Health Spectator

Johnson & Johnson announced yesterday that it was recalling Tylenol, Motrin, and St. Joseph’s aspirin as well as other over-the-counter drugs because they emit a moldy smell that has sickened some users. The Food and Drug Administration (FDA) has criticized the New Brunswick, NJ-based company and sent it a warning letter for not taking faster action, as the problem first occurred in early 2008 and recurred less than a month ago, but little has been done by the firm to address the issue.

The New Brunswick, NJ manufacturer has agreed to stop shipping products while it investigates the problem, which apparently has been traced to a chemical used to treat wooden shipping pallets. The Associated Press is reporting that the FDA traced the problem to a facility in Las Piedras, Puerto Rico.

Products affected include both regular and extra-strength Tylenol, children’s Tylenol, eight-hour Tylenol, Tylenol arthritis, Tylenol PM, children’s Motrin, Motrin IB, Benadryl Rolaids, Simply Sleep, and St. Joseph’s aspirin. Consumers can find out exactly which batches have been recalled by going to the McNeil website. (McNeil is the division of Johnson and Johnson responsible for these products.)

These problems come not long after an FDA advisory panel recommended removing acetaminophen-containing narcotic drugs from the market last summer because of the potential harm to the livers of patients caused by acetaminophen. Acetaminophen is the active ingredient in Tylenol. That same panel recommended lowering the largest dose of acetaminophen or Tylenol from 500 mg to 325 mg.

To date, no further action has been taken and Extra Strength Tylenol—available over the counter in any drugstore—still contains 500mg of acetaminophen.

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Frankly, we weren’t scheduled to post this until tomorrow, but in light of yesterday’s announcement of the $2.3 billion settlement between Pfizer and the U.S. Department of Justice, it just seemed too a propos to postpone.

Our thanks to Eleni Prokopeas for having posted this video on her site, Green Diva Mom, thereby bringing it to our attention. We liked it enough that we thought you would enjoy seeing it here.

Bill Maher does one of his send-ups—and this time, the patient is Big Pharma.

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The U.S. Department of Justice announced today that it had reached the largest settlement ever with a pharmaceutical manufacturer as Pfizer pled guilty to felony charges of fraudulent promotion of pharmaceuticals.

According to a DOJ press release, the company will pay a criminal fine of $1.195 billion, the largest criminal fine ever imposed in the United States for any matter. Pharmacia & Upjohn (subsidiaries of Pfizer) will also forfeit $105 million, for a total criminal resolution of $1.3 billion. The companies were misbranding Bextra with the intent to defraud or mislead. Bextra is an anti-inflammatory drug that Pfizer pulled from the market in 2005.

Misbranding in this case refers to the practice of recommending a drug for a purpose that has not been approved by the Food and Drug Administration (FDA).

The company also settled civil suits with the DOJ for violation of the False Claims Act as a result of illegally promoting four drugs—Bextra; Geodon, an anti-psychotic drug; Zyvox, an antibiotic; and Lyrica, an anti-epileptic drug—and causing false claims to be submitted to government health care programs for uses that were not medically accepted by the FDA and therefore not covered by those programs. The civil settlement also resolves allegations that Pfizer paid kickbacks to health care providers to induce them to prescribe these and other drugs. The federal share of the civil settlement is $668,514,830 and the state Medicaid share of the civil settlement is $331,485,170.

The DOJ further stated that this is the largest civil fraud settlement in history against a pharmaceutical company.

“This historic settlement will return nearly $1 billion to Medicare, Medicaid, and other government insurance programs, securing their future for the Americans who depend on these programs,” said Kathleen Sebelius, Secretary of Department of Health and Human Services. “The Department of Health and Human Services will continue to seek opportunities to work with its government partners to prosecute fraud wherever we can find it. But we will also look for new ways to prevent fraud before it happens. Health care is too important to let a single dollar go to waste.”

“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,” said Tony West, Assistant Attorney General for the Civil Division. “This civil settlement and plea agreement by Pfizer represent yet another example of what penalties will be faced when a pharmaceutical company puts profits ahead of patient welfare.”

Are you enraged by any of this? If so, leave your comments below.

