The Good the Bad and the Ugly – Medical Economics 101

“Primum non-nocere” (“first, do no harm”) is something doctors are taught but not phqarmaceutical companies… when studies showed synthetic hormones given to women in menopause INCREASED cancer risk, instead of apologizing, the drug companies tried a nasty strategy (see second article below)

Hormone Replacement Therapy Linked to Breast Cancer

by Sarah Webbfor DISCOVER Jan 2008

In 2003, breast cancer rates dropped rapidly, and several studies in 2007 cited decreased use of hormone replacement therapy (HRT) as the likely cause. The drop in hormone use dates back to July 2002, when the Women’s Health Initiative, a 15-year study tracking the health of more than 160,000 women, abruptly ended its long-term study of estrogen-progestin hormone replacement therapy because women taking the drugs faced an elevated risk of invasive breast cancer and heart disease.

As a result, doctors wrote 20 million fewer prescriptions for HRT in 2003. Then, when researchers measured the incidence of breast cancer between 2001 and 2004, they found it had dropped by almost 9 percent, according to a report in April in the New England Journal of Medicine. “That big a drop actually reduced the risk levels to those of about 20 years ago,” says Peter Ravdin of theM.D.AndersonCancerCenter in Houston, the first author on that study. During the 1990s, he adds, “the levels had been gradually increasing” by about 1 percent per year in theUnited States.

The research doesn’t conclusively show that the drop in HRT use lowered the incidence of breast cancer, Ravdin says. Another factor in the lower numbers could be that 3 percent fewer women had mammograms in 2003 than in 2000, reducing the likelihood of a cancer’s being detected. Yet, according to two studies published in August, breast cancer rates also dipped among smaller groups of women who had been screened regularly, making reduced detection an unlikely cause. Other data supporting a link to HRT: The rates fell only among women 50 and older, and estrogen-receptor-positive cancers””whose growth is stimulated by estrogen””decreased by nearly 15 percent.

The research doesn’t change the national guidelines for women considering hormone replacement therapy, says Ravdin, adding, “[HRT] confers a small amount of additional risk, which, as long as you’re going to be taking it for a short period, for most people, is an acceptable level.” Longer exposure, he says, would make the risk of developing cancer much higher.

The strategy was to sue the compounding pharmacies which dispense the natural hormones which are safe and effective. Rather than acknowledge error, they attack the people who had it right all along.I guess that a loss of 20 million prescriptions of HRT in 2003 hurt the companies more than the knowledge that their product was causing cancer…

Hormone Replacement Therapy News

“FDA Cracks Down on Drug Compounding”

August 29 , 2006

In searching for an alternative to hormone replacement therapy drugs like Wyeth’s Prempro””associated with an increased risk of cancer and other serious ailments””many women seek the help of compounding pharmacists who create bio-identical hormone combinations considered safer by many.

These compounded blends of hormones estrogen and progesterone are intended to provide relief from menopausal symptoms without the side effects posed by products such as Wyeth’s, which are made from horse urine.

For many years, the Food and Drug Administration has taken a “hands-off” approach to compounding pharmacists, who blend custom drugs using bulk ingredients. Compounding pharmacies offer a true benefit to many consumers, offering products that can feature lower doses for children or the absence of an ingredient that a patient is allergic to.

However, with increased pressure from Wyeth to control the compounding industry, which poses a clear threat to the drug company’s market share, the FDA has suddenly reversed its stance on compounding. Many argue this is another example of the FDA falling pawn to drug industry interests.

FDA crackdown

The FDA has pledged stricter oversight of the compounding industry. This month alone, the federal agency has issued three warning letters to compounding firms and has threatened to take additional action if their demands are not met.

In an effort to expand their jurisdiction to suit their agenda, the FDA now says that custom blended treatments are “new unapproved drugs.” This gives the agency power to regulate these drugs and the pharmacists who create them.

The compounding battle

Wyeth, through a citizen’s petition, is seeking tighter federal regulation of the compounding industry. They want to make it so that pharmacists are required to inform the public about the safety of custom-made hormone replacement therapies, which compete with the company’s products.

While Wyeth claims to seek such regulation in the name of public safety, it is blaringly clear to many that the company is belligerently guarding its bottom line.

