ONE PAYCHECK AWAY FROM HUMANITY

THE STREETS OF CLEVELAND were filled with people last week, due mainly to the record-setting attendance levels at the 33rd Annual Cleveland International Film Festival (CIFF). If anyone doubts the power of the arts to engage citizens and revitalize communities, they would be wise to note how many suburbanites have flocked to downtown for CIFF during March.

AS I WANDERED through the streets of Cleveland and hosted out-of-town visitors, a few other thoughts bubbled to the surface as well. The numbers of homeless on the streets was staggering and seemed to be higher than the dreadful period in the late 80s and early 90s when beggars seemed to outnumber businessmen.

So it was sobering, to say the least — and upon request, I handed out $1 bills to dozens of men and women. I implored them all to avoid using the money for alcohol or drugs. Most were clear-eyed and appeared alcohol free, so perhaps my human investment did indeed go for food rather than ‘the devil’s tonic’ or some other destructive device.

Nevertheless, one of my guests gently criticized me for handing out dollar bills, saying, “don’t you realize you’re being scammed?”

I nodded his way and smiled, and recalled a similar event from New York City a decade prior. I was in New York frequently as a literary agent in 1997, and a nearly identical scenario existed. On every block there was a new person begging for money. Nearly every time I would give them a dollar until my dollar bills ran dry. A friend of mine, a hardened New Yorker who had lived in the Concrete Jungle for over twenty years, flipped out. “What the *%#@ are you doing, man?” he blurted out. “These people are here every day. This is what they DO. Why are you giving them money?”

I turned and smiled, calmly. I’d heard this reasoning many times before, especially during the production of my film, THE PROMISED LAND. “My friend,” I began, “if these people have fallen so far that they feel the need to scam change to survive, then I’ll give them a dollar.” My friend grumbled and uttered something about the streets of Manhattan meting out its “New York-style” justice to those who aren’t strong enough to survive, but I ignored the sentiment.

I once wrote that “the poor will always be my brothers and sisters,” and that even though I was raised as “Middle Class,” and had dined with the wealthy and powerful, that I would always feel great empathy for the poor. Being a filmmaker, at least thus far, has not made we wealthy, so I certainly can identify with those who are “one paycheck away from poverty,” and those who are already suffering.

A number of years ago I was dropping off some clothes and food to a soup kitchen in Cleveland. It was a particularly ugly day; temperatures were in the teens and it was snowing like Antarctica. A smiling African American gentleman lept to his feet and opened the door as I approached the entrance. He thanked me for bringing clothes and food to help the poor. I smiled back and proceeded inside where the soup kitchen was about to open.

After dropping off my donation I came back into the winter cold and pulled the collar of my long American Eagle overcoat up around my neck. As I reached my car, I stopped — and turned to look at the man who had opened the door for me. He waved and smiled as the snow continued to swirl around him.

I crossed the street and approached the man, who was in line with about 100 others. I asked him how long he had been coming to the Catholic center for food and he explained that he had lost his job a few months prior and had been unable to find work.

“Where are you sleeping?” I asked.

“Inside, when I can,” he joked.

“And how often is that?” I asked.

“About two times a week,” he said matter-of-factly.

So I took off my oversized American Eagle coat and told him, “You need this more than I.” He was a big man — about 6’2 — and the coat fit him perfectly, even over the layers of shirts and sweaters he’d been wearing.

“God Bless you,” he said to me.

“No sir, may God Bless you,” was my reply.

Over the coming weeks and months, I often saw the man wearing my coat as I made my way downtown. We spoke a number of times after that, and occasionally I would buy him a coffee. My simple act seemed to touch him beyond belief, but I tried to make him realize how much he had taught me; and how he helped put things into perspective.

During today’s horrific economic times, my “family” is hurting again, and the lack of compassion is more startling than ever. I suspect that we’ll see millions more on the streets, in tent villages, and more in the coming months.

Others will judge, rationalize, pontificate about the “scam artists and the bums” living on the streets, but I will not be among them.

Others will hoard and singularize, but to tell you the truth, I am thinking of walking the opposite direction.

If I can create a film about the plight of the poor, I will.

If I have bread to share, I shall.

If I have kindness to give, I will do my best to provide it.

If I can satisfy the afflicted, I will. And yes, if I have a dollar bill to invest in a fellow human, I will give it gladly.

I know I am naïve, but I still believe in the tenet, “There but for the grace of God go I,” and “what you put out comes back.”

For until things change, our humanity is all we have left. It is a perfect opportunity to change — and to evolve — if we so choose.

Godspeed.

