Pfizer defends Viagra and its safety record

As expected, Pfizer is denying that Viagra has any problems at all and that it needs to do anything beyond changing the label. The company took a similar line of argument about its other two drugs, Celebrex and Bextra, that had similar adverse side effects.

The company says that in a review of 103 Viagra clinical trials involving 13,000 patients, there were no reports of non-arteritic anterior ischemic optic neuropathy (NAION). Outside of clinical trials, Viagra has been used by more than 23 million men worldwide over the past seven years and reports of visual field loss due to NAION are extremely rare. Pfizer argues that, "There is no evidence showing that NAION occurred more frequently in men taking Viagra than men of similar age and health who did not take Viagra."

NAION is the most common acute optic nerve disease in adults over age 50 and it shares a number of common risk factors with erectile dysfunction: age over 50, high blood pressure, high cholesterol, diabetes. Most of the reported cases in which NAION has occurred in men taking Viagra have involved patients with underlying anatomic or vascular risk factors associated with the development of NAION.

Pfizer reports that it is in discussions with the Food and Drug Administration (FDA) to update the Viagra label to reflect these rare ocular occurrences. Pfizer's competitor, Eli Lilly (the maker of Cialis), has already updated its label. While the number of cases arising from Levitra is still small, the manufacturer has been warned in the past about misleading ads for Levitra.

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Viagra and blindness link investigated

CBS News is reporting that the Food & Drug Administration (FDA) is investigating if Viagra may have caused blindness in some men. Ophthalmologists at the University of Minnesota first reported the link between Viagra and blindness on March 31st this year. As drug companies often ignore research that may affect their sales, the company essentially did nothing, but the FDA is now taking action.

FDA also is not known for being meticulous about drug safety. Dangerous drugs stay on the market for years either because FDA has no way to monitor their safety after approval or it is just too afraid of big pharma, particularly of their lobbyists and politicians in Washington that almost always receive huge campaign donations from the drug firms. That is why dangerous drugs like Vioxx, Celebrex, Bextra, Adderall, Accutane, etc. end up harming Americans.

According to CBS News, there are as many as 50 Americans who are reporting vision loss due to Viagra. Pfizer, the maker of Viagra, is notorious for misleading advertisements and has often been warned by the FDA. Pfizer's two Cox-2 drugs, Celebrex and Bextra, stayed on the market despite several studies showed that they were too dangerous. Only when forced by the FDA did Pfizer recall Bextra and put a black box warning on Celebrex.

Pfizer had no statement on their website about Viagra's safety concerns.

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Photos of Carrie Underwood show that she needs more style

Carrie Underwood, the new American idol, is not your typical celebrity for one reason - a look at her photos and her performance on television makes her look like the girl next door. Not because she lacks style or she is not good looking, but because of her attitude. No wonder then that America loves.

As part of our research, we conducted a survey of her photos available in the public domain and all we can say is that her good looks, simple style, and beautiful voice would go a long way in helping her go ahead.

Like Ryan Starr, she is a gorgeous woman with a melodious voice. In today's world, that is important even though all we should look for in a singer is her/his voice. And Norah Jones has shown that if you have only a great voice you can be a winner. Not that Norah Jones is not attractive but she does not use her looks as a selling point the way Britney Spears leverages her looks.

So what do we like about Carrie Underwood?

She is truly American. I mean how much more American can it get than to be from Checotah, Oklahoma. Her family raises cattle but Carrie does not eat beef (may be that is the only un-American part in her) because she may be eating one of her pets.

Carrie Underwood's style has evolved

• February 22, Carrie wore a black, shoulders-off dress, somewhat short, but the longer (though sheer) portion clearly said that she is a sexy woman.
• March 1st, Carrie had what we call the "Oklahoma Look." It was quite a contrast from the more formal look of the previous week.
• Next week, she looked more trendier, more like a woman in her 20s would dress in Los Angeles or New York. An attractive, feminine blouse with dark pants. She combined the "Oklahoma Look" with the Los Angeles attitude, and though we did not think she looked her best, she pulled it off reasonably well.
• It was nice to see her on March 22nd. Nothing like a combination of black and white for the celebrity look.
• On March 29, she got her balance right. Jeans when combined with a jacket always looks good and the scarf brought out the artist side of Carrie Underwood.
• Next week, she came out in a gorgeous dress reminding of her very first outfit. Not what you see singers using much these days while singing, but she looked like a fairy.
• On April 12, again it seemed that she was alternating between more classic look and a casual style. Jeans with a top - nothing to talk about really.
• April 19th, as expected, she was in this gorgeous dress that would be perfect when she walks the red carpet soon. Starting to wonder if she should stick to formal dresses.
• On April 26th, she was back in her jeans but her top was much better this time. Just the right kind of outfit that one would wear to hang out in the mall.
• May 3rd, she was wearing this pretty, Indian-pattern long skirt that seem to be the rage all over. Zara has them and so does H&M.
• Next week, she looked almost like a business woman - not the best outfit for a singer but perfect when you are signing deals and negotiating contracts.
• On May 17, she was back in her casual style though her top was cute with those jewels in the front. We know that there are thongs with jewels too.
• Carrie Underwood must have known that she had a 50-50 chance to win when she showed up for the final. What a pretty dress she wore and great that she won.

