Medical Detox Programs in a stress-free environment

October 29, 2008

Pfizer Exec Sentenced For Possession Of Child Pornography

Filed under: Big Pharma, FDA — Rod Malcolm @ 1:54 pm

Pfizer’s global patent director was arrested in March, later fired, and now faces 6½ years in prison for ‘receipt and distribution of child pornography.’

Wall Street Journal’s Health Blog reports that a former executive at Pfizer Corp. has been sentenced to 6½ years in prison for possessing and trading in child pornography.

Alan Hesketh, a 61-year old British citizen living and working for Pfizer in America, was sentenced last week in U.S. District Court after pleading guilty to receipt and distribution of child pornography.

At first reading, this story didn’t seem particularly relevant to our blog, which focuses primarily on how the practices of Big Pharma and the FDA continue to threaten public safety. But I soon found it compelling because of its subtext: Big Pharma exec is living a secret, dark and shameful double life, driven by out-of-control forces to commit unspeakable acts regardless of the consequences.

Wow! Suddenly the story resonated with all that has come to be revealed in recent years about Big Pharma’s own dark, innermost secrets behind its marketing and sales activities. Like an 18-wheeler in an out-of-control skid down a rain-swept mountain highway, Big Pharma has committed fabulous breaches of ethics, lied to its shareholders, the FDA, Congress, physicians, medical journals and the public. Its marketing and PR execs have been consumed with lying and cheating as a way life, utterly regardless of the potentially disastrous consequences.

Like poor pedophilic kiddie-porn-collector Hesketh, the consequences of bad habits have been dire indeed. While some of the more vociferous critics of Big Pharma are saying that its predatory marketing execs should join Hesketh in prison, at least the industry has had to face legal settlements that now total in the many billions of dollars. It’s getting harder than ever to hide the hateful habits of a lifetime.

Whether the fines and other legal and PR pressures to clean up its act will suffice, or actual jail time for key offenders will be needed, sooner or later the industry is going to have to respond and reform itself. The alternative is to go the way of the dinosaur — be replaced by smaller, smarter and quicker entities, in this case ones who value their customers and see how important honesty and transparency are in the overall scheme of survival.

Of course, we all know that some habits are almost impossible to overcome. Hesketh has 6½ years to ruminate about his. Only time will tell whether he, and Big Pharma, can and will reform, or whether their destructive bad habits will be driven deeper underground hoping to evade detection.

October 28, 2008

Healthcare Must Regain Independence From Destructive Influences

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:44 am

There was a time when physicians, and the medical schools, were fiercely independent — scientifically, intellectually and financially. That is no longer the case, and the repercussions have damaged public perceptions and the quality of patient care.

Getting our stuff fixed properly, expertly and honestly — a car, an appliance, a leaky roof, almost anything — can sometimes present problems.

Will the mechanic or contractor diagnose the problem and fix it correctly the first time? Or will he botch it two or three times before getting it right, costing us unnecessary money and grief?

Will he do an honest job and charge us fairly for the service? Or will we be duped into paying for work that was not needed, gouged by the kind of greedy crook we hear about on the 11 o’clock news?

It’s been common for generations to ask friends to recommend a contractor or mechanic with proven honesty and capability. Yet even with a recommendation, we still proceed with watchful caution. But I can remember when we didn’t ask friends or relatives for the name of a clinic, hospital or doctor that could be trusted to do the job right, do it honestly with care and compassion, and not overcharge us, or god forbid, hurt us some way.

Back in the day, when it came time to repair our bodies, we expected nothing less than near-perfection from our healthcare professionals, regardless of whether or not such god-like standards existed — and indeed, any doctor will tell you they did not.

But we naively assumed medical science offered a standard of knowledge and ethical care that transcended the fraud and greed we might expect from shifty-eyed grease-monkeys at the local garage.

Oh my! How our perceptions have changed.

When it comes to repairing our bodies and our health these days, we’re no longer so innocent and trusting, according to reports. Horror stories from all parts of the country have become commonplace, usually about injuries or deaths due to hospital, physician and pharmaceutical errors, if not outright malfeasance.

