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July 21, 2009

OxyContin A Major Factor In World’s Deadliest Pandemic

Filed under: Big Pharma, pharmaceutical giants, pharmaceuticals, prescription drug abuse, prescription drug addiction — Rod Malcolm @ 9:52 am

If anything deserves to be called a pandemic, it’s the scourge of prescription drug addiction, especially opioid painkillers, and particularly OxyContin.

I’ve been wondering about pandemics and mass deaths lately. It’s a morbid kind of preoccupation, but reading the daily news can do that to a person.

I’ve been observing, like you, like everyone, how governments around the world, prodded along by the World Health Organization and a fairly steady media frenzy, are gearing up at great public expense to do battle with the H1N1 “swine flu” viral infection. And I’ve been comparing all the noise and fanfare surrounding the so-called “swine flu pandemic” with the complacent foot-dragging here and in most other Western nations regarding drug addiction and abuse, by far and away the deadliest pandemic in the history of mankind.

If one counts, as one must, that drug addiction and abuse has continued to rage uninterrupted and effectively untreated for decades, and one also factors in the widespread devastation and sheer numbers of injuries and deaths — hundreds of thousands here, millions around the world — there can be no argument as to its status as a pandemic.

No one knows for sure how many hundreds of billions of world-wide law-enforcement tax dollars have been thrown at it in vain. And if you count medical and productivity losses, we must be looking at $trillions.

I’m just guessing. But maybe some study somewhere, some United Nations or WHO study, has accurate figures of the total costs, both financial and human, of the most ignored pandemic in our history.

So far, swine flue has sickened some 28,000 or so people in the entire world. And in all the world only 144 people have died. These figures are roughly parallel to those appearing in studies and media reports concerning just prescription drug abuse in the U.S., never mind the rest of the world, and that’s before adding in the common illicit street drugs. And that’s for every year for a quarter of a century or more.

In the past decade alone, prescription drug addiction and abuse has taken many thousands of lives, and ruined the lives of hundreds of thousands of people in the U.S.

If that’s not a pandemic, nothing is. And the most abused, most dangerous drugs, are the opioid painkillers. These are the root viruses that are driving and spreading the prescription drug pandemic.

In the U.S. at least, one prescription opioid painkiller could easily make a bid for the dubious distinction of the leading cause of death, injury, and family devastation of all of them — Purdue Pharma’s notoriously addictive and harmful OxyContin.

OxyContin is featured daily in news reports from around the country about dead babies, dead mothers, dead fathers, dead brothers and sisters, dead uncles and aunts, dead cousins and friends, dozens of arrests, drugstore robberies, even a murder or two, every day, somewhere in America.

OxyContin has addicted, injured and killed so many people for so many years, that Americans are sick and tired of it. The fact that the company, Purdue Pharma, along with several of its executives, was fined $634 million for lying about its addictiveness, and that no one went to jail, has America up in arms.

A petition calling on the FDA to ban it from the marketplace, and revert to any of several equally effective and less dangerous drugs to control chronic pain, has appeared on the internet. Sponsored by a concerned pharmacist and a drug detox specialist, the petition has already attracted nearly 3,000 signatures.

We urge you to sign the petition. And you should browse the brief stories from hundreds of signatories who describe their personal tragedies, and occasional triumphs, concerning OxyContin.

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June 19, 2009

FDA Soft-pedals Study Linking Child Deaths To ADHD Meds

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 11:00 am

Kids haven’t been beaten down into ant-like goody-goody social behavior. They aren’t adults, shouldn’t be expected to behave like adults, and don’t deserve to risk death because of the irrational expectations of lazy parents and educators.

The FDA issued a “safety communication” this week admitting there “may be an association” between the use of ADHD amphetamine meds, like Adderall, Concerta, Vyvanse and Ritalin, and sudden death in healthy children.

