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Eli Lily skates after a federal judge tosses out a class action suit by angry investors. But the decision raises questions about the FDA’s role in the whole Zyprexa scandal, and the ethics of investors who turn a blind eye to fraud in the hope it will magically vanish.

Drug-maker Eli Lilly, under siege by a number of law suits concerning alleged misrepresentations about its best-selling drug Zyprexa, won a class action suit from Lilly investors who claimed their investments were damaged by the company’s fraudulent marketing actions.

The suit alleges that Lilly and numerous employees misrepresented or failed to disclose Zyprexa’s serious side effects, including weight gain and diabetes. It also alleges the company’s marketing of Zyprexa for non-approved, off-label uses was illegal and drove down share prices.

Many other cases for damages or criminal penalties have been settled or are continuing, including 30,000 individual-plaintiff personal injury cases, civil and criminal cases filed by attorneys general of states that claim they overpaid for Zyprexa, and a class action suit by tens of thousands of insurers and unions who also claim overpayment.

But in the investor case, Eastern District of New York Judge Jack B. Weinstein found in favor of Lilly, saying investors should have known years earlier when problems with Zyprexa first surfaced. The 2007 suit missed by years the required two-year statute of limitations, he said, because debates over Zyprexa extend back into the 1990s.

Indeed, the Journal of Clinical Psychiatry reported in 2001 that the FDA knew of 19 cases of diabetes associated with the use of Zyprexa — one patient died from pancreatitis associated with diabetes. Another study published in Pharmacotherapy in July 2002, suggested a link between Zyprexa and elevated blood sugar disorders and complications, including hyperglycemia, diabetes, and potentially fatal diabetic ketoacidosis and coma. These and many other examples can certainly be called ‘storm warnings’.

During the decade of storm warnings since its approval by the FDA in 1996, Eli Lilly plowed ahead, withholding evidence of injury and death, misrepresenting the facts to the FDA, the medical community, even many of its employees, and engaged in criminal off-label marketing — in other words, worked night and day to expand the Zyprexa patient base to include every human being possible on its list of victims.

Don’t you wonder where the FDA was during this? I certainly do.

Dozens of papers, articles, meetings, conferences — the years dragged on, hundreds more were injured or killed, and in spite of all the red flags flying the FDA did nothing effective to prevent the carnage except request some label changes. And Zyprexa became Eli Lilly’s most successful drug in its history — in terms of sales, not patient health.

Quoting from the recent St. Petersburg Times expose on Zyprexa, the Alliance For Human Research Protection blog says things will get even worse if the agency approves Zyprexa for adolescents.

Meanwhile, what about the poor investors, claiming to be financially harmed by the company’s actions? Oh please. As much as I hate to see Lilly skate on this one, the investors are no better than the FDA or even Lilly itself. They’re all complicit in turning a blind eye to criminality as long as the cash rolls in. They deserve what they get for investing in a known criminal activity. Oh, and Lilly shares rose 1.3 percent to $48.75 after the news of the dismissal.

If you have had any doubts about the money-and-greed-driven system under which Big Pharma, the FDA, and the investment community operate together — a system which is supposed to provide safe, life-saving drugs and better health to all — this rotten episode should put all your doubts to rest.

Drug testing and marketing is horribly flawed, and the system which perpetuates it plainly stinks and needs to be changed.

It’s a complicated issue, but once you sort through the details, it looks like Pfizer has pulled off a remarkably slimy example of putting marketing ahead of science.

Popular pharma-watcher Howard Brody, MD, PhD, has awarded a “brilliant sleaze” award to Pfizer Inc., the world’s largest research-based pharmaceutical company and numero uno in world-wide sales.

In his well-read blog, Hooked: Ethics, Medicine, and Pharma, Dr. Brody describes in painstaking detail how the company has schemed to increase sales of its major money-maker Lipitor, the anti-cholesterol statin drug, by deceiving physicians around the world with a questionable on-line heart attack risk assessment tool. Pfizer has been widely promoting use of the calculator, which indicates more patients are at risk — and therefore ripe for Lipitor prescriptions — than may be scientifically accurate.

The efficacy of the drug and of statins in general have been under considerable scrutiny lately, too, but that’s another matter, Dr. Brody says. “This entire theory of when statins are good for you is probably deeply flawed,” Dr. Brody says, “and as a whole shows how industry marketing has come to dominate science to an embarrassing extent. But for present purposes ignore all that. Imagine that the guidelines [for using statins] actually represent good science.”

He then goes on to explain how the NIH-based National Cholesterol Education Project (NCEP) developed two risk assessment tools, one automated, and the second a pencil-and-paper-based manual test. Higher risk for heart attack indicates a greater need for a statin drug like Lipitor. The differences in the two tests apparently were not unknown, but not widely known among the bulk of physicians who might prescribe statins.