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In the wake of our report on links between atrial fibrillation and bisphosphonate drugs such as Fosamax and Reclast, Health Spectator performed a routine follow-up investigation of the health claims and side effects of this class of drugs. We discovered that, contrary to the majority of reports we had read when researching the initial story, other complications from treatment with bisphosphonates were already known.

Specifically, a condition known as osteonecrosis of the jaw (a condition in which the bone tissue of the jaw literally dies) had previously been linked to taking Fosamax. A check of the Merck website on May 6 showed no mention of this possible complication either under side effects or dosing information. Nevertheless, we found that no less prestigious a group than the New York Academy of Science is sponsoring a conference on bisphosphonates and osteonecrosis of the jaw (ONJ) later this month. In fact, that conference is partially funded by Merck & Co., Inc, Novartis, and Procter & Gamble Pharmaceuticals, the major manufacturers of bisphosphonates.

What’s more, it turns out that the bisphosphonates have been associated with cases of osteonecrosis of the jaw since 2003. That’s when reports surfaced of bisphosphonate-associated osteonecrosis of the jaw (BON) linked to use of Zometa (zolendronic acid) and Aredia (pamidronate). Novartis manufactures pamidronate, as well as zolendronic acid under the names Zometa and Reclast. Zometa is used to treat bone loss in cancer patients and others who are undergoing a more rapid form of bone disintegration than occurs in osteoporosis. Reclast has been approved by the FDA for Paget’s disease and is being considered for treating osteoporosis.

For the most part, early reports of BON were associated with dental work, especially dental work that directly affected the jaw, such as tooth extraction. But then it became apparent that some BON episodes were spontaneous and not the result of dental intervention. The odds of suffering from BON are much greater as a result of dental intervention, so patients who are about to undergo therapy with zolendronic acid (or any bisphosphonate, for that matter) are urged to take care of any essential dental work before beginning treatment.

At this point, the possible complications of treatment with bisphosphonates are unfamiliar to many medical professionals, hence the interest in symposia such as the NYAS educational conference on ONJ and bisphosphonates.

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We felt glued to our seats. My wife and I were sitting in a small cafe in southern New Hampshire—the only diners in the place—and on the TV in the corner was Neil Cavuto on Fox TV conducting an interview (a debate, really) about the new over-the-counter weight-loss pill just approved by the Food and Drug Administration: Alli.

A fitness expert was trying valiantly to argue, in effect, that Alli was the work of the devil, pointing out its negative side effects and advocating a saner approach to weight loss that might involve, say, proper diet and exercise. But she was outgunned—outgunned by Cavuto himself and his MD interviewee, Fox’s own health commentator, Dr. Manny.

While watching this one-sided boxing match in which the underdog was throwing all the right punches and still couldn’t seem to score at round’s end, we had an epiphany: What’s most noticeable about all the publicity Alli is getting is that the medical community seems to be bending over backwards to remain neutral or to find positive things to say about the drug.

It may be they’re nonplussed by all the hubbub and by the fact that a prescription drug (Xenical) that had not been particularly popular has now obtained FDA approval for over-the-counter use at half the prescription dosage. In fact, such a move could indicate that manufacturers are trying to perform an end run around doctors themselves. (”Doctors don’t seem to be pushing it, so let’s try direct marketing to consumers ourselves.”) And the FDA has lent its imprimatur to the whole proceeding.

Or perhaps we’ve just not caught the right members of the medical community yet. (After all, drug companies do advertise on TV, which may explain the free-for-all we witnessed on Fox.)

But we’ll be happy to point out that there are negatives to a weight-loss program that depends upon not absorbing fats, which is what orlistat, Alli’s active ingredient, is all about. It works by preventing the pancreas from releasing an enzyme (lipase) that enables the breakdown and absorption of triglycerides by the gut. In simple terms, the fat you eat doesn’t get digested and absorbed by your body. It just passes through to be eliminated by the bowel.

Since triglycerides in the blood are one of those things—along with cholesterol—that your doctor is probably trying to get you to reduce, that’s a good thing, right? Well, not exactly. Actually, the high levels of serum triglycerides your doctor is worried about are caused by eating carbohydrates.

And fats, as it turns out, are an important part of the diet. Ever hear the phrase “essential fatty acids?” In case you haven’t, there are essential fatty acids (EFAs) and essential amino acids, neither of which can be produced by the body, which is what makes them essential in the first place. As T.S. Wiley and Bent Formby, authors of the book Lights Out point out, there is no such thing as an essential carbohydrate. So cutting carbohydrates to lose weight actually makes more sense.

