Drugs/Medical Archive

LAS Lookout: Fastin Weight Loss Ad – Read the Small Print

January 5th, 2012. By AbiK

Note to self: when a one-page ad in a magazine has 12 daggers—those are those “†” symbols that lead you to some teeny-tiny footnote disclaimer—pause to ponder what the ad is really telling you.

It’s important as now that we’re in flu season, we’re seeing more and more homeopathic ‘remedy’ ads popping up with questionable claims and the telling footnote or two.

The 12-dagger ad above is actually a recent ad for Fastin, “the world’s most advanced weight loss aid ever developed!†” (there’s that dagger!). The ad appeared in Self magazine. And yes, it has 12—no joke, twelve—daggers in it, all leading to the footnote below. Don’t believe it? They’re all circled on the actual ad above.

Just about everything but where to buy Fastin has a dagger leading you to the disclaimer (the disclaimer is reprinted below.

In fact, even the doctor’s statement has the disclaimer. And there’s another tip-off to something potentially askew: try to locate some quick background info on Dr. Mark Wright. You can’t. Oh sure, he has his own website, but try to find him on doctor rating sites like RealSelf.com, Vitals.com, Avvo.com, or HealthGrades.com. He’s not there. He’s also not showing up as

Tags: Dr. Mark Wright, false advertising, Fastin, Homeopathic remedy, Homeopathy, homeopathy-remedy-fraud, weight loss
Posted in Consumer Fraud, Drugs/Medical | 1 Comment »

Hair Restoration Society Issues Statement on Propecia Sexual Dysfunction

December 16th, 2011. By AbiK

We were waiting for this one. The International Society of Hair Restoration Surgery (ISHRS)—yes, there is such an organization—issued a press release earlier this week to state its position on the claims of Propecia sexual dysfunction that have been swirling around.

The ISHRS aims to quell concerns over reported Propecia side effects—namely those regarding sexual dysfunction, loss of sexual interest, and claims of infertility—by stating that there have been “no evidence-based data substantiating the link between finasteride and persistent sexual side effects after discontinued use of the drug in numerous, double blinded, placebo controlled studies conducted evaluating the use of Propecia 1mg for hair loss.”

Additionally, the ISHRS states that anecdotal reports of adverse events (as in erectile dysfunction) “should not define the safety and effectiveness of this drug”. Such a statement is reminiscent of that line about a disease being “rare” until you’re the one affected by it. True, some random report from a guy on Propecia having sexual difficulties is not perhaps indicative of a large-scale problem or cause for alarm. Unfortunately, though, the anecdotal reports are more than just a few one-off’s, and they are a cause of concern for the men who report them.

Propecia Erectile Dysfunction AERS Reports

According to drugcite.com–a website that aggregates data from the FDA Adverse Event Reporting System (AERS), there have been 363 adverse events reported to the FDA for Finasteride (Propecia and Proscar). Of note, the most common reported Finasteride adverse event is erectile dysfunction.

The numbers seem low at first glance, but hair loss and sexual dysfunction don’t tend to be topics that anyone really wants to “come out” about and certainly not call attention to. And that raises the question of underreporting—could it be that due to the nature of the side effects not too many men really want to come forward and first, admit there is a problem to themselves, and then take it a step further and officially report it?

Given the upward trend of AERS reports from 2009 to 2011, one can only surmise that as more information regarding Propecia sexual side effects has hit the mainstream media—for example, the recent story in Men’s Health magazine—perhaps the stigma of talking about it has been reduced a bit (“see honey, it’s not me—it’s that hair loss drug I’ve been on…“).

Propecia, Sexual Dysfunction and the Middle-Aged Man?

Of note, the ISHRS release mentions that sexual dysfunction can be hard (no pun there) to assess—after all, there are numerous factors that can contribute to such problems: “nicotine, alcohol, prescription medications, stress, anxiety, fatigue and depression”. And, according the the release which quotes a 2006 study in the Archives of Internal Medicine, incidence of erectile dysfunction in middle-aged or older men in the general population can be as high as 49%.

That make sense—except when you look at the anecdotal reports from Propecia users (some of which are on LawyersandSettlements.com) and see that the victims can be rather young—in their 20’s and 30’s, some even as young as 19. So not quite in that “middle-aged or older” group.

According to AmericanHairLoss.org, “Approximately twenty five percent of men who suffer with male pattern baldness begin the painful process before they reach the age of twenty-one.” The ISHRS itself states on its site that “Hair loss in men is likely to occur primarily between late teen-age years and age 40-50″—if so, it would appear that the statistic of E.D. occurring in potentially 49% of middle-aged or older men is somewhat irrelevant.

