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Sunscreen Scare or Media Hype?

June 29th, 2010. By janem

Is there nothing new under the sun? The media is all over the link between sunscreen and cancer but it’s yesterday’s news (specifically, a number of years ago)–everyone knows that too much sun can cause skin cancer. But here’s the problem: the media could be sending out a misleading message to sun worshippers who believe sunscreen can cause melanoma, so they might soak up the rays sans sunscreen. Duh. Besides, the problem isn’t sunscreen; it’s retinyl palmitate, a compound used by sunscreen manufacturers.

A new (!) report has found that vitamin A and its derivatives, retinol and retinyl palmitate, may speed up the cancer that sunscreen is used to prevent.

On May 24, the Environmental Working Group (EWG) published its  2010 report on sunscreen that calls into question the protection offered by most products and raises a red flag about a chemical additive called retinyl palmitate that could increase cancer risk. EWG recommends that consumers choose vitamin A-free sunscreens and it also lambastes the FDA for its failure to issue regulations regarding sunscreen containing vitamin A.

“There was enough evidence 10 years ago for FDA to caution consumers against the use of vitamin A in sunscreens,” Jane Houlihan, EWG’s senior vice president for research, told AOL News. “FDA launched this one-year study, completed their research and now 10 years later, they say nothing about it, just silence.” Incredibly, the FDA denied the allegations. As reported by AOL News,  an FDA spokesperson said, “We have thoroughly checked and are not aware of any studies…[the spokesperson] checked with bosses throughout the agency and found no one who knew of the vitamin A sunscreen research being done by or on behalf of the agency.

But documents from the FDA and the National Toxicology Program showed that the agency had done the research in 2000, and they have been made public!

In October 2000, a report by the National Toxicology Program said that ” Retinyl palmitate was selected by (FDA’s) Center for Food Safety and Applied Nutrition for photo-toxicity and photocarcinogenicity testing based on the increasingly widespread use of this compound in cosmetic retail products for use on sun-exposed skin.”

I don’t see any studies done on people who slathered on sunscreen, stayed out of the sun, and wound up with melanoma.  So why hasn’t the FDA gone after the maker of retinyl, which is Read the rest of this entry »

Tags: sunscreen, sunscreen skin cancer
Posted in Consumer Fraud | No Comments »

Zimmer and Surgeon Split Ways–FDA in the Middle?

June 22nd, 2010. By janem

Zimmer Holdings, the manufacturer of medical devices, has cut loose its long-time consultant, Dr. Richard A. Berger, after his reports that Zimmer’s mechanical knee replacement is prone to failure. He could’ve been a whistleblower. Instead he complained to Zimmer and his next year’s contract has not been renewed.

I wonder what would have happened if he first complained to the federal government and the FDA—which is typically the first action to take if a whistleblower plans to file a qui tam lawsuit ( claims against pharmaceutical companies are becoming almost commonplace). Second, you find a good attorney.

Getting back to the good doctor. It’s not like he needed the money: according to the New York Times, Zimmer portrayed Dr. Berger as a master surgeon and paid him more than $8 million over a decade. On his website, Dr. Berger freely admits that he “receives royalties and payments from the manufacturers of these devices”.

But in 2005, Dr. Berger implanted Zimmer’s NexGen CR-Flex device in about 125 patients and within about a year, x-rays showed that the device was loose and had not fused completely. Patients were in pain, apparently because of the loose joint. Dr. Berger did his due diligence and reported the problems to the maker.

Here’s the crunch: the FDA never required Zimmer to study the device in patients before selling it. Zimmer dismissed the doctor, saying it was his technique to blame and not a manufacturing defect. Dr. Berger told the Times that other surgeons were soon reporting similar problems.

In the Times article, experts cited that the falling out between Dr. Berger and Zimmer highlights the lack of independent, unbiased information about orthopedic implants, since there is no system of tracking the performance of artificial hips and knees in the US.

