Roxane, you don't have to put out the red light

01/14/2011 08:00 AM |

But make the label bright yellow.

Roxane Laboratories is reissuing its high-potency morphine with a redesigned label bearing bold colors, a boxed warning and other precautions following deaths and other serious adverse events due to misreading of the dosage - six months after the director of FDA's Division of Medication Error Prevention and Analysis said publicly that the company's standardized use of label colors was causing confusion.

The redesigned label uses color to make sure prescribers and patients understand the dosage for Roxane's 100 mg/5 mL morphine sulfate oral solution and can distinguish it at a glance from lower-strength Roxane morphine products.

Where the old label used brown lettering on a white background, the new one uses a bright yellow background on multiple sides of the product, so that it is distinct from other Roxane morphine products that still use a white background. Also, the new high-potency label gives the drug name, strength and concentration in white lettering on a red background.

The problem and the solution were both foreshadowed at a June 24 workshop FDA sponsored on medication errors At that meeting, Marissa Craddock, a regulatory affairs/labeling specialist for Roxane, said that the company uses brown on most of its drug labels, but distinguishes the highest strengths with red.

"A lot of the types of errors that we see, especially with the Roxane product line, are really attributed to that brown ... that's used across all the products," Carol Holquist director of FDA's Division of Medication Error Prevention and Analysis, said. "It's really great that you differentiate strength, but it's really hard to tell what product's in there."

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Vitamin C gets an A

01/14/2011 07:53 AM |

Now if only you could enhale it!

Researchers report that in a cohort of older adults, use of vitamin C or calcium supplements was associated with a reduced risk for Type 2 diabetes, although multivitamin use was not.

The National Institute of Environmental Health Sciences assessed supplemental use of individual vitamins and minerals, as well as multivitamins, reported in the 1995-1996 period and evaluated links with self-reported diabetes diagnosed after 2000 in a group of 232,007 individuals.

The participants were enrolled in the National Institutes of Health-American Association of Retired Persons Diet and Health Study and were aged 50-71 years in 1995-1996.

Of the 135,423 men and 96,584 women, 53.6% and 64.5%, respectively, took multivitamin supplements, a corresponding 78.7% and 78.4% of whom reported daily use.

No significant associations were found between consumption of multivitamins and reduction in diabetes risk, even in those who took multivitamins seven or more times per week.

The most commonly taken individual supplement was vitamin C, taken by 34.6% of the overall cohort. Vitamin E and calcium supplements were also commonly consumed by 31.6% and 29.4% of the participants, respectively.

The team found that participants who took daily vitamin C or calcium supplements were a significant 9% and 15% less likely to have developed diabetes after 2000 compared with nonusers.

The results of this study are published in the journal Diabetes Care.

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Doctored Truth, Dead Babies

01/13/2011 10:56 PM |

GOLDBERG: Doctored truth, dead babies

Fantasy vaccine fears go deeper than one fraudulent study

Tom and Patsy Morris wanted what was best for their son, Nikolas, who was facing a battery of critical immunizations. Like most parents, the Morrises relied on information from the Web to assess risks associated with vaccinating children. After being alarmed by Internet statements and news accounts like those based on Andrew Wakefield's false claim that vaccines cause autism, they decided against completing Nikolas' pertussis vaccination. A year later, he nearly died from whooping cough.

Nikolas survived, but many children are not so lucky. Millions of Americans each year are victims of a misinformation campaign I call "tabloid medicine." Mr. Wakefield is discredited, but his approach, enabled by uncertainty and the media's willingness to believe conspiracy theories, lives on. The Internet - the wellspring of Mr. Wakefield's influence - brims with medical myths fueled by inflammatory blogs, websites and "expert" resources.

In recent years, Congress, the Obama administration and even the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) - the group of experts charged with making far-reaching recommendations about what vaccinations America's children should receive - have let tabloid medicine, instead of medical science, shape policy. In 2011, a new Congress can reverse that course.

In 1998, Mr. Wakefield made the unproven claim that the vaccine for measles, mumps and rubella (MMR) inflamed the digestive systems of children and let neurotoxins attack the brain. Immediately, panic spread through Europe and the United States. Vaccine rates declined.

In 1999, other anti-vaccine groups suggested that the "neurotoxin" in vaccines was a trace amount of thimerosal, used since the 1930s to prevent contamination and bacteria in many medical products. The media spread fear, and Congress held hearings, with Mr. Wakefield as star witness calling for thimerosal's removal from all vaccines.

