The FDA is working on a new warning label for Byetta a widely used diabetes drug marketed by Amylin Pharmaceuticals Inc. and Eli Lilly & Co.
This comes as The Food and Drug Administration said Monday it has received six additional reports of patients developing a dangerous form of pancreatitis while taking Byetta. Two of the patients died and four were recovering.
Last October the FDA issued an alert about 30 reports of Byetta patients developing pancreas problems. At that time Byetta’s makers agreed to add information about the reports to the drug’s label.
This is an example of how dangerous side effects of certain medications are not evident until after the FDA has approved the drug. If Wythe vs. Levine were to be successful, there will be no legal remedy for the damages incurred.
Now, because of mounting evidence that the drug levequin alsong with cirpro and others in it is class of flouroquinolone drugs, can cause injury to tendons and tendon ruptures, the FDA has issued its most urgent safety warning- THE BLACK BOX. Last week the FDA announced that fluoroquinolone antimicrobial drugs, like Levaquin and Cipro, would now carry the agency’s strictest warning. Antimicrobial drugs are used to treat or prevent certain types of serious bacterial infections, including pneumonia. These drugs have been linked to an increased risk of tendinitis and tendon rupture. The FDA notified manufacturers that the Risk Evaluation and Mitigation Strategy (REMS) is necessary to ensure that the benefits outweigh the risks associated with the medications.
In 2005 various groups including the consumer group Public Citizen began petitioning the FDA to put the black box warning on these drugs. They eventually sued the FDA prior to the FDA’s decision to take this action.
It is not really understood how these drugs cause the tendon ruptures but studies show that the drugs have a toxic effect on cellular components of connective tissue. The most commonly effected tendons are the Achilles tendon in the heel and the tendons connecting muscles to bones in the hand, shoulder and arm.
The FDA alert indicates that this risk is increased in patients over age 60 and in patients taking steroids. Physicians are advised to take patients off fluoroquinolone medications at the first sign of tendon pain or swelling.
The had filed a petition asking for these warnings two years ago and eventually sued the FDA prior to the FDA’s The FDA would not cite a specific number, but admit they have received several hundred complaints
The warning now reads”Tendon ruptures that required surgical repair or resulted in prolonged disability have been reported in patients receiving quinolones, including levofloxacin, during and after therapy. This risk is increased in patients over 65 years old, and is further increased with concomitant corticosteroid therapy. Discontinue in patients experiencing pain, inflammation, or tendon rupture.”
Unfortunately for some, the warning again comes too late.
Guidant Corporation executives knew of potentially deadly problems with their defibrillators six months before sharing those concerns with the public. In a state court trial proceeding, documents, including a slide-presentation dated October 20, 2004 warned that up to 55 Guidant defibrillators could short circuit by November 2005. Despite company’s knowledge of the problem, Guidant did not notify the public and recall devices until June 17, 2005. The New York Times estimated that more than seven people have died because of faulty Guidant defibrillators.
Responding to backlash from the Vioxx disaster of 2004, the FDA has pledged to bar committee appointees with financial biased from voting on approval of drugs. The conflict of interests when screening members has up to this point been a non-issue. One reason, the industry is a small group and very interconnected. It is difficult in this industry to find someone without ties to the private sector. It is where the money is.
Among the new standards, appointees with more than 50,000$ invested in companies affected by the outcome will not be allowed to vote.
Good. That’s a lot of money. Of course, if a committee member has 45,000$ invested and there is nothing else objectionable according to the FDA regarding that person’s qualification, voting will be allowed. You know, that is a lot of money too. The FDA hopes to post its decisions and the reasons for waiving this restriction every time they do it. Good luck. From what I hear, you guys are pretty bogged down.
This is different than the proposal put forward a year ago, when FDA officials with financial conflicts up to 50,000$ would be allowed to attend the meetings, but not to vote.
Other disqualifications including working on the clinical trial of the drug, or working on a rival product…The more I learn about this the more I’m shocked that it has been operating in such fashion for so long. For example, the nonprofit advocacy group Public Citizen found that 73% of the committee meetings (from 2001-2004) had at least one member with a conflict of interest. These conflicts could be anything from receiving a grant for their own research or consultation fees exceeding 100,000$!
With that many zeros, I’m tempted to say “consultation fees” instead of consultation fees.
AP
FDA faulted over unapproved uses of medications
Sunday July 27, 11:40 am ET
By Ricardo Alonso-Zaldivar, Associated Press Writer
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Report: Drug companies that promote unapproved uses face little risk of getting caught
An additional 11 cases involving off-label promotions wound up in the hands of the Justice Department during the same period. Last year, for example, Bristol-Myers Squibb Co. agreed to pay the government more than $500 million to settle claims involving a series of alleged infractions, including promoting the drug Abilify — approved to treat schizophrenia and bipolar disorder — for treatment of dementia-related psychosis and for use in treating children.
