West Palm Beach Personal Injury Lawyer - FDA

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

Correcting Injustice--The Medical Device Safety Act

John Hopkins — Mon, 26 Oct 2009 10:26:43 GMT

The decision in the Supreme Court case of Riegel v Medtronic created special protection for medical device manufacturers that defied all logic and contradicted 30 years of experience in medical device regulation. The Riegel case set forth that lawsuits against medical device manufacturers were preempted where the manufacturer had properly submitted the device to and received approval from the food & Drug Administration. This decision ignored real world issues. Nearly everyone knowledgeable at the FDA will tell you they have neither the time nor the budget to conduct sufficient independent analysis of every medical device. Largely, their approval relies on the truthfulness and sufficiency of the testing reported to them by the device manufacturer. By necessity, the FDA’s process is somewhat like the fox guarding the henhouse, in situations where the manufacturer has failed, intentionally or negligently, to put the medical device through the testing that would best evaluate the product’s safety. The Medical Device Safety Act, currently in Congress, would seek to correct this error and place consumers back on level footing with medical device manufacturers. US Representative Henry Waxman summarized the situation well when he said:

"As the Supreme Court affirmed in its Wyeth decision yesterday, lawsuits by injured consumers play a critical role in helping to ensure safety," said Chairman Waxman. "The Court noted that these lawsuits 'uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.' The same is true for medical devices. We must act quickly to enact this important legislation that will restore the ability of patients injured by defective medical devices to seek compensation, and realign the incentives for manufacturers to ensure the ongoing safety of their products."

The bill has now garnered support from many organizations including:

AARP

Center for Justice & Democracy

Consumer Federation of America

Consumers Union

Homeowners Against Deficient Dwellings

National Association of Consumer Advocates

National Consumers League

OWL - The Voice of Midlife and Older Women

Progressive States Network Public Citizen

U.S. Public Interest Research Group

The New England Journal of Medicine

National Conference of State Legislators

National Research Center for Women & Families

What can you do?

Call your legislators and ask them to do the correct and just thing—vote in favor of the bill.

Go here to find contact information for congressional members!!

Originally posted at InjuryBoard by John Hopkins

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

Drug and Medical Device Manufacturers: "It is someone else's fault"

John Hopkins — Thu, 03 Sep 2009 10:59:13 GMT

A responsible FDA has brought a drug manufacturer to justice. The FDA has settled with Pfizer over its off label and deceptive marketing of the drug Bextra; $2.3 billion in fines and penalties. Sounds like a lot of money until you consider that in 2004 alone, Pfizer sold over $1.4 billion in Bextra. Sadly, this chapter is simply the tip of an ever increasing iceberg.

Assistant Attorney General Tony West had this to say about the settlement:

"Illegal Conduct and fraud by pharmaceutical companies puts the public health at risk, corrupts medical decisions by health care providers and costs the government billions of dollars. This civil settlement and plea agreement by Pfizer represent (sic) yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”

Mr. West is correct as long as there is an FDA willing to hold manufacturers to compliance with the law and judges who see corporate obfuscation when it is in front of them. When drug and medical device manufacturers encourage off label, unapproved uses it should be with a foundation of study and evaluation for the safety of the recommended use.

Manufacturers of pain pumps, for example, encouraged an off label, unapproved use of their devices causing severe and crippling injuries in young adults with their whole lives in front of them. Although pain pump manufacturers did no research or evaluation of the safety of their off label use recommendations, they did go to considerable expense to produce manuals and DVD’s to teach doctors how to code billing to maximize profit if the physicians used the pain pumps in the ways recommended by the manufacturer. Breg, Stryker, IFlow and other manufacturers told physicians to use pain pumps in a way that they knew had not been approved by the FDA, in fact in ways that at least some of the manufacturers knew has been absolutely forbidden by the FDA without specific testing and research.

Did the pain pump manufacturers do the testing or research that the FDA had set forth was necessary? Did these manufacturers avoid intensive marketing to physicians for use of the pain pumps in a way not approved by the FDA? The answer is a resounding, no!

But, wait, it gets better. Through their lawyers, the pain pump industry appears to have devised a scheme to create a defense to their conduct by not complying with the FDA. They apparently understood that if they neglected to conduct the appropriate, required scientific studies, no one else would either. If no one conducted any meaningful scientific studies, then pain pump manufacturers would be able to pull the devices once they started hurting people and then argue to judges that all the victims’ lawsuits should be dismissed because no reliable scientific evidence exists to substantiate the injured victims’ claims.

