Medical Journal Articles Promoting Risky prescription Drugs Were Actually Written by Drug Maker

According to the New York Times, Wyeth, a giant pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro. Wyeth admitted this in response to a Congressional inquiry investigating the company’s involvement in medical ghostwriting. At least one of these articles was published after a federal study found the drug raised the risk of breast cancer.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot.

Mr. Grassley’s staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed connection between Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

At the peak of hormone replacement therapy, in 2001, more than 126 million prescriptions for such drugs were written for women in the United States. Sales that year, primarily by Wyeth, were $3 billion. But after the federal findings of cancer risks, sales of the hormone drugs plummeted. The drugs, which contain cancer warnings on the label, are still approved to treat severe symptoms of menopause, but their use is advised at only the lowest possible doses.

The medical journal articles all involved reviews of clinical studies and other research. While such reviews are common in medical publishing, what Mr. Grassley contends happened with the Wyeth-commissioned articles is that those expert authors whose names appear on the articles became involved only after outlines or drafts of the articles were already written.

Two months before the negative findings of the federal study were released, a May 2002 memo to DesignWrite employees said that Michael S. Dey, who was president of Wyeth’s Women Healthcare Business unit, asked a committee to increase the number of positive journal articles related to another of its hormone replacement drugs, Premarin. “Mike would like us to publish at least 1 study per month,” the memo said.

No one deserves to be put at risk because of a dangerous or defective product or medication. If you or a loved one has been injured due to a defective product or medication, contact our experienced Michigan personal injury attorneys immediately for a free confidential legal consultation.

Long-Term Care…Know Your Options

An accident that results in a permanent disabling injury or the birth of a special needs child can force people to assume a lifelong care giving role. As the number of people with severe disabilities, debilitating chronic diseases and terminal illnesses grows, concern about their care has focused primarily on long-term care facilities, nursing homes, home health aides and hospices. Relatively little official attention has been paid to those who provide the overwhelming amount of services for people, both young and old, who are unable to care for themselves.

Various surveys have found that 20 million to 50 million family members in the United States provide care that was traditionally performed by nurses and social workers. Family caregivers supply about 80 percent of the care for ill or disabled relatives, and the need for their services will only rise as the population ages and modern medicine improves its ability to prolong lives.

Financial burdens can also complicate matters, especially when the family caregiver is forced to quit a job or cut back on outside work for pay. About a third of family caregivers lose most or all of their savings as a result of care giving, studies have shown. Family caregivers provide an estimated $237 billion in unpaid services a year.

Most family caregivers have no training for the physically and emotionally demanding tasks they undertake. And many are struggling themselves with age-related disabilities and chronic ailments. Others are members of the so-called “sandwich generation” who must juggle care giving with paying jobs and the needs of their own family.

It is important family members and caregivers know their options for help. The Michigan Department of Community Health (MDCH) has five programs that offer services to eligible persons in the home:

Home Health provides in-home skilled nursing services and associated personal care from qualified nurses and home health aides.
Home Help provides unskilled personal services such as meal preparation, assistance with eating, grooming, laundry, shopping and moving about the home.
PDS provides assistance in purchasing durable medical equipment and home modifications not otherwise covered by Medicaid.
MI Choice Program provides services such as personal care, transportation, private duty nursing, meal preparation and routine household care to allow an individual to remain in his or her home.
PACE provides comprehensive medical and long-term care services to program enrollees who are 55 years of age or older.

Additional services:

Hospices offer end-of-life care, usually provided in the home. In some cases care may also be provided in a residential facility such as a nursing home. Support is provided for the family through counseling, and for the individual with skilled nursing services, pain management and personal care.
Nursing homes are residences that provide housing, meals, rehabilitative care, skilled nursing services and protective supervision for post--acute and long-term care needs.

Other resources that may help:

MMAP is the Michigan Medicare and Medicaid Assistance Program that offers free counseling and education on Medicare and Medicaid benefits. You can contact MMAP toll-free at 1-800-803-7174.

MISeniors.net is Michigan’s Office of Services to the Aging website. The website lists support services for the elderly, housing options, information on nutrition and health care providers: www.MISeniors.net.

The Department of Human Services- DHS is a State of Michigan agency that provides information on independent living, senior services, adult community placement and medical services. To locate county DHS offices, call 517-373-2035, or select ‘County Offices’ from its website at www.michigan.gov/dhs.

Eligibility for long-term care services is determined by assessing your medical needs and functional abilities, and looking at financial criteria. MI Choice Program, PACE and nursing homes use Michigan’s Medicaid Nursing Facility Level of Care Determination to identify eligibility.

Financial eligibility is determined by your local Department of Human Services (DHS) office. If you are determined eligible for services, you will be informed of program options. If you are determined ineligible, you will be informed of other services in your community that may help you, and your right to appeal a determination of ineligibility. Contact your local Area Agency on Aging or community service organization for more information about all program options.