So what is our advice to Carrie? Hey, get some professional help with your style. You have the basic sense of style, but you need a bit more pizzaz now that you are the American idol.

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Paris Hilton burger video ad sparks controversy

Paris Hilton thrives on controversy and in the world of advertising that is good. It is very likely that her latest commercial shot for Carl's Jr.'s Spicy BBQ Six-Dollar Burger may never be on the air, but it has served its purpose. The target audience of males 18-34 have already seen it some place other than their television.

So what is the big deal about the ad? Well, in the ad, Paris Hilton seductively washes a Bentley car, clad only in a skimpy bathing suit and stiletto heels, while a version of Cole Porter's "I Love Paris" plays in the background. Her moves throughout the commercial are any young man's fantasy. Even the way in which she bites the burger is meant to show something other than how delicious the burger is.

While the commercial has nothing really that would characterize it as inappropriate for television, but the United States, which is currently experiencing a wave of conservative values, the FCC may well ban it. Most such ads in Europe and many Asian countries are common fare on even daytime television.

More reasons for Crestor recall presented

The controversial cholesterol-lowering drug Crestor is more likely than other similar drugs (belonging to the family of drugs called statins) to cause muscle deterioration that can lead to kidney disease and failure, according to a study publisher in medical journal, Circulation.

A group of doctors that includes Alawi Alsheikh-Ali, Marietta Ambrose, Jeffrey Kuvin, and Richard Karas, show that their analysis supports concerns about the relative safety of rosuvastatin (sold as Crestor) at the range of doses used in common clinical practice in the general population. It may be recalled that there have been other studies that show the adverse side effects of Crestor and the consumer rights group Public Citizen has demand a recall of Crestor by the FDA - a request that was denied. (Related article: FDA criticizes misleading Crestor ads but refuses a recall)

The new research that challenges the position of FDA shows that Crestor-associated adverse events reported to the FDA raises concerns about the safety of this drug at the range of doses used in common clinical practice in the general population. Accordingly, the scientists recommend that healthcare providers consider other statins as first-line therapy, to initiate therapy in appropriate patients at lower doses, to consider combination LDL-C–lowering therapy(e.g., statin combined with ezetimibe or Zetia), and to vigilantly monitor for adverse events if rosuvastatin is used.

Not all doctors agree with the new research. Dr. Scott Grundy, at the Center for Human Nutrition and Departments of Clinical Nutrition and Internal Medicine, University of Texas Southwestern Medical Center at Dallas, writes in an accompanying editorial that "One must keep in mind that statins generally are safe and that they substantially reduce risk for coronary events in higher-risk patients. Nonetheless, statins, like all drugs, can have side effects, and care must be taken in their use in persons with predisposing conditions."

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Batalla en el Cielo causes stir at Cannes

A Mexican movie has caused a big stir at the Cannes film festival. Director Carlos Reygadas, who is widely regarded for Japon, has come up with another controversial film, Batalla en el Cielo (or Battle in Heaven), about Mexico that shows life in Mexico as it is.

Battle in Heaven follows Marcos (Marcos Hernández) in his daily life, a chauffeur to a general, who lives with the haunting story that he and his wife kidnapped a baby for ransom, but it went tragically wrong. Kidnapping kids for ransom is a crime that is very common in most Latin American countries right now and is literally forcing families with young children to live in horror. He confesses his guilt to the general's daughter Ana (Anapola Mushkadiz) in search of redemption. Ana prostitutes herself for pleasure and she pleases Marcos in the movie in some very graphic scenes that have become the talk of the town all over Mexico and Latin America.

