Medical Detox Programs in a stress-free environment

December 22, 2008

Book Report: ‘Side Effects’ by Alison Bass

Filed under: Big Pharma, FDA, pharmaceuticals, prescription drug abuse, prescription drug addiction — Rod Malcolm @ 12:22 pm

‘Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial’ by Boston Globe medical reporter Alison Bass, says USA Today, “is both a public-policy primer and a compelling account of how seeming miracle cures are sometimes death sentences.”

In her new book ‘Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial’, Boston Globe reporter Alison Bass examines Big Pharma’s efforts to sell blockbuster drugs with little heed for patient safety, by zeroing in on a groundbreaking trial and the drama of the personal stories surrounding the case.

Reviews of this book are so uniformly praiseworthy and extraordinarily positive that I can’t wait for my copy to arrive — I’m recommending it even before reading it, based on my ongoing admiration for her reporting, her insightful blog, and reviews like these:

“When Alison Bass was reporting for the Boston Globe in the 1990s, she began gathering string for the rope she has skillfully twined around drug companies and the psychiatric profession in Side Effects . . . Her narrative bristles with data without fraying into tedium. And she underlines the gravity of hiding patients’ injuries. Side Effects is long-form journalism at its best.” — The Washington Post

“Side Effects lays out the compelling drama of how New York’s then-attorney general Elliot Spitzer — before his downfall while state governor — charged GlaxoSmithKline with fraud for deceiving doctors about its blockbuster antidepressant, paroxetine (Paxil). Writing with a novelist’s touch and honing her material for its underside, Bass has produced a gripping whodunit replete with dead bodies, hidden documents, public monies spent on nonexistent studies and even a sham court verdict.” — The Canadian Medical Association Journal

“In her new book Alison Bass obeys the most important rule of investigative journalism: She follows the money wherever it leads. In “Side Effects,” her examination of mammoth pharmaceutical companies and their pursuit of profits at any cost, she exposes the dark web of researchers, doctors, and regulators feeding at the Big Pharma trough and undermining public health in the process . . . Meanwhile, it took the New York attorney general’s office to compel GlaxoSmithKline to publicly disclose Paxil’s link to suicidal thoughts. Bass provides a dramatic account of this lawsuit, following state attorney Rose Firestein as she digs up evidence of Glaxo’s deceptive conduct. — The Boston Globe

“Alison Bass, a former medicine, science, and technology reporter at The Boston Globe, has put on trial in her book far more than just a bestselling antidepressant  — she has used the case of Paxil to expose the unsavory and self-serving relationships among members of the pharmaceutical industry, psychiatrists, and members of the FDA. And she does it in a book that has the brio of a crime thriller . . . Bass’s riveting and well-researched account of these disturbing ties should be widely read by members of the medical profession, many of whom continue to believe, despite all evidence to the contrary, that they are immune to the influence of drug companies.” — New England Journal of Medicine (pdf)

“Side Effects, by investigative journalist Alison Bass, grapples with the controversy over drugs used to treat depression, with a focus on Paxil, Prozac and Zoloft . . . Bass’ book humanizes the controversy in a way that makes the statistical arguments come alive. Because of her research and storytelling skills, a book exists that is both a public-policy primer and a compelling account of how seeming miracle cures are sometimes death sentences.” — USA Today

Alison Bass an award-winning, Pulitzer Prize-nominated journalist and long-time medical writer for The Boston Globe. Her articles and essays have also appeared in numerous other newspapers and magazines around the country. She is a Senior Lecturer in Journalism at Mount Holyoke College and an Adjunct Professor of Journalism at Brandeis University.

‘Side Effects: A Prosecutor, a Whistleblower, and A Bestselling Antidepressant on Trial’
By Alison Bass, Algonquin Books, June 17, 2008

December 19, 2008

Big Pharma Blew Some Smoke, And Massachusetts Sucked It Up

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 8:54 am

Massachusett’s public health department has caved in to Big Pharma’s threats to end research spending in the state, allowing doctors paid for research and consulting an end-run around the state’s financial disclosure laws.

The state of Massachusett’s proposed new regulations requiring Big Pharma to disclose the nature of financial relationships with physicians has officially been emasculated, and basically by a puff of Big Pharma smoke, it appears.

Back in August, we blogged about the state’s apparently caving in to threats from Big Pharma to take its research business out of state if the law was passed as written. The House backed down, and like a pack of cowering dogs approved a stripped-down version of the measure. It turned the proposed tough legislation into a vague statement of intent, and sent it to the Health Department to work out the actual regulations.

