Caste of Characters

• 09.16.2008

The House Energy & Commerce Committee needs to help fix the problem, not the blame.

Statements coming out of the committee like -- “The FDA has refused to take meaningful regulatory action despite the fact that, for the past three years, it possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices.” -- is not being fair to an agency that at the time under debate and yet today is under-funded and under-staffed.

But when the committee says -- “The FDA, for example, conducted preapproval inspections for only 17 percent of the Ranbaxy applications approved since January 2005. It also allowed Ranbaxy to perform the key bioequivalence studies for generic drug approvals in facilities owned by the firm and conducted by clinicians employed by the firm.” – they’re right.  The same rule that holds true for innovator companies must also applied to generic drug manufacturers – otherwise the public’s queasiness about the quality and character of generic drugs will continue.

But Representative John Dingell, who chairs the committee, goes to far when he says, “The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud. This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health.”

That’s not true.  It’s not fair.  And it’s not helpful.

Panic Over Plastics

• 09.16.2008

FDA Inks Penn

• 09.16.2008

Safety vs. Safe Use: Why Not Both?

• 09.15.2008

With all the focus on drug safety, what’s gotten lost in the shuffle is the issue of safe use.

According to an April 2007 Harris Poll, more than one-third of Americans surveyed decided not to take a prescribed medicine because of safety concerns about risks and more than a quarter chose not to fill a prescription at all over safety concern.

And, according to Gretchen S. Dieck, Ph.D., senior vice president, Safety and Risk Management for Pfizer, “… surveys of practicing physicians, health policy experts and the general public have revealed a lack of understanding of the fundamental safety science, processes and terminology.  This can contribute to misinformed decisions by patients about treatment options, which can lead to sub-optimal health outcomes.”

To that end, Pfizer Inc announced today the launch of a new interactive online educational resource,

http://www.pfizer.com/responsibility/medicine_safety/medicine_safety_education.jsp

It’s worth a look – and it’s a good conversation starter on the important issue of sharing responsibility when it comes to both the safety and safe use of medicines.

Insuring Profits

• 09.15.2008

Talk about putting profits before patients!

According to a Medical Society of the State of New survey, the vast majority of physicians practicing in New York say they feel pressure from insurance companies to prescribe certain medical treatments, sometimes at the expense of what is best for patients.

Of the over 1200 physicians surveyed this month, 90% said they changed the way they treat patients based on restrictions from an insurance company, and 92% said incentives and disincentives offered by insurance companies regarding treatment options "may not be in the best interest of patients."

87% of physicians said they sometimes feel pressure to prescribe a treatment based on cost. About 93% of physicians said insurance companies have required them to change prescriptions in the past.

To see how that plays out when you extrapolate private greed to bureaucratic need, click here.

The Comrade Commissars of Government Health Care

• 09.15.2008

Representative Henry Waxman (D-CA), America’s very own Oversighter-in-Chief, wants to require drug companies to submit reprints of journal articles that discuss off-label use to the FDA before said companies can provide them to physicians.

A modest proposal.

You know what would be even better – what about this – all medical journals have to submit their manuscripts to Mr. Waxman's office before they’re even published in the first place. After all, shouldn’t we address the problem in its most nascent stage?

(Yes, of course, after peer review.)

Better yet, maybe congressionally-appointed health care commissars should sit in on the peer review process of every medical publication? Why not? And, while we're at it, these new comrade commissars should also attend all pre-NDA agency meetings that discuss clinical trial designs.  Needless to say, a statutory voting seat (with veto authority!) on all advisory committies should be de rigueur.

Better still, perhaps PDUFA fees should cover the hiring of FDA political commissars who would have veto power over agency decisions?

These ideas are perfectly consistent with so many other congressional efforts at improving our health care system – just like “academic detailers” – health care commissars of another sort.

Welcome to the Comrade Commissars of Government Heath Care.

And caveat emptor.

Autism's False Prophets

• 09.15.2008

Gardasil Approved to Target More Cancers

Sept. 12, 2008 -- The FDA today announced that the vaccine Gardasil may be used to prevent some cancers of the vulva and vagina in girls and women ages 9-26.

