Sen. Arlen Spector Sharply Criticizes the FDA

Senator Arlen Spector has sharply criticized the FDA for failing to ask for more funding beyond that which was requested by President Bush in this year’s budget.  Apparently, the FDA was hesitant to reveal their true financial needs because of an administrative rule that forbids any public disagreement with the budget.  As a result, the FDA has become ineffective at policing food and drug supplies– as shown by the recent influx of tainted heparin, dog food, salmonella tomatoes, and lead paint toys.

Sadly, after months of public outrage regarding the failures listed above, FDA officials finally began to drop hints concerning their true financial needs.   They further attempted to thwart the public outrage by blaming Congress for their dragging their feet regarding their untimely $275 Million request.  This week, representatives of the FDA told reporters that they “would like to once again strongly urge Congress to act quickly to enhance the safety of food and medical products.”

However, correcting the record regarding the FDA’s own failure to act was Senator Arlen Spector, who hand wrote a letter to HHS Secretary Michael Levitt stating, “I am really surprised by your comment quoted in the NY Times today urging Congress to act quickly when the Administration is drastically hindering NECESSARY IMMEDIATE RELIEF by delaying the funding for 8-9 months.  The FDA NEEDS this money now to save lives.”

I’m glad Sen. Spector publically exposed the FDA’s inefficiency as an agency designed to protect the American public from dangerous food and drugs.  If they can’t handle making budget requests or making sure that they have the necessary capital to operate effectively, then its clear they can not be trusted with our health and safety.  We can only hope that this open criticism from Sen. Spector will put the pressure on the FDA to shape up and take their job of policing imports and dangerous products seriously.

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Medical Malpractice

Your Opinions on the Recent Trasylol and Heparin Recalls

I wanted to highlight a comment posted by one of our readers over at My Fox Philly regarding our recent post, “Lessons Learned From Vioxx: Why Trasylol and Heparin Victims Must File Suit To Ensure Honest Marketing and Safer Drug Products. I believe this comment reflects most of the feedback that we have gotten concerning the recent drug recalls and the questionable inspection standards of the FDA. The comment is as follows:

“I”m not a fan of trial lawyers, but when it comes to the FDA and drug companies, you go for it! Clindamycin is another dangerous antibiotic drug in which the FDA and drug companies know there are serious and potential side effects, yet they will do nothing about it. And those who have suffered are often no longer in any condition to be able to sue or to afford to sue. It”s pretty odd that nurses would all know as common knowledge the risks of prescribing this drug and see the potential results first-hand. But the FDA, doctors, drug companies and pharmacies are in denial. And the side affects are most often not reversible. Same with Lipitor. Many have no problem. But those that do find that once they experience side effects, they are irreversible, even if they stop taking the drug, which again doctors, drug companies, pharmacies and the FDA will deny! It”s a racket. I know they do lots of good, but they”ve created an over-drugged and unnecessarily drugged society in which many times the cure is worse than the disease itself they are trying to treat.” – Stever2258

I find this comment to be such an honest and genuine assessment of the drug crisis happening in our nation. This is more than a “get rich quick scheme” by “sue happy people and lawyers“. The real “get rich quick scheme” is an invention of the multi-billion dollar drug companies who produce a questionable product, offer incentives to doctors to market the drug and issue a recall as soon as people start dying. So remember, the next time drug companies post record high profits from drug sales, real people are suffering irreversible and permanent injuries at their expense.

So thank you to our readers for sharing your comments. Hopefully trial lawyers and consumers can work together to put an end to this problem in the near future.

Free Legal Advice: Mininno Law Office

Lessons Learned From Vioxx: Why Trasylol and Heparin Victims Must File Suit To Ensure Honest Marketing and Safer Drug Products

Byron Richards from has written a very interesting post entitled, “Vioxx Shocker-Merck Wrote Many Of the Published Studies.” Needless to say, he had me at hello on this one. After a few weeks of researching the cover-ups and shoddy scientific testing of dangerous drugs such as Heparin and Trasylol, this post solidified in my mind why it is so important for victims of these drugs to come forward and file suit.

Richards reports:

The lawsuits over Vioxx have forced very uncomfortable documents into public view, exposing that Big Pharma has massively corrupted the scientific database with what amounts to promo pieces written by its own employees who then pay for prestigious doctors to attach their names to the studies as if they are legitimate – hiding the fact the drug companies wrote their own studies and conclusions in the first place.

The interesting thing about this post is that Richards is not a lawyer. He is an unbiased author writing on medical wellness. Yet he clearly sees the link between Vioxx lawsuits and the exposure of documents that clearly show the corruption behind the marketing of dangerous drug products. Sadly, without the constant probing from lawyers and the courts, who knows what other incriminating studies actually exist regarding popular prescription drugs.

And while its already too late for the thousands of people that have died from dangerous drugs such as Vioxx, Trasylol and now Heparin, it”s not too late to demand better scientific research and honest marketing procedures by holding these companies accountable via the court system. Admittedly, litigation is not fun. It”s often a long and emotional process for families and attorneys alike. But it”s the only solution. As I noted in my previous post on the Trasylol recalls, Congress will not get involved unless it is in their best interest to do so. Right now it”s in their best interest to let shady testing and marketing procedures continue because the “donations” from drug companies keep them in office. So if we can’t count on Washington, we have to go right to the source and demand more from these pharmaceutical giants by filing suit and making it financially impractical to continue doing business this way.