However, Carlos Reygadas said that he did not include graphic scenes to shock anyone or to excite the viewer. "In the opening scene of my film, we see the face of a man, his body and then the girl who is looking towards the camera, crying. I intended to project an image that goes way beyond a simple...act. It is not something natural but rather as an observer, a sort of mystery... The characters make love and something happens at that moment. It is not a question of ‘we make love and then do something else,' it's all in how they make love and how they communicate at that moment."

Carlos Reygadas who has known the team of actors for a long time, added "What encourages me the most is the actors. I have known Marcos Hernández for 15 years and like his style, way of talking, acting...As for Anapola, she showed up for the casting and she appealed to me very much."

Strongly recommended by MYNIPPON.com

The picture below shows Salma Hayek along with Carlos Reygadas, Anapola Mushkadiz and Marcos Hernández. (Photo courtesy: Cannes Film Festival)

Latest lingerie designs from Japan

When it comes to lingerie design, Japanese lingerie stands apart. Of course, some European brands like La Perla are unique in their own way, and Victoria's Secret is also pushing the envelope, the really outrageous designs do come from Japan. Now mind you, the Japanese girls do wear some of these designs but others are developed just to create buzz. (Related article: Where to shop for Japanese lingerie?)

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New Zealand acts on Vioxx, Celebrex, Bextra, Cox2 drugs

The class of medicines known as COX-2 inhibitors will stay on the market in New Zealand, but with considerably stronger warnings for their use and the requirements for pharmaceutical companies to collect and report information on usage, according to MedSafe, the agency that monitors drug safety in the country. Recommendations made by the Medicines Adverse Reactions Committee (MARC), and accepted by the Ministry of Health, end months of uncertainty for patients. A review of the cardiovascular safety of the COX-2 inhibitors was begun in October 2004 after Vioxx (rofecoxib), one of six COX-2 inhibitors marketed in New Zealand, was withdrawn after international findings that its use was associated with an increased risk of heart attacks and strokes.

Pharmaceutical companies will also have to provide Medsafe with additional safety information as it becomes available. The Ministry is also seeking to extend, until further notice, the voluntary ban by pharmaceutical companies on promoting these products, some of which have been previously advertised on television. In February this year the Ministry warned against using COX-2 inhibitors in patients at high risk of heart attacks or strokes. High risk patients include those with a previous history of heart attack or stroke; those with diabetes, high blood pressure, high cholesterol levels or patients who smoke.

In early April a second COX-2 inhibitor, Bextra (valdecoxib), was voluntarily withdrawn by its manufacturer due to concerns about an increased risk of serious skin reactions. It is anticipated that a decision regarding the most appropriate strategy to manage the risk associated with Bextra (valdecoxib) will be made after the MARC meeting in June 2005.

"The advice which we are issuing today, based on the MARC recommendations, reflects our earlier view that an increased risk of heart attacks and strokes can occur with all COX-2 inhibitors," Ministry spokesman Dr Stewart Jessamine said. "However, we accept the very strong arguments from some patients and prescribers that for some people these medicines are the best treatment option. Therefore, we are allowing continued use but with restrictions to ensure that they are used mainly by those patients for whom they offer the most benefit and the least risk. This approach puts us in line with our European counterparts, the European Medicines Evaluation Agency, and pretty close to Australia," Dr Jessamin added.

Dr Jessamine, however, commented, "there are still a number of unanswered questions about the safety of the COX-2 inhibitors and Medsafe has asked companies to supply more information on the cardiovascular and gastrointestinal safety of these agents as it becomes available. Given this uncertainty, Medsafe and the University of Otago's Pharmacovigilance Centre will be keeping a close eye on these medicines for some time into the future. Knowing how many patients are taking these medicines is vital if we hope to make well informed decisions about risk to patients. "

"While the MARC has also recommended prohibiting Direct-to-Consumer advertising of COX-2 inhibitors, there has been a voluntary moratorium in place since Medsafe requested companies to stop professional and consumer advertising of these products in December 2004". Dr Jessamine said. " As this approach has been effective, Medsafe has requested that all pharmaceutical companies which market COX-2 inhibitors continue their voluntary moratorium on advertising to patients and prescribers, until further notice." New Zealand is the only other country, besides the United States, to allow direct to consumer advertising of prescription drugs. There have been calls for banning this form of advertising in the US too. (Related article: Impact of drug advertising and promotion on prescriptions)

"In summary, we believe we have a way forward which gives New Zealand patients and prescribers access to a class of medicines which we acknowledge are the best option for some people, while doing our best to ensure that they are selected only for those people and are used on the basis of informed decisions by both prescribers and consumers. We realise it's been a trying time for some, particularly arthritis patients. However, we trust the approach we have outlined today will reassure patients and prescribers that we have listened to what they have to say, and are acting in their best interests," Dr Jessamine said.

