Illinois Deserves the Truth

What Is Up With The FDA? A Few Highlights

Cross posted from The Pop Tort by Amanda.

Several months ago the New York Times opined, "The F.D.A. in Crisis: It Needs More Money and Talent,"

That had come shortly after Congress was told that the FDA wasn't able to guarantee the safety of the drugs manufactured abroad (um, almost all of them) because overseas manufacturing facilities have less rigorous safety standards.

Gregory Curfman, the Executive Editor of the New England Journal of Medicine during his recent congressional testimony in front of the House Committee on Oversight and Government Reform said:

We have learned over the years that approval of a new drug by the FDA by no means guarantees its safety. It is not uncommon for drugs to be approved by the FDA without long-term studies of their safety. Indeed, FDA approval of a drug is just one milestone along a path to the assessment of long-term safety. It is essential that a drug's safety continue to be carefully monitored during the post-marketing period, because we know that serious safety issues may come to light only after a drug has entered the market. 

Just yesterday, MSNBC reported that the FDA has been experiencing a "brain drain" as many of the most experienced scientists are being wooed into the private sector – leaving the federal agency inexperienced and understaffed.  Included in the article were anecdotal reports of scientists leaving in part because of concerns over safety issues:

FDA's outside advisers say frustration with FDA culture is a major reason its turnover rate is twice that of other agencies.

Staffers who disagree with management are reportedly discouraged from speaking up, according to an Institutes of Medicine report on FDA's drug safety system.

Staffers say strict deadlines for the review of drugs also contribute to stress.

"People are under enormous pressure to meet those review dates and they get burned out," said David Ross, a former FDA drug reviewer who now teaches at George Washington University's medical school.

Ross left FDA in 2006 after a dispute with agency management over the safety of an antibiotic.

Then of course there was Dr. David Graham, who had spent his entire career at the FDA's Office of Drug Safety and garnered national attention when he was highly critical of the federal agency in the way it handled Vioxx.  In 2004, Dr. Graham testified in front of Congress saying:

In my opinion, the FDA has let the American people down, and sadly, betrayed a public trust…. It is important that this Committee and the American people understand that what has happened with Vioxx is really a symptom of something far more dangerous to the safety of the American people.  Simply put, FDA and its Center for Drug Evaluation and Research [CDER] are broken… the scientific standards CDER applies to drug safety guarantee that unsafe and deadly drugs will remain on the US market.

What perhaps makes matters worse is the chilling drive by drug companies to allow them complete immunity when their drugs or medical devices harm or kill people.  In fact, the U.S. Supreme Court has already ruled that if the FDA has approved a medical device, then the manufacturer can't be sued.  Luckily, Congress has decided to get into the act. 

House Energy and Commerce Health Subcommittee Chairman Frank Pallone, (D-NJ), and House Oversight and Government Reform Chairman Henry Waxman (D-CA) will introduce legislation before the Independence Day recess that would explicitly state that FDA regulation does not trump medical device patients' ability to seek damages under state law.

State Attorneys General do it again

Earlier today Express Scripts Inc. reached an agreement with the offices of 28 states--including Illinois--to pay $9.5 million for misleading consumers by encouraging docs to switch patient's cholesterol drugs "under the guise of controlling costs."

Through the agreements, state attorneys general "have changed how these companies treat patients and doctors when they ask to change their prescription medications,'' said Martha Coakley, attorney general in Massachusetts, one of the participating states, with $255,000 in settlement money. "Those requests now include full information on costs savings and the reasons for the proposed switch.''

Agreements like this have a very real effect on consumer safety.  For more on the critical work of state AGs, read the CJ&D report, State Attorneys General: The People's Champion

Enough with the pharma ads!

I wanted to share an insightful editorial from this morning's St. Louis Post-Dispatch.  Everyone knows how crazed drug manufacturers are over advertising to consumers.  It's no surprise, since their efforts are successfully undermining physician authority and bloating the industry.

One recent medical study found that advertising is creating markets for drugs that would otherwise not exist. It's one reason that more than half of all insured Americans are taking at least one prescription medication for chronic health problems.

The number of direct-to-consumer ads more than doubled between 2003 and 2007. Among them was a campaign for the cholesterol drug Vytorin...

Ads for the drug, made jointly by Merck and Schering-Plough, were pulled in January after release of a study that showed Vytorin is no more effective at reducing cholesterol build-up than a cheaper drug called Zocor, which is available as a generic.

