All Things Whistleblower: A GAP Blog

The Other Big Story This Week

The other big story not to forget about this week was the Supreme Court hearing on Monday. According to a number of articles (Washington Post, New York Times, NPR, Los Angeles Times), the case seemed to go pretty well, with both conservative and swing justices posing critical questions to the pharmaceutical industries attorneys. From the Washington Post:

The company's argument caused divisions within the conservative bloc on the court, which has sided with corporations in several recent similar cases. Justice Samuel A. Alito Jr. questioned how the Food and Drug Administration approved the anti-nausea drug, Phenergan, as "safe and effective" when "you have the risk of gangrene."

Justice Anthony M. Kennedy disputed Wyeth's contention that it could not have followed the Vermont law under which Levine sued without violating the federal law that regulates drug labeling. "As a textual matter, as a logical matter, as a semantic matter, I don't agree with you," Kennedy, often a swing vote in important cases, told a Wyeth attorney.

But other conservative judges appeared to be unmoved. From the LA Times:

But Justice Antonin Scalia and Chief Justice John G. Roberts Jr. appeared to be on the side of the drug makers. They questioned whether drug makers can be held liable if they alerted the FDA to these risks, but no change in the warning label was ordered. "The labeling says it is dangerous to use an IV push," Scalia said.

Disagreeing, an attorney for Levine said the warning label fell short of protecting patients. A "reasonably prudent manufacturer" who learned patients had suffered amputations would have warned against ever injecting this drug, Washington lawyer David Frederick said. The warning label "is not set in stone," he added, and Wyeth could have added stronger cautions.

Today, an excellent NYT masthead editorial detailing exactly why the Supreme Court should not decide in favor of the pharmaceutical industry stated this:

We do not buy Wyeth’s argument that it did everything it needed to, or could have done, to warn doctors about the dangers involved in the treatment Ms. Levine received. Wyeth did warn of some dangers of the drug treatment, in words approved by the F.D.A., but the state court was well within its rights to conclude that those warnings were insufficient.

And that is the greater point. When Congress revised the federal law governing the F.D.A. in 2007, drug companies wanted, but did not get, a provision shielding them from this sort of lawsuit. The drug industry and its administration allies now want the court to ignore the absence of express legal language and grant drug companies immunity based on a phony assertion that state lawsuits improperly usurp federal regulatory authority.

For the court to broadly endorse the concept of “implied pre-emption” in this case would show disrespect for the considered decisions of Congress and could foreclose injury suits involving not only drugs, but also motor vehicles, household products and other things. The ultimate effect would be to undermine consumer safety.

Right on. Congress already decided this point. Let’s hope the Court recognizes that.

-- Dylan Blaylock

Big Pharma Problems

Gardiner Harris of the New York Times has reported a couple of important stories over the last few days. Last Friday, it was revealed that one of America’s “most influential psychiatrists” has, over the last seven years, failed to report at least $1.2 million in income earned through consulting arrangements with major drug manufactures. This remarkable ethical breach has come as part of a continued crusade by Senate whistleblower champion Charles Grassley to expose wrongful connections between doctors and pharmaceutical companies:

The Congressional inquiry, led by Senator Charles E. Grassley, Republican of Iowa, is systematically asking some of the nation’s leading researchers to provide their conflict-of-interest disclosures, and Mr. Grassley is comparing those documents with records of actual payments from drug companies. The records often conflict, sometimes starkly.

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

Then today, Harris covered that a new study from a medical journal shows that free drug samples actually result in increased health risks for children.

Important stuff. Good stuff.

-- Dylan Blaylock

Not the PR that the FDA Was Hoping For

A front-page Washington Post story details how FDA workers used personal connections to direct a public-relations contract that should have been open for competitive bidding (as government contacts typically are) to a firm where the same FDA staff previously worked.

