Drug Injury Watch

April 2008: FDA Web Site Adds Two New Pages For Learning About Drug Safety

Some Important Terms Are Defined And Various Research Resources From FDA Are Listed

(Posted by Tom Lamb at DrugInjuryWatch.com)

On April 11, 2008 the FDA added to its web site one page that gives short definitions for some important terms used in the realm of prescription drug safety, and another page that is intended to assist one when researching medication safety issues. 

We look, first, at "A Guide to Drug Safety Terms at FDA", which begins with this introduction:

The Food and Drug Administration (FDA) approves a drug for marketing after determining that the drug's benefits of use outweigh the risks for the condition that the drug will treat. But even with a rigorous evaluation process, some safety problems surface only after a drug has been on the market and has been used in a broader population. This guide offers descriptions of some of the drug safety terms commonly used by FDA throughout the life cycle of a drug.

The drug safety terms defined on this FDA web page are organized by the different stages of a drug's history.  Here is a summary of the stages and terms found on this page:

1.  FDA REVIEW

• Pre-Clinical Data
• New Drug Approval Process
• Adverse Drug Reaction

2.  TAKING MEDICATION

• Medication Guides
• Consumer Medication Information (CMI)
• Prescription Drug Labeling
• Nonprescription Drug Label ("Drug Facts")
• Boxed Warning

3.  MONITORING AFTER APPROVAL

• Post-Market Surveillance
• Adverse Event Reporting System (AERS)
• MedWatch

4.  REMOVAL FROM THE MARKET

• Drug Recall
• Drug Withdrawal

5.  TYPES OF SAFETY ANNOUNCEMENTS

• Early Communication About an Ongoing Safety Review
• Public Health Advisories
• Letters to Health Care Professionals ("Dear Doctor" letters)
• Information for Health Care Professionals

The second new page at the FDA site has to do with researching the safety of prescription medications; it is titled "Find the Latest Drug Product and Safety Information".

Here are some of the FDA resources for drug safety research provided on this page:

Index to Drug-Specific Information
www.fda.gov/cder/drug/drugsafety/DrugIndex.htm

Public Health Advisories
www.fda.gov/cder/news/pubpress.htm

MedWatch Alerts
www.fda.gov/medwatch/

DailyMed
http://dailymed.nlm.nih.gov

Drugs @ FDA
www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm

FDA Drug Safety Podcasts
www.fda.gov/cder/drug/podcast/default.htm

FDA Drug Safety Newsletter
www.fda.gov/cder/dsn/default.htm

FDA Consumer Health Information
www.fda.gov/consumer/default.htm

Recalls, Market Withdrawals and Safety Alerts
www.fda.gov/opacom/7alerts.html

We thank the FDA for posting these two new drug safety-related web pages -- both of which can be downloaded in an attractive brochure-like PDF for distribution.  Furthermore, we encourage you to share these FDA materials with family and friends who may have an interest in learning more about the safety of medications that they have been prescribed or are currently using.

April 2008 FDA "Patient Safety News" Videos For Doctors Online

Covers Chantix And Ortho Evra, As Well As Botox And Myobloc

(Posted by Tom Lamb at DrugInjuryWatch.com)

The FDA's Patient Safety News (PSN) is a series of monthly video news shows intended primarily for doctors and other health care professionals.  Generally, this series covers significant approvals, recalls, and safety alerts for prescription drugs and medical devices.  Some of the FDA PSN videos contain footage and demonstrations relevant to protecting patients from serious side effects and other unwanted consequences.

Subjects covered in the April 2008 edition of the FDA Patient Safety News include the following:

• New Safety Warnings about Chantix:  Possible neuropsychiatric problems and changes in behavior linked to Chantix (varenicline), a smoking-cessation drug.
• Early Communication on Adverse Events from Botox and Myobloc:  Botulinum toxin may have spread beyond injection site and cause symptoms associated with botulism, including dysphagia and respiratory insufficiency.
• New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch:  Results of new study found women aged 15-44 who used the patch were at higher risk of developing venous thromboembolism than women using birth control pills.

One can find more information about this April 2008 PSN edition and the series in general on the Patient Safety News section of the FDA's web site.

New Article With 25 Big Pharma Facts, And Free Online Tool To Search MedWatch Report Data

A Couple Of Recent Offerings From Our Readers, For Your Consideration

(Posted by Tom Lamb at DrugInjuryWatch.com)

As you will see, we have two readers who emailed me recently to thank for today's post.

First, Sally Thompson sent an email to let me know that "25 Shocking Facts About the Pharmaceutical Industry" had been published on the Nursing Online Education Database web site.  This interesting article by Laura Milligan starts out as follows:

Researching and snagging an adequate, wallet-friendly health care plan is tough these days, despite its high-profile presence in political debates. A large part of the controversy over expensive health costs stems from criticism of high-priced medications marketed by powerful pharmaceutical companies. From Medicare fraud to CEOs worth billions of dollars, big drug companies are accused of putting profits above patients, spinning false PR campaigns and more. We've uncovered 25 of the most shocking facts about the pharmaceutical industry in this list.

