The Recall Lawyers

According to the New York Times, Lilly may be paying a $1 billion fine to settle a case related to the marketing of prescription drug Zyprexa. http://www.nytimes.com/2008/01/31/business/31drug.html?_r=2&hp&oref=slogin&oref=slogin

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

Here is a nice article called: The Vytorin Controversy for Dummies from http://blog.wired.com/wiredscience/2008/01/the-vytorin-con.html

By Brandon Keim

What would a new year be without a full-blown pharmaceutical controversy?
Last summer there were black-box warnings for Avandia and Actos, two diabetes drugs associated with heart failure. In the fall came Trasylol, a blood loss drug pulled by Bayer after being linked to an increased risk of death. And now there's Vytorin, a cholesterol-lowering drug that in just weeks has gone from blockbuster to black hole.
The resulting controversy has drawn attention not only to Vytorin, but to the whole class of cholesterol-lowering drugs, to problems in modern drug development and approval, and to potential corruption in the medical community. Caught in the center of this tangle are average people just trying to figure out whether their drugs are safe to take. And with those people in mind, here's the controversy in a nutshell -- and what you ought to do about it.
Hailed as a potential blockbuster by its joint manufacturers, Merck and Schering-Plough, Vytorin was approved by the FDA in 2004. It combined two existing drugs -- one to reduce production of so-called LDL cholesterol, also known as bad cholesterol, and another to reduce absorption. Cutting cholesterol was expected to protect against heart problems heart disease by eliminating arterial fat buildups.
Some cardiologists were wary of Vytorin. The mechanism made sense, but Merck/Schering-Plough hadn't actually done studies on the cardiovascular health of people taking the drug. They'd merely extrapolated from the LDL drops.
Four years and five billion dollars later, the extrapolation seems premature. The ENHANCE study, released last week by Merck/Schering-Plough, showed that people at high genetic risk for heart disease were helped no more by Vytorin than people taking Zocor, one of Vytorin's two ingredients. The generic form of Zocor also happens to be three times cheaper.
Even ENHANCE relied on extrapolation: it measured arterial deposit buildup rather than actual heart problems. But it was enough to suggest that Vytorin might not be everything it was advertised to be. Meanwhile, though the study was released last week, it was completed in April 2006. The near two-year delay prompted accusations of malfeasance. Merck/Schering Plough denied these, but their abandoned attempt to change the the study's endpoints -- the standards by which success or failure would be declared -- had already raised suspicion, as did the trial's inexplicable lack of safety and steering committees.
Merck and Schering-Plough's stock prices plunged. Class-action lawsuits ensued. Michigan Democrats John Dingell and Bart Stupak, leaders of the House Energy and Commerce Committee, announced an investigation into Vytorin's approval by the FDA, along with Merck/Schering-Plough's advertising practices and stock sales. Merck/Schering-Plough yanked its TV ads and took out a series of explanatory print advertisements. The American Heart Association defended Vytorin -- but the AHA receives nearly $2 million and has been criticized for funneling visitors to their websites into the websites of pharmaceutical industry sponsors. Dingell and Stupak expanded their investigation to include the AHA's corporate relationships, and Senator Charles Grassley (R-Iowa) added his own investigation to the mix.
Furor aside, basic questions remain over Vytorin's effectiveness. It's possible that it reduces heart attacks in at-risk people; it's possible that it doesn't. It's possible that the entire class of cholesterol-lowering statin drugs only works in in people who've already had heart problems, or have a family history of same, and won't do anything for those who simply want to lower their risks.
The ENHANCE study wasn't comprehensive, or even designed to measure the drug's ultimate intended outcome -- lower risks of heart disease and death. Critics almost unanimously say that the federal Food and Drug Administration needs to make such studies a condition of drug approval: if a drug is allowed to market, long-term studies should be started immediately, and the studies should measure real endpoints, not so-called surrogate markers like cholesterol (or, in the case of Avandia, blood sugar).
Some say those studies should be conducted before a drug is even approved. But the pharmaceutical industry says those studies are immensely expensive, and being forced to conduct them on drugs that haven't been approved would discourage companies from developing drugs in the first place, and force drug prices up. Their sentiments might be mixed with crocodile tears -- but even industry critics often agree with them. Patient groups might not be so open to delays, either; the use of surrogate markers rather than concrete endpoints has helped lifesaving AIDS drugs get to market far sooner than would otherwise be possible. The human costs of delaying -- perhaps for years -- a beneficial drug's approval need to be part of the equation, too.
So while the FDA grapples with the use of surrogate markers and post-marketing studies, what should people do? I called Arthur Levin, director of the medical watchdog Center for Medical Consumers and a member of numerous FDA safety panels. Levin recommended that would-be users of Vytorin -- or any cholesterol-lowering drug -- take as many natural steps as possible to improve their health: eating well, exercising, not smoking and so on.
Then, when it comes to taking drugs, "You should be asking your doctor broad questions, particularly with newer drugs. If there is an older and better-understood drug, you shouldn't take a drug until it's been around for five to seven years, until we understand it better. You should always ask questions: what are my alternatives? What do you it to achieve, and what's the evidence?"