The agency’s statement follows publication in the American Journal of Psychiatry the findings of a study funded by the FDA and the National Institute of Mental Health (NIMH) that compared sudden death among 564 previously healthy kids on the meds, and 564 kids, also on the ADHD meds, dying in car accidents.

Results: Drug-only unexpected deaths, 10; car accident deaths, 2.

In spite of frequent case reports raising concerns since the early 1990s that stimulants increase the risk for sudden unexplained childhood death, the FDA minimizes the study, and says more comprehensive studies are forthcoming.

Said the FDA: “Given the limitations of this study’s methodology, the FDA is unable to conclude that these data affect the overall risk and benefit profile of stimulant medications used to treat ADHD in children. FDA believes that this study should not serve as a basis for parents to stop a child’s stimulant medication.”

In spite of their findings associating the meds with sudden childhood death, the study’s authors also downplayed the risk, using mushy statements such as: “Stimulants are not innocuous….However, it is equally clear that…it is not possible to quantify the risk beyond estimating that it is very small.”

Let’s say it again: The risk of sudden unexplained death of children is “very small”, and shouldn’t serve as a basis to stop a child’s stimulant medication.

Sorry, but the risk of sudden death is never too small to ignore, especially in kids who are given no choice in the decision. And the risk is off the charts considering many studies, both here and abroad, that have debunked ADHD as a valid condition, and one only treatable with powerful and dangerous drugs.

For example, the Netherlands has already denied the validity of America’s ADHD diagnoses, and other countries including the UK are at least in partial disagreement. ADHD is primarily an American social-cultural phenomenon, jumped on years ago by the profiteering, drug-pushing Big Pharma-psychiatric consortium, much to the detriment of American children, families and American society in general.

Of course, the authors of the current study, being American psychiatrists, are fully sold on the validity of ADHD, and ipso facto, the validity of treating kids with dangerous amphetamines. They blandly estimate that 2.5 million kids are now on ADHD meds in America — a low-ball figure according to some estimates.

And they quote that figure as some sort of proof of validity for ADHD and the drugging of an entire generation of children, rather than for what it really is — a horrifying statistic showing how far the psychs and Big Pharma are taking the hellacious idea to drug America’s population from the cradle to the grave.

Adding to the ADHD $billions rolling into Big Pharma’s coffers are the tens of thousands of adults now being encouraged to leap onto the “I’ve-got-ADHD-too-please-pass-the-amphetamines” bandwagon. Which, by the way, only further legitimizes the drug-our-kids movement.

It’s pathetic, really. I wouldn’t put any child on amphetamines for any reason short of an emergency life-saving treatment, if any condition might require it.

The millions of American parents whose kids already have been targeted by school officials, nurses and physicians for an ADHD prescription should insist on the full battery of heart and blood tests before agreeing to it.

Wait, no, they should just disagree to it, period. Instead, they should research the validity of ADHD itself, without listening to the psychs, Big Pharma, and their official spokespeople on this subject, the FDA.

Kids are kids — people who haven’t been beaten down yet into ant-like goody-goody social behavior. They aren’t adults, and shouldn’t be expected to behave like adults. And they don’t deserve to be forced to risk death from dangerous drugs for any kind of behavior.

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June 8, 2009

Should OxyContin Be Banned? The Evidence Says “YES”

Filed under: Big Pharma, FDA, drug addiction, pharmaceutical giants, pharmaceutical sales, pharmaceuticals, prescription drug addiction — Rod Malcolm @ 12:39 pm

Since Purdue Pharma began producing and selling it in 1995, OxyContin has been implicated in many times more U.S. deaths than were caused by 9/11 and the Iraq War combined.

OxyContin is molecularly almost identical to, and acts in the body in the same manner as, the illegal street drug heroin.

Heroin — the target of billions of our tax dollars in drug-war funding, as any school kid knows, is the main source of income for Afghanistan’s tens of thousands of rural opium poppy farmers and their Taliban supporters.

So the question must be asked: “If heroin is illegal, why is OxyContin legal?”