The 25 facts presented are wide-ranging and even-balanced; here's the last one, for example:

Pharmaceutical Companies donated millions to Hurricane Katrina relief programs:  Americans are used to bashing pharmaceutical companies, just as they criticize health insurance companies, rising gas prices and monopolies. It may come as a shock, then, to discover the philanthropic efforts undertaken by big drug companies. Medical News Today writes that companies like Abbott, Eli Lilly, Merck, Pfizer and others have donated millions of dollars in cash and supplies to the Hurricane Katrina relief efforts.

Each of the 25 facts is linked to the source material used by the author so if you want to learn more about any of the items all you need to do is click-thru for more information.

This article by Laura Milligan on the Nursing Online Education Database site is worth a read by people interested in the doings -- good, bad, and ugly -- of Big Pharma.

Moving back in time, last week Paul N. Danese, Ph.D., the co-founder of FDAble LLC, contacted me after seeing a comment I had left on another site  regarding Consumer Union's proposal for a consumer-based adverse-events reporting system.

Dr. Danese wanted to bring to my attention his company's adverse drug events search engine at FDAble.com, which allows one to access and search the vast compilation of data which the FDA obtains from MedWatch reports that the agency receives. 

Here's how Dr. Danese described this search tool to me:

FDAble allows users to search all modern U.S. FDA-related adverse events (Q4 1997 to Q3 2007).

Users may search for adverse-events by drug name, outcome, patient age, weight and other metrics.

All searches are free.  We also offer a yearly subscription service, which allows users to generate an unlimited number of custom adverse event reports.

The FDAble.com search page interface is clean and conspicuously shows this disclaimer:

FDAble is not associated with the Food and Drug Administration.

The search results from the FDA adverse drug events database are, due to their nature, probably of more use to researchers than consumers and patients. 

What is remarkable, based on my experience doing drug injury litigation over the years, is that this information is now so readily available.  It use to be the case that one had to submit a Freedom of Information Act (FOIA) request to the FDA for this type of data -- and, believe me, that was a very, very slow process.

Anyone with a need to review the FDA's MedWatch database for reports of side effects concerning a particular prescription drug will greatly appreciate this new search tool at FDAble.com.  We thank Dr. Danese and his company for their efforts in getting this much needed service online and, moreover, letting us use it for free.

If you have any information or news relevant to the topics covered here on Drug Injury Watch, please feel free to contact me using the link in the sidebar.

More Information About Reports Of Byetta Use Being Linked To Acute Pancreatitis

March 2008 Article In FDA's Drug Safety Newsletter Discusses Two Cases In Detail

(Posted by Tom Lamb at DrugInjuryWatch.com)

The quarterly issue of the FDA's online Drug Safety Newsletter [DSN] which was published on March 18, 2008 includes an article about a postmarket safety review of Byetta (Exenatide) that associates this diabetes drug with acute pancreatitis.

As background, one may recall that in October 2007 the FDA issued an alert to doctors informing them that the agency had reviewed 30 postmarketing reports of acute pancreatitis in patients taking Byetta, which was approved by the FDA on April 28, 2005 to treat adults with type 2 diabetes.

As seen here, this March 2008 DSN article about Byetta builds upon those 30 reports of acute pancreatitis:

FDA has been monitoring cases of acute pancreatitis in its postmarketing review of adverse event reports associated with the use of [Byetta] exenatide. Spontaneous adverse event reports of acute pancreatitis were described in the Adverse Reactions section of product labeling. Further postmarketing review of [Byetta] exenatide identified additional cases of acute pancreatitis associated with use of the drug. The product labeling has been updated to include information about acute pancreatitis in the Precautions section of the label, and information for healthcare professionals has been posted on FDA's Web site. [Text of footnote 1:  Exenatide (Byetta) product labeling.]  This article, based on the review of 30 reports of acute pancreatitis, describes the postmarketing data that prompted the revision to product labeling and provides recommendations to healthcare professionals regarding this serious adverse event.

As an aside, one part of this FDA article about the suspected Byetta - pancreatitis link caused a double-take:

Exenatide was originally identified in the saliva of the poisonous Gila monster lizard. Pancreatitis has been reported with envenomation with Gila monster saliva due to overstimulation of the pancreas. [Text of footnote 2: Sherman M. Therapeutic Venoms. US Pharm. 2005;12:33-36.]

