NYT TO PHARMA--FUGGEDABOUDIT

Reform for Raising Prices


Following its earlier report about record-breaking increases on drug prices, the NYT today editorializes that Congress should abandon its "deal" with the drug industry, which traded industry support for healthcare reform for $80 B in price cuts, mainly to Medicare and Medicaid.

http://www.nytimes.com/2009/11/18/opinion/18wed3.html?emc=tnt&tntemail1=y

The industry claims are all those we've heard in every other context in which its interest has needed defending--the price of new drug development, meeting FDA's regulatory demands, etc., etc..

How real was this "deal" ever? Is it time to fuggedaboudit?

DEVICE LOBBY TO HOUSE--SUSTAIN PREEMPTION!

In a statement released by Advamed, the medical device folks appear to be endorsing significant provisions of health-care reform as passed by the U.S. House. But they go out of their way to warn about compromising FDA preemption, framed in the code language of allowing states to create a variety of standards.

See the statement here:

http://presszoom.com/story_150419.html

As others have observed, it appears that the language of "tort reform" and "preemption" will be at the core of arguments used by those who would like to "bend the curve" of reform toward their particular interests.

Swine flu Vaccine - I think I'll.... nope not for me....

About the swine flu pandemic..

I am sorry for people who get sick with the flu, I am deeply sorry for anyone who becomes gravely ill and for those families who have lost a loved one.

At this point in time though, I am in morning over the missed opportunity we had to yet once again, teach our fellow human beings how to stay healthy. We've been extolled to wash our hands, get the vaccine. It goes much deeper than that. We should be sending flyers to homes about eating healthy, getting out in the fresh air, exercising....No, instead we are opting for the "quick fix solution" - which really isn't a fix at all.

Follow the link to the article about how no flu vaccines have actually been proven to work. The well known Cochrane Institute has once again done their homework....

However, the flu vaccines have injected lots of money into the health care system, not to mention the big three companies scrambling to meet the demands as a result of all the fear mongering.

The response from the pharma industry this week is announcements of job cuts - thanks guys....

With CEO salary earnings at some Pharma's reaching some of the highest peaks every reported, well I wonder who is the real "swine" this flu season.

On average 41,400 people died each year in the United States between 1979 and 2001 from influenza. Interestingly 44,000 people die prematurely each year in the U.S. from not having access to health care, but I digress...

So, read the article in the link and give it some thought then cast your vote on the poll....

Are we really a society that uses/abuses the most vulnerable of our population and exploits them as a means to an end?

600 Suits Against Medtronic Dismissed

The (Preemption) Beat Goes On.....


FDA preemption in the arena of devices still rules in many cases. Here is a report about a judge in Minnesota who dismissed 600 cases against Medtronic over the Sprint Fidelis pacemaker.

http://massdevice.com/news/minnesota-judge-dismisses-600-sprint-fidelis-suits-against-medtronic

As most here will know, there is a bill in Congress now that would amend the Medical Device Act in order to allow tort liability for FDA-approved medical devices.

It is also well known that "irregularities" in FDA's device approval process increasingly make the news. As we report below, FDA itself publicized the story of a device the review of which was apparently influenced by the intervention of four Democratic congresspeople

THE NEW PHARMALITTLE

It's Not Good-bye. It's Onward!

Friends--Now that our beloved Ed Silverman and Pharmalot have returned, Pharmalittle will refine its focus.

Of course, we never imagined we could be more than a small stop-over for a few people. We are glad that we have been that and had some fun along the way. That will continue. But, beginning today, we will devote the lion's share of our reporting and commentary to the issues of accountability in the medical device and drug industries--both nationally and, for drugs, especially in Michigan. That means the issues of FDA preemption and civil liability, of course. But it also includes FDA regulation, Department of Justice actions, incentives for integrity, and examples of self-regulation that we view as terrific.

We expect to discuss these issues in detail--not only the law, but the politics, the spin, the tactics, the money, and more. We will connect the dots. And we will do so as advocates. No surprise there.

We are also what we have always been--a group of people representing both major political parties, healthcare professionals, academics, folks from industry (yes, that's true), patient advocates, and--above all--concerned citizens.

Our discussions will be linked directly to the combined organizations, Americans for Drug and Device Accountability / Justice in Michigan.

http://pharmaccountability.org/index.html

Whatever our own positions, we fervently hope that this space will serve as a forum for discussion and debate. In our view, the greatest travesty of all is that most people know nothing about these issues, or what they think they know is simply false.

For those who represent perspectives we oppose: If we think you knowingly lied, we will call you a liar, and we will say why. If we think you are arguing sincerely, you will maintain our respect, and we will tell you so. Count on both.

Let's hash it out. Let's tell the truth. Let's see what just and rational policy dictates.

Onward!

WARNING LABEL!!! Tort Reform Attached to Reform Bill

While Americans wait for a bill that will bring about health care reform, some in Congress are working to erode the rights of Americans.

Ted Kennedy’s good friend, Sen.Orrin Hatch, supports tort reform and wants to make it part of a health care bill.

"I think that this is an important step in the right direction and these numbers show that this problem deserves more than lip service from policy-makers." - CNN.com - Transcripts

A step in the right direction towards Hell, maybe. Perhaps the senator was referring to the number he got from the Insurance Industry. Here’s a letter sent to Hatch from Congress.Org.

Subject: Your $600,000 from the insurance industry.

To: Sen. Orrin Hatch

October 3, 2009

"I pledge allegiance to the insurance companies of America …"Following is a list of the money taken from the insurance lobby by United States senators (opensecrets.org). I stopped the list at $500,000. No-one gives this kind of money without expecting something in return, or takes it without the reasonable expectation of being asked to deliver.

(From the list):

Hatch, Orrin G (R-UT) $672,557

For the full list of payees see: - Congress.org - : Letter to Senator Orrin Hatch (R-Utah): Your $600,000 from the insurance industry.

Bend over America . You are about to get pricked by health care reform. Might we someday see warning labels on our medicine bottles:

“WARNING: The Attorney General has determined that if this medication is harmful to your health, you are S.O.L.”

DON'T CRY FOR US, ARGENTINA!

PhamaLittle Round the World

Looking at our visitors over the past month, we note one of our first from South America. Welcome, Argentina! We are readying our naked hang-gliding team (PharmaLittle in-joke) for the Olympics. That's a heads-up.

We also had visits from every U.S. state with the exception of the Dakotas, Wyoming, Montana, Idaho, Iowa, and Mississippi. Obviously, we have a buffalo problem, including the rare Buffalo du Sud.

Our readership appears down in central Europe--we were hot in Slovakia and Slovenia for a while--but western Europe is strong. And we've had visitors from Russia, India, Turkey, and Malaysia. Japan and Australia drop by often.