More specifically, the FDA worker in question utilized a loophole in the competitive bidding process – selecting a small firm based in Alaska which is exempt from having to compete for government contract competitively because of its ownership (Alaska Natives). That company, ANI, essentially agreed to act as a front, leaving the actual work to be done to a Washington D.C.-based firm, Qorvis Communications, which would have been subject to the competitive bidding process. Check out the ‘smoking gun’ emails:With unusual candor, people involved in the FDA deal discussed the fact that ANI was brought in so the FDA could work with Qorvis, e-mails show.

While the deal was being formulated last October, James Dunn, a private consultant who had dealings with ANI, sent the following e-mail to a Qorvis executive, who forwarded it to an FDA official: "ANI will gladly serve as a prime for Qorvis on the FDA deal, knowing that the agency would intend to direct them to you as a subcontractor to perform all the work."

This great read of an article also includes a nice take from an expert on such matters:

Steven Schooner, co-director of the government procurement law program at George Washington University, said he has rarely seen such a detailed example of officials and contractors working to avoid competition. "The story line is as bad as anything I've ever heard," he said. "It's not transparent. It's not competitive. It's not arm's length."

Yep, that sounds right.
-- Dylan Blaylock

Adventures in Drug Transparency

Although the big issue GAP is following today is the potential passage of whistleblower rights in the bailout bill, there are a couple of important drug safety stories from the past couple of days.

First, yesterday, HealthDay News reported that a new study shows that more than half of drug trial data in the United States goes completely unpublished, even years after products have been on the market.

This travesty and assault on transparency is even more heinous, when you consider the fact that the Supreme Court may very well decide later this year to grant drug companies immunity from personal injury lawsuits in the future.

Then today, in much better news, the New York Times reported that two major pharmaceutical companies have announced that, starting next year, they plan to publicly divulge payments made to outside doctors.

Although this seems like very good news on face value, with the track record of drug companies and transparency, it’s probably best to react to this news with cautious optimism.

-- Dylan Blaylock

A Very Important Case

This New York Times article details a woman who lost her hand and part of her arm after taking an anti-nausea drug. A jury found for her in a product liability suit against the drug’s maker, Wyeth, for not adequately warning about possible drug risks. This case, however, is set to be heard in front of the Supreme Court in November, in a case that will determine whether drug companies can be held liable for personal injury, provided that the drug was granted FDA approval. This legal debate, “pre-emption,” may be the most important case of the court’s term.

This issue was detailed earlier this year in reports, when medical device makers were actually shielded from personal injury lawsuits in a separate terrible decision.

Hopefully, more and more articles will emerge covering what easily could be the most important patient rights case for decades to come.

-- Dylan Blaylock

Hold the BPA

Yesterday at a public hearing, the FDA defended the controversial chemical BPA, found in many common plastics, as “safe.” Health watchdogs are understandably very upset, as over 100 studies have linked BPA to negative health ramifications in animals. But there’s more! From the Washington Post:

The FDA maintains that BPA is safe largely on the basis of two studies funded by the chemical industry, a fact that was repeatedly cited at yesterday's forum.

"We're concerned that the FDA is basing its conclusion on two studies while downplaying the results of hundreds of other studies," said Amber Wise of the Union of Concerned Scientists. "This appears to be a case of cherry-picking data with potentially high cost to human health."

A potentially high cost is right. Especially considering the results of a new study by the Journal of the American Medical Association, highlighting the first human-BPA health links. From the Associated Press:

 Using a health survey of nearly 1,500 adults, the study found that those exposed to higher amounts of BPA were more likely to report having heart disease and diabetes. Because of the possible public health implications, the results "deserve scientific follow-up," its authors said.

There’s also evidence from the study correlating BPA and liver abnormalities.

Warning - Watch your BPA intake (plastic usage).

-- Dylan Blaylock

Big Pharma's Lobbying Increase

A new report reveals a huge increase in Big Pharma’s lobbyist spending after the Democrats took Congress in 2006, which unfortunately seems to be paying off. The industry has won several major concessions from Congress, including blocking new advertising restrictions and renewing two bills that speed up the FDA approval process. This is particularly troubling at a time when Big Pharma is increasingly criticized for irresponsible business practices. From the Wall Street Journal:

The industry's support for limiting drug imports comes at a time when it is coming under attack over safety issues for its foreign outsourcing of drug manufacturing as well as for its own imports from other countries such as China.