What’s more, as these authors point out, fat-soluble vitamins such as A, K, D and E enter the body by hitching a ride with fatty acids in the gut. If you don’t absorb those fatty acids, you may have to do without those fat-soluble vitamins. The information supplied about Alli clearly states that users are urged to take a multivitamin as a part of the accompanying diet regimen. (Much has been made of the manufacturer’s forthrightness in presenting this warning.) What may not be so clear is that the multivitamin likely will have little effect in increasing the absorption of the fat-soluble vitamins if the body is busy not absorbing fats.

We’ve no doubt that Glaxo SmithKline has a winner with Alli. Since the entry cost to try it is around $50, the curiosity factor alone should account for blockbuster sales. But we won’t personally be tempted, given the pill’s health downside and potentially nasty side effects, which include incontinence and get worse from there. (Let’s just say there are worse ways you can be “glued” to your seat.)

We’ll try to cut back on the carbs and treat our bodies to some “burst” exercise. Anybody have a set of kettlebells they’d like to donate?

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If you’re looking to see a doctor, bring lunch. That’s one of the finding in a recent article on doctors and drug-company reps published in the latest AARP Bulletin (Ties that Bind, by Barbara Basler).

We found some interesting figures there, figures that otherwise seem to go unpublicized. For example, the pharmaceutical industry’s spending on direct marketing to doctors rose 275% from 1996 to 2004 and currently stands around $7 billion. That doesn’t count prescription samples given to doctors at an annual industry cost of $18 billion. And yes, buying lunch for doctors and their staffs are one of the main rites of entry. That makes doctors no different from, say, editors or purchasing agents.

But statistics from inside the industry itself show that if a rep gets to spend just one minute with a doctor, that doctor will write prescriptions for that rep’s drug at a 16 percent higher rate. Give the rep five minutes, and prescriptions increase 52 percent. Since primary-care physicians interact on average 28 times a week with drug sales reps, we’re looking at a huge increase in drug prescriptions that is up for grabs. And none of this is necessarily good for the patient.

In fact, it’s become such a problem that states such as Pennsylvania and South Carolina
have begun hiring their own reps to go out and counteract the pharmaceutical industry’s propaganda. It is worthwhile for them to do this simply to assure better patient outcomes, since newer drugs—the ones being pushed aggressively by the industry—are also the most expensive drugs, but not necessarily the best drugs for the patient. A beneficial side effect is a reduction in the cost of drug subsidies to patients.

Pennsylvania’s “unsales” program, while costing $3 million over three years, has so far saved state programs about $572,000 a year in prescriptions for stomach-acid suppression alone.

For while doctors naively proclaim themselves not for sale, industry figures such as those already quoted indicate they are readily influenced. Just last year a poll published in the New England Journal of Medicine showed 94 percent of doctors reporting “direct ties” to the dug industry.

Alarmed by such figures, some state legislatures have begun to fight back, trying to restrict the industry’s antics, but pharmaceutical companies are aggressive in defense of what they regard as their territory.

For example, New Hampshire passed a law in 2006 prohibiting drug companies from purchasing information about doctors’ prescribing habits. The industry got the law overturned in federal court a year later. Similar laws passed by Maine and Vermont are being challenged in court.

And last year, 17 states drafted legislation to regulate gifts to doctors and require their disclosure.

Not one of those bills became law.

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Hear how Big Pharma spent $40 million just in April, May and June of this year to influence Congress against single-payer plans and to ensure that pharmaceutical companies will come out on top in whatever healthcare plan results. This report will tell you why you don’t find discussion of certain issues during the healthcare debate.

Andrea Seabrook and Peter Overby explain that one of the most powerful players in health care is a group called the Pharmaceutical Research and Manufacturers of America, or PhRMA. It represents just 32 brand-name drug companies, but it has so much influence that when Congress passes a bill, PhRMA almost always gets its way. One big reason why: PhRMA and its members have spent millions of dollars lobbying Congress as lawmakers work to overhaul health care.

You can read their story here, or click here to listen to All Things Considered, July 23, 2009 while you browse our site.

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