So the sun never sets on PharmaLittle. With the possible exception of an hour or two in the Azores...

WHAT GETS PEOPLE HOOKED ON DRUGS?

Why Are We Here?

As the curtain is about to rise on Pharmalot II, and before we start eating each other for breakfast, I started to think about what gets people so hooked on this topic in the first place.

Of course, there are those whose interest reflects their work in industry. But, unless they ended up in pharma entirely by accident, there remains the question of why they chose that way.

Likewise, those who end up on the regulatory side.

And there are those whose lives were saved, or radically improved, by drugs. Or who believe approval of a particular drug will have that impact for themselves and others.

And, conversely, there are those who have been injured by drugs--or close to those who have--who become involved as a result of that experience.

Still, I think there remains a large number of people, including members of the groups above, who find the topic intrinsically fascinating, almost addicting.

How come?

As I see it in my students, I believe one factor is that the topic is precisely on the crossroads of issues in the natural sciences, social sciences, and humanities. Or, more specifically, where medicine, politics, economics, ethics, and more all meet. No question there is a "moral drama" inherent in many pharma issues--the promise of such much good; the commission, at times, of very bad--it's a soap opera (or even a high opera) all its own.

Perhaps pills are, or have become, doctors in miniature. And they attract the same complex mix, and spectrum, of feelings--hope/trust/uncertainty/mistrust.

As I sometimes say to my students, "When a sociologist messes up, nobody gives a fig. But when pharma messes up....."

A different story.

HE'S BAAAACCCCCK!

Ed Has Returned

OK, we jumped the gun slightly on an earlier post. But this is even better--to let Ed be the one to announce his return.

Above all, we hope the whole lawn party comes back as well, and some new folks too. As relayed, it was the talk across perspectives--to the degree it could veer away from the nasty--that was so wonderful about Pharmalot.

As Ed has conveyed, the new Pharmalot will be smaller, in terms of posts, than what he created as a full-time gig. But I doubt that will mean it will be any less informative and useful.

Here on 'Lil, we are likely to focus on issues of greatest concern to us--device preemption, Michigan's full preemption law, pharma and reform, FDA, and interviews with a variety of peanuts and illicitly promoted drugs.

What the heck.

OFF-LABEL PROMOTION: WHEN PREEMPTORS THINK "SECOND-GUESSING" THE FDA IS A GREAT IDEA

On FDA Preemption and Off-Label Promotion

As many here will know, the most vociferous defenders of FDA preemption have also been the most vociferous critics of limiting off-label promotion. As replayed in a recent exchange on the Drug and Device Law blog, the argument is that a strong FDA is good (and should trump all civil liability), but not one that interferes with "constitutional right of private speech." So state courts and plaintiffs can't "second-guess" the FDA, but off-label promoters are free to do so.

Now, on one level, I'm not sure when speech becomes "private." I suppose the crowded theater is not such a place. How about off-label promotion to representatives of Medicare or the Army? Private or public? And what difference does it make, Constitutionally, if the off-label promotion is knowingly miseleading or outright false--as was alleged in the recent Pfizer cases?

These are real questions. For example, Holocaust denial is protected by the Constitution in the U.S., although not in other countries. So how about risk denial or benefit inflation, if engaged in by a company? Does it matter if the consequence of such misinformation may be, not "only" racist hatred, but prescribing that leads to deaths or injuries that would not have otherwise occurred?

Or is all of that a separate issue--if "private speech" can be proven to be associated with death or injury, one may suffer consequences--civil or criminal. Be that as it may, however, it is protected by the Constitution. Just as is one's right to risk civil or criminal prosecution--not for the "private" (if fraudulent) speech itself--but for its alleged consequences.


What do you all think?

AZ TO FDA--BITE ME!

Astra Asks for "More Teeth" from FDA

In an upcoming speech, AZ's CEO will ask for an FDA with "teeth," so it can do its regulatory job more efficiently. The Times of London has it here:

http://business.timesonline.co.uk/tol/business/industry_sectors/health/article6860949.ece#

Readers will remember last year's lurid emails in the WSJ from AZ employeess discussing studies they buried or camouflaged, particularly concerning Seroquel and its links with obesity/diabetes. They are in a post below that I can't find (someone will). So, I suppose, this request makes sense: "Stop me before I sleaze again."

Anyway, if the teeth don't cut it, the DOJ may have an alternative approach.

NYT ON "SHODDY" FDA APPROVALS

Editorial on Device case

Today's NYT carries an editorial on the device case discussed last week on Pharmalittle--the intervention by four Dem congressmen on behalf of a device, its getting fast-track appoval without appopriate review of either safety or efficacy (both of which had gotten thumbs-down by earlier FDA reviewers), and the pols receiving large campaign contributions from the manufacturer soon after. FDA will now do the review it should have done in the first place.

The editorial is here

http://www.nytimes.com/2009/10/03/opinion/03sat3.html?_r=1&emc=tnt&tntemail0=y

The NYT calls it "shoddy." A little understated in my view. A knee device, like this one, seems unlikely to cause avoidable death. But serious injury, which could lead, in turn, to death, does not seem out of the picture. So this is potentially negligent homicide on the part of the pols and FDA Commish Von Esch who was there at the time, and involved in the bogus approval.

If there are any FDA'ers out there, current or former, I wonder if they could estimate how often such approvals occur?

Should the facts so indicate, all in this case should be prosecuted. And not for "shoddiness."

Enlighten the people…

On September 22, 2009, the Huffington Post featured a timely article by Anthony Tarricone, President of the American Association for Justice. In his piece, Mr. Tarricone warns about the “bargain” for tort reform being played out in Congress:

“As part of a ‘grand bargain’ to create a bipartisan health care bill, some have said tort reform should be included.”

Although some in Congress are attempting to include tort reform into the health bill, that inclusion would not be an enhancement for the American people; rather, it would be a disaster for civil rights, health and safety.

As Mr. Tarricone points out and, most certainly, Congress is aware:

• "98,000 people dead every year from preventable medical errors, at a cost of $29 billion. (Institute of Medicine).
• To put this into perspective, 98,000 deaths is like two 737s crashing every day for a whole year.
• Countless more are seriously injured with astronomical costs.
• The Congressional Budget Office and Government Accountability Office have looked at tort reform multiple times, and said it will save practically no money.
• They also found no evidence of so-called 'defensive medicine,' finding that doctors run more tests because of the fee-for-service structure, or because of the benefits extra tests have on patient care.
• Additionally, a 2006 study from Harvard found that 97% of cases were meritorious, totally debunking the idea that frivolous lawsuits plague our courts.
• And while 46 states have enacted some kind of tort reform, health care costs have continued to skyrocket, while injured patients or their families often can't seek justice."
  