ACIP wanted to respond to the panic by insisting that thimerosal was safe. But one ACIP member sided with the activists. When the other members of ACIP balked because there was no science supporting his position, the lone holdout threatened to run to the media and trial lawyers. Ultimately, the full ACIP committee caved.

Removing thimerosal from vaccines was intended to calm fears, but it only led to more concern and less immunization. A spate of websites, hearings, media accounts and lawsuits reinforced the unfounded belief that scientists and doctors - in cahoots with drug companies - were hiding other dangers from the public.

Our children have been endangered by this hijacking of science. In 2007, 85 percent of doctors reported that a parent had refused one or more vaccine shots for his or her children in the past year, and 55 percent said that at least one parent had refused to vaccinate his or her child at all. African nations are immunizing and protecting more children from measles, mumps and the whooping cough. Yet these diseases are coming back in some of the wealthiest parts of America.

As the British Medical Journal observed: "The damage to public health continues, fueled by unbalanced media reporting and an ineffective response from government, researchers, journals and the medical profession."

Initially, it seemed ACIP would seek to repair that damage when in 2000 it identified the elimination of meningitis in infants as a public health goal. Meningococcal disease is among the leading causes of preventable infant death in the United States. Infants are 10 to 15 times more likely to contract meningitis. Approximately one in 10 infants who get the disease die. More than 20 percent of survivors suffer from amputation of arms, legs, fingers and toes; blindness; deafness; brain damage; and cerebral palsy.

As recently as 2008, the CDC appeared supportive of a meningitis vaccine being developed for children younger than 2. That year, ACIP reported that vaccines in trials were "safe and immunogenic" and had "the potential to greatly reduce" the disease burden.

Yet last year, ACIP's Meningococcal Working Group seemed to reverse itself, without warning. The group indicated it was considering not adding meningococcal vaccines to other shots infants receive. Among the reasons cited: the potential for a rare adverse event. Invoking such fears would give ACIP a reason to say a meningitis vaccine is not cost-effective given the "potential for risk" - as if saving the lives of 40,000 children over the next decade is risky.

The Food and Drug Administration (FDA) is expected to approve the meningococcal vaccine later this year. If ACIP then vetoes the vaccine, it would be the first time the committee has refused to recommend a safe, proven FDA-approved vaccine.

Americans and Congress have a right to know if ACIP and President Obama's new health care law are part of the problem or part of the healing. Are public health decisions going to be made based on tabloid medicine or medical science? Congress can and should begin by asking ACIP and the Obama administration whether they will perpetuate or end Mr. Wakefield's lethal legacy.

 

Dr. Robert M. Goldberg is vice president of the Center for Medicine in the Public Interest and author of "Tabloid Medicine: How the Internet Is Being Used to Hijack Medical Science for Fear and Profit" (Kaplan, 2010).

© Copyright 2011 The Washington Times, LL  Read More & Comment...

The Savage Club of Safety

01/13/2011 09:39 AM |

Phase One of the FDA's  Sentinel program for real-time monitoring of drug safety problems is now operational.

At a meeting in Washington and in a simultaneous online publication in the New England Journal of Medicine, program leaders drew back the curtain on Mini-Sentinel, a pilot program that accesses patient databases maintained by health plans and other organizations.

The FDA contracted with the Harvard Pilgrim Health Care Institute in Boston and the Brookings Institution's Engelberg Center for Health Care Reform to design the system, which is now capable of querying claims data on some 60 million individuals, without revealing identities of specific patients.

In the NEJM article, representatives of the three organizations reviewed the development of Mini-Sentinel and plans for its future. Authors of the paper are the agency’s Rachel Behrman (lead author), Janet Woodcock and former CMS Administrator and FDA Commissioner Mark McClellan  (Engelberg Center).

 "The FDA will soon begin to actively monitor the data, seeking answers to specific questions about the performance of medical products, such as the frequency of myocardial infarction among users of oral hypoglycemic agents …Using the Mini-Sentinel system, the FDA will also be able to obtain rapid responses to new questions about medical products and, eventually, to evaluate the health effects of its regulatory actions," they wrote.

