FDA Goes After Natural HRT Alternatives Following Petition From Drug Giant

(NaturalNews) The FDA has issued a warning letter to seven pharmacies, instructing them to stop claiming that "bio-identical hormone replacement therapy" (BHRT) is different or safer than conventional hormone replacement therapy (HRT), and to stop selling prescriptions for an unapproved hormone.

The warning came in response to a petition from pharmaceutical giant Wyeth, in addition to concerns expressed by health-care companies and consumer groups.

"Many pharmacy compounders use the term bio-identical to imply that their drugs are natural," said Deborah M. Autor, director of the FDA Center for Drug Evaluation and Research's Office of Compliance. "There is no creditable scientific support for this claim."

The agency warned that the pharmacies, mostly online retailers, might face drug seizures or other sanctions if they do not correct their practices. The agency noted that with the exception of compound drugs containing estriol, which is not approved for U.S. use, the sale of BHRT drugs is not illegal.

A landmark 2002 study called the Women's Health Initiative found that HRT places post-menopausal women at increased risk of heart attacks, strokes and cancer. The FDA recommends that HRT be avoided as a treatment for menopausal symptoms. If it must be used, the lowest possible dose should be used for the shortest possible time.

Phil Pylant, owner of Village Compounding Pharmacy, which received one of the warning letters, expressed confusion as to why his pharmacy was singled out.

"I am one of 5,000 to 8,000 compounding pharmacies in the country that's doing the exact same thing - including CVS and Walgreens - and they all use the same drugs we use," Pylant said.

Pylant noted that he only fills prescriptions written by doctors, and that his pharmacy makes no health claims about HRT or BHRT.

"The claims are being made by other people," he said. "There are books being written by physicians and people who use this stuff, and they make claims. If I'm claiming anything, it's because I'm a messenger. Why kill the messenger?"


Walgreens Mistakenly Replaced Prenatal Vitamins with Chemotherapy Drugs, Lawsuit Alleges

(NaturalNews) A couple from St. Louis has filed a wrongful death and medical malpractice lawsuit against Walgreen Co. after Chanda Givens had her prescription for prenatal vitamins filled instead with a chemotherapy drug that caused her to miscarry.

Givens became pregnant in February and was given a prescription for prenatal vitamins under the brand name Materna in early March. According to the lawsuit, her prescription was instead filled with Matulane, a chemotherapy drug used to treat Hodgkin's disease. The drug functions by interfering with DNA development, cell growth and cell reproduction.

Soon after beginning the drug regimen, Givens began feeling nauseous and vomiting, but she assumed that she was just suffering from morning sickness. She miscarried in April. Because she hoped to become pregnant again, Givens continued taking the drug and phoned in for a refill when she ran out. At this point, the pharmacy discovered and informed her of the error.

The Givens' lawsuit accuses Walgreens of failing to properly supervise pharmacy staff, failing to check the prescription with Givens' doctor and failure to follow proper protocol.

Walgreens has, to date, refused to admit even that the prescription error occurred.

"We're just very sorry this miscarriage occurred," company spokesperson Carol Hively said.

"I think it has really taken an emotional toll on Chanda especially," said Dawn Mefford, the Givens' attorney. "She describes it as a nightmare."

Mefford also expressed concern over the Matulane's long-term effects on not only Givens' ability to have another child in the future, but also on her own health. An oncologist warned Givens that having taken the chemotherapy drug inappropriately may increase her risk of developing solid tumors, such as lung cancer, in the future.

"If true, this demonstrates part of what's wrong with our pharmaceutical-based medical system today," said consumer health advocate Mike Adams, founder of the non-profit Consumer Wellness Center (www.ConsumerWellness.org). "The very fact that toxic poisons like chemotherapy drugs are even considered medicine is nothing short of


Walk-in health clinics at pharmacy retailers operate with conflict of interest, charges AMA

(NaturalNews) The American Medical Association (AMA) has passed a resolution asking federal and state agencies to investigate whether walk-in health clinics at retail stores are operating with a conflict of interest that may put patients at risk.

Retail, or store-based, clinics are walk-in offices inside large retail outlets, including pharmacies, supermarkets and mega-stores such as Wal-Mart. Customers can see a nurse practitioner or physician assistant without an appointment, and pay a relatively low price for basic medical procedures such as injections. A full physician must supervise the clinic, but is not required to be on site.

But the medical professionals at these clinics are also authorized to write prescriptions, which is where the alleged conflict of interest comes into play. Because the clinics are not totally independent of the pharmacies that house them, the AMA detects a conflict-of-interest in the writing of prescriptions.

The AMA says that it first became concerned about comments by retail stores that having walk-in clinics boosts sales, helping to "drive additional store traffic."

"There are clear incentives for retailers to participate in the implementation and operation of store-based health clinics," said Peter Carmel, a member of the AMA board. "The nation's physicians want the AMA to ensure [that] these incentives do not compromise the basic obligation of store-based health clinics to provide patients with quality care."

The association has also expressed concern that the clinics disrupt the relationship between physician and patient, and complicate decisions about who is responsible for the patient's welfare.

The AMA also passed a resolution demanding that insurance companies apply the same rules to doctors and walk-in clinics; currently, insurers allow retail clinics to waive patients' co-payments but prohibit physicians from doing so. This creates a financial incentive for patients to visit clinics over doctors. But some newspaper editorials have accused the AMA of targeting the retail clinics less from concern for patients and more from fear of lost profits.

There were more than 200 store-based clinics in the United States in 2006, and the number is expected to reach 1,000