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September 29, 2008

Insider Tell-all Reveals How High, And How Deep, The Vioxx Scandal Reached

Filed under: Big Pharma, FDA, Merck, Vioxx, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 10:22 am

“Drawing on internal Merck documents, court testimony, and exclusive interviews, as well as three decades of experience inside the medical industry, author Tom Nesi tells the dramatic story of what the drug’s manufacturer, Merck, knew and when.”

The editorial review at Amazon for Poison Pills: The Untold Story of the Vioxx Drug Scandal, by Tom Nesi (from Thomas Dunne Books) introduces the characters and the plot of a story few people could imagine in a new book that reads more like a mystery novel as it delves deeply into a scandal that rocked Big Pharma and has seen Merck settle with plaintiffs for roughly $50 billion (yes, BILLION) — and it’s not over yet.

Tom Nesi, a former PR director for Bristol-Myers Squibb and a 30-year veteran of the pharmaceutical industry, takes us through the corporate intricacies behind the rise and fall of the painkiller Vioxx, a $20-billion bonanza for Merck & Co. that crashed and burned in late 2004 after it was revealed it could cause heart attacks and death.

For those who don’t know about the Vioxx case, here is some background, some more here, and even more here.

The book ranges across the history of Big Pharma, and follows the breakdown of the US medical system, the failures of the FDA, and the staggering profits earned by a pharmaceutical industry at the cost of thousands of lives.

In a recent interview with Ed Silverman of Pharmalot, Nesi says the book idea came after he had begun researching the case, and realized here was “a much bigger story than anybody could believe.”

Some juicy Nesi quotes:

“Chicanery has been part and parcel of the pharmaceutical industry since whenever. So no, it’s not really new. But what sets the Vioxx story apart, or makes it unique, was the scope. Yes, it’s happened before that we’ve seen chicanery, but the level of the characters, the stars, the advertising . . . there were billions of dollars spent on marketing, the doctors involved, the samples handed out. And this was not just an action by Merck. There was total failure — the FDA, the New England Journal of Medicine, opinion leaders. It went on and on, and infected everything.”

“Merck knew full there were many times more heart attacks in the Vioxx group versus the naproxen group . . . and they issued a press release reaffirming the cardiovascular safety of Vioxx anyway . . . The whole effort to position the drug was a company-wide strategy.”

“The similarities between Vioxx and Vytorin are very frightening — and the fact that the FDA will have to take six months, at least, to evaluate the data is absurd. That is the amount of time it takes to get a fast track approval. Why isn’t the agency calling an emergency meeting as we speak?”

For anyone with even a passing interest in the billions of pills we take every day, the pills we are coaxed, persuaded, urged and exhorted to consume with ever-increasing fervor by Big Pharma and its medical minions, and the roles that the Food and Drug Administration and our government play in this deadly game of pharmaceutical roulette, this book is a must-read.

As one Amazon reviewer commented, you may hesitate to even take an aspirin ever again.

September 22, 2008

Why More States Are Suing Big Pharma Over Psych Drug Marketing

Filed under: Big Pharma, Merck, Vioxx, Zyprexa, pharmaceutical giants, pharmaceutical sales — Rod Malcolm @ 8:58 am

A Utah assistant attorney general says Big Pharma has overcharged Medicaid, misled the FDA about drug safety, and improperly encourages off-label, unsafe drugging of children.

More states are filing lawsuits against Big Pharma over allegations of failing to disclose side effects and for improper marketing of antipsychotics, resulting in state Medicaid overpayments.

In a recent Pharmalot blog, Ed Silverman asked Utah special assistant attorney general David Stallard to explain why so many states are on the legal warpath against several Big Pharma antipsychotic makers.

Last year, Utah became the eighth state to sue Eli Lilly alleging the drugmaker hid side effects and risks of Zyprexa — weight gain and diabetes — while ‘illegally’ promoting off-label prescribing for the drug.

Stallard, who has spent several years working exclusively on pharmaceutical Medicaid fraud in Utah, said Medicaid sales are a huge business for pharmaceutical companies, and a very attractive market — what he called “feeding at the taxpayer trough.”

“Pharmaceutical companies try to get as much reimbursement as they can from Medicaid, because it’s a big payer,” Stallard said. “And not just on price, but utilization. As many pills as they can, and the highest price they can engineer.”