If you or a loved one has been injured to due to the negligence of a nursing home or long-term care facility, protect your rights. Contact one of our experienced Michigan personal injury attorneys immediately for a free confidential consultation today.

Small Melamine Amounts in Baby Formula Safe?

Public health groups, consumer advocates and members of Congress blasted the Food and Drug Administration on November 26, 2008 for failing to act after discovering trace amounts of the industrial chemical melamine in baby formula sold in the United States.

The FDA began testing infant formula in September and has so far analyzed 74 of the 87 products it has collected. None of the samples contained both melamine and a related compound, cyanuric acid. After reviewing the samples and animal studies, the agency decided that either melamine or cyanuric acid alone is safe formula at 1 part per million or less. Melamine can cause kidney and bladder stones and, in worst cases, kidney failure and death. If melamine and cyanuric acid combine, they can form round yellow crystals that can also damage kidneys and destroy renal function.

Melamine was found In Good Start Supreme Infant Formula with Iron made by Nestle, and cyanuric acid was detected in Enfamil Lipil with Iron infant formula powder made by Mead Johnson. A spokesman for Nestle did not respond to repeated calls and e-mails for comment. Gail Wood, a spokeswoman for Mead Johnson, said the company does not think that cyanuric acid poses a health threat to infants. “Cyanuric acid is approved by the FDA to sanitize processing equipment,” she said. “The risks of not sanitizing equipment are far greater than ultra trace amounts of residual cyanuric acid found in formula.

Agency scientists have maintained they could not set a safe level of melamine exposure for babies because they do not understand the effects of long-term exposure on a baby’s developing kidneys. The problem is exacerbated by the fact that infant formula is a baby’s sole source of food for many months. Premature infants absorb an especially large dose of the chemical, compared with full-term babies.

The FDA spokeswoman said no illnesses have been linked to melamine consumption in the United States. Chinese manufacturers deliberately added the chemical to watered-down formula to make it appear to contain higher levels of protein. More than 50,000 Asian infants were hospitalized, and at least four died.

Critics said the FDA’s reassurance about products carry less weight after the recent controversy over bisphenol-A, a chemical found in plastic baby bottles, dinnerware and the linings of food cans. The FDA dismissed a growing body of scientific evidence that has linked BPA to health problems even as worried consumers stopped buying BPA-containing products. Instead, the FDA relied on two industry-funded studies that concluded the BPA did not pose a health risk. Last month, the agency’s science advisory board said the agency should no longer maintain that BPA is safe.

Your child’s safety is one of our law firm’s main concerns. If you or a loved one is injured due to consumption of a dangerous product, contact our experienced Michigan layers immediately.

Strengthening United States Consumer Product Safety

In recent months, millions of toys have been recalled from stores across America because the products violate basic safety standards. Shopping for young children has become increasingly difficult, because it often is impossible to tell which toys are safe and which are not. Some of the recalled products were covered in lead paint, built with deadly magnets, or coated in a substance similar to the “date rape” drug.

These dangerous toys should never have reached retail store shelves. However, recent Congressional investigations have revealed that the federal Consumer Product Safety Commission (CPSC) is failing to protect the public from defective products.

When children are injured or killed by toxic toys or other products, their families encounter huge legal hurdles if they seek compensation for their losses. Over 70% of all toys now sold in this country were manufactured overseas, mostly in China. These products, although cheaper, receive minimal regulatory oversight. Additionally, foreign manufacturers have argued that they are not subject to jurisdiction in United States courts.

The U. S. Congress is working on legislation to secure the rights of American consumers against foreign manufacturing mistakes. Many lawmakers agree that foreign manufacturer should be legally accountable for non-compliance with U.S. safety standards. Both the House of Representatives and the Senate are boosting the CPSC’s annual budget, as well as increasing the standards of testing and certification before products can be sold.

Marketing defective products is not only dangerous, it is wrong. Injuries sustained by simple toys can be substantial, and in some cases fatal. We encourage the U.S. Congress to continue to put pressure on the CPSC, American importers, and foreign manufacturers to ensure the safety of our families.

At the Bernstein Law Firm, we have been protecting the legal rights of victims injured by defective products for over 40 years. If you or a loved one was injured by a defective product, we recommend that you contact an experienced product liability attorney immediately.

Health Insurance Companies Resort to New Ways of Denying Medical Benefits to Policyholders

Health insurance companies are finding new ways to avoid paying claims of policyholders most in need of medical treatment.

One of the latest insurance company tactics is rescinding policies after individuals file claims, and encouraging them to pursue benefits from Medicare, Medicaid, or other sources. Another serious problem is “dual-role insurers,” which are companies that not only pay benefits, but also decide who is entitled to receive them. While the federal Employee Retirement Income Security Act allows insurance companies to do this, many argue this dual role presents an inherent conflict of interest.