In spite of the dedication and commitment of the vast majority of them, doctors in general have lost their halos, and hospitals have become institutions more often feared than trusted. Healthcare professionals and institutions are no longer perceived as able to deliver that absolute standard of care, even as they strive to do so. Public expectations are approaching rock-bottom.

There’s several reasons for this, and although they’re too complex to deal with in any detail here, for the most part they center around a shattering loss of independence in recent decades by doctors and hospitals — hospitals being basically a collection of complex services provided by doctors.

There was a time when physicians, and the universities that trained them, were independent — financially, scientifically and intellectually. As in any profession, there were always a few brilliant leaders and innovators, the rest being what you might call journeymen practitioners. But, excluding a very few bad apples here and there, they were all by and large ruled by their devotion to their science, their art, and their patients health and safety. The Hippocratic Oath, in part scientifically out of date and not obligatory for graduation or practice, still plays a role in medical practice — most doctors adhere to some standards of ethical care. But is it enough today?

To achieve the sky-high standard that raises medicine above the usual questions we might ask when looking for someone to fix our air-conditioning, physicians must be free from certain irrelevant and destructive influences that have corrupted their ability to deliver the safe and effective care they want to deliver, care that we, the public, expect and need.
 
To deserve the respect and trust they were once unquestioningly accorded (and which most patients yearn to accord again) physicians must regain their independence of thought and action from, at the very least:

1. Big Pharma’s “there’s a pill for everything” mentality, espoused endlessly in professional and consumer advertising. Get back to treating whole patients, not writing brush-off prescriptions for every tiny complaint.

2. Big Pharma’s $millions and their minions; get them out of all med schools and research institutes, completely and for good. Retake control of teaching and medical research from Big Pharma and Wall Street.

3. FDA’s drug approvals system that has seen far too many new drugs damaging too many people. Get more proactive, probably collectively through professional medical organizations, and demand that lawmakers provide the funding needed to make the FDA independent from Big Pharma.

4. Hospital systems and insurance plans designed to benefit the bottom line more than patient health and safety. Get more proactive here too, in overcoming the control big business has over what should be your patient care.

I know a lot of physicians. They mean well, they try hard, and many work exhausting schedules on behalf of their patients. But in my humble opinion, acceptance of the status quo — control of medical practice by forces not dedicated to patients but to profit — is an abdication of at least some of the responsibility that came with the diploma. And all the rest of us — including the lawmakers who are also patients — need to vociferously support the medical profession in its efforts to regain independence and control of its destiny.

October 24, 2008

Pfizer Will Pay $894 Million To Settle Celebrex, Bextra Lawsuits

Filed under: Big Pharma, Merck, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 1:12 pm

Stemming from allegations that Pfizer improperly marketed its two pain relievers and that the drugs caused bodily harm, the settlement will retire injury claims, class action fraud suits, and state civil suits.

The world’s largest pharmaceutical company has agreed to pay $894 million towards the settlement of some 8,000 lawsuits over its painkillers Celebrex and Bextra.

A Pfizer statement says the amount includes $745 million to settle 90 percent of lawsuits claiming personal injuries, and that under “agreements in principle” it will pay another $89 million for consumer fraud lawsuits, and an additional $60 million to 33 states and Washington, D.C., over alleged illegal promotion of Bextra.

According to Bloomberg news, Pfizer was being sued for personal injury and fraud over allegations that the drugs increased the risk of heart attacks or strokes, and by states claiming Pfizer marketed Celebrex and Bextra for off-label uses not approved by the FDA.

The settlement, reported as the fourth largest Big Pharma legal payout in the U.S. this year, is chump change compared to the $4.85 billion in settlements over Merck’s Vioxx, a similar pain killer that was pulled from the market for the same types of side effects in 2004.