So, manufacturers violated the law by not conducting safety research on their devices.

Devices start causing crippling injuries after being on the market long enough for manufacturers to amass huge profits.

Injured victims sue manufacturers.

Pain pump companies pull their devices before anyone does any meaningful testing (the same testing the FDA told the manufacturers to do before putting pain pumps on the market).

Do pain pump manufacturers defend the lawsuits by arguing that their devices were safe and here is the evidence of the testing they did to ensure the safety of the public? No.

Pain pump manufacturers actually argue that it was the doctors’ fault for using the pain pumps and they (the physicians) should have known better. In the alternative, pain pump manufacturers tell scientifically unsophisticated judges that lawsuits should be dismissed because no reliable evidence exists to prove their pain pumps are defective. Injured victims ask the manufacturers for their studies and pain pump makers respond by boldly stating they did none.

Experts for injured victims testify that the violation of the law by not conducting analysis, which the FDA specifically requires, is negligence. Orthopedic surgeons testify that the patient’s injuries were caused by the improper use of the medical devices. Pain pump manufacturers respond by arguing this testimony is purely opinion and irrelevant because the absence of scientific studies means the injured victims can not prove their cases.

Some judges listen to the medical device manufacturers’ arguments that the lack of scientific study, largely caused by their failure to follow the law, should give them a free ride away from injured victims’ claims.

In the Pfizer case, whistle blower John Kopchinski revealed: “In the Army, I was expected to protect people at all costs. At Pfizer I was expected to increase profits at all costs, even when sales meant endangering lives. I couldn't do that." Apparently there are plenty of drug and medical device employees who can make money on the backs of injured people.

So, do not blindly allow physicians to use medical devices and drugs to treat you. Ask questions. Make inquiries. Do research. Require complete answers. The physicians may possibly be as much in the dark as the patient in some cases.

Originally posted at InjuryBoard by John Hopkins

My Alli and Me (an Ode to Glaxo’s Orlistat)

Armand Rossetti — Tue, 25 Aug 2009 13:57:26 GMT

Rx to OTC: We’re losing weight, my Alli and me.

No doctor’s involved as far's I can see.

I'll take two smaller pills instead of one?

Since Alli’s available to all and prescribed by none.

OTC’s 60; script’s 120; but why complain?

I don’t need a doctor, now that seems insane.

Worries about safety, why have a fit?

Glaxo to the rescue; it gave me a kit.

If that weren’t enough, GSK penned a book

With tips on diet ‘n workout fit for trainer and cook.

A “no quick fixes” campaign and lifestyle refrain

Before ‘t was orlistat…then Xenical; now Alli's so mundane.

There’s no doctor’s decision to get in the way

Of self diagnoses, prognoses, or affairs of the day.

Heartburn and headaches and allergies galore,

Misuse and abuse might bring Doc Wolf to my door.

Bizarre words like crypt foci flash ‘fore my eyes,

But, who cares? I’ll look great!..despite the French fries.

If the government approved it who are my, to question?

Let Congress handle the details when it’s back in session.

None can deny that Alli’s a block buster,

And I can’t see why there’s been such a fluster.

Hey look it’s been working, or so they say.

Fair warning, keep using it, and grave dues we might pay.

…Inspired by PAL

Originally posted at InjuryBoard by Armand Rossetti

Adderall IR; Adderall XR: Are they from Shire, Barr, Teva, or Ranbaxy?

Armand Rossetti — Mon, 17 Aug 2009 15:01:00 GMT

Adderall is in the news today. Barr Laboratories (Barr) recalled lot #311756 of the powerful psychostimulant, indicating that consumers might receive exceedingly potent dosages due to oversized tablets.

To get a better idea of the complex under currents in Big Pharma, let’s discuss the pharmaceutical giant,Teva, a player by acquisition in the Adderall recall:

For 7.5 billion dollars, Israeli drug giant, Teva Pharmaceutical Industries (now the world’s largest generic drug manufacturer) acquired Barr Laboratories in 2008. Barr currently owns intellectual property rights to Adderall.

The average consumer might not be familiar with Teva as a drug manufacturer. However, due to numerous acquisitions and joint ventures, Teva is huge. As a result, the giant generic pharmaceutical concern has become the utmost patent copycat pharmaceutical player on the international scene.

