Drug Injury Watch

The Ernst Vioxx Verdict: A Retrospective Look Into the Jury Room, Part Three

The Ernst v. Merck Jury: On Why Punitive Damages Were Warranted, and How They Arrived at the $229 Million Amount

The Association of Trial Lawyers of America ("ATLA"), of which I am a proud member, has compiled selected statements made by some of the jurors who heard the evidence presented during the Ernst v. Merck trial in Texas.  These Vioxx juror quotes provide some insight about what inspired this jury to hand down their massive $253 million verdict in favor of the plaintiff in the Ernst case on August 19, 2005 in Brazoria County, Texas.

Part One of this series showed how the Ernst jury believed it was sending a message to Merck and Big Pharma as concerns unsafe drug issues, and Vioxx in particular, by means of its verdict.

Part Two of the series examined how the Ernst jury regarded Merck's decision to market Vioxx despite knowing about the cardiovascular problems associated with their drug. 

This third part of the series will delve into how the Ernst jury determined that punitive damages were warranted, and how the jurors arrived at the $229 million punitive damages amount.

Let's get right to the jury's comments about their massive punitive damages award.

• Juror Rhonda Wade: “Our award was based on the fact that once they figured out they had no choice to make the [warning] label change, they chose to stall it in order to make as much as $229 million. And we don't want them to stall. We want them to tell us the truth, and be responsible.  …  Looking through their evidence, and time after time, you could see where they knew about the CV [cardiovascular] events and how important it was and they didn't do anything about it. That's what made up my mind.”  [Newsnight with Aaron Brown, CNN, 8/19/05]

• Lisa Stark, ABC News Reporter (Voice Over): “The case against Merck relied heavily on internal company documents including ones that seemed to show Merck knew about possible heart risks, even before Vioxx went on the market.  Jurors were also told Merck delayed strengthening Vioxx's warning label. And that's how they decided on the amount of punitive damages.” Juror David Webb: “$229 million was the amount of money that Merck would gain if they put off changing the label.” [Good Morning America, ABC News Transcripts, 8/20/05]

• “Carol Ernst was awarded $ 253.45 million Friday, including $ 229 million in punitive damages.  ‘That was a number they kept saying over and over,’ juror Stacy Smith, a 21-year-old college student, said. ‘It was in our mind.  When you're sitting there for five weeks and that number kept being repeated, the number stuck in our mind.’” [Houston Chronicle, 8/20/05]

• “Because of caps under state law, Hardin will have to reduce the amount of the punitive damages to $ 1.65 million, making the total $ 26.1 million.  Juror Rhonda Wade, 41, of Clute, said those on the seven-man, five-woman jury were not aware of a cap on punitive damages.  ‘We assumed that no matter what the number, it would be cut back,’ she said. ‘We wanted to get the message across.’” [The Houston Chronicle, 8/20/05]

• “In interviews after the decision, jurors said they had made the large punitive award to send a message that drug makers must disclose the risks of their medicines.  ‘Respect us, that's the message,’ said Derrick Chizer, a juror. ‘Respect us.’” [The New York Times, 8/20/05]

• “‘When you write that figure ($ 229 million), it means Merck is going to have to get responsible,’ said Rhonda Wade, 41, of Clute.  ‘It's not the money,’ added Marsha Robbins, 53, of Freeport, who served as the presiding juror. ‘It's accountability.’”  [The Houston Chronicle, 8/20/05]

A final thanks to ATLA for providing the various quotes from members of the Ernst trial jury which were used in this series on the recent Texas Vioxx verdict.

(Posted by: Tom Lamb)

The Ernst Vioxx Verdict: A Retrospective Look Into the Jury Room, Part Two

The Ernst v. Merck Jury: On Merck's Decision to Market Vioxx Despite Knowing About the Cardiovascular Problems

The Association of Trial Lawyers of America ("ATLA"), of which I am a proud member, has compiled selected statements made by some of the jurors who heard the evidence presented during the Ernst v. Merck trial in Texas.  These Vioxx juror quotes provide some insight about what inspired this jury to hand down their massive $253 million verdict in favor of the plaintiff in the Ernst case on August 19, 2005 in Brazoria County, Texas.