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

Here is the latest from the FDA on 1/25/08:

On January 14, 2008, Merck/Schering Plough Pharmaceuticals issued a Press Release reporting preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone. Merck/Schering Plough Pharmaceuticals, the company that conducted the trial, stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries despite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin compared to simvastatin. FDA has not received a final study report and at this time it is not clear why the lower levels of LDL cholesterol in the patients who took Vytorin did not lead to lesser amounts of plaque compared to patients treated with simvastatin alone.

ENHANCE was a 2-year, multi-national, randomized, double-blind study conducted in 720 patients with heterozygous familial hypercholesterolemia (HeFH), a condition that is associated with very high cholesterol levels and affects approximately 0.2 percent of the population. Half of the patients were treated with 10 mg of ezetimibe combined with 80 mg of simvastatin and half with 80 mg of simvastatin alone.

An elevated LDL-cholesterol level is an established risk factor for heart disease and many studies have supported the conclusion that lowering cholesterol levels reduces the risk for heart attack and stroke. Ezetimibe inhibits the absorption of cholesterol in the intestine and is approved to lower LDL-cholesterol levels. Simvastatin (Zocor) is a lipid-lowering agent ("statin") approved to reduce LDL and increase high-density lipoprotein (HDL) (good) cholesterol levels and reduce the risk of cardiovascular events such as heart attack and stroke. Vytorin is approved for reducing LDL and increasing HDL cholesterol levels.

There are no clinical studies available that demonstrate a reduction in risk of heart attack or stroke when ezetimibe is used alone or in combination with a statin, including the fixed-dosed combination drug of ezetimibe and simvastatin, Vytorin. While the overall incidence of cardiovascular events in ENHANCE was similar in both the ezetimibe/simvastatin and simvastatin-alone groups, there were not enough patients in this study to reliably test whether treatment with ezetimibe/simvastatin compared with simvastatin alone reduces the risk of cardiovascular events. An ongoing trial known as IMPROVE-IT (Improved Reduction of Outcomes: Vytorin Efficacy International Trial) is examining this question in 12,500 patients and will likely be completed in 2011. Physicians and patients should carefully consider the available data and current labeling for Zetia and Vytorin as they make individual treatment decisions.

This early communication is in keeping with FDA's commitment to inform the public about ongoing postmarketing drug issues. Once Merck/Schering Plough Pharmaceuticals completes the analysis of the unblinded data from ENHANCE, it will submit a final study report to FDA. Once FDA receives the final study report, FDA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA's current approach to drugs that lower LDL cholesterol are warranted.

Patients should talk to their doctors if they have any questions about the information from the ENHANCE trial.

The FDA urges both healthcare professionals and patients to report side effects from the use of ezetimibe to the FDA's MedWatch Adverse Event Reporting program

online at www.fda.gov/medwatch/report.htm; by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787; faxing the form to 1-800-FDA-0178; or by phone at 1-800-332-1088

http://www.fda.gov/cder/drug/early_comm/ezetimibe_simvastatin.htm

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

The makers of the popular cholesterol prescription drugs Vytorin and Zetia are being sued in states across the country over allegations that Merck & Co. and Scherin-Plough Corp. misled consumers into thinking the drugs were more effective than generic ones.