  So, why would a Congressional leader support tort reform, and why would they want it attached to the health bill? And, if it becomes so, will health reform end up sanctioning 98,000 deaths a year?
  
  For the welfare of us all, we need to know where our elected officials stand on this issue.
  
  Related: PharmaLittle: HOW HEALTH CARE REFORM SAVED FDA PREEMPTION,
  http://pharmalittle.blogspot.com/2009/09/how-health-care-reform-saved-fda.html
  
  

NEW JERSEY DEMOCRATS ON THE TAKE

FDA Cites Pressure from Congressman and Inappropriate Approval

Since this blog more often criticizes Republicans than Democrats, there is something admittedly gratifying about a story in which Democratic Congressman are described as corrupt as anyone else.

Equally interesting is that this conclusion was reached by the FDA itself, in a probe spearheaded by Joshua Sharfstein.

It is "ironic," I suppose, that people like Frank Pallone, who have been active against device preemption, would also be active in approving devices outside appropriate FDA review procedures.

So reports the NYT:

http://www.nytimes.com/2009/09/25/health/policy/25knee.html?_r=1&emc=tnt&tntemail0=y

Eat, Drink & Be Merry…

Consumer Watchdog reports that Congressional members who sit on the five key committees charged with healthcare reform have, this year, been invited to 130 health industry fundraisers:

“The fundraisers included donations ranging from a low $500 to attend a ‘Healthcare Industry Reception’ for Rep. Mike Ross (D-AR) in July, a $1,500 Mexican dinner at La Loma with Sen. Mike Crapo (R-ID), to a $5,000 “PAC Gold Host” contribution for a breakfast event benefiting Sen. Tom Coburn (R-OK).”

Belgium waffles have really become expensive! Although, probably free for senators.

Over the same period of time health industry Political Action Committees (PACs) and individuals donated $30.7 million to committee members.

“$30M in Industry Money Clouding Debate, Says Consumer Watchdog.”

While the uninvited American taxpayer waits to learn the details of healthcare reform, members of Congress are being wined and dined by lobbyists.

“Who can tell which hard decisions on health reform are being made over $1,000 high-balls shared by lobbyists and politicians while the public’s locked out of the room?” - Carmen Balber, Washington Director for Consumer Watchdog

Per Consumer Watchdog, Sen. Max Baucus’ plan was under consideration yesterday by his committee. In it, all Americans would be required to have health insurance; however, there would be no cap on what insurance companies could charge. Furthermore, no public option is offered. Under such a plan, middle-class families might be paying almost 20% of their yearly income on health care.

“A mandate for individuals to purchase private health insurance with no affordable coverage alternative is exactly what the health care lobby hoped for from health reform.” – Consumer Watchdog

Here is something to think about:

“Lobbying disclosure filings for the first quarter of 2009 reveal that five of Baucus’ former staffers currently work for a total of twenty-seven different organizations that are either in the health care or insurance sector or have a noted interest in the outcome. The organizations represented include some of the top lobbying organizations in the health sector: Pharmaceutical Manufacturers and Researchers of America (PhRMA), America’s Health Insurance Plans (AHIP), Amgen, and GE Health Care.” See: - http://blog.sunlightfoundation.com/2009/06/22/the-max-baucus-health-care-lobbyist-complex/

The Baucus’ plan doesn’t sound like a plan for America. However, it would probably work for Max.

Full story: http://www.consumerwatchdog.org/patients/articles/?storyId=29608

Data analysis of fundraisers, campaign contributions and health care lobbyists:
http://www.consumerwatchdog.org/resources/healthcarefundraisers.xls

HAT TIP TO OURSELVES....

Pharmalittle to be Honored at White House

OK, so we lied. It's all part of the same strategy. As the impressive badge on the left (suitable for framing) shows, this blog has been named one of the top 100 pharma blogs. Did anyone know there were that many pharma blogs?

Anyway, a lot of people out there will wonder how we accomplished this. It's simple. We followed basic marketing principles:

1. We promoted the blog for off-label uses. For example, it makes a great eye chart and may help slow the growth of cataracts.

2. We gave kickbacks to everyone on the internet. Really.

3. We buried studies 34, 57, and 105.

4. We changed the endpoints in study 35 and left out the last six months of data.

5. We delayed the appearance of generic Pharmalittle (liloxazorx) through a bunch of nuisance suits.

6. We intimidated people who read other blogs.

7. We hired Key Opinion Leaders like Anonymous to talk us up.

8. We funded studies showing all the dangers of other pharma blogs.

9. We convinced people that failure to read Pharmalittle will result in the end of innovation in the industry and the complete dissolution of life-saving medications.

10. We avoided being bought by Pfizer.

11. There is no evidence reading Pharmalittle leads to weight gain, morbid obesity, and diabetes. And anyone who thinks differently will never find Study 57 anyway.

12. We don't believe in morbid obesity. If you're going to be obese, at least be up-beat about it.

And stuff like that.

POST-LEVINE, FDA TO CHANGE PHENERGAN WARNINGS

Levine Appears Vindicated


The NY Times reports that the FDA will require stronger warnings about administering Phenergan via IV push:

http://www.nytimes.com/2009/09/19/health/19drug.html?_r=1

Needless to say, this is a fascinating sequel to the Wyeth v. Levine case. The new warnings will apparently be what Diana Levine argued should have been on the label in the first place. The FDA reports the change is based on the number of cases it has received in which IV push administration led to gangrene and amputation--precisely what happened to Levine.

There is no suggestion that the label change was based on "new information" per se, but rather a few additional cases along with rethinking the older warning. The Vermont juries that twice upheld Levine agreed with her argument that Wyeth knew enough at the time of her injury, and had the authority, to make precisely such a change on its own (under the "Changes Being Effected" rules). While FDA would have had to agree, there are virtually no instances when it has not under such circumstances.

In an interesting closing, Gardiner Harris writes that this change may lend support to FDA's older position--pre-Bush administration--that civil liability and FDA regulation are overlapping, generally complementary, systems of consumer protection.

SELLING VYTORIN THROUGH $60 M OF CME

Arteries Clogged by Moolah


Cardiobrief, via Dow Jones newswire, reports on the extraordinary sums MSP provided to CME related to Vytorin. One single grant amount to $6 M.

See: http://cardiobrief.org/2009/09/16/senate-investigation-uncovers-huge-expenditures-for-vytorin-cme/

The information emerged through a Senate investigation.

I'm glad that pharma is supporting health-care reform.

HOW HEALTH CARE REFORM SAVED FDA PREEMPTION

Call this a speculation. That's what it is.