Merck’s Vioxx and Lilly’s Zyprexa are the two main targets in Utah, Stallard said, for “what I call failure to warn — risks we allege were known early on by the company but concealed” from the public, the FDA and the medical community.

Stallard says there was also pricing fraud — overcharging Medicaid by falsely inflating list prices. And in the case of Lilly, there was a lot of off-label use that was promoted improperly by Lilly, which is illegal federally, but which Utah is pursuing under state law alleging the practice caused Utah to pay more than it should have.

But the perhaps the biggest issue that could come from Utah’s cases will derive from Stallard’s analysis of federal and state Medicaid payment regulations, which require a drug to be a covered outpatient drug that “has to be used for a medically accepted indication.”

And a doctor legally, at his own whim, prescribing a medication for off-label use does not qualify it for Medicaid support. “That’s a separate issue … In order to get federal funding, Medicaid programs must comply with federal law.”

Stallard says he is opposed to the uncontrolled drugging of children with atypical antipsychotics, for which none have been approved, and it isn’t about the money it has been costing the state.

“I think they shouldn’t be experimenting when it’s never been tested on children. It’s a big mistake. Sometimes, legislators say they need to be liberal with vulnerable segments of society to give them medicines that may have some benefit. I turn it around and say we shouldn’t be experimenting with the most vulnerable segments of our society.”

September 19, 2008

Drug Safety Issues Are Reaching The Minds Of Middle America

Filed under: Big Pharma, FDA, Uncategorized, pharmaceutical giants — Rod Malcolm @ 1:22 pm

A strong statement this week on the shortcomings of Big Pharma and the FDA concerning drug safety appeared in an unlikely place — The Buffalo News of Buffalo, NY.

The way I see it, when a middle-America newspaper like The Buffalo News takes up the drug safety issue — not the usual venues like New York Times or Wall Street Journal or Washington Post — America is waking up to the drug safety nightmare.

A Buffalo News editorial this week says that the American people and the FDA are “too reliant on the good graces of drug companies” to make sure that medications “not only help with disease but also don’t cause any horrible problems along the way.”

Although that sounds like all the blame falls on Big Pharma, the editors do go on to also include the FDA itself as a source of the problems.

“The highly complex nature of evaluating drugs, the ever-improving marketing savvy of the drug companies and the weakness of the Food and Drug Administration are clearly combining to tilt the deal too far on the side of profits and too little on the side of human health,” say the editors.

The editorial describes the situation we face in this country with some drugs already causing serious problems, and others under investigation for possible problems. Assurances of efficacy and safety require extensive premarket trials and exhaustive after-market follow-up, say the editors. Providing this is a moral responsibility, and if Big Pharma doesn’t realize that, then the responsibility should mandated, they say.

I may be wrong, but that responsibility already is mandated, and the FDA, on behalf of the federal government and the American people, oversees these specific laws.

But from current and past experience, the system of drug approvals and safety is far from perfect.

A few members of Congress are trying to make a difference on an issue-by-issue basis, and recent additional FDA funding for more staff I supposed to help. But that’s really a drop in the bucket, when you consider what really needs to be done.

So the problems within the FDA of failing to catch so-so and bad drugs from reaching the market continue. And Big Pharma continues its fiddling with test results, outrageous marketing irresponsibility, and outright fiscal fraud.

Clearly, fundamental changes are needed to improve our lousy record of drug approvals and safety.

September 16, 2008

FDA Now Posting Drug Safety Issues On The Internet

Filed under: Big Pharma, FDA, pharmaceutical giants — Rod Malcolm @ 1:32 pm

Under the new Food and Drug Administration Amendments Act, the FDA must inform the public each quarter of new safety information or potential signals of serious risk.

The Food and Drug Administration has announced its first quarterly report listing certain drugs that are being evaluated for potential safety issues. The suspect drugs are identified from reviews of FDA’s Adverse Event Reporting System (AERS).

The Food and Drug Administration Amendments Act, signed into law Sept. 27, 2007, requires that FDA inform the public each quarter of new safety information or potential signs of serious risk based on reviews of adverse event reports.

The agency’s announcement said that the drugs are on the list because a causal relationship between the drug and the risk may exist, but that only a potential safety issue has been identified.

