Roanoke Personal Injury Lawyer - FDA & Prescription Drugs

Medical Journals Don't Want Scrutiny

Dan Frith — Mon, 23 Mar 2009 13:50:18 GMT

I was amazed by an article which appeared in today's Wall Street Journal entitled, "Medical Journal Decries Public Airing of Conflicts." The story is based upon a change in policy by the editors of the Journal of the American Medical Association (JAMA).

It appears the editors don't want any of its members criticizing study authors for failing to disclose they have been paid by drug companies, or others, who sell the products and medications which are the subjects of the reported study. Are you kidding me!

JAMA was criticized last year for its delay in admitting that a study it published on the use of antidepressants in stroke patients was authored by a psychiatrist who failed to disclose his financial relationship with the maker of the drug. That embarrassment brought about the recent policy change when another physician (practicing medicine in the US) became aware of the failure to disclose/conflict of interest and wrote a letter to the British Medical Journal disclosing the fact.

So what does JAMA do? It institutes a new policy requiring any physician who reports a conflict of interest must remain quiet while JAMA investigates the allegations, which may take months and months. What if JAMA never gets around to completing its investigation? What if patients are killed or injured in the interim?

My Take: Sounds like the fox is guarding the hen house!

Originally posted at InjuryBoard by Dan Frith

ORENCIA - the new RA DRUG, WITH FREE CO-PAY?

Lauren Ellerman — Mon, 23 Feb 2009 09:44:29 GMT

I am very sleepy today.For one reason. I stayed up to watch the OSCARS. For an East Coast girl on a Sunday night, this requires dedication.

I cheered for my favorite movies, actors etc - and over the course of the evening, I became obsessed with something not connected to the show... The commercials for Bristol-Myers Squibb's (BMS) new Rheumatoid Arthritis Drug, Orencia (c). The Commercial (which aired many many times) showed a younger woman holding a blue card that said ORENCIA PROMISE PROGRAM. She said that BMS would pay for your co-pay of the medication for 6 months!

SERIOUSLY? Well I am a skeptic, but I looked it up. According to the drug's website www.orencia.com, if you sign up you must have health insurance (not a governmental funded program), must not live in Massachusetts, and must receive a specific number of infusions. If you don't like the medication there is a way you can get a refund or rather $500 toward another medicine.

This new program raises all sorts of questions for me:

1. Are you really signing up to be in a study?
2. Won't your health insurance company put a lien on that $500 since they paid for the drug for many months?
3. Do you have to have a prescription before you can sign up for the "PROMISE" Program?

Well - apparently the answers to the above questions are (1) NO (2) MAYBE and (3) NO!
You can sign up without ever having received a prescription.. Then you go to your doctor and say "Give me this, I have a free co-pay.." Then what if she refuses?

This is where I see a conflict. Patients signing up for medications and pressuring their physicians.

We will see. I would love to hear from anyone on the program or doctors who have been asked to prescribe because of free co-pays.

Originally posted at InjuryBoard by Lauren Ellerman

Lawsuits Protect Consumers! Who Said That?

Dan Frith — Tue, 19 Aug 2008 10:22:08 GMT

Most people would believe that only a trial lawyer would say "lawsuits protect consumers." You know...those greedy trial lawyers who do nothing positive for our society or economy.

But do you know who said lawsuits protect consumers? Doctors...that's right, Doctors!

According to an article in USA Today, lawsuits can serve as "a vital deterrent" and protect consumers if drug companies do not disclose risks to the U.S. Food and Drug Administration before it approves medicines for use, the editors of the New England Journal of Medicine said in a friend-of-the-court brief. The FDA "is in no position" to guarantee drug safety, the brief said.

The case is Wyeth v. Levine, expected to be heard late this year and could have far-reaching implications for litigation over allegedly harmful drugs. Basically, Wyeth argues that it cannot be sued in state court (I say held accountable) for injuries caused by medications it manufactures as long as the FDA has approved the drug.

Poppycock...and the Doctors and anyone else who is honest and unbiased know it!

Originally posted at InjuryBoard by Dan Frith

The FDA and the Wall Street Journal: Dumb and Dumber

Dan Frith — Thu, 14 Aug 2008 10:51:24 GMT

The Wall Street Journal ran an editorial yesterday (August 13) titled, "Devices for Lawyers." The piece was very critical of trial lawyers in America for lobbying Congress to pass the "Medical Safety Device Act," which would overturn the U.S Supreme Court's decision in Riegel v. Medtronic.

The U.S. Supreme Court's decision in Riegel has, and will, do more damage to the rights of Americans than any other case in recent history. You see, the Court held that if the Food and Drug Administration approves a new drug or medical device as safe...then an individual who is injured or killed by such drug or medical device cannot hold the manufacturer of the product responsible in state court. The Court believes the FDA can be the protector of the American public! Right!

Do you remember such FDA fiasco's with the approval of Digitek (digoxin), the Ortho Evra Patch, Fosamax (alendronate), Bextra (valdecoxib)...? All are medicines initially approved by the FDA and then later serious problems arose...even recalls....but how many people were injured or killed in the interim? Should they have a right to hold the manufacturer accountable?

How about the FDA's other fiascos with approval of medical devices like the Medtronic Sprint Fidelis Defibrillator Leads, Sunrise Medical Power Wheelchairs, Baxter Healthcare Infusion Pumps, Guidant Pacemakers, and the list of previously approved then recalled devices goes on and on and on....

