Source: - Doug Bremner's 'Before You Take That Pill' Blog

One has to admire the work of Sen. Charles Grassley. His thirst for the truth is admirable and he will not stop until the flames are put to rest at GSK.

His latest release to the public is a brochure from a GlaxoSmithKline program called "Psychnet".

http://fiddaman.blogspot.com/

"Psychnet" was created by GlaxoSmithKline in 2000 and, it seems, was a promotion tool for Paxil [Seroxat]

Basically, "Psychnet" was developed for the sole purpose of rounding up 'influential' psychiatrists so they could be trained to give other psychiatrists their 'wisdom' regarding the wonders of Paxil [Seroxat]. GSK label the brochure the 'Consultant Resource Manual'.

The intro states that the booklet is provided as a guide to help plan Psychnet programs in various regions. The brochure states "Psychnet is a new resource for all consultants to use for dinner programs, round tables or any speaker engagement".

They proudly boast, "Psychnet physicians have all been educated on the benefits of Paxil and its effective treatment on mood and anxiety disorders."

Personally, I just love the following line - "Psychnet Paxil Clinicians Speaker Council is one of many physician programs the Paxil team has developed for 2000 to engender solid relationships with influential pysicians in each region."

Further on they add, "Psychnet is an ideal way for key opinion leaders to influence clinicians in your region on the benefits of Paxil versus competitors."

Now Sen. Grassley has released this brochure I really hope he asks for the Psychnet presentations and slide kits. Each Psychnet speaker were trained on a total of 5 presentations and provided with 35MM slides and CD ROMS.

The brochure goes on to explain just how much money each physician will get for their presentation and to dangle the carrott more the brochure states:

To ensure that your Psychnet physician gets paid properly and in a timely fashion, you must:

- Write "Psychnet Presentation" in the "NOTES" section of your speaker request form and indicate $2500 for the honorarium.

- Send in your Speaker Request Form as quickly as possible, no later than 30 days prior to the speaking engagement.

- Work with the physician to ensure that he/she submits his/her expense form as quickly as possible after the speaking engagement.

The 'gagging order' comes in the form of, "Psychnet speakers have signed a confidentiality agreement to not disclose or share information about the Psychnet program, including compensation and content of materials."

GlaxoSmithKline... Don't you just love them!


Hat tip to Gianna Kali of Beyond Meds for bringing this to my attention.

Doug Bremner writes about this in more detail here. In the past Doug and I have had differing opinions but I have to applaud him with this gem of an article.

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This is a perfect example where,as a parent,
I would wonder what in the hell I had done wrong, if my child were involved in something like this.  Unbelieveable!!  Obviously some of these kids involved in the bullying incident are low class and pathetic.  

It is nice to see other students, with morals, stand up for what they believe in and support a girl they dont even know.  Hats off to you guys!!

Students from a Cambridge separate high school English class penned letters yesterday in support of bullied high school student Lindsay Hyde.

"My class wrote a bunch of letters in support of what she's going through," said St. Benedict's teacher Filomena Bosagri.

Her 21 Grade 9 students learned of Hyde's plight while studying newspapers in class.

In the most recent incident on Sunday night, Hyde's Mississauga home was pelted with eggs, yogurt, watermelon and condoms.

The West Credit high school student and her mother came forward more than a week ago after an alleged incident in which the teen was attacked on a bus in January while the bus driver and other students did nothing.

She had pens thrown at her, gum shoved down her shirt and a condom wiped over her face and jacket. Hyde was also punched in the face while getting off the bus

She had also been taunted with names and shoved in school hallways before the bus ride.

Peel Regional Police charged a female with assault and breaching her conditions of release.

Hyde's ordeal elicited support from far and wide. More than 100 letters and e-mails have been sent to the Sun in reaction to the story about the Grade 10 student.

"The families of targeted kids don't get a day off from this problem," one mom wrote in a letter to the editor yesterday.

She said her son is being bullied at his school.

"As a parent of a child who is being bullied, the article really sparks a wide range of emotions," she wrote of the Sun's coverage.

Tags: Lindsay Hyde School Bullying

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Geniuses don't exist in the present. Think of the people you've met: Would you call any of them a genius in the Mozart, Einstein, Shakespeare sense of the word? Even the MacArthur Foundation's "genius" grants don't call their winners geniuses.

