Our Views

Eli Lily skates after a federal judge tosses out a class action suit by angry investors. But the decision raises questions about the fairness of the law.

Sometimes there just doesn’t seem to be any justice in the world, or so the saying goes, but that all depends on who you ask. Drug-maker Eli Lilly, already battered by a number of other huge law suits concerning alleged misrepresentations about its all time best selling drug Zyprexa, is celebrating justice this week. The company will skate on a class action suit from Lilly investors who claim their investments were damaged by the company’s fraudulent actions.

The suit claims Lilly and numerous employees misrepresented or failed to disclose the link between Zyprexa and serious side effects, including weight gain and diabetes. It also cites the company’s illegal practice of marketing the drug for non-approved off-label uses, all of which negatively affected the company’s stock value. We’re wondering if Lilly’s new CEO John Lechleiter, briefly profiled in the Wall Street Journal’s Health Blog, will try to turn around the company’s marketing ethics as well as improve its stock picture.

But with several other large actions already against the company, including alleged marketing fraud, and $1.2 billion in payouts underway for thousands of Zyprexa deaths and injuries, one can only wonder how a judge could find against the investors who have taken a beating because of Lilly’s illegal actions.

Well, the answer is fairly straightforward, and shows that a judge doesn’t necessarily have to be in Lilly’s pocket to reach a verdict favoring Lilly. In this case, the judge doesn’t need to be changed, just the law.

According to Eastern District of New York Judge Jack B. Weinstein, the suit was dismissed because it wasn’t filed within the required two-year statute of limitations — two years from when plaintiffs “reasonably should have known” that they sustained damages because of Eli Lilly’s purported fraud.

And the judge is probably right. In his 82-page decision, the judge said what is referred to as ‘storm warnings’ about Zyprexa stretch back to the 1990s — he called it an “extended public debate” over Zyprexa — including numerous reports in the medical literature, by investment analysts, and presentations at medical conferences, dating back to within a year of the drug’s release in the mid 1990s.

Attorneys for the plaintiffs argued that the statute should have begun with three articles about Zyprexa in the New York Times in December, 2006. The suit was filed four months later on March 28, 2007. But the judge said that under ruling law, ‘storm warnings’ are available to the stock market and place reasonably astute investors on notice of the need for further inquiry — creating the hypothetical date that begins the two-year statute of limitations. The judge added that “individual unsophisticated investor’s lack of awareness is ignored; the law tilts the . . . balance against such a consumer. It applies the much-debated ‘caveat emptor’ [Let the buyer beware - Ed.] principle favoring greater and freer commerce by limiting litigation, and requiring dismissal of this case.”

“Let the buyer beware” — the principle that the seller of a product cannot be held responsible for its quality unless it is guaranteed, and the buyer alone is responsible for assessing the quality of a purchase before buying — just doesn’t cut it in a case like this.

A two-year statute of limitations favoring a criminal conspiracy is a very, very bad law, and Lilly — which hasn’t escaped its guilt for the thousands of sick, dying and dead Zyprexa patients — should not be allowed to skate from its investors either. American investors are the engine that helps drive business and industry, and this case just gives the whole concept another black eye.

NEXT: What about the ethics of the investors and brokers who ignore a decade of storm warnings about the dangers of Zyprexa? And more importantly, where was the FDA while people sickened and died? Perhaps dozing as usual in the shade of Big Pharma’s money.

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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.

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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.

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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.

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Suit alleges the pharmaceutical giants violated state consumer protection laws and federal and state antitrust laws by delaying availability of cheaper, generic versions through trickery or deception.

Florida and Massachusetts are among 26 other states that are joined in an antitrust lawsuit against pharmaceutical companies for allegedly blocking access to cheaper drugs, costing the states millions of dollars in .