Here are some of the details about these 30 postmarket reports of serious side effects in patients taking Byetta:

• From April 28, 2005, to December 31, 2006, FDA received 30 domestic reports of acute pancreatitis in patients who received [Byetta] treatment.
• In 21 of the 30 cases (70%), the patients were hospitalized.
• There were no fatalities and no cases describing a hemorrhagic or necrotizing pancreatitis event.
• Nineteen (63%) patients were female.
• The median age of patients described in the case reports was 60 years (range: 43-72 years).
• The median time to onset of symptoms of acute pancreatitis from the start of [Byetta] therapy was 34 days (range: 4-300 days).
• Twenty-seven cases (90%) reported one or more possible contributory factors, including concomitant use of medications that list pancreatitis among reported adverse events in product labeling, or confounding conditions such as obesity, gallstones, severe hypertriglyceridemia, and alcohol use.
• A dose-response relationship was observed in six patients who reported the onset or worsening of symptoms associated with acute pancreatitis soon after the dose of [Byetta] was increased from 5 mcg twice daily to 10 mcg twice daily.
• Twenty-two patients improved after [Byetta] therapy was discontinued, and 15 reports described the event as resolved at the time of the report.
• These findings suggested a strong temporal association between [Byetta] and acute pancreatitis.

In this March 2008 Drug Safety Newsletter article about Byetta one finds two reported cases discussed in some detail.  Both of these selected case reports in this part of the article serve to show the temporal relationship between initiation of Byetta treatment or dose escalation and the onset of symptoms associated with acute pancreatitis.  (Note: The first case has been presented previously in a medical journal article -- Denker PS, Dimarco PE. Exenatide (exendin-4)-induced pancreatitis: a case report. Diabetes Care. 2006;29(2):471.)

We will continue to watch the medical journals for reports of acute pancreatitis in association with the use of Byetta.

Issue: Should We Be Prohibited From Filing Product Liability Lawsuits Against Medical Device Manufacturers And Pharmaceutical Companies?

Opinion: Patient Lawsuits Are A Significant Incentive For These Manufacturers And Companies To Ensure That Their Products Are Safe For Use By American Patients

(Posted by Tom Lamb at DrugInjuryWatch.com)

First of all, I presume most of you believe – because as Americans we have always looked to our court system to vindicate our rights – that we are allowed to file these lawsuits today. 

With regard to most cases against medical device companies, however, as of February 2008 you are wrong; and, soon, injured patients may not be allowed to get any legal compensation from a pharmaceutical company for serious side effects caused by their prescription drug.

On February 20, in the Riegel v. Medtronic case, the U.S. Supreme Court granted legal immunity to manufacturers of medical devices which had been approved by the FDA.  This  means that in the future, for most instances, the medical device manufacturers will have no financial accountability for their mistakes if and when their products harm a patient. 

To reach this decision, the Supreme Court used the legal doctrine of  “federal preemption”.  Ironically, this doctrine comes from our Founding Fathers’ Constitution, but in recent years it has been used by the current Bush Administration to abolish a person’s right to sue when injured by a company’s product.

As a start, let us focus on the FDA-approval part of the Supreme Court’s Riegel decision. 

During this past year, the Institute of Medicine, the Government Accountability Office, and the FDA’s own science board have all issued reports that essentially reach the same conclusion: The FDA is largely incapable of protecting the public from unsafe medical devices and drugs.

Moreover, the FDA does not do its own testing; rather, the FDA is almost totally dependent on the companies that it is suppose to oversee to provide the agency with data concerning the safety and effectiveness of new prescription drugs and medical devices. 

Further, the vast majority of FDA approvals occur without there being any representation of patients’ interests; and, safety decisions after the drug or device is approved rarely include input from patient advocacy groups.

Meanwhile, the medical device manufacturers and the pharmaceutical companies clearly have an inherent conflict of interest when addressing safety issues concerning their products, which are intended to make them a profit. 

In addition, these business corporations have stronger legal obligations to their stockholders than they do to the patients who use their products.

Let’s return to the question at hand: Should patients have access to our court systems in oder to file lawsuits for injuries caused by unsafe drugs and medical devices?

In October of this year, 2008, the Supreme Court will hear oral arguments in the Wyeth v. Levine case.  The primary issue in that case is whether people who suffered a drug injury should be able to get any legal compensation from the pharmaceutical company responsible for that drug. 

You will probably be surprised to learn that, at this hearing, the drug company’s lawyers will be assisted by the Bush Administration’s Solicitor General in making their argument that an injured patient should not have any legal right to compensation.

In more detail, the drug company Wyeth and the Bush Administration will be arguing in this Levine case that the Food, Drug and Cosmetic Act of 1938 -- under which the FDA regulates prescription drugs -- has "implied preemption" due to the structure of this statute, i.e., the law's actual text does not include any preemption clause. 

The Levine case involves a Vermont woman who lost a hand and forearm to gangrene after being improperly injected with the drug Phenergan. At the trial of this lawsuit, Wyeth argued that its drug had met FDA’s federal labeling requirements and, therefore, the drug company should not have any legal liability under state law for this patient’s injury. 