We throw the g-word around where it's safe: in reference to dead people. Since there's no one alive who witnessed Wolfgang Amadeus Mozart pee in his kindergarten pants or saw young Pablo Picasso eating crayons, we can call them geniuses in safety, as their humanity has been stripped from our memory.

Even if you believe geniuses exist, there's little consensus on what being a genius means. Some experts say genius is the capacity for greatness. Others believe it's that you've accomplished great things.

Forget this pointless debate. Chasing definitions never provides what we want: a better understanding of how to appreciate, and possibly become, interesting creative people. Instead let's run through the history of geniuses and pull out some telling patterns.

Have a great, or horrible, family

Picasso, Mozart, Beethoven, Einstein and Goethe are popular geniuses whose parents were interested in their creative lives. Mozart and Beethoven both had fathers who were professional musicians and they were taught by them during childhood to play instruments. Can you guess what Picasso's dad did? Yes, he was a painter, and he spent many hours with young Pablo.

One popular legend surrounding Einstein is that he was obsessed with a compass given to him by his dad. The more potent factor in his development was family friend Max, who taught Einstein science and philosophy. Then, of course, there's Van Gogh. The only healthy relationship he ever had was with his brother Theo.

But lousy families can make geniuses, too.

Beethoven's dad was cruel, torturing him during practice sessions. Unlike many child prodigies who burn out at adolescence, Beethoven kept his passion for music. Leonardo da Vinci barely knew his father.

Isaac Newton was also born to a single-parent home and hated his stepfather. From that broken relationship may have come the seed of unrest that fueled his independent life and ideas.

Be obsessed with work

Show me a genius and I'll show you a workaholic. Van Gogh produced 2,000 works of art between 1880 and 1890 (or 1,100 paintings and 900 sketches). That's four works of art a week for a decade. He didn't even get started until age 25.

Da Vinci's journals represent one clear fact: Work was the center of his life. He had neither a spouse nor children. Picasso was a machine, churning out 12,000 works of art. He said, "Give me a museum and I'll fill it" and made good on that boast. Shakespeare wrote more than 40 plays, plus dozens of sonnets, poems and, of course, grocery lists.

These are people who sacrificed many ordinary pleasures for their work.

The list of lazy geniuses is short. There are burnouts, suicides and unproductive years in retreat--but none could be called slackers. Malcolm Gladwell, in his book Outliers contends that the key to any success is 10,000 hours of practice.

The debate over talent vs. effort is moot: History makes it clear you always need extraordinary effort.

Have emotional or other serious problems

For all their brilliance, most geniuses did not live well-adjusted lives. Picasso, Van Gogh, Edison, Einstein and Nietzsche (and most major modern philosophers) were often miserable. Many never married or married often, abandoned children and fought depression.

Newton and Tesla spent years in isolation by choice and had enough personality disorders to warrant cabinets full of pharmaceuticals today. Michelangelo and da Vinci quit jobs and fled cities to escape debts.

Kafka and Proust were both hypochondriacs, spending years in bed or in hospitals for medical conditions, some of which were psychological. Voltaire, Thoreau and Socrates all lived in exile or poverty, and these conditions contributed to the works they're famous for.

Happily positive emotions can work as fuel, too. John Coltrane, C.S. Lewis and Einstein had deeply held, and mostly positive, spiritual beliefs that fueled their work.

But the real lesson is that all emotions, positive or negative, provide fuel for work and geniuses are better at converting their emotions into work than more ordinary people.

Don't strive for fame in your own lifetime

Most people we now consider geniuses received little publicity in their lifetimes compared with the accolades heaped on them after their deaths. Kafka and Van Gogh died young, poor and with little fame.

Desiring fame in the present may spoil the talents you have. This explains why many young stars have one amazing work but never rise to the same brilliance later: They've lost their own opinions. Perhaps it's best to ignore opinions except from a trusted few and concentrate on the problems you wish to solve.

To focus on learning and creating seems wise. Leave it to the world after you're gone to decide if you were a genius or not. As long as you're free to create in ways that satisfy your passions and a handful of fans, you're doing better than most, including many of the people we call geniuses.

Leonardo da Vinci (1452-1519)

He was estranged from his father. One of his most frequently cited childhood memories was finding a terrifying cave where he felt monsters lurked. He learned through apprenticeship.