Debate Over Drugs For ADHD Reignites: Study Admits Drugs May Have 'Long-Term Risk'

By Shankar Vedantam
Washington Post Staff Writer

New data from a large federal study have reignited a debate over the effectiveness of long-term drug treatment of children with hyperactivity or attention-deficit disorder, and have drawn accusations that some members of the research team have sought to play down evidence that medications do little good beyond 24 months.

The study also indicated that long-term use of the drugs can stunt children's growth.

The latest data paint a very different picture than the study's positive initial results, reported in 1999.

One principal scientist in the study, psychologist William Pelham, said that the most obvious interpretation of the data is that the medications are useful in the short term but ineffective over longer periods but added that his colleagues had repeatedly sought to explain away evidence that challenged the long-term usefulness of medication. When their explanations failed to hold up, they reached for new ones, Pelham said.

"The stance the group took in the first paper was so strong that the people are embarrassed to say they were wrong and we led the whole field astray," said Pelham, of the State University of New York at Buffalo. Pelham said the drugs, including Adderall and Concerta, are among the medications most frequently prescribed for American children, adding: "If 5 percent of families in the country are giving a medication to their children, and they don't realize it does not have long-term benefits but might have long-term risks, why should they not be told?"

The disagreement has produced a range of views among the researchers about how to accurately present the results to the public. One e-mail noted that an academic review of the group's work, called the Multimodal Treatment Study of Children With ADHD (MTA), asked why the researchers were "bending over backward" to play down negative implications for drug therapy.

Peter Jensen, one of Pelham's fellow researchers, responded that Pelham was biased against the use of drugs and was substituting his personal opinion for science.

Jensen said Pelham was the only member of the team of researchers who took away "the silly message" that the study raised questions about the long-term utility of drugs, but interviews and e-mails show that Pelham was not alone.

The MTA was designed to test whether children diagnosed with attention-deficit hyperactivity disorder, or ADHD, do better when treated with drugs, with drugs plus talk therapy, with talk therapy alone or with routine medical care alone. Children with the disorder have trouble paying attention, are restless and hyperactive, and are sometimes disruptive in school.

The initial 14-month analysis published in 1999 randomly assigned children to one of four treatment options and showed clearly that those treated with medication did much better than those who got only talk therapy or routine care. The drugs' manufacturers distributed thousands of reprints of the article to physicians at a time when diagnoses of ADHD were spiraling upward. Because children given drugs alone appeared to do about as well as those treated with both drugs and talk therapy, the study skewed treatment in the direction of medication.

In a second phase of the study, the researchers followed the children and compared how they fared, but researchers no longer randomly assigned them to the various treatment options, making this phase less scientifically rigorous.

In August 2007, the MTA researchers reported the first follow-up data, which by then no longer showed differences in behavior between children who were medicated and those who were not. But the data did show that children who took the drugs for 36 months were about an inch shorter and six pounds lighter than those who did not.

A news release issued by the National Institute of Mental Health (NIMH) at the time, however, presented the results in a more favorable light. The release, dated July 20, 2007, was titled "Improvement Following ADHD Treatment Sustained in Most Children." The release noted that the initial advantages of drug treatment were no longer evident, but it quoted Jensen as saying this did not mean that long-term drug therapy was ineffective.

Jensen said, "We were struck by the remarkable improvement in symptoms and functioning across all treatment groups." And rather than saying the growth of children on medication was stunted, the release said children who were not on medication "grew somewhat larger."

As the MTA study continued to find smaller and smaller behavioral differences between children who were medicated and those who were not, use of the drugs soared. Pelham said most parents and doctors took away the message that the study had found drug therapy effective over the long run. In 2004, physicians wrote 28.3 million prescriptions for ADHD drugs; last year, they wrote 39.5 million, according to data provided by IMS Health.

With the MTA having followed the children for eight years, the latest data have confirmed that there are no long-term differences between children who were continuously medicated and those who were never medicated. Some of the data were published online yesterday in the Journal of the American Academy of Child and Adolescent Psychiatry.

In a telephone interview, Jensen denied that the researchers had misled the public, pointing out that some children getting the drugs did do better over the long term. Looking at overall results was not as useful as studying how particular groups of children fared, he said.

Jensen and another co-author, L. Eugene Arnold at Ohio State University, who are both psychiatrists, emphasized the importance of individualizing treatment -- and warned parents against abruptly terminating drug therapy.

The subgroup analysis found that children in homes that were socially and economically stable did the same in the long term with or without medication. Children from troubled or deprived backgrounds slid backward as soon as the intensive therapy stopped and they went back to their communities. About one-third -- those with the least impairment to begin with -- continued to improve over the long term.