Behrman and colleagues noted that the system could benefit agencies and organizations beyond the FDA, such as those concerned with quality measurement, public health surveillance, and comparative effectiveness.

"Healthcare data represent a precious resource that must be used to the fullest possible extent to promote the public health, while the rights of patients and consumers are protected.”

“Science is nothing but trained and organized common sense, differing from the latter only as a veteran may differ from a raw recruit: and the methods differ from those of common sense only as far as the guardsman’s cut and thrust differ from the manner in which a savage wields his club.”

Thomas Huxley

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Jenny McCarthy Channels Wakefield

01/12/2011 06:04 PM |

I wrote about the BMJ expose of Wakefield in a previous blog and in an oped I wrote for the that you can find here:

Since then Jenny McCarthy has fired back — I guess such words are still allowed by Congress — through her blog on the Huffington Post, which has been a reliable platform for vaccine conspiracy types since it’s founding.

Here is what she wrote back in March of 2010:

The idea that vaccines are a primary cause of autism is not as crackpot as some might wish. Autism’s 60-fold rise in 30 years matches a tripling of the US vaccine schedule.

With so many kids with autism, the environment has to be to blame, and vaccines are an obvious culprit. Almost all kids get vaccines — injected toxins — very early in life, and our own government clearly acknowledges vaccines cause brain damage in certain vulnerable kids.

Take those simple facts, along with tens of thousands of parental reports of regression after vaccination, not to mention a growing list of court cases where our government paid claims to children with autism acknowledging vaccines as the trigger, and the case we Moms are making makes sense.

http://tinyurl.com/yzbkd4w

Yesterday she lamely tried to defend the flimsy pseudo science behind her anti-vaccine cause as NOT anti-vaccine. She claimed that Wakefield never claimed vaccines caused autism and then contradicts herself by claiming once again that lots of shots cause lots of autism.

Rebutting these silly claims takes up time and diverts resources from more important matters. Which is the point. Going forward the response to tabloid medicine has to be proactive and anticipatory. As I noted in my American Spectator article: Wakefield wannabes now overrun scientific discourse, dominate medical journals , flood the blogs, intimidate public health officials. They shape public perception of medical innovation­’s risks and benefits and damage the public health.

The best defense is a good offense.  Read More & Comment...

Keynesian Drug Safety

01/12/2011 09:29 AM |

In 2010 the FDA’s Drug Safety and Risk Management Advisory Committee held 13 days of meetings encompassing discussion of 10 drugs and two drug classes. In 2009 the committee held six days of meetings regarding four drugs and one class.

 

Discuss.

 

“Meetings are indispensable when you don’t want to do anything.”

 

                        -- John Kenneth Galbraith

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Cheaper by the Dozen

01/11/2011 02:46 PM |

Representatives Anna G. Eshoo (D, CA), Jan Inslee (D,WA), and Joe Barton (R,TX) have sent a letter to the FDA, explaining the "legislative intent" of the data exclusivity provisions of the bill.

Their letter states that P.L.111-148 does not provide a market exclusivity period.  Instead, the bill provides 12 years of data exclusivity.  The differences between these two types of exclusivity are "significant and critical," because the intent of these legislators was to "prohibit[] the FDA from allowing another manufacturer to rely on the data of an innovator to support approval of another product."  The law was not intended to "prohibit or prevent another manufacturer from developing its own data to justify FDA approval of a similar of competitive product."  This interpretation would encourage biologic drug competitors (presumably using the innovator's FDA submission as a roadmap) to submit their own data in support of an independent biologic license application (BLA) pursuant to Sec. 351 of the Public Health Service Act.

The letter also emphasizes that the bill prohibits "evergreening" by innovators, specifically that "no product, under any circumstances, can be granted 'bonus' years of data exclusivity for mere improvements on a product."  New products, termed "next generation" by the letter's signatories, are not within the definition of evergreening -- such a new product (having "significant changes in safety, purity or potency") is considered a "new biologic [that] will receive its own 12-year period of data exclusivity" (emphasis in original).  However the letter positively asserts that while its authors "care deeply about patient access to biologics," they "also care about the advancement of science and our ability to treat the most complex diseases."  Thus, they warn that "[a]ny proposal to limit the definition of a 'new' product, and thus one which is entitled to its own period of data exclusivity has the potential to stifle innovation and negatively impact patient care," which they oppose.

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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.”

 

  Read More & Comment...

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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