The suit alleges that Illinois-based Abbott Laboratories and French drug companies Fournier Industrie et Sante and Laboratoires Fournier, S.A., violated state consumer protection laws and federal and state antitrust laws by delaying availability of cheaper, generic versions of TriCor, a cholesterol lowering drug that last year accounted for more than $1 billion of Abbott’s sales.

The states’ complaint seeks relief in the amount of three times the amount of overcharges paid by states and consumers for TriCor, plus costs and civil penalties.  The states are also seeking injunctive relief, prohibiting Abbott and Fournier from engaging in similar anticompetitive practices in the future.

The states allege in U.S. District Court in Wilmington that the companies continuously made minor changes in the formulation of TriCor to prevent cheaper generic versions from being marketed. The complaint seeks triple the amount of damages incurred by the states’ public health agencies and individual consumers.

Ed Silverman in his Pharmalot blog reports that Abbott spokeswoman Melissa Brotz told the Associated Press that the company’s actions were lawful, that Abbott hasn’t prevented the marketing of drugs similar to TriCor, and that there are eight other products already available. Neil Hirsch, a spokesman for Fournier’s parent Solvay, told the AP Fournier hasn’t engaged in any wrongdoing and intends to vigorously defend itself against the allegations.

But Maryland Attorney General Doug Gansler said Abbott and Fournier obtained patents protecting TriCor from competition by deceiving the U.S. Patent Office with incomplete and misleading data. And Florida Attorney General Bill McCollum said Florida’s growing senior population faces ever increasing costs of prescription drugs, and the state “cannot permit drug companies to edge out competition and potentially less expensive generic alternatives.”

The states joining Massachusetts in the investigation and prosecution of this action against Abbott and Fournier are:  Florida, Arizona, Arkansas, California, Connecticut, Idaho, Iowa, Kansas, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nevada, New York, North Carolina, Ohio, Oregon, South Carolina, Texas, Vermont, Washington, West Virginia, Pennsylvania, and the District of Columbia.

Big Pharma’s obsession with profits at any cost is threatening to destroy what was once the envy of the world—the United States medical system.

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Lawmakers in Massachusetts have decided they’ve had enough of Big Pharma “bribing” physicians, and if a new bill becomes law, allows fines of up to $5,000 for even offering a gift.

The Massachusetts state Senate has approved a bill containing a sweeping package of reforms it hopes will control skyrocketing health-care costs. Among other measures, the bill bans Big Pharma from giving gifts of any value to physicians and health care facilities.

The state’s doctor-gift provision may get Big Pharma’s attention, since it has the teeth that were missing in a federal bill proposed recently by Herb Kohl (D., WI), and Chuck Grassley (R., IA), which we discussed recently in Our Views, requiring Big Pharma only to report all payments and gifts made to physicians. Massachusetts first-of-its-kind bill actually sets fines of up to $5,000 for Pharma or device marketers who “offer or give to a physician, a member of a physician’s immediate family, a physician’s employee or agent, a healthcare facility or employee or agent of a healthcare facility, a gift of any value.”

An earlier version of the bill made such gifts a crime, but the criminal clause was removed from the final version. Before taking effect, the bill must pass the state House of Representatives and be signed by Governor Deval Patrick.

Reaction from the industry has been predictably noisy, including an op-ed piece in the Boston Herald by two notable physicians, Dr. Thomas Stossel of Harvard and his colleague, Dr. Dennis Ausiello, who decry the bill as a really bad idea. But as Dr. Howard Brody points out in his blog Hooked, Ausiello is a director at Pfizer and Stossel is a paid consultant to Merck, with each having several other major interests as well. What else are they going to say?

Banning pharma gifts is a trend, not some solitary new idea

The writing is on the wall. Gifts from Big Pharma and its device-making counterparts may soon be unwelcome at all 129 of the nation’s medical colleges, according to a new report from the Association of American Medical Colleges, which spent two years on the project. Also, according to The Prescription Project, in 2007 over half of all state legislatures considered bills addressing various aspects of bribery-based pharmaceutical marketing, and more of them will soon follow suit. In Minnesota, gifts worth more than $50 are banned already, and Vermont requires public disclosure of gifts over $25.