In fact, that was the $64 million question asked of FDA officials at a Maryland public hearing recently on the dangers of the OxyContin. Not one of them could — or would — answer the question.

In 1898, heroin was introduced by the Bayer company as a substitute for morphine, which unlike morphine, said Bayer, was not addictive. It was widely promoted as an effective treatment for coughs and colds and even treatment for morphine addicts.

After various Acts and laws affecting it, heroin finally became an illegal drug in the United States in 1924, with passage of The Heroin Act. (The Bayer company, in 1913, had long since stopped manufacturing it.) The Act spawned a thriving black market, which persists to this day in one form or another.

It had taken a while for scientists to discover that heroin metabolizes into morphine in the body, and is devastatingly addictive. But tens of thousands of people had already learned how viciously addictive it is, thousands of them fatally, during the preceding decades. The Heroin Act was too little, too late.

OxyContin, from Purdue Pharma, has had an almost identical history: Made by a prominent drug company, which promotes it as non-addictive compared to other narcotics, but it soon becomes known as an addictive killer. More than a decade passes, while nothing is done, and thousands die.

And ironically, OxyContin becomes the drug of choice among heroin addicts, when their heroin supply is interrupted. In fact, thousands prefer it, because it offers pharmaceutical purity and predictability. And although it’s available at any pharmacy for someone with a gun or a knife, it’s also available in vast quantities on the street for a decent price — just high enough to ensure drug crime becomes a way of life for addicts.

In 2007, as we all know, Purdue and three top execs pled guilty in to misleading the public about the addictive nature of OxyContin. The company paid fines totaling over $634 million, including the individuals, who were also assigned hundreds of hours of community service.

But no Purdue exec went to jail, the U.S. Attorney allowed a Purdue affiliate to take the fall and be barred from doing business with the federal government, the FDA has allowed OxyContin to remain on the market, and thousands continue to fall victim to OxyContin addiction and abuse, injury, and early death.

Anyone with a shred of good sense and compassion should pop over to the Ban OxyContin petition website and sign the petition, and while there, browse the tales of tragedy associated with the drug shared by hundreds of visiting petitioners.

OxyContin is a viral epidemic that has infected every community in America. There are plenty of other drugs that work just as well than OxyContin, essentially just legal heroin, at controlling chronic pain, that do not cause widespread addiction and death.

Ideally, the FDA should remove OxyContin from the marketplace entirely. At the very least, OxyContin should be reclassified and prescribed only for chronic end-of-life pain.

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June 1, 2009

OxyContin And Big Pharma’s Prescription Drug Bonanza

Filed under: Big Pharma, FDA, OxyContin addiction, pharmaceutical giants, pharmaceutical sales, pharmaceuticals, prescription drug addiction — Rod Malcolm @ 11:37 am

Between 1980 and 2003, Americans doubled their spending on new autos, tripled what they paid for clothing, but increased their spending on prescription drugs nearly 17-fold, thanks to the $billions Big Pharma spends on marketing. And with drugs like OxyContin in the mix, the entire world has fallen victim to the greatest epidemic in history.

There is a grass-roots movement afoot to restrict the use of the narcotic painkiller OxyContin to, at most, end-stage cancer patients and similar cases — or to ban it outright.

An online-petition to ban OxyContin is gathering thousands of signatures, and will be presented to the FDA and other relevant government agencies soon. We encourage all readers to hasten over and sign the petition now.

So why ban a painkiller that purportedly helps people get along?

It’s no longer a secret that prescription drugs can harm you. In the relentless search for the next billion-dollar blockbuster, Big Pharma’s aggressive marketing of unsafe drugs has become a painful thorn in the side for thousands of Americans.

Thousands of innocent people have been killed or maimed by drugs like OxyContin — drugs which were not just unsafe, but were heavily marketed by drug-makers who knew about its dangers and lied about it.

