Tampa Bay Personal Injury Lawyer - FDA & Prescription Drugs

FDA’s Oversight of Post-Marketing Studies Inadequate

C. Todd Alley — Tue, 10 Nov 2009 11:05:08 GMT

The Government Accountability Office (GAO) has released a new report about the FDA’s lack of post-marketing oversight in a number of the drugs which it conditionally approved.

The FDA normally makes a decision to approve a drug based on clinical trials. If the clinical trials yielded favorable results, the FDA would then likely approve the drug and sales of the drug can be introduced to the U.S. market. The downside to this traditional route, though, is that the clinical trials can take years to complete, and cost the pharmaceutical company millions of dollars. With this in mind, in 1992 the FDA instituted an optional route to approval: surrogate end-points. Surrogate end-points are the end-results yielded by a drug in a laboratory setting which tend to show positive health benefits. For example, HIV-related drugs are often approved based on its virus-lowering power, a major factor in increased survival for HIV-infected patients. A cholesterol drug could be approved to prevent heart disease, an end-point, by showing that the drug lowers cholesterol – since there is a connection between high cholesterol and heart disease. Utilizing this approval route means that manufacturers can get their drugs to the market faster and patients in need have faster access to the drug.

Unfortunately with surrogate end-point approval there are often many factors unknown, namely long-term effects of the drug’s usage. Long term clinical studies provide this information, but drugs using surrogate end-point trials are often approved so quickly that long-term effects are not known until the drug is on the market - which means that adverse effects may not be known until after the drug’s approval. As such, the FDA approves these drugs conditionally. This means that the FDA will require the manufacturer to conduct ongoing research beyond the drug’s approval, or else the drug’s approval will be revoked.

Despite all of these conditionally approved drugs requiring the conduction of post-marketing studies, the GAO found only 52% of these drugs actually have adequately completed them. 18% haven’t even started, 7% were still ongoing, and 2% were delayed. The remaining 21% were either not yet reviewed or found no longer necessary.

The GAO also noted the FDA’s inability to provide accurate record keeping of post-marketing research. Additionally, the GAO found that no drug approved under the surrogate-endpoint system has ever been unapproved, despite a large number of delinquent manufacturers.

This is not the first time the FDA has come under fire from the GAO. In 2006, the GAO chastised the FDA for its lack of a clear oversight process, and inability to quickly evaluate post-marketing data. Clearly, the FDA has a responsibility to demand post-marketing studies be completed and submitted to prove a drug’s long-term safety and efficacy

Originally posted at InjuryBoard by C. Todd Alley

The FDA Must Improve Communication to Patients

C. Todd Alley — Thu, 29 Oct 2009 15:36:27 GMT

The American Recovery and Reinvestment Act allocated $1.1 billion dollars to coordinate research and guide investments in comparative research funded by the Act. Some critics suggest that a whole lot of money could have been saved just by looking to the FDA.

Dr. Lisa Schwartz and Dr. Steven Woloshin have co-authored a New England Journal of Medicine article titled Lost in Transmission – FDA Drug Information That Never Reaches Clinicians, in which they talk about the fallacies of the current system, and possible ways to correct it. Primarily, on the journey from clinical trials to FDA approval to the production of a drug label, potentially vital information is lost. For example, the FDA approved the drug Rozerem in 2005 to treat chronic insomnia, but in one phase 3 clinical trial, the drug failed to provide any benefit at all for this condition. In fact, a memo created by the FDA’s own medical review team debated whether to even approve the drug since the insignificant benefits provided by the drug may be outweighed by its potential side effects, but Rozerem was eventually approved. Obviously, knowing this background information would certainly appear to have an effect on a doctor’s enthusiasm to prescribe the drug, and a patient’s willingness to take the drug. Unfortunately, though, this type of important information is not placed on the FDA’s approved drug label, so none of it is clearly communicated to the public.

To its credit, the FDA has issued new guidelines about drug labeling, such as including phase 3 trial results and other effectiveness data, but this information is not mandated as it should be. In the case of Rozerem, the effectiveness data is still absent even after the label was updated. Bottom line - more needs to be done.

The FDA is currently undergoing a pilot test of a “drug fact boxes” which would include a succinct table of effectiveness data such as reviews and labels. This would give doctors more pertinent information about drugs and also allow patients to make a more educated decision before they take a new medication. The FDA is still debating internally how to use these “drug fact boxes.”