The AERS contains “millions of reports of adverse events submitted to FDA by drug manufacturers, health care professionals and patients,” says the release. For a drug to appear on this report, an FDA reviewer “has determined there is a reason to examine a drug more closely based on either the seriousness or number of AERS reports associated with the drug. The drugs for which issues have been identified are under evaluation for the listed potential risk.”

The first list, for the quarter January to March 2008, is posted here. There are 20 drugs listed on this first report, each with its “Potential Signal of Serious Risk/New Safety Information.”

In the blog Eye On FDA, Mark Senak points out how the information is far too brief — the name of the drug and then one, two or maybe three words for the risk — and how actually unhelpful such scant information may be. “For example,” Mark says, “the list contains the following ‘Desflurane (Suprane) – Cardiac Arrest’. Not much to go on.  This may be a classic example where a little information becomes a dangerous thing.

“How many instances were there, what other drugs were the people taking, what percentage have been affected, what does the drug treat? If you want to know the answers to those questions, you’ll have to dig further and perhaps even file a Freedom of Information Act request (good luck with that) to find out.”

Even more interesting to me is OxyContin on the list with a potential risk of “drug misuse, abuse and overdose.” Potential risk still under evaluation? Is this the FDA’s official statement on the status of a drug that was found so dangerous that the company was fined $653 million for not disclosing how dangerous it was?

One wonders, not being a physician with clinical experience, what the actual situation is with the other 19 drugs too. And one also wonders what the FDA is doing about any of them.

September 12, 2008

Medical Schools Reclaiming Control Of Continuing Medical Education

Filed under: Big Pharma — Rod Malcolm @ 9:34 am

America’s major med schools are making significant changes to end decades of powerful influence by Big Pharma over the content and structure of medical education.

A New York Times article by Gardner Harris reports that Stanford University School of Medicine has announced it will “severely restrict industry financing of doctors’ continuing education at its medical school.”

The new policy allows Big Pharma funding to continue, but only as contributions to a school-wide pool fund to be distributed by the school as it sees fit — including courses that don’t mention a company’s products.

The announcement makes Stanford the sixth major medical school to form a pool for contributions for continuing medical education from pharmaceutical and device makers.

Other schools recently instituting similar policies are at the universities of Massachusetts, Pittsburgh, Colorado, Kansas and California Davis. And the Memorial Sloan-Kettering Cancer Center has completely banned all industry support for its classes.

Continuing medical education, called CME in the industry, is required for most physicians in the country. Several billion dollars a year in contributions, as well as influence over course content, is managed by medical education and communication companies (MECCs) acting as agents for Big Pharma.

Billions more in drug industry largesse comes as personal gifts, favors, and payments to the physicians on the staff of teaching institutions. Several universities have also banned acceptance of such gifts.

Big Pharma says its money is intended only to keep doctors up to date. But an increasingly vocal army of critics say the support is purely marketing, and generally comes only for classes that promote their products.

In an article in the current issue of the Journal of the American Medical Association (JAMA), Dr. Arnold Relman writes: “The public relies on the medical profession to evaluate the products that industry wants to sell, so the profession should not be beholden to industry for any reason. To be trusted, medicine must be free of all such dependency; it should be accountable only to the society it serves and to its own professional standards.

“The responsibility for medical education should be entirely in the hands of the medical profession and funding should not compromise, or even call into question, the integrity and independence of what is taught or of the physicians who teach. Marketing drugs, on the other hand, is industry’s job. Industry likes to call this education but it is not. It is marketing.”

Dr. Relman is professor emeritus of medicine and social medicine at Harvard Medical School, and a former editor of the New England Journal of Medicine, who now writes extensively on medical publishing and reform of the U.S. health care system.

CME refresher courses have long been paid for by Big Pharma — much longer than even most physicians realize. Another article in the current JAMA details some of the history of the practice, quoting from articles by physicians in medical journals deploring the practice from as far back as the late 1950s and early 60s.

For example, in 1961, Dr. Charles D. May, editor of the journal Pediatrics, wrote an article titled, “Selling drugs by educating physicians.” Dr. May complained about medical education being hi-jacked by the pharmaceutical industry:

“A vicious cycle is created by a mad scramble for a share of the market: the doctor is made to feel he needs more ‘education’ because of the prolific outpouring of strange brands but not really new drugs, produced for profit rather than to fill an essential purpose; and then the promoter offers to rescue him from confusion by a corresponding brand of ‘education.’”