Big Pharma’s unethical, greed-driven marketing practices are creating an enormous backlash, a subculture of anti-pharma activists who have lost loved ones to the deadly side-effects of prescription drugs, or who have been injured themselves. We’re not talking about prescription drugs illicitly obtained and consumed recreationally — the majority of victims received legal prescriptions from family doctors.

One of the most publicized drugs in this category, OxyContin from drug-maker Purdue Pharma, ranks among the highest on prescription drug activists’ outrage list. Essentially legal heroin, OxyContin has caused or been involved in the deaths of thousands, and the devastation of addiction and ruined lives for many tens of thousands more.

It’s old news that Purdue was fined $600 million a couple of years ago for its lies about the dangers of OxyContin. And senior executives pleaded guilty to criminal charges, were personally fined more than $34 million, and were assigned to hundreds of hours of community service in drug rehab centers. Numerous other drug companies have also been charged with misleading the medical profession, regulators and the public about the dangers of their drugs. Lawsuits number in the many thousands.

As the horrific catalog of Big Pharma’s marketing lies and unethical excesses continues to be revealed in courtrooms across the land, citizens are calling for an end to the practice of promoting and distributing unproven, unsafe drugs — essentially turning the public into experimental guinea pigs.

And they want more punitive results from the legal system, which has thus far treated pharmaceutical companies and their complicit executives to slaps on the wrist, rather than the jail terms normally accorded drug dealers and admitted felons.

A heartless street dealer may be complicit in the harm of a few, but Big Pharma’s list of victims is in the hundreds of thousands. In any other situation, such statistics are considered genocide. In this light, corporate drug dealers deserve far more severe punishment than street dealers.

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May 19, 2009

Massachusetts Biotech Chief Fined $10,000 Over Ethics Breaches

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 11:04 am

Former state economic development aide used position to develop tax breaks and other incentives for biotech companies, while secretly seeking top job with the biotech trade council.

The Massachusetts Ethics Commission has levied a $10,000 fine on Robert K. Coughlin, the former top economic development aide to Governor Deval Patrick, for secretly seeking the presidency of the Massachusetts Biotechnology Council last year — and all while using his government job to help push through various tax breaks and incentives crucial to the biotech industry’s lobbying group.

The Boston Globe reports that the ethics commission found that Coughlin, a former Democratic state representative, began his own lobbying activities to land the $350,000-a-year job with the biotech lobbying group only a few weeks after the governor hired him to be undersecretary of business development. Coughlin spent the next five months secretly pursuing the job without telling administration officials, and without removing himself from policy decisions affecting his future employer, which is required by state law.

In finding that Coughlin violated state ethics law, the commission said his actions created an appearance that the Mass Biotechnology Council could unduly enjoy his favor in the performance of his official duties.

Created an appearance? Oh please! It’s was a lot more than “an appearance”.

And other than the fine, the commission has taken no action against Coughlin, and tried to keep its findings secret.

As for the ethics of the biotech council members themselves, it’s interesting to note that Coughlin’s predecessor in the top job at the biotech council, Thomas F. Finneran, was forced to resign after pleading guilty to federal obstruction charges almost two years ago. And the disgraced Finneran, before he took the biotech council job, was formerly the state House speaker!

Meanwhile, undaunted, the 550-member biotech council, which includes many large corporations, is said to be delighted with their new president, and looking forward to his inspired leadership in the coming year.

Whew.

The whole affair emphasizes the abysmal level of ethics of the pharmaceutical industry in general, and reminds us yet again of how its pervasive $eduction of politicians reaches into all levels of government.

Like the old saying goes, “Money talks, bull**** walks.”

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April 30, 2009

Psychs Feeling The Pressure Of Bad Media Over Unreported Payola

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 2:02 pm

A featured topic at the 2009 International Forum on Mood and Anxiety Disorders conference in Monaco is “Making sense of media attacks on experts: is this a wanton witch hunt?” If the shoe fits . . .