Michelangelo (1475-1564)

His mother died when he was 7. He was notorious for quitting jobs and overbooking his schedule. Even so, he was a fountain of productivity in the form of paintings, sculpture, poetry and, yes, engineering.

Johann Wolfgang von Goethe (1749-1832)

Considered one of Germany's greatest literary stars, he was born into a noble family and had the best tutors in Germany.

Friedrich Nietzsche (1844-1900)

He suffered from migraines and stomach problems his entire life and had what many believed to be a psychotic breakdown when he was in his mid-40s. His mother and sister took care of him until he died.

Thomas Alva Edison (1847-1931)

He suffered most of his life from hearing problems. His school teacher called him "addled." His best invention may be the collaborative research lab not the light bulb.

Vincent Van Gogh (1853-1890)

He made 2,000 works of art in 10 years. Cutting off his ear was hardly a fashion statement. He committed suicide.

Nikola Tesla (1856-1943)

Inventor and engineer extraordinaire, he suffered what was apparently a nervous breakdown in his early 20s. He would see bright flashes of light before his eyes and have hallucinations. He obsessed about doing things in threes and, surprise, likely had obsessive compulsive disorder.

Johann Wolfgang von Goethe (1749-1832)

Considered one of Germany's greatest literary stars, he was born into a noble family and had the best tutors in Germany.

Tags: Thomas Edison Wolfgang Von Goethe

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WINNIPEG - A man who believed he was following God's orders when he stabbed and beheaded a fellow passenger on a Greyhound bus in Manitoba has been found not criminally responsible, to the consternation of the victim's loved ones.

Justice John Scurfield said Vince Li's attack on Tim McLean last summer was "grotesque" and "barbaric," but "strongly suggestive of a mental disorder."

"He did not appreciate the actions he committed were morally wrong. He believed he was acting in self defence," Scurfield said Thursday.

Both Crown and defence psychiatrists had testified at Li's trial that he was suffering from schizophrenia and believed God wanted him to kill McLean because the young man was a force of evil.

Li, 40, was charged with second-degree murder but pleaded not guilty.

McLean's mother, Carol deDelley, was upset but not surprised by the verdict

DeDelley said Li may have been mentally ill when he attacked her son, but the fact remains that a crime was committed.

"He still did it," she told reporters outside court. "Whether he was in his right frame of mind or not, he still did the act. There was nobody else on that bus holding a knife slicing up my child. Nobody else did that. Just one individual did that."

DeDelley said the law needs to be changed so someone can be found not psychologically accountable but still criminally responsible for a crime.

She also took a shot at Canadian immigration policies which she said allowed Li, who was born in China, into the country with a mental illness in the first place.

Crown prosecutor Joyce Dalmyn agreed with the decision.

"This was justice," Dalmyn said outside court. "I feel that the judge did his job properly and reached the correct conclusion. Obviously these are very difficult files to deal with."

Li will be institutionalized without a criminal record and will be reassessed every year by a mental health review board to determine if he is fit for release into the community.

Such boards look at police reports and transcripts of previous judicial hearings and also hear evidence from treating psychiatrists, who testify about a patient's current mental condition, treatment plan and prognosis. Crown and defence lawyers get the opportunity to ask questions.

The board must carefully consider whether a patient could function in society or would pose a risk to the public. Members take into account a patient's insight into the illness as well as into what happened.

DeDelley said she and her family will attend the annual reviews to try to ensure that Li will never be allowed on the streets again.

Dalmyn said she has faith in the process.

"I have confidence that the review board will do its job properly," she said.

Scurfield's decision brings an end to a trial that lasted barely two days and only heard from the two psychiatrists, both of whom testified that Li is mentally ill and didn't realize killing McLean was wrong.

McLean's family has dismissed the trial as a "rubber stamp" that is allowing Li to get away with murder. They are vowing to turn their attention to fighting the law that allows people who are found not criminally responsible to be released once they are deemed well, without serving a minimum sentence in jail.

DeDelley said her son didn't die in vain. His death highlights concerns about the justice system, she has said.

That Li killed the 22-year-old carnival worker - brutally stabbing him dozens of times, beheading him and then mutilating his body - was never in question at the trial.

An agreed statement of facts read in court detailed how Li sat next to McLean after he gave him a smile and asked how he was doing. It was after McLean closed his eyes to listen to music on his headphones that Li said he heard the voice of God.