Here are several examples of Teva’s acquisitions and agreements:

Teva and India’s largest generic drug manufacturer, Ranbaxy, reached an agreement in 2004 for Teva to ship its Quinapril HCL tablets.

In 2008, Teva and the Japanese generic firm, Kowa partnered for a 50-50 stake in Teva-Kowa, which would become a leading generic producer in Japan.

In January of 2009, Teva and Swiss based Lonza Group formed a joint venture to manufacture and market a portfolio of “biosimilars.”

On June 29, 2009, Teva and its partner, Antares, announced the introduction of a needle-free injector product.

Teva plans to spend another billion dollars to acquire Indian drug companies and to set up Greenfield manufacturing facilities.

In March of 2009 Stem-Ex, Gamida Cell-Teva joint venture product received the European Union’s orphan drug equivalent.

In fact, Teva is not afraid to challenge any drug company for the right to make generic copies of drugs. For example, Teva has challenged and prevailed over Novartis, concerning the right to manufacture a generic copy of Lotrel, even though Novartis’ patent is valid until 2017.

Win a few and lose a few.

In 2008, The Court of Appeals for the Federal District of New York ruled in favor of TAP Pharmaceutical in its quest to prevent Teva from infringing TAP’s patent for Prevacid.

The Barr-Shire Connection:

Last year, Teva acquired Barr, but not before Barr acquired Shire, plc’s intellectual property rights to Adderall.

Adderall XR (extended release) is the brand name for a mixture of extended release encapsulated amphetamine salts that Shire is still manufacturing and selling, and that physicians prescribe to treat attention deficit hyperactivity disorder (ADHD).

In 2006, Shire’s worldwide sales of Adderall XR were 864 million dollars. Then Barr applied for and received an abbreviated new drug application (ANDA) from the FDA that would permit Barr to manufacture a bioequivalent generic Adderall. After Bar received its ANDA designation for Adderall, Shire sued in New York’s Federal District Court for the Southern District to protect its patent rights.

In an effort to end the intellectual property tussle in August 2006, Shire and Barr reached an agreement whereby Shire would pay Barr a net amount of up to $102 million.

The structured deal had Shire paying Barr’s subsidiary, Duramed, up to $165 million; $25 million immediately and up to $140 million over eight years, described as compensation for product development. In return, Barr agreed to pay Shire $63 million as compensation for transferring Shire’s rights to Adderall IR (immediate release) tablets.

After the parties consummated their deal, Barr retained of exclusivity eligibility regardless of the patent suit. In return, Shire agreed not to release an authorized generic for 180 days, during which time, Barr would pay Shire a royalty. Thereafter, the Adderall license would be non-exclusive and royalty-free. In addition, Barr received the rights to Shire’s Adderall IR and the opportunity to purchase an innitial supply of Adderall IR from Shire.

The settlement removed Shire’s threat via lawsuit and created a protective intellectual property bottleneck. As part of the same agreement, Barr agreed to enter the market on April 9, 2009 (a date in between the earliest point that Barr could have entered the Adderall market and the time that Shire’s patent was due to expire). See pages 133-134 of: Testimony of C. Scott Hemphill, Associate Professor, Columbia Law School before the House Committee on Energy and Commerce Subcommittee on Commerce, Trade and Consumer Protection; Hearing on H.R. 1902, Protecting Consumer Access to Generic Drugs Act of 2007.

A second drug company called Impax was also on the ANDA side of the Shire-Barr patent lawsuit. Unlike Barr as first filer, Impax was a later filer and, therefore, had no eligibility for intellectual property exclusivity. As further compensation, Impax received cash for promotion of another drug.

Given the compression of competition due to the agreement, the FTC caught wind of the Shire-Barr-Impax agreement and opened an investigation in October 2006:

“The US Federal Trade Commission (‘FTC’) informed Shire on October 3, 2006 that it was reviewing the ADDERALL XR patent litigation settlement agreement between Shire and Barr Laboratories, Inc. (‘Barr’). On June 22, 2007, the Company received a civil investigative demand requesting that it provides information to the FTC relating to its settlement with Barr and its earlier settlement with Impax Laboratories, Inc. The Company is co-operating fully with this investigation and believes that the settlements are in compliance with all applicable laws.”

The Aftermath of it all:

Of course this whole intellectual property rights tussle died down, and in 2008 Teva acquired Barr, together with all of Barr’s intellectual property and manufacturing know how. But there is something else that might be important to note.

