More on FDA and Pre-Emption

I've written a couple of times on the issue of pre-emption, which states that manufacturers cannot be held liable for any drug or medical device approved by the FDA. This includes drugs such as Vioxx, the approval of which was in no small part contingent upon ghost-written, dishonest research publications promoting the drug, despite evidence that it may have been harmful. In another instance, Johnson & Johnson, makers of the Ortho-Evra birth control patch, withheld evidence that it released significantly more estrogen than advertised and presented a danger to patients.

If the Supreme Court were to rule in favor of pre-emption in a case it has before it, Americans who suffered as a result of manufacturers' malfeasance and dishonest practices would have no outlet, and would assume the liability themselves. The House Committee on Oversight and Government Reform held a hearing this past Wednesday on the subject, hearing testimony from Dennis Quaid, various doctors, and lawyers, with all but one opposing pre-emption. [Obviously, Henry Waxman controlled the invitations, so the discrepancy is anecdotal at best.]

William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston

Dr. Maisel testified about medical devices, and the specific case of Mark Gleeson, victim of a short-circuiting pacemaker. As Dr. Maisel stated, "the U.S. Food and Drug Administration regulates more than 100,000 different medical devices manufactured by more than 15,000 companies, [and] receive several thousand new and supplemental device applications annually."

That the FDA would be able to catch every flaw or questionable scientific backing in all of those devises, in addition to regulating the 11,000 drugs on the market is ludicrous.

St. Jude Medical, the manufacturer of Mr. Gleeson’s pacemaker, had become aware of the short circuit problem 2 years prior to Mark Gleeson’s pacemaker failure because other faulty pacemakers had been returned to the manufacturer. After studying the problem for over a year and validating a fix, St. Jude asked for and received FDA approval for a modified version of the device that corrected the problem. This approval came several months prior to Mr. Gleeson’s device failure although the reason for the device modification and a patient warning were not publicly provided at that time. Furthermore, St. Jude Medical continued to distribute the already manufactured potentially faulty pacemakers. Mark Gleeson was unlucky enough to receive one as his replacement device – even though corrected pacemakers had been built and were available. Eight months after receiving FDA approval for the corrected device and nearly 2.5 years after initially learning of the problem, St. Jude Medical issued a recall of 163,000 pacemakers, including Mark Gleeson’s new unit.

The timeline in this particular case should eradicate any misconceptions about the efficiency of the FDA and its ability to protect consumers. St. Jude was aware of the problem a full year ahead of providing him the first pacemaker, and had a fix several months prior. Once it did provide a fix, neither the fix nor the underlying issue were made public. Indeed, when Gleeson's first pacemaker failed, he was provided with another faulty device, despite the availability of the newer model.

All of the issues involving the short-circuiting pacemakers became publicly available only 2.5 years after the problem was discovered.

Aaron S. Kesselheim, M.D., J.D., Harvard Medical School, Division of Pharmacoepidemiology

These lawsuits are important because in the current US regulatory system, a drug’s manufacturer plays the central role in the development and dissemination of knowledge about its product, and therefore exerts considerable influence over what is known about its product and how it is used in the marketplace.

This fact, of course, places greater emphasis upon the issues surrounding Vioxx (ghost writing) and Ortho-Evra (suppression of detrimental evidence). If the manufacturers themselves are in control of what the FDA (and the public) knows about the drug, pre-emption would place them in total control both coming and going. Not only are they capable of controlling what is known, but once that drug is approved on that cherry-picked information, the public is helpless but to hope nothing bad happens.

Dr. Kesselheim also brings up the limited testing that drugs go to prior to release, "often on patients healthier than those for whom it will be prescribed." Given that the FDA doesn't have the resources to follow every drug for its lifetime on the market, it is often up to the manufacturer to track adverse events and other safety issues.

Manufacturers have a strong financial incentive to promote their drugs’ effectiveness and increase sales of their products, but manufacturers may also sometimes be faced with their own safety-related data that suggest limiting use of their product, or withdrawing it from the market altogether.

Vioxx is again held up as an example, along with Baycol. In the case of Baycol, the manufacturer intentionally failed to follow-up once the drug went to market: "A company memorandum reportedly stated 'If the FDA asks for bad news, we have to give, but if we don’t have it, we can’t give it to them.'"

Then there's the lovable sales reps:

At the same time, a drug’s manufacturer manages how the drug is promoted to physicians and patients. Numerous studies show that these promotional messages are extremely powerful in influencing physicians’ prescribing practices. However, like any sales messages, they also tend to inflate the benefits of a medication and downplay its risks. Vioxx’s manufacturer continued actively promoting its wide use even after it reportedly knew about the drug’s association with cardiovascular adverse events. Such promotional tactics included specific instructions to its retailers how to dodge questions from physicians concerned about these side effects.

David Vladeck, J.D., Professor of Law, Georgetown University Law Center

Let’s be clear about this: Under FDA’s view, consumers are forced to assume the risks of unsafe drugs and medical devices. At the same time, manufacturers of drugs and medical devices who fail to take reasonable steps to assure their drug or device is safe are immunized from liability, and, these days, essentially immune from FDA enforcement.