Merck and Schering-Plough sat on that study for two years, advertising heavily the whole time. Last year, after data had been collected but before it was released, Vytorin rang up sales of $5.1 billion.

The editorial goes on to stress the importance of efforts currently on the legislative agenda.

U.S. Rep. Rosa DeLauro, D-Conn., has sponsored a bill that would ban consumer advertising for the first three years a new drug is on the market. That would give regulators time to better assess its potential risks. The idea is endorsed by Consumers Union, publisher of Consumer Reports.

A Senate committee today will is scheduled to hear testimony on a proposal to require that all drug ads list a telephone number where consumers can file reports about drug side-effects...

The FDA must do a better job of policing drug ads. But it won't until Congress gives it the tools it needs. Lawmakers should do so without delay.

Kudos to the Post-Dispatch editorial board for such a strong endorsement.

Pre-emption = Bad

Cross posted from The Pop Tort by Amanda

Like the tobacco companies, for decades the drug companies have been trying to excuse themselves from any liability when their products harm or kill people.

Take for example the much discussed Riegel v. Medtronic decision where the U.S. Supreme Court decided that if the FDA has approved a medical device, then the manufacturer can't be sued.  Or, more recently, the Third U.S. Circuit Court of Appeals ruled that the makers of selective serotonin re-uptake inhibitors (a type of antidepressant) cannot be sued for failing to warn consumers of the risk of suicide -  because the FDA had previously refused to place a warning on those drugs.

The muckety-mucks in the drug industry must have been dancing in the streets (or at least dancing in their gold-plated, money filled offices) at these recent rulings because it lets them avoid responsibility when things go wrong with their products.

Yet, I don't think the FDA should be the end-all-be-all when it comes to deciding what is safe with no recourse for consumers (just look at Michigan’s tragic drug industry immunity law). It is becoming common knowledge that the agency has been politically co-opted by the very industry it is supposed to regulate, part of which is due to the fact that it receives at least a third of its budget for approving new drugs – directly from the pharmaceutical companies.

But don't just take my word for it, check out this recent editorial in the New York Times

April 14, 2008
The Dangers in Pre-emption (excerpt)


The pharmaceutical industry and its good friends in the Bush administration are working hard to prevent consumers from filing damage suits for injuries caused by federally approved drug products. They may soon get a helping hand from the Supreme Court, which has already barred many suits over faulty medical devices.

If this perverse legal doctrine, known as federal pre-emption, continues to spread, the public will be deprived of a vital tool for policing companies and unearthing documents that reveal their machinations.
...

[I]t would be a mistake to rely solely on the F.D.A.’s judgment. The agency is short of skilled scientists. If a company buries important information deep in the bowels of a report, the agency may not detect it or appreciate its significance. Injured patients should not lose the right to sue if they are harmed by duplicitous manufacturers.

Another Record Year for Tort "Deform" Lobbying

Unfortunately, we in Illinois know this scenario all to well. 

Cross posted from The Pop Tort by Amanda,

If there were a group of people that shouldn't be afraid of the purported recession, it would probably be lobbyists.  We are not saying all lobbying is bad, but just take a look at who outspent the rest in their efforts to have their way with Washington:   

According to information released last week from the Center for Responsive Politics, the U.S. Chamber of Commerce, the tort deform "champion", was victorious this past year in spending more money ($52.8 million) than any other lobbying group. 

The industries that dolled out the biggest of the big bucks: drug and health care product companies ($227 million) and insurance industries ($138 million).

FDA, Stop the Madness

I'm ashamed to say it, but going through the news this morning I asked myself, "is it possible there is a race going on to see who can put the most harmful products on the market?"  If there is, the pharmaceutical industry is giving toy companies a run for their money.

The latest is the blood thinner heparin. This drug has been in the news so much lately its hard to keep all of the developments straight. Let’s see… First we heard about a rise in adverse side-effects to the drug, then came the recall, then the revelation that foreign manufacturers may be contaminating the drug, and through it all there was Dennis Quaid’s horror story (covered here and on ThePopTort). To date, heparin has been linked to as many as 19 deaths and hundreds of serious illnesses.  The FDA just announced they would begin inspecting imports of all heparin products, but is that enough? After all, every time you think they are taking control of a situation another story breaks.

Time and again the FDA has failed to keep dangerous products off our shelves. The good news is that when federal bodies aren't working, consumers can always count on the civil justice system to get results themselves (except of course in Michigan--read this CJ&D report).