In the Adderall IR settlement, Barr agreed to provide manufacturing backup for products that might emerge from the development agreement. Right now, Shire manufactures the XR formula and Teva (through its division Barr-Duramed) manufactures the Adderall IR formula. Shire's Adderall XR formula is still patent protected until 2018. However, Duramed is free to manufacture the IR formula. And lest we forget, India’s Ranbaxy also produces a generic form of Adderall. If I recall correctly, the now Japanese owned Ranbaxy is also the company that falsified data on drug applications?

Consumer Confusion:

Internet discussion boards are replete with commentary concerning the different kinds of Adderall on the market, and the way that physicians go about prescribing that drug:

Comment #1 (orange or pink);

Comment #2 (Insurance decides and potent v. impotent);

Comment #3 (Barr or Ranbaxy); and

Comment #4 (A drug for wrong reasons).

It is pretty clear to see why something as simple as oversized pills might elude Big Pharma's quality control effort. There's probably too much wheeling and dealing taking everyone's attention off the ball; the ball being, consumer safety.

Originally posted at InjuryBoard by Armand Rossetti

Anabolic Steroids -The consumer, the FDA and the Manufacturer

Alyssa DiEdwardo — Mon, 10 Aug 2009 06:31:51 GMT

Even If the most conscientious consumer sifted through the mountains of available information and then carefully weighed each source of the information prior to making a determination if a product was safe, it would take hundreds of hours for some products. Even after completing the research, the consumer is at a distinct disadvantage in trying to determine safe from unsafe and good from bad.

An “overly broad warning” and Public Health Advisory (PHA) from the FDA on the dangers of anabolic steroids has served only to confuse the public more. In their advisory, the FDA set forth only a few unlisted ingredients in Body Building type products: containing androgen-, estrogen-, and progestin-related active ingredients. But, public information like this does as much to confuse or fail to engage with a confused, non-scientific public. Mistrust of the Government is an epidemic and is as much caused by a failure to inform the consumer about dangers in a way that any consumer will understand.

Anabolic Steroids are synthetically produced variations of testosterone a naturally occurring male hormone. The two major effects of these steroids are an “anabolic effect”; an often unnatural building of tissues, mainly muscle, accomplished by the promotion of protein synthesis.

People abusing steroids may take up to 100 times a normal dosage and more than one at a time (called stacking); alternate with high dose, then low dose (called cycling); or slowly escalate the dosage amount (called pyramiding). Anabolic Steroids are so widespread now that users include school-age children, athletes, business professionals, and a growing trend of woman striving to have the perfect physique.

The progression of steroid use caused the FDA, DEA and Federal law to place anabolic steroids in Schedule III of the Controlled Substances Act (CSA). The Anabolic Steroid Control Act of 2004, placed 32 additional steroids in Schedule III and expanded the DEA’s regulatory and enforcement authority relating to steroids. Unfortunately, this has resulted in manufacturers becoming cleverer in the delivery of their product to the market and they have found a loophole through the unregulated Dietary Supplement Industry.

Many consumers are under the impression that all “steroids” have been banned and are off the shelf. The scary fact is that only the ones that have been identified by the FDA are safely out of consumer products. New formulations are being developed that do not require FDA approval because the ingredients are “listed” as Dietary Supplements” and have successfully flown under the radar of the FDA.

The belief that these products are safe is a dangerous one. In some respects, these “dietary supplement” products are more dangerous because they either contain actual banned steroids or compounds in the products can have the same medical consequences.

In recent years, mostly as a result of failed drug testing in athletes, it has it been discovered that synthetic pro hormones or anabolic steroids are being used as Dietary Supplements. Although the marketed product may not contain actually banned steroids, it may contain substances that have not yet been approved by the FDA or properly evaluated by the manufacturer. As was seen in 2003 when U.S. track and field athletes tested positive for THG, they were caused by legally obtained products derived from synthetic steroids, trenbolone and gestrinone, and they were ultimately banned.

According to the DEA, the following three steroids meet the criteria for “anabolic steroids” under the Anabolic Steroid Control Act of 2004 (”Classification of Three Steroids as Schedule III Anabolic Steroids Under the Controlled Substances Act,” April 25).”

