Las Vegas Personal Injury Lawyer - Defective Drugs

Advice on Avoiding Bad Prescription Drugs

Stewart White — Sat, 16 Feb 2008 16:16:24 GMT

After a few years in this business of representing patients/clients who have been injured by defective drugs, it appears that:
1. The FDA doesn't protect consumers, though it might try
2. All should know that the FDA doesn't test drugs
3. The drug companies are in it for profit first, helping people second (no surprise)
4. You shouldn't take any new drug until it has been out on the market for at least 5 years, being tested on others.

1. The FDA does try to protect the consumer, but there's just too much money (from the Drug companies) against it. There are just not enough employees there to catch all the bad drugs, and to catch all the lies the drug companies constantly tell them, and certainly not enough brave employees at the FDA willing to tell the truth if it is against the best interest of the drug companies. There are some, but not enough.

2. Most people think that a particular drug wouldn't be out there, being advertised and prescribed by doctors, if it had not been tested and found to be safe by the FDA. People think the FDA tests drugs. The FDA doesn't test any drug at all. The current system has the drug companies doing all the testing on the new drug before it is submitted to the FDA for approval. So, we have to "trust" the drug companies to tell the truth. Fat chance. There have been instances, as with Vioxx, where the companies "fudged" on the test data they submitted to the FDA, to make the drug appear safer than it really was. In fact, a major scientific journal roundly criticized the makers of Vioxx for misleading the FDA in the approval process. The current system has the fox watching the henhouse.

3. Profit is good. All of us love profit. It is part of the American way, and capitalism is what makes this such a great country. But, the drug companies are obviously in it far more for profit than they are in it for the best interests of the patients. It seems to have become much worse now that they allow all that advertising for drugs on t.v. and magazines, etc. When the profit motive overcomes the need to make safe drugs, it's the customers that pay.
The drug companies think of it as just a cost of doing business. This is how they think: We'll make a drug, with some bad side effects (heck, ALL drugs have side effects), not warn of the side effects or water the warning down so much that no one will notice it, and make a lot of money. We'll make $10Billion dollars over 5 years until the dangers make us withdraw it from the market. Then, when we get sued and have to give back $4Billion of those dollars to all the people whose lives we've ruined, we are still ahead by $6Billion. AND, we can yell about needing "tort reform" and "evil personal injury attorneys" costing us so much money we'd otherwise spend on research, to boot. Good deal."
Some of you may have read in the paper about the latest assault on the FDA and drug safety. The drug companies now are trying to get the FDA to allow them to sell doctors on "off label" uses of existing drugs. This "off label use" is using a drug approved by the FDA for only one thing, like arthritis, to treat something else entirely, like migraines. This is just amazing. In fact, since right now the FDA doesn't allow this, drug companies have to do more tests on their drug to ensure it is safe for another not-yet-approved use. And, it is often in this "more testing" phase that the drug companies confirm already known dangers of thier drug that they've been withholding from the FDA and the public. That was what happened with Vioxx. Merck was testing it for another use besides for arthritis. Merck wanted to see if it also reduced colon polyps (precursors to colon cancer) as they believed, so they could market it for that too, as an "on label" use. Merck instead confirmed in that test very clearly what they already knew, that Vioxx caused many more heart attacks than the comparison drug. This caused Merck finally to voluntarily withdraw Vioxx from the market. Now, the proposal is to let them market the drugs for "off label" use without prior approval of the FDA. Amazing what they will do to earn even more profit at the expense of their customers.

4. I think the best thing to do to protect yourself and your loved ones from defective drugs is this: Don't take any drug that has not been on the market for at least 5 years. The next time your doctor prescribes you a drug (even if you've taken it before), ask him how long it has been on the market. If it hasn't been on the market for 5 years, ask him to prescribe you another, older drug. If he doesn't know, before you fill the prescription, google the drug and find out when it came on the market. It seems like it takes about 5 years of testing on 100's of thousands of people before the real side effects (that the company generally already knew about but withheld or downplayed) become widely known. That was the case with Vioxx, and with Viagra, and with some others I cannot remember right now. Let someone else be the guinea pig, not you. Of course, there are drugs that have been out for over 5 years that are still later found defective (like Hormone Replacement Therapy, or phenylpropanolamine), but at least the 5 year rule would cover most of the defective drugs.