In their defense, ten compounding pharmacists have argued in federal court that the FDA is amiss in treating compounded products as new unapproved drugs. The presidingUSdistrict judge has made comments indicating he will side with the compounders in his upcoming ruling.

This judgment is expected to have a ripple effect across the nation.

Compounded Hormone Replacement Therapy

One of the most popularly compounded drugs, called “Tri-est,” is a hormone replacement therapy combining three estrogens and progesterone, hormones which diminish with age. Some proclaim such drugs are safer than Wyeth products, which have been the target of several lawsuits claiming they increase the risk of cancer.

“There is extensive medical literature that says that you are better off taking something that is bio-identical to your body, as opposed to something that comes from an animal,” contends Stephen Bernardi, co-owner of Johnson Drug, a compounding pharmacy inMassachusetts.

The stakes are high for these compounders, who blend and dispense up to five percent of the nation’s prescription drugs.

For more information on Hormone Replacement Therapy contact us to confer with a lawyer.

More Hormone Replacement Therapy News…

Wyeth Sued Over Prempro Once Again

Studies Support Isoflavones for Hot Flushes

Rate of Breast Cancer Drops With Decline in HRT Use

New Study Differentiates Characteristics of Cancer in HRT Users

Is Bioidentical Hormone Therapy Safe?

Jury Rules Prempro Caused Breast Cancer In HRT Trial

Study: Hormone Replacement Therapy Raises Ovarian Cancer Risk


If you are currently taking hormone replacement therapy, the combination of estrogen and progestin, you are advised to contact your doctor IMMEDIATELY for hormone replacement therapy alternatives.

For more information on hormone replacement therapy alternatives and your legal rights, please contact a hormone replacement therapy lawyer.

Hormone Replacement Therapy Side Effects News- Top of Page


Des Moines Register…IFE02/603180301/1042Hormone replacement dispute ragesWyeth Pharmaceuticals has filed a petition with the FDA to restrict the plant-based compounds.


March 18, 2006There’s a new conflict brewing over hormone replacement therapy.

At the center of the debate: Bioidentical hormones ”” custom-made, plant-based prescriptions women use as alternatives to synthetic hormone therapies.

On one side is drug manufacturer Wyeth Pharmaceuticals ”” maker of hormone-replacement therapy drugs Prempro and Premarin ”” which has filed a petition with the Federal Drug Administration to restrict the plant-based compounds.

On the other side are the compounding pharmacies who make the drugs, the health care professionals who prescribe them and the patients inIowaand nationwide who take them.

They say Wyeth is trying to remove competition in the hormone replacement therapy market.

That leaves women like Jan Castagnoli concerned about losing access to the compounded hormones. Castagnoli began taking them three years ago, when the drug Prempro was unsuccessful in easing her menopausal symptoms. A friend told her about Dr. Jean Lorentzen, a physician in Boone who specializes in bioidentical hormones.

Since Castagnoli began taking the hormones prescribed by Lorentzen, she says her life has made a 180-degree turn.

“I have no desire to go back to synthetic drugs at all,” said Castagnoli, 54, who lives in Waukee.

In its petition, Wyeth claims some compounding pharmacies are misleading women by telling them they are safer and more effective hormone alternatives. The manufacturer also claims the hormones have been “illegally” mass-produced instead of tailored to individual needs.

The public has until April 4 to send comments to the FDA about the petition.

Advocates for bioidentical hormones, including health care professionals and patients inIowa, say Wyeth’s petition will limit women’s health-care options. Some local patients, who credit the individualized formulations with dramatically increasing the quality of their lives, say they would consider getting them outside theUnited Statesif they could no longer get them here.

Maggie McGill, 59, ofWindsorHeightshas been on “natural” hormone therapy for three months. She said she’d be willing to look for the drugs in another country, “but I’m optimistic that won’t happen.”

FDA evaluates petition
Resolution may not come for months, even years. After the comment period, the FDA evaluates the petition, a process that can take several weeks to more than a year, depending on how complex the issue is, said Laura Alvey, spokeswoman for the agency.

If a petitioner is dissatisfied with the results, the case can be taken to court, she said.