Part One of this series showed how the Ernst jury believed it was sending a message to Merck and Big Pharma as concerns unsafe drug issues, and Vioxx in particular, by means of its verdict.

This second segment of the series will examine how the Ernst jury considered Merck's decision to market Vioxx despite knowing about the cardiovascular problems associated with their drug. 

Last but not least, Part Three will delve into how the Ernst jury determined that punitive damages were warranted, and how the jurors arrived at the $229 million punitive damages amount.

So, what did members of the Ernst jury have to say about Merck's decision to keep selling Vioxx despite knowing about the significant number of heart attacks and strokes that had been associated with Vioxx, their blockbuster drug?

• “One of the jurors, 21-year-old Stacy Smith, said she was shocked at evidence that showed the company knew the dangers of Vioxx long before it withdrew the drug. ‘They knew, and they still put it out anyway,’ she said.” [Sunday Express (U.K.), 8/21/05]

• “Several jurors said that company documents showed Merck seemed to care more about profits from the drug than the public's welfare.  Stacy Smith, 21, said she was swayed by documents written by Merck executives. ‘They knew,’ she said, ‘and they still put [Vioxx] out.’  …  Juror Lorraine Blas, 41, said she reviewed several documents in the jury room and found a particularly damaging Merck e-mail on cardiovascular events and testing dating back years. ‘I felt Merck knew something was going on as early as 1997,’ she said.  Juror Derrick Chizer, a Social Security service representative, said he was irritated that Merck failed to send any executives who were responsible for bringing Vioxx to market to the trial.  ‘Not one bigwig from Merck came down. Not one of them took the time,’ Chizer said. ‘One death in my life would make a difference. Why wouldn't it make a difference to them?’” [Los Angeles Times, 8/20/05]

• Juror Lorraine Blas: “The evidence there – after reviewing all the evidence in the jury room, I decided from looking at the paperwork they knew the problems this medication was causing and they hid it from us. Rather than telling us the good and the bad, they only told us the good.”  [The Early Show, CBS News Transcripts, 8/20/05]

• “‘Merck did not let us know the full problems of the drug,’ juror Rhonda Wade said. ‘I was shocked.’” [The Dallas Morning News, 8/20/05]

• “’This case certainly opened my eyes,’ said juror Rhonda Wade, a 41-year-old mother of four from nearby Clute, Texas. ‘They ignored an FDA warning letter about their marketing and they didn't give [regulators] all of the information.’  ‘I will probably never take another pill without totally investigating it, questioning my doctor and pharmacists and reading all the information I can,’ Wade said.”  [Chicago Tribune, 8/20/05]

• Juror Stacy Smith: “The issue, to me, was, did Merck know before they put the drug on the market, and when they did, why didn't they do something about it immediately?” [World News Tonight, ABC News Transcripts, 8/19/05]

• '”’Look at the evidence,'’ said Marsha Robbins, the forewoman, when asked whether the award was excessive.  ‘They knew they had a problem,'’ she said of Merck, the maker of Vioxx. … One factor that swayed the jury, Ms. Blas said, was another look at Merck's labeling of Vioxx, even after the company began warning doctors that the drug could be linked to ‘cardiovascular events’ like heart attacks and strokes.  ‘In the first label, it didn't jump out at you that C.V. events were happening,’ Ms. Blas said, referring to a cardio vascular event. ‘You had to dig three levels to see it.’”  [The New York Times, 8/20/05]

Thanks again to ATLA for pulling together this jury information from the Ernst Vioxx trial.  Return here tomorrow to read Part Three of this Texas Vioxx verdict series.

(Posted by: Tom Lamb)

The Ernst Vioxx Verdict: A Retrospective Look Into the Jury Room, Part One

The Ernst v. Merck Jury: On Sending a Message to Merck and Big Pharma

The Association of Trial Lawyers of America ("ATLA"), of which I am a proud member, has compiled selected statements made by some of the jurors who heard the evidence presented during the Ernst v. Merck trial in Texas.  These Vioxx juror quotes provide some insight about what inspired this jury to hand down their massive $253 million verdict in favor of the plaintiff in the Ernst case.