After a half-century, Dr. May’s comments could have been written yesterday. But we are finally seeing some action, and hope all med schools will soon reject Big Pharma’s undisguised marketing-as-education, and reclaim what rightfully belongs to them — the education of our doctors.

September 9, 2008

Judge Unseals Damning Zyprexa Documents “In Public Interest”

Filed under: Big Pharma, Eli Lilly, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 5:40 am

“Lilly’s legitimate interest in confidentiality does not outweigh the public interest in disclosure,” writes the federal judge in the Zyprexa class action case.

The New York Times reports that Judge Jack B. Weinstein of Federal District Court has unsealed confidential materials about Eli Lilly’s top-selling antipsychotic drug Zyprexa, citing “the health of hundreds of thousands of people” and “fundamental questions” about the way drugs are approved for new uses.

The judge’s decision is part of a ruling granting class-action status to a case seeking billions of dollars from Lilly by insurance companies, pension funds and unions. They contend Lilly hid Zyprexa’s side effects and marketed it for unapproved uses.

The confidential documents were placed under a protective court order shortly after Lilly provided them in a related suit by patients claiming that Zyprexa caused excessive weight gain and diabetes. In lifting the order, Judge Weinstein said Lilly’s “legitimate interest in confidentiality does not outweigh the public interest in disclosure at this stage.”

A Lilly spokesperson said the company will not appeal the decision but will appeal the certification of class action.

The issue of confidentiality arose in 2006 after the “Zyprexa papers” were secretly provided to a reporter for the Times, which ran front page articles based their contents, revealing evidence that Lilly executives suppressed the side effects.

Lilly has denied withholding the information, saying the documents were “cherry-picked” to give a biased view.

The developing situation with Lilly and Zyprexa highlights yet again how Big Pharma’s aggressive marketing practices are turning around to bite their creators in the two spots where it hurts most, the pocketbook, and public opinion.

But far more relevant to Americans, and far more serious, are the “fundamental questions” Judge Weinstein raised about how drugs are approved for new uses. The American public, health care providers and the health care industry have been clamoring for answers to these questions for over a decade.

The FDA needs to confront the issues surrounding the management of drug safety and deal with them right now, before some other new drug threatens “the health of hundreds of thousands people”.

And if the agency continues to foot-drag, play politics, and dramatize its schizophrenic relationship with Big Pharma, no less than Congress should step in and demand a complete overhaul of a system that is so flawed, in fact so barbaric, that Americans have to resort to courts of law — after the fact — to protest, and to seek compensation, for millions of injuries and deaths that could have been prevented.

September 7, 2008

Flawed Study Suggests Direct-to-Consumer Drug Ads Don’t Work

Filed under: Big Pharma, FDA, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 5:43 am

The Harvard Med School study is basically flawed because it was conducted on Canadian consumers who, the researchers didn’t notice, are not American.

A study by Harvard University, in conjunction with University of Alberta in Canada, has found that Big Pharma’s near-$5B a year DTC ad campaigns are a waste of money, or at best only marginally useful.

Until now, no testing has been performed on two similar populations where one was exposed to the advertising, and another one not exposed. But research has shown that for every dollar Big Pharma spends on DTC, it makes two dollars back. In other words, DTC ads work just fine.

But the Harvard team, suspecting that DTC ad research is flawed, wanted to test it on populations exposed and not exposed — impossible in the US where virtually everyone has an opportunity to see it.

So the researchers got the bright idea to use Canada, where both populations exist: English-speaking Canadians are exposed to imported US DTC TV and print ads, but French-speaking Canadians in the Province of Quebec primarily watch local French language TV and read French publications, which do not carry DTC ads — DTC drug advertising in Canadian-produced media is, at least for the time being, still illegal.

The researchers looked at three drugs: Enbrel (for rheumatoid arthritis), Nasonex (for nasal allergies), and Zelnorm (for irritable bowel syndrome — since withdrawn from the market), and tracked prescription statistics over a five-year period from about 2,700 pharmacies.