Gardasil is already approved to help prevent a leading cause of cervical cancer in women of that same age range.

Gardasil targets four strains of the human papillomavirus (HPV) that cause most cases of cervical cancer. Two of those HPV strains can also cause some vulvar and vaginal cancers.

"There is now strong evidence showing that this vaccine can help prevent vulvar and vaginal cancers due to the same viruses for which it also helps protect against cervical cancer," Jesse L. Goodman, MD, MPH, director of the FDA's Center for Biologics Evaluation and Research, says in a news release.

"While vulvar and vaginal cancers are rare, the opportunity to help prevent them is potentially an important additional benefit from immunization against HPV," Goodman says.
http://children.webmd.com/vaccines/news/20080912/gardasil-approved-to-treat-more-cancers

Yeah, well to the media it's all just "hype". 

http://well.blogs.nytimes.com/2008/08/29/blaming-the-media-for-gardasil-hype/

One Good Pitts Deserves Another

• 09.12.2008

From Parklawn to Parking on the Lawn

• 09.12.2008

AP reports that Food and Drug Administration has recently hired more than 1,300 professional staffers in a move that “officials hope will help it better protect the public health amid rapid technological and scientific change.”

40% or so of the total positions are paid for via PDUFA fees; ergo the new hires will mainly be evaluating new drugs or medical devices and, in some cases, monitoring safety issues.

That’s great news.  But where are they all going to park? White Oak isn’t even finished yet and already it’s looking like the seating charts will have to be rearranged – particularly since CDER is getting 663 new staffers.

It's a good problem to have.

CFSAN is slotted to get 104 -- a 10% increase (a good start – but not enough). And ORA will grow by 245. Good news.

1,000 of the new hires have already started, with another 158 due to report later this month. An additional 160 have accepted offers. Of those on the job already, more than 850 are professionals, including chemists, biologists, pharmacologists, statisticians, medical officers, microbiologists and field inspectors.

Of the total 1,317 positions, 770 are new jobs and 547 are posts that were left vacant by people leaving the agency for other jobs or due to retirement.

But it’s not all rosy and it’s not as easy as reporting numbers.

The FDA hired nine cancer specialists, but another 20 rejected offers. "They could not make the money they would be making on the outside if they came into public service," said Kimberly Holden, the FDA’s senior manager directing the recruitment initiative. The agency could offer as much as $275,000 a year, she said, but oncologists can make $400,000 annually outside of government service.

All-in-all, it’s a good start. But it’s just the end of the beginning -- and just barely.

COI Coyness

• 09.11.2008

Here’s the first paragraph from the story in today’s Wall Street Journal on the continuing controversy swirling around academic research and pharmaceutical industry funding:

“WASHINGTON -- Some major universities are reviewing the way they handle funding from drug companies in the wake of criticism from Sen. Chuck Grassley, who is pressing the federal agency that controls government health-research money to get tougher on universities that don't disclose ties to the industry.”

It seems that some academic researchers are being either sloppy or stupid about disclosing research grants they receive from industry.

Giving these folks the benefit of the doubt may be the right thing to do (you know –like “innocent until proven guilty”) but it ain’t gonna happen in today’s shoot-first-and-ask-qustions-later environment – and it could very lead to individual researchers (and their institutions) losing NIH funding.

Here’s what Senator Grassley has to say about the matter:
 
"Starting today, the NIH could send a signal that business as usual is over … The simple threat of losing prestigious and sizable NIH grants would force accurate financial disclosure."

The Senator is right.  But the issue is quickly morphing beyond mere issues of filling out the required forms in at timely manner.

Consider the comments of Jerome Kassirer, the purer-than-pure (despite mega-millions in pharmaceutical advertising revenue), former editor of the New England Journal, "Universities have been treading on dangerous ground with their increasingly complex financial ties to industry.  They are worried that these things could ultimately affect their tax-free status."

Get the picture?

(Note to Jerry – you may be next.)

For more on the COI controversy, please attend our September 22nd conference, "Industry Support for Continuing Education of Health Care Professionals:  An Evidence-Based Evaluation."  There's no cost -- and here's the complete invitation.