Today's segment will focus on how the Ernst jury believed it was sending a message to Merck and Big Pharma as concerns unsafe drug issues, and Vioxx in particular, by means of its verdict.

Part Two of this series will focus on how the Ernst jury considered Merck's decision to market Vioxx despite knowing about the cardiovascular problems associated with their drug. 

Last but not least, Part Three will delve into how the Ernst jury determined that punitive damages were warranted, and how the jurors arrived at the $229 million punitive damages amount.

Now, let's see what members of the Ernst jury had to say about the message they meant to send by the verdict which they rendered in Brazoria County, Texas on August 19, 2005.

• “‘Stop doing the minimum to put a drug on the market,’” juror Derrick Chizer said. ‘Go out there and do your very best. ... Merck makes a lot of medicines. They're staking our lives. Be responsible.’” [The Dallas Morning News, 8/20/05]

• “Juror Derrick Chizer, who voted for Ernst, said the majority of jurors believed a heart attack triggered the Texas man's fatal arrhythmia, or irregular heartbeat.  ‘It could have been prevented,’ he said. ‘That is the message (to pharmaceutical companies). Respect us.’” [The Associated Press, 8/20/05]

• “[Juror Derrick] Chizer said the message jurors wanted to send to Merck was for the company to take their responsibility seriously.  ‘Every life counts to us. They should be responsible. If they care, then show it,’ said Chizer, 43, of Pearland, who works for the Social Security Administration.  [The Houston Chronicle, 8/20/05]

• Juror Lorraine Blas: “We wanted to make a statement. We wanted to let all the companies know that they can't do this. It's not right. You can't hide information. You have to give all the information.” [The Early Show, CBS News Transcripts, 8/20/05]

• “‘They needed to be held accountable for putting a drug out there that shouldn't be out there,’ said Stacy Smith, a 21-year-old child care provider who stood with the majority in the 10-2 vote in favor of the man's widow, Carol Ernst.  ‘I want them to listen,’ said Marsha Robbins, a 53-year-old homemaker who was the presiding juror and the oldest of the panel. …  David Webb, a 20-year-old electrician and one of the two youngest jurors on the panel, said he went into deliberations supporting Ernst, ‘but I wanted to give the defendants a chance. We just really didn't find anything that helped them.’” [Associated Press, 8/19/05]

Again, thanks to ATLA for pulling together this Vioxx jury information for our consideration.  Come back tomorrow to read Part Two of this Texas Vioxx verdict series.

(Posted by: Tom Lamb)

Scios / J&J to Educate Doctors Regarding Which Patients Should, and Should Not, Receive Natrecor

Guidance to Doctors Prompted by Natrecor Expert Panel or US DOJ Investigation of Sales Tactics?

Johnson & Johnson's Scios unit announced on August 22, 2005 the launch of a new program intended to educate prescribing doctors regarding which patients should receive Natrecor and, conversely, those patients for whom Scios does not recommend the use of Natrecor based on currently available clinical data.

Natrecor, an intravenous treatment, was approved by the FDA in 2001 for use in acutely ill heart-failure patients, people who arrived at the hospital with severe shortness of breath.  In the years following this FDA approval, however, Natrecor was increasingly used in outpatient infusion clinics, where heart-failure patients came for regularly scheduled treatments. Such "off-label" use contributed to sales of Natrecor in 2004 of $400 million.

The current controversy over Natrecor's off-label use in an outpatient setting arose after the publication of studies in two medical journals questioned whether Natrecor contributed to worsened kidney function and increased death rates.

There are conflicting theories as to why Scios and Johnson & Johnson (J&J) may have launched their new initiative at this juncture.  According the drug companies, this Natrecor recommended use initiative is a response to recommendations which the companies received recently from an expert panel made up of leading cardiologists. On the other hand, this decision by Scios and J&J to conduct an education campaign follows close on the heels of a disclosure last month that the U.S. Department of Justice (DOJ) was investigating whether Scios had engaged in the unlawful promotion of outpatient off-label use of Natrecor.