Jensen and co-author Benedetto Vitiello at the NIMH said drugs may not have shown an overall long-term benefit because the quality of routine care that children received may have been inferior to the care they got during the initial part of the study. Jensen said the take-home message is that community care needs improvement.

Brooke Molina, also a co-author and a University of Pittsburgh associate professor of psychology and psychiatry, argued in an e-mail that if the researchers wanted to draw attention to subgroups that might be helped by medication over the long run, they also should acknowledge that "long-term treatment with medication may not be efficacious" for others.

In an interview, Molina said the data do not "support that children who stay on medication longer than two years have better outcomes than children who don't." In an e-mail she shared with Pelham, she noted that academic "reviewers thought we were bending over backward (inappropriately) to dismiss the failure to find medication effects at 8 years."

James Swanson, another MTA co-author and a psychologist at the University of California at Irvine, said he believes that the researchers have been open about the diminishing benefits of medication therapy. He cited a variety of scientific publications in which he and others reported data showing that medications lost effectiveness over time and stunted growth.

"If you want something for tomorrow, medication is the best, but if you want something three years from now, it does not matter," he said. "If you take medication long-term beyond three years, I don't think there is any evidence that medication is better than no medication."

Pelham, who has conducted many drug therapy studies, said the drugs have a valuable role: They buy parents and clinicians time to teach youngsters behavioral strategies to combat inattention and hyperactivity. Over the long term, he said, parents need to rely on those skills.

A yet-to-be-published study, Pelham added, found that 95 percent of parents who were told by clinicians to first try behavioral interventions for ADHD did so. When parents were given a prescription for a drug and then told to enroll their children in behavioral intervention programs, 75 percent did not seek out the behavioral approaches.

SEN. GRASSLEY TO FDA: WE WILL PROTECT WHISTLEBLOWERS

Senator Chuck Grassley today said that employees of the Food and Drug Administration deserve clarification from the Acting Commissioner about their ability to communicate with Congress and the Inspector General following a memo issued last week that warned employees about releasing information. Grassley stated that he would indeed protect whistleblowers like FDAs Dr. David Graham (pictured above), and that Federal statutes guarantee their safety and protection.

"Federal laws protect whistleblowers and allow people who work in the federal bureaucracy to discuss what's happening inside an agency with other officials. Attempts to silence whistleblowers are illegal," Grassley said. "If the memo sent last week was intended to have a chilling effect on FDA employees who want to speak up about problems, then that memo is contrary to the President's call for open and transparent government, and the Acting Commissioner needs to set the record straight."

Grassley is a longtime advocate for whistleblower protections for federal employees. He co-authored the Whistleblower Protection Act of 1989, and has co-sponsored legislation to update the law. Grassley also conducts extensive congressional oversight. He has sought administrative and legislative reforms to address problems he has revealed at the Food and Drug Administration during the last five years.

Last month, Grassley urged President Obama to have a Rose Garden ceremony honoring federal whistleblowers to send a message from the top of the executive branch to the bottom that "speaking the truth" deserves rewards not reprisals for exposing mismanagement and fraud, waste and abuse of tax dollars. This month, Grassley sharply protested the President's signing statement on the American Recovery and Reinvestment Act, the economic stimulus bill, for the way it contradicts campaign pledges and promises to protect whistleblowers.

The text of the letter Grassley sent today to the Acting Commissioner of the Food and Drug Administration is below.


March 24, 2009

Frank M. Torti, MD, MPH
Acting Commissioner
U.S. Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857

Dear Dr. Torti:

As a senior member of the United States Senate and the Ranking Member of the Committee on Finance (Committee), I have a duty under the Constitution to conduct oversight into the actions of executive branch agencies, including the activities of the Food and Drug Administration (FDA/Agency). In this capacity, I work to ensure that FDA is completing its mission to protect the public's health and makes responsible use of the public funding provided for medical studies. Decisions made by FDA often form the basis for action taken by the Medicaid and Medicare programs which fall under the exclusive jurisdiction of the Committee.

I am concerned about a recent memorandum you sent to FDA employees warning them of their obligations to keep certain information confidential. While I appreciate the fact that some information, including certain business trade secrets, needs to be protected from unauthorized disclosures, I have serious concerns that your memorandum goes beyond legitimate privacy concerns and appears to run contrary to many statutes protecting executive branch communications with members of Congress.

Specifically, your memorandum notes that certain information acquired from businesses and industry is protected as confidential and may only be disclosed in limited circumstances. Your memorandum cited the Food, Drug, and Cosmetic Act, the Freedom of Information Act (FOIA), the Trade Secrets Act, and the Privacy Act, as well as FDA regulations as the controlling authority for determining when a document or information may be disclosed. You added that FDA employees who violate these provisions may face disciplinary sanctions and criminal liability.