Thus, instead of having liability claims as a second front of protection for the consumer, an over-burdened FDA beholden to the forthrightness of the manufacturers becomes the only form of coverage. Given the track record, it is fact, not opinion, that this is an ineffective system and to the severe detriment of consumers.

But here's the real kicker. Republicans love to rail against 'activist judges' and unelected officials ruling by fiat. But only on select issues, namely those they don't agree with. Tort reform (read: elimination) is a different story:

What makes this result all the more indefensible is that the decision to wipe away state liability law was not made by Congress through legitimate, democratic means. Instead, it was made by unelected and unaccountable agency officials — many of whom worked for drug and device companies before their government service and have returned or will return via the revolving door to represent the same companies. These decisions were not made in a transparent, publicly accountable way. Rather, they were made in obscure regulatory documents, with no opportunity for public input, and with no regard for the clear-cut requirements of Executive Order 13,132, which disfavors preemption and requires agencies to consult with states, local governments and the public before making preemption decisions.

I'm sure George Bush and John McCain will come out against 'judicial activism' if the Supreme Court legislates from the bench on this issue.

The federal government has regulated the sale of drugs for one hundred years without any hint that state liability actions interfered with FDA’s ability to do its job. Nothing in the statutes FDA administers suggests that they oust state liability actions for drug products. Indeed, FDA has long taken the view that state liability litigation for pharmaceuticals is an important, independent discipline on the market. And Congress has not acted to preempt or limit state liability actions, even though Congress has long been aware of the steady procession of liability actions against drug makers — including those that pre-date FDA and its forerunners.

The issue of pre-emption isn't even close. Tactically speaking, the insinuation that the FDA is effective as the exclusive check on pharmaceutical and medical device safety is fallacious and ludicrous, given the extensive pile of evidence to the contrary.

But aside from the logistics, there remains the legal issue. If the Court were to decide in favor of pre-emption, it would do so in contradiction to a century of precedent, both within Congress and the FDA, itself.

Pre-emption would be a great coup for those in the Bush administration who will be returning to corporate jobs in 2009, many in the pharmaceutical arena. It would also take a sledgehammer to consumer protection and legitimate governance.

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Ghosts in the Medicine Cabinet

Just this past Tuesday, I wrote about the federal government's efforts to enforce a policy of pre-emption, which would render moot any attempt to sue the manufacturer of a drug which had been approved by the FDA.

One of the key points I tried to emphasize was that a policy of pre-emption is implicitly reliant upon the presumption that the FDA's rulings are based on a sufficient volume of and intellectually honest array of facts regarding those drugs. I didn't expect a significant payoff to that theme so quickly, but then came this article in Wednesday's New York Times.

The drug maker Merck drafted dozens of research studies for a best-selling drug, then lined up prestigious doctors to put their names on the reports before publication, according to an article to be published Wednesday in a leading medical journal.

The article, based on documents unearthed in lawsuits over the pain drug Vioxx, provides a rare, detailed look in the industry practice of ghostwriting medical research studies that are then published in academic journals.

The report the article refers to is Guest Authorship and Ghostwriting in Publications Related to Rofecoxib, which appeared in the Journal for the American Medical Association. (Rofecoxib is the generic name for Vioxx)

Thus, as the Bush administration pushes hard for pre-emption in the pharmaceutical industry, information proving the policy's reliance on demonstrably false and potentially fatal tenets abound. From Johnson & Johnson's withholding of evidence as to the true levels of estrogen in its Ortho Evra birth control patch to an even more egregious policy of ghostwriting at Merck, the level of scientific dishonesty implicit in these revelations is astounding.

But this is more than a case of intellectually dishonest research practices. The failure to adhere to generally accepted rules governing scientific research--adherence to the Scientific Method, peer review, etc.--goes hand-in-hand with the argument against pre-emption.

If the FDA were accepted as the sole and unmutable authority governing the pharmaceutical industry, it would be imperative to prove that the rulings made by that agency were based on sound scientific judgment. Yet every day that goes by brings more evidence to the contrary.

Americans place an enormous amount of faith in the pharmaceutical industry and the FDA. That faith must be backed by an equally-large investment from the industry in scientifically and intellectually honest research practices. That it has not illustrated such a commitment is overwhelmingly evident by recent revelations. To back up that lack of commitment with a promise not to prosecute--or allow civil retribution of any kind--those dishonest practices would be a monumental failure of the FDA's responsibility to the American public.

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While You Were Out, April 15

Drug Makers Near Old Goal: A Legal Shield

In keeping with the theme of 'if we say it's okay, it is,' the Bush administration is pushing for a policy known as 'pre-emption' which would declare that pharmaceutical companies could not be sued over drugs that had been approved by the FDA.

The Bush administration has argued strongly in favor of the doctrine, which holds that the F.D.A. is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The Supreme Court is to rule on a case next term that could make pre-emption a legal standard for drug cases. The court already ruled in February that many suits against the makers of medical devices like pacemakers are pre-empted.

This theory, or course, works off the assumption that if the FDA has investigated a drug and approved it and its label, the courts are in no position to rule in opposition to the medical experts of the federal agency. But that relies on the FDA being provided with all of the facts and studies of the pill, something that drug companies are demonstrably opposed to complying with.