So, the Wall Street Journal believes the trial lawyers in America are wrong for lobbying Congress to pass a law to hold manufacturers of previously FDA approved medicines and devices accountable when those medicines and devices prove to be a danger.

That is criticism I can live with.

Originally posted at InjuryBoard by Dan Frith

No Confidence in the Food and Drug Administration

Dan Frith — Tue, 22 Jul 2008 09:33:11 GMT

I've written this post many times before but the FDA does very little to protect the safety and well-being of Americans. I believe most of those working at the FDA have good intentions but they are under-staffed and under-budgeted...you can thank the current White House Administration for this problem.

I recently ran across a blog written by current and former employees of the FDA. It provides some good reading...as long as you don't get queasy easily!

Originally posted at InjuryBoard by Dan Frith

Incest: Big Pharma and the Doctors

Dan Frith — Tue, 10 Jun 2008 13:09:12 GMT

I am no fan of Big Pharma...the pharmaceutical industry in America it out to make money at all costs!

However, some (naive) people believe the Food and Drug Administration and the doctors at teaching hospitals who conduct drug safety studies will protect their interest. Well, if you believe the FDA is doing a good job of protecting Americans then I want to sell you a piece of beach front property in Kansas. So, lets turn to those doctors at renowned medical institutions who conduct their own reviews and studies on new drugs and their relationship with Big Pharma.

The Wall Street Journal reported on June 9 that 3 prominent Harvard psychiatrists underreported payments they received from drug makers.The three doctors reported collective income of "a couple of hundred thousand dollars" over the 7 year period from 2000 to 2007. However, would you believe the real numbers were more like $1 million for one doctor and $1.6 million for each of the other two doctors! Do you think this kind of money might influence these Harvard doctors to push certain drugs over others?

Remember the 1996 Tom Cruise movie, Jerry Maguire, in which Cuba Gooding, Jr. plays a professional athlete and his favorite phrase is "Show me the money."Looks like Big Pharma has been showing the money to these Harvard doctors....and don't think they are alone!

Originally posted at InjuryBoard by Dan Frith

VIOXX ISSUES

Lauren Ellerman — Fri, 30 May 2008 10:13:16 GMT

Please don't think that when a jury awards $13,000,000 to a family in a Vioxx suit, that the defense walks across the Court room with a check! What actually happens in large pharm cases, or any product case, is that the jury award is just the beginning with appeals.

Yesterday, both Texas and New Jersey courts threw out jury awards in Vioxx cases. Why? Well - there are a few reasons. One court held there was not sufficient evidence to support the jury's finding. The other held that Federal law trumped state law - and that under federal law, when a medication is approved by federal regulators at the FDA - punitive damages are not available.

Let this be a reminder - that while our justice system is "independent" and you may have access to a jury of your peers - the legislative branch holds the keys to the kingdom. If federal law says you can't sue because a drug was approved by the FDA.... well, good luck convincing a local judge or jury that federal law shouldn't apply!

Originally posted at InjuryBoard by Lauren Ellerman

Congress finally works for us!

Lauren Ellerman — Thu, 22 May 2008 14:13:59 GMT

Rep. Stupak Nudges FDA Toward Subpoena Power

Now that Rep. Bart Stupak has helped push FDA Chief Andrew von Eschenbach into asking for more money for inspections, the congressman wants to prod the commissioner into asking for something else new: subpoena power. Stupak, the Michigan Democrat who runs the investigations panel of the House Commerce Committee, wrote von Eschenbach last week formally soliciting his opinion on the FDA’s need for subpoena authority. Well, nudging him in that direction seems more like it. Stupak would like to add the enforcement tool to a controversial bill on drug importation pending in the House. The FDA hasn’t had authority to demand certain documents from regulated companies short of going to the Justice Department for help. But the agency hasn’t asked for subpoena power either. That shortcoming has annoyed key Democrats on the House Commerce Committee since at least 2002 because they think the absence of subpoena power has limited the FDA’s inve stigations of drugmakers.”

Alicia Mundy, Wall Street Journal Health Blog, 5-20-08
http://blogs.wsj.com/health/2008/05/20/rep-stupak-nudges-fda-toward-subpoena-power/?mod=WSJBlog

Originally posted at InjuryBoard by Lauren Ellerman

You know better...

Lauren Ellerman — Fri, 09 May 2008 11:58:00 GMT

You know better than your doctor does. No, maybe not about how the liver metabolizes certain substances and other complicated medical issues, but you know better about your own body, and what medicine works, and what doesn't work etc.

Does your new med make you feel drowsy? Upset? Not help as much as the old? Tell your doctor and ask why the change was made. It may be for a good reason like recent FDA studies reflect bad side effects... or it may be because your doctor forgot about your old med, and the pharmaceutical rep for the new one just dropped some samples off.. Either way, be sure to share your thoughts and experience, and ASK WHY the change was made.

Afterall - sometimes you do know better.

Originally posted at InjuryBoard by Lauren Ellerman

Birth Control Patch - Scary?

Lauren Ellerman — Fri, 09 May 2008 07:56:29 GMT

This week a consumer advocacy group petitioned Washington to take birth control patch off the market. Why? Studies show that users have an increased chance of blood clots. a 60% higher chance. Although the FDA has updated the warnings on the box, little else has been done.

So doctors took to the halls of Congress to bring attention to the issue.

It is a good idea to petition the government when studies reflect medication side effects outweight benefits. Afterall, hard for your Senator and the FDA to say they had no idea when it is too late!

Originally posted at InjuryBoard by Lauren Ellerman