While it is not illegal for doctors to use drugs in ways beyond the FDA-approved indication -- such as the regularly scheduled infusions of Natrecor in outpatient clinics -- drug companies are prohibited from promoting their respective drugs for such unapproved uses. Scios and J&J have denied that they promoted any unapproved, or off-label, uses of Natrecor.

In a statement about this new Natrecor initiative, Scios said its education campaign would include training the entire Natrecor sales force on the recommended uses of the drug, as well as providing new promotional materials directed at those doctors prescribing Natrecor and putting educational advertisements for Natrecor in leading medical journals.  Dr. Darlene Horton, senior vice president of clinical research and medical affairs at Scios, provided this additional comment:

We are committed to our recommended use initiative and we are confident that it will further assist healthcare professionals in identifying appropriate patients for treatment with Natrecor....  Natrecor continues to be an important therapy for patients presenting to the hospital with ADHF. These patients have few well-studied treatment options.

Finally, Scios said that it has sent a letter to more than 160,000 healthcare professionals advising doctors and others on the proper prescribing and use of Natrecor.

(Posted by: Tom Lamb)

New Drug Safety Panel Will Mean More FDA Scrutiny of Drugs Already on Market, But Perhaps Not Enough

Congress Should Give FDA Authority to Impose New Labeling Language on Approved Drugs Without Needing Big Pharma's Permission

When Health and Human Services (HHS) Secretary Michael Leavitt was announcing the new Drug Safety Oversight Board (DSOB), he admitted that the FDA was trying to address continuing criticism concerning the agency's handling of drug safety issues related to currently marketed medications: "The public has spoken, and they want more oversights and openness," said Leavitt. "They want to know what we know, and what we do with the information, and why we do it."

Thus far FDA Commissioner Lester Crawford has rejected suggestions that its Office of Drug Safety should be made an independent entity, and instead is proceeding with the Drug Safety Oversight Board (DSOB) plan of action.  Under that plan, the DSOB is supposed to operate on two levels. First, the DSOB will consider the broad regulatory issues, such as what the FDA's drug-safety policies should be, e.g., how to balance risks and benefits.  Second, the DSOB will examine safety issues about specific prescription drugs already approved by the FDA, and attempt to resolve internal conflicts within the FDA about a particular drug-safety issue.

Looking beyond the FDA's public relations efforts in support of the DSOB plan of action, one must be concerned that the powers of the DSOB will be limited. A prime example is that although the FDA has promised that all DSOB drug-safety conclusions will be made public on a new Web site, the DSOB panel can only issue advisories. That is, the DSOB panel will not be able to force any FDA-approved drug off the market nor order changes in a pharmaceutical company's sales practices regarding a specific drug.

This limitation of the DSOB's power as concerns possibly unsafe drugs already on the market part is part of the reason that some top FDA officials do not believe the DSOB plan of action, by itself, is sufficient.  Given the current emphasis on how the FDA deals with the potential dangers of currently marketed drugs, those top FDA officials also want expanded legal authority from Congress.  On March 1, 2005 Sandra Kweder, deputy director of the FDA's Office of New Drugs, asked Congress for authority to impose new labeling language on approved drugs when the agency learns of problems related to a drug's safe use. As it stands at present, although the FDA can dictate label language as a condition of approving a drug for marketing, once the marketing approval has been given by the FDA, "we don't have the authority to tell a company, 'This is how your label has to look,'" Kweder testified.

In more depth, presently -- unless the Health and Human Services (HHS) Secretary declares that a prescription drug's current labeling creates an "imminent hazard", or the FDA moves to take the drug off the market entirely, i.e., a drug recall, extreme situations, both -- all the FDA can do is "negotiate" with a pharmaceutical company over changes to the package insert label of a possibly unsafe drug being used by thousands of patients, daily. 