Several prominent psychiatrists have been receiving seriously negative media lately following Congressional revelations that they failed to disclose payments from Big Pharma for “studying” various drugs and promoting them around the country.

For some background from earlier blogs about non-disclosure of millions of Big Pharma payola bucks, go here and here and here and here.

The Alison Bass blog reports this week that “some of these key opinion leaders (KOLs as they are known in the industry) are pushing back, accusing the press of launching a ‘witch-hunt’ and trying to intimidate some of the media messengers.”

Evidence of the growing unease among psychs about the negative publicity is a featured topic at the 2009 conference of the International Forum on Mood and Anxiety Disorders in Monaco in November. Titled ‘Making sense of media attacks on experts: is this a wanton witch hunt?’ the forum is “essentially an ‘astroturf creation’ of Pharma directed by two prominent psychiatrists with industry ties in Europe,” Ms. Bass reports.

The Forum’s speaker list includes Alan Schatzberg, who claims his stepping down from the psychiatry chair at Stanford has nothing to do with the media blitz over his own failure to disclose financial ties to Big Pharma, revealed by the Congressional investigative team run by Sen. Chuck Grassley. Turns out Schatzberg owned $4.8 million in stocks in Corcept Therapeutics, a company he co-founded, while operating as principal investigator of a NIH-funded study of Corcept’s own drug for depression.

Stanford did not fully disclose Schatzberg’s stock ownership until The New York Times, Business Week and other media reported the story. Shortly thereafter Stanford asked Schatzberg to step down as principal investigator of the NIH study — NIH prohibits its grant money from being blended into Big Pharma personal payola. And now, says Ms. Bass, Stanford is looking for a new chair of its psychiatry department, although they claim that Schatzberg decided to step down long before the conflict of interest story broke. Yeah, sure.

Meanwhile, says Ms. Bass, Shatzberg and Stanford have been berating various media for continuing to discuss the situation: the New York Review of Books for running Marcia Angell’s medical corruption article which included Schatzberg’s financial conflicts); CBS, which covered the Stanford problems; and the Corporate Crime Reporter, which published an interview with Ms. Bass about conflicts of interest in medicine. In spite of demands for corrections from the doctor and the university, none has been issued.

A few years ago, Schatzberg sued University of Massachusetts psychiatrist Anthony Rothschild, alleging that Rothschild libeled and defamed him by claiming on a Yahoo message board under an assumed name that Schatzberg was using his position at Stanford to promote Corcept’s new drug, and that he and his cofounder both knew since 2005 that the drug didn’t work, yet they continued to sell company stock. (Corcept stock has dropped from over $8 five years ago to around 90 cents.)

Rothschild and Schatzberg have an interesting back-story, reports Ms. Bass. In the late 1980s, while both were at Harvard’s McLean Hospital, they began working on the idea of using a drug to block the stress hormone cortisol as a possible treatment for depression. Then Schatzberg went to Stanford in 1991, and took the idea with him, co-founding Corcept to develop the new drug. Partners, which owns McLean Hospital, sued Stanford over the patent for Corcept’s drug, but the case was settled in mediation.

“What all this shows is that Schatzberg is not afraid to throw lawyers at his critics,” Ms. Bass suggests. “I wonder if that’s the kind of aggressive action he’ll advise at the wanton witch-hunt session in Monaco. What I want to know is: who’s paying for his trip there?”

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April 28, 2009

Court Discloses More Proof That Merck Knew Vioxx Was Risky

Filed under: Big Pharma, Vioxx, pharmaceutical giants, pharmaceutical sales — Rod Malcolm @ 8:31 am

In an internal email from 2001, a critical senior Merck researcher says interpretation of Vioxx test data was “wishful thinking . . .interpreted to support a preconceived hypothesis.”

Merck paid a cardiologist to sign his name to a 2001 medical journal article written by Merck staff that claimed no evidence of cardiovascular events arising from its painkiller Vioxx, according to court records in an on-going Australian class-action suit.