Not only that, many academic medical centers have banned drug company gifts, including Yale, Stanford, University of Michigan, University of Pennsylvania, Boston Medical Center, Vanderbilt University, University of Pittsburg, and University of Massachusetts. And the University of California will soon follow with its gift ban.

Of course, banning gifts is only the first step to putting integrity back into our medical system. As long as academic medical centers continue to rely on huge “grants” from Big Pharma to fund medical research, the “results” will never truly be independent. As long as most of the continuing medical education available to doctors is funded by drug companies who promote their products then doctors will not really receive unbiased information.

Although we’d liked to have seen the criminal felony clause retained in the bill, the $5000 fine for even offering a gift is a start. We hope the House and the Governor approves it. Hitting Big Pharma in the pocket book may be the only thing this industry understands. Big Pharma should just knock off the bribery. If their products really work they will be purchased—just like any other product.

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FDA’s letter to GSK warns Big Pharma to get its act together and start reporting all adverse event information or suffer the consequences of fines and criminal proceedings.

In his In Vivo blog, Micheal McCaughan suggests that the warning letter sent to GlaxoSmithKline (GSK) about its diabetes drug Avandia is more than just bad news for the company, but a warning for other biopharmaceutical companies as well.

After inspecting the firm’s post-market adverse event reporting procedures and discovering that GSK has not filed all the necessary reports on Avandia, the FDA issued a strongly worded letter, addressed to the firm’s CEO Jean-Pierre Garnier. Since the Food, Drug and Cosmetics act is a “strict liability” statute, top executives — starting with the CEO — can be held criminally accountable for violations they knew nothing about.

McCaughan says this is the key section in the letter:

FDA’s inspection revealed that your firm lacked appropriate knowledge of the studies associated with Avandia, resulting in the reporting deficiencies noted. Absent a clear explanation of the extent and cause of these deficiencies and an adequate plan to correct them, we are concerned that similar deficiencies in the postmarket reporting for your firm’s other FDA-approved drugs may exist . We expect that your corrective actions will include a comprehensive evaluation of your firm’s reporting of postmarketing studies for all drug products for which your firm holds an approved application.

McCaughan goes on to say: “The warning letter should be a must read for all biopharma companies with products on the market (and all companies who hope to be so lucky as to have products some day). The letter does indeed add to GSK’s headaches, but for the rest of the industry it should serve as notice that the agency is likely to do a lot more enforcement of postmarketing study reporting requirements in the months and years ahead.

“Congress, remember, has just handed FDA new enforcement authority over postmarketing trials, in the form of the ability to mandate Phase IV studies — and fine sponsors who fail to live up to their commitments.

“In the new world of post-marketing oversight and regulation,” he adds, “expect the agency to make sure that every company gets that message loud and clear.”

Post-marketing adverse events are what we, the public, are all too familiar with. That’s when we usually hear about drug problems — headlines citing injuries, deaths and massive lawsuits, or worse, learning that someone we know or love is a victim.

The FDA’s record on ensuring that prerelease drug testing is thoroughly done before drugs reach the market has been less than stellar in recent years. Many clinical trials showing that a drug had problems were kept from the FDA and the public. Most new drugs are released on the public after being tested with less than 1000 to 3000 carefully chosen patients. This is why the FDA admits that the real tests of a new drug only occur after their release to the public and is why post-marketing disclosures are so important.

That is why it is so critical that post-marketing adverse effects are reported promptly. But post-marketing muscle has been flabby as well, with drugs causing hundreds or even thousands of adverse events before the FDA acts.