"Suddenly the sunshine came in the bus and the voice said, 'Quick. Hurry up. Kill him and then you'll be safe,"' Li told one of his psychiatrists. "It was so quick, such an angry voice, and I had to do what it said. I was told that if I didn't listen to the voice, I would die immediately."

Li ignored other horrified passengers as he repeatedly stabbed the young man, who unsuccessfully fought for his life.

When the bus pulled over near Portage la Prairie, Man., Li was engrossed with stabbing and mutilating McLean's body. Passengers fled the bus and stood outside.

Li tried numerous times to leave the vehicle but was locked inside and continued methodically carving up McLean's body. Police said body parts were found throughout the bus in plastic bags, although part of his heart and both eyes were never found and were presumed to have been eaten by Li.

The victim's ear, nose and tongue were found in Li's pocket.

God told him to cut up McLean and scatter his body parts around the bus, Li said.

"God told me to do it. Otherwise it would come back to life very quick and kill me. So I cut it up to make sure he couldn't come back to life ... God told me to cut off his head, so I did."

Li tried to escape from the bus through a window and was taken into custody.

After that, with blood smeared on his face from the attack, he politely apologized to police and pleaded with officers to take his life.

Tags: Canada Beheading Li Tim McClean

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OTTAWA - Nadia Kajouji might not be the only person who was allegedly coaxed into taking her own life by a Minnesota man, according to police.

Investigators with the Minnesota Internet Crimes Against Children unit (ICAC) are looking into the possibility that 46-year-old William Francis Melchert-Dinkel is involved in "encouraging, advising and assisting adults and juveniles with committing suicide through the Internet."

Investigators have made no arrests and laid no charges against Melchert-Dinkel, a male nurse with a history of disciplinary action from the Minnesota Board of Nursing.

Minnesota courts can impose a maximum sentence of 15 years in prison if an individual is found guilty of encouraging a suicide.

Authorities seized a computer last March, finding online correspondence between a man, who was posing as a depressed young female, and Kajouji, who disappeared from her Carleton University dorm room March 9, 2008.

Investigators confirmed there were several Internet chats between the two, in which Kajouji was encouraged to take her own life.

Police said the final correspondence between the two occurred on the day Kajouji disappeared. Her body was discovered six weeks later on the banks of the Rideau River.

ICAC investigators are following up with other individuals contacted in online conversations about suicide.

Staff Sgt. Uday Jaswal said the Ottawa police investigation into Kajouji's death yielded much of the same information as their American counterparts.

"It's no secret that there was a chat log that we located off Nadia's computer, and some of that information was pertinent to the Minnesota investigation," said Jaswal.

AEDAN.HELMER

Tags: Francis Melchert-Dinkel Is Involved In "encouraging Advising And Assisting

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Tags: Japanese Woman Impregnated With Wrong Egg

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Recent headlines have uncovered one shocking lapse after another at the Food and Drug Administration: A popular diabetes drug can sharply increase the risk of heart attack, a finding the agency knew but took two years to reveal. An FDA-approved antibiotic can destroy your liver in just five days. And despite mounting concerns about the safety of Chinese-made drugs, the agency had only enough field inspectors last year to check a mere 13 of the 714 Chinese factories that produce medicines for U.S. consumers.

Many of the nation’s leading doctors, scientists and lawmakers now agree that the FDA is in crisis. Lurching from one disaster to another, the 102-year-old agency learns of dangers too late and then moves too slowly to remedy them. Insiders say it’s woefully underfunded, dangerously understaffed and fractured by bitter internal tensions. Instead of depending on the FDA, Americans are doubting it — and for good reason.

The FDA is expected to regulate $1.5 trillion in food, drugs, vaccines, medical devices, blood and tissues, radiation-emitting machines, animal feeds and drugs, cell phones, dietary supplements, biotechnology and gene therapy — and, post-9/11, sniff out any food-borne terrorist plot. Yet the agency’s annual funding, $2 billion, is about what Fairfax County, Virginia, pays for its public schools.

“Think your pacemaker, heart valve, microwave oven or morning vitamin was inspected?” asks former associate commissioner William Hubbard. “Dream on.”