Candace Steele, director of global public relations at Wyeth Pharmaceuticals, said the company’s petition is aimed only at pharmacies mass-producing and marketing prescriptions, instead of making customized drugs for individual women.

If the FDA gets involved and these plant-based hormone drugs come under its jurisdiction, it could affect access, but no one knows how much.

Right now, the compounding of bioidentical hormones by pharmacies is regulated by the state.

Wyeth also disputes claims that bioidentical hormones are safer and more effective than other synthetic hormone replacement drugs already on the market, Steele said.

“We’re doing this because it could be an important health risk for women.”

Josh Wenderoff, a spokesman for the International Academy of Compounding Pharmacists, said women should be concerned about the potential impact of Wyeth’s petition. The group represents about 1,800 pharmacists, pharmacy technicians, physicians and patients nationwide, and inCanadaandAustralia.

Far-reaching consequences
“It would have far-reaching consequences for all patients who rely on bioidentical hormones,” Wenderoff said. “Wyeth is asking the FDA to impose far-reaching restrictions on the preparation of bioidentical hormones that would restrict patients’ access to them.”

One physician at theUniversityofIowais concerned that women are getting false information about the hormones.

“There simply isn’t any scientific evidence that compounded estrogen preparations are either safer or more effective than estrogen obtained through some commercially available preparation,” said Dr. Susan Johnson, director of the university’s menopause clinic.

“It’s likely that all estrogens (bioidentical and synthetic) have the same risk profile.”

Estrogen alone in any form can cause blood clots and increased risk of stroke. A combination of estrogen and progestin can also cause heart attack and breast cancer.

No research has been done to study the bioidentical versus synthetic hormone replacement therapy.

Wyeth’s critics say the company is seeking to recoup considerable financial losses stemming from declining sales of hormone-therapy replacement drugs Prempro and Premarin.

In 2002, Prempro, a combination of estrogen and progestin, was found in a large federal study to increase the risk of breast cancer, stroke, heart attack and blood clots. The study was halted three years early because of the findings.

Comparing the first six months of 2002 and 2003, Prempro prescriptions declined 66 percent and Premarin 33 percent, according to the Journal of the American Medical Association.

In the wake of the results from the Women’s Health Initiative study, millions of women nationwide questioned the safety of their hormone-replacement drugs. Some stopped hormone therapy completely; others turned to plant-based alternatives.

“My belief is it is about the bottom line” and Wyeth’s financial losses, said Carolyn Walker, a family nurse practitioner at Prevention & Healing ofIowainUrbandale.

Walker, who prescribes bioidentical hormones, says between 85 to 90 percent of her patients see her for hormone imbalance. Some come from out of state to get treatment.

She and pharmacist Sue Horton, owner of Central Iowa Compounding inUrbandale, are longtime proponents of bioidentical hormones. They estimate that within the last seven years, they’ve taught 3,500 to 4,000 individuals about these alternative therapies in adult education classes. Both are outraged with Wyeth’s petition.

Surge in interest
They say they’ve seen a surge in interest in bioidentical hormones as women demand individualized health care. That includes an in-depth history, lab tests to determine different hormone levels, and the customized, compounded hormones.

“I think a lot of women are taking charge of their own health care. The baby boomer women are demanding this,” Horton said.

About 65 percent of her clientele take bioidentical hormones.

Johnson said she has no qualms about women taking bioidentical hormones, which can be pricey because they are customized, as long as they are taking the appropriate dose. Because the prescriptions are made by individual pharmacists, she said, there are concerns with getting accurate doses.

“There isn’t the same kind of quality control that you would have in a plant where a drug is manufactured under FDA guidelines.”

Lorentzen has been prescribing bioidentical hormones since 1996. She said some of Wyeth’s concerns may be legitimate, including a failure to include information on the risks of taking estrogen. But Lorentzen said that as far as she knows,Iowacompounders provide that information to patients.

“I’m just very concerned about further restricting physicians’ rights to prescribe an individualized therapy for a patient for any reason,” she said. “I don’t think a third party should second-guess what a physician agrees to prescribe and what a patient agrees to take.

Prescribing compounded hormones gives her the ability to tweak the prescription dosages and the form of medication to fit each patient profile.

