Florida Personal Injury Blog - FDA & Prescription Drugs

Wyeth Must Pay for Practicing to Deceive

John Hopkins — Mon, 23 Nov 2009 16:27:38 GMT

Cases involving lawsuits against Wyeth (a division of Pfizer) are going to trial and juries are being permitted to hear all the evidence against Wyeth. The evidence is clear: Wyeth acted in a way that was negligent and at least one juror has characterized Wyeth’s conduct as “despicable”.

Studies now confirm that 200,000 women – our grandmothers, our mothers, our sisters and our wives – would not have suffered breast cancer but for their use of combination hormone therapy drugs.

The evidence has caused two juries to deliver verdicts for combined totals of over 10 million dollars in compensatory damages and over 100 million dollars in punitive damages. In a total of 10 jury trials, jurors have delivered verdicts to plaintiffs of over 30 million dollars in compensatory damages and over 160 million dollars in punitive damages.

Was Wyeth negligent in its placing Prempro on the market? Clearly, the evidence demonstrates and the jury verdicts ratify that Wyeth was negligent.

The evidence of Wyeth’s conduct in these cases is damning. As early as 1975, Wyeth was on notice that combination hormone therapy causes breast cancer. Wyeth did nothing and continued to market the drug and take in huge profits.

Wyeth took steps to try and downplay the risk of these drugs and made efforts to contain data from other institutions, which demonstrated the risk.

Wyeth sponsored a practice of “ghost writing” of medical literature that promoted combination hormone therapy like PremPro. In addition, Wyeth exaggerated the benefits of hormone therapy in these very same “authoritative” articles written by Wyeth employees or agents.

Wyeth failed to conduct further studies of HRT even after the FDA told them in 1983 that human clinical trials were the only way to ascertain the safety of their drug.

The trial of these cases and the verdicts after jury upon jury has heard the evidence is a classic illustration of the justice system as a method for consumer protection when no other system will accomplish it.

Wyeth would not listen to “the truth will set you free” and they now are paying for decades of profits gained “while practicing to deceive”.

Originally posted at InjuryBoard by John Hopkins

Fighting the Good Fight -- Hormone Replacement Therapy Litigation

John Hopkins — Mon, 23 Nov 2009 09:53:49 GMT

They weighed profits against safety and profits won out. Women across the country lost and were forced to suffer with breast cancer. That is the conduct attached to Wyeth for their handling of hormone replacement therapy drugs (HRT).

In 1983, the Food & Drug Administration told Wyeth that human trials were necessary for the safe marketing of HRT medication, PremPro. Wyeth made the conscious decision to refuse doing the trials. Internal documents demonstrate that Wyeth refused to perform additional studies in order to conceal the risks associated with what they knew would be a drug, which would reap huge profits for Wyeth.

www.youtube.com/watch

Women such as Connie Barton and Donna Kendall demonstrated the courage to bring Wyeth into court to answer for their conduct. Jurors who have heard evidence related to Wyeth’s negligence and intentional failures have used terms such as “despicable” and "outrageous conduct” to characterize Wyeth’s behavior.

It was not until Wyeth was forced to admit the dangers of the HRT drugs that they finally took some action. When the study through the Women’s Health Initiative was terminated due to the development of breast cancer by participants, Wyeth’s hand was forced. What did Wyeth do? They “circled the wagons”; continued to deny their fault; and stone-walled women’s claims concerning the danger of their product.

Women such as plaintiffs, Connie Barton and Donna Kendall suffered the loss of their breasts and horrible consequences of cancer treatment because a corporation thought that profit was more important than patient safety.

Originally posted at InjuryBoard by John Hopkins

Making Health Care Easier and More Affordable

Eddie Farah — Tue, 17 Nov 2009 22:22:08 GMT

When you need to access health care in a hurry in Florida, you might not be thinking about cost comparisons like you would with food or toys.

But consider this. Shop for health care like you shop for anything when you want to save money – wisely. The state of Florida is making it a bit easier.

Many uninsured consumers of medical services in Florida may not know that under law they have the right to reliable and understandable information about their health care charges.

As of January 1, 2009, when the “Health Care Consumer’s Right to Information Act” took effect (SB 1488), consumers were entitled to be provided with a reasonable estimate of charges for any planned non emergency medical service from a health care provider.

The estimate is supposed to be written in lay language that anyone can understand, and should represent the average charge for that diagnosis or procedure. And for facilities not operated by the state, the bill requires them to provide the estimate of reasonably anticipated charges within seven days after the center confirms the individual is uninsured.

The law requires the facility to put a notice in the reception area concerning any discounts or charity discounts, under what condition they are available. A failure to do so subjects the facility to a $500 fine.

Also access the information on the state Web site (www.floridahealthfinder.gov) which lists undiscounted charges for no fewer than 150 of the most commonly performed adult and pediatric procedures.