The class action alleges Merck covered up a higher risk of cardiovascular conditions.

More than 1000 complainants cite cardiovascular conditions following at least one prescription of the drug.

The Sydney Morning Herald reports that a 2001 email submitted in court shows that senior Merck researcher Briggs Morrison “expressed concern about the claim that Vioxx was not associated with an increased risk of cardiovascular events.”

“That seems wishful thinking, not a critical interpretation of the data,” Dr. Morrison said in the email to colleagues. “The data appears to have been interpreted to support a pre-conceived hypothesis.”

But the claim of no risk was nonetheless included in the final version of the article, which was sent to consulting U.S. cardiologist Dr. Marvin Konstam for approval and signature, and eventually published in the medical journal Circulation in October 2001, the Herald reports.

Dr. Konstam was named lead author, five of the authors were Merck employees, and the other two, including Dr. Konstam, were paid consultants.

If you’ve been following the Vioxx saga for the past few years, the name Briggs Morrison might ring a bell. Back in 2005 in Atlantic City, NJ, Morrison achieved notoriety of sorts when the judge in the second Vioxx trial ordered his defense testimony on behalf of Merck be stricken from the record, saying he overstepped his role as a fact witness.

Judge Higbee said at the time: “Quite frankly, I felt sick yesterday afternoon. I realized how I have got sucked into this. I feel that I was misled during the testimony.”

Higbee said Morrison, Merck’s lead-off defense witness, testified about a series of animal tests and their implications for the safety of Vioxx, but was not an expert on the subject and completely unqualified to testify.

Will it ever end? Merck’s grasping financial greed and ethical deficiencies are matched only by its stupidity.

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April 23, 2009

Vermont Report Reveals Psychs Got More Pharma Money Than Any Other Specialty

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 12:13 pm

Nearly $3 million was paid out by Big Pharma in miniscule Vermont. The mind boggles at the vast amounts pumped into the system across all 50 states. And some people still wonder why drugs are so expensive in America.

A report from Vermont’s attorney general, William H. Sorrell, shows psychiatrists received more money from Big Pharma than any other medical specialty during the period from July, 2007, through June, 2008. And Eli Lilly’s spending lead the parade in the state’s list of drug-company payments to health professionals.

The report, made annually as part of Vermont’s Pharmaceutical Marketing Disclosure Law adopted in 2002, breaks down Big Pharma payments and gifts to physicians, hospitals, universities and others involved in health care, including consulting and speaker fees, travel expenses, gifts and food.

Items exempt from disclosure include free samples, payments for clinical trials, and gifts less than $25 in value. And Pharma can nominate not to disclose certain details, citing protection of trade secrets.

This last aspect of the statute continues to generate discussion and criticism among consumer protection groups, lawmakers and more than a few health care professionals. But Big Pharma is adamant, claiming some expenditures could reveal marketing strategies to competitors.

Excuse me? Some of us thought that publicly revealing Big Pharma’s marketing payola strategies was the purpose of the statute. Oh well.

This year, 78 drug makers reported spending a total of $2,935,248 to market their products to the health care industry in Vermont. According to the annual report, the top five givers in rank order were: Lilly, Pfizer, Novartis, Merck and Forest Pharmaceuticals.

The report also reveals Big Pharma’s favorites. Nearly $1,770,000 was expended on only 100 individual recipients out of the total 2,280 of them.

“With approximately 2280 recipients,” says the report, “4.3% of the recipients received 60% of the total payments in that year. The greatest amount of expenditures went to psychiatrists as a group, totaling nearly half a million dollars; one psychiatrist received over $112,000 — the greatest amount of pharmaceutical marketing dollars spent on any single person in [fiscal year 2008].”