More ... http://www.chron.com/disp/story.mpl/ap/fn/5483825.html

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

It's not easy being a drug company these days. A recent spate of scandals over the safety or effectiveness of medications like Vytorin, Vioxx, Avandia and Ortho Evra, coupled with astronomical drug prices have made Big Pharma an easy target for politicians and consumer advocacy groups. But as many of the drug scandals - especially the most recent one involving Vytorin - illustrate, the drug companies only have themselves to blame. According to The Wall Street Journal, there is a growing field of investigative research being done by physicians that's focused on industry influence and the reliability of medical literature - especially as it applies to drug studies and clinical trials. Catherine DeAngelis, editor in chief of JAMA, the Journal of the American Medical Association, told the Wall Street Journal that there are more articles on the drug industry's role in research coming soon. "I want to show how they manipulate the data and why we have to be so cynical about them".

More ... http://www.newsinferno.com/archives/2437

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

By Bill Haymin January 23, 2008 Shane Ellison M. Sc.

The People's Chemist

NewsWithViews.com As a medicinal chemist, I´m often asked, "How can I live to be a 100 years old?" My answer is simple, "Learn to control blood sugar and insulin."

The biggest threat to longevity is high blood sugar and insulin. Known as type II diabetes - or more accurately insulin resistance - it has become a nationwide epidemic that steals 11 to 20 years from a person´s lifespan. It is one of the main culprits behind depression, obesity, heart disease and even cancer. Understanding two simple facts about the pandemic killer may help you avoid it - and live to be 100 years old rather than 65 or 70!

Fact #1: Anti-Diabetic Drugs like Avandia and Actos are Deadly

To curb the threat, family physicians are madly prescribing Avandia and Actos in hopes of reversing type II diabetes - total sales have reached over $4 billion annually. Unknown to most, Avandia users have a whopping 30-40% increased risk of heart attack and other heart-related adverse events (heart failure) compared to patients treated with placebo.[1] This side-effect is partly due to the drugs ability to lower "hemoglobin."

More ... http://www.americanchronicle.com/articles/50001

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

B. Braun's Supplier Prompts Voluntary Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flush Syringes AM2PAT Inc. manufactures these pre-filled syringes under both its private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical Inc. label

Contact: Stephanie Euler, 908-276-4344 ext. 213 Susan Denby, 610-997-4856

FOR IMMEDIATE RELEASE -- January 18, 2008 -- B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.

Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted. Customers may contact the B. Braun Medical Inc. Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.

Based on ongoing FDA inspection of AM2PAT Inc.'s facility, and CDC investigation it has been determined that there is a potential for the sterility of these affected products to be compromised, which may result in potential contamination. AM2PAT previously initiated a recall of one lot of Sierra Pre-Filled Heparin (lot #070926H) that was found to be contaminated with Serratia marcescens, which may lead to patient infections. CDC has confirmed growth of Serratia marcescens from several unopened syringes of this product in this specific AM2PAT lot. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular Mail: use postage-paid FDA form 3500 available at: www.fda.gov/MedWatch/getforms.htm. Mail to MedWatch 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 1-800-FDA-0178

Posted by Louisville, Kentucky lawyer: Larry Jones

The FDA has issued a public health advisory to alert patients and healthcare professionals about important safety information concerning the drug Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. As a result, FDA is reviewing the benefit/risk profile of Edetate Disodium to determine if the benefits for its intended use continue to outweigh the serious risks. More ... http://www.fda.gov/cder/drug/infopage/edetate_disodium/default.htm

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

The Food and Drug Administration (FDA) has approved additional changes to the Ortho Evra Contraceptive Transdermal (Skin) Patch label to include the results of a new epidemiology study that found that users of the birth control patch were at higher risk of developing serious blood clots, also known as venous thromboembolism (VTE), than women using birth control pills. VTE can lead to pulmonary embolism.

more .... http://www.fda.gov/bbs/topics/NEWS/2008/NEW01781.html

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

A Philadelphia judge has ruled that a $1.5 million jury verdict should be vacated in another hormone replacement therapy case. The breast cancer patient claimed her prescriptions caused her cancer. However, the court held that she failed to prove that her doctors would not have prescribed the hormone therapy drugs if the drugs' warnings were different.