The trial court judge disagreed with Wyeth on this issue, and the jury in that case went on to award $6.8 million in legal compensation to Mrs. Levine for her injury. 

The Vermont Supreme Court ultimately upheld the judge’s ruling and the jury verdict; but the U.S. Supreme Court later accepted this case for review – upon the request of the drug company and the Bush Administration.

As stated above, oral arguments regarding the federal preemption issue will be made to the nine Supreme Court Justices in the Levine case later this year, in October 2008. 

Sometime thereafter, and no later than the summer of 2009, our Supreme Court will decide whether the FDA approval of a prescription drug will serve as a prohibition against patients filing their personal injury and wrongful death lawsuits against drug companies.

According to some critics, the prohibition of drug injury lawsuits by operation of the federal preemption doctrine may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%.  But that has not been the situation in the past, nor is it the case today.

It is my opinion that the U.S. Congress should move quickly to pass legislation that would correct the Riegel decision by the Supreme Court, and serve to prevent such a ruling against patients’ rights in the Levine case.   

This legislation is needed because, in my experience, the possibility of becoming involved in product liability litigation is a significant incentive for the medical device manufactures and the pharmaceutical companies to ensure that their products are safe for use by American patients.

I would like to hear what you think about this issue as well as my opinion about use of the federal preemption doctrine in this context.  You can do so by submitting a Comment, below. 

Also, I encourage you to share this piece with others by email, bookmarking, etc.  Of course, I understand that not all people will line-up with me on this issue.  I believe, however, that all citizens will agree that this federal preemption issue is too important to remain as low-profile as it has been to this point in time.

(Thanks for reading this issue-and-opinion piece, which is a departure from the usual news and information about prescription drug side effects that is presented here at Drug Injury Watch.)

P.S.  I have posted this issue on the HeyMonkeyBrain! part of Squidoo: 

"What if you were hurt by a drug and couldn't sue?"

That page can be found here:  http://www.squidoo.com/preemption

Perhaps you can help get this debate started?

Thanks for your effort and time.  (3/20/08)

P.S.  Read an interview with Diane Levine which was done by Ed Silverman and posted on his blog, Pharmalot, earlier this year.  (3/24/08)

Sprint Fidelis Recall Showed That FDA's Medical Device Safety System Is Flawed

Dr. Hauser: "Just because a device is FDA-approved does not necessarily mean it is safe."

(Posted by Tom Lamb at DrugInjuryWatch.com)

In his March 5, 2008 article -- "Medical device safety in spotlight; M.D. uses Medtronic recall in critique of FDA, manufacturers" -- reporter Christopher Snowbeck explores how the Sprint Fidelis lead wire recall in October 2007 by Medtronic Inc. showed the medical device safety system as it currently operates here in the U.S. is fundamentally flawed.

For this article about the Medtronic recall last year, Mr. Snowbeck uses as his starting point a "Perspective" piece by William H. Maisel, M.D., M.P.H., which was published in the March 6, 2008 edition of The New England Journal of Medicine (NEJM), "Semper Fidelis — Consumer Protection for Patients with Implanted Medical Devices", which he describes as follows: 

Dr. William Maisel, an expert on medical device safety at Boston's Beth Israel Deaconess Medical Center, writes in today's edition of the New England Journal of Medicine that the Medtronic recall is the latest example of how manufacturers and the U.S. Food and Drug Administration have failed to provide the public with timely, critical information about device malfunctions....

Maisel said that five months before Medtronic recalled the Sprint Fidelis lead wire, the company submitted an application to the FDA to change the product's design and manufacturing.

That request was not publicized to physicians or patients, Maisel wrote, even though doctors had received letters from Medtronic in February 2007 stating that there could be a problem with the lead. He noted that after FDA approved the design changes, old versions of the Sprint Fidelis lead remained on hospital shelves for use in patients.

"Often, a flawed product continues to be marketed while the manufacturer submits a revised marketing application to the FDA and awaits approval of the amended product design and manufacturing plan," Maisel wrote. "Manufacturers have repeatedly and knowingly sold potentially defective devices without public disclosure."

Mr. Snowbeck then permits Medtronic an opportunity to respond to these contentions by Dr. Maisel:

Rob Clark, a Medtronic spokesman,... maintained Maisel's editorial omits key details in describing how the company handled the Sprint Fidelis matter.

"The narrative is incomplete and omits facts that are essential to any full accounting or analysis of the events and their ramifications," Clark said.

.. Clark said the Sprint Fidelis design change sought by the company in May had nothing to do with the problems that ultimately led to the recall. Manufacturers regularly make such design changes as they improve products, Clark said, and those changes don't indicate earlier versions are flawed.