Anecdotal Propecia AERS Reports Lead to Task Force

Perhaps the most telling aspect of the ISHRS press release is the announcement that the organization has formed a task force to review the anecdotal reports of sexual dysfunction among certain Propecia users. While it’s certainly the responsible thing to do, it also somehow validates that there is growing concern over the drug’s potential for harmful side effects.

According to the release, the ISHRS has also reached out to “dermatologists, hair loss physicians, urologists, endocrinologists and sexual medicine specialists” to be a part of the task force and share their data and experiences with finasteride in a “fact-based manner”.

Undoubtedly there will be more to come—Propecia lawsuits included.

Tags: Finasteride, International Society of Hair Restoration Surgery, ISHRS, Propecia, Propecia Lawsuit, Propecia Sexual Dysfunction, Proscar
Posted in Drugs/Medical, Emerging Issues, lawsuits, Personal Injury | 2 Comments »

Yaz Scandal? Doc’s Accusations v. Bayer Unsealed, Revealed

December 7th, 2011. By AbiK

Admittedly, it lacks the titillating quality of Warren Commission Report—but it could, in its own right, be linked to what some plaintiffs would likely describe as murder, and also conspiracy theory.

Earlier this week, expert opinion regarding Yaz birth control was unsealed in a federal court in Illinois. The expert opinion was in the form of a 196-page document written by Dr. David Kessler.

What’s interesting—or take your pick of adjectives here: damning, alarming, scandalous—is that Dr. Kessler’s report point-blank accuses Bayer of hiding critical data regarding Yaz’ blood clot link (the basis for numerous Yaz lawsuits right now).

According to Kessler’s conclusion, “By failing to disclose all thromoembolic event risk information and marketing Yaz and Yasmin off-label, Bayer needlessly exposed large numbers of women to risks of serious or fatal thromboembolic events.”

Kessler’s accusation of failure to disclose comes as a result of his claim that, in 2004, Bayer wrote a white paper draft—the white paper being what would ultimately be submitted to the FDA for review—that initially stated that Yasmin had a “several-fold” increase in DVT (deep vein thrombosis), pulmonary embolism and VTE (venous thromboembolism) when compared with three other commonly used birth control pills.

That was the draft version.

The version that Kessler states was submitted, according to Medpage Today, said, “The spontaneous reporting data do NOT signal a difference in VTE rates for Yasmin and other [oral contraceptive] uses. We see NO signal of a difference.”

Key to those edits, according to Kessler’s accusations, is that there was no additional data presented by Bayer to support the 180-degree turnaround in their conclusion.

According to MedPage, Kessler went on to state “…that Bayer presented a selective view of the data, and that presentation obscured the potential risks associated with Yasmin.”

Compounding this is Kessler’s assertion that Bayer extensively marketed Yaz off-label for PMS—for which Bayer did get a wrist-slap fine—but the aggressive marketing, it’s alleged, exposed a greater number of women to the potential risks of the drug.

The unsealing of the Kessler report comes mere days before the FDA Reproductive Health Drugs Advisory Committee is to meet. Their agenda: the risks and benefits of oral contraceptives that contain drospirenone (including Yaz, Yasmin, Ocella, Safyral). LawyersndSettlements.com has reported extensively on drospirenone-based birth control and its link to DVT and VTE.

Is a new warning label in the offing? Stay tuned.

Tags: Adverse Events, Bayer, Dr David Kessler, Drospirenone, DVT, FDA, VTE, Warning Label, Yasmin, Yaz, Yaz lawsuit, Yaz side effects
Posted in Drugs/Medical, Emerging Issues, lawsuits, Personal Injury | No Comments »

Big Pharma’s Big Credo: Money is King

September 8th, 2011. By Hunter West

A long time ago, in a different life, the instructor in a business course I was taking asked the class the Number One Reason why people go into businesses. The answers varied from creating jobs, to bringing new products to market, to the prestige that can come with being a business owner, to ultimately helping mankind and make the world a better place.

As I sat there, listening to all of this, it suddenly struck me what the basic foundation for any business enterprise was, is and always will be.

“Making money,” I blurted out.

And apparently, I was right.

The successful former businessman in his own right, the founder of his share of multi-million dollar corporations, maintained that different businesses would have different credos, goals and objectives.

But all of that takes a back seat to profits. You don’t have any of the other stuff—prestige, job creation, R&D, charitable good works—without the money.

It’s all about the money, stupid. Show Me The Money.

Think about that the next time you take that pill for the umpteenth time, or undergo that hip replacement, or accept that pacemaker.

The drugs, the devices available to prolong our lives in the modern age are, in many ways, nothing short of remarkable. They really are. And I like to think that the doctor, who prescribes all this stuff to me, truly has my best health and welfare uppermost in his mind.