According to Pfizer whistle-blower Dr. Jesse Polansky, who is embroiled in his own suit against Pfizer about alleged off-label marketing of Lipitor, the manual test mistakenly misclassifies a number of patients as high-risk who are actually at moderate risk, but never misclassifies patients downward by mistake. In fact, by finding more higher-risk patients, it does exactly what Pfizer would like it to do, which is increase Lipitor sales.

Two major Big Pharma players, AstraZenica and Merck, have risk calculators on their websites, but these are NCEP’s more accurate computerized calculators. Instead, Pfizer converted the paper-and-pencil test to an automated on-line version, and has since been promoting it’s use to physicians. Not only that, it appears Pfizer is distributing the computerized calculator to doctors as a PDA program, and distributing it by other on-line information sources.

Pfizer deserves a lot worse than the good doctor’s “brilliant sleaze” award. These are the kinds of actions that have destroyed not just the public’s trust in what was once an honorable industry, but the trust of medical institutions and the medical fraternity. Ethical breaches of this magnitude deserve hefty fines, and even prison time.

Colorado’s new bill banning health insurers giving kickbacks to doctors to prescribe cheaper generics ignores Big Pharma’s similar, and even more lavish, practice in favor of their pricier brand name drugs.

In Colorado, where a bill is pending approval that bans health insurers from providing incentives (read “payola”) to doctors to switch patients’ drugs from more expensive brand names to cheaper generics, there’s nothing to deal with the Big Pharma’s equally offensive widespread practice of doctor bribery supporting brand names.

This is a big switcheroo from Massachusetts, where a bill is nearing approval that outright bans Big Pharma from bribing — sorry, from providing “incentives” — to doctors to encourage them to prescribe their brand name drugs. Even a federal bill is pending that requires Big Pharma to report to the feds any and all “gifts” made to physicians over a value of $25.

Lynn Parry, past president of the Colorado Medical Society which was involved in creating the Colorado bill, told the Associated Press that in Colorado, drug makers can still offer lunches or dinners to doctors to provide information about their drugs. “It’s not a hard sell by any means and I think they work as hard as they can to not directly influence, but they’re a business,” she said.

In his Pharmalot blog, Ed Silverman nicely sums up our opinion of Parry’s statement: “Hmmm . . . How much of a difference is there between incentives?”

To which I would add: Ms. Parry, wake up and smell the coffee. Lunches or dinners? What about free golfing trips to sunny tropical isles, expenses-paid conferences in exotic foreign lands, or expensive nights out on the town with hints at sexual favors?

Big Pharma’s lavish “incentives”, well documented by former pharma reps, make the health insurers paltry “incentives” look like garage-sale discounts.

Goodness knows why any doctor with a shred of integrity accepts kick-backs, bribes or “incentives” from the insurance industry or Big Pharma, under any guise or for any reason. But apparently most or many do, and the practice is getting worse, not better.

It’s fine to curb physician bribery by the insurance industry, but Colorado should take another look at Big Pharma’s billion-dollar doctor bribery system that it’s been using to great effect for years, and follow Massachusetts’ example. There should be no financial incentives from any quarter when it comes to patient health.

Let doctors make prescription decisions based on science, not a free lunch.

A Colorado bill will prevent health insurers from offering incentives to doctors to prescribe cheaper generics rather than Big Pharma’s pricier brands.

An interesting development in the ongoing pharmaceutical doctor-bribing drama across the country is taking place in Colorado, where a bill is pending approval that bans health insurers from providing incentives (read “payola”) to doctors to switch patients’ drugs from more expensive brand names to cheaper generics.

Sen. Paula Sandoval, (D-Denver), sponsoring the Colorado bill, told Associated Press that a patient’s health should be a doctor’s primary concern. “There shouldn’t be any financial incentive interfering with that decision,” she said, adding that there have been reports of kickbacks from insurance companies and lawsuit settlements in other states, and the new bill would ensure it doesn’t happen in Colorado.

Of course, Kaiser Permanente, along with major insurance players AARP and the insurance industry’s Colorado Association of Health Plans, all oppose the bill. These are the folks who write the checks for brand-name prescriptions. More generics save them a bundle.

But believe it or not, major Big Pharma player Pfizer Inc., which ranks number one in the world in sales, was actively involved in helping Colorado’s medical society shape the bill. If doctors were to prescribe more generic replacements for Pfizer’s blockbuster cholesterol drug Lipitor, for example, which cranks out a whopping $13.5 billion in annual sales and accounts for nearly a third of Pfizer’s revenue and 40 percent of its profit, it could inflict serious damage.

We don’t need to ask why Pfizer has taken an interest in this bill. What we need to ask is why the state of Colorado and Sen. Sandoval in particular have brought in, or even allowed, an individual Big Pharma corporation with billions at stake to help draft a bill that keeps the billions rolling in?

That’s just inviting the fox in to help design the hen-house fence.