The top five drugs, neatly tallied for us by the Wall Street Journal Health Blog, were:

Drug Use Maker

Strattera ADHD Eli Lilly

Cymbalta Depression, Neuropathic Pain, Anxiety Disorder Eli Lilly

Exelon Alzheimer’s, Parkinson’s Novartis

Januvia Diabetes Merck

Lexapro Depression, Anxiety Disorder Forest

And the top five specialties receiving pharma-money were:

Specialty Total Rec’d Recipient average

Psychiatry $479,306.19 $43,573.29

Internal Medicine $332,880.14 $14, 473.05

Neurology $185,007.43 $23,125.93

Endocrinology/Diabetes/Metabolism $156,832.36 $52,227.45

Ionizing Radiation Privileges $111,326.98 $12,369.66

When you consider that nearly $3 million was paid out by Big Pharma to the miniscule medical population of Vermont, we can only imagine the vast amounts pumped into the system across all 50 states. It boggles the mind. And some people still wonder why drugs are so expensive in America, compared to every other country in the world.

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April 20, 2009

New Leadership Could Bring Needed Changes At The FDA

Filed under: FDA, pharmaceutical giants, pharmaceuticals — Rod Malcolm @ 12:36 pm

“For too long the agency has behaved as though its job is to speed brand-name drugs to market, not to ensure that they are safe and effective,” says Dr. Marcia Angell.

Writing in the Boston Globe last week, Dr. Marcia Angell suggests seven crucial, and very reasonable, changes in FDA policy, which the new leadership should adopt to foster safer medications without seriously affecting Big Pharma’s time-to-market.

Dr. Angell also says that the newly nominated commissioner, former public health administrator Dr. Margaret Hamburg, and newly appointed deputy commissioner, Joshua Sharfstein (“a longtime critic of the pharmaceutical industry,” Dr. Angell says) offers new hope that such changes could become reality. As an appointee, Sharfstein doesn’t need Senate approval, and already has taken charge of the agency as acting commissioner, pending Dr. Hamburg’s (hopefully swift) Senate confirmation.

Dr. Angell, former editor of New England Journal of Medicine, and author of the widely-read and chillingly insightful book, The Truth About Drug Companies, is up-beat about the new FDA leadership.

“[Sharfstein’s] appointment gives real hope that the FDA will stop kowtowing to the big drug companies,” Dr. Angell says. “For too long the agency has behaved as though its job is to speed brand-name drugs to market, not to ensure that they are safe and effective. But while new leadership is crucial, more needs to be done.”

Dr. Angell’s proposals should be considered in depth, so do follow the link above to her Globe article.

Briefly, Dr. Angell says:

Congress should repeal the Prescription Drug User Fee Act.

Consultants for drug companies should no longer be permitted to serve on FDA advisory panels.

The agency should ensure that post-marketing studies it mandates are actually carried out.

The FDA should review generic drugs as fast as brand-name drugs.

Congress should give the FDA the authority to require drug companies to compare new drugs with existing drugs of the same type.

The FDA should stop approving me-too drugs on the basis of surrogate endpoints.

The FDA should prohibit direct-to-consumer advertising for three years after drugs are approved.

The first point, to repeal the Prescription Drug User Fee Act, is essential. “This 1992 law, renewable every five years, authorizes drug companies to pay ‘user fees’ to the FDA for every drug the agency considers for approval,” Dr. Angell says. “That puts the FDA on the payroll of the industry it regulates, and makes it more likely that drugs will be reviewed favorably — a bargain for drug companies. Drug companies should not be considered ‘users’ of the FDA; the public is the user, and it alone should support the agency.”

Hear hear! Nothing would go further than giving financial and political independence back to the FDA.

“It is time to restore the FDA to its purpose, which is to protect the public from unsafe food, drugs, and devices, not to accommodate the industries it regulates. The change in leadership is reason for optimism,” Dr. Angell concludes.

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April 16, 2009

Sen. Grassley Probes Big Pharma Financing Of Mental Health Group

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 7:56 am

Continuing his investigation into drug company influence on health care costs, the Republican from Iowa wants to know who’s financing the non-profit psych front group National Alliance for Mental Illness.