More ... http://www.law.com/jsp/article.jsp?id=1200477947326

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

If you are the parent of a child under two and you are planning to give your child over the counter cough or cold medicines, the FDA says DON'T DO IT!!!! http://www.chicagotribune.com/features/lifestyle/health/chi-fdajan17,1,6495336.story?ctrack=1&cset=true

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

Here is an article from The Record (http://www.madisonrecord.com/news/206363-diabetes-drug-avandia-named-in-federal-court-action) regarding a new Avandia lawsuit.

1/16/2008 2:16 PM By Ann Knef

GlaxoSmithKline (GSK) is being sued in federal court over allegations its diabetes drug Avandia is defective.

Plaintiff Mamie Coleman of St. Louis County claims she suffered a cardiac injury after using Avandia, according to a suit filed Jan. 15 in U.S. District Court for the Southern District of Illinois.

Represented by John Driscoll of Brown & Crouppen in St. Louis, Coleman is seeking damages for personal injuries and economic losses as a result of using Avandia.

She alleges GSK failed to conduct sufficient testing, which if properly performed, would have shown that Avandia had serious side effects, including cardiothrombotic events, cardiac injury and other serious side effects, according to the complaint.

Coleman also claims GSK marketed and promoted Avandia despite knowing there were safer methods and products for diabetes mellitus type 2.

Type 2 diabetes, which occurs when the body fails to properly use insulin, combined with relative insulin deficiency, is the most common type of diabetes, according to the complaint.

"GSK has misrepresented information concerning the safety and efficacy of Avandia for treating diabetes," the complaint states. "For instance, GSK has allowed positive information about Avandia to be disclosed, publicly, but has withheld and concealed negative information concerning the safety and effectiveness of the drug as treatment for diabetic patients. Thus, GSK has prevented physicians and patients, including the Plaintiff and the Plaintiff's physicians, from properly and independently exercising informed judgment."

The complaint also alleges GSK failed to:

# Include adequate warnings that would alert Avandia users to the potential risks and side effects;

# Warn Coleman that use of Avandia carried a risk of death or permanent disability from cardiothrombotic events, cardiac injuries and other serious side effects; and/or

# Advise the Food and Drug Administration, the health care industry, and the public about the adverse reports it had received regarding Avandia.

According to a report in LawyersandSettlements.com last month, there have been approximately 50 state and federal Avandia cases filed across the country.

An Avandia Multi-District Litigation (MDL) has been established in the Eastern District of Pennsylvania, where GSK's U.S. headquarters is located.

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

Here is an article from the American Chronicle:

Diabetes and the Drugs to Control It Could Shorten Your Life By Total Health Breakthroughs January 16, 2008 By Shane Ellison

I'm often asked, "How can I live to be 100 years old?" My answer is simple, "Just say no to prescription drugs and learn how to control insulin and blood sugar."

Why? Because the populations that live the longest are naturally highly sensitive to insulin. Conversely, those who die the youngest from conditions such as obesity, diabetes, heart disease, and even cancer are grossly insensitive to insulin or are taking a prescription drug.

In the US, the biggest threat to longevity is type II diabetes caused by high levels of blood sugar and insulin resistance. It has become a nationwide epidemic that can steal 11 to 20 years from a person's lifespan.

To curb the threat, physicians are madly prescribing anti-diabetic drugs like Avandia and Actos. With so many people using them, scientists have learned two valuable lessons about longevity.

First lesson: You cannot use these drugs to increase lifespan.

In addition to eliciting a moderate drop in blood sugar, anti-diabetic meds damage the cardiovascular system.

According to a recent study, Avandia users had a whopping 30-40% increased risk of heart attack and other heart-related adverse events (heart failure) compared to patients treated with placebo.(1) This risk is due to the drug's effect of lowering vital hemoglobin levels.

Hemoglobin is used by the body to transport oxygen throughout the entire 100,000 miles of veins, arteries, and capillaries in the adult body. Without hemoglobin, a condition known as ischemia sets in. This is a fancy term for "suffocation." Clinically, heart attack or heart failure can be the result.