Boldione (aka androsta-1,4-diene-3,17-dione)
Desoxymethyltestosterone (aka DMT and 17a-methyl-5a-androst-2-en-17b-ol)
19-nor-4,9(10)-androstadienedione (aka 19-norandrosta-4,9(10)-diene-3,17-dione and esta-4,9(10)-diene-3,17-dione)

A recent study revealed contamination of approximately 25% of popular dietary supplements in the U.S. with low levels of steroids that were not declared on the product label. The International Olympic Committee (IOC) conducted a study between 2000 and 2002 that revealed “15% of dietary supplements, purchased in various countries, contained undeclared steroid and/or prohormone ingredients.”

Some explanations for the high incidence of steroids and stimulants found in sports supplements according to the DEA are:

Intentional contamination. There have been allegations that some supplement companies may have added undeclared ingredients, usually by the addition of a stimulant, so that the consumer actually “feels” that the product is working. For example, the overall success of the sports nutrition supplement industry is largely due to the “placebo effect” - if the consumer “feels” something from the supplement, they think it is working. Consumers are convinced that if it “feels” like it is working, it may actually have benefit (placebo) and they will continue to buy the product.
Cross-contamination. Many factories manufacturer varieties of different categories of supplements in the same facility. For example, ephedrine products may be processed on the same equipment as vitamin and mineral products; hormonal products may be processed on same line as protein powders. If the equipment is not cleaned properly, contamination can result.
Contaminated raw material. Supplement manufacturers often import raw materials from Asia, India and Eastern Europe. This could be contaminated with impurities.

The dietary supplement industry is a “buyer beware”; consumer educate thyself industry. Although responsible, careful manufacturers exist, the ingredients are largely unregulated and the quality is not consistently verified.

The purchase of dietary supplements is one of those areas in which the consumer must educate themselves; ask questions, research, and carefully consider. The FDA simply does not have the resources to gain control over drugs and medical devices. Although remarks delivered on 8/9/09, by newly installed FDA Chief Margaret Hamburg gives new hope, the public should still not rely on the FDA to manage the dietary supplement industry at this point:

“Last week, we took action against companies selling anabolic steroids under the guise of dietary supplements.

One manufacturer, American Cellular Labs, sells eight of these products on its website. The site promotes the products with claims like, “MASS Xtreme is perfect if you are focused on adding muscle mass, power and strength to your physique,” and “ESTRO Xtreme… You get two estrogen blocking effects in one fantastic product!”

In fact, these over-the-counter body-building products have been associated with serious and life-threatening adverse events, including liver injury, stroke, kidney failure, and pulmonary embolism.

These are unproven and unapproved drugs, not dietary supplements.”

Originally posted at InjuryBoard by Alyssa DiEdwardo

Attorneys have played a role in the FDA’s evolving approach to enforcement

Armand Rossetti — Fri, 07 Aug 2009 09:45:07 GMT

Today’s headlines are replete with news about the FDA’s recent commitment to stronger enforcement. I suspect that attorneys’ public comments over the years, concerning the FDA’s seeming lack of vigilance, strategy, timeliness, and visibility have reached the eyes and ears of someone who is going to act efficiently and effectively in the public interest.

I was quite pleased to learn that FDA Commissioner, Margaret Hamburg, MD, after only eight weeks on the job, has boldly advanced an agenda that if followed will give the current FDA a welcome “makeover.”

Some readers may remember Commissioner Hamburg’s appearance on Charlie Rose to discuss the Ebola virus. Dr. Hamburg is eminently qualified for her position. In fact, the US Senate gave Dr. Hamburg unanimous approval to become FDA Commissioner. For a more comprehensive idea of Dr. Hamburg's plans for the FDA, please view the webcast of Commissioner Hamburg’s address before the Food and Drug Law Institute (FDLI).

If Commissioner Hamburg can ensure improved consumer safety without undue delay, because of red tape laden road blocks, it will definitely be a consumers’ "dream come true."

Originally posted at InjuryBoard by Armand Rossetti

“The Heavy Weight Fight” – Extreme Dangers of Bodybuilding Supplements

Alyssa DiEdwardo — Mon, 03 Aug 2009 08:08:05 GMT

Bodybuilding has been known as an Extreme Sport, because it is associated with extreme diets, rigorous weight lifting and rigorous competitions. Famous names such as Arnold Schwarzenegger, Lou Ferrigno, and Charles Atlas come to mind. However with the aggressive marketing of dietary “natural” supplements to speed up results or create short cuts to the perfect physical condition, an unhealthy “opportunity” exists to market and sell dangerous supplements that have slipped under the radar of the FDA. As seen in the weight loss supplement industry, with the harmful effects of ephedra and related deaths, we are seeing the same with anabolic steroids. But like “The Night of the Living Zombies” these supplements get reformulated and remarketed and spun out again onto the shelves of health foods stores as “safe and natural.”