As we have heard, "tort reform" has now been included in the Obama administration's package of initiatives. As the Prez indicated in his speech last week, he is in favor of restricting medical malpractice suits in certain locales--yet unspecified--to assess the impact of those limitations. This, of course, was to win a few Republicans. So far, he has won curses, crazies, and a few claps for this particular concept. Claps aren't votes.

Med mal is not device preemption. But the "tort reform" agenda as pushed by Bush/Rove kept that distinction as fuzzy as possible. While the fight was for the industry's agenda spearheaded by Dan Troy, the "face" of tort reform was always doctors and nurses. They look a lot better in newspapers.

Undoubtedly, Congressional Republicans will also mush med mal issues with FDA preemption, which still fully stands in the device arena. And how much stomach will Congress have for amending the Medical Device Act in a way that could reverse Riegel, with or without the O administration's early statements on agency preemption?

I'd say....very, very little.

IS THAT REALLY US?

From today's NYT, an op ed by Kristoff

September 13, 2009
Op-Ed Columnist
The Body Count at Home
By NICHOLAS D. KRISTOF
In the debate over health care, here’s an inequity to ponder: Nikki White would have been far better off if only she had been a convicted bank robber.
Nikki was a slim and athletic college graduate who had health insurance, had worked in health care and knew the system. But she had systemic lupus erythematosus, a chronic inflammatory disease that was diagnosed when she was 21 and gradually left her too sick to work. And once she lost her job, she lost her health insurance.
In any other rich country, Nikki probably would have been fine, notes T. R. Reid in his important and powerful new book, “The Healing of America.” Some 80 percent of lupus patients in the United States live a normal life span. Under a doctor’s care, lupus should be manageable. Indeed, if Nikki had been a felon, the problem could have been averted, because courts have ruled that prisoners are entitled to medical care.
As Mr. Reid recounts, Nikki tried everything to get medical care, but no insurance company would accept someone with her pre-existing condition. She spent months painfully writing letters to anyone she thought might be able to help. She fought tenaciously for her life.
Finally, Nikki collapsed at her home in Tennessee and was rushed to a hospital emergency room, which was then required to treat her without payment until her condition stabilized. Since money was no longer an issue, the hospital performed 25 emergency surgeries on Nikki, and she spent six months in critical care.
“When Nikki showed up at the emergency room, she received the best of care, and the hospital spent hundreds of thousands of dollars on her,” her step-father, Tony Deal, told me. “But that’s not when she needed the care.”
By then it was too late. In 2006, Nikki White died at age 32. “Nikki didn’t die from lupus,” her doctor, Amylyn Crawford, told Mr. Reid. “Nikki died from complications of the failing American health care system.”
“She fell through the cracks,” Nikki’s mother, Gail Deal, told me grimly. “When you bury a child, it’s the worst thing in the world. You never recover.”
We now have a chance to reform this cruel and capricious system. If we let that chance slip away, there will be another Nikki dying every half-hour.
That’s how often someone dies in America because of a lack of insurance, according to a study by a branch of the National Academy of Sciences. Over a year, that amounts to 18,000 American deaths.
After Al Qaeda killed nearly 3,000 Americans, eight years ago on Friday, we went to war and spent hundreds of billions of dollars ensuring that this would not happen again. Yet every two months, that many people die because of our failure to provide universal insurance — and yet many members of Congress want us to do nothing?
Mr. Reid’s book is a rich tour of health care around the world. Because he has a bum shoulder, he asked doctors in many countries to examine it and make recommendations. His American orthopedist recommended a titanium shoulder replacement that would cost tens of thousands of dollars and might or might not help. Specialists in other countries warned that a sore shoulder didn’t justify the risks of such major surgery, although some said it would be available free if Mr. Reid insisted. Instead, they offered physical therapy, acupuncture and other cheap and noninvasive alternatives, some of which worked pretty well.
That’s a window into the flaws in our health care system: we offer titanium shoulder replacements for those who don’t really need them, but we let 32-year-old women die if they lose their health insurance. No wonder we spend so much on medical care, and yet have some health care statistics that are worse than Slovenia’s.
My suggestion for anyone in Nikki’s situation: commit a crime and get locked up. In Washington State, a 20-year-old inmate named Melissa Matthews chose to turn down parole and stay in prison because that was the only way she could get treatment for her cervical cancer. “If I’m out, I’m going to die from this cancer,” she told a television station.
Mr. and Mrs. Deal say they are speaking out because Nikki wouldn’t want anyone to endure what she did. “Nikki was a college-educated, middle-class woman, and if it could happen to her, it can happen to anyone,” Mr. Deal said. “This should not be happening in our country.”
Struggling to get out the words, Mrs. Deal added: “The loss of a child is the greatest hurt anyone will ever suffer. Because of the circumstances she endured with the health care system, I lost my daughter.”
Complex arguments are being batted around in this health care debate, but the central issue isn’t technical but moral. The first question is simply this: Do we wish to be the only rich nation in the world that lets a 32-year-old woman die because she can’t get health insurance? Is that really us?

PhRMA, AMA, AND REFORM

CME for the Folks

The NYT has an interesting piece on the strategies PhRMA, AMA, and others are using to intertwine support of some version of health-care reform and controlling the outcome.

None of this is surprising, but it provides a few more particulars.

http://www.nytimes.com/2009/09/12/health/policy/12lobby.html?emc=tnt&tntemail1=y

GHOSTEST WITH THE MOSTEST

Spooks to Form own Journal--Name it!

Must be a slow news day. the NYT published yet another piece about how many ghosts write major journal articles, the relevant editors express relevant surprise, and life goes on (even for the ghosts).

http://www.nytimes.com/2009/09/11/business/11ghost.html?_r=1&emc=tnt&tntemail1=y


What you may not know is that the Ghosts are preparing to form their own peer-reviewed medical journal with the hope of competing in the majors. "We're tired of being booed by the media," said one translucent source, until he disappeared. "We're going to float out on our own."

The name of the new journal remains uncertain. JAGA, the obvious source, may not be it. A number of Ghosts are also members of the American Science Fiction Writers Association, and so linking up with that organization, perhaps not too publicly, is also a possibility. _Spiritual Medicine_ was rejected as too hippy dippy.

There are rumors the look of the new journal may also be different. Instead of the usual covers, there may simply be light white cloth, with a pair of eyes cut out. "But we don't want to be confused with the Klan," said one member. "No problem," said another. "The Klan does it for free."

We'll see where all this flits.

WAS THE PFIZER SETTLEMENT A GIFT?

You Be the Feds....

Vera Shavner has sent out an interesting post on the recent Pfizer/DOJ settlement that can be accessed at:

http://www.ahrp.org/cms/content/view/634/9/

In essence, Vera suggests that Pfizer got off the hook in the recent settlement because they were not banned from future federal contracts, at least for a period of time, which they were threatened with in the "Corporate Integrity Agreement" regarding Neurontin.