I appreciate your concerns with protecting confidential information from unauthorized disclosures. These protections play an important role in allowing business and industry to work cooperatively with regulatory agencies. However, I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA's regulatory mission. My concern is that this recent memorandum could be viewed by some as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws to communicate with Congress.

Fox example, internal FDA documents released recently seem to suggest that lobbying may have influenced the decision in a device approval.[1] Another internal document shows that a physician was removed for inappropriate reasons from a recent safety panel.[2] In both, cases, I do not believe that Congress would be notified unless whistleblowers spoke up.

Dr. Torti, I have been an outspoken advocate for whistleblowers and have authored numerous whistleblower protection provisions. Whistleblowers are some of the most patriotic people I know—men and women who labor, often anonymously, to let Congress and the American people know when the Government isn't working so we can fix it. As such, it would have been prudent for you to include a section in your memorandum that outlines the interplay between protected confidential and trade secret information and making protected disclosures to Congress and/or Inspectors General in accordance with the whistleblower protection laws. Absent such a discussion, many FDA employees could take this memo to mean that they could be criminally sanctioned for providing information to Congress.

As you may be aware, 18 U.S.C. § 1505 states, in pertinent part:
Whoever corruptly, or by threats or force, or by any threatening letter or communication influences, obstructs, or impedes or endeavors to influence, obstruct, or impede the due and proper administration of the law under which any pending proceeding is being had before any department or agency of the United States, or the due and proper exercise of the power of inquiry under which any inquiry or investigation is being had by either House, or any committee of either House or any joint committee of the Congress —

Shall be fined under this title, imprisoned not more than 5 years or, if the offense involves international or domestic terrorism (as defined in section 2331), imprisoned not more than 8 years, or both.

Additionally, denying or interfering with employees' rights to furnish information to Congress is also against the law. I have attached another copy of 5 U.S.C. § 7211 to this letter for your reference. That law states:

The right of employees, individually or collectively, to petition Congress or a Member of Congress, or to furnish information to either House of Congress, or to a committee or Member thereof, may not be interfered with or denied.

Finally, federal officials who deny or interfere with employees' rights to furnish information to Congress are not entitled to have their salaries paid by taxpayers' dollars. I have attached a copy of P.L. 111-5 § 714 to this letter for your reference, which states:

No part of any appropriation contained in this or any other Act shall be available for the payment of the salary of any officer or employee of the Federal Government, who —

(1) prohibits or prevents, or attempts or threatens to prohibit or prevent, any other officer or employee of the Federal Government from having any direct oral or written communication or contact with any Member, committee, or subcommittee of the Congress in connection with any matter pertaining to the employment of such other officer or employee or pertaining to the department or agency of such other officer or employee in any way, irrespective of whether such communication or contact is at the initiative of such other officer or employee or in response to the request or inquiry of such Member, committee, or subcommittee; or
(2) removes, suspends from duty without pay, demotes, reduces in rank, seniority, stats, pay, or performance of efficiency rating, denies promotion to, relocates, reassigns, transfers, disciplines, or discriminates in regard to any employment right, entitlement, or benefit, or any term or condition of employment of, any other officer or employee of the Federal Government, or attempts or threatens to commit any of the foregoing actions with respect to such other officer or employee, by reason of any communication or contact of such other officer or employee with any Member, committee, or subcommittee of the Congress as described in paragraph (1).
FDA employees have the right to talk to Congress and to provide Congress with information free and clear of Agency influence. Further, these employees have the right to be free from fear of retaliation or reprisal. You should review these important statutes and reevaluate the message sent by your memorandum. I believe that you should take the further step of issuing a second memorandum to FDA employees outlining their rights and whistleblower protections, as well as outlining the FDA's responsibilities for respecting those protected disclosures. Such a memorandum would go a long way toward ensuring that the FDA remains "committed to the principles of open Government and transparency" as you stated in your memorandum.

Sincerely,
Charles E. Grassley
Ranking Member



*Photo of Dr. David Graham: New York Times

CONTAMINATED VACCINES DISCOVERED - COULD HAVE KILLED HUNDREDS OF THOUSANDS

A large consignment of seasonal flu vaccine, which was due to be circulated to 18 European countries, has been infected with deadly live avian flu virus. Had the contamination not been detected, the vaccines may have started an avian flu pandemic, killing hundreds of thousands of people.

The World Health Organization is carrying out investigations at the Austrian research facility of Baxter International, the pharmaceutical company, where the contamination happened. Baxter has confirmed that the consignment contained live H5N1 virus, which causes avian flu.