One needs to look no further than Vioxx (rofecoxib) for an illustration of this problem.  As the FDA's Kweder testified before Congress in March 2005, safety-related label change negotiations for Vioxx took 14 months because Merck rejected the FDA's suggestions and, in turn, agency officials rejected Merck's proposals.

Let's hope lawmakers take heed of this request for more FDA authority, so that the FDA can get back to being the regulator as opposed to just another stakeholder who must grovel with the drug companies over warning label changes that would protect patients.

(Posted by: Tom Lamb)

Upcoming Vioxx Trials: The Fall 2005 Line-up for Merck and Its Lawyers

A Summary of the Vioxx Lawsuits Coming Soon in New Jersey, Texas, and Louisiana

As is well-known by now, Merck & Co. lost its first Vioxx trial in a Texas state court last week, where the jury found that Vioxx was responsible for the death of Robert Ernst, and awarded his widow a resounding verdict of $253 million.

Merck is scheduled to defend itself this fall in three Vioxx cases set for trial in New Jersey, Texas, and Louisiana.  Here is a summary for each Vioxx lawsuit going to trial this fall, including a description of the plaintiff and Merck's likely defense strategy at the respective trial.

The New Jersey Vioxx trial is scheduled to start September 12, 2005 in an Atlantic County state superior court, and is expected to last four to five weeks.  The plaintiff in that lawsuit is Frederick Humeston of Boise, Idaho, who alleges that his September 18, 2001 heart attack was caused by Vioxx. Mr. Humeston was 56 at the time of his heart attack, which he survived.  According to his attorney, Mr. Humeston started taking Vioxx regularly on July 16, 2001 -- two months before his heart attack.

Merck will likely defend this New Jersey Vioxx case by asserting that Mr. Humeston had numerous pre-existing risk factors, including his age, male gender, cholesterol problems, borderline hypertension, obesity, and a lack of physical activity. The period of Vioxx use by the plaintiff will also be a basis for Merck's contention that this was a heart attack waiting to happen, and it had nothing to do with Vioxx.

The Texas Vioxx trial is scheduled to begin in October 2005 in a state court in Edinburgh, Texas.  The plaintiffs is that case will be the family of Anna Marie Guerra, who died on May 6, 2001 at age 39.  Ms. Guerra started taking Vioxx in April 2001, such that her use of Vioxx is only about one month.  Furthermore, Ms. Guerra reportedly was overweight and there is a family history of heart disease.

The Merck attorneys for this Texas Vioxx case will likely emphasis the pre-existing medical conditions and the short duration of Vioxx use.  Of course, the specter of the recent massive jury verdict in the Ernst case will be hanging over their heads as they attempt to defend the drug company in this second Texas Vioxx trial.

The Vioxx case planned to start on November 28, 2005 in Louisiana is the first federal court Vioxx trial.  The case will be heard by a jury sitting in New Orleans, and this case is part of the federal court Multi-district Litigation ("MDL").  The Plaintiff is Evelyn Irvin, who is suing Merck for the wrongful death of her late husband, Richard Irvin Jr., who resided in Florida.  Mr. Irvin died in May 2001 of a heart attack after taking Vioxx for just one month.

As for the anticipated defense in this case, Merck will likely focus on the short time period, one month, that Mr. Irvin took Vioxx. Recall that back in September 2004, the study that prompted Merck to withdraw Vioxx from the market had shown there was a higher risk of suffering a Vioxx-related heart attack only after use of Vioxx for 18 months or more.

Notably, the plaintiffs' attorneys for all three Vioxx cases, above, maintain that there is sufficient medical evidence available for them to successfully show a jury that short-term and long-term usage of Vioxx can cause a heart attack.

We will keep you posted on any developments regarding these Vioxx trial dates.

(Posted by: Tom Lamb)

Patients Discharged From Hospital Often Lack Sufficient Knowledge About Their Medications

Drug-safety Issue: Prescription Medication Noncompliance Due to Patient Misunderstanding

In the August 2005 issue of Mayo Clinic Proceedings (Mayo Clin Proc 2005;80:991-994) a small study report suggests that poor communication with patients when being discharged from the hospital is probably the leading cause of medication noncompliance. 