Some insurers are directing staff to scrutinize each claim, to find any hint of “misrepresentation” that would be an excuse to cancel a policy. For example, a company might try to revoke a policy, if an individual did not identify a previous health problem or medical procedure on his or her initial insurance application.

Increasing public attention has prompted state industry regulators to investigate and fine some health insurers for these unfair and unlawful practices. One recent investigation revealed that an insurer paid employee bonuses, based on the number of policies they cancelled.

In short, these companies increase profits by wrongfully denying claims of their sickest policyholders, and continuing coverage only to those who are healthy.

If you or a loved one has encountered similar problems with your insurance company, you need to protect your legal rights. Contact an experienced attorney who can help you receive the medical benefits and coverage that you deserve.

The Shrinking Supreme Court Docket

In 2006, the U.S. Supreme Court issued decisions on only 69 cases –the smallest number since before the Civil War. In the 1980’s, it was common for the Court to produce decisions on approximately 150 cases each year. In the early 1990’s, the number was still well over 100 cases — 117 decisions were produced in 1991.

During 2005 Senate confirmation hearings, Chief Justice John Roberts said he would work to increase docket size — but the exact opposite happened. Obtaining certiorari has always been a difficult task. Now it is not only harder for litigants trying to get final resolution of their disputes.
The number of requests for Supreme Court review has not declined. At present, the Court receives more than 8,000 petitions for review, but chooses fewer than 70 for briefing and oral argument. This causes problems in cases turning on issues on which the lower courts are sharply divided.

There are several possible reasons for the Supreme Court’s decreased caseload. First, the Justices may want to take fewer cases and work harder on them. It is true that the average number of pages per decision has increased to 100 pages. However, longer Court opinions are not necessarily better than shorter ones.

Second, the U.S. government is seeking Supreme Court review in fewer cases. Throughout the 1980’s, the U.S. Solicitor General’s office sought certiorari for about 50 cases a year. Now, it is requesting review of only about 10 cases a year. Because the Solicitor General’s office has substantial influence on the Court’s willingness to grant certiorari, this could contribute to the decline in its docket.

Third, the Justices themselves may be employing more strategic voting tactics. While it only requires four Justices to grant certiorari, any four may be reluctant to grant review, unless they are confident of receiving a fifth vote on the final decision.

Next, the use of the “cert pool” could be reducing the Court docket. Eight out of the nine Justices have agreed that one law clerk will read each case and prepare a memorandum summarizing reasons to either grant or deny certiorari. It has been suggested that law clerks feel pressured to advise against certiorari, because the Justices are more likely to accept this recommendation.

Lastly, a worthy explanation is that the lower federal courts and the Supreme Court have become ideologically similar. Majorities of both the Supreme Court and most federal Courts of Appeals have been appointed by Republican Presidents and tend to be conservative. Because these lower federal courts and the Supreme Court generally agree with each other, the latter may feel more comfortable accepting fewer cases.

Unfortunately, the Court never really explains its reasoning for declining a particular case — it usually provides a one-sentence order denying review.

However, as the Supreme Court keeps reducing its own workload, it continues to leave important legal questions unresolved.

Expanding Access for the Disabled

The Bush Administration is pushing for new rules concerning the disabled. The new legislation would give people with disabilities more access to many facilities that they are currently barred from. It would also update and revise the national standards for the Americans with Disabilities Act in an effort to support an aging population and the growing number of disabled war veterans. The new legislation would affect more than seven milllion businesses and all state and local government agencies. Things as basic as the location of light switches would have to be modified. However, this number is small in comparison to the 51 million Americans who live with some sort of disability. Of course, the U.S. Chamber of Commerce criticizes the proposal, hailing it as costly. While the value of these public benefits was originally expected to reach $23 billion, it is now estimated at $54 billion. On the other hand, advocates for the disabled say that it isn’t drastic enough. By 2010, it is estimated that 2% of the adult population will use wheelchairs, while 4% will us some sort of mobility device. The proposed rules would change the way that facilities are built in order to be more accessible to the disabled. For exmaple, courts would have to provide a lift or ramp to make sure that people in wheelchairs could make it to the witness stand. Light switches in a hotel room could not be more than 48 inches high. Also, at least half the holes on a miniature golf course must be accessible to people in wheelchairs. As the war in Iraq continues, a new generation of disabled men and women are thrust into American society. As many of our clients each year have disabilities, we applaud the Bush Administration for their efforts to increase the accessability to public facilities for those who need it. Our law firm is among the leaders in protecting and expanding the rights of the disabled. Attorney Richard Bernstein manages a department of litigators who focus on representing the disabled in complex, groundbreaking civil rights litigation. His work has won important victories in cases involvolving the City of Detroit, Northwest Airlines, and the University of Michigan. To name a few.