A chilling new report commissioned by the FDA’s own advisory Science Board describes an organization nearly out of control. “We were shocked at the appalling state of science at the FDA,” says Garret FitzGerald, MD, chairman of the pharmacology department at the University of Pennsylvania School of Medicine and an advisor on the report. “The analogy is Katrina. But we have to fix this before the hurricane hits.”

Drug safety is perhaps the greatest concern. The respected Institute of Medicine, created in 1970 by the National Academy of Sciences, recently labeled the FDA’s drug branch “dysfunctional,” saying it muzzles scientific dissent, inadequately monitors drug safety and relies too heavily on drug company dollars.

Even the department’s champions are worried. “I don’t think the FDA is at a collapse point yet, but it’s getting close,” says Hubbard, who retired in 2005 after 26 years at the agency. “In some places, regulation is so weak that there’s nothing left.”

The agency’s most recent difficulties began in 2004, when officials came under fire for silencing a staff scientist who had concluded that antidepressants could increase suicidal behavior in teens. That same year, the FDA was criticized for not acting quickly to take the painkiller Vioxx off the market after it was shown to increase the risk of heart attack and stroke.

“Every generation has required some health disaster to reform the FDA,” says David Graham, MD, a drug safety expert who has worked at the agency for 24 years. Today, he says, that window of opportunity has been pried open by debacles such as Vioxx. Former FDA commissioner David Kessler, MD, agrees: “These are the times when things get fixed.”

Congress has begun that job. Last September, lawmakers did increase the FDA’s funding by $145 million, although only about one fourth went to the drug-review branch (more on that later) and boosted its regulatory powers. Observers hope FDA officials will use their new clout to restore the agency’s lost luster. But they say the public needs to weigh in to make sure that happens. Here, the five key problems, what’s being done to fix them and how you can help.

• Problem: Pressure From the Industry
There’s pressure to speed decisions, and there’s pressure to soft-pedal problems. That means drugs may go on the market without adequate vetting — or follow-up. Critics of the FDA like to say it’s the best agency the pharmaceutical industry can buy. That’s a political jab, and agency advocates say it’s unfair. “The extraordinary efforts of these committed staff members are the very reason further catastrophic food-and-drug events have been averted,” an otherwise scathing review by the FDA’s Science Board concluded last November.

But most agree that there’s at least a problem of perception, and perhaps more than that, caused by the growing chunk of the agency’s budget that comes directly from drug companies. Industry dollars now pay for more than half of the FDA’s drug-review budget; in five years, that proportion is expected to jump to 70 percent.

Called user fees, this $400 million a year is designed to speed decisions on applications for new drugs. “User fees seem to save taxpayers money,” says Susan Wood, PhD, the former assistant commissioner for women’s health at the FDA and now a professor of public health at George Washington University. “But they undermine public confidence in the FDA’s independence and impose time pressures that could end up costing lives.”

Faster approval of drugs, of course, is a very good thing if you need a lifesaving medicine. Many patients are clamoring for that speed. Review times have been cut from 27 months to less than a year. Vioxx was fast-tracked in just six months. But some argue that the pendulum has swung too far. “A lifesaving drug should be sped along,” says Steven Nissen, MD, chair of the department of cardiovascular medicine at the Cleveland Clinic and a frequent advisor to the FDA. “But with user fees, we’ve pressed the accelerator on all drugs, and that’s a mistake.”

Here’s the danger: “The easiest way to make those deadlines is not raise too many questions and just accept what the drug companies say about safety,” says former FDA drug reviewer David Ross, MD. Too often, Dr. Ross says, reviewers tell their FDA supervisors that a drug doesn’t work or has a major safety problem and “managers come up with contrived reasons to approve the drug anyway.” He says the standards of safety and efficacy have slipped to the point that the drug reviewers “can end up approving almost anything.”

No one can say that moving drugs more quickly from the laboratory to the pharmacy always puts Americans at risk. But there is a smoking gun: an alarming spike in adverse drug reactions reported to the FDA recently, from 267,000 in 2000 to over 471,000 in 2006. And the number of reported deaths has nearly tripled, from 5,519 to 15,107. That’s only part of the story: The agency estimates that it learns of fewer than one in ten drug reactions.

Janet Woodcock, MD, the FDA’s deputy commissioner and chief medical officer, flatly denies that user fees and sped-up approvals compromise safety. “The FDA is legendarily tough — our requirements are viewed as a really tough bar to get over.”