Which COX-2 inhibitors are available in New Zealand?

Celecoxib (brand name: Celebrex)

Etoricoxib (brand name: Arcoxia)

Meloxicam (brand name: Mobic)

Parecoxib (brand name: Dynastat)

Valdecoxib (brand name: Bextra) - voluntarily withdrawn April 2005

What alternative anti-inflammatory agents are available?

Alternative anti-inflammatory agents include:

Diclofenac (brand names: Apo-Diclofenac, Apo-Diclo SR, Voltaren)

Ibuprofen (brand names: I-Profen, Brufen, Brufen Retard)

Sulindac (brand names: Clinoril, Daclin)

Tiaprofenic acid (brand names: Surgam, Surgam SA)

Ketoprofen (brand names: Orudis, Oruvail)

Naproxen (brand names: Naxen, Naprosyn SR, Synflex)

Tenoxicam (brand names: Tilcotil)

Piroxicam (brand names: Piram D)

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EMEA

Natrecor recall averted for the time being

Natrecor has been mired in controversy and the first step for a possible recall was taken yesterday at the Cleveland Clinic. As is well known, the Cleveland Clinic is among the top hospitals in the world and its cardiology department is among the best. It also has the unique distinction of having Dr. Eric Topol on its team, who is not only the best in his field, he has also contributed enormously towards ensuring drug safety in America by actively arguing for research and testing. He was instrumental in forcing a recall of Vioxx when he was pointing out the risks of Vioxx at a time that Merck was aggressively promoting the drug.

While a majority of the doctors at Cleveland Clinic want to ban Natrecor, the ad hoc committee of the Pharmacy and Therapeutics Committee took a slightly different view regarding the use of Natrecor for patients with congestive heart failure. The committee consists of a multi-disciplinary team of experts from pharmacy, pharmacology, cardiovascular medicine, critical care medicine, and drug information.

The meeting resulted in 8 recommendations including:

1. Natrecor will remain on the formulary at The Cleveland Clinic.
2. Natrecor will be used for decompensated congestive heart failure patients only.
3. Natrecor will be used in the FDA approved dose.
4. It should be used in accordance with the current FDA package insert.
5. Natrecor will be prescribed by the cardiovascular or critical care physicians.
6. Consistent with current policy, inpatients should be treated on appropriate inpatient floors within the hospital with training and education of support staff, including nurses.
7. The committee is aware that there will be an independent review and assessment of data associated with Natrecor chaired by Eugene Braunwald, M.D. of Harvard Medical School, in the near future and are awaiting their findings with interest.
8. The Cleveland Clinic will continue to gather and analyze data on the use of Natrecor.

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Calls for Accutane recall after study shows depression link

Accutane, the only drug that works for adult acne treatment, has always been a controversial drug. While it does wonders for women who suffer from acne, it has serious side effects. In fact, Dr. David Graham, the FDA expert who has blasted the agency for leaving dangerous drugs on the market, includes Accutane with other dangerous drugs like Vioxx, Celebrex, and Bextra.

Now another study suggests that treatment with Accutane (isotretinoin) is associated with changes in brain functioning. In a study published by J. Douglas Bremner, M.D., Negar Fani, M.S., Ali Ashraf, M.D., John R. Votaw, Ph.D., Marijn E. Brummer, Ph.D., Thomas Cummins, M.D., Viola Vaccarino, M.D., Ph.D., Mark M. Goodman, Ph.D., Lai Reed, M.B.A., Sajid Siddiq, M.D., and Charles B. Nemeroff, M.D., Ph.D., it has been found that "Isotretinoin (technical name for Accutane) but not antibiotic treatment was associated with decreased brain metabolism in the orbitofrontal cortex (–21% change versus 2% change for antibiotic), a brain area known to mediate symptoms of depression. There were no differences in the severity of depressive symptoms between the isotretinoin and antibiotic treatment groups before or after treatment."

Although there have been reports suggesting a relationship between treatment with Accutane and the development of depression and suicide, this topic remains controversial. In order for isotretinoin to cause depression, it must have an effect on the brain; however, the effects of isotretinoin on brain functioning in acne patients had not been established. This study has successfully done that.

There are other controversies that plague Accutane. Public Citizen’s Health Research Group has been warning the FDA about the risks of birth defects and mental retardation for fetuses exposed to Accutane for over 20 years. The consumer rights group has been demanding a recall of Accutane for years now.