Whisteblowers have file qui tam lawsuits against several medical device companies, alleging improper marketing when the products were sold off-label, which resulted in Medicare paying excessive reimbursements. If successful, these suits can reimburse the government big time. But what would happen if a whistleblower came forward in the case of the Zimmer knee replacement, when the FDA didn’t require any controls, nor clinical trials? It would seem that someone should blow the whistle on the FDA…

Tags: Dr. Berger, knee replacement, Medical Device, Zimmer
Posted in Defective Products, Drugs/Medical | 5 Comments »

Risky Companies should Pay before they Get Paid

June 16th, 2010. By janem

How’s this idea: any company with a checkered past, and/or even the slightest possibility of a risk to the public, either from a drug such as Paxil that causes birth defects, a product such as asbestos or from an environmental hazard such as that caused by BP and Exxon, has to pay into some kind of trust before its top dogs and shareholders get paid.

Take BP, for instance–and who isn’t? Although BP shareholders are suing CEO Tony Hayward and board members alleging they underestimated the risk of an accident, and even though the spill reduced BP’s market value by 45 percent, and even after the spill—albeit in the early days– Hayward planned to pay more than $10 billion to shareholders this year.

Transocean, the company that owned and operated the oil rig that sunk into the Gulf of Mexico, quietly announced just five days after appearing before Congress to testify about its responsibility that it would shell out $1 billion in dividends to shareholders.

Transocean had insured the rig for $560 million and received $401 million from the insurance policy. Apparently the company made a few hundred million from the spill. Companies like Transocean shouldn’t be allowed to strike up these “backroom deals” with BP and its insurer. And not if Mr Obama and Congress have their way.

Either way, BP is stuck between a rock and a hard place: many UK investors are depending upon the payment as their income, but how much income is that? Obama said that BP had “moral and legal obligations” to Gulf Coast residents that may supercede its obligations to shareholders.

Prime Minister Stephen Harper would be wise to echo Obama’s words regarding a $58 million bank loan the Quebec government is considering for Jeffrey Mine Inc., that plans to exploit a massive new underground asbestos deposit. This company, like BP, has the potential of creating a massive amount of harm to countless people so it should be required to pay before the fact.

Of course it’s nearly impossible to estimate how much a company should pay but the respective governments could take a look at history: how much did Exxon pay for the cleanup and multiply that tenfold; how much did Libby mine pay to mesothelioma victims, how much did GlaxoSmithKline, the maker of Paxil, a drug that causes birth defects, make in profits last year …then tag on all their expected future profits…  BP and pharmaceutical companies have deep pockets. If it can’t afford to shell out that kind of money upfront, it shouldn’t be operating. As for Jeffrey Mine, the Quebec government should also be held accountable if it signs the loan.

Posted in Emerging Issues | 1 Comment »

Stevens Johnson Syndrome Increasing?

June 8th, 2010. By janem

Many health practitioners still believe that Stevens Johnson Syndrome is a “rare skin disorder” but with the increase in adverse drug reactions (Health Canada reports adverse drug reactions are up 35 percent), this life-threatening disease is not as rare as we have been led to believe.

The Stevens Johnson Syndrome Foundation says it hears of 15 new cases a week and that is likely the tip of the iceberg—not everyone diagnosed with SJS has internet access or is aware of the foundation. As well, drug companies are required to tell the FDA (and other health agencies, such as Health Canada) about any reports of serious adverse reactions they receive, but not every doctor or patient takes the time to report side effects. This means that adverse reactions to certain drugs can go unnoticed for a long time.

And to this day, some doctors don’t know what SJS is, even when it’s staring them in the face. When their patient is covered in the most horrific sores and blisters, they might even prescribe the same medication to treat the disease that caused SJS in the first place!

According to Public Citizen, about 1.5 million hospitalizations a year were caused by adverse drug reactions—that’s more than 4,000 patients per day. It gets worse: 57 percent of these adverse drug reactions were not recognized by the attending physician at the time of admission. Many of these admissions should have been prevented. And many patients develop adverse drug reactions while they are in hospital.