In this study researchers asked some patients being discharged from a New York hospital about their discharge diagnosis as well as the names, purposes, and side effects of their prescribed medications. On average, these patients were prescribed 3.89 medications upon hospital discharge.

The researchers found that about 42% of patients could correctly state their diagnosis upon discharge, with just 37% knowing the purpose for which their medications had been prescribed, and only 28% able to recite the names of these medications that had been prescribed.  Most alerting, perhaps, is that fewer than one in six (14%) of the discharged patients were aware of the common side effects associated with those medications that they had been prescribed.

The study's co-author, Dr. Eli A. Friedman, from the State University of New York in Brooklyn, made this observation in a statement about the published study report:

All methods that enhance patient's understanding of his or her discharge treatment plan focus on one central aspect -- proper communication.  Although not all patients are noncompliant because of poor communication, this is probably the leading cause of noncompliance.

Dr. Edward Rosenow, a Mayo Clinic physician and author of a related editorial, said, "I collectively refer to the issues contributing to misunderstanding and medication noncompliance as the sixth vital sign, because in many ways they are as important as the well-known four vital signs and the new fifth vital sign of pain."

One certainly hopes that this small study report gets some major attention in hospitals across the land so that fewer patients suffer problems due to medication noncompliance resulting from this apparent failure by prescribing doctors to communicate well with their patients.

(Posted by: Tom Lamb)

Ernst v. Merck Vioxx Trial: Massive Verdict for Plaintiff; Knock-out Punch for Merck?

Merck Vows to Fight All Comers Despite Texas Jury's Condemnation of Vioxx to Tune of $253 Million

On August 19, 2005 Merck & Co. was found negligent in the nation's first Vioxx trial, Carol A. Ernst v. Merck & Co. Inc., in the District Court of Brazoria County, Texas.  This wrongful death case concerned Robert Ernst, a 59-year-old triathlete who used Vioxx for eight month before his death.  Mr. Ernst's death certificate said he died of an arrhythmia, or irregular heartbeat.  At the Texas trial, the attorneys for Carol Ernst argued that her husband actually died from a Vioxx-related heart attack. 

The Texas jury of seven men and five women heard competing evidence during the five-week trial about whether Vioxx caused Mr. Ernst's death and in the end, by a 10 to 2 vote, found the drug company Merck liable for this death.  In turn, the Brazoria County jurors awarded the plaintiff $24 million in actual, or compensatory, damages, and then another $229 million in punitive damages, for a total of around $253 million.

Texas law, however, limits the amount of punitive damages a plaintiff can receive despite what the jury believes is justified.  By operation of this statutory "cap" the punitive damages aspect of the Ernst case jury verdict will be reduced by the judge to $1.6 million, meaning the final overall award will be about $26.1 million -- if the verdict is not modified or overturned by Texas appellate courts.

According to a company press release issued the same day that the trial verdict was handed down, Merck said its lawyers are considering the following grounds for appeal as concerns the Ernst Vioxx case:

"Allowing opinion testimony to be given to the jury by unqualified experts";

"Allowing opinion testimony that was not based on a reliable scientific basis as required by Texas law";

"Allowing evidence with no relevance to the issues of the case, which unfairly prejudiced the jury"; and,

"Allowing undisclosed surprise witness and expert testimony contrary to Texas law."

Before the Ernst trial verdict, Merck had said every Vioxx lawsuit would be contested in court, rather than settled out of court.  The drug company's primary "handler" as regards the Vioxx litigation, Kenneth C. Frazier, senior vice president and general counsel of Merck, reiterated that defiant stance after the Texas jury's verdict was announced. 

"We believe that we have strong points to raise on appeal and are hopeful that the appeals process will correct the verdict....  Our appeal is about fundamental rights to a fair trial....  There are other Vioxx cases coming to trial and we will vigorously defend them one by one over the coming years."

State court Vioxx trials are scheduled to begin in the next few months in New Jersey and possibly California and Alabama.  The first federal court Vioxx trial is scheduled for November in New Orleans.