There are other potential alternatives, but the authors concisely (and correctly) conclude, “Whatever approach the agency adopts, it needs a better way ofcommunicating drug information to clinicians. We don’t needto wait for new comparative-effectiveness results in order toimprove practice. We need to better disseminate what is alreadyknown.”

Originally posted at InjuryBoard by C. Todd Alley

Injectable Pain Drug Recall Expanded

Joe Saunders — Fri, 23 Oct 2009 11:40:58 GMT

The manufacturer of an injectable pain medicine is expanding its recall due to possible contamination. The recalled drug Ketorolac Tromethamine Injection USP 30 mg/ml, is used to treat moderate to severe pain. The contamination may cause blockage in blood vessels which can lead to pulmonary emboli or thrombosis. The drug had been distributed nationwide to wholesalers and hospitals, surgical centers, and pharmacies have been notified of the product recall.

Originally posted at InjuryBoard by Joe Saunders

Pfizer Pleads Guilty to Criminally Illegal Marketing

Don Greiwe — Mon, 21 Sep 2009 09:42:52 GMT

Earlier this month, drug giant Pfizer agreed to pay a $2.3 billion penalty to settle claims over payment of kickbacks and illegal drug marketing and promotion that violated federal drug laws over an extensive period of time. The $2.3 billion settlement is the largest health care fine in U.S. history. As part of the settlement, Pfizer will pay a $1.2 billion criminal fine, a $105 criminal forfeiture, and pay another $1 billion to Medicaid, Medicare, and other federal healthcare programs. The government said the Pfizer promoted four prescription drugs, including the pain killer Bextra, Geodon (anti-psychotic), Zyvox (an anti-biotic) and Lyrica (an anti-epileptic), as treatments for medical conditions different than those the drugs had been approved for by the FDA.

While it’s not uncommon for doctors to prescribe drugs for off-label medical conditions, drug manufacturers are strictly prohibited from marketing drugs for uses that have not been approved by the Food and Drug Administration. According to federal authorities, Pfizer encouraged its agents to wine and dine doctors in order to encourage prescribing the four drugs for off-label medical conditions. Pfizer officials even went so far as to create phony doctor requests for medical information in order to send unsolicited information to doctors about unapproved uses and dosages.

"Combating health care fraud is one of this administration's top priorities," Assistant Attorney General Thomas Perelli said in announcing the settlement. Perelli added the settlement illustrates ways the department "can help the American public at a time when budgets are tight and health care costs are rising."

The fraud and illegal conduct by Pfizer jeopardizes public health, corrupts medical decisions by health care providers, and wastes billions of government dollars. This massive settlement is just an example of how far the government is willing to go to combat this egregious behavior and corporate greed. Hopefully, it will serve to deter other pharmaceutical companies from similar practices.

Originally posted at InjuryBoard by Don Greiwe

Free Drug Samples: Does it Really Benefit a Patient?

C. Todd Alley — Tue, 08 Sep 2009 14:40:59 GMT

A problem we have come across time and again in our personal injury practice is that drug samples handed out by medical providers are often not well-documented (if even documented at all) in our clients’ medical charts. This can especially be problematic if there is a drug recall and the patient cannot be notified, or if the client suffers a drug-related injury and cannot document how many pills, including the dosage information and lot numbers, or for how long the medication was ingested. In the May 2009 issue of PLoS Medicine (Public Library of Science), an article entitled “No More Free Drug Samples?” raises some valid questions and concerns regarding the practice of drug sampling by physicians:

Drug samples don’t help the poor – According to the authors, studies show that less than one-third of drug samples handed out by physicians are to the poor, while the highest income category patients are the most likely to receive samples. Additionally, low-income patients without insurance were less likely to receive samples as opposed to patients with health insurance. According to research published last year in the February 2008 issue of the American Journal of Public Health, only 28 percent of those who got samples were poor, whether insured or not.

Samples serve as marketing, not charity – Pharmaceutical companies spend a considerable portion of their advertising budgets on marketing and distributing samples to doctors. Numerous studies have shown that samples have a major influence on the prescribing habits of physicians. In one study, doctors with access to samples were more likely to prescribe those drugs instead of an over-the-counter alternative.

