FDA cracks down on custommade hormones
Thu, 10 Jan 2008 02:17:09 GMTBy RANDOLPH E. SCHMID, AP Science Writer
WASHINGTON - Government health officials on Wednesday began cracking down on Internet sales of custom-mixed hormones for menopausal women, a market born when doctors deemed prescription estrogen therapy too risky for many.
But the Food and Drug Administration says these alternative hormone mixes are no safer, and told seven makers to stop selling them.
The FDA said it sent warning letters to the companies saying their claims about the "bio-identical hormone replacement therapy" or BHRT products are not supported by medical evidence and are considered false and misleading.
"We want to assure that Americans receive accurate information about the risks and benefits of drug therapies," Dr. Janet Woodcock, FDA's chief medical officer, said in a statement.
The agency said it is concerned that the claims for safety and effectiveness mislead patients, as well as doctors and other health care professionals.
Compounded drugs are not reviewed by the FDA for safety and effectiveness, and FDA encourages patients to use FDA-approved drugs whenever possible, the agency said.
The warning letters say the pharmacy operations violate federal law by making false and misleading claims about their hormone therapy drugs.
Following a 2002 study that found replacement hormones made by drug companies raised the risk of heart attacks, breast cancer and strokes, many women turned to the estrogen, progesterone and testosterone products sold by compounding pharmacies.
Medical researchers concluded in 2003 that hormone replacement pills should be taken only as a brief treatment to help women weather the worst symptoms of menopause.
The drug company Wyeth later complained to the FDA about the Internet sales of compounded products.
Millions of young abusing cough medicine
Thu, 10 Jan 2008 05:19:45 GMTWASHINGTON - About 3.1 million people between the ages of 12-25 have used cough and cold medicine to get high, the government reported Wednesday.
The number of young people who abused over-the-counter cold medicines is comparable to use of LSD and much greater than that for methamphetamine among the age group, according to the federal Substance Abuse and Mental Health Services Administration.
The agency's 2006 survey on drug abuse and health found that more than 5 percent of teenagers and young adults had misused cough and cold medicines and indicated that these people also had experimented frequently with illicit drugs.
Nearly 82 percent also had used marijuana. Slightly less than half also used inhalants or hallucinogens, such as LSD or Ecstasy, the agency said.
The cough suppressant DXM is found in more than 140 cough and cold medications available without a prescription. When taken in large amounts, DXM can cause disorientation, blurred vision, slurred speech and vomiting.
Among all persons aged 12 to 25, the rate of past year misuse among whites was 2.1 percent, which was three times higher than the level for blacks, 0.6 percent, and also significantly higher than the level for Hispanics, 1.4 percent.
"While increasing attention has been paid to the public health risk of prescription drug abuse, we also need to be aware of the growing dangers of misuse of over-the-counter cough and cold medications, especially among young people," said Terry Cline, the agency's administrator.
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On the Net: http://www.samhsa.gov
Exreps say Amgen used patient records
Thu, 10 Jan 2008 06:23:54 GMTBy LINDA A. JOHNSON, AP Business Writer
TRENTON, N.J. - Two former sales representatives for Amgen Inc. are suing the biotech company, alleging it pushed its sales force to search doctor's confidential medical records for potential patients to boost sales of a drug used to treat psoriasis.
The two former representatives, who are seeking lost pay, punitive damages and other compensation totaling more than $15 million apiece, allege they objected to superiors and refused to go along with the scheme, which legal experts say violates federal patient privacy law.
In addition, the veteran sales reps were encouraged to get insurance companies to approve reimbursement for Enbrel for patients with mild psoriasis, their attorney, Lydia Cotz, said Wednesday.
Enbrel, an injected, genetically engineered drug, is only approved for use in patients with moderate to severe psoriasis; it has severe side effects in some patients, including occasionally fatal infections. The drug is also used to treat rheumatoid arthritis.
One of the sales representatives, Elena Ferrante of Montvale, N.J., was fired in August 2005, while the other, Mark Engelman of Laguna Niguel, Calif., resigned last year after Cotz said he received a negative performance review.
The lawsuits are being handled through national arbitration services, because Amgen requires in its employment contracts that disputes be settled that way, Cotz said. Ferrante's case was filed in October in New York and Engelman's was filed in mid-December, she said.
Amgen spokesman David Polk said in a statement that the company "does not comment on pending litigation or personnel matters. Our sales creed emphasizes that Amgen sales representatives follow compliance guidelines with absolute consistency."