Like Heparin, which resulted in scores of American deaths and hundreds of illnesses. Now more than ever we need responsible drug safety oversight, and Congressional Democrats need to keep their priorities in order.

Getting Away With Murder

The FDA has decided to allow a heartworm drug for dogs, which was been linked to over 500 canine deaths before its use was suspended four years ago, back on the market. The drug, Proheart 6, was developed by pharmaceutical giant Wyeth. The company had such cozy relationships with the FDA that in late 2004, when Proheart 6 was pulled, a smear campaign they orchestrated against FDA veterinarian and GAP client Victoria Hampshire, who discovered the link between the drug and the fatalities, forced her out of her job. Hampshire was eventually cleared of all wrongdoing of the bogus charges brought against her.

So what justification had the FDA used in deciding to re-release the drug? Good question…From Reuters:

Tests by Fort Dodge Animal Health, the Wyeth unit that makes Proheart 6, found residue from solvents used to make the drug could cause allergic reactions, the FDA said. A manufacturing change decreased the presence of residues, and allergic reactions dropped after the reformulated product went on sale in other countries, Wyeth said.

So we should just take Wyeth’s word for it, right? If that doesn't convince you, the Director of the FDA's Center for Veterinary Medicine gave the drug this vote of confidence:

"While we concur with the limited return of ProHeart 6 to the U.S. market, we strongly encourage veterinarians and pet owners to report any possible adverse reactions".

This quote doesn’t quite instill confidence that they’re sure about the drug, does it? To dog-owners out there – fair warning.

FDA Burnout

One potential reason for the FDA’s sub-par performance over the last few years may be the “revolving door” linking government and private workers. This article details how the stress of dealing with drug review deadlines, coupled with the lucrative opportunities outside the agency, drives FDA scientists into the private sector.

And the companies target these workers. From USA Today (this actually begins the article):

When pharmaceutical consulting firm Quintiles wants to hire a new employee, the first place it looks is the Food and Drug Administration.

The article also discusses how a lack of funding leads to high turnover as well:

FDA's outside advisers point the blame for staffing problems toward the White House and Congress, which have heaped new responsibilities on the agency without increasing its funding.

In the last 15 years, FDA has received more than 100 new assignments, but the number of government-provided staffers has fallen from roughly 9,000 to 8,000. The result is less regulation even as the industries FDA oversees grow larger.

And let’s not forget how the agency treats whistleblowers:

FDA's outside advisers say frustration with FDA culture is a major reason its turnover rate is twice that of other agencies.

Staffers who disagree with management are reportedly discouraged from speaking up, according to an Institutes of Medicine report on FDA's drug safety system.

It certainly appears that things could be better.

- Dylan Blaylock

Dingell Stands Up for Consumers

House Energy and Commerce Committee Chairman John Dingell scolded FDA Commissioner Andrew C. von Eschenbach yesterday, and rightfully so. Dingell and others are quite upset over the palpable ineptitude of the FDA to inspect foreign drug imports and ensure American public safety, especially in light of the recent multitude of American deaths from the tainted blood-thinner heparin.

Dingell really let Eschenbach have it (from Medill News Service):

Pounding his desk and raising his voice, [Dingell] castigated the Food and Drug Administration's oversight of imported drug safety as "archaic and fraught with inaccuracies."

and

"Quite frankly, I am establishing that you don't have the resources and you can't do your job," said Dingell, calling FDA oversight of imported drugs "indefensible."

Eschenbach admitted to Dingell (agreeing with a previous GAO report) that it would take some 30 years for the FDA to properly inspect all American-importing Chinese drug plants alone. Again, from MNS:

“I've been talking to Food and Drug Administration commissioners for 40 years…I want to maintain my respect for you, but I can't maintain my respect for you if you keep toe-dancing around," said Dingell, still pounding the table.

Nice!

-- Dylan Blaylock