Personally, I disagree with Vera's analysis. I will post my response to her. But what do you all think?

OUT TO LUNTZ

The Spinmeister

In a thread below, Diane makes the extremely important point that the repeated arguments against healthcare reform have been scripted for some time. Frank Luntz, who has made a career as a propagandist, has indeed been central in writing that script.

It is also relevant that some of Luntz's largest clients are the major preemptors--The US Chamber of Commerce, the National Association of Manufacturers (NAM), and the Business Roundtable. NAM has been headed for several years by John Engler, the former Michigan Governor who put our blanket shield law in place.

Re: healthcare propaganda, it is noted:

"Here are some suggested arguments for Republicans that Luntz calls “clear winners”:

—“It could lead to the government setting standards of care, instead of doctors who really know what’s best.”

—“It could lead to the government rationing care, making people stand in line and denying treatment like they do in other countries with national healthcare.”

-“President Obama wants to put the Washington bureaucrats in charge of healthcare. I want to put the medical professionals in charge, and I want patients as an equal partner.”

Read more: http://www.politico.com/news/stories/0509/22155.html#ixzz0QBro3B2y

The Eyes of Texas

A Reuters’ story tells about John Kopchinski, a Gulf War veteran from Texas who later became a disgruntled sales representative for Pfizer. John found Pfizer’s sales tactics hard to swallow. As he explains it:

"In the Army I was expected to protect people at all costs....At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives.”

Unable to live down to Pfizer’s ethics, he blew the whistle on ‘em.

Click link for full story.

REPUBLICAN LYING

Michigan GOP Spearheads Deceit

OK, this is obviously not going to be a non-partisan post (but then how many such have there ever been here?). If someone is able and willing to argue the other side, I would be both grateful and welcoming. Genuinely. It is terrifying to see one of our major parties devolve further into the Big Lies.

I am not naive. I have spent enough time in state politics to know that the truth does not count for much in political debate. It's talking points v. talking points. Sustained and fair-minded exploration of an issue is rare indeed.

But this level of fear-mongering and deceit strikes me as grotesque as anything I've seen. In a democracy, I do not hesitate to call attempting to willfully deceive the public a kind of treason.

Here is what I just received from the Chair of Michigan's Republican party.

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"Dear Friends:

Some Democrats in Congress, including members from Michigan, are trying to pass laws to cancel your private health insurance and put your family on Medicare.

This is not a scare tactic; it’s the truth. ...

“The Democrats have presented very false choices to the American people..,” said Congressman Mike Rogers. “I believe we can do better. The American people deserve real bipartisan health care reform that will lower costs and keep the federal government out of personal health care decisions.”

Click here to hear the other damaging and life threatening options Obama and Pelosi are offering. You can donate today to send a message back to Congressman Rogers and the other members of our Congressional Delegation and tell them what you think!

In the past six weeks you have helped us kill ObamaCare and protect the health of American families. But the liberal elites who run the Democrat Party are back at it again. They’ve retooled their approach and are strengthening their voice in memory of the late Senator Ted Kennedy. They are determined.

The threat to your families health care is not just in Washington, D.C.
Michigan’s Lieutenant Governor John Cherry recently said in a townhall meeting state government should provide a system of health care for all. Cherry also encouraged a group of leftwing activists earlier this year to hit the streets promoting his vision of a government take-over of family health care. [Cherry is the likely Dem candidate for Governor.]

Pfizer coughs up $2.3 billion in marketing fraud fines

This case has been billed as the biggest case of fraud against medicare and medicaid and primarily involves the now discontinued Bextra as well as Zyvox, Geodon and Lyrica.

Interestingly the article states:"Marketing fraud cases against pharmaceutical companies have become almost routine, with almost every major drug maker having been accused of giving kickbacks to doctors or shortchanging the Medicaid program on prices. Prosecutors said that they had become so alarmed by the growing criminality in the industry that they had begun increasing fines into the billions of dollars and would soon start charging doctors individually as well."

I hope they put the billion dollars in fines received back into the health care plans.....

Speaking of cutting costs....

Forest Pharmaceuticals Lexapro Marketing Plan, 2004 is now floating around the senate. In it are details on how Forest Pharmaceutical took a drug called Celexa licensed from Lundbeck, tweeked it, then sold it at a higher cost and made $2.3 billion dollars in sales. The marketing plan called for positioning Lexapro as superior to Celexa even though they were virtually the same drug. At the time, the FDA did not require them to prove this difference statistically.

It seems that Forest Pharmaceuticals have been very generous with putting money in Doctors pockets and food in their mouths. The article mentions that it is illegal to pay doctors to prescribe drugs, but not illegal to pay them to educate their colleagues about drugs. The article highlight the plan's strategy to put more money in the doctors pocket. From the article: “Rep Promotional Programs,” the document said the company planned to spend $34.7 million to pay 2,000 psychiatrists and primary care doctors to deliver 15,000 marketing lectures to their peers in one year.“These meetings may be large-scale dinner programs with a slide presentation, small roundtable discussions or one-on-one advocate lunches,” the document states.

Seems to me that this is one loop hole that should be shut, industry sponsored CME. Imagine all the money that could be saved. In this case $34.7 million dollars.....

How to reduce Unecessary Health Care costs...

Dr Lundberg of the Lundberg Institute has come up with seven ways to reduce health care costs - right now.

He is calling for an alliance between patients and their physicians. This seems most appropriate. Dr's seem very quick to prescribe without guiding patients with the information they need to make lifestyle changes were possible. We've had the discussion before here, but it does seem now that the tracking being done by companies such as IMS seem to have launched Dr's into some sort of competition, much like the monthly and annual sales numbers reports do inside Pharma, to be a top prescriber and earn "frequent flier points"

So, does the good doctor make sense? What are the chances of these changes happening?

Interesting no?

NPR LOOKS AT MYLAN

Appalachian Sting

West Virgina Public Radio presented an interesting piece that updates that Mylan story. As reported here, Mylan has filed suit against the Pittsburgh Post-Gazette and the two reporters who wrote the original story re: Mylan's internal report about workers overriding computer warnings. The FDA has since reviewed the issue and declared appropriate remediation was taken by the company.

The suit against the reporters, and the newspaper, focuses on how they obtained, and used, the internal report.

In the meantime, the Post-Gazette is the same newspaper that broke the story of the bogus MBA obtained by Mylan's CEO. That former CEO was promoted to President of the company a month ago. A feud in the hollows?