There was still some hope among health care and consumer activists that the health department might do something useful with it, but a report in today’s Boston Globe reveals that is not the case.

Doctors will not be required to disclose consulting and research funding from Big Pharma under the proposed regulations — the very interest-conflicting back-door payments that prompted the idea for such regulations in the first place.

The new rules, if finally passed, will require physicians to report free meals, gifts and vacation junkets from drug companies, and report any money they receive to promote drug company products.

Oh please. That is chump change compared to the billions paid to doctors to test and report on new drugs, and stump around the countryside promoting the new drugs to doctors.

The Globe says a memo from Health and Human Services’ deputy general counsel has ruled that the proposed regulations do not cover “bona fide services” for drug and medical device manufacturers such as consulting services, research, participation on advisory boards, company-sponsored presentations and education.

These so-called “bona fide services” are what really influence doctors in practice to prescribe one drug rather than another. This is the real influence peddling, not a free lunch.

In her blog on the story, journalist and author Alison Bass says “research shows that doctors who receive personal payments from drug companies are much more likely to report and promote positive findings about the company’s products than doctors who don’t have these conflicts.”

The other unfunny joke here is Big Pharma’s claim that revealing payments for clinical trials would tip off competitors and jeopardize proprietary information.

Pure smoke, to put it delicately. And the state’s lawmakers just sucked that up too.

As Dan Carlat points out in his blog, information about clinical trials is already publically available at ClinicalTrials.gov, an online registry of all significant clinical trials.

“There are currently 65,825 trials registered,” Dr. Carlat says, “so if you are Pfizer, and you want to know what kind of research Eli Lilly is conducting, the answer is only a few clicks away.”

This whole exercise is a little more than a sad, bad joke. It’s a travesty of public trust for the citizens of the Commonwealth of Massachusetts.

December 17, 2008

AstraZeneca Caught In Two Seroquel Scams In One Week

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 2:07 pm

It’s a double setback for AstraZeneca and Seroquel — revelations they withheld diabetes risk since 2000, and FDA charges of blatant off-label promotion.

AstraZeneca took double-jabs to the jaw last week, and deservedly so.

First, documents filed in a federal court in Tampa show that the drugmaker was aware its antipsychotic Seroquel causes diabetes as far back as 2000, reports Bloomberg News. Almost simultaneously, the FDA released a letter sent to AstraZeneca, charging that a company sales rep told a doctor that Seroquel was approved for treating depression — which it is not.

One of the internal documents appearing in court show AstraZeneca’s global safety officer Wayne Geller concluding there is “reasonable evidence to suggest Seroquel therapy can cause” diabetes and related conditions. Geller drew his conclusions from various studies and internal trials.

And the FDA’s letter about off-label marketing reveals that when the physician asked for relevant documentation about Seroquel used for depression, AstraZeneca had the gall to send the doctor a summary of studies clearly supporting Seroquel for depression, in blatant violation of off-label marketing regulations.

Back in 2006, AstraZeneca came under the gun for recommending Seroquel to treat dementia patients, and the FDA warned that Seroquel and other atypical antipsychotics are associated with an increased risk of death when treating dementia. This constituted another “off-label” use of the drug, because Seroquel was never approved to treat dementia.

And as far back as 2003, the Wall Street Journal examined a study on atypical antipsychotic medications, including Seroquel, that clearly indicate that the drugs are more likely to cause diabetes than ‘older’ medications. Quetiapine, marketed by AstraZeneca as Seroquel, by Orion Pharma as Ketipinor and by others in countries with expired patents, is one of the ‘newer’ atypical antipsychotics approved for schizophrenia and bipolar disorder. It has received off-label uses for a variety of other conditions including anxiety disorders, insomnia, Alzheimer’s and dementia.

In January 2004, the FDA asked AstraZeneca to include warnings about the risk of hyperglycemia (high blood sugar) and diabetes associated with the use of Seroquel.  The FDA said that in some cases the hyperglycemia resolved when the drugs were discontinued, but that some patients continue to require treatment despite discontinuation of the drug.

AstraZeneca is facing claims in state and federal courts across the U.S. The Tampa trial, set to begin Feb. 2 next year, is a complaint filed by Linda Guinn of Palm Bay, Florida that her use of Seroquel led to a diabetic condition.