Bextra was recalled in 2005 because of connections to a rare skin condition, but state and federal judges ruled that plaintiffs failed to present reliable scientific evidence proving that Celebrex can cause heart attacks or strokes at its most commonly prescribed dose. Celebrex remains on the market, and it’s still a blockbuster for Pfizer, earning $2.3 billion last year.

Bextra, Celebrex, and Vioxx are among the class of painkillers called cox-2 inhibitors, or non-steroidal anti-inflammatory drugs, which also include ibuprofen and naproxen. The FDA has warned that these drugs can increase the risk of heart attack and stroke.

Amy Schulman, Pfizer’s general counsel, told Bloomberg that “anytime that you have an opportunity to resolve litigation, which is inevitably something that creates uncertainty, in terms that make sense for the people and corporation, it is a good thing to do.” The company is “hopeful that it can resolve the remaining 8% to 10% of the Celebrex and Bextra personal injury cases that weren’t part of the settlement.” None of those cases have reached the trial stage.

When you add the roughly $1 billion Big Pharma has had to shell out in legal fees to the staggering billions of dollars in settlements, it’s no wonder the costs of drugs are so high in this country. The solution is for pharma to reign in its unethical and even fraudulent marketing practices, and for the FDA and pharma to do a better job of ensuring drugs are safe before millions of prescriptions are written.

October 20, 2008

Election News: Big Pharma Favors Obama 2-to-1 Over McCain

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 1:03 pm

Nearly 60% of pharma-connected people polled say they will vote for Obama, while less than 30% will vote for McCain. And through September, the Democrats had scored more pharma contributions than Republicans, but the tide may be turning the other way.

According to the results of an Internet poll conducted by Pharma Marketing News, if a vote were held today, 57.3 percent of people involved in some way  with Big Pharma would vote for Democrat candidate Sen. Barack Obama, while only 29.6 percent would cast their votes for the Republican, Sen. John McCain.

John Mack at Pharma Marketing reports that the informal, non-scientific ,“Who’s Better for Pharma: Obama or McCain?” survey is the only one specifically targeting a broad range of professionals working within and for the pharmaceutical industry.

As of October 17, 2008, the poll showed:

Barack Obama  57.3%

John McCain  29.6%

Undecided  9.9%

Neither   2.4%

Other     0.9% 
 
You can access the latest results — minus identities of respondents any comments — up to election night.

In a related blog, John Mack reported last week that in the past week or two, the growth in Big Pharma PAC campaign contributions to the McCain camp has overtaken the rate of growth in contributions to Obama. This is a reversal of the trend earlier in the year that saw Obama contributions consistently growing faster than McCain contributions.

Mack has a graph of the contributions on his blog page. The total of Big Pharma PAC contributions to Obama continues to be far ahead of McCain.

Even with the slight swing towards the Republicans in the past week or two, the greater total of contributions, and the results of the voter survey, says that Big Pharma is definitely banking on a Democratic government led by Barack Obama.

October 16, 2008

NJ Senator Stonewalling Parental Informed Consent Bill

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 1:51 pm

Informed consent, which on the surface at least appears to be a right guaranteed in the Declaration of Independence, is apparently not in the best interests of Big Pharma and Big Health Care Insurers.

A couple of New Jersey moms are trying to get a bill passed that would require a doctor or nurse to obtain informed consent from a minor’s parent before writing a prescription for any psychotropic drug that already carries a Black Box warning.

Although the bill has passed the Assembly, it’s been stymied by Sen. Joe Vitale, chairman of the Health, Human Services, and Senior Citizens Committee, who so far has refused to send it forward for a vote, or provide any explanation why.

In his Pharmalot blog, Ed Silverman reports, “Vitale refuses to come to the phone to explain his decision. Do contributions from drugmakers have anything to do with it? Vitale gets money from lots of sources, so you can speculate yourself by gazing at his lists of contributors.”