A researcher in the Czech Republic discovered the lethal contamination when laboratory ferrets that he had injected with the H3N2 flu vaccine suddenly died. The H5N1 virus becomes lethal as an injection only when it is mixed with H3N2, a process known as reassortment.

The WHO investigation team says it doesn’t have evidence to suggest that Baxter had deliberately reassorted the two viruses, but “what remains unanswered are the circumstances surrounding the incident in the Baxter facility,” a WHO official said.

Despite dire warnings from health officials, no avian flu pandemic has occurred as human-to-human infection hasn’t happened. So far, several hundred people have died after catching the virus from poultry, although governments have warned that millions would die if people could infect each other.

Baxter is currently working on a new type of avian flu vaccine, called Celvapan, which is based on cell culture technology. The technology, which is being developed at Baxter’s research facility in the Czech Republic, by-passes the conventional process where a virus is incubated in chicken eggs. Instead, Baxter is working with the ‘native’ virus that does not need to be modified.

Last year the vaccine passed the first two phases of safety trials, and Baxter announced that “Celvapan combines innovative science and breakthrough production technology with the aim of protecting people against an H5N1 pandemic flu infection.”

(Sources: Toronto Sun, February 27, 2009; New England Journal of Medicine, 2008; 358: 2573-84).
by Healthy News Service

“Generation RX” highlights the dangers of mood-altering drugs on youth

by Meaghan S. Earley

In his latest documentary “Generation RX,” local filmmaker Kevin P. Miller explores the painful (and sometimes fatal) side effects of mood-altering drugs and the impact they have on our nation’s youth.

In this timely film, Miller shows why parents who trust their doctors are quick to place their children on these drugs — and why the decision is often unwise.

“If medicine is to be trusted,” he says, “integrity and ethics must be at its core.” Miller’s ability to adequately portray life
issues in his films are due to his ability to empathize with his subjects.

“... I’ve always tried to walk a mile in the shoes of the afflicted so that I could communicate to the reader or the audience a genuine sense of their suffering and angst,” he says.

Speaking with the parents who have lost their children is heartbreaking, to say the least. But behind the pain is a story driven by common sense — something Miller hopes his film illustrates.

“When people watched [“Generation RX”], they could truly see how illogical and dangerous it is to mass-drug children with
‘speed’ or other psychiatric medicines,” he says. Miller hopes “Generation RX” will touch parents, teachers and college students alike andthat everyone will re-examine their reasons for giving children these drugs.

“If we had more ‘talking’ and behavioral therapy, and less drugging with these powerful intoxicants,” he says, “our society would be far better off.”

–Meaghan S. Earley
from CIFF Daily
an Official Publication of the Cleveland International Film Festival

AP: GERMAN SHOOTER "UNDERWENT TREATMENT FOR DEPRESSION" AT PSYCH CLINIC - ARE SSRIs ONCE AGAIN THE CULPRIT?

By VANESSA GERA and MELISSA EDDY, Associated Press Writers

WINNENDEN, Germany – The psychological profile of a teenager who went on a shooting spree at his former school and killed 15 people began to take shape Thursday, as investigators described a withdrawn young man from an intact family who broke off psychiatric treatment for depression.

But investigators faced a setback as they struggled to authenticate a chat room posting that purportedly warned of a bloody rampage hours before 17-year-old Tim Kretschmer wreaked havoc on this quiet town near Stuttgart, southwest Germany.
Kretschmer returned to his former high school on Wednesday to kill nine students and three teachers before fleeing on foot and by car, killing three more people, and eventually turning a 9 mm Beretta pistol on himself after a shootout with police.

A joint statement released late Thursday by regional police and Stuttgart prosecutors said that, "in the course of the afternoon, doubts arose about the veracity of the Internet chat."

Police spokesman Klaus Hinderer said a search of Kretschmer's computer had shown no trace of his having made the chat room posting.

A message posted Thursday to the site — krautchan.net — said, "No killing spree was announced here." Prosecutors said they were trying to reach the U.S.-based provider of the site.

Across Germany, government buildings lowered their flags to half staff Thursday, while schools held moments of silence for the victims. Germany's national soccer league, the Bundesliga, said players would wear black armbands in upcoming games.
In Winnenden, hundreds of people filed into a church in a drizzle after dark for a prayer service. A crowd of many more watched on a large video screen outside as a message of condolence from Pope Benedict XVI, a fellow German, was read aloud.
Throughout the day, students and residents paid homage to the dead outside the school, where they lit candles and laid tulips, roses, handwritten notes and stuffed animals in a memorial.

Fourteen-year-old Kristin Puengel said a friend of hers was among the eight girls killed. Three female teachers and a boy were also shot in the school. Another three men were killed as Kretschmer fled police.