Thousands of consumers have sued over the deadly side effects of atypical antipsychotics — AstraZeneca over Seroquel, Eli Lilly over Zyprexa, Johnson & Johnson over Risperdal — claiming these companies hid the risks of the drugs, and marketed them for unapproved purposes. Lilly has already paid out $1.2 billion to settle 31,000 Zyprexa claims, and it isn’t over yet.

It just leaves one wondering what Big Pharma is thinking. Or if they’re thinking at all.

December 16, 2008

Unpublished Negative Trials Still A Situation That The FDA Is Missing

Filed under: Big Pharma, FDA — Rod Malcolm @ 1:10 pm

As long as the FDA is suffering from lack of staff and funding, policing Big Pharma’s propensity for crossing ethical boundary will remain a problem.

A roundup of the literature concerning unpublished negative clinical trial results in recent years appeared in the Wall Street Journal this week, bannered “What You Don’t Know About a Drug Can Hurt You”, all serving to remind us that this is a situation that won’t go away.

Under a subtitle of “Untold Numbers of Clinical-Trial Results Go Unpublished; Those That Are Made Public Can’t Always Be Believed”, the news story references numerous recent studies showing that the vast majority of unpublished studies were negative rather than positive.

Emphasizing the situation a few more notches, the Journal also covered its news article in a concurrent Health Blog under the banner, “How Many Negative Drug Studies Still Go Unpublished?”, commenting that the news story “brings the issue into sharp relief” and raising the question so many people have been asking for so long: “Based on clinical trials, we know a fair amount about drugs on the market. But how much don’t we know?”

The Journal reports that “for a decade or more, researchers, federal regulators, pharmaceutical companies and medical journal editors have sought a balance between commercial secrecy, scientific openness and the public health. Incomplete test results can lull doctors into believing that drugs they prescribe are better than a placebo, and mislead scientists conducting follow-up studies.”

Deliberately obscuring negative test results and then aggressively marketing the drugs to an unsuspecting medical and patient community is almost incomprehensibly unethical. Law suit after law suit stemming directly from drug injuries and deaths have cost the industry billions of dollars, product withdrawals, and a devastating loss of public trust and respect, yet the practice continues.

“There is data that you are not seeing,” Deborah Zarin, director of the National Library of Medicine’s online clinical trials registry, told the Journal. “There is a huge problem here if an unknown amount of the information is censored and you don’t even know it is censored.”

Charged with watching the industry’s ethics is a hopelessly compromised FDA, under-staffed, under-funded, significantly reliant on Big Pharma approvals money, overrun with Big Pharma lobbyists and White House-appointed lawyers tinkering with rules and regulations to protect Big Pharma — an agency which has lost not just its ability but its will to police and control Big Pharma, an agency where public servants have become industry servants.

And still to come is another looming disaster — a Supreme Court decision on federal preemption in Wyeth v. Levine that, were it to find for Wyeth, would remove the public’s last right to pursue product liability suits — the essential secondary level of protection and safety. Preemption would make the FDA’s approval of a drug the unchallengeable “Gold Standard” — and we all know where that has gotten us.

Yet it is these very state-level product liability lawsuits that have been absolutely pivotal, not only in revealing the dangerous side effects of dozens of pharmaceuticals that the FDA’s own testing and approvals systems failed to discover, but also in bringing to light Big Pharma’s continuing, obviously incurable, fabric of conspiracy, lies, deception and treachery.

Big Pharma cannot see past its own Pinochio-stretched nose, and will undoubtedly continue to cross all ethical boundaries in the pursuit of profit heedless of public safety. The industry’s ethical blinders are endemic, an ingrained belief system evolved over the decades that isn’t going to go away without major surgery at almost all levels.

Massive fines have already been leveled against a few Big Pharma execs, for deception and breaches of marketing regulations. We can’t help but agree with many critics who believe there are dozens more for whom only jail time is warranted.

December 12, 2008

New Congress Should Call A Moratorium On DTC

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 7:46 am

Congressman Henry Waxman is said to be planning a serious dialog on DTC marketing when the new Congress reconvenes in January.

It won’t be all about economics and industry bailouts when Congress reconvenes in January, says a report from Reuters. Direct-to-consumer (DTC) drug advertising will be on the roster for discussion when Rep. Henry Waxman, the new chairman of the House Energy and Commerce Committee, renews a bid to give regulators the power to ban DTC when a new medicine first reaches the market, and its risks are not fully known.

Waxman listed the idea as one of many he would like to pursue after a Congress begins tackling a range of health-care issues.