Finally, Mr. Snowbeck goes beyond the NEJM article dispute to get the insight and opinion of a man who helped bring the Sprint Fidelis problem to light. In July 2007 Dr. Robert Hauser, of the Minneapolis Heart Institute, published a medical journal article that suggested patients with implantable defibrillators which had Sprint Fidelis lead wires were being needlessly and repeatedly shocked because those lead wires were fracturing at an unusually high rate. Here's what Dr. Hauser told Mr. Snowbeck as he prepared his March 2008 story:

"When you stand back and look at this, what's so disturbing is that physicians started implanting this lead because it was FDA-approved — they thought, 'Well, it's a nice, small lead, and it's FDA-approved so it must be OK,'" said Hauser. "Just because a device is FDA-approved does not necessarily mean it is safe."

Unfortunately for us, however, Medtronic and other makers of medical devices like implantable defibrillators are now immune from legal liability any injury or death their product might cause as long as it was FDA-approved.  This situation is the result of an opinion issued by the U.S. Supreme Court on February 20, 2008, in the case Riegel v. Medtronic Inc. (No. 06-179).

As explained by New York Times reporter in her February 21, 2008 article, "Justices Shield Medical Devices From Lawsuits":

The 8-to-1 decision [in the Riegel v. Medtronic case] was a victory for the Bush administration, which for years has sought broad authority to pre-empt tougher state regulation.

In 2004, the administration reversed longstanding federal policy and began arguing that "premarket approval" of a new medical device by the F.D.A. overrides most claims for damages under state law. Because federal law makes no provision for damage suits against device makers, injured patients have turned to state law and have won substantial awards.

The Bush administration will continue its push for pre-emption in another F.D.A. case that the court has accepted for its next term, on whether the agency’s approval of a drug, as opposed to a device, pre-empts personal injury suits. Drugs and medical devices are regulated under separate laws.

The prescription drug injury case referred to in that last paragraph is Wyeth v. Levine and in that case the Supreme Court will decide whether a patient should be able to sue a pharmaceutical company when there is a serious side effect that the company did not fully disclose, amongst other scenarios where currently the patient does have access to the court system here in the U.S.

The short of it is, as seen by this March 5 article about the defective Sprint Fidelis lead wire, just because a medical device was approved by the FDA does not mean it is a safe product.

P.S.  A well-written Opinion article from attorney Thomas R. Kline, "Immunity is a bad medicine for Americans' well-being", was published by The Philadelphia Inquirer on March 7, 2008.  It begins with this paragraph:

On Feb. 20, the U.S. Supreme Court granted legal immunity to manufacturers of medical devices that secure "pre-market approval" from the Food and Drug Administration for their products. The 8-1 decision in Riegel v. Medtronic guarantees medical-device manufacturers will have no financial accountability for their mistakes when their products are simply made according to FDA minimum specifications. Those standards are, in the words of noted Harvard pharmaco-epidemiologist Jerry Avorn, so minimal they "would be unacceptable anywhere else in research."...

Patient Lawsuits Against Pharmaceutical Companies For Drug Injuries Might Be Prohibited In U.S.

Our Tort System Provides A Needed Means Of Accountability; Law Professor: "A lot is lost without these lawsuits."

(Posted by Tom Lamb at DrugInjuryWatch.com)

On March 3, 2008 the U.S. Supreme Court issued its ruling in the Warner-Lambert v. Kent case and, in so doing, declined the invitation of pharmaceutical companies -- and the Bush administration -- to prohibit drug injury lawsuits from being filed by patients who have suffered serious side effects caused by unsafe prescription drugs.

The tie vote by which the Supreme Court arrived at its decision in Warner-Lambert v. Kent, however, means that this ruling does not set any precedent on the federal preemption issue that is the increasing focus of products liability lawsuits that involve FDA-approved prescription drugs and medical devices.   

From the March 4, 2008 article, "Court Allows Suit Against Drug Maker", by New York Times reporter Linda Greenhouse:

This case, Warner-Lambert Co. v. Kent, presented a narrow slice of the broad pre-emption issue that the court will take up in its next term. In that new case, Wyeth v. Levine, the question is whether the Food and Drug Administration’s approval of a drug’s label precludes individual damage suits based on the claim that the label failed to include sufficient information or adequate warnings.

In essence, if the answer is yes, most individual lawsuits for damages caused by approved drugs would be pre-empted. Last month, in Riegel v. Medtronic Inc., the court interpreted a federal law, the Medical Device Amendments, as barring most individual lawsuits against manufacturers of approved medical devices....

The Bush administration, which has embraced a broad theory of federal pre-emption of individual tort suits, entered the case on the manufacturer’s behalf. It argued that “permitting lay juries to second-guess” the adequacy of a drug application would interfere with the agency’s “exercise of its expert judgment.”

In more detail, the Bush administration will be arguing in Wyeth v. Levine (No. 06-1294) that the Food, Drug and Cosmetic Act of 1938 -- under which the FDA regulates prescription drugs -- has "implied preemption" due to the structure of this statute, i.e., the law's text does not include any preemption clause. 