Samples lead to a negative quality of care – There are many valid reasons the authors give as to why samples actually decrease the quality of care. Since most samples are for expensive, new drugs (and not generics), samples make it easier to ignore cheaper generic options that could be saving patients and the system cash over time. Also, new drugs often lack long-term medical studies confirming safety and efficacy. Perhaps most dangerous, though, is the lack of pharmacy oversight. Pharmacists are trained to identify potentially harmful drug interactions, intercept medication errors, and offer more detailed instructions and warnings to patients. A sample given by the doctor, in contrast, does not have any oversight by a pharmacist. This could lead to dangerous medication errors or interactions.

Samples lead to increased healthcare costs – health care costs increase because of samples, for both the patient receiving them and the industry as a whole. Samples create an even more competitive prescription drug market, as manufacturers spend an immense amount of money to increase their market share. In turn, these costs are recouped in the ever-increasing drug cost to consumers. Prescription drug costs in the U.S. increased FIVE TIMES from 1990 to 2005. This number is still rising – another article predicts prescription drug costs will increase from $216 billion in 2006, to over $500 billion in 2017.

Obviously, economic times are tough for many people and medical costs are soaring, but there are a number of safety issues in giving drug samples that are troubling. Even if some instructions are given to the patient, there's usually no information about potential interactions with other drugs, much less instructions on how the drug should be taken. The authors instead suggest using a voucher system that would enable a patient to have a prescription filled at a pharmacy without charge. This certainly would help to eliminate some of the problems plaguing the current system like inadequate documentation and lack of pharmaceutical review.

Originally posted at InjuryBoard by C. Todd Alley

Xenical/Alli Under FDA Investigation After Patient Complaints

C. Todd Alley — Thu, 27 Aug 2009 14:07:50 GMT

The FDA has begun investigating a potential link between liver damage and Orlistat (obesity drugs marketed as Xenical and Alli). On Monday, the FDA issued an Early Communication report to alert consumers and medical providers about a potential link between Orlistat and liver damage, particularly weakness or fatigue, fever, jaundice or brown urine.

Xenical is a prescription weight-loss drug marketed by Roche Applied Science. Alli is the popular over-the-counter (OTC) version of Xenical, marketed by GlaxoSmithKline, and is the first OTC weight loss pill to be approved by the FDA. These two drugs work by preventing the intestines from absorbing fatty acids. As a result, fats are not digested and the patient’s bowel movements are disrupted, leading to gas with oily discharge, increased bowel movements, and inability to control bowel movements. These side effects are amplified after eating meals containing large amounts of fat. Effectively, both these drugs work by forcing the patient to switch to a low-fat diet and trim fats, or face the uncomfortable and embarrassing consequences.

At this point, it’s too early to conclusively link Alli or Xenical to liver damage or disease, but the FDA has found enough merit behind these complaints to investigate further. The next step will be to wait for the final FDA investigational report and recommendations. If you or a loved one are taking Xenical or Alli, and have experienced any of the liver-related side effects mentioned, you should report side effects to your medical provider and to the FDA's MedWatch Adverse Event Reporting program.

Originally posted at InjuryBoard by C. Todd Alley

Alli Diet Drug Investigated by FDA for Liver Injury

Joe Saunders — Mon, 24 Aug 2009 22:41:29 GMT

Alli, the over-the-counter weight loss drug manufactured by GlaxoSmithKline and its prescription counterpart Xenical, manufactured by Roche, are being investigated by the FDA after more than two dozen adverse event reports have associated the drugs with liver injury.

Alli contains half the dose of orlistat than the prescription drug Xenical is designed to block fat absorption in the intestines. Xenical was approved for use in 1999 while Alli appeared on the market in 2007.

Originally posted at InjuryBoard by Joe Saunders

Published Medical Journal Articles Concerning HRT Revealed to Be “Ghostwritten”

Jim Clark — Thu, 20 Aug 2009 08:00:00 GMT

Recently disclosed court documents reveal that Wyeth, the pharmaceutical giant behind hormone replacement medications Premarin and Prempro, has played a “major role” in 26 scientific articles published backing the medications. The articles are being criticized as over-emphasizing the benefits of hormone replacement therapy and downplaying the known risks. Wyeth solicited and paid surrogate non-medical authors to draft the articles and then paid doctors, who were “consensus builders” within the medical community, to sign off as authors in order to create the illusion of a positive general consensus among doctors that the therapy was safe and effective. And for a time, this “ghostwriting” worked. Sales of Wyeth’s HRT drugs soared to $2 billion in 2001.

