal Register on Dec. 23.

 

"Physicians will be more savvy about the particulars of the chemical entities and the realism of the clinical benefits and we do not wish to make them skeptical of our purposes," FDA states. "We agree that this approach is preferable for consumers and so we will inform them that this is a potentially new drug in that part of the study."

 

The consumer survey will present identical safety information under one of two randomly chosen headlines - "Important Safety Information" or "Important Risk Information" - to see whether that makes a difference in the respondents' understanding.

 

General practitioners will be asked to look at a label for one of the fictitious drug and answer questions designed to show how they use the prescribing information - which sections of the label they choose to read, for how long, and in what order. They will be asked how they perceive the drug's efficacy and how well they can recall the claimed benefits, and their answers will be compared with those of the consumers.

 

In other words, the GPs will know this is a test.  Isn’t it likely then, that they will pay closer attention to the details? Isn't it just as important to learn how much (or how little) physicians really understand the information presented in the P.I.? In fact -- isn't it more important since they are the "learned intermediaries?"

 

Comments from Eli Lilly & Co. suggested that benefits and risks be viewed  together and in a similar format so as not to bias the results. FDA agreed that "the benefits and risks should be evaluated together and [we] have several measures to investigate both. ...[but] because of the complexity of DTC ads, we cannot manipulate both benefits and risks at the same time."

 

Hm.

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Burying the Lead

12/27/2010 09:21 AM |

During the Blizzard of Boxing Day, the New York Times editorialized on the FDA's decision to remove Avastin's indication for breast cancer. The Gray Lady was mostly supportive and neglected to say that many breast cancer organizations (including the Susan B. Komen Foundation) strongly believe that the agency made the wrong decision.

Alas, the editorial buried the lead in the final paragraph:

"Genentech plans to request a hearing with the F.D.A. to argue the case for retaining Avastin’s status as an approved breast cancer treatment. It should focus on proposing ways to identify the subset of women who can really benefit from Avastin."

The full editorial can be found here.

Burying the lead is one thing.  Prematurely burying patients is something altogether different.

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