Thanks, Stewart White, Reno, NV office of White Meany & Wetherall.

Originally posted at InjuryBoard by Stewart White

FDA Not Too Underfunded to Screw Consumers

Peter Wetherall — Tue, 04 Dec 2007 05:05:32 GMT

Yesterday, I commented on the FDA's difficulties in meeting its mandate as described in the FDA Report on Science and Technology published on December 3, 2007, by the FDA Science Board Advisory Committee. Despite the severe limitations on the FDA's abilities set forth in that report, the FDA is forging ahead with proposed "Guidance for Industry" which would allow drug companies to distribute "off-label" use studies to physicians,

Which begs the question: Given the present functional impairments of the FDA as described by the FDA itself, why is the one action the FDA is apparently capable of making a plus for big pharma, and a slap in the face to consumers? Encouraging off-label use is one sure way to provoke the over-prescribing of a drug, and also encourages drug sales representatives to exaggerate the risk-benefit profile of the drugs they're selling in conversations with doctors. The result will certainly be that persons will be injured who would never have used a drug except for this encouragement of its off-label use.

Forgive my cynicism, but when I see the FDA acting as an arm of big pharma in its words and deeds, it just reinforces what I already believe - the FDA is no more capable of protecting us than the drug companies themselves, and we all know how much big pharma cares. They remind us in their shiny, happy ads played incessantly throughout the nightly news.

Originally posted at InjuryBoard by Peter Wetherall

FDA's Pursuit of Drug Safety an Underfunded Farce

Peter Wetherall — Tue, 04 Dec 2007 04:33:27 GMT

http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html
http://www.fda.gov/ohrms/dockets/ac/07/briefing/2007-4329b_02_00_index.html

According to an FDA Report on Science and Technology published on December 3, 2007, the FDA is essentially not able to fulfill its mandate of assuring the safety of drugs. This isn't the "greedy" plaintiffs' lawyers talking - it's an internal self-assessment by the FDA itself.

The Report contains these major findings of the subcommittee:

1.2.1 The FDA cannot fulfill its mission because its scientific base
has eroded and its scientific organizational structure is weak.
1.2.2 The FDA cannot fulfill its mission because its scientific
workforce does not have sufficient capacity and capability.
1.2.3 The FDA cannot fulfill its mission because its information
technology (IT) infrastructure is inadequate.

The Report goes on to include in its Summary Statement:

In contrast to previous reviews that warned crises would arise if
funding issues were not addressed, recent events and our findings
indicate that some of those crises are now realities and American lives
are at risk.

I suppose this dire appraisal could just be a cry for help of a type politicians and bureaucrats use to justify more funding, but even by political standards, this Report is scary. Clearly, all is not well at the FDA, and to the extent anyone out there still clings to the notion that we're being meaningfully protected from many drug companies' reckless quest for profits, this Report should shatter that illusion.

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Peter Wetherall

Vioxx settlement and the client's money decision

Stewart White — Mon, 19 Nov 2007 17:02:51 GMT

Consideration of the Vioxx settlement and whether one is going to participate is going to take at least a 3-4 weeks. There are many questions still to answer before an attorney can advise his or her clients if the Settlement is best for him or her.