“770,000 additional patients a year—more than 2,000 patients a day—suffer an adverse event caused by drugs once they are admitted,” said the not-for-profit agency.  In 2004, the Centers for Disease Control (CDC) reported that more than 40 percent of Americans were taking at least one prescription drug. People develop SJS from commonly prescribed drugs, including antibiotics, anti-convulsants, and non-steroidal inflammatory drugs (NSAIDS), including over-the-counter drugs such as Ibuprofen and Motrin.  Age is no barrier: Numerous children’s medications have caused SJS.

But countless medical facilities and doctors don’t recognize SJS in the early stages because they aren’t familiar with the symptoms. Until SJS turns into TEN and usually by that time, it’s too late. It boggles the mind: why aren’t all health practitioners given mandatory training to recognize this life-threatening disease? Don’t they read drug labels or their Blue Book before prescribing drugs? It’s like a toss of the dice. When a drug such as Bextra has been known –since 2002—to cause SJS, perhaps the doctor believes the good outweighs the risk.

Just last August Tibotec Therapeutics reported postmarketing cases of SJS with its Intelence drug and the FDA’s MedWatch said “Intelence therapy should be immediately discontinued when signs and symptoms of severe skin or hypersensitivity reactions develop.” How about adding, “get thee to a burn unit, fast.”  And bring along a list of drugs that may have caused the reaction.

Tags: adverse drug reactions, Bextra, SJS, Stevens Johnson Syndrome
Posted in Drugs/Medical | 1 Comment »

Fosamax Femur Fractures in Media Spotlight

June 1st, 2010. By janem

I feel sorry for health officials and researchers whose warnings about adverse drug reactions fall on deaf ears; if only they could employ TV anchor Diane Sawyer to heighten public awareness. Case in point: the link between Fosamax and femur fractures.

Since 2008 researchers have suggested that patients-especially women–using Fosamax may be at risk for increased risk of bone fracture. Although the femur is the strongest and biggest bone in the body, a number of Fosamax patients have fractured their femurs simply from from walking. You can watch Diane Sawyer’s investigation and a follow-up report on ABC News here.

But not even Diane Sawyer and the media can budge the FDA. It says a warning to doctors at this point isn’t justified, but they will “seriously look into it”. That’s good news for Merck.  But if the agency sends a letter to doctors, it would allow them to get data they need to have Merck slap a femur fracture warning on the drug. Merck has likely banked heavily on Fosamax profits, especially given the age of baby boomers…

Back to those researchers. In 2008 Cornell University Medical School researchers showed that Fosamax patients are more than 125 times as likely to suffer non-traumatic femur fractures than patients who have not taken Fosamax. And there have been more studies to back-up Cornell.

At first, Fosamax prevents bone loss but loss over time it may also limit the bone’s natural ability to protect itself from stress. A rheumatologist at National Rehabilitation Hospital in Washington DC said that in up to 60 cases he looked at, most patients had been taking Fosamax or another type of bisphosphonate for more than five years.  Potentially, many women who have taken Fosamax for 5 years or more can be walking around with brittle bones that can fracture at any time.

Here’s the clincher: on its website, Merck, the Fosamax manufacturer, says that “…after you start taking Fosamax, even though you won’t see or feel a difference and that for fosamax to continue to work, you need to keep taking it. From what I could glean, none of Merck’s clinical trials lasted more than four years. So how long does Merck want you to take it for?

For that matter, should any drug be taken longer than indicated in clinical trials? After all, the drug was approved based on most trials from 1-2 years. When it was initially approved, Merck stated that “side effects observed in clinical trials were generally mild. The most commonly reported drug-related side effects in subjects taking Fosamax were abdominal and musculoskeletal.

Recent label changes made Merck add the following: bone, joint, and/or muscle pain, occasionally severe, and rarely incapacitating; joint swelling; low-energy femoral shaft and subtrochanteric fractures. But who reads that? Thanks, Ms. Sawyer.

Tags: femur fracture, Fosamax, fosamax femur
Posted in Drugs/Medical | 17 Comments »