“The review standards have not changed one bit since the introduction of user fees,” says Alan Goldhammer, PhD, deputy vice president for the Pharmaceutical Research and Manufacturers of America, the drug industry lobby. “We’ve been careful never to compromise the independence of the FDA. Congress would not permit it.”

Nevertheless, says Dr. Woodcock, “I understand that there’s a perception problem.”

What’s Being Done
Congress slightly increased the FDA’s drug safety budget last year but accomplished that mostly by boosting user fees once again. To help offset that influence, and enable the FDA to tackle all its other responsibilities, reformers say Americans should pay 3 cents a day to fund the agency, rather than the 1.5 cents we now pay. The agency’s Science Board argues, “That’s a great price to pay for the assurance that our food and drug supply is, indeed, the best and safest in the world.”

• Problem: Safety of New Drugs
When the FDA approves a drug or medical device, staff scientists must, in effect, make a judgment call about its safety. They’re relying on industry studies that usually follow between 600 and 3,000 people, often for just a few months. Those small clinical trials are designed to measure a drug’s safety and effectiveness in a targeted group of patients — not the dangers the drug might pose when it’s taken by people with a wide variety of backgrounds and health conditions. “If it kills one in 2,000 people, or makes one go blind, you may not see that in the trial,” says Drummond Rennie, MD, a deputy editor of The Journal of the American Medical Association (JAMA) and a professor of medicine at the University of California, San Francisco. “You start adding that up, and that’s ten in 20,000 going blind, and that’s a lot of people.”

Those risks are revealed only after a medicine goes on sale and has been used for months or years by hundreds of thousands or even millions of people. Keeping track of those reactions is called post-market surveillance, and experts say it’s one of the most important phases of drug testing. Historically, user fees were not allowed to go toward checking the safety of drugs once they were on the market. And until now, those follow-up reports haven’t been mandatory. A 2006 report found that 65 percent of the studies that drug firms promised to conduct in recent years hadn’t even begun.

What’s Being Done
Congress authorized the FDA to spend $25 million from user fees this year to improve drug safety. But agency insiders say that’s not nearly enough. “You’ve still got a mismatch,” says Hubbard, who is now a senior advisor for the Alliance for a Stronger FDA, a group that includes seven former agency commissioners and three former Secretaries of Health and Human Services. “You still have all this effort going into getting the drugs on the market, and not much going into making sure they’re safe once they’re out there.”

On that issue, Congress got tough last year. The FDA can now require companies to trace the long-term effects of their drugs. If firms renege, they face stiff fines, up to $10 million for repeat offenses.

Another crucial reform: Companies can no longer treat the results of clinical trials as trade secrets. Until this year, a manufacturer could cherry-pick what it revealed — publishing a favorable study in a medical journal and sticking less rosy findings in a drawer. A report in the January New England Journal of Medicine revealed that one-third of antidepressant drug trials are not published, which can mislead doctors into thinking the drugs are more effective than they really are.

Here, too, Congress has drawn the line: Companies must post results of clinical trials on a public database, ClinicalTrials.gov, within one year of their completion. Independent experts should soon be able to evaluate the findings and better inform doctors and consumers about what the studies mean. Unfortunately, companies can wait three years to post summaries written for the general public.

That new measure of openness draws kudos from Dr. Woodcock, the FDA deputy commissioner. “People volunteered for those trials, and their lives may have been altered as a result,” she says. “They deserve to know that their information has contributed to society.” Having such full disclosure about a treatment or device is the only way to know what medical research means for all of us.

• Problem: Sloppy Record Keeping
For an organization whose core function is gathering and analyzing crucial facts quickly, the FDA’s partially computerized database “is like something that came off the ark,” says Dr. FitzGerald, the Penn pharmacologist and agency advisor.

Companies are required to tell the FDA about any severe reactions they learn of, and do so within 15 days if the injuries are life-threatening. And the agency operates a website called MedWatch (www.fda.gov/medwatch), where doctors (and patients) can download a form to report problems. But few physicians bother to use it. The result: Only a small fraction of adverse reactions get passed on. Even more important, the FDA doesn’t have the time or money to make sense of the information it does receive.

The agency is notified of half a million problems each year, a third of them serious, says Dr. Woodcock. Most of those reports arrive via paper fax and have to be sorted by hand. More worrisome, the FDA’s skeleton staff of 35 report analysts have only eight minutes to read even the most serious case, says Hubbard, who tracked such things as associate commissioner.