She said she only knew Kretschmer — who appeared in pictures shown on German television to be a dark-haired teen with glasses and short sideburns — by sight, but that he was not a friend.

"He was somewhat withdrawn, but I would never have thought (he would be capable) of anything like this," Puengel said.
Authorities and friends said that although Kretschmer played table tennis and lifted weights, his main hobbies appeared to be shooting and spending hours on his computer — where investigators said they found pornographic films, violent computer games and a collection of horror and action films that included "Rambo First Blood," "Freddy vs. Jason," and "The Marksman."
Officials said he had been interested in a girl of about his own age, but that the feelings were apparently never reciprocated.
"It didn't work out," said Ralf Michelfelder, police chief in the nearby town of Waiblingen.

Kretschmer's father was a well-off businessman who legally owned 15 weapons and belonged to a gun club where his son regularly turned up for target practice, said Baden Wuerttemburg state Interior Minister Heribert Rech.
"He was well-trained in firing weapons," Rech said of the teen.

The teen, who graduated from Albertville high school with average grades in 2008, underwent several treatment sessions for depression at a psychiatric clinic that year, said investigator Siegfried Mahler. He showed up for five sessions between April and September, and was expected to continue outpatient therapy at a different clinic, but never began it, Mahler said.
Although authorities said he had struggled in school, Kretschmer was studying sales at a vocational school.

Authorities said they found some 60 shell casings in the school and that the number of victims could have been much higher had educators and police not carried out a plan learned in an earlier training program preparing them to respond to such a shooting.

When the first police squads arrived minutes later, they immediately stormed the building, under fire from Kretschmer as they came up the stairs before chasing him from the building, said state police president Erwin Hetger.

"We know from previous school shootings that the perpetrators only stop when they run out of ammunition, when they feel threatened by the police, or when they take their own lives," Hetger said.

"This gunman had more than 250 bullets on him when he entered the school," Hetger said.
___
Melissa Eddy reported from Berlin.

SUPREME COURT REJECTS LIMITS ON DRUG LAWSUITS

On November 3, 2008 I wrote A SUPREME TEST OF PATIENTS' RIGHTS about the case of Diana Levine, who lost her arm because of a botched injection of an anti-nausea medication. She sued Wyeth Pharmaceuticals, who claimed that since their drug was approved by federal regulators at the FDA, that Wyeth should bear no financial responsibility for Ms. Levine's tragic loss.

"For the nation," I wrote then, "Wyeth's appeal of a $6.7 million verdict Levine won from a Vermont state jury has far reaching consequences. Backed by the Bush administration, Wyeth argued that "once a drug's warning label gets FDA approval, consumers cannot pursue state law claims that they were harmed.”

Today comes the breaking news that Wyeth's appeal to the Supreme Court has been rejected. Thus, health freedom has been preserved for another day, thanks to Diana Levine.


SUPREME COURT REJECTS LIMITS ON DRUG LAWSUITS

By MARK SHERMAN, Associated Press Writer

WASHINGTON – The Supreme Court on Wednesday upheld a $6.7 million jury award to a musician who lost her arm because of a botched injection of an anti-nausea medication. The court brushed away a plea for limiting lawsuits against drug makers.
In a 6-3 decision, the court rejected Wyeth Pharmaceuticals' claim that federal approval of its Phenergan anti-nausea drug should have shielded the company from lawsuits like the one filed by Diana Levine of Vermont.

Levine, 63, struggled with her emotions when told of the ruling in a phone call from an Associated Press reporter Wednesday: "Oh, my God. I'm so, so happy. I can't believe this phone call," she said.

"I've been waiting for so long, and I had no idea of what the chances were. I'm just ecstatic. I'm going to have to sit down," said Levine, once a professional guitar and piano player. She now plays with one hand, and sings.

Levine's lawsuit said she wasn't sufficiently warned of the risks of using Phenergan. But Bert Rein, a Washington lawyer who represents Wyeth, said the company's label complied with federal law.

"The medical and scientific experts at FDA are in the best position to weigh the risks and benefits of a medicine and to assess how those risks and benefits should be described in the product's label," Rein said in a statement.

Wyeth is in the process of being bought by rival Pfizer, Inc., in a $68 billion deal that is expected to close later this year.
The decision is the second this term to reject business groups' arguments that federal regulation effectively pre-empts consumer complaints under state law.

A Vermont jury agreed with Levine's claim that Wyeth failed to provide a strong and clear warning about the risks of quickly injecting the drug into a vein, a method called IV push. Gangrene is likely if the injection accidentally hits an artery — precisely what happened to Levine.