The Settlement Agreement is set up so that each individual's case is assessed separately. That is fair. A young person (in 40's say) with few risk factors having a serious heart attack probably should get more money for an injury like that than an older person (in their 70's say) that had several other risk factors that could cause a heart attack and who had a minor heart attack (if ANY heart attack can be called "minor").
But, what my Vioxx clients really want to know is: "How much will I get if I participate in the Settlement?" Completely understandable, that, and don't think attorneys don't ask the same thing. But, the answer is hard to say, instantly. In fact, the official settlement documents do include a "calculator" that allows a person to try to calculate his or her potential recovery "points." However, the calculator requires a person to fill in just a myriad of information, first to set out the starting # of points (more severe heart attacks and strokes start with more points), and then to set out reductions to the # of points (for risk factors, such as controlled hypertension, prior heart attack before starting on Vioxx and having a heart attack, prior migraine headaches before starting Vioxx and having a stroke, etc., etc.).
It seems to me that the attorney, if he's going to give the client the most information possible, must review all the client's medical records he's collected, and, for each client, figure out the # of points, as above, for each client. If it is possible to do for a client, we should try our best to do it, to give him or her the best guidance we can.
But, then, all you have is the # of points the client ended up with, say 280 points after all the additions and deductions. We won't know what a point is worth, completely, until every participating person who is in the settlement is "scored", when you can finally take the # of total points for all people in the settlement and divide that total into $4Billion for heart attacks and $850 Million for strokes. All you can do, before that, is estimate.
The good attorneys who worked out this settlement have, in a fairly complicated process, tried to estimate now the number of claimants that will make it thru all the many hoops of this settlement and get points calculated, and have also tried to estimate the total # of ultimate points. Thus, if a point is worth $1000, 280 points is worth $280,000; if it's worth $1500 per point, then the 280 points is worth $420,000. It's not likely that a point will be worth over $2000.
So, what we will be trying to do for our clients is run each of them thru the calculator and give each client a very conservative estimate of the # of points each will get, and then some conservative estimates of what each point will be worth. At this point, which is very early on in the process, that seems like the most reasonable thing to do to help our clients decide whether they want to participate in the settlement.
So, the settlement truly does look good, and that's a LOT of money, but there is still a lot of work to do. White Meany & Wetherall has sucessfully participated in many of these types of settlements, and we know, and hope our many Vioxx clients know, that there is a long road ahead before any payments will be made here. Stewart White

For more information on this subject, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Stewart White

Reports of Adverse Drug Effects Have Doubled Over the Last Decade

Chrissie Cole — Wed, 26 Sep 2007 15:25:33 GMT

Adverse drug effects reported to the FDA over the last decade have more than doubled, according to a new study. Deaths associated with adverse effects have also more than doubled.

"A change of this magnitude ought to be cause for alarm," says Thomas J. Moore, senior scientist, drug safety and policy, for the Institute for Safe Medication Practices in Huntingdon Valley, Pa., and the lead author of the study.

Moore and his colleagues analyzed serious adverse drug events voluntarily reported to the FDA though the Adverse Events Reporting System (AERS), known as the "MedWatch" reports, from 1998 to 2005. A serious adverse drug event is defined as one that results in death, a birth defect, disability, hospitalization, was life-threatening, or needed intervention to avoid harm.

The most common drugs found to be associated with adverse side effects include insulin, Tylenol (over-the-counter pain reliever), Paxil (anti-depressant) and Celebrex (anti-inflammatory) along with the painkiller Fentanyl.

The new study was published in the September 10, 2007 issue of the Archives of Internal Medicine.

In total, 467,809 serious events were reported during 1998 to 2005. However, annually the numbers increased 2.6 from the years 1008 to 2005. In 1998, 34,996 adverse events were reported but by 2005, the number had increased to 89,842.

Adverse drug event fatalities increased from 5,510 to 15,107 - a 2.7 increase.

View the list of drugs identified in fatal events.

For more information on this topic, please refer to our section on FDA Drugs.

Originally posted at InjuryBoard by Chrissie Cole

Fentora Painkiller Tied to Deaths

Chrissie Cole — Fri, 14 Sep 2007 06:34:33 GMT

Four fatalities have been linked to the recently approved drug, Fentora, a powerful painkiller intended for cancer pain, according to Cephalon Inc., the drug manufacturer Thursday.

It appears all four deaths are the result of improper use of the drug, Fentora, manufacturer Cephalon Inc. said.

The drug was approved in September by the FDA for use by cancer patients. Fentora contains fentanyl, a drug similar to morphine, but much stronger and highly addictive. The FDA classifies Fentanyl as a Schedule II substance, which puts the drug in the same category as cocaine.

Cephalon said Fentora has been linked to a total of four deaths. The company said three of those, which appeared to result from respiratory failure, were related to inappropriate prescribing of Fentora. Two of the patients were prescribed the potent drug for headaches even though they weren't on round-the-clock opiate therapy, the company said. The company said it also received a report of a fourth death, a person who committed suicide while taking the drug but wasn't prescribed the drug by a doctor.

Doctors are permitted to prescribe drugs as they deem fit, including off-label use. However, off-label marketing by the drug manufacturer is illegal.