But you have to wonder at a regulator like the US Food and Drug Administration (FDA) that is partially funded by the industry over which it is charged to police on our behalf.

You have to wonder about the various loopholes and shortcuts that allow manufacturers to bring ‘promising’ new product to market faster—with minimal testing—only to have a lot of these drugs and medical devices turn out to be hugely problematic, if not outright dangerous.

You have to wonder at an FDA that acknowledges side effects as a necessary evil to the ingestion of chemicals whose benefits outweigh the risks for the largest segment of the population (there is no such thing, therefore, as a completely safe drug…).

You also have to wonder, the next time your grandmother breaks out her pill organizer and proceeds to ingest an insane number of different-colored pills…

How many of those pills are actually prescribed to treat an actual condition, v. the number that are needed to counteract the side effects from other pills?

And I wonder just how important that is to the drug companies, and their respective bottom lines? (And, I’m not the only one who’s wondered–I’m recalling the documentary “Big Bucks Big Pharma” from a few years ago.)

Their profits…

Pharmaceutical companies, and medical device manufacturers appear to be licenses to print money—especially with the large Baby Boomer sector approaching retirement. There’s so much money, in fact, that the cost of defending lawsuits is simply a cost of doing business.

There’s that word again. Business. Profits, and revenue, and dividends for shareholders. How important is it for drug companies to know their products are helping us to live longer, v. the money they are making off of us to their ultimate benefit and that of their investors?

I know what my business instructor, all those years ago, would say…

There’s nothing wrong with running a business—with making profits. That’s what business does.

What bothers me about the pharmaceutical and medical device industries, is that the consumer doesn’t have a choice…

Need a car? You can buy GM, or Toyota, or Honda, or Chrysler Fiat, or Mitsubishi…

If you need a TV, there’s Samsung, or LG, or Sony, or…

Or maybe you don’t want to buy one at all…

The difference with prescription drugs and medical devices is that more often than not, we don’t have a choice. We are mandated to take it, conscripted to do it. We rarely have the capacity to choose. And, if we’re lucky, the one choice we might get is to go for the generic version.

I’m at the age now where I’m on a low-dose aspirin a day, to keep my blood from getting as thick as my own head. I’ll probably be doing that for the rest of my life. But I’m also on a statin for high cholesterol, and I hate it. The sooner I can get my bad cholesterol in check by my own hand—diet and exercise—the happier I will be, and I can kiss the statin goodbye.

Ultimately, I don’t want to take something that I don’t need. But beyond that, I loathe being made to take something against my free will—something with which Big Pharma is laughing all the way to the bank.

I’ve always maintained that health—products, devices, drugs, health care of any kind—should be not-for-profit, free from greed and the blind pursuit of revenue.

But then, it wouldn’t be America, would it?

Tags: Big Pharma, Drugs, FDA, medical devices, pharmaceuticals
Posted in Drugs/Medical | 3 Comments »

When Cancer Research is Faulty, is it Fraud?

August 30th, 2011. By Hunter West

Cancer is so widespread that it touches us all in some way. Either you have lost a loved one or friend to cancer, you know someone who is afflicted—or you, yourself might be in the throes of battling some kind of cancer. It’s everywhere. Without getting into the debate as to why cancer rates appear to be rising, at least we can take solace in the research that we hope will one day result in a cure.

But perhaps that day may never happen. And recent events involving cancer research and fundraising have raised some doubts as to the effectiveness—and worth—of the cancer machine.

The New York Times recently chronicled the rise and fall of Dr. Anil Potti, a cancer researcher at Duke University Medical Center. Dr. Potti and colleagues had undertaken promising studies on genomic testing for molecular traits of cancerous tumors, and determining which chemotherapy treatment would be most appropriate.

Lung cancer patient Juliet Jacobs had a lot to gain and everything to lose, to that promise. Jacobs was part of the Duke University study, hoping for a breakthrough that would prolong her life.

Instead, the promising research was discredited due to the discovery of errors. Four gene signature papers were retracted, three trials at Duke were shuttered and the lead researcher resigned.

Juliet Jacobs died a few months following treatment that promised much but proved ineffective. Her family has launched a lawsuit, as have the relatives of other similarly doomed patients who had high hopes from the Duke research, since dashed.

Then, there’s the controversy in Canada over the allocation of fundraised dollars to research, compared with other needs of an apparently ravenous cancer machine.

A consumer advocacy arm of the Canadian Broadcasting Corporation last month looked at the financial records of the Canadian Cancer Society, following a complaint from a cancer researcher that research dollars appear to be harder to get—even though more people are Read the rest of this entry »

Tags: Cancer Drug Clinical Trials, Cancer Drugs, Cancer Research, Cancer Society, Duke University Medical Center
Posted in Drugs/Medical | No Comments »