Post-marketing inspection and reporting is at least as important as prerelease clinical trials and testing, because no program can possibly cover every possible scenario that could and will exist in the real world. Post-marketing vigilance is critical, and we’re glad to see the FDA stepping up to the plate to get the attention of Big Pharma, and exercising the new muscle given to it by Congress last year in changes to the FD&C Act.
We just hope that the FDA is not just making a show but are serious about this and will take affirmative action if GSK doesn’t immediately correct the problem.

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Whistle-blower lawsuit alleges Schering-Plough failed to reveal problems with a drug that killed five people, including two children, and seriously injured 53 others.

Schering-Plough recently spent $14.3 billion to buy the drug company Organon, and now must face allegations that serious “adverse events” associated with Organon’s neuromuscular blocking agent Raplon were not disclosed before or after FDA approval back in 1999. After five people died, including two children, and at least 53 others suffered severe bronchospasm, Organon withdrew Raplon from the market in March 2001.

Raplon was designed to paralyze a patient’s throat to facilitate intubation — inserting a breathing tube into the trachea — and claimed to induce paralysis faster than older generic drugs that cost less than $1 per unit compared with $20 for a unit of Raplon. Problems arose when patients receiving Raplon suffered serious bronchospasms that stopped their breathing.

According to Ed Silverman’s Pharmalot blog on the subject, the Raplon problems occurred when Schering-Plough’s senior vp for global fertility, Hans Vemer, was still the top man over at Organon. The whistle-blower, Jeff Feldstein, a former Organon employee, first filed his charges in 2002, about the same time he filed a wrongful termination lawsuit against Organon. The US Attorney in Boston declined to join the whistleblower charges at that time, so Feldstein now is pursuing the case independently.

Feldstein’s lawsuit in federal court in New Jersey alleges that Organon executives knew of the serious problems with Raplon and instead withheld the evidence from the FDA in order to get approval. As well as failure to disclose, Feldstein also claims that Organon’s behavior caused false claims to be submitted to Medicaid and Medicare.

Schering-Plough, of course, vehemently denies the charges, saying it will “vigorously defend Organon”. However, the evidence offered by the suit, including copies of internal memos, strongly suggests that Organon ignored the warning bells expressed by clinical investigators prior to the drug’s launch.

If it is determined that Organon did fail to disclose to the FDA its concerns about bronchospasm, it will be yet another blow to Schering-Plough, already suffering from its partnership with Merck over the Vytorin and Zetia debacle. Then there’s the $435 million settlement in 2006 for federal civil and criminal charges that it illegally promoted several drugs for off-label use, and defrauded Medicaid — the third such settlement for Schering in just two years. Schering Sales pled guilty to one count of conspiracy for making false statements to the government and paid a $180 million criminal fine as well.

So, yes, the FDA has some changes to make to prevent these kinds of situations, and they need to do it fast. New policies are needed to jolt Big Pharma enough to wake up and smell the fire and brimstone. It’s time for new business models, both at the FDA and for Big Pharma.

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Merck and Schering-Plough are not the only Big Pharma players getting hurt by their own actions.

Before Merck and Co. withdrew the painkiller Vioxx in 2004, it was linked to tens of thousands of heart attacks. Now a new study of internal Merck documents alleges the company knew of the dangers years earlier, but falsified statistics to hide them from the FDA.

In the five years it was on the market, Vioxx was a blockbuster for Merck that generated billions of dollars. When it was eventually linked to heart attacks and strokes, the product was pulled from the market. Earlier this year, Merck agreed to almost $5 billion in compensation to the victims of the Vioxx — I hesitate to use it, but there’s just no other word to describe it — scam.

A scam is “a confidence game or other fraudulent scheme, especially for making a quick profit.” A popular synonym is the word “swindle”. And that’s exactly what Merck, a Big Pharma player, worked on its millions of patients, their physicians, and before that, the Food and Drug Administration that approved the drug.