The prescription drug Actos has the same mechanism of action as Avandia -- they both work to reduce insulin resistance. Not surprisingly, it also carries the same risks. Health Canada sounded the alarm about this class of drugs as early as 2001! But unfortunately, the warning has not yet reached the American public.

Commenting on this unannounced danger, the U.S. Congress stated that, "the FDA's apparently callous disregard for the safety of diabetics taking Avandia is very reminiscent of the Agency's failure to move on Vioxx when substantial safety signals first became known. Like Vioxx, Avandia may have unnecessarily risked the lives of tens of thousands of Americans."(2)

More .... http://www.americanchronicle.com/articles/49101

Posted by Louisville, Kentucky lawyer: Larry Jones

Coalition of Doctors Condemn FDA Decision to Deny Women Access to Bioidentical Hormones.

A coalition of gynecologists, internists, allergists, ER physicians and general practitioners responsible for treating thousands of women today criticized the Food and Drug Administration (FDA) for taking action that threatens to deny hundreds of thousands of women access to customized medications they take for symptoms of menopause. There are no legitimate medical, scientific or legal reasons for the FDA to take this action.

(PRWEB) January 14, 2008 -- A coalition of gynecologists, internists, allergists, ER physicians and general practitioners responsible for treating thousands of women today criticized the Food and Drug Administration (FDA) for taking action that threatens to deny hundreds of thousands of women access to customized medications they take for symptoms of menopause.

The FDA last week announced that the hormone estriol can no longer be used in estrogen medications customized for women by compounding pharmacies. Estriol is a component of 90 percent or more of these customized preparations. The FDA action is in response to a "citizen petition" filed by the giant drug maker Wyeth Pharmaceuticals. Wyeth is the maker of Premarin and Prempro, two hormone treatments for women that have been linked to cancer, heart disease and stroke by a 2002 Women's Health Initiative, National Institute of Health (NIH) study. Millions of women have discontinued taking Wyeth's hormone products as a result of the WHI study, which was halted because of the serious health risks that were discovered in 2002. For more: http://www.prweb.com/releases/BHI/FDA/prweb623221.htm

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

Here is the most recent word from the FDA on Avandia and heart attacks. http://www.fda.gov/cder/drug/InfoSheets/HCP/rosiglitazone200707HCP.htm#2007_5

FDA ALERT #1: 5/21/2007, updated 11/19/2007: This update highlights changes to the prescribing information for rosiglitizone including a new BOXED WARNING and changes to the WARNINGS, PRECAUTIONS, and INDICATIONS sections of the label about the potential increased risk of myocardial ischemia. FDA also has requested that the manufacturer, GlaxoSmithKline, develop a Medication Guide for patients that provides information about the safe use of rosiglitazone. Healthcare professionals should factor this new information into their individual treatment decisions for their patients.

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

The FDA is warning healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

A Nevada state-court jury has ordered Wyeth to pay more than $43 million each to three women who alleged that the company's hormone-replacement drugs caused their breast cancer. http://blogs.wsj.com/law/2007/10/11/hot-flash-1345-prempro-verdict-in-nevada/

Ken Suggs, the former President of ATLA, wrote a column about hormone replacement therapy and its links to breast cancer several years ago. The column is below:

By Ken Suggs*

October is National Breast Cancer Awareness Month. All the pink, looped ribbons you see throughout the year--and especially this month--are out there for a reason: In 2005, an estimated 212,000 new cases of invasive breast cancer and 58,000 cases of non-invasive (non-spreading) breast cancer will be diagnosed. And, this year 40,000 women will likely die from this disease.

There are many factors that contribute to whether a woman will develop breast cancer, such as her age or whether there is a history of the disease in her family. For other women, breast cancer may have been triggered by other causes such as the use of hormone-replacement therapy (HRT) during menopause.

Specifically, these are women who took a combination of manufactured estrogen and progestin in a pill called Prempro. Many women now want to know why the drug manufacturer, Wyeth, did not do a long-term, randomized study to test for cancerous side effects before putting the drug on the market.

"The drug makers knew back in the 1970s that women on estrogen alone had higher risk of uterine cancer," says James Ronca, a Pennsylvania lawyer who represents women in their cases against Wyeth.