The Levine case involves a Vermont woman who lost a hand and forearm to gangrene after being improperly injected with the drug Phenergan. At the trial of this lawsuit, Wyeth argued that its drug had met FDA labeling requirements and, accordingly, the drug company should face no liability under state law.  The trial court judge disagreed, and the jury in that case awarded $6.8 million in legal compensation to Levine for her injury.

According to some critics, federal preemption of drug injury cases may have some merit in an ideal world where the FDA was performing its drug-safety regulatory functions at 100%.  But that has not been the situation in the past, nor is it the case today.

In his March 3, 2008 article, "Patients' ability to sue at risk", Los Angeles Times reporter Daniel Costello presented these facts which tend to show why federal preemption of drug injury cases is a bad idea:

The FDA "doesn't have the ability at this time to oversee in a comprehensive fashion everything it regulates," said David A. Kessler, a former FDA chief and a professor at UC San Francisco.

A trio of recent reports, including one by the FDA's own advisory committee, has raised serious questions about the agency's recent performance.

Last fall a yearlong study by the FDA's advisory committee found "the agency is so underfunded and understaffed that it's putting U.S. consumers at risk in terms of food and drug safety."

In an unusual public departure from the view of the Bush administration, the current FDA commissioner, Andrew C. von Eschenbach, said in an interview last week that the agency needed a systemic overhaul that could take years....

Some legal experts and attorneys are concerned that without such lawsuits, regulators and the public may never hear of evidence that manufacturers knowingly marketed products they knew were unsafe.

In recent years, documents and e-mails uncovered in court cases have shown that some companies kept safety issues involving their products from the FDA.

"Without the tort system, what reasonable assurance do we have we will learn about the bad actors?" asked David Vladek [sic], a law professor at Georgetown University.

"A lot is lost without these lawsuits."

Oral arguments in the Levine case are scheduled for October 2008.  Sometime thereafter the Supreme Court will decide whether FDA approval of a prescription drug prohibits the filing of personal injury and wrongful death lawsuits against drug companies.

No doubt we will continue to hear a lot about this important policy issue in the months to come.

P.S.  Dr. David A. Kessler, Dean and Vice Chancellor for Medical Affairs at the University of California San Francisco and former FDA Commissioner, and David C. Vladeck, Professor of Law at Georgetown University Law Center, explore the legality and wisdom of this continuing effort by the FDA and the Bush administration to persuade lower courts, including the Supreme Court, to preempt most failure-to-warn claims asserted by patients against drug companies in this recent law review article:

David A. Kessler & David C. Vladeck, A Critical Examination of the FDA’s Efforts To Preempt Failure-To-Warn Claims, 96 GEO. L.J. 461 (2008).

Dean Kessler and Professor Vladeck explain how the FDA’s position, if ultimately adopted by the Supreme Court, would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of failure-to-warn product liability litigation.  The authors explain, also, why the FDA’s view that the agency, alone, is capable of regulating the safety of prescription drugs in the U.S. is unrealistic. 

This 35-page scholarly article is compelling and insightful as to why federal preemption of drug injury cases is a bad idea.  (3/5/08)

Medication Mistakes And Pharmacy Errors Continue To Be A Large Problem

Prescription Drugs Wrongly Prescribed Or Improperly Dispensed Are Preventable Adverse Events Which Need To Be Reduced In Number -- And This Can Be Done

(Posted by Tom Lamb at DrugInjuryWatch.com)

In a February 14, 2008 article, "1 in 10 patients gets drug error", Boston Globe reporter Patricia Wen presented some disturbing data from a study which examined adverse events involving prescription errors that occurred in six undisclosed Massachusetts community hospitals:

One in every 10 patients admitted to six Massachusetts community hospitals suffered serious and avoidable medication mistakes, according to a report being released today by two nonprofit groups that are urging all hospitals in the state to install a computerized prescription ordering system.

The report is the first large-scale study of preventable prescription errors in community hospitals, and its author, Dr. David Bates of Brigham and Women's Hospital in Boston, said he was surprised that these mistakes were so frequent in these community hospitals....

The researchers reviewed a total of 4,200 randomly selected patient medical charts at the six community hospitals, covering stays from January 2005 to August 2006. An average of 10.4 percent of patients suffered a preventable "adverse drug event" - defined as a case in which the patient was given a drug even though the medical records noted that the medication could trigger a drug allergy or that the dose given would exacerbate a medical condition. Medication errors were counted only when patients suffered serious reactions, including going into shock or suffering kidney failure. In nearly every instance, the patients remained in the hospital longer to recover from the mistake. Nobody died from any of the mistakes, researchers said.

This February 14 article in the Globe goes on to describe how the computerized prescription ordering system mentioned above works, as well as what types of results its use can produce:

[T]e computerized physician order entry system, which requires doctors to type into a central database every medical order, including prescriptions, diagnostic tests, and blood work. The doctors' orders are matched against the patient's medical history, triggering red flags to prevent problems related to drug allergies, overdoses, and dangerous interactions with other drugs.