Bodybuilding, which once was for the chosen few, has become so mainstream that every young person is being told they not only can, but should, engage in this severe sport. Products designed to convince us that anyone can achieve a bodybuilder’s physique with “a “just add water” approach and the “magic” of modern pharmaceuticals..
This has not gone entirely unnoticed by the FDA and under the New Rule and current Obama administration the newly nominated commissioner Margaret Hamburg warnings are now being posted to alert the public that body building products marketed as containing steroids or steroid-like substances should be discontinued immediately.
In a recent Public Health Advisory (PHA), the FDA announced a warning to consumers to avoid using bodybuilding supplements claiming to contain steroids, steroid-like substances, steroid alternatives and hormone products.

However the FDA warning did not list specific product ingredients and the overly broad warning creates confusion and suspicion toward all “body building supplements”. These compounds are not regulated by the FDA and it is difficult to determine what products are safer than others or which manufactures are more trustworthy. In the release it is stated that all the products marketed for the claims of body enhancing, increasing muscle mass, alternatives to anabolic steroids for increasing muscle mass and strength and “promoted to athletes to improve sports performance and to aid in recovery from training and sporting events” are all included in the warning posts.

This appears to have been designed to dissuade the public to completely steer away from all products because the consumer can not determine the safety and efficacy of dietary supplements under DSHEA. Reading between the lines the FDA acknowledges that aside from sending out a “broad warning” there is nothing that they can do to recall or ban dangerous products timely and that more than ever the buyer should beware. No one will disagree that the FDA has failed miserably and allowed unscrupulous manufactures to market and sell dangerous products but the question remains what can be done about it now?

The FDA’s positions on these substances, containing synthetic steroids are frequently marketed as dietary supplements, but they are NOT dietary supplements. Instead they are unapproved drugs that have not been reviewed by the FDA for safety and effectiveness. Systems most often associated with the use of these dietary supplements include: nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, jaundice (yellowing of the skin or whites of the eyes) or brown/discolored urine precursors to liver injury, kidney failure, stroke, and hormone-associated adverse effects, such as blood clots, including pulmonary embolism and deep vein thrombosis.

In a recent warning the FDA set forth that “Due to the potentially serious health risks associated with using these types of products, the FDA recommends that consumers immediately stop using all body building products that claim to contain steroids or steroid-like substances.”

Originally posted at InjuryBoard by Alyssa DiEdwardo

Marketing Pharmaceuticals and “All that Yaz”

John Hopkins — Wed, 29 Jul 2009 15:56:53 GMT

When I see drug companies advertising on television, I often wonder whether their research departments are as well funded as their marketing efforts.

Bayer Healthcare Pharmaceuticals and their birth control drug, Yaz, is a good example. The commercials for this product remind me more of a Broadway extravaganza or a drama series than informational drug commercials.

All of this, of course, ignores my complete wonder at why drug companies market complicated drugs with various medical applications to a public that sometimes has trouble choosing between Tylenol and Advil (is it 6 times the number of Tylenol or 8?).

The reason, of course, is that for the amount they spend, they get to influence not just the physicians who prescribe these drugs, but the patients who will visit those physicians and announce that they really want the latest, greatest drug they saw on television.

In the case of Yaz, take a look at their commercials. Young, vibrant, intelligent women who all solve a whole host of problems with this amazing drug called Yaz. The name alone projects the feeling that it is a wondrous drug: Y-a-zzzz!

What I am afraid is often lost between the glitz and the glamour are the complications of these drugs. In the case of Yaz, they are many:

· Arterial thrombosis and thromboembolic events
· Venous thrombosis and thromboembolic events
· Myocardial infarction
· Heart attack
· Stroke
· Thromboembolism
· Hepatic neoplasia
· Gallbladder disease
· Hypertension
· Blood clots
· Deep Vein Thrombosis
· Pulmonary embolism
· Death

In 2008, the FDA did something seldom done. The FDA wrote a seven page letter to Bayer Healthcare Pharmaceuticals. In it, they said that the Yaz ads were misleading; overstated the efficacy of Yaz; failed to warn that Yaz has not been evaluated for treatment of PMS; created misleading impressions about the claims of Yaz; and that the ads failed to clearly convey the real risks of the drug.

Originally posted at InjuryBoard by John Hopkins