“It is in these first few years of a drug’s life that drug companies often aggressively market their products and engage in direct-to-consumer advertising. This increases the number of consumers exposed to safety risks of new products long before those risks are truly understood,” Waxman said at a conference sponsored by The Prescription Project, a group critical of industry marketing.

Waxman supported a Congressional proposal in 2007 to allow the FDA to ban television ads for new medicine for up to three years if officials decided it was necessary to protect the public health. Officials would decide on a case-by-case basis rather than blanket all new drugs with the ban.

“That concept makes a great deal of sense and can provide FDA an important tool to protect the public health,” Waxman said.

The attempt last year failed after some lawmakers objected it would violate constitutional protections of free speech. Instead, Congress gave the FDA authority to fine companies for running false or misleading promotions.

My question to those objecting lawmakers is: Since when was there free speech on television? I think we know who’s pockets those lawmakers were in.

Meanwhile, Big Pharma’s TV commercials have continued to receive criticism for promising benefits that many, if not most users, will never see, and for minimizing the seriousness of the usually long lists of horrendous side effects and contraindications.  There are also studies showing the commercials lead to excessive prescribing, often for new drugs demanded by patients when less expensive generics are just as effective.

In Eye On FDA, Mark Senak says that some companies have voluntarily imposed a 6-month moratorium on DTC. But apparently Waxman has something much longer in mind — a term of three years, enough time to protect public health by giving sufficient time to estimate safety before aggressive advertising expands its use.

A second reason for the moratorium could be cost, Senak suggests. Inevitably higher drug prices get attributed to higher marketing costs, but limiting marketing costs by removing DTC could not only lower patient drug costs, but also reduce expenditures by the federal government  — the largest purchaser of drugs — that are inflated by DTC marketing. 

A DTC ban won’t come soon enough for many of us, who are weary not just of the endless string of drug commercials every night accompanied by rapid-fire litanies of nasty side effects, but also weary of the deaths, injuries and class-actions that follow in the footsteps of so many newer drugs.

December 11, 2008

Obama Team Needs To Overhaul The Suffering FDA

Filed under: FDA — Rod Malcolm @ 11:32 am

“FDA is close to being at a tipping point — the agency is hanging on by its fingertips in protecting us,” says former Associate Commissioner William K. Hubbard.

The new administration of President-elect Barack Obama “will inherit a Food and Drug Administration widely seen as struggling to protect Americans from unsafe medication, contaminated food and a flood of questionable imports from China and other countries,” the Washington Post reported in a recent article

E-coli infections in foods, fatal or dangerous side effects of approved medications like Vioxx, Avandia and several psych drugs, imported drug and food products contaminated with a variety of nasty additives, and all manner of complaints from industry and Congress, are all signs of troubles at the FDA that Obama team will have to do something about.

The Post went on to say that the FDA’s food and drug divisions have both been hobbled by its inability to adequately monitor goods pouring into the United States from around the world, including food, drugs and raw materials, highlighted by contaminated toothpaste from China, tainted pet food that killed hundreds of dogs and cats, and the fouled blood thinner heparin, which took the lives of at least 81 Americans and caused hundreds of serious illnesses.

“FDA is close to being at a tipping point — the agency is hanging on by its fingertips in protecting us,” said William K. Hubbard, former Associate Commissioner with 27 years at the agency. “If something is not done, they could become a failed institution, and no one wants that. The FDA is not only important to protecting the public health but also to the industries it regulates.”

“Everywhere you go, you hear the same chorus: The agency’s in trouble,” said David A. Kessler, FDA commissioner under Presidents George H.W. Bush and Bill Clinton. “There’s a general perception the agency is suffering mightily.”

The FDA is responsible for overseeing products that account for one-quarter of consumer spending in the United States, including over-the-counter and prescription medications, heart valves, stents and other medical devices, the blood supply, and food.

With nearly 11,000 employees and an annual budget of more than $2 billion, the agency is barely surviving, let alone excelling at its jobs. Morale inside and credibility outside have both plummeted in recent years. The agency has been stretched to keep pace with its responsibilities, is struggling from serious internal strife and dissension among its ranks, and labors under widespread accusations that it is biased toward industry rather than the consumers it is pledged to protect.

Although some overseas offices have been established to police safety standards at the source, experts say much more needs to be done. Carl R. Nielsen, former head of the FDA’s import operations, said that for starters the agency needs to sharply boost inspections abroad, develop strict new regulatory standards, and update and integrate its computer systems which are woefully antiquated and disjointed.