Bates said that after this system was put in place at Brigham and Women's Hospital in 1995, preventable medication errors declined by 55 percent over the next two years....

Ms. Wen includes in her article various discussions about how medical insurers, government officials, and healthcare providers, all, would benefit from the computerized system being used at more hospitals in Massachusetts and across the nation.

Turning to another aspect of medication errors, on February 12, 2008 the Indianapolis Star published a lengthy USA Today article, "Too many prescriptions, too few pharmacies", which reported the results of an investigation that USA Today conducted:

The investigation reviewed policies and alleged errors at rivals Walgreens and CVS, the nation's two largest drugstore chains, which fill nearly one-third of all retail prescriptions nationwide. It included a review of scores of lawsuits, as well as pharmacy board disciplinary actions in 10 states and interviews with pharmacists, drug-error victims, their families and attorneys. Some common factors emerged:

• Too many prescriptions, too few pharmacists....
• An emphasis on speed....
• A reliance on technicians....
• Pharmacist incentive awards....
• Counseling gaps....

We learned from this February 2008 USA Today article about prescriptions being improperly filled by pharmacists that, remarkably, the North Carolina Board of Pharmacy is the only state board that requires all major drug errors to be reported to the agency.

The online version of this USA Today article has an interactive graphic component, "How prescriptions are filled and where errors can occur", which gives one a better idea about what goes on behind the counter at your typical chain-store pharmacy.

For anyone interested in the causes and effects of medication errors, both of these February 2008 news reports are well worth your time.

FDA Proposed Rule About Drug Label Warning Changes Will Lessen Agency's Power To Protect Us

This January 2008 Rule Issued By FDA Is An Attempt To "End-Run" Congress And Lays The Groundwork For Another Unsafe Drug Debacle Like Vioxx

(Posted by Tom Lamb at DrugInjuryWatch.com)

On January 16, 2008 the FDA issued a proposed rule whereby a drug company would only have to revise the package insert, or label, for its prescription drugs to add an increased warning about a serious side effect where the drug company, itself, is satisfied there was “sufficient evidence of a causal association” between its medication -- i.e., product that it sells for profit -- and the side effect.  This is a process which could literally take years (bringing to the mind the recent Vytorin and Zetia "delay" in the release of the ENHANCE clinical study results, albeit that foot-dragging was apparently more about drug efficacy than drug safety).

This new rule proposed by the FDA in January 2008 is wrong for various reasons that we will explore below and, moreover, is such a threat to patient safety that people should contact their members of Congress to express disapproval of this conduct by our FDA.

Let us explore the number of ways in which this FDA proposed rule is not only wrong in theory but actually detrimental to drug safety, also.

To start, the rule proposed by the FDA directly contradicts Congress’ expressed intent when it passed the Food and Drug Administration Amendments Act of 2007 (FDAAA) just four months ago.  Our Congress included language in FDAAA that confirmed it is the responsibility of a drug company to promptly update a drug label if the company became aware of any new drug safety information, as shown by remarks made by Senators Durbin, Enzi, Kennedy, and Leahy, as well as others, when it passed the FDAAA -- which encompasses the Prescription Drug and User Fee Act (PDUFA).

In more detail, Congress was clear that it intended to keep the burden squarely on drug companies to update their warning labels. Congress explicitly stated that with the passage of this FDAAA law it did not intend to ease the requirements on drug companies to inform doctors and patients about potential drug hazards as soon as possible.  Rather, as evidenced by the remarks of those several Senators mentioned above, Congress reiterated the need for drug companies to change their labels promptly when they learned of any reasonable information that there was an increased risk of a serious side effect associated with their prescription medications.

Despite this clear Congressional intent, the FDA promulgated this new proposed rule just four months after the FDAAA became law.  One might wonder why?  Here's a possibility.  Lobbyists for the drug companies fought hard to have Congress include in the FDAAA legislation some language to loosen warning label obligations, but failed, i.e., Congress specifically left that language out of the final bill.  Following passage of an FDAAA law which is not to their liking, it seems that the drug companies directed their lobbyists to persuade some FDA bureaucrats about this "end-run" on the Congress.

A more important reason that this new rule proposed by the FDA is wrong: It lessens the agency's ability to protect patients from unsafe drugs.  Specifically, the FDAAA requires a drug company to update its package insert, or label, to include a warning about an increased risk of a serious drug side effect as soon as there is some reasonable evidence of that risk.  By this means, the FDAAA law allows doctors and patients to become aware of a prescription drug’s potential risks at the earliest possible time.  In turn, this awareness could help prevent the countless injuries and deaths caused by a drug like Vioxx.  Recall, Merck fought with FDA and thereby delayed changing the Vioxx label such that it served to sufficiently warn about the risks of heart attacks and strokes -- so that, seemingly, the drug company Merck could continue to sell its so-called "blockbuster" drug Vioxx (this delay, of course, did involve drug safety).