“I would not want to see women lose the right to have their hormone prescriptions individualized,” Lorentzen said. ” I think it’s a clinical tool that is really needed.”

Women tell their stories

Maggie McGill, 59
Windsor Heights

Maggie McGill began taking Premarin 20 years ago after a hysterectomy, then stopped completely after five years. McGill said her mother’s breast cancer diagnosis, coupled with research she had read about the increased risk of breast cancer among women taking Premarin, sealed her decision.

Thereafter, her journey to find a remedy to alleviate nagging hot flashes and increase her quality of life was tough.

“I tried diet, some herbal remedies, and these were all in combination with increased exercise,” she said. “Nothing worked.”

A nurse practitioner recommended bioidentical hormones, derived from plants. Working with Sue Horton at Central Iowa Compounding inUrbandale, McGill eventually was put on a regimen of three creams ”” progesterone, estrogen and testosterone. She remained on the drugs for four years.

Then results from a federal study in 2002 found that a combination of estrogen and progestin (a synthetic form of progesterone) increased the risk of breast cancer, heart attack and stroke, and she reconsidered.

“I think I panicked,” said McGill of her decision to go off the bioidentical hormones completely for two years. Again, life became miserable for the retired elementary school principal. About three months ago, she decided to get back on the bioidentical hormone regimen.

“Women in the generation before mine were more accepting of this (symptoms of menopause),” said McGill, who now pays about $90 monthly for her prescriptions with little insurance coverage.

“But I think that women in this day and age are aware that you don’t have to live like this as a woman.”

Barbara Rosberg, 52
Dallas County

After Barbara Rosberg found a lump in her breast, she said her doctor was “adamant” about taking her off the estrogen patch she’d been wearing since a hysterectomy.

With encouragement from her physician, Rosberg then visited Dr. Jean Lorentzen in Boone to discuss bioidentical hormones.

“I was in her office within a week, went through an extremely thorough bloodwork,” said Rosberg, who has been taking bioidentical hormones for about two years. “I can tell you I feel better at 52 years old than I did at 25. My mind is clearer, I have more energy and do a decent job keeping up with my grandkids and working.”

Before, Rosberg said severe night sweats and hot flashes woke her several times each night. She was lethargic during the day and had trouble concentrating.

The plant-based hormones seemed to cause headaches and water retention, Rosberg said, but stopped after a change in her prescriptions. She also said she exercises and eats healthfully.

Jan Castagnoli, 54

Five years ago, Jan Castagnoli says she no longer recognized the person she had become. She had started taking Prempro, a hormone replacement drug. After two years of being on the medication, life seemed to only be getting worse.

She took antidepressants, had trouble sleeping at night, was often sick, cried often, gained weight and suffered joint pain.

“I didn’t want to face people; I didn’t want to talk to anybody,” she said. “I didn’t feel good inside . . . so I projected a very unkind disposition. I couldn’t find any goodness.”

Nearly three years ago, a friend told her about Dr. Jean Lorentzen, a physician in Boone who specializes in bioidentical hormones. Now, Castagnoli’s regimen includes a host of hormones, as well as vitamins and supplements.

She said she has the energy to exercise regularly, do weightlifting and cardio workouts. She has lost 22 pounds, no longer has joint pain and is on a lower dose of antidepressant.

The cost of feeling well isn’t cheap. It costs Castagnoli about $300 a month, with insurance covering three prescriptions.

“I feel like I’m about 30,” she said. “I’m 150 percent better than I was before I started this.”

Bioidentical hormone replacement Q&A
Q. What is bioidentical hormone replacement therapy?
A. These are plant-based, or “natural,” alternatives to commercially available hormone replacement therapy. They are prescribed by a doctor or other health care professional, and are individualized formulations made at compounding pharmacies.

Q. How are bioidentical hormones different from other synthetic hormone drugs already on the market?
A. Health care professionals who prescribe and dispense bioidentical hormones say they have the same structure as the human body’s steroids, with some women experiencing fewer side effects than with traditional hormone therapy. Premarin, an estrogen drug from Wyeth Pharmeceuticals, is made from the urine of pregnant mares.

Q. What forms can bioidentical hormones be taken in?
A. They include oral, slow-release capsules, topical creams, capsules and lozenge-like medications that dissolve under the tongue or in the cheek.