A cursory browse through Vitale’s contributors does reveal modest sums from Big Pharma players such as Aventis, Schering, GlaxoSmithKline, Bayer, and Eli Lilly — one of the heaviest contributors. There also are interests like Garden State Pharmacy Owners and Nursing organizations, but more telling are the contributions from health insurance interests, including Aetna and Amerigroup, the latter of which in August this year settled the largest ever Medicaid fraud suit in the history of the state of Illinois — $225 million settled a $334-million court decision for fraudulent claims.

Senator Vitale apparently has not sent the bill back with questions about aspects of it, asked for clarifications, requested rewrites, deletions or additions, or given any other explanation. I say apparently, because I don’t know that for sure. But if that’s true, then what is influencing the senator to stall?

Let’s assume that the bill itself isn’t completely off the mark. And to be fair, let’s assume that political contributions are playing no role. Barring a bad bill, barring Big Pharma money (of course BP wants their drugs consumed by everyone in the world), barring insurance company money (they don’t want to pay for the extra time it would take to inform parents), there seems only one other reasonably plausible motive: Senator Vitale personally doesn’t want parents to have a chance to make a better-informed decision about the state-ordered drugging of their kids. He just wants those kids doped up now!

Could that be true? It’s hard to believe, and it seriously undermines the senator’s main message on his senatorial web site, which reads:

“Senator Vitale’s foremost priority is protecting the health of children and working families as well as making health insurance accessible for all New Jerseyans. To make his vision a reality, Senator Vitale has crafted numerous pieces of legislation to improve the quality and efficiency of health care in New Jersey.”

In light of that statement, it’s tough to see how improving the health of New Jersey children is supported by the indiscriminate drugging of infants, children and teens with mind-altering psychotropics. These are drugs have never been tested on children even short-term, never mind long term, drugs not only NOT approved for that population, but NEVER evaluated for risk / benefit beyond just shoveling them out to kids and keeping one’s fingers crossed. And usually without ensuring parents’ informed consent.

These drugs have been indisputably linked to suicide, violence and aberrant behavior among young people across the nation — drugs with Black Box warning labels about giving them to kids!

Senator Vitale, it is difficult to believe that you could oppose parents being fully informed about these drugs. You have a reputation of “putting the people of New Jersey first.”

The two concerned mothers who spearheaded the bill are “people of New Jersey” too. 

If the bill is faulty or simply incomplete, they and those in government who passed it forward deserve an opportunity to amend the bill, or receive an explanation of why you refuse to schedule it for a vote.

A bill like this one is going to get passed somewhere, some day, in some state, probably sooner rather than later. In fact, this bill could blaze a trail across the country, from state to state. And whomever champions that bill will be well remembered.

Informed consent is a big and growing issue among all concerned with child drugging, and their numbers are in the tens of millions. Forcing drugs on children is bad enough, but when parents are shunted aside like mindless cattle who couldn’t possibly understand, it’s even more un-American than anyone should care to think.

October 13, 2008

Experts Say Pfizer Manipulated Neurontin Studies For Market Advantage

Filed under: Big Pharma, FDA, Merck, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 1:47 pm

Despite the lack of scientifically valid evidence to support a dose-related effect at dosages above 1800 mg/day, the company launched a marketing campaign advocating  dosages up to and above 3600 mg/day.

A New York Times article reports that Pfizer earlier this decade “manipulated the publication of scientific studies to bolster the use of its epilepsy drug Neurontin for other disorders, while suppressing research that did not support those uses.” The charges come from experts who reviewed thousands of company documents for plaintiffs in a lawsuit against the company for promoting the drug for off-label uses it knew were ineffective.

Says the Times, “Pfizer’s tactics included delaying the publication of studies that had found no evidence the drug worked for some other disorders, “spinning” negative data to place it in a more positive light, and bundling negative findings with positive studies to neutralize the results, according to written reports by the experts, who analyzed the documents at the request of the plaintiffs’ lawyers.”

Promotion of unapproved, off label uses for Neurontin, such as bipolar disorder, certain types of pain and prevention of migraine headaches, helped propel sales of the drug to more than $3 billion a year before patent protection was lost in 2004 (the drug’s generic name is gabapentin). Publication of negative studies certainly would have impacted that bottom line, the experts said.

