All Things Whistleblower: A GAP Blog

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

Viva Viagra Online Safety Information

The FDA has sent a written warning to drug giant Pfizer over that company’s online advertisements of men singing the praises of Viagra. The FDA objected to the online advertisements’ failure to list the drug’s potential risks.

Pfizer claims that the omission was a result of an error by CNN.com, the site running the ad. CNN spokesman say that their site did indeed experience an error.

In the Reuters article, a Pfizer spokesman indicated that the company has "pulled all 30-second Internet video ads that require safety information to appear separately on the screen rather than within the advertisement."

This would be a good trend for drug companies to follow. It just seems like online ads are more error-prone to omit important safety information than television ones are.

-- Dylan Blaylock

Vioxx Study Ghostwriters

A New York Times article from yesterday details the gross practice of giant pharmaceutical companies using ghostwriters to draft research studies on their own drugs, and then finding “prestigious doctors” who are well recognized in the medical community to lend their names as authors of the piece. The NY Times article was actually reporting early on the finding of an academic journal article that is to be released today by JAMA (Journal of the American Medical Association).

In this case, the big pharma culprit was Merck. Evidence of the practice was discovered through litigation procedures over Vioxx, a hugely popular arthritis drug that GAP client (and FDA Safety Officer) David Graham exposed as causing at least 40,000 fatal heart attacks to Americans by 2004, when it was removed from shelves.

Besides numerous other pieces of evidence, one ‘smoking gun’ was:

The article cited one draft of a Vioxx research study that was still in want of a big-name researcher, identifying the lead writer only as “External author?”

Nice. The lead author of the JAMA article put this latest revelation in perspective pretty well:

“It almost calls into question all legitimate research that’s been conducted by the pharmaceutical industry with the academic physician.”

This isn’t just a few select research papers, either:

For example, in 16 of 20 papers that reported on clinical trials, a Merck employee was designated as the author of the first draft of the manuscript. But an outside academic scientist was listed as the lead author when the study was published.

Finally, the article details a JAMA editorial that calls for changes to be made to correct this situation:

In an editorial on Wednesday, the journal said the analysis showed that Merck had apparently manipulated dozens of publications to promote Vioxx.

“It is clear that at least some of the authors played little direct roles in the study of review, yet still allowed themselves to be named as authors,” the editorial said.

The editorial called for immediate changes in the practice, calling upon medical journal editors to require each author to report his or her specific contributions to articles.

That’s exactly what should happen. Transparency is absolutely essential when dealing with drug studies. Deceptions of study authorship undermine American public health and consumer confidence of the FDA’s ability to protect patients. Of course, that confidence is pretty low nowadays anyway.

-- Dylan Blaylock

Coming soon to a Health Plan near You

More and more health insurance companies are setting new pricing structures for expensive prescription drugs by shifting the cost to the consumer. The traditional fixed co-pay is being jettisoned for a flat-rate percentage (20-33%). Common diseases for which the new system is in place for include MS, arthritis, and some cancers. In short (from the NY Times):

The system means that the burden of expensive health care can now affect insured people, too.

This new system is called Tier 4. The article does a good job of providing an example of what may become much more commonplace. Ms. Steinwand suffers from MS:

In January, shortly after Ms. Steinwand renewed her insurance policy with Kaiser Permanente, she went to refill her prescription for Copaxone. She had been insured with Kaiser for 17 years through her husband, a federal employee, and had had no complaints about the coverage.

She had been taking Copaxone since multiple sclerosis was diagnosed in 2000, buying 30 days’ worth of the pills at a time. And even though the drug costs $1,900 a month, Kaiser required only a $20 co-payment.

Not this time. When Ms. Steinwand went to pick up her prescription at a pharmacy near her home in Silver Spring, Md., the pharmacist handed her a bill for $325.

There must be a mistake, Ms. Steinwand said. So the pharmacist checked with her supervisor. The new price was correct. Kaiser’s policy had changed. Now Kaiser was charging 25 percent of the cost of the drug up to a maximum of $325 per prescription. Her annual cost would be $3,900 and unless her insurance changed or the drug dropped in price, it would go on for the rest of her life.

-- Dylan Blaylock

Drug Makers Getting Closer to Legal Shield

An excellent New York Times story from yesterday details what will (hopefully) become a hot legal issue later this year. The story details how court decisions could effectively shield drug makers from personal injury lawsuits – even when the companies intentionally misrepresent data about their products to the public.