In an interesting twist to the usual discourse between law and medicine, The New England Journal of Medicine recently published a perspective (July 3, 2008) alerting doctors to the upcoming Supreme Court hearing of Wythe v. Levine. In this landmark case, Wythe, a pharmaceutical manufacturer, is vying for a ruling to make Federal Drug Administration (FDA) approval subject to preemption. If Wythe gets their way, it will set a major precedent in the history against consumer protection, a return to 19th century consumer rights.
Preemption is a function of the U.S. Constitution, whereby any contradiction between state and federal law errs on the side of the Feds. In this situation, it means that if a drug has received FDA approval, patients will not have the right to seek restitution for dangerous, and in some cases lethal drugs prescribed to them.
In recent years, there has been a lot of ink spilled and tempers’ lost over frivolous lawsuits. Critics of tort litigation argue that such litigation dissuades pharmaceutical companies from experimenting and thereby limiting possible new miracle drugs. They also say that the drawn out process of testing drugs for customer safety is excessive and costly to the company. The truth of the matter is that the pharmaceutical industry lives by the quest for the next miracle drug. Any serious contender in the field must experiment, because the real profits come when a company holds the patent to a new drug. Until that patent expires, the company holds a virtual monopoly on that drug, so the cost of research is peanuts compared to the profits.
It should also be noted that FDA turnover has been increasing for over a decade. As drugs become more complex to meet the demands of the growing sophistication of the medical community, the vigilance of those entrusted to regulate those drugs has to equal this sophistication, and quite frankly, the resources at the FDA have been cut back. They cannot handle the demand. Therefore, tort litigation is a necessary member of the regulating bodies.
Margaret Jane Porter, a former chief counsel of the FDA, says “FDA product approval and state tort legislation usually operate independently, each providing a significant, yet distinct, layer of consumer protection”1.
However, current FDA officials are not inclined to agree. One may consider the fact that since passing The Prescription Drug User Fee Act (PDUFA) in 1992, over 50% of FDA funding has come from the companies seeking product approval. The act was passed to meet growing demands for FDA staff without petitioning Congress for more funding. Instead, an agreement was struck between the pharmaceutical industry and the federal government, whereby the company pays a user fee for every time they wish the FDA to test a product. In exchange, the FDA must reach a decision within a specific timeframe.
To some this may appear to be the Reaganomics ideal, but in effect this gives the pharmaceutical industry the power of the purse. Hence the paradigms shift over at the FDA. In the history of consumer protection, tort litigation that holds the producer liable for product safety has been a natural and effective deterrent to unsafe drugs. FDA approval has never been considered a 100% guarantee against harmful side effects. In fact, FDA approval is a minimum standard within the industry, not a gold standard, but the minimum. Hardly the vote of confidence necessary to negate legal censure; especially when one considers that the FDA is one of the few federal agencies that have no power of subpoena. The only test data they see is what the company applying for the stamp of approval gives to them.
Regardless of what one believes about the mechanisms of quality control in a market economy, the last word on this issue is accountability. The FDA, in the pitch of arrogant self-regard, argues that a jury of lay-people lacks the qualifications to judge the nuances of drug safety. I don’t know about you, but if a group of appointees (that’s right, FDA officials are not elected) getting their funds and data from the defendant think they are the only ones capable of fair and balanced judgments, then I say they need to get their heads examined. We owe a lot to tort litigation in the development of consumer safety, like safe air bags and safe tires.
The irony in this situation is that such a dissenting voice should come not from the American Trial Lawyers Association, but from the New England Journal of Medicine. The Journal’s staff wrote this article for other doctors. If doctors are concerned that granting preemption to drug companies will undermine their profession, then what are the rest of us to think? Clearly, such measures are in the best interest of a single group: the drug companies. Everyone else will be forced to live with the consequences of their legal immunity.
Ultimately, these lawsuits are not frivolous so long as we value the trust between doctors and patients, and the safety of the general public. Granting preemption to drug companies will only harm this trust and endanger the pubic. If Wythe gets what they want, the drug companies will be in a good position to start selling snake oil.
[1] Porter MJ. The Lohr decision: FDA perspective and position. Food Drug Law J 1997 52:7-11. as cited in The New England Journal of Med. Curfman, Gregory D., MD., et al. “Why Doctors Should Worry About Preemption” Perspectives. 2008.