The reports, unsealed last Monday in a federal court in Boston, add to a growing body of evidence that Big Pharma has long been engaged in “blurring the lines between science and marketing,” the newspaper said.

For example, it was learned that Merck hired ‘ghostwriters’ to produce scientific articles about its pain reliever Vioxx, then paid prestigious doctors to serve as their official authors. After research showed it could cause strokes and heart attacks, Vioxx was withdrawn from the market in 2004, but not before it had earned billions. And Merck and Schering-Plough both have been condemned for delaying release of a study showing that its cholesterol drug Vytorin didn’t slow the growth of arterial plaque.

One of the experts, Brian Alldredge, PharmD, Professor of Clinical Pharmacy and Neurology at University of California, concluded that a review of all clinical trials failed to establish any dose-related effect (i.e., continued improvement in efficacy) at dosages above 1800 mg/day, an assertion supported by FDA rulings, yet Parke-Davis/Pfizer heavily marketed dosages up to and above 3600 mg/day. This higher dosage / higher efficacy message was strategically discussed in Parke-Davis planning documents, promoted via company-sponsored publications, continuing medical education programs and materials, and via presentations/lectures that targeted Neurontin prescribers, relying on lower quality evidence at the exclusion or minimization of higher quality evidence.

“The effect was to increase Neurontin sales, to increase Parke-Davis/Pfizer profits, and to increase the expenditures of payors (including patients),” Alldredge said

There are several important factors to look at when considering Big Pharma’s deceptive marketing practices: patient health, and the cost of health care in general

The goals of patients — better health –  and those of their physicians — to bring health and do no harm — are deliberately and criminally subverted when research is withheld or altered.

And for anyone concerned the country’s massive, out-of-control health care bill, do the math:

The cumulative cost to patients, to insurance providers, and to all levels of government involved in health care, for the purchase and administration of tens of millions, and in some cases hundreds of millions, of ineffective and even harmful prescription drugs, can cost this country hundreds of billions of dollars a year.

It’s time these realities should be interpreted legally and applied ruthlessly to any pharmaceutical company that engages in practices that place profits above the well-being of patients, and/or that threatens the viability of our health care systems.

October 10, 2008

FDA Forced To Suspend $300,000 Sham PR Contract

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

A devastating investigation by the Washington Post reveals how agency officials tried to by-pass contract bidding regulations to award a contract directly to a DC public relations agency with ties to the FDA official arranging the deal.

FDA execs are madly back-pedaling and calling for an internal investigation of a shady $300,000 deal to hire a PR agency without going through the government’s required bidding process to find the lowest bidder.

According to internal FDA memos and emails, says the Washington Post, agency officials had decided a PR company was needed to polish up the agency’s tarnished public image. But instead of calling for bids, numerous agency officials appear to be complicit in a scheme to award the contract to Alaska Newspapers Inc. (ANI), a firm owned by an Alaska Native corporation that does not have to compete for federal work because it qualifies for special Native American set-asides, which would then hand the work over to Qorvis Communications, a Washington PR firm specializing in corporate communications.

Adding to the stench wafting off this deal, Mildred Cooper, the FDA executive in charge of the project, had personal ties to Qorvis. Says the Post, she called a friend at Qorvis and was referred to Qorvis exec Don Goldberg, who with another Qorvis exec came up with the idea of putting the contract through ANI to avoid the bidding process. And subsequent correspondence from ANI confirms that the murky deal was indeed underway.

So here we have the FDA, Qorvis and ANI all complicit in an illegal, exceedingly  smelly deal, all starting with the FDA worried about its image. Well, that image is at an all-time new low after this.

Of course, senior agency officials are protesting any knowledge of wrong-doing, have suspended the PR contract, and are calling for an internal investigation. But lawmakers charged with FDA oversight appear less than appeased.

Rep. John Dingell (D-Mich.), chairman of the Committee on Energy and Commerce, which oversees the FDA, said: “The agency chose to use its limited resources to save face, instead of saving the public health.” And he has launched his own investigation.