Bottom line - Transparency in costs will help consumers shop more wisely for health care like consumer goods and lead to greater competition and incentive to keep costs down.

As reducing the cost of health care is on everyone’s mind, forcing transparency in the health care industry is one way we can lower our bills and keep everyone honest. #

Originally posted at InjuryBoard by Eddie Farah

Number of Yaz and Yasmin Lawsuits Growing

Eddie Farah — Fri, 13 Nov 2009 19:10:56 GMT

In 2007, Susan Galinis of San Francisco was the happy mother of 3-year-old twins, until doctors put her on the Yaz birth control pill. Four weeks and one day later she suffered a stroke.

Today it’s obvious to see part of her skull has been removed. Doctors had to operate to accommodate the brain swelling following her stroke. Her IQ is 77. She has chronic pain and no short-term memory. Her twins have gone to counselling to deal with the differnt mother who returned from the hospital after six months.

Galinas has sued Bayer HealthCare. Her doctors told her it was Yaz that caused her stroke.

Anne Marie Eakins, 34, a history teacher and mother of two is also suing. She developed blood clots in both lungs in 2007 after starting Yaz. That resulted in partial loss of her right lung.

Yaz is the newest sister to drug, Yasmin, both made by Bayer. Ocella birth control is the generic version that is sold by Teva Pharmaceuticals.

All three oral contraceptives are among the most widely used and involve a combination of ethinyl estradiol with a new type of progestin, drospirenone that has been inked to health problems including strokes, heart attacks, deep vein thrombosis, gallbladder disease, pulmonary embolisms, and death.

Our firm is taking in a number of cases by women who have been hurt by these oral contraceptives which should be taken off the market. With six new cases being filed around the country every day and class action lawsuits being launched around the country, it won't be long before the drug is taken off the market.

Until then, women have to suffer.

The go-to drugs for women under the age of 35 generated sales of about $1.8 billion for Bayer last year. A multi-million dollar ad campaign promises the pill is a quality of life treatment that will improve acne and severe premenstrual depression. Bayer had to spend $20 million correcting those ads after the FDA said the company went well beyond what the drug approval.

Bayer stands behind its oral contraceptives and plans to defend itself vigorously against the rising number of lawsuits filed by lawyers and the women they represent, to hopefully soon bring the marketing of these dangerous oral contraceptives to an end.

Originally posted at InjuryBoard by Eddie Farah

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

FDA Addresses Medical Errors And $4 Billion Pricetag

Eddie Farah — Fri, 06 Nov 2009 13:29:47 GMT

As we look at saving money on health care spending, Americans should consider drugs, specifically the huge cost of medical errors involving prescriptions.

Medication interactions, a mix-up in the pharmacy such as switching out the wrong prescription, an inability read a doctor’s handwriting, all can lead to drug dosage errors which cost us all about $4 billion a year, not to mention lives and injuries.

Now the Food and Drug Administration (FDA) says it is trying to identify the most serious threats to better understand and get a handle on the problem. Consider this- errors with medication happen often - about 1.5 million errors every year according to a two- year-old study by the Institute of Medicine.

A recent Hearst Newspaper group investigation, "Dead By Mistake" profiles many who lost their lives through medication errors.

It so astonishing that even the new FDA commissioner, Margaret Hamburg, who is a doctor, was stunned by the numbers. She announced a new plan called “Safe Use Initiative” by saying it “doesn’t require a new scientific discovery or a budget appropriation.”

In holding public hearing and gathering information from the public about that problem, the FDA would be wise to speak with personal injury attorneys.

Every week we hear of the adverse events that can occur from drugs, even when they are used as directed of prescribed. Consider Tylenol that can cause liver damage when taken in excess, and the devastating outcomes of drugs when they are not.

Public Citizen is onboard with this scrutiny of package labels, and inserts, and instructions given to dispensing pharmacists. Dr. Sidney Wolfe says that about 99.5 percent of pamphlets are missing critical information.

While medication is supposed to make us feel better and perhaps save lives, patients and doctors forget almost every medication eventually has a side effect. The presumption of safety needs to be challenged.

Instead of relying on a “Pill for every Ill” Americans need to remember that “safe medication” is an oxymoron. #

Originally posted at InjuryBoard by Eddie Farah

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

The Drug Business, Broadway, and Casper the Friendly Ghost

John Hopkins — Tue, 27 Oct 2009 09:13:35 GMT

“Ghost writing”: a person who writes books, articles, etc. for another who professes to be the author. Drug companies spend billions of dollars advertising drugs that neither I nor you can go to the store and buy.

Drug companies produce million dollar ad campaigns filled with beautiful fields of flowers; balloons flying around beautiful actors; and very sophisticated, successful, or just plain fun people who take the drug du jour, much to the better fulfillment of their lives. Then these same drug companies spend millions to market these drugs to physicians; ultimately the only class of people who can really open the gate to consuming of drug company products. Quite a long way around the block and a huge investment to sell a product.