“We’ve never had enough resources to really do the job and hire the staff,” says Dr. Woodcock, who has been at the FDA for two decades. “And it’s not that we didn’t try.”

What’s Being Done
Congress has responded, telling the agency to invest several million dollars to connect to large medical-records databases run by the Veterans Health Administration, Medicare and HMOs. Using these databases will allow the FDA to better track and analyze adverse drug side effects. That means the FDA will know much sooner if a newly marketed drug needs to be relabeled or pulled off the market, even whether one medication works better than another. And thanks to Congressional intervention, the agency will now be able to make label changes quickly, without prolonged negotiations with the drug companies.

Problem: Conflicts of Interest

The FDA’s advisory boards, which vote on drugs and devices, are intended to represent a broad spectrum of physicians, researchers and patient advocates — not stockholders. But a study published in JAMA in 2006 found that in 22 percent of advisory board meetings, more than half the members had direct financial interests in the companies whose medical products they evaluated, or their rivals.

The agency says it’s doing the best it can. Because drug companies underwrite most clinical research, even at universities and hospitals, some say it’s difficult to find top medical experts with no ties to industry.

What’s Being Done
Congress has decided to roll up the red carpet. Over the next five years, the FDA will have to cut by 25 percent the number of advisory committee members with financial ties to a product under review. Consumer groups had hoped for an outright ban but say this is a step in the right direction.

• Problem: Muzzled Experts
Dr. Graham, in the FDA’s drug safety office, says that a few years ago he was ordered to soften his assessment of a drug he thought should be withdrawn because it could cause liver failure and death. “Industry is our client,” a supervisor told him.

“It may be your client,” Dr. Graham says he replied, “but it will never be mine.”

When told this story, FDA spokeswoman Julie Zawisza said, “Our client is really the public.”

Still, other agency scientists share Dr. Graham’s concerns. Drug reviewer Rosemary Johann-Liang, MD, suggested two years ago that the diabetes drug Avandia carry a black box on its label (the agency’s strongest warning), alerting patients and doctors to its cardiac risks. Instead, Dr. Johann-Liang says, her supervisors reprimanded her and deep-sixed her report.

Last August the agency did finally issue an urgent warning about the drug and placed a black box on its label. But by then Dr. Johann-Liang had resigned — and millions of Avandia prescriptions had already been filled.

Many agency staffers say they’ve felt similar pressure to soft-pedal product dangers. In a poll of 1,000 FDA scientists, conducted in 2006 by the Union of Concerned Scientists, 20 percent said agency decision makers had asked them explicitly “to provide incomplete, inaccurate or misleading information to the public, regulated industry, media or elected/senior government officials.” And 40 percent said they could not publicly express concerns about public health “without fear of retaliation.”

The tone has been set from the top. Last year Andrew von Eschenbach, MD, the FDA commissioner, told a roomful of staffers to stop making their gripes public. “If they don’t follow the team,” he said, “the first time, they’ll be spoken to; the second time, they’ll be benched; and the third time, they’ll be traded.” (FDA spokeswoman Zawisza says Dr. von Eschenbach has no desire to limit dissent.)

The tangled story of Ketek, a once-promising new antibiotic, illustrates what can happen when the agency’s scientists feel marginalized.

What’s Being Done
Last year Congress created the Office of Chief Scientist of the FDA, to give staff members a forum for debates and improve the quality of research. The new law also gives in-house staffers the right to publish their critiques in medical journals and makes sure their assessments, even if overruled, are made part of the public record.

Money alone won’t solve the FDA’s morale problem. In recent years, dozens of career scientists and senior managers have left the agency, a much higher turnover than that of the National Institutes of Health or the Centers for Disease Control and Prevention. Public trust in the agency has slid from 67 percent in 2001 to 36 percent in 2006.

Without change at the top, longtime agency watchers say, there’s no assurance that officials will get tough on industry scofflaws. In fact, from 2000 to 2005, FDA enforcement against drug, vaccine and medical device manufacturers dropped by more than 50 percent, according to a recent investigation by California Congressman Henry Waxman.

A discouraging sign: One of the first regulations the agency proposed this year is intended as a shield, according to some Congressional leaders, designed to protect drug companies from lawsuits brought by people who believe they’ve been injured by drugs or medical devices.