Amen.

October 9, 2008

Free Prescription Samples A Risk to Kids, Says Study

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 8:40 am

Few prescription drug samples actually go to needy children, and often don’t include black box warnings.

A new study has found that free prescription drug samples distributed to pediatric patients may be unsafe because they don’t carry new black box warnings or significant revisions to existing warnings. And they aren’t finding their way to poor and needy kids, their almost all going to insured or better-off kids whose parents can afford a private physician — and new drugs.

The study, published in the October 2008 issue of Pediatrics, examined data on 10,295 children and adolescents from the 2004 Medical Expenditure Panel Survey.

“New medications are frequently released before their safety profile is fully understood,” said lead author Sarah Cutrona, a physician at Cambridge Health Alliance and an instructor of medicine at Harvard Medical School, “and samples tend to be newer medications. Free samples encourage the casual use of medications in our children before enough is known about potential harm.”

Four of the 15 most frequently distributed samples in 2004 were identified by the FDA as having significant new safety concerns, including new black box warnings or significant revisions to existing warnings. The top 15 samples include Strattera (atomoxetine) and Adderall (amphetamine/dextroamphetamine), drugs used to treat attention deficit hyperactivity disorder (ADHD). Both of those medications are Schedule II controlled substances, meaning they are controlled and monitored by the DEA due to high potential for abuse.

Another author, Dr. Neal LeLeiko, director of the pediatric gastroenterology and nutrition at Hasbro Children’s Hospital, and a professor of pediatrics at the Warren Alpert Medical School of Brown University, said previous findings in adults strongly suggest that free drug samples are just a marketing tool. “Our study shows that samples can pose a serious and unappreciated risk to our children,” Dr. LeLeiko said.

Some physicians welcome the use of free sample medications as a way to get medications to needy patients. But this study’s findings showed that few free samples actually go to the children who most need them.

Only 16 percent of the children who received free samples were uninsured for all or part of 2004, and less than one-third had low family incomes, defined as less than $38,000 for a family of four. Children who were uninsured for part or all of the year were no more likely to receive free samples than were those who were insured all year (4.5% vs 5.1%). And 84.3% of all sample recipients were insured.

October 8, 2008

FDA Ruling On Kids’ Cough And Cold Medicines Could Take Years

Rejecting evidence from pediatricians and consumer health groups for an outright ban, the agency’s plans to rewrite regulations will go forward — but that could take years.

At a day-long public hearing last week to solicit views about how the rules governing children’s cough and cold medications should be changed, consumer health activists and medical experts urged the FDA to pull the remedies off the market, or make them available only by prescription.

The Wall Street Journal reports that the agency rejected the plea for an outright ban, but says will go forward with plans to rewrite the decades-old regulations covering how the remedies are marketed for children. The public hearing was a follow-up of a recommendation made a year ago by an FDA advisory panel that concluded no evidence supports the effectiveness of OTC cough and cold medicines for children. In fact, the panel said, OTC cold medicines should not be given to infants and children younger than 6 years old.

New regulations could result in a more stringent requirements, such as requiring drug makers to seek approvals similar to prescription drugs. But that could take years, and until then the dangerous drugs will remain on the shelves.

An estimated 95 million packages of kids’ OTC cold medicines are sold each year in the US. Popular brands include Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic and Wyeth’s Robitussin, according to industry estimates.

The FDA’s John Jenkins, director of the Office of New Drugs, said the current system governing OTC cold and cough products, which is decades old, was designed to “grandfather” the OTC medicines already on the market since the 1960s.

The system allows certain active ingredients (such as those in decongestants) to be legally marketed without obtaining prior FDA approval for each individual product.

Big Pharma already voluntarily withdrew cold and cough medicines aimed at kids under 2 — but it was only marketing and labels, not much of a product withdrawal. And an industry statement yesterday talked about a “multiyear plan” to study the safety of the drugs in kids between 2 and 12 — suggesting no industry action is imminent.