On the direct marketing side, virtual Broadway productions are put together to convince consumers to ask their physician to prescribe this drug or that drug to cure the ills they have; or the ills they have finally realized they have after seeing the well heeled drug company ad. We are entertained and we are informed of all the symptoms we did not know we had; the diseases we might have; and the drugs available to treat one or the other.

Drug companies have traditionally justified the effectiveness of their drugs through “independent” research, usually funded by the drug company manufacturing the drug being researched. Once the research was conducted and the conclusions reached, the findings were published in responsible, self-regulating medical journals. These various articles served to demonstrate to the medical community, largely physicians, that the particular drug was a good one for patients.

We now find that at least some drug companies have been ghost writing supposed “independent” research articles for physicians, researchers, and experts. I am guessing that the way it works is Big Drug Company marketing person calls well established, expert physician and says something like:

“Gee, doc, we have this research we have done that leads us to the well founded conclusion that our new drug can cure the common cold. We need someone like you (an expert with a well heeled reputation) to sign off on the legitimacy of the research in an article we intend to submit to one of the well respected, self-regulated journals. What? Oh, of course its all true. We did this research entirely independently and our, er your conclusions are well supported. Yes, we stand to make a kazillion dollars on this one. Well, we can’t pay you a kazillion in fees, but maybe something in the high multiple figure range."

We then see a big production commercial about drugs and our learned physicians, for good reason, are forced to rely on Big Pharma’s Fairy Tales for evaluation of whether to prescribe a given drug.

Some publications like the Journal of the American Medical Association are questioning the real extent of ghostwriting, but frankly in my book, any is too much. The New England Journal of Medicine opines that maybe around 10% of articles involve some amount of ghostwriting.

Senator Charles Grassley has been spearheading Senate bill 309, Physician Payments Sunshine Act of 2009:

Physician Payments Sunshine Act of 2009 - Amends part A (General Provisions) of title XI of the Social Security Act to provide for transparency in the relationship between physicians and applicable manufacturers with respect to payments and other transfers of value and physician ownership or investment interests in manufacturers. Requires any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, or a physician group practice to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services. Requires any such manufacturer, or related group purchasing organization, also to report annually to the Secretary, in electronic form, certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer or group purchasing organization during the preceding year. Prescribes administrative penalties for failure to comply with these requirements. Requires report submission procedures to ensure public availability of required information on a website.

So what can the consumer do? When you see your physician, be open and candid about your actual symptoms and your entire medical history. Your physician is trying to help you.

Ask questions about any tests your physician wants to do; what your physician expects the tests may show; and what your physician thinks you could be suffering from. Ask your physician where you might go to read about the tests and his or her differential diagnosis.

If your physician suggests prescribing drug treatment, ask questions:

What condition is he or she trying to treat?

What is the drug intended to treat?

What are the potential complications of taking the drug?

What adverse reactions from the drug are possible and what reactions are more likely than some of the others.

Is there a period of time before you will begin to experience the effects of the drug?

How long will you need to take the drug?

Are there alternative drugs to the one being prescribed? If so, why is your physician prescribing this particular drug?

Are there alternatives to taking any drug for the particular medical condition? If so, why is the physician recommending drug therapy?

Ask anything else you want an answer to and insist on clear, understandable answers. It’s your body and your healthcare decisions to make with the guidance of a trusted physician.

Originally posted at InjuryBoard by John Hopkins

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

Loss of Sight Due to Possible Contamination of Ocular Drug-- Hyaluronidase

John Hopkins — Thu, 15 Oct 2009 16:14:32 GMT

Wydase (hyaluronidase) was manufactured by Wyeth until 2001 and was successfully used in various ocular surgeries to potentiate the effectiveness of anesthetics. Bupivicaine and Lidocaine are reportedly more efficacious when combined with hyaluronidase.

In 2001, Wyeth made the economic decision to stop manufacturing Wydase and subsequent manufacture of hyaluronidase based compounds were taken over by other manufacturers.

When Wyeth discontinued its manufacture of Wydase (hyaluronidase), ophthamologists were so entrenched in its use that many turned to compounding pharmacies to create the appropriate compound for them. Compounding pharmacists are supposed to be skilled in the actual combining of ingredients on premises for specific drug compounds. The FDA maintains jurisdiction over compounding pharmacies to the extent they are prohibited from compounding (combining ingredients) drugs without a patient-specific request from a physician. In addition, the FDA controls many of the ingredients compounding pharmacies use in arriving at their final product.

Fellow blogger, Cal Warriner, has discovered a potential contamination of hyaluronidase; believed to be specially prepared by a compounding pharmacy. In this instance I understand that hyaluronidase in a surgical procedure may have been the cause of the complete loss of sight in a patient.

Originally posted at InjuryBoard by John Hopkins