“It’s still largely a paper-driven agency,” Nielsen said. “The agency has great information pigeonholed all over the place, but it cannot be applied in real time, which is what you need today.”

As for its perceived bias in favor of the industries it regulates, the FDA has been one of many federal agencies where Bush administration critics say ideology has trumped science.

“The agency needs to get back to using science as the basis for its decision-making,” said Jane E. Henney, who ran the FDA under Clinton from 1998 to 2001.

December 5, 2008

A New Government Must Seek To Minimize Supreme Court Preemption Decisions

Filed under: FDA — Rod Malcolm @ 10:50 am

A Democratic White House and Congress increases the chances that new legislation will seek to minimize the impact of the Riegel v. Medtronic federal preemption decision, and deal similarly with Wyeth v. Levine should the Supreme Court find for Wyeth.

State tort medical device liability lawsuits appear to have largely been eliminated following a recent Supreme Court decision favoring the manufacturer in Riegel v. Medtronic Inc., in which the Court barred a suit claiming Medtronic was liable for a heart catheter that burst during an angioplasty procedure.

The Supreme Court ruled that federal medical device law preempts state tort claims against manufacturers, provided those products are approved through FDA’s premarket approval (PMA) process. Under the Medical Device Amendments to the Federal Food Drug and Cosmetic Act (FD&C Act), federal law bars the imposition of state requirements that differ from or attempt to add to established FDA requirements.

In Wyeth v. Levine, a drug labeling liability case heard earlier this month by the Supreme Court, plaintiff Diana Levine claimed she was injured by inappropriate IV administration of Wyeth’s Phenergan, causing gangrene and subsequent amputation of her forearm.  When a state court upheld Levine’s claims that Wyeth’s (and ergo, the FDA’s) warnings were inadequate, Wyeth appealed to the Supreme Court.

Both cases deal with the extent of federal preemption of state tort law, but medical devices and drugs are governed by slightly different provisions. Federal law expressly provides for the preemption of state tort claims for medical devices under certain conditions. But drugs alone, as well as combination products — medical devices combined with drug or biological elements — do not have similar explicit protection.

Already, legislative efforts began in the last Congress following the Riegel v. Medtronic decision. Congressional Democrats proposed anti-preemption bills that could preserve state tort liability for medical devices.

While we await the Court’s decision in Wyeth v. Levine, we can only hope that the newly forming Democratic White House and Congress is preparing to minimizing a finding for Wyeth through similar or better, even stronger legislation, to protect state rights in both pharmaceutical and medical device liability suits.

December 4, 2008

DTC Ads “Single Worst Decision” By Pharma, Says Roche Exec

Filed under: Big Pharma, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 3:06 pm

Big Pharma has lost credibility about its alleged R&D spending because the public can obviously see massive outlays on TV advertising campaigns. And the proliferation of generics, plus a sagging economy, says the days of big-bucks DTC are over.

According to William Burns, Roche’s head of pharmaceuticals, U.S.-style direct to consumer (DTC) advertising has been “a big mistake for the global drug industry,” and the days of big spending on DTC are over.

According to Reuters News, Burns told a Financial Times pharmaceutical conference in London this week that DTC “was the single worst decision for the industry because it has undermined the reputation of the sector in the eyes of patients.”

“When industry says we’re spending all the money on R&D but actually it’s spending it on TV advertising to preserve margins, it doesn’t get much credibility,” he added.

Prescription drug DTC is only permitted in the U.S. and New Zealand. And while the U.S. has “gone overboard” in allowing drugmakers to promote direct to patients, Burns said, Europe is too restrictive. Unreliable information is widely available on the Internet, but Pharma can’t directly enlighten consumers.

According to Reuters, however, the European Commission has drawn up new legislation that would allow Big Pharma to disseminate a degree of information, though advertising will remain off limits. The legislation was expected last week, but has been delayed.

“You’ve got the two extremes on the planet,” Burns said, “where we are given access to the public in America, which is too much, and in Europe we’re not given access to information [at all].”

A whopping $4.2 billion was spent on U.S. DTC advertising in 2005, a 330 percent increase from 1996, according to a New England Journal of Medicine study. But the sagging economy and proliferating generic versions of many of today’s big sellers means that the days of big spending on DTC, which promises only marginal competitiveness anyway, are ending.

“The marginally-different-and-market-it-like-hell model is over,” Burns said.

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