Q. Does insurance cover the cost of bioidentical hormones?
A. It depends on your specific insurance plan. Some women say they pay from almost $100 to $300 a month for these hormones, with insurance covering little of the cost.

Meanwhile vitamin D comes to the rescue:Calcium with D3 offered 60% more protection from developing all cancers compared with calcium alone.Trouble is, (in the eyes ofBig Pharma),you can’t patent or profit from a natural vitamin D3!

Can Vitamin D Save Your Life?

New studies highlight the importance of the forgotten vitamin.

by Mariana GosnellDISCOVERJanuary 2008

For years doctors believed that vitamin D, sometimes called the “sunshine vitamin” because sunlight triggers the body to produce it, was important primarily in preventing rickets (a softening of the bones) in children. Once milk became fortified with vitamin D, rickets pretty much disappeared, and the problem of vitamin D deficiency seemed to have been solved. But according to Michael F. Holick, director of the Vitamin D, Skin, and Bone Research Laboratory atBostonUniversityMedicalCenter, who has spent 30 years studying the vitamin, “rickets can be considered the tip of the vitamin D-deficiency iceberg.”

Today a lack of the vitamin has been linked to a host of other maladies, including cancers of the colon, prostate, and breast; tuberculosis; schizophrenia; multiple sclerosis; hip fractures; and chronic pain. How can one vitamin play a role in so many diverse illnesses? The answer seems to lie in the fact that most tissues and cells in the human body (and not just those in the intestine and bone that help fix calcium) have receptors for vitamin D, suggesting that the vitamin is needed for overall optimal health. In addition, some cells carry enzymes for converting the circulating form of vitamin D to the active form, making it available in high concentrations to the tissues locally.

A recent laboratory experiment atBostonUniversityrevealed that by activating the circulating form of the vitamin, prostate cells could regulate their own growth and possibly prevent the rise of cancer. Directly or indirectly, Holick points out, “the active form of vitamin D controls up to 200 different genes,” including ones responsible for cell proliferation, differentiation, and death.

Theories about vitamin D’s cancer-prevention qualities have begun to be validated. In June, Joan M. Lappe, professor of nursing and medicine at Creighton University School of Medicine in Omaha, and her colleagues published the results of a 4-year, double-blind, randomized trial in which nearly 1,200 healthy postmenopausal women took calcium alone, calcium with 1,100 international units (IU) of vitamin D a day, or a placebo. The women who took calcium with vitamin D had a 60 percent lower risk of developing cancers of any type than the placebo group; the calcium-only group’s risk didn’t significantly change.

Currently, the median vitamin D intake of adult Americans is only about 230 IU a day; Lappe was prompted by the study’s findings to recommend the dose be increased to 1,500 to 2,000 IU. “It’s low risk, with maybe a high payoff,” she told a Canadian newspaper in June. Vitamin D comes from three sources: the sun’s ultraviolet (UVB) rays penetrating the skin, a few D-rich foods like fatty fish and some fortified foods, and supplements. The Canadian Paediatric Society has already recommended that pregnant or breast-feeding women get 2,000 IU of vitamin D daily.

Some clinicians have suggested that increased vitamin D intake might help ward off multiple sclerosis (MS), believed to be a progressive autoimmune disease. Last December, a team of researchers at the Harvard School of Public Health and other institutions published results from the first large-scale prospective study of the relationship between vitamin D levels and MS. After analyzing stored blood samples taken from 7 million military personnel and identifying those individuals who developed MS during a 12-year period, the team determined that the risk of getting MS was 62 percent lower for those whose blood concentration of vitamin D put them in the top quintile than for those in the bottom quintile. The study did not make clear, however, whether low vitamin D levels were a cause of MS or a marker of MS risk.