Now Merck is embroiled in another possible scam, this one over its massively profitable — $5.1 billion in 2007 — cholesterol drug Vytorin, a combination of Merck’s Zocor and Schering-Plough Corp.’s newer drug Zetia. An ongoing study shows that Vytorin is no more effective than cheaper, generic versions of the statin drug Zocor at reducing plaque buildup. The report has doctors nationwide reverting to older, cheaper statin drugs. And Congress is investigating whether the two companies withheld the unfavorable study results to boost sales.

In spite of widespread public concerns about the FDA’s effectiveness at protecting us from drug dangers, the agency appears to be stepping up to plate with Merck.

The FDA has rejected Merck’s application to sell the cholesterol drug Mevacor over the counter, and it has begun an investigation into the asthma and allergy drug Singulair, linking it to higher rates of suicide. Merck had already updated the drug’s warning label about side effects including tremors, anxiousness, depression and suicidal behavior, but further investigation may reveal more problems.

Merck shares fell 35 percent in the first quarter, much of the loss due to the Vioxx scandal, according to Wall Street analysts. The company is far from the only Big Pharma player in trouble, as scams, swindles and scandals continue to surface across the playing field. According to Ed Silverman in his Pharmalot blog, Schering-Plough’s share prices have been “ravaged” by the Vytorin controversy, caused “massive layoffs”, and in general “sullied the company’s reputation.”

Well, as the old saying goes, if the shoe fits . . .

There are plenty of laws on the books, at all levels of government, designed to protect the public from scams and swindles. It’s time for our lawmakers to take a very long hard look at how Big Pharma is being regulated and its products are tested and approved. And part of the scrutiny needs to be directed at the FDA itself. A lot of people need reassurance that the scams aren’t getting some help from Big Pharma friends on the inside.

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Big Pharma’s ethics also need a major overhaul or the industry will go the way of the dinosaur.

The Journal of the American Medical Association (JAMA) reported this week that Merck and Co. faked reports on Vioxx. In other words, Merck employees wrote the reports, then attributed the articles to academic investigators hired and paid by the company to use their names.

Now that the JAMA report has made national news, all sorts of industry insiders are coming out of the woodwork and saying it’s common knowledge that Big Pharma hires ghost-writers — pays for the use of academic names — for research and development reports.

For example, in the In The Pipeline blog this week, Derek Lowe says there’s little doubt that the practice goes on. “I’ve never been in a position to see it happen, but it’s been reported for years,” he says.

Lowe points out that no one is suggesting the articles contain bad science or that conclusions drawn in them are faked, even if they written by Merck people.

“I haven’t seen anyone suggesting that the Merck studies themselves are bogus – they had damn well better not be – but by playing games with the external author list, the company invites suspicion,” Lowe says. The practice is driven by what he suggests is a need to bolster a drug’s image because of the money involved. Developing a new drug and shepherding it to market is enormously expensive.

Lowe gets close to the truth when he concludes that the only way to win back public trust, which he says “we’ve lost, in case anyone hasn’t noticed”, is to cut out the shortcuts and double-talk and “act as if what we’re doing — drug discovery — is something to be proud of.”

Calling for ethical changes in Big Pharma’s approach to its business is right on the money. But Lowe shows a lot of altruistic optimism when he says if such practices aren’t curtailed, the industry could face serious price controls, lots and lots of marketing restrictions, the FDA raising the bar for approvals to never-before-seen levels, and “flocks of lawyers beating their wings, circling around our every move” — as if Big Pharma can, on its own, accomplish the fundamental changes it needs to make.

Seeing as Big Pharma’s shady practices are so ingrained and so widespread, it seems to me that one of the measures Lowe warns of — the FDA revamping its approvals process and raising the bar – will almost certainly not be enough incentive to get Big Pharma’s ethics levels demonstrably high enough to warrant a return of public trust.

And while we’re talking about public trust, let’s face the flip side. The FDA itself has a long way to go in that department, too. The public wouldn’t be forced to resort to lawyers and the legal system if the FDA was really on the job.

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