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Bextra class action lawsuits being filed

The pharmaceutical firms produce often drugs that are not always tested for all the side effects, then these drugs are aggressively marketed (US is only one of the two countries in the world that allow direct-to-consumer marketing of prescription drugs), and when victims ask for damages, Americans are accused by drugmakers and politicians of raising insurance premiums. But what everyone forgets that Americans are the losers in this game. “Americans pay higher prices, we are told, to ensure drug safety; so Americans must hold drug companies responsible for the promised drug safety,” asserts Joseph Gorman, Esq., an attorney practicing class action and mass tort litigation at Pellettieri, Rabstein & Altman.

“Through victim lawsuits the judicial process helps the agencies of our administrative branch of government enforce patient safety laws.” explains Arthur Penn, Esq., currently chairman of the Pellettieri, Rabstein & Altman class action and mass tort litigation department and formerly Director of the Division of Public Interest Advocacy for the New Jersey Department of the Public Advocate, Assistant Commissioner in the New Jersey Department of Public Advocate and Member of the New Jersey Supreme Court Committee on Civil Procedure. “When drug companies face the expense and publicity of widespread victim lawsuits, they learn to recalculate the cost-benefit analyses to include more extensive, responsible testing into the side effects of future drugs. You will limit defective drug lawsuits by reducing the number of defective drug victims, and that will only happen by preventing defective drugs from coming to and remaining on the market.”

The cox-2 inhibitors have been embroiled in controversy when in September of last year, Merck announced Vioxx recall but FDA had to force Pfizer to act on Bextra recall. Despite repeated calls for Celebrex recall from consumer rights groups, Pfizer has taken no action and on instructions from the FDA, the Celebrex merely carries a black box warning. (Related article: Black box warning on Celebrex)

The Food and Drug Administration also issued its strongest “black box” warnings for other non-steroidal, anti-inflammatory drugs (NSAID). These medications include over-the-counter products such as Advil, Aleve and Motrin. The warning will indicate that these drugs carry an increased risk of gastric bleeding and heart attacks. Patients, hopefully, will seriously consider these newly indicated side effects.

A recent meeting by the American Heart Association discussed the possible side effects of Bextra on the heart. It was claimed that Bextra patients undergoing heart surgery could be at increased risk. Another study by WellPoint Inc., linked the painkillers (Vioxx, Celebrex and Bextra) to increased cardiovascular risk, further reinforcing findings of other trials that already have sparked concern over the safety of the popular category of drugs. That study indicated that Vioxx increased patients' risk of heart attack and stroke by about 20 percent while Bextra increased the risk by 50 percent.

A study submitted by Pfizer to the FDA on November 5, 2004, which included over 1,500 patients treated after undergoing coronary artery bypass graft (CABG), showed increased risk in patients treated with Bextra, compared with those treated with a placebo, of cardiovascular events such as myocardial infarction (heart attack), cerebrovascular incident (stroke), deep vein thrombosis (blood clots in the leg), and pulmonary embolism (blood clot in the lung). However deep surgical infections and sternal wound complications following coronary artery bypass surgery are also a serious Bextra concern.

In a December 10, 2004 letter from the Vice President and Medical Director of Pfizer Canada to “health care professionals”, the maker of Bextra revised their product monograph (a drug’s clinical profile) to warn doctors that Bextra has led to an increased incidence of cardiovascular/thromboembolic events, deep surgical infections or sternal wound complications. Pfizer Canada, after discussions with Health Canada, the Canadian government agency responsible for drug safety, now officially advises Canadian doctors and pharmacists that Bextra is contraindicated (not recommended) for the treatment of patients for pain following coronary artery bypass surgery (CABG) due to surgical infections and sternal wound complications, as well as heart attacks, strokes and blood clot embolisms.

The FDA advised patients to seek their doctors' advice and emphasized that short-term use of over-the-counter strength versions of the NSAID medicines does not appear to pose the same risks. “When patients “self-dispense”, or purchase medicines over-the-counter, they may not sufficiently review or may not fully understand the side effects. They are in pain and totally focused on relief. If physicians are more aware of their patients’ use of over-the-counter NSAIDs, or other over-the-counter medicines, then physicians can explain the nature of and monitor these side effects. They can help patients make more informed choices. Just because a drug is offered in over-the-counter strength does not mean that it has no potentially harmful side effects,” says Connie Bowen, RN, a registered nurse working with Pellettieri, Rabstein & Altman.

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