Vitamin D status may also affect vulnerability to infections. For example, African Americans need more sun exposure than Caucasians to make sufficient vitamin D; they also suffer from increased risk of tuberculosis. In a breakthrough study published in March, scientists from several institutions, including UCLA, discovered a possible link. On encountering the TB bacillus, receptors on immune-system scavenger cells known as macrophages stimulate the conversion of circulating vitamin D to its active form, which produces a peptide that destroys the bacillus. If circulating levels of D are low, macrophages can’t activate the vitamin D to initiate this response. A similar scenario could be operating with other infectious agents, maybe even the influenza virus

Rx for the FDA

Faced with controversies over drug warnings and recalls, the drug agency tries to revamp itself.

by Apoorva MandavilliDISCOVER MAGAZINEJANUARY 2008

For the Food and Drug Administration, the agency charged with ensuring drug safety, 2007 brought a slew of charges undermining its credibility. The most widely reported involved a study by Cleveland Clinic cardiologist Steven Nissen showing that the diabetes drug Avandia, FDA-approved in 1999, raised the risk of heart attack by 30 to 40 percent. The agency was also called to testify before Congress about its inaction regarding side effects of the antibiotic Ketek and a widely used class of anemia drugs. In addition, a study published in the Archives of Internal Medicine in September found that reports of serious side effects and deaths caused by FDA-approved medicines nearly tripled between 1998 and 2005, to about 90,000.

The accumulation of evidence apparently forced a reckoning in Congress and the White House. On September 27, President Bush signed into law an amendment(pdf) giving the agency unprecedented new powers to conduct and demand safety studies on approved drugs, police drug advertisements, and require companies to register data from their clinical trials in a publicly available database. The new law also boosts the agency’s budget, an increase approved in time to avert the layoffs of some 2,000 FDA employees, including many researchers.

“This has been a tough year,” acknowledges Janet Woodcock, deputy commissioner of the FDA and acting director of the agency’s Center for Drug Evaluation and Research. “[But] I do think this is an inflection point about the communication on drug safety. We have the opportunity to set up new systems.”

Bruce Psaty, a drug safety expert at theUniversityofWashington, says the agency had been too sluggish in responding to reported problems about Avandia. “On occasion, there will be problems [with drugs]. That’s normal,” says Psaty. “The FDA should not be judged to have made an error when a drug is found to be unsafe. But it’s an issue of timeliness. With Avandia, they did not seem to me to do well because they had this info for nearly a year.” The European Medicines Agency, in contrast, added a warning to the label in 2006.

Woodcock says the agency was evaluating the information when Nissen published his analysis in the New England Journal of Medicine last May. “We weren’t sitting still,” she says. “There are times when we are also going to be criticized for putting information out too early.”

Among the new law’s mandates is the creation of a clinical trial registry as well as an active surveillance system””rather than the current network of anecdotal reports from doctors and companies””that would spot problems with approved drugs faster. The law also calls for a new database that would scan hospital and insurance records for trends in side effects of certain drugs and include data from 25 million patients by 2010.

When the agency spots problems, it now has the authority to require companies to conduct follow-up studies on approved drugs and to make changes to the drug labels. The FDA also has greater powers to ensure that drug advertisements, including those that target consumers directly, present safety risks clearly””and not merely in quick, tacked-on lists, like those that now follow most television ads for drugs.

Many of the law’s provisions were outlined in an Institute of Medicine (IOM) report, The Future of Drug Safety, released in 2006. Fulfilling one of that report’s recommendations, in September the agency launched a drug-safety newsletter to update doctors. The FDA also announced in June that a new committee of ethicists, journalists, and marketing specialists would advise the agency on communicating drug risks to the public. Further, in an attempt to make the agency more credible and independent, the law aims to limit the number of scientists with financial conflicts of interest who can serve on FDA advisory panels.

The law does not, however, tackle one of the report’s principal recommendations: an overhaul of the user-fee system. Under this system, drug and device manufacturers pay the FDA user fees totaling more than $300 million””to be increased under the new law to at least $400 million””each year in exchange for speedier review of their applications. The IOM report recommended that the companies have no say in how that money is spent and that the funds be directed to improving drug safety and other programs at the FDA.

Critics note that by maintaining the status quo, the law keeps FDA officials’ salaries dependent on the very industry they regulate.

Merrill Goozner, director of the Integrity in Science project at the Center for Science in the Public Interest, inWashington,D.C., contends there should be a publicly funded drug safety arm that functions completely independently within the FDA and has veto power over new drug approvals. In the meantime, he says, “This is progress, there’s no doubt about it.”














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