The FDA is closely monitoring the issue and working with the company to assure the safest use of Fentora. At this time the FDA has not addressed who is at fault for the deaths.

Originally posted at InjuryBoard by Chrissie Cole

Avandia Recall Information

Chrissie Cole — Mon, 28 May 2007 23:45:11 GMT

The Food and Drug Administration (FDA) is aware of a safety issue regarding the drug rosiglitazone maleate, marketed under the brand name Avandia. The drug is for type 2 diabetes.

Safety data analysis of controlled clinical trials shows a significant increase in the risk of heart attack and heart related health issues and deaths in patients that take Avandia.

Published and unpublished data from long term clinical trials provides a contradictory argument about the risk of heart related health problems in patients taking Avandia.

The FDA's review of data is still ongoing. The FDA is yet to confirm the significance of the reported increase risk of heart risks in context to other such studies.

Originally posted at InjuryBoard by Chrissie Cole

Permax to be Pulled from Market

Christina Cole — Wed, 18 Apr 2007 22:45:27 GMT

Permax, a drug used by thousands of patients that suffer with Parkinson's disease, is being recalled and pulled from the market due to reports of heart valve damage caused by the drug.

The Food and Drug Administration (FDA) says that pergolide, sold under the name Permax, is also available in generic form is being recalled at the agency's request.

An FDA official says other drugs can act as a substitution. He estimates that there are currently 12,025 patients that use the drug. 14 of these patients have needed to have a heart valve replacement, but officials believe that estimate to be higher.

Patients have been advised to not stop taking the drug abruptly, first consult your medical doctor about a medication switch or a gradual reduction for your safety.

Originally posted at InjuryBoard by Christina Cole

Zelnorm Taken Off the Market

Christina Cole — Fri, 30 Mar 2007 22:37:39 GMT

The FDA has issued a public health advisory to notify health care professionals and patients that the sponsor of Zelnorm, Novartis Pharmaceuticals Corporation, agreed to take Zelnorm off the market.

The Zelnorm recall is due to new safety analysis that found a higher chance of heart attack; stroke and chest pain can become a heart attack in patients treated with Zelnorm. Compared to those patients treated with a sugar pill and led to believe it was Zelnorm.

Effective immediately, the FDA announces the following:

â€¢ At FDA's request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.

â€¢ Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.

â€¢ Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.

â€¢ Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

In March 2007, Novartis Pharmaceuticals gave the FDA results of a new analysis that included 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal conditions. The data was combined to assess the chances of side effects on the heart and blood vessels.

In each study, patients were assigned randomly to either Zelnorm or a sugar pill that they "believed" was Zelnorm. The 29 studies included 11, 614 patients treated by Zelnorm and 7, 031 patients treated with a sugar pill.

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.
Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke. Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.

Originally posted at InjuryBoard by Christina Cole

Anemia Drugs Pose Health Risk

Christina Cole — Fri, 09 Mar 2007 14:33:20 GMT

On Friday, the FDA issued a public health advisory to warn patients and care providers that the use of common anemia drugs can increase a risk of death and other serious problems in kidney disease or cancer.

The drugs that are causing concern are Epogen, Aranesp and Procrit, all of which are erythropoiesis-stimulating agents. Genetically engineered, these drugs are versions of a natural protein known as erythropoietin that increases red blood cells.

Recent studies and research show these drugs in higher doses indicate an increased risk of death, blood clots, heart attack and stroke in patients with chronic kidney failure. High doses of these agents promoted tumor growth in the patients that have head and neck cancer.

The FDA wants new boxed warnings to advise doctors to monitor red blood cell counts and to adjust the ESA dose to help maintain the lowest hemoglobin levels need to avoid any need for a blood transfusion.

The safety concerns resulted from earlier ESA studies discussed during a 2004 meeting of the Oncologic Drugs Advisory Committee. Product labeling was previously revised in 1997, 2004, and 2005 to reflect new safety information.
The drugs, Aranesp, Epogen, and Procrit, are approved to treat anemia in patients with chronic kidney failure and in patients with cancer whose anemia is caused by chemotherapy.
Epogen and Procrit are indicated for patients scheduled for major surgery to reduce potential blood transfusions and for the treatment of anemia due to zidovudine therapy in HIV patients.

Originally posted at InjuryBoard by Christina Cole