In any event, there remain a number of interesting features of the story, including:

1. The reality of internal regulation, which is obviously a good thing.

2. Whether Mylan ought to have at least notified the FDA of its own policing, what it found, and what it did?

3. Whether such events are "newsworthy" if material for their reporting is appropriately obtained. It would seem that the version of the story we now have--Mylan's successfully halting what might have been an enormously serious problem--would only be good for the company's reputation. But the opportunity to bring it out was never taken.

4. Is it possible that a habit of secrecy, certainly legitimate in many instances, also works to the industry's disfavor in others?


http://www.wvpubcast.org/newsarticle.aspx?id=10964

TED IS GONE

Any comments, memories, reflections are welcome.

WAXMAN TAKING ON THE $80 BILLION "DEAL"

The Waxman Cometh


The New York Times reports today on Henry Waxman's plan to challenge the apparent "deal" between pharma and the administration in which pharma would give up $80 B in exchange for DTC'ing in favor of healthcare reform, not having to negotiate Medicare pricing further, and supporting some version of reform in general.

The article includes an interesting array of responses from pols, analysts, conservative think tankers, industry folks, et. al. As already noted here, Billy Tauzin says a Waxman-like move would be a "deal breaker." I have personally speculated that such a result would not be entirely unwelcome by the industry at this juncture.

http://www.nytimes.com/2009/08/26/health/policy/26dual.html?_r=1&emc=tnt&tntemail1=y

OFF-LABEL PALOOZA

What, Me Worry?

A fascinating study recently showed that a substantial number of docs have little or no idea what applications of drugs have or have not been approved by FDA.

One can imagine multiple reasons--from indifference to ignorance to the success of borderline-legal promotion to industry-sponsored CME, etc.. And, of course, off-label rx'ing has never been unusual. But the degree of pure lack of knowledge adds an interesting angle.

Thanks to Fierce Pharma for the tip:

http://www.fiercebiotech.com/press-releases/physicians-lack-knowledge-label-drug-use-and-fda-approval-status

Death Squad

I wasn’t sure what a “Death Panel” was, so I did some research. MedPageToday had a great article by Dr. Rob. He tried to find some at Home Depot, but they didn’t have any available. See: MedPage Today Blogs: Medical News plus CME from MedPage Today. Sarah Palin said a Death Panel is a group of government bureaucrats who would decide if the sick, old, disabled, and unproductive would be granted life or be sentenced to death. Scary thought. I mean, I was picturing these bad guys in military uniforms smoking cigarettes and blowing smoke rings. But, somewhere, like a being rescued out of a nightmare, I heard the phrase “Give me your tired, your poor, your huddled masses yearning to breathe free ...” And I remembered, “We live in America, not Hitler’s Germany or Stalin’s Russia.” And I thought, “Maybe Sarah’s been gazing at Russia too much.”

But, then I heard something today, and now I know what the Death Panel is. It is the gang of activists who would kill health reform, who have worked the crowds into frenzy and who managed to scare America into not getting the care they need and deserve.

SUIT/COUNTERSUIT RE: MYLAN?

You Be the Judge

AP reports that Mylan is suing the Pittsburgh Post-Gazette in response to the story they ran about the drugmaker's Morgantown, WV, plant. The focus of the suit appears to the the paper's use of "propietary" documents, which Mylan wants returned, along with damages awarded.

Here is Mylan's own release about the suit:

http://mylan.mediaroom.com/index.php?s=43&item=449

In the meantime, a BNET summary suggests that what the paper reported was essentially the same as what FDA found, although with a more ominous ring. That story can be found at:

http://industry.bnet.com/pharma/10003720/did-mylans-ceo-libel-pittsburgh-reporters-who-triggered-fda-probe/

You be the judge.

MIXED MESSAGES ON GARDASIL

JAMA, FDA, CDC Speak in Many Voices

The Gardasil vaccine has been mired in controversy pretty since its introduction three years ago. Merck lobbied very hard to make the vaccine mandatory in many states, and very nearly succeeded in a number of them. Were it not for the arm-twisting/pocket-lining suggested by Merck's tactics, and the Vioxx legacy, the company would almost certainly have succeeded.

This week, we have heard a range of messages about the vaccine. JAMA reported on overall safety to date. The summary conclusion was that even the most serious events following administration of the vaccine--including about 30 cases of ALS--could not be causally linked to the vaccine. That said, a JAMA editorial raised the question of whether even this degree of risk was outweighed by the benefits of the vaccine. See

http://jama.ama-assn.org/cgi/content/full/302/7/795

In the meantime, the same JAMA article chastised Merck for promotional tactics (same old, same old) particularly through various medical societies. See Fierce Pharma's summary at:

http://www.fiercepharma.com/story/jama-gardasil-safe-promos-questionable/2009-08-19

In the wake of all of this, both the FDA and CDC have pronounced the vaccine safe for use based on current data available. But essentially no one is pushing anymore for mandatory vaccination, as was the case two years ago.

Ford Kicks Reps Out of the Driver’s Seat

Dr. Kathleen Yaremchuk of Michigan’s Henry Ford Health System, “shook up the relationship with sales representatives when she helped implement a program requiring certification of pharmaceutical sales reps that also “banned gifts, free drug samples and free food from the system's seven hospitals and 27 medical centers.”

The Henry Ford Health System is one of the first organizations to have implemented such a program.

Dr. Yaremchuk calls it “our influence-free policy.” Its objectives are, “to increase medical professionalism, to improve patient safety, to free up physician time and to reduce prescription costs.”

“At lunch time we would have all kinds of vendors lining up to bring food in for physicians and staff,” Yaremchuk said. “You would have patients waiting and someone from a pharmaceutical company would get ushered into the back with the food. It was a clear attempt to influence people who were writing prescriptions.”

Today, reps meeting with Henry Ford Health System doctors must have had completed Ford’s certification program. Certification classes include, “privacy policies, health safety procedures and confidentiality issues.” Additionally, when visiting a surgical department reps are required to wear black scrubs rather than the green worn by medical staff.

Although some physicians and staff miss the freebies, small vendors feel the policy offers a level playing field:

“Some were positive because it leveled the playing field for the smaller companies that didn't have a big budget for pizza and inviting people out to dinner.”

The Henry Ford Health System has benefited from their policy. The company estimates a savings of $10 million a year due to its reduced use of brand name drugs and increased use of generics. Additionally, doctors are not interrupted by sales reps. Under the new policy, certified representatives must make appointments via an Internet registration system, the request has to be made at least five days in advance, and appointments are limited to 15 minutes. A “do not call” list has also been instituted.

Dr. Yaremchuk points out:

"At 15 minutes for each appointment, the policy has saved the health system lots of work time: eight full-time equivalents of physician time per year.”

*****

It appears that the Henry Ford Health System policy would help cut the cost of health care nation-wide, while curtailing influence peddling. What are your thoughts?