(Posted by: Tom Lamb)

Abbott's Weight-loss Drug Meridia Gets a Confidence Vote by FDA

FDA Denies Public Citizen's Petition to Remove Meridia from Market
   

The FDA has decided that the benefits of Abbott Laboratories' prescription weight-loss drug Meridia continue to outweigh the drug's risks for select obese patients.  As such, on August 16, 2005 the FDA denied a petition that had filed by the consumer advocacy group Public Citizen three years ago asking the FDA to take Meridia off the market in the U.S.

Public Citizen filed its petition with the FDA because the group alleged that adverse event reports made to the FDA showed Meridia having contributed to more than 400 adverse patient reactions, including dozens of fatalities, since Meridia was approved by the FDA in 1997.

Meridia has had a checkered past as regards whether or not it should be on the market.  At the outset, an FDA advisory panel voted 5-4 against marketing approval for Meridia in 1996.  After the filing of the Public Citizen Meridia petition three years ago, attention to the drug-safety issues for Meridia faded for awhile.  However, those issues were at the forefront, again, in the fall of 2004 when FDA safety officer Dr. David Graham listed Meridia among five potentially dangerous drugs the agency needed to review -- a list that also included  Crestor (cholesterol drug), Bextra (painkiller), Accutane (acne drug), and Serevent (asthma medicine).

In more detail, the Public Citizen petition framed this issue for the FDA: Does Meridia's benefits outweigh the risks of high blood pressure and stroke.  Commenting on the FDA's decision to deny their petition, Public Citizen said the FDA's decision about the safety of Meridia was misguided and issued a statement by Sidney M. Wolfe, MD, Director of Public Citizen’s Health Research Group.  "This means the FDA has made another mistake," said Dr. Wolfe. "A lot of the people who died from this were very young, in their 20s, 30s and 40s. It is very difficult for the FDA to admit they made mistakes."

One hopes that for the sake of those people who are using Meridia, the FDA has made the right decision, here.

(Posted by: Tom Lamb)

Crawford & Co. Go on Tour: FDA Road Show Will Visit Miami, Boston, and Phoenix

"Vision 2006" Public Meetings to be Hosted by FDA Commissioner Lester Crawford

According to news reports published August 16, 2005, Lester Crawford, the new head of the FDA, will be putting on a series of public hearings in Arizona, Florida, and Massachusetts starting next month.  According to those reports, Crawford has decided to use a talk-show format for this series of public hearings, which he has named "Vision 2006".

As described, FDA commissioner Crawford will host these events, mingling with those in attendance and taking their questions. The intended aim of the Vision 2006 FDA public meeting series is to allow Crawford and his colleagues at the FDA to find out what is on the minds of American consumers as regards "direct to consumer" (DTC) drug advertising, actual and perceived conflicts of interest among federal advisers, and prescription drug safety, among other topics.

The schedule for the Vision 2006 tour by Crawford and company is as follows:

• September 13, 2005 in Miami, FL
• November 2, 2005 in Boston, MA
• November 30, 2005 in Phoenix, AZ

Suzanne Trevino, an FDA spokeswoman, said that each session will run 10 a.m. to 4 p.m., and that the FDA hopes each session will attract at least 150 people.  According to a notice published in the August 16, 2005 edition of the Federal Register, people who are interested in attending may of the Vision 2006 public hearing can register at the following web site: www.grad.usda.gov/vision

Some FDA-watchers pointed out, quickly, that the Vision 2006 meetings idea resembles some of the public session events put on by Dr. David A. Kessler while serving as FDA commissioner from 1990 to 1997.

It seems that the FDA chose locations around the nation for the Vision 2006 events in order to hear different types of concerns and questions, on the presumption those would vary by region.  For example, FDA spokeswoman Trevino said Florida was selected for the diversity of its aging population, and Arizona was included because many seniors travel to Mexico to buy inexpensive prescription drugs. In turn, Boston has a high concentration of prescription drug and medical device companies which are directly affected by the FDA's regulatory actions.

(Posted by: Tom Lamb)