Under the new rule proposed by the FDA in January 2008, a drug company will only need to revise their warning label after the company established “sufficient evidence of a causal association”, a process which could take several years (for all kinds of reasons, as one can imagine).  To be clear, under the new FDA rule it is the drug company, itself, that has to establish this significantly higher standard before the company is required to inform doctors and patients about a new potential hazard associated with its drug -- leaving doctors and patients in the dark all the while (as the company looks for something it might prefer not to find in the first place, it seems).

In summary, here are the three main things that are wrong with this new proposed rule issued by the FDA:

1. With this rule FDA has ignored the expressed Congressional intent for FDAAA.  Members of Congress clearly said that FDAAA was not intended to loosen the requirements on drug companies to inform doctors and patients of new serious side effects.  This new FDA rule, however, will give drug companies broad discretion to determine whether to revise the drug label to so warn;
2. This new rule issued by FDA is a step backwards for the agency's purpose of making prescription drug use safer for Americans.  The new FDA rule lessens the agency's power to require that drug companies warn doctors and patients of potential drug safety problems at the earliest possible time.  Instead, this proposed rule will give drug companies the ability to choose not to inform doctors and patients even if there is new evidence of a potential serious side effect; and,
3. The FDA proposed rule makes it more difficult for people injured by an unsafe drug to hold a negligent drug company accountable in court.  By seeking shelter under the FDA’s new rule, a drug company will be immunized from accountability -- in terms of legal liability, which currently is available by operation of the FDAAA law -- with the dual contentions that it did not have the "sufficient evidence" such that the company was not required to update its label and warn about a known serious side effect.  In turn, if the injured person does not have recourse for legal compensation from the drug company, costs of care and treatment for that drug injury could become a substantial burden to taxpayers like you and me.

In closing, please urge your respective members of Congress to oppose this proposed rule issued by the FDA in January 2008.  Unelected bureaucrats in the FDA should not be allowed to make this end-run on Congress so as to undermine the FDAAA law which our representatives in Washington voted in favor of as being the best way to protect the health and safety of Americans regarding the use of prescription drugs.

Dr. Dennis Mangano Says On 60 Minutes In February 2008 That Trasylol Should Have Been Recalled As Early As January 2006

Delay By Bayer And FDA Until November 2007, When Trasylol Sales Were "Suspended", Caused 22,000 Excess Deaths Per CBS Report

(Posted by Tom Lamb at DrugInjuryWatch.com)

According to interviews broadcast by CBS Television's 60 Minutes program about Trasylol on February 17, 2008, an estimated 22,000 patient lives could have been saved if the FDA had acted quicker to recall Trasylol, Bayer AG's drug used to stem bleeding during open heart surgery.

Trasylol (aprotinin injection) sales in the U.S. and Canada were suspended by Bayer in early November 2007. Trasylol was used to reduce blood loss during coronary artery bypass surgery.

As background, in mid-February 2006 the FDA announced it was evaluating the safety of Trasylol after new studies had linked this heart surgery drug to higher risks of kidney problems, heart attacks, and strokes.  At the end of February 2006 a "Dear Doctor" letter from Bayer regarding Trasylol was posted on Health Canada's MedEffect web site.

Later, the FDA held an advisory committee meeting in September 2006 and, thereafter, convened another such meeting on September 12, 2007 to further discuss Trasylol. 

A February 15, 2008 Reuters article, "22,000 died amid delayed Bayer drug recall: doctor", provided these details based on a review of this 60 Minutes report about Trasylol that had been posted on the CBS News web site in advance of the February 17 broadcast:

Dr. Dennis Mangano, the study's researcher, said during the program that 22,000 lives could have been saved if Trasylol had been taken off the market when he first published his study in January 2006....

He said in the broadcast that Bayer failed to disclose to the FDA during an FDA advisory panel meeting in September 2006 -- at which Mangano's negative findings were discussed -- that the German drugmaker had conducted its own research which confirmed the same dangers established by his study.

The chairman of the FDA advisory panel, Dr. William Hiatt, told 60 Minutes he would have voted to remove Trasylol from the market had he been informed about Bayer's study, according to the CBS report.

As acknowledged by company spokeswoman Meredith Fischer in the February 15 Reuters article, product liability lawsuits have been filed against Bayer on behalf of patients who had died or been seriously injured following the use of Trasylol during their heart surgery.

P.S.  In advance of the September 2006 advisory committee meeting about Trasylol, FDA reviewers asked Dr. Mangano for his group’s data in order to see if Trasylol should be withdrawn based on the new evidence.  Read what happened thereafter in Merrill Goozner's November 27, 2006 article, "CABG from NEJM on Thanksgiving", which he posted at Gooznews.com  (2/19/08)