Cotz said the New Jersey attorney general's office is investigating and has interviewed Ferrante.
Jeff Lamm, a spokesman for state Attorney General Anne Milgram, said the office never confirms or denies the existence of such investigations.
Milgram last fall convened a task force to investigate how the doctor-patient relationship is affected by the widespread practice of drug and medical device makers giving physicians gifts and fees for researching, consulting and speaking about their products.
Jim Cohen, a Fordham University law professor specializing in legal ethics and criminal law, and John Thomas, a health law professor at Quinnipiac University School of Law, said that accessing patient medical files violates the federal Health Insurance Portability and Accountability Act, known as HIPAA.
Cotz said the scheme started in 2005 or sooner, after new drugs competing with Enbrel came on the market. Enbrel, one of Amgen's top sellers, had sales of nearly $3 billion in 2006.
"Amgen stepped up their marketing practices to ... get all these people who were not indicated for Enbrel" to start taking the drug, she said. "Patients didn't even know what was going on."
Cotz said her clients were instructed to go into dermatologists' offices and get permission to go through files to identify patients with psoriasis based on the diagnostic coding system insurers use for reimbursement. The representatives were told to then call insurers covering patients with mild psoriasis to seek approval for reimbursement of Enbrel, which Cotz said costs $20,000 to $50,000 per year, depending on the severity of the sometimes-painful skin condition.
"They would get on, and they wouldn't identify themselves as Amgen representatives. They would say, 'I'm calling on behalf of Dr. so-and-so,'" Cotz said.
She said representatives also were told to write letters on behalf of doctors, seeking advance approval so doctors could write prescriptions for Enbrel. Doctors writing prescriptions would benefit from frequent patient visits to have the drug injected.
"Respondents unethically and in contradiction of the available scientific data, promoted the prescription of Enbrel for "mild" cases of psoriasis by reinterpreting "moderate" cases" as mild, the lawsuit states, in "a total disregard of the proper care of patient recipients of Enbrel."
Cotz said sales representatives from the northeast to Hawaii have confirmed the scheme's existence.
Thomas said the allegations, if true, implicate any physicians who went along with the scheme for authorizing "marketing of medication not designed to treat their patients."
Cohen noted that HIPAA contains very tough sanctions for disclosing someone's health information — up to 10 years in jail and a $250,000 fine if the information was transferred or used for commercial advantage.
A hearing has not yet been scheduled in the case, but could occur in February.
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On the Net:
Amgen: http://www.amgen.com
Report Quaids newborns put at risk
Thu, 10 Jan 2008 05:30:57 GMTLOS ANGELES - A hospital put three children, including Dennis Quaid's newborn twins, in danger by giving them overdoses of a blood thinner, California regulators said Wednesday.
The California Department of Public Health said the Cedars-Sinai Medical Center gave the pediatric patients 1,000 times the intended dosage of heparin on Nov. 18.
State regulators said the "violations caused, or were likely to cause, serious injury or death to the patients who received the wrong medication," and they faulted the hospital for its "deficient practices" around administrating the drug.
The 20-page report does not identify the patients, but the Quaid family's representatives previously confirmed the newborns' involvement.
All three children recovered, but two needed a drug that reverses the effects of heparin.
The regulators' report found that the hospital did not adequately educate staff about safe use of heparin, which it described as a "high alert, high risk" blood thinner, and that nurses sometimes failed to adequately read labels on vials of the drug.
Cedars-Sinai's chief medical officer, Michael Langberg, said in a statement that the state's review echoed the hospital's own findings about the error and that the facility had cooperated fully with the investigation.
"While this is a rare event, we are pleased that the shares our view that it is an important opportunity for the entire institution to explore any and all ways we can further improve medication safety," Langberg said.
The hospital has apologized to the patients' families and said it made changes to prevent a recurrence, including providing more training and requiring four pharmacy workers to verify a high-alert medication before putting it in a patient care unit.
The Quaid twins were at Cedars-Sinai for treatment of an infection. They were receiving intravenous medications, and the heparin was used to flush the catheters to prevent clotting.
Quaid and his wife, Kimberly, have sued Baxter Healthcare Corp., the Illinois-based makers of heparin, accusing the firm of negligence in packaging different doses of the product in similar vials with blue backgrounds.
A similar dosage error killed three premature infants at an Indianapolis hospital in 2006. Three others survived overdoses.
In February, Baxter Healthcare Corp. sent a letter warning health care workers to carefully read labels on the heparin packages to avoid a mix-up.