Jenkins said the agency is wary of banning the drugs because parents would simply give their kids adult cold medicines. “It really is a conundrum for us,” Jenkins added.

Jenkins and the FDA should reconsider:

First, studies that established ingredient safety were done almost entirely on adults. Dosing recommendations for kids are simply reduced adult doses, which modern science has clearly shown is faulty science. Children don’t metabolize substances the same as adults — especially toxic drugs.

Second of all, and contrary to Jenkins’ opinion, parents of small children can be educated — especially if they get the warnings from doctors, pharmacists, point-of-purchase materials, packaging inserts, and big, bold warnings on new labels that “This medicine can be fatal to children under 6 years of age”.

It sounds to me like the FDA doesn’t want to ask Big Pharma to lose another nickel on sales aimed at children, or spend another nickel adding warnings and producing educational materials, ads and commercials that would help parents make the right decisions.

It’s the same old story: Keep American consumers stupid and drugged, no matter the cost is in deaths and injuries. Short-term profits out-point long-term problems like massive class-action suits and legal settlements.

October 7, 2008

Another Top Psychiatrist Fails To Report Millions In Big Pharma Payments

Our financial transparency system for drug and device maker payments to medical consultants isn’t working, and universities are all but incapable of policing their faculty’s conflicts of interests.

A New York Times article reports this week that the ongoing Congressional inquiry into financial conflict-of-interest disclosures has revealed another influential psychiatrist violated federal research rules by failing to report income from Big Pharma.

Dr. Charles B. Nemeroff of Emory University, the Times reports, is “the most prominent example to date in a series of disclosures that is shaking the world of academic medicine and seems likely to force broad changes in the relationships between doctors and drug makers.”

Dr. Nemeroff earned more than $2.8 million in consulting arrangements with drug makers between 2000 and 2007, and violated federal research rules by not reporting at least $1.2 million of it to his university, according to documents provided to the Congressional investigation being spearheaded by Sen. Charles R. Grassley, Republican of Iowa.

“After questioning about 20 doctors and research institutions, it looks like problems with transparency are everywhere,” Sen. Grassley said. “The current system for tracking financial relationships isn’t working.”

In one “telling example”, the Times reports, Dr. Nemeroff signed a letter dated July 15, 2004, promising Emory administrators that he would earn less than the federal legal limit of $10,000 a year from GlaxoSmithKline. “But on that day, he was at the Four Seasons Resort in Jackson Hole, Wyo., earning $3,000 of what would become $170,000 in income that year from the British drug giant — 17 times the figure he had agreed on,” says the Times.

The findings, says the Times, suggest that universities are all but incapable of policing their faculty’s conflicts of interests. Almost every major medical school and medical society is now reassessing its relationships with drug and device makers.

Not An Isolated Problem

Dr. Nemeroff isn’t the first psychiatrist the inquiry has found coming up short on financial conflict-of-interest disclosures to their institutions.

Last spring, Sen. Grassley began his investigation by questioning Dr. Melissa P. DelBello of the University of Cincinnati after the Times questioned her connections to drug makers. Although Dr. DelBello reported that she earned about $100,000 from 2005 to 2007 from eight drug makers, Sen. Grassley discovered that AstraZeneca alone paid her $238,000 during the period.

In earlier blogs, we reported on several prominent Harvard psychs, and Sen. Grassley’s growing interest in how much money from Big Pharma is flowing into the American Psychiatric Association itself. The senator also looked closely at Dr. Alan F. Schatzberg of Stanford, the APA’s president-elect, because of his $4.8 million in stock holdings in a drug development company.

Sen. Grassley is pushing the “Physician Payment Sunshine Act” that would require drug and device companies to publicly list payments made to doctors that exceed $500. Several states have already legislated similar requirements, and revelations from the Congressional investigation appear to be motivating some motion in the industry itself. Big Pharma’s trade organizations and some medical colleges say they support the Sunshine bill, and Eli Lilly and Merck announced they will publicly list doctor payments next year even without the legislation.

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