The results? According to FiercePharma, the study found little change after major ad campaigns. A $194 million Enbrel campaign and $235 million Nasonex push failed to boost sales in the English-speaking provinces; prescription volumes were unchanged before and after the ads. Zelnorm sales did spike by 40 percent in the English-speaking areas after the campaign started, but was relatively short-lived, and, after a few years, prescription rates in both groups resumed identical patterns.

The problems begin when the researchers cavalierly assume their findings apply to US drug consumer advertising. I can say with direct personal knowledge that Canadian consumers are definitely not American consumers. There may be plenty of similarities, but there are also plenty of significant differences, as any marketing consultant with experience in both markets will confirm.

This would be especially true in the field of health care. Canada is one of many nations boasting a government-run, tax-supported national health care system which, after several decades, has certainly had an enormous effect on the psyche of each and every Canadian regarding all aspects of medicine, especially including all aspects of decision-making about prescription and OTC drugs.

In almost any national health care system that has existed for more than generation, ‘Big Brother’ does much of the thinking for you, and also much of the drug buying.

Establishing a marketing beachhead in the fore-brains of such consumers would require a totally different kind of campaign approach, and Big Pharma marketers surely know this. These people don’t commit $billions to advertising that doesn’t bring results.

As one commenter at FiercePharma said, “Perhaps Harvard Business School should be conceiving, structuring and executing marketing and advertising research instead of Harvard Medical School.”

I couldn’t have said it any better.

September 3, 2008

Merck Takes Gardasil Marketing To A New Level Of Nastiness

Filed under: Big Pharma, FDA, Merck, pharmaceutical giants, pharmaceutical sales, pharmaceuticals — Rod Malcolm @ 4:21 pm

Brilliant? Or a new low in manipulative marketing? Your answer might reveal your level of simple humanity.

Merck’s latest attack on — oops, sorry, marketing approach to — teenagers and young women, for its Gardasil HPV anti-cancer vaccine, is an incredibly expensive four-page heavy-stock spread in Vogue magazine selling Gardasil vaccine jewelry — yes, you heard it right, gold and silver charm bracelets sporting darling little charms.

And, naturally, they’re calling the campaign “Charm 4 Life” — so cute, so appealingly girly, and so diabolical, it must have taken a whole team of bright-young-thing creative directors and copywriters an entire weekend to come up with it — probably the same team of hucksters who dreamed up the Gardasil commercials that have been playing in theaters showing “Sex And The City” (and a whole slew of other films) this year, all targeting the 19-to-26-year-old female demographic.

Charm 4 Life even has its own darling web site, linked to the jewelry makers’ site where, if you pony up $32, you can get four “limited edition” (oh please) bangles from designer Carolyn Rafaelian of Alex and Ani jewelers, who cut a deal with Merck which promises $5 from each sale to the Prevent Cancer Foundation.

Mike Huckman, in his Pharma’s Market blog at CNBC, says the Vogue ad and jewelry concept “represents a whole new idea in the world of direct-to-consumer (DTC) drug advertising.” And Merck, writes Huckman, is “hoping” the FDA will soon approve Gardasil for women into their 40s, and wants approval to market Gardasil to “young men and boys, who can carry and transmit HPV.”

For more background on Merck’s Gardasil marketing, which targets girls as young as 9, check out my recent blog in which I quote a critical New York Times article by a physician-reporter who says no one knows the long-term effects of Gardasil on anyone, especially people still in the growing stages of life.

Even though pharmaceutical DTC advertising is only allowed here in the USA and New Zealand — so far — an absolutely enormous industry has grown up around it. I know that the FDA and the lawmakers who green-lighted DTC in the 1980s never imagined anything like this — jewelry, donations to charities, theater ads?

Where the heck is the FDA? If this kind of thing isn’t stopped or more stringently regulated, the opportunity for even more manipulative DTC pharmaceutical marketing staggers the imagination. It must have ad execs drooling and stockholders getting out their checkbooks and calling their brokers.

If you think Merck’s billion-dollar Gardasil-for-every-one-in-the-world campaign is brilliant, you’re a pro-anything-goes Big Pharma stakeholder, or you’re a generic marketing type whose personal values have degenerated, like Big Pharma’s, to nothing but numbers.

Anyone with an ounce or two of humanity would be horrified.

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