A recent article in Bloomberg News reports that Senator Chuck Grassley (R, IA), as part of his ongoing investigation into Big Pharma’s financial influence on the practice of medicine, is asking the National Alliance for Mental Illness (NAMI) about its funding.

Sen. Grassley recently sent a letter to NAMI requesting the nonprofit mental health front group to disclose any direct financial backing from Big Pharma and any foundations or other front groups created by Big Pharma (of which of course there are many).

Over the past year or two, Sen. Grassley has been on something of a crusade to unearth Big Pharma’s financial influence on America’s health care providers, researchers and educators.

“I have come to understand that money from the pharmaceutical industry shapes the practices of nonprofit organizations which purport to be independent in their viewpoints and actions,” Sen. Grassley wrote in his letter.

Bloomberg says NAMI did not return calls asking for comments on Sen. Grassley’s request.

Founded in 1979, NAMI calls itself “the nation’s largest grassroots organization for people with mental illness and their families.” NAMI’s web site claims to have affiliates in every state, and in more than 1,100 local communities across the country.

Bloomberg reports that NAMI came under scrutiny in 1999, when the magazine Mother Jones reported that 18 drug companies gave the group $11.7 million from 1996 to mid-1999. These included Janssen ($2.08 million), Novartis ($1.87 million), Pfizer ($1.3 million), Abbott Laboratories ($1.24 million), Wyeth-Ayerst Pharmaceuticals ($658,000), and Bristol-Myers Squibb ($613,505), the Mother Jones article said.

The article also reported that at one point, Jerry Radke, a Lilly executive, was “on loan” to NAMI, working out of the organization’s Arlington, VA, headquarters.

The 2007 NAMI annual report showed that the group’s “corporate partners” included:

* Abbott Laboratories
* AstraZeneca Pharmaceuticals
* Bristol-Myers Squibb
* Eli Lillyy
* Forest Laboratories
* GlaxoSmithKline
* Janssen
* Magellan Behavioral Health (a mental health specialty HMO)
* McNeil Consumer Healthcare (a Johnson & Johnson subsidiary)
* Otsuka America Pharmaceutical, Inc.
* Pfizer, Inc.
* PhRMA (the drug industry’s DC lobbyist trade association)
* Solvay Pharmaceuticals, Inc.
* Vanda Pharmaceuticals
* Wyeth Pharmaceuticals

Vera Sharav, president of the Alliance for Human Research Protection, a New York-based nonprofit that promotes ethical research, told Bloomberg News that NAMI may have drawn Grassley’s attention because it lobbies Congress for mental-health funding.

“Academics and physicians give an appearance of authority,” Sharav told Bloomberg. “Industry gives them the money. Grassley has been going after each group systematically, and the dots are being connected.”

In January, Sen. Grassley and Senator Herb Kohl, (D, WI.), reintroduced the Physician Payment Sunshine Act. If passed by Congress, the act would require manufacturers of pharmaceutical drugs, devices and biologics, with $100 million or more in annual gross revenues, to disclose the amount of money they give to doctors through payments, gifts, honoraria, travel and other means. Penalties for not reporting would range from $10,000 to $100,000 per violation.

“Right now the public has no way to know whether a doctor’s been given money that might affect prescribing habits,” Sen. Grassley said last September when the bill was first introduced. “This bill is about letting the sun shine in so that the public can know. Whether it’s dinner at a restaurant or tens of thousands of dollars or more in fees and travel, patients shouldn’t be in the dark about whether their doctors are getting money from drug and device makers,” he added.

“At our June hearing,” Sen. Kohl said at the time, “the pharmaceutical industry told the Aging Committee that they believe their practices are above-board. If that is the case, full disclosure will only serve to prove them right. If that is not the case, full disclosure will bring their influence-peddling out from the shadows. Either way, patients win.”

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