Unfortunately, what these companies do not realize is that when safety is put first, the profits will come. Look at Volvo. Their cars are ugly, they are expensive but they are known to be safe. And because of their clear desire to protect people, they are tremendously successful. Pharmaceutical companies may have to spend a bit more at the onset of a drug launch for better testing, etc., but the profits will be huge because Americans will put their trust behind the product. So if there are any Big Pharma executives reading this post, consider a consumer friendly way of doing business before the public forces you out of the market via lawsuits and bad press.

Free Legal Advice: Medical Malpractice

Profit Before Health: Bayer Hid Information From FDA About Deadly Drug Trasylol

“Good medicine demands that you protect the patient. That”s the issue here, and not the drug, and not the profit margin,” stated Dr. Dennis Mangano, the San Fransico doctor who conducted the largest study to date concerning the dangers of the anti-bleeding drug Trasylol. Dr. Mangano offered these comments during a scathing report featured on 60 Minutes which revealed that Trasylol”s manufacturer, Bayer, hid studies from the FDA which showed a clear link between the drug and heart and kidney failure. Other doctors interviewed by CBS suggest that Bayer was aware of dangerous side effects from Trasylol as early as the 1980″s.

Trasylol is an anti-bleeding drug that is given to approximately 1/3 of patients undergoing heart surgery. Trasylol was heavily marketed by Bayer and was projected to be the next billion-dollar drug in 2008. Fortunately, Dr. Mangano”s efforts set into motion a chain of events that would eventually put a stop to Bayer”s ability to profit (and profit a lot) from other”s misfortunes.

After following 5,065 patients in 17 countries, Dr. Mangano found that patients given Trasylol were more likely to experience death and kidney failure after heart surgery. This study was then published in the New England Journal of Medicine, which prompted other doctors to speak out regarding the deadly drug. According to Dr. Juergen Fischer, director of the Institute of Experimental Medicine at the University of Cologne, Bayer was not interested in his results from studies conducted in the 1980″s that showed severe kidney damage in animals given Trasylol. Dr. Nicholas Kouchoukos also received the cold shoulder from the pharmaceutical company for his human study in 1992 that showed that patients given Trasylol were more likely to experience kidney failure after surgery.

Kouchoukos called this study a “red flag”, but explained that safety studies are generally not taken seriously until they involve thousands of participants. Since Bayer did not conduct a large-scale investigation of the drug following these complaints, the proof was not available to pull the drug from the market. Consequently the FDA approved Trasylol in 1993–noting kidney problems as a potential side effect from the drug.

Thankfully, Dr. Mangano”s 5,065 patient study in 2005 was sufficient to finally catch the FDA”s attention. The FDA scheduled a meeting with Bayer executives to discuss the issue eight months after the report was issued. As a result, Bayer went on the defense and set out to conduct a study of it”s own to dispute Dr. Mangano”s study. Their plan backfired. Bayer”s study confirmed Dr. Mangano”s findings that Trasylol may have been responsible for thousands of deaths and serious injuries in the United States.

What Bayer decided to do with this information next, in my opinion, proves the company”s clear disregard for patient safety. Bayer hid their study from the FDA. They acted as though it never took place. It wasn”t until a whistleblower from Bayer contacted the FDA regarding the proven dangers of Trasylol that the true findings from the report were made public. Following this disclosure, Canadian researchers attempted to perform their own Trasylol study, but had to stop because too many people were dying.

So what are the consequences of Bayer”s lack of scientific testing and honesty regarding Trasylol? According to Dr. Mangano, “Between my study and November 5, when it was taken off the market, there were approximately 431,000 patients who received the drug. As I calculated, 22,000 lives could have been saved. It”s about a 1,000 lives saved per month delay in taking that drug off the market.”

Sad. And while the story reads like a bad novel, real people”s lives have been ruined by this drug. Loved ones have died or were forced to go on dialysis after otherwise routine procedures. Livelihoods were stolen as injured patients struggle just to pay the bills with their meager disability check. Ironically, Bayer walks away with millions of dollars and no consequences from the FDA. And I can almost guarantee that the politicians in Washington will turn a blind eye as well. After all, they need a paycheck too and who do you think funds the campaign that allows them to stay in office? The pharmaceutical companies of course. What politician in his right mind would bite the hand that feeds him?

Clearly, the only remedy for patients that have experienced side effects from Trasylol is to file a lawsuit against Bayer. It”s more than just money-it”s the only way to change the system. Complaints to the FDA do not work. Letters to Washington do not work. Pharmaceutical sales are big business driven by the desire for profit at any cost. To change the system, the American people have to take what matters the most from these companies-their profit. When they finally realize that they will have to pay for hurting people, maybe they will invest some of their billions into better scientific testing and personnel to handle investigations before drugs like Trasylol, Vioxx and now Heparin take the lives of trusting people who depend on this medicine to make them better, not worse.

Alternatively, if you or a loved one may have suffered a serious reaction to Trasylol, a lawyer in our New Jersey or Philadelphia office can help answer any questions you may have. For further information on Trasylol or Trasylol side effects, click on the links below:

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