The company appealed and, backed by the Bush administration, argued that once a drug's warning label gets approval from the Food and Drug Administration, the label can't be changed without further FDA approval and consumers cannot pursue state law claims that they were harmed.

Justice John Paul Stevens, writing the majority opinion, said Wyeth could "unilaterally strengthen its warning."
Stevens said he was persuaded that until a recent change by the FDA, the agency "traditionally regarded state law as a complementary form of drug regulation" because it monitors 11,000 drugs.

Justice Clarence Thomas agreed with the outcome of the case, but did not join Stevens' opinion.

Justice Samuel Alito wrote a dissent that was joined by Chief Justice John Roberts and Justice Antonin Scalia.
"This case illustrates that tragic facts make bad law," Alito said. "The court holds that a state tort jury, rather than the Food and Drug Administration, is ultimately responsible for regulating warning labels for prescription drugs."

The FDA has approved the use of Phenergan by injection, including the method at issue in Levine's case. The drug has been available for decades to treat nausea and when used properly, both sides agree it is safe and effective.

The Bush administration and business groups aggressively pushed limits on lawsuits through the doctrine of pre-emption — asserting the primacy of federal regulation over rules that might differ from state to state.

The Supreme Court had largely agreed, ruling last term that FDA approval shields medical devices from most lawsuits. That case turned on a provision of federal law prohibiting states from imposing their own requirements on the devices.
The Levine case drew a lot of attention because the administration and Wyeth contended that, although the federal Food, Drug and Cosmetic Act lacks a similar provision, drug manufacturers also are protected from most suits over federally approved drugs.

Stevens said there could be circumstances where consumer lawsuits would not be allowed, including if the FDA had considered and rejected a stronger warning label.

But that was not the case with Phenergan, he said. "As we have discussed, the FDA did not consider and reject a stronger warning against IV-push injection of Phenergan," Stevens said.

Justice Stephen Breyer agreed in a brief, separate opinion. "It is also possible that state tort law will sometimes interfere with the FDA's desire to create a drug label containing a specific set of cautions and instructions," Breyer said.
The case is Wyeth v. Levine, 06-1249.
___
Associated Press writer John Curran contributed reporting from Montpelier, Vt.


######

MED STUDENTS PUT HARVARD CONFLICT-OF-INTEREST POLICIES UNDER THE MICROSCOPE

by Alexandra Andrews, ProPublica

Two rival gangs are battling it out at Harvard Medical School. No, they're not fashioning makeshift weapons out of stethoscopes and tongue depressors, but there are millions of dollars at stake, along with what some say is Harvard's reputation.

The first group, made up of around 200 students and faculty members, is "intent on exposing and curtailing the industry influence in their classrooms and laboratories, as well as in Harvard's 17 affiliated teaching hospitals and institutes," reports today's New York Times.

Harvard recently earned an F from the American Medical Student Association, which grades medical schools' conflict-of-interest policies on money from the pharmaceutical industry, even as other top-tier schools like the University of Pennsylvania, Stanford and Columbia secured A's and B's.

Harvard also faced embarrassment last year when Sen. Charles Grassley (R-IA) accused two of its psychiatrists of potentially breaking federal and university conflict-of-interest rules by failing to fully report huge fees from drug companies.

A first-year Harvard Medical student tells the Times:

Before coming here, I had no idea how much influence companies had on medical education. And it's something that's purposely meant to be under the table, providing information under the guise of education when that information is also presented for marketing purposes.

But there's another faction that thinks industry funds have gotten an unfair rap, and it insists that they're a necessity. The medical school's new dean, Dr. Jeffrey Flier, seems to agree to a certain extent. According to the Times, Flier doesn't want to "tighten the spigot" on industry money: "One entirely appropriate source, if done properly, is industrial funds," he said.

But Flier also "wants Harvard to catch up with the best practices at other leading medical schools." He recently formed a 19-member committee to "re-examine" Harvard's conflict-of-interest policies, which the Times says currently do not require faculty members "to report specific amounts received for speaking or consulting, other than broad indications like 'more than $30,000.'" Nor are there "limits on companies' making outright gifts to faculty -- free meals, tickets, trips or the like."

On the other hand, Harvard Medical School does require all professors and lecturers to "disclose their industry ties in class -- a blanket policy that has been adopted by no other leading medical school."

The committee examining these policies will meet on Thursday, but any suggestions to sever the school's ties with industry will likely meet a wall of opposition. The school's Web site has this to say on ties between "biomedical research institutions" and the industry: "The Harvard Faculty of Medicine remains strongly committed to continued growth in these innovative and mutually beneficial relationships." In other words, they're probably not going away any time soon.