But having stronger tools and the right leadership could gradually restore the FDA to what it once was — a highly respected band of medical detectives, apolitical and immune to corporate pressure.

There is one bright spot on the horizon, says Jerry Avorn, MD, a professor of medicine at Harvard Medical School and an expert on the drug-approval process. “There is more public awareness of this issue than I’ve seen in 30 years,” he says. “And that can help put the agency’s many smart, dedicated people back into the driver’s seat. Because a lot of this is really not about very arcane science. It’s about common sense. And that’s what’s been missing, until now.”

Tags: FDA Dangerous Drugs

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Major Reality Check

When the pain reliever Vioxx was withdrawn from the market last fall after the announcement that it increased patients’ risk of heart attacks and strokes, millions of Americans panicked. The sometimes-sensationalized headlines didn’t help: People wondered, Should I trust my doctor? Could a medication that I thought would help me actually kill me? Is our drug safety system broken?

Suddenly, ads for the drug were replaced with ads looking for Vioxx “victims.” Law firms across the nation began recruiting anyone who had ever taken the drug as plaintiffs for class-action suits. Merck, the company that developed the drug, could be liable for billions of dollars, making it one of the costliest liability cases ever. No surprise, then, that Merck’s stock plummeted 40 percent in just six weeks.

But the real cost was even greater: Not only did patients stop taking Vioxx but, doctors say, many people stopped taking their other medicines, too — sometimes putting their health at serious risk.

Vioxx was the first pebble in the pharmaceutical rock slide. Soon, accusations about a spate of other drugs were making headlines, including all COX-2 inhibitors which, like Vioxx, relieve pain. The charges didn’t stop there. The FDA was accused of simply rubber-stamping new drugs; drug companies were blamed for hiding information about unsafe products; and the efficacy of clinical trials that did not reveal how large numbers of people would react was questioned. But one question that was rarely asked could determine whether or not pharmaceutical companies continue to develop and produce breakthrough medications that can save or extend lives and help people live without pain. The question: Do Americans expect drugs to be risk-free? And, if someone suffers a bad reaction, will lawyers rather than doctors be the first people we call?

Panic Over Pills: Overreaction?
During the ten-year period between 1994 and 2004, the FDA approved 321 completely new drugs (this doesn’t include approvals for changes to existing medicines), bringing the total to more than 10,000 drug products on the market. During that same period, eight drugs were withdrawn for reasons of safety, such as the diet drug fenfluramine (fen-phen, associated with heart-valve disease) and the allergy drug Seldane (linked to heart arrhythmias). But the Vioxx recall created a shock wave for the American consumer like no other. Many people had come to depend on their “meds,” and they expected them to be safe, too, especially when they cost so much. Prescription drugs account for, some say, the fastest growing segment (about one-tenth) of all health expenditures, with some specialty drugs costing hundreds of dollars per dose.

“With Vioxx, the real shock and outrage came when there was a suggestion that people in authority may have known about these harmful side effects and not shared them with doctors or the public,” says Anne Woodbury, chief health advocate for the Center for Health Transformation, a think tank founded by Newt Gingrich. It made people question their faith in the pharmaceutical industry, federal regulators and physicians: those we trust to make sure our drugs are safe. Before, taking a newly prescribed pill with a slug of water was as routine as brushing your teeth. For many people, this is no longer the case.

“Now patients and doctors are going to ask themselves: Could this new drug be another Vioxx?,” says Jerry Avorn, MD, a professor of medicine at Harvard Medical School and the author of Powerful Medicines: The Benefits, Risks and Costs of Prescription Drugs.

People have reason to worry. In clinical trial data submitted to the FDA, Vioxx showed no connection to heart problems. The drug was approved in May 1999. But after Vioxx hit the market and grew in popularity, heart problems were revealed — lots of them. Tens of thousands of people may have been affected, and Merck was accused of hiding that information.

“The system is not perfect,” comments Marianne J. Legato, MD, professor of clinical medicine at Columbia University College of Physicians and Surgeons in New York City. “Sometimes a company may not want to show data that are negative till they really know what’s going on. But it’s ridiculous to suggest that they would suppress things willy-nilly, because if a drug is going to cause severe side effects, it’s not in their best interest to hide that.”

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