Consider Ortho Evra, the birth control patch made by Johnson & Johnson, around which this article is centered:

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.

Allowing for the FDA to be the final voice on all things pharmaceutical is based on the presumption that there is no pertinent information withheld. Clearly that isn't the case. Johnson & Johnson is not the first drug maker to be outed as having held back information, and they won't be the last. The makers of OxyContin actually marketed their drug (an opiate) as non-addictive, a laughable proposition for a drug of its sort, but approved as such by the FDA nonetheless.

If we expect the FDA to act as the only oversight arm of the entire drug business, we have to be assured that its acting well-informed and as an operative of the public. That isn't happening, and if lawsuits are a vehicle toward achieving an end better suited to the needs and expectations of American citizens then pre-emption is a disastrous precedent to set.

But pharmaceuticals aren't the only area where the protective arm of pre-emption is being extended, as this AP story details.

If you think the prescription drug you took for headaches caused your heart attack, the Food and Drug Administration says you can't sue the maker for injury if it met agency standards.

The Consumer Product Safety Commission says you can't sue a mattress maker if your mattress bursts into flame despite meeting commission standards. Companies making sport utility vehicles would get similar protection from suits brought by people injured or the families of those killed in rollovers under National Highway Traffic Safety Administration proposals for stronger roofs.

Plaintiffs' attorneys call it "silent tort reform."

Tort reform has been a platform for the Republican Party in recent years, and certainly supported by Bush. But for all its clamoring about judicial activism and laws made by fiat instead of legislation, the Party seems to be quietly utilizing that very same method to achieve its own ends. Obviously, its not activist judges they're worried about, its judges who aren't activist in their direction.

Surely frivolous lawsuits abound in the United States, but eliminating them altogether removes just one more bullet in the arsenal of consumer protection in the midst of a continual volley by the Bush administration.


Supplier Under Scrutiny on Arms for Afghans

Sure, fighting terrorism costs a lot of money, but what's the price of freedom, smart guy?

If you're a 22-year old arms dealer with a massuer for VP, about $300 million.

But to arm the Afghan forces that it hopes will lead this fight, the American military has relied since early last year on a fledgling company led by a 22-year-old man whose vice president was a licensed masseur.

With the award last January of a federal contract worth as much as nearly $300 million, the company, AEY Inc., which operates out of an unmarked office in Miami Beach, became the main supplier of munitions to Afghanistan’s army and police forces.

Since then, the company has provided ammunition that is more than 40 years old and in decomposing packaging [sic]. Much of the ammunition comes from the aging stockpiles of the old Communist bloc, including stockpiles that the State Department and NATO have determined to be unreliable and obsolete, and have spent millions of dollars to have destroyed.

The ends of eliminating terrorism (however much a fantasy that may be) has always been held to justify the means of its incredible expense in the eyes of those that would have the United States police the world. Whether or not that is the case, shouldn't that expenditure come attached to a bit of research?

If it's not granting no-bid contracts to former employers of the Vice President, the Defense Department is shelling out money to a man just old enough to have finished college for worn-out arms made in China between 1962 and 1974.

The Soviet Union, which designed the ammunition that AEY bought, developed similar tests, which are still in use. But when the Army wrote its Afghan contract, it did not enforce either NATO or Russian standards. It told bidders only that the munitions must be “serviceable and issuable to all units without qualification.”

What this meant was not defined. An official at the Army Sustainment Command said that because the ammunition was for foreign weapons, and considered “nonstandard,” it only had to fit in weapons it was intended for.

“There is no specific testing request, and there is no age limit,” said Michael Hutchison, the command’s deputy director for acquisition.

In purchasing munitions, the contractor has also worked with middlemen and a shell company on a federal list of entities suspected of illegal arms trafficking.

Bang-up job, fellas. Another case that screams out for the elimination of anyone watching how the government conducts its business.


Judge dismisses challenge to lobbying disclosure law

The National Association of Manufacturers suffered a major blow Friday in its legal battle against the new ethics and lobbying law.

Judge Colleen Kollar-Kotelly of the U.S. District Court dismissed the group’s challenge to a key provision of the law. The group took issue with the clause that would require disclosure of the member companies of “stealth lobbying” coalitions.

Part of the Honest Leadership and Open Government Act, the measure would require public disclosure of members of such coalitions who gave at least $5,000 every quarter to the group and participated actively in lobbying campaigns.

On what grounds would lobbyists oppose transparency of this sort? Why, free speech protection, of course.

The NAM argued the provision was constitutionally vague, hindering protections for free association and speech, and could lead to harassment of its member companies.

Yet again we are faced with an argument centered on free speech centered not on the ability to express yourself, but rather on the ability of others to respond to that expression. The First Amendment doesn't say anything about no one being able to react to free speech, but that's essentially the position the NAM has taken here.

In regards to free association, the new law--effective April 21--again says nothing about lobbyists not being able to associate or give money. It just says people have the right to know to whom and by whom.

That there is opposition to that premise illustrates the need for it by virtue of its very existence.

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