Toys for Docs

Cross posted from The Pop Tort by John Guyette

Like the “Toys for Tots” charitable drive to provide gifts to children during the holiday season, it appears big pharmaceutical companies have adapted a similar program.  Except it doesn’t involve toys for children, but rather, for doctors.  We’ll call it “Toys for Docs.”  And we mean big “grown-up” toys, like free meals, trips, paid consulting contracts and even super bowl tickets. 

And it’s year-round.  No wonder.  As this article points out, “The number of prescriptions for a drug rises in direct proportion to the handouts a physician accepts from the manufacturer of that drug.” Meanwhile, both drug companies and doctors are going around the country trying to make sure that if patients are made sick or injured by these drugs, they can’t do anything about it.

That’s some sweet deal for a drug, oops I mean toy, pusher!

What’s Hot! Hot! Hot! in Michigan?

Cross post from The Pop Tort by Amanda

No, it's not the weather – which was a whole 14° F in Lansing as I was writing this. 

The Governor talked about it in her State of the State address, state legislators are talking about it, it’s in the newspapers and on TV – even the U.S. Supreme Court has been talking about it.

And what is it? 

Drugs, and not just any drugs – FDA approved drugs.  Why?

Michigan has an unprecedented law that prevents residents harmed by dangerous drugs from gaining access to the civil justice system, which has been devastating for Michiganders while failing to accomplish any promised economic benefits for the state concludes a new report, A Tragic Blunder:  Michigan’s Drug Industry Immunity Law, released today by the Center for Justice & Democracy.

According to the report, since the law went into effect in 1996, numerous unsafe drugs have been marketed with approval by the Food and Drug Administration that have killed or injured Michigan residents.  Unlike victims in any other state in the country, Michigan residents are barred from seeking compensation for these deaths or injuries.  Meanwhile, contrary to what the law’s proponents promised, thousands of good paying jobs in the pharmaceutical industry have left the state.

There is real support for this repeal.  The House of Representatives passed repeal legislation last year, but the bill has been stalled in the Senate.  A petition to get the Senate talking about it began circulating on Tuesday.

So, perhaps the Senate ought to take a look at the CJ&D report, in case they are only hearing what the drug lobbyists are telling them?

False Advertising

Cross posted from The Pop Tort by John Guyette.

So what’s wrong with spending $258 million on advertising – if it brings in $12.7 billion in sales?  Sounds like a good investment right? 

Ok, ok, so what if after two years of this advertising campaign you pull the ads because they are frequently criticized for being inaccurate and misleading.  Check out today’s article in the New York Times but what I want to know is where is the FDA in all of this? I mean if we're thinking about giving up our right to take drug companies to court and relinquish all health and safety oversight to the FDA (thanks to the U.S. Supreme Court) shouldn’t they care that millions of advertising dollars gives an accurate portrayal of a drug?

Sadly, the answer is no.  Almost a decade ago the FDA relaxed its rules on drug advertising so there is less accountability for pharmaceutical companies in honest and accurate promotion of their drugs.

In Love: U.S. Supreme Court and the Drug Industry

Cross posted from The Pop Tort by Amanda

The other day I was having lunch with a friend who was lamenting that he needed an idea for his next screenplay.  This friend usually writes romantic comedies, so I thought, I’ve got a great idea for his next film.  It’s called, “The U.S. Supreme Court Is In Love With the Pharmaceutical Industry.”

Wednesday’s Supreme Court decision, allowing the makers of certain unsafe medical devices to get away with implanting them in people without legal accountability, was clearly Valentine gift (a few days belated) to drug companies - and there’s more to come!

And what's not to love?  It's an obscenely wealthy industry that has all the Viagra and Cialis it wants.

But like my last relationship, they make a badly matched couple.  And like a good friend sitting you down and saying, "what were you thinking?" it is going to take an intervention by the U.S. Congress to break up this love affair.

That's right, Congress can (and hopefully will) step in using that old system of checks and balances we learned about in civics class, and end this terribly destructive relationship.  Luckily, key members of Congress seem ready to step in, according to the New York Times Senator Edward M Kennedy (D-Mass) said,

"In enacting legislation on medical devices, Congress never intended that F.D.A. approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices ...Congress obviously needs to correct the court's decision."

And Representative Henry Waxman (D-CA) said,

"The Supreme Court's decision strips consumers of the rights they've had for decades... This isn't what Congress intended, and we'll pass legislation as quickly as possible to fix this nonsensical situation."

So, I don't know if this story will be next summer's box office blockbuster, but regardless, it’s a relationship that Congress needs to do something about – before people get hurt!