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THE WISDOM OF COMMON PEOPLE

I have learned so much by simply listening to the people I’ve met while producing my films LET TRUTH BE THE BIAS, WE BECOME SILENT, and most recently GENERATION RX. As journalists, as Producers, we are supposed to be good listeners — we are supposed to be the link to reason, to balance, and to well-researched wisdom.

This kind of wisdom, however, can come only from meeting countless someones scattered across the globe, people who willingly bare their souls for the sake of the greater good. By sharing their health challenges, big and small, and by stepping forward to be counted, the wisdom of common people allows the masses to judge on their own whether they believe natural cures are a viable option. I write about this again in GENERATION RX near the conclusion of the film.

At a recent public appearance in Philadelphia, I was asked, “Who will lead us in the fight for health freedom?” The question alluded to the threats against health freedom such as Codex Alimentarius and the ongoing threat to DSHEA, the Dietary Supplement Health Education Act. His question resonated throughout the hall, and in the moments that followed his words echoed rather eerily through the auditorium.

The audience leaned forward, waiting for my answer. Here is what I told them.

During the 1990s, a juggernaut of real-people coalitions came together with industry forces, bound by their desire to both prevent the monoliths of medicine from exerting their capitalistic notions over all of us, and to preserve “medical freedom of choice.” Those who came together to fight for justice represented the plurality of America, and came from every political, racial, religious and socio-economic stratum. The amazing happened: people actually put aside their differences and forced Congress to honor their wishes. . .a rare occurrence in American political life.

Collectively, they unearthed a new day in America—a time when the wisdom of common people became not only relevant, but also dominant. Millions—no, tens of millions stood up to the forces of power and money and called for change. They besieged Washington with millions of letters, faxes, and phone calls. As a result, DSHEA, the greatest health law written heretofore, passed in an overwhelming fashion.

“You are the people who accomplished that,” I emphatically reminded them. “You made the calls, you passed out the literature, you wrote the letters, YOU created a your own kind of pre-internet blogs, and passed the word across the nation.”

These days, however, this wonderful consortium of individuals and interests has become divided by a myriad of so-called health freedom leaders. We have lazily allowed others to do the thinking for us—and the results have been toxic, to say the least. Certain vitamin, herbal and health food trade associations—among others—have replaced the wisdom of common people with the elitist attitude that “only we know what’s right for consumers,” and dismissed those who sounded the alarm about Codex and other health freedom issues as “alarmists.” They seem to have forgotten that is the loyal buyer, the local or regional health advocates—through thousands of health food stores, co-ops, and doctors’ offices—who made DSHEA happen. In truth, it is we consumers who fund the vitamin and health food industries in the first place, so it’s time we made our voices heard again.

As I told the crowd in Philadelphia, quit waiting for leaders to lead. . .you might not like where they are taking you. It may be a tired adage, but it is true nonetheless: think globally and act locally.

The people who say “Codex is no threat to us here in the USA,” well, let them know that you disagree with them. Email, call, fax, blog, and write letters-to-the-editor. In short, do whatever you can—communicate in the strongest terms possible—and tell them what you think. If you see a story on the local news, call or write to voice your displeasure. You are in charge of our collective health freedom—and the time for allowing others to do the work for you is over.

As health advocate Scott Tips of the National Health Federation often says, “be persistently vocal,” don’t give up—and don’t give in.

Arm yourself with information from trusted sources like Dr. Robert Verkerk’s Alliance for Natural Health (http://www.alliance-natural-health.org/) in the UK, the Dr. Rath Health Foundation (http://www.dr-rath-foundation.org/), and the National Health Federation (http://www.thenhf.com/) and Mike Adams. These are credible websites for consumers to examine, and I will share more action links in future blogs.

Finally, for those who believe Codex, CAFTA, the Free Trade Area of the Americas (FTAA), and our membership in the WTO don’t impact health freedom, simply go to the web and see my documentary WE BECOME SILENT. It was put online free as a service to consumers—and you can spread the word by referring people to the website or by buying this film, which is narrated by the world-class UK actress Dame Judi Dench.

We live in an Age when the issues are so immensely complicated. The reality is that most people need reliable and easy-to-understand information in order to form an intelligent opinion. My films are a resource but there are many others as well.

Multi-national food and drug companies are edging us closer to the precipice. If we don’t act soon, we will fail to preserve the hard-fought health freedom efforts of the past 20-30 years. . . and we could find ourselves facing a new allopathic version of the Dark Ages for generations to come.

The wisdom of common people is what we need — as we fight for our right to preserve not only our basic access to vitamins and minerals, but to the ancient medicines that preceded them.

Roll up your sleeves, do your research and be a critical thinker.

Then, get busy — and spread the word as if your life depends on it.