For the full story see: http://www.crainsdetroit.com/article/20090809/AWARDS/308099992/1166, 8/10/09

Bill and Melinda Gates Foundation sells off most of their Pharmaceutical Holdings

Bill and Melinda Gates Foundation sells off most of their Pharmaceutical Holdings Close to 35 million dollars worth of holdings including J&J, Wyeth, Eli Lilly, Merck. As well some biothech holdings have been sold off.

Notably, the foundation has held onto 3 million-share stake in Seattle Genetics Inc.

The foundation did not answer calls in an effort to determine the story behind the story.

The Bill and Melinda Gates foundation is the world's largest private philanthropy fund, and is dedicated to finding cures for AIDS and vaccinations....

However, news report this morning say, Buffet just bought them. Sell high - buy low?

Me thinks this is a statement, anyone care to guess?

J & J Whistleblower case for Procrit/Eprex allowed to go forward

From the Associated Press:

A multibillion dollar medicare fraud case has been revived. Two former reps from J&J alleged kickbacks were paid to oncologists and other doctors in an effort to boost sales of Procrit/Eprex. These drugs are used to stimulate red blood cell growth and are often administered to patients who have cancer, AIDS or are undergoing kidney dialysis.

A couple of interesting facts about the case are that the federal government has put restrictions on which patients can access the drug due to the potential for harm to patients, including allowing cancer to progress. This case involves inducing doctors to over prescribe, in some cases by one third, the drugs to patients in order to improve sales. It is also noted that this wasn't an exception, this is actually how the drug was marketed.

The drug was delivered in the doctors office at a discount, but then medicare was charged the full amount.

It is J&J's third leading drug with sales of up to 2.5 billion dollars, annually.

J&J's competition is Amgen with their drug Aranesp.

Hmm, Amgen, who recently gave 5 million dollars to Senator Edward Kennedy for his Institute, in exchange for Kennedy to convince congress to increase patent protection laws, which delays the approval of generics.... Funny how Kennedy who has worked all his life to get health care to the people, can be made to forget is life's passion and principles for 5 million dollars - but I digress....

Patients health were knowingly jeopardized by having doctors over prescribe the drug. What this case must do is bring to light any oncologist who participated in this plan. Presumably it was quite effective. in 2006 J&J's sales of Procrit were 3.6 billion dollars.....

MYLAN UPDATE

End of the Story?

Yesterday, Mylan released a statement saying that the FDA had found its Morgantown plant "in full compliance." Immediately, its share price went up about 5%. A brief sumary can be found here:

http://www.marketwatch.com/story/mylan-fda-clears-w-va-plant-2009-08-13

I have found no report to this effect from FDA itself. Such regulatory actions are not always easy to access, but it may be worth keeping in mind that the last time the company said the investigation was complete the FDA directly contradicted it.

In the meantime, being "in full compliance" now does not answer the question of the compliance status some months ago, and during the two years production warnings were allegedly overridden. Nor does it answer whether, and how much, defective meds may have gotten into circulation.

Since this story potentially impacts so many people, we will continue to follow it.

PhRMA CHIEF BILLY TAUZIN PROMISES $80 BILLION IN PROTECTION MONEY

The Wall Street Journal, in its opinion article - Billy and the Beanstalk reports that the PhRMA president Billy Tauzin -

"...ostentatiously blabbed to the media that his industry's deal to help fund Obama Care with $80 billion in prescription-drug discounts was really protection money. In particular, he bragged that he had secured promises from the White House that President Obama would fend off Congressional Democrats who want to "negotiate" drug prices, which in practice means price controls."

The article claims that these mutual "promises" may be somewhat hollow from both party's perspective. None the less it seems like a rather slimy statement to make at a time the pharmaceutical industry is looking for as much traction as possible for their political and business concerns.





You may remember that the July 15/08 Wall Street Journal Health Blog - Note to Pharma: ‘Your House Is On Fire, and You’re Still Smoking in Bed’ noted Mr. Tauzin's sermon on pharmaceutical morality. At the time he admonished the industry that their reputation was going up in smoke and -

“It’s an accumulation of things some companies did over the years, now it’s death by a thousand cuts.” He told drugmakers, “We gotta stop the bleeding.”

Maybe Billy needs to put the razor blade down now.

FDA Chief Janet Woodcock under investigation of COI

The Wall Street Journal reports that Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research is being investigated by the inspector general. The ethics complaint was filed by Amphastar Pharmaceuticals and comes to light during their six year quest for approval of a generic form of Lovenox, a multi million dollar blood thinner. They are saying that their competitor has “special access” to Dr. Woodcock, and that Dr. Woodcock even co-authored a paper with scientists from the competition, Momenta Pharmaceuticals Inc.

They are asking that she rescue herself from the matter.

This surrounds the tainted Heparin incident. Dr. Woodcock co-authored the paper that addressed the sources of the Chinese tainted Heparin and won kudos’ for Momenta. Interestingly, although the FDA didn’t find any contamination in the Amphastar version, Amphastar did find out that the Chinese had misled them as to the origins of the raw material used to produce it.

Momenta is teaming up with Novartis to market the drug. Novartis has it’s own generic company, Sandoz.

It seems to me, that if anyone were being completely ethically fair, Dr. Woodcock would have also included the scientist from Amphastar in the paper. Anyone who makes Heparin should have been brought into the “fold” precisely to assure everyone that all measures, I mean ALL measures to ensure the general public safety were being addressed. This has to be extended to generic drugs as much as it is for brand name drugs. What’s fair, is fair....

Mr. Epstein and FDA Preemption

Mr. Epstein speaks out in Forbes against Medical Device Preemption AND repeal of Drug Preemption. Mr. Epstein is one of the leading proponents of FDA Preemption.

It is time to examine the arguments of this fine lawyer and see if his words hold water.

Please take a look at the link and let us know what you think.

PFIZER DENIES USE OF INTIMIDATION

Accusations of Witness Intimidation in the Neurontin Trial

According to the American Laywer (law.com), Pfizer has been accused of using a private detectice and former CIA agent to intimidate Dr. David Franklin, well known as the whistleblower who initiated the Neurontin qui tam suit that, for many years, was the largest criminal and civil bust for off-label promotion (until Pfizer's marketing of Bextra and Lilly's of Zyprexa broke the Neurontin record).

See the story at:

http://www.law.com/jsp/article.jsp?id=1202432898903

Once again, this is the sort of behavior, if it occurred, which is entirely outside the scope of FDA jurisdiction but relevant in civil suits. And thus another reason why even a utopian FDA would not cover delinquencies covered by civil liability, and thus why FDA preemption remains a bankrupt doctrine.