Researchers found a way to prevent uterine cancers by giving women estrogen plus progestin, says Ronca, but, when Wyeth combined the two hormones into one pill -- Prempro -- and put it on the market in 1995, the company "never tested the long-term effects to show if the drug combination would also be a risk."

There had been earlier studies that suggested risks and benefits of hormone therapy, but, no long-term study of combination HRT until the Women's Health Initiative (WHI, funded by the National Institutes of Health) started tracking the effects of Prempro in the late 1990s. In July 2002, the study was halted prematurely after researchers noticed that far more women who took Prempro developed breast cancer than the women who took a placebo (inactive pill). The cancers found in women on HRT were "larger and had spread more throughout the body than those in the placebo group," according to the WHI. Overall, there was a 24% increase in the risk for breast cancer due to combination HRT.

"Much less was known about progestin or the estrogen plus progestin combination," said principal WHI investigator Marcia L. Stefanick, Ph.D., at the press conference announcing the study's end. "The bottom line is that none of these earlier studies was able to provide the definitive answers about the overall balance of risks and benefits that we now have in the WHI study."

The study also found that women on combined HRT were more likely to have abnormal mammograms. Of Prempro users, 9.4 percent had an abnormal mammogram after one year, compared with 5.4 percent of women on placebo. Risk of abnormal mammograms went up as Prempro use continued, from about 1 in 25 women after one years use, to about 1 in 10 women after 5.5 years of use.

WHI investigators also determined that combination HRT caused a significant increase in the risk of heart attacks (29%), blood clots (100%), and cardiovascular disease (22%). HRT studies were halted in 2003 in the United Kingdom and in 2004 in Sweden, also due to concerns of increased risk of breast cancer.

The attorneys who represent injured people say they see a repeating pattern, whether its Prempro, Vioxx, Bextra or other products: not enough testing to make sure a drug is safe before it hits the market.

"There should be more emphasis on safety and less emphasis on speed of [drug] approval," says Pennsylvania attorney Michael Monheit. "I have no problem with expediting approval for drugs for cancer and other deadly diseases. Menopause is not a disease."

Monheit would like to see the U.S. Federal Drug Administration (FDA) make some changes so that the approval process is completely separate from the monitoring process. Other wishes on Monheit's and Ronca's list include: drug promotion solely for the FDA's specified and approved use; full disclosure to the public if drug companies provide money to sponsor medical education seminars or studies; and design and approval of all studies by an independent organization. Says Ronca, "Independence is the key when it comes to people's health."

Prempro is still on the market. The FDA has approved lower doses of the drug and now requires all estrogen and estrogen plus progestin products to include "black box" labels to warn of the products' risks that were uncovered in the WHI study.

For more information on National Breast Cancer Awareness Month please see: http://www.nbcam.org/.

For information about the Women's Health Initiative, see http://www.whi.org/.

For HRT information from the FDA, see: http://www.fda.gov/bbs/topics/NEWS/2004/NEW01022.html

Posted by Louisville, Kentucky lawyer: Larry Jones 1-888-KYLAW22

The Federal Food and Drug Administration issued a safety alert about Avandia (rosiglitazone maleate) on May 21, 2007 after a study in the New England Journal of Medicine linked the very popular diabetes drug to a 43% increase in the risk of heart attack and a 64% increase in the risk of death from all cardiovascular causes. Avandia has been one of GlaxoSmithKline's best selling drugs. Over 6 million American consumers have used the drug to treat adult onset, type 2 diabetes.

Avandia's History

The FDA approved Avandia in 1999 for treatment of type 2 diabetes, a serious and life threatening disease that affects about 18 to 20 million Americans. Diabetes is a leading cause of coronary heart disease, blindness, kidney failure and limb amputation. Since the drug was approved by the FDA, it has been monitoring several heart-related adverse events (e.g., fluid retention, edema and congestive heart failure) based on signals seen in previous controlled clinical trials of Avandia. The FDA has updated the product's labeling on several occasions to reflect these new data, most recently in 2006. The most recent labeling change for Avandia also included a new warning about a potential increase in heart attacks and heart-related chest pain in some individuals using Avandia. This new warning was based on the result of a controlled clinical trial in patients with existing congestive heart failure.