But, in 2002, a huge ($700 million, 8 year) U.S. government study (Woman's Health Initiative) stopped early when researchers found menopausal patients faced a big increased risk for invasive breast cancer, heart disease, and stroke while on HRT medication. Multiple follow-up studies have been published including one from February of 2009 in the New England Journal of Medicine that support the conclusion that the decline in U.S. breast cancer rates is largely related to the decline in HRT use. Sales have plummeted for HRT medication in light of recent media reports, and prescriptions are down from nearly 70 million in 2001 to less than 15 million in 2008.

Wyeth claims that the practice of hiring surrogate authors who serve as “ghostwriters” and then having doctors sign off on these favorable articles is common practice and a matter of convenience, not deception. Wyeth also claims that the articles are scientifically accurate. Even if convenience is a valid consideration – and even if the numbers in the articles were accurate – that does not mean that the articles were not written in a way favorable to Wyeth (when in fact, they were). Nor did the articles disclose Wyeth’s funding of the article’s production. Effectively – whether or not Wyeth’s ghostwritten articles were truthful in what they did say is irrelevant because it was deceptive in what they did not say.

Our firm has been deeply involved with HRT litigation, and we currently are representing over 100 women injured by HRT medication. In May of 2010, our firm has the first HRT trial scheduled in the State of Florida against Wyeth.

Originally posted at InjuryBoard by Jim Clark

FDA’s Top Medical Device Regulator Steps Down, Another Top Official Under Investigation

C. Todd Alley — Wed, 19 Aug 2009 20:58:49 GMT

As my colleague wrote about in April, the FDA has come under fire from internal dissent over questionable medical device approval. Earlier this month on August 11, Dr. Daniel G. Shultz, the FDA’s Director of the Center for Devices and Radiological Health, announced he is resigning after 15 years on the post. The move comes after a “mutual agreement” with newly appointed FDA Commissioner Margaret Hamburg.

The controversy about Dr. Schultz came to light two years ago when Senator Chuck Grassley (R – Iowa) held hearings over Dr. Schultz’s approval of a nerve stimulation device, an approval that came over the objections of several FDA doctors. Dr. Schultz defended his decision, stating it was based solely on sound scientific data, although critics say he favored the industry over patient health.

Then again in March of this year, Senator Grassley opened an investigation over Dr. Schultz’s approval of a knee-surgery device – Menaflex - manufactured by ReGen Biologics, Inc due to reports of the Wall Street Journal. Dr. Schultz took full control of the process, and again approved a device despite vocal objections by FDA reviewers and doctors. In addition to approving the device, the approval process was even put on the fast track approval route, allowing it to reach the market quicker than normal.

These controversial decisions are not all that will define Dr. Schultz – Dr. Hamburg praised him in a statement, saying he will leave behind a “strong legacy,” but his ethical decisions are in part what has plagued the FDA in recent years. It’s good to see the new commissioner may be taking the steps necessary to preserve the integrity of the FDA.

The departure of Dr. Schultz was made around the same time that the longtime head of the FDA’s Center for Drug Evaluation and Research, Dr. Janet Woodcock, came under investigation after a drug company accused her of having inappropriate close professional ties to a rival drug company. The Inspector General’s Office at the Department of Health and Human Services is now investigating these claims.

Originally posted at InjuryBoard by C. Todd Alley

FDA: They Don't Know What They Don't Know

Joe Saunders — Tue, 21 Jul 2009 18:56:34 GMT

According to the Government Accounting Office, the FDA doesn't have enough data to even make a decision about what it needs to keep consumers safe. While this isn't surprising to those of us who've followed the FDA over the years, it should be alarming to Congress and consumers who depend on the federal agency for regulation and safety of such issues pharmaceutical drugs and medical devices.

To be fair to the FDA, the agency has been underfunded for quite some time. This is most likely not a matter of incompetency. Rather, it's a lack of funding. The FDA has been stretched beyond its fiscal ability to cover the areas in which the federal government has expected it to cover.

On the positive side, at least we know they don't know. That's a plus.

Originally posted at InjuryBoard by Joe Saunders