DIABETES CHARITABLE GROUP DUMPS MEDTRONIC

IPump.Org, Inc. Will Refuse Diabetic Supplies Made by Medtronic

In what could become an unprecedented kind of initiative, IPump, Inc. has issued a statement that it will no longer accept donated products manufactured by Medtronic.

IPump is a 501(c)3 organization founded to get needed supplies to diabetic children in families that cannot otherwise afford that care. It is no small thing, therefore, for such an organization to close the door on a corporate donor.

IPump's statement on the matter can be accessed at:

http://www.ipump.org/blog/2009/08/08/why-we-are-no-longer-accepting-medtronic-insulin-pumps-and-pump-supplies/

There is discussion both of recurrently failing Medtronic devices, cover-ups, and Medtronic's role in the the fight for FDA preemption in the arena of medical devices.

The statement begins:

"Legal and Ethical Concerns Over Medtronic’s Business Practices

Medtronic has a court-documented track record of failing to properly notify its customers in a timely fashion of known product defects. Product failure has resulted in deaths, hospitalizations, and both individual and class action lawsuits against the company. Their inexcusable behavior has even prompted new proposed legislation because legal rights for patients who died or were injured by Medtronic products were substantially limited when it came to suing for tort damages."

IPump further describes Medtronic collecting used and returned devices and "donating" them to IPump, so that the organization has become (their phrase) a "medical device dumpster." It is also a tax write-off for individual donors of used devices and, until now, good PR for the company.

Quite extraordinary development, I think.

The Argument of Preemption In Practice

Wisconsin Court Finds Preemption Argument to be Invalid in Paxil Case

As reported in ExpertClick on August 7 2009 - "A Wisconsin federal judge has denied GlaxoSmithKline's claim of immunity from liability for a Paxil-induced injury case, allowing the plaintiffs product liability case to move forward. "

For months arguments for and against FDA Preemption have been bandied about both here and elsewhere on the internet. Countless hours of sometimes heated discussion have passed as we speculate on preemption’s use and its affect in the real world.

In the attached article we can see the real world attempted application of FDA Preemption in a court of law. Its use as a blunt force instrument to drive plaintiffs out of the court room has failed in this case.

The case is also significant because it involves the Paxil – Suicide allegation. It will be interesting given what we already know about GlaxoSmithKline's management failures with Paxil. The court will now be able to take a deep dive into the situation.

Note that the court held, among other things -

• "Federal law does not prohibit drug manufacturers from updating their labels to warn of known risks when the FDA-approved labeling did not include the updated language. Instead, a drug manufacturer has a duty to advise consumers of risks because it 'bears responsibility for the content of its label at all times.”

• "State tort claims are harmonious with Congress' regulatory goals and do not compel application of preemption"
• ". . . the fact that the FDA approved prior Paxil labeling without an enhanced warning does not mean that the agency would oppose a request by GSK to include such a warning"
• "GSK's 'overwarning' argument also assumes that the subject drug label warns of a non-existent risk," however, the Court stated that it "refuse[s] to find that Paxil does not increase suicidality as a matter of law"
• "State law litigation provides an additional oversight on drug labeling and helps flesh out which warnings are 'substantiated' and necessary for the protection of consumers"

FDA GOING ACTIVIST

Hamburg Outlines New Approach--Law Enforcement

The below, from todays WashPost, will be welcome news to most people here.

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FDA Poised for More Aggressive Approach

By Lyndsey LaytonWashington Post Staff WriterThursday, August 6, 2009 4:05 PM

Margaret A. Hamburg, commissioner of the Food and Drug Administration, said Thursday that her agency will take a faster, more aggressive approach to enforcing regulations and laws.

"The FDA must be vigilant, the FDA must be strategic, the FDA must be quick and the FDA must be visible," Hamburg told the Food and Drug Law Institute in a noontime address.
Hamburg said she was making changes to FDA's internal processes to streamline and speed up the way it enforces regulations governing the safety of food, drugs and medical devices.

"In some cases, serious violations have gone unaddressed for far too long," Hamburg said. "These include violations involving product quality, adulteration, and misbranding; false, misleading, or otherwise unlawful labeling; and misleading advertising."

Hamburg, who has been on the job for eight weeks, said the FDA has often been hampered by lengthy internal debates and prolonged negotiations with violators, she said.

"Frankly, I can see in some past responses, there's a lot of back and forth, a lot of stall and delay, [the attitude of] 'let's wait and see what the company does,' " Hamburg said. "We need to be as clear as we possibly can about our expectations and standards, and when there are ongoing problems or when a problem emerges that has as serious impact on health, then we have to aggressively act."

For example, the FDA will no longer issue multiple warning letters to violators before taking enforcement action, Hamburg said. And if there is a "significant" threat to public health, the FDA might act before it even sends a formal warning letter, she said.

Hamburg said she thinks tough enforcement will act as a deterrent to companies who might otherwise violate the law. "Ultimately, the FDA's success should be measured not by the number of warning letters or injunctions or seizures but by our impact on the health and welfare of the public. Enforcement of the law is not simply an end in itself -- enforcement is critical to the agency's public health mission."

Cigna Executive becomes "Whistleblower"

Think about this:

Government agencies and universities research diseases and come up with innovative medicines and treatments in parallel to the private research from the pharmaceutical industry. The drugs and innovations are then negotiated over to for profit business, i.e. the pharmaceutical industry, who expertly mass produce them and bring them to the public. Sometimes as direct distributions, but more often than not, through distribution chains, which jack up the costs, as they stock up their for profit owned pharmacies who tack on their profits as well. Depending on the drug, the consumer may wind up paying double the price than that at which it left the Pharmaceutical manufacturing plant. Then we have the insurance companies, as the article notes " Confusing customers and dumping the sick: all to appease the investors on Wall Street". In short doing what they can to not pay the bill.

But what happens to the sick patient?

Glad Wendell Potter has had enough - many of us have....

THE GHOSTS OF PREMPRO

Wyeth's Hired Hands

As James notes in the thread below, there is an unusually detailed article in today's NYT about the extent of ghost-written articles used to promote the use of Prempro, including numerous meta-analyses, etc. Nothing new about ghostwriting. But what seems unusual (but may not be) here is the extent of it, creating the illusion of medical consensus, as well as the role of the journals themselves and their publisher in all of this.

http://www.nytimes.com/2009/08/05/health/research/05ghost.html?_r=1&emc=tnt&tntemail1=y

FDA WORKING ON MYLAN INVESTIGATION

FDA Expected to Release Report in a "Few Weeks"

According to an AP release below, FDA has said it will release the results of its investigation of Mylan's plant in a few weeks. See the link:

http://www.forbes.com/feeds/ap/2009/08/04/ap6738395.html

Pharmalittle will report on that investigation whatever it does, or does not, find. We would be very glad if the company was fully exonerated.