The Supreme Court, which granted similar protection to medical device producers earlier this year, is set to hear and decide a case on this topic later this year. The argument for this corporate protection, which the Bush administration whole-heartedly supports, is simple: The FDA, in all its effectiveness and glory, is the only governmental department with enough expertise to decide whether a drug is safe enough to hit the market (i.e., whether society benefits from its availability). Its authority, therefore, should not be ‘second-guessed’ by lawsuits from hurt patients. This legal argument is known as ‘pre-emption.’

But the NY Times article does an excellent job of illustrating why this is a truly a terrible idea. The story details one case before lower courts right now, involving a Johnson & Johnson birth control patch that released a much greater amount of estrogen than it claimed it did. Higher amounts of estrogen lead to blood clots and stroke. From the article:

Documents and e-mail messages from Johnson & Johnson, made public as part of the lawsuits against the company, show that even before the drug agency approved the product in 2001, the company’s own researchers found that the patch delivered far more estrogen each day than low-dose pills. When it reported the results publicly, the company reduced the numbers by 40 percent.

So we know the company knew of the increased health risks, and failed to act on their data. It doesn’t take a genius to figure out why. Furthermore:

The F.D.A. did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80 percent, to 187,000 by last February from 900,000 in March 2004.

So from the time the company originally knew of the problem to the time the FDA alerted the public, six years had passed. During that time, at least 50 deaths have occurred (allegedly) as a result of the drug’s use. But the article goes on:

Last month, at a trial over the schizophrenia drug Zyprexa, Dr. John Gueriguian, a scientist who worked at the F.D.A. for two decades, testified that the agency did not always ask for strong warnings even if it believed a drug was risky. Companies typically oppose warnings, and the agency knows it must compromise on its requests or face years of delay, Dr. Gueriguian said.

The article also details how several experts believe (as is the growing public consensus) that the FDA is ill-equip to safeguard public health and that its system for doing so is broken. This is correct.

The Supreme Court decision later this year could be terrible.

-- Dylan Blaylock

*Photo courtesy of Tom Varco

Yes, the FDA is Overextended, but Come On…

Tobacco giant Reynolds American, in an effort to thwart federal legislation that would grant the FDA authority over tobacco companies, has begun a multi-media ad campaign painting the FDA as weak, overextended, and incapable of providing adequate oversight. But other reasons appear to be the driving force behind the ad push. From the New York Times:

Analysts contend that the bill could benefit Philip Morris over its smaller competitors. By imposing tighter restrictions on advertising, the new regulations could make it harder for Reynolds to market Camel — No. 3 in the United States market — against the industry’s top seller, Marlboro, which is made by Philip Morris.

So there’s that. But the Reynolds argument also implies that the FDA will have to pull resources from other important areas. But…

But the bill tries to address that concern by establishing a new center for tobacco regulation within the F.D.A. It would be financed by tobacco industry fees projected at more than $5 billion over the next 10 years.

So the argument’s reasoning seems thin as well. Last, but not least,

The bill would also ban candy-flavored cigarettes and give the F.D.A. authority to regulate the content of tobacco products.

Candy flavored cigarettes? Candy-flavored?

-- Dylan Blaylock

No Surprise: FDA Deadlines Greatly Increase Safety Risk

In a first-of-its-kind study, medicines that are approved by the FDA close to or at a mandated deadline have been shown to be much less safe than those not approved near a deadline date.

Examples of unsafe drugs to have been approved near a deadline include Vioxx, Bextra, Rezulin, Baycol.

FDA watchdogs and critics are using this opportunity to spread the word about this one (of several) major problems with the FDA drug approval process. How was this system started? From the AP:

Deadlines were first imposed on FDA by a 1992 law that allowed drug makers to pay millions of dollars in fees directly to the cash-strapped agency so it could hire more reviewers and clear a backlog of pending drug applications. In return, FDA had to make a decision — either approve or reject — on 90 percent of all drug candidates within 12 months of their application, or lose money. The deadline was 6 months for drugs so novel or potentially lifesaving to be classified high-priority.

Congress tightened the deadline for most drugs to 10 months in 1997.

And about the study:

Amid concern about risky drugs, Harvard professor Daniel Carpenter took a closer look at the impact. First, he found approval is 3.4 times as likely in the two months leading up to the user-fee deadline as at any other time.

Drugs approved in that just-before-deadline period had a four- to five-fold higher rate of later being withdrawn or requiring serious safety warnings, compared with drugs approved faster — presumably slam-dunks — or those that miss the deadline, Carpenter concluded.

This latest revelation, along with other major stories that break on what seems like a weekly basis, is yet another reason that the